As filed with the Securities and Exchange Commission on May 7, 2019

 

Registration No. 333-230168          

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

 

Amendment No. 2

to

FORM S-4

 

REGISTRATION STATEMENT

UNDER 

THE SECURITIES ACT OF 1933

OHR PHARMACEUTICAL, INC.

(Exact name of Registrant as specified in its charter)

Delaware 2834 46-5622433

(State or other jurisdiction of 

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification No.)

800 Third Avenue, 11th Floor 

New York, New York 10022 

(212) 682-8452 

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices) 

Jason S. Slakter 

Chief Executive Officer 

Ohr Pharmaceutical, Inc. 

800 Third Avenue, 11th Floor 

New York, New York 10022 

(212) 682-8452

(Name, address, including zip code, and telephone number, including area code, of agent for service) 

Copies of all correspondence to:

 

Aurora Cassirer, Esq.

Joseph Walsh, Esq.

Troutman Sanders LLP

875 Third Avenue

New York, New York 10022

(212) 704-6000

Dr. Dietrich Stephan

President and Chief Executive Officer

NeuBase Therapeutics, Inc.

213 Smithfield Street

Pittsburgh, Pennsylvania 15222
(646) 450-1790 

Jeffrey T. Hartlin, Esq.  
Samantha Eldredge, Esq.  
Paul Hastings LLP  
1117 S. California Avenue  
Palo Alto, California 94304  
(650) 320-1800

 

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after the effectiveness of this registration statement and the satisfaction or waiver of all other conditions under the merger agreement described herein. 

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box. ☐  

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐  

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. 

Large accelerated filer ☐  Accelerated filer ☐ 
Non-accelerated filer ☐  Smaller reporting company ☒
  Emerging growth company ☐ 

If emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐ 

If applicable, please an X in the box to designate the appropriate rule provision relied upon in conducting this transaction: 

Exchange Act Rule 13c-4(i) (Cross-Border Issuer Tender Offer)                   ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)         ☐

 

CALCULATION OF REGISTRATION FEE

Title of Each Class of
Securities to be Registered
  Amount to
be Registered(1)
    Proposed Maximum
Offering Price
per Share
    Proposed Maximum
Aggregate Offering
Price(2)
    Amount of
Registration Fee(3)
Common Stock, Par Value $0.0001  16,032,377     N/A     $   10,047,468      $  1,218(4)

 

(1)Relates to common stock, $0.0001 par value per share, of Ohr Pharmaceutical, Inc., a Delaware corporation (“Ohr”), issuable to holders of common stock, $0.00001 par value per share, and options to purchase common stock, of NeuBase Therapeutics, Inc., a Delaware corporation (“NeuBase”), in the proposed merger of Ohr Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Ohr, with and into NeuBase (the “merger”). The amount of Ohr common stock to be registered is based on the estimated number of shares of Ohr common stock that are expected to be issued pursuant to the merger, after taking into account an assumed investment of approximately $9.0 million in NeuBase which is expected to occur following the date hereof and prior to or concurrently with the consummation of the merger and an assumed exchange ratio of 1.019055643 shares of pre-reverse stock split Ohr common stock for each outstanding share of NeuBase common stock and for each option exercisable for shares of NeuBase common stock and without taking into account the reverse stock split of Ohr common stock immediately prior to the merger.
(2)Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(f) of the Securities Act of 1933, as amended, based upon the estimated book value of the NeuBase securities to be exchanged in the merger, as of immediately prior to the merger (which such calculation takes into effect an assumed investment of approximately $9.0 million in NeuBase which is expected to occur following the date hereof and prior to or concurrently with the consummation of the merger). NeuBase is a private company, and no market exists for its securities.
(3)This fee has been calculated pursuant to Section 6(b) of the Securities Act of 1933, as amended.
(4) Previously paid.

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 

 

 

The information in this preliminary joint proxy statement/prospectus is not complete and may be changed. Ohr Pharmaceutical, Inc. may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This joint proxy statement/prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer, solicitation or sale is not permitted.

 

Subject to completion, dated May 7, 2019

 

 

 

 

PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT 

 

Dear Stockholders of Ohr Pharmaceutical, Inc.:

 

Ohr Pharmaceutical, Inc., a Delaware corporation (“Ohr”), and NeuBase Therapeutics, Inc., a Delaware corporation (“NeuBase”), have entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) pursuant to which a wholly owned subsidiary of Ohr will merge with and into NeuBase, with NeuBase surviving as a wholly owned subsidiary of Ohr (the “merger”). The merger will result in a biopharmaceutical company focused on developing next generation of gene silencing therapies with its flexible and highly specific synthetic antisense oligonucleotides for rare genetic diseases.

 

At the effective time of the merger, each share of common stock of NeuBase, par value $0.00001 per share (“NeuBase common stock”), will be converted into the right to receive approximately 1.019055643 shares of common stock of Ohr, par value $0.0001 per shares (“Ohr common stock”), subject to adjustment to account for a reverse stock split of Ohr common stock to be implemented prior to the consummation of the merger as discussed in the accompanying joint proxy statement/prospectus. This exchange ratio is an estimate only, and the final exchange ratio will be determined pursuant to a formula described in more detail in the Merger Agreement and in the accompanying joint proxy statement/prospectus and as described below. Based on the estimated exchange ratio described above, the estimated number of shares of Ohr common stock that will be issued to the NeuBase stockholders at the effective time of the merger without giving effect to the reverse stock split of Ohr common stock is 12,694,971. Ohr will assume all outstanding and unexercised options to purchase shares of NeuBase common stock, and they will be converted into options to purchase shares of Ohr common stock. Ohr’s stockholders will continue to own and hold their existing shares of Ohr common stock, and certain of the unexercised options and all of the warrants to purchase shares of Ohr common stock will otherwise remain in effect pursuant to their terms. In connection with the merger, NeuBase has entered into financing agreements which will result in gross proceeds to NeuBase of $9.0 million (“the NeuBase Financings”) as described in the accompanying joint proxy statement/prospectus. As a result of the NeuBase Financings resulting in proceeds of $9.0 million, it is expected that immediately after the merger, and after giving effect to the NeuBase Financings, current stockholders, option holders, warrant holders and note holders of NeuBase will own, or hold rights to acquire, approximately 85% of the fully-diluted common stock of Ohr, and Ohr’s current stockholders, option holders and warrant holders will to own, or hold rights to acquire, approximately 15% of the fully-diluted common stock of Ohr.

 

Shares of Ohr common stock are currently listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “OHRP.” Prior to consummation of the merger, Ohr intends to file an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. After completion of the merger, Ohr will be renamed “NeuBase Therapeutics, Inc.” and expects to trade on Nasdaq under the symbol “NBSE.”

 

On May 6, 2019, the last trading day before the date of the accompanying joint proxy statement/prospectus, the closing sale price of Ohr common stock on Nasdaq was $2.76 per share.

 

 

 

 

Ohr is holding a special meeting of its stockholders (the “Ohr special meeting”) in order to obtain the stockholder approvals necessary to complete the merger. At the Ohr special meeting, which will be held at                              , Eastern Time, on                           , 2019 at the offices of Troutman Sanders LLP, located at 875 Third Avenue, New York, NY 10022, unless postponed or adjourned to a later date, Ohr will ask its stockholders to, among other things: (i) adopt the Merger Agreement thereby approving the merger and the issuance of the Ohr common stock, (ii) approve an amendment to Ohr’s certificate of incorporation effecting a reverse stock split of Ohr’s common stock, at a ratio of not less than one-for-two and not more than one-for-fifteen, (iii) approve an amended and restated certificate of incorporation, (iv) approve, on a non-binding basis, the compensation to be paid to Ohr’s named executive officers, and (v) approve the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan, each as described in the accompanying joint proxy statement/prospectus.

 

As described in the accompanying joint proxy statement/prospectus, each of the officers and directors of Ohr and NeuBase have entered into a support agreement with both Ohr and NeuBase. The support agreements place certain restrictions on the transfer of the shares of Ohr and NeuBase held by the respective signatories thereto and include covenants as to the voting of such shares in favor of adoption of the Merger Agreement and approval of the transactions contemplated thereby and against any actions that could adversely affect the consummation of the merger. In addition, pursuant to the conditions of the Merger Agreement, NeuBase will solicit the written consent of its stockholders in lieu of a meeting pursuant to Section 228 of the Delaware General Corporation Law for purposes of, among other things, adopting the Merger Agreement and approving the merger and all other transactions contemplated by the Merger Agreement.

 

After careful consideration, the Ohr board of directors has (i) determined that the transactions contemplated by the Merger Agreement, including the merger, are fair to, advisable and in the best interests of Ohr and its stockholders, (ii) approved and declared advisable the Merger Agreement and the transactions contemplated thereby, including the merger and the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that Ohr’s stockholders vote “FOR” the proposal to adopt the Merger Agreement and thereby approve the transactions contemplated thereby, including the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement.

 

 

 

 

More information about Ohr, NeuBase and the proposed transaction is contained in the accompanying joint proxy statement/prospectus. Ohr urges you to read the accompanying joint proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 37 OF THE ACCOMPANYING JOINT PROXY STATEMENT/ PROSPECTUS.

 

Ohr and NeuBase are excited about the opportunities the merger brings to both Ohr’s and NeuBase’s stockholders and thank you for your consideration and continued support.

 

  Yours sincerely,
     
Dr. Jason Slakter   Dr. Dietrich Stephan
Chief Executive Officer
Ohr Pharmaceutical, Inc.
  President, Chief Executive Officer and Director
NeuBase Therapeutics, Inc.

  

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved the merger described in the accompanying joint proxy statement/prospectus or the Ohr common stock to be issued in connection with the merger or determined if the accompanying joint proxy statement/prospectus is accurate or adequate. Any representation to the contrary is a criminal offense.

 

The accompanying joint proxy statement/prospectus is dated                   , 2019, and is first being mailed or otherwise delivered to Ohr’s stockholders on or about                     , 2019.  

 

 

 

 

 

 

800 THIRD AVENUE, NEW YORK, NEW YORK 10022

 

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD ON                , 2019 

 

To the Stockholders of Ohr Pharmaceutical, Inc.:

 

On behalf of the board of directors of Ohr Pharmaceutical, Inc., a Delaware corporation (“Ohr”), Ohr is pleased to deliver this joint proxy statement/prospectus for the proposed merger between Ohr and NeuBase Therapeutics, Inc., a Delaware corporation (“NeuBase”), pursuant to which Ohr Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Ohr (“Merger Sub”), will merge with and into NeuBase, with NeuBase surviving as a wholly owned subsidiary of Ohr (the “merger”). The special meeting of stockholders of Ohr (the “Ohr special meeting”) will be held on                            , 2019 at                             a.m., Eastern Time, at the offices of Troutman Sanders LLP, located at 875 Third Avenue, New York, New York 10022, for the following purposes:

 

1.To consider and vote upon a proposal to adopt the Agreement and Plan of Merger and Reorganization, dated as of January 2, 2019 (the “Merger Agreement”), by and among Ohr, Merger Sub, and NeuBase, a copy of which is attached as Annex A to this joint proxy statement/prospectus, and approve the transactions contemplated thereby, including the merger and the issuance of shares of Ohr’s common stock, par value $0.0001 per share (“Ohr common stock”), to NeuBase’s stockholders pursuant to the terms of the Merger Agreement;

 

2.To consider and vote upon a proposal to approve an amendment of Ohr’s Certificate of Incorporation, in the form attached as Annex B to this joint proxy statement/prospectus, to effect a reverse stock split prior to the effective time of the merger contemplated by the Merger Agreement at a ratio of not less than one-for-two and not more than one-for-fifteen, with the exact ratio to be determined by mutual agreement between the Ohr board of directors and the NeuBase board of directors and approved by the Ohr board of directors;

 

3.To approve an amendment and restatement of Ohr’s Certificate of Incorporation, in the form attached as Annex C to this joint proxy statement/prospectus, to be effective immediately prior to the effectiveness of the merger;

 

4.To approve, on a non-binding, advisory basis, the compensation that will be paid or may become payable to Ohr’s named executive officers in connection with completion of the merger;

 

5.To approve the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan;

 

6.To consider and vote upon an adjournment of the Ohr special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 and 3; and

 

7.To transact such other business as may properly come before the Ohr special meeting.

 

 

 

 

The Ohr board of directors has fixed                          , 2019, as the record date for the determination of Ohr’s stockholders entitled to notice of, and to vote at, the Ohr special meeting and any adjournment or postponement thereof. Only holders of record of shares of Ohr common stock at the close of business on the record date are entitled to notice of, and to vote at, the Ohr special meeting. At the close of business on the record date, Ohr had                   shares of Ohr common stock outstanding and entitled to vote. This joint proxy statement/prospectus is first being mailed to Ohr’s stockholders on or about                         , 2019.

 

Your vote is important. The affirmative vote of a majority of the outstanding shares of Ohr common stock entitled to vote is required for the approval of Proposal No. 1. The affirmative vote of the holders of a majority of the shares of Ohr common stock present in person or represented by proxy at the Ohr special meeting and entitled to vote is required for approval of Proposal Nos. 2, 3 and 6. The affirmative vote of the holders of a majority of the votes cast is required for approval of Proposal Nos. 4 and 5. Each of Proposal Nos. 1, 2 and 3 is conditioned upon the other. Therefore, the merger cannot be consummated without the approval of Proposal Nos. 1, 2 and 3.

 

Whether or not you plan to attend the Ohr special meeting in person, please submit your proxy promptly by telephone or via the internet in accordance with the instructions on the enclosed proxy card or complete, date, sign and promptly return the accompanying proxy card in the enclosed postage paid envelope to ensure that your shares will be represented and voted at the Ohr special meeting. If you date, sign and return your proxy card without indicating how you wish to vote, your proxy will be counted as a vote in favor of Proposal Nos. 1 through 6. You may revoke your proxy at any time before the polls close at the Ohr special meeting by sending a written notice to the Corporate Secretary of Ohr, by providing a duly executed proxy card bearing a later date than the proxy being revoked, by submitting a proxy on a later date by telephone or via the internet (only your last telephone or internet proxy will be counted) before 11:59 p.m., Eastern Time, on       , 2019 or by attending the Ohr special meeting and voting in person.

 

Ohr’s stockholders also will consider and act on any other matters as may properly come before the Ohr special meeting or any adjournment or postponement thereof, including any procedural matters incident to the conduct of the Ohr special meeting.

 

  By Order of the Board of Directors of Ohr
  Pharmaceutical, Inc.
   
  Dr. Jason Slakter
  President, Chief Executive Officer and Director

  

         , 2019
New York, New York

 

 

 

 

THE OHR BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE, FAIR AND IN THE BEST INTERESTS OF OHR AND ITS STOCKHOLDERS AND HAS UNANIMOUSLY APPROVED EACH SUCH PROPOSAL. THE OHR BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT OHR’S STOCKHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.  

 

 

 

 

REFERENCES TO ADDITIONAL INFORMATION

 

This joint proxy statement/prospectus incorporates important business and financial information about Ohr that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission (the “SEC”) website (www.sec.gov) or upon your written or oral request by contacting the Chief Financial Officer of Ohr Pharmaceutical, Inc. 800 Third Avenue, 11th Floor, New York, NY 10022, Tel: (212) 682-8452.

 

To ensure timely delivery of these documents, any request should be made no later than                           , 2019 to receive them before the Ohr special meeting.

 

For additional details about where you can find information about Ohr, please see the section entitled “Where You Can Find More Information” beginning on page 316 of this joint proxy statement/prospectus.

 

 

 

 

TABLE OF CONTENTS

 

    Page
     
QUESTIONS AND ANSWERS ABOUT THE OHR SPECIAL MEETING AND THE MERGER   1
SUMMARY   15
SELECTED HISTORICAL AND PRO FORMA COMBINED FINANCIAL DATA   28
MARKET PRICE AND DIVIDEND INFORMATION   36
RISK FACTORS   37
Risks Related to the Merger   37
Risks Related to the Ohr Reverse Stock Split   42
Risks Related to Ohr   43
Risks Relating to Ohr’s Financial Position and Need for Capital   43
Risks Related to Ohr’s Business and Industry   47
Risks Related to FDA, Comparable Foreign Regulatory Authority and Healthcare Regulations   54
Risks Related to Ohr’s Intellectual Property   57
Risks Related to Ohr Common Stock   62
Risks Related to NeuBase   67
Risks Related to NeuBase’s Intellectual Property   86
Risks Related to Government Regulation of NeuBase   96
Risks Related to the Combined Company   113
CAUTIONARY INFORMATION REGARDING FORWARD-LOOKING STATEMENTS   122
THE MERGER   125
Background of the Merger   125
Ohr’s Reasons for the Merger; Recommendations of the Ohr Special Committee and the Ohr Board of Directors   143
NeuBase’s Reasons for the Merger   147
Opinion of Ohr’s Financial Advisor   150
Interests of Ohr’s Directors and Executive Officers in the Merger   161
Ohr Named Executive Officer Golden Parachute Compensation   165
Interests of NeuBase’s Directors and Executive Officers in the Merger   167
Form of the Merger   168
Merger Consideration   168
Effective Time of the Merger   170
Regulatory Approvals   171
Material U.S. Federal Income Tax Consequences of the Merger   171
Anticipated Accounting Treatment   173
Nasdaq Listing   173
Appraisal Rights and Dissenters’ Rights   174
THE OHR SPECIAL MEETING   178
Date, Time and Place   178
Purpose of the Ohr special meeting   178
Recommendation of the Ohr Board of Directors   179
Record Date; Shares Outstanding and Entitled to Vote   179
How to Vote Your Shares   180
How to Change Your Vote   180
Quorum Requirement; Proxies; Counting Your Vote   181
Appraisal Rights and Dissenters’ Rights    182
Voting by Ohr’s Directors, Executive Officers and Certain Stockholders   182
Solicitation of Proxies   183
THE MERGER AGREEMENT   184
General   184
Merger Consideration   184
Treatment of NeuBase Stock Options   186
Treatment of NeuBase Warrant   187
NeuBase Convertible Notes   187
Directors and Executive Officers of the Combined Company Following the Merger   187
Conditions to the Completion of the Merger   188
Representations and Warranties   193
No Solicitation   194
Stockholders Meetings and Consents   196
Ohr Change in Recommendation   196
Covenants; Conduct of Business Pending the Merger   198
NeuBase Financings   202
Other Agreements   203
Termination   204
Termination Fee   206
Amendment   207
AGREEMENTS RELATED TO THE MERGER   207
Support Agreements   207
Lock-Up Agreements    208
NeuBAse Financings   208
OHR EXECUTIVE COMPENSATION   209
Summary Compensation Table   209
Employment Agreements   210
Outstanding Equity Awards at Fiscal Year-End   210
Equity compensation plans and other benefit plans   211

 

i

 

 

COMPENSATION OF OHR DIRECTORS   224
NEUBASE EXECUTIVE COMPENSATION   226
COMPENSATION OF NEUBASE DIRECTORS   229
MATTERS BEING SUBMITTED TO A VOTE OF OHR’S STOCKHOLDERS   230
Proposal No. 1: Adoption of the Merger Agreement and Approval of the Transactions Contemplated Thereby   230
Proposal No. 2: Approval of the Ohr Reverse Stock Split   231
Proposal No. 3: Approval of the Post-Merger Certificate of Incorporation   237
Proposal No. 4: Advisory Vote on Merger Related Compensation   241
Proposal No. 5 Approval of the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan   242
Proposal No. 6: Approval of Possible Adjournment of the Ohr Special Meeting   250
OHR’S BUSINESS   251
Overview   251
Corporate and Historical Information   251
Assets and Technologies   251
Competitive Factors   252
Patents and Other Proprietary Rights   253
Number of Persons Employed   254
Government Compliance   254
Legal Proceedings   255
Market Price and Dividend Information for Ohr Common Stock   256
NEUBASE’S BUSINESS   257
Company Overview   257
Business Strategy   258
Corporate Information   258
Industry Segment Background   258
NeuBase’s PATrOL™ Technology Platform   260
Product Pipeline   263
Intellectual Property   264
License Agreement with Carnegie Mellon University   265
Manufacturing   266
Sales and Marketing   266
Competition   266
Government Regulation   267
Employees   281
Facilities   282
Legal Proceedings    282
ohr’S Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Year Ended September 30, 2018 and the Three Months Ended December 31, 2018   282
General   282
First Fiscal Quarter of 2019   282
Fiscal Year 2018   284
Critical Accounting Estimates   285
Off-Balance Sheet Arrangements   287
NEUBASE’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS   287
Overview   288
Components of Results of Operations   289
Off-Balance Sheet Arrangements   291
Critical Accounting Policies and Significant Judgments and Estimates   291
DIRECTORS AND EXECUTIVE OFFICERS OF THE COMBINED COMPANY FOLLOWING THE MERGER   294
Directors and Executive Officers   294
Committees of the Board of Directors   296
RELATED PARTY TRANSACTIONS OF DIRECTORS AND EXECUTIVE OFFICERS OF OHR   297
RELATED PARTY TRANSACTIONS OF DIRECTORS AND EXECUTIVE OFFICERS OF NEUBASE   300
Affiliations with CEO and Principal Stockholder   300
Dr. Stephan Restricted Stock Purchase Agreement; Option Grant   300
Agreement with LifeX Labs LLC   300
Dr. Stephan Support Agreement   301
Policy for Approval of Related Person Transactions   301
Affiliation with Carnegie Mellon   301
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION   301
DESCRIPTION OF OHR’S CAPITAL STOCK   311
Common Stock   311
Transfer Agent and Registrar   311
Preferred Stock   311
PRINCIPAL STOCKHOLDERS OF OHR   313
PRINCIPAL STOCKHOLDERS OF NEUBASE   315
LEGAL MATTERS   316
EXPERTS   316
WHERE YOU CAN FIND MORE INFORMATION   316
OTHER MATTERS    318
Section 16(a) Beneficial Ownership Reporting Compliance   318
Stockholder Proposals   318
Communication with the Ohr Board of Directors   318
OHR PHARMACEUTICAL, INC. FINANCIAL STATEMENTS   F-A-1
NeuBase Therapeutics, Inc. Financial Statements   F-B-1
Annex A - Agreement and Plan of Merger and Reorganization   A-1
Annex B - Ohr Pharmaceutical, Inc. Certificate of Amendment regarding Reverse Stock Split   B-1
Annex C - NeuBase Therapeutics, Inc. Amended and Restated Certificate of Incorporation   C-1
Annex D - Opinion of Roth Capital Markets, LLC   D-1
Annex E - Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan   E-1
Annex F - Section 262 of the General Corporation Law of the State of Delaware Regarding Appraisal Rights   F-1
PART II  INFORMATION NOT REQUIRED IN JOINT PROXY STATEMENT/PROSPECTUS   II-1

 

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QUESTIONS AND ANSWERS ABOUT THE OHR SPECIAL MEETING AND THE MERGER

 

Except as specifically indicated, the following information and all other information contained in this joint proxy statement/prospectus does not give effect to the reverse stock split described in Proposal No. 2 but does give effect to the one-for-twenty reverse stock split of Ohr common stock effective on February 4, 2019. Unless otherwise noted, impacted amounts and share information of Ohr included in the financial statements and notes thereto, and elsewhere in this joint proxy statement/prospectus, have been retroactively adjusted for the February 4, 2019, reverse stock split, as if such reverse stock split occurred on the first day of the first period presented. Certain amounts in the Ohr financial statements, the notes thereto, and elsewhere in this joint proxy statement/prospectus, may be slightly different than previously reported due to rounding of fractional shares as a result of the February 4, 2019, reverse stock split.

 

The following section provides answers to frequently asked questions about the Ohr special meeting and the merger. This section, however, only provides summary information. These questions and answers may not address all issues that may be important to you as a stockholder. For a more complete response to these questions and for additional information, please refer to the cross-referenced pages below. You should carefully read this entire joint proxy statement/prospectus, including each of the annexes.

 

Q: What is the merger? 
   
A:

Ohr Pharmaceutical, Inc., a Delaware corporation (“Ohr”), and NeuBase Therapeutics, Inc., a Delaware corporation (“NeuBase”), have entered into an Agreement and Plan of Merger and Reorganization, dated as of January 2, 2019 (the “Merger Agreement”), which contains the terms and conditions of the proposed business combination of Ohr and NeuBase. Under the Merger Agreement, Ohr Acquisition Corp. (“Merger Sub”), a Delaware corporation and a wholly owned subsidiary of Ohr, will merge with and into NeuBase, with NeuBase surviving as a wholly owned subsidiary of Ohr (the “merger”).

 

1

 

At the effective time of the merger, each share of common stock of NeuBase, par value $0.00001 per share (“NeuBase common stock”), will be converted into the right to receive approximately 1.019055643 shares of common stock of Ohr, par value $0.0001 per share (“Ohr common stock”), subject to adjustment to account for a reverse stock split of Ohr common stock at a ratio of not less than one-for-two and not more than one-for-fifteen with the exact ratio to be determined by mutual agreement between the Ohr board of directors and the NeuBase board of directors and approved by the Ohr board of directors (the “Ohr Reverse Stock Split”) to be implemented prior to the consummation of the merger (the “Ohr Reverse Stock Split”) as discussed in this joint proxy statement/prospectus. This exchange ratio is an estimate only, and the final exchange ratio will be determined pursuant to a formula described in more detail in the Merger Agreement and in this joint proxy statement/prospectus. Based on the estimated exchange ratio described above, the estimated number of shares of Ohr common stock that will be issued to the NeuBase stockholders at the effective time of the merger without giving effect to the Ohr Reverse Stock Split is 12,694,971. Ohr will assume all outstanding and unexercised options to purchase shares of NeuBase common stock, and they will be converted into options to purchase shares of Ohr common stock. Ohr’s stockholders will continue to own and hold their existing shares of Ohr common stock, and certain of the options and all of the warrants to purchase shares of Ohr common stock will otherwise remain in effect pursuant to their terms. In connection with the merger, NeuBase has entered into financing agreements which will result in gross proceeds to NeuBase of $9.0 million (the “NeuBase Financings”). For a more complete discussion of the NeuBase Financings, please see section entitled “The Merger Agreement—NeuBase Financings” beginning on page 202 of this joint proxy statement/prospectus. As a result of the NeuBase Financings resulting in proceeds of $9.0 million, it is expected that immediately after the merger, and after giving effect to the NeuBase Financings, current stockholders, option holders, warrant holders and note holders of NeuBase will own, or hold rights to acquire, approximately 85% of the fully-diluted common stock of Ohr, and Ohr’s current stockholders, option holders and warrant holders will own, or hold rights to acquire, approximately 15% of the fully-diluted common stock of Ohr.

 

After the completion of the merger, Ohr will change its corporate name to “NeuBase Therapeutics, Inc.” as required by the Merger Agreement.

 

For a more complete description of the merger, please see the section of this joint proxy statement/prospectus entitled “The Merger Agreement” beginning on page 184.

   
Q: What will happen to Ohr if, for any reason, the merger with NeuBase does not close?  
   
A: Ohr has invested significant time and incurred, and expects to continue to incur, significant expenses related to the proposed merger with NeuBase. In the event the merger does not close, Ohr will have a limited ability to continue operations without obtaining additional financing. Although the Ohr board of directors may elect to, among other things, attempt to complete another strategic transaction if the merger with NeuBase does not close, the Ohr board of directors may instead divest all or a portion of Ohr’s business or take steps necessary to liquidate or dissolve Ohr’s business and assets if a viable alternative strategic transaction is not available.  If Ohr decides to dissolve and liquidate its assets, Ohr would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims. There can be no assurances as to the amount or timing of available cash left to distribute to Ohr’s stockholders, if anything, after paying the debts and other obligations of Ohr and setting aside funds for reserves.

 

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Q: Why is Ohr proposing to merge with NeuBase?  
   
A:

The Ohr board of directors considered a number of factors that supported its decision to approve the Merger Agreement and the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to the NeuBase stockholders. In the course of its deliberations, the Ohr board of directors also considered a variety of risks and other countervailing factors related to entering into the Merger Agreement.

 

For a more complete discussion of Ohr’s reasons for the merger, please see the section of this joint proxy statement/prospectus entitled “The Merger—Ohr’s Reasons for the Merger; Recommendations of the Ohr Special Committee and Board of Directors” beginning on page 143.

   
Q: Why am I receiving this joint proxy statement/prospectus?
   
A:

You are receiving this joint proxy statement/prospectus because you have been identified as a stockholder of Ohr as of the applicable record date,               , 2019. If you are a stockholder of Ohr, you are entitled to vote at Ohr’s special meeting of its stockholders (the “Ohr special meeting”) to be held on                  , 2019 at              a.m. Eastern Standard Time, at the offices of Troutman Sanders LLP, located at 875 Third Ave., New York, New York 10022. The Ohr special meeting was called for the purpose of adopting the Merger Agreement and approving the transactions contemplated thereby, including the merger and the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement. This document serves as:

 

●     a proxy statement of Ohr used to solicit proxies for the Ohr special meeting; and

 

●     a prospectus of Ohr used to offer shares of Ohr common stock in exchange for shares of NeuBase capital stock in the merger and issuable upon the exercise of NeuBase options and warrants.

   
Q: What is required to consummate the merger?  
   
A:

To consummate the merger, (1) Ohr’s stockholders must (a) adopt the Merger Agreement and approve the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement (Proposal No. 1), (b) approve an amendment of Ohr’s Certificate of Incorporation to effect the Ohr Reverse Stock Split, in the form attached as Annex B  to this joint proxy statement/prospectus (Proposal No. 2) and (c) approve an amendment and restatement of Ohr’s Certificate of Incorporation, in the form attached as Annex C to this joint proxy statement/prospectus (the “Post-Merger Certificate of Incorporation”), to be effective immediately prior to the effectiveness of the merger (Proposal No. 3) and (2) NeuBase’s stockholders must adopt the Merger Agreement and approve the merger and the other transactions contemplated in the Merger Agreement.

