Jasper Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 5, 2024.
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FY2023 · Filed Mar 5, 2024
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Notes to Consolidated Financial Statements
NOTE 1. ORGANIZATION AND DESCRIPTION OF BUSINESS
Description of Business
Jasper Therapeutics, Inc. and its consolidated subsidiary, Jasper Tx Corp. (collectively, “Jasper” or the “Company”), is a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases such as Chronic Spontaneous Urticaria and Chronic Inducible Urticaria. The Company also has ongoing programs in diseases where targeting diseased hematopoietic stem cells can provide benefits, such as Lower to Intermediate Risk Myelodysplastic Syndrome, and stem cell transplant conditioning regimens.
On September 24, 2021 (the “Closing Date”), the Company consummated the previously announced business combination (the “Business Combination” or “Reverse Recapitalization” for accounting purposes) pursuant to the terms of the Business Combination Agreement, dated as of May 5, 2021 (the “BCA”), by and among the Company, formerly known as Amplitude Healthcare Acquisition Corporation (“AMHC”), Ample Merger Sub, Inc., a then-wholly-owned subsidiary of AMHC (“Merger Sub”), and the pre-Business Combination Jasper Therapeutics, Inc. (now named Jasper Tx Corp.) (“Old Jasper”). Pursuant to the terms of the BCA, on the Closing Date, (i) Merger Sub merged with and into Old Jasper, with Old Jasper as the surviving company in the Business Combination, and, after giving effect to such Business Combination, Old Jasper became a wholly owned subsidiary of AMHC and changed its name to “Jasper Tx Corp.”, and (ii) AMHC changed its name to “Jasper Therapeutics, Inc.”
The Company is headquartered in Redwood City, California. The Company is a Delaware corporation and was incorporated in March 2018. In September 2021, the Company completed a merger with Amplitude Healthcare Acquisition Corporation (“AMHC”) and became a public company.
Recent Financing
On February 8, 2024, the Company sold 3,900,000 shares of its common stock in an underwritten offering and received estimated net proceeds of $47.2 million, after deducting underwriting discounts and commissions and other offering expenses.
Liquidity and Going Concern
The Company has incurred significant losses and negative cash flows from operations since its inception. During the years ended December 31, 2023 and 2022, the Company incurred net losses of $64.5 million and $37.7 million, respectively. During the years ended December 31, 2023 and 2022, the Company had negative operating cash flows of $52.1 million and $45.9 million, respectively. As of December 31, 2023, the Company had an accumulated deficit of $169.6 million. The Company expects to continue to incur substantial losses, and its ability to achieve and sustain profitability will depend on the successful development, approval, and commercialization of product candidates and on the achievement of sufficient revenues to support the Company’s cost structure.
As of December 31, 2023, the Company had cash and cash equivalents of $86.9 million. The Company’s management expects that the existing cash and cash equivalents, together with the total estimated net proceeds of $47.2 million from the underwritten offering that closed in February 2024, will be sufficient to fund the Company’s operating plans for at least twelve months from the issuance date of these consolidated financial statements. The Company will need to raise additional financing to continue its products’ development for the foreseeable future, and expects to continue needing to do so until it becomes profitable. The Company’s management plans to monitor expenses and raise additional capital through a combination of public and private equity, debt financings, strategic alliances, and licensing arrangements. The Company’s ability to access capital when needed is not assured and, if capital is not available to the Company when, and in the amounts needed, the Company may be required to significantly curtail, delay or discontinue one or more of its research or development programs or the commercialization of any product candidate, or be unable to expand its operations or otherwise capitalize on the Company’s business opportunities, as desired, which could materially harm the Company’s business, financial condition and results of operations.
The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) andapplicable rules andregulations of the U.S. Securities and Exchange Commission for financial reporting.
The financial statements are consolidated for the years ended December 31, 2023 and 2022, and include the accounts of Jasper Therapeutics, Inc. and its wholly-owned subsidiary, Jasper Tx Corp. All intercompany transactions and balances have been eliminated upon consolidation.
Reverse Stock Split
On January 4, 2024, the Company effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of its common stock. The par value per share and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of common stock underlying outstanding stock options, common stock warrants and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. In addition, the shares available for grants under the Company’s incentive plans were adjusted as a result of the Reverse Stock Split. All references to common stock, options to purchase common stock, outstanding common stock warrants, common stock share data, per share data, and related information contained in the consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgements that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions made in the consolidated financial statements include but are not limited to, the determination of the accrued research and development expenses, valuation of earnout liability and the measurement of stock-based compensation expense. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates.
