Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
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 | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 973 | |
Local Phone Number | 242-0005 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | SNPX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 10,164,529 | |
Entity Central Index Key | 0001571934 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 32,899,410 | $ 37,478,480 |
Prepaid Clinical trial expenses | 130,548 | 367,714 |
Prepaid expenses and other current assets | 385,769 | 739,467 |
TOTAL CURRENT ASSETS | 33,415,727 | 38,585,661 |
Fixed assets, net of accumulated depreciation | 21,438 | 22,145 |
TOTAL ASSETS | 33,437,165 | 38,607,806 |
CURRENT LIABILITIES | ||
Accounts payable | 439,147 | 660,206 |
Accrued expenses | 68,137 | 536,714 |
Dividend payable | 115,890 | |
Accrued Series B Convertible Preferred payments payable | 2,265,375 | |
TOTAL CURRENT LIABILITIES | 2,772,659 | 1,312,810 |
Warrant liability | 1,129,000 | 1,510,000 |
Derivative liability | 2,628,000 | 370,300 |
TOTAL LIABILITIES | 6,529,659 | 3,193,110 |
Commitments and contingencies | ||
Series B Convertible redeemable preferred stock, $.0001 par value and $1,000 face value, 1,000,000 shares authorized; 14,000 and 15,000 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively. Liquidation preference of $14,000,000 plus dividends accrued at 7% per annum of $165,375 as of June 30, 2023. | 2,077,379 | 2,721,723 |
STOCKHOLDERS' EQUITY | ||
Common stock - 150,000,000 shares authorized, $0.0001 par value; 7,365,280 shares issued and outstanding as of June 30, 2023 and 7,267,032 shares issued and outstanding as of December 31, 2022. | 738 | 728 |
Additional paid-in capital | 56,849,293 | 52,523,762 |
Accumulated deficit | (32,019,904) | (19,831,517) |
TOTAL STOCKHOLDERS' EQUITY | 24,830,127 | 32,692,973 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 33,437,165 | $ 38,607,806 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Condensed Balance Sheets | ||
Series B Convertible redeemable preferred stock, par value per share | $ 0.0001 | $ 0.0001 |
Series B Convertible redeemable preferred stock, face value per share | $ 1,000 | $ 1,000 |
Series B Convertible redeemable preferred stock, Shares authorized | 1,000,000 | 1,000,000 |
Series B Convertible redeemable preferred stock, Shares issued | 14,000 | 15,000 |
Series B Convertible redeemable preferred stock, Shares outstanding | 14,000 | 15,000 |
Series B Convertible redeemable preferred stock, Liquidation preference value | $ 14,000,000 | |
Series B Convertible redeemable preferred stock, Liquidation preference, percentage of accrued dividends | 7% | |
Series B Convertible redeemable preferred stock, Liquidation preference, amount of accrued dividends | $ 165,375 | |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 7,365,280 | 7,267,032 |
Common stock, shares outstanding | 7,365,280 | 7,267,032 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
OPERATING EXPENSES: | ||||
Research and development | $ 307,211 | $ 1,941,101 | $ 1,184,928 | $ 3,427,175 |
General and administrative | 1,522,502 | 1,855,290 | 3,566,726 | 3,651,748 |
TOTAL OPERATING EXPENSES | 1,829,713 | 3,796,391 | 4,751,654 | 7,078,923 |
OTHER INCOME (EXPENSE): | ||||
Interest income | 427,159 | 44,487 | 823,516 | 49,097 |
Change in fair value of warrant liability | (207,000) | 381,000 | ||
Change in fair value of derivative liability | (2,484,400) | 0 | (2,258,600) | 0 |
TOTAL OTHER INCOME (EXPENSE) | (2,264,241) | 44,487 | (1,054,084) | 49,097 |
Net loss before income taxes | 4,093,954 | 3,751,904 | 5,805,738 | 7,029,826 |
Net loss | 4,093,954 | 3,751,904 | 5,805,738 | 7,029,826 |
Preferred Stock dividends | 423,575 | 689,649 | ||
Deemed dividend - preferred stock extinguishment | 5,693,000 | 5,693,000 | ||
Net loss attributable to common stockholders | $ 10,210,529 | $ 3,751,904 | $ 12,188,387 | $ 7,029,826 |
PER SHARE DATA: | ||||
Basic loss per common share | $ 1.39 | $ 0.54 | $ 1.66 | $ 1.01 |
Diluted loss per common share | $ 1.39 | $ 0.54 | $ 1.66 | $ 1.01 |
Basic weighted average common shares outstanding | 7,361,300 | 6,959,400 | 7,356,600 | 6,949,400 |
Diluted weighted average common shares outstanding | 7,361,300 | 6,959,400 | 7,356,600 | 6,949,400 |
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, 2021 | $ 0 | $ 674 | $ 47,670,744 | $ (14,141,670) | $ 33,529,748 |
Balance, Beginning (in shares) at Dec. 31, 2021 | 0 | 6,730,180 | |||
Stock based compensation | $ 0 | $ 0 | 1,728,248 | 0 | 1,728,248 |
Issuance of warrants for consulting fees | 71,603 | 71,603 | |||
Issuance of common stock for consulting fees | $ 1 | 100,349 | 100,350 | ||
Issuance of common stock for consulting fees (in shares) | 15,146 | ||||
Exercise of common stock warrants | $ 7 | 553,143 | 553,150 | ||
Exercise of common stock warrants (in shares) | 65,000 | ||||
Net loss | (7,029,826) | (7,029,826) | |||
Balance, Ending at Jun. 30, 2022 | $ 682 | $ 682 | 50,124,087 | (21,171,496) | 28,953,273 |
Balance, Ending (in shares) at Jun. 30, 2022 | 6,810,326 | 6,810,326 | |||
Balance, Beginning at Mar. 31, 2022 | $ 682 | $ 0 | 49,102,898 | (17,419,592) | 31,683,988 |
Balance, Beginning (in shares) at Mar. 31, 2022 | 6,809,647 | 0 | |||
Stock based compensation | $ 0 | $ 0 | 1,016,690 | 0 | 1,016,690 |
Issuance of common stock for consulting fees | 4,499 | 4,499 | |||
Issuance of common stock for consulting fees (in shares) | 679 | ||||
Net loss | (3,751,904) | (3,751,904) | |||
Balance, Ending at Jun. 30, 2022 | $ 682 | $ 682 | 50,124,087 | (21,171,496) | 28,953,273 |
Balance, Ending (in shares) at Jun. 30, 2022 | 6,810,326 | 6,810,326 | |||
Balance, Beginning at Dec. 31, 2022 | $ 728 | $ 2,721,723 | 52,523,762 | (19,831,517) | 32,692,973 |
Balance, Beginning (in shares) at Dec. 31, 2022 | 7,267,032 | 15,000 | |||
Beginning balance at Dec. 31, 2022 | $ 2,721,723 | ||||
Beginning balance (in shares) at Dec. 31, 2022 | 15,000 | ||||
Stock based compensation | $ 0 | $ 0 | 979,197 | 0 | $ 979,197 |
Issuance of common stock for consulting fees | $ 10 | 108,990 | 109,000 | ||
Issuance of common stock for consulting fees (in shares) | 98,248 | ||||
Accrued preferred stock dividends | (689,649) | (689,649) | |||
Preferred stock dividends paid | (689,649) | (689,649) | |||
Reclassification of accrued dividends upon probable redemption of preferred stock | 165,375 | ||||
Deemed dividend - preferred stock extinguishment | 689,649 | 5,693,000 | (5,693,000) | ||
Preferred stock redemptions | $ (1,000,000) | ||||
Preferred stock redemptions (in shares) | (1,000) | ||||
Accrual of preferred stock and dividend redemption | $ (2,265,375) | 2,265,375 | |||
Preferred stock accretion | 2,455,656 | (2,455,656) | (2,455,656) | ||
Net loss | (5,805,738) | (5,805,738) | |||
Balance, Ending at Jun. 30, 2023 | $ 738 | $ 2,077,379 | 56,849,293 | (32,019,904) | 24,830,127 |
Balance, Ending (in shares) at Jun. 30, 2023 | 7,365,280 | 14,000 | |||
Beginning balance at Mar. 31, 2023 | $ 737 | $ 2,721,723 | 53,273,034 | (21,809,375) | 31,464,396 |
Beginning balance (in shares) at Mar. 31, 2023 | 7,359,871 | 15,000 | |||
Stock based compensation | $ 0 | $ 0 | 334,416 | 0 | 334,416 |
Issuance of common stock for consulting fees | $ 1 | 4,499 | 4,500 | ||
Issuance of common stock for consulting fees (in shares) | 5,409 | ||||
Accrued preferred stock dividends | (423,575) | (423,575) | |||
Preferred stock dividends paid | (423,575) | (423,575) | |||
Reclassification of accrued dividends upon probable redemption of preferred stock | 165,375 | ||||
Deemed dividend - preferred stock extinguishment | 423,575 | 5,693,000 | (5,693,000) | ||
Preferred stock redemptions | $ (1,000,000) | ||||
Preferred stock redemptions (in shares) | (1,000) | ||||
Accrual of preferred stock and dividend redemption | $ (2,265,375) | ||||
Preferred stock accretion | 2,455,656 | (2,455,656) | (2,455,656) | ||
Net loss | (4,093,954) | (4,093,954) | |||
Balance, Ending at Jun. 30, 2023 | $ 738 | $ 2,077,379 | $ 56,849,293 | $ (32,019,904) | $ 24,830,127 |
Balance, Ending (in shares) at Jun. 30, 2023 | 7,365,280 | 14,000 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | |
CASH FLOW USED IN OPERATING ACTIVITIES | |||
Net loss | $ (4,093,954) | $ (5,805,738) | $ (7,029,826) |
Adjustments to reconcile net loss to net cash used by operating activities | |||
Stock based compensation | 979,197 | 1,728,248 | |
Change in fair value of warrant liability | 207,000 | (381,000) | |
Change in fair value of derivative liability | 2,258,600 | ||
Consulting services paid by issuance of common stock | 109,000 | 100,349 | |
Consulting services paid by issuance of common stock warrants | 71,603 | ||
Depreciation expense | 3,414 | 2,697 | |
Change in assets and liabilities: | |||
Decrease in prepaid expenses | 590,864 | 486,372 | |
Decrease in accounts payable | (221,059) | (1,015,640) | |
Decrease in accrued expenses | (468,577) | (353,292) | |
Total adjustments | 2,870,439 | 1,020,337 | |
Net Cash Used in Operating Activities | (2,935,299) | (6,009,489) | |
CASH FLOWS USED IN INVESTING ACTIVITIES | |||
Purchase of fixed assets | (2,707) | (3,029) | |
Net Cash Used in Investing Activities | (2,707) | (3,029) | |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from exercise of investor warrants | 553,150 | ||
Redemption of Series B Convertible Preferred Stock | (1,000,000) | ||
Dividends on Series B Convertible Preferred Stock | (641,064) | ||
Net Cash Provided by Financing Activities | (1,641,064) | 553,150 | |
NET DECREASE IN CASH AND EQUIVALENTS | (4,579,070) | (5,459,368) | |
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD | 37,478,480 | 34,213,989 | |
CASH AND EQUIVALENTS AT END OF PERIOD | 32,899,410 | 32,899,410 | 28,754,621 |
DISCLOSURES OF NON-CASH FINANCING ACTIVITIES: | |||
Accrual of Series B Convertible Preferred Stock Dividends | 689,649 | $ 115,890 | |
Accretion of Series B Convertible Preferred Stock to redemption value | $ 2,455,656 | 2,455,656 | |
Deemed dividend for Series B Convertible Preferred Stock modification | 5,693,000 | ||
Accrual of Series B Convertible Preferred Stock and Dividend Redemption | $ 2,265,375 |
Organization, Business, Risks a
Organization, Business, Risks and Uncertainties: | 6 Months Ended |
Jun. 30, 2023 | |
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). In connection with the separation from Neurotrope, the Company 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. On December 16, 2022, the Company issued a press release announcing that an extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the Severe Impairment Battery (“SIB”) total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, the Company announced results of its analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (Mini Mental State Exam 2 (“MMSE”) (baseline scores: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive. On April 24, 2023, the Company received a written notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the preceding 30 consecutive business days, the Company’s common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until October 23, 2023, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance can be achieved automatically and without further action if the closing bid price of the Company’s stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed. If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by October 23, 2023, the Company may be eligible for additional time to comply. Liquidity Uncertainties As of June 30, 2023, the Company had approximately $32.9 million in cash and cash equivalents as compared to $37.5 million at December 31, 2022. The Company expects that its current cash and cash equivalents, approximately $32.5 million as of the date of this Quarterly Report on Form 10-Q, will be sufficient to support its projected operating requirements and financial commitments 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 financial commitments include the potential redemption of the Series B Convertible Preferred Stock for cash. 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 of 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 future trials. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our future clinical trials. 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: | 6 Months Ended |