 

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The adoption of the Merger Agreement and approval of the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to the NeuBase stockholders pursuant to the Merger Agreement (Proposal No. 1) by Ohr’s stockholders requires the affirmative vote of a majority of the outstanding shares of Ohr common stock entitled to vote thereon. The approval of the Ohr Reverse Stock Split (Proposal No. 2) and the Post-Merger Certificate of Incorporation (Proposal No. 3) each require the affirmative vote of the holders of a majority of the shares of Ohr common stock present in person or represented by proxy at the Ohr special meeting and entitled to vote thereon. The approval of the Ohr Reverse Stock Split (Proposal No. 2) is required in order to continue the listing of Ohr common stock on the Nasdaq Capital Market (“Nasdaq”) following the merger. If the requisite stockholders of Ohr fail to approve either Proposal Nos. 1, 2 or 3, the merger will not be consummated.

 

The adoption of the Merger Agreement, the approval of the merger and all other transactions contemplated by the Merger Agreement by NeuBase’s stockholders requires the affirmative vote (or written consent) of the holders of a majority of the outstanding shares of NeuBase common stock entitled to vote thereon.

 

Certain of NeuBase’s stockholders who in the aggregate own approximately 76.12% of the outstanding shares of NeuBase capital stock (excluding options, warrants and notes convertible into common stock upon the closing of the merger), and certain of Ohr’s stockholders who in the aggregate own 8.9% of the outstanding shares of Ohr common stock, are parties to support agreements with both NeuBase and Ohr, whereby such stockholders have agreed, subject to the terms of their respective support agreements, to vote their shares in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement. In addition, pursuant to the conditions of the Merger Agreement, NeuBase will solicit the written consent of its stockholders in lieu of a meeting pursuant to Section 228 of the Delaware General Corporation Law for purposes of, among other things, adopting the Merger Agreement and approving the merger and, if required, the NeuBase Financings, and all other transactions contemplated by the Merger Agreement.

 

In addition to the requirement of obtaining the approvals of Ohr’s stockholders and NeuBase’s stockholders as described above and appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

 

For a more complete description of the closing conditions under the Merger Agreement, please see the section of this joint proxy statement/prospectus entitled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 188.

 

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Q: Are there any federal or state regulatory requirements that must be complied with or federal or state regulatory approvals or clearances that must be obtained in connection with the merger?  
   
A: Neither Ohr nor NeuBase is required to make any filings or to obtain any approvals or clearances from any antitrust regulatory authorities in the United States or other countries to consummate the merger. Ohr must comply with applicable federal and state securities laws and Nasdaq rules and regulations in connection with the issuance of shares of Ohr common stock pursuant to the terms of the Merger Agreement, including the filing with the SEC of this joint proxy statement/prospectus and the required stockholder approvals under Nasdaq rules. Prior to consummation of the merger, Ohr intends to file an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules and to effect the initial listing of Ohr common stock issuable in connection with the merger.  
   
Q:

What are the material U.S. federal income tax consequences of the merger to U.S. Holders of NeuBase shares?

   
A: The merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986 (the “Code”). In connection with the filing of the registration statement of which this joint proxy statement/prospectus is a part, Troutman Sanders LLP (“Troutman Sanders”), Ohr’s counsel, has delivered to Ohr, and Paul Hastings LLP (“Paul Hastings”), NeuBase’s counsel, has delivered to NeuBase, their respective opinions that, for United States federal income tax purposes, subject to the limitations, assumptions and qualifications described in the opinions and in the section entitled “Material U.S. Federal Income Tax Consequences of the Merger,” the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code.
   
 

Accordingly, if you are a U.S. holder (as defined in the section entitled “Material U.S. Federal Income Tax Consequences of the Merger”) of NeuBase common stock, you will not recognize any gain or loss for U.S. federal income tax purposes upon your exchange of shares of NeuBase common stock for shares of Ohr common stock in the merger, except with respect to cash received in lieu of fractional shares of Ohr common stock. Notwithstanding the foregoing, your tax treatment will depend on your specific situation and many variables not within Ohr’s or NeuBase’s control. If any of the representations and assumptions upon which the opinions are issued is incorrect, incomplete or inaccurate or is violated, the accuracy of the opinions may be affected and the tax consequences of the merger could differ from those described in this proxy statement/prospectus/information statement.

 

For further information, see the section entitled “Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 171.

 

The U.S. federal income tax consequences described above may not apply to all holders of NeuBase common stock. Your tax consequences will depend on your individual situation. Accordingly, we strongly urge you to consult your tax advisor for a full understanding of the particular tax consequences of the merger to you. 

   
Q: What are the material U.S. federal income tax consequences of the Ohr Reverse Stock Split to Ohr U.S. Holders?
   
 

An Ohr U.S. holder generally should not recognize gain or loss upon the Ohr Reverse Stock Split, except possibly to the extent an Ohr U.S. holder receives a whole share of Ohr common stock in lieu of a fractional share of Ohr common stock. Please review the information in the section entitled “Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” for a more complete description of the material U.S. federal income tax consequences of the Ohr Reverse Stock Split to Ohr U.S. holders.

 

The tax consequences to you of the Ohr Reverse Stock Split will depend on your particular facts and circumstances. Please consult your tax advisors as to the specific tax consequences to you. 

   
Q: What proposals are to be voted on at the Ohr special meeting, other than the merger proposal (Proposal No. 1); the Ohr Reverse Stock Split proposal (Proposal No. 2) and the Post-Merger Certificate of Incorporation (Proposal No. 3) required in connection with the merger?  
   
A:

At the Ohr special meeting, the holders of Ohr common stock will also be asked to consider the following proposals, along with any other business that may properly come before the Ohr special meeting or any adjournment or postponement thereof:

 

●     Proposal No. 4 to approve, on a non-binding, advisory basis, the compensation that will be paid or may become payable to Ohr’s named executive officers in connection with the completion of the merger.

 

●     Proposal No. 5 to approve the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan.

 

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●     Proposal No. 6 to approve an adjournment of the Ohr special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 and 3.

   
  The approval of Proposal Nos. 4, 5 and 6 are not conditions to the merger. The approval of advisory Proposal No. 4 is not binding on the Ohr board of directors.  All of such proposals, together with Proposal Nos. 1, 2 and 3, are referred to collectively in this joint proxy statement/prospectus as the “proposals”.
   
Q: What is the Ohr Reverse Stock Split and why is it necessary?  

 

A: Immediately prior to the effective time of the merger, the outstanding shares of Ohr common stock will be reclassified into a lesser number of shares to be determined by the Ohr board of directors and the NeuBase board of directors. The Ohr board of directors believes that the Ohr Reverse Stock Split may be desirable for a number of reasons, including, to maintain the listing of the combined company’s post-merger common stock on Nasdaq given the minimum share price requirement of Nasdaq, to help avoid a delisting of Ohr common stock from Nasdaq in the future, to bring the share price of the combined company to a level that is customary among successful companies listed on the major U.S. stock exchanges, to broaden the pool of potential investors into the combined company by meeting the requirements of certain institutional investors who have internal policies prohibiting them from purchasing stocks below certain minimum share price, and by meeting the requirements of certain financial advisors who have policies to discourage their clients from investing into such stocks, to potentially allow inclusion of the combined company’s common stock in certain biotech indices, and thereby allow investment in the combined company by certain index funds to facilitate future financings by Ohr. Ohr common stock is currently, and will be following the completion of the merger, listed on Nasdaq. According to applicable Nasdaq rules, in order for Ohr common stock to continue to be listed on Nasdaq, Ohr must satisfy certain requirements established by Nasdaq. The Ohr board of directors expects that the Ohr Reverse Stock Split will increase the market price of Ohr common stock so that Ohr is able to maintain compliance with the relevant Nasdaq listing requirements for the foreseeable future.  

 

Q: How does the Ohr board of directors recommend that Ohr’s stockholders vote?  
   
A:

After careful consideration, the Ohr board of directors unanimously recommends that Ohr’s stockholders vote:

 

●     “FOR” Proposal No. 1 to adopt the Merger Agreement and approve the transactions contemplated thereby, including the merger and the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement; 

 

●     “FOR” Proposal No. 2 to approve an amendment of Ohr’s Certificate of Incorporation to effect the Ohr Reverse Stock Split;  

 

●     “FOR” Proposal No. 3 to approve the Post-Merger Certificate of Incorporation; 

 

●     “FOR” Proposal No. 4 to approve, on a non-binding, advisory basis, the compensation that will be paid or may become payable to Ohr’s named executive officers in connection with the completion of the merger; 

 

●     “FOR” Proposal No. 5 to approve the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan; and  

 

●     “FOR” Proposal No. 6 to adjourn the special meeting, if necessary, if a quorum is present, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 and 3.

 

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Q: What is the quorum requirement?
   
A:

A quorum is necessary to hold a valid meeting. Under the bylaws of Ohr, a majority of the outstanding shares entitled to vote, present in person or represented by proxy, constitute a quorum at the Ohr special meeting. On the record date, there were                         shares of Ohr common stock outstanding and entitled to vote. Thus, at least                     shares must be present in person or represented by proxy at the Ohr special meeting in order to have a quorum.

 

Your shares will be counted towards the quorum only if you submit a valid proxy (or one is submitted on your behalf by your broker, bank or other nominee) or if you vote in person at the meeting. Abstentions and broker non-votes will be counted towards the quorum requirement.

   
Q: What vote is required to approve each of the proposals at the Ohr special meeting?
   
A: The following table summarizes the minimum vote needed to approve each proposal:

  

Proposal Proposal Description Voting Required for Approval
Proposal No. 1 Adoption of Merger Agreement and approval of transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders. Affirmative vote of a majority of the outstanding shares of Ohr common stock entitled to vote
Proposal No. 2 Approval to amend Ohr’s Certificate of Incorporation to effect the Ohr Reverse Stock Split Affirmative vote of the holders of a majority of the shares of Ohr common stock present in person or represented by proxy at the Ohr special meeting and entitled to vote
Proposal No. 3 Approval of the Post-Merger Certificate of Incorporation Affirmative vote of the holders of a majority of the shares of Ohr common stock present in person or represented by proxy at the Ohr special meeting and entitled to vote
Proposal No. 4 Approval, on a non-binding, advisory basis, of certain payments in connection with the completion of the merger Affirmative vote of the holders of a majority of the votes cast
Proposal No. 5 Approval of the Ohr Pharmaceutical, Inc. 2019 Stock Incentive Plan Affirmative vote of the holders of a majority of the votes cast

 

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Proposal No. 6 Adjournment of the Ohr special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 and 3 Affirmative vote of the holders of a majority of the shares of Ohr common stock present in person or represented by proxy at the Ohr special meeting and entitled to vote

 

The following table summarizes the effect of abstentions and broker non-votes, if any, on the outcome of the votes with respect to each of the proposals:

 

Proposal Effect of Abstentions and Broker Non-votes, if Any
Proposal No. 1 The same effect as a vote “AGAINST
Proposal No. 2 Abstentions, if any, will have the same effect as a vote “AGAINST.”  Brokers have discretionary authority to vote on Proposal No. 2
Proposal No. 3 Abstentions, if any, have same effect as a vote “AGAINST.”  Broker non-votes, if any, have no effect on the outcome of the vote, because those shares of Ohr common stock are not present in person or represented by proxy at the Ohr special meeting
Proposal No. 4 No effect on the outcome of the vote, because abstentions and broker non-votes, if any, will not be considered votes cast at the Ohr special meeting
Proposal No. 5 No effect on the outcome of the vote, because abstentions and broker non-votes, if any, will not be considered votes cast at the Ohr special meeting
Proposal No. 6 Abstentions, if any, have same effect as a vote “AGAINST.”  Broker non-votes, if any, have no effect on the outcome of the vote, because those shares of Ohr common stock are not present in person or represented by proxy at the Ohr special meeting

 

Votes will be counted by the inspector of election appointed for the Ohr special meeting, who will separately count “FOR” and “AGAINST” votes, abstentions and broker non-votes.

 

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Q: Who will be the directors of Ohr following the merger?

 

A:

Immediately following the effective time of the merger, the combined company’s board of directors will consist of five directors. Pursuant to the terms of the Merger Agreement, all such directors will be designated by NeuBase. It is anticipated that, following the closing of the merger, the combined company’s board of directors will consist of the following individuals:

 

Name Age Current Principal Affiliation
Dr. Dietrich Stephan 49 President, Chief Executive Officer and a Director of NeuBase
Dr. Dov A. Goldstein 51 Individual Investor
Dr. Diego Miralles 56 Chief Executive Officer of Vividion Therapeutics, Inc.
Dr. Franklyn G. Prendergast 74 Professor, Mayo Medical Clinic
Eric I. Richman 58 Interim Chief Executive Officer of LabConnect, Inc.

 

Q: Who will be the executive officers of Ohr immediately following the merger?
   
A: Immediately following the consummation of the merger, the executive management team of combined company’s is expected to be composed of the members of the NeuBase executive management team prior to the merger other than Sam Backenroth, Ohr’s current Chief Financial Officer who is expected to continue to serve as Chief Financial Officer of the combined company following the merger:

 

Name Title
Dr. Dietrich Stephan President, Chief Executive Officer and Director
Sam Backenroth Chief Financial Officer

 

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Q: What risks should Ohr’s stockholders consider in deciding whether to vote to adopt the Merger Agreement and thereby approve the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, and approve the Ohr Reverse Stock Split?  

 

A: Ohr’s stockholders should carefully read the section of this joint proxy statement/prospectus entitled “Risk Factors” beginning on page 37, which sets forth certain risks and uncertainties related to the merger and the Ohr Reverse Stock Split, risks and uncertainties to which the combined company’s business will be subject, risks and uncertainties to which Ohr, as an independent company, is subject and risks and uncertainties to which NeuBase, as an independent company, is subject.  

 

Q: When do you expect the merger to be consummated?  

 

A:

Ohr and NeuBase anticipate that the consummation of the merger will occur in the second quarter of calendar year 2019 as promptly as practicable after the Ohr special meeting and following satisfaction or waiver of all closing conditions under the Merger Agreement. However, the exact timing of the consummation of the merger is not yet known.

 

 

For a more complete description of the closing conditions under the Merger Agreement, please see the section of this joint proxy statement/prospectus entitled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 188.

 

Q: How will the Ohr Reverse Stock Split and the merger affect stock options and warrants to acquire Ohr common stock and Ohr’s stock option plans?  
   
A: As of the effective time of the Ohr Reverse Stock Split, Ohr will adjust and proportionately decrease the number of shares of Ohr common stock reserved for issuance upon exercise of, and adjust and proportionately increase the exercise price of, all options and warrants to acquire Ohr common stock. All stock options and warrants to acquire shares of Ohr common stock that are outstanding and unexercised immediately prior to the effective time of the merger and are not subject to cancellation per the Merger Agreement, will remain outstanding following the effective time of the merger. In addition, as of the effective time of the Ohr Reverse Stock Split, Ohr will adjust and proportionately decrease the total number of shares of Ohr common stock that may be the subject of future grants under Ohr’s stock option plans.  
   
Q: What do I need to do now?  
   
A: You are urged to read this joint proxy statement/prospectus carefully, including each of the annexes, and to consider how the merger affects you. If your shares are registered directly in your name, you may submit your proxy promptly by telephone or via the internet in accordance with the instructions on the enclosed proxy card or complete, date and sign the enclosed proxy card and mail it in the enclosed postage-paid envelope. Alternatively, you can deliver your completed proxy card in person or vote by completing a ballot in person at the Ohr special meeting.  

 

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Q: What happens if I do not return a proxy card or otherwise provide proxy instructions?

 

A:

The failure to return your proxy card or, in some cases, otherwise provide proxy instructions, will reduce the aggregate number of votes required to approve Proposal Nos. 4, 5 and 6 and will have the same effect as voting “AGAINST” Proposal Nos. 1, 2 and 3.

 

Your proxy will be voted according to your instructions. If you are an Ohr stockholder of record and do not vote via the internet or telephone or by returning a signed proxy card, your shares of Ohr common stock will not be voted unless you attend the Ohr special meeting and vote your shares. If you vote via the internet or telephone and do not specify contrary voting instructions, your shares of Ohr common stock will be voted in accordance with the recommendations of the Ohr board of directors. Similarly, if you sign and submit your proxy card or voting instruction card with no instructions, your shares of Ohr common stock will be voted in accordance with the recommendations of the Ohr board of directors.

 

If your shares are held in “street name” by your broker, Ohr does not believe your broker will have discretion to vote “FOR” or “AGAINST” Proposal Nos. 1, 3, 4, 5 or 6 if you do not provide your broker with instructions. However, Ohr believes your broker will have discretion to vote “FOR” or “AGAINST” Proposal No. 2. For additional discussion regarding broker non-votes and broker discretion to vote on the proposals, please see the answer to “Q: If my Ohr shares are held in ‘street name’ by my broker, will my broker vote my shares for me?” beginning on page 12.

 

 

You are encouraged to submit your voting instructions to your broker to ensure your shares of Ohr common stock are voted at the Ohr special meeting with respect to all of the proposals.

 

Q: May I vote in person?  
   
A:

If you are a stockholder of Ohr and your shares of Ohr common stock are registered directly in your name with Ohr’s transfer agent, you are considered, with respect to those shares, the stockholder of record, and the proxy materials and proxy card are being sent directly to you by Ohr. If you are an Ohr stockholder of record, you may attend the Ohr special meeting to be held on                            , 2019 and vote your shares in person, rather than signing and returning your proxy.

 

If your shares of Ohr common stock are held by a bank, broker or other nominee, you are considered the beneficial owner of shares held in “street name,” and the proxy materials are being forwarded to you together with a voting instruction card. As the beneficial owner, you are also invited to attend the Ohr special meeting. Since a beneficial owner is not the stockholder of record, you may not vote these shares in person at the Ohr special meeting unless you obtain a proxy from your broker issued in your name giving you the right to vote the shares at the Ohr special meeting.

 

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Q: If my Ohr shares are held in “street name” by my broker, will my broker vote my shares for me?  
   
A:

Brokers are not expected to have discretionary authority to vote for any of the proposals other than Proposal No. 2 (the Ohr Reverse Stock Split), so your broker will not be able to vote your shares of Ohr common stock without instructions from you for Proposal Nos. 1, 3, 4, 5 and 6. Ohr believes that each of Proposal Nos. 1, 3, 4, 5 and 6 are deemed to be “non-discretionary” matters under certain rules applicable to brokers, which does not allow brokers to vote on these matters if they are not provided with voting instructions by the beneficial owners of the shares. Therefore, if you fail to provide instructions to your broker as to how to vote your shares on each of Proposal Nos. 1, 3, 4, 5 and 6, your broker will not have the discretion to vote your shares on those proposals. To make sure that your vote is counted, you should instruct your broker to vote your shares, following the procedures provided by your broker.

 

Ohr believes that Proposal No. 2 is a routine matter for which brokers will have authority to vote your shares of Ohr common stock at the Ohr special meeting if you do not give instruction on how to vote your shares. Consequently, if a beneficial owner of shares held in “street name” does not give any direction, brokers will be permitted to vote such shares of Ohr common stock at the Ohr special meeting in relation to Proposal No. 2. Nevertheless, Ohr encourages you to submit your voting instructions to your broker to ensure your shares of Ohr common stock are voted at the Ohr special meeting.

   
Q: May I change my vote after I have submitted a proxy by telephone or via the internet or mailed my signed proxy card?  
   
A: Any Ohr stockholder of record voting by proxy, other than those Ohr stockholders who have executed a support agreement, has the right to revoke the proxy at any time before the polls close at the Ohr special meeting by sending a written notice stating that he, she or it would like to revoke his, her or its proxy to the Corporate Secretary of Ohr, by providing a duly executed proxy card bearing a later date than the proxy being revoked, by submitting a proxy on a later date by telephone or via the internet (only your last telephone or internet proxy will be counted), before 11:59 p.m., Eastern Time, on                , 2019, or by attending the Ohr special meeting and voting in person. Attendance alone at the Ohr special meeting will not revoke a proxy.  If a stockholder of Ohr has instructed a broker to vote its shares of Ohr common stock that are held in “street name,” such stockholder must follow directions received from its broker to change those instructions.  
   
Q: Who will count the vote?  
   
A: Votes will be counted by the inspector of elections appointed for the Ohr special meeting, who will separately count “FOR” and “AGAINST” votes and abstentions.  
   
Q: Should Ohr’s stockholders send in their stock certificates now?
   
A: No. After the merger is consummated, Ohr’s stockholders will receive written instructions, as applicable, from Ohr’s transfer agent for exchanging their certificates representing shares of Ohr common stock for new certificates giving effect to the Ohr Reverse Stock Split.

 

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Q: Am I entitled to appraisal rights?  
   
A: Ohr’s stockholders are not entitled to appraisal rights in connection with the merger or any of the proposals to be voted on at the Ohr special meeting.  
   
Q: Have NeuBase’s stockholders agreed to adopt the Merger Agreement?  

 

A:

Yes. Certain stockholders of NeuBase who currently own approximately 76.12% of the outstanding shares of NeuBase common stock are parties to support agreements with NeuBase and Ohr, whereby such stockholders have agreed, subject to the terms of the support agreements, to vote their shares in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated thereby. Pursuant to the conditions of the Merger Agreement, NeuBase will solicit the written consent of its stockholders in lieu of a meeting pursuant to Section 228 of the Delaware General Corporation Law for purposes of, among other things, adopting the Merger Agreement and approving the merger and, if required, the NeuBase Financings, and all other transactions contemplated by the Merger Agreement.

 

For a more complete discussion of the support agreements, please see the section of this joint proxy statement/prospectus entitled “Agreements Related to the Merger—Support Agreements” beginning on page 207.

 

Q: Have any of Ohr’s stockholders agreed to vote in favor of the issuance of the shares to NeuBase’s stockholders in the merger?  

 

A:

Yes. In connection with the execution of the Merger Agreement, holders of approximately 8.9% of Ohr’s Fully Diluted Common Stock have entered into support agreements with NeuBase and Ohr that provide, among other things, that such stockholders will adopt the Merger Agreement and approve the transactions contemplated thereby, including the merger and the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, and against any proposal made in opposition to, or in competition with, the transactions contemplated by the Merger Agreement.

 

For a more complete discussion of the support agreements, please see the section of this joint proxy statement/prospectus entitled “Agreements Related to the Merger—Support Agreements” beginning on page 207.

 

Q: Who is paying for this proxy solicitation?  
   
A: Ohr will bear the cost of soliciting proxies, including the printing, mailing and filing of this joint proxy statement/prospectus, the proxy card and any additional information furnished to Ohr’s stockholders. You will need to obtain your own internet access if you choose to access the proxy materials and/or vote over the internet. Ohr and NeuBase may use the services of their directors, officers and other employees to solicit proxies from Ohr’s stockholders without additional compensation. Arrangements will also be made with banks, brokers, nominees, custodians and fiduciaries who are record holders of Ohr common stock for the forwarding of solicitation materials to the beneficial owners of Ohr common stock. Ohr will reimburse these banks, brokers, nominees, custodians and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials.

 

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Q: Who can provide me with additional information and help answer my questions?  
   
A: If you would like additional copies, without charge, of this joint proxy statement/prospectus or if you have questions about the merger and the proposals being considered at the Ohr special meeting, including the procedures for voting your shares, you should contact Ohr’s Chief Financial Officer, by telephone at (212) 682-8452.

 

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SUMMARY

 

This summary highlights selected information from this joint proxy statement/prospectus and may not contain all of the information that is important to you. To better understand the merger and the proposals being considered at the Ohr special meeting, you should read this entire joint proxy statement/prospectus carefully, including the materials attached as annexes, as well as other documents referred to or incorporated by reference herein. See the section entitled “Where You Can Find More Information” beginning on page 316 of this joint proxy statement/prospectus. Page references are included in parentheses to direct you to a more detailed description of the topics presented in this summary.

 

The Companies

 

Ohr Pharmaceutical, Inc.

800 Third Avenue, 11th Floor

New York, New York, 10022

(212) 682-8452

 

Ohr Pharmaceutical, Inc., a Delaware corporation, is a pharmaceutical company that was focused on the development of novel therapeutics and delivery technologies for the treatment of ocular disease. On January 5, 2018, Ohr reported topline data from the MAKO study which did not meet its primary efficacy endpoint. The MAKO study evaluated the efficacy and safety of topically administered squalamine in combination with monthly Lucentis® injections for the treatment of wet-AMD. The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis. Subjects receiving squalamine combination therapy (n=119) achieved a mean gain of 8.33 letters from baseline versus 10.58 letters from baseline with Lucentis® monotherapy (n=118). There were no differences in the safety profile between the two treatment groups. Based on these results, Ohr has discontinued further development of Squalamine and pursued strategic alternatives.

 

Ohr Acquisition Corp.

800 Third Avenue, 11th Floor

New York, New York, 10022

(212) 682-8452

 

Ohr Acquisition Corp., a Delaware corporation, is a wholly owned subsidiary of Ohr that was recently incorporated solely for the purpose of the merger. It does not conduct any business and has no material assets.

 

NeuBase Therapeutics, Inc.

213 Smithfield Street

Pittsburgh, Pennsylvania 15222

(646) 450-1790 

 

NeuBase Therapeutics, Inc., a Delaware corporation, is a biotechnology company focused on developing the next generation of gene silencing therapies to treat rare genetic diseases caused by mutant proteins. The type of therapies that NeuBase is developing are termed antisense oligonucleotide therapies (“ASOs”), which are short, single strands of nucleic acids (traditionally thought of as single stranded RNA molecules) which will bind to defective RNA targets in cells and inhibit their ability to be translated into defective proteins that cause disease. NeuBase is a leader in the discovery and development of the class of ribonucleic acid-targeted ASO drugs called peptide nucleic acids (“PNAs”). Its proprietary gamma Peptide-nucleic acid AnTisense OLigonucleotide (“PATrOL™”) platform allows for rapid drug development, potentially transforming the treatment paradigm for a multitude of people affected by rare genetic diseases, with an initial focus on neurological disorders.

 

NeuBase was recently incorporated in August 2018, has not initiated any clinical trials for any of its product candidates or submitted an Investigational New Drug Application (“IND”), and does not currently possess the resources necessary to independently develop its product candidates. In addition, the PATrOL™ technology is licensed from a third party. NeuBase has a very limited operating history, is not currently profitable, does not expect to become profitable in the near future and may never become profitable. All of NeuBase’s therapeutic candidates are in the preclinical development stage, and NeuBase has not initiated clinical trials for any of its product candidates, nor have any products been approved for commercial sale and NeuBase has not generated any revenue. For the foreseeable future, NeuBase expects to continue to incur losses, which will increase significantly from historical levels as NeuBase expands its drug development activities, seeks regulatory approvals for its product candidates and begins to commercialize them if they are approved. Even if NeuBase succeeds in developing and commercializing one or more product candidates, NeuBase may never become profitable. Furthermore, the approach NeuBase is taking to discover and develop nucleic acid therapeutics is novel and may never lead to marketable products. NeuBase has concentrated its efforts and research and development activities on nucleic acid therapeutics and its synthetic chemistry drug development platform comprised of peptide nucleic acids with natural and engineered nucleotides. NeuBase’s future success depends on the successful development and manufacturing of such therapeutics and the effectiveness of its platform. Relatively few nucleic acid therapeutic product candidates have been tested in humans, and a number of clinical trials for such therapeutics conducted by other companies have not been successful. Few nucleic acid therapeutics have received regulatory approval. Despite these factors, NeuBase believes it is a leader in the discovery and development of PNAs as therapies because of its intellectual property which protects its composition of matter and initial fields of use in Huntington’s disease and Myotonic Dystrophy, because of the know-how in designing and manufacturing PNAs that comes with hiring a co-inventor of the technology to join NeuBase full time, and because of NeuBase’s broader team’s experience in therapeutic development.

 

The PATrOL™ platform enables rapid drug development because the peptide backbone is rigid, and once strung together to form a series of backbone subunits, forms a single pre-organized structure. At a more detailed level, each molecule or subunit of the peptide backbone has only a single chiral center – a point in the chemical structure where the conformation of the backbone could fluctuate – and this chiral center is locked into one conformation and thus pre-organized to form only a single stereoisomer. A stereoisomer is a term used in the ASO therapeutics field to mean a string of backbone subunits (usually sugars or modified sugars) with nuclear bases attached that are put together into a specific sequence that matches the target sequence, but because of the nature of the backbone subunits used, the drug assumes various conformations often with varying affinity for the target sequence. These stereoisomer often require a manufacturing step to purify the heterogeneous mixture of conformations into a more homogenous mixture or even a single conformation of the drug in order to obtain the hoped-for therapeutic effect. Our PNAs assume only a single conformation with any constellation of nuclear bases added to the backbone or any oligomer length.

 

In addition to the backbone conformational purity which allows more rapid drug development, NeuBase also has a kit of 16 proprietary bifacial nucleotides (traditional nucleotides only have a single binding face and thus are restricted to only binding single-stranded RNA targets) which can be used in any combination to access RNA secondary structures (RNA targets which are folded upon themselves) such as hairpins. This allows NeuBase to access regions of the target transcript which may be unique in secondary structure to allow enhanced selectivity for the target (mutant) RNA vs. the normal RNA. Enhanced selectivity for mutant RNAs vs. normal RNAs is critical as normal RNAs are likely required for effective functioning of the cell.

