Audit Information |
12 Months Ended |
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Dec. 31, 2023 | |
Auditor [Table] | |
Auditor Name | Marcum llp |
Auditor Firm ID | 688 |
Auditor Location | Hartford, CT |
Balance Sheets (Parentheticals) - $ / shares |
Dec. 31, 2023 |
Dec. 31, 2022 |
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Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Class A Common Stock | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 84,295,000 | 84,295,000 |
Common stock, shares issued | 10,251,764 | 6,127,320 |
Common stock, shares outstanding | 10,251,764 | 6,127,320 |
Class B Common Stock | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 15,705,000 | 15,705,000 |
Common stock, shares issued | 14,855,539 | 14,891,085 |
Common stock, shares outstanding | 14,855,539 | 14,891,085 |
Statements of Operations - USD ($) $ in Thousands |
12 Months Ended | |
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Dec. 31, 2023 |
Dec. 31, 2022 |
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Revenues | ||
Total revenues | $ 709 | $ 1,222 |
Cost of revenues | 488 | 725 |
Gross profit | 221 | 497 |
Operating expenses | ||
General and administrative | 11,401 | 8,119 |
Research and development | 9,066 | 9,370 |
Sales and marketing | 783 | 1,051 |
Total operating expenses | 21,250 | 18,540 |
Loss from operations | (21,029) | (18,043) |
Other (expense) and income | ||
Lawsuit expense | (30) | (1,398) |
Other refundable tax credits | 23 | 306 |
Other (expense) income, net | (377) | 300 |
Total other expenses, net | (384) | (792) |
Net loss | (21,413) | (18,835) |
Dividend attributable to warrant down round feature | (798) | |
Net loss attributable to common stockholders | $ (22,211) | $ (18,835) |
Basic net loss per share (in Dollars per share) | $ (1.02) | $ (0.9) |
Basic weighted average common shares outstanding (in Shares) | 21,734,901 | 20,969,032 |
Grant revenue | ||
Revenues | ||
Total revenues | $ 41 | $ 282 |
Clinical trial revenue | ||
Revenues | ||
Total revenues | $ 668 | $ 940 |
Statements of Operations (Parentheticals) - $ / shares |
12 Months Ended | |
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Dec. 31, 2023 |
Dec. 31, 2022 |
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Income Statement [Abstract] | ||
Diluted net loss per share | $ (1.02) | $ (0.90) |
Diluted weighted average common shares outstanding | 21,734,901 | 20,969,032 |
Statements of Comprehensive Loss - USD ($) $ in Thousands |
12 Months Ended | |
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Dec. 31, 2023 |
Dec. 31, 2022 |
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Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (21,413) | $ (18,835) |
Other comprehensive loss: | ||
Net unrealized losses on available-for-sale securities | (357) | |
Total comprehensive loss | $ (21,413) | $ (19,192) |
Statements of Stockholders’ Equity (Parentheticals) $ in Thousands |
12 Months Ended |
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Dec. 31, 2023
USD ($)
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Statement of Stockholders' Equity [Abstract] | |
Class A Common Stock issued for stock rights offering, net of issuance costs | $ 325 |
Class A common stock issued in direct placements, net of issuance costs | $ 1,229 |
Nature of Business, Basis of Presentation, and Liquidity |
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Nature of Business, Basis of Presentation, and Liquidity [Abstract] | |||||||||||||||||||
Nature of Business, Basis of Presentation, and Liquidity | 1. Nature of Business, Basis of Presentation, and Liquidity
Nature of business:
Longeveron LLC was formed as a Delaware limited liability company on October 9, 2014 and authorized to transact business in Florida on December 15, 2014. On February 12, 2021, Longeveron LLC converted its corporate form (the “Corporate Conversion”) from a Delaware limited liability company (Longeveron, LLC) to a Delaware corporation, Longeveron Inc. (the “Company,” “Registrant,” “Longeveron,”, “we,” “us,” or “our”). The Company is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company operates out of its leased facilities in Miami, Florida.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on licenses, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities.
The Company’s product candidates are currently in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, partners and consultants.
Going Concern and Liquidity:
Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the U.S. Food and Drug Administration (“FDA”), and has only generated revenues from grants, the Bahamas Registry Trials and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations. The Company intends to continue its efforts to raise additional equity financing, develop its intellectual property, and secure regulatory approvals to commercialize its products. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. These financial statements do not include adjustments that might result from the outcome of these uncertainties.
The Company has incurred recurring losses from operations since its inception, including a net loss of $21.4 million and $18.8 million for the years ended December 31, 2023 and 2022, respectively. In addition, as of December 31, 2023, the Company had an accumulated deficit of $85.0 million. The Company expects to continue to generate operating losses for the foreseeable future.
As of December 31, 2023, the Company had cash and cash equivalents of $4.9 million and marketable securities of $0.4 million. The Company has prepared a cash flow forecast which indicates that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. To address the future funding requirements, in addition to planning future sales of equity securities, management has undertaken the following initiatives:
In a concurrent private placement, the Company also sold to the Purchaser unregistered Series A warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock and unregistered Series B warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock (the “Warrants”)( the “October 2023 Private Placement” and collectively, with the October 2023 Registered Direct Offering, the “October 2023 Offering”). The Series A Warrants have an exercise price of $1.65 per share and have a term of five and one-half years from the date of issuance. The Series B Warrants have an exercise price of $1.65 per share and have a term of eighteen months from the date of issuance. The Series A and B warrants became exercisable upon stockholder approval on December 26, 2023, and each Warrant is exercisable for one share of Class A common stock. The net proceeds to the Company from the October 2023 Offering was approximately $3.4 million, after deducting placement agent fees and other offering expenses paid by the Company totaling approximately $0.6 million.
In private placement on December 22, 2023, concurrent with the December 2023 Registered Direct Offering, the Company also sold to the Purchaser unregistered long-term warrants to purchase up to an aggregate of 1,355,301 shares of its Class A common stock (the “December 2023 Private Placement”, and together with the December 2023 Registered Direct Offering, the “December 2023 Offering”) . The unregistered December 2023 Private Placement warrants have an exercise price of $1.62 per share, became immediately exercisable upon issuance, and expire on June 20, 2029. The purchaser may not exercise any portion of the December 2023 Private Placement warrants to the extent the Purchaser would own more than 4.99% of the Company’s outstanding common stock immediately after the exercise. The Purchaser may decrease, upon at least 61 days’ prior notice to the Company, increase this percentage with respect to the December 2023 Private Placement warrants. In no event shall such beneficial ownership limitation exceed 9.99%. and have . The net proceeds to the Company from the 2023 December 2023 Offering was approximately $2.0 million, after deducting placement agent fees and other offering expenses paid by the Company totaling approximately $0.3 million.
The Company’s financial statements do not include any adjustments to the assets carrying amount, to the expenses presented and to the reclassification of the balance sheets items that could be necessary should the Company be unable to continue its operations. |
Summary of Significant Accounting Policies |
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Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies
Basis of presentation:
The financial statements of the Company were prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”).
Certain reclassifications have been made to prior period amounts to conform to the current period presentation. These reclassifications had no impact on previously reported net loss for the year ended December 31, 2022.
Use of estimates:
The presentation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Accounting Standard Updates
A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s financial statements.
In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, “Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments”. The standard requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The adoption of the standard as of January 1, 2023, did not have a material impact on the Company’s financial statements.
In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures”. The amendments in this ASU change disclosure requirements for various items, including effective tax rate reconciliations and cash taxes paid. This ASU is effective for public companies for the financial reporting periods beginning on January 1, 2025, with early adoption permitted. We have not adopted ASU 2023-09 for our financial period ending December 31, 2023, and will continue to evaluate early adoption for our financial period ending December 31, 2024.
Cash and cash equivalents:
The Company considers cash to consist of cash and cash equivalents and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.
Marketable Securities:
Marketable securities at December 31, 2023 and 2022 consisted of marketable fixed income securities, primarily corporate bonds, as well as U.S. Government and agency obligations which are categorized as available-for-sale securities and are thus marked to market and stated at fair value in accordance with Accounting Standards Codification (“ASC”) 820 Fair Value Measurement. These investments are considered Level 1 and Level 2 investments within the ASC 820 fair value hierarchy. The fair value of Level 1 investments, including cash equivalents, money funds and U.S. government securities, are substantially based on quoted market prices. The fair value of corporate bonds is determined using standard market valuation methodologies, including discounted cash flows, matrix pricing and / or other similar techniques. The inputs to these valuation techniques include but are not limited to market interest rates, credit rating of the issuer or counterparty, industry sector of the issuer, coupon rate, call provisions, maturity, estimated duration and assumptions regarding liquidity and estimated future cash flows. In addition to bond characteristics, the valuation methodologies incorporate market data, such as actual trades completed, bids and actual dealer quotes, where such information is available. Accordingly, the estimated fair values are based on available market information and judgments about financial instruments categorized within Level 1 and Level 2 of the fair value hierarchy. Interest and dividends are recorded when earned. Realized gains and losses on investments are determined by specific identification and are recognized as incurred in the statement of operations. Changes in net unrealized gains and losses are reported in other comprehensive loss and represent the change in the fair value of investment holdings during the reporting period. Changes in net unrealized gains and losses were $0.3 million and ($0.3) million for the years ended December 31, 2023 and 2022, respectively.
Inventory:
The Company will begin carrying inventory of its biological products on its balance sheets following commercial launch of such products. Inventory will consist of raw materials, biological products in process, and finished goods available for sale. The Company will determine its inventory values using the average cost method. Inventory will be valued at the lower of cost or net realizable value and will exclude units that the Company anticipates distributing for clinical evaluation. As of each of December 31, 2023 and 2022, all of the Company’s biological products were anticipated to be distributed for clinical evaluation.
