UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2020

 

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________________ to __________________

 

Commission File Number: 001-38045

 

 

Neurotrope, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada 46-3522381
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)

 

1185 Avenue of the Americas, 3rd Floor

New York, New York 10036

(973) 242-0005

(Registrant’s telephone number, including area code)

 

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)  

Name of each exchange on which

registered

Common Stock, par value $0.0001 per share

Preferred Stock Purchase Rights

  NTRP  

The Nasdaq Stock Market

The Nasdaq Stock Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an 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 x
Non-accelerated filer ¨ Smaller reporting company x
    Emerging growth company ¨

 

If an 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 13(a) of the Exchange Act. ¨

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ¨ No x

 

As of June 10, 2020, there were 23,674,089 shares of the registrant’s common stock, $0.0001 par value per share, issued and outstanding.

 

 

 

 

EXPLANATORY NOTE

 

Due to the outbreak of the novel strain of the coronavirus, on May 11, 2020, Neurotrope, Inc. (the “Company”) filed a Current Report on Form 8-K to avail itself of an extension to file this Quarterly Report on Form 10-Q, originally due on May 11, 2020, relying on an order issued by the Securities and Exchange Commission on March 25, 2020 pursuant to Section 36 of the Securities Exchange Act of 1934, as amended (Release No. 34-88465) (the “Order”) regarding exemptions granted to certain public companies. The Company has a small accounting staff all currently working from home. As a result, given that the Company is an accelerated filer with more limited staff in-person interaction, meeting the timeline for filing became more difficult. The Company is therefore relying on the Order in connection with the filing of this Quarterly Report on Form 10-Q.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

 

Certain statements in this report contain or may contain forward-looking statements. These statements, identified by words such as “plan,” “anticipate,” “believe,” “estimate,” “should,” “expect” and similar expressions, include our expectations and objectives regarding our future financial position, operating results and business strategy. These statements are subject to known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These forward-looking statements were based on various factors and were derived utilizing numerous assumptions and other factors that could cause our actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, our inability to identify potential strategic transactions and to complete any transaction we pursue, our inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, our patent portfolio, our inability to expand our business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of our raw materials, existing or increased competition, stock volatility and illiquidity, and the our failure to implement our business plans or strategies. Most of these factors are difficult to predict accurately and are generally beyond our control. You should consider the areas of risk described in connection with any forward-looking statements that may be made herein. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. Readers should carefully review this report in its entirety, including but not limited to our financial statements and the notes thereto and the risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission (the “SEC”). We advise you to carefully review the reports and documents we file from time to time with the SEC, particularly our quarterly reports on Form 10-Q and our current reports on Form 8-K. Except for our ongoing obligations to disclose material information under the Federal securities laws, we undertake no obligation to publicly release any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

 

OTHER INFORMATION

 

When used in this report, the terms, “we,” the “Company,” “our,” and “us” refer to Neurotrope, Inc., a Nevada corporation (formerly BlueFlash Communications, Inc., a Florida corporation) and its consolidated subsidiary Neurotrope Bioscience, Inc. (“Neurotrope Bioscience”).

  

  2  

 

 

TABLE OF CONTENTS

 

    Page
     
Part I – FINANCIAL INFORMATION    
     
Item 1. Financial Statements (Unaudited)   4
     
Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019   4
     
Condensed Consolidated Statements of Operations for the three months ended March 31, 2020 and 2019   5
     
Condensed Consolidated Statement of Changes in Shareholders’ Equity for the three months ended March 31, 2020 and 2019   6
     
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019   7
     
Notes to Condensed Consolidated Financial Statements   8
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   19
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk   25
     
Item 4. Controls and Procedures   25
     
Part II – OTHER INFORMATION    
     
Item 1. Legal Proceedings   27
     
Item 1A. Risk Factors   27
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   27
     
Item 3. Defaults upon Senior Securities   28
     
Item 4. Mine Safety Disclosures   28
     
Item 5. Other Information   28
     
Item 6. Exhibits   28
     
Signatures   29

 

  3  

 

 

PART I

FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

Neurotrope, Inc and Subsidiary

Condensed Consolidated Balance Sheets

 

(Unaudited)

 

ASSETS                
             
    March 31,     December 31,  
    2020     2019  
CURRENT ASSETS                
Cash and cash equivalents   $ 32,160,754     $ 17,382,038  
Prepaid expenses     338,766       494,112  
                 
TOTAL CURRENT ASSETS     32,499,520       17,876,150  
                 
Fixed assets, net of accumulated depreciation     23,099       21,671  
                 
TOTAL ASSETS   $ 32,522,619     $ 17,897,821  
                 
                 
 LIABILITIES AND SHAREHOLDERS' EQUITY                
                 
CURRENT LIABILITIES                
Accounts payable   $ 266,822     $ 413,081  
Accrued expenses     80,642       65,975  
                 
TOTAL CURRENT LIABILITIES     347,464       479,056  
                 
Commitments and contingencies                
                 
SHAREHOLDERS' EQUITY                
Convertible preferred stock - 100,000 shares authorized, $0.0001 par value;                
4,998 shares issued and outstanding as of March 31, 2020,                
0 shares issued and outstanding as of December 31, 2019                
Liquidation preference of $2,483,606 and $0 as of                
March 31, 2020 and December 31, 2019, respectively.     1       -  
Common stock - 150,000,000 shares authorized, $0.0001 par value;                
20,948,330 shares issued and outstanding as of March 31, 2020;                
13,068,023 shares issued and outstanding as of December 31, 2019;     2,096       1,307  
Additional paid-in capital     123,527,245       106,234,301  
Accumulated deficit     (91,354,187 )     (88,816,843 )
                 
TOTAL SHAREHOLDERS' EQUITY     32,175,155       17,418,765  
                 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY   $ 32,522,619     $ 17,897,821  

 

See accompanying notes to condensed consolidated financial statements.

 

  4  

 

 

Neurotrope, Inc. and Subsidiary

 

Condensed Consolidated Statements of Operations

 

(Unaudited)

 

   

Three Months

Ended

   

Three Months

Ended

 
    March 31,     March 31,  
    2020     2019  
             
 OPERATING EXPENSES:                
 Research and development     156,047       1,861,293  
 General and administrative - related party     7,361       12,500  
 General and administrative     1,787,987       1,328,500  
 Stock-based compensation - related party     21,001       78,289  
 Stock-based compensation     635,815       1,515,475  
                 
 TOTAL OPERATING EXPENSES     2,608,211       4,796,057  
                 
 OTHER INCOME (EXPENSE):                
 Interest income     70,867       106,899  
                 
 Net loss before income taxes     2,537,344       4,689,158  
                 
 Provision for income taxes     -       -  
                 
 Net loss   $ 2,537,344     $ 4,689,158  
                 
 PER SHARE DATA:                
                 
 Basic and diluted loss per common share   $ (0.14 )   $ (0.36 )
                 
 Basic and diluted weighted average common shares outstanding     18,228,800       12,922,400  

 

See accompanying notes to condensed consolidated financial statements.

 

  5  

 

 

Neurotrope, Inc. and Subsidiary

Condensed Consolidated Statement of Changes in Shareholders’ Equity

 

(Unaudited)

 

  Three Months Ended March 31, 2019  
              Additional          
  Common Stock   Preferred Stock   Paid-In   Accumulated      
  Shares   Amount   Shares   Amount   Capital   Deficit   Total  
                             
 Balance January 1, 2019   12,922,370   $ 1,292   $ -   $ -   $ 100,202,110   $ (73,682,093 ) $ 26,521,309  
                                           
 Stock based compensation   -     -     -     -     1,593,764     -     1,593,764  
                                           
 Issuance of warrants for consulting fees   -     -     -     -     -     -     -  
                                           
 Sale of preferred stock and warrants   -     -     -     -     -     -     -  
                                           
 Conversion of preferred stock to common stock   -     -     -     -     -     -     -  
                                           
 Net loss   -     -     -     -     -     (4,689,158 )   (4,689,158 )
                                           
 Balance March 31, 2019   12,922,370   $ 1,292     -   $ -   $ 101,795,874   $ (78,371,251 ) $ 23,425,915  
                                           
                                           
                                           
  Three Months Ended March 31, 2020  
              Additional          
  Common Stock   Preferred Stock   Paid-In   Accumulated      
  Shares   Amount   Shares   Amount   Capital   Deficit   Total  
                             
 Balance January 1, 2020   13,068,023   $ 1,307     -   $ -   $ 106,234,301   $ (88,816,843 ) $ 17,418,765  
                                           
 Stock based compensation   -     -     -     -     656,816     -   $ 656,816  
                                           
 Issuance of warrants for consulting fees   -     -     -     -     116,930     -     116,930  
                                           
 Sale of preferred stock and warrants   -     -     18,000     2     16,519,986     -     16,519,988  
                                           
 Conversion of preferred stock to common stock   7,880,307     789     (13,002 )   (1 )   (788 )   -     -  
                                           
 Net loss   -     -     -     -     -     (2,537,344 )   (2,537,344 )
                                           
 Balance March 31, 2020   20,948,330   $ 2,096     4,998   $ 1   $ 123,527,245   $ (91,354,187 ) $ 32,175,155  

 

See accompanying notes to condensed consolidated financial statements.

 

  6  

 

 

Neurotrope, Inc. and Subsidiary

Condensed Consolidated Statements of Cash Flows

 

(Unaudited)

 

   

Three Months

Ended

   

Three Months

Ended

 
    March 31, 2020     March 31, 2019  
CASH FLOW USED IN OPERATING ACTIVITIES                
Net loss   $ (2,537,344 )   $ (4,689,158 )
 Adjustments to reconcile net loss to net cash used by operating activities                
Stock based compensation     656,816       1,593,764  
Consulting services paid by issuance of common stock warrants     116,930       -  
Depreciation expense     1,171       897  
Change in assets and liabilities                
Decrease in prepaid expenses     155,346       176,739  
(Decrease) in accounts payable     (146,259 )     (1,901,107 )
Increase in accrued expenses     14,667       2,244  
Total adjustments     798,671       (127,463 )
                 
Net Cash Used in Operating Activities     (1,738,673 )     (4,816,621 )
                 
CASH FLOWS USED IN INVESTING ACTIVITIES                
Purchase of fixed assets     (2,599 )     (5,214 )
                 
Net Cash Used in Investing Activities     (2,599 )     (5,214 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Net proceeds from issuance of preferred stock and warrants     16,519,988       -  
                 
Net Cash Provided by Financing Activities     16,519,988       -  
                 
NET INCREASE (DECREASE) IN CASH AND EQUIVALENTS     14,778,716       (4,821,835 )
                 
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD     17,382,038       28,854,218  
                 
CASH AND EQUIVALENTS AT END OF PERIOD   $ 32,160,754     $ 24,032,383  

 

See accompanying notes to condensed consolidated financial statements.

 

  7  

 

 

NEUROTROPE, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(UNAUDITED)

 

Note 1 – Organization, Nature of Business, and Liquidity:

 

Organization & Business

 

Neurotrope Bioscience was incorporated in Delaware on October 31, 2012. Neurotrope Bioscience was formed to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). Neurotrope Bioscience is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4, “Related Party Transactions and Licensing / Research Agreements”).

 

On September 9, 2019, the Company issued a press release announcing that the confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD patients did not achieve statistical significance on the primary endpoint, which was change from baseline to Week 13 in the Severe Impairment Battery (“SIB”) total score. An average increase in SIB total score of 1.3 points and 2.1 points was observed for the Bryostatin-1 and placebo groups, respectively, at Week 13. There were multiple secondary outcome measures in this trial, including the changes from baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically significant difference was observed in the change from baseline in SIB total score between the Bryostatin-1 and placebo treatment groups. On January 22, 2020, the Company announced the completion of an additional analysis in connection with the confirmatory Phase 2 study, which examined moderately severe to severe AD patients treated with byrostatin-1 in the absence of memantine. To adjust for the baseline imbalance observed in the study, a post-hoc analysis was conducted using paired data for individual patients, with each patient as his/her own control. For the pre-specified moderate stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the Bryostatin-1 treatment group and 33 patients in the placebo group.  There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. Although there was a signal of Bryostatin-1’s benefit for the moderately severe stratum, the difference between the Bryostatin-1 and placebo treatment groups was not statistically significant (p=0.2727). The Company, while proceeding with its next Phase 2 clinical trial, is determining how to proceed with respect to its development programs for Bryostatin-1.

 

On October 8, 2019, following the Company’s announcement of top-line results from its Phase 2 study of Bryostatin-1 in moderate to severe AD, the Company announced its plans to explore strategic alternatives to maximize shareholder value. The Company’s Board of Directors (the “Board”) has formed a strategic alternatives committee to aid in evaluating its alternatives, including, but not necessarily limited to, collaborations or merger and acquisition transactions (see Note 9, “Subsequent Events - Planned Merger and Spin-Off”.)

 

Liquidity

 

As of March 31, 2020, the Company had approximately $32.2 million in cash and cash equivalents as compared to $17.4 million at December 31, 2019. The increase in cash is attributable to the Company’s issuance of preferred stock and warrants pursuant to a registered direct offering in January 2020 (see Note 6, “Common Stock”) partially offset by cash used for operating activities during the 2020 period. The Company expects that its current cash and cash equivalents will be sufficient to support its projected operating requirements over at least the next 12 months from the Form 10-Q filing date, which will include the continuing development of bryostatin, our novel drug targeting the activation of PKC epsilon, and which projected operating requirements do not take into account the completion of the planned merger or spin-off.

 

  8  

 

 

The future course of the Company’s operations and research and development activities will be contingent upon the further analysis of results from its recently completed trial mentioned herein as well as the Company’s current plans regarding the strategic alternative disclosed in Note 9, “Subsequent Events - Planned Merger and Spin-Off”.

 

Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm its business, financial condition and results of operations.

 

National Institutes of Health Award

 

On January 22, 2020, the Company announced the approval of a $2.7 million award from the National Institutes of Health to support an additional Phase 2 clinical study focused on the moderate stratum for which the Company saw improvement in the 203 study. The grant provides for funds in the first year of approximately $1.0 million and funding in year two of approximately $1.7 million subject to satisfactory progress of the project. The Company is planning to meet with the Food and Drug Administration to present the totality of the clinical data for Bryostatin-1. On May 28, 2020, Neurotrope Bioscience entered into a non-binding letter of intent with WCT pursuant to which the parties agreed to negotiate a definitive agreement for the provision of clinical trial development services by WCT in connection with a proposed Phase 2 study assessing safety, tolerability and long-term efficacy of bryostatin in the treatment of moderately severe AD subjects not receiving memantine treatment.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed consolidated financial statements included herein contain all adjustments necessary to present fairly the Company's financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the three months ended March 31, 2020 may not be indicative of results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes to those statements for the year ended December 31, 2019 included in our Annual Report on Form 10-K.

 

Note 2 – Summary of Significant Accounting Policies:

 

Use of Estimates:

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and Cash Equivalents and Concentration of Credit Risk:

 

The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At March 31, 2020, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.6 million. In addition, approximately $29.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

 

  9  

 

 

Fixed Assets:

 

Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years.

  

Research and Development Costs:

 

All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE are expensed when incurred. FASB ASC Topic 730 requires companies involved in research and development activities to capitalize non-refundable advance payments for such services pursuant to contractual arrangements because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services at March 31, 2020 and December 31, 2019.

 

Loss Per Share:

 

Basic loss per common share amounts are computed by dividing net loss by the weighted average number of common shares outstanding. In periods where there is net income, the Company applies the two-class method to calculate basic and diluted net income (loss) per share of common stock, as the Company’s preferred stock is a participating security. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as the Company’s preferred stock does not contractually participate in its losses.

 

Diluted loss per share amounts are based on the weighted average number of common shares outstanding, plus the incremental shares that would have been outstanding upon the assumed exercise of all potentially dilutive stock options and warrants subject to anti-dilution limitations. All such potentially dilutive instruments were anti-dilutive as of March 31, 2020 and 2019, which were approximately 24.1 million shares and 12.4 million shares, respectively.

 

Income Taxes:

 

The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

 

The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $64.3 million for the period from October 31, 2012 (inception) through March 31, 2020. The net operating loss carryforwards resulted in a deferred tax asset of approximately $16.1 million at March 31, 2020. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. The deferred tax asset is offset by a full valuation allowance.

 

The Company applies the provisions of FASB ASC 740-10, Accounting for Uncertain Tax Positions, which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard also provides guidance on de-recognition, classification, interest and penalties, and accounting in interim periods, disclosure and transitions.

 

  10  

 

 

The Company has concluded that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing.

 

Under Section 382 of the Internal Revenue Code of 1986, as amended, changes in the Company’s ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. The Company has not performed a study to assess whether an ownership change for purposes of Section 382 has occurred, or whether there have been multiple ownership changes since the Company’s inception, due to the significant costs and complexities associated with such study.

  

Risks and Uncertainties:

 

The Company operates in an industry that is subject to rapid technological change, intense competition, and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risk. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the limited supply of raw materials, the ability to obtain favorable licensing, manufacturing or other agreements, including risk associated with our CRE licensing agreement, for its product candidates and the ability to raise capital to achieve strategic objectives.

 

CRE has entered into a material transfer agreement with the National Cancer Institute (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for the Company’s pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of all of the clinical trials that the Company is required to conduct in order to seek U.S. Food and Drug Administration (“FDA”) approval of bryostatin for the treatment of AD. Therefore, CRE or the Company will have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or the Company are unable to secure such additional agreements, or if the NCI otherwise discontinues for any reason supplying the Company with bryostatin, then the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize bryostatin for the treatment of AD.

