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, 2020 . 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. Explanatory Note OnMay 17, 2020 ,Neurotrope, Inc. (Neurotrope or Parent) announced plans for the complete legal and structural separation of us fromNeurotrope , also known as the Spin-Off. Under the Separation and Distribution Agreement,Neurotrope planned to distribute all of its equity interest in us toNeurotrope's stockholders. Following the Spin-Off,Neurotrope would not own any equity interest in us, and we would operate independently fromNeurotrope .Neurotrope Bioscience, Inc. was a wholly-owned subsidiary ofNeurotrope prior to the completion of the Spin-Off onDecember 7, 2020 (see below for description of Spin-Off).Neurotrope Bioscience, Inc. represented substantially all the business ofNeurotrope . OnDecember 6, 2020 ,Neurotrope approved the final distribution ratio and holders of record ofNeurotrope common stock,Neurotrope preferred stock and certain warrants as ofNovember 30, 2020 received a pro rata distribution at the rate of (i) one share of our Common Stock for every five shares ofNeurotrope common stock held, (ii) one share of our Common Stock for every five shares ofNeurotrope common stock issuable upon conversion ofNeurotrope preferred stock held and (iii) one share of our Common Stock for every five shares ofNeurotrope common stock issuable upon exercise of certainNeurotrope warrants held that were entitled to participate in the Spin-Off pursuant to the terms thereof.
Basis of Presentation
The unaudited financial statements for the fiscal quarters endedMarch 31, 2021 and 2020 include a summary of our significant accounting policies and should be read in conjunction with the discussion below and our financial statements and related notes included elsewhere in this quarterly report. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in the financial statements. All such adjustments are of a normal recurring nature. Subsequent to the Spin-Off, the Company's financial statements as ofDecember 31, 2020 and for the periodDecember 7, 2020 toDecember 30, 2020 are presented on a consolidated basis as the Company became a standalone public company onDecember 7, 2020 . The Company's combined financial statements as ofMarch 31, 2020 were derived from the consolidated financial statements and accounting records ofNeurotrope , the former Parent. These combined financial statements reflect the historical results of operations, financial position and cash flows of the former Parent's Spin-Off business which was a wholly owned subsidiary ofNeurotrope .Neurotrope Bioscience, Inc. represented substantially all the business ofNeurotrope . As a result, the historical financial statements ofSynaptogenix are virtually identical to those ofNeurotrope , other than
capitalization. Overview
We are a biopharmaceutical company with product candidates in pre-clinical and clinical development. We 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, 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.
Neurotrope had been a party to a technology license and services agreement with the originalBlanchette Rockefeller Neurosciences Institute (which has been known asCognitive Research Enterprises, Inc. 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. We were 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, theNIH , 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 us in collaboration with CRE. 21
Spin-Off from
OnDecember 1, 2020 ,Neurotrope , Petros Pharmaceuticals, Inc., aDelaware corporation ("Petros"), PM Merger Sub 1, LLC, aDelaware limited liability company and a wholly-owned subsidiary of Petros ("Merger Sub 1"), PN Merger Sub 2, Inc., aDelaware corporation and a wholly-owned subsidiary of Petros ("Merger Sub 2"), andMetuchen Pharmaceuticals LLC , aDelaware limited liability company ("Metuchen"), consummated the transactions (the "Mergers") contemplated by that certain Agreement and Plan of Merger by and amongNeurotrope , Petros, Merger Sub 1, Merger Sub 2 and Metuchen, dated as ofMay 17, 2020 (the "Original Merger Agreement"), as amended by the First Amendment to the Original Merger Agreement (the "First Amendment"), dated as ofJuly 23, 2020 and the Second Amendment to the Original Merger Agreement, dated as ofSeptember 30, 2020 (the "Second Amendment" and, together