Jun. 30, 2023 | |
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 three and six months ended June 30, 2023 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023. 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 shares of common stock 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 shares of common stock 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 June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share for the three and six months ended June 30, 2023 and 2022. The weighted average dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022 respectively, because to do so would be anti-dilutive (in Common Stock equivalents), are as follows: For the Three Months Ended For the Six Months Ended June 30, June 30, 2023 2022 2023 2022 Common Stock Options 741,850 130,000 703,183 128,428 Restricted Stock Units — 495,000 — 495,000 Convertible Preferred Stock 17,876,707 — 17,876,707 — Common Stock Warrants 7,179,919 5,487,927 7,179,919 5,855,262 Total 25,798,476 6,112,927 25,759,809 6,478,690 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 June 30, 2023, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.2 million. In addition, approximately $30.7 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. Fair Value of Financial Instruments: The carrying amounts reflected in the balance sheets for payables approximate fair value due to the short maturities of these instruments. The carrying amounts for warrant liability and derivative liability approximate fair value based on level 3 of the fair value hierarchy. Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable markets. Level 3 — Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. Fixed Assets and Leases: The Company has two leases, one of which has a term of two years during the respective reporting periods. The Company has deemed the two year lease immaterial and has not recorded it as an obligation on the balance sheet nor a right-of-use asset. The total future expense relating to this lease is approximately $50,000 per year. 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, Inc. (“WCT”), at June 30, 2023 and December 31, 2022. 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 $93.4 million for the period from October 31, 2012 (inception) through June 30, 2023. The net operating loss carryforwards resulted in Federal and state deferred tax asset of approximately $27.4 million at June 30, 2023. 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. However, 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 June 30, 2023 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 six months ended June 30, 2023 of $0 and approximately $100,000 for the three and six months ended June 30, 2022. See Note 5, “ Other Commitments – 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 June 30, 2023. 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 will be effective for interim and annual periods beginning after December 15, 2021. The Company has adopted ASU 2020-06 as of January 1, 2022. In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard establishes an impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses, which is intended to result in a timelier recognition of losses. Under the CECL model, entities will estimate credit losses over the entire contractual term of the instrument (considering estimated prepayments, but not expected extensions or modifications) from the date of initial recognition of the financial instrument. Measurement of expected credit losses are to be based on relevant forecasts that affect collectability. The scope of financial assets within the CECL methodology is broad and includes trade receivables from certain revenue transactions and certain off-balance sheet credit exposures. Different components of the guidance require modified retrospective or prospective adoption. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. ASU 2018-19 clarifies that receivables arising from operating leases are not within the scope of the credit losses standard. Instead, entities would need to apply other U.S. GAAP, namely Topic 842 (Leases), to account for changes in the collectability assessment for operating leases. Other than operating lease receivables, Partnership trade receivables include receivables from finance leases and equipment sales. Under Topic 606 (Revenue from Contracts with Customers), revenue is recognized when, among other criteria, it is probable that the entity will collect the consideration to which it is entitled for goods or services transferred to a customer. At the point that finance lease receivables are recorded, they become subject to the CECL model and estimates of expected credit losses over their contractual life will be required to be recorded at inception based on historical information, current conditions, and reasonable and supportable forecasts. Trade receivables derived from equipment sales are of short duration and there is not a material difference between incurred losses and expected losses. In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issued ASU 2019-05, Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief, which amends Topic 326 to allow the fair value option to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December 15, 2022. The Company adopted this new guidance, including the subsequent updates to Topic 326, on January 1, 2023 and the adoption did not have a material impact on the Company’s financial statements and related disclosures. |
Collaborative Agreements and Co
Collaborative Agreements and Commitments | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, 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 June 30, 2023, no royalties nor milestone payments have been earned or made. The Company has advanced the development of synthetic bryostatin by demonstrating the equivalence of the synthetic to the natural bryostatin product. The estimated cost to initiate and produce sufficient quantities of the synthetic bryostatin drug product is approximately $1.5 million. The Company is evaluating production alternatives at this time. 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 application (“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 $200,000 consisting of licensing fees of $125,000 plus development costs and patent fees of approximately $75,000. As of June 30, 2023, 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 June 30, 2023. 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 $2.0 million. As of June 30, 2023, the Company has incurred cumulative expenses associated with this agreement of approximately $100,000. The Company has filed an IND with the FDA. The FDA has placed the development of the IND on clinical hold pending completion of further analytics relating to drug pharmacokinetics and pharmacodynamics. The Company is currently evaluating its plans to advance Fragile X development. Cleveland Clinic On February 23, 2022, the Company announced its collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis (“MS”), and on July 19, 2023, the Company announced that it had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. The total estimated costs associated with this collaboration are approximately $2.0 million. 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”). Pursuant to the CRE License Agreement, CRE and NRV II provide research services and have 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, 2022 and 2021, respectively, or during the six months ended June 30, 2023. 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 | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions | |
Related Party Transactions | Note 4- Related Party Transactions: On August 4, 2016, Neurotrope 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 the Company as of December 1, 2020. For the three and six months ended June 30, 2023 and 2022, $30,000 and $60,000 is reflected in the Company’s statements of operations, respectively. |
Other Commitments
Other Commitments | 6 Months Ended |
Jun. 30, 2023 | |
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 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”).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 which was subsequently canceled with no charges incurred by the Company. The updated total estimated budget for the current trial services, including pass-through costs, was approximately $11.0 million. As noted below, Neurotrope was granted a $2.7 million award from the National Institutes of Health, which award was used to support the Phase 2 Study, resulting in an estimated net budgeted cost of the Phase 2 Study to Neurotrope of $9.3 million. Synaptogenix may terminate the 2020 Services Agreement without cause upon 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 $8.3 million. The NIH grant provided 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 $10.5 million of cumulative expenses associated with the current Phase 2 clinical trial as of June 30, 2023. Of the total $10.5 million incurred for the trial as of June 30, 2023, approximately $77,000 and $0.4 million is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively, and approximately $1.2 million and $4.6 million is reflected in the statement of operations for the three and six months ended June 30, 2022, respectively. As of June 30, 2023 included in the Company’s balance sheet, approximately $131,000 of WCT prepayments is included as a prepaid expense and other current assets. In addition, approximately $171,000 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 related 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 provided services to enroll approximately twelve 2022 Study subjects. 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. The Company terminated the 2022 Services Agreement in December 2022. The Company incurred approximately $1.6 million of cumulative expenses associated with the current 2022 Study as of June 30, 2023. Of the total $1.6 million incurred for the trial as of June 30, 2023, approximately $33,000 and $157,000 is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively and $0 for the comparable periods in 2022. As of June 30, 2023, $0 of WCT 2022 Study prepayments is included as a prepaid expense and other current assets in the Company’s balance sheet. In addition, approximately $55,000 is included in accounts payable and accrued expenses as of June 30, 2023. Other Consulting Agreements Effective as of January 1, 2021, the Company entered into an amended consulting agreement with Katalyst Securities LLC (“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 and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the three and six months ended June 30, 2022, $30,000 and $111,283 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to Katalyst. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the Katalyst Agreement in December 2022. Effective as of January 1, 2021, the Company entered into an amended consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”) 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 warrants 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 and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the comparable periods in 2022, $30,000 and $120,320 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to GPN. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the GPN Agreement in December 2022. 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 receives an annual base salary of $222,000, with an annual discretionary bonus of up to 50% of his base salary then in effect. 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 (the “Second 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 (as defined in the Offer Letter), Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary. Effective June 7, 2023, the Company entered into an additional amendment to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2024, with automatic monthly renewals thereafter unless earlier terminated in accordance with the terms of the Second Amendment. Other Commitments and Agreements See Notes 3 and 4 for Collaboration and License Agreement related commitments. Contingencies Pursuant to the Separation Agreement and Tax Matters Agreement with Neurotrope, 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 ourselves. As of the reporting date, there are no claims relating to the indemnification agreement. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