 

Stock Compensation:

 

The Company accounts for stock-based awards to employees and consultants in accordance with applicable accounting principles, which requires compensation expense related to share-based transactions, including employee stock options and consultant warrants, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options or warrants. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option and consulting expenses are recognized over the employee’s or consultant’s requisite service period (generally the vesting period of the equity grant). The Company’s option pricing model requires the input of highly subjective assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions can significantly impact stock-based compensation expense.

 

Total stock-based compensation for the three months ended March 31, 2020 was $656,816, of which $234,901 was classified as research and development expense and $421,915 was classified as general and administrative expense. For the three months ended March 31, 2019, total stock-based compensation was $1,593,764, of which $557,748 was classified as research and development expense and $1,036,016 was classified as general and administrative expense.

 

Recent Accounting Pronouncements

  

Accounting Pronouncements Adopted During the Period:

 

In November 2018, the FASB issued ASU-2018-18, Collaborative Arrangements (Topic 808). In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customer’s guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and requires, that in a transaction with a collaborative arrangement participant who is not a customer, presenting the transaction together with revenue recognized under contracts with customers is precluded. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company will assess the impact of the adoption of this guidance on its consolidated financial statements once it becomes probable that the Company may generate revenue and, because the Company is not anticipating generating revenues in the foreseeable future, did not have an impact on our current financial statements.

 

In August 2018 the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. This standard modifies certain disclosure requirements on fair value measurements. This standard became effective for the Company on January 1, 2020. The adoption of this standard did not have a material impact on the Company’s disclosures.

 

  11  

 

 

Note 3 – Collaborative Agreements:

 

Stanford License Agreements

 

On May 12, 2014, the Company entered into a license agreement (the “Stanford Agreement”) with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as “bryologs,” for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury, for the life of the licensed patents. The Company is required by the Stanford Agreement to use commercially reasonable efforts to develop, manufacture and sell products (“Licensed Products”) in the Licensed Field of Use (as defined in the Stanford Agreement) during the term of the licensing agreement which expires upon the termination of the last valid claim of any licensed patent under this agreement. In addition, the Company must meet specific diligence milestones, and upon meeting such milestones, make specific milestone payments to Stanford. The Company must also pay Stanford royalties of 3% of net sales, if any, of Licensed Products (as defined in the Stanford Agreement) and milestone payments of up to $3.7 million dependent upon stage of product development. As of March 31, 2020, no royalties nor milestone payments have been required.

 

On January 19, 2017, the Company entered into an additional, second license agreement with Stanford, pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of “Bryostatin Compounds and Methods of Preparing the Same,” or synthesized bryostatin, for use in the treatment of neurological diseases, cognitive dysfunction and psychiatric disorders, for the life of the licensed patents. The Company paid Stanford $70,000 upon executing the license and is obligated to pay an additional $10,000 annually as a license maintenance fee. In addition, based upon certain milestones which include product development and commercialization, the Company will be obligated to pay up to an additional $2.1 million and between 1.5% and 4.5% royalty payments on certain revenues generated by the Company relating to the licensed technology. The Company has made all required annual maintenance payments. As of March 31, 2020, no royalties nor milestone payments have been required.

 

Mt. Sinai License Agreement

 

On July 14, 2014, Neurotrope Bioscience entered into an Exclusive License Agreement (the “Mount Sinai Agreement”) with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”). Pursuant to the Mount Sinai Agreement, Mount Sinai granted Neurotrope Bioscience (a) a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai’s interest in certain joint patents held by the Company and Mount Sinai (the “Joint Patents”) as well as in certain results and data (the “Data Package”) and (b) a non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information, both relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of Protein Kinase C Epsilon (“PKCε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows Neurotrope Bioscience to research, discover, develop, make, have made, use, have used, import, lease, sell, have sold and offer certain products, processes or methods that are covered by valid claims of Mount Sinai’s interest in the Joint Patents or an Orphan Drug Designation Application covering the Data Package (“Mount Sinai Licensed Products”) in the Mount Sinai Field of Use (as such terms are defined in the Mount Sinai Agreement).

 

  12  

 

 

The Company will pay Mt. Sinai milestone payments of $2 million upon approval of a new drug approval (“NDA”) in the United States and an additional $1.5 million for an NDA approval in the European Union or Japan. In addition, the Company would be obligated to pay Mt. Sinai royalties on net sales of licensed product of 2.0% for up to $250 million of net sales and 3.0% of net sales over $250 million. Since inception, the Company has paid Mt. Sinai approximately $150,000 consisting of licensing fees of $75,000 plus development costs and patent fees of approximately $75,000. As of March 31, 2020, no royalties nor milestone payments have been required.

 

Clinical Trial Services Agreements

 

On May 4, 2018, Neurotrope Bioscience executed a new Services Agreement (the “New Services Agreement”) with Worldwide Clinical Trials (“WCT”). The New Services Agreement relates to services for Neurotrope Bioscience’s Phase 2 confirmatory clinical study assessing the safety, tolerability and efficacy of bryostatin in the treatment of moderately severe to severe AD (the “Study”). Pursuant to the terms of the Services Agreement, WCT is providing services to target enrollment of approximately one hundred (100) Study subjects. The total estimated budget for the services, including pass-through costs, drug supply and other statistical analyses, was approximately $7.8 million. Of the total estimated Study costs, as of March 31, 2020, the Company has incurred approximately $7.6 million in expenses of which WCT has represented a total of approximately $7.2 million and approximately $400,000 of expenses have been paid to other trial-related vendors and consultants of which all amounts have been paid as of March 31, 2020. The Company has incurred substantially all of the expenses associated with WCT as of March 31, 2020.

 

Note 4 – Related Party Transactions and Licensing / Research Agreements:

 

Cognitive Research Enterprises, Inc.

 

James Gottlieb, who resigned as a director of the Company on February 21, 2020, serves as a director of CRE, and Shana Phares, who resigned as a director of the Company on February 25, 2020, served as President and Chief Executive Officer of CRE. CRE is a stockholder of a corporation, Neuroscience Research Ventures, Inc. (“NRV, Inc.”), which owned approximately 1.3% of the Company’s outstanding common stock as of March 31, 2020.

 

Effective October 31, 2012, Neurotrope Bioscience executed a Technology License and Services Agreement (the “TLSA”) with CRE, a related party, and NRV II, LLC (“NRV II”), another affiliate of CRE, which was amended by Amendment No. 1 to the TLSA as of August 21, 2013. As of February 4, 2015, the parties entered into an Amended and Restated Technology License and Services Agreement (the “CRE License Agreement”). The CRE License Agreement provides research services and has granted Neurotrope Bioscience the exclusive and nontransferable world-wide, royalty-bearing right, with a right to sublicense (in accordance with the terms and conditions described below), under CRE’s and NRV II’s respective right, title and interest in and to certain patents and technology owned by CRE or licensed to NRV II by CRE as of or subsequent to October 31, 2012, to develop, use, manufacture, market, offer for sale, sell, distribute, import and export certain products or services for therapeutic applications for AD and other cognitive dysfunctions in humans or animals (the “Field of Use”). Additionally, the TLSA specifies that all patents that issue from a certain patent application shall constitute licensed patents and all trade secrets, know-how and other confidential information claimed by such patents constitute licensed technology under the CRE License. The CRE License Agreement terminates on the later of the date (a) the last of the licensed patent expires, is abandoned, or is declared unenforceable or invalid or (b) the last of the intellectual property enters the public domain.

 

After the initial Series A Stock financing, the CRE License Agreement required Neurotrope Bioscience to enter into scope of work agreements with CRE as the preferred service provider for any research and development services or other related scientific assistance and support services. There were no such statements of work agreements entered into or work being performed under such statements of work during the three months ended March 31, 2020 or fiscal year 2019.

 

  13  

 

 

In addition, the CRE License Agreement requires the Company to pay CRE a “Fixed Research Fee” of $1 million per year for five years, commencing on the date that the Company completes a Series B Preferred Stock financing resulting in proceeds of at least $25,000,000 (the “Series B Financing”) which shall also include the proceeds from the exercise of any Series A warrants, Series B warrants, and Series E warrants. This Fixed Research Fee has not been triggered. The CRE License Agreement also requires the payment of royalties ranging between 2% and 5% of the Company’s revenues generated from the licensed patents and other intellectual property, dependent upon the percentage ownership that NRV, Inc. holds in the Company.

  

In addition, on November 10, 2018, Neurotrope Bioscience and CRE entered into a second amendment (the “Second Amendment”) to the TLSA to which CRE granted certain patent prosecution and maintenance rights to Neurotrope Bioscience. Under the Second Amendment, Neurotrope Bioscience will have the sole and exclusive right and the obligation, to apply for, file, prosecute and maintain patents and applications for the intellectual property licensed to Neurotrope Bioscience, and pay all fees, costs and expenses related to the licensed intellectual property. Neurotrope Bioscience paid CRE $10,000 in consideration of this Second Amendment.

 

Note 5 – Commitments:

 

Consulting Agreements

 

On August 4, 2016, the Company entered into a consulting agreement with SM Capital Management, LLC (“SMCM”), a limited liability company owned and controlled by the Company’s Chairman of the Board, Mr. Joshua N. Silverman (the “Consulting Agreement”). Mr. Silverman was appointed to the Board on August 4, 2016. Pursuant to the Consulting Agreement, SMCM shall provide consulting services which shall include, but not be limited to, providing business development, financial communications and management transition services, for a one-year period, subject to annual review thereafter. SMCM’s annual consulting fee is $120,000, payable by the Company in monthly installments of $10,000. In addition, SMCM shall be reimbursed for (i) all pre-approved travel in connection with the consulting services to the Company, (ii) upon submission to the Company of appropriate vouchers and receipts, for all other out-of-pocket expenses reasonably incurred by SMCM in furtherance of the Company’s business.

 

Effective as of June 1, 2019, the Company entered into a consulting agreement with Katalyst Securities LLC (“Katalyst”), pursuant to which Katalyst agreed to provide investment banking consulting services to the Company (the “Katalyst Agreement”). The term of the agreement continues until the second anniversary from the effective date and may be canceled by either Katalyst or the Company with 30 days’ advance notice. As consideration for its services under the Katalyst Agreement, the Company agreed to pay to Katalyst $25,000 per month, plus five-year warrants to purchase 90,000 shares of the Company’s common stock on the effective date of the Katalyst Agreement and on each of the three month anniversaries following the effective date. The warrants have an exercise price equal to the closing price of the Company’s stock price on the date of issuance. Katalyst’s cash and stock-based compensation is included as general and administrative expenses in the Company’s statement of operations.

 

Effective as of June 5, 2019, the Company entered into a consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”), pursuant to which GPN agreed to provide investment banking consulting services to the Company. The term of the agreement continues until the second anniversary from the effective date and may be canceled by either GPN or the Company with 30 days’ advance notice. As consideration for its services under the GPN Agreement, the Company agreed to pay to GPN $8,000 per month, plus five-year warrants to purchase 24,000 shares of the Company’s common stock on the effective date and on each of the three month anniversaries following the effective date. The warrants have an exercise price equal to the closing price of the Company’s stock price on the date of issuance. On February 1, 2020, the Company amended the GPN Agreement, increasing the cash compensation to $17,500 per month and increasing the number of warrants issued each three-month period from 24,000 to 50,000. GPN’s cash and stock-based compensation is included as general and administrative expenses in the Company’s statement of operations.

 

  14  

 

 

Note 6 – Common and Preferred Stock:

 

Adoption of a Shareholder Rights Plan

 

Overview

 

On September 9, 2019, the Company announced that its Board had adopted a shareholder rights plan (the “Rights Plan”). The Rights Plan is intended to protect the interests of the Company’s stockholders and enable them realize the full potential value of their investment by reducing the likelihood that any person or group gains control of the Company through open market accumulation or other tactics without appropriately compensating all stockholders. Pursuant to the Rights Plan, the Company issued, by means of a dividend, one preferred share purchase right for each outstanding share of the Company’s common stock to shareholders of record on the close of business on September 19, 2019. Initially, these Rights (as defined below) will trade with, and be represented by, the shares of the Company’s common stock. The Rights will generally become exercisable only if any person (or any persons acting as a group) acquires 15% or more of the Company’s outstanding common stock (the “Acquiring Person”) in a transaction not approved by the Board, subject to certain exceptions, as explained below.

 

If the Rights become exercisable, all holders of Rights, other than the Acquiring Person, will be entitled to acquire shares of the Company’s common stock at a 50% discount or the Company may exchange each Right held by such holders for one share of its common stock. In such situation, Rights held by the Acquiring Person would become void and will not be exercisable. If any person at the time of the first public announcement of the Rights Plan owned more than the triggering percentage then that stockholder’s existing ownership percentage will be grandfathered, although, with certain exceptions, the Rights will become exercisable if at any time after the announcement of the Rights Plan such stockholder increases its ownership of the Company’s common stock.

 

Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the Rights will expire at the close of business on September 8, 2021. The Board may terminate the Rights Plan before that date if the Board determines that there is no longer a threat to shareholder value.

 

Key Features

 

On September 9, 2019, the Board declared a dividend of one preferred share purchase right (a “Right”), payable on September 19, 2019, for each share of common stock, par value $0.0001 per share, of the Company outstanding on September 19, 2019, to the stockholders of record on that date. In connection with the distribution of the Rights, the Company entered into a Rights Agreement (the “Rights Agreement”), dated as of September 9, 2019, between the Company and Philadelphia Stock Transfer, Inc., as rights agent. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series C Preferred Stock, par value $0.0001 per share (the “Preferred Shares”), of the Company at a price of $20 per one one-thousandth of a Preferred Share represented by a Right, subject to adjustment. Each one one-thousandth of a Preferred Share entitles the holder thereof to receive (i) the same dividends and liquidation rights as if the holder held one share of common stock and will be treated the same as one share of common stock in the event of a merger, consolidation or other share exchange and (ii) one vote on all matters submitted to a vote of the Company’s stockholders, in each case subject to adjustment as described in the Certificate of Designations, Preferences and Rights of Series C Preferred Stock of Neurotrope Inc. Until a right is exercised, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends. As of March 31, 2020, there is no Series C Preferred Stock outstanding.

 

January 2020 Offering

 

On January 22, 2020, the Company entered into a securities purchase agreement with certain institutional investors and certain pre-existing high net worth individual investors. Pursuant to the terms of the purchase agreement, the Company issued to the purchasers in a registered offering an aggregate of 18,000 shares of Series D Convertible Preferred Stock, par value $0.0001 per share (the “Series D Preferred Stock”) (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock for an aggregate gross purchase price of approximately $18 million.

 

  15  

 

 

The warrants are exercisable at a price of $1.65 per share immediately upon issuance. They feature a five-year term and a right by the Company, in certain circumstances, to call for the cancellation of up to 50% of the shares of common stock underlying such warrants for consideration equal to $0.0001 per share of underlying common stock in the event the value weighted average price of the Company’s common stock exceeds $5.00 for each of 10 consecutive trading days in a 30-day calendar period. The Series D Preferred Stock and the Series H warrants are immediately separable and were issued separately. The net proceeds to the Company from the offering were approximately $16.4 million, after deducting financial advisory fees and offering expenses paid by the Company.

 

In connection with the offering, on January 22, 2020, the Company filed with the Secretary of State of the State of Nevada a Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (the “Series D Certificate of Designation”) establishing and designating the rights, powers and preferences of the Series D Preferred Stock. The Company designated 18,000 shares of Series D Preferred Stock. Pursuant to the Series D Certificate of Designation, the holders of the Series D Preferred Stock are entitled, among other things, to the right to participate in any dividends and distributions paid to common stockholders on an as-converted basis. The Series D Preferred Stock has no voting rights except as required by law. The Series D Preferred Stock is convertible at any time and from time to time without the payment of additional consideration into shares of the Company’s common stock at a conversion price of $1.65 per share, subject to certain adjustments and has a stated value of $1,000 per share of Series D Preferred Stock. In the event of any liquidation or dissolution of the Company, the Series D Preferred Stock will rank junior to the Company’s Series C Preferred Stock under the Rights Agreement, if applicable, and any other class of preferred stock of senior rank to the Series D Preferred Stock, senior to any other class of preferred stock and to the Company’s common stock in the distribution of assets, to the extent legally available for distribution.

 

During the three months ended March 31, 2020, 13,002 shares of Series D Preferred Stock were converted into an aggregate of 7,880,307 shares of common stock. The remaining 4,997 shares of Series D Preferred Stock are convertible into an aggregate of 3,028,793 shares of common stock.

 

Note 7 – Stock Options:

 

Option Grants

 

The following is a summary of stock option activity under the stock option plans for the three months ended March 31, 2020:

 

   

Number
of

Shares

   

Weighted-

Average

Exercise

Price

   

Weighted-

Average

Remaining

Contractual

Term

(Years)

   

Aggregate

Intrinsic

Value

(in
millions)

 
Options outstanding at January 1, 2020     2,366,519     $ 12.86       7.5          
Options granted     60,000     $ 0.82                  
Less options forfeited     (27,282 )   $ 5.30                  
Less options expired/cancelled     (72,664 )   $ 10.38                  
Less options exercised     -     $ -                  
Options outstanding at March 31, 2020     2,326,573     $ 7.28       7.3     $ -  
Options exercisable at March 31, 2020     1,789,278     $ 14.92       7.4     $ -  

 

Pursuant to the Company’s non-employee director compensation plan, in March 2020, the Company granted stock options to purchase an aggregate of 60,000 shares of the Company’s common stock to six members of the Board. The stock options have an exercise price of $0.8203 per share and an expiration date that is ten years from the date of issuance. All of these options vest upon the first anniversary of the issuance date.