with the Original Merger Agreement and the First Amendment, the "Merger Agreement"). As a condition to the Mergers,Neurotrope approved the Spin-Off, which became effective onDecember 7, 2020 , whereby (i) any cash in excess of$20,000,000 , subject to adjustment as provided in the Merger Agreement, and all of the operating assets and liabilities ofNeurotrope not retained byNeurotrope in connection with the Mergers were contributed toNeurotrope Bioscience, Inc. (now known asSynaptogenix, Inc. ), and (ii) holders of record ofNeurotrope common stock,Neurotrope preferred stock and certain warrants as of the Spin-Off Record Date received a pro rata distribution at the rate of (i) one share of our Common Stock for every five shares ofNeurotrope common stock held, (ii) one share of our Common Stock for every five shares ofNeurotrope common stock issuable upon conversion ofNeurotrope preferred stock held and (iii) one share of our Common Stock for every five shares ofNeurotrope common stock issuable upon exercise of certainNeurotrope warrants held that were entitled to participate in the Spin-Off pursuant to the terms thereof (collectively, the "Distribution"). Any fractional shares were paid in cash. In addition, in connection with the Spin-Off, the holders ofNeurotrope's amended and restated warrants to purchase shares ofNeurotrope common stock (the "A&R Warrants") received warrants to purchase shares of our Common Stock at the ratio of one share of our Common Stock for every five shares ofNeurotrope common stock issuable upon exercise of such A&R Warrants held as of the Spin-Off Record Date (collectively, the "Spin-Off Warrants"). OnDecember 6, 2020 , we entered into the Separation and Distribution Agreement withNeurotrope that sets forth our agreements withNeurotrope regarding the principal transactions necessary to separate us fromNeurotrope , including: (i) the contribution of cash in excess of$20,000,000 , as adjusted pursuant to the Merger Agreement, and all of the operating assets and liabilities not retained byNeurotrope in connection with the Merger to us and (ii) the Distribution. The Separation and Distribution Agreement also sets forth the other provisions that govern certain aspects ofNeurotrope's relationship with us after the completion of the Spin-Off and provides for the allocation of assets, liabilities and obligations between us andNeurotrope in connection
with the Spin-Off. OnDecember 6, 2020 , we entered into a Tax Matters Agreement withNeurotrope (the "Tax Matters Agreement") that generally governs the parties' respective rights, responsibilities and obligations after the Spin-Off with respect to taxes. Under the Tax Matters Agreement,Neurotrope will be liable for and shall indemnify us from all taxes ofNeurotrope for any taxable period and any transfer taxes for whichNeurotrope is responsible as a result of the Spin-Off. We will be liable for and shall indemnifyNeurotrope from (i) all taxes, other than transfer taxes ofNeurotrope for any pre-Spin-Off tax period to the extent they are attributable to us (ii) all taxes, other than transfer taxes, of us for any taxable period other than a pre-Spin-Off tax period, (iii) from all taxes, other than transfer taxes, ofNeurotrope related to the recapture of any "dual consolidated loss" and (iv) any transfer taxes for which it is responsible
as a result of the Spin-Off. OnDecember 7, 2020 , we filed an amended and restated certificate of incorporation which, among other things, changed our name toSynaptogenix, Inc. Our Common Stock is quoted on the OTCQB market of the OTC Markets Group, Inc. under the symbol "SNPX". 22
OnJanuary 21, 2021 , we entered into Securities Purchase Agreements (the "Purchase Agreement") with certain accredited investors (the "Purchasers") to issue (a) an aggregate of 9,335,533 shares of our Common stock and/or Pre-Funded Warrants to purchase shares of Common Stock, (b) Series E Warrants to purchase 9,335,533 shares of Common Stock, with an exercise price of$2.1275 per share (subject to adjustment), for a period of twelve months from the date of an effective registration statement and (c) Series F Warrants to purchase up to an aggregate of 9,335,533 shares of Common Stock, with an exercise price of$1.725 per share (subject to adjustment), for a period of five years from the date of issuance