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. November 2022 Private Placement On November 17, 2022, the Company entered into a Securities Purchase Agreement (as amended on May 11, 2023, the “November Purchase Agreement”) with certain accredited investors (the “November Investors”), pursuant to which it agreed to sell to the November Investors (i) an aggregate of 15,000 shares of the Company’s newly-designated Series B convertible preferred stock with a stated value of $1,000 per share (the “Series B Preferred Stock”), initially convertible into up to 1,935,485 shares of Common Stock at a conversion price of $7.75 per share (the “Series B Preferred Shares”), and (ii) warrants to acquire up to an aggregate of 1,935,485 shares of Common Stock (the “November Warrants”) (collectively, the “November Private Placement”). On May 12, 2023, the Company filed an amendment (the “CoD Amendment”) to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company amended the terms of the Series B Preferred Stock by removing all references to the “Make-Whole Amount”. In connection with the CoD Amendment, on May 11, 2023, the Company entered into an amendment to the November Purchase Agreement pursuant to which it agreed to extend the investors’ right of participation in a subsequent financing until the one year anniversary following the later of (x) such time that the Preferred Shares are no longer outstanding and (y) the maturity date of the Series B Preferred Stock. The terms of the Series B Preferred Stock are as set forth in the Certificate of Designations for the Series B Preferred Stock (as amended on March 17, 2023 and May 12, 2023, the “Certificate of Designations”). The Series B Preferred Stock will be convertible into Series B Preferred Shares at the election of the holder at any time at an initial conversion price of $7.75 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). The Company will be required to redeem the Series B Preferred Stock in 15 equal monthly installments, commencing on June 1, 2023. The amortization payments due upon such redemption are payable, at the Company’s election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) a 15% discount to the average of the three lowest closing prices of the Common Stock during the thirty The holders of the Series B Preferred Stock will be entitled to dividends of 7% per annum, compounded monthly, which will be payable in cash or shares of Common Stock at the Company’s option, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series B Preferred Stock will accrue dividends at the rate of 15% per annum. The holders of Series B Preferred Stock have no voting rights on account of the Series B Preferred Stock, other than with respect to certain matters affecting the rights of the Series B Preferred Stock. Notwithstanding the foregoing, the Company’s ability to settle conversions and make amortization payments using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designations, including a limit on the number of shares that may be issued until the time, if any, that the Company’s stockholders have approved the issuance of more than 19.9% of the Company’s outstanding shares of Common Stock in accordance with Nasdaq listing standards (the “Nasdaq Stockholder Approval”). The Company agreed to seek stockholder approval of these matters at a meeting to be held no later than June 1, 2023, and such approval was obtained at the Company’s special meeting of stockholders held on April 14, 2023. Further, the Certificate of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Certificate of Designations or November Warrants. The Certificate of Designations includes certain Triggering Events (as defined in the Certificate of Designations), including, among other things, the failure to file and maintain an effective registration statement covering the sale of the holder’s securities registrable pursuant to the November Registration Rights Agreement (defined below) and the Company’s failure to pay any amounts due to the holders of the Series B Preferred Stock when due. In connection with a Triggering Event, each holder of Series B Preferred Stock will be able to require the Company to redeem in cash any or all of the holder’s Series B Preferred Stock at a premium set forth in the Certificate of Designations. The Company will be subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters. The November Warrants are exercisable for Warrant Shares immediately at an exercise price of $7.75 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). There is no established public trading market for the November Warrants and the Company does not intend to list the November Warrants on any national securities exchange or nationally recognized trading system. In connection with the November Purchase Agreement, the Company and the November Investors entered into a Registration Rights Agreement (the “November Registration Rights Agreement”) on November 17, 2022. Under the terms of the November Registration Rights Agreement, the Company agreed to register 200% of the Series B Preferred Shares, the Warrant Shares and the shares of Common stock issuable as amortization payments as well as any shares of Common stock paid as dividends. The Company filed a registration statement for the resale of such securities on December 16, 2022. The Company also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement. In connection with the November Private Placement, pursuant to an Engagement Letter, between the Company and Katalyst Securities LLC (the “November Placement Agent”), the Company paid the November Placement Agent (i) a cash fee equal to 7% of the gross proceeds from any sale of securities in the November Private Placement and (ii) warrants to purchase shares of Common Stock equal to 3% of the number of shares of Common stock that the Series B Preferred Shares are initially convertible into, with an exercise price of $7.75 per share and a five-year term. On June 1, 2023, the Company paid the holders of the Series B Preferred Stock approximately $1.64 million to satisfy the first amortization payment due. On June 30, 2023, the holders of the Series B Preferred Stock elected to defer the cash payment due on July 1, 2023 of approximately $1.14 million to August 1, 2023. On July 13, 2023, the holders of the Series B Preferred Stock elected to convert cash payments due on August 1, 2023 of approximately $2.16 million into 3,125,907 shares of Common Stock. On July 31, 2023, the holders of the Series B Preferred Stock elected to defer cash payments due on August 1, 2023 of approximately $953,000 to September 1, 2023. On August 1, 2023, the Company provided notice to the Series B Preferred Stock investors that it would issue 1,680,675 shares of pre-amortization Common Stock to satisfy the amortization payment due September 1, 2023. As of August 10, 2023, 2,799,249 total shares of Common Stock have been issued to the holders of the Series B Preferred Stock. Accounting Treatment of November Private Placement Series B Preferred Shares Effective April 14, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment modified (i) the definition of Floor Price to mean the lower of (i) $1.25 and (ii) 20% of the “Minimum Price” (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on the date of receipt of Stockholder Approval (as defined in the Agreement), (ii) the definition of Installment Date to mean June 1, 2023, and thereafter, the first Trading Day of each calendar month immediately following the previous Installment Date until the Maturity Date, and the Maturity Date, and (iii) the definition of Maturity Date to mean August 31, 2023. In accordance with ASC 470-50 and 470-60, the Company has made an accounting policy election to account for amendments of the Series B Preferred Stock as modifications or extinguishments based on the change in fair value of the instrument immediately before and immediately after the amendment. The Company accounted for the amendment as an extinguishment as the change in fair value of the Series B Preferred Stock was 34% (greater than ten percent (10%)) immediately before and immediately after. In accordance with ASC 260-10-S99-2, the Company recognized the $5.7 million increase in fair value as a deemed dividend on the statement of operations. On May 11, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment removed the definition of Make-Whole Amount (as was previously defined in the Agreement) and modified the definition of the Conversion Amount so as to remove the Make-Whole Amount from said definition. In accordance with ASC 470-50 and 470-60, the Company accounted for the amendment as a modification as the change in fair value of the Series B Preferred Stock was 0.05% (less than ten percent (10%)) immediately before and immediately after. The Company analogized to the share-based payments model for the appropriate modification accounting and did not recognize a deemed dividend as the fair value decreased upon modification. The Series B Preferred Shares were determined to be more akin to a debt-like host than an equity-like host. The Company identified the following embedded features that are not clearly and closely related to the debt host instrument: 1) make-whole interest upon a contingent redemption event, 2) make-whole interest upon a conversion event, 3) an installment redemption upon an Equity Conditions Failure (as defined in the Certificate of Designation), and 4) variable share-settled installment conversion. These features were bundled together, assigned probabilities of being affected and measured at fair value. Subsequent changes in fair value of these features are recognized in the Consolidated Statement of Operations. The Company estimated the $2.2 million fair value of the bifurcated embedded derivative at issuance using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $6.52 on the issuance date, estimated equity volatility of 85.0%, estimated traded volume volatility of 255.0%, the time to maturity of 1.61 years, a discounted market interest rate of 7.3%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 8.2%. The fair value of the