 

  16  

 

 

As of March 31, 2020, there was approximately $1.7 million of total unrecognized compensation costs related to unvested stock options. These costs are expected to be recognized over a weighted average period of 1.3 years.

 

The Company used the Black-Scholes valuation model to calculate the fair value of stock options. The fair value of stock options issued for the three months ended March 31, 2020 was estimated at the grant date using the following weighted average assumptions: Dividend yield 0%; Expected term 10 years; an aggregate volatility based upon a blend of the Company’s and guideline company historical volatility of 99.46%; and Risk-free interest rate 0.92%. The weighted average grant date fair value of options granted for the three months ended March 31, 2020 is $0.73 per option, or a total for all grants of approximately $44,000.

  

Note 8 – Common Stock Warrants:

 

The following is a summary of common stock warrant activity for the three months ended March 31, 2020:

 

    Number
of shares
 
Warrants outstanding January 1, 2020     10,482,158  
Warrants issued     11,249,100  
Warrants exercised     -  
Warrants outstanding March 31, 2020     21,731,258  

 

Pursuant to its January 2020 offering, the Company issued a total of 11,109,100 five-year warrants to purchase shares of common stock at $1.65 per share (See Note 6, “Common Stock” above for details of the January 2020 offering.) Of the total warrants issued, 10,909,100 were issued to investors and 200,000 to the Company’s financial advisor.

 

The Company used the Black-Scholes valuation model to calculate the fair value of warrants. The fair value of the 140,000 warrants issued in connection with certain consulting agreements for the three months ended March 31, 2020 was estimated at the grant date using the following weighted average assumptions: Dividend yield 0%; Expected term five years; Volatility 99.4%; and Risk-free interest rate 0.88%. The weighted average grant date fair value of warrants granted for the three months ended March 31, 2020 is $0.8352 per warrant, or approximately $117,000.

 

As of March 31, 2020, the Company’s warrants by exercise price were as follows: 147,606 warrants exercisable at $0.32, 114,000 warrants exercisable at $0.86, 140,000 warrants exercisable at $1.13, 11,109,100 warrants exercisable at $1.65, 4,916,603 warrants exercisable at $4.37, 114,000 warrants exercisable at $5.31, 100,240 warrants exercisable at $6.25, 382,887 warrants exercisable at $6.40, 24,000 warrants exercisable at $7.12, 90,000 warrants exercisable at $7.13, 3,772,908 warrants exercisable at $12.80 and 819,914 warrants exercisable at $32.00.

 

Note 9 – Subsequent Events:

 

Registered Direct Offering

 

During April, May and June 2020, four investors in the Company’s January 22, 2020, registered direct offering converted 4,497.5 shares of Series D Preferred Stock into an aggregate of 2,725,759 shares of the Company’s common stock.

 

“Universal Shelf” Registration Statement

 

On April 17, 2020, the Company filed a “universal shelf” registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”), which provides for the issuance by the Company of up to $100,000,000 in common stock, preferred stock, debt securities, warrants and rights, either individually or in units. The registration statement was declared effective by the SEC on April 24, 2020.

 

  17  

 

 

Planned Merger and Spin-Off

 

On May 17, 2020, the Company, Petros Pharmaceuticals, Inc., a Delaware corporation formed for the purposes of effecting transactions contemplated by the Merger Agreement (as defined below) (“Petros”), PM Merger Sub 1, LLC, a Delaware limited liability company and a wholly-owned subsidiary of Petros (“Merger Sub 1”), PN Merger Sub 2, Inc., a Nevada corporation and a wholly-owned subsidiary of Petros (“Merger Sub 2”), and Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”), entered into an Agreement and Plan of Merger (the “Merger Agreement”). The Merger Agreement provides for (1) the merger of Merger Sub 1, with and into Metuchen, with Metuchen surviving as a wholly-owned subsidiary of Petros (the “Metuchen Merger”) and (2) the merger of Merger Sub 2 with and into the Company, with the Company surviving as a wholly-owned subsidiary of Petros (the “Neurotrope Merger” and together with the Metuchen Merger, the “Mergers”).

 

As a result of the Metuchen Merger, each outstanding common unit or preferred unit of Metuchen will be exchanged for a number of shares of Petros common stock equal to the quotient resulting from the formula of (i) 95,908,502 divided by (ii) the number of fully-diluted units of the Company outstanding immediately prior to the effective time of the Mergers. As a result of the Neurotrope Merger, each outstanding share of the Company’s common stock will be exchanged for one (1) share of Petros common stock and each outstanding share of the Company’s preferred stock will be exchanged for one (1) share of Petros preferred stock. Following the Mergers, the Petros Preferred Stock will have substantially the same conversion rights (proportionally adjusted to give effect to the Mergers), powers, rights and privileges as the Company’s preferred stock prior to the Mergers. In addition, each outstanding option to purchase the Company’s common stock or outstanding warrant to purchase common stock that has not previously been exercised prior to the closing of the Mergers (the “Closing”) will be converted into equivalent options and warrants to purchase shares of Petros common stock and will be adjusted to give effect to the exchange ratios set forth in the Merger Agreement. All the options will become immediately exercisable pursuant to the change of control provisions contained therein.

 

Upon Closing, the current shareholders of the Company will own approximately 20.0% of the combined company and the current Metuchen investors will own approximately 80.0% of the combined company. The Board of Directors of Petros is expected to consist of nine members, five of whom will be designated by Metuchen and four of whom will be designated by the Company. Upon closing, Metuchen will be the accounting acquirer in the Mergers, but not the legal acquirer. As such, the Mergers are deemed a reverse recapitalization under the guidance of ASC 805 and, upon consummation, the historical financial statements of Metuchen will become the historical financial statements of the combined company.

 

In connection with the Mergers, the Company plans to spin-off (the “Spin-Off”) its wholly-owned subsidiary, Neurotrope Bioscience, Inc. Substantially all of the consolidated operations of the Company were conducted through such subsidiary and substantially all of the consolidated operating assets and liabilities of the Company reside in such subsidiary. The Spin-Off is planned to be made as a distribution to the Company’s stakeholders as of a record date prior to the Mergers, but the distribution is currently contemplated to occur after the Closing. The spun-off entity will be capitalized with all cash in excess of the $20 million which is to be retained in the combined company, subject to adjustment for the proceeds from any exercise of the Company’s warrants between the date of execution of the Merger Agreement and closing of the Mergers. The proceeds of any such warrant exercises will be split 80% to Metuchen and 20% to the spun-off entity. The record date for the Spin-Off, the ratio of the Spin-Off shares distributed to the Company shareholders held as of the record date and the extent to which other stakeholders of the Company may be entitled to participate in the Spin-Off have not yet been determined.

 

Consummation of the Mergers is subject to certain closing conditions, including, among other things, approval by the common stockholders of the Company and Metuchen and the listing of the Petros common stock on the Nasdaq Stock Market after the Mergers. The Company has not yet set a date for its shareholder meeting The Merger Agreement contains certain termination rights for both the Company and Metuchen, and further provides that, upon termination of the Merger Agreement under specified circumstances, either party may be required to pay the other party a termination fee of $1.0 million plus third party expenses incurred by the terminating party.

 

WCT Letter of Intent

 

On May 28, 2020, Neurotrope Bioscience entered into a letter of intent with WCT (the “LOI”), pursuant to which the parties agreed to negotiate a definitive agreement for the provision of clinical trial development services by WCT in connection with a proposed Phase 2 study assessing safety, tolerability and long-term efficacy of bryostatin in the treatment of moderately severe AD subjects not receiving memantine treatment. Pursuant to the terms of the LOI, Neurotrope Bioscience agreed to pay to WCT a cash fee of approximately $0.6 million as an advance in order to fund the initial commitment and certain upfront costs of third party vendors.

 

Agreements with BryoLogyx

 

On June 9, 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to serve as the Company’s exclusive supplier of synthetic Bryostatin-1. Pursuant to the terms of the Supply Agreement, the Company has agreed to place an initial order of one gram of current good manufacturing practice (“cGMP”) synthetic Bryostatin-1 as an active pharmaceutical ingredient to be used in a drug product (“API”), to be shipped by BryoLogyx within 60 days after the date upon which BryoLogyx obtains cGMP certification for production of API, which certification shall be obtained no later than March 31, 2021. The Company may place additional orders for API beyond the initial order by making a written request to BryoLogyx no later than six months prior to the requested delivery date.

 

In connection with the Supply Agreement, on June 9, 2020, the Company entered into a transfer agreement (the “Transfer Agreement”) with BryoLogyx. Pursuant to the terms of the Transfer Agreement, the Company agreed to assign and transfer to BryoLogyx all of the Company’s right, title and interest in and to that certain Cooperative Research and Development Agreement, dated as of January 29, 2019 (the “CRADA”), by and between the Company and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute of the National Institutes of Health (“NCI”), under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. The transfer is subject to the receipt of NCI’s consent. The Company further agreed that, following the transfer of the CRADA, it will assign to BryoLogyx its investigational new drug application (“IND”) for CD22 currently on file with the U.S. Food and Drug Administration. As consideration for the transfer of the CRADA and IND, BryoLogyx has agreed to pay to the Company 2% of the gross revenue received in connection with the sale of bryostatin products, up to an aggregate payment amount of $1 million.

 

  18  

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this report and our annual report on Form 10-K for the year ended December 31, 2019.

 

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described, and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on the unaudited financial statements contained in this report, which we have prepared in accordance with United States generally accepted accounting principles. You should read the discussion and analysis together with such financial statements and the related notes thereto.

 

Overview

 

We are a biopharmaceutical company with product candidates in pre-clinical and clinical development. Neurotrope Bioscience began operations in October 2012. We are principally focused on developing a product platform based upon a drug candidate called bryostatin for the treatment of Alzheimer’s disease (“AD”), which is in the clinical testing stage. We are also evaluating bryostatin for other neurodegenerative or cognitive diseases and dysfunctions, such as Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick Type C disease, which have undergone pre-clinical testing. In addition, we are also in the early stages of testing bryostatin activity which may lead to applications in Leukemia and Lymphoma. Neurotrope has been a party to a technology license and services agreement with the original Blanchette Rockefeller Neurosciences Institute (“BRNI”) (which has been known as Cognitive Research Enterprises, Inc. (“CRE”) since October 2016), and its affiliate NRV II, LLC, which we collectively refer to herein as “CRE,” pursuant to which we now have an exclusive non-transferable license to certain patents and technologies required to develop our proposed products. Neurotrope Bioscience was formed for the primary purpose of commercializing the technologies initially developed by BRNI for therapeutic applications for AD or other cognitive dysfunctions. These technologies have been under development by BRNI since 1999 and, until March 2013, had been financed through funding from a variety of non-investor sources (which include not-for-profit foundations, the National Institutes of Health, which is part of the U.S. Department of Health and Human Services, and individual philanthropists). From March 2013 forward, development of the licensed technology has been funded principally through the Company in collaboration with CRE.

 

Planned Merger and Spin-Off

 

On May 17, 2020, we entered into the Merger Agreement with Petros, Merger Sub 1, Merger Sub 2 and Metuchen. The Merger Agreement provides for (1) the merger of Merger Sub 1, with and into Metuchen, with Metuchen surviving as a wholly-owned subsidiary of Petros and (2) the merger of Merger Sub 2 with and into us, with us surviving as a wholly-owned subsidiary of Petros.

 

As a result of the Metuchen Merger, each outstanding common unit or preferred unit of Metuchen will be exchanged for a number of shares of Petros common stock equal to the quotient resulting from the formula of (i) 95,908,502 divided by (ii) the number of our fully-diluted units outstanding immediately prior to the effective time of the Mergers. As a result of the Neurotrope Merger, each outstanding share of our common stock will be exchanged for one (1) share of Petros common stock and each outstanding share of our preferred stock will be exchanged for one (1) share of Petros preferred stock. Following the Mergers, the Petros Preferred Stock will have substantially the same conversion rights (proportionally adjusted to give effect to the Mergers), powers, rights and privileges as our preferred stock prior to the Mergers. In addition, each outstanding option to purchase our common stock or outstanding warrant to purchase common stock that has not previously been exercised prior to the closing of the Mergers (the “Closing”) will be converted into equivalent options and warrants to purchase shares of Petros common stock and will be adjusted to give effect to the exchange ratios set forth in the Merger Agreement.

 

  19  

 

 

Upon the Closing, on a pro forma basis, our current shareholders will own approximately 20.0% of the combined company and current Metuchen investors will own approximately 80.0% of the combined company.

 

In connection with the Mergers, we plan to spin-off our wholly-owned subsidiary, Neurotrope Bioscience, Inc. Substantially all of our consolidated operations were conducted through such subsidiary and substantially all of the consolidated operating assets and liabilities of ours reside in such subsidiary. The Spin-Off is planned to be made as a distribution to our stakeholders as of a record date prior to the Mergers, but the distribution is currently contemplated to occur after the Closing. The spun-off entity will be capitalized with all cash in excess of the $20 million to be retained by Metuchen, subject to adjustment for the proceeds from any exercise of our warrants between the date of execution of the Merger Agreement and closing of the Mergers. The proceeds of any such warrant exercises will be split 80% to Metuchen and 20% to the spun-off entity. The record date for the Spin-Off, the ratio of the Spin-Off shares distributed to our shares held as of the record date and the extent to which other stakeholders of ours may be entitled to participate in the Spin-Off have not yet been determined.

 

Consummation of the Mergers is subject to certain closing conditions, including, among other things, approval by our securityholders and Metuchen and the listing of the Petros common stock on the Nasdaq Stock Market after the Mergers. The Company has not yet set a date for its shareholder meeting.

 

Results of Most Recent Confirmatory Phase 2 Clinical Trial

 

On May 4, 2018, we announced a confirmatory, 100 patient, double-blinded clinical trial for the safe, effective 20 μg dose protocol for advanced AD patients not taking memantine as background therapy to evaluate improvements in SIB scores with an increased number of patients. We engaged Worldwide Clinical Trials, Inc. (“WCT”), in conjunction with consultants and investigators at leading academic institutions, to collaborate on the design and conduct of the trial, which began in April 2018. During July 2018, the first patient was enrolled in this study. Pursuant to a new Services Agreement (the “New Services Agreement”) with WCT dated as of May 4, 2018, WCT provided services relating to the trial. The total estimated budget for the services, including pass-through costs, drug supply and other statistical analyses, was approximately $7.8 million. The trial was substantially completed as of December 31, 2019. We incurred approximately $7.7 million in total expenses of which WCT has represented a total of approximately $7.3 million and approximately $400,000 of expenses were incurred to other trial-related vendors and consultants, resulting in a total savings for this trial of approximately $500,000.

 

On September 9, 2019, we issued a press release announcing that the confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the SIB total score.

 

An average increase in SIB total score of 1.3 points and 2.1 points was observed for the Bryostatin-1 and placebo groups, respectively, at Week 13. There were multiple secondary outcome measures in this trial, including the changes from baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically significant difference was observed in the change from baseline in SIB total score between the Bryostatin -1 and placebo treatment groups.

 

The confirmatory Phase 2 multicenter trial was designed to assess the safety and efficacy of Bryostatin-1 as a treatment for cognitive deficits in patients with moderate to severe AD — defined as a Mini Mental State Exam 2 (“MMSE-2”) score of 4-15 – who are not currently taking memantine. Patients were randomized 1:1 to be treated with either Bryostatin-1 20μg or placebo, receiving 7 doses over 12 weeks. Patients on memantine, an NMDA receptor antagonist, were excluded unless they had been discontinued from memantine treatment for a 30-day washout period prior to study enrollment. The primary efficacy endpoint was the change in the SIB score between the baseline and week 13. Secondary endpoints included repeated SIB changes from baseline SIB at weeks 5, 9, 13 and 15.

 

  20  

 

 

On January 22, 2020, we announced the completion of an additional analysis in connection with the confirmatory Phase 2 study, which examined moderately severe to severe AD patients treated with byrostatin-1 in the absence of memantine. To adjust for the baseline imbalance observed in the study, a post-hoc analysis was conducted using paired data for individual patients, with each patient as his/her own control. For the pre-specified moderate stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the Bryostatin-1 treatment group and 33 patients in the placebo group.  There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. Although there was a signal of Bryostatin-1’s benefit for the moderately severe stratum, the difference between the Bryostatin-1 and placebo treatment groups was not statistically significant (p=0.2727). As a further test of the robustness of this Moderate Stratum benefit signal, a pre-specified trend analysis (measuring increase of SIB improvement as a function of successive drug doses) was performed on the repeated SIB measures over time (Weeks 0, 5, 9, and 13).  These trend analyses showed a significant positive slope of improvement for the treatment groups in the 203 study that was significantly greater than for the placebo group (p<.01).