The Company does not currently carry any inventory for its biological products, as it has yet to launch a product for commercial distribution. Historically the Company’s operations have focused on clinical trials and discovery efforts, and accordingly, costs of manufactured clinical doses of biological product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once the Company begins commercial distribution, costs of all newly manufactured biological products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred.
Accounts and grants receivable:
Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of December 31, 2023 and 2022 are deemed to be collectible and no amount has been recognized for doubtful accounts. MSCRF-TEDCO (defined below under Revenue Recognition) generally advance grant funds and therefore a receivable is not usually recognized. In addition, for the clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the clinical trial revenue are recorded to deferred revenue.
Accounts and grants receivable by source, as of (in thousands):
Deferred offering costs:
The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering.
Property and equipment:
Property and equipment, including improvements that extend useful lives of related assets, are recorded at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs.
Intangible assets:
Intangible assets include payments on license agreements with the Company’s co-founder and Chief Scientific Officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired.
Payments for license agreements are amortized using the straight-line method over the estimated term of the agreements, which range from 5-20 years. Patents are amortized over their estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the statements of operations as the assets are primarily related to the Company’s clinical programs.
Impairment of Long-Lived Assets:
The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected on the statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets during the years ended December 31, 2023 and 2022.
Deferred revenue:
The unearned portion of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the balance sheets. For the years ended December 31, 2023 and 2022, the Company recognized $0 and $0.1 million, respectively, of funds that were previously classified as deferred revenue. Due to the MSCRF – TEDCO – grant ARDS program being discontinued, the $0.4 million recorded as deferred revenue will be reversed when the funds are returned to MSCRF – TEDCO.
Revenue recognition:
The Company recognizes revenue when performance obligations related to respective revenue streams are met. For grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. For clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment. For contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and / or statement of work has been satisfied. Payment terms may vary depending on specific contract terms. There are no significant judgments affecting the determination of the amount and timing of revenue recognition.
Revenue by source (in thousands):
The Company records cost of revenues based on expenses directly related to revenue. For Grants, the Company records allocated expenses for Research and development costs to a grant as a cost of revenues. For the Clinical trial revenue directly related expenses for that program are expensed as incurred. These expenses are similar to those described under “Research and development expense” below.
Research and development expense:
Research and development costs are charged to expense when incurred in accordance with ASC 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
Concentrations of credit risk:
Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, marketable securities, and accounts and grants receivable. Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts.
Income taxes:
The Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company’s tax provision was $0 for the years ended December 31, 2023 and 2022 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the uncertainty of realizing a benefit in the future.
The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of December 31, 2023 and 2022, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable.
Equity-based compensation:
The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for stock-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model.
The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options.
Neither the Company’s stock options nor its restricted stock units (“RSUs”) trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of ten years. The Company had insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life. |
Marketable Securities |
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Marketable securities | 3. Marketable securities
The following is summary of marketable securities that the Company measures at fair value (in thousands):
As of December 31, 2023 and 2022, the Company reported accrued interest receivable related to marketable securities of less than $0.1 million. These amounts are recorded in other assets on the Balance Sheets and are not included in the carrying value of the marketable securities.
As of December 31, 2023 and 2022, the Company recorded unrealized losses attributable to changes in marketable securities of $0 and $0.4 million, respectively. These unrealized losses were recorded on the balance sheets as accumulated other comprehensive loss.
As of December 31, 2023 and 2022, the amortized cost of these securities was $0.4 million and $9.4 million, respectively. |
Property and Equipment, Net |
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Property and equipment, net | 4. Property and equipment, net
Major components of property and equipment are as follows (in thousands):
Depreciation and amortization expense amounted to approximately $0.7 million for the years ended December 31, 2023 and 2022. |
Intangible Assets, Net |
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Intangible assets, net | 5. Intangible assets, net
Major components of intangible assets as of December 31, 2023 are as follows (in thousands):
Major components of intangible assets as of December 31, 2022, are as follows (in thousands):
Amortization expense related to intangible assets amounted to approximately $0.2 million for the years ended December 31, 2023 and 2022. During the year ended December 31, 2023, the Company wrote-off $0.3 million of abandoned patents that it was no longer pursuing in several jurisdictions.
Future amortization expense for intangible assets as of December 31, 2023 is approximately as follows (in thousands):
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Leases |
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Leases | 6. Leases
The Company records a right-of-use operating lease asset and a lease liability related to its operating leases (there are no finance leases). The Company’s corporate office lease expires in March 2027. As of December 31, 2023, the operating lease asset and operating lease liability were approximately $1.2 million and $2.0 million, respectively. As of December 31, 2022, the operating lease asset and operating lease liability were approximately $1.5 million and $2.6 million, respectively.
Future minimum payments under the operating leases as of December 31, 2023 are as follows (in thousands):
During the years ended December 31, 2023 and 2022, the Company incurred approximately $0.9 million and $1.0 million, respectively, of total lease costs that are included in the general and administrative expenses in the statements of operations.
On July 1, 2020, the Company entered into a sublease agreement for a portion of its leased space for a one-year period ending June 30, 2021, with optional one-year renewal periods, and $10,000 in monthly payments. The sublease was terminated in the second quarter of 2022. For the year ended December 31, 2022, $27,000 was recognized as sublease income, due to the Company receiving $17,000 of equipment and $10,000 of security deposit forfeited. |
Stockholders’ Equity |
12 Months Ended |
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Dec. 31, 2023 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | 7. Stockholders’ Equity
Class A Common Stock
RSUs are taxable upon vesting based on the market value on the date of vesting. The Company is required to make mandatory tax withholding for the payment and satisfaction of income tax, social security tax, payroll tax, or payment on account of other tax related to withholding obligations that arise by reason of vesting of an RSU. The taxable income is calculated by multiplying the number of vested RSUs for each individual by the closing share price as of the vesting date and a tax liability is calculated based on each individual’s tax bracket. During the year ended December 31, 2023, a total of 253,084 RSUs vested for Class A common stock shares. Of that amount, the Company withheld 52,227 Class A common stock shares to satisfy employee tax liabilities. During the year ended December 31, 2022, a total of 172,274 RSUs vested for Class A common stock shares. Of that amount, the Company withheld 32,438 Class A common stock shares to satisfy employee tax liabilities. The shares withheld are available for reissuance pursuant to the Company’s 2021 Incentive Award Plan.
On November 16, 2022, the Company accounted for but had not issued 48,140 RSUs convertible to unregistered shares of Class A common stock, with an aggregate value of $207,000 as payment for accrued expenses under a consulting agreement with Dr. Hare. On May 24, 2023, these shares were issued to Dr. Hare.
On June 22, 2022, a total of 27,854 RSUs were granted to the Company’s former Chief Executive Officer, Geoff Green, in exchange for $170,000 of compensation, as agreed upon in connection with his separation.
On April 18, 2023, the Company finalized the Separation Agreement dated March 31, 2023, for Dr. Christopher Min, the Company’s former interim Chief Executive Office and Chief Medical Officer. In part for his agreement to a general release the Company agreed to pay Dr. Min: $112,000 as severance compensation and allowed for the immediate acceleration and vesting of 40,000 RSUs that were previously granted.
On April 19, 2023, the Company finalized the Separation Agreement effective June 9, 2023, for James Clavijo, the Company’s former Chief Financial Officer (“CFO”). In part for his agreement to a general release the Company agreed to pay Mr. Clavijo $275,000 as severance compensation, three months of payment for COBRA insurance coverage and the immediate acceleration and vesting of 6,690 RSUs that were previously granted. Mr. Clavijo entered into a concurrent consulting agreement with the Company to continue as interim CFO until a permanent successor joined the Company. The consulting agreement has since expired.
On June 27, 2023, the Company filed a registration statement with the SEC to conduct a tradeable subscription rights offering for up to $30.0 million of shares of Class A common stock to its stockholders and holders of certain warrants to purchase common stock. On July 28, 2023, the Company filed a first amendment to the registration statement. On August 16, 2023, the registration statement was declared effective by the SEC, and on August 22, 2023, the Company launched the subscription rights offering at a subscription price of $3.00 per share of Class A common stock. On September 21, 2023, the subscription period for the rights offering of the Company expired. At the end of the subscription period, the Company sold 108,497 shares of its Class A common stock at a price of $3.00 per share. There were no net proceeds to the Company after deducting the $0.3 million of expenses associated with the rights offering.
On October 11, 2023, the Company entered into a securities purchase agreement with an institutional and accredited investor (the “Purchaser”) relating to the registered direct offering and sale of an aggregate of 2,365,000 shares of the Company’s Class A common stock, par value $0.001 per share and pre-funded warrants to purchase up to 59,243 shares of Class A common stock at an exercise price of $0.001 per share, at a purchase price of $1.65 per share and $1.649 per pre-funded Warrant (the “October 2023 Registered Direct Offering”), which Offering closed and was funded October 13, 2023.
In a concurrent private placement, the Company also sold to the Purchaser unregistered Series A warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock and unregistered Series B warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock (the “Warrants”)( the “October 2023 Private Placement” and collectively, with the October 2023 Registered Direct Offering, the “October 2023 Offering”). The unregistered Series A Warrants have an exercise price of $1.65 per share, became exercisable December 26, 2023, and have a term of five and one-half years from the date of issuance. The unregistered Series B Warrants have an exercise price of $1.65 per share, became exercisable December 26, 2023, and have a term of eighteen months from the date of issuance. The Series A and B warrants became exercisable upon stockholder approval on December 26, 2023, and each Warrant is exercisable for one share of Class A common stock. The net proceeds to the Company from the October 2023 Offering was approximately $3.4 million, after deducting placement agent fees and other offering expenses paid by the Company.