 

 

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In addition to the backbone and modified nuclear bases, the platform toolkit also includes linkers which, when added to both ends of the PNAs, allow concatenation at the target RNA to form longer and more tightly bound drugs.

 

The final component of the platform is a proprietary chemical moiety which is used to decorate the peptide backbone and allows the PNAs to penetrate both cell membranes and move across the blood-brain barrier when administered systemically.

 

This relatively simple toolkit of components forms the PATrOL™ platform and allows NeuBase to manufacture transcript-specific PNAs quickly for screening, with little to no downstream medicinal chemistry for lead optimization necessary. 

 

The Combined Company

 

In connection with the merger, NeuBase has entered into financing agreements which will result in gross proceeds to NeuBase of $9.0 million consisting of (i) the NeuBase Equity Financing and (ii) the NeuBase Debt Financing. The initial exchange ratio in the Merger Agreement was based on Ohr having minimum cash of $1.0 million at the closing of the merger and NeuBase receiving minimum proceeds of $4.0 million in the NeuBase Financings, and if such amounts were achieved, the current stockholders, option holders, warrant holders and note holders of NeuBase were expected to own, or hold rights to acquire, the Original NeuBase Allocation Percentage (80%) of the Fully-Diluted Common Stock of Ohr, and Ohr’s current stockholders, option holders and warrant holders were expected to own, or hold rights to acquire, the Original Ohr Allocation Percentage (20%) of the Fully-Diluted Common Stock of Ohr. The Merger Agreement provides that the Original NeuBase Allocation Percentage will be increased by 0.1% for every $100,000 that the proceeds from the NeuBase Financings exceed $4.0 million, and the Original Ohr Allocation Percentage will be decreased by 0.1% for every $100,000 that the proceeds from the NeuBase Financings exceed $4.0 million. As a result of the NeuBase Financings resulting in proceeds of $9.0 million, it is expected that immediately after the merger, and after giving effect to the NeuBase Financings, current stockholders, option holders, warrant holders and note holders of NeuBase will own, or hold rights to acquire, approximately 85% of the Fully-Diluted Common Stock of Ohr, and Ohr’s current stockholders, option holders and warrant holders will own, or hold rights to acquire, approximately 15% of the Fully-Diluted Common Stock of Ohr.

 

The principal executive offices of the combined company are expected to be located in Pittsburgh, Pennsylvania.

 

Summary of the Merger

 

If the merger is completed, Merger Sub will merge with and into NeuBase, with NeuBase surviving as a wholly owned subsidiary of Ohr.

 

At the effective time of the merger, each share of NeuBase common stock will be converted into the right to receive approximately 1.019055643 shares of Ohr common stock, subject to adjustment to account for the Ohr Reverse Stock Split to be implemented prior to the consummation of the merger as discussed in this joint proxy statement/prospectus. This exchange ratio is an estimate only, and the final exchange ratio will be determined pursuant to a formula described in more detail in the Merger Agreement and in this joint proxy statement/prospectus. Based on the estimated exchange ratio described above, the estimated number of shares of Ohr common stock that will be issued to the NeuBase stockholders at the effective time of the merger without giving effect to the Ohr Reverse Stock Split is 12,694,971. Ohr will assume all outstanding and unexercised options to purchase shares of NeuBase common stock, and they will be converted into options to purchase shares of Ohr common stock. Ohr’s stockholders will continue to own and hold their existing shares of Ohr common stock, and certain of the options and all of the warrants to purchase shares of Ohr common stock will otherwise remain in effect pursuant to their terms. As a result of the NeuBase Financings resulting in proceeds of $9.0 million, it is expected that immediately after the merger, and after giving effect to the NeuBase Financings, current stockholders, option holders, warrant holders and note holders of NeuBase will own, or hold rights to acquire, approximately 85% of the Fully-Diluted Common Stock of Ohr, with Ohr’s current stockholders, option holders and warrant holders will own, or hold rights to acquire, approximately 15% of the Fully-Diluted Common Stock of Ohr.

 

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The closing of the merger will occur no later than three business days after satisfaction or waiver of the conditions to the merger set forth in the Merger Agreement, or at another time as Ohr and NeuBase may mutually agree. Ohr and NeuBase anticipate that the consummation of the merger will occur promptly after the Ohr special meeting. However, because the merger is subject to a number of conditions, neither Ohr nor NeuBase can predict exactly when the closing will occur or if it will occur at all.

 

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Opinion of Ohr’s Financial Advisor (see page 150)

 

The Ohr board of directors and the Ohr special committee retained Roth Capital Partners LLC (“Roth”) to provide them with sale advisory services and an opinion as to whether the merger and the merger consideration are fair to Ohr’s stockholders from a financial point of view. The Ohr board of directors and the Ohr special committee selected Roth to act as their financial advisor based on Roth’s qualifications, expertise and reputation. At the meeting of the Ohr board of directors on January 2, 2019, Roth rendered its oral opinion, subsequently confirmed in writing, that as of January 2, 2019, based upon and subject to the various considerations set forth in the opinion, the merger and the merger consideration are fair to Ohr’s stockholders from a financial point of view.

 

The full text of the written opinion of Roth, dated as of January 2, 2019, is attached hereto as Annex D and is incorporated into this joint proxy statement/prospectus by reference.

 

Overview of the Merger Agreement

 

Merger Consideration (see page 168)

 

At the effective time of the merger:

 

each share of NeuBase capital stock issued and outstanding immediately prior to, and contingent upon the occurrence of, the effective time of the merger, including shares of NeuBase capital stock issued in, or issued upon conversion, exercise or exchange of securities issued in the NeuBase Financings, will be converted into and represent the right to receive such number of shares of validly issued, fully paid and nonassessable shares of Ohr common stock equal to the exchange ratio, and cash in lieu of any fractional shares of Ohr common stock to be issued or paid in consideration therefor; and

 

each option to purchase NeuBase common stock (each, a “NeuBase Option”) that is outstanding and unexercised as of immediately prior to the effective time of the merger will be assumed by Ohr and will be converted into and become an option to purchase that number of shares of Ohr common stock (each, an “Ohr Option”), multiplied by the exchange ratio (and rounding the resulting number down to the nearest whole share), at an exercise price equal to the per share exercise price of such NeuBase Option divided by the exchange ratio (and rounding the resulting number up to the nearest whole cent).

 

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As a result of the NeuBase Financings resulting in proceeds of $9.0 million, it is expected that immediately after the merger, and after giving effect to the NeuBase Financings, current stockholders, option holders, warrant holders and note holders of NeuBase will own, or hold rights to acquire, approximately 85% of the fully-diluted common stock of Ohr, and Ohr’s current stockholders, option holders and warrant holders will to own, or hold rights to acquire, approximately 15% of the fully-diluted common stock of Ohr.

 

There will be no adjustment to the total number of shares of Ohr common stock that NeuBase’s stockholders will be entitled to receive for changes in the market price of Ohr common stock. Accordingly, the market value of the shares of Ohr common stock issued pursuant to the merger will depend on the market value of the shares of Ohr common stock at the time the merger closes, and could vary significantly from the market value on the date of this joint proxy statement/prospectus.

 

Treatment of NeuBase Options (see page 186)

 

At the effective time of the merger, each NeuBase Option, whether vested or not vested, will be converted into an Ohr Option and each Ohr Option may be exercised solely for shares of Ohr common stock. At the effective time of the merger: (i) each NeuBase Option assumed by Ohr may be exercised solely for shares of Ohr common stock; (ii) the number of shares of Ohr common stock subject to each NeuBase Option assumed by Ohr will be determined by multiplying (x) the number of shares of NeuBase common stock that were subject to such NeuBase Option, as in effect immediately prior to the effective time of the merger by (y) the exchange ratio and rounding the resulting number down to the nearest whole number of shares of Ohr common stock; and (iii) the per share exercise price for the Ohr common stock issuable upon exercise of each NeuBase Option assumed by Ohr will be determined by dividing (x) the per share exercise price of NeuBase common stock subject to such NeuBase Option, as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio and rounding the resulting exercise price up to the nearest whole cent.

 

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Any restriction on the exercise of any NeuBase Option assumed by Ohr will continue in full force and effect and the term, exercisability, vesting schedule, status as an “incentive stock option” under Section 422 of the Code, if applicable, and other provisions of such NeuBase Option will otherwise remain unchanged; provided, however, that: (1) to the extent provided under the terms of a NeuBase Option, such NeuBase Option assumed by Ohr will, in accordance with its terms, be subject to further adjustment as appropriate to reflect any stock split, division or subdivision of shares, stock dividend, reverse stock split, consolidation of shares, reclassification, recapitalization or other similar transaction with respect to Ohr common stock subsequent to the effective time of the merger; and (2) the Ohr board of directors or a committee thereof will succeed to the authority and responsibility of the NeuBase board of directors or any committee thereof with respect to each NeuBase Option assumed by Ohr.

 

Conditions to Completion of the Merger (see page 188)

 

To consummate the merger, Ohr’s stockholders must (a) adopt the Merger Agreement and approve the transactions contemplated thereby, including the merger and the issuance of shares of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, (b) approve an amendment of Ohr’s Certificate of Incorporation to effect the Ohr Reverse Stock Split and (c) approve the Post-Merger Certificate of Incorporation. Additionally, NeuBase’s stockholders must adopt the Merger Agreement and approve the merger and the other transactions contemplated by the Merger Agreement. In addition to obtaining such stockholder approvals and appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

 

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No Solicitation (see page 194)

 

Each of Ohr and NeuBase agreed that, subject to limited exceptions, Ohr and NeuBase will not, and will not authorize or permit any of their respective subsidiaries or any of their respective affiliates, officers, directors, employees, partners, attorneys, accountants, advisors, agents or representatives of such parties or of any such party’s subsidiaries or other affiliates to, directly or indirectly:

 

solicit, initiate, knowingly encourage, induce or facilitate the making, submission or announcement of any “acquisition proposal” as defined below or take any action that would reasonably be expected to lead to an acquisition proposal;

 

furnish any nonpublic information regarding it or its subsidiaries to any person in connection with or in response to an acquisition proposal or an inquiry or indication of interest that could lead to an acquisition proposal;

 

engage in discussions or negotiations with any person with respect to any acquisition proposal;

 

approve, endorse or recommend any acquisition proposal; or

 

enter into any letter of intent or similar document or any agreement contemplating or otherwise relating to any “acquisition transaction” as defined in the Merger Agreement.

 

However, before obtaining the Ohr stockholder approval required to adopt the Merger Agreement, Ohr may furnish nonpublic information regarding Ohr and its subsidiaries to, or enter into discussions with, any person in response to an acquisition proposal that, after consultation with its outside financial and legal advisors, the Ohr board of directors determines in good faith is, or would reasonably be expected to result in, a “superior offer,” and:

 

neither Ohr nor any of its representatives (or its subsidiaries) will have breached the solicitation provisions of the Merger Agreement described above;

 

the Ohr board of directors concludes in good faith, after having taken into account the advice of its outside legal counsel, that such action is required in order for the Ohr board of directors to comply with its fiduciary obligations to its stockholders under applicable law;

 

at least two business days prior to furnishing any such information to, or entering into discussions with, such person, Ohr gives NeuBase written notice of the identity of such person and of Ohr’s intention to furnish information to, or enter into discussions with, such person, and Ohr receives from such person an executed confidentiality agreement on terms no more favorable to Ohr than the confidentiality agreement between Ohr and NeuBase and containing customary limitations on the use and disclosure of all nonpublic written and oral information furnished to such person by or on behalf of Ohr as well as customary “standstill” provisions; and

 

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at least two business days prior to furnishing any such information to such person, Ohr furnishes such nonpublic information to NeuBase (to the extent such nonpublic information has not been previously furnished by Ohr to NeuBase).

 

Termination of the Merger Agreement (see page 204)

 

Either Ohr or NeuBase can terminate the Merger Agreement under certain circumstances (including, but not limited to, the failure to close the merger by June 30, 2019, the prohibition of the merger determined by a court or government agency or the failure to obtain the approval of the respective stockholders), which would prevent the merger from being consummated.

 

Termination Fee (see page 206)

 

If the Merger Agreement is terminated under certain circumstances, Ohr or NeuBase will be required to pay the other party a termination fee of $250,000.

 

Agreements Related to the Merger

 

Support Agreements (see page 207)

 

Certain NeuBase securityholders that beneficially own or control approximately 76.12% of the voting power of NeuBase’s outstanding capital stock as of May 6, 2019 entered into support agreements with NeuBase and Ohr pursuant to which, among other things, they agreed to vote all of their shares of NeuBase capital stock (1) in favor of the adoption of the Merger Agreement and approval of the merger and, if required, the NeuBase Financings and all other transactions contemplated by the Merger Agreement; (2) against any action or agreement that, to the knowledge of such securityholder, would reasonably be expected to result in a breach in any material respect of any covenant, representation or warranty or any other obligation or agreement of NeuBase or any of its subsidiaries or affiliates under the Merger Agreement or that would reasonably be expected to result in any of the conditions to NeuBase’s or any of its subsidiaries’ or affiliates’ obligations under the Merger Agreement not being fulfilled; and (3) against any “acquisition proposal” (as defined in the Merger Agreement), or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the merger and all other transactions contemplated by the Merger Agreement. Such securityholders also agreed not to take any actions inconsistent with the foregoing obligations.

 

Certain Ohr securityholders that beneficially own or control 8.9% as of May 6, 2019 entered into support agreements with NeuBase and Ohr pursuant to which, among other things, they agreed to vote all their shares of Ohr capital stock: (1) in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated thereby, including the merger and the issuance of Ohr common stock and the Ohr Reverse Stock Split, which is part of this joint proxy statement/prospectus, in connection with, or related to, the consummation of the merger for which the Ohr board of directors has recommended that Ohr’s stockholders vote in favor; (2) against any action or agreement that, to the knowledge of such securityholders, would reasonably be expected to result in a breach in any material respect of any covenant, representation or warranty or any other obligation or agreement of Ohr or any of its subsidiaries or affiliates under the Merger Agreement or that would reasonably be expected to result in any of the conditions to Ohr’s or any of its subsidiaries’ or affiliates’ obligations under the Merger Agreement not being fulfilled; and (3) against any “acquisition proposal” (as defined in the Merger Agreement), or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the merger and all other transactions contemplated by the Merger Agreement. Such securityholders also agreed not to take any actions inconsistent with the foregoing obligations, except in the event that the Ohr board of directors withdraws or modifies its recommendation of the merger.

 

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Lock-Up Agreements (see page 208)

 

Certain NeuBase and Ohr securityholders that entered into support agreements also entered into lock-up agreements with Ohr, pursuant to which they agreed, from the closing date of the merger until 90 days after the closing date of the merger and except in limited circumstances, not to (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Ohr common stock or any securities convertible into or exercisable or exchangeable for Ohr common stock (including, without limitation, Ohr common stock or such other securities which may be deemed to be beneficially owned by such securityholder in accordance with the rules and regulations of the SEC and securities of Ohr which may be issued upon exercise of a stock option or warrant that are currently or hereafter owned by such securityholder (collectively, the “Lock-Up Shares”)), or publicly disclose the intention to make any such offer, sale, pledge, grant, transfer or disposition; (ii) enter into any swap, short sale, hedge or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Lock-Up Shares regardless of whether any such transaction described in clause (i) above or this clause (ii) is to be settled by delivery of Ohr common stock or such other securities, in cash or otherwise; or (iii) make any demand for or exercise any right with respect to the registration of any shares of Ohr common stock or any security convertible into or exercisable or exchangeable for Ohr common stock.

 

Directors and Executive Officers of the Combined Company Following the Merger (see page 187)

 

Effective as of the closing of the merger, the combined company’s executive officers are anticipated to include:

 

Name Title
Dr. Dietrich Stephan President and Chief Executive Officer
Sam Backenroth Chief Financial Officer

 

Pursuant to the terms of the Merger Agreement, the combined company’s board of directors shall consist of five directors designated by NeuBase. It is anticipated that, following the merger, the board of directors of the combined company will consist of the following individuals:

 

Name Age Current Principal Affiliation
Dr. Dietrich Stephan 49 President, Chief Executive Officer and a Director of NeuBase
Dr. Dov A. Goldstein 51 Individual Investor
Dr. Diego Miralles 56 Chief Executive Officer of Vividion Therapeutics, Inc.
Dr. Franklyn G. Prendergast 74 Professor, Mayo Medical Clinic
Eric I. Richman 58 Interim Chief Executive Officer of LabConnect, Inc.

 

 

 

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Interests of Certain Directors, Officers and Affiliates of Each of Ohr and NeuBase (see pages 161 and 167)

 

When considering the recommendation of the Ohr board of directors, you should be aware that Ohr’s directors and executive officers have interests in the merger that are different from, or in addition to, your interests as a stockholder. The Ohr board of directors was aware of and considered these interests, among other matters, in evaluating and negotiating the Merger Agreement and the merger, and in recommending that the Merger Agreement be adopted by Ohr’s stockholders. For example, all of Ohr’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement and coverage pursuant to insurance policies maintained by Ohr. In addition, Dr. Dietrich Stephan, Chief Executive Officer of NeuBase, has discussed with Sam Backenroth, the Chief Financial Officer of Ohr, whether Mr. Backenroth would be amenable to joining the combined company as its Chief Financial Officer at a salary of $320,000 per annum, a signing bonus of $95,000, and an initial equity grant of 3.4% of the fully diluted shares allocated from the combined company’s incentive option pool, as well as his eligibility to participate in a board-approved benefits and bonus plan. These discussions are ongoing. A formal offer of employment has not yet been extended to Mr. Backenroth, and his employment is subject to formal approval by the directors of NeuBase upon consummation of the merger.

 

As of May 6, 2019, the directors and executive officers of Ohr, together with their affiliates, owned 8.9% of the outstanding shares of Ohr common stock, and each of the Ohr directors and executive officers has entered into a support agreement in connection with the merger. The support agreements are discussed in greater detail in the section of this joint proxy statement/prospectus entitled “Agreements Related to the Merger—Support Agreements” beginning on page 207.

 

In considering the recommendation of the NeuBase board of directors with respect to the adoption of the Merger Agreement and the approval of the NeuBase Financings, if required, and the related transactions by written consent, NeuBase’s stockholders should be aware that Dr. Stephan, NeuBase’s sole director and executive officer, is expected to become a director and President and Chief Executive Officer of Ohr upon the closing of the merger, and will be entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.

 

As of May 6, 2019, Dr. Stephan, together with his affiliates, owned approximately 38.14% of the outstanding shares of the NeuBase common stock, excluding those shares issuable upon the exercise of outstanding stock options. Dr. Stephan has also entered into a support agreement with NeuBase and Ohr in connection with the merger. The support agreement is discussed in greater detail in the section entitled “Agreements Related to the Merger—Support Agreements” beginning on page 207 of this joint proxy statement/prospectus. Upon the consummation of the NeuBase Financings, Dr. Stephan will receive a cash bonus equal to $150,000.

 

Dr. Jason Slakter, Ohr’s President and Chief Executive Officer and a director, is eligible for a retention bonus payment of $75,000 upon the earliest to occur of the following: (i) Dr. Slakter’s continued service with Ohr in his current position through and including the closing date of the merger, or (ii) Dr. Slakter is involuntarily separated from service without cause by Ohr prior to the closing date of the merger. Mr. Backenroth is expected to remain the Chief Financial Officer of the combined company after the closing of the merger and will not be eligible for severance payments in connection with the merger pursuant to his current employment agreement. In the event Mr. Backenroth does not remain Chief Financial Officer of the combined company, he will be entitled to a severance payment of $400,000. The compensation payable to Dr. Slakter and Mr. Backenroth are discussed in greater detail in the section of this joint proxy statement/prospectus entitled “Interests of Ohr’s Directors and Executive Officers in the Merger” beginning on page 161.

 

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Considerations with Respect to U.S. Federal Income Tax Consequences of the Merger (see page 171)

 

The merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. In connection with the filing of the registration statement of which this joint proxy statement/prospectus is a part, Troutman Sanders, Ohr's counsel, has delivered to Ohr, and Paul Hastings, NeuBase's counsel, has delivered to NeuBase, their respective opinions that, for United States federal income tax purposes, subject to the limitations, assumptions and qualifications described in the opinions and in the section entitled "Material U.S. Federal Income Tax Consequences of the Merger," the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. Accordingly, if you are a U.S. holder (as defined in the section entitled “Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 171) of NeuBase common stock, you will not recognize any gain or loss for U.S. federal income tax purposes upon your exchange of shares of NeuBase common stock for shares of Ohr common stock in the merger, except with respect to cash received in lieu of fractional shares of Ohr common stock. Notwithstanding the foregoing, your tax treatment will depend on your specific situation and many variables not within Ohr’s or NeuBase’s control. If any of the representations and assumptions upon which the opinions are issued is incorrect, incomplete or inaccurate or is violated, the accuracy of the opinions may be affected and the tax consequences of the merger could differ from those described in this proxy statement/prospectus/information statement.

 

The U.S. federal income tax consequences described above may not apply to all holders of NeuBase common stock. Your tax consequences will depend on your individual situation. Accordingly, we strongly urge you to consult an independent tax advisor for a full understanding of the particular tax consequences of the merger to you.

 

Material U.S. Federal Income Tax Consequences of the Ohr Reverse Stock Split (see page 236)

 

An Ohr U.S. Holder generally should not recognize gain or loss upon the Ohr Reverse Stock Split, except possibly to the extent an Ohr U.S. holder receives a whole share of Ohr common stock in lieu of a fractional share of Ohr common stock. Please review the information in the section entitled “Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” beginning on page 236 for a more complete description of the material U.S. federal income tax consequences of the Ohr Reverse Stock Split to Ohr U.S. Holders.

 

The tax consequences to you of the Ohr Reverse Stock Split will depend on your particular facts and circumstances. Please consult your tax advisors as to the specific tax consequences to you.

 

Risk Factors (see page 37)

 

Ohr and NeuBase are subject to various risks associated with their businesses and their industries. In addition, the merger poses a number of risks to each of Ohr and NeuBase and their respective stockholders, including, but not limited to, the following risks:

 

the exchange ratio is not adjustable based on the market price of Ohr common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed;

 

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failure to complete the merger may result in NeuBase or Ohr paying a termination fee to the other and could harm the common stock price of Ohr and the future business, liquidity and operations of each company;

 

if the conditions to the merger are not met, the merger may not occur;

 

the merger may be completed even though material adverse changes may result from the announcement of the merger, industry-wide changes and other causes;

 

some Ohr and NeuBase executive officers and directors have interests in the merger that are different from yours and that may influence them to support or approve the merger without regard to your interests;

 

the market price of the combined company common stock may decline as a result of the merger;

 

Ohr and NeuBase stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger;

 

during the pendency of the merger, Ohr and NeuBase may not be able to enter into a business combination with another party at a favorable price (subject to certain exceptions) because of restrictions in the Merger Agreement, which could adversely affect their respective businesses; and

 

certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.

 

These risks and other risks are discussed in greater detail under the section of this joint proxy statement/prospectus entitled “Risk Factors” beginning on page 37. Ohr and NeuBase both encourage you to read and consider all of these risks carefully.

 

Regulatory Approvals (see page 171)

 

Ohr must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Ohr common stock and the filing of this joint proxy statement/prospectus with the SEC.

 

Nasdaq Listing (see page 173)

 

Prior to consummation of the merger, Ohr intends to file an initial listing application for the combined company with Nasdaq pursuant to Nasdaq “reverse merger” rules. If such application is accepted, Ohr anticipates that Ohr common stock will be listed on Nasdaq following the closing of the merger under the trading symbol “NBSE.”

 

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Anticipated Accounting Treatment (see page 173)

 

The merger will be treated by Ohr as a reverse acquisition under the acquisition method of accounting in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). For accounting purposes, NeuBase is considered to be acquiring Ohr in the merger.

 

Appraisal Rights and Dissenters’ Rights (see page 174)

 

Ohr’s stockholders are not entitled to appraisal rights in connection with the merger. NeuBase’s stockholders are entitled to appraisal rights in connection with the merger under Delaware law. For more information about such rights, see the provisions of Section 262 of the Delaware General Corporation Law, attached hereto as Annex F, and the section of this joint proxy statement/prospectus entitled “The Merger—Appraisal Rights and Dissenters’ Rights” beginning on page 174.

 

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SELECTED HISTORICAL AND PRO FORMA COMBINED FINANCIAL DATA

 

The following tables present summary historical financial data for each of Ohr and NeuBase, summary unaudited pro forma condensed combined financial data for Ohr and NeuBase and comparative historical and unaudited pro forma per share data for Ohr and NeuBase.

 

Selected Historical Consolidated Financial Data of Ohr

 

The selected consolidated statements of operations data for the years ended September 30, 2018 and 2017 and the selected consolidated balance sheet data as of September 30, 2018 and 2017 are derived from Ohr’s audited consolidated financial statements included elsewhere in this joint proxy statement/prospectus. The selected consolidated statements of operations data for the three months ended December 31, 2018 and the selected consolidated balance sheet data as of December 31, 2018 are derived from Ohr’s unaudited interim consolidated financial statements included elsewhere in this joint proxy statement/prospectus. Ohr’s unaudited interim consolidated financial statements have been prepared in accordance with U.S. GAAP on the same basis as its audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal, recurring adjustments, necessary for the fair statement of those unaudited interim consolidated financial statements. Ohr’s historical results are not necessarily indicative of the results that may be expected in any future period and the results for the three months ended December 31, 2018 are not necessarily indicative of results to be expected for the full year ending September 30, 2019 or any other period.

 

The following information does not give effect to the Ohr Reverse Stock Split described in Proposal No. 2. but does give effect to the one-for-twenty reverse stock split of Ohr common stock on February 4, 2019. Unless otherwise noted, impacted amounts and share information of Ohr included in the financial statements and notes thereto, and elsewhere in this joint proxy statement/prospectus, have been retroactively adjusted for the February 4, 2019, reverse stock split, as if such reverse stock split occurred on the first day of the first period presented. Certain amounts in the Ohr financial statements, the notes thereto, and elsewhere in this joint proxy statement/prospectus, may be slightly different than previously reported due to rounding of fractional shares as a result of the February 4, 2019, reverse stock split.

 

The selected historical consolidated financial data below should be read in conjunction with the sections entitled “Ohr’s Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 282 of this joint proxy statement/prospectus and “Risk Factors—Risks Related to Ohr” beginning on page 43 of this joint proxy statement/prospectus and Ohr’s consolidated financial statements and related notes included elsewhere in this joint proxy statement/prospectus.

 

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OHR PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
         
   For the Years Ended   For the Three Months Ended 
   September 30,   December 31, (Unaudited) 
   2018   2017   2018   2017 
OPERATING EXPENSES                    
                     
General and administrative  $3,634,474   $5,278,272   $680,995   $1,510,032 
                     
Research and development   4,319,165    17,406,869    58,021    2,387,731 
                     
Depreciation and amortization   1,124,569    1,165,689    167,370    284,986 
                     
Loss on Impairment of Goodwill   740,912             
                     
Loss on Impairment of intangible asset   5,313,640             
                     
Gain on settlement of liabilities   (1,228,805)   (70,757)        
                     
TOTAL OPERATING EXPENSES   13,903,955    23,780,073    906,386    4,182,749 
                     
LOSS FROM OPERATIONS   (13,903,955)   (23,780,073)   (906,386)   (4,182,749)
                     
OTHER INCOME (EXPENSE)                    
                     
Other income (expense)   592,584    (1,349)   8,762    31,391 
Interest income (expense), net   74,471    (29,574)        
                     
Total Other Income (Expense)   667,055    (30,923)   8,762    31,391 
                     
NET LOSS  $(13,236,900)  $(23,810,996)  $(897,624)  $(4,151,358)
                     
BASIC AND DILUTED LOSS PER SHARE   $(4.69)  $(10.64)  $(0.32)  $(1.48)
                     
WEIGHTED AVERAGE  SHARES OUTSTANDING:                    
BASIC AND DILUTED   2,819,994    2,238,534    2,829,248    2,810,189 

 

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OHR PHARMACEUTICAL, INC.
CONSOLIDATED BALANCE SHEETS
         
   September 30,   December 31, 
   2018   2017   2018
(Unaudited)
 
ASSETS
CURRENT ASSETS               
Cash  $3,750,436   $12,801,085   $3,110,441 
Prepaid expenses and other current assets   247,998    223,278    103,269 
                
Total Current Assets   3,998,434    13,024,363    3,213,710 
                
EQUIPMENT, net   15,763    63,757    13,421 
                
OTHER ASSETS               
Security deposit       12,243     
Intangible assets, net   7,611,918    14,087,602    7,446,891 
Goodwill       740,912     
                
TOTAL ASSETS  $11,626,115   $27,928,877   $10,674,022 
                
LIABILITIES AND STOCKHOLDERS' EQUITY 
CURRENT LIABILITIES               
Accounts payable and accrued expenses  $651,781   $4,827,525   $597,152 
Notes payable   73,217    106,387     
                
Total Current Liabilities   724,998    4,933,912    597,152 
                
Long-term liabilities       150,000     
                
TOTAL LIABILITIES   724,998    5,083,912    597,152 
                
STOCKHOLDERS' EQUITY               
Preferred stock, Series B; 6,000,000 shares authorized, $0.0001 par value, 0 shares issued and outstanding, respectively            
Common stock; 180,000,000 shares authorized, $0.0001 par value, 2,829,248, 2,815,748, and 2,829,248 shares issued and outstanding, respectively   283    282    283 
Additional paid-in capital   132,226,341    130,933,290    132,299,718 
Accumulated deficit   (121,325,507)   (108,088,607)   (122,223,131)
                
Total Stockholders' Equity   10,901,117    22,844,965    10,076,870 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $11,626,115   $27,928,877   $10,674,022 

 

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NEUBASE THERAPEUTICS, INC.

