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 endedDecember 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 withUnited 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 inOctober 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 originalBlanchette Rockefeller Neurosciences Institute ("BRNI") (which has been known asCognitive Research Enterprises, Inc. ("CRE") sinceOctober 2016 ), and its affiliateNRV 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, untilMarch 2013 , had been financed through funding from a variety of non-investor sources (which include not-for-profit foundations, theNational Institutes of Health , which is part of theU.S. Department of Health and Human Services , and individual philanthropists). FromMarch 2013 forward, development of the licensed technology has been funded principally through the Company in collaboration
with CRE. Planned Merger and Spin-Off OnMay 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 theNasdaq 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
OnMay 4, 2018 , we announced a confirmatory, 100 patient, double-blinded clinical trial for the safe, effective 20 ?g 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 engagedWorldwide 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 inApril 2018 . DuringJuly 2018 , the first patient was enrolled in this study. Pursuant to a new Services Agreement (the "New Services Agreement") with WCT dated as ofMay 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 ofDecember 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
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 20?g 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
OnJanuary 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 theNational 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 theFood 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. OnMay 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 aCooperative Research and Development Agreement ("CRADA") with theNational Cancer Institute ("NCI") onJanuary 29, 2019 for the research and clinical development of Bryostatin-1. Under the CRADA, we will collaborate with theNCI'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 OnSeptember 5, 2018 , we announced a collaboration with The Nemours / Alfred I. duPontHospital for Children ("Nemours"), a premierU.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 OnJanuary 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
OnFebruary 21, 2020 ,James Gottlieb resigned as a member of our Board and from all committees thereof, effective immediately. OnFebruary 25, 2020 ,Shana Phares resigned as a member of the Board and from all committees thereof, effective immediately.Mr. Gottlieb andMs. 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
The following table summarizes our results of operations for the three months
ended
Three months ended March 31, Dollar % 2020 2019 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
Operating Expenses Overview Total operating expenses for the three months endedMarch 31, 2020 were$2,608,211 as compared to$4,796,057 for the three months endedMarch 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 endedMarch 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 endedMarch 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 endedMarch 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 theStanford andMount Sinai license agreements and$6,914 for development of alternative drug supply withStanford University as compared to, for the three months endedMarch 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 theStanford andMount Sinai license agreements and$4,000 for development of alternative drug supply withStanford 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 endedMarch 31, 2020 versus$12,500 for the three months endedMarch 31, 2019 . The decrease is attributable to the resignation of two members of our board of directors inFebruary 2020 , who are affiliates of CRE. We incurred$1,787,987 and$1,328,500 of general and administrative expenses for the three months endedMarch 31, 2020 and 2019, respectively, an increase of approximately 35%. Of the amounts for the three months endedMarch 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 endingMarch 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 ourJanuary 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
We incurred$635,815 and$1,515,475 of non-related party non-cash expenses for the three months endedMarch 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
Net loss and loss per share
We incurred losses of$2,537,344 and$4,689,158 for the three months endedMarch 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 endedMarch 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 endedMarch 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 endedMarch 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 ofMarch 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 ofDecember 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 . OnJanuary 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 endedMarch 31, 2020 2019
Cash used in operating activities
2,599 5,214 Cash provided by financing activities 16,519,988 -
Cash used in operating activities was$1,738,673 for the three months endedMarch 31, 2020 , compared to$4,816,621 for the three months endedMarch 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 endedMarch 31, 2020 .
Net cash used in investing activities was
24
Net Cash Provided by Financing Activities
Net cash provided by financing activities was$16,519,988 for the three months endedMarch 31, 2020 compared to$0 for the three months endedMarch 31, 2019 . Net cash provided for the three months endedMarch 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. OnJanuary 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 ofMay 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.
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