Cash, Cash Equivalents, and Restricted Cash
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total amount shown in the consolidated statements of cash flows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Cash and cash equivalents | $86,887 | $38,250 |
| Restricted cash | 417 | 417 |
| Total cash, cash equivalents and restricted cash | $87,304 | $38,667 |
Cash and cash equivalents consist of cash held in operating accounts and investments in money market funds. Restricted cash relates to the letter of credit secured in conjunction with the operating lease (Note 8).
Concentrations of Credit Risk and Other Risks and Uncertainties
The Company’s cash and cash equivalents are maintained with financial institutions in the United States of America. Cash balances are held at financial institutions and account balances may exceed federally insured limits. To date, the Company has not experienced any losses on its cash, cash equivalents and marketable securities’ balances and periodically evaluates the creditworthiness of its financial institutions.
The Company is subject to risks common to companies in the development stage, including, but not limited to, development and regulatory approval of new product candidates, development of markets and distribution channels, dependence on key personnel, and the ability to obtain additional capital as needed to fund its product plans. To achieve profitable operations, the Company must successfully develop and obtain requisite regulatory approvals for, manufacture, and market its product candidates. There can be no assurance that any such product candidate can be developed and approved or manufactured at an acceptable cost and with appropriate performance characteristics, or that such product will be successfully marketed. These factors could have a material adverse effect on the Company’s future financial results.
Products developed by the Company require approval from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s future products will receive the necessary clearances. If the Company were denied such clearances or such clearances were delayed, it could have a materially adverse impact on the Company.
Property and Equipment, Net
Property and equipment, net is stated at cost less accumulated depreciation and amortization. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, generally 3 to 5 years. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the remaining term of the lease. Upon the sale or retirement of assets, the cost and related accumulated depreciation and amortization are removed from the balance sheets and the resulting gain or loss is reflected in the consolidated statements of operations and comprehensive loss. Maintenance and repairs are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company reviews its long-lived assets for impairment, principally property and equipment, whenever events or changes in business circumstances indicate the carrying amount of an asset may not be fully recoverable. Recoverability of assets held and used is measured by comparing the carrying amount of an asset to future net cash flows expected to be generated by the asset. If the Company determines that the carrying value of long-lived assets may not be recoverable, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Fair value is determined through various valuation techniques, principally discounted cash flow models, to assess the fair values of long-lived assets. The Company did not record any impairment of long-lived assets during the years ended December 31, 2023 and 2022.
Leases
The Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease is classified as a financing lease or operating lease at the commencement date of the lease. Leases with a term greater than one year are recognized on the balance sheet as operating right-of-use assets, current portion of operating lease liabilities and non-current portion of operating lease liabilities. The Company elected not to recognize the right-of-use assets and lease liabilities for leases with lease terms of 12 months or less (short-term leases). Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. As the interest rate implicit in the Company’s lease contracts is not readily determinable, the Company utilizes a collateralized incremental borrowing rate based on the information available at the commencement date to determine the present value of lease payments. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received and impairment charges if the Company determines the right-of-use asset is impaired.
The Company considers the lease term to be the noncancelable period that it has the right to use the underlying asset, together with any periods where it is reasonably certain it will exercise an option to extend (or not terminate) the lease. Periods covered by an option to extend (or not terminate) the lease in which the exercise of the option is controlled by the lessor are included in the lease term.
Rent expense for operating leases is recognized on a straight-line basis over the lease term and is presented in operating expenses on the consolidated statements of operations and comprehensive loss. The Company has elected to not separate lease and non-lease components for its real estate leases and has instead accounted for each separate lease component and the non-lease components associated with that lease component as a single lease component. Variable lease payments are recognized as lease expense as incurred and are presented in operating expenses on the consolidated statements of operations and comprehensive loss.
The Company has no finance leases as of December 31, 2023 and 2022.
Fair Value of Financial Instruments
The Company’s financial instruments consist of cash and cash equivalents, other receivables, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities, common stock warrant liability, earnout liability and other non-current liabilities. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The carrying amounts of cash, other receivables, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities, approximate fair value due to their short-term maturities.