 

In connection with the additional analysis, we also announced the approval of a $2.7 million award from the National Institutes of Health to support an additional Phase 2 clinical study focused on the moderate stratum for which we saw improvement in the 203 study. The grant provides for funds in the first year of approximately $1.0 million and funding in year two of approximately $1.7 million subject to satisfactory progress of the project. We are planning to meet with the Food and Drug Administration (“FDA”) to present the totality of the clinical data for Bryostatin-1. We are continuing to determine how to proceed with respect to our current development programs for Bryostatin-1. On May 28, 2020, Neurotrope Bioscience, Inc. entered into a non-binding letter of intent with WCT pursuant to which the parties agreed to negotiate a definitive agreement for the provision of clinical trial development services by WCT in connection with a proposed Phase 2 study assessing safety, tolerability and long-term efficacy of bryostatin in the treatment of moderately severe AD subjects not receiving memantine treatment.

 

Other Development Projects

 

To the extent resources permit, we may pursue development of selected technology platforms with indications related to the treatment of various disorders, including neurodegenerative disorders such as AD, based on our currently licensed technology and/or technologies available from third party licensors or collaborators.

 

For example, we have entered into a Cooperative Research and Development Agreement (“CRADA”) with the National Cancer Institute (“NCI”) on January 29, 2019 for the research and clinical development of Bryostatin-1. Under the CRADA, we will collaborate with the NCI’s Center for Cancer Research, Pediatric Oncology Branch (“POB”) to develop a Phase 1 clinical trial testing the safety and toxicity of Bryostatin-1 in children and young adults with CD22 + leukemia and B-cell lymphoma. In the growing era of highly effective immunotherapies targeting cell-surface antigens (e.g., CAR-T cell therapy), and the recognition that antigen modulation plays a critical role in evasion of response to immunotherapy, the ability for Bryostatin-1 to upregulate CD22 may serve a synergistic role in enhancing the response to a host of CD22 targeted therapies. Under the CRADA, Bryostatin-1 is expected to be tested in the clinic to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ disease, while evaluating safety, toxicity and overall response. In connection with the Transfer Agreement, we agreed to assign and transfer to BryoLogyx all of the Company’s right, title and interest in and to the CRADA, subject to the receipt of NCI’s consent.

 

Nemours Agreement

 

On September 5, 2018, we announced a collaboration with The Nemours / Alfred I. duPont Hospital for Children (“Nemours”), a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome (“Fragile X”). In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior.

 

Recent Developments

 

Registered Direct Offering

 

On January 22, 2020, we entered into a securities purchase agreement with certain institutional investors and certain pre-existing high net worth individual investors. Pursuant to the terms of the purchase agreement, we issued to the purchasers in a registered offering an aggregate of 18,000 shares of our newly designated Series D Convertible Preferred Stock, par value $0.0001 per share (the “Series D Preferred Stock”) (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock for an aggregate purchase price of approximately $18 million. The warrants are exercisable at a price of $1.65 per share immediately upon issuance. They feature a five-year term and a right by us, in certain circumstances, to call for the cancellation of up to 50% of the shares of common stock underlying such warrants for consideration equal to $0.0001 per share of underlying common stock in the event the value weighted average price of our common stock exceeds $5.00 for each of 10 consequence trading days in a 30-day calendar period. The Series D Preferred Stock and the Series H warrants are immediately separable and were issued separately. The net proceeds to us from the offering were approximately $16.4 million, after deducting financial advisory fees and offering expenses paid by us.

 

  21  

 

 

Director Resignations

 

On February 21, 2020, James Gottlieb resigned as a member of our Board and from all committees thereof, effective immediately. On February 25, 2020, Shana Phares resigned as a member of the Board and from all committees thereof, effective immediately. Mr. Gottlieb and Ms. Phares served as the two Board designees of the licensor of the patents and technologies utilized by us in our attempts to develop therapeutic applications for Alzheimer’s disease and other cognitive dysfunctions.

 

Comparison of the three months ended March 31, 2020 and March 31, 2019

 

The following table summarizes our results of operations for the three months ended March 31, 2020 and 2019: 

 

    Three months ended
March 31,
             
    2020     2019     Dollar
Change
    %
Change
 
Revenue   $ -     $ -     $ -       0 %
Operating Expenses:                                
Research and development expenses – Other   $ 156,047     $ 1,861,293     $ (1,705,246 )     (91.6 )%
General and administrative expenses – Related party   $ 7,361     $ 12,5000     $ (5,139 )     (41.1 )%
General and administrative expenses – Other   $ 1,787,987     $ 1,328,500     $ 459,487       34.6 %
Stock based compensation expenses – Related Party   $ 21,001     $ 78,289     $ (57,288 )     (73.2 )%
Stock based compensation expenses – Other   $ 635,815     $ 1,515,475     $ (879,660 )     (58.0 )%
Other income, net   $ 70,867     $ 106,899     $ (36,032 )     (33.7 )%
Net loss   $ 2,537,344     $ 4,689,158     $ (2,151,814 )     (45.9 )%

 

Revenues

 

We did not generate any revenues for the three months ended March 31, 2020 and 2019.

 

Operating Expenses

 

Overview

 

Total operating expenses for the three months ended March 31, 2020 were $2,608,211 as compared to $4,796,057 for the three months ended March 31, 2019, a decrease of approximately 46%. The decrease in total operating expenses is due primarily to a decrease in research and development expenses and stock-based, non-cash, compensation expenses offset by an increase in our general and administrative expenses.

 

Research and Development Expenses

 

For the three months ended March 31, 2020, we incurred $156,047 in research and development expenses with non-related parties as compared to $1,861,293 for the three months ended March 31, 2019. These expenses were incurred pursuant to developing the potential AD therapeutic product, specifically expenses relating to the recently concluded confirmatory Phase 2 clinical trial for AD. Of these expenses, for the three months ended March 31, 2020, $75,026 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $66,628 for clinical consulting services, $7,479 of amortization of prepaid licensing fees relating to the Stanford and Mount Sinai license agreements and $6,914 for development of alternative drug supply with Stanford University as compared to, for the three months ended March 31, 2019, $1,628,962 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $220,901 for clinical consulting services, $7,430 of amortization of prepaid licensing fees relating to the Stanford and Mount Sinai license agreements and $4,000 for development of alternative drug supply with Stanford University.

 

  22  

 

 

We expect our research and development expenses to substantially decrease, in the short term, as our confirmatory Phase 2 clinical trial was recently concluded. Other development might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our current development programs for Bryostatin-1.

 

General and Administrative Expenses

 

We incurred related party general and administrative expenses totaling $7,361 for the three months ended March 31, 2020 versus $12,500 for the three months ended March 31, 2019. The decrease is attributable to the resignation of two members of our board of directors in February 2020, who are affiliates of CRE.

 

We incurred $1,787,987 and $1,328,500 of general and administrative expenses for the three months ended March 31, 2020 and 2019, respectively, an increase of approximately 35%. Of the amounts for the three months ended March 31, 2020, as compared to the comparable 2019 period: $652,060 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $610,320 for the 2019 comparable period. The increase for the three months ending March 31, 2020 is principally based upon contractual bonus payments made to certain officers of $272,500; $318,973 was incurred for ongoing legal expenses versus $76,088 for the 2019 comparable period based upon work associated with our strategic alternatives and planning for our January 2020 capital raise; $399,751 was incurred for outside operations consulting services, versus $162,684 for the 2019 comparable period as we incurred additional cash and non-cash expenses for investment banking consulting services; $43,898 was incurred for travel expenses, versus $57,585 for the 2019 comparable period; $133,179 was incurred for investor relations services versus $189,042 for the 2019 comparable period; $31,212 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services, versus $62,307 for the 2019 comparable period; $154,314 was incurred for insurance, versus $107,500 for the 2019 comparable period; and $54,600 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other versus $62,974 for the 2019 comparable period.

 

Stock Based Compensation Expenses

 

We incurred related party non-cash expenses totaling $21,001 and $78,289 for the three months ended March 31, 2020 and 2019, respectively. The decrease is primarily attributable to fully expensing certain options in 2019.

 

We incurred $635,815 and $1,515,475 of non-related party non-cash expenses for the three months ended March 31, 2020 and 2019, respectively. The decrease for the comparable period is primarily attributable to newly issued stock options during the first quarter of 2019, which included awards with accelerated vesting terms.

 

Other Income, net

 

We earned $70,867 of interest income for the three months ended March 31, 2020 as compared to $106,899 for the three months ended March 31, 2019 on funds deposited in interest bearing money market accounts.

 

Net loss and loss per share

 

We incurred losses of $2,537,344 and $4,689,158 for the three months ended March 31, 2020 and 2019, respectively. The decreased loss was primarily attributable to the decrease in research and development expenses associated with completing our most recent Phase 2 confirmatory clinical trial and a decrease in non-cash stock-based compensation expenses offset by the increase in our general and administrative expenses. Earnings (losses) per common share were ($0.14) and ($0.36) for the three months ended March 31, 2020 and 2019, respectively. The decrease in loss per share is primarily attributable to the decrease in our net loss and an increase in weighted average common shares outstanding.

 

  23  

 

 

The computation of diluted loss per share for the three months ended March 31, 2020 excludes 21,731,258 warrants and options to purchase 2,326,573 shares of our common stock as they are anti-dilutive due to our net loss. For the three months ended March 31, 2019, the computation excludes 10,214,357 warrants and options to purchase 2,195,246 shares of our common stock, as they are anti-dilutive due to our net loss.

 

Financial Condition, Liquidity and Capital Resources

 

Cash and Working Capital

 

Since inception, we have incurred negative cash flows from operations. As of March 31, 2020, we had an accumulated deficit of $91,354,187 and had working capital of $32,152,056 as compared to working capital of $17,397,094 as of December 31, 2019. The $14,754,962 increase in working capital was primarily attributable to an increase in cash of approximately $16.5 million, net of transaction expenses, from our registered direct offering of common stock and warrants (described below) offset by our net loss, excluding non-cash compensation and consulting expenses and depreciation, of $1,762,427 plus capital expenditures of $2,599.

 

On January 22, 2020, we entered into a securities purchase agreement with certain institutional investors and certain pre-existing high net worth individual investors, pursuant to which we sold in a registered offering an aggregate of 18,000 shares of Series D Preferred Stock (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock, for an aggregate purchase price of approximately $18 million (See Footnote 6 to the Financials - Common Stock, for transaction details.)

 

Sources and Uses of Liquidity

 

Since inception, we have satisfied our operating cash requirements from the private placement of equity securities sold principally to outside investors. We expect to continue to incur expenses, resulting in losses and negative cash flows from operations, over at least the next several years as we may continue to develop AD and other therapeutic products. We anticipate that this development may include new clinical trials and additional research and development expenditures. We are continuing to determine how to proceed with respect to our current development programs for Bryostatin-1.

 

    Three months ended March 31,  
    2020     2019  
Cash used in operating activities   $ 1,738,673     $ (4,816,621 )
Cash used in investing activities     2,599       5,214  
Cash provided by financing activities     16,519,988       -  

 

Net Cash Used in Operating Activities

 

Cash used in operating activities was $1,738,673 for the three months ended March 31, 2020, compared to $4,816,621 for the three months ended March 31, 2019. The $3,077,948 decrease primarily resulted from the decreased net loss of approximately $2.1 million and by the decrease in payable of approximately $1.7 million, offset by a decrease in non-cash stock-based compensation expenses of approximately $800,000, for the three months ended March 31, 2020.

 

Net Cash Used in Investing Activities

 

Net cash used in investing activities was $2,599 for the three months ended March 31, 2020 compared to $5,214 for the three months ended March 31, 2019. The cash used in investing activities for both periods was for capital expenditures.

 

  24  

 

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities was $16,519,988 for the three months ended March 31, 2020 compared to $0 for the three months ended March 31, 2019. Net cash provided for the three months ended March 31, 2020 was the result of funds raised through the sale of common stock and warrants to investors from our registered direct public offering as described below.

 

On January 22, 2020, we raised, through a registered direct offering, approximately $16.5 million in net proceeds. Pursuant to the terms of a purchase agreement, we issued to the purchasers an aggregate of 18,000 shares of Series D Preferred Stock (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock for an aggregate purchase price of approximately $18 million.

 

As of May 8, 2020, we had approximately $31.8 million in cash, cash equivalents and marketable investment securities. We expect that our existing capital resources will be sufficient to support our projected operating requirements over at least the next 12 months from the Form 10-Q filing date, including the potential continued development of bryostatin, our novel drug targeting the activation of PKC epsilon. The future course of our operations and research and development activities will be contingent upon the further analysis of results from our recently completed trial, in addition to our current plans regarding the strategic alternative disclosed above in “Overview - Planned Merger and Spin-Off.”

 

We expect to require additional capital in order to initiate, pursue and complete all potential AD clinical trials, including the development of bryostatin for other potential product applications, or in connection with any strategic alternatives that we may pursue. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to initiate, pursue and complete all planned clinical trials or continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, and may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Not applicable to a smaller reporting company.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

An evaluation was performed under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive officer and principal financial officer, respectively, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. Based on their evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are not effective due to: inadequate segregation of duties consistent with control objectives in the areas over certain payroll and banking systems and user access controls; ineffective processes over period end financial disclosure and reporting including documentation of GAAP disclosure and reporting reviews supporting the financial reporting process and changes to chart of accounts; and ineffective information technology (IT) general computing controls including lack of risk and design assessments supporting IT security policies and procedures, user access, and IT controls within third party contracts. These weaknesses may affect management’s ability to determine if errors or inappropriate actions have taken place. Management is required to apply its judgment in evaluating the cost-benefit relationship of possible changes in our disclosure controls and procedures.

 

We previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, that our management, including our Chairman of the Board, principal executive officer and principal financial officer, assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting established in the 2013 Internal Control— Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and SEC guidance on conducting such assessments. Based on that evaluation, they concluded that, during the period covered by the Annual Report on Form 10-K for the fiscal year ended December 31, 2019, such internal controls and procedures were not effective to detect the inappropriate application of US generally accepted accounting principles. This was due to deficiencies that existed in the design or operation of our internal controls over financial reporting that may be considered to be material weaknesses. This material weakness continues to exist. The material weaknesses did not result in any identified misstatements to the consolidated financial statements and there were no changes to previously released financial results.

 

  25  

 

 

The Company intends to hire additional personnel to allow for improved financial reporting controls and segregation of duties and institute further IT controls when the Company’s operations and revenues have grown to the point of warranting such controls.

 

Changes in Internal Controls over Financial Reporting

 

There was no change in our internal controls over financial reporting that occurred during the period covered by this report, which has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

 

  26  

 

 

PART II

OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

None.

 

Item 1A. Risk Factors.

 

Except as set forth below, there have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the period ended December 31, 2019. For a further discussion of our Risk Factors, refer to the “Risk Factors” discussion contained in our Annual Report on Form 10-K.

 

Our business may be adversely affected by the ongoing coronavirus pandemic.

 

In December 2019, a novel strain of coronavirus (“COVID-19”) surfaced in Wuhan, China, and has since spread to multiple countries, including the United States. In March 2020, the World Health Organization characterized COVID-19 as a pandemic, and the President of the United States declared the COVID-19 outbreak a national emergency. The outbreak has resulted in governments around the world implementing increasingly stringent measures to help control the spread of the virus, including quarantines, “shelter in place” and “stay at home” orders, travel restrictions, business curtailments, and other measures.

 

These and similar, and perhaps more severe, disruptions may affect patient recruitment and the pace of enrollment in our next Bryostatin-1 clinical trial. Some patients and clinical investigators may not be able to comply with clinical trial protocols and patients may choose to withdraw from our studies as quarantines impede patients’ movement or interrupt healthcare services. Restrictions on transport of clinical materials, as well as diversion of hospital staff and resources to COVID-19 infected patients, may also delay our next Bryostatin-1 clinical trial.

 

The spread of COVID-19, may also materially affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it has significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. A recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our common stock.

 

The ultimate impact of the COVID-19 outbreak or a similar health epidemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems or the global economy as a whole. However, the effects could have a material impact on our business, results of operations and financial condition, and we will continue to monitor the COVID-19 situation closely.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

Other than as set forth below, there have been no other unregistered sales of equity securities during the three months ended March 31, 2020.

 

On March 2, 2020, we issued warrants to purchase 90,000 shares of common stock to Katalyst Securities LLC as compensation for financial advisory services.

 

On March 2, 2020, we issued warrants to purchase 50,000 shares of common stock to GP Nurmenkari Inc. as compensation for investor relations services.

 

  27  

 

 

Item 3. Defaults upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

We are providing the following disclosure in lieu of filing a Current Report on Form 8-K relating to Item 1.01, “Entry into a Material Definitive Agreement.”

 

Supply Agreement

 

On June 9, 2020, we entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to serve as our exclusive supplier of synthetic Bryostatin-1. Pursuant to the terms of the Supply Agreement, we have agreed to place an initial order of one gram of current good manufacturing practice (“cGMP”) synthetic Bryostatin-1 as an active pharmaceutical ingredient to be used in a drug product (“API”), to be shipped by BryoLogyx within 60 days after the date upon which BryoLogyx obtains cGMP certification for production of API, which certification shall be obtained no later than March 31, 2021. We may place additional orders for API beyond the initial order by making a written request to BryoLogyx no later than six months prior to the requested delivery date. We agreed to pay a price per gram of API equal to the cost of goods sold plus 15%, in each case calculated as at the time of production of the API requested by us.

 

The supply period under the Supply Agreement commences on the date that BryoLogyx receives cGMP certification for production of API and we accept the initial production run, and terminates upon (i) the fifth (5th) anniversary of the date of completion by us of our Phase III clinical trial using API or (ii) such earlier or later date as is agreed to by the parties.  Either party may terminate the Supply Agreement for cause as set forth in the Supply Agreement.