On December 20, 2023 the Company entered into a securities purchase agreement with an institutional and accredited investor (the “Purchaser”) relating to the registered direct offering and sale of an aggregate of 1,355,301 shares of the Company’s Class A common stock, par value $0.001 per share, at a purchase price of $1.745 per share of common stock (the “December 2023 Registered Direct Offering”), which Offering closed and was funded on December 22, 2023.
In a concurrent private placement on December 22, 2023, concurrent with the December 2023 Registered Direct Offering, the Company also sold to the Purchaser unregistered long-term warrants to purchase up to an aggregate of 1,355,301 shares of its Class A common stock (the “December 2023 Private Placement”, and together with the December 2023 Registered Direct Offering, the “December 2023 Offering”). The unregistered December 2023 Private Placement warrants have an exercise price of $1.62 per share, became immediately exercisable upon issuance, expire on June 20, 2029, and have a term of five and one-half years from the date of issuance. The net proceeds to the Company from the December 2023 Offering was approximately $2.0 million, after deducting placement agent fees and other offering expenses paid by the Company.
During the year ended December 31, 2023, no stock options were exercised for shares of Class A common stock. During the year ended December 31, 2022, 374 stock options were exercised for shares of Class A common stock at an average exercise price of $5.73 for $2,143.
Class B Common Stock
In connection with the Corporate Conversion, 2,000,000 outstanding Series A and B units were converted into 15,702,834 shares of our unregistered Class B common stock.
Holders of Class A common stock generally have rights identical to holders of Class B common stock, except that holders of Class A common stock are entitled to one vote per share and holders of Class B common stock are entitled to five (5) votes per share. The holders of Class B common stock may convert each share of Class B common stock into one share of Class A common stock at any time at the holder’s option. Class B common stock is not publicly tradable.
During the year ended December 31, 2023, shareholders exchanged 35,546 shares of Class B common stock for 35,546 shares of Class A common stock. During the year ended December 31, 2022, shareholders exchanged 811,749 shares of Class B common stock for 811,749 shares of Class A common stock.
Warrants
As part of the IPO, the underwriter received warrants to purchase 106,400 shares of Class A common stock. The warrants are exercisable at any time and from time to time, in whole or in part, during the four and a half-year period commencing August 12, 2021, at a price of $12.00 per share. Total grant date fair value of warrants as of December 31, 2021 was approximately $0.5 million. During 2021, the underwriters assigned 95,760 of the warrants to its employees. As of December 31, 2023, 51,061 warrants have been exercised for Class A common stock shares at an exercise price of $12.00 for $612,732.
As part of the December 2021 PIPE Offering, the Company issued 1,169,288 warrants to investors (“Purchaser Warrants”) to purchase up to a number of shares of Class A common stock equal to the number of shares of Class A common stock purchased by such investor in the offering, at an exercise price of $17.50 per share. The purchaser warrants are immediately exercisable, expire five years from the date of issuance and have certain downward pricing adjustment mechanisms, subject to a floor, as set forth in greater detail in the purchase warrants. In addition, the Company granted the underwriters warrants, under similar terms, to purchase 46,722 shares of Class A common stock, at an exercise price of $17.50 per share.
On August 16, 2023, the Company announced its Stock Rights Offering, which triggered the downward pricing mechanism on the Purchaser Warrants, at which time these warrants were adjusted downward to an exercise price of $5.25 for the period remaining through expiration. This resulted in a deemed dividend to common stockholders of approximately $0.8 million for the change in the fair value of the warrants using a Black-Scholes pricing model.
As part of the October 2023 Offering, the Company issued an aggregate of 2,424,243 Series A warrants and 2,424,243 Series B warrants to the purchaser to purchase up to a number of shares of Class A common stock. The Series A warrants have an exercise price of $1.65 per share and have a term of five and one-half years from the date of issuance. The Series B warrants have an exercise price of $1.65 per share and have a term of eighteen months from the date of issuance. Both the Series A and Series B warrants became exercisable as of December 26, 2023, following stockholder approval. In addition, the Company granted the underwriters warrants, under similar terms, to purchase 169,697 shares of Class A common stock, at an exercise price of $2.0625 per share.
As part of the December 2023 Offering, the Company sold unregistered long-term warrants to purchase an aggregate of 1,355,301 warrants to the purchase shares of Class A common stock. These unregistered warrants have an exercise price of $1.62 per share, became immediately issuable upon issuance, and expire on June 20, 2029. In addition, the Company granted the underwriters warrants, under similar terms, to purchase 94,871 shares of Class A common stock, at an exercise price of $2.1813 per share. |
Equity Incentive Plan |
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Equity Incentive Plan | 8. Equity Incentive Plan
RSUs
As part of the Company’s IPO, the Company adopted and approved the 2021 Incentive Award Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company may grant cash and equity incentive awards to employees and eligible service providers in order to attract, motivate and retain the talent for which the Company competes.
On November 16, 2022, the Company accounted for but had not issued 48,140 RSUs convertible to unregistered shares of Class A common stock, with an aggregate value of $207,000 as payment for accrued expenses under a consulting agreement with Dr. Hare. On May 24,2023, these shares were issued to Dr. Hare.
On June 22, 2022, the Company granted $170,000 of separation compensation to Mr. Green (Mr. Green resigned as CEO effective June 1, 2022), which were converted into 27,854 RSUs. The RSU were issued based on the three-day average of the fair market value prior to the time of grant, June 22, 2022, of $6.10.
On June 3, 2022, the Company granted a bonus to each of Mr. Clavijo and Mr. Lehr in the form of RSUs. Mr. Clavijo and Mr. Lehr were each granted 40,000 RSUs each that vested one-third at the grant date, with the remaining two thirds vesting on the first- and second-year anniversary of the grant date. The RSU were issued based at fair market value at the time of grant, June 3, 2022, of $8.73.
On April 4, 2022, the Company appointed K. Chris Min, M.D., Ph.D. as its Chief Medical Officer. Dr. Min’s employment agreement provided for annual base salary of $350,000, and he was eligible to receive a performance bonus equal to 30% of his base salary, prorated for his first year of employment. Dr. Min received a $60,000 signing bonus, with 50% of this amount paid in RSUs and 50% in stock options. Dr. Min also received two equity incentive awards: 150,000 RSUs and a stock option award exercisable for 50,000 shares. Each award was to vest 25% upon the first-year anniversary of his first day of employment with Longeveron, with 25% vesting thereafter on the second, third and fourth anniversaries of his employment. In each case, the vesting of the equity awards was to be subject to Dr. Min’s continued service through the applicable vesting dates. RSUs were being expensed on a quarterly basis at the rate of $0.1 million for the quarterly vesting amount of 9,375 RSUs, with a price per share of $12.85 (the closing price of the Company’s stock on April 4, 2022). Stock options were being expensed based upon a Black-Scholes calculation, the price per share to be expensed was $11.34 and a total cost of $0.6 million would be expensed ratably over 48 months. On April 18, 2023, the Company finalized the Separation Agreement dated March 31, 2023, for Dr.Min. In part for his agreement to a general release, the Company agreed to pay Dr. Min: $112,000 as severance compensation and allowed for the immediate acceleration and vesting of 40,000 RSUs that were previously granted.
On March 1, 2023, the Company granted the newly-hired Chief Executive Officer, Mr. Hashad a signing bonus of 50,000 RSUs, which vested in quarterly installments on each of April 1, 2023, July 1, 2023, September 1, 2023, and December 31, 2023. Mr. Hashad will also receive annual long-term equity incentive awards through 2026 consisting of 50,000 shares of time-based vesting stock options and up to 125,000 of performance share units “(PSUs”), in accordance with the terms of the Longeveron 2021 Incentive Award Plan.
On April 19, 2023, the Company finalized the Separation Agreement effective June 9, 2023, for James Clavijo, the Company’s former Chief Financial Officer. In part for his agreement to a general release, the Company agreed to pay Mr. Clavijo $275,000 as severance compensation, three months of payment for COBRA insurance coverage and the immediate acceleration and vesting of 6,690 RSUs that were previously granted. Mr. Clavijo entered into a concurrent consulting agreement with the Company to continue as interim Chief Financial Officer until a permanent successor joined the Company. This agreement has since expired.
On June 9, 2023, the Company granted newly elected Board of Directors, Khoso Baluch and Jeffrey Pfeffer, 5,000 RSUs each. The RSUs vested 50% on the date of grant and will vest 25% on each of the next annual anniversary dates.
On July 24, 2023, the Company granted Nataliya Agafonova, Chief Medical Officer, a signing bonus of 30,000 RSUs, which vest in quarterly installments on each of July 24, 2023, October 1, 2023, January 1, 2024, and April 1, 2024.
On July 31, 2023, the Company granted Lisa Locklear, Executive Vice President and Chief Financial Officer, a signing bonus of 40,000 RSUs, which vest in quarterly installments on each of October 1, 2023, January 1, 2024, April 1, 2024, and July 31, 2024.
As of December 31, 2023 and 2022, the Company had 112,393 and 329,746, respectively RSUs outstanding (unvested).
RSU activity for the year ended December 31, 2023 was as follows:
Stock Options
Stock options may be granted under the 2021 Incentive Plan. The exercise price of options is equal to the fair market value of the Company’s Class A common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The 2021 Incentive Plan provides for equity grants to be granted up to 5% of the outstanding common stock shares.