bifurcated derivative liability was estimated utilizing the with and without method which uses the probability weighted difference between the scenarios with the derivative and the plain vanilla maturity scenario without a derivative. The discount to the fair value is included as a reduction to the carrying value of the Series B Preferred Shares. During 2022, the Company recorded a total discount of approximately $12.3 million upon issuance of the Series B Preferred Shares, which was comprised of the issuance date fair value of the associated embedded derivative of approximately $2.2 million, stock issuance costs of approximately $0.5 million and the fair value of the Warrants of approximately $9.6 million. During the three months ended June 30, 2023, it was deemed probable that the Series B Preferred Shares will be redeemed for cash upon Installment Redemptions (as defined the Certificate of Designation). As such, the Company recognized $2,455,656 to additional paid-in capital to accrete the Series B Preferred Shares to redemption amount pursuant to ASC 480-10-S99-3A with a corresponding increase in the carrying value of the Series B Preferred Shares. During the three and six months ended June 30, 2023, the Company recorded a loss of $2,484,400 and $2,258,600, respectively, and $0 for the comparable periods in 2022, related to the change in fair value of the derivative liability which is recorded in other income (expense) on the Statements of Operations. The Company estimated the $2,628,000 fair value of the bifurcated embedded derivative at June 30, 2023 using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $0.93 per share on the valuation date, estimated equity volatility of 145%, estimated traded volume volatility of 240%, the time to maturity of 1.7 years, a discounted market interest rate of 6.5%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 0.9%. Common Stock Warrants Pursuant to the Private Placement, the Company issued to investors Warrants and, pursuant to its advisory agreements, the Company issued to its advisor additional Warrants with the same terms. The Broker Warrants are within the scope of ASC 718 pursuant to ASC 718-10-20 but are subject to liability classification as they would be required to be classified as liabilities in accordance with ASC 480. The Warrants were determined to be within the scope of ASC 480-10 as they are puttable to the Company at Holders’ election upon the occurrence of a Fundamental Transaction (as defined in the agreements). As such, the Company recorded the Warrants as a liability at fair value with subsequent changes in fair value recognized in earnings. The Company utilized the Black Scholes Model to calculate the value of these warrants issued during the year ended December 31, 2022. The fair value of the Warrants of approximately $9.9 million was estimated at the date of issuance using the following weighted average assumptions: dividend yield 0%; expected term of five years; equity volatility of 105%; and a risk-free interest rate of 3.97%. Transaction costs incurred attributable to the issuance of the Warrants of $0.9 million were immediately expensed in accordance with ASC 480. During the three and six months ended June 30, 2023 and 2022, the Company recorded a loss of $207,000 and a gain of $381,000, respectively, and $0 for comparable periods in 2022, related to the change in fair value of the warrant liability which is recorded in other income (expense) on the Statements of Operations. The fair value of the Warrants of approximately $1,129,000 was estimated at June 30, 2023 utilizing the Black Scholes Model using the following weighted average assumptions: dividend yield 0%; remaining term of 4.38 years; equity volatility of 130%; and a risk-free interest rate of 4.24%. |
Stock Based Compensation
Stock Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
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 at 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. On October 11, 2022, the Company held its annual meeting of stockholders at 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. The Compensation Committee of the Company’s board of directors (the “Committee”) administers the 2020 Plan and has full power to grant stock options and Common Stock, construe and interpret the 2020 Plan, establish rules and regulations and perform all other acts, including the delegation of administrative responsibilities, as it believes reasonable and proper. The Committee, in its absolute discretion, may award Common Stock to employees, consultants, and directors of the Company, and such other persons as the Committee may select, and permit holders of options to exercise such options prior to full vesting. Stock and Option Grants The following is a summary of stock option activity under the stock option plans for the three months ended June 30, 2023: Weighted- Average Aggregate Weighted- Remaining Intrinsic Number Average Contractual Value of Exercise Term (in Shares Price (Years) millions) Options outstanding at January 1, 2023 661,850 $ 7.27 9.5 $ — Options granted 80,000 $ 0.87 10.0 — Less options forfeited — $ — — — Less options expired/cancelled — $ — — — Less options exercised — $ — — — Options outstanding at June 30, 2023 741,850 $ 6.15 9.1 $ — Options exercisable at June 30, 2023 661,850 $ 6.08 9.0 $ — The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.923 for the Company’s common shares on June 30, 2023 and the closing stock price of $1.16 for the Company’s common shares on December 31, 2022. As of June 30, 2023, the Company had unrecognized stock option expense of approximately $45,000 and a remaining weighted average period for recognition of 0.75 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. As of February 16, 2023, these stock 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 112.75%, a risk free interest rate of 2.05% and a fair value of $42,108. The options were expensed over the one-year vesting period from date of issuance. On November 15, 2022, pursuant to its 2020 Plan, the Company granted stock options to six Board members, including two officers who are also Board members, and two employees to purchase an aggregate of 531,850 shares of Common Stock. The stock options have an exercise price of $6.07 per share and an expiration date that is ten years from the date of issuance. 50% of the options vest upon issuance with the remaining 50% vesting on May 15, 2023. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 107.05%, a risk free interest rate of 3.93% and have a fair value of $2,570,328. The options are being expensed 50% at date of issuance and the remaining 50% expensed on a straight line basis over the six-month vesting period from date of issuance. On March 29, 2023, Synaptogenix granted stock options to four Board members to purchase an aggregate of 80,000 shares of common stock. The stock options have an exercise price of $.87 per share and an expiration date of ten years. They vest on the one-year anniversary from the date of the grant. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 123.92%, a risk free interest rate of 3.66% and have a fair value of $59,763. Director’s Compensation Policy On March 29, 2023, Synaptogenix adopted an amended and restated 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 20,000 shares of Synaptogenix’s Common Stock to each of Synaptogenix’s non-employee 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. Each newly appointed or elected director will also receive 20,000 options, and such options shall vest 50% on the grant date, 25% on the first anniversary of the grant date and 25% on the second anniversary of the grant date, subject to the director’s continued service on the Board of Directors on each vesting date. The Company recorded total expenses relating to the outstanding stock options of $334,416 and $979,207 for the three and six months ended June 30, 2023, and $11,544 and $47,918 for the three and six months ended June 30, 2022, 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. On November 30, 2022, one director and one officer forfeited a total of 86,000 RSUs to satisfy the 2020 Plan limitation of total issuances per year to any individual holder. The Company reversed approximately $370,000 of expense resulting from the forfeited RSUs. 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 was announced on December 16, 2022, and so the RSUs vested on such date. As of December 31, 2022, 100% of the 411,000 RSUs vested 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 $91,429. 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 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. All stock issuances are expensed upon issuance. 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%, a fair value of $25,000 and are expensed upon issuance. 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 a fair value of $25,000. The warrants are expensed when issued. On December 7, 2022, the Company issued 893 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 $4,501, expensed upon issuance. On January 5, 2023, the Company issued 88,339 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 $100,000. On March 22, 2023, the Company issued 4,500 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, expensed upon issuance. On June 7, 2023, the Company issued 5,409 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, expensed upon issuance. Stock Compensation Expense Total stock-based compensation for the three and six months ended June 30, 2023 was $334,416 and 979,197, respectively, of which $49,863 and $149,589, respectively, was classified as research and development expense, and $284,553 and $829,608 was classified as general and administrative expense, respectively. Total stock-based compensation for the three and six months ended June 30, 2022 was $1,016,690 and $1,728,248, respectively, of which $172,601 and $293,651, respectively, was classified as research and development expense, and $844,089 and $1,434,597 was classified as general and administrative expense, respectively. The Company currently estimates, beginning at the closing date of the November Private Placement, implied volatility factor for all options and warrants based upon a blend of the Parent Company’s and Company’s historical volatility. Up until November 21, 2022, the Company computed implied volatility based upon a blend of the Parent Company’s and Company’s historical volatility along with the volatility of selected comparable publicly traded companies as, at that time, the Company lacked sufficient historical stock trading activity. It incorporated 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 | 6 Months Ended |
Jun. 30, 2023 | |
Common Stock Warrants | |