Common Stock Warrant Liability
The Company has 4,999,863 outstanding warrants to purchase an aggregate of 499,986 shares of its common stock (the “Common Stock Warrants”), all of which were issued in connection with AMHC’s initial public offering and entitle a holder to purchaseone share of the Company’s common stock for everyten warrants at an exercise price of $115.00 per share. The Common Stock Warrants are publicly traded and exercisable during the exercise period, which commenced on October 24, 2021 and ends on September 24, 2026, for cash or, in certain circumstances, on a cashless basis. The Common Stock Warrants are accounted as derivative financial instruments. As long as the Company had shares of non-voting common stock outstanding, the Common Stock Warrants did not meet the equity classification guidance and were accounted as liabilities at fair value. The Common Stock Warrants were subsequently remeasured at each reporting date with changes in fair value recorded in the consolidated statements of operations and comprehensive loss until exercise or expiration. On January 31, 2023, the 91,102 outstanding shares of the Company’s non-voting common stock were converted into 91,102 shares of the Company’s voting common stock per the holder’s request, leaving no shares of non-voting common stock remaining outstanding as of January 31, 2023. Upon conversion of all outstanding shares of non-voting common stock into shares of voting common stock, the Common Stock Warrants met the equity classification guidance and were reclassified to equity at the then-current fair value.
Earnout Liability
At the closing of the Business Combination, the Company recognized the earnout liability related to the Sponsor Support Agreement, dated May 5, 2021 and amended on September 24, 2021, by and among the Company, Amplitude Healthcare Holdings LLC (the “Sponsor”) and Jasper Tx Corp. (as amended, the “Sponsor Support Agreement”), pursuant to which 105,000 shares of common stock that were previously issued to the Sponsor were placed in escrow (the “Earnout Shares”). These shares will be released from escrow upon achieving agreed upon common stock price targets during the specified periods and in three tranches. Refer to Note 7 for additional details. In accordance with Accounting Standards Codification (“ASC”) Topic 815-40, the Earnout Shares are not indexed to the common stock and therefore are accounted as a liability at fair value and subsequently remeasured at each reporting date with changes in fair value recorded in the consolidated statements of operations and comprehensive loss. The Company reassesses the classification of the Earnout Shares as triggering events are met or expire.
Accrued Research and Development Expenses
The Company has entered into various agreements with outsourced vendors, contract manufacturing organizations and clinical research organizations. The Company makes estimates of accrued research and development expenses as of each balance sheet date based on facts and circumstances known at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments, if necessary. Research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development services provided, but not yet invoiced, are included in accrued expenses on the consolidated balance sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered. To date, there have been no material differences between estimates of such expenses and the amounts actually incurred.
Research and Development
The Company expenses research and development (“R&D”) expenses as incurred. R&D expenses consist primarily of personnel-related expenses, clinical studies, engineering and product development costs to support regulatory clearance of, and related regulatory compliance for, the Company’s products. Specifically, R&D expenses that support regulatory approval of, and related regulatory compliance for, the Company’s products include costs associated with the Company’s clinical studies, consisting of clinical trial design, clinical site establishment and management, clinical data management, travel expenses and the costs of products used for the Company’s clinical trials. Personnel-related expenses include salaries, benefits, bonuses and stock-based compensation of the Company’s R&D employees. Non personnel-related expenses include costs of outside consultants, testing, materials and supplies, and allocated overhead. The Company allocates overheads related to rent, facility costs, information technology and human resources costs. R&D expenses are charged to expense when incurred.
General and Administrative
General and administrative expenses include compensation, employee benefits and stock-based compensation for executive management, finance administration and human resources, allocated facility and information technology costs, professional service fees and other general overhead costs, including allocated depreciation to support the Company’s operations.
Stock-Based Compensation
The Company measures its stock options granted to employees and non-employees based on the estimated fair values of the awards as of the grant date using the Black-Scholes option-pricing model. The model requires management to make a number of assumptions, including common stock fair value, expected volatility, expected term, risk-free interest rate and expected dividend yield. For restricted stock unit awards, the estimated fair value is the fair market value of the underlying stock on the grant date. The Company expenses the fair value of its equity-based compensation awards on a straight-line basis over the requisite service period, which is the period in which the related services are received. The Company accounts for award forfeitures as they occur. The expense for stock-based awards with performance conditions is recognized when it is probable that a performance condition is met during the vesting period.