 

The Supply Agreement contains customary representations, warranties and agreements by the parties, as well as certain covenants regarding matters such as confidentiality.  The foregoing description of the Supply Agreement is not complete and is qualified in its entirety by reference to the full text of the Supply Agreement, a copy of which is attached to this report as Exhibit 10.4.

 

Transfer Agreement

 

In connection with the Supply Agreement, on June 9, 2020 (the “Effective Date”), we entered into a transfer agreement (the “Transfer Agreement”) with BryoLogyx. Pursuant to the terms of the Transfer Agreement, we agreed to assign and transfer to BryoLogyx all of our right, title and interest in and to that certain Cooperative Research and Development Agreement, dated as of January 29, 2019 (the “CRADA”), by and between us and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute of the National Institutes of Health (“NCI”), under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. The transfer is subject to the receipt of NCI’s consent. We further agreed that, following the transfer of the CRADA, we will assign to BryoLogyx our investigational new drug application (“IND”) currently on file with the U.S. Food and Drug Administration. As consideration for the transfer of the CRADA and IND, BryoLogyx has agreed to pay to us 2% of the gross revenue received in connection with the sale of bryostatin products, up to an aggregate payment amount of $1 million (the date of receipt of such aggregate amount, the “End Date”).

 

The term of the Transfer Agreement commences on the Effective Date and will terminate upon the earliest to occur of the following: (i) the fifth (5th) business day after the Effective Date if the transfer has not occurred and we have not provided certain required notifications, (ii) the End Date, (iii) such other date as the parties agree to in writing or (iv) thirty (30) days following the delivery by one party of a written notice of an uncured material breach of an obligation by the other party. 

 

The Transfer Agreement contains customary representations, warranties and agreements by the parties, as well as certain covenants regarding matters such as confidentiality.  The foregoing description of the Transfer Agreement is not complete and is qualified in its entirety by reference to the full text of the Transfer Agreement, a copy of which is attached to this report as Exhibit 10.5.

 

Item 6. Exhibits.

 

Exhibit Number  
   
2.1** Agreement and Plan of Merger and Reorganization, dated as of May 17, 2020, by and among Petros, the Company, Merger Sub 1, Merger Sub 2 and Metuchen (incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 17, 2020).
   
2.2 Form of Neurotrope Voting Agreement, by and between Metuchen and certain stockholders of the Company (incorporated by reference to Exhibit 2.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 17, 2020).
   
2.3 Form of Metuchen Voting Agreement, by and between the Company and certain unitholders of Metuchen (incorporated by reference to Exhibit 2.3 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 17, 2020). 
   
2.4 Form of Lock-Up Agreement, by and between Petros, the Company, Metuchen and certain securityholders of the Company and Metuchen (incorporated by reference to Exhibit 2.4 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 17, 2020).
   
3.1 Form of Series D Preferred Certificate of Designation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on January 23, 2020).
   
4.1 Form of Series H Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on January 23, 2020).
 
10.1 Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on January 23, 2020).
   
10.2 Consulting Advisory Agreement dated as of January 22, 2020, by and between the Company and Katalyst Securities, LLC (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on January 23, 2020).
   
10.3 Form of Juggernaut Backstop Agreement, by and between the Company and JCP III SM AIV, L.P. (incorporated by reference to Exhibit 99.9 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 18, 2020)
   
10.4* Supply Agreement, dated as of June 9, 2020, by and between the Company and BryoLogyx Inc.
   
10.5* Transfer Agreement, dated as of June 9, 2020, by and between the Company and BryoLogyx Inc.
   
31.1* Certification of the President and Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
31.2* Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
32.1* Certification of the President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
32.2* Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
101* The following financial information from this Quarterly Report on Form 10-Q for the period ended March 31, 2020, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; and (iv) the Notes to Consolidated Financial Statements, tagged as blocks of text.
   
  * Filed herewith.
   
  **Certain schedules and exhibits to the Merger Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K.  A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.

  28  

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  Neurotrope, Inc. 
     
Date: June 12, 2020 By: /s/ Charles S. Ryan, JD, Ph.D.
    Charles S. Ryan, JD, Ph.D. 
    Chief Executive Officer (principal executive officer) 
     
Date: June 12, 2020 By: /s/ Robert Weinstein
    Robert Weinstein 
    Chief Financial Officer, Executive Vice President, 
    Secretary and Treasurer (principal financial officer) 

 

  29  

Exhibit 10.4

 

FINAL

Supply Agreement

 

This Supply Agreement (the “Agreement”) is made, effective as of June 9, 2020 (the “Effective Date”) by and between BryoLogyx Inc. (“BryoLogyx”) and Neurotrope Bioscience, Inc. (“Neurotrope”), each of Neurotrope and BryoLogyx being referred to herein individually as a “Party” and collectively as the “Parties,” with respect to the supply by BryoLogyx to Neurotrope of cGMP synthetic bryostatin-1 under the terms and conditions set forth herein.

 

BACKGROUND

 

A. Neurotrope is a clinical-stage biotech company leveraging bryostatin-1 and its analogues to discover and develop targeted therapeutics for neurodegenerative diseases and developmental disorders, and is a party to that certain Cooperative Research And Development Agreement with the U.S. Department of Health and Human Services, as represented by National Cancer Institute of the NIH dated January 29, 2019 (the “CRADA”) under which Neurotrope would study bryostatin-1 in its application to cancer therapy using Neurotrope’s inventory of naturally derived bryostatin-1.

 

B. BryoLogyx is a clinical-stage biotech company currently dedicated to developing drugs to enhance the response rates and treatment durability of cancer immunotherapies, and has developed a method of manufacturing synthetic bryostatin-1 pursuant to the process invented by Dr. Paul Wender at Stanford University (“the Wender Process”). Stanford University owns the rights to the Wender Process and has licensed BryoLogyx to use, and manufacture for its use, the Wender Process for the development of drugs for cancer treatments.

 

C. Neurotrope is also licensed by Stanford University to use the Wender Process for the treatment of neurological or neurodegenerative diseases.

 

D. The Parties have entered into that certain Transfer Agreement of even date herewith pursuant to which Neurotrope will transfer the CRADA to BryoLogyx, and will assign Neurotrope’s IND PIND140578 to BryoLogyx, all in furtherance of BryoLogyx’s own clinical development program, in exchange for a revenue share.

 

E. Neurotrope would like to source synthetic bryostatin-1 from BryoLogyx, and BryoLogyx is willing to supply such material to Neurotrope, all as set forth in more detail herein.

 

F. It is the intent and agreement of the Parties that this Agreement and the above referenced Transfer Agreement together constitute the entire agreement of the Parties with respect to the matters governed thereby.

 

1.             Definitions and Interpretation

 

1.1               Definitions. The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, will have the meaning for such relevant term set forth below or, if not listed below, the meaning designated elsewhere in this Agreement.

 

(a)    “Additional Order” has the meaning set forth therefor in Section 2.4 hereof.

 

(b)    “API” means cGMP synthetic bryostatin-1 as an active pharmaceutical ingredient to be used in a drug product, and meeting the Specifications, and named in the Quality Agreement.

 

(c)    “Applicable Requirements” means (a) all requirements of the Quality Agreement, (b) the Useful Life requirement (which condition will not apply to the Initial Order), and (c) all applicable international, supranational, multinational, federal, regional, state, provincial and local laws, ordinances, rules and regulations of any governmental authority that apply to API or the Processing of API or this Agreement, including (i) all applicable laws, ordinances, rules and regulations of the jurisdiction where the Facility is located; (ii) cGMP; (iii) Regulatory Agencies’ regulations and guidelines; and (iv) those pertaining to workplace health and safety, all as may be amended from time to time.

 

 

 

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(d)    ““bryostatin-1” means a macrocyclic lactone and a potent activator of protein kinase C (PKC) either isolated from the bryozoan Bugula Neritina or chemically synthesized.

 

(e)    business day” means a day on which national banks in the United States are open in New York, New York.

 

(f)     “cGMP” means those practices in the manufacture of pharmaceutical products that are recognized as current good manufacturing practice regulations and guidelines as described and promulgated by Regulatory Authorities including (i) the FDA in accordance with FDA regulations guidelines and other administrative interpretations, and, without limitation, (ii) the then-current International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients as adopted by the relevant Regulatory Authority in the subject jurisdiction, and (iii) The European Union’s Eudralex Volume 4,
Part II (independent of the Annexes) where it is in direct agreement with ICH Q7, all as updated, amended, and revised from time to time.

 

(g)    “COGS” means BryoLogyx’s fully-burdened cost of all direct materials and labor and
fully-allocated manufacturing overhead directly attributable to the cost of process development and validation and the Processing of API for Neurotrope hereunder, calculated in accordance with US GAAP, consistently applied; provided, that manufacturing overhead will not include allocation of idle capacity.

 

(h)    “Confidential Information” will have the meaning set forth in Section 8 hereof.

 

(i)     “Defect” or “Defective” means a unit of API that does not conform to the Specifications or was not Processed in accordance with Applicable Requirements or does not meet the Useful Life, provided that such Useful Life requirement in order for API to not be Defective will apply only to Additional Orders and not to the Initial Order.

 

(j)     “Deficiency Notice” means a written notice from Neurotrope to BryoLogyx claiming a Defect with respect to API, and/or shortages in the amount of delivered API, and describing in reasonable detail such Defect or shortage.

 

(k)    “Dollar” or “$” means the lawful currency of the United States.

 

(l)     “FDA” means the U.S. Food and Drug Administration, or any successor agency thereto having jurisdiction over the manufacture of the API.

 

(m)  “Initial Order” has the meaning therefor set forth in Section 2.2 hereof.

 

(n)    “Intellectual Property” means any right or protection existing from time to time in a specific jurisdiction, whether registered or not, under any patent law or other invention or discovery law, copyright law, trade-secret law, trademark law or trade name law, and includes legislation by competent governmental authorities and judicial decisions under common law or equity.

 

(o)    “Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

(p)       “Processing” means all steps and activities to be performed for the manufacture, storage and delivery of API for supply by BryoLogyx to Neurotrope pursuant to this Agreement.

 

  2  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(q)       “Quality Agreement” means a separate written agreement that has been entered into between BryoLogyx and BryoLogyx’s contract manufacturer for the API that describes the quality assurance and technical requirements for Processing, a copy of which will be provided to Neurotrope as promptly as possible when the Quality Agreement has been updated for the cGMP synthetic processing of bryostatin-1, which Quality Agreement, when so furnished, will be deemed confidential and will thus be subject to the confidentiality provisions of Section 8 hereof.

 

(r)        “Regulatory Agency” means any national, federal, state or local or other regulatory agency, department, bureau or other governmental entity (including the FDA) which is responsible for issuing approvals, licenses, registrations or authorizations necessary for the manufacture, import, distribution, sale and use of API.

 

(s)     “Specifications” means the specifications for API as set forth in Exhibit A attached hereto and incorporated herein by reference, as such Exhibit may be amended from time to time by the Parties in writing in accordance with the terms of this Agreement.

 

(t)     “Supply Period” means the period of time commencing with the date of cGMP certification and Neurotrope’s acceptance of the initial production run of synthetic bryostatin-1 produced by BryoLogyx under a license to BryoLogyx from Stanford University, and ending upon the earlier of (i) the fifth (5th) annual anniversary of the date of completion by Neurotrope of Phase 3clinical trials using API, provided that Neurotrope will promptly inform BryoLogyx in writing of the date of completion of such Phase 3 clinical trials, or (ii) such earlier or later date as is agreed by the Parties in writing in accordance with the terms of this Agreement.

 

(u)    “Term” means the Supply Period.

 

(v)    “Third Party” means any Person other than Neurotrope or BryoLogyx.

 

(w)  “UNCISG” means the United Nations Convention on Contracts for the International Sale of Goods, as in effect from time to time.

 

(x)    “Unit Price” Means the price per gram of API which is equal to COGS of such gram of API plus 15%, in each case calculated as at the time of production of the API requested by Neurotrope under the Initial Order or under the relevant Additional Order.

 

(y)    “Useful Life” means the time period within which API will remain stable after the date of BryoLogyx’s release of the relevant lot of API to Neurotrope, which BryoLogyx expects to be at least twenty-four (24) months, with the Parties acknowledging, however, that the Useful Life of API is not known or confirmed as at the Effective Date and thus will not be an applicable requirement as to API in the Initial Order, provided, however, that BryoLogyx will use its commercially diligent efforts, in working with its contract manufacturer of API, to determine and confirm Useful Life for API, and will promptly communicate such confirmed Useful Life to Neurotrope in writing as soon as it is confirmed to BryoLogyx, and such confirmed Useful Life thereafter will be applicable to determining whether API in an Additional Order is Defective or meets the Applicable Requirements.

 

1.2               Interpretation. The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Sections will refer to the particular Sections of or to this Agreement. Unless the context otherwise clearly requires, whenever used in this Agreement: (a) the words “include” or “including” will be construed as incorporating, also, “but not limited to” or “without limitation;” (b) the word “day,” “quarter” or “year” (and derivatives thereof, e.g., “quarterly”) means a calendar day, calendar quarter or calendar year unless otherwise specified (and “annual” or “annually” refer to a calendar year); (c) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement; (d) the word “hereof,” “herein,” “hereby” and derivative or similar word refers to this Agreement; (e) the word “or” has its inclusive meaning identified with the phrase “and/or;” (f) provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise; (g) words of any gender include the other gender; and (h) words using the singular or plural number also include the plural or singular number, respectively.

 

  3  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.             Supply of API by BryoLogyx to Neurotrope

 

2.1               Sole Source. Commencing on the date upon which cGMP certification from its contract manufacturer is obtained by BryoLogyx for production of API provided such date is not later than March 31, 2021 (or such later date as the Parties may agree in writing) and thereafter during the Term, and as so long as BryoLogyx is able to supply API to Neurotrope in accordance with the terms of this Agreement and meeting Neurotrope’s volume requirements, the Applicable Requirements, and the Specifications, BryoLogyx will be the exclusive supplier to Neurotrope, even as to Neurotrope itself, of API.

 

2.2               Initial Order. The execution and delivery by the parties of this Agreement constitutes Neurotrope’s firm order for the purchase by Neurotrope and BryoLogyx of a total of one (1) gram of API (the “Initial Order”).

 

2.3               Delivery Of The Initial Order. The Initial Order will be shipped by BryoLogyx to Neurotrope within sixty (60) days after the date upon which cGMP certification is obtained by BryoLogyx for production of API. BryoLogyx will notify Neurotrope promptly in writing of the date that such cGMP approval is obtained. Such delivery will be made by BryoLogyx to such location in the United States as Neurotrope informs BryoLogyx in writing within thirty (30) days after the Effective Date.

 

2.4               Additional Orders By Neurotrope For API; Delivery Of Additional Orders. Any orders by Neurotrope for API beyond the Initial Order (each an “Additional Order”) must be (a) in writing, (b) for not less than one (1) gram of API unless otherwise agreed in writing by BryoLogyx in accepting the relevant Additional Order and (c) placed by Neurotrope with BryoLogyx at least six (6) months lead time before the delivery date of such Additional Order desired by Neurotrope, or such shorter period of time as BryoLogyx may agree in writing with Neurotrope, and provided that as the manufacturing process for API is further developed after the Effective Date the Parties will discuss with each other in good faith any potential shortening in such lead time that may be appropriate and any such changes agreed to will be in writing as an amendment to this Agreement. Delivery of each Additional Order will be made by BryoLogyx in accordance with the terms of the Additional Order to the location to which the Initial Order was delivered, or to such location in the United States as Neurotrope informs BryoLogyx in writing when placing the Additional Order.

 

2.5               Shipment; Title And Risk Of Loss Or Damage; Acceptance; Deficiency Notice;
Latent Defect.

 

(a)                Shipment. Shipment to Neurotrope of the Initial Order and of Additional Orders will be made using appropriate packaging and an appropriate carrier and delivery method as determined in each case by Neurotrope. 

 

(b)                Title and Risk of Loss or Damage. BryoLogyx will, as to the Initial Order and as to Additional Orders, retain title to, and will carry the risk of loss or of damage to, API until such API is loaded onto the carrier specified by Neurotrope. Title and risk of loss or of damage to API will, as to the Initial Order and as to Additional Orders, transfer to Neurotrope upon being loaded on the carrier. 

 

(c)                Acceptance; Deficiency Notice; Latent Defect. Neurotrope will be deemed to have accepted the Initial Order, and will be deemed to have accepted any Additional Orders unless it has sent to BryoLogyx a Deficiency Notice with respect to the relevant shipment of API within thirty (30) days after Neurotrope’s receipt of such API. If a Defect in API could not reasonably be discovered by Neurotrope within such thirty (30) day period (a “Latent Defect”), then Neurotrope will have the right to reject such API within ten (10) business days after discovering the Latent Defect during the intended useable life of API, provided Neurotrope has given written notice, in commercially reasonable detail as to such Latent Defect, to BryoLogyx within such 10 business day period. Without limiting other remedies available to Neurotrope, BryoLogyx will, at its sole cost and expense, make up the shortage or replace the rejected API, as applicable, by delivering replacement API to Neurotrope within thirty (30) days at no extra charge to Neurotrope. Neurotrope’s actual or deemed acceptance of API will not be construed as limiting any remedies given Neurotrope at law or under this Agreement. Subject to the provisions of this Section 2.5, Neurotrope has the right to reject and return, at the expense of BryoLogyx and for full credit, any portion of any shipment of API which deviates from the Specifications or cGMP, without invalidating the remainder of the order. If BryoLogyx does not agree with Neurotrope’s determination that API is Defective, then the Parties will designate an independent testing laboratory to determine whether the API is Defective, the findings of which will be binding on the Parties, absent manifest error. All costs and expenses of such laboratory testing will be borne by the Party whose position is determined to have been in error, or if the laboratory cannot place the cause of the rejection or defect noticed, then all costs and expenses of such laboratory testing will be borne by the Parties equally. All rejected API will be disposed of pursuant to Applicable Requirements. BryoLogyx will not subcontract, transfer or delegate its performance under this Agreement without Neurotrope’s prior written consent.

