Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 05, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 001-40458 | |
Entity Registrant Name | Synaptogenix, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-1585656 | |
Entity Address, Address Line One | 1185 Avenue of the Americas | |
Entity Address, Address Line Two | 3rd Floor | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
City Area Code | 973 | |
Local Phone Number | 242-0005 | |
Entity Address, Postal Zip Code | 10036 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | SNPX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001571934 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 6,848,047 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 26,334,137 | $ 34,213,989 |
Prepaid Clinical trial expenses | 599,631 | 410,357 |
Prepaid expenses and other current assets | 395,342 | 879,869 |
TOTAL CURRENT ASSETS | 27,329,110 | 35,504,215 |
Fixed assets, net of accumulated depreciation | 21,532 | 20,445 |
TOTAL ASSETS | 27,350,642 | 35,524,660 |
CURRENT LIABILITIES | ||
Accounts payable | 483,390 | 1,296,506 |
Accrued expenses | 200,205 | 698,406 |
TOTAL CURRENT LIABILITIES | 683,595 | 1,994,912 |
Commitments and contingencies | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock - 1,000,000 shares authorized as of September 30, 2022, $0.0001 par value; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | ||
Common stock - 150,000,000 shares authorized as of September 30, 2022, $0.0001 par value; 6,841,169 shares issued and outstanding as of September 30, 2022 and 6,730,180 shares issued and outstanding as of December 31, 2021. | 685 | 674 |
Additional paid-in capital | 50,864,334 | 47,670,744 |
Accumulated deficit | (24,197,972) | (14,141,670) |
TOTAL STOCKHOLDERS' EQUITY | 26,667,047 | 33,529,748 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 27,350,642 | $ 35,524,660 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets | ||
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 6,841,169 | 6,730,180 |
Common stock, shares outstanding | 6,841,169 | 6,730,180 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
OPERATING EXPENSES: | ||||
Research and development | $ 1,484,694 | $ 836,716 | $ 4,911,869 | $ 2,974,776 |
General and administrative | 1,682,512 | 2,092,662 | 5,334,260 | 5,404,968 |
TOTAL OPERATING EXPENSES | 3,167,206 | 2,929,378 | 10,246,129 | 8,379,744 |
OTHER INCOME (EXPENSE): | ||||
Interest income | 140,730 | 2,445 | 189,827 | 4,592 |
Net loss before income taxes | 3,026,476 | 2,926,933 | 10,056,302 | 8,375,152 |
Net loss attributable to common stockholders | $ 3,026,476 | $ 2,926,933 | $ 10,056,302 | $ 8,375,152 |
PER SHARE DATA: | ||||
Basic loss per common share | $ 0.43 | $ 0.47 | $ 1.44 | $ 1.89 |
Diluted loss per common share | $ 0.43 | $ 0.47 | $ 1.44 | $ 1.89 |
Basic weighted average common shares outstanding | 6,988,000 | 6,196,600 | 6,962,400 | 4,420,200 |
Diluted weighted average common shares outstanding | 6,988,000 | 6,196,600 | 6,962,400 | 4,420,200 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) | Common stock | Preferred stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance, Beginning at Dec. 31, 2020 | $ 126 | $ 0 | $ 6,668,859 | $ (1,530,473) | $ 5,138,512 |
Balance, Beginning (in shares) at Dec. 31, 2020 | 1,257,579 | 0 | |||
Stock based compensation | 1,918,651 | 1,918,651 | |||
Issuance of warrants for consulting fees | 481,496 | 481,496 | |||
Issuance of common stock for consulting fees | $ 1 | 22,657 | 22,658 | ||
Issuance of common stock for consulting fees (in shares) | 3,255 | ||||
Exercise of common stock warrants | $ 104 | 8,382,412 | 8,382,516 | ||
Exercise of common stock warrants (in shares) | 1,038,898 | ||||
Reverse stock split rounding | (1,529) | (1,529) | |||
Reverse stock split rounding (in shares) | (345) | ||||
Private placement of common stock and warrants | $ 384 | 23,783,777 | 23,784,161 | ||
Private placement of common stock and warrants (in shares) | 3,837,580 | ||||
Net loss | (8,375,152) | (8,375,152) | |||
Balance, Ending at Sep. 30, 2021 | $ 615 | $ 0 | 41,256,323 | (9,905,625) | 31,351,313 |
Balance, Ending (in shares) at Sep. 30, 2021 | 6,136,967 | 0 | |||
Balance, Beginning at Jun. 30, 2021 | $ 604 | $ 0 | 39,168,084 | (6,978,692) | 32,189,996 |
Balance, Beginning (in shares) at Jun. 30, 2021 | 6,038,798 | 0 | |||
Stock based compensation | 1,198,860 | 1,198,860 | |||
Issuance of warrants for consulting fees | 84,648 | 84,648 | |||
Issuance of common stock for consulting fees | $ 1 | 4,501 | 4,502 | ||
Issuance of common stock for consulting fees (in shares) | 665 | ||||
Exercise of common stock warrants | $ 10 | 800,230 | 800,240 | ||
Exercise of common stock warrants (in shares) | 97,504 | ||||
Net loss | (2,926,933) | (2,926,933) | |||
Balance, Ending at Sep. 30, 2021 | $ 615 | $ 0 | 41,256,323 | (9,905,625) | 31,351,313 |
Balance, Ending (in shares) at Sep. 30, 2021 | 6,136,967 | 0 | |||
Balance, Beginning at Dec. 31, 2021 | $ 674 | $ 0 | 47,670,744 | (14,141,670) | 33,529,748 |
Balance, Beginning (in shares) at Dec. 31, 2021 | 6,730,180 | 0 | |||
Stock based compensation | 2,238,995 | 2,238,995 | |||
Issuance of warrants for consulting fees | 146,603 | 146,603 | |||
Issuance of common stock for consulting fees | $ 4 | 254,849 | 254,853 | ||
Issuance of common stock for consulting fees (in shares) | 45,989 | ||||
Exercise of common stock warrants | $ 7 | 553,143 | 553,150 | ||
Exercise of common stock warrants (in shares) | 65,000 | ||||
Net loss | (10,056,302) | (10,056,302) | |||
Balance, Ending at Sep. 30, 2022 | $ 685 | $ 0 | 50,864,334 | (24,197,972) | 26,667,047 |
Balance, Ending (in shares) at Sep. 30, 2022 | 6,841,169 | 0 | |||
Balance, Beginning at Jun. 30, 2022 | $ 682 | $ 0 | 50,124,087 | (21,171,496) | 28,953,273 |
Balance, Beginning (in shares) at Jun. 30, 2022 | 6,810,326 | 0 | |||
Stock based compensation | 510,747 | 510,747 | |||
Issuance of warrants for consulting fees | 75,000 | 75,000 | |||
Issuance of common stock for consulting fees | $ 3 | 154,500 | 154,503 | ||
Issuance of common stock for consulting fees (in shares) | 30,843 | ||||
Net loss | (3,026,476) | (3,026,476) | |||
Balance, Ending at Sep. 30, 2022 | $ 685 | $ 0 | $ 50,864,334 | $ (24,197,972) | $ 26,667,047 |
Balance, Ending (in shares) at Sep. 30, 2022 | 6,841,169 | 0 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
CASH FLOW USED IN OPERATING ACTIVITIES | ||
Net loss | $ (10,056,302) | $ (8,375,152) |
Adjustments to reconcile net loss to net cash used by operating activities | ||
Stock based compensation | 2,238,995 | 1,918,651 |
Consulting services paid by issuance of common stock | 254,853 | 22,657 |
Consulting services paid by issuance of common stock warrants | 146,603 | 481,496 |
Depreciation expense | 4,188 | 3,727 |
Change in assets and liabilities | ||
Decrease (Increase) in prepaid expenses | 295,253 | (111,778) |
(Decrease) in accounts payable | (813,116) | (324,959) |
(Decrease) in accrued expenses | (498,201) | (280,200) |
Total adjustments | 1,628,575 | 1,709,594 |
Net Cash Used in Operating Activities | (8,427,727) | (6,665,558) |
CASH FLOWS USED IN INVESTING ACTIVITIES | ||
Purchase of fixed assets | (5,275) | |
Net Cash Used in Investing Activities | (5,275) | |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Private placements of common stock and warrants | 23,784,161 | |
Proceeds from exercise of investor warrants | 553,150 | 8,382,516 |
Cash in lieu of shares for reverse stock split | (1,529) | |
Net Cash Provided by Financing Activities | 553,150 | 32,165,148 |
NET (DECREASE) INCREASE IN CASH AND EQUIVALENTS | (7,879,852) | 25,499,590 |
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD | 34,213,989 | 5,795,055 |
CASH AND EQUIVALENTS AT END OF PERIOD | $ 26,334,137 | $ 31,294,645 |
Organization, Business, Risks a
Organization, Business, Risks and Uncertainties | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Business, Risks and Uncertainties | |
Organization, Business, Risks and Uncertainties | Note 1 – Organization, Business, Risks and Uncertainties: Organization and Business On May 17, 2020, Neurotrope, Inc. (“Neurotrope” or “the Parent”) announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc., from Neurotrope (the “Spin-Off”). Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in this wholly owned subsidiary to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope does not own any equity interest in the Company, and the Company operates independently from Neurotrope. On December 7, 2020, the Company became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) when the Company filed an amended and restated certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. The Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), are listed on The Nasdaq Capital Market under the symbol “SNPX.” Neurotrope Bioscience, Inc. was incorporated in Delaware on October 31, 2012 to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). The Company 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). In connection with the separation from Neurotrope, we entered into a Separation and Distribution Agreement and several other ancillary agreements. These agreements govern the relationship between the parties after the separation and allocate between the parties’ various assets, liabilities, rights and obligations following the separation, including employee benefits, intellectual property, information technology, insurance and tax-related liabilities. Liquidity Uncertainties As of September 30, 2022, the Company had approximately $26.3 million in cash and cash equivalents as compared to $34.2 million at December 31, 2021. The Company expects that its current cash and cash equivalents, approximately $25.6 million as of the date of this quarterly report, will be sufficient to support its projected operating requirements for at least the next 12 months from this date. The operating requirements include the current development plans for Bryostatin-1, our novel drug candidate targeting the activation of Protein Kinase C Epsilon and other development projects. The Company expects to need additional capital in order to initiate and pursue potential additional development projects, including the continuing development beyond the ongoing Phase 2 trial of Bryostatin-1. 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 likely have a materially adverse effect on our business, financial condition and results of operations. Other 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 and regulatory. 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, and the ability to raise capital to achieve strategic objectives. CRE has entered into a material transfer agreement with the National Cancer Institute of the National Institutes of Health (“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. Therefore, CRE or the Company would 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 were unable to secure such additional agreements, or if the NCI otherwise discontinues the supply, the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize Bryostatin-1 for the treatment of AD. In June 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to be the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company received its initial order of one gram synthetic bryostatin. See Note 3. The Company also faces the ongoing risk that the coronavirus pandemic may slow, for an unforeseeable period, the conduct of the Company’s 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 current Phase 2 clinical trial. 