Income Taxes
The Company accounts for income taxes using the asset and liability method. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.
In evaluating the ability to recover its deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, ongoing tax planning, and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. In the event the Company determines that it would be able to realize its deferred income tax assets in the future in excess of their net recorded amount, it would make an adjustment to the valuation allowance that would reduce the provision for income taxes. Conversely, if all or part of the net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to the provision of income taxes in the period when such determination is made. As of December 31, 2023 and 2022, the Company has recorded a full valuation allowance on its deferred tax assets.
Tax benefits related to uncertain tax positions are recognized when it is more likely than not that a tax position will be sustained during an audit. Interest and penalties related to unrecognized tax benefits are included within the provision for income tax. To date, there have been no interest or penalties recorded in relation to unrecognized tax benefits.
Foreign Currency Transactions
Transactions denominated in foreign currencies are initially measured in U.S. dollars using the exchange rate on the date of the transaction. Foreign currency denominated monetary assets and liabilities are subsequently re-measured at the end of each reporting period using the exchange rate at that date, with the corresponding foreign currency transaction gain or loss recorded in the consolidated statements of operations and comprehensive loss and consolidated statements of cash flows. Nonmonetary assets and liabilities are not subsequently re-measured.
Comprehensive loss
Comprehensive loss represents all changes in stockholders’ equity except those resulting from distributions to stockholders. There have been no items qualifying as other comprehensive income (loss) during the years ended December 31, 2023 and 2022, and therefore, the Company’s comprehensive loss was the same as its reported net loss.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders adjusted for income (expenses), net of tax, related to any diluted securities, by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, the redeemable convertible preferred stock, common stock subject to repurchase, common stock subject to restricted stock awards, the Earnout Shares, the Common Stock Warrants and stock options are considered to be potentially dilutive securities.
Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities. The Company considers all series of its redeemable convertible preferred stock, common stock subject to repurchase, common stock subject to restricted stock awards and the Earnout Shares to be participating securities as the holders are entitled to receive dividends on a pari passu basis in the event that a dividend is paid on common stock. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss is attributed entirely to common stockholders. For the years ended December 31, 2023 and 2022, the diluted net loss per common share was the same as basic net loss per share of common stock, as the impact of potentially dilutive securities was antidilutive to the net loss per common share. The Earnout Shares and common stock subject to restricted stock awards are contingently issuable shares and are not included in the diluted net loss per share calculation until contingencies are resolved.
Segment Reporting
The Company has determined it operates as a single operating and reportable segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources. All long-lived assets are located in the United States.
Recent Accounting Pronouncements
In June 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sales Restrictions, which (1) clarifies the guidance in Topic 820 on the fair value measurement of an equity security that is subject to contractual restrictions that prohibit the sale of an equity security and (2) requires specific disclosures related to such an equity security. This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The Company does not expect the adoption of this ASU to have a significant impact on the Company’s consolidated financial statements.
In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments in this ASU were effective for all entities as of March 12, 2020 through December 31, 2022; however, in December 2022, the FASB issued ASU No. 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, which extended the sunset date from December 31, 2022 to December 31, 2024. An entity may elect to apply the amendments for contract modifications by Topic or Industry Subtopic as of any date from the beginning of an interim period that includes or is subsequent to March 12, 2020, or prospectively from the date that the financial statements are available to be issued. Once elected for a Topic or an Industry Subtopic, the amendments must be applied prospectively for all eligible contract modifications for that Topic or Industry Subtopic. The Company does not expect the adoption of this ASU to have a significant impact on the Company’s consolidated financial statements.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC Topic 280 on an interim and annual basis. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact the adoption of this standard will have on the disclosures within our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact the adoption of this standard will have on the disclosures within our consolidated financial statements.
NOTE 3. FAIR VALUE MEASUREMENTS
The Company measures certain financial assets and liabilities at fair value on a recurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:
| ● | Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; |
| ● | Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and |
| ● | Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. |
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The fair value of Level 1 securities is determined using quoted prices in active markets for identical assets. Level 1 securities consist of highly liquid money market funds. In addition, restricted cash collateralized by money market funds is a financial asset measured at fair value and is a Level 1 financial instrument under the fair value hierarchy.
Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data, such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. The Company had no financial instruments classified at Level 2 as of December 31, 2023 and 2022.
Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques and at least one significant model assumption or input is unobservable. Level 3 liabilities that are measured at fair value on a recurring basis included the derivative tranche liability, which was extinguished in February 2021, and earnout liability, which was recognized in connection with the business combinationin September 2021.
During the periods presented, the Company has not changed the manner in which it values liabilities that are measured at estimated fair value using Level 3 inputs. There were no transfers within the hierarchy during the years ended December 31, 2023 and 2022.
The following tables set forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets | ||||
| Money market funds | $85,887 | $— | $— | $85,887 |
| Total fair value of assets | $85,887 | $— | $— | $85,887 |
| Financial liabilities | ||||
| Earnout liability | $— | $— | $— | $— |
| Total fair value of financial liabilities | $— | $— | $— | $— |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets | ||||
| Money market funds | $37,250 | $— | $— | $37,250 |
| Total fair value of assets | $37,250 | $— | $— | $37,250 |
| Financial liabilities | ||||
| Common stock warrant liability | $150 | $— | $— | $150 |
| Earnout liability | — | — | 18 | 18 |
| Total fair value of financial liabilities | $150 | $— | $18 | $168 |
The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands):
| Earnout Liability | |
|---|---|
| Fair Value as of December 31, 2021 | $5,743 |
| Change in the fair value included in other income | (5,725) |
| Fair Value as of December 31, 2022 | $18 |
| Fair Value as of December 31, 2022 | $18 |
| Change in the fair value included in other income | (18) |
| Fair Value as of December 31, 2023 | $— |
The estimated fair value of the earnout liability is determined using a Monte Carlo simulation model, which uses a distribution of potential outcomes on a monthly basis over the earnout period prioritizing the most reliable information available. The assumptions utilized in the calculation are based on the achievement of certain stock price milestones, including the Company’s current common stock price, expected volatility, risk-free rate and expected term. The estimates of fair value are uncertain and changes in any of the estimated inputs used as of the date of this report could have resulted in significant adjustments to the fair value.
As of December 31, 2023, the fair value of the earnout liability was minimal. The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements classified in Level 3 of the fair value hierarchy at December 31, 2023:
| Fair value (in thousands) · Valuation methodology · Significant unobservable input | ||||
|---|---|---|---|---|
| Earnout liability | $— | Monte Carlo Simulation | Common stock price | $7.9 |
| Expected term (in years) | 0.73 | |||
| Expected volatility | 94.0% | |||
| Risk-free interest rate | 4.92% | |||
The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements classified in Level 3 of the fair value hierarchy at December 31, 2022:
| Fair value (in thousands) · Valuation methodology · Significant unobservable input | ||||
|---|---|---|---|---|
| Earnout liability | $18 | Monte Carlo Simulation | Common stock price | $4.8 |
| Expected term (in years) | 1.73 | |||
| Expected volatility | 105.0% | |||
| Risk-free interest rate | 4.40% | |||
NOTE 4. CONSOLIDATED BALANCE SHEET COMPONENTS
Prepaid expenses and other current assets
The following table summarizes the details of prepaid expenses and other current assets as of the dates set forth below (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Prepaid insurance | $877 | $1,362 |
| Research and development prepaid expenses | 615 | 842 |
| Payroll tax credit receivable | 250 | 250 |
| Other prepaid expenses and current assets | 244 | 246 |
| Other | 65 | 118 |
| Total | $2,051 | $2,818 |
Property and equipment, net
The following table summarizes the details of property and equipment, net as of the dates set forth below (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Leasehold improvements | $2,477 | $2,477 |
| Lab equipment | 1,973 | 1,706 |
| Office furniture & fixtures | 502 | 502 |
| Computer equipment | 145 | 145 |
| Capitalized software | 90 | 90 |
| Property and equipment, gross | 5,187 | 4,920 |
| Less: accumulated depreciation and amortization | (2,460) | (1,352) |
| Property and equipment, net | $2,727 | $3,568 |
Depreciation and amortization expense for the years ended December 31, 2023 and 2022 was $1.1 million and $1.0 million, respectively.