Common Stock Warrants | Note 8 – Common Stock Warrants: As of June 30, 2023, the Company had warrants outstanding consisting of the following: Number of shares Warrants outstanding January 1, 2022 6,265,525 Warrants issued 2,028,762 Warrants exercised (65,000) Warrants expired (1,049,368) Warrants outstanding and exercisable December 31, 2022 and June 30, 2023 7,179,919 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 year ended December 31, 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 three and six months ended June 30, 2023 was $0 and $71,603, respectively. On November 22, 2022, pursuant to the November Private Placement (See Note 6 above), the Company issued warrants to purchase 1,993,485 shares of Common Stock, immediately exercisable with at an exercise price of $7.75 per share and expiring five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). 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 105% and a weighted average Risk-free interest rate of 3.97%. The total value recorded during the year period, classified as a liability on the Company’s balance sheet in November 2022, is approximately $9.6 million. As of June 30, 2023, the liability is $1,129,000. As of June 30, 2023, the weighted average exercise price and the weighted average remaining life of the total warrants were $11.79 per warrant and 3.17 years, respectively. The intrinsic value of the warrants as of June 30, 2023 was approximately $134,800. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.928 for the Company’s common shares on June 30, 2023. During the six months ended June 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. During the three months ended June 30, 2022, no warrant holders exercised warrants. Total cash proceeds from these warrant exercises was $553,150. During the three and six months ended June 30, 2023, no warrant holders exercised warrants. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | Note 9 - Fair Value Measurements Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the six months ended June 30, 2023 and 2022. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of June 30, 2023 and December 31, 2022 due to their short-term nature. The fair value of the bifurcated embedded derivative related to the convertible preferred stock was estimated using a Monte Carlo simulation model, which uses as inputs the fair value of our Common stock and estimates for the equity volatility and traded volume volatility of our Common stock, the time to maturity of the convertible preferred stock, the risk-free interest rate for a period that approximates the time to maturity, dividend rate, a penalty dividend rate, and our probability of default. The fair value of the warrant liability was estimated using the Black Scholes Model which uses as inputs the following weighted average assumptions, as noted above: dividend yield, expected term in years, equity volatility, and risk-free interest rate. Fair Value on a Recurring Basis The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the warrant liability and bifurcated embedded derivatives represent Level 3 measurements. The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis at June 30, 2023 and December 31, 2022, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value: June 30, December 31, Description Level 2023 2022 Liabilities: Warrant liability (Note 6) 3 $ 1,129,000 $ 1,510,000 Bifurcated embedded derivative liability (Note 6) 3 $ 2,628,000 $ 370,300 The following table sets forth a summary of the change in the fair value of the warrant liability that is measured at fair value on a recurring basis: December 31, 2022 Balance on December 31, 2021 $ — Issuance of warrants 9,915,000 Change in fair value of warrant liability (8,405,000) Balance on December 31, 2022 $ 1,510,000 Change in fair value of warrant liability (381,000) Balance on June 30, 2023 $ 1,129,000 The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis: December 31, 2022 Balance on December 31, 2021 $ — Issuance of convertible preferred stock with bifurcated embedded derivative 2,191,300 Change in fair value of bifurcated embedded derivative (1,821,900) Balance on December 31, 2022 $ 369,400 Change in fair value of warrant liability 2,258,600 Balance on June 30, 2023 $ 2,628,000 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events | |
Subsequent Events | Note 10 – Subsequent Events See Note 6 above. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
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 three and six months ended June 30, 2023 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023. |
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 shares of common stock 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 shares of common stock 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 June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share for the three and six months ended June 30, 2023 and 2022. The weighted average dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022 respectively, because to do so would be anti-dilutive (in Common Stock equivalents), are as follows: For the Three Months Ended For the Six Months Ended June 30, June 30, 2023 2022 2023 2022 Common Stock Options 741,850 130,000 703,183 128,428 Restricted Stock Units — 495,000 — 495,000 Convertible Preferred Stock 17,876,707 — 17,876,707 — Common Stock Warrants 7,179,919 5,487,927 7,179,919 5,855,262 Total 25,798,476 6,112,927 25,759,809 6,478,690 |
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 June 30, 2023, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.2 million. In addition, approximately $30.7 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments: The carrying amounts reflected in the balance sheets for payables approximate fair value due to the short maturities of these instruments. The carrying amounts for warrant liability and derivative liability approximate fair value based on level 3 of the fair value hierarchy. Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable markets. Level 3 — Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
Fixed Assets and Leases | Fixed Assets and Leases: The Company has two leases, one of which has a term of two years during the respective reporting periods. The Company has deemed the two year lease immaterial and has not recorded it as an obligation on the balance sheet nor a right-of-use asset. The total future expense relating to this lease is approximately $50,000 per year. 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, Inc. (“WCT”), at June 30, 2023 and December 31, 2022. |
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 $93.4 million for the period from October 31, 2012 (inception) through June 30, 2023. The net operating loss carryforwards resulted in Federal and state deferred tax asset of approximately $27.4 million at June 30, 2023. 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. However, 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 June 30, 2023 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 six months ended June 30, 2023 of $0 and approximately $100,000 for the three and six months ended June 30, 2022. See Note 5, “ Other Commitments – 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 June 30, 2023. |
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 will be effective for interim and annual periods beginning after December 15, 2021. The Company has adopted ASU 2020-06 as of January 1, 2022. In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard establishes an impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses, which is intended to result in a timelier recognition of losses. Under the CECL model, entities will estimate credit losses over the entire contractual term of the instrument (considering estimated prepayments, but not expected extensions or modifications) from the date of initial recognition of the financial instrument. Measurement of expected credit losses are to be based on relevant forecasts that affect collectability. The scope of financial assets within the CECL methodology is broad and includes trade receivables from certain revenue transactions and certain off-balance sheet credit exposures. Different components of the guidance require modified retrospective or prospective adoption. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. ASU 2018-19 clarifies that receivables arising from operating leases are not within the scope of the credit losses standard. Instead, entities would need to apply other U.S. GAAP, namely Topic 842 (Leases), to account for changes in the collectability assessment for operating leases. Other than operating lease receivables, Partnership trade receivables include receivables from finance leases and equipment sales. Under Topic 606 (Revenue from Contracts with Customers), revenue is recognized when, among other criteria, it is probable that the entity will collect the consideration to which it is entitled for goods or services transferred to a customer. At the point that finance lease receivables are recorded, they become subject to the CECL model and estimates of expected credit losses over their contractual life will be required to be recorded at inception based on historical information, current conditions, and reasonable and supportable forecasts. Trade receivables derived from equipment sales are of short duration and there is not a material difference between incurred losses and expected losses. In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issued ASU 2019-05, Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief, which amends Topic 326 to allow the fair value option to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December 15, 2022. The Company adopted this new guidance, including the subsequent updates to Topic 326, on January 1, 2023 and the adoption did not have a material impact on the Company’s financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Schedule of anti-dilutive securities excluded from calculation | For the Three Months Ended For the Six Months Ended June 30, June 30, 2023 2022 2023 2022 Common Stock Options 741,850 130,000 703,183 128,428 Restricted Stock Units — 495,000 — 495,000 Convertible Preferred Stock 17,876,707 — 17,876,707 — Common Stock Warrants 7,179,919 5,487,927 7,179,919 5,855,262 Total 25,798,476 6,112,927 25,759,809 6,478,690 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stock Options | |
Stock Based Compensation | |
Summary 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, 2023 661,850 $ 7.27 9.5 $ — Options granted 80,000 $ 0.87 10.0 — Less options forfeited — $ — — — Less options expired/cancelled — $ — — — Less options exercised — $ — — — Options outstanding at June 30, 2023 741,850 $ 6.15 9.1 $ — Options exercisable at June 30, 2023 661,850 $ 6.08 9.0 $ — |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Common Stock Warrants | |
Schedule of warrants outstanding | Number of shares Warrants outstanding January 1, 2022 6,265,525 Warrants issued 2,028,762 Warrants exercised (65,000) Warrants expired (1,049,368) Warrants outstanding and exercisable December 31, 2022 and June 30, 2023 7,179,919 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements | |
Schedule of liabilities that are measured at fair value on a recurring basis | June 30, December 31, Description Level 2023 2022 Liabilities: Warrant liability (Note 6) 3 $ 1,129,000 $ 1,510,000 Bifurcated embedded derivative liability (Note 6) 3 $ 2,628,000 $ 370,300 |
Summary of the change in the fair value of the liabilities that is measured at fair value on a recurring basis | December 31, 2022 Balance on December 31, 2021 $ — Issuance of warrants 9,915,000 Change in fair value of warrant liability (8,405,000) Balance on December 31, 2022 $ 1,510,000 Change in fair value of warrant liability (381,000) Balance on June 30, 2023 $ 1,129,000 December 31, 2022 Balance on December 31, 2021 $ — Issuance of convertible preferred stock with bifurcated embedded derivative 2,191,300 Change in fair value of bifurcated embedded derivative (1,821,900) Balance on December 31, 2022 $ 369,400 Change in fair value of warrant liability 2,258,600 Balance on June 30, 2023 $ 2,628,000 |
Organization, Business, Risks_2
Organization, Business, Risks and Uncertainties: (Details) | Jun. 30, 2023 USD ($) $ / shares | Apr. 24, 2023 D $ / shares | Dec. 31, 2022 USD ($) $ / shares |
Organization, Business, Risks and Uncertainties | |||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | |