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 a pandemic resurgence 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 suppliers. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies: Basis of Presentation: The accompanying unaudited condensed 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 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 nine months ended September 30, 2022 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022. Use of Estimates: The preparation of financial statements in conformity with GAAP 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 expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results. Comprehensive Income (Loss) The Company follows FASB ASC 220 in reporting comprehensive income (loss). Comprehensive income (loss) is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income (loss). Since the Company has no items of other comprehensive income (loss), comprehensive loss is equal to net loss for all periods presented. Net Earnings or Loss per Share: Net earnings or loss per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding during the period, excluding shares subject to redemption or forfeiture. The Company presents basic and diluted net earnings or loss per share. Diluted net earnings or loss per share reflect the actual weighted average of common shares issued and outstanding during the period, adjusted for potentially dilutive securities outstanding. Potentially dilutive securities are excluded from the computation of the diluted net earnings or loss per share if their inclusion would be anti-dilutive. As all potentially dilutive securities are anti-dilutive as of September 30, 2022 and 2021, diluted net loss per share is the same as basic net loss per share for the three and nine months ended September 30, 2022 and 2021. The dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2022 and 2021 respectively, because to do so would be anti-dilutive (in common equivalent shares), are as follows: September 30, 2022 September 30, 2021 Common stock warrants 5,176,916 6,847,930 Common stock options 130,000 123,850 Unvested restricted stock units 495,000 495,000 Total 5,801,916 7,466,780 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 September 30, 2022, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $0.7 million. In addition, approximately $25.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. 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 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. Non-refundable advance payments for research and development are capitalized 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, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, at September 30, 2022 and December 31, 2021. 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 under the “Separate return method.” 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 applies the provisions for 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 Company has determined 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. The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $86.9 million for the period from October 31, 2012 (inception) through September 30, 2022. The net operating loss carryforwards resulted in a deferred tax asset of approximately $18.2 million at September 30, 2022. 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 may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At September 30, 2022 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities. Under Section 382 of the Code, 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. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations. Expense Reimbursement for Grant Award: The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the three and nine months ended September 30, 2022 of approximately $0 and $100,000, respectively, and $0 for the three and nine months ended September 30, 2021. See Note 5, “ Clinical Trial Services Agreements Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of September 30, 2022. Recent Accounting Pronouncements: In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 is effective for interim and annual periods beginning after December 15, 2021. The Company has evaluated the adoption of ASU 2020-06 and has concluded that it does not apply at this time. |
Collaborative Agreements and Co
Collaborative Agreements and Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Collaborative Agreements and Commitments | |
Collaborative Agreements and Commitments | Note 3– Collaborative Agreements and Commitments: 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 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 product development 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 the end of the period covered by this quarterly report, no royalties nor milestone payments have been required. On January 19, 2017, the Company entered into a 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 that 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. On November 9, 2021, the Company revised the existing licensing agreement with Stanford. The revisions extended all the required future product development and commercialization milestones. The Company is currently in full compliance with the revised agreement and is moving forward on its commitments. As of the end of the period covered by this quarterly report, no royalties nor milestone payments have been earned or made. Mt. Sinai License Agreement On July 14, 2014, the Company 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 the Company (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 (“PKC ε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows the Company 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 is required to pay Mt. Sinai milestone payments of $2.0 million upon approval of a new drug applications (“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 is required 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 $180,000 consisting of licensing fees of $105,000 plus development costs and patent fees of approximately $75,000. As of September 30, 2022, no royalties nor milestone payments have been required. 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. Pursuant to the terms of the Supply Agreement, the Company placed an initial order and subsequently received one gram of current good manufacturing practice (“cGMP”) synthetic bryostatin as an active pharmaceutical ingredient to be used in a drug product (“API”). 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. The Company is not currently using synthetic bryostatin for its current Phase 2 clinical trial and will determine when to incorporate the synthetic into the clinical trial process. 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 NCI, under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. Pursuant to guidance provided by NCI, the Company CRADA has been cancelled and BryoLogyx has initiated a request for a new CRADA in its name. BryoLogyx will be filing its own investigational new drug application (“IND”) for CD22 with the FDA. As consideration for the transfer of rights to the CRADA, 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. No such revenues have been earned as of September 30, 2022. Nemours Agreement On September 5, 2018, we announced a collaboration with Nemours A.I. DuPont Hospital (“Nemours”), a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome, a genetic disorder. 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. On August 5, 2021, the Company announced its memorandum of understanding with Nemours to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the Bryostatin-1 and obtain the IND and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $700,000. As of the end of the period covered by this quarterly report, the Company has not incurred any expenses associated with this agreement. Cleveland Clinic On February 23, 2022, the Company announced its collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis. The collaboration entails filing an IND and conducting initial clinical trials using Bryostatin-1. Future development work will be conducted pursuant to statements of work to be determined. Cognitive Research Enterprises, Inc. (“CRE”) Effective October 31, 2012, the Company 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 amended and restated on February 4, 2015 (the “CRE License Agreement”). The CRE License Agreement provides research services and has granted the Company 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 CRE License Agreement 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 Neurotrope’s initial Series A Stock financing, the CRE License Agreement required the Company 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 during the years ended December 31, 2021 and 2020, respectively, or during the three and nine months ended September 30, 2022. In addition, on November 10, 2018, the Company and CRE entered into a second amendment (the “Second Amendment”) to the TLSA pursuant to which CRE granted certain patent prosecution and maintenance rights to the Company. Under the Second Amendment, the Company 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 the Company, and pay all fees, costs and expenses related to the licensed intellectual property. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | Note 4- Related Party Transactions: Related Party Agreements On August 4, 2016, Neurotrope, Inc. 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”). 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. This contract was assigned to Synaptogenix, Inc. as of December 1, 2020. For the three and nine months ended September 30, 2022 and 2021, $30,000 and $90,000 is reflected in the Company’s statements of operations, respectively. |
Other Commitments
Other Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Other Commitments | |