The fair value of the options issued are estimated using the Black-Scholes option-pricing model and for 2023 have the following assumptions: a dividend yield of 0%; an expected life of years; volatility ranging from 90%-95%; and risk-free interest rate based on the grant date ranging from of 3.89% to 4.01%. For 2022, the following assumptions were used: a dividend yield of 0%; an expected life of years; volatility of 95%; and risk-free interest rate based on the grant date ranging from of 1.23% to 3.68%. Each option grant made during 2023 and 2022, will be expensed ratably over the option vesting periods, which approximates the service period.
As of December 31, 2023, the Company has recorded issued and outstanding options to purchase a total of 437,843 shares of Class A common stock pursuant to the 2021 Incentive Plan, at a weighted average exercise price of $4.96 per share. Also, as of December 31, 2022, the Company has recorded issued and outstanding options to purchase a total of 470,191 shares of Class A common stock pursuant to the 2021 Incentive Plan, at a weighted average exercise price of $6.18 per share.
For the year ended December 31, 2023:
For the year ended December 31, 2022:
Stock Option activity for the year ended December 31, 2023 was as follows:
On December 21, 2023, the Company granted an award of 12,000 Class A common stock options to each of its non-employee directors (a total of 96,000 options). The stock option award has a four-year vesting period, vesting 25% per year, and has an exercise price of $1.25. Based upon a Black-Scholes calculation, the price per share to be expensed was $1.09 and a total cost of $0.1 million that would be expensed ratably over 48 months.
On March 1, 2023, the Company granted an award of 50,000 Class A common stock options to Mr. Hashad. The stock option award has a one-year vesting period, vesting on the first anniversary of the grant date, and has an exercise price of $3.62. Based upon a Black-Scholes calculation, the price per share to be expensed was $3.23 and a total cost of $0.2 million would be expensed ratably over 12 months.
On December 21, 2022, the Company granted an award of 5,000 Class A common stock options to each of its non-employee directors (a total of 45,000 options). The stock option award has a four-year vesting period, vesting 25% per year, and has an exercise price of $3.00. Based upon a Black-Scholes calculation, the price per share to be expensed was $2.67 and a total cost of $0.1 million that would be expensed ratably over 48 months.
On November 16, 2022, the Company granted an award of 22,843 Class A common stock options to Mr. Paul Lehr, General Counsel and Corporate Secretary. The stock option award has a four-year vesting period, vesting 25% per year, and has an exercise price of $4.30. Based upon a Black-Scholes calculation, the price per share to be expensed was $2.94 and a total cost of less than $0.1 million would be expensed ratably over 48 months.
On September 6, 2022, the Company granted an award of 10,000 Class A common stock options to an employee. The stock option award has a four-year vesting period, vesting 25% per year, and has an exercise price of $4.67. Based upon a Black-Scholes calculation, the price per share to be expensed was $4.15 and a total cost of less than $0.1 million would be expensed ratably over 48 months.
On June 3, 2022, the Company granted an award of 5,000 Class A common stock options to Mr. Lehr. The stock option award vested upon the grant date and has an exercise price of $8.73. Based upon a Black-Scholes calculation, the price per share to be expensed was $7.73 and a total cost of less than $0.1 million was expensed on the grant date.
On March 14, 2022, the Company granted an award of 22,000 Class A common stock options to employees. The stock option award has a four-year vesting period, vesting 25% per year, and has an exercise price of $5.94. Based upon a Black-Scholes calculation, the price per share to be expensed was $5.23 and a total cost of less than $0.1 million would be expensed ratably over 48 months.
On January 6, 2022, the Company granted awards of 84,825 Class A common stock options to employees. The stock option awards have four-year vesting periods, vesting 25% per year, and have an exercise price of $10.00. Based upon a Black-Scholes calculation, the price per share to be expensed was $8.78 and a total cost of $0.7 million would be expensed ratably over 48 months.
For the years ended December 31, 2023 and 2022, the equity-based compensation expense amounted to approximately $2.0 million and $2.3 million, respectively, which is included in the research and development and general and administrative expenses in the statements of operations for the years ended December 31, 2023 and 2022.
As of December 31, 2023, the remaining unrecognized equity-based compensation (which includes RSUs, PSUs and stock options) of approximately $1.5 million will be recognized over a weighted average time period of approximately years. |
Commitments and Contingencies |
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Dec. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies
Master Services and Clinical Studies Agreements:
As of December 31, 2023, the Company had three active master services agreements with third parties to conduct its clinical trials and manage clinical research programs and clinical development services on behalf of the Company. The Company expects these agreements or amended current agreements to have total expenditures of approximately $1.1 million over the next two years.
As of December 31, 2022, the Company had two active master services agreements with third parties to conduct its clinical trials and manage clinical research programs and clinical development services on behalf of the Company.
Consulting Services Agreement:
On November 20, 2014, the Company entered into a ten-year consulting services agreement with Dr. Joshua Hare, its CSO. Under the agreement, the Company has agreed to pay the CSO $265,000 annually. The compensation payments are for scientific knowledge, medical research, technical knowledge, skills, and abilities to be provided by the CSO to further develop the intellectual property rights assigned by the CSO to the Company. This agreement requires the CSO to also assign to the Company the exclusive right, title, and interest in any work product developed from his efforts during the term of this agreement. On November 16, 2022, the Company accounted for but had not issued 48,140 RSUs convertible to unregistered shares of Class A common stock, with an aggregate value of $207,000 as payment for accrued expenses under a consulting agreement with the CSO. These shares were issued on May 24, 2023. As of December 31, 2023 and 2022, the Company had accrued balances due to the CSO of approximately $0.1 million and less than $0.1 million, respectively, included in accrued expenses and approximately $0.1 million for both years included in accounts payable in the accompanying balance sheets.
Technology Services Agreement:
On March 27, 2015, the Company entered into a technology services agreement with Optimal Networks, Inc. (a related company owned by Dr. Joshua Hare’s brother-in-law) for use of information technology services. The technology services agreement was terminated as of April 14, 2023. As of December 31, 2023 and 2022, the Company owed $0 and less than $0.1 million, respectively, pursuant to this agreement, which is included in accounts payable in the accompanying balance sheets.
Exclusive Licensing Agreements:
UM Agreement
On November 20, 2014, the Company entered into an Exclusive License Agreement with UM (the “UM License”) for the use of certain Aging-related Frailty Mesenchymal Stem Cell (“MSC”) technology rights developed by our CSO at UM. The UM License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how specifically related to the development of the culture-expanded MSCs for Aging-related Frailty used at the Human-induced pluripotent stem cell-derived MSCs (IMSCs”), all standard operating procedures used to create the IMSCs, and all data supporting isolation, culture, expansion, processing, cryopreservation and management of the IMSCs. The Company is required to pay UM (i) a license issue fee of $5,000, (ii) a running royalty in an amount equal to three percent of annual net sales on products or services developed from the technology, payable on a country-by-country basis beginning on the date of first commercial sale through termination of the UM License Agreement, and which may be reduced to the extent we are required to pay royalties to a third party for the same product or process, (iii) escalating annual cash payments of up to fifty thousand dollars, subject to offset. The agreement extends for up to 20 years from the last date a product or process is commercialized from the technology and was amended in 2017 to modify certain milestone completion dates as detailed below. In 2021 the license fee was increased by an additional $100,000, to defray patent costs. In addition, the Company issued 110,387 unregistered shares of Class A common stock to UM.
The milestone payment amendments shifted the triggering payments to three payments of $500,000, to be paid within six months of: (a) the completion of the first Phase 3 clinical trial of the products (based upon the final data unblinding); (b) the receipt by the Company of approval for the first new drug application (“NDA”), biologics application (“BLA”), or other marketing or licensing application for the product; and (c) the first sale following product approval. “Approval” refers to Product approval, licensure, or other marketing authorization by the U.S. Food and Drug Administration, or any successor agency. The amendments also provided for the Company’s license of additional technology, to the extent not previously included in the UM License, and granted the Company an exclusive option to obtain an exclusive license for (a) the Hypoplastic Left Heart Syndrome (“HLHS”) investigational new drug application (“IND”) with ckit+ cells; and (b) UMP-438 titled “Method of Determining Responsiveness to Cell Therapy in Dilated Cardiomyopathy.”
The Company has the right to terminate the UM License upon 60 days’ prior written notice, and either party has the right to terminate upon a breach of the UM License. To date, the Company has made payments totaling $365,000 to UM, and as of December 31, 2023 and 2022, in the accompanying balance sheets, we had accrued $50,000 in milestone fees payable to UM for both years and $15,000 and $30,000, respectively, for patent related reimbursements based on the estimated progress to date.
CD271
On December 22, 2016, the Company entered into an exclusive license agreement with an affiliated entity of Dr. Joshua Hare, JMH MD Holdings, LLC (“JMHMD”), for the use of CD271 cellular therapy technology. The Company recorded the value of the cash consideration and membership units issued to obtain this license agreement as an intangible asset. The Company is required to pay as royalty 1% of the annual net sales of the licensed product(s) used, leased, or sold by or for licensee or its sub-licensees. If the Company sublicenses the technology, it is also required to pay an amount equal to 10% of the net sales of the sub-licensees. In addition, on December 23, 2016, as required by the license agreement, the Company paid an initial fee of $250,000 to JMHMD, and issued to it 10,000 Series C Units, valued at $250,000. The $0.5 million of value provided to JMHMD for the license agreement, along with professional fees of approximately $27,000, were recorded as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. Further, expenses related to the furtherance of the CD271+ technology is being capitalized and amortized as incurred over 20 years. There were no license fees due for the years ended December 31, 2023 and 2022 pertaining to this agreement.