STATEMENTS OF OPERATIONS

 

Selected Historical Financial Data of NeuBase

The selected financial data as of December 31, 2018, for the three months ended December 31, 2018 and the period from August 28, 2018 (inception) to September 30, 2018, are derived from NeuBase’s audited financial statements prepared using U.S. GAAP, which are included in this proxy statement/prospectus/information statement. The statement of operations data for the three months ended December 31, 2018, as well as the balance sheet data as of December 31, 2018, are derived from the NeuBase unaudited condensed financial statements included in this proxy statement/prospectus/information statement. In the opinion of management, the unaudited financial statements reflect all adjustments, which include normal recurring adjustments, necessary to state fairly NeuBase’s results of operations and financial position. These historical results are not necessarily indicative of results to be expected in any future period. The selected financial data should be read in conjunction with NeuBase’s financial statements and the related notes to those statements included in this joint proxy statement/prospectus/information statement and “NeuBase Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 287 of this joint proxy statement/prospectus.

         
   From August 28, 2018 (Inception) to
September 30,
   For the Three Months Ended December 31, 
   2018   2018
(unaudited)
 
OPERATING EXPENSES          
           
General and administrative  $28,393   $620,692 
Research and development  12,819   54,459 
TOTAL OPERATING EXPENSES   41,212    675,151 
           
LOSS FROM OPERATIONS   (41,212)   (675,151)
           
OTHER INCOME (EXPENSE)          
Interest expense   (740)   (4,521)
Total Other Expense   (740)   (4,521)
           
NET LOSS  $(41,952)  $(679,672)
           
BASIC AND DILUTED LOSS PER SHARE  $(0.01)   (0.13)
           
WEIGHTED AVERAGE SHARES OUTSTANDING:          
BASIC AND DILUTED   4,120,000    5,216,467 

 

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NEUBASE THERAPEUTICS, INC.
BALANCE SHEETS
         
   September 30,   December 31, 
   2018   2018 
       (Unaudited) 
ASSETS
CURRENT ASSETS          
Cash  $249,600   $137,190 
Other current assets   1     
           
Total Current Assets   249,601    137,190 
           
OTHER ASSETS          
Intangible assets       1,488,301 
           
TOTAL ASSETS  $249,601   $1,625,491 
           
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) 
CURRENT LIABILITIES          
Accounts payable and accrued expenses  $41,497   $164,667 
Contingent consideration       163,356 
           
Total Current Liabilities   41,497    328,023 
           
LONG-TERM LIABILITIES          
Convertible Note Payable   250,000    250,000 
           
Total Long-term Liabilities   250,000    250,000 
           
TOTAL LIABILITIES   291,497    578,023 
           
STOCKHOLDERS' EQUITY (DEFICIT)          
Common Stock; 15,000,000 shares authorized, $.00001 par value, 5,620,000 shares issued and outstanding as of September 30, 2018, 5,620,000 shares issued and 4,245,000 outstanding as of December 31, 2018   56    56 
Treasury stock, at cost; 0 as of September 30, 2018; 1,375,000 as of December 31, 2018       (14)
Additional paid-in capital       1,769,050 
Accumulated deficit   (41,952)   (721,624)
           
Total Stockholders' Equity (Deficit)   (41,896)   1,047,468 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $249,601   $1,625,491 

 

Selected Unaudited Pro Forma Combined Financial Data of Ohr and NeuBase

 

The following selected unaudited pro forma condensed combined financial information has been prepared to reflect the acquisitions of Ohr by NeuBase using the acquisition method of accounting. On January 2, 2019, Ohr and NeuBase entered into the Merger Agreement pursuant to which a wholly owned subsidiary of Ohr will merge with and into NeuBase, with NeuBase becoming a wholly owned subsidiary of Ohr and the surviving company of the merger. For accounting purposes, NeuBase is considered to be acquiring Ohr in the merger.

 

The unaudited pro forma condensed combined financial statements were prepared in accordance with the regulations of the SEC. The unaudited pro forma condensed combined balance sheet as of September 30, 2018 is presented as if the merger had been completed on September 30, 2018. The unaudited pro forma condensed combined statements of operations for the three months ended December 31, 2018 and for the year ended September 30, 2018 assumes that the merger took place as of October 1.

 

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The following information does not give effect to the Ohr Reverse Stock Split described in Proposal No. 2. but does give effect to the one-for-twenty reverse stock split of Ohr common stock on February 4, 2019.

 

The selected unaudited pro forma condensed combined financial data are presented for illustrative purposes only and are not necessarily indicative of the combined financial position or results of operations of future periods or the results that actually would have been realized had the entities been a single entity during these periods. The selected unaudited pro forma condensed combined financial data as of and for the three months ended December 31, 2018 and for the year ended September 30, 2018 are derived from the unaudited pro forma condensed combined financial information and should be read in conjunction with that information. For more information, please see the section of this joint proxy statement/prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Statements.”

 

   For the Period
Ended September 30, 2018 (1)
  For the Three Months Ended December 31, 2018
      (unaudited)
       
Consolidated Statements of Operations Data:      
Operating expenses:      
Research and development  $4,331,984   $112,480 
General and administrative   3,662,867    6,146,463 
Depreciation and amortization   1,124,569    167,370 
Loss on impairment of goodwill   740,912    —   
Loss on impairment of intangible asset   5,313,640    —   
Gain on settlement of liabilities   (1,228,805)   —   
Total operating expenses   13,945,167    6,426,313 
Loss from operations   (13,945,167)   (6,426,313)
Other and interest Income (expense)   666,315    4,241 
Net loss   (13,278,852)   (6,422,072)
Net loss per share—basic and diluted  $(0.86)  $(0.41)
Weighted-average common shares outstanding—basic and diluted   15,514,965    15,524,219 

 

(1)Includes the following periods: The year ended September 30, 2018, for Ohr, and the period from August 28, 2018 (inception), to September 30, 2018, for NeuBase.

 

 

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   At December 31, 2018
    
Consolidated Balance Sheet Data:   
Cash and cash equivalents  $11,519,033 
Total current assets  $12,222,312 
Other assets  $7,825,168 
Total assets  $20,060,901 
Total liabilities  $2,928,370 
Total stockholders’ equity (deficit)  $17,132,531 

 

Comparative Historical and Unaudited Pro Forma Per Share Data

 

The information below reflects historical per share information for Ohr and NeuBase and unaudited pro forma per share information of the combined company as if Ohr and NeuBase had been combined as of or for the periods presented. The per share amounts below do not give effect to the proposed Ohr Reverse Stock Split described in the section of this joint proxy statement/prospectus entitled “Matters Being Submitted to a Vote of Ohr’s Stockholders—Proposal No. 2: Approval of the Ohr Reverse Stock Split,” beginning on page 231.

 

The pro forma amounts in the table below have been derived from the unaudited pro forma combined financial information included in the section of this joint proxy statement/prospectus entitled “Selected Unaudited Pro Forma Combined Financial Statements of Ohr and NeuBase,” beginning on page 32. The pro forma amounts are presented for illustrative purposes only and are not necessarily indicative of what the financial position or the results of operations of the combined company would have been had Ohr and NeuBase been combined as of or for the periods presented.

 

The following information does not give effect to the Ohr reverse Stock Split described in Proposal No. 2. but does give effect to the one-for-twenty reverse stock split of Ohr common stock on February 4, 2019.

 

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The information below should be read in conjunction with the audited and unaudited consolidated financial statements of Ohr and the related notes, the audited and unaudited financial statements of NeuBase and the related notes, and the unaudited pro forma combined financial information and the related notes, all of which are included elsewhere in this joint proxy statement/prospectus or in annexes to this joint proxy statement/prospectus.

 

   As of and for
the period ended
September 30, 2018 (4)
  As of and for
the three months ended
December 31, 2018
Ohr      
Book value per share—historical (1)  $3.85   $3.56 
Basic and diluted net loss per share—historical  $(4.69)  $(0.32)
NeuBase          
Book value per share—historical (1)  $(0.01)  $0.25 
Basic and diluted net loss per share—historical  $(0.01)  $(0.13)
NeuBase Unaudited Pro Forma Equivalent Data per Share (2)          
Book value per share—pro forma  $(0.01)  $0.25 
Basic and diluted net loss per share—historical  $(0.01)  $(0.13)
Unaudited Pro Forma Combined          
Book value per share—pro forma (3)    N/A    $1.10 
Basic and diluted net loss per share—pro forma   (0.86)   (0.41)

 

 (1) Historical book value per share is calculated by taking total stockholders’ equity divided by total outstanding common shares (Ohr) or total outstanding ordinary shares (NeuBase), as of the end of the period.  
   
 (2) NeuBase Unaudited Pro Forma Equivalent Data per share is calculated by applying the preliminary pro forma share exchange ratio of 1.019055643 to the unaudited historical per share data.  
   
 (3) Combined pro forma book value per share is calculated by taking pro forma combined total stockholder equity divided by pro forma combined total outstanding common shares.  
   
(4) Includes the following periods: The year ended September 30, 2018, for Ohr, and the period from August 28, 2018 (inception), to September 30, 2018, for NeuBase.

 

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MARKET PRICE AND DIVIDEND INFORMATION

 

Ohr common stock trades on Nasdaq under the symbol “OHRP.” The following table details the high and low closing prices for the Ohr common stock as reported by Nasdaq for the periods indicated. On January 23, 2019, Ohr filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect a one-for-twenty reverse stock split. The shares of Ohr common stock began trading on a split adjusted basis when the market opened on February 4, 2019. The share prices below are shown on a post-split basis.

 

   Price Range (1)
   High  Low
       
Fiscal Year 2017      
First Quarter   75.00    30.00 
Second Quarter   33.00    15.60 
Third Quarter   18.40    12.00 
Fourth Quarter   15.80    11.40 
Fiscal Year 2018          
First Quarter   38.40    11.80 
Second Quarter   40.80    4.40 
Third Quarter   6.60    3.80 
Fourth Quarter   4.80    3.00 
Fiscal Year 2019          
First Quarter   6.20    1.80 
Second Quarter   3.60    1.92 
Third Quarter (through May 6, 2019)   2.76    2.21 

 

(1) These prices have been adjusted to reflect a 1-for-20 reverse stock split that became effective on February 4, 2019, rounded to the nearest whole cent.

 

NeuBase is a private company and its ordinary shares are not publicly traded. There has never been, nor is there expected to be in the future, a public market for NeuBase’s common stock.

 

On January 2, 2019, the last full trading day prior to the public announcement of the proposed merger, the closing price per share of Ohr common stock as reported on Nasdaq was $2.20 per share. On May 6, 2019, the last practicable date before the printing of this joint proxy statement/prospectus, the closing price per share of Ohr common stock as reported on Nasdaq was $2.76 per share.

 

Following the consummation of the merger, and subject to successful application for initial listing with Nasdaq, Ohr common stock will continue to be listed on Nasdaq, but will trade under the symbol “NBSE” and under the combined company’s new name, “NeuBase Therapeutics, Inc.”

 

As of the record date, Ohr had approximately 253 stockholders of record.

 

Ohr has never declared or paid cash dividends on its capital stock. Ohr currently intends to retain earnings, if any, to finance the growth and development of its business, and does not expect to pay any cash dividends to its stockholders in the foreseeable future. Payment of future dividends, if any, will be at the discretion of the Ohr board of directors.

 

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RISK FACTORS

 

You should consider the following factors in evaluating whether to adopt the Merger Agreement and thereby approve the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, the Ohr Reverse Stock Split and the Post-Merger Certificate of Incorporation. These factors should be considered in conjunction with the other information included or incorporated by reference by Ohr in this joint proxy statement/prospectus.

 

Risks Related to the Merger

 

If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.

 

The consummation of the proposed merger with NeuBase is subject to a number of closing conditions, including the approval by Ohr’s stockholders, approval by Nasdaq of Ohr’s application for initial listing of Ohr common stock in connection with the merger, a minimum amount of financing into NeuBase, and other customary closing conditions. Ohr is targeting a closing of the transaction in the second quarter of calendar year 2019.

 

If the proposed merger is not consummated, Ohr may be subject to a number of material risks, and its business and stock price could be adversely affected, as follows:

 

Ohr has incurred and expects to continue to incur significant expenses related to the proposed merger with NeuBase even if the merger is not consummated.

 

The Merger Agreement contains covenants relating to Ohr’s solicitation of competing acquisition proposals and the conduct of Ohr’s business between the date of signing the Merger Agreement and the closing of the merger. As a result, significant business decisions and transactions before the closing of the merger require the consent of NeuBase. Accordingly, Ohr may be unable to pursue business opportunities that would otherwise be in its best interest as a standalone company. If the Merger Agreement is terminated after Ohr has invested significant time and resources in the transaction process, Ohr will have a limited ability to continue operations without obtaining additional financing to fund its operations.

 

Ohr’s prospective customers, collaborators and other business partners and investors in general may view the failure to consummate the merger as a poor reflection on its business or prospects.

 

Some of Ohr’s suppliers, distributors, collaborators and other business partners may seek to change or terminate their relationships with Ohr as a result of the proposed merger.

 

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As a result of the proposed merger, current and prospective employees could experience uncertainty about their future roles within the combined company. This uncertainty may adversely affect Ohr’s ability to retain its key employees, who may seek other employment opportunities.

 

Ohr’s management team may be distracted from day to day operations as a result of the proposed merger.

 

The market price of Ohr common stock may decline to the extent that the current market price reflects a market assumption that the proposed merger will be completed.

 

In addition, if the Merger Agreement is terminated and the Ohr board of directors determines to seek another business combination, it may not be able to find a third party willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the merger. In such circumstances, the Ohr board of directors may elect to, among other things, divest all or a portion of Ohr’s assets, or take the steps necessary to liquidate all of Ohr’s business and assets, and in either such case, the consideration that Ohr receives may be less attractive than the consideration to be received by Ohr pursuant to the Merger Agreement.

 

The exchange ratio is not adjustable based on the market price of Ohr common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

 

The Merger Agreement has set the exchange ratio for the NeuBase common stock. Any changes in the market price of Ohr common stock before the completion of the merger will not affect the number of shares NeuBase securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the merger the market price of Ohr common stock declines from the market price on the date of the Merger Agreement, then NeuBase securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the merger the market price of Ohr common stock increases from the market price on the date of the Merger Agreement, then NeuBase securityholders could receive merger consideration with substantially more value for their shares of NeuBase capital stock than the parties had negotiated for in the establishment of the exchange ratio. Because the exchange ratio does not adjust as a result of changes in the value of Ohr common stock, for each one percentage point that the market value of Ohr common stock rises or declines, there is a corresponding one percentage point rise or decline, respectively, in the value of the total merger consideration issued to NeuBase securityholders.

 

Some of Ohr’s officers and directors have conflicts of interest that may influence them to support or approve the merger.

 

Officers and directors of Ohr participate in arrangements that provide them with interests in the merger that are different from yours, including, among others, Sam Backenroth’s, Ohr’s current Chief Financial Officer, continued employment as Chief Financial Officer of the combined company, retention and severance benefits, the acceleration of option vesting and continued indemnification. These interests, among others, may influence the officers and directors of Ohr to support or approve the merger. For a more detailed discussion, please see the section entitled “The Merger—Interests of Ohr’s Directors and Executive Officers in the Merger” beginning on page 161 of this joint proxy statement/prospectus.

 

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The market price of the combined company’s common stock may decline as a result of the merger.

 

The market price of the combined company’s common stock may decline as a result of the merger for a number of reasons including:

 

the combined company does not achieve the perceived benefits of the merger as rapidly or to the extent anticipated by financial or industry analysts;

 

the effect of the merger on the combined company’s business and prospects is not consistent with the expectations of financial or industry analysts; or

 

investors react negatively to the effect on the combined company’s business and prospects from the merger.

 

Ohr’s stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger.

 

If the combined company is unable to realize the strategic and financial benefits currently anticipated from the merger, Ohr’s stockholders will have experienced substantial dilution of their ownership interest without receiving any commensurate benefit. Significant management attention and resources will be required to integrate the two companies. Delays in this process could adversely affect the combined company’s business, financial results, financial condition and stock price following the merger. Even if the combined company were able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

 

During the pendency of the merger, Ohr may not be able to enter into a business combination with another party and will be subject to contractual limitations on certain actions because of restrictions in the Merger Agreement.

 

Covenants in the Merger Agreement impede the ability of Ohr or NeuBase to make acquisitions or complete other transactions that are not in the ordinary course of business pending completion of the merger. As a result, if the merger is not completed, the parties may be at a disadvantage to their competitors. In addition, while the Merger Agreement is in effect and subject to limited exceptions, each party is prohibited from soliciting, initiating, encouraging or taking actions designed to facilitate any inquiries or the making of any proposal or offer that could lead to entering into certain extraordinary transactions with any third party, such as a sale of assets, an acquisition of Ohr common stock, a tender offer for Ohr common stock, a merger or other business combination outside the ordinary course of business. Any such transactions could be favorable to such party’s stockholders.

 

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The opinion received by the Ohr board of directors from Roth has not been, and is not expected to be, updated to reflect changes in circumstances that may have occurred since the date of the opinion.

 

Roth delivered its opinion to the Ohr board of directors of Ohr that, as of January 2, 2019, and based upon and subject to the various assumptions made, procedures followed, matters considered and qualifications and limitations set forth in its opinion, the merger consideration was fair, from a financial point of view, to Ohr. The opinion does not speak as of the time the merger will be completed or any date other than the date of such opinion. The opinion does not reflect changes that may occur or may have occurred after the date of the opinion, including changes to the operations and prospects of Ohr or NeuBase, changes in general market and economic conditions or regulatory or other factors. Any such changes may materially alter or affect the relative values of Ohr and NeuBase. Roth does not have any obligation to update, revise or reaffirm its opinion to reflect subsequent developments and has not done so. See the section of this joint proxy statement/prospectus entitled “The Merger—Opinion of Ohr’s Financial Advisor” beginning on page 150 and Annex D.

 

Certain stockholders could attempt to influence changes within Ohr which could adversely affect Ohr’s operations, financial condition and the value of Ohr common stock.

 

Ohr’s stockholders may from time-to-time seek to acquire a controlling stake in Ohr, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes. Campaigns by stockholders to effect changes at publicly-traded companies are sometimes led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the entire company. Responding to proxy contests and other actions by activist stockholders can be costly and time-consuming, and could disrupt Ohr’s operations and divert the attention of the Ohr board of directors and senior management from the pursuit of the proposed merger transaction. These actions could adversely affect Ohr’s operations, financial condition, Ohr’s ability to consummate the merger and the value of Ohr common stock.

 

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Ohr and NeuBase may become involved in securities litigation or stockholder derivative litigation in connection with the merger, and this could divert the attention of Ohr and NeuBase management and harm the combined company’s business, and insurance coverage may not be sufficient to cover all related costs and damages.

 

Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or announcement of a business combination transaction. Ohr and NeuBase may become involved in this type of litigation in connection with the merger, and the combined company may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect the business of Ohr, NeuBase and the combined company.

 

On February 14, 2018, plaintiff, Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr and several current and former officers, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc. filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On November 13, 2018, plaintiffs filed a motion to strike exhibits appended to the motion to dismiss. A decision on the motion to strike is pending, and the motion to dismiss will then be fully briefed based on a schedule to be determined by the court. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

 

On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

 

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In September 2018, plaintiff John Tomson, derivatively and on behalf of Ohr, commenced an action against Michael Ferguson, Sam Backenroth, Irach Taraporewala, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the U.S. District Court for the Southern District of New York alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their various breaches of fiduciary duties, corporate waste and unjust enrichment that occurred between April 4, 2014 through January 4, 2018. Thereafter, the complaint largely summarized the allegations of the amended complaint filed in the securities class action described above. It does not quantify alleged damages. On March 18, 2019, Plaintiff Tomson filed a notice of Voluntary Dismissal without Prejudice and, on March 21, 2019, the court entered an order for the case to be closed.

 

Following the issuance of the preliminary joint proxy statement/prospectus, on March 18, 2019, a lawsuit was filed by an individual shareholder in the United States District Court for the Southern District of New York against Ohr and its board of directors, captioned Gomez v. Ohr Pharmaceutical, Inc., et al., Case No. 1:19-cv-02386 (the “Gomez Action”).  The plaintiff in the action alleges that the preliminary joint proxy/prospectus statement filed by Ohr with the SEC on March 8, 2019 contained false and misleading statements and omitted material information in violation of Section 14(a) of the Exchange Act and SEC Rule 14a-9 promulgated thereunder, and further that the individual defendants are liable for those alleged misstatements and omissions under Section 20(a) of the Exchange Act.  On March 19, 2019, another individual action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr’s board of directors and additionally naming NeuBase and Ohr Acquisition Corp., but not Ohr, as defendants, captioned Barke v. Ferguson, et al., Case No. 1:19-cv-02445 (the “Barke Action”).  On March 20, 2019, a putative class action lawsuit was filed in the United States District Court for District of Delaware asserting similar claims under Section 14(a) and Section 20(a) and naming as defendants Ohr and its board of directors, NeuBase, and Ohr Acquisition Corp., captioned Wheby v. Ohr Pharmaceutical, Inc., et al., Case No. 1:19-cv-00541-UNA (the “Wheby Action”).  On March 20, 2019, another putative class action was filed in the Court of Chancery of the State of Delaware asserting a breach of fiduciary duty claim against Ohr’s board of directors arising out of the same facts and circumstances regarding certain alleged omissions in the preliminary joint proxy/prospectus statement, captioned Lowinger v. Ferguson, et al., Case No. 2019-0221-SG (the “Lowinger Action”). On April 4, 2019, another putative class action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr and its board of directors, captioned Garaygordobil v. Ohr Pharmaceutical, Inc., et al., Case No. 1:19-cv-03006 (the “Garaygordobil Action”). On May 1, 2019, the Lowinger Action was ordered dismissed pursuant to the stipulation of the parties. The actions seek, among other things, to enjoin the merger or, if the merger has been consummated, to rescind the merger or an award of damages, and an award of attorneys’ and experts’ fees and expenses.  Although it is not possible to predict the outcome of litigation matters with certainty, Ohr believes that the claims raised in the actions are without merit and intends to defend against them vigorously.

 

Roth's fairness opinion relies on projections provided by NeuBase, which do not consider the possibility that NeuBase product candidates may not receive FDA approval, and such failure would adversely impact the combined company’s potential to generate revenue, its business and its results of operations.

In performing its fairness analysis, Roth relied, without independent investigation or verification, on projections prepared by NeuBase management (the “NB Projections”). The NB Projections are solely the responsibility of NeuBase. The assumptions underlying the NB Projections reflected the best available estimates and good faith judgments of NeuBase management as to the future financial performance of NeuBase and included but were not limited to an approval and launch of NT0100 by the end of 2024, and approval and launch of NT0200 by the end of 2025. The NB Projections were not prepared by NeuBase management with a view toward public disclosure or toward complying with U.S. GAAP, the published guidelines of the SEC regarding projections and the use of non-GAAP measures or the guidelines established by AICPA for preparation and presentation of prospective financial information. Neither Ohr’s independent public accounting firm, nor NeuBase’s independent accounting firm, nor any other independent accountants, has compiled, examined or performed any procedures with respect to the NB Projections contained herein, nor have they expressed any opinion or any other form of assurance on such information or its achievability, and assume no responsibility for, and disclaim any association with, the NB Projections.

 

The failure or delay in obtaining FDA approval of any of the combined company’s product candidates would prevent or delay commercialization of the combined company’s product candidates and adversely impact its potential to generate revenue, its business and its results of operations. The process of obtaining FDA and other required regulatory approvals, including foreign regulatory approvals and clearances, would require a substantial amount of time and significant capital expenditure. Despite the time and expense expended, regulatory approval is never guaranteed. (See Risk Factor entitled, “Pharmaceutical companies face heavy government regulation. FDA regulatory approval and/or comparable foreign regulatory authority’s approval of any products is uncertain.”)

 

Risks Related to the Ohr Reverse Stock Split

 

The Ohr Reverse Stock Split may not increase Ohr’s stock price over the long-term.

 

The purpose of the Ohr Reverse Stock Split is to increase the per-share market price of Ohr common stock above the minimum bid price requirement under the Nasdaq Listing Rules so that the listing of the combined company and the shares of Ohr common stock being issued in the merger will be approved for listing on Nasdaq. It cannot be assured, however, that the Ohr reverse Stock Split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of Ohr common stock, it cannot be assured that the Ohr Reverse Stock Split will increase the market price of its common stock by a multiple of the Ohr reverse Stock Split ratio chosen by its board of directors in its sole discretion, or result in any permanent or sustained increase in the market price of Ohr common stock, which is dependent upon many factors, including Ohr’s business and financial performance, general market conditions, and prospects for future success. Thus, while the stock price of the combined company might meet the continued listing requirements for Nasdaq, initially, it cannot be assured that it will continue to do so.

 

The Ohr Reverse Stock Split may decrease the liquidity of Ohr common stock.

 

Although the board of directors believes that the anticipated increase in the market price of Ohr common stock could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the Ohr Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for Ohr common stock.

 

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The Ohr Reverse Stock Split may lead to a decrease in Ohr’s overall market capitalization.

 

Should the market price of Ohr common stock decline after the Ohr Reverse Stock Split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the Ohr Reverse Stock Split. A Reverse Stock Split is often viewed negatively by the market and, consequently, can lead to a decrease in Ohr’s overall market capitalization. If the per share market price does not increase in proportion to the Ohr Reverse Stock Split ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected a reverse stock split subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of Ohr common stock will remain the same after the Ohr Reverse Stock Split is effected, or that the Ohr Reverse Stock Split will not have an adverse effect on Ohr’s stock price due to the reduced number of shares outstanding after the Ohr Reverse Stock Split.

 

Risks Related to Ohr

 

Risks Relating to Ohr’s Financial Position and Need for Capital

 

Ohr’s business was substantially dependent on the success of squalamine, which failed to meet its primary efficacy endpoint in the MAKO Study. Unless Ohr executes on a strategic alternative, Ohr may be required to liquidate, dissolve, or otherwise wind down its operations.

 

Until January 5, 2018, squalamine for the treatment of wet-AMD was Ohr’s lead product candidate. On January 5, 2018, Ohr announced topline results from its MAKO Study which did not meet its primary efficacy endpoint. Based on these results, Ohr has discontinued further development of squalimine and has been evaluating strategic alternatives to maximize stockholder value. Ohr has no assurance that it will be able to execute on a strategic alternative and may be required to liquidate, dissolve or otherwise wind down Ohr’s operations if Ohr is unable to do so. There is no assurance that the transaction with NeuBase will be consummated. (See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”)

 

Ohr may not be able to monetize any or some of the non-squalamine assets, including the SKS sustained release ocular drug delivery platform technology, the CEP assets, or Ohr’s interest in the Depymed joint venture.

 

Ohr may not be able to monetize any or some of the non-squalamine assets, including the SKS sustained release ocular drug delivery platform technology, the CEP assets, or Ohr’s interest in the Depymed joint venture. In that event, Ohr may be constrained to write off those assets, in whole or in part. At December 31, 2018, Ohr significantly wrote down the value of its SKS sustained release asset and there can be no assurance that Ohr will not be required to further write down or write off the asset entirely in the future.

 

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Ohr is subject to securities class action litigation and derivative shareholder litigation. If an unfavorable ruling were to occur, there exists the possibility of a material adverse impact on Ohr.

 

As a result of Ohr’s announcement of negative results from the MAKO Study, Ohr’s stock price declined substantially. On February 14, 2018, plaintiff, Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr and several current and former officers, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc. filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On November 13, 2018, plaintiffs filed a motion to strike exhibits appended to the motion to dismiss. A decision on the motion to strike is pending, and the motion to dismiss will then be fully briefed based on a schedule to be determined by the court. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

 

On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

 

In September 2018, plaintiff John Tomson, derivatively and on behalf of Ohr, commenced an action against Michael Ferguson, Sam Backenroth, Irach Taraporewala, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the U.S. District Court for the Southern District of New York alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their various breaches of fiduciary duties, corporate waste and unjust enrichment that occurred between April 4, 2014 through January 4, 2018. Thereafter, the complaint largely summarized the allegations of the amended complaint filed in the securities class action described above. It does not quantify alleged damages. On March 18, 2019, Plaintiff Tomson filed a notice of Voluntary Dismissal without Prejudice and, on March 21, 2019, the court entered an order for the case to be closed.

 

Following the issuance of the preliminary joint proxy statement/prospectus, on March 18, 2019, the Gomez Action was filed by an individual shareholder in the United States District Court for the Southern District of New York against Ohr and its board of directors.  The plaintiff in the Gomez Action alleges that the preliminary joint proxy/prospectus statement filed by Ohr with the SEC on March 8, 2019 contained false and misleading statements and omitted material information in violation of Section 14(a) of the Exchange Act and SEC Rule 14a-9 promulgated thereunder, and further that the individual defendants are liable for those alleged misstatements and omissions under Section 20(a) of the Exchange Act.  On March 19, 2019, the Barke Action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr’s board of directors and additionally naming NeuBase and Ohr Acquisition Corp., but not Ohr, as defendants.  On March 20, 2019, the Wheby Action was filed in the United States District Court for District of Delaware asserting similar claims under Section 14(a) and Section 20(a) and naming as defendants Ohr and its board of directors, NeuBase, and Ohr Acquisition Corp.  On March 20, 2019, the Lowinger Action was filed in the Court of Chancery of the State of Delaware asserting a breach of fiduciary duty claim against Ohr’s board of directors arising out of the same facts and circumstances regarding certain alleged omissions in the preliminary joint proxy/prospectus statement. On April 4, 2019, the Garaygordobil Action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr and its board of directors. On May 1, 2019, the Lowinger Action was ordered dismissed pursuant to the stipulation of the parties. The actions seek, among other things, to enjoin the merger or, if the merger has been consummated, to rescind the merger or an award of damages, and an award of attorneys’ and experts’ fees and expenses.  Although it is not possible to predict the outcome of litigation matters with certainty, Ohr believes that the claims raised in the actions are without merit and intends to defend against them vigorously.