Other Commitments | Note 5 – Other Commitments: Clinical Trial Services Agreements On July 23, 2020, the Company entered into the 2020 Services Agreement with Worldwide Clinical Trials, Inc. (“WCT”). The 2020 Services Agreement relates to services for the current Phase 2 clinical trial assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment (the “2020 Study”). Pursuant to the terms of the 2020 Services Agreement, WCT is providing services to enroll approximately one hundred (100) 2020 Study subjects, which enrollment is currently completed. The first 2020 Study site was initiated during the third quarter of 2020. On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. In addition, on February 10, 2022, the Company signed an additional agreement with a third-party vendor to assist with the increased trial recruitment retention totaling approximately $1.0 million. The updated total estimated budget for the services, including pass-through costs, is currently approximately $12.0 million. The Company may terminate the 2020 Services Agreement without cause upon sixty (60) days prior written notice. The Company was awarded a $2.7 million grant from the NIH, which will be used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to the Company of $9.3 million. The NIH grant provides for funds in the first year, which began in April 2020, of approximately $1.0 million and funding in year two, which began April 2021, of approximately $1.7 million. As of February 22, 2022, virtually all of the NIH grant has been received and offset against the clinical trial costs. The Company incurred approximately $10.3 million of cumulative expenses associated with the current Phase 2 clinical trial as of September 30, 2022. Of the total $10.3 million incurred for the trial to date, approximately $0.9 million and $3.4 million is reflected in the statement of operations for the three and nine months ended September 30, 2022, respectively, and $1.6 million and $3.2 million is reflected in the statement of operations for the three and nine months ended September 30, 2021, respectively. As of September 30, 2022 included in the Company’s balance sheet, approximately $235,000 of WCT prepayments is included as a prepaid expense and other current assets. In addition, approximately $268,000 is included in accounts payable and accrued expenses. On May 12, 2022, the Company entered into a services agreement with WCT (the “2022 Services Agreement”). The 2022 Services Agreement relates to services for a Phase 2 “open label,” dose ranging study, clinical trial assessing the safety, tolerability and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the “2022 Study”). Pursuant to the terms of the 2022 Services Agreement, WCT is providing services to enroll approximately 12 2022 Study subjects, which enrollment is currently underway. The first 2022 Study site was initiated during the third quarter of 2022. The total estimated budget for the services, including pass-through costs, is currently approximately $2.0 million. Either party may terminate the 2022 Services Agreement without cause upon ninety The Company incurred approximately $865,000 of cumulative expenses associated with the current 2022 Study as of September 30, 2022. Of the total $865,000 incurred for the trial to date, approximately $442,000 and $865,000 is reflected in the statement of operations for the three and nine months ended September 30, 2022. As of September 30, 2022, approximately $365,000 of WCT 2022 Study prepayments is included as a prepaid expense and other current assets in the Company’s balance sheet. In addition, approximately $311,000 is included in accounts payable and accrued expenses. On January 19, 2022, the Company issued a work order (the “Work Order”) to Cyprotex US, LLC (“Cyprotex”), pursuant to which Cyprotex will perform certain drug interaction services for the Company for an aggregate fee of $165,455. The Work Order is governed by the Cyprotex’s Standard Terms and Conditions for Discovery Services dated August 2, 2021. The Company incurred approximately $0 and $177,000 for this Work Order for the three and nine months ended September 30, 2022, respectively. On January 31, 2022, the Company entered into a Statement of Work (the “SOW”) with Charles River Laboratories, Inc. (“Charles River”). The Statement of Work is subject to the General Terms and Conditions of Charles River. Pursuant to the SOW, Charles River will conduct a certain pre-clinical animal study (the “Study”) relating to Bryostatin-1 pharmacodynamics and drug distribution, for an initial aggregate fee of $197,600. Either party may terminate the 2022 Services Agreement without cause upon ninety Other Consulting Agreements Effective as of June 1, 2019, the Company entered into a consulting agreement with Katalyst Securities LLC (“Katalyst”), pursuant to which Katalyst provided investment banking consulting services to the Company and Neurotrope (the “Katalyst Agreement”). The term of the Katalyst Agreement continued until it was canceled. As consideration for its services under the Katalyst Agreement, the Company paid Katalyst $25,000 per month through December 1, 2020, plus five-year warrants to purchase 4,500 shares of Neurotrope’s common stock on the effective date of the Katalyst Agreement and on each of the three-month anniversaries following the effective date with the last issuance on December 1, 2020. Effective as of January 1, 2021, the Company entered into an amended consulting agreement with Katalyst reducing the cash payment to $20,000 per month. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with Katalyst reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, Katalyst was granted warrants to purchase 25,000 shares of Common Stock at $11.46 per share, on April 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.80 per share, on July 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.76 per share, on October 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.30 per share, and, on January 3, 2022, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.69 per share. For the three months ended September 30, 2022 and 2021, $30,000 and $96,982 is reflected in the Company’s statements of operations, respectively, and $141,283 and $530,994 is reflected in the Company’s statements of operations for the nine months ended September 30, 2022 and 2021, respectively. The Company uses the Black Scholes method to value its warrant issuances to Katalyst as detailed below. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. Implied Risk Free Interest Fair Value of Issuance Date Volatility Rate Issuance Feb. 16, 2021 130.69 % 0.57 % $ 245,833 April 1, 2021 129.36 % 0.90 % $ 33,867 July 1, 2021 125.22 % 0.89 % $ 36,982 October 1, 2021 118.73 % 0.93 % $ 34,312 Jan. 2, 2022 112.86 % 1.37 % $ 31,283 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 and Neurotrope. The term of the agreement continued until December 1, 2020. On February 1, 2020, the Company amended the GPN Agreement, increasing the cash compensation to $17,500 per month through November 30, 2020 and increasing the number of warrants issued each three-month period to 2,500, with the last issuance on December 1, 2020. Effective as of January 1, 2021, the Company entered into an amended consulting agreement with GPN reducing the cash payment to $12,000 per month. Effective as of July 1, 2021, the Company entered into a second amended consulting agreement with GPN increasing the cash payment to $20,000 per month and increasing warrant issued for each three-month period beginning July 1, 2021 to 5,800, with the last issuance on October 1, 2021. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with GPN reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, GPN was granted warrants to purchase 10,000 shares of Common Stock at $11.46 per share, on April 1, 2021, was granted warrants to purchase an additional 2,500 shares of Common Stock at $8.80 per share, on July 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.76 per share, on October 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.30 per share, and, on January 3, 2022, was granted warrants to purchase an additional 5,800 shares of Common Stock at $8.69 per share. For the three months ended September 30, 2022 and 2021, $30,000 and $107,666 is reflected in the Company’s statements of operations, respectively, and $150,320 and $341,039 is reflected in the Company’s statements of operations for the nine months ended September 30, 2022 and 2021, respectively. The Company uses the Black Scholes method to value its warrant issuances to GPN as detailed below. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. Implied Risk Free Interest Fair Value of Issuance Date Volatility Rate Issuance Feb. 16, 2021 130.69 % 0.57 % $ 98,333 April 1, 2021 129.36 % 0.90 % $ 18,815 July 1, 2021 125.22 % 0.89 % $ 47,666 October 1, 2021 118.73 % 0.93 % $ 44,225 Jan. 2, 2022 112.86 % 1.37 % $ 40,320 Effective as of July 7, 2022, the Company entered into a three month agreement (the “Initial Term”) with Sherwood Ventures LLC (“Sherwood”) pursuant to which Sherwood agreed to provide investor relations consulting services to the Company. Under the terms of the agreement with Sherwood, the Company pays $30,000 per month, with an aggregate of $90,000 for the first three months paid on July 7, 2022. Additionally, the Company issued 30,303 shares of restricted Common Stock valued at $150,000 and warrants to purchase 15,459 shares of Common Stock with an exercise price of $13.26 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free rate of 3.05% and have a fair value of $75,000. The warrants are exercisable for a period of five years from the date of issuance and are expensed when issued. This agreement automatically renews for successive one-month periods (the “Renewal Term”) immediately following the Initial Term until written notice of termination is provided by either party at least five business days prior to the end of the Initial Term or Renewal Term. The Company has entered in the first Renewal Term as of October 7, 2022. As compensation for each Renewal Term, the Company will pay Sherwood $30,000 per month, $50,000 of restricted common stock valued as of the Renewal Term date, and warrants to purchase shares of common stock valued, using the Black Scholes valuation model, at $25,000, with an exercise price equal to 100% of the closing price of the Common Stock on the date of the Renewal Term. As of September 30, 2022, the Company reflected a total of approximately $281,000 as compensation to Sherwood. During October 2022, the Company paid Sherwood $30,000 and issued to Sherwood 6,878 shares of restricted Common Stock valued at $50,000 and were expensed when issued, and warrants to purchase 4,659 shares of Common Stock, with an exercise price of $14.54 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.14% and have a fair value of $25,000. During November 2022, the Company paid Sherwood $30,000 and issued to Sherwood 7,092 shares of restricted Common Stock valued at $50,000 and were expensed when issued, and warrants to purchase 4,795 shares of Common Stock, with an exercise price of $14.10 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.39% and have a fair value of $25,000. The warrants are exercisable for a period of five years from the date of issuance and are expensed when issued. Employment Agreements On December 7, 2020, the Company entered into an offer letter (the “Offer Letter”) with Alan J. Tuchman, M.D., pursuant to which Dr. Tuchman agreed to serve as the Company’s Chief Executive Officer, commencing on December 7, 2020. In addition, in connection with his appointment as the Company’s Chief Executive Officer, Dr. Tuchman was appointed to the board of directors of the Company. Dr. Tuchman will receive an initial annual base salary of $222,000, with an annual discretionary bonus of up to 50% of his base salary then in effect. Dr. Tuchman also received an initial equity grant (subject to Board approval which was received in January 2021) of 12,575 options to purchase a number of shares of Common Stock equal to at least 1% of the Company’s outstanding shares of Common Stock immediately following the Spin-Off. As of December 7, 2021, such options are fully vested. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 129.94%, a risk free interest rate of 0.48% and have a fair value of $106,759. The options are exercisable for a period of ten years from the date of issuance and were expensed over the one-year vesting period from the date of issuance. The term of Dr. Tuchman’s employment pursuant to the Offer Letter is one year, which shall be extended automatically for six-month periods unless either party gives timely written notice. Dr. Tuchman’s agreement was previously extended until December 7, 2022. On August 4, 2022, the Company entered into an amendment to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2023, and such term shall be extended for an additional six months upon Dr. Tuchman’s written notice to the Company at least 30 days prior to June 7, 2023. Pursuant to the Amendment, if Dr. Tuchman is terminated without Cause, Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary. Other Commitments and Agreements See Notes 3 and 4 for Collaboration and License Agreement related commitments. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | Note 6 – Stockholders’ Equity: The Company’s certificate of incorporation authorizes it to issue 150,000,000 shares of Common Stock and 1,000,000 shares of preferred stock, par value $0.0001 per share. The holders of Common Stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as the Board from time to time may determine. To date, the Company has not paid dividends on its Common Stock. Holders of Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders. There is no cumulative voting of the election of directors then standing for election. The Common Stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of the Company, the assets legally available for distribution to stockholders are distributable ratably among the holders of Common Stock after payment of liabilities, accrued dividends and liquidation preferences, if any. Each outstanding share of Common Stock is duly and validly issued, fully paid and non-assessable. January 2021 Private Placement On January 21, 2021, the Company entered into Securities Purchase Agreements (the “Purchase Agreement”) with certain accredited investors (the “Purchasers”) to issue (a) an aggregate of 2,333,884 shares of Common Stock and/or prefunded warrants to purchase shares of Common Stock at an exercise price of $0.04 per share (the “Pre-Funded Warrants”), (b) Series E warrants to purchase 2,333,908 shares of Common Stock, with an exercise price of $8.51 per share (subject to adjustment), for a period of twelve months from the date of an effective registration statement (the “Series E Warrants”) and (c) Series F warrants to purchase up to an aggregate of 2,333,908 shares of Common stock, with an exercise price of $6.90 per share (subject to adjustment), for a period of five years from the date of issuance (the “Series F Warrants” and together with the Series E Warrants, the “Warrants”) at a combined purchase price of $6.00 per share of Common Stock and Warrants (the “Offering”). The Company received total gross proceeds of approximately $14,000,000 and net proceeds of approximately $12.5 million. In connection with the Offering, we paid our placement agents Katalyst and GPN (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) 233,391 warrants to purchase 233,391 shares of Common Stock (equal to ten percent (10%) of the number of shares of Common Stock sold to Purchasers introduced by the placement agents), with an exercise price of $6.90 per share and a five-year term. June 2021 Private Placement On June 14, 2021, the Company entered into Securities Purchase Agreements (the “June Purchase Agreement”) with certain accredited investors (the “June Purchasers”) to issue (a) an aggregate of 1,653,281 shares of the Company’s Common Stock and/or prefunded warrants to purchase shares of Common Stock at an exercise price of $0.01 per share (the “June Pre-Funded Warrants”) and (b) Series G warrants to purchase up to an aggregate of 1,653,281 shares of Common stock, with an exercise price of $8.51 per share (subject to adjustment), for a period of five years from the date of issuance (the “June Warrants”) at a combined purchase price of $7.547 per share of Common Stock and June Warrant (the “June Offering”). The Company received total gross proceeds of approximately $12.5 million and net proceeds of approximately $11.2 million. In connection with the June Offering, pursuant to an Engagement Agreement, dated June 14, 2021 (the “June Engagement Agreement”), between the Company and Katalyst Securities LLC (the “June Placement Agent”), the Company paid the June Placement Agent (i) a cash fee equal to ten percent (10%) of the gross proceeds from the sale of securities in the June Offering sold to June Purchasers introduced by the June Placement Agent and (ii) 152,378 warrants to purchase 152,378 shares of Common Stock (equal to ten percent (10%) of the number of shares of Common Stock sold to June Purchasers introduced by the June Placement Agent), with an exercise price of $7.547 per share and a five-year term (the “June Broker Warrants”). Furthermore, the Company agreed to pay the June Placement Agent a warrant exercise fee equal to ten percent (10%) of the aggregate exercise price that is paid in connection with each exercise, if any, of the June Warrants initially held by June Purchasers introduced by the June Placement Agent. The total potential fee payable to the June Placement Agent if all Series G warrants are exercised is approximately $1.4 million. The June Placement Agent is also entitled to the foregoing fees with respect to any future financing or capital-raising transaction by the Company (a “Subsequent Financing”), to the extent such financing or capital is provided to the Company by investors whom the Placement Agent had introduced to the Company, in the event such Subsequent Financing is consummated within eighteen (18) months following the closing of the June Offering. Adoption of a Stockholder Rights Plan On January 13, 2021, the Company adopted a stockholder rights plan (the “Rights Plan”). The Rights Plan is intended to protect the interests of the Company’s stockholders and enable them to 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 will issue, by means of a dividend, one preferred share purchase right for each outstanding share of our Common Stock to stockholders of record on the close of business on January 25, 2021. Initially, these Rights will trade with, and be represented by, the shares of our Common Stock. The Rights will generally become exercisable only if any person (or any persons acting as a group) acquires 15% or more of our 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 Common Stock at a 50% discount or the Company may exchange each Right held by such holders for one share of 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 owns 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 Common Stock. On January 13, 2021, the board of directors of the Company (the “Board”) declared a dividend of one preferred share purchase right (a “Right”), payable on January 25, 2021, for each share of Common Stock outstanding on January 25, 2021 (the “Record Date”) 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 January 19, 2021, 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 A Preferred Stock, par value $0.001 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 (the “Purchase Price”), subject to adjustment. Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the Rights will expire at the close of business on January 13, 2023. The Board may terminate the Rights Plan before that date if the Board determines that there is no longer a threat to stockholder value. Reverse Stock Split At the Special Meeting (as defined below), the stockholders approved our proposal to effect one reverse stock split of the Company’s outstanding shares of Common Stock, at any ratio between 1-for-1.5 and 1-for-20, at such time as the Company’s Board of Directors shall determine, in its sole discretion, before December 31, 2022. On May 19, 2021, the Company effected a 1-for-4 |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock Based Compensation | |
Stock Based Compensation | Note 7 – Stock Based Compensation: 2020 Equity Incentive Plan Upon completion of the Spin-Off, the Company’s 2020 Equity Incentive Plan (the “2020 Plan”) became effective on December 7, 2020. The total number of securities available for grant under the 2020 Plan was 250,000 shares of Common Stock, subject to adjustment. On April 7, 2021, the Company held a special meeting of stockholders (the “Special Meeting”) in which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock from 250,000 to an aggregate of 625,000 shares of Common Stock. On October 11, 2022, the Company held its annual meeting of stockholders (the “Annual Meeting”) in which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock authorized for issuance from 625,000 to an aggregate of 1,375,000 shares. Stock and Option Grants The following is a summary of stock option activity under the stock option plans for the nine months ended September 30, 2022: Weighted- Average Aggregate Weighted- Remaining Intrinsic Number Average Contractual Value of Exercise Term (in Shares Price (Years) millions) Options outstanding at January 1, 2022 123,850 $ 9.84 8.30 $ — Options granted 6,150 $ 7.29 9.38 — Less options forfeited — $ — — — Less options expired/cancelled — $ — — — Less options exercised — $ — — — Options outstanding at September 30, 2022 130,000 $ 9.72 8.35 $ — Options exercisable at September 30, 2022 126,925 $ 9.78 8.33 $ — As of September 30, 2022, the Company had unrecognized stock option expense of approximately $16,000 and a remaining weighted average period for recognition of 0.38 years. On February 16, 2022, pursuant to its 2020 Plan, the Company granted stock options to purchase an aggregate of 6,150 shares of Common Stock to its Chief Executive Officer. The stock options have an exercise price of $7.29 per share and an expiration date that is ten years from the date of issuance. 25% of the options vest each quarter over one year, with the initial 25% vesting on May 16, 2022. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 112.75%, a risk free interest rate of 2.05% and have a fair value of $42,108. The options are being expensed over the one-year vesting period from date of issuance. On March 12, 2021, Synaptogenix adopted a new non-employee director compensation policy (the “Director Compensation Policy”). The Director Compensation Policy provides for the annual automatic grant of nonqualified stock options to purchase up to 1,500 shares of Synaptogenix’s Common Stock to each of Synaptogenix’s nonemployee directors. Such grants shall occur annually on the fifth business day after the filing of Synaptogenix’s Annual Report on Form 10-K, if available under the Plan, and shall vest on the one-year anniversary from the date of grant subject to the director’s continued service on the Board of Directors on the vesting date. The Director Compensation Policy also provides for the automatic grant of nonqualified stock options to purchase up to 1,200 shares of Synaptogenix’s Common Stock, plus options to purchase an additional 300 shares of Common Stock for service on a committee of the Board of Directors, to each newly appointed director following the date of his or her appointment. Such options shall vest as follows: fifty percent (50%) on the date of the grant, twenty-five percent (25%) on the one year anniversary from the date of the grant, and twenty-five percent (25%) on the second year anniversary from the date of the grant, subject to the director’s continued service on the Board of Directors on the applicable vesting dates. The Company recorded total expense relating to the outstanding stock options of $10,612 and $154,274 for the three months ended September 30, 2022 and 2021, respectively, and $58,530 and $874,065 for the nine months ended September 30, 2022 and 2021, respectively. Restricted Stock Unit Grants On July 13, 2021, the Company granted a total of 495,000 restricted stock units (RSUs), of which 425,000 were granted to seven Board members (including two executives), 60,000 to the Company’s CFO and 10,000 to two employees. The RSUs were amended on January 12, 2022 to vest 100% on September 15, 2022 and then further amended on June 20, 2022 to vest 100% on the earlier of release of Phase 2 clinical trial top line data or December 31, 2022. Top line data is expected to be announced during the fourth quarter of 2022. As of September 30, 2022, the Company had unrecognized RSUs expense of approximately $385,000 and a remaining weighted average period for recognition of 0.19 years. The fair value of the RSUs issued was based upon the closing trading price of the Common Stock on the grant date of $9.75 per share. The grant date fair value of the RSUs granted was approximately $4.8 million. The Company recorded total expense of $500,135 and $1,044,586 for the three months ended September 30, 2022 and 2021, respectively, and $1,505,281 and $2,180,466 relating to the outstanding RSUs for the nine months ended September 30, 2022 and 2021, respectively. Restricted Stock Issuances On February 15, 2022, the Company granted 13,775 shares of restricted stock to two consultants that were engaged to provide investor relations services with a total fair market value on date of issuance of $98,078. On March 14, 2022, the Company granted 692 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On June 7, 2022, the Company granted 679 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On July 8, 2022, the Company granted 30,303 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $150,000 and warrants to purchase 15,459 shares of Common Stock with an exercise price of $13.26 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 3.05% and have a fair value of $75,000. The warrants are expensed over the three-month term of the consulting agreement. On September 8, 2022, the Company issued 540 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On October 8, 2022, the Company issued 6,878 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $50,000 and warrants to purchase 4,659 shares of Common Stock with an exercise price of $14.54 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.14% and have a fair value of $25,000. During November 2022, the Company issued to Sherwood 7,092 shares of restricted Common Stock valued at $50,000 and were expensed when issued, and warrants to purchase 4,795 shares of Common Stock, with an exercise price of $14.10 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.39% and have a fair value of $25,000. The warrants are expensed when issued. Stock Compensation Expense Total stock-based compensation for the three and nine months ended September 30, 2022 was $510,747 and $2,238,995, respectively of which $85,882 and $379,533 was classified as research and development expense, respectively, and $424,993 and $1,859,462 was classified as general and administrative expense. Total stock-based compensation for the three and nine months ended September 30, 2021 was $1,198,860 and $1,918,651, respectively, of which $215,528 and $424,993 was classified as research and development expense, respectively, and $983,332 and $1,493,658 was classified as general and administrative expense, respectively. The Company estimates implied volatility factor for all options and warrants utilizing the weighted average volatility based upon a blend of the Parent Company’s and company historical volatility along with the volatility of selected comparable publicly traded companies. Since the Company lacks sufficient historical stock trading activity, it incorporates the historical volatility of the Parent company as the Parent company’s historical volatility provides a good estimation of the Company’s volatility since its operations were identical to the Company’s prior to the spin-out. |
Common Stock Warrants
Common Stock Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Common Stock Warrants | |
Common Stock Warrants | Note 8 – Common Stock Warrants: As of September 30, 2022, the Company had warrants outstanding consisting of the following: Number of shares Warrants outstanding January 1, 2022 6,265,525 Warrants issued 25,759 Warrants exercised (65,000) Warrants expired (1,049,368) Warrants outstanding and exercisable September 30, 2022 5,176,916 On January 3, 2022, pursuant to its advisory agreements, the Company issued warrants to purchase 10,300 shares of Common Stock, with an exercise price of $8.96 per share, for a period of five years from the issuance date. The Company used the Black-Scholes valuation model to calculate the value of these warrants issued to advisors during the nine months ended September 30, 2022. The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%; Expected term five years; weighted average implied volatility of 111.8%; and a weighted average Risk-free interest rate of 2.38%. The total expense recorded during the year period was approximately $147,000. As of September 30, 2022, the weighted average exercise price and the weighted average remaining life of the total warrants were $13.34 per warrant and 3.44 years, respectively. The intrinsic value of the warrants as of September 30, 2022 was approximately $1.0 million. During the nine months ended September 30, 2022, three affiliated warrant holders exercised 50,000 Series E Warrants to purchase 50,000 shares of Common Stock at $8.51 per share and one holder exercised 15,000 Series G Warrants to purchase 15,000 shares of Common Stock at $8.51 per share. Total cash proceeds from these warrant exercises was $553,150. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events | |
Subsequent Events | Note 9 – Subsequent Events See Note 4, Note 5 and Note 7 above. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation: The accompanying unaudited condensed 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 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 nine months ended September 30, 2022 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022. |
Use of Estimates | Use of Estimates: The preparation of financial statements in conformity with GAAP 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 expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) The Company follows FASB ASC 220 in reporting comprehensive income (loss). Comprehensive income (loss) is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income (loss). Since the Company has no items of other comprehensive income (loss), comprehensive loss is equal to net loss for all periods presented. |
Net Earnings or Loss per Share | Net Earnings or Loss per Share: Net earnings or loss per share is computed by dividing net income or loss by the weighted-average number of common shares outstanding during the period, excluding shares subject to redemption or forfeiture. The Company presents basic and diluted net earnings or loss per share. Diluted net earnings or loss per share reflect the actual weighted average of common shares issued and outstanding during the period, adjusted for potentially dilutive securities outstanding. Potentially dilutive securities are excluded from the computation of the diluted net earnings or loss per share if their inclusion would be anti-dilutive. As all potentially dilutive securities are anti-dilutive as of September 30, 2022 and 2021, diluted net loss per share is the same as basic net loss per share for the three and nine months ended September 30, 2022 and 2021. The dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2022 and 2021 respectively, because to do so would be anti-dilutive (in common equivalent shares), are as follows: September 30, 2022 September 30, 2021 Common stock warrants 5,176,916 6,847,930 Common stock options 130,000 123,850 Unvested restricted stock units 495,000 495,000 Total 5,801,916 7,466,780 |
Cash and Cash Equivalents and Concentration of Credit Risk | 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 September 30, 2022, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $0.7 million. In addition, approximately $25.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. |
Fixed Assets | 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 |
Research and Development Costs | 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. Non-refundable advance payments for research and development are capitalized 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, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, at September 30, 2022 and December 31, 2021. |
Income Taxes | 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 under the “Separate return method.” 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 applies the provisions for 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 Company has determined 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. The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $86.9 million for the period from October 31, 2012 (inception) through September 30, 2022. The net operating loss carryforwards resulted in a deferred tax asset of approximately $18.2 million at September 30, 2022. 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 may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At September 30, 2022 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities. Under Section 382 of the Code, 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. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations. |