at a combined purchase price of$1.50 per share of Common Stock and Warrants (the "Offering"). We received total gross proceeds of approximately$14,000,000 in Offering. In connection with the Purchase Agreement, we entered into a Registration Rights Agreement with the Purchasers (the "Registration Rights Agreement") onJanuary 21, 2021 . Under the terms of the Registration Rights Agreement, we agreed to register the shares of Common Stock and the shares of Common Stock issuable upon exercise of the Warrants and the Pre-Funded Warrants sold to the Purchasers pursuant to the Purchase Agreement. We are required to file a registration statement for the resale of such securities within 30 days following the closing date and to use its commercially reasonable efforts to cause each such registration statement to be declared effective no later than the earlier of (i) 120 days following the closing date (or 150 days following the closing date if theSecurities and Exchange Commission causes a delay) and (ii) the fifth business day after we are notified that the registration statement will not be further reviewed. We may incur liquidated damages if we do not meet certain deadlines with respect to our registration obligations under the Registration Rights Agreement or if certain other events occur. We also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement. In connection with the Offering, we paid our Placement Agents (i) a cash fee equal to ten percent (10%) of the gross proceeds from any sale of securities in the Offering sold to Purchasers introduced by the Placement Agent and (ii) warrants to purchase shares of Common Stock equal to ten percent (10%) of the number of shares of Common Stock sold to Purchasers introduced by the Placement Agent, with an exercise price of$1.725 per share and a five-year term.
Results of Most Recent Confirmatory Phase 2 Clinical Trial
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 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. 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). 23
In connection with the additional analysis, we also announced the approval of a$2.7 million award from theNIH 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 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. OnJuly 23, 2020 , we entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for our Phase 2 clinical study assessing the safety, tolerability and long-term efficacy of bryostatin in the treatment of moderately severe AD subjects not receiving memantine treatment. The total estimated budget for the services, including pass-through costs, is approximately$9.8 million . As previously disclosed onJanuary 22, 2020 , we have received a$2.7 million award from theNIH , which award will be used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to us of$7.1 million . In connection with the entry into the Letter of Intent and 2020 Services Agreement,Synaptogenix paid the following advance payments: (i) services fees of approximately$943,000 ; (ii) pass-through expenses of approximately$266,000 ; and (iii) investigator/institute fees of approximately$314,000 . As ofMarch 31, 2021 , we incurred approximately$2.8 million of expenses associated with services provided by WCT. Of those amounts, approximately$1.0 million was paid utilizing prepayments on deposit with WCT (which totaled approximately$1.5 million as detailed above), leaving a balance in prepaid expenses of approximately$0.5 million . In addition, we reflected an offset to these expenses of approximately$975,000 of amounts received and receivable from theNIH . As ofFebruary 18, 2021 , theNIH , pursuant to the$2.7 million award (noted above), has reimbursed us approximately$975,000 for expenses incurred during the third and fourth quarters of 2020. See Note 1 - Organization, Nature of Business, and Liquidity and Note 5 - Commitments in the notes to the condensed financial statements contained within this Quarterly Report. 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 CRADA with 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 our 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 Nemours, a premierU.S. children's hospital, to initiate a clinical trial in children with 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. As ofMarch 31, 2021 the Company continues to pursue its development of a therapeutic to possibly treat Fragile X thru future clinical trials. 