Cash and cash equivalents | $ | $ 32,899,410 | $ 37,478,480 | |
Cash and cash equivalents expected amount at financial reporting date | $ | $ 32,500,000 | ||
Number of preceding consecutive business failed to maintain minimum closing bid price | D | 30 | ||
Minimum closing bid price failed to be maintained in the preceding 30 consecutive business days | $ / shares | $ 1 | ||
Number of calendar days given as grace period to attain minimum bid price requirement | D | 180 | ||
Stock price to be maintained for minimum 10 consecutive business days in the grace period to achieve compliance | $ / shares | $ 1 | ||
Number of minimum nonconsecutive business days in the grace period to maintain the bid price requirement to achieve compliance | D | 10 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies: (Details) - USD ($) | 6 Months Ended | |||
Jul. 23, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Summary Of Significant Accounting Policies: | ||||
Cash balance of insured FDIC amount | $ 2,200,000 | |||
Cash balance of uninsured amount | $ 30,700,000 | |||
Lease term | 2 years | |||
Total future expense relating to the lease | $ 50,000 | |||
Capitalized research and development services | 0 | $ 0 | ||
Net operating loss carryforwards | 93,400,000 | |||
Expense related to grants recognized | $ 0 | $ 100,000 | ||
Maximum | ||||
Summary Of Significant Accounting Policies: | ||||
Estimated useful life (years) | 10 years | |||
Minimum | ||||
Summary Of Significant Accounting Policies: | ||||
Estimated useful life (years) | 3 years | |||
National Institutes of Health | 2020 Services Agreement | ||||
Summary Of Significant Accounting Policies: | ||||
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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Summary of Significant Accounting Policies | ||||
Antidilutive securities | 25,798,476 | 6,112,927 | 25,759,809 | 6,478,690 |
Common stock options | ||||
Summary of Significant Accounting Policies | ||||
Antidilutive securities | 741,850 | 130,000 | 703,183 | 128,428 |
Restricted stock units | ||||
Summary of Significant Accounting Policies | ||||
Antidilutive securities | 495,000 | 495,000 | ||
Convertible Preferred Stock | ||||
Summary of Significant Accounting Policies | ||||
Antidilutive securities | 17,876,707 | 17,876,707 | ||
Common stock warrants | ||||
Summary of Significant Accounting Policies | ||||
Antidilutive securities | 7,179,919 | 5,487,927 | 7,179,919 | 5,855,262 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Significant components of deferred tax assets and liabilities (Details) $ in Millions | Jun. 30, 2023 USD ($) |
Significant components of the Company's deferred tax assets and liabilities | |
Net operating loss carryforward | $ 27.4 |
Collaborative Agreements and _2
Collaborative Agreements and Commitments (Details) | 6 Months Ended | 12 Months Ended | |||||||
Feb. 23, 2023 USD ($) | May 08, 2021 USD ($) | Jun. 09, 2020 USD ($) | Jan. 19, 2017 USD ($) | Jul. 14, 2014 USD ($) | May 12, 2014 USD ($) | Jun. 30, 2023 USD ($) agreement | Dec. 31, 2022 agreement | Dec. 31, 2021 agreement | |
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Number of statements of work agreements entered | agreement | 0 | 0 | 0 | ||||||
Stanford License Agreements | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Royalty payment percentage | 3% | ||||||||
Payments for royalties | $ 0 | ||||||||
Commitment to pay additional fee | $ 2,100,000 | ||||||||
Estimated cost | 1,500,000 | ||||||||
Mt. Sinai License Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Milestone payments made | 0 | ||||||||
Payments for royalties | 0 | ||||||||
Additional milestone payments | $ 1,500,000 | ||||||||
Total amount paid | 200,000 | ||||||||
Licensing fees | 125,000 | ||||||||
Development costs and patent fees | 75,000 | ||||||||
Payable of milestone payments | $ 2,000,000 | ||||||||
Mt. Sinai License Agreement | Net sales up to $250 million | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
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 | |||||||||
Royalty payment percentage | 3% | ||||||||
Threshold net sales | $ 250,000,000 | ||||||||
Agreements with BryoLogyx | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Percentage of gross revenue | 2% | ||||||||
Other income | 0 | ||||||||
Nemours Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Estimated cost | $ 2,000,000 | ||||||||
Cumulative expenses incurred | $ 100,000 | ||||||||
Cleveland Clinic | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Estimated cost | $ 2,000,000 | ||||||||
License | Stanford License Agreements | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Aggregate amount paid | 70,000 | ||||||||
Annual license maintenance fee | $ 10,000 | ||||||||
Minimum | Mt. Sinai License Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Royalty payment percentage | 1.50% | ||||||||
Maximum | Stanford License Agreements | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
Royalty payment percentage | 4.50% | ||||||||
Milestone payments made | $ 3,700,000 | ||||||||
Maximum | Agreements with BryoLogyx | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative | |||||||||
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 | 6 Months Ended | |||
Aug. 04, 2016 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Related Party Transaction | |||||
Contract payments, term | 1 year | ||||
Annual consulting fee | $ 120,000 | ||||
Monthly installment of annual consulting fee | $ 10,000 | ||||
Consultancy fees | $ 30,000 | $ 60,000 | $ 30,000 | $ 60,000 |
Other Commitments (Details)
Other Commitments (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||||||
Aug. 04, 2022 | May 12, 2022 item | Feb. 10, 2022 USD ($) | Jan. 01, 2022 USD ($) | Jul. 01, 2021 USD ($) $ / shares shares | Jan. 01, 2021 USD ($) | Dec. 07, 2020 USD ($) | Jul. 23, 2020 USD ($) | Aug. 04, 2016 USD ($) | Apr. 30, 2020 USD ($) | Jun. 30, 2023 USD ($) Y $ / shares | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) Y $ / shares shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Jan. 22, 2022 USD ($) | Jan. 03, 2022 $ / shares shares | Oct. 01, 2021 $ / shares shares | Apr. 30, 2021 USD ($) | Apr. 01, 2021 $ / shares shares | Feb. 16, 2021 $ / shares shares | |
Other Commitments | |||||||||||||||||||||
Clinical trial expenses | $ 307,211 | $ 1,941,101 | $ 1,184,928 | $ 3,427,175 | |||||||||||||||||
Exercise price of warrants | $ / shares | $ 11.79 | $ 11.79 | |||||||||||||||||||
Number of options granted | shares | 80,000 | ||||||||||||||||||||
Options exercisable period | 9 years | ||||||||||||||||||||
Volatility | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | 1.118 | 1.118 | |||||||||||||||||||
Risk-free interest rate | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | 0.0238 | 0.0238 | |||||||||||||||||||
Expected term | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||
Dividend yield | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | 0 | 0 | |||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Monthly installment of annual consulting fee | $ 10,000 | $ 20,000 | |||||||||||||||||||
Consultancy fees | $ 0 | 30,000 | $ 0 | 111,283 | |||||||||||||||||
Warrants to purchase shares of common stock | shares | 4,500 | 4,500 | 4,500 | 4,500 | 25,000 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 9.76 | $ 8.69 | $ 9.30 | $ 8.80 | $ 11.46 | ||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | Expected term | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||
Consulting Agreement with Katalyst Securities LLC | Dividend yield | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | 0 | 0 | |||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Monthly installment of annual consulting fee | $ 10,000 | $ 20,000 | $ 12,000 | ||||||||||||||||||
Consultancy fees | $ 0 | 30,000 | $ 0 | 120,320 | |||||||||||||||||
Warrants to purchase shares of common stock | shares | 5,800 | 5,800 | 5,800 | 2,500 | 10,000 | ||||||||||||||||
Warrants term following the effective date | 3 months | ||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 9.76 | $ 8.69 | $ 9.30 | $ 8.80 | $ 11.46 | ||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | Expected term | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||||||||||
Consulting Agreement with GP Nurmenkari, Inc | Dividend yield | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Warrants, measurement input | 0 | 0 | |||||||||||||||||||
2020 Services Agreement | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Amount funded against the total trial cost | $ 1,000,000 | $ 1,400,000 | |||||||||||||||||||
Total estimated budget for the services | $ 9,300,000 | $ 11,000,000 | $ 11,000,000 | ||||||||||||||||||
Clinical trial expenses | 77,000 | 1,200,000 | 400,000 | 4,600,000 | |||||||||||||||||
WCT prepayments included as a prepaid expense and other current assets | 131,000 | 131,000 | |||||||||||||||||||
WCT payments included in accounts payable | 171,000 | 171,000 | |||||||||||||||||||
Charges Incurred | $ 0 | ||||||||||||||||||||
2020 Services Agreement | National Institutes of Health | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Total estimated budget for the services | $ 8,300,000 | ||||||||||||||||||||
Threshold period of prior written notice to terminate agreement | 60 days | ||||||||||||||||||||
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 | 10,500,000 | ||||||||||||||||||||
2022 Services Agreement | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Target enrollment of study subjects | item | 12 | ||||||||||||||||||||
Total estimated budget for the services | 2,000,000 | 2,000,000 | |||||||||||||||||||
Clinical trial expenses | 33,000 | 157,000 | $ 0 | ||||||||||||||||||
WCT prepayments included as a prepaid expense and other current assets | 0 | 0 | |||||||||||||||||||
WCT payments included in accounts payable | 55,000 | 55,000 | |||||||||||||||||||
2022 Services Agreement | National Institutes of Health | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Clinical trial expenses | 1,600,000 | ||||||||||||||||||||
Employment agreement with Alan J. Tuchman, M.D | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Initial annual base salary | $ 222,000 | ||||||||||||||||||||
Annual discretionary bonus payable (as a percent) | 50% | ||||||||||||||||||||
Term of agreement | 1 year | ||||||||||||||||||||
Extension periods of agreement | 6 months | ||||||||||||||||||||
Additional extension period of agreement | 6 months | ||||||||||||||||||||
Consulting Agreement with SM Capital Management, LLC | |||||||||||||||||||||
Other Commitments | |||||||||||||||||||||
Contract payments, term | 1 year | ||||||||||||||||||||
Annual consulting fee | $ 120,000 | ||||||||||||||||||||
Monthly installment of annual consulting fee | $ 10,000 | ||||||||||||||||||||
Consultancy fees | $ 30,000 | $ 60,000 | $ 30,000 | $ 60,000 |
Other Commitments - Warrants Me
Other Commitments - Warrants Measurement Input and Fair Value (Details) | Jun. 30, 2023 Y |
Dividend yield | |
Other Commitments | |
Warrants, measurement input | 0 |
Volatility | |
Other Commitments | |
Warrants, measurement input | 1.118 |
Risk-free interest rate | |
Other Commitments | |
Warrants, measurement input | 0.0238 |
Expected term | |
Other Commitments | |
Warrants, measurement input | 5 |
Consulting Agreement with Katalyst Securities LLC | Dividend yield | |
Other Commitments | |
Warrants, measurement input | 0 |
Consulting Agreement with Katalyst Securities LLC | Expected term | |
Other Commitments | |
Warrants, measurement input | 5 |
Consulting Agreement with GP Nurmenkari, Inc | Dividend yield | |
Other Commitments | |
Warrants, measurement input | 0 |