Expense Reimbursement for Grant Award | Expense Reimbursement for Grant Award: The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the three and nine months ended September 30, 2022 of approximately $0 and $100,000, respectively, and $0 for the three and nine months ended September 30, 2021. See Note 5, “ Clinical Trial Services Agreements Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of September 30, 2022. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements: In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 is effective for interim and annual periods beginning after December 15, 2021. The Company has evaluated the adoption of ASU 2020-06 and has concluded that it does not apply at this time. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of anti-dilutive securities excluded from calculation | The dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2022 and 2021 respectively, because to do so would be anti-dilutive (in common equivalent shares), are as follows: September 30, 2022 September 30, 2021 Common stock warrants 5,176,916 6,847,930 Common stock options 130,000 123,850 Unvested restricted stock units 495,000 495,000 Total 5,801,916 7,466,780 |
Other Commitments (Tables)
Other Commitments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Consulting Agreement with Katalyst Securities LLC | |
Other Commitments [Line Items] | |
Schedule of fair value measurement inputs | Implied Risk Free Interest Fair Value of Issuance Date Volatility Rate Issuance Feb. 16, 2021 130.69 % 0.57 % $ 245,833 April 1, 2021 129.36 % 0.90 % $ 33,867 July 1, 2021 125.22 % 0.89 % $ 36,982 October 1, 2021 118.73 % 0.93 % $ 34,312 Jan. 2, 2022 112.86 % 1.37 % $ 31,283 |
Consulting Agreement with GP Nurmenkari, Inc | |
Other Commitments [Line Items] | |
Schedule of fair value measurement inputs | Implied Risk Free Interest Fair Value of Issuance Date Volatility Rate Issuance Feb. 16, 2021 130.69 % 0.57 % $ 98,333 April 1, 2021 129.36 % 0.90 % $ 18,815 July 1, 2021 125.22 % 0.89 % $ 47,666 October 1, 2021 118.73 % 0.93 % $ 44,225 Jan. 2, 2022 112.86 % 1.37 % $ 40,320 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock Based Compensation | |
Schedule of stock option activity under the stock option plans | Weighted- Average Aggregate Weighted- Remaining Intrinsic Number Average Contractual Value of Exercise Term (in Shares Price (Years) millions) Options outstanding at January 1, 2022 123,850 $ 9.84 8.30 $ — Options granted 6,150 $ 7.29 9.38 — Less options forfeited — $ — — — Less options expired/cancelled — $ — — — Less options exercised — $ — — — Options outstanding at September 30, 2022 130,000 $ 9.72 8.35 $ — Options exercisable at September 30, 2022 126,925 $ 9.78 8.33 $ — |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Common Stock Warrants | |
Schedule of warrants outstanding | Number of shares Warrants outstanding January 1, 2022 6,265,525 Warrants issued 25,759 Warrants exercised (65,000) Warrants expired (1,049,368) Warrants outstanding and exercisable September 30, 2022 5,176,916 |
Organization, Business, Risks_2
Organization, Business, Risks and Uncertainties - Liquidity Uncertainties (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Business, Risks and Uncertainties | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Cash and cash equivalents | $ 26,334,137 | $ 34,213,989 |
Cash and cash equivalents expected amount at financial reporting date | $ 25,600,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Jul. 23, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Cash balance of insured FDIC amount | $ 700,000 | $ 700,000 | ||||
Cash balance of uninsured amount | 25,600,000 | 25,600,000 | ||||
Capitalized research and development services | 0 | 0 | $ 0 | |||
Net operating loss carryforwards | 86,900,000 | 86,900,000 | ||||
Deferred tax assets of operating loss carryforwards | 18,200,000 | 18,200,000 | ||||
Expense related to grants recognized | $ 0 | $ 0 | $ 100,000 | $ 0 | ||
Maximum | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful life (years) | 10 years | |||||
Minimum | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful life (years) | 3 years | |||||
National Institutes of Health | 2020 Services Agreement | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Amount of award received | $ 2,700,000 | $ 2,700,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Anti-dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities | 5,801,916 | 7,466,780 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities | 5,176,916 | 6,847,930 |
Common stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities | 130,000 | 123,850 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities | 495,000 | 495,000 |
Collaborative Agreements and _2
Collaborative Agreements and Commitments (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Aug. 05, 2021 USD ($) | Jun. 09, 2020 USD ($) | Jan. 19, 2017 USD ($) | Jul. 14, 2014 USD ($) | May 12, 2014 USD ($) | Sep. 30, 2022 item | Sep. 30, 2022 USD ($) item | Dec. 31, 2021 item | Dec. 31, 2020 item | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Annual license maintenance fee | $ 10,000 | ||||||||
Commitment to pay additional fee | 2,100,000 | ||||||||
Number of statements of work agreements entered | item | 0 | 0 | 0 | 0 | |||||
Stanford License Agreements | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty payment percentage | 3% | ||||||||
Payments for royalties | $ 0 | ||||||||
Mt. Sinai License Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Milestone payments made | 0 | ||||||||
Payments for royalties | 0 | ||||||||
Payable of milestone payments | $ 2,000,000 | ||||||||
Additional milestone payments | 1,500,000 | ||||||||
Total amount paid | 180,000 | ||||||||
Licensing fees | 105,000 | ||||||||
Development costs and patent fees | $ 75,000 | ||||||||
Mt. Sinai License Agreement | Net sales up to $250 million | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty payment percentage | 2% | ||||||||
Threshold net sales | $ 250,000,000 | ||||||||
Mt. Sinai License Agreement | Net sales over $250 million | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty payment percentage | 3% | ||||||||
Threshold net sales | $ 250,000,000 | ||||||||
Agreements with BryoLogyx | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Percentage of gross revenue | 2% | ||||||||
Other income | $ 0 | ||||||||
Nemours Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Cost on Trail and investigation new drug documentation expenses | $ 700,000 | ||||||||
License [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Aggregate amount paid | $ 70,000 | ||||||||
Minimum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty payment percentage | 1.50% | ||||||||
Maximum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty payment percentage | 4.50% | ||||||||
Maximum | Stanford License Agreements | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Milestone payments made | $ 3,700,000 | ||||||||
Maximum | Agreements with BryoLogyx | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Payments for royalties | $ 1,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - Consulting Agreement with SM Capital Management, LLC - USD ($) | 3 Months Ended | 9 Months Ended | |||
Aug. 04, 2016 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related Party Transaction [Line Items] | |||||
Contract payments, term | 1 year | ||||
Annual consulting fee | $ 120,000 | ||||
Monthly installment of annual consulting fee | $ 10,000 | ||||
Consultancy fees | $ 30,000 | $ 90,000 | $ 30,000 | $ 90,000 |
Other Commitments (Details)
Other Commitments (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||||||||||||||||||||
Oct. 07, 2022 USD ($) | Aug. 04, 2022 | Jul. 07, 2022 USD ($) D shares | May 12, 2022 item | Jan. 31, 2022 USD ($) | Jan. 19, 2022 USD ($) | Jan. 01, 2022 USD ($) | Dec. 07, 2021 USD ($) | Jul. 01, 2021 USD ($) $ / shares shares | Jan. 01, 2021 USD ($) | Dec. 07, 2020 USD ($) shares | Dec. 01, 2020 shares | Nov. 30, 2020 shares | Jul. 23, 2020 USD ($) item | Feb. 01, 2020 USD ($) | Jun. 01, 2019 USD ($) | Nov. 30, 2022 USD ($) $ / shares shares | Oct. 31, 2022 USD ($) $ / shares shares | Apr. 30, 2020 USD ($) | Sep. 30, 2022 USD ($) Y item $ / shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Y item $ / shares shares | Sep. 30, 2021 USD ($) | Jul. 06, 2022 $ / shares | Feb. 10, 2022 USD ($) | Jan. 22, 2022 USD ($) | Jan. 03, 2022 $ / shares shares | Jan. 02, 2022 USD ($) | Oct. 01, 2021 USD ($) $ / shares shares | Apr. 30, 2021 USD ($) | Apr. 01, 2021 USD ($) $ / shares shares | Feb. 16, 2021 USD ($) $ / shares shares | Jan. 31, 2021 | |
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Clinical trial expenses | $ 1,484,694 | $ 836,716 | $ 4,911,869 | $ 2,974,776 | |||||||||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 13.34 | $ 13.34 | |||||||||||||||||||||||||||||||
Number of options granted | shares | 6,150 | ||||||||||||||||||||||||||||||||
Options exercisable period | 8 years 3 months 29 days | ||||||||||||||||||||||||||||||||
Volatility | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | item | 111.8 | 111.8 | |||||||||||||||||||||||||||||||
Risk-free interest rate | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | item | 0.0238 | 0.0238 | |||||||||||||||||||||||||||||||
Expected term | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Monthly installment of annual consulting fee | $ 10,000 | $ 20,000 | |||||||||||||||||||||||||||||||
Consultancy fees | $ 30,000 | 96,982 | $ 141,283 | 530,994 | |||||||||||||||||||||||||||||
Payments for consulting per month | $ 25,000 | ||||||||||||||||||||||||||||||||
Warrants term | 5 years | ||||||||||||||||||||||||||||||||
Warrants to purchase shares of common stock | shares | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 25,000 | |||||||||||||||||||||||||||
Warrants term following the effective date | 3 months | ||||||||||||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 9.76 | $ 8.69 | $ 9.30 | $ 8.80 | $ 11.46 | ||||||||||||||||||||||||||||
Fair value of issuance | $ 36,982 | $ 31,283 | $ 34,312 | $ 33,867 | $ 245,833 | ||||||||||||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | Volatility | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 125.22 | 112.86 | 118.73 | 129.36 | 130.69 | ||||||||||||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | Risk-free interest rate | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 0.89 | 1.37 | 0.93 | 0.90 | 0.57 | ||||||||||||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | Expected term | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Monthly installment of annual consulting fee | $ 10,000 | $ 20,000 | $ 12,000 | $ 17,500 | |||||||||||||||||||||||||||||
Consultancy fees | $ 30,000 | 107,666 | $ 150,320 | 341,039 | |||||||||||||||||||||||||||||
Warrants to purchase shares of common stock | shares | 5,800 | 2,500 | 5,800 | 5,800 | 2,500 | 10,000 | |||||||||||||||||||||||||||
Warrants term following the effective date | 3 months | 3 months | |||||||||||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 9.76 | $ 8.69 | $ 9.30 | $ 8.80 | $ 11.46 | ||||||||||||||||||||||||||||