24 Impact of COVID-19 InJanuary 2020 , theWorld Health Organization ("WHO") announced a global health emergency because of a new strain of coronavirus originating inWuhan, China (the "COVID-19 outbreak") and the risks to the international community. InMarch 2020 , theWHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. As a result of the COVID-19 pandemic, which continues to rapidly evolve, "shelter in place" orders and other public health guidance measures have been implemented across much ofthe United States ,Europe andAsia , including in the locations of our offices, key vendors and partners. The Company faces the ongoing risk that the coronavirus pandemic may slow the conduct of the Company's 2020 trial. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our Phase 2 clinical trial of Bryostatin-1 for the treatment of patients with Alzheimer's disease. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of the ongoing coronavirus pandemic may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and supplier of API. In light of the COVID-19 outbreak, the FDA has issued a number of new guidance documents. Specifically, as a result of the potential effect of the COVID-19 outbreak on many clinical trial programs in the US and globally, the FDA issued guidance concerning potential impacts on clinical trial programs, changes that may be necessary to such programs if they proceed, considerations regarding trial suspensions and discontinuations, the potential need to consult with or make submissions to relevant ethics committees,Institutional Review Board ("IRBs"), and the FDA, the use of alternative drug delivery methods, and considerations with respect the outbreak's impacts on endpoints, data collection, study procedures, and analysis. Such developments may result in delays in our development of Bryostatin-1. Results of Operations
Comparison of the three months ended
The following table summarizes our results of operations for the years endedDecember 31, 2020 and 2019: Three months ended March 31, Dollar 2021 2020 Change % Change Revenue $ - $ - $ - 0 %
Operating Expenses:
Research and development expenses
192.9 % General and administrative expenses - Related party $ -$ 28,362 $ (28,362 ) (100.0 )% General and administrative expenses$ 2,003,413 $ 2,186,604 $ (183,191 ) (8.4 )% Other income, net$ 816 $ 70,867 $ (70,051 ) (98.8 )% Net loss$ 3,154,377 $ 2,537,344 $ 617,033 24.3 % Revenues We did not generate any revenues for the three months endedMarch 31, 2021 and 2020. 25 Operating Expenses Overview Total operating expenses for the three months endedMarch 31, 2021 were$3,155,193 as compared to$2,608,211 for the three months endedMarch 31, 2020 , an increase of approximately 21%. The increase in total operating expenses is due primarily to increases in our research and development and general and administrative expenses.
Research and Development Expenses
For the three months endedMarch 31, 2021 , we incurred$1,151,780 in research and development expenses as compared to$393,245 for the three months endedMarch 31, 2020 . These expenses were incurred pursuant to developing the potential AD therapeutic product, specifically expenses relating to the recently concluded confirmatory Phase 2 clinical trial plus the recently initiated Phase 2 clinical trial for AD. Of these expenses, for the three months endedMarch 31, 2021 ,$898,589 was incurred principally relating to our confirmatory clinical trial and related storage of drug product,$63,650 for clinical consulting services,$7,397 of amortization of prepaid licensing fees relating to theStanford andMount Sinai license agreements,$8,442 for development of alternative drug supply withStanford University and$173,702 of non-cash stock options compensation expense as compared to, 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,$6,914 for development of alternative drug supply withStanford University and$237,198 of non-cash stock options compensation expense.
We expect our research and development expenses to substantially increase, in the short term, as our current Phase 2 clinical trial for AD was recently initiated. Other development expenses 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 other current development programs for Bryostatin-1.