 

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If Ohr fails to continue to meet all applicable Nasdaq requirements and Nasdaq determines to delist Ohr common stock, the delisting could adversely affect the market liquidity of Ohr common stock and the market price of Ohr common stock could decrease.

 

On February 20, 2018, Ohr received a written notice (the “First Notice”) from NASDAQ Stock Market LLC (“Nasdaq”) that Ohr had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a period of 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

 

In accordance with Nasdaq’s Listing Rule 5810(c)(3)(A), Ohr had a period of 180 calendar days, or until August 20, 2018, to regain compliance with the minimum closing bid price requirement. Ohr did not regain compliance with the minimum closing bid price requirement by August 20, 2018. Ohr was notified by Nasdaq that it might be afforded a second 180 calendar period to regain compliance with the minimum closing bid price requirement under certain circumstances. As a result, Ohr applied for an extension of the cure period, as permitted under the notification. In order to cure the deficiency, Ohr indicated that, to that extent necessary, it planned to seek approval for a reverse stock split in order to meet the minimum closing bid price requirement at a special meeting of Ohr’s stockholders which Ohr would hold prior to the expiration of the second 180 day period and effectuate the reverse stock split immediately thereafter.

 

On August 21, 2018, Ohr received a written notice from Nasdaq that Ohr had been granted an additional 180 calendar days, or until February 19, 2019, to regain compliance with the minimum $1.00 bid price per share requirement of the Listing Rules of Nasdaq (“Second Notice”). According to the Second Notice, if at any time before February 19, 2019, the bid price of Ohr common stock closed at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq would provide written notification that Ohr has achieved compliance with the minimum closing bid price requirement. If, however, compliance with the minimum closing bid price requirement cannot be demonstrated by February 19, 2019, Nasdaq will provide written notification that the Ohr common stock would be delisted. At that time, Ohr could appeal Nasdaq’s determination to a Hearings Panel.

 

On January 18, 2019, at a special meeting of Ohr’s stockholders, Ohr’s stockholders approved an amendment to Ohr’s certificate of incorporation to effect a reverse stock split of Ohr common stock at a split ratio of not less than one-for-three and not more than one-for-twenty, to be effective, if at all, at such time as the Ohr board of directors shall determine in its sole discretion. On January 18, 2019, following the Ohr special meeting, the Ohr board of directors approved a one-for-twenty reverse stock split of Ohr’s issued and outstanding shares of common stock. On January 22, 2019, Ohr filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect the reverse stock split. Ohr common stock began trading on a split-adjusted basis when the market opened on February 4, 2019. On February 20, 2019, Ohr received written confirmation from Nasdaq this it had regained compliance with Nasdaq listing requirements, and Nasdaq considers the matter closed. Although Ohr has regained compliance with the minimum $1.00 bid price requirement since Ohr common stock closed at $1.00 per share or more for a minimum of ten consecutive business days, there can be no assurance that Ohr will be able to maintain compliance with the requirements for listing Ohr common stock on Nasdaq. The failure to maintain Ohr’s listing on Nasdaq could have an adverse effect on the market price and liquidity of Ohr’s shares of common stock.

 

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There is no certainty that Ohr will be able to execute on any strategic alternatives to maximize stockholder value. If Ohr is unable to execute such strategic alternatives, Ohr may be forced to cease operations and liquidate.

 

Based on the results of the MAKO study, Ohr began a comprehensive review of strategic alternatives to maximize stockholder value. As part of its review of strategic alternatives, Ohr formed a special committee of independent directors. The Ohr board of directors and the Ohr special committee retained Roth to advise and assist Ohr in this review. The strategic alternatives that Ohr was exploring included some or all of the following: license, divestiture, or monetization of current assets; license or acquisition of additional assets; merger, reverse merger, joint venture, partnership, or other business combination with another entity, public or private. There can be no assurance that this review process will result in a transaction, or that if a transaction does occur, that it will successfully enhance stockholder value. Ohr’s expected cash position, net of all liabilities, limits Ohr’s attractiveness to potential merger candidates and the value that Ohr may receive in such merger, joint venture, partnership, or other business combination scenarios may be less than the current market value of Ohr. If Ohr is unable to execute on this strategic or any other strategic alternative, Ohr may be forced to liquidate.

 

The process of exploring strategic alternatives could adversely impact Ohr’s business, financial condition and results of operations. Ohr could incur substantial expenses associated with identifying, evaluating, and executing on potential strategic alternatives, including those related to equity compensation, severance pay and insurance, legal, accounting and financial advisory fees. In addition, the process may be time consuming and disruptive to Ohr’s business operations, could divert the attention of management and the board of directors from Ohr’s business, could negatively impact Ohr’s ability to attract, retain and motivate key employees, and could expose Ohr to potential litigation in connection with this process or any resulting transaction. Further, speculation regarding any developments related to the review and execution of strategic alternatives and perceived uncertainties related to Ohr’s future could cause Ohr stock price to fluctuate significantly.

 

Ohr identified NeuBase as the right strategic partner based on its strategic plan. However, there is no assurance that the transaction with NeuBase will be consummated. See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”

 

Ohr has incurred significant losses and anticipate that Ohr will incur additional losses. Ohr might never achieve or sustain revenues.

 

Ohr has experienced significant net losses since its inception. As of December 31, 2018, Ohr had an accumulated deficit of approximately $122.2 million. Ohr expects to continue to incur net losses.

 

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The report of Ohr’s independent registered public accounting firm expresses substantial doubt about Ohr’s ability to continue as a going concern. Such “going concern” opinion could impair Ohr’s ability to obtain financing.

 

Ohr’s auditors, MaloneBailey, LLP, have indicated in their report on Ohr’s financial statements for the fiscal year ended September 30, 2018 that conditions exist that raise substantial doubt about Ohr’s ability to continue as a going concern due to Ohr’s recurring losses from operations. A “going concern” opinion could impair Ohr’s ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives. Ohr’s ability to continue as a going concern will depend upon the availability and terms of future funding. If Ohr is unable to achieve this goal, Ohr’s business would be jeopardized and Ohr may not be able to continue. If Ohr ceased operations, it is likely that all of Ohr’s investors would lose their investment.

 

Ohr depends upon key officers and consultants in a competitive market for skilled personnel. If Ohr is unable to retain key personnel, it could adversely affect its business. The negative result of the MAKO study and Ohr’s limited financial resources may make Ohr less successful at retaining employees.

 

Ohr is highly dependent upon the principal members of its management team, especially Ohr’s Chief Executive Officer, Dr. Jason Slakter, and Vice President of Business Development and Chief Financial Officer, Sam Backenroth, as well as Ohr’s directors and key consultants. A loss of any of these personnel may have a material adverse effect on aspects of Ohr’s business.

 

The announcement that Ohr has commenced a review of strategic alternatives may create uncertainty about Ohr’s prospects as an independent business entity and make it more difficult to retain qualified executive and other key personnel. The review process may also be costly, time-consuming, divert the attention of management or result in changes in Ohr’s management team or the Ohr board of directors, all of which could materially and adversely affect Ohr’s business. Ohr may be required to enter into retention agreements with its key employees to ensure execution of a strategic transaction, once such transaction is identified. In addition, Ohr’s stock price may experience periods of increased volatility as a result of these activities or related rumors and speculation.

 

Ohr identified NeuBase as the right strategic partner based on its strategic plan. However, there is no assurance that the transaction with NeuBase will be consummated. See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”

 

Risks Related to Ohr’s Business and Industry

 

Ohr currently does not have, and may never have, any products that generate revenues.

 

Ohr is a development stage pharmaceutical company and currently does not have, and may never have, any products that generate revenues. Investment in pharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. To date, Ohr has not generated any product revenues.

 

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Ohr is highly dependent upon its ability to raise additional capital. Raising additional capital may cause dilution to Ohr’s stockholders, restrict Ohr’s operations or require it to relinquish rights to its technologies.

 

Until such time, if ever, as Ohr can generate substantial product revenues, Ohr may finance its cash needs through a combination of equity offerings, debt financings, and partnerships. Ohr does not have any committed external source of funds. To the extent that Ohr raises additional capital through the sale of equity or convertible debt securities, Ohr’s stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect Ohr’s stockholders’ rights as holders of Ohr common stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting Ohr’s ability to take specific actions.

 

If Ohr raises capital through a partnership, Ohr may have to relinquish rights to its technologies or grant licenses on terms that may not be favorable to Ohr. If Ohr is unable to raise additional funds through equity or debt financings when needed, Ohr may be required to cease operations and liquidate.

 

Ohr is highly dependent upon its ability to enter into agreements with collaborative partners to develop, commercialize, and market any products.

 

Ohr is dependent on strategic partnerships to develop technologies and products. To date, Ohr has not entered into any strategic partnerships for any products. Ohr faces significant competition in seeking appropriate strategic partners, and these strategic partnerships can be intricate and time consuming to negotiate and document. Ohr may not be able to negotiate strategic partnerships on acceptable terms, or at all. Ohr is unable to predict when, if ever, Ohr will enter into any strategic partnerships because of the numerous risks and uncertainties associated with establishing strategic partnerships.

 

While Ohr’s strategy is to partner with an appropriate party, no assurance can be given that any third party would be interested in partnering with Ohr. Ohr currently lacks the resources to conduct clinical trials, to manufacture any product candidates on a large scale, and Ohr has no sales, marketing or distribution capabilities. In the event Ohr is not able to enter into a collaborative agreement with a partner or partners, on commercially reasonable terms, or at all, Ohr may be unable to conduct clinical trials, or to develop products which would have a material adverse effect upon Ohr’s business, prospects, financial condition, and results of operations.

 

Even if Ohr succeeds in securing a partner, the partner collaborators may fail to develop or effectively commercialize products using Ohr’s technologies. Such partnership would pose a number of risks, including the following:

 

partners may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus;

 

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collaborators may believe Ohr’s intellectual property or the product candidate infringes on the intellectual property rights of others;

 

partners may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues;

 

partners may decide to pursue a competitive product developed outside of the partnership arrangement;

 

partners may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals;

 

partners may delay the development or commercialization of any product candidates in favor of developing or commercializing another party’s product candidate; or

 

partners may decide to terminate or not to renew the collaboration for these or other reasons.

 

Thus, should Ohr ever be successful in entering into a partnership agreement, the agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. Partnership agreements are generally terminable without cause on short notice. Ohr also face competition in seeking out collaborators. If Ohr is unable to secure new partners that achieve the partner’s objectives and meet Ohr’s expectations, Ohr may be unable to advance any product candidates and may not generate meaningful revenues.

 

Ohr has no experience selling, marketing or distributing products and no internal capability to do so.

 

Ohr currently has no sales, marketing or distribution capabilities and no experience in building a sales force and distribution capabilities. If Ohr is ever in a position to commercialize any products, of which there can be no assurance, Ohr must develop internal sales, marketing and distribution capabilities, which will be expensive and time consuming, or make arrangements with third parties to perform these services. If Ohr decides to market any products directly, Ohr must commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution capabilities. Building an in-house marketing and sales force with technical expertise and distribution capabilities will require significant expenditures, management resources and time. Factors that may inhibit Ohr’s efforts to commercialize any products directly and without strategic partners include:

 

Ohr’s inability to recruit and retain adequate numbers of effective sales and marketing personnel;

 

The inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any products;

 

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The lack of complementary products to be offered by sales personnel, which may put Ohr at a competitive disadvantage relative to companies with more extensive product lines; and

 

Unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.

 

Ohr may not be successful in recruiting the sales and marketing personnel necessary to sell any products and even if Ohr does build a sales force, they may not be successful in marketing any products, which would have a material adverse effect on Ohr’s business and results of operations.

 

If Ohr is ever to conduct additional clinical trials, Ohr would continue to rely on third parties to conduct any such trials for Ohr. If such third parties do not successfully carry out their duties or if Ohr loses its relationships with such third parties, Ohr’s drug development efforts could be delayed.

 

Ohr is dependent on contract research organizations, third-party vendors and independent investigators for preclinical testing, and clinical trials related to any potential drug discovery and development efforts. These parties are not Ohr’s employees, and Ohr cannot control the amount or timing of resources that they devote to any programs. If they fail to devote sufficient time and resources to any drug development programs or if their performance is substandard, it would delay the development and commercialization of these product candidates. The parties with which Ohr would contract for execution of its clinical trials would play a significant role in the conduct of the trials and the subsequent collection and analysis of data. Their failure to achieve their research goals or otherwise meet their obligations on a timely basis could adversely affect clinical development of these product candidates.

 

Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:

 

Have staffing difficulties;

 

Fail to comply with contractual obligations;

 

Experience regulatory compliance issues;

 

Undergo changes in priorities or become financially distressed; or

 

Form relationships with other parties, some of which may be Ohr’s competitors.

 

These factors may materially adversely affect the willingness or ability of third parties to conduct any clinical trials and may lead to unexpected cost increases. Nevertheless, Ohr is responsible for ensuring that each of Ohr’s studies would be conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and Ohr’s reliance on contract research organizations would not relieve Ohr of its regulatory responsibilities. Ohr and its contract research organizations would be required to comply with applicable current Good Laboratory Practice (“CGLP”), current Good Manufacturing Practice (“CGMP”), and current Good Clinical Practice (“CGCP”) regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces these CGCP regulations through periodic inspections of clinical trial sponsors, principal investigators and trial sites. If Ohr or its contract research organizations fail to comply with applicable CGCP, the clinical data generated in these clinical trials might be deemed unreliable and the FDA or comparable foreign regulatory authorities may require additional clinical trials before approving the marketing applications. Ohr cannot assure that, upon inspection, the FDA or any comparable foreign regulatory authority will determine that any clinical trials would comply with CGCP. In addition, clinical trials must be conducted with product produced under CGMP regulations and would require a large number of test subjects. Ohr’s failure or the failure of its contract research organizations to comply with these regulations might require Ohr to repeat clinical trials, which would delay the regulatory approval process and could also subject Ohr to enforcement action up to and including civil and criminal penalties.

 

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If Ohr is ever to conduct any additional trials and its contract research organizations do not successfully carry out their duties or if Ohr was to lose relationships with contract research organizations, any drug development efforts could be delayed or terminated.

 

If Ohr was to lose relationships with any one or more of these parties, Ohr could experience a significant delay in both identifying another comparable provider and then contracting for its services. Ohr may be unable to retain an alternative provider on reasonable terms, if at all. Even if Ohr locates an alternative provider, it is likely that this provider might need additional time to respond to Ohr’s needs and might not provide the same type or level of service as the original provider. In addition, any provider that Ohr retains would be subject to CGLP and CGCP, other regulatory standards, and similar foreign standards, and Ohr does not have control over compliance with these regulations by these providers. Consequently, if these practices and standards are not adhered to by these providers, the development and commercialization of any products could be delayed, and have a material adverse effect on Ohr’s business.

 

Ohr may not be able to continue or fully exploit its relationships with outside advisors, which could impair Ohr’s business.

 

Ohr works with advisors who are experts in their respective fields. They advise Ohr with respect to its business and operations. These advisors are not Ohr’s employees and may have other commitments that would limit their future availability to Ohr. If a conflict of interest arises between their work for Ohr and their work for another entity, Ohr may lose their services, which may impair its reputation in the industry and its business efforts.

 

Ohr has no manufacturing capabilities, and, if needed, would rely completely on third-party manufacturers, which might result in delays in research, development, clinical trials, regulatory approvals and product introductions.

 

Ohr has no manufacturing facilities and does not have extensive experience in the manufacturing of drugs or in designing drug manufacturing processes. Ohr would have to contract with third-party manufacturers to produce, in collaboration with Ohr, any products for clinical trials. Ohr’s reliance on these third parties for development activities would reduce Ohr’s control over these activities but would not relieve Ohr of its responsibility to ensure compliance with all required regulations and study and trial protocols. If these third parties were not to successfully carry out their contractual duties, meet expected deadlines or conduct studies in accordance with regulatory requirements or Ohr’s stated study and trial plans and protocols, or if there were disagreements between Ohr and these third parties, Ohr would not be able to initiate, or complete, or may be delayed in completing, the clinical trials required to support future approval of any products. In some such cases, Ohr might need to locate an appropriate replacement third-party relationship, which may not be readily available or with acceptable terms, which would cause additional delay with respect to the approval of products and would thereby have a material adverse effect on Ohr’s business, financial condition, results of operations and prospects.

 

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Contract manufacturers are subject to significant regulatory oversight with respect to manufacturing products. The manufacturing facilities on which Ohr would need to rely may not continue to meet regulatory requirements and may have limited capacity.

 

Any manufacturers of product candidates are obliged to operate in accordance with FDA-mandated CGMPs. In addition, the facilities that would be used by contract manufacturers or other third party manufacturers to manufacture product candidates must be approved by the FDA or other foreign regulatory authority pursuant to inspections that would be conducted after Ohr requests regulatory approval from the FDA or other foreign regulatory authority. A failure of any contract manufacturers to establish and follow CGMPs and to document their adherence to such practices may lead to significant delays in development, or in clinical trials or in obtaining regulatory approval of product candidates or the ultimate launch of products into the market. Furthermore, any contract manufacturers are likely to be engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes them to regulatory risks for the production of such materials and products. As a result, failure to satisfy the regulatory requirements for the production of those materials and products may affect the regulatory clearance of the contract manufacturers’ facilities generally. Failure by third-party manufacturers or Ohr to comply with applicable regulations could result in sanctions being imposed on Ohr, including fines, injunctions, civil penalties, failure of the government to grant pre-market approval of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of products, operating restrictions, and criminal prosecutions. Many aspects of the clinical trial and manufacturing process are outside of Ohr’s control. The facilities and quality systems of third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of product candidates. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of product candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted.

 

The regulatory authorities also may, at any time following approval of a product for sale, audit Ohr’s manufacturing facilities or those of third-party manufacturers. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of product specifications or applicable regulations occurs independent of such an inspection or audit, Ohr or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for Ohr or third-party manufacturers to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a manufacturing facility. Any such remedial measures imposed upon Ohr or third parties with whom Ohr might contract could materially harm Ohr’s business.

 

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Developments by competitors may render Ohr’s technologies obsolete or non-competitive which would have a material adverse effect on Ohr’s business and results of operations.

 

Any drug candidates would have to compete with existing therapies and therapies under development by competitors. In addition, the commercial opportunities may be reduced or eliminated if competitors develop and market products that are less expensive, more effective or safer. Even if Ohr is successful in developing effective drugs, they may not compete successfully with products produced by Ohr’s competitors. Most of Ohr’s competitors, either alone or together with their collaborative partners, operate larger research and development programs, have larger staffing and facilities, and have substantially greater financial resources than Ohr does, as well as significantly greater experience in:

 

Developing drugs;

 

Undertaking preclinical testing and human clinical trials;

 

Obtaining FDA and other regulatory approvals, including foreign regulatory approvals, of drugs;

 

Formulating and manufacturing drugs; and

 

Launching, marketing and selling drugs.

 

These organizations also compete with Ohr for mergers, acquisitions and joint venture candidates and for other collaborations.

 

Ohr’s employees, partners, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 

Ohr is exposed to the risk that its employees, partners, independent contractors, consultants, and vendors may engage in fraudulent or other illegal activity with respect to Ohr’s business. Such misconduct could include intentional, reckless and/or negligent conduct or unauthorized activity that violates: (1) FDA or any comparable foreign regulatory authority regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or any comparable foreign regulatory authority; (2) manufacturing standards; (3) federal, state and foreign healthcare fraud and abuse laws and regulations; or (4) laws that require the true, complete and accurate reporting of financial information or data. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions and serious harm to Ohr’s reputation. Any incidents or any other conduct that leads to an employee receiving an FDA or other regulatory authority debarment could result in a loss of business from Ohr’s partners and severe reputational harm. Ohr has adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter misconduct, and the precautions Ohr takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Ohr from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against Ohr, and Ohr is not successful in defending itself or asserting Ohr’s rights, those actions could have a significant impact on Ohr’s business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Ohr’s operations, any of which could adversely affect Ohr’s ability to operate its business, operating results and financial condition.

 

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Security breaches and other disruptions could compromise Ohr’s information and expose Ohr to liability, which would cause Ohr’s business and reputation to suffer.

 

Ohr stores sensitive data, including intellectual property, its proprietary business information and personally identifiable information of its employees, in its data centers and on its networks. The secure maintenance of this information is critical to Ohr’s operations. Despite Ohr’s security measures, Ohr’s information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could compromise Ohr’s networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, and damage Ohr’s reputation.

 

Ohr’s business and operations would suffer in the event of system failures.

 

Despite the implementation of security measures, Ohr’s internal computer systems and those of its contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such an event could cause interruption of Ohr’s operations. To the extent that any disruption or security breach were to result in a loss of or damage to Ohr’s data, or inappropriate disclosure of confidential or proprietary information, Ohr could incur liability and the development of product candidates could be delayed.

 

Risks Related to FDA, Comparable Foreign Regulatory Authority and Healthcare Regulations.

 

Pharmaceutical companies face heavy government regulation. FDA regulatory approval and/or comparable foreign regulatory authority’s approval of any products is uncertain.

 

The research, testing, manufacturing and marketing of drug products are subject to extensive regulation by federal, state and local government authorities, including the FDA or any comparable foreign regulatory authority. To obtain regulatory approval of a product, one must demonstrate to the satisfaction of the applicable regulatory agency that, among other things, the product is safe and effective for its intended use. In addition, one must show that the manufacturing facilities used to produce the products are in compliance with CGMP regulations.

 

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The process of obtaining FDA and other required regulatory approvals, including foreign regulatory approvals and clearances, would require a substantial amount of time and significant capital expenditure. Despite the time and expense expended, regulatory approval is never guaranteed. The number of preclinical and clinical trials that would be required for FDA approval, or any comparable foreign regulatory authority’s approval, varies depending on the drug candidate, the disease or condition for which the drug candidate is in development, and the requirements applicable to that particular drug candidate. The FDA or other foreign health authority can delay, limit or deny approval of a drug candidate for many reasons, including that:

 

a drug candidate may not be shown to be safe or effective;

 

the FDA or any comparable foreign regulatory authority may not approve the manufacturing process;

 

the FDA or any comparable foreign regulatory authority may interpret data from preclinical and clinical trials in different ways; and

 

the FDA may not meet, or may extend, the Prescription Drug User Fee Act date with respect to a particular NDA.

 

If and when products do obtain marketing approval, the marketing, distribution and manufacture of such products would remain subject to extensive ongoing regulatory requirements. Failure to comply with applicable regulatory requirements could result in:

 

warning letters;

 

fines;

 

civil penalties;

 

injunctions;

 

recall or seizure of products;

 

total or partial suspension of production;

 

refusal of the government to grant future approvals;

 

withdrawal of approvals; and

 

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criminal prosecution.

 

Ohr has not received regulatory approval to market any product candidates in any jurisdiction.

 

Following regulatory approval of any drug products, ongoing regulatory obligations and restrictions might result in significant expense and limit the ability to commercialize any products.

 

With regard to drug candidates, if any, approved by the FDA or by another regulatory authority, including a foreign regulatory authority, Ohr would be held to extensive regulatory requirements over product manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping. Regulatory approvals may also be subject to significant limitations on the indicated uses or marketing of the drug candidates. Potentially costly follow-up or post-marketing clinical studies may be required as a condition of approval to further substantiate safety or efficacy, or to investigate specific issues of interest to the regulatory authority. Previously unknown problems with the drug candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.

 

In addition, the law or regulatory policies governing pharmaceuticals may change. Ohr cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or elsewhere. If Ohr was able to maintain regulatory compliance, Ohr might not be permitted to market any drugs, which could have a material adverse effect on Ohr’s business and competitive position.

 

Healthcare policy changes, including proposals to reform the U.S. healthcare system, may harm Ohr’s future business.

 

Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices Ohr would be able to charge for products, or the amounts of reimbursement available for these products from governmental agencies and third party payors. These limitations could in turn reduce the amount of investment into development, and the amount of revenues that Ohr would be able to generate in the future from sales of products and licenses of Ohr’s technology.

 

The Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act of 2010, together, the Healthcare Reform Act, is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of health insurance mandates on employers and individuals, the provision of subsidies to eligible individuals enrolled in plans offered on the health insurance exchanges, and the expansion of the Medicaid program. This law has substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry. In addition, the Healthcare Reform Act imposes an annual fee, which will increase annually, on sales by branded pharmaceutical manufacturers starting in 2011. The financial impact of these discounts, increased rebates and fees and the other provisions of the legislation on Ohr’s business is unclear and there can be no assurance that Ohr’s business will not be materially adversely affected. In addition, these and other ongoing initiatives in the United States have increased and will continue to increase pressure on drug pricing. The announcement or adoption of any government initiatives could have an adverse effect on potential revenues from any product that Ohr may successfully develop.

 

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Moreover, additional legislative or regulatory changes remain possible and appear likely. In this regard, the U.S. Tax Cuts and Jobs Act of 2017, or U.S. Tax Act, signed into law in December 2017, includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Healthcare Reform Act on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” The nature and extent of any additional legislative or regulatory changes to the Healthcare Reform Act are uncertain at this time. Ohr expects that the Healthcare Reform Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future could have a material adverse effect on Ohr’s industry generally. In addition to the Healthcare Reform Act, there will continue to be proposals by legislators at both the federal and state levels, regulators and third party payors to keep healthcare costs down while expanding individual healthcare benefits.

 

Various healthcare reform proposals have also emerged at the state level. Ohr cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on Ohr. However, an expansion in government’s role in the U.S. healthcare industry may lower the revenues for future products and adversely affect Ohr’s future business, possibly materially.

 

Risks Related to Ohr’s Intellectual Property

 

Ohr’s ability to compete may be undermined if Ohr does not adequately protect its proprietary rights.

 

Ohr’s commercial success depends on obtaining and maintaining proprietary rights to product candidates and technologies and their uses, as well as successfully defending these rights against third-party challenges. Ohr will be able to most effectively protect product candidates, technologies, and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them. Nonetheless, the issued patents and patent applications covering Ohr’s technologies remain subject to uncertainty due to a number of factors, including:

 

Ohr may not have been the first to make one or more of the inventions covered by Ohr’s pending patent applications or issued patents;

 

Ohr may not have been the first to file patent applications for one or more of Ohr’s technologies Ohr relies upon;

 

others may independently develop similar or alternative technologies or duplicate any of Ohr’s technologies;

 

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Ohr’s disclosures in a particular patent application may be determined to be insufficient to meet the statutory requirements for patentability;

 

one or more of Ohr’s pending patent applications may not result in issued patents

 

Ohr may not seek or obtain patent protection in all countries that will eventually provide a significant business opportunity;

 

one or more patents issued to Ohr or to its collaborators may not provide a basis for commercially viable products, may not provide Ohr with any competitive advantages or may be challenged by third parties;

 

Ohr may fail to file for patent protection in all of the countries where patent protection will ultimately be necessary or fail to comply with other procedural, documentary, fee payment or other provisions during the patent process in any such country, and Ohr may be precluded from filing at a later date or may lose some or all patent rights in the relevant jurisdiction;

 

one or more of Ohr’s technologies may not be patentable;

 

others may design around one or more of Ohr’s patent claims to produce competitive products which fall outside of the scope of Ohr’s patents;

 

others may identify prior art which could invalidate Ohr’s patents; or

 

changes to patent laws may limit the exclusivity rights of patent holders.

 

Even if Ohr has or obtains patents covering Ohr’s technologies, it may still be barred from making, using and selling one or more of its technologies because of the patent rights of others. Others have or may have filed, and in the future are likely to file, patent applications covering compounds, assays, therapeutic products and delivery systems, including sustained release delivery, that are similar or identical to Ohr. Numerous U.S. and foreign issued patents and pending patent applications owned by others exist in the area of medical disorders. These could materially affect Ohr’s ability to develop products. Because patent applications can take years to issue, there may be currently pending applications unknown to Ohr that may later result in issued patents that Ohr’s technologies may infringe. These patent applications may have priority over one or more patent applications filed by Ohr.

 

If Ohr’s competitors have prepared and filed patent applications in the United States that claim technology Ohr also claim, it may have to participate in interference proceedings required by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial costs, even if Ohr ultimately prevails. Results of interference proceedings are highly unpredictable and may result in Ohr having to try to obtain licenses in order to develop or market drug products.

 

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Disputes may arise regarding the ownership or inventorship of Ohr’s inventions. It is difficult to determine how such disputes would be resolved. Others may challenge the validity of Ohr’s patents. If one or more of Ohr’s patents are found to be invalid, Ohr will lose the ability to exclude others from making, using or selling the inventions claimed therein.

 

Research collaborators and scientific advisors have rights to publish data and information to which Ohr has rights. Additionally, employees whose positions may be eliminated may seek future employment with Ohr’s competitors. Each of Ohr’s employees is required to sign a confidentiality agreement and invention assignment agreement with Ohr at the time of hire. While such arrangements are intended to enable Ohr to better control the use and disclosure of Ohr’s proprietary property and provide for Ohr’s ownership of proprietary technology developed on Ohr’s behalf, they may not provide Ohr with meaningful protection for such property and technology in the event of unauthorized use or disclosure. In addition, technology that Ohr may in-license may become important to some aspects of its business. Ohr generally will not control all of the patent prosecution, maintenance or enforcement of in-licensed technology.