Other Royalty
Under the grant award agreement with the Alzheimer’s Association, the Company may be required to make revenue sharing or distribution of revenue payments for products or inventions generated or resulting from this clinical trial program. The potential payments, although not currently defined, could result in a maximum payment of five times (5x) the award amount of $3.0 million.
Contingencies – Legal
On September 13, 2021, the Company and certain of its directors and officers were named as defendants in a securities lawsuit filed in the U.S. District Court for the Southern District of Florida and brought on behalf of a purported class. The suit alleges there were materially false and misleading statements made (or omissions of required information) in the Company’s initial public offering materials and in other disclosures during the period from our initial public offering on February 12, 2021, through August 12, 2021, in violation of the federal securities laws. The action sought damages on behalf of a proposed class of purchasers of the Company’s common stock during said period. On July 12, 2022, all parties preliminarily agreed to settle the action for approximately $1.4 million, which settlement was preliminarily approved by the Court on or about May 12, 2023, and which settlement amount was paid on May 24, 2023. Legal expenses incurred in ordinary business activities are reported within general and administrative expenses.
On or about May 18, 2023, a former employee of the Company filed a charge with the Equal Employment Opportunities Commission (“EEOC”) and the Florida Commission on Human Relations alleging discrimination based on disability, and on or about August 15, 2023, the former employee filed a complaint in Miami-Dade Circuit Court alleging unpaid wages were outstanding. Both matters were addressed and fully resolved and settled in a mediation between the Company and the former employee held on September 28, 2023, by which it was agreed that the former employee would be paid $75,000 (a total of $35,000 towards this resolution was paid by the Company and all remaining costs were covered by the Company’s insurance carrier) and that the EEOC and FCHR charges were withdrawn and the action in the Miami-Dade Circuit Court was dismissed with prejudice. |
Employee Benefits Plan |
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Dec. 31, 2023 | |
Employee Benefits Plan [Abstract] | |
Employee Benefits Plan | 10. Employee Benefits Plan
The Company sponsors a defined contribution employee benefit plan (the “Plan”) under the provisions of Section 401(k) of the Internal Revenue Code. The Plan covers substantially all full-time employees of the Company who are eligible upon date of hire. Contributions to the Plan by the Company are at the discretion of the Board of Directors.
The Company contributed approximately $131,000 and $88,000 to the Plan during the years ended December 31, 2023 and 2022, respectively. |
Income Taxes |
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Income Taxes [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | 11. Income Taxes
The tax effects of temporary differences and net operating loss (“NOL”) carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were approximately as follows at December 31, 2023 and December 31, 2022 (in thousands):
As of December 31, 2023, the Company had NOL carryforwards for federal purposes of approximately $30.9 million, all of which have no expiration. The Company also had state NOL carryforwards of approximately $29.9 million, all of which have no expiration. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points in shares owned by any 50% owner. In addition, the NOL carry forwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs may be substantially limited.
Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended December 31, 2023 and 2022 were as follows:
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2023, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from 2021, the earliest year with a net operating loss carryover, because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2023 and 2022. |
Loss Per Share |
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Loss Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share | 12. Loss Per Share
Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. We have outstanding stock-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive.
The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive:
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Subsequent Events |
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Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events
In line with the Company’s 2024 strategic direction to focus its resources on HLHS and AD and manage its cash spend, the Company decided to discontinue its previously disclosed clinical trial in Japan to evaluate Lomecel-BTM for Aging-related Frailty.
On February 21, 2024, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse stock split of its outstanding shares of Class A common stock and Class B common stock at a ratio, ranging from one-for-five (1:5) to one-for-fifteen (1:15), with the exact ratio to be set within that range at the discretion of its Board of Directors without further approval or authorization of its stockholders. The date of the reverse stock split and the ratio has not yet been determined. |
Pay vs Performance Disclosure - USD ($) $ in Thousands |
12 Months Ended | |
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Dec. 31, 2023 |
Dec. 31, 2022 |
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Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (21,413) | $ (18,835) |
Insider Trading Arrangements - shares |
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Dec. 31, 2023 |
Sep. 29, 2024 |
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Trading Arrangements, by Individual | ||
Rule 10b5-1 Arrangement Adopted | false | |
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Neil Hare [Member] | ||
Trading Arrangements, by Individual | ||
Name | Neil Hare | |
Title | member of the Company’s Board of Directors | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | December 29, 2023 | |
Aggregate Available | 45,044 |
Accounting Policies, by Policy (Policies) |
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Summary of Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of presentation | Basis of presentation: The financial statements of the Company were prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). Certain reclassifications have been made to prior period amounts to conform to the current period presentation. These reclassifications had no impact on previously reported net loss for the year ended December 31, 2022. |
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Use of estimates | Use of estimates: The presentation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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Accounting Standard Updates | Accounting Standard Updates A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s financial statements. In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, “Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments”. The standard requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The adoption of the standard as of January 1, 2023, did not have a material impact on the Company’s financial statements. In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures”. The amendments in this ASU change disclosure requirements for various items, including effective tax rate reconciliations and cash taxes paid. This ASU is effective for public companies for the financial reporting periods beginning on January 1, 2025, with early adoption permitted. We have not adopted ASU 2023-09 for our financial period ending December 31, 2023, and will continue to evaluate early adoption for our financial period ending December 31, 2024. |
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Cash and cash equivalents | Cash and cash equivalents: The Company considers cash to consist of cash and cash equivalents and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.
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Marketable securities | Marketable Securities: Marketable securities at December 31, 2023 and 2022 consisted of marketable fixed income securities, primarily corporate bonds, as well as U.S. Government and agency obligations which are categorized as available-for-sale securities and are thus marked to market and stated at fair value in accordance with Accounting Standards Codification (“ASC”) 820 Fair Value Measurement. These investments are considered Level 1 and Level 2 investments within the ASC 820 fair value hierarchy. The fair value of Level 1 investments, including cash equivalents, money funds and U.S. government securities, are substantially based on quoted market prices. The fair value of corporate bonds is determined using standard market valuation methodologies, including discounted cash flows, matrix pricing and / or other similar techniques. The inputs to these valuation techniques include but are not limited to market interest rates, credit rating of the issuer or counterparty, industry sector of the issuer, coupon rate, call provisions, maturity, estimated duration and assumptions regarding liquidity and estimated future cash flows. In addition to bond characteristics, the valuation methodologies incorporate market data, such as actual trades completed, bids and actual dealer quotes, where such information is available. Accordingly, the estimated fair values are based on available market information and judgments about financial instruments categorized within Level 1 and Level 2 of the fair value hierarchy. Interest and dividends are recorded when earned. Realized gains and losses on investments are determined by specific identification and are recognized as incurred in the statement of operations. Changes in net unrealized gains and losses are reported in other comprehensive loss and represent the change in the fair value of investment holdings during the reporting period. Changes in net unrealized gains and losses were $0.3 million and ($0.3) million for the years ended December 31, 2023 and 2022, respectively. |
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Inventory | Inventory: The Company will begin carrying inventory of its biological products on its balance sheets following commercial launch of such products. Inventory will consist of raw materials, biological products in process, and finished goods available for sale. The Company will determine its inventory values using the average cost method. Inventory will be valued at the lower of cost or net realizable value and will exclude units that the Company anticipates distributing for clinical evaluation. As of each of December 31, 2023 and 2022, all of the Company’s biological products were anticipated to be distributed for clinical evaluation. The Company does not currently carry any inventory for its biological products, as it has yet to launch a product for commercial distribution. Historically the Company’s operations have focused on clinical trials and discovery efforts, and accordingly, costs of manufactured clinical doses of biological product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once the Company begins commercial distribution, costs of all newly manufactured biological products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred. |
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Accounts and grants receivable | Accounts and grants receivable: Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of December 31, 2023 and 2022 are deemed to be collectible and no amount has been recognized for doubtful accounts. MSCRF-TEDCO (defined below under Revenue Recognition) generally advance grant funds and therefore a receivable is not usually recognized. In addition, for the clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the clinical trial revenue are recorded to deferred revenue. Accounts and grants receivable by source, as of (in thousands):
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Deferred offering costs | Deferred offering costs: The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering.
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Property and equipment | Property and equipment: Property and equipment, including improvements that extend useful lives of related assets, are recorded at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs. |
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Intangible assets | Intangible assets: Intangible assets include payments on license agreements with the Company’s co-founder and Chief Scientific Officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired. Payments for license agreements are amortized using the straight-line method over the estimated term of the agreements, which range from 5-20 years. Patents are amortized over their estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the statements of operations as the assets are primarily related to the Company’s clinical programs. |
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Impairment of Long-Lived Assets | Impairment of Long-Lived Assets: The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected on the statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets during the years ended December 31, 2023 and 2022. |
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Deferred revenue | Deferred revenue: The unearned portion of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the balance sheets. For the years ended December 31, 2023 and 2022, the Company recognized $0 and $0.1 million, respectively, of funds that were previously classified as deferred revenue. Due to the MSCRF – TEDCO – grant ARDS program being discontinued, the $0.4 million recorded as deferred revenue will be reversed when the funds are returned to MSCRF – TEDCO. |
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Revenue recognition | Revenue recognition: The Company recognizes revenue when performance obligations related to respective revenue streams are met. For grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. For clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment. For contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and / or statement of work has been satisfied. Payment terms may vary depending on specific contract terms. There are no significant judgments affecting the determination of the amount and timing of revenue recognition.