 

  4  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.6               Certain Limitations And Further Conditions. The fulfillment by BryoLogyx of the Initial Order and of any Additional Orders will be subject to the following conditions in each case:

 

(a)       Cancellation; Reduction. Neurotrope may not cancel or reduce the amount of API in the Initial Order nor may it cancel or reduce the amount of API in any Additional Order, unless in each case such cancellation or reduction is agreed to in writing by BryoLogyx (such agreement not to be unreasonably withheld).

 

(b)       Conditions For Supply Of API To Neurotrope For Commercial Sale. BryoLogyx’s obligations hereunder to supply API to Neurotrope for commercial sale will be subject to (i) BryoLogyx having achieved such regulatory approvals, if any, as may be required with respect to commercial sale of API, and (ii) BryoLogyx having established for itself a commercial-level manufacturing and supply process therefor.

 

2.7               Certain Further Limitations On Neurotrope As To Marketing, Offer To Sell Or Selling API. During the period of time during the Term in which Neurotrope is using API for its clinical research and clinical trials, Neurotrope will not market, offer to sell or sell API to any Third Party without the prior written consent of BryoLogyx, and during the remainder of the Term with respect to commercial sales by Neurotrope, Neurotrope will not market, offer to sell or sell API as a standalone product by itself, but will only market, offer to sell or sell API as a component of a drug product in a licensed clinical application.

 

2.8               Changes to Specifications. If either BryoLogyx or Neurotrope believes that any Applicable Requirement requires a change to the Specifications, the Party believing that such change is required will promptly notify the other Party in writing thereof, in commercially reasonable detail and thereafter the Parties will in good faith discuss such proposed change to the Specifications. If BryoLogyx and Neurotrope are unable to reach written agreement regarding whether, and to what extent, an amendment to the Specifications is required, then such dispute will be resolved pursuant to Section 9 of this Agreement.

 

2.9               Records. BryoLogyx will maintain complete and accurate records developed in the course of its performance under this Agreement and will maintain such records for the period of time required by Applicable Requirements, and will make such records available to the FDA and other applicable regulatory bodies. With the direct participation of BryoLogyx, Neurotrope may (a) review, but may not make copies of, API manufacturing and testing records, and may (b) audit and manufacturing facilities, all to the extent that BryoLogyx has such rights pursuant to the Quality Agreement. BryoLogyx will, upon the written request of Neurotrope therefor, make available to the FDA and other applicable regulatory bodies, solely for use by reference in Neurotrope’s regulatory filings, the CMC section of BryoLogyx’s IND with respect to the API, and the manufacturer’s Drug Master File, and such other CMC provisions of BryoLogyx’s IND as are reasonably required in support of Neurotrope’s regulatory filings.

 

  5  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.10           Exclusivity. During the term hereof, BryoLogyx will not, directly or indirectly, including by authorization, license or permission, either itself or on behalf of or with another person or entity, research, develop, distribute, commercialize, manufacture, license, sell, or supply synthetic bryostatin-1 to any party other than Neurotrope as a pharmaceutical ingredient to be used in the diagnosis, treatment or prevention of neurological or neurodegenerative disease to the extent governed by the License Agreement between Stanford University and Neurotrope with respect to the field of use rights granted therein to Neurotrope for the use of synthetic bryostatin-1 in neurological or neurodegenerative disease.

 

3.            PRICING; FREIGHT CHARGES; SALES TAXES; INSURANCE; INVOICING; PAYMENT

 

3.1               Pricing. Neurotrope will pay to BryoLogyx, in cash, for API ordered by Neurotrope and delivered by BryoLogyx pursuant to this Agreement at the Unit Price.

 

3.2               Freight Charges; Sales Taxes; Insurance. Neurotrope will pay freight charges for delivery of API order hereunder to Neurotrope, and any applicable sales taxes required by law to be charged by BryoLogyx. The cost of any insurance desired by Neurotrope with respect to any shipment of API hereunder will be borne by Neurotrope, and Neurotrope will arrange for any such insurance that it so desires.

 

3.3               Invoicing; Payment. BryoLogyx will invoice Neurotrope upon shipment of API to Neurotrope. Each invoice will set out the quantity of API which is the subject of the invoice, the Unit Price, and freight/delivery charges and applicable sales tax amounts. Neurotrope will pay all invoices in accordance the payment method will be specified by BryoLogyx in the relevant invoice, wire transfer to such account and routing instructions as will be set forth in such invoice, with wiring or other transmission fees to be paid by Neurotrope, or by check payable to BryoLogyx be sent to the address as indicated by BryoLogyx in such invoice. Neurotrope will pay all invoiced amounts that are not in good faith disputed by Neurotrope, within thirty (30) days after Neurotrope’s receipt of the relevant invoice. The Parties will discuss and finalize in good faith promptly any amounts invoiced by BryoLogyx to Neurotrope that are disputed in all good faith by Neurotrope.

 

4.             REGULATORY AGENCY COMMUNICATIONS

 

Each Party will notify the other immediately in writing, in commercially reasonable detail, if the notifying Party receives any communication from or on behalf of a Regulatory Agency with respect to API, including without limitation any notice of any deficiencies noted or otherwise referenced by any Regulatory Agency with respect to API and/or its manufacture or with respect to any drug product manufactured from or incorporating API. Reference is hereby made to the provisions of Section 2.9 hereof, with respect to the availability to FDA and other applicable regulatory bodies solely for use by reference in Neurotrope’s regulatory filings the CMC section of BryoLogyx’s IND with respect to the API, and the manufacturer’s Drug Master File, and such other CMC provisions of BryoLogyx’s IND, as are reasonably required in support of Neurotrope’s regulatory filings.

 

5.             Representations and Warranties

 

5.1               General. Each Party represents and warrants to the other Party that:

 

(a)          Authority. The representing Party has all corporate or other authority to perform this Agreement and this Agreement has been duly executed and delivered and constitutes such Party's legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles;

 

(b)          No Action or Proceeding. The representing Party is not involved in any action or proceeding and has not received notice of any threatened action or proceeding that would jeopardize its performance under this Agreement;

 

  6  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(c)          The execution, delivery and performance by the representing Party of this Agreement and its compliance with the terms hereof, does not and will not conflict with or result in a breach of any term of, or constitute a default under (i) any agreement or instrument binding or affecting it or its property; (ii) its charter documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;

 

(d)          The representing Party has obtained any consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or regulatory authority required for the execution, delivery and performance of this Agreement by such Party, and the execution, delivery and performance of this Agreement will not violate any law, rule or regulation applicable to such Party; and

 

(e)          Approvals. The representing Party has obtained all necessary corporate approvals to enter into and execute this Agreement and to perform such Party’s obligations hereunder.

 

5.2               Additional Representation by BryoLogyx. In addition to its representations under Section 5.1 hereof, BryoLogyx further represents and warrants to Neurotrope that BryoLogyx’ method of manufacturing synthetic bryostatin-1 results in a product that is equivalent in all analytical respects to natural bryostatin-1 as supplied by the NCI and that each unit of API at the time of delivery to Neurotrope will conform to the Specifications, be free from Defects, fit for such products intended use, properly packaged and labeled to the extent required by law, and be delivered free from any encumbrances. BryoLogyx represents and certifies that all persons engaged by it to perform work relating to this Agreement have never been and are not currently debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335(a), as amended, or any similar state law or regulation, excluded by the Office of Inspector General pursuant to 42 U.S.C. § 1320a-7, et seq. or any state agency from participation in any Federal or state health care program or otherwise disqualified or restricted by the FDA pursuant to 21 C.F.R. 312.70 or any other regulatory authority.

 

5.3               Disclaimer. EXCEPT AS PROVIDED IN THIS SECTION 5, NEITHER PARTY MAKES ANY WARRANTIES, whether EXPRESS, IMPLIED, or STATUTORY, WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES.

 

6.             Term and Termination

 

6.1               Term. The Term of this Agreement will commence on the Effective Date and will continue in full force and effect for the Supply Period unless earlier terminated as provided herein (the “Term”).

 

6.2               Termination for Cause. Either Party may terminate this Agreement immediately (or in the case of events described in Section 6.2(a) hereof, after the applicable cure period has elapsed) and without prior written notice to the other Party, upon the happening of any of the following events of default, provided that the terminating Party will provide written notice to the other Party, after such termination, of such termination and of the effective date thereof, and provided that any termination under this Section 6.2 will be subject to the provisions of Section 6.4 hereof:

 

(a)                Material Uncured Breach. The other Party materially breaches any obligation, warranty or representation hereunder of such Party (which will include without limitation, the failure of the Neurotrope to pay any undisputed monies when payable hereunder) and such breach is not cured within thirty (30) days after written notice thereof from the non-breaching Party, setting forth the nature of the alleged breach in commercially reasonable detail; or

 

(b)                Bankruptcy, Etc. The other Party makes a general assignment for the benefit of its creditors, suspends business or commits any act amounting to business failure, voluntarily assigns or transfers all or substantially all of its property, files a voluntary petition or has an involuntary petition filed against it seeking its reorganization, adjustment, liquidation, or dissolution under any present or future law or regulation relating to bankruptcy, which petition is not dismissed within 90 days, insolvency, relief of debtors or protection of creditors, termination of legal entities, or has a receiver, trustee, liquidator, assignee or custodian appointed for it.

 

  7  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(c)                cGMP. BryoLogyx is unable to obtain cGMP certification from its contract manufacturer by March 31, 2021 and the Parties are unable to agree in writing to a later date as set forth in Section 2.1.

 

6.3               Termination for Convenience. Until the date that Neurotrope places its first Additional Order for commercial supply of API, Neurotrope may not terminate this Agreement, other than for the reasons set forth in Section 6.2 hereof. After the date upon which Neurotrope places its first Additional Order for commercial supply of API, either Party may terminate this Agreement for any reason or no reason upon at least six (6) months’ prior written notice to the other Party, subject to the provisions of Section 6.2 hereof. Any termination under this Section 6.3 will be subject to the provisions of Section 6.4 hereof.

 

6.4               Effect of Termination.

 

(a)                Fulfillment Of Certain Obligations. Upon any termination of this Agreement, both Parties will fully perform all of their obligations hereunder that have accrued through the date of such termination.

 

(b)                Shipment Of API By BryoLogyx To Neurotrope. Upon the effective date of termination of this Agreement by either party, then, unless the Parties agree otherwise in writing, BryoLogyx will deliver to Neurotrope all API in inventory or storage, with respect to the Initial Order and each Additional Order, and Neurotrope will be required to pay for such API under the terms for payment set forth in this Agreement.

 

(c)                Transition Assistance. If Neurotrope terminates this Agreement pursuant to Section 6.2(b) hereof, then BryoLogyx will, at Neurotrope’s written request, promptly and diligently work with AMRI (formerly known as Albany Molecular Research Inc.; “AMRI”) to cause AMRI to provide API directly to Neurotrope under such terms as set forth in the agreement between BryoLogyx and AMRI until AMRI and Neurotrope enter into their own separate written agreement for such supply, provided that Neurotrope will pay AMRI directly for supply of API by AMRI to Neurotrope. BryoLogyx acknowledges that time is of the essence in BryoLogyx’s performance of this Section 6.4(c) and will use its commercially diligent efforts to facilitate the transition to AMRI of API supply to Neurotrope.

 

6.5               Survival. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party will be without prejudice to other remedies such Party may have at law or equity. Sections
1, 2.8, 4, 6.4, 6.5, 7, 8, 9 and 10 hereof, and all liabilities that accrue during the Term, will survive expiration or termination of this Agreement and will continue to be enforceable.

 

7.            Intellectual Property Rights

 

Each Party will retain, and no license or other right is granted to the other Party with respect to, such first Party’s intellectual property rights, however arising, including any intellectual property rights of the relevant Party which may arise after the Effective Date, and including without limitation any such intellectual property rights with respect to bryostatin in any form or formulation, and further provided that the Parties do not intend to conduct with each other during the Term any research and development activities related to bryostatin in any form or formulation and that any such collaborative activities will be the required to be set forth in and governed by a separate written agreement between the Parties with respect thereto.

 

  8  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

8.            Confidentiality

 

8.1               Confidentiality. The Parties are parties to that certain Mutual Confidentiality Agreement dated as of April 13, 2018 (the “CDA”). BryoLogyx and Neurotrope each acknowledge and agree that they have been and will be in a confidential relationship to the other Party pursuant to this Agreement and that each has gained and will gain knowledge that comprises valuable trade secrets and other confidential information of the other Party, including customer lists, other customer data and information, sales and marketing data and information, technical data and information, Processing information, Intellectual Property, and other data and information concerning API, including the Specifications, or the Party’s respective businesses, all of which, including without limitation the Quality Agreement as confidential information of BryoLogyx, constitutes confidential information of the relevant Party under the CDA, and the Parties’ use of such information will be governed by the CDA and this Agreement.

 

8.2               Public Announcements. Neither Party will advertise, issue any press release, post any image or make any other public statement, including without limitation any disclosure requirements of Neurotrope under applicable securities laws, regarding or relating to the Parties’ relationship pursuant to this Agreement, including the terms and conditions of this Agreement, without the other Party’s express prior written approval, which will not be unreasonably or untimely withheld or denied.

 

9.           DISPUTE RESOLUTION.

 

Any claim arising out of or relating to this Agreement or the validity, enforcement, or breach thereof, will be first referred by either Party, in writing to the other Party, simultaneously to the President or Chief Executive Officer the other Party, which individuals will promptly and in good faith discuss and attempt to resolve such matter, including in such discussion the possibility of mediation or arbitration, provided that if after such good faith discussion the matter is not successfully resolved, each Party will have the right to pursue such judicial remedy or remedies as are available to it.

 

10.         Miscellaneous

 

10.1           Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR LOSS OF PROFITS, LOSS OF REVENUE OR INCOME, LOSS OF BUSINESS REPUTATION OR OPPORTUNITY, OR OTHER INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES UNDER THIS AGREEMENT, EXCEPT FOR DAMAGES CAUSED BY (A) A BREACH OF SECTION 8 (CONFIDENTIALITY) HEREOF, OR (B) A PARTY’S GROSS NEGLIGENCE, MISCONDUCT OR VIOLATION OF LAW, OR (C) BRYOLOGYX’S BREACH OF SECTION 2.10 HEREOF.

 

10.2           Governing Law. This Agreement and all actions arising out of or in connection with this Agreement will be governed by and construed in accordance with the laws of the State of California, without regard to the conflict of laws provisions thereof or of any other state and provided that the UNCISG will not apply to this Agreement.

 

10.3           Independent Contractors. The relationship between Neurotrope and BryoLogyx hereunder will be that of independent contractors, and nothing in this Agreement will be deemed to constitute a joint venture, partnership, agency or employer/employee arrangement between the Parties. Neither Party will have any authority or power to bind the other Party or to contract in the name of, or make any representations or warranties, express or implied, on behalf of the other Party, or otherwise create any liability against the other Party in any way for any purpose.

 

10.4           Force Majeure. The Parties hereto will not be responsible for any loss or breach due to delay in delivery or performance hereunder caused by causes outside of such Party’s reasonable control which may include governmental regulations, controls or directions, outbreak of a state of emergency, hostilities, civil commotion, riots, epidemics, acts of God, other natural casualties, fires, strikes, or walkouts or other similar unforeseeable cause or causes not caused by the affected Party’s negligence. In the event that any Party will be delayed in, or prevented from, performing its obligations under this Agreement as a result of any of the foregoing, such Party will promptly notify the other Party of such delay or cessation in performance. In the event that such Party is unable to resume performance hereunder within sixty (60) days after the date on which its performance was suspended, the other Party will have the right to terminate this Agreement upon at least ten (10) days prior written notice to the non-performing Party.

 

10.5           Assignment. Neither Party may assign this Agreement without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned; provided, however, that each Party may assign this Agreement without the consent of the other Party to a successor to all or substantially all of such Party’s business or assets relating to this Agreement whether by sale, amalgamation, merger, operation of law or otherwise. The Party assigning this Agreement will notify the other Party in writing promptly (but in no event more than ten (10) days) after such assignment, which notice will include the name and address of the assignee, and provided that it will be a condition of any such assignment that the assignee agrees in writing specifically for the benefit of the non-assigning Party to fully assume and discharge the remaining undischarged obligations of the assigning Party. Any assignment in violation of this Section 10.5 will be null and void.

 

  9  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

10.6           Counting Of Time. Whenever days are to be counted under this Agreement, the first day will not be counted and the last day will be counted.