 

Ohr relies on confidentiality agreements that could be breached and may be difficult to enforce, which could have a material adverse effect on its business and competitive position.

 

Ohr’s policy is to enter into agreements relating to the non-disclosure of confidential information with third parties, including its contractors, consultants, advisors and research collaborators, as well as agreements that purport to require the disclosure and assignment to Ohr of the rights to the ideas, developments, discoveries and inventions of Ohr’s employees and consultants while Ohr employs them. However, these agreements can be difficult and costly to enforce. Moreover, to the extent that Ohr’s contractors, consultants, advisors and research collaborators apply or independently develop intellectual property in connection with any of Ohr’s projects, disputes may arise as to the proprietary rights to this type of information. If a dispute arises, a court may determine that the right belongs to a third party, and enforcement of Ohr’s rights can be costly and unpredictable. In addition, Ohr relies on trade secrets and proprietary know-how that it will seek to protect in part by confidentiality agreements with its employees, contractors, consultants, advisors or others. In addition, courts outside the United States may be less willing to protect trade secrets. Despite the protective measures Ohr employs, it still faces the risk that:

 

these agreements may be breached;

 

these agreements may not provide adequate remedies for the applicable type of breach; or

 

Ohr’s trade secrets or proprietary know-how will otherwise become known.

 

Any breach of Ohr’s confidentiality agreements or Ohr’s failure to effectively enforce such agreements would have a material adverse effect on Ohr’s business.

 

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If Ohr infringes the rights of third parties, it could be forced to pay damages and required to defend against litigation which could result in substantial costs and may have a material adverse effect on Ohr’s business and results of operations.

 

Ohr has not received to date any claims of infringement by any third parties. However, should Ohr’s public profile be raised, such infringement claims may be more likely. Defending against such claims, and an occurrence of a judgment adverse to Ohr, could result in unanticipated costs and may have a material adverse effect on Ohr’s business. If any of Ohr’s technologies, methods, processes and other technologies infringe the proprietary rights of other parties, it could incur substantial costs and it may have to:

 

obtain licenses, which may not be available on commercially reasonable terms, if at all;

 

redesign products or processes to avoid infringement;

 

stop using the subject matter claimed in the patents held by others;

 

defend litigation or administrative proceedings that may be costly whether Ohr win or lose, and which could result in a substantial diversion of management resources; or

 

pay damages.

 

Any costs incurred in connection with such events or the inability to develop products may have a material adverse effect on Ohr’s business and results of operations.

 

Intellectual property litigation is increasingly common and increasingly expensive and may result in restrictions on Ohr’s business and substantial costs, even if Ohr prevails.

 

Patent and other intellectual property litigation is becoming more common in the pharmaceutical industry. Litigation is sometimes necessary to defend against or assert claims of infringement, to enforce Ohr’s patent rights, including those Ohr has licensed from others, to protect trade secrets or to determine the scope and validity of proprietary rights of third parties. Currently, no third party is asserting that Ohr is infringing upon their patent rights or other intellectual property, nor is Ohr aware or believe that it is infringing upon any third party’s patent rights or other intellectual property. Ohr may, however, be infringing upon a third party’s patent rights or other intellectual property, and litigation asserting such claims might be initiated in which Ohr would not prevail, or Ohr would not be able to obtain the necessary licenses on reasonable terms, if at all. All such litigation, whether meritorious or not, as well as litigation initiated by Ohr against third parties, is time-consuming and very expensive to defend or prosecute and to resolve. In addition, if Ohr infringes the intellectual property rights of others, it could lose its right to develop, manufacture or sell products or could be required to pay monetary damages or royalties to license proprietary rights from third parties. An adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent Ohr from manufacturing or selling products, which could harm Ohr’s business, financial condition and prospects.

 

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A dispute concerning the infringement or misappropriation of Ohr’s proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm Ohr’s business.

 

There is significant litigation in Ohr’s industry regarding patent and other intellectual property rights. While Ohr is not currently subject to any pending intellectual property litigation, and are not aware of any such threatened litigation, it may be exposed to future litigation by third parties based on claims that its technologies or activities infringe the intellectual property rights of others. If any drug development activities are found to infringe any such patents, Ohr may have to pay significant damages or seek licenses to such patents. If any products are found to infringe any such patents, Ohr may have to pay significant damages or seek licenses to such patents. A patentee could prevent Ohr from making, using or selling the patented compounds. Ohr may need to resort to litigation to enforce a patent issued to Ohr, protect its trade secrets or determine the scope and validity of third-party proprietary rights. From time to time, Ohr may hire scientific personnel formerly employed by other companies involved in one or more areas similar to the activities conducted by Ohr. Either Ohr or these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of their prior affiliations. If Ohr becomes involved in litigation, it could consume a substantial portion of its managerial and financial resources, regardless of whether it wins or lose. Ohr also may not be able to afford the costs of litigation.

 

The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to Ohr, could negatively impact its patent position.

 

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date. The U.S. Patent and Trademark Office’s standards are uncertain and could change in the future. Consequently, the issuance and scope of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or circumvented. U.S. patents and patent applications may also be subject to interference or derivation proceedings, and U.S. patents may be subject to inter partes review, post grant review and ex parte reexamination proceedings in the U.S. Patent and Trademark Office (and foreign patents may be subject to opposition or comparable proceedings in the corresponding foreign patent office), which proceedings could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. Similarly, opposition or invalidity proceedings could result in loss of rights or reduction in the scope of one or more claims of a patent in foreign jurisdictions. Such interference, inter partes review, post grant review and ex parte reexamination and opposition proceedings may be costly. Accordingly, rights under any issued patents may not provide Ohr with sufficient protection against competitive products or processes.

 

Changes in or different interpretations of patent laws in the United States and foreign countries may permit others to develop and commercialize Ohr’s technology without providing any compensation to Ohr or may limit the number of patents or claims Ohr can obtain. In particular, there have been proposals to shorten the exclusivity periods available under U.S. patent law that, if adopted, could substantially harm Ohr’s business. If the exclusivity period for patents is shortened, then Ohr’s ability to generate revenues without competition would be reduced and Ohr’s business could be materially adversely impacted. The laws of some countries do not protect intellectual property rights to the same extent as U.S. laws, and those countries may lack adequate rules and procedures for defending Ohr’s intellectual property rights. For example, some countries, including many in Europe, do not grant patent claims directed to methods of treating humans and, in these countries, patent protection may not be available at all to protect product candidates. In addition, U.S. patent laws may change, which could prevent or limit Ohr from filing patent applications or patent claims to protect Ohr’s technologies or limit the exclusivity periods that are available to patent holders. For example, the LeahySmith America Invents Act, or the Leahy-Smith Act, was recently signed into law and includes a number of significant changes to U.S. patent law. These include changes to transition from a “first-to-invent” system to a “first-to-file” system and to the way issued patents are challenged. These changes may favor larger and more established companies that have more resources to devote to patent application filing and prosecution. The U.S. Patent and Trademark Office has been in the process of implementing regulations and procedures to administer the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act may affect Ohr’s ability to obtain, enforce or defend Ohr’s patents. Accordingly, it is not clear what, if any, impact the LeahySmith Act will ultimately have on the cost of prosecuting Ohr’s patent applications, Ohr’s ability to obtain patents based on its discoveries and Ohr’s ability to enforce or defend its issued patents.

 

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If Ohr fails to obtain and maintain patent protection and trade secret protection of any product candidates, proprietary technologies and their uses, it could lose its competitive advantage and competition it faces would increase, reducing its potential revenues and adversely affecting its ability to attain profitability.

 

Risks Related to Ohr Common Stock

 

The market price and volume of Ohr common stock fluctuate significantly and could result in substantial losses for individual investors.

 

The stock market from time to time experiences significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These broad market fluctuations may cause the market price and volume of Ohr common stock to decrease. In addition, the market price and volume of Ohr common stock is highly volatile.

 

Factors that may cause the market price and volume of Ohr common stock to decrease include:

 

delisting or other changes in status of Nasdaq listing (See Risk Factor entitled, “If Ohr fails to continue to meet all applicable Nasdaq requirements and Nasdaq determines to delist Ohr common stock, the delisting could adversely affect the market liquidity of Ohr common stock and the market price of Ohr common stock could decrease.”);

 

changes in stock market analyst recommendations regarding Ohr common stock or lack of analyst coverage;

 

fluctuations in Ohr’s results of operations, timing and announcements of its corporate news;

 

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developments concerning the NeuBase merger (See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”);

 

developments concerning discussions that Ohr may be in, or enter into, regarding strategic alliances, partnerships, reverse mergers, mergers, acquisitions, or similar transactions;

 

adverse actions taken by regulatory agencies with respect to any drug products, clinical trials, manufacturing processes or sales and marketing activities;

 

any lawsuit involving Ohr or any drug products;

 

developments with respect to Ohr’s patents and proprietary rights;

 

announcements of technological innovations by Ohr’s competitors;

 

public concern as to the safety of products developed by Ohr or others;

 

regulatory developments in the United States and in foreign countries;

 

the pharmaceutical industry conditions generally and general market conditions;

 

failure of Ohr’s results of operations to meet the expectations of stock market analysts and investors;

 

sales of Ohr common stock by its executive officers, directors and five percent stockholders or sales of substantial amounts of Ohr common stock;

 

changes in accounting principles; and

 

loss of any of Ohr’s key scientific or management personnel.

 

The market for Ohr common stock is illiquid. Ohr’s stockholders may not be able to resell their shares at or above the purchase price paid by such stockholders, or at all.

 

Ohr common stock is listed on Nasdaq. The market for Ohr’s securities is illiquid. This illiquidity may be caused by a variety of factors including:

 

lower trading volume;

 

low stock price; and

 

market conditions.

 

There is limited trading in Ohr common stock and Ohr’s security holders may experience wide fluctuations in the market price of Ohr’s securities. Such price and volume fluctuations have particularly affected the trading prices of equity securities of many pharmaceutical and biotechnology companies. These price and volume fluctuations often appear to have been unrelated to the operating performance of the affected companies. These fluctuations may have an extremely negative effect on the market price of Ohr’s securities and may prevent a stockholder from obtaining a market price equal to the purchase price such stockholder paid when the stockholder attempts to sell Ohr’s securities in the open market. In these situations, the stockholder may be required either to sell Ohr’s securities at a market price which is lower than the purchase price the stockholder paid, or to hold Ohr’s securities for a longer period of time than planned. An inactive market may also impair Ohr’s ability to raise capital by selling shares of capital stock.

 

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As a “smaller reporting company,” Ohr may avail itself of reduced disclosure requirements, which may make Ohr common stock less attractive to investors.

 

Because the market value of Ohr common stock as of the end of its most recently completed second fiscal quarter was less than $250 million, Ohr is a “smaller reporting company” under applicable SEC rules and regulations. As a “smaller reporting company,” Ohr has relied on exemptions from certain disclosure requirements that are applicable to other public companies. Ohr may continue to rely on such exemptions for so long as Ohr remains a “smaller reporting company.” These exemptions include reduced financial disclosure, reduced disclosure obligations regarding executive compensation, and not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002. Ohr’s reliance on these exemptions may result in the public finding Ohr common stock to be less attractive and adversely impact the market price of Ohr common stock or the trading market thereof.

 

Ohr will not pay cash dividends and investors may have to sell their shares in order to realize their investment.

 

Ohr has not paid any cash dividends on its common stock and does not intend to pay cash dividends in the foreseeable future. Ohr intends to use Ohr’s cash for reinvestment in the development and marketing of products, technologies, and services. As a result, investors may have to sell their shares of common stock to realize any of their investment.

 

Ohr’s internal controls over financial reporting may not be effective which could have a significant and adverse effect on Ohr’s business and reputation.

 

Ohr is subject to the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 and the rules and regulations of the SEC thereunder (“Section 404”). Section 404 requires Ohr to report on the design and effectiveness of Ohr’s internal controls over financial reporting. In the past, Ohr’s management has identified certain “material weaknesses” in Ohr’s internal controls over financial reporting which Ohr believes has been remediated. However, any failure to maintain effective controls could result in significant deficiencies or material weaknesses, and cause Ohr to fail to meet Ohr’s periodic reporting obligations, or result in material misstatements in Ohr’s financial statements. Ohr may also be required to incur costs to improve its internal control system and hire additional personnel. This could negatively impact Ohr’s results of operations.

 

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Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses and divert management’s attention from operating Ohr’s business, which could have a material adverse effect on Ohr’s business.

 

There have been other changing laws, regulations and standards relating to corporate governance and public disclosure in addition to the Sarbanes-Oxley Act, as well as new regulations promulgated by the Commission and rules promulgated by the national securities exchanges. These new or changed laws, regulations and standards are subject to varying interpretations in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. As a result, Ohr’s efforts to comply with evolving laws, regulations and standards are likely to continue to result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities. Ohr’s board members, Chief Executive Officer and Chief Financial Officer could face an increased risk of personal liability in connection with the performance of their duties. As a result, Ohr may have difficulty attracting and retaining qualified board members and executive officers, which could have a material adverse effect on Ohr’s business. If Ohr’s efforts to comply with new or changed laws, regulations and standards differ from the activities intended by regulatory or governing bodies, Ohr may incur additional expenses to comply with standards set by regulatory authorities or governing bodies which would have a material adverse effect on Ohr’s business and results of operations.

 

Delaware law could discourage a change in control, or an acquisition of Ohr by a third party, even if the acquisition would be favorable to stockholders.

 

The Delaware General Corporation Law contains provisions that may have the effect of making more difficult or delaying attempts by others to obtain control of Ohr, even when these attempts may be in the best interests of stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited takeovers or delay or prevent changes in Ohr’s control or management, including transactions in which stockholders might otherwise receive a premium for their shares of common stock over then current market prices. These provisions may also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.

 

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The Ohr board of directors has the authority to issue Serial Preferred Stock, which could affect the rights of holders of the Ohr common stock and may delay or prevent a takeover that could be in the best interests of Ohr’s stockholders.

 

The Ohr board of directors has the authority to issue up to 9,416,664 shares of Serial Preferred Stock, $.0001 par value per share (the “Serial Preferred Stock”) (after giving effect to the conversion and cancellation of a previous issue of 5,583,336 shares of Series B Preferred), in one or more series and to fix the number of shares constituting any such series, the voting powers, designation, preferences and relative participation, optional or other special rights and qualifications, limitations or restrictions thereof, including the dividend rights and dividend rate, terms of redemption (including sinking fund provisions), redemption price or prices, conversion rights and liquidation preferences of the shares constituting any series, without any further vote or action by the stockholders. 6,000,000 shares of the Serial Preferred Stock, designated the Series B Preferred, have been authorized, 5,583,336 were issued and, as of the date of this filing, all such shares have been converted and no Series B Preferred shares remain issued and outstanding. The issuance of additional Serial Preferred Stock could affect the rights of the holders of Common Stock. For example, such issuance could result in a class of securities outstanding that would have preferential voting, dividend, and liquidation rights over the Common Stock, and could (upon conversion or otherwise) enjoy all of the rights appurtenant to the shares of common stock. The authority possessed by the board of directors to issue Serial Preferred Stock could potentially be used to discourage attempts by others to obtain control of Ohr through merger, tender offer, proxy contest or otherwise by making such attempts more difficult or costly to achieve. The board of directors may issue the Serial Preferred Stock without stockholder approval and with voting and conversion rights which could adversely affect the voting power of holders of common stock. There are no agreements or understandings for the issuance of Serial Preferred Stock and the board of directors has no present intention to issue any Serial Preferred Stock.

 

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Risks Related to NeuBase

 

NeuBase is a preclinical-stage company, has a very limited operating history, is not currently profitable, does not expect to become profitable in the near future and may never become profitable.

 

NeuBase is a preclinical-stage biotechnology company specializing in the discovery and development of the class of ribonucleic acid-targeted drugs called peptide nucleic acids. Since NeuBase’s incorporation in August 2018, it has focused primarily on the development of preclinical-stage therapeutic candidates. All of NeuBase’s therapeutic candidates are in the preclinical development stage, and NeuBase has not initiated clinical trials for any of its product candidates, nor have any products been approved for commercial sale and NeuBase has not generated any revenue. To date, NeuBase has not completed a clinical trial (including a pivotal clinical trial), obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for a third party to do so on the combined company’s behalf, or conducted sales and marketing activities necessary for successful product commercialization. Drug development is also a highly uncertain undertaking and involves a substantial degree of risk.

 

As a result, NeuBase has no meaningful historical operations upon which to evaluate NeuBase’s business and prospects and has not yet demonstrated an ability to obtain marketing approval for any of its product candidates or successfully overcome the risks and uncertainties frequently encountered by companies in the pharmaceutical industry. NeuBase also has not generated any revenues from collaboration and licensing agreements or product sales to date, and continues to incur research and development and other expenses. For the period of inception (August 28, 2018) through September 30, 2018 and for the three months ended December 31, 2018, NeuBase reported a net loss of $41,952 and $679,672, respectively, and had an accumulated deficit of $721,624 as of December 31, 2018. NeuBase’s prior losses, combined with expected future losses, have had and will continue to have an adverse effect on its stockholders’ deficit and working capital, and the future success of NeuBase is subject to significant uncertainty.

 

For the foreseeable future, NeuBase expects to continue to incur losses, which will increase significantly from historical levels as NeuBase expands its drug development activities, seeks regulatory approvals for its product candidates and begins to commercialize them if they are approved by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or comparable foreign authorities. Even if NeuBase succeeds in developing and commercializing one or more product candidates, NeuBase may never become profitable.

 

The approach NeuBase is taking to discover and develop nucleic acid therapeutics is novel and may never lead to marketable products.

 

NeuBase has concentrated its efforts and research and development activities on nucleic acid therapeutics and its synthetic chemistry drug development platform comprised of peptide nucleic acids with natural and engineered nucleotides. NeuBase’s future success depends on the successful development and manufacturing of such therapeutics and the effectiveness of its platform. The scientific discoveries that form the basis for NeuBase’s efforts to discover and develop new drugs, including NeuBase’s discoveries about the relationships between oligonucleotide stereochemistry and pharmacology, are relatively new. The scientific evidence to support the feasibility of developing drugs based on these discoveries is limited. Skepticism as to the feasibility of developing nucleic acid therapeutics generally has been, and may continue to be, expressed in scientific literature. In addition, decisions by, and negative results of, other companies with respect to their oligonucleotide development efforts may increase skepticism in the marketplace regarding the potential for oligonucleotides.

 

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Relatively few nucleic acid therapeutic product candidates have been tested in humans, and a number of clinical trials for such therapeutics conducted by other companies have not been successful. Few nucleic acid therapeutics have received regulatory approval. The pharmacological properties ascribed to the investigational compounds NeuBase is testing in laboratory studies may not be positively demonstrated in clinical trials in patients, and they may interact with human biological systems in unforeseen, ineffective or harmful ways. If NeuBase’s nucleic acid product candidates prove to be ineffective, unsafe or commercially unviable, NeuBase’s entire platform and pipeline would have little, if any, value, which would substantially harm NeuBase’s business, financial condition, results of operations and prospects.

 

In addition, NeuBase’s approach, which focuses on using nucleic acid therapeutics for drug development, as opposed to multiple or other, more advanced proven technologies, may expose NeuBase to additional financial risks and make it more difficult to raise additional capital if NeuBase is not successful in developing a nucleic acid therapeutic that achieves proof of concept in animal models, desired tissue distribution, selectivity for the target, and/or regulatory approval. Because NeuBase’s programs are all in the research or preclinical stage, NeuBase has not yet been able to assess safety in humans, and there may be long-term effects from treatment with any product candidates that NeuBase develops that NeuBase cannot predict at this time. Any product candidates NeuBase may develop will act at the level of DNA or RNA, and because animal DNA and RNA often differs from human DNA or RNA at the sequence level, in its regulation and degradation, secondary and tertiary structural conformations and ultimately in being translated into proteins with varying amino acid sequences conformations and functions, testing of NeuBase’s product candidates in animal models may not be predictive of the results it observes in human clinical trials of its product candidates for either safety or efficacy. Also, animal models may not exist for some of the diseases NeuBase chooses to pursue in its programs. As a result of these factors, it is more difficult for NeuBase to predict the time and cost of product candidate development, and NeuBase cannot predict whether the application of its gene silencing technology, or any similar or competitive gene silencing technologies, will result in the identification, development, and regulatory approval of any products. There can be no assurance that any development problems NeuBase experiences in the future related to its gene silencing technology or any of its research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved. Any of these factors may prevent NeuBase from completing its preclinical studies or any clinical trials that it may initiate or from commercializing any product candidates NeuBase may develop on a timely or profitable basis, if at all.

 

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NeuBase is highly dependent on the success of its initial product candidates targeting rare genetic diseases, and NeuBase cannot be certain that any of them will receive regulatory approval or be commercialized.

 

NeuBase has spent time, money and effort on the licensing and development of its core asset: the PATrOL™ platform. To date, NeuBase has not submitted an IND to the FDA, and no clinical trials have commenced with any of NeuBase’s product candidates. All of NeuBase’s product candidates will require additional development, including further preclinical studies and bioanalytic method development as well as clinical trials to evaluate their toxicology, carcinogenicity and pharmacokinetics, efficacy, and optimize their formulation, and regulatory clearances before they can be commercialized. Positive results obtained during early development do not necessarily mean later development will succeed or that regulatory clearances will be obtained. NeuBase’s drug development efforts may not lead to commercial drugs, either because NeuBase’s product candidates are not deemed safe and effective, because of competitive or market forces, intellectual property issues or because NeuBase has inadequate financial or other resources to advance NeuBase’s product candidates through the clinical development and approval processes. If any of NeuBase’s product candidates fail to demonstrate safety or efficacy at any time or during any phase of development, NeuBase would experience potentially significant delays in, or be required to abandon, development of the product candidate.

 

NeuBase does not anticipate that any of its current product candidates will be eligible to receive regulatory approval from the FDA, the EMA or comparable foreign authorities and begin commercialization for a number of years, if ever. Even if NeuBase ultimately receives regulatory approval for any of these product candidates, NeuBase or its potential future partners, if any, may be unable to commercialize them successfully for a variety of reasons. These include, for example, the availability of alternative treatments, lack of cost-effectiveness, the cost of manufacturing the product on a commercial scale and competition with other drugs. The success of NeuBase’s product candidates may also be limited by the prevalence and severity of any adverse side effects. If NeuBase fails to commercialize one or more of its current product candidates, NeuBase may be unable to generate sufficient revenues to attain or maintain profitability, and NeuBase’s financial condition may decline.

 

If development of NeuBase’s product candidates does not produce favorable results, NeuBase and its collaborators, if any, may be unable to commercialize these products.

 

To receive regulatory approval for the commercialization of NeuBase’s use of the PATrOL™ platform, or any other product candidates that NeuBase may develop, adequate and well-controlled clinical trials must be conducted to demonstrate safety and efficacy in humans to the satisfaction of the FDA, the EMA and comparable foreign authorities. In order to support marketing approval, these agencies typically require successful results in one or more Phase 3 clinical trials, which NeuBase’s current product candidates have not yet reached and may never reach. The development process is expensive, can take many years and has an uncertain outcome. Failure can occur at any stage of the process. NeuBase may experience numerous unforeseen events during, or as a result of, the development process that could delay or prevent commercialization of NeuBase’s current or future product candidates, including the following:

 

preclinical studies conducted with product candidates for potential clinical development to evaluate their toxicology, carcinogenicity and pharmacokinetics and optimize their formulation, among other things, may produce unfavorable results;

 

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patient recruitment and enrollment in clinical trials may be slower than NeuBase anticipates;

 

clinical trials may produce negative or inconclusive results;

 

costs of development may be greater than NeuBase anticipates;

 

the potential market advantages of the PATrOL™-enabled drugs may not materialize and thus would confer no benefits to patients over other products that may emerge;

 

NeuBase’s product candidates may cause undesirable side effects that delay or preclude regulatory approval or limit their commercial use or market acceptance, if approved;

 

collaborators who may be responsible for the development of NeuBase’s product candidates may not devote sufficient resources to these clinical trials or other preclinical studies of these candidates or conduct them in a timely manner; or

 

NeuBase may face delays in obtaining regulatory approvals to commence one or more clinical trials.

 

Additionally, because NeuBase’s technology potentially involves gene silencing via genome editing across multiple cell and tissue types, NeuBase is subject to many of the challenges and risks that advanced therapies such as gene therapies face, including:

 

regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future; to date, no products that involve the genetic modification of patient cells have been approved in the United States and only one gene therapy product has been approved in the European Union;

 

improper modification of a gene sequence in a patient’s genome could lead to lymphoma, leukemia or other cancers, or other aberrantly functioning cells; and

 

the FDA recommends a follow-up observation period of 15 years or longer for all patients who receive treatment using gene therapies, and NeuBase may need to adopt and support such an observation period for its product candidates.

 

Success in early development does not mean that later development will be successful because, for example, product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials.

 

Furthermore, NeuBase has licensed or acquired virtually all of the intellectual property related to its product candidates from third parties. NeuBase has licensed intellectual property from Carnegie Mellon University. All preclinical studies and other analyses performed to date with respect to NeuBase’s product candidates have been conducted by their original owners. Therefore, as a company, NeuBase has limited experience in conducting preclinical trials for its product candidates. Since NeuBase’s experience with its product candidates is limited, NeuBase will need to train its existing personnel or hire additional personnel in order to successfully administer and manage its preclinical studies and clinical trials as anticipated, which may result in delays in completing such anticipated preclinical trials and clinical studies.

 

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NeuBase currently does not have strategic collaborations in place for clinical development of any of its current product candidates. Therefore, in the future, NeuBase or any potential future collaborative partner will be responsible for establishing the targeted endpoints and goals for development of its product candidates. These targeted endpoints and goals may be inadequate to demonstrate the safety and efficacy levels required for regulatory approvals. Even if NeuBase believes data collected during the development of its product candidates are promising, such data may not be sufficient to support marketing approval by the FDA, the EMA or comparable foreign authorities. Further, data generated during development can be interpreted in different ways, and the FDA, the EMA or comparable foreign authorities may interpret such data in different ways than NeuBase or its collaborators. NeuBase’s failure to adequately demonstrate the safety and efficacy of NeuBase’s product candidates would prevent NeuBase’s receipt of regulatory approval, and such failure would ultimately prevent the potential commercialization of these product candidates.

 

Since NeuBase does not currently possess the resources necessary to independently develop and commercialize its product candidates or any other product candidates that NeuBase may develop, NeuBase may seek to enter into collaborative agreements to assist in the development and potential future commercialization of some or all of these assets as a component of NeuBase’s strategic plan. NeuBase’s discussions with potential collaborators, however, may not lead to the establishment of collaborations on acceptable terms, if at all, or it may take longer than expected to establish new collaborations, leading to development and potential commercialization delays, which would adversely affect NeuBase’s business, financial condition and results of operations.

 

NeuBase expects to continue to incur significant research and development expenses, which may make it difficult for NeuBase to attain profitability.

 

NeuBase expects to expend substantial funds in research and development, including preclinical studies and clinical trials of its product candidates, and to manufacture and market any product candidates in the event they are approved for commercial sale. NeuBase will likely need additional funding to develop or acquire complementary companies, technologies and assets, as well as for working capital requirements and other operating and general corporate purposes. Moreover, an increase in NeuBase’s headcount would dramatically increase NeuBase’s costs in the near and long-term.

 

Such spending may not yield any commercially viable products. Due to NeuBase’s limited financial and managerial resources, NeuBase must focus on a limited number of research programs and product candidates and on specific indications. NeuBase’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities.

 

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Because the successful development of NeuBase’s product candidates is uncertain, NeuBase is unable to precisely estimate the actual funds NeuBase will require to develop and potentially commercialize them. In addition, NeuBase may not be able to generate sufficient revenue, even if NeuBase is able to commercialize any of its product candidates, to become profitable.

 

NeuBase may expend its limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

 

Because NeuBase has limited financial and managerial resources, NeuBase will initially develop its lead product candidate for particular rare genetic diseases. As a result, NeuBase may forego or delay pursuit of opportunities in other types of diseases that may prove to have greater treatment potential. Likewise, NeuBase may forego or delay the pursuit of opportunities with other potential product candidates that may prove to have greater commercial potential.

 

NeuBase’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. NeuBase’s spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable product candidates. If NeuBase does not accurately evaluate the commercial potential or target market for a particular product candidate, NeuBase may relinquish valuable rights to that product candidate through collaboration, licensing or other similar arrangements in cases in which it would have been more advantageous for NeuBase to retain sole development and commercialization rights to the product candidate.

 

The opinion of NeuBase’s independent registered public accounting firm assumed NeuBase’s ability to continue as a going concern, and NeuBase must raise additional funds to finance its operations to remain a going concern.

 

Based on its cash balances, recurring losses since inception and inadequacy of existing capital resources to fund planned operations for a twelve-month period, NeuBase’s independent registered public accounting firm has included an emphasis of matter paragraph in its report on NeuBase’s financial statements as of and for the period from inception (August 28, 2018) to September 30, 2018 assuming NeuBase’s ability to continue as a going concern. NeuBase will, during the remainder of 2019 and 2020, require significant additional funding to continue operations even after taking into account the financing that is expected to take place immediately prior to or concurrently with the completion of the merger. If NeuBase is unable to raise additional funds when needed, it will not be able to continue development of its product candidates, or NeuBase will be required to delay, scale back or eliminate some or all of its development programs or cease operations. Any additional equity or debt financing that NeuBase is able to obtain may be dilutive to its current stockholders, and debt financing, if available, may involve restrictive covenants or unfavorable terms. If NeuBase raises funds through collaborative or licensing arrangements, it may be required to relinquish, on terms that are not favorable to NeuBase, rights to some of its technologies or product candidates that it would otherwise seek to develop or commercialize. Moreover, if NeuBase is unable to continue as a going concern, it may be forced to liquidate its assets, and the values it receives for its assets in liquidation or dissolution could be significantly lower than the values reflected in its financial statements.

