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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.