 

10.7           Notices. All notices, consents and other formal or legal communications hereunder to any Party will be deemed to be sufficient if contained in a written instrument delivered in person, including delivery by recognized express courier, fees prepaid, or sent by electronic mail with confirmed receipt (“email”) in each case addressed as set forth below such Party’s signature below, or to such other address as may hereinafter be designated in writing by the recipient to the sender pursuant to this Section 10.7. Notices hereunder may not be sent by facsimile or by mail. All such notices, consents and communications will be deemed to have been received in the case of personal delivery, including delivery by express courier, on the date of such delivery, or in the case of email transmission, upon confirmation of transmission.

 

10.8           No Waiver. No failure to delay on the part of either Party in exercising any right or remedy hereunder will operate as a waiver thereof, nor will any single or partial exercise of any such right or remedy preclude any other or further exercise thereof or of any other right or remedy. No provision of this Agreement may be waived except in a writing signed by the Party granting such waiver.

 

10.9           Expenses. Each Party will, except as otherwise set forth specifically in this Agreement bear such Party’s own fees and expenses incurred with respect to the negotiation and execution of this Agreement and with respect to the transactions contemplated hereby.

 

10.10        Severability. If any Section, or portion thereof, of this Agreement is held invalid by reason of any law, statute, or regulation existing now or in the future in any jurisdiction by any court of competent authority or by a legally enforceable directive of any governmental body, such section or portion thereof will be validly reformed so as to approximate the intent of the Parties as nearly as possible and, if unreformable, will be deemed divisible and deleted with respect to such jurisdiction, but the Agreement will not otherwise be affected.

 

10.11        Further Actions and Documents. Each Party will execute, acknowledge and deliver all such further instruments, and to do all such further acts, as may be reasonably necessary or appropriate to carry out the intent and purposes of this Agreement.

 

10.12        Entire Agreement; Amendment. This Agreement, together with the CDA, constitutes and contains the entire understanding and agreement of the Parties respecting the subject matter hereof and cancels and supersedes any and all prior and contemporaneous negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter. If the terms of this Agreement conflict with any order, the terms of this Agreement will control and prevail, and no terms, provisions or conditions of any purchase order, invoice or other business form or written authorization used unilaterally (as opposed to matters agreed to in writing by the Parties together as provided herein) by either Party as to the matters governed by this Agreement will have any effect on the rights, duties or obligations hereunder or otherwise modify this Agreement. No agreement or understanding varying or extending this Agreement will be binding upon either Party, and no amendment hereto, will be valid unless set forth in a writing which specifically refers to the Agreement and the relevant matter, and that is signed by duly authorized officers or representatives of the respective Parties, and the provisions of the Agreement not specifically amended thereby will remain in full force and effect. Nothing in this Agreement removes or overrides any right of action by any Party in respect of any fraudulent misrepresentation, fraudulent concealment or other fraudulent action by the other Party. This Agreement binds the Parties’ successors and permitted assigns. In the event of a conflict between the terms of this Agreement and the Quality Agreement, the terms of the Quality Agreement will govern with respect to quality and technical terms, and the terms of this Agreement will govern all other matters.

 

  10  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

10.13        Construction; References. This Agreement has been negotiated by the Parties and their respective counsel. This Agreement will be fairly interpreted in accordance with its terms and without any strict construction in favor of or against any Party, and any ambiguity will not be interpreted against the drafting Party. References to “Sections” herein are to Sections hereof.

 

10.14        Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, but which together will constitute one and the same instrument. Any signature page delivered by electronic image transmission, including without limitation a PDF by email, will be binding to the same extent as an original signature page.

 

[Signature page follows]

 

  11  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

  

IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Agreement.

 

Neurotrope bioscience, Inc. BRYOLOGYX INC.
   
By: /s/ Robert Weinstein By:  /s/ Thomas M. Loarie
Robert Weinstein Thomas M. Loarie
Chief Financial Officer Chief Executive Officer
Date signed:  June 9, 2020 Date signed:  June __, 2020

Address: Attention: CFO Address:  Attention:  CEO
  1185 Avenue of the Americas   2485 Holly Oak Drive
  New York, NY 10036   Danville, CA 94506-2043
  Email: rweinstein@neurotropebioscience.com   Email:  tloarie@bryologyx.com

 

 

 

 

  12  

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

EXHIBIT A

 

SPECIFICATIONS

 

[Note: These are initial specifications as at the Effective Date, and are to be updated with completion of analytical method development to confirm final specifications and provided that such updated specification will be set forth on this Exhibit A at such time, as an automatic amendment of this Exhibit A.]

 

Test Description Acceptance Criteria  
Physical description Visual Assessment White to off-white  
Identity 1H NMR Conforms to structure  
HPLC Sample retention time corresponds to  reference marker retention time (Ratio agreement 0.95 – 1.05)  
Chemical Purity (% area) HPLC NLT 96.0%  
Optical rotation Polarimeter Report results  
 
Potency (%w/w) Quantitative NMR 96-104%  
Individual and Total Related Substances (% area) HPLC Specified  and  Unspecified Impurities: report  
Total Impurities: NMT 4.0%  

Residual Solvents l

GC t-Butylmethylether: NMT 5000 ppm  
Dicholoromethane: NMT 600 ppm  
Ethylacetate : NMT 5000 ppm  
n-Heptane: NMT 5000 ppm  
Methanol: NMT 3000 ppm  
Tetrahydrofuran: NMT 720 ppm  
Toluene : NMT 890 ppm  
Melting Point (°C) DSC Report  
Water Content (%) Karl Fisher Report results (%)  
Microbial (cfu/g) USP

Total Aerobic Microbial Count: NMT 103

Total Yeast and Mold Count: NMT 102

 

 

  13  

 

Exhibit 10.5

 

FINAL

 

TRANSFER AGREEMENT

 

This Transfer Agreement (the “Agreement”) is effective as of June 9, 2020 (“Effective Date”) and is entered into by and between Neurotrope Bioscience, Inc., having a principal place of business at 1185 Avenue of the Americas, New York, New York 10036 (“Neurotrope”) and BryoLogyx Inc., having a principal place of business at 2485 Holly Oak Drive, Danville, CA 94506 (“BryoLogyx”).

 

BACKGROUND

 

A. Neurotrope is a clinical-stage biotech company leveraging bryostatin-1 and its analogues to discover and develop targeted therapeutics for neurodegenerative diseases and developmental disorders, and is a party to that certain Cooperative Research And Development Agreement with the U.S. Department of Health and Human Services, as represented by National Cancer Institute of the NIH (“NCI”) dated January 29, 2019 (the “CRADA”) under which Neurotrope would study bryostatin-1 in its application to cancer therapy using Neurotrope’s inventory of naturally derived bryostatins.

 

B. BryoLogyx is a clinical-stage biotech company currently dedicated to developing drugs to enhance the response rates and treatment durability of cancer immunotherapies, and has developed a method of manufacturing synthetic bryostatin-1.

 

C. The parties are concurrently entering into a Supply Agreement of even date herewith under which BryoLogyx will supply Neurotrope with synthetic bryostatin-1. It is the intent and agreement of the Parties that this Transfer Agreement and the Supply Agreement together constitute the entire agreement of the parties.

 

D. The parties wish to collaborate in furtherance of their respective therapeutic goals as set forth more specifically herein.

 

AGREEMENT

 

In consideration of the mutual promises, covenants, and conditions hereinafter set forth and in exchange for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, agree as follows:

 

 

1. Assignment of the CRADA by Neurotrope to BryoLogyx.

 

1.1.             Assignment of the CRADA by Neurotrope and Assumption of the CRADA by BryoLogyx. Subject to NCI’s written consent to such transfer, in satisfaction of Section 1.7 of the CRADA (the date of such written consent from NCI referred to herein as the “Transfer Date”), and subject to the provisions of Sections 1.2, 1.3 and 8.1 hereof, (a) Neurotrope assigns and transfers to BryoLogyx, effective as of the Transfer Date when, and provided, it occurs, all of Neurotrope’s right, title and interest in and to the CRADA, and (b) effective as of the Transfer Date BryoLogyx accepts and assumes the assignment of the CRADA and all rights and obligations thereunder, including compliance with applicable regulations of the Food and Drug Administration (“FDA”), Office for Human Research Protections, and federal grants policy. All rights and obligations under the CRADA arising, accruing or relating to the period commencing upon the Transfer Date will be allocated to, and thereafter will be the obligation of, BryoLogyx. The parties will further cooperate with each another as may be reasonably necessary to implement and document such assignment of the CRADA from Neurotrope to BryoLogyx and the assumption thereof by BryoLogyx.

 

1.2.             Certain Actions by Neurotrope. In furtherance of the assignment and assumption provided for in Section 1.1 hereof, Neurotrope will, as promptly as possible following the Effective Date, formally and procedurally properly inform NCI with respect to, and diligently coordinate with NCI and BryoLogyx to obtain from NCI, as quickly as possible, NCI’s consent to the transfer described herein, and upon obtaining such consent, to effect as quickly as possible, the full transfer to BryoLogyx of all of Neurotrope's rights and responsibilities under the CRADA. Neurotrope will, within thirty (30) days after the Transfer Date, deliver to BryoLogyx all records and files generated by Neurotrope in performance of research under the CRADA through the date of such delivery, and that BryoLogyx reasonably determines, after consultation with Neurotrope with respect thereto, is necessary to effect such full transfer.

 

 

 

 

1.3.             No Assumed Liabilities. BryoLogyx does not assume any obligations of Neurotrope arising under the CRADA prior to the Transfer Date, for which Neurotrope will be solely liable, and Neurotrope will be relieved of all obligations of BryoLogyx arising under the CRADA upon and after the Transfer Date, for which BryoLogyx will be solely liable.

 

2.                   Investigational New Drug Application (“IND”). Neurotrope will, promptly following the Transfer Date, (a) notify the FDA in writing of Neurotrope’s intent to turn over and assign to BryoLogyx all matters pertaining to the preliminary IND, PIND140578, that had been commenced by Neurotrope, and (b) provide BryoLogyx with such documents in the possession or under the control of Neurotrope as BryoLogyx may request in writing as being, in the view of BryoLogyx, documents needed to support the IND filing, and (c) instruct Amarex Clinical Research LLC (“Amarex”) in writing to promptly provide BryoLogyx with the partially-completed IND application that had been commenced by Neurotrope, as well as all reference documents, reports, protocols, methods and the like in Amarex’s possession that will be made part of the IND. From and after the Transfer Date, BryoLogyx, as the new owner and sponsor of the IND, will accept all sponsorship obligations under 21 C.F.R Part 312 and will comply with all agreements, promises, conditions and covenants contained in PIND140578.

 

3.                   Vendor Agreements. As of the Effective Date, Neurotrope is party to the following agreements (each a “Vendor Agreement”) that are relevant to the subject matter of and the transactions described in this Agreement:

 

3.1.             Singota. Neurotrope will, at its expense, instruct Singota Solutions (“Singota”) in writing not later than five (5) days after the Effective Date, as follows:

 

3.1.1.        Singota will be instructed in such notice to, as promptly as possible, separate and hold for BryoLogyx:

 

(a)                A total of 640 vials of unlabeled, typically appearing “Bryostatin for Injection” 0.025 mg lyophilized per vial, lot# 260 180725 (“Drug Product”) which is stored pursuant to current Good Manufacturing Practice (“cGMP”) at Singota, to enable the labeling of such vials by Singota for, and instruct Singota to label such vials as a single lot for, BryoLogyx (for purposes of this Agreement, the phrase “typically appearing” means cakes that are complete and intact, whereas a non-intact cake exhibits an atypical appearance, consistent in each case with the categorization of lots into two groups, by Lyophilization Technologies, Inc.,(“LTI”) as having typical and atypical appearance); and

 

(b)                A total of 640 vials of unlabeled PET Diluent (Lot# 261-180802) (“Diluent”), which is also stored pursuant to cGMP at Singota, to enable the labeling of such vials for, and instruct Singota to label such vials as a single lot for, BryoLogyx.

 

3.1.2.        Singota will be instructed in such notice:

 

(a)                To release to BryoLogyx within sixty (60) days after the Transfer Date, (i) one half (320 vials) of the labeled Drug Product, and (ii) one-half (320 vials) of the labeled Diluent, and to retain the remaining 320 vials of Drug Product and 320 vials of Diluent until Singota has received written confirmation from Neurotrope referenced in Section 3.1.2(b) hereof; and

 

  2

 

 

(b)                To release to BryoLogyx (i) the remaining one half (320 vials) of the labeled Drug Product, and (ii) the remaining one-half (320 vials) of the labeled Diluent, within thirty (30) days after Singota has received written confirmation from Neurotrope of the delivery by BryoLogyx to Neurotrope of one (1) gram, or such lesser amount as BryoLogyx and Neurotrope may agree in writing, of synthetic bryostatin-1 pursuant to a separate Supply Agreement entered into by BryoLogyx and Neurotrope, and provide that Neurotrope will give written notice to Singota of such receipt within five (5) days after Neurotrope’s receipt of such bryostatin-1 from BryoLogyx.

 

3.2.             Intertek, Alcami and LTI. As soon as possible after the Transfer Date, Neurotrope will, at its expense, complete validation of analytical methods at Intertek Pharmaceutical Services (“Intertek”) and have existing product retested, using validated methods, at Intertek and at Alcami Corporation (“Alcami”), in an effort to show that both “Bryostatin for Injection” and PET diluent to be transferred to BryoLogyx meet all Neurotrope specifications, and were manufactured pursuant to cGMP, which includes:

 

3.2.1.        Providing to BryoLogyx final reports including validation reports, methods, and certificates of analyses by Neurotrope or its contracted parties with respect thereto.

 

3.2.2.        Providing to BryoLogyx batch summary reports, batch records for Bryostatin for Injection and PET diluent provided (Lots# 260-180725 and 262-180802, respectively) and cGMP certifications.

 

3.2.3.        Permitting BryoLogyx to use all validated methods developed by Intertek and Alcami in their contractual relationship with Neurotrope, as well as permitting Intertek and Alcami to work with BryoLogyx, to allow for future retesting of existing lots for stability, and for release testing of future manufactured lots by BryoLogyx.

 

3.3.             Payments. Neurotrope will pay all payables for services rendered to Neurotrope by third parties pursuant to Neurotrope’s agreements with such third parties that are related to the CRADA, IND, and method validations, and with respect to such transfer to BryoLogyx under this Agreement of material, methods, testing and rights related thereto.

 

3.4.             Vendor Agreements. Neurotrope will, promptly after the Transfer Date and in an appropriate manner, and with an appropriate level of detail/content, in each case as approved in advance by BryoLogyx (which approval will not to be unreasonably or untimely withheld), inform, in writing, all relevant third parties with which Neurotrope has a contractual relationship, including Amarex (regarding the IND), LTI, Intertek and Alcami (regarding drug product manufacture, method validation and testing), and Singota (regarding labeling and kitting of bryostatin-1 and PET diluent allotted to BryoLogyx), with respect to the transfer of rights and responsibilities as to activities to BryoLogyx as effected under this Agreement on and after the Transfer Date.

 

4.                   Certificate of Analysis. BryoLogyx will provide Neurotrope with a Certificate of Analysis demonstrating comparability of synthetic bryostatin-1 molecule to natural bryostatin-1 when such data become available.

 

5. Revenue Share.

 

5.1.             Revenue Share; End Date. As full consideration for the transfer by Neurotrope to BryoLogyx of the CRADA and the PIND/IND and of Neurotrope’s performance of Neurotrope’s other obligations as described herein, commencing with the calendar quarter in which the first commercial sale is made by BryoLogyx or by a BryoLogyx affiliate (with “affiliate” defined for purposes of this Agreement as a party controlling, controlled by or under common control with BryoLogyx), distributor, licensee or sublicensee (BryoLogyx and each such other entity referred to as a “Selling Entity”) of a drug product which contains bryostatin-1, for the treatment of B-cell Acute Lymphoblastic Leukemia, CD22 directed CAR-T mono-therapies ( a “Bryostatin Product”), BryoLogyx will pay Neurotrope two percent (2%) of the gross revenues received by each Selling Entity from the sale by such Selling Entity of such Bryostatin Product ( the “Revenue Share”), provided that when a Bryostatin Product is sold by a Selling Entity as a combination therapy with at least one additional active pharmaceutical ingredient, the Revenue Share as to such sale will be calculated and will be payable only upon gross revenues of the bryostatin-1 drug product component of such combination therapy Bryostatin Product; provided, however, that if the gross revenues of the bryostatin-1 drug product component of such combination therapy Bryostatin Product cannot reasonably be determined, then the Revenue Share will be calculated and will be payable upon the commercial value of such bryostatin-1 drug product portion of such combination therapy Bryostatin Product as BryoLogyx and Neurotrope will in good faith agree in writing, based upon commercial precepts applicable to the pricing of similar combination therapy products. Such Revenue Share will be payable by BryoLogyx to Neurotrope until such date as the aggregate cumulative amount of Revenue Share paid by BryoLogyx to Neurotrope reaches One Million Dollars ($1,000,000.00) (the “End Date”). Payments based on sales of Bryostatin Products or any other payments will not be required to be made by BryoLogyx to Neurotrope after the End Date.

 

  3

 

 

5.2.             Payment of Revenue Share. Revenue Share will be calculated and reported by BryoLogyx for each calendar quarter or portion thereof through and including the End Date. BryoLogyx will deliver to Neurotrope within forty five (45) days after the end of each calendar quarter in which sales of Bryostatin Products have occurred prior to the End Date, a report certified in writing by BryoLogyx as accurate, setting forth for such calendar quarter or portion thereof the following information on a country-by-country basis: (a) the gross revenues received in such quarter or portion thereof by each Selling Entity from such Selling Entity’s sale of Bryostatin Products, (b) a calculation of the corresponding Revenue Share with respect to such gross revenues, and (iii) the exchange rate used by BryoLogyx for converting gross revenue recorded in a currency other than United States dollars (“USD”), with such relevant exchange rate determined as set forth in Section 5.3 hereof.