Revenue by source (in thousands):
The Company records cost of revenues based on expenses directly related to revenue. For Grants, the Company records allocated expenses for Research and development costs to a grant as a cost of revenues. For the Clinical trial revenue directly related expenses for that program are expensed as incurred. These expenses are similar to those described under “Research and development expense” below. |
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Research and development expense | Research and development expense: Research and development costs are charged to expense when incurred in accordance with ASC 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. |
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Concentrations of credit risk | Concentrations of credit risk: Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, marketable securities, and accounts and grants receivable. Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts. |
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Income taxes | Income taxes: The Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company’s tax provision was $0 for the years ended December 31, 2023 and 2022 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the uncertainty of realizing a benefit in the future. The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of December 31, 2023 and 2022, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable.
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Equity-based compensation | Equity-based compensation: The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for stock-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options. Neither the Company’s stock options nor its restricted stock units (“RSUs”) trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of ten years. The Company had insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life. |
Summary of Significant Accounting Policies (Tables) |
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Schedule of Accounts and Grants Receivable | Accounts and grants receivable by source, as of (in thousands):
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Schedule of Revenue | Revenue by source (in thousands):
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Marketable Securities (Tables) |
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Marketable Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Marketable Securities | The following is summary of marketable securities that the Company
measures at fair value (in thousands):
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Property and Equipment, Net (Tables) |
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Schedule of Major Components of Property and Equipment | Major components of property and equipment are as follows (in thousands):
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Intangible Assets, Net (Tables) |
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Schedule of Major Components of Intangible Assets | Major components of intangible assets as of December
31, 2023 are as follows (in thousands):
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Schedule of Future Amortization Expense for Intangible Assets | Future amortization expense for intangible assets as of December 31,
2023 is approximately as follows (in thousands):
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Leases (Tables) |
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Dec. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Payments Under the Operating Leases | Future minimum payments under the
operating leases as of December 31, 2023 are as follows (in thousands):
|
Equity Incentive Plan (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Securities, Restricted [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of RSU Activity | RSU activity for the year ended December 31, 2023
was as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Issued and Outstanding Options | For the year ended December 31, 2023:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option Activity | Stock Option activity for the year ended December
31, 2023 was as follows:
|
Income Taxes (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Tax Effects of Temporary Differences and Net Operating Loss (“NOL”) Carryforwards | The tax effects of temporary differences and net operating loss (“NOL”)
carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were approximately as follows
at December 31, 2023 and December 31, 2022 (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Reconciliations of Income Tax Benefit Federal and State Statutory Tax Rates | Reconciliations of the difference between
income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended
December 31, 2023 and 2022 were as follows:
|
Loss Per Share (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investment Company, Investment Income (Loss) from Operations, Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Calculation of Diluted Net Loss Per Share | The following instruments (in thousands) were excluded from the calculation
of diluted net loss per share because their effects would be antidilutive:
|
Summary of Significant Accounting Policies (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Summary of Significant Accounting Policies [Line Items] | ||
Net unrealized losses | $ (300,000) | $ (300,000) |
Deferred revenue | 400,000 | |
Tax provision | $ 0 | 0 |
Options granted maximum term | 10 years | |
Minimum [Member] | Finite-Lived Intangible Assets [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Intangible assets estimated useful life | 5 years | |
Maximum [Member] | Finite-Lived Intangible Assets [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Intangible assets estimated useful life | 20 years | |
Deferred Revenue [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Deferred revenue recognized | $ 0 | $ 100,000 |
Summary of Significant Accounting Policies (Details) - Schedule of Accounts and Grants Receivable - USD ($) $ in Thousands |
Dec. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Schedule of Accounts and Grants Receivable [Line Items] | ||
Accounts and grants receivable | $ 111 | $ 218 |
National Institutes of Health – Grant [Member] | ||
Schedule of Accounts and Grants Receivable [Line Items] | ||
Accounts and grants receivable | 96 | 218 |
Accounts receivable from customers [Member] | ||
Schedule of Accounts and Grants Receivable [Line Items] | ||
Accounts and grants receivable | $ 15 |
Summary of Significant Accounting Policies (Details) - Schedule of Revenue - USD ($) $ in Thousands |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|||
Schedule of Revenue [Line Items] | ||||
Total revenue | $ 709 | $ 1,222 | ||
National Institute of Health - grant [Member] | ||||
Schedule of Revenue [Line Items] | ||||
Total revenue | 41 | 164 | ||
Clinical trial revenue [Member] | ||||
Schedule of Revenue [Line Items] | ||||
Total revenue | 668 | 940 | ||
MSCRF – TEDCO - grants [Member] | ||||
Schedule of Revenue [Line Items] | ||||
Total revenue | [1] | $ 118 | ||
|
Marketable Securities (Details) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Marketable securities [Line Items] | ||
Accrued interest receivable amount | $ 0.1 | $ 0.1 |
Unrealized losses marketable securities | 0.0 | 0.4 |
Securities of amortized cost | $ 0.4 | $ 9.4 |
Property and Equipment, Net (Details) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Property and Equipment, Net [Abstract] | ||
Depreciation and amortization expense | $ 0.7 | $ 0.7 |
Property and Equipment, Net (Details) - Schedule of Major Components of Property and Equipment - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment | $ 6,969 | $ 6,676 |
Less accumulated depreciation and amortization | 4,440 | 3,727 |
Property and equipment, net | $ 2,529 | 2,949 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Lives | 10 years | |
Total Property and Equipment | $ 4,328 | 4,328 |
Furniture/Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Lives | 7 years | |
Total Property and Equipment | $ 2,483 | 2,224 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Lives | 5 years | |
Total Property and Equipment | $ 120 | 46 |
Software/Website [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Lives | 3 years | |
Total Property and Equipment | $ 38 | $ 38 |
Intangible Assets, Net (Details) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Intangible Assets, Net [Abstract] | ||
Amortization expense related to intangible assets | $ 0.2 | $ 0.2 |
Abandoned patents | $ 0.3 |
Intangible Assets, Net (Details) - Schedule of Major Components of Intangible Assets - USD ($) $ in Thousands |
Dec. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 3,196 | $ 3,094 |
Accumulated Amortization | (909) | (685) |
Total | $ 2,287 | $ 2,409 |
License agreements [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Lives | 20 years | 20 years |
Cost | $ 2,043 | $ 2,043 |
Accumulated Amortization | (909) | (685) |
Total | 1,134 | 1,358 |
Patent Costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 959 | 887 |
Accumulated Amortization | ||
Total | 959 | 887 |
Trademark costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 194 | 164 |
Accumulated Amortization | ||
Total | $ 194 | $ 164 |
Intangible Assets, Net (Details) - Schedule of Future Amortization Expense for Intangible Assets $ in Thousands |
Dec. 31, 2023
USD ($)
|
---|---|
Schedule of Future Amortization Expense for Intangible Assets [Abstract] | |
2024 | $ 224 |
2025 | 224 |
2026 | 102 |
2027 | 61 |
2028 | 61 |
Thereafter | 462 |
Total | $ 1,134 |
Leases (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Jul. 01, 2020 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Leases [Abstract] | |||
Operating lease asset | $ 1,221,000 | $ 1,531,000 | |
Operating lease ilability | 2,041,000 | 2,600,000 | |
Lease costs | $ 900,000 | 1,000,000 | |
Sublease monthly payment | $ 10,000 | ||
Sublease income | 27,000 | ||
Equipment | 17,000 | ||
Security deposit forfeited | $ 10,000 |
Leases (Details) - Schedule of Future Minimum Payments Under the Operating Leases - USD ($) $ in Thousands |
Dec. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Schedule of Future Minimum Payments Under the Operating Leases [Abstract] | ||
2024 | $ 682 | |
2025 | 682 | |
2026 | 682 | |
2027 | 169 | |
Total | 2,215 | |
Less interest (5% discount rate) | 174 | |
Present value of lease liability | $ 2,041 | $ 2,600 |
Leases (Details) - Schedule of Future Minimum Payments Under the Operating Leases (Parentheticals) |
Dec. 31, 2023 |
---|---|
Schedule of Future Minimum Payments Under the Operating Leases [Abstract] | |
Interest discount rate | 5.00% |
Stockholders’ Equity (Details) - USD ($) |
12 Months Ended | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 26, 2023 |
Dec. 22, 2023 |
Dec. 20, 2023 |
Oct. 11, 2023 |
Aug. 22, 2023 |
Aug. 16, 2023 |
Apr. 19, 2023 |