Consulting Agreement with GP Nurmenkari, Inc | Expected term | |
Other Commitments | |
Warrants, measurement input | 5 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 6 Months Ended | |
Jun. 30, 2023 Vote $ / shares shares | Dec. 31, 2022 shares | |
Stockholders' Equity | ||
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Preferred stock, shares authorized | 1,000,000 | |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |
Votes per share of common stock | Vote | 1 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||
Aug. 10, 2023 shares | Jul. 13, 2023 USD ($) shares | May 11, 2023 | Apr. 14, 2023 USD ($) $ / shares | Nov. 17, 2022 USD ($) $ / shares Y item installment D shares | Jun. 30, 2023 USD ($) Y $ / shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) Y $ / shares | Jun. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Aug. 01, 2023 shares | Jul. 31, 2023 USD ($) | Jun. 01, 2023 USD ($) | |
Stockholders' Equity | |||||||||||||
Series B Preferred Stock, face value per share | $ / shares | $ 1,000 | $ 1,000 | |||||||||||
Warrants exercise price | $ / shares | $ 11.79 | $ 11.79 | |||||||||||
Fair value of warrants | $ 1,129,000 | $ 1,129,000 | $ 1,510,000 | ||||||||||
Change in fair value of derivative liability | (2,484,400) | $ 0 | (2,258,600) | $ 0 | |||||||||
Gain on change in fair value of the warrant liability | 207,000 | (381,000) | |||||||||||
Payment of temporary equity to satisfy first amortization payment due | $ 1,640,000 | ||||||||||||
Deferred cash payment | $ 1,140,000 | $ 1,140,000 | $ 953,000 | ||||||||||
Cash payments elected to convert into commons stock | $ 2,160,000 | ||||||||||||
Common stock shares issued | shares | 2,799,249 | 3,125,907 | |||||||||||
Pre-amortization Common Stock to satisfy amortization payment | shares | 1,680,675 | ||||||||||||
Series E Warrants | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants to purchase shares of common stock | shares | 50,000 | 50,000 | |||||||||||
Warrants exercise price | $ / shares | $ 8.51 | $ 8.51 | |||||||||||
Series G Warrants | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants to purchase shares of common stock | shares | 15,000 | 15,000 | |||||||||||
Warrants exercise price | $ / shares | $ 8.51 | $ 8.51 | |||||||||||
Dividend yield | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants, measurement input | 0 | 0 | |||||||||||
Expected term | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants, measurement input | Y | 5 | 5 | |||||||||||
Volatility | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants, measurement input | 1.118 | 1.118 | |||||||||||
Risk-free interest rate | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants, measurement input | 0.0238 | 0.0238 | |||||||||||
Series B Preferred Stock | |||||||||||||
Stockholders' Equity | |||||||||||||
Percentage of changes in fair value convertible preferred stock | 34% | ||||||||||||
Additional paid-in capital to accrete the preferred shares to redemption value | 2,455,656 | ||||||||||||
November 2022 Private Placement | |||||||||||||
Stockholders' Equity | |||||||||||||
Number of Series B Preferred Stock issued | shares | 15,000 | ||||||||||||
Series B Preferred Stock, face value per share | $ / shares | $ 1,000 | ||||||||||||
Preferred shares issuable upon conversion of Series B Preferred Stock | shares | 1,935,485 | ||||||||||||
Series B Preferred Stock, conversion price per share | $ / shares | $ 7.75 | ||||||||||||
Warrants to purchase shares of common stock | shares | 1,935,485 | ||||||||||||
Number of equal monthly installments to redeem Series B Preferred Stock | installment | 15 | ||||||||||||
Percentage of discount on average closing share prices considered for determination of amortization payments | 15% | ||||||||||||
Number of lowest closing share prices considered for determination of amortization payments | item | 3 | ||||||||||||
Trading day period considered for determination of amortization payments | 30 days | ||||||||||||
Percentage of minimum price, considered for determination of amortization payments | 20% | ||||||||||||
Series B Preferred Stock, Stock price trigger for conversion | $ / shares | $ 11.625 | ||||||||||||
Series B Preferred Stock, Threshold Consecutive trading days considered for conversion | D | 20 | ||||||||||||
Series B Preferred Stock, Daily trading volume of the Common Stock trigger for conversion | shares | 100,000 | ||||||||||||
Series B Preferred Stock, dividend rate | 7% | ||||||||||||
Series B Preferred Stock, dividend rate during the continuance of a Triggering Event | 15% | ||||||||||||
Warrants exercise price | $ / shares | $ 7.75 | ||||||||||||
Term of warrants | 5 years | ||||||||||||
Issuance date fair value of the associated embedded derivative | $ 2,628,000 | $ 2,628,000 | |||||||||||
Bifurcated embedded derivative, measurement input | $ / shares | 0.93 | 0.93 | |||||||||||
Fair value of warrants | $ 1,129,000 | $ 1,129,000 | $ 9,900,000 | ||||||||||
Warrant Issuance Costs | 900,000 | ||||||||||||
Gain on change in fair value of the warrant liability | $ 207,000 | $ 0 | $ 381,000 | $ 0 | |||||||||
November 2022 Private Placement | Minimum | |||||||||||||
Stockholders' Equity | |||||||||||||
Per share value of Common stock, considered for determination of amortization payments | $ / shares | $ 1.25 | ||||||||||||
November 2022 Private Placement | Maximum | |||||||||||||
Stockholders' Equity | |||||||||||||
Per share value of Common stock, considered for determination of amortization payments | $ / shares | 0.172 | ||||||||||||
November 2022 Private Placement | Placement Agents | |||||||||||||
Stockholders' Equity | |||||||||||||
Warrants exercise price | $ / shares | $ 7.75 | ||||||||||||
Term of warrants | 5 years | ||||||||||||
Percentage of offering fees in cash | 7% | ||||||||||||
Percentage of offering fees in warrants | 3% | ||||||||||||
November 2022 Private Placement | Dividend yield | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.07 | 0.07 | |||||||||||
Warrants, measurement input | 0 | ||||||||||||
November 2022 Private Placement | Expected term | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | Y | 1.7 | 1.7 | |||||||||||
Warrants, measurement input | 4.38 | 4.38 | 5 | ||||||||||
November 2022 Private Placement | Risk-free interest rate | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.065 | 0.065 | |||||||||||
Warrants, measurement input | 0.0424 | 0.0424 | 0.0397 | ||||||||||
November 2022 Private Placement | Estimated equity volatility | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 1.45 | 1.45 | |||||||||||
Warrants, measurement input | 1.30 | 1.30 | 1.05 | ||||||||||
November 2022 Private Placement | Estimated traded volume volatility | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 2.40 | 2.40 | |||||||||||
November 2022 Private Placement | Penalty dividend rate | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.150 | 0.150 | |||||||||||
November 2022 Private Placement | Probability of default | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.009 | 0.009 | |||||||||||
Warrants, measurement input | 0 | 0 | |||||||||||
November 2022 Private Placement | Series B Preferred Stock | |||||||||||||
Stockholders' Equity | |||||||||||||
Percentage of common stock shares, agreed to register under the November registration rights agreement | 200% | ||||||||||||
Issuance date fair value of the associated embedded derivative | $ 2,200,000 | ||||||||||||
Total discount upon issuance of Preferred Shares | 12,300,000 | ||||||||||||
Stock issuance costs | 500,000 | ||||||||||||
Fair value of warrants | $ 9,600,000 | ||||||||||||
Percentage of preferred share floor price | 20% | ||||||||||||
Percentage of changes in fair value convertible preferred stock | 0.05% | ||||||||||||
Increase in fair value of deemed dividend on preferred stock | $ 5,700,000 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Minimum | |||||||||||||
Stockholders' Equity | |||||||||||||
Floor price | $ / shares | $ 1.25 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Maximum | |||||||||||||
Stockholders' Equity | |||||||||||||
Percentage of changes in fair value convertible preferred stock | 10% | 10% | |||||||||||
November 2022 Private Placement | Series B Preferred Stock | Dividend yield | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.07 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Expected term | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | Y | 1.61 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Risk-free interest rate | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.073 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Fair value of our common stock | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | $ / shares | 6.52 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Estimated equity volatility | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.850 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Estimated traded volume volatility | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 2.550 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Penalty dividend rate | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.150 | ||||||||||||
November 2022 Private Placement | Series B Preferred Stock | Probability of default | |||||||||||||
Stockholders' Equity | |||||||||||||
Bifurcated embedded derivative, measurement input | 0.082 | ||||||||||||
November 2022 Private Placement | Preferred Stock | Series B Preferred Stock | |||||||||||||
Stockholders' Equity | |||||||||||||
Issuance date fair value of the associated embedded derivative | $ 2,200,000 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||||||||||||
Jun. 07, 2023 USD ($) shares | Mar. 29, 2023 USD ($) item $ / shares shares | Mar. 22, 2023 USD ($) shares | Jan. 05, 2023 USD ($) shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 07, 2022 USD ($) shares | Nov. 30, 2022 USD ($) director $ / shares shares | Nov. 15, 2022 USD ($) item $ / shares shares | Oct. 08, 2022 USD ($) $ / shares shares | Sep. 15, 2022 | Sep. 08, 2022 USD ($) shares | Jul. 08, 2022 USD ($) $ / shares shares | Jun. 07, 2022 USD ($) shares | Mar. 14, 2022 USD ($) shares | Feb. 16, 2022 $ / shares shares | Feb. 15, 2022 USD ($) shares | Jul. 13, 2021 USD ($) director employee shares | Nov. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Oct. 11, 2022 shares | Apr. 07, 2021 shares | Dec. 07, 2020 shares | |
Stock Based Compensation | ||||||||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 625,000 | 625,000 | ||||||||||||||||||||||||
Closing stock price | $ / shares | $ 1.16 | $ 0.923 | $ 0.923 | $ 1.16 | ||||||||||||||||||||||
Unrecognized compensation costs | $ | $ 45,000 | $ 45,000 | ||||||||||||||||||||||||
Total unrecognized compensation costs expected to be recognized over a weighted average period | 9 months | |||||||||||||||||||||||||
Number of options granted | 80,000 | |||||||||||||||||||||||||
Exercise price | $ / shares | $ 0.87 | |||||||||||||||||||||||||
Fair value of stock options | $ | $ 0 | 0 | $ 0 | $ 0 | ||||||||||||||||||||||
Stock options expense | $ | $ 334,416 | $ 11,544 | $ 979,207 | $ 47,918 | ||||||||||||||||||||||
Number of awards exercised | 65,000 | |||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 11.79 | $ 11.79 | ||||||||||||||||||||||||
Volatility | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Warrants, measurement input | 1.118 | 1.118 | ||||||||||||||||||||||||
Risk-free interest rate | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Warrants, measurement input | 0.0238 | 0.0238 | ||||||||||||||||||||||||