Fair value of issuance | $ 47,666 | $ 40,320 | $ 44,225 | $ 18,815 | $ 98,333 | ||||||||||||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | Volatility | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 125.22 | 112.86 | 118.73 | 129.36 | 130.69 | ||||||||||||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | Risk-free interest rate | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 0.89 | 1.37 | 0.93 | 0.90 | 0.57 | ||||||||||||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | Expected term | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||||||||||||||
2020 Services Agreement | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Target enrollment of study subjects | item | 100 | ||||||||||||||||||||||||||||||||
Amount funded against the total trial cost | $ 1,000,000 | $ 1,400,000 | |||||||||||||||||||||||||||||||
Total estimated budget for the services | $ 12,000,000 | ||||||||||||||||||||||||||||||||
Threshold period of prior written notice to terminate agreement | 60 days | ||||||||||||||||||||||||||||||||
Clinical trial expenses | $ 900,000 | $ 1,600,000 | $ 3,400,000 | $ 3,200,000 | |||||||||||||||||||||||||||||
WCT prepayments included as a prepaid expense and other current assets | 235,000 | 235,000 | |||||||||||||||||||||||||||||||
WCT payments included in accounts payable | 268,000 | 268,000 | |||||||||||||||||||||||||||||||
2020 Services Agreement | National Institutes of Health | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Total estimated budget for the services | $ 9,300,000 | ||||||||||||||||||||||||||||||||
Amount of award received | $ 2,700,000 | 2,700,000 | |||||||||||||||||||||||||||||||
Funding received | $ 1,000,000 | ||||||||||||||||||||||||||||||||
Funding receivable in year two | $ 1,700,000 | ||||||||||||||||||||||||||||||||
Clinical trial expenses | 10,300,000 | ||||||||||||||||||||||||||||||||
2022 Services Agreement | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Target enrollment of study subjects | item | 12 | ||||||||||||||||||||||||||||||||
Total estimated budget for the services | 2,000,000 | 2,000,000 | |||||||||||||||||||||||||||||||
Threshold period of prior written notice to terminate agreement | 90 days | ||||||||||||||||||||||||||||||||
Threshold period to terminate agreement due to material breach | 30 days | ||||||||||||||||||||||||||||||||
Clinical trial expenses | 442,000 | 865,000 | |||||||||||||||||||||||||||||||
WCT prepayments included as a prepaid expense and other current assets | 365,000 | 365,000 | |||||||||||||||||||||||||||||||
WCT payments included in accounts payable | $ 311,000 | 311,000 | |||||||||||||||||||||||||||||||
2022 Services Agreement | National Institutes of Health | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Clinical trial expenses | 865,000 | ||||||||||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Monthly installment of annual consulting fee | $ 30,000 | $ 30,000 | |||||||||||||||||||||||||||||||
Consultancy fees | $ 281,000 | ||||||||||||||||||||||||||||||||
Payments for consulting per month | $ 90,000 | $ 30,000 | $ 30,000 | ||||||||||||||||||||||||||||||
Warrants term | 5 years | 5 years | 5 years | ||||||||||||||||||||||||||||||
Number of restricted shares issued | shares | 30,303 | 7,092 | 6,878 | ||||||||||||||||||||||||||||||
Amount of restricted shares issued | 50,000 | $ 150,000 | $ 50,000 | $ 50,000 | |||||||||||||||||||||||||||||
Warrants to purchase shares of common stock | shares | 15,459 | 4,795 | 4,659 | ||||||||||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 14.10 | $ 14.54 | $ 13.26 | ||||||||||||||||||||||||||||||
Consulting agreement term | 3 months | ||||||||||||||||||||||||||||||||
Agreement renewal term | 1 month | ||||||||||||||||||||||||||||||||
Agreement termination, number of business days | D | 5 | ||||||||||||||||||||||||||||||||
Fair value of issuance | $ 25,000 | $ 75,000 | $ 25,000 | $ 25,000 | $ 25,000 | ||||||||||||||||||||||||||||
Warrants exercise price (as a percentage) | 100% | ||||||||||||||||||||||||||||||||
Options exercisable period | 10 years | ||||||||||||||||||||||||||||||||
Vesting period | 1 year | ||||||||||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Volatility | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 112.75 | 112.75 | 112.75 | 112.75 | |||||||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Risk-free interest rate | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Warrants, measurement input | 3.05 | 4.39 | 4.14 | 4.14 | |||||||||||||||||||||||||||||
Employment agreement with Alan J. Tuchman, M.D | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Initial annual base salary | $ 222,000 | ||||||||||||||||||||||||||||||||
Annual discretionary bonus payable (as a percent) | 50% | ||||||||||||||||||||||||||||||||
Options granted to purchase shares of common stock as a percent of Company's outstanding shares of common stock immediately following the Spin-Off | 1% | ||||||||||||||||||||||||||||||||
Term of agreement | 1 year | ||||||||||||||||||||||||||||||||
Extension periods of agreement | 6 months | ||||||||||||||||||||||||||||||||
Additional extension period of agreement | 6 months | ||||||||||||||||||||||||||||||||
Number of options granted | shares | 12,575 | ||||||||||||||||||||||||||||||||
Volatility | 129.94% | ||||||||||||||||||||||||||||||||
Risk-free interest rate | 0.48% | ||||||||||||||||||||||||||||||||
Fair value of options | $ 106,759 | ||||||||||||||||||||||||||||||||
Work order to Cyprotex US, LLC | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Consultancy fees | $ 165,455 | $ 0 | $ 177,000 | ||||||||||||||||||||||||||||||
Statement Of Work With Charles River Laboratories, Inc | |||||||||||||||||||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||||||||||||||||||
Threshold period of prior written notice to terminate agreement | 90 days | ||||||||||||||||||||||||||||||||
Threshold period to terminate agreement due to material breach | 30 days | ||||||||||||||||||||||||||||||||
Consultancy fees | $ 197,600 | $ 50,100 | $ 50,100 |
Other Commitments - Warrants Me
Other Commitments - Warrants Measurement Input and Fair Value (Details) | Sep. 30, 2022 Y item | Jan. 02, 2022 USD ($) | Oct. 01, 2021 USD ($) | Jul. 01, 2021 USD ($) | Apr. 01, 2021 USD ($) | Feb. 16, 2021 USD ($) |
Dividend yield | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | item | 0 | |||||
Volatility | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | item | 111.8 | |||||
Risk-free interest rate | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | item | 0.0238 | |||||
Expected term | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | Y | 5 | |||||
Consulting Agreement with Katalyst Securities LLC | ||||||
Other Commitments [Line Items] | ||||||
Fair value of issuance | $ | $ 31,283 | $ 34,312 | $ 36,982 | $ 33,867 | $ 245,833 | |
Consulting Agreement with Katalyst Securities LLC | Dividend yield | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 0 | |||||
Consulting Agreement with Katalyst Securities LLC | Volatility | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 112.86 | 118.73 | 125.22 | 129.36 | 130.69 | |
Consulting Agreement with Katalyst Securities LLC | Risk-free interest rate | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 1.37 | 0.93 | 0.89 | 0.90 | 0.57 | |
Consulting Agreement with Katalyst Securities LLC | Expected term | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | Y | 5 | |||||
Consulting Agreement with GP Nurmenkari, Inc | ||||||
Other Commitments [Line Items] | ||||||
Fair value of issuance | $ | $ 40,320 | $ 44,225 | $ 47,666 | $ 18,815 | $ 98,333 | |
Consulting Agreement with GP Nurmenkari, Inc | Dividend yield | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 0 | |||||
Consulting Agreement with GP Nurmenkari, Inc | Volatility | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 112.86 | 118.73 | 125.22 | 129.36 | 130.69 | |
Consulting Agreement with GP Nurmenkari, Inc | Risk-free interest rate | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | 1.37 | 0.93 | 0.89 | 0.90 | 0.57 | |
Consulting Agreement with GP Nurmenkari, Inc | Expected term | ||||||
Other Commitments [Line Items] | ||||||
Warrants, measurement input | Y | 5 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 9 Months Ended | |
Sep. 30, 2022 Vote $ / shares shares | Dec. 31, 2021 $ / shares shares | |
Stockholders' Equity | ||
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Votes per share of common stock | Vote | 1 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 9 Months Ended | ||||||
Jun. 14, 2021 USD ($) $ / shares shares | May 19, 2021 | Jan. 21, 2021 USD ($) $ / shares shares | Jan. 19, 2021 $ / shares shares | Jan. 13, 2021 shares | Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 $ / shares | |
Class of Stock [Line Items] | |||||||
Warrants exercise price | $ / shares | $ 13.34 | ||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||
Reverse Stock Split, conversion ratio | 0.25 | ||||||
Minimum | |||||||
Class of Stock [Line Items] | |||||||
Reverse Stock Split, conversion ratio | 1.5 | ||||||
Maximum | |||||||
Class of Stock [Line Items] | |||||||
Reverse Stock Split, conversion ratio | 20 | ||||||
Placement Agents | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 152,378 | ||||||
Warrants exercise price | $ / shares | $ 7.547 | ||||||
Warrants exercise period | 5 years | ||||||
Percentage of offering fees in cash | 10% | ||||||
Number of shares issued upon exchange | shares | 152,378 | ||||||
Percentage of offering fees in warrants | 10% | ||||||
Percentage of offering fees on aggregate price of warrant exercise | 10% | ||||||
Period within which future financing should be consummated | 18 months | ||||||
Securities Purchase Agreements | |||||||
Class of Stock [Line Items] | |||||||
Warrants exercise period | 5 years | ||||||
Combined purchase price of common stock and warrants | $ / shares | $ 7.547 | $ 6 | |||||
Gross proceeds in offering | $ | $ 12,500,000 | $ 14,000,000 | |||||
Net proceeds in offering | $ | $ 11,200,000 | $ 12,500,000 | |||||
Securities Purchase Agreements | Placement Agents | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 233,391 | ||||||
Warrants exercise price | $ / shares | $ 6.90 | ||||||
Warrants exercise period | 5 years | ||||||
Percentage of offering fees in cash | 10% | ||||||
Number of shares issued upon exchange | shares | 233,391 | ||||||
Percentage of offering fees in warrants | 10% | ||||||
Shareholder Rights Plan | |||||||
Class of Stock [Line Items] | |||||||
Number of preferred share purchase right for each outstanding share of Common Stock by means of dividend | shares | 1 | ||||||
Minimum acquisition percentage of outstanding common stock to exercise rights | 15 | ||||||
Discount available to right holders to purchase common stock upon acquisition of minimum shareholding by acquiring person | 50% | ||||||
Number of common shares for each right | shares | 1 | ||||||
Rights Agreement | |||||||
Class of Stock [Line Items] | |||||||
Number of One-Thousandth share of Series A Preferred stock Issued In Right | shares | 1 | ||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||||||
Purchase price of right | $ / shares | $ 20 | ||||||
Prefunded warrants | Securities Purchase Agreements | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 1,653,281 | 2,333,884 | |||||