General and Administrative Expenses
We incurred related party general and administrative expenses totaling$0 for the three months endedMarch 31, 2021 as compared to$28,362 for the three months endedMarch 31, 2020 . The decrease is attributable to the resignation of two members ofNeurotrope's board of directors inFebruary 2020 ,who are affiliates of CRE. We incurred$2,003,413 and$2,186,604 of non-related party general and administrative expenses for the years endedMarch 31, 2021 and 2020, respectively, a decrease of approximately 8.4%. Of the amounts for the year endedMarch 31, 2021 , as compared to the comparable 2020 period:$430,214 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus$652,060 for the 2020 comparable period. The decrease is primarily attributable to the termination of our Chief Executive Officer at the end of 2020;$234,584 was incurred for legal expenses versus$318,973 for the 2020 comparable period. The decrease for 2021 is based upon one-time work associated with our strategic alternatives, planning, restructuring and spin-off ofSynaptogenix, Inc. in 2020;$592,676 was incurred for outside operations consulting services, versus$399,751 for the 2020 comparable period as, for 2021, we incurred additional non-cash expenses associated with warrant issuances for investment banking consulting services;$10,751 was incurred for travel expenses, versus$43,898 for the 2020 comparable period, which decrease is primarily attributable to limited travel due to the COVID-19 contagion;$67,069 was incurred for investor relations services versus$133,179 for the 2020 comparable period, which additional expenses during 2020 were primarily attributable to non-cash compensation paid to advisors and an increase in our market exposure;$49,895 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services, versus$31,212 for the 2020 comparable period, which additional expenses during the current period were incurred for fees associated with our strategic transactions;$162,108 was incurred for insurance, versus$154,314 for the 2020 comparable period, which increase is primarily attributable to an increase in coverage;$61,579 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other versus$54,600 for the 2020 comparable period, and$394,537 was recorded as non-cash stock options compensation expense versus$398,617 for
the 2020 comparable period. 26 Other Income / Expense
We earned$816 of interest income for the three months endedMarch 31, 2021 as compared to$70,867 for the three months endedMarch 31, 2020 on funds deposited in interest bearing money market accounts. The decrease is primarily attributable to the decrease in money market interest income rates. Net loss
We incurred losses of$3,154,377 and$2,537,344 for the three months endedMarch 31, 2021 and 2020, respectively. The increased loss was primarily attributable to the increase in net research and development expenses associated with completing our most recent Phase 2 confirmatory clinical trial offset by the decrease in our general and administrative expenses. The computation of diluted loss per share for the three months endedMarch 31, 2021 excludes 23,989,414 warrants and options to purchase 465,400 shares of our common stock as they are anti-dilutive due to our net loss. For the three months endedMarch 31, 2020 , the computation excludes 4,346,252 warrants and options to purchase 465,315 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, 2021 , we had working capital of$15,388,243 as compared to working capital of$5,116,300 as ofDecember 31, 2020 . The$10,271,943 increase in working capital was primarily attributable to ourJanuary 2021 Private Placement resulting in net cash proceeds from our Private Placement of approximately$12.5 million , offset by a decrease in cash of approximately$2.3 million from operating expenses. As ofMarch 31, 2021 , we had approximately$14.8 million in cash and cash equivalents as compared to$5.8 million atDecember 31, 2020 . The approximately$9.0 million decrease in cash is primarily attributable to ourJanuary 2021 private placement offering resulting in net cash proceeds of approximately$12.5 million , offset by the aforementioned cash used for operations of$3.5 million . We expect that our current cash and cash equivalents of approximately$15.8 million which includes the$12.5 million of net proceeds received under theJanuary 2021 Private Placement and the remaining cash expected to be received from theNIH of approximately$1.7 million , will be sufficient to support our projected operating requirements for at least the next 12 months from the Form 10-Q filing date, which would include the continuing development and current Phase 2 clinical trial, of bryostatin, our novel drug targeting the
activation of PKC epsilon. Sources and Uses of Liquidity Since inception, we have satisfied our operating cash requirements from transfers of cash fromNeurotrope , which was raised byNeurotrope through 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 clinical trials in addition to our current ongoing clinical trial and additional research and development expenditures. Three Months EndedMarch 31, 2021 2020
Cash used in operating activities
- 2,599
Cash provided by financing activities 12,512,667 16,519,988
27
Cash used in operating activities was
Net cash used in investing activities was
Net cash provided by financing activities was$12,512,667 for the three months endedMarch 31, 2021 compared to cash provided by financing activities of$16,519,988 for the three months endedMarch 31, 2020 . The change in net cash provided by financing activities for 2020 and 2021 were the result of net transfers from our Parent of approximately$16.5 million in 2020 and$12.5 of net proceeds from our private placement during the first quarter of 2021. We expect that our existing capital resources of approximately$14.1 million plus$1.7 million from ourNIH grant, 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. 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. 28
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