Apr. 18, 2023 |
Nov. 16, 2022 |
Jul. 22, 2022 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Jun. 27, 2023 |
Aug. 12, 2021 |
|
Stockholders’ Equity [Line Items] | |||||||||||||||
RSUs vested | 172,274 | ||||||||||||||
Employee tax liabilities shares | 52,227 | 32,438 | |||||||||||||
Payment for accrued expenses (in Dollars) | $ 207,000 | ||||||||||||||
Severance compensation (in Dollars) | $ 275,000 | $ 112,000 | |||||||||||||
Common stock shares | 1,355,301 | ||||||||||||||
warrant term | 1 year | 5 years | |||||||||||||
Net proceeds (in Dollars) | $ 2,000,000 | ||||||||||||||
Conversion of outstanding shares | 2,000,000 | ||||||||||||||
Stock Option [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Stock options exercised | |||||||||||||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price (in Dollars per share) | |||||||||||||||
Warrant [Member] | Maximum [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
Warrant [Member] | Minimum [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.649 | ||||||||||||||
Series A warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
warrant term | 5 years | ||||||||||||||
Series B warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | $ 1.65 | |||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.62 | ||||||||||||||
Private Placement [Member] | Series A warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
October 2023 Offering [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
warrant term | 5 years | ||||||||||||||
October 2023 Offering [Member] | Series A warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
October 2023 Offering [Member] | Series B warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
Underwriters [Member] | Warrant [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 95,760 | ||||||||||||||
Purchaser Warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 17.5 | ||||||||||||||
Warrants issued to investors | 1,169,288 | ||||||||||||||
December 2023 Offering [Member] | Underwriters Warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 94,871 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 2.1813 | ||||||||||||||
Class A Common Stock [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
RSUs vested | 253,084 | ||||||||||||||
Subscription shares (in Dollars) | $ 30,000,000 | ||||||||||||||
Subscription price per share (in Dollars per share) | $ 3 | ||||||||||||||
Common stock shares | 2,365,000 | 108,497 | |||||||||||||
Public offering price per share (in Dollars per share) | $ 3 | ||||||||||||||
Warrants purchase (in Dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 0.001 | ||||||||||||||
Number of warrants or rights outstanding. | 59,243 | ||||||||||||||
Price per share (in Dollars per share) | $ 1.65 | ||||||||||||||
Stock options exercised | 2,143 | ||||||||||||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price (in Dollars per share) | $ 5.73 | ||||||||||||||
Common stock voting rights | one | ||||||||||||||
Shareholders exchanged shares | 35,546 | 811,749 | |||||||||||||
Class A Common Stock [Member] | Stock Option [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Stock options exercised | 374 | ||||||||||||||
Class A Common Stock [Member] | Warrant [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 59,243 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 0.001 | $ 12 | |||||||||||||
Net proceeds (in Dollars) | $ 612,732 | ||||||||||||||
Class A Common Stock [Member] | Series A warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
Class A Common Stock [Member] | Series B warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
Class A Common Stock [Member] | Underwriters Warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 169,697 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 2.0625 | ||||||||||||||
Class A Common Stock [Member] | October 2023 Offering [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Net proceeds (in Dollars) | $ 3,400,000 | ||||||||||||||
Class A Common Stock [Member] | IPO [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 106,400 | ||||||||||||||
Class A Common Stock [Member] | Warrant [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 51,061 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 12 | ||||||||||||||
Fair value of warrants (in Dollars) | $ 0.5 | ||||||||||||||
Class A Common Stock [Member] | Purchaser Warrants [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 46,722 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 17.5 | ||||||||||||||
Class A Common Stock [Member] | December 2023 Offering [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrant purchase shares | 1,355,301 | ||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 1.62 | ||||||||||||||
Class B Common Stock [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants purchase (in Dollars per share) | $ 0.001 | $ 0.001 | |||||||||||||
Conversion of outstanding shares | 15,702,834 | ||||||||||||||
Common stock voting rights | five | ||||||||||||||
Shareholders exchanged shares | 35,546 | 811,749 | |||||||||||||
Series A warrants [Member] | October 2023 Offering [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Number of warrants or rights outstanding. | 2,424,243 | ||||||||||||||
Valuation Technique, Consensus Pricing Model [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Warrants exercise price per share (in Dollars per share) | $ 5.25 | ||||||||||||||
Fair value of warrants (in Dollars) | $ 800,000 | ||||||||||||||
Securities purchase agreement [Member] | Class A Common Stock [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Aggregate shares | 2,365,000 | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Convertible unregistered shares | 48,140 | ||||||||||||||
Granted shares | 182,000 | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Granted shares | 40,000 | 27,854 | |||||||||||||
Compensation amount (in Dollars) | $ 170,000 | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | Chief Financial Officer [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Granted shares | 6,690 | ||||||||||||||
Securities purchase agreement [Member] | Class A Common Stock [Member] | |||||||||||||||
Stockholders’ Equity [Line Items] | |||||||||||||||
Common stock shares | 1,355,301 | ||||||||||||||
Public offering price per share (in Dollars per share) | $ 0.001 | ||||||||||||||
Price per share (in Dollars per share) | $ 1.745 |
Equity Incentive Plan (Details) - USD ($) |
12 Months Ended | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 21, 2023 |
Jun. 09, 2023 |
Mar. 01, 2023 |
Dec. 21, 2022 |
Nov. 16, 2022 |
Sep. 06, 2022 |
Jun. 03, 2022 |
Apr. 04, 2022 |
Mar. 14, 2022 |
Jan. 06, 2022 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Jul. 31, 2024 |
Apr. 01, 2024 |
Jan. 01, 2024 |
Oct. 01, 2023 |
Jul. 24, 2023 |
Apr. 19, 2023 |
Jun. 22, 2022 |
|
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Payment for accrued expenses (in Dollars) | $ 207,000 | ||||||||||||||||||
RSUs convertible shares | 40,000 | ||||||||||||||||||
Annual base salary (in Dollars) | $ 350,000 | ||||||||||||||||||
Performance bonus percentage | 30.00% | ||||||||||||||||||
Bonus amount (in Dollars) | $ 60,000 | ||||||||||||||||||
Bonus percentage | 50.00% | ||||||||||||||||||
Stock option award exercisable | 50,000 | ||||||||||||||||||
Price per share (in Dollars per share) | $ 11.34 | ||||||||||||||||||
Total cost (in Dollars) | $ 200,000 | $ 600,000 | |||||||||||||||||
Expensed ratably over | 48 months | ||||||||||||||||||
Severance compensation (in Dollars) | $ 112,000 | $ 275,000 | |||||||||||||||||
Unvested shares | 112,393 | 329,746 | |||||||||||||||||
Stock options exercisable term | 4 years | ||||||||||||||||||
Stock option expiration term | 10 years | ||||||||||||||||||
Share percentage | 5.00% | ||||||||||||||||||
Dividend yield | 0.00% | 0.00% | |||||||||||||||||
Expected life | 10 years | 10 years | |||||||||||||||||
Risk-free interest rate | 95.00% | ||||||||||||||||||
Exercise price (in Dollars per share) | $ 3.62 | $ 4.96 | |||||||||||||||||
Non-employee option | 96,000 | ||||||||||||||||||
Black-Scholes calculation price (in Dollars per share) | $ 3.23 | $ 2.67 | $ 2.94 | $ 4.15 | |||||||||||||||
Expensed ratably over period | 48 months | 12 months | 48 months | 48 months | 48 months | ||||||||||||||
Equity-based compensation expense (in Dollars) | $ 2,000,000 | $ 2,300,000 | |||||||||||||||||
Recognized over a weighted average time period | 1 year 6 months | ||||||||||||||||||
Minimum [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Risk-free interest rate | 90.00% | 1.23% | |||||||||||||||||
Maximum [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Risk-free interest rate | 95.00% | 3.68% | |||||||||||||||||
Stock Options [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Total cost (in Dollars) | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 | |||||||||||||||
Vesing shares | 160,107 | 151,258 | |||||||||||||||||
Stock option issued and outstanding | 437,843 | 470,191 | |||||||||||||||||
Exercise price (in Dollars per share) | $ 4.96 | $ 7.07 | |||||||||||||||||
Granted shares | 146,000 | ||||||||||||||||||
Non-employee option | 277,736 | 318,933 | |||||||||||||||||
Black-Scholes calculation price (in Dollars per share) | $ 1.09 | ||||||||||||||||||
Share-Based Payment Arrangement, Tranche One [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesting period | 25.00% | ||||||||||||||||||
Second, Third and Fourth Anniversaries [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesting period | 25.00% | ||||||||||||||||||
Stock Option Award Has a Four-Year [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesting period | 25.00% | 25.00% | 25.00% | 25.00% | |||||||||||||||
Class A Common Stock [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Total cost (in Dollars) | $ 700,000 | ||||||||||||||||||
Granted shares | 50,000 | ||||||||||||||||||
Class A Common Stock [Member] | 2021 Incentive Plan [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Exercise price (in Dollars per share) | $ 6.18 | ||||||||||||||||||
Class A Common Stock [Member] | Stock Options [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Total cost (in Dollars) | $ 100,000 | ||||||||||||||||||
Exercise price (in Dollars per share) | $ 1.25 | $ 3 | $ 4.3 | $ 4.67 | $ 5.94 | $ 10 | |||||||||||||
Granted shares | 12,000 | 5,000 | 22,843 | 10,000 | 22,000 | 84,825 | |||||||||||||
Non-employee option | 45,000 | ||||||||||||||||||
Black-Scholes calculation price (in Dollars per share) | $ 8.78 | ||||||||||||||||||
Expensed ratably over period | 48 months | 48 months | |||||||||||||||||
Class A Common Stock [Member] | Stock Options [Member] | 2021 Incentive Plan [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Stock option issued and outstanding | 437,843 | 470,191 | |||||||||||||||||
Class A Common Stock [Member] | Stock Option Award Has a Four-Year [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesting period | 25.00% | ||||||||||||||||||