Warrants exercise price | $ / shares | $ 0.01 | $ 0.04 | |||||
Series E Warrants | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 50,000 | ||||||
Warrants exercise price | $ / shares | $ 8.51 | ||||||
Series E Warrants | Securities Purchase Agreements | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 2,333,908 | ||||||
Warrants exercise price | $ / shares | $ 8.51 | ||||||
Warrants exercise period | 12 months | ||||||
Series G Warrants | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 15,000 | ||||||
Warrants exercise price | $ / shares | $ 8.51 | ||||||
Potential fee | $ | $ 1,400,000 | ||||||
Series G Warrants | Securities Purchase Agreements | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 1,653,281 | ||||||
Warrants exercise price | $ / shares | $ 8.51 | ||||||
Series F Warrants | Securities Purchase Agreements | |||||||
Class of Stock [Line Items] | |||||||
Common share issuable upon exercise of warrants | shares | 2,333,908 | ||||||
Warrants exercise price | $ / shares | $ 6.90 | ||||||
Warrants exercise period | 5 years |
Stock Based Compensation (Detai
Stock Based Compensation (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||||||||||||||
Oct. 08, 2022 USD ($) $ / shares shares | Oct. 07, 2022 USD ($) | Sep. 08, 2022 USD ($) shares | Jul. 08, 2022 USD ($) $ / shares shares | Jul. 07, 2022 USD ($) shares | Jun. 07, 2022 USD ($) shares | May 16, 2022 | Mar. 14, 2022 USD ($) shares | Feb. 16, 2022 $ / shares shares | Feb. 15, 2022 USD ($) shares | Dec. 07, 2021 | Jul. 13, 2021 director employee shares | Mar. 12, 2021 shares | Nov. 30, 2022 USD ($) $ / shares shares | Oct. 31, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) item $ / shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) item $ / shares shares | Sep. 30, 2021 USD ($) | Oct. 11, 2022 shares | Oct. 10, 2022 shares | Jul. 06, 2022 $ / shares | Apr. 07, 2021 shares | Dec. 07, 2020 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of options granted | 6,150 | |||||||||||||||||||||||
Stock options expense | $ | $ 10,612 | $ 154,274 | $ 58,530 | $ 874,065 | ||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 1,375,000 | 625,000 | 625,000 | 250,000 | ||||||||||||||||||||
Exercise price | $ / shares | $ 7.29 | |||||||||||||||||||||||
Total unrecognized compensation costs | $ | $ 16,000 | $ 16,000 | ||||||||||||||||||||||
Total unrecognized compensation costs expected to be recognized over a weighted average period | 4 months 17 days | |||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 13.34 | $ 13.34 | ||||||||||||||||||||||
Volatility | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Warrants, measurement input | item | 111.8 | 111.8 | ||||||||||||||||||||||
Risk-free interest rate | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Warrants, measurement input | item | 0.0238 | 0.0238 | ||||||||||||||||||||||
2020 Equity Incentive Plan | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Stock options expense | $ | $ 510,747 | 1,198,860 | $ 2,238,995 | 1,918,651 | ||||||||||||||||||||
Volatility | 112.75% | |||||||||||||||||||||||
Risk-free interest rate | 2.05% | |||||||||||||||||||||||
Fair value portion of warrants | $ | 42,108 | $ 42,108 | ||||||||||||||||||||||
Vesting period | 1 year | |||||||||||||||||||||||
2020 Equity Incentive Plan | Research and development | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Stock options expense | $ | 85,882 | 215,528 | $ 379,533 | 424,993 | ||||||||||||||||||||
2020 Equity Incentive Plan | General and administrative | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Stock options expense | $ | 424,993 | 983,332 | 1,859,462 | 1,493,658 | ||||||||||||||||||||
2020 Equity Incentive Plan | Chief Executive Officer | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of options granted | 6,150 | |||||||||||||||||||||||
Expected term | 10 years | |||||||||||||||||||||||
Exercise price | $ / shares | $ 7.29 | |||||||||||||||||||||||
Vesting percentage | 25% | 25% | ||||||||||||||||||||||
Vesting period | 1 year | |||||||||||||||||||||||
RSU's | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Stock options expense | $ | 500,135 | $ 1,044,586 | 1,505,281 | $ 2,180,466 | ||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 495,000 | |||||||||||||||||||||||
Vesting percentage | 100% | |||||||||||||||||||||||
Number of director | director | 7 | |||||||||||||||||||||||
Number of executive directors | director | 2 | |||||||||||||||||||||||
Total unrecognized compensation costs | $ | $ 385,000 | $ 385,000 | ||||||||||||||||||||||
Total unrecognized compensation costs expected to be recognized over a weighted average period | 2 months 8 days | |||||||||||||||||||||||
Grant date fair value of RSU's issued (per share) | $ / shares | $ 9.75 | |||||||||||||||||||||||
Grant date fair value of RSU's issued | $ | $ 4,800,000 | |||||||||||||||||||||||
Restricted Stock | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Volatility | 112.75% | 112.75% | ||||||||||||||||||||||
Risk-free interest rate | 4.14% | 3.05% | ||||||||||||||||||||||
Fair value portion of warrants | $ | $ 25,000 | $ 75,000 | ||||||||||||||||||||||
Number of shares granted | 6,878 | 540 | 30,303 | 679 | 692 | 13,775 | ||||||||||||||||||
Fair market value of shares issued | $ | $ 50,000 | $ 4,500 | $ 150,000 | $ 4,500 | $ 4,500 | $ 98,078 | ||||||||||||||||||
Warrants to purchase shares of common stock | 4,659 | 15,459 | ||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 14.54 | $ 13.26 | ||||||||||||||||||||||
Warrants term | 5 years | 5 years | ||||||||||||||||||||||
Nonemployee directors | Director Compensation Policy | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of securities available for grant | 1,500 | |||||||||||||||||||||||
Nonemployee directors | RSU's | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of shares granted | 425,000 | |||||||||||||||||||||||
Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of securities available for grant | 1,200 | |||||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 300 | |||||||||||||||||||||||
Employee | RSU's | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Entity number of employees | employee | 2 | |||||||||||||||||||||||
Number of shares granted | 10,000 | |||||||||||||||||||||||
CFO | RSU's | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Number of shares granted | 60,000 | |||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Vesting period | 1 year | |||||||||||||||||||||||
Warrants to purchase shares of common stock | 15,459 | 4,795 | 4,659 | |||||||||||||||||||||
Warrants exercise price | $ / shares | $ 14.10 | $ 14.54 | $ 13.26 | |||||||||||||||||||||
Warrants term | 5 years | 5 years | 5 years | |||||||||||||||||||||
Number of restricted shares issued | 30,303 | 7,092 | 6,878 | |||||||||||||||||||||
Amount of restricted shares issued | $ | $ 50,000 | $ 150,000 | $ 50,000 | $ 50,000 | ||||||||||||||||||||
Fair value of issuance | $ | $ 25,000 | $ 75,000 | $ 25,000 | $ 25,000 | $ 25,000 | |||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Volatility | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Warrants, measurement input | 112.75 | 112.75 | 112.75 | 112.75 | ||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Risk-free interest rate | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Warrants, measurement input | 3.05 | 4.39 | 4.14 | 4.14 | ||||||||||||||||||||
Date of grant | Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Vesting percentage | 50% | |||||||||||||||||||||||
First anniversary from Start Date | RSU's | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Vesting percentage | 100% | |||||||||||||||||||||||
First anniversary from Start Date | Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Vesting percentage | 25% | |||||||||||||||||||||||
Second anniversary from Start Date | Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||
Vesting percentage | 25% |
Stock Based Compensation - Stoc
Stock Based Compensation - Stock option activity under the stock option plans (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Dec. 31, 2021 | Oct. 11, 2022 | Oct. 10, 2022 | Apr. 07, 2021 | Dec. 07, 2020 | |
Number of Shares | ||||||
Options outstanding at the beginning | 123,850 | |||||
Options granted | 6,150 | |||||
Stock option grant authorized for service on a committee of the Board of Directors | 1,375,000 | 625,000 | 625,000 | 250,000 | ||
Options outstanding at the end | 130,000 | 123,850 | ||||
Options exercisable at the end | 126,925 | |||||
Weighted-Average Exercise Price | ||||||
Options outstanding at the beginning (in dollars per share) | $ 9.84 | |||||
Options granted (in dollars per share) | 7.29 | |||||
Options outstanding at the end (in dollars per share) | 9.72 | $ 9.84 | ||||
Options exercisable at the end (in dollars per share) | $ 9.78 | |||||
Weighted-Average Remaining Contractual Term (Years) | ||||||
Options granted (in years) | 9 years 4 months 17 days | |||||
Options outstanding at the end (in years) | 8 years 4 months 6 days | 8 years 3 months 18 days | ||||
Options exercisable at the end (in years) | 8 years 3 months 29 days | |||||
Aggregate Intrinsic Value | ||||||
Options outstanding at the end (in dollars) | $ 0 | $ 0 | ||||
Options exercisable at the end (in dollars) | $ 0 |
Common Stock Warrants - Common
Common Stock Warrants - Common stock warrant activity (Details) | 9 Months Ended |
Sep. 30, 2022 shares | |
Common Stock Warrants | |
Warrants outstanding January 1, 2022 | 6,265,525 |
Warrants issued | 25,759 |
Warrants exercised | (65,000) |
Warrants expired | (1,049,368) |
Warrants outstanding September 30, 2022 | 5,176,916 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) | 9 Months Ended | ||
Sep. 30, 2022 USD ($) item Y $ / shares shares | Sep. 30, 2021 USD ($) | Jan. 03, 2022 $ / shares shares | |
Warrants exercise price | $ / shares | $ 13.34 | ||
Weighted average remaining life of warrants | 3 years 5 months 8 days | ||
Intrinsic value of the warrants | $ | $ 1,000,000 | ||
Proceeds from warrant exercises | $ | 553,150 | $ 8,382,516 | |
Warrant | |||
Proceeds from warrant exercises | $ | $ 553,150 | ||
Series G Warrants | |||
Number of warrant holders who exercised their warrants | item | 1 | ||
Warrants outstanding | shares | 15,000 | ||
Warrants exercise price | $ / shares | $ 8.51 | ||
Warrants to purchase shares of common stock | shares | 15,000 | ||
Series E Warrants | |||
Number of warrant holders who exercised their warrants | item | 3 | ||
Warrants outstanding | shares | 50,000 | ||
Warrants exercise price | $ / shares | $ 8.51 | ||
Warrants to purchase shares of common stock | shares | 50,000 | ||
Dividend yield | |||
Warrants, measurement input | item | 0 | ||
Expected term | |||
Warrants, measurement input | Y | 5 | ||
Volatility | |||
Warrants, measurement input | item | 111.8 | ||
Risk-free interest rate | |||
Warrants, measurement input | item | 0.0238 | ||
Advisory Agreements [Member] | |||
Warrants exercise price | $ / shares | $ 8.96 | ||
Warrants to purchase shares of common stock | shares | 10,300 | ||
Warrants term | 5 years | ||
Total expense | $ | $ 147,000 |