 

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Given NeuBase’s lack of current cash flow, NeuBase will need to raise additional capital; however, it may be unavailable to NeuBase or, even if capital is obtained, may cause dilution or place significant restrictions on NeuBase’s ability to operate its business.

 

Since NeuBase will be unable to generate sufficient, if any, cash flow to fund its operations for the foreseeable future, NeuBase will need to seek additional equity or debt financing to provide the capital required to maintain or expand its operations.

 

There can be no assurance that NeuBase will be able to raise sufficient additional capital on acceptable terms or at all. If such additional financing is not available on satisfactory terms, or is not available in sufficient amounts, NeuBase may be required to delay, limit or eliminate the development of business opportunities, and its ability to achieve its business objectives, its competitiveness, and its business, financial condition and results of operations may be materially adversely affected. In addition, NeuBase may be required to grant rights to develop and market product candidates that it would otherwise prefer to develop and market itself. NeuBase’s inability to fund its business could lead to the loss of your investment.

 

NeuBase’s future capital requirements will depend on many factors, including, but not limited to:

 

the scope, rate of progress, results and cost of its preclinical studies, clinical trials and other related activities;

 

its ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;

 

the timing of, and the costs involved in, obtaining regulatory approvals for any of its current or future product candidates;

 

the number and characteristics of the product candidates it seeks to develop or commercialize;

 

the cost of manufacturing clinical supplies, and establishing commercial supplies, of its product candidates;

 

the cost of commercialization activities if any of its current or future product candidates are approved for sale, including marketing, sales and distribution costs;

 

the expenses needed to attract and retain skilled personnel;

 

the costs associated with being a public company;

 

the amount of revenue, if any, received from commercial sales of its product candidates, should any of its product candidates receive marketing approval; and

 

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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing possible patent claims, including litigation costs and the outcome of any such litigation.

 

Any additional capital efforts may divert NeuBase’s management from their day-to-day activities, which may adversely affect its ability to develop and commercialize its product candidates. Moreover, if NeuBase raises additional capital by issuing equity securities, the percentage ownership of its existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution. NeuBase may also issue equity securities that provide for rights, preferences and privileges senior to those of its common stock. Given NeuBase’s need for cash and that equity issuances are the most common type of fundraising for similarly situated companies, the risk of dilution is particularly significant for NeuBase’s stockholders. Furthermore, the incurrence of indebtedness would result in increased fixed payment obligations and NeuBase may be required to agree to certain restrictive covenants, such as limitations on its ability to incur additional debt and other operating restrictions that could adversely impact NeuBase’s ability to conduct its business. NeuBase could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and NeuBase may be required to relinquish rights to some of its product candidates or otherwise agree to terms unfavorable to NeuBase, any of which may have a material adverse effect on its business, operating results and prospects.

 

NeuBase’s efforts to discover product candidates beyond NeuBase’s current product candidates may not succeed, and any product candidates NeuBase recommends for clinical development may not actually begin clinical trials.

 

NeuBase intends to use its technology, including its licensed technology, knowledge and expertise to develop novel drugs to address some of the world’s most devastating and costly central nervous system and other disorders, including orphan genetic indications. NeuBase intends to expand its existing pipeline of core assets by advancing drug compounds from current ongoing discovery programs into clinical development. However, the process of researching and discovering drug compounds is expensive, time-consuming and unpredictable. Data from NeuBase’s current preclinical programs may not support the clinical development of its lead compounds or other compounds from these programs, and NeuBase may not identify any additional drug compounds suitable for recommendation for clinical development. Moreover, any drug compounds NeuBase recommends for clinical development may not demonstrate, through preclinical studies, indications of safety and potential efficacy that would support advancement into clinical trials. Such findings would potentially impede NeuBase’s ability to maintain or expand NeuBase’s clinical development pipeline. NeuBase’s ability to identify new drug compounds and advance them into clinical development also depends upon NeuBase’s ability to fund its research and development operations, and NeuBase cannot be certain that additional funding will be available on acceptable terms, or at all.

 

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The pharmaceutical market is intensely competitive. If NeuBase is unable to compete effectively with existing drugs, new treatment methods and new technologies, NeuBase may be unable to commercialize successfully any drugs that NeuBase develops.

 

The pharmaceutical market is intensely competitive and rapidly changing. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs for the same diseases that NeuBase is targeting or expect to target. Many of NeuBase’s competitors have:

 

much greater financial, technical and human resources than NeuBase has at every stage of the discovery, development, manufacture and commercialization of products and product candidates;

 

more extensive experience in designing and conducting preclinical studies and clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling pharmaceutical products and product candidates;

 

product candidates that are based on previously tested or accepted technologies;

 

products and product candidates that have been approved or are in late stages of development; and

 

collaborative arrangements in NeuBase’s target markets with leading companies and research institutions.

 

NeuBase will face intense competition from drugs that have already been approved and accepted by the medical community for the treatment of the conditions for which NeuBase may develop drugs. NeuBase also expects to face competition from new drugs that enter the market. NeuBase believes there are a significant number of drugs currently under development that may become commercially available in the future, for the treatment of conditions for which NeuBase may try to develop drugs. These drugs may be more effective, safer, less expensive, or marketed and sold more effectively, than any products NeuBase develops. It is possible that the potential advantages of PATrOL™-derived therapies (including, among other potential advantages, the ability to systemically deliver drugs and get broad tissue distribution and penetration across the blood-brain barrier, minimal to no innate or adaptive immune responses after single dose or multiple-dose administration, appropriate dose schedules to address the disease appropriately or that is viable in the marketplace) do not materialize.

 

NeuBase’s competitors may develop or commercialize products with significant advantages over any products NeuBase is able to develop and commercialize based on many different factors, including:

 

the safety and effectiveness of NeuBase’s products relative to alternative therapies, if any;

 

the ease with which NeuBase’s products can be administered and the extent to which patients accept relatively new routes of administration;

 

the timing and scope of regulatory approvals for these products;

 

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the availability and cost of manufacturing, marketing and sales capabilities;

 

price;

 

reimbursement coverage; and

 

patent position.

 

Any collaboration arrangement that NeuBase may enter into in the future may not be successful, which could adversely affect NeuBase’s ability to develop and commercialize NeuBase’s current and potential future product candidates.

 

NeuBase may seek collaboration arrangements with pharmaceutical companies for the development or commercialization of its current and potential future product candidates. To the extent that NeuBase decides to enter into collaboration agreements, NeuBase will face significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to negotiate, execute and implement. NeuBase may not be successful in its efforts to establish and implement collaborations or other alternative arrangements should NeuBase choose to enter into such arrangements, and the terms of the arrangements may not be favorable to NeuBase. If and when NeuBase collaborates with a third party for development and commercialization of a product candidate, NeuBase can expect to relinquish some or all of the control over the future success of that product candidate to the third party. The success of NeuBase’s collaboration arrangements will depend heavily on the efforts and activities of its collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. As such, NeuBase’s inability to control its collaborators, and the potentially adverse results of NeuBase’s collaborators, may materially and adversely affect NeuBase’s product candidates and, more generally, NeuBase’s PATrOL™ platform, and NeuBase may not be able to conduct its program in the manner or on the time schedule it currently contemplates, which could negatively impact its business.

 

If NeuBase’s potential future collaborations do not result in the successful discovery, development and commercialization of products or if one of NeuBase’s collaborators terminates its agreement with NeuBase, NeuBase may not receive any future research funding or milestone or royalty payments under the collaboration. If NeuBase does not receive the funding it expects under these agreements, NeuBase’s development of its technology and product candidates could be delayed and NeuBase may need additional resources to develop product candidates and its technology.

 

Finally, disagreements between parties to a collaboration arrangement can lead to delays in developing or commercializing the applicable product candidate and can be difficult to resolve in a mutually beneficial manner. In some cases, collaborations with biopharmaceutical companies and other third parties are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect NeuBase’s business, financial condition and results of operations.

 

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NeuBase, or any future collaborators, may not be able to obtain orphan drug designation or orphan drug exclusivity for NeuBase’s product candidates.

 

Regulatory authorities in some jurisdictions, including the U.S. and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the U.S. In the U.S. and Europe, obtaining orphan drug approval may allow NeuBase to obtain financial incentives, such as an extended period of exclusivity during which only NeuBase is allowed to market the orphan drug for the orphan indications that NeuBase is developing. While NeuBase may seek orphan drug designation from the FDA for any of its product candidates, NeuBase, or any future collaborators, may not be granted orphan drug designations for its product candidates in the U.S. or in other jurisdictions.

 

Even if NeuBase or any future collaborators obtain orphan drug designation for a product candidate, NeuBase or such collaborators may not be able to obtain orphan drug exclusivity for that product candidate. Generally, a product with orphan drug designation only becomes entitled to orphan drug exclusivity if it receives the first marketing approval for the indication for which it has such designation, in which case the FDA or the EMA will be precluded from approving another marketing application for the same drug for that indication for the applicable exclusivity period. The applicable exclusivity period is seven years in the U.S. and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

 

Even if NeuBase or any future collaborators obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because FDA has taken the position that, under certain circumstances, another drug with the same active chemical and pharmacological characteristics, or moiety, can be approved for the same condition. Specifically, the FDA’s regulations provide that it can approve another drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

 

NeuBase is subject to a multitude of manufacturing risks, any of which could substantially increase NeuBase’s costs and limit supply of its product candidates.

 

The process of manufacturing NeuBase’s product candidates is complex, highly regulated, and subject to several risks. For example, the process of manufacturing NeuBase’s product candidates is extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes for any of NeuBase’s product candidates could result in reduced production yields, product defects, and other supply disruptions. If microbial, viral, or other contaminations are discovered in NeuBase’s product candidates or in the manufacturing facilities in which its product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. In addition, the manufacturing facilities in which its product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures and numerous other factors. For instance, NeuBase’s therapeutic molecules are complex and comprised of both peptides and nucleic acids, and it may be difficult or impossible to find GLP and GMP-grade manufacturers, manufacturing may be cost prohibitive and manufacturing may not be available to fulfill regulatory requirements.

 

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In addition, any adverse developments affecting manufacturing operations for NeuBase’s product candidates may result in shipment delays, inventory shortages, lot failures, withdrawals or recalls, or other interruptions in the supply of NeuBase’s product candidates. NeuBase also may need to take inventory write-offs and incur other charges and expenses for product candidates that fail to meet specifications, undertake costly remediation efforts or seek costlier manufacturing alternatives.

 

NeuBase relies, and will continue to rely, predominantly, on third parties to manufacture NeuBase’s preclinical and clinical drug supplies and NeuBase’s business, financial condition and results of operations could be harmed if those third parties fail to provide NeuBase with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.

 

NeuBase has the capability internally to manufacture small quantities of its drugs for preclinical studies. However, NeuBase does not currently have, nor does NeuBase plan to acquire, the infrastructure or capability internally to manufacture NeuBase’s clinical drug supplies for use in its clinical trials, and NeuBase lacks the resources and the capability to manufacture any of NeuBase’s product candidates on a clinical or commercial scale. NeuBase relies on its manufacturers to purchase from third-party suppliers the materials necessary to produce NeuBase’s product candidates for NeuBase’s clinical trials. There are a limited number of suppliers for raw materials that NeuBase uses to manufacture its product candidates, and there may be a need to identify alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce NeuBase’s product candidates for its clinical trials, and, if approved, ultimately for commercial sale. NeuBase does not have any control over the process or timing of the acquisition of these raw materials by NeuBase’s manufacturers. Any significant delay or discontinuity in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay completion of NeuBase’s clinical trials, product testing and potential regulatory approval of NeuBase’s product candidates, which could harm NeuBase’s business, financial condition and results of operations.

 

If NeuBase is unable to develop its own commercial organization or enter into agreements with third parties to sell and market NeuBase’s product candidates, NeuBase may be unable to generate significant revenues.

 

NeuBase does not have a sales and marketing organization, and NeuBase has no experience as a company in the sales, marketing and distribution of pharmaceutical products. If any of NeuBase’s product candidates are approved for commercialization, NeuBase may be required to develop its sales, marketing and distribution capabilities, or make arrangements with a third party to perform sales and marketing services. Developing a sales force for any resulting product or any product resulting from any of NeuBase’s other product candidates is expensive and time consuming and could delay any product launch. NeuBase may be unable to establish and manage an effective sales force in a timely or cost-effective manner, if at all, and any sales force NeuBase does establish may not be capable of generating sufficient demand for NeuBase’s product candidates. To the extent that NeuBase enters into arrangements with collaborators or other third parties to perform sales and marketing services, NeuBase’s product revenues are likely to be lower than if NeuBase marketed and sold its product candidates independently. If NeuBase is unable to establish adequate sales and marketing capabilities, independently or with others, NeuBase may not be able to generate significant revenues and may not become profitable.

 

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The commercial success of NeuBase’s product candidates depends upon their market acceptance among physicians, patients, healthcare payors and the medical community.

 

Even if NeuBase’s product candidates obtain regulatory approval, NeuBase’s products, if any, may not gain market acceptance among physicians, patients, healthcare payors and the medical community. The degree of market acceptance of any of NeuBase’s approved product candidates will depend on a number of factors, including:

 

the effectiveness of NeuBase’s approved product candidates as compared to currently available products;

 

patient willingness to adopt NeuBase’s approved product candidates in place of current therapies;

 

NeuBase’s ability to provide acceptable evidence of safety and efficacy;

 

relative convenience and ease of administration;

 

the prevalence and severity of any adverse side effects;

 

restrictions on use in combination with other products;

 

availability of alternative treatments;

 

pricing and cost-effectiveness assuming either competitive or potential premium pricing requirements, based on the profile of NeuBase’s product candidates and target markets;

 

effectiveness of NeuBase’s or its partners’ sales and marketing strategy;

 

NeuBase’s ability to obtain sufficient third-party coverage or reimbursement; and

 

potential product liability claims.

 

In addition, the potential market opportunity for NeuBase’s product candidates is difficult to precisely estimate. NeuBase’s estimates of the potential market opportunity for its product candidates include several key assumptions based on NeuBase’s industry knowledge, industry publications, third-party research reports and other surveys. Independent sources have not verified all of NeuBase’s assumptions. If any of these assumptions proves to be inaccurate, then the actual market for NeuBase’s product candidates could be smaller than NeuBase’s estimates of its potential market opportunity. If the actual market for NeuBase’s product candidates is smaller than NeuBase expects, NeuBase’s product revenue may be limited, it may be harder than expected to raise funds and it may be more difficult for NeuBase to achieve or maintain profitability. If NeuBase fails to achieve market acceptance of NeuBase’s product candidates in the U.S. and abroad, NeuBase’s revenue will be limited and it will be more difficult to achieve profitability.

 

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If NeuBase fails to obtain and sustain an adequate level of reimbursement for its potential products by third-party payors, potential future sales would be materially adversely affected.

 

There will be no viable commercial market for NeuBase’s product candidates, if approved, without reimbursement from third-party payors. Reimbursement policies may be affected by future healthcare reform measures. NeuBase cannot be certain that reimbursement will be available for its current product candidates or any other product candidate NeuBase may develop. Additionally, even if there is a viable commercial market, if the level of reimbursement is below NeuBase’s expectations, NeuBase’s anticipated revenue and gross margins will be adversely affected.

 

Third-party payors, such as government or private healthcare insurers, carefully review and increasingly question and challenge the coverage of and the prices charged for drugs. Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors. Reimbursement rates may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. There is a current trend in the U.S. healthcare industry toward cost containment.

 

Large public and private payors, managed care organizations, group purchasing organizations and similar organizations are exerting increasing influence on decisions regarding the use of, and reimbursement levels for, particular treatments. Such third-party payors, including Medicare, may question the coverage of, and challenge the prices charged for, medical products and services, and many third-party payors limit coverage of or reimbursement for newly approved healthcare products. In particular, third-party payors may limit the covered indications. Cost-control initiatives could decrease the price NeuBase might establish for products, which could result in product revenues being lower than anticipated. NeuBase believes its drugs will be priced significantly higher than existing generic drugs and consistent with current branded drugs. If NeuBase is unable to show a significant benefit relative to existing generic drugs, Medicare, Medicaid and private payors may not be willing to provide reimbursement for NeuBase’s drugs, which would significantly reduce the likelihood of NeuBase’s products gaining market acceptance.

 

NeuBase expects that private insurers will consider the efficacy, cost-effectiveness, safety and tolerability of NeuBase’s potential products in determining whether to approve reimbursement for such products and at what level. Obtaining these approvals can be a time consuming and expensive process. NeuBase’s business, financial condition and results of operations would be materially adversely affected if NeuBase does not receive approval for reimbursement of its potential products from private insurers on a timely or satisfactory basis. Limitations on coverage could also be imposed at the local Medicare carrier level or by fiscal intermediaries. Medicare Part B, which covers medical insurance to Medicare patients as discussed below, does not require participating insurance plans to cover all drugs that have been approved by the FDA. NeuBase’s business, financial condition and results of operations could be materially adversely affected if Part B medical insurance were to limit access to, or deny or limit reimbursement of, NeuBase’s product candidates or other potential products.

 

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Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis. In many countries, the product cannot be commercially launched until reimbursement is approved. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. The negotiation process in some countries can exceed 12 months. To obtain reimbursement or pricing approval in some countries, NeuBase may be required to conduct a clinical trial that compares the cost-effectiveness of its products to other available therapies.

 

If the prices for NeuBase’s potential products are reduced or if governmental and other third-party payors do not provide adequate coverage and reimbursement of NeuBase’s drugs, NeuBase’s future revenue, cash flows and prospects for profitability will suffer.

 

NeuBase is exposed to product liability, non-clinical and clinical liability risks which could place a substantial financial burden upon NeuBase, should lawsuits be filed against NeuBase.

 

NeuBase’s business exposes it to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical formulations and products. In addition, the use in NeuBase’s anticipated clinical trials of pharmaceutical products and the subsequent sale of these products by NeuBase or its potential collaborators may cause NeuBase to bear a portion of or all product liability risks. A successful liability claim or series of claims brought against NeuBase could have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

Because NeuBase does not currently have any clinical trials ongoing, it does not currently carry product liability insurance. NeuBase anticipates obtaining such insurance upon initiation of its clinical development activities; however, NeuBase may be unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A successful product liability claim or series of claims brought against NeuBase could adversely affect NeuBase’s results of operations and business if judgments therewith exceed NeuBase’s insurance coverage.

 

If NeuBase fails to retain Dr. Stephan, or to attract and keep additional key personnel, NeuBase may be unable to successfully develop or commercialize NeuBase’s product candidates.

 

NeuBase’s success depends on NeuBase’s continued ability to attract, retain and motivate highly qualified management and scientific personnel. As of February 2019, Dr. Dietrich A. Stephan, NeuBase’s President, Chief Executive Officer, Treasurer and Secretary, is the only employee of NeuBase. Dr. Shivaji Thadke (Director of Chemistry) and Dr. Ramesh Batwal (Associate of Chemistry) have both been offered and accepted employment with NeuBase pending visa approvals from U.S. Citizenship and Immigration Services. NeuBase has engaged with several other individuals as consultants or advisory boards. NeuBase has identified several additional individuals that are expected to become full-time employees of the combined company prior to or shortly following the closing of the merger and fill the following open positions: Chief Financial Officer, Accounting Manager, Operations Manager, Associate of Chemistry, Associate of Bioinformatics, and Associate of Biology. However, competition for qualified personnel is intense. NeuBase may not be successful in attracting qualified personnel to fulfill NeuBase’s current or future needs, and there is no guarantee that any of these individuals will join the combined company on a full-time employment basis, or at all. In the event the combined company is unable to fill critical open employment positions, NeuBase may need to delay its operational activities and goals, including the development of its product candidates, and may have difficulty in meeting its obligations as a public company. NeuBase does not maintain “key person” insurance on any of its employees.

 

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In addition, competitors and others are likely in the future to attempt to recruit NeuBase’s employees. The loss of the services of any of NeuBase’s key personnel, the inability to attract or retain highly qualified personnel in the future or delays in hiring such personnel, particularly senior management and other technical personnel, could materially and adversely affect NeuBase’s business, financial condition and results of operations. In addition, the replacement of key personnel likely would involve significant time and costs, and may significantly delay or prevent the achievement of NeuBase’s business objectives.

 

From time to time, NeuBase’s management seeks the advice and guidance of certain scientific advisors and consultants regarding clinical and regulatory development programs and other customary matters. These scientific advisors and consultants are not NeuBase’s employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to NeuBase. In addition, NeuBase’s scientific advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with NeuBase’s.

 

NeuBase will need to increase the size of NeuBase’s organization and may not successfully manage NeuBase’s growth.

 

NeuBase is a preclinical-stage pharmaceutical company with a small number of planned employees, and NeuBase’s management systems currently in place are not likely to be adequate to support NeuBase’s future growth plans. NeuBase’s ability to grow and to manage its growth effectively will require NeuBase to hire, train, retain, manage and motivate additional employees and to implement and improve its operational, financial and management systems. These demands also may require the hiring of additional senior management personnel or the development of additional expertise by NeuBase’s senior management personnel. Hiring a significant number of additional employees, particularly those at the management level, would increase NeuBase’s expenses significantly. Moreover, if NeuBase fails to expand and enhance its operational, financial and management systems in conjunction with its potential future growth, such failure could have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

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Because NeuBase’s Chief Executive Officer is involved with several unaffiliated privately-held companies, he may experience conflicts of interest and competing demands for his time and attention.

 

Dietrich Stephan, NeuBase’s Chief Executive Officer, is a member of the governing bodies of several unaffiliated privately-held companies, as well as a general partner of Cyto Ventures and, as such, he does not serve NeuBase on a full-time basis. Although Dr. Stephan expects to devote substantially all of his time to NeuBase, he expects to continue in each of these positions for the foreseeable future. Conflicts of interest could arise with respect to business opportunities that could be advantageous to third party organizations affiliated with Dr. Stephan, on the one hand, and NeuBase, on the other hand.

 

The majority of NeuBase’s current management lacks public company experience, which could put NeuBase at greater risk of incurring fines or regulatory actions for failure to comply with federal securities laws and could put NeuBase at a competitive disadvantage and require NeuBase’s management to devote additional time and resources to ensure compliance with applicable corporate governance requirements.

 

None of NeuBase’s current executive officers have experience in managing and operating a public company, which could have an adverse effect on their ability to quickly respond to problems or adequately address issues and matters applicable to public companies. Any failure to comply with federal securities laws, rules or regulations could subject NeuBase to fines or regulatory actions, which may materially adversely affect NeuBase’s business, financial condition and results of operations. Further, since NeuBase’s current executive officers do not have experience managing and operating a public company, NeuBase may need to dedicate additional time and resources to comply with legally mandated corporate governance policies relative to NeuBase’s competitors whose management teams have more public company experience.

 

NeuBase relies significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm NeuBase’s ability to operate NeuBase’s business effectively.

 

Despite the implementation of security measures, NeuBase’s internal computer systems and those of third parties with which NeuBase contracts are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in NeuBase’s operations, and could result in a material disruption of NeuBase’s drug development and preclinical and clinical activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. The loss of drug development or clinical trial data could result in delays in NeuBase’s regulatory approval efforts and significantly increase NeuBase’s costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, NeuBase’s data or applications, or inappropriate disclosure of confidential or proprietary information, NeuBase could incur liability and its development programs and the development of its product candidates could be delayed.

 

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NeuBase’s employees and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 

NeuBase is exposed to the risk of employee or consultant fraud or other misconduct. Misconduct by NeuBase’s employees or consultants could include, among other things, intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to NeuBase. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements. Employee and consultant misconduct also could involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to NeuBase’s reputation. It is not always possible to identify and deter such misconduct, and the precautions NeuBase takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting NeuBase from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against NeuBase, and NeuBase is not successful in defending itself or asserting NeuBase’s rights, those actions could have a material adverse effect on NeuBase’s business, financial condition and results of operations, and result in the imposition of significant fines or other sanctions against NeuBase.

 

Business disruptions such as natural disasters could seriously harm NeuBase’s future revenues and financial condition and increase its costs and expenses.

 

NeuBase and its suppliers may experience a disruption in their business as a result of natural disasters. A significant natural disaster, such as an earthquake, hurricane, flood or fire, could severely damage or destroy NeuBase’s headquarters or facilities or the facilities of NeuBase’s manufacturers or suppliers, which could have a material and adverse effect on NeuBase’s business, financial condition and results of operations. In addition, terrorist acts or acts of war targeted at the U.S., and specifically the Pittsburgh, Pennsylvania and greater New York, New York regions, could cause damage or disruption to NeuBase, its employees, facilities, partners and suppliers, which could have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

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NeuBase may engage in strategic transactions that could impact its liquidity, increase its expenses and present significant distractions to its management.

 

From time to time, NeuBase may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of products, product candidates or technologies. Additional potential transactions that NeuBase may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require NeuBase to incur non-recurring or other charges, may increase NeuBase’s near- and long-term expenditures and may pose significant integration challenges or disrupt NeuBase’s management or business, which could adversely affect NeuBase’s business, financial condition and results of operations. For example, these transactions may entail numerous operational and financial risks, including:

 

exposure to unknown liabilities;

 

disruption of NeuBase’s business and diversion of NeuBase’s management’s time and attention in order to develop acquired products, product candidates or technologies;

 

incurrence of substantial debt or dilutive issuances of equity securities to pay for any of these transactions;

 

higher-than-expected transaction and integration costs;

 

write-downs of assets or goodwill or impairment charges;

 

increased amortization expenses;

 

difficulty and cost in combining the operations and personnel of any acquired businesses or product lines with NeuBase’s operations and personnel;

 

impairment of relationships with key suppliers or customers of any acquired businesses or product lines due to changes in management and ownership; and

 

inability to retain key employees of any acquired businesses.

 

Accordingly, although there can be no assurance that NeuBase will undertake or successfully complete any transactions of the nature described above, any transactions that NeuBase does complete may be subject to the foregoing or other risks, and could have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

The estimates and judgments NeuBase makes, or the assumptions on which NeuBase relies, in preparing its financial statements could prove inaccurate.

 

NeuBase’s financial statements have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires NeuBase to make estimates and judgments that affect the reported amounts of NeuBase’s assets, liabilities, revenues and expenses, the amounts of charges accrued by NeuBase and related disclosure of contingent assets and liabilities. NeuBase bases its estimates on historical experience and on various other assumptions that NeuBase believes to be reasonable under the circumstances. NeuBase cannot assure, however, that NeuBase’s estimates, or the assumptions underlying them, will not change over time or otherwise prove inaccurate. For example, NeuBase’s estimates as they relate to anticipated timelines and milestones for its preclinical development or clinical trials may prove to be inaccurate. If this is the case, NeuBase may be required to restate its financial statements, which could, in turn, subject NeuBase to securities class action litigation. Defending against such potential litigation relating to a restatement of NeuBase’s financial statements would be expensive and would require significant attention and resources of NeuBase’s management. Moreover, NeuBase’s insurance to cover its obligations with respect to the ultimate resolution of any such litigation may be inadequate. As a result of these factors, any such potential litigation could have a material adverse effect on NeuBase’s financial results or harm its business.

 

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Risks Related to NeuBase’s Intellectual Property

 

NeuBase may not be successful in obtaining or maintaining necessary rights to its product candidates through acquisitions and in-licenses.

 

Because several of NeuBase’s programs currently require the use of proprietary rights held by third parties, the growth of NeuBase’s business will likely depend in part on NeuBase’s ability to maintain and exploit these proprietary rights. In addition, NeuBase may need to acquire or in-license additional intellectual property in the future. NeuBase may be unable to acquire or in-license any compositions, methods of use, processes or other intellectual property rights from third parties that NeuBase identifies as necessary for its product candidates. NeuBase faces competition with regard to acquiring and in-licensing third-party intellectual property rights, including from a number of more established companies. These established companies may have a competitive advantage over NeuBase due to their size, cash resources and greater clinical development and commercialization capabilities. In addition, companies that perceive NeuBase to be a competitor may be unwilling to assign or license intellectual property rights to NeuBase. NeuBase also may be unable to acquire or in-license third-party intellectual property rights on terms that would allow it to make an appropriate return on NeuBase’s investment, and NeuBase may not be able to market products or perform research and development or other activities covered by these patents.

 

NeuBase may enter into collaboration agreements with U.S. and foreign academic institutions to accelerate development of NeuBase’s current or future preclinical product candidates. Typically, these agreements include an option for the company to negotiate a license to the institution’s intellectual property rights resulting from the collaboration. Even with such an option, NeuBase may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to NeuBase. If NeuBase is unable to license rights from a collaborating institution, the institution may offer the intellectual property rights to other parties, potentially blocking NeuBase’s ability to pursue its desired program.

 

If NeuBase is unable to successfully obtain required third-party intellectual property rights or maintain NeuBase’s existing intellectual property rights, NeuBase may need to abandon development of the related program and NeuBase’s business, financial condition and results of operations could be materially and adversely affected.