 

5.3.             Payment. BryoLogyx will pay the Revenue Share concurrently with delivery of the reports described in Section 5.2. All payments will be made by electronic (wire or ACH) transfer in immediately available funds to such bank account and with such routing number and other relevant wire or ACH transfer information as is designated in writing by Neurotrope to BryoLogyx within thirty (30) days after the Transfer Date, or to such bank account and with such updated information as Neurotrope informs BryoLogyx in writing at least 30 days prior to the end of the relevant calendar quarter, prior to the End Date, for which Revenue Share will become payable. All payments will be free and clear of any transfer fees or charges. All payments hereunder will be payable in USD. In the case of gross revenues from outside the United States, payments received by BryoLogyx will be expressed in the USD equivalent calculated on a quarterly basis in the currency of the country of sale, and converted to their USD equivalent using the average rate of exchange over the applicable calendar quarter to which the sales relate, in accordance with the rate of exchange for such currency reported in The Wall Street Journal, Internet U.S. Edition at www.wsj.com, as of the last day of the applicable reporting period (or, if unavailable on such date, the first date thereafter on which such rate is available).

 

5.4.             Late Payments. Interest will accrue on payments of Revenue Share not made by BryoLogyx on the date such payment is due, at a monthly interest rate equal to the lesser of (a) one and one-half percent (1.5%) or (b) the highest rate permissible by applicable law, with such interest accruing from the date such payment was originally due.

 

5.5.             Tax Withholding. This Agreement is being entered into with the assumption that no withholding tax will apply to the payments made hereunder. In the event that applicable laws require that taxes be withheld from a payment due from BryoLogyx to Neurotrope under this Agreement, the parties will discuss promptly and in good faith and will agree in writing, how to handle efficiently the payment of such withholding tax. Unless otherwise agreed between the parties in writing, BryoLogyx will (a) withhold as required by applicable Law the relevant amount of taxes from such payment due from it to Neurotrope, (b) make payment of the withheld taxes to the applicable tax authority, and (c) deliver to Neurotrope written evidence of such payment of tax made to the tax authority promptly following such payment. Neurotrope will provide BryoLogyx with such documentation in Neurotrope’s possession that is necessary for BryoLogyx to lawfully avoid or reduce any amounts of withholding tax or other applicable taxes under any applicable law, including any applicable tax treaty. To the extent that amounts are so withheld, such amounts will be treated for all purposes of this Agreement as having been paid to Neurotrope. The parties acknowledge and agree that it is mutual objective and intent to minimize, to the extent feasible under applicable laws, any taxes payable in connection with this Agreement, and will reasonably cooperate each other in good faith in accordance with applicable laws to minimize any taxes in connection with this Agreement.

 

  4

 

 

5.6.             Audits. BryoLogyx will keep (and will cause each Selling Party to keep) complete and accurate records pertaining to the sale or other disposition of Bryostatin Products and calculations of the Revenue Share in sufficient detail to permit Neurotrope to confirm the accuracy of all payments due to it hereunder. Neurotrope will have the right to cause an independent, certified public accountant reasonably acceptable to BryoLogyx to audit such records to confirm gross revenues and the Revenue Share for a period covering up to but not more than the preceding five (5) calendar years. Such audit rights may be exercised during normal business hours upon at least thirty (30) days prior written notice to BryoLogyx. If the auditor determines that there has been an underpayment by BryoLogyx, BryoLogyx will pay to Neurotrope the underpayment within thirty (30) days after the auditor’s decision, plus interest from the original due date. Neurotrope will bear its and the auditor’s cost of such audit unless such audit discloses an underpayment by BryoLogyx of five percent (5%) or more during the period audited, in which case, BryoLogyx will bear the entire cost and reasonable and documented expense incurred by Neurotrope in performing such audit.

 

5.7.             Survival of Revenue Share Payment Obligation. BryoLogyx’ obligation to pay the Revenue Share, and the corresponding provisions of this Section 5, shall survive termination of this Agreement made pursuant to Section 8.1.4.

 

6.                   Reservation of Rights. Neither party grants any license, express or implied, under its intellectual property rights, nor any other rights, to the other party in connection with this Agreement, whether by implication, estoppel or otherwise, and each party reserves all such rights of itself.

 

7.                   Treatment of Confidential Information.

 

7.1.             Definition. “Confidential Information” means with respect to a party (the “Receiving Party”), all non-public business, technical, financial, legal or other information, including, without limitation, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including, preclinical data, clinical trial data, databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, together with any copies, abstracts or derivatives thereof, disclosed by the other party (the “Disclosing Party”) to the Receiving Party or to any of its affiliates or representatives under this Agreement that (a) is marked as confidential or indicated at the time of disclosure as being confidential or, in the case of information that is orally disclosed, that is subsequently summarized in writing and transmitted to the Receiving Party within thirty (30) days of the initial disclosure or (b) by its nature a reasonable person would understand to be confidential or proprietary; provided that Confidential Information will not include any information that the Receiving Party can demonstrate by written record that such information: (i) is, as of the date of disclosure, demonstrably known to the Receiving Party other than by virtue of a prior confidential disclosure to it; (ii) is, as of the date of disclosure, in, or subsequently enters, the public domain, through no fault of the Receiving Party; (iii) was obtained by the Receiving Party from a third party which can be reasonably assumed to have a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (iv) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party, as demonstrated by the Receiving Party’s records kept in the ordinary course of its business.

 

  5

 

 

7.2.             Confidential Obligations. Each party will keep confidential using reasonable precautions (including all precautions it employs with respect to its own confidential materials), and without prior written consent of the other party, will not disclose, Confidential Information of the other party. Neither party will access, use or permit to be used any Confidential Information of the other party for any purpose whatsoever other than fulfilling its obligations or exercising any rights granted to it or reserved by it under this Agreement without prior written consent of the other party.

 

7.3.             Exceptions. Notwithstanding the foregoing:

 

7.3.1.        Each party may disclose Confidential Information to the extent such disclosure is reasonably necessary to comply with applicable laws, regulations, judicial or administrative process, or court orders (including any stock exchange regulations) provided, however, that if a party is required to make any such disclosure of the other party’s Confidential Information in connection with any of the foregoing, it will (1) give reasonable advance notice to the other party of such disclosure requirement (2) (other than in the case where such disclosure is necessary, in the reasonable opinion of the Disclosing party’s outside legal counsel, to comply with securities laws, regulations or guidances) will use commercially reasonable efforts to assist such other party in efforts to secure confidential treatment of such information required to be disclosed and (3) only disclose that Confidential Information that is, at the direction of legal counsel, required to be disclosed;

 

7.3.2.        Each party may disclose the Disclosing party’s Confidential Information to its affiliates and their employees and agents to the extent reasonably necessary for the purpose of fulfilling its obligations or exercising any rights granted to it or reserved by it hereunder; provided that the recipient of such disclosed Confidential Information will be (A) apprised of the confidential nature of such information and (B) bound by obligations of confidentiality substantially the same as the obligations hereunder. Each party will be responsible for any breach of the confidentiality obligations set forth in this Section 7 by those entities individuals that it has disclosed the other party’s Confidential Information as permitted under this Section 7; and

 

7.3.3.        Each party may disclose the Disclosing party’s Confidential Information to the extent such disclosure is reasonably necessary: (A) to such party’s attorneys, independent accountants and financial advisors for the sole purpose of enabling such attorneys, independent accountants and financial advisors to provide advice to the Receiving party, provided that in each such case on the condition that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations substantially consistent with those contained in this Agreement; or (B) to actual or potential investors, acquirers, licensees and other financial or commercial partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition or collaboration, public offering, merger or acquisition of such party, or sale or substantially all of its business to which this Agreement relates, provided that any such third party agrees to be bound by confidentiality and non-use obligations that are no less stringent than those contained in this Agreement (except to the extent that a shorter confidentiality period is customary in the industry).

 

8.                   Term and Termination.

 

8.1.          Term. The term of the Agreement will commence upon the Effective Date and will terminate upon the earliest to occur of the following:

 

8.1.1. The fifth (5th) business day, as hereinafter defined, after the Effective Date or such later date as BryoLogyx may agree with Neurotrope in writing, if by such date (a) the Transfer Date has not occurred, and (b) Neurotrope has not notified Singota in writing with respect to the matters set forth in Section 3.1 and with BryoLogyx not being required to send in writing to Neurotrope, which termination will be automatic upon such fifth business day or later date as may be agreed by BryoLogyx if such two aforementioned conditions have not been met; or

 

  6

 

 

8.1.2. The End Date; or

 

8.1.3. Such date as the parties agree in writing; or

 

8.1.4. Such date prior to the End Date as is set forth for such termination in a written notice by one party to the other for uncured material breach by the other party of an obligation of the other party hereunder, which obligation and which material breach will be set forth in such notice by the sending party in reasonable detail, which has not been cured by the other party within thirty (30) days after the date such notice is received by the other party, or within such longer period of time for cure as the party sending such notice sets forth in such notice.

 

8.2.             Survival. The parties’ respective rights and obligations under the following Sections (and all associated definitions), and any other rights or remedies that accrue prior to termination or expiration of this Agreement, shall survive the termination or expiration of this Agreement: Sections 5.7, 7, 8.2 and 9.

 

9. Additional Terms.

 

9.1.             Disclaimer. NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH REGARD TO ANY MATTER RELATING TO THIS AGREEMENT, INCLUDING REGARDING THE CRADA, VENDOR AGREEMENTS, THE IND, OR BRYOSTATIN PRODUCTS, AND EACH PARTY DISCLAIMS ALL IMPLIED AND STATUTORY WARRANTIES INCLUDING OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT AND OF CUSTOM OR TRADE.

 

9.2.             Limitation on Liability. NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY LOSS, DAMAGE, OR LIABILITY WITH RESPECT TO ANY SPECIAL, INDIRECT, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGE OF ANY KIND WHATEVER AND HOWEVER CAUSED, AND INCLUDING LOSS OF BUSINESS OR PROFITS, AND WHETHER BASED ON AN ACTION OR CLAIM IN CONTRACT, TORT (INCLUDING NEGLIGENCE), BREACH OF STATUTORY DUTY OR OTHERWISE, AND EVEN IF FORESEEABLE OR SUFFERED IN CIRCUMSTANCES WHERE A PARTY HAS BEEN ADVISED PRIOR TO THE DATE OF THIS AGREEMENT OF THE POSSIBILITY OF SUCH LOSSES. Notwithstanding the foregoing, nothing in this Section 9.2 limits or restricts damages caused by a party’s breach of Section 7.

 

9.3.             Notification. All notices, consents and other formal or legal communications hereunder will be in writing, will be addressed to the receiving party’s address set forth below, and will be delivered by hand or sent by a nationally recognized courier service such as UPS, DHL or FedEx, which can provide evidence of receipt by the recipient party, and will be sent to the parties as follows:

 

If to Neurotrope: Neurotrope Bioscience, Inc.
  1185 Avenue of the Americas
  New York, New York 10036
  United States of America
  Attention: Chief Financial Officer

 

  7

 

 

 

If to BryoLogyx:

 

BryoLogyx, Inc.

2485 Holly Oak Drive

Danville, CA 94506

Attention: Thomas Loarie, Chief Executive Officer 

 

All such notices will be deemed to have been given upon receipt. For the avoidance of doubt, any notice, consent, or other formal or legal communication, as opposed to ongoing communication by the parties about the subject matter hereof, cannot be sent by email, facsimile or regular mail and if so sent will not be deemed to be a valid notice under this Agreement

 

9.4.             Governing Law. This Agreement will be construed, interpreted and applied in accordance with the laws of the State of New York, without reference to any rules or principles of conflict of laws.

 

9.5.             Venue. The exclusive venue for the resolution of disputes arising out of or relating to this Agreement (including intellectual property) will be the state and federal courts located in New York, New York, and such courts will have exclusive jurisdiction. The parties hereby submit themselves to the jurisdiction of such courts for such purposes. EACH PARTY HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT IT MAY LEGALLY AND EFFECTIVELY DO SO, TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING HEREUNDER. The prevailing party in any dispute is entitled to recover its reasonable attorneys’ fees.

 

9.6.             Entire Agreement. This Agreement is the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior representations, understandings and agreements between the parties with respect to the subject matter hereof, including that certain Outline of Key Elements With Respect to Transfer to BryoLogyx by Neurotrope of CRADA and IND Matters for the Study of Bryostatin-1 in its Application to Cancer Therapy signed by the parties and dated March 31, 2020.

 

9.7.             Amendment and Waiver. This Agreement may not be amended except in a writing signed by both parties. Any such amendment will not affect the continuing effectiveness of all other provisions hereof that are not so amended. Any term or condition of the Agreement may be waived only by a written instrument executed by the party waiving compliance. The failure of either party at any time or times to require performance of any provision hereof will in no manner affect its rights at a later time to enforce the same. No waiver by either party of any condition or term will be deemed as a continuing waiver of such condition or term or of another condition or term.

 

9.8.             Assignment; Binding Upon Successors and Permitted Assigns. Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by either party without the prior express written consent of the other party; provided that each party with prior written notice but without such consent may assign the Agreement in its entirety to a successor in interest in connection with the sale of all or substantially all of the business or assets to which the Agreement relates or similar change of control. This Agreement will be binding upon and will inure to the benefit of the parties’ successors and permitted assigns.

 

9.9.             Construction. The parties acknowledge and agree that: (a) each party and its counsel reviewed and negotiated the terms and provisions of the Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting party will not be employed in the interpretation of the Agreement; and c) the terms and provisions of the Agreement will be construed fairly as to all parties hereto and not in favor of or against any party, regardless of which party was generally responsible for the preparation of the Agreement. The following rules of interpretation will apply unless the context will require otherwise: (i) references to a person include bodies corporate and an unincorporated association of persons; (ii) the words “hereby”, “hereof”, “herein” and “hereunder” and words of similar import when used in this Agreement will refer to this Agreement as a whole and not to any particular provision of this Agreement; (iii) whenever the words “include”, “includes” or “including” are used in this Agreement, they will be deemed to be followed by the words “without limitation”; and (iv) the word “or” will not be deemed to be exclusive.

 

  8

 

 

9.10.          Severability. If any provision(s) of the Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable, it is the intention of the parties that the remainder of the Agreement will not be affected thereby provided that a party’s rights under the Agreement are not materially affected. The parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of the Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the parties that the basic purposes of the Agreement are to be effectuated.

 

9.11.          Further Assurances. Each party will execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of the Agreement.

 

9.12.          Compliance with Law. Each party will comply with all applicable laws in performing this Agreement.

 

9.13.          Independent Parties. This Agreement will not be construed as creating a relationship of employment, agency, partnership, joint venture, or any other form of legal association between the parties. Neither party has any power to bind the other party or to assume or to create any obligation or responsibility on behalf of the other party or in the other party’s name.

 

9.14.          Counting Of Time; “Business Days”. Whenever days are to be counted under this Agreement, the first day will not be counted and the last day will be counted. For purposes of this Agreement a “business day” means a day upon which national banks are open in New York, New York.

 

9.15.          Counterparts; Signatures. This Agreement may be executed simultaneously in one or more counterparts, each of which will be deemed an original, but both of which together will constitute one and the same instrument. Any signature of a party delivered electronically, as a PDF or other image, will be effective as an original signature and will be deemed to be an original signature by the parties.

 

[SIGNATURES FOLLOW ON THE NEXT PAGE.]

 

  9

 

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

NEUROTROPE BIOSCIENCE, INC. BRYOLOGYX, INC.
   
   
/s/ Robert Weinstein /s/ Thomas M. Loarie
Robert Weinstein Thomas M. Loarie
Chief Financial Officer Chief Executive Officer

 

 

  10

 

Exhibit 31.1

 

CERTIFICATION

OF

CHARLES S. RYAN, J.D., PH.D.

CHIEF EXECUTIVE OFFICER

OF

NEUROTROPE, INC.

 

I, Charles S. Ryan, JD, Ph.D., Chief Executive Officer of Neurotrope, Inc., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Neurotrope, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: June 12, 2020

 

  /s/ Charles S. Ryan, J.D., Ph.D.
  Charles S. Ryan, J.D., Ph.D.
  Chief Executive Officer

 

   

Exhibit 31.2

 

CERTIFICATION

OF

ROBERT WEINSTEIN

CHIEF FINANCIAL OFFICER

OF

NEUROTROPE, INC.

 

I, Robert Weinstein, Chief Financial Officer of Neurotrope, Inc., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Neurotrope, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: June 12, 2020 

 

  /s/ Robert Weinstein
  Robert Weinstein
  Chief Financial Officer, Executive Vice President, Secretary and Treasurer

 

   

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Neurotrope, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2020, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Charles S. Ryan J.D., Ph.D., Chief Executive Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: June 12, 2020  

 

  /s/ Charles S. Ryan, J.D., Ph.D.
  Charles S. Ryan, J.D., Ph.D.
  Chief Executive Officer

 

   

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Neurotrope, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2020, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Weinstein, Chief Financial Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: June 12, 2020

 

  /s/ Robert Weinstein
  Robert Weinstein
  Chief Financial Officer, Executive Vice President, Secretary and Treasurer