Board members, officers and employees | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of options granted | 80,000 | |||||||||||||||||||||||||
Exercise price | $ / shares | $ 0.87 | |||||||||||||||||||||||||
Volatility | 123.92% | |||||||||||||||||||||||||
Risk-free interest rate | 3.66% | |||||||||||||||||||||||||
Vesting period | 1 year | |||||||||||||||||||||||||
Number of board members to whom stock options were granted | item | 4 | |||||||||||||||||||||||||
Expiration period | 10 years | |||||||||||||||||||||||||
Fair value of stock options | $ | $ 59,763 | |||||||||||||||||||||||||
Equity Incentive Plan 2020 | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 1,375,000 | 250,000 | 250,000 | |||||||||||||||||||||||
Volatility | 112.75% | |||||||||||||||||||||||||
Risk-free interest rate | 2.05% | |||||||||||||||||||||||||
Fair value portion of warrants | $ | $ 42,108 | $ 42,108 | ||||||||||||||||||||||||
Vesting period | 1 year | |||||||||||||||||||||||||
Stock options expense | $ | 334,416 | 1,016,690 | $ 979,197 | 1,728,248 | ||||||||||||||||||||||
Equity Incentive Plan 2020 | Research And Development | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Stock options expense | $ | 49,863 | 172,601 | 149,589 | 293,651 | ||||||||||||||||||||||
Equity Incentive Plan 2020 | General And Administrative | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Stock options expense | $ | 284,553 | 844,089 | 829,608 | 1,434,597 | ||||||||||||||||||||||
Equity Incentive Plan 2020 | Chief Executive Officer | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of options granted | 6,150 | |||||||||||||||||||||||||
Exercise price | $ / shares | $ 7.29 | |||||||||||||||||||||||||
Expected term | 10 years | |||||||||||||||||||||||||
Equity Incentive Plan 2020 | Board members, officers and employees | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of options granted | 531,850 | |||||||||||||||||||||||||
Exercise price | $ / shares | $ 6.07 | |||||||||||||||||||||||||
Volatility | 107.05% | |||||||||||||||||||||||||
Risk-free interest rate | 3.93% | |||||||||||||||||||||||||
Vesting period | 6 months | |||||||||||||||||||||||||
Number of board members to whom stock options were granted | item | 6 | |||||||||||||||||||||||||
Number of officers to whom stock options were granted | item | 2 | |||||||||||||||||||||||||
Number of employees to whom stock options were granted | item | 2 | |||||||||||||||||||||||||
Expiration period | 10 years | |||||||||||||||||||||||||
Vesting percentage | 50% | |||||||||||||||||||||||||
Fair value of stock options | $ | $ 2,570,328 | |||||||||||||||||||||||||
Percentage of expensing at the date of issuance | 50% | |||||||||||||||||||||||||
Percentage of expensing over the vesting period | 50% | |||||||||||||||||||||||||
Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Stock option grant authorized for service on a committee of the Board of Directors | 495,000 | |||||||||||||||||||||||||
Stock options expense | $ | $ 1,005,146 | 0 | $ 1,680,330 | |||||||||||||||||||||||
Number of director | director | 7 | |||||||||||||||||||||||||
Number of executive directors | director | 2 | |||||||||||||||||||||||||
Number of directors who forfeited the award | director | 1 | |||||||||||||||||||||||||
Number of officers who forfeited the award | director | 1 | |||||||||||||||||||||||||
Number of awards forfeited | 86,000 | |||||||||||||||||||||||||
Reversal of allocated share-based compensation expense | $ | $ 370,000 | |||||||||||||||||||||||||
Percentage of awards vested and exercised | 100% | |||||||||||||||||||||||||
Number of awards vested | 411,000 | |||||||||||||||||||||||||
Number of awards exercised | 411,000 | |||||||||||||||||||||||||
Total unrecognized compensation costs | $ | $ 2,560,000 | $ 0 | $ 0 | $ 2,560,000 | ||||||||||||||||||||||
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 | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
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 | $ 91,429 | ||||||||||||||||||||
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 | ||||||||||||||||||||||||
Non employee directors | Director Compensation Policy | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of securities available for grant | 20,000 | |||||||||||||||||||||||||
Non employee directors | Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of shares granted | 425,000 | |||||||||||||||||||||||||
Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Vesting percentage | 50% | |||||||||||||||||||||||||
Number of securities available for grant | 20,000 | |||||||||||||||||||||||||
Employee | Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of shares granted | 10,000 | |||||||||||||||||||||||||
Entity number of employees | employee | 2 | |||||||||||||||||||||||||
CFO | Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of shares granted | 60,000 | |||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Number of shares granted | 5,409 | 4,500 | 88,339 | 893 | ||||||||||||||||||||||
Fair market value of shares issued | $ | $ 4,500 | $ 4,500 | $ 100,000 | $ 4,501 | ||||||||||||||||||||||
Warrants to purchase shares of common stock | 4,795 | 4,795 | ||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 14.10 | $ 14.10 | ||||||||||||||||||||||||
Number of restricted shares issued | 7,092 | |||||||||||||||||||||||||
Amount of restricted shares issued | $ | $ 50,000 | |||||||||||||||||||||||||
Fair value of issuance | $ | $ 25,000 | $ 25,000 | ||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock | Volatility | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Warrants, measurement input | 1.1275 | 1.1275 | ||||||||||||||||||||||||
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock | Risk-free interest rate | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Warrants, measurement input | 0.0439 | 0.0439 | ||||||||||||||||||||||||
First anniversary from Start Date | Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Vesting percentage | 100% | |||||||||||||||||||||||||
First anniversary from Start Date | Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Vesting percentage | 25% | |||||||||||||||||||||||||
Second anniversary from Start Date | Unvested restricted stock units | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
Vesting percentage | 100% | |||||||||||||||||||||||||
Second anniversary from Start Date | Newly appointed director | Director Compensation Policy | ||||||||||||||||||||||||||
Stock Based Compensation | ||||||||||||||||||||||||||
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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Options outstanding at the beginning | 661,850 | |
Options granted | 80,000 | |
Options outstanding at the end | 741,850 | 661,850 |
Options exercisable at the end | 661,850 | |
Weighted-Average Exercise Price | ||
Options outstanding at the beginning (in dollars per share) | $ 7.27 | |
Options granted (in dollars per share) | 0.87 | |
Options outstanding at the end (in dollars per share) | 6.15 | $ 7.27 |
Options exercisable at the end (in dollars per share) | $ 6.08 | |
Weighted-Average Remaining Contractual Term (Years) | ||
Options granted (in years) | 10 years | |
Options outstanding at the end (in years) | 9 years 1 month 6 days | 9 years 6 months |
Options exercisable at the end (in years) | 9 years | |
Aggregate Intrinsic Value | ||
Options outstanding at the beginning (in dollars) | $ 0 | |
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 outstanding (Details) | 6 Months Ended |
Jun. 30, 2023 shares | |
Common Stock Warrants | |
Warrants outstanding January 1 | 6,265,525 |
Warrants issued | 2,028,762 |
Warrants expired | (1,049,368) |
Warrants exercised | (65,000) |
Warrants outstanding December 31 | 7,179,919 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2023 USD ($) Y $ / shares | Nov. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) Y item $ / shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) Y item $ / shares | Jun. 30, 2022 USD ($) item $ / shares shares | Dec. 31, 2022 USD ($) | Nov. 22, 2022 $ / shares shares | Jan. 03, 2022 $ / shares shares | |
Common Stock Warrants | |||||||||
Warrants to purchase shares of common stock | $ / shares | $ 0.928 | $ 0.928 | $ 0.928 | ||||||
Warrants exercise price | $ / shares | $ 11.79 | $ 11.79 | $ 11.79 | ||||||
Change in fair value of warrant liability | $ 207,000 | $ (381,000) | |||||||
Warrant liability | $ 1,129,000 | 1,129,000 | 1,129,000 | $ 1,510,000 | |||||
Weighted average remaining life of warrants | 3 years 2 months 1 day | ||||||||
Intrinsic value of the warrants | $ 134,800 | $ 134,800 | $ 134,800 | ||||||
Number of warrant holders who exercised their warrants | 0 | 0 | 0 | ||||||
Proceeds from warrant exercises | $ 553,150 | ||||||||
Warrant [Member] | |||||||||
Common Stock Warrants | |||||||||
Proceeds from warrant exercises | $ 553,150 | ||||||||
Series E Warrants | |||||||||
Common Stock Warrants | |||||||||
Warrants to purchase shares of common stock | shares | 50,000 | 50,000 | |||||||
Warrants exercise price | $ / shares | $ 8.51 | $ 8.51 | |||||||
Number of warrant holders who exercised their warrants | item | 3 | ||||||||
Warrants outstanding | shares | 50,000 | 50,000 | |||||||
Series G Warrants | |||||||||
Common Stock Warrants | |||||||||
Warrants to purchase shares of common stock | shares | 15,000 | 15,000 | |||||||
Warrants exercise price | $ / shares | $ 8.51 | $ 8.51 | |||||||
Number of warrant holders who exercised their warrants | item | 1 | ||||||||
Warrants outstanding | shares | 15,000 | 15,000 | |||||||
Dividend yield | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 0 | 0 | 0 | ||||||
Expected term | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | Y | 5 | 5 | 5 | ||||||
Volatility | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 1.118 | 1.118 | 1.118 | ||||||
Risk-free interest rate | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 0.0238 | 0.0238 | 0.0238 | ||||||
Advisory Agreements | |||||||||
Common Stock Warrants | |||||||||
Warrants to purchase shares of common stock | shares | 1,993,485 | 10,300 | |||||||
Warrants exercise price | $ / shares | $ 7.75 | $ 8.96 | |||||||
Warrants term | 5 years | 5 years | |||||||
Change in fair value of warrant liability | $ 9,600,000 | $ 0 | $ 71,603 | ||||||
Warrant liability | $ 1,129,000 | $ 1,129,000 | $ 1,129,000 | ||||||
Advisory Agreements | Dividend yield | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 0 | ||||||||
Advisory Agreements | Volatility | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 1.05 | ||||||||
Advisory Agreements | Risk-free interest rate | |||||||||
Common Stock Warrants | |||||||||
Warrants, measurement input | 0.0397 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - Fair Value, Inputs, Level 3 - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Warrant liability | ||
Fair Value Measurements | ||
Liabilities, fair value | $ 1,129,000 | $ 1,510,000 |
Bifurcated embedded derivative liability | ||
Fair Value Measurements | ||
Liabilities, fair value | $ 2,628,000 | $ 370,300 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in the fair value (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Warrant liability | ||
Change in the fair value of the liability | ||
Beginning balance | $ 1,510,000 | |
Issuance | $ 9,915,000 | |
Change in fair value of warrant liability | (381,000) | (8,405,000) |
Ending balance | 1,129,000 | 1,510,000 |
Bifurcated embedded derivative liability | ||
Change in the fair value of the liability | ||
Beginning balance | 369,400 | |
Issuance | 2,191,300 | |
Change in fair value of warrant liability | 2,258,600 | (1,821,900) |
Ending balance | $ 2,628,000 | $ 369,400 |