 

If NeuBase fails to comply with its obligations in the agreements under which NeuBase in-licenses intellectual property and other rights from third parties or otherwise experiences disruptions to NeuBase’s business relationships with NeuBase’s licensors, NeuBase could lose intellectual property rights that are important to its business.

 

NeuBase’s license agreement with Carnegie Mellon University (the “CMU License Agreement”), as the licensor (the “Licensor”), is important to NeuBase’s business, and NeuBase expects to enter into additional license agreements in the future. The CMU License Agreement imposes, and NeuBase expects that future license agreements will impose, various royalties, sublicensing fees and other obligations on NeuBase. If NeuBase fails to comply with NeuBase’s obligations under these agreements, or if NeuBase files for bankruptcy, NeuBase may be required to make certain payments to the Licensor, NeuBase may lose the exclusivity of its license, or the Licensor may have the right to terminate the license, in which event NeuBase would not be able to develop or market products covered by the license. Additionally, the royalties and other payments associated with these licenses could materially and adversely affect NeuBase’s business, financial condition and results of operations.

 

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Pursuant to the terms of the CMU License Agreement, the Licensor has the right to terminate the CMU License Agreement with respect to the program licensed under certain circumstances, including, but not limited to: (i) if NeuBase does not pay amounts when due and within the applicable cure periods or (ii) if NeuBase files or has filed against NeuBase a petition in bankruptcy or makes an assignment for the benefit of creditors. In the event the CMU License Agreement is terminated by the Licensor, all licenses (or, in the determination of the Licensor, the exclusivity of such licenses) granted to NeuBase by the Licensor will terminate immediately.

 

In some cases, patent prosecution of NeuBase’s licensed technology may be controlled solely by the licensor. If NeuBase’s licensor fails to obtain and maintain patent or other protection for the proprietary intellectual property NeuBase in-licenses, then NeuBase could lose its rights to the intellectual property or its exclusivity with respect to those rights, and its competitors could market competing products using the intellectual property. In certain cases, NeuBase may control the prosecution of patents resulting from licensed technology. In the event NeuBase breaches any of NeuBase’s obligations related to such prosecution, NeuBase may incur significant liability to NeuBase’s licensing partners. Licensing of intellectual property is of critical importance to NeuBase’s business and involves complex legal, business and scientific issues. Disputes may arise regarding intellectual property subject to a licensing agreement, including, but not limited to:

 

the scope of rights granted under the license agreement and other interpretation-related issues;

 

the extent to which NeuBase’s technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

the sublicensing of patent and other rights;

 

NeuBase’s diligence obligations under the license agreement and what activities satisfy those diligence obligations;

 

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by NeuBase’s licensors and NeuBase and NeuBase’s collaborators; and

 

the priority of invention of patented technology.

 

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If disputes over intellectual property and other rights that NeuBase has in-licensed prevent or impair NeuBase’s ability to maintain NeuBase’s current licensing arrangements on acceptable terms, NeuBase may be unable to successfully develop and commercialize the affected product candidates. If NeuBase fails to comply with any such obligations to NeuBase’s licensor, such licensor may terminate their licenses to NeuBase, in which case NeuBase would not be able to market products covered by these licenses. The loss of NeuBase’s licenses would have a material adverse effect on NeuBase’s business.

 

NeuBase may be required to pay royalties and sublicensing fees pursuant to the CMU License Agreement, which could adversely affect the overall profitability for NeuBase of any products that NeuBase may seek to commercialize.

 

Under the terms of the CMU License Agreement, NeuBase will be required to pay royalties on future worldwide net product sales and a percentage of sublicensing fees that NeuBase may earn. These royalty payments and sublicensing fees could adversely affect the overall profitability for NeuBase of any products that it may seek to commercialize.

 

NeuBase may not be able to protect its proprietary or licensed technology in the marketplace.

 

NeuBase depends on NeuBase’s ability to protect its proprietary or licensed technology. NeuBase relies on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection. NeuBase’s success depends in large part on NeuBase’s ability and any licensor’s or licensee’s ability to obtain and maintain patent protection in the U.S. and other countries with respect to NeuBase’s proprietary or licensed technology and products. NeuBase currently in-licenses some of NeuBase’s intellectual property rights to develop NeuBase’s product candidates and may in-license additional intellectual property rights in the future. NeuBase cannot be certain that patent enforcement activities by its current or future licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. NeuBase also cannot be certain that its current or future licensors will allocate sufficient resources or prioritize their or NeuBase’s enforcement of such patents. Even if NeuBase is not a party to these legal actions, an adverse outcome could prevent NeuBase from continuing to license intellectual property that NeuBase may need to operate its business, which would have a material adverse effect on its business, financial condition and results of operations.

 

NeuBase believes it will be able to obtain, through prosecution of patent applications covering NeuBase’s owned technology and technology licensed from others, adequate patent protection for NeuBase’s proprietary drug technology, including those related to NeuBase’s in-licensed intellectual property. If NeuBase is compelled to spend significant time and money protecting or enforcing its licensed patents and future patents NeuBase may own, designing around patents held by others or licensing or acquiring, potentially for large fees, patents or other proprietary rights held by others, NeuBase’s business, financial condition and results of operations may be materially and adversely affected. If NeuBase is unable to effectively protect the intellectual property that NeuBase owns or in-licenses, other companies may be able to offer the same or similar products for sale, which could materially adversely affect NeuBase’s business, financial condition and results of operations. The patents of others from whom NeuBase may license technology, and any future patents NeuBase may own, may be challenged, narrowed, invalidated or circumvented, which could limit NeuBase’s ability to stop competitors from marketing the same or similar products or limit the length of term of patent protection that NeuBase may have for its products.

 

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Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and NeuBase’s patent protection for licensed patents, licensed pending patent applications and potential future patent applications and patents could be reduced or eliminated for non-compliance with these requirements.

 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or patent applications will be due to be paid to the U.S. Patent and Trademark Office (“USPTO”) and various governmental patent agencies outside of the U.S. in several stages over the lifetime of the applicable patent and/or patent application. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If this occurs with respect to NeuBase’s in-licensed patents or patent applications NeuBase may file in the future, NeuBase’s competitors might be able to use its technologies, which would have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

The patent positions of pharmaceutical products are often complex and uncertain. The breadth of claims allowed in pharmaceutical patents in the U.S. and many jurisdictions outside of the U.S. is not consistent. For example, in many jurisdictions, the support standards for pharmaceutical patents are becoming increasingly strict. Some countries prohibit method of treatment claims in patents. Changes in either the patent laws or interpretations of patent laws in the U.S. and other countries may diminish the value of NeuBase’s licensed or owned intellectual property or create uncertainty. In addition, publication of information related to NeuBase’s current product candidates and potential products may prevent NeuBase from obtaining or enforcing patents relating to these product candidates and potential products, including without limitation composition-of-matter patents, which are generally believed to offer the strongest patent protection.

 

Patents that NeuBase currently licenses and patents that NeuBase may own or license in the future do not necessarily ensure the protection of NeuBase’s licensed or owned intellectual property for a number of reasons, including, without limitation, the following:

 

the patents may not be broad or strong enough to prevent competition from other products that are identical or similar to NeuBase’s product candidates;

 

there can be no assurance that the term of a patent can be extended under the provisions of patent term extensions afforded by U.S. law or similar provisions in foreign countries, where available;

 

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the issued patents and patents that NeuBase may obtain or license in the future may not prevent generic entry into the market for NeuBase’s product candidates;

 

NeuBase, or third parties from whom NeuBase in-licenses or may license patents, may be required to disclaim part of the term of one or more patents;

 

there may be prior art of which NeuBase is not aware that may affect the validity or enforceability of a patent claim;

 

there may be prior art of which NeuBase is aware, which NeuBase does not believe affects the validity or enforceability of a patent claim, but which, nonetheless, ultimately may be found to affect the validity or enforceability of a patent claim;

 

there may be other patents issued to others that will affect NeuBase’s freedom to operate;

 

if the patents are challenged, a court could determine that they are invalid or unenforceable;

 

there might be a significant change in the law that governs patentability, validity and infringement of NeuBase’s licensed patents or any future patents NeuBase may own that adversely affects the scope of NeuBase’s patent rights;

 

a court could determine that a competitor’s technology or product does not infringe NeuBase’s licensed patents or any future patents NeuBase may own; and

 

the patents could irretrievably lapse due to failure to pay fees or otherwise comply with regulations or could be subject to compulsory licensing.

 

If NeuBase encounters delays in NeuBase’s development or clinical trials, the period of time during which NeuBase could market its potential products under patent protection would be reduced.

 

NeuBase’s competitors may be able to circumvent its licensed patents or future patents NeuBase may own by developing similar or alternative technologies or products in a non-infringing manner. NeuBase’s competitors may seek to market generic versions of any approved products by submitting abbreviated new drug applications to the FDA in which NeuBase’s competitors claim that NeuBase’s licensed patents or any future patents NeuBase may own are invalid, unenforceable or not infringed. Alternatively, NeuBase’s competitors may seek approval to market their own products similar to or otherwise competitive with NeuBase’s products. In these circumstances, NeuBase may need to defend or assert NeuBase’s licensed patents or any future patents NeuBase may own, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find NeuBase’s licensed patents or any future patents NeuBase may own invalid or unenforceable. NeuBase may also fail to identify patentable aspects of its research and development before it is too late to obtain patent protection. Even if NeuBase owns or in-licenses valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve NeuBase’s business objectives.

 

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The issuance of a patent is not conclusive as to its inventorship, scope, ownership, priority, validity or enforceability. In this regard, third parties may challenge NeuBase’s licensed patents or any future patents NeuBase may own in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit NeuBase’s ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of NeuBase’s technology and potential products. In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized.

 

NeuBase may infringe the intellectual property rights of others, which may prevent or delay its drug development efforts and prevent NeuBase from commercializing or increase the costs of commercializing NeuBase’s products.

 

NeuBase’s commercial success depends significantly on NeuBase’s ability to operate without infringing the patents and other intellectual property rights of third parties. For example, there could be issued patents of which NeuBase is not aware that NeuBase’s current or potential future product candidates infringe. There also could be patents that NeuBase believes NeuBase does not infringe, but that NeuBase may ultimately be found to infringe. NeuBase has licensed intellectual property from Carnegie Mellon University under the CMU License Agreement, and prior generation intellectual property was licensed to other entities. Such intellectual property, in conjunction with further developed technologies for gene editing therapies using such intellectual property, may overlap with NeuBase’s own intellectual property.

 

Furthermore, because the nucleic acid therapeutics intellectual property landscape is still evolving and NeuBase’s product candidates have not been through clinical trials or commercialized, it is difficult to conclusively assess NeuBase’s freedom to operate without infringing third party rights. There are numerous companies that have pending patent applications and issued patents directed to certain aspects of nucleic acid therapeutics. NeuBase is aware of third party competitors in the oligonucleotide therapeutics space, whose patent filings and/or issued patents may include claims directed to targets and/or products related to some of NeuBase’s programs. It is possible that at the time that NeuBase commercializes its products these third-party patent portfolios may include issued patent claims that cover NeuBase’s products or critical features of their production or use. NeuBase’s competitive position may suffer if patents issued to third parties or other third party intellectual property rights cover, or may be alleged to cover, NeuBase’s products or elements thereof, or methods of manufacture or use relevant to NeuBase’s development plans. In such cases, NeuBase may not be in a position to develop or commercialize product candidates unless NeuBase successfully pursues litigation to nullify or invalidate the third party intellectual property right concerned or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms.

 

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Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which NeuBase is unaware that may later result in issued patents that NeuBase’s product candidates or potential products infringe. For example, pending applications may exist that claim or can be amended to claim subject matter that NeuBase’s product candidates or potential products infringe. Competitors may file continuing patent applications claiming priority to already issued patents in the form of continuation, divisional, or continuation-in-part applications, in order to maintain the pendency of a patent family and attempt to cover NeuBase’s product candidates.

 

Third parties may assert that NeuBase is employing their proprietary technology without authorization and may sue NeuBase for patent or other intellectual property infringement. These lawsuits are costly and could adversely affect NeuBase’s business, financial condition and results of operations and divert the attention of managerial and scientific personnel. If NeuBase is sued for patent infringement, NeuBase would need to demonstrate that its product candidates, potential products or methods either do not infringe the claims of the relevant patent or that the patent claims are invalid, and NeuBase may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if NeuBase is successful in these proceedings, NeuBase may incur substantial costs and the time and attention of NeuBase’s management and scientific personnel could be diverted in pursuing these proceedings, which could have a material adverse effect on NeuBase. In addition, NeuBase may not have sufficient resources to bring these actions to a successful conclusion. If a court holds that any third-party patents are valid, enforceable and cover NeuBase’s products or their use, the holders of any of these patents may be able to block NeuBase’s ability to commercialize its products unless it acquires or obtains a license under the applicable patents or until the patents expire.

 

NeuBase may not be able to enter into licensing arrangements or make other arrangements at a reasonable cost or on reasonable terms. Any inability to secure licenses or alternative technology could result in delays in the introduction of NeuBase’s products or lead to prohibition of the manufacture or sale of products by NeuBase. Even if NeuBase is able to obtain a license, it may be non-exclusive, thereby giving NeuBase’s competitors access to the same technologies licensed to NeuBase. NeuBase could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, in any such proceeding or litigation, NeuBase could be found liable for monetary damages, including treble damages and attorneys’ fees, if NeuBase is found to have willfully infringed a patent. A finding of infringement could prevent NeuBase from commercializing its product candidates or force NeuBase to cease some of its business operations, which could materially and adversely affect NeuBase’s business, financial condition and results of operations. Any claims by third parties that NeuBase has misappropriated their confidential information or trade secrets could have a similar material and adverse effect on NeuBase’s business, financial condition and results of operations. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on NeuBase’s ability to raise the funds necessary to continue NeuBase’s operations.

 

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Any claims or lawsuits relating to infringement of intellectual property rights brought by or against NeuBase will be costly and time consuming and may adversely affect its business, financial condition and results of operations.

 

NeuBase may be required to initiate litigation to enforce or defend its licensed and owned intellectual property. Lawsuits to protect NeuBase’s intellectual property rights can be very time consuming and costly. There is a substantial amount of litigation involving patent and other intellectual property rights in the pharmaceutical industry generally. Such litigation or proceedings could substantially increase NeuBase’s operating expenses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

 

In any infringement litigation, any award of monetary damages NeuBase receives may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of NeuBase’s confidential information could be compromised by disclosure during litigation. Moreover, there can be no assurance that NeuBase will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are resolved. Further, any claims NeuBase asserts against a perceived infringer could provoke these parties to assert counterclaims against NeuBase alleging that NeuBase has infringed their patents. Some of NeuBase’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than NeuBase can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on NeuBase’s ability to compete in the marketplace.

 

In addition, NeuBase’s licensed patents and patent applications, and patents and patent applications that NeuBase may apply for, own or license in the future, could face other challenges, such as interference proceedings, opposition proceedings, re-examination proceedings and other forms of post-grant review. Any of these challenges, if successful, could result in the invalidation of, or in a narrowing of the scope of, any of NeuBase’s licensed patents and patent applications and patents and patent applications that NeuBase may apply for, own or license in the future subject to challenge. Any of these challenges, regardless of their success, would likely be time consuming and expensive to defend and resolve and would divert NeuBase’s management and scientific personnel’s time and attention.

 

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing NeuBase’s ability to protect NeuBase’s product candidates or potential products.

 

As is the case with other pharmaceutical companies, NeuBase’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity and is costly, time-consuming and inherently uncertain. For example, the U.S. previously enacted and is currently implementing wide-ranging patent reform legislation. Specifically, on September 16, 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law and included a number of significant changes to U.S. patent law, and many of the provisions became effective in March 2013. However, it may take the courts years to interpret the provisions of the Leahy-Smith Act, and the implementation of the statute could increase the uncertainties and costs surrounding the prosecution of NeuBase’s licensed and future patent applications and the enforcement or defense of NeuBase’s licensed and future patents, all of which could have a material adverse effect on NeuBase’s business, financial condition and results of operations.

 

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In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. The recent decision by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc. precludes a claim to a nucleic acid having a stated nucleotide sequence which is identical to a sequence found in nature and unmodified. NeuBase currently is not aware of an immediate impact of this decision on NeuBase’s patents or patent applications which contain modifications that NeuBase believes are not found in nature. However, this decision has yet to be clearly interpreted by courts and by the USPTO. NeuBase cannot make assurances that the interpretations of this decision or subsequent rulings will not adversely impact NeuBase’s patents or patent applications. In addition to increasing uncertainty with regard to NeuBase’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken NeuBase’s ability to obtain new patents or to enforce patents that NeuBase might obtain in the future.

 

NeuBase may not be able to protect its intellectual property rights throughout the world.

 

Filing, prosecuting and defending patents on product candidates throughout the world would be prohibitively expensive. Competitors may use NeuBase’s licensed and owned technologies in jurisdictions where NeuBase has not licensed or obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where NeuBase may obtain or license patent protection, but where patent enforcement is not as strong as that in the U.S. These products may compete with NeuBase’s products in jurisdictions where NeuBase does not have any issued or licensed patents, and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

 

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could make it difficult for NeuBase to stop the infringement of NeuBase’s licensed patents and future patents NeuBase may own, or marketing of competing products in violation of NeuBase’s proprietary rights generally. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the U.S. As a result, NeuBase may encounter significant problems in protecting and defending its licensed and owned intellectual property both in the U.S. and abroad. For example, China currently affords less protection to a company’s intellectual property than some other jurisdictions. As such, the lack of strong patent and other intellectual property protection in China may significantly increase NeuBase’s vulnerability regarding unauthorized disclosure or use of its intellectual property and undermine its competitive position. Proceedings to enforce NeuBase’s future patent rights, if any, in foreign jurisdictions could result in substantial cost and divert its efforts and attention from other aspects of NeuBase’s business.

 

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NeuBase may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

 

In order to protect NeuBase’s proprietary and licensed technology and processes, NeuBase relies in part on confidentiality agreements with its corporate partners, employees, consultants, manufacturers, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of NeuBase’s confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover NeuBase’s trade secrets and proprietary information. Failure to obtain or maintain trade secret protection could adversely affect NeuBase’s competitive business position.

 

NeuBase may be subject to claims that NeuBase’s employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

 

NeuBase expects to employ individuals who were previously employed at other pharmaceutical companies. Although NeuBase has no knowledge of any such claims against NeuBase, NeuBase may be subject to claims that it or its employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of NeuBase’s employees’ former employers or other third parties. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and even if NeuBase is successful, litigation could result in substantial cost and be a distraction to NeuBase’s management and other employees.

 

NeuBase may be subject to claims challenging the inventorship of its licensed patents, any future patents NeuBase may own and other intellectual property.

 

Although NeuBase is not currently experiencing any claims challenging the inventorship of its licensed patents or NeuBase’s licensed or owned intellectual property, NeuBase may in the future be subject to claims that former employees, collaborators or other third parties have an interest in NeuBase’s licensed patents or other licensed or owned intellectual property as an inventor or co-inventor. For example, NeuBase may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing NeuBase’s product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If NeuBase fails in defending any such claims, in addition to paying monetary damages, NeuBase may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on NeuBase’s business, financial condition and results of operations. Even if NeuBase is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

 

If NeuBase does not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation extending the terms of NeuBase’s licensed patents and any future patents NeuBase may own, NeuBase’s business, financial condition and results of operations may be materially and adversely affected.

 

Depending upon the timing, duration and specifics of FDA regulatory approval for NeuBase’s product candidates, one or more of its licensed U.S. patents or future U.S. patents that NeuBase may license or own may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during drug development and the FDA regulatory review process. This period is generally one-half the time between the effective date of an IND (falling after issuance of the patent) and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application. Patent term restorations, however, cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval by the FDA.

 

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The application for patent term extension is subject to approval by the USPTO, in conjunction with the FDA. It takes at least six months to obtain approval of the application for patent term extension. NeuBase may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than NeuBase requests. If NeuBase is unable to obtain patent term extension or restoration or the term of any such extension is less than NeuBase requests, the period during which NeuBase will have the right to exclusively market its product will be shortened and NeuBase’s competitors may obtain earlier approval of competing products, and NeuBase’s ability to generate revenues could be materially adversely affected.

 

Risks Related to Government Regulation of NeuBase

 

NeuBase is very early in its development efforts. All of its product candidates are still in preclinical development. If NeuBase is unable to advance its product candidates to clinical development, obtain regulatory approval and ultimately commercialize its product candidates or experience significant delays in doing so, its business will be materially harmed.

 

NeuBase is very early in its development efforts, and all of its product candidates are still in preclinical development. NeuBase has invested substantially all of its efforts and financial resources in the identification and preclinical development of ASOs, including the development program for the treatment of Huntington’s Disease. NeuBase’s ability to generate product revenues, which it does not expect will occur for many years, if ever, will depend on the successful development and eventual commercialization of its product candidates, which may never occur. NeuBase currently generates no revenue from sales of any products, and it may never be able to develop or commercialize a marketable product. In addition, certain of NeuBase’s product candidate development programs contemplate the development of companion diagnostics, which are assays or tests to identify an appropriate patient population. Companion diagnostics are subject to regulation as medical devices and must themselves be approved for marketing by the FDA or certain other foreign regulatory agencies before NeuBase may commercialize its products. The success of its product candidates will depend on several factors, including the following:

 

successful completion of preclinical studies;

 

approval of INDs for NeuBase’s planned clinical trials or future clinical trials;

 

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successful enrollment in, and completion of, clinical trials;

 

successful development of companion diagnostics for use with certain of NeuBase’s product candidates;

 

receipt of regulatory approvals from applicable regulatory authorities;

 

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers for clinical supply and commercial manufacturing;

 

obtaining and maintaining patent and trade secret protection or regulatory exclusivity for NeuBase’s product candidates;

 

launching commercial sales of NeuBase’s product candidates, if and when approved, whether alone or in collaboration with others;

 

acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors;

 

effectively competing with other therapies;

 

obtaining and maintaining third-party insurance coverage and adequate reimbursement;

 

enforcing and defending intellectual property rights and claims; and

 

maintaining a continued acceptable safety profile of the product candidates following approval.

 

If NeuBase does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize its product candidates, which would materially harm its business. If NeuBase does not receive regulatory approvals for its product candidates, NeuBase may not be able to continue its operations.

 

Furthermore, the FDA has relatively limited experience with nucleic acid therapeutics, which may increase the complexity, uncertainty and length of the regulatory review process for NeuBase’s product candidates. To date, the FDA has approved few nucleic acid therapeutics for marketing and commercialization, and the FDA and its foreign counterparts have not yet established any definitive policies, practices or guidelines specifically in relation to these drugs. The lack of policies, practices or guidelines specific to nucleic acid therapeutics may hinder or slow review by the FDA of any regulatory filings that NeuBase may submit. Moreover, the FDA may respond to these submissions by defining requirements NeuBase may not have anticipated. Such responses could lead to significant delays in the development of NeuBase’s product candidates. In addition, because there may be approved treatments for some of the diseases for which NeuBase may seek approval, in order to receive regulatory approval, NeuBase may need to demonstrate through clinical trials that the product candidates NeuBase develops to treat these diseases, if any, are not only safe and effective, but safer or more effective than existing products. Furthermore, in recent years, there has been increased public and political pressure on the FDA with respect to the approval process for new drugs, and the FDA’s standards, especially regarding drug safety, appear to have become more stringent. As a result of the foregoing factors, NeuBase may never receive regulatory approval to market and commercialize any product candidate.

 

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Preclinical and clinical trials are expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials.

 

All of NeuBase’s product candidates are still in the preclinical stage, and their risk of failure is high. Before NeuBase can commence clinical trials for a product candidate, it must complete extensive preclinical testing and studies that support NeuBase’s planned INDs in the U.S., or similar applications in other jurisdictions. NeuBase cannot be certain of the timely completion or outcome of its preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept NeuBase’s proposed clinical programs or if the outcome of NeuBase’s preclinical testing and studies will ultimately support the further development of its programs. It is also impossible to predict when or if any of NeuBase’s product candidates will complete clinical trials evaluating their safety and effectiveness in humans or will receive regulatory approval. To obtain the requisite regulatory approvals to market and sell any of NeuBase’s product candidates, NeuBase must demonstrate through extensive preclinical studies and clinical trials that its product candidates are safe and effective in humans for use in each target indication. To date, NeuBase has never advanced a product candidate into a clinical trial. Preclinical and clinical testing is expensive and can take many years to complete, and the outcome is inherently uncertain. Failure can occur at any time during the preclinical or clinical trial process. NeuBase’s preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect its ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on its business.

 

Additionally, the results of preclinical studies and future clinical trials of product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy results despite having progressed through preclinical studies and initial clinical trials. Many companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to adverse safety profiles or lack of efficacy, notwithstanding promising results in earlier studies. Similarly, NeuBase’s future clinical trial results may not be successful for these or other reasons.

 

This product candidate development risk is heightened by any changes in the anticipated clinical trials compared to the completed clinical trials. As product candidates are developed from preclinical through early to late stage clinical trials towards approval and commercialization, it is customary that various aspects of the development program, such as manufacturing and methods of administration, are altered along the way in an effort to optimize processes and results. While these types of changes are common and are intended to optimize the product candidates for late stage clinical trials, approval and commercialization, such changes carry the risk that they will not achieve these intended objectives.

 

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Any of these changes could make the results of NeuBase’s anticipated clinical trials or other future clinical trials NeuBase may initiate less predictable and could cause NeuBase’s product candidates to perform differently, including causing toxicities, which could delay completion of NeuBase’s clinical trials, delay approval of its product candidates, and/or jeopardize NeuBase’s ability to commence product sales and generate revenues.

 

NeuBase may rely on third parties to conduct investigator-sponsored clinical trials of NeuBase’s product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of NeuBase’s product candidates may delay or impair its ability to obtain regulatory approval for other product candidates.

 

NeuBase may rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to its product candidates. NeuBase will not control the design or conduct of the investigator-sponsored trials, and it is possible that the FDA or non-U.S. regulatory authorities will not view these investigator-sponsored trials as providing adequate support for future clinical trials, whether controlled by NeuBase or third parties, for any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results.

 

Such arrangements will likely provide NeuBase certain information rights with respect to the investigator-sponsored trials, including access to and the ability to use and reference the data, including for NeuBase’s own regulatory filings, resulting from the investigator-sponsored trials. However, NeuBase would not have control over the timing and reporting of the data from investigator-sponsored trials, nor would NeuBase own the data from the investigator-sponsored trials. If NeuBase is unable to confirm or replicate the results from the investigator-sponsored trials or if negative results are obtained, NeuBase would likely be further delayed or prevented from advancing further clinical development of its product candidates. Further, if investigators or institutions breach their obligations with respect to the clinical development of NeuBase’s product candidates, or if the data proves to be inadequate compared to the first-hand knowledge NeuBase might have gained had the investigator-sponsored trials been sponsored and conducted by NeuBase, then NeuBase’s ability to design and conduct any future clinical trials itself may be adversely affected.

 

Additionally, the FDA or non-U.S. regulatory authorities may disagree with the sufficiency of NeuBase’s right of reference to the preclinical, manufacturing or clinical data generated by these investigator-sponsored trials, or its interpretation of preclinical, manufacturing or clinical data from these investigator-sponsored trials. If so, the FDA or other non-U.S. regulatory authorities may require NeuBase to obtain and submit additional preclinical, manufacturing, or clinical data before NeuBase may initiate its anticipated trials and/or may not accept such additional data as adequate to initiate its anticipated trials.

 

NeuBase’s product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or commercialization or have other significant adverse implications on NeuBase’s business, financial condition and results of operations.

 

Undesirable side effects observed in preclinical studies or in clinical trials with NeuBase’s product candidates could interrupt, delay or halt their development and could result in the denial of regulatory approval by the FDA, the EMA or comparable foreign authorities for any or all targeted indications or adversely affect the marketability of any such product candidates that receive regulatory approval. In turn, this could eliminate or limit NeuBase’s ability to commercialize its product candidates.

 

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NeuBase’s product candidates may exhibit adverse effects in preclinical toxicology studies and adverse interactions with other drugs. There are also risks associated with additional requirements the FDA, the EMA or comparable foreign authorities may impose for marketing approval with regard to a particular disease.

 

NeuBase’s product candidates may require a risk management program that could include patient and healthcare provider education, usage guidelines, appropriate promotional activities, a post-marketing observational study, and ongoing safety and reporting mechanisms, among other requirements. Prescribing could be limited to physician specialists or physicians trained in the use of the drug, or could be limited to a more restricted patient population. Any risk management program required for approval of NeuBase’s product candidates could potentially have an adverse effect on NeuBase’s business, financial condition and results of operations.

 

Undesirable side effects involving NeuBase’s product candidates may have other significant adverse implications on NeuBase’s business, financial condition and results of operations. For example:

 

NeuBase may be unable to obtain additional financing on acceptable terms, if at all;

 

NeuBase’s collaborators may terminate any development agreements covering these product candidates;

 

if any development agreements are terminated, NeuBase may determine not to further develop the affected product candidates due to resource constraints and may not be able to establish additional collaborations for their further development on acceptable terms, if at all;

 

if NeuBase were to later continue the development of these product candidates and receive regulatory approval, earlier findings may significantly limit their marketability and thus significantly lower NeuBase’s potential future revenues from their commercialization;

 

NeuBase may be subject to product liability or stockholder litigation; and

 

NeuBase may be unable to attract and retain key employees.

 

In addition, if any of NeuBase’s product candidates receive marketing approval and NeuBase or others later identify undesirable side effects caused by the product:

 

regulatory authorities may withdraw their approval of the product, or NeuBase or NeuBase’s partners may decide to cease marketing and sale of the product voluntarily;

 

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