Mr. Green [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
RSUs convertible shares | 27,854 | ||||||||||||||||||
Fair market value prior grant (in Dollars per share) | $ 6.1 | ||||||||||||||||||
Mr. Clavijo [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
RSUs convertible shares | 40,000 | ||||||||||||||||||
Fair market value prior grant (in Dollars per share) | $ 8.73 | ||||||||||||||||||
Mr. Bailey [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
RSUs convertible shares | 9,375 | ||||||||||||||||||
Quarterly vesting amount (in Dollars) | $ 100,000 | ||||||||||||||||||
Price per share (in Dollars per share) | $ 12.85 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Minimum [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Risk-free interest rate | 3.89% | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Maximum [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Risk-free interest rate | 4.01% | ||||||||||||||||||
Mr. Lehr [Member] | Class A Common Stock [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Total cost (in Dollars) | $ 100,000 | ||||||||||||||||||
Exercise price (in Dollars per share) | $ 8.73 | ||||||||||||||||||
Granted shares | 5,000 | ||||||||||||||||||
Black-Scholes calculation price (in Dollars per share) | $ 7.73 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Convertible unregistered Shares | 48,140 | ||||||||||||||||||
RSUs convertible shares | 50,000 | ||||||||||||||||||
Bonus percentage | 50.00% | ||||||||||||||||||
Stock option award exercisable | 150,000 | ||||||||||||||||||
Unvested shares | 112,393 | 329,746 | |||||||||||||||||
Restricted Stock Units vested percentage | 25.00% | ||||||||||||||||||
Unrecognized equity-based compensation amount (in Dollars) | $ 1.5 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Equity Incentive Plan [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesing shares | 50,000 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Nataliya Agafonova [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Unvested shares | 30,000 | 30,000 | |||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Stock Option Award Has a Four-Year [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesting period | 25.00% | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Subsequent Event [Member] | Nataliya Agafonova [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Unvested shares | 30,000 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Forecast [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Unvested shares | 40,000 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Forecast [Member] | Nataliya Agafonova [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Unvested shares | 30,000 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Chief Financial Officer [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
RSUs convertible shares | 6,690 | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Board of Directors Chairman [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Unvested shares | 5,000 | ||||||||||||||||||
Restricted Stock Units vested percentage | 50.00% | ||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Mr. Green [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Compensation amount (in Dollars) | $ 170,000 | ||||||||||||||||||
Phantom Share Units (PSUs) [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Vesing shares | 125,000 | ||||||||||||||||||
Stock Options [Member] | Class A Common Stock [Member] | |||||||||||||||||||
Equity Incentive Plan [Line Items] | |||||||||||||||||||
Black-Scholes calculation price (in Dollars per share) | $ 5.23 |
Equity Incentive Plan (Details) - Schedule of RSU Activity - Restricted Stock Units (RSUs) [Member] |
12 Months Ended |
---|---|
Dec. 31, 2023
shares
| |
Equity Incentive Plan (Details) - Schedule of RSU Activity [Line Items] | |
Number of Outstanding (unvested) at December 31, 2022 | 329,746 |
Number of RSUs granted | 182,000 |
Number of RSUs vested | (265,584) |
Number of RSU expired/forfeited | (133,769) |
Number of Outstanding (unvested) at December 31, 2023 | 112,393 |
Equity Incentive Plan (Details) - Schedule of Issued and Outstanding Options - Stock Option [Member] - shares |
Dec. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Equity Incentive Plan (Details) - Schedule of Issued and Outstanding Options [Line Items] | ||
Stock options vested (based on ratable vesting) | 160,107 | 151,258 |
Total stock options outstanding | 277,736 | 318,933 |
Total stock options outstanding | 437,843 | 470,191 |
Equity Incentive Plan (Details) - Schedule of Stock Option Activity - Stock Option [Member] |
12 Months Ended |
---|---|
Dec. 31, 2023
$ / shares
shares
| |
Equity Incentive Plan (Details) - Schedule of Stock Option Activity [Line Items] | |
Number of Stock Options, Outstanding beginning | shares | 470,191 |
Weighted Average Exercise Price, Outstanding beginning | $ / shares | $ 7.07 |
Number of Stock Options, Options granted | shares | 146,000 |
Weighted Average Exercise Price, Options granted | $ / shares | $ 2.06 |
Number of Stock Options, Options exercised | shares | |
Weighted Average Exercise Price, Options exercised | $ / shares | |
Number of Stock Options, Options expired/forfeited | shares | (178,348) |
Weighted Average Exercise Price, Options expired/forfeited | $ / shares | $ 8.12 |
Number of Stock Options, Outstanding ending | shares | 437,843 |
Weighted Average Exercise Price, Outstanding ending | $ / shares | $ 4.96 |
Commitments and Contingencies (Details) - USD ($) |
12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|
Sep. 28, 2023 |
Nov. 16, 2022 |
Dec. 23, 2016 |
Dec. 22, 2016 |
Nov. 20, 2014 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Jul. 12, 2022 |
|
Commitments and Contingencies [Line Items] | |||||||||
Expenditures amount | $ 265,000 | ||||||||
Payments term | 2 years | ||||||||
Issued RSUs shares (in Shares) | 48,140 | ||||||||
Aggregate value | $ 207,000 | ||||||||
Accrued expenses | $ 100,000 | ||||||||
Accounts payable | 100,000 | $ 100,000 | |||||||
License fee | 5,000,000 | ||||||||
Annual cash payments | $ 50,000 | ||||||||
Terms of agreement | 20 years | ||||||||
Milestone payment | 500,000,000 | ||||||||
Milestone fees payable | 50,000,000 | 50,000,000 | |||||||
Annual net sales percentage | 1.00% | ||||||||
Net sales of sub licensees percentage | 10.00% | ||||||||
Initial fee paid | $ 250,000,000 | ||||||||
License agreement amount | 500,000 | ||||||||
Professional fees | $ 27,000,000 | ||||||||
license agreement | 20 years | ||||||||
Incurred terms | 20 years | ||||||||
Award amount | 3,000,000 | ||||||||
Settlement amount | $ 1,400,000 | ||||||||
Employee paid | $ 75,000,000 | ||||||||
Remaining costs | $ 35,000,000 | ||||||||
UM License [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Payments to UM | 365,000,000 | ||||||||
Common Class A [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Unregistered shares (in Shares) | 110,387 | ||||||||
Series C Units [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Shares issued (in Shares) | 10,000 | ||||||||
Company value amount | $ 250,000,000 | ||||||||
Chief Science Officer [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Accrued expenses | 100,000 | ||||||||
Master Services Agreements [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Expenditures amount | 1,100,000 | ||||||||
UM Agreements [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Milestone fees payable | 15,000,000 | $ 30,000,000 | |||||||
Technology Services Agreement [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
Accounts payable | $ 0 | ||||||||
UM License [Member] | |||||||||
Commitments and Contingencies [Line Items] | |||||||||
License fee | $ 100,000,000 |
Employee Benefits Plan (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Employee Benefits Plan [Abstract] | ||
Company contributed amount | $ 131,000 | $ 88,000 |
Income Taxes (Details) $ in Millions |
12 Months Ended |
---|---|
Dec. 31, 2023
USD ($)
| |
Income Taxes [Line Items] | |
Federal taxes | $ 30.9 |
State taxes | $ 29.9 |
Ownership change more than percentage | 50.00% |
Ownership [Member] | |
Income Taxes [Line Items] | |
Ownership change more than percentage | 50.00% |
Income Taxes (Details) - Schedule of Tax Effects of Temporary Differences and Net Operating Loss (“NOL”) Carryforwards - USD ($) $ in Thousands |
Dec. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Deferred tax assets: | ||
Net operating loss carry forwards | $ 7,790 | $ 6,103 |
ASC 842 Lease liability | 514 | 690 |
Equity based compensation | 201 | 1,993 |
Fixed assets | 435 | |
Intangible assets | 106 | 45 |
Capitalized research & development expenses | 3,830 | 1,753 |
Tax credits | 1,258 | |
Accrual to cash adjustment | 911 | |
Other | 468 | |
Total deferred tax assets | 14,167 | 11,930 |
Valuation allowance | (13,776) | (11,524) |
Deferred tax assets, net of valuation allowance | 391 | 406 |
Deferred tax liabilities: | ||
ASC 842 Right-of-use asset | (307) | (406) |
Depreciation and amortization | (84) | |
Total deferred tax liabilities | (391) | (406) |
Deferred tax assets and liabilities, net of valuation allowance |
Income Taxes (Details) - Schedule of Reconciliations of Income Tax Benefit Federal and State Statutory Tax Rates |
12 Months Ended | 24 Months Ended |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2023 |
|
Schedule of Reconciliations of Income Tax Benefit Federal and State Statutory Tax Rates [Abstract] | ||
Federal tax at statutory rate | 21.00% | 21.00% |
State tax benefits, net of federal benefit | 4.20% | 6.90% |
Other | 1.60% | 0.80% |
Change in valuation allowance | (26.70%) | (28.70%) |
Income tax benefit |
Loss Per Share (Details) - Schedule of Calculation of Diluted Net Loss Per Share - shares shares in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Schedule of Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total | 8,415 | 2,071 |
RSUs [Member] | ||
Schedule of Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total | 112 | 330 |
PSUs [Member] | ||
Schedule of Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total | 125 | |
Stock options [Member] | ||
Schedule of Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total | 438 | 470 |
Warrants [Member] | ||
Schedule of Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total | 7,740 | 1,271 |
Subsequent Events (Details) - Subsequent Event [Member] |
Feb. 21, 2024
shares
|
---|---|
Class A Common Stock [Member] | Minimum [Member] | |
Subsequent Event [Line Items] | |
Reverse stock split | 1 |
Class A Common Stock [Member] | Maximum [Member] | |
Subsequent Event [Line Items] | |
Reverse stock split | 5 |
Class B Common Stock [Member] | Minimum [Member] | |
Subsequent Event [Line Items] | |
Reverse stock split | 1 |
Class B Common Stock [Member] | Maximum [Member] | |
Subsequent Event [Line Items] | |
Reverse stock split | 15 |