Accrued expenses and other current liabilities
The following table summarizes the details of accrued expenses and other current liabilities as of the dates set forth below (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development accrued expenses | $5,169 | $2,651 |
| Accrued employee and related compensation expenses | 1,767 | 1,587 |
| Other | 317 | 194 |
| Total | $7,253 | $4,432 |
Other non-current liabilities
The following table summarizes the details of other non-current liabilities as of the dates set forth below (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| CIRM grant liability | $2,264 | $2,264 |
| Restricted stock liability | — | 9 |
| Other non-current liabilities | — | 80 |
| Total | $2,264 | $2,353 |
NOTE 5. CIRM GRANT
In November 2020, California Institute for Regenerative Medicine (“CIRM”) awarded the Company $2.3 million in support of the research project related to a monoclonal antibody that depletes blood stem cells and enables chemotherapy-free transplants. The award is payable to the Company upon achievement of milestones over the next three years that are primarily based on patient enrollment in the Company’s clinical trials. CIRM could permanently cease disbursements if milestones are not met within four months of the scheduled completion date. Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions of the grant, CIRM may suspend or permanently cease disbursements. Funds received under this grant may only be used for allowable project costs specifically identified with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and itemized clinical study costs. Under the terms of the grant, both CIRM and the Company will co-fund the research project and the amount of the Company’s co-funding requirement is predetermined as a part of the award. Under the terms of the CIRM grant, the Company is obligated to pay royalties and licensing fees based on 0.1% of net sales of CIRM-funded product candidates or CIRM-funded technology per $1.0 million of CIRM grant. As an alternative to revenue sharing, the Company has the option to convert the award to a loan. In the event the Company exercises its right to convert the award to a loan, it would be obligated to repay the loan within ten business days of making such election. Repayment amounts vary dependent on when the award is converted to a loan, ranging from 60% of the award granted to amounts received plus interest at the rate of the three-month LIBOR rate plus 25% per annum. Since the Company may be required to repay some or all of the amounts awarded by CIRM, the Company accounted for this award as a liability. Given the uncertainty in amounts due upon repayment, the Company has recorded amounts received without any discount or interest recorded, and upon determination of amounts that would become due, the Company will adjust accordingly. In the absence of explicit U.S. GAAP guidance on contributions received by business entities from government entities, the Company has applied to the CIRM grant the recognition and measurement guidance in Accounting Standards Codification Topic 958-605 by analogy. The Company has received an aggregate of $2.3 million from CIRM through December 31, 2023, of which $0.7 million was received during the year ended December 31, 2023. As of December 31, 2023, $50,000 is available for future distribution to the Company under the grant upon the achievement of a future milestone.
NOTE 6. SIGNIFICANT AGREEMENTS
Amgen License Agreement
In November 2019, the Company entered into a worldwide exclusive license agreement with Amgen Inc. (“Amgen”) for briquilimab (formerly known as AMG-191 and JSP191) that also includes translational science and materials from The Board of Trustees of the Leland Stanford Junior University (“Stanford”) (the “Amgen License Agreement”). The Company was assigned and accepted Amgen’s rights and obligations, effective November 21, 2019, under the Investigator Sponsored Research Agreement (the “ISRA”), entered into in June 2013, between Amgen and Stanford, and the Quality Agreement between Amgen and Stanford, effective as of October 7, 2015. Under the ISRA, the Company exercised its option and entered into a definitive license with Stanford for rights to certain Stanford intellectual property related to the study of briquilimab (see Stanford License Agreement below).
The Amgen License Agreement terminates on a country-by-country basis on the 10th anniversary of the date on which the exploitation of the licensed products is no longer covered by a valid claim under a licensed patent in such country. On a country-by-country basis, upon the expiration of the term in each country with respect to the licensed products, the licenses to the Company by Amgen become fully paid and non-exclusive. The Company and Amgen have the right to terminate the agreement for a material breach as specified in the agreement.
Stanford License Agreement
In March 2021, the Company entered into an exclusive license agreement with Stanford (the “Stanford License Agreement”). In July 2023, the Company entered into an amendment to the Stanford License Agreement to modify certain milestones set forth thereunder. The Company received a worldwide, exclusive license, with a right to sublicense, for briquilimab in the field of depleting endogenous blood stem cells in patients for whom hematopoietic cell transplantation is indicated. Stanford transferred to the Company certain know-how and patents related to briquilimab (together, the “Licensed Technology”). Under the terms of this agreement, the Company is required to use commercially reasonable efforts to develop, manufacture, and sell licensed product and to develop markets for a licensed product. In addition, the Company is required to use commercially reasonable efforts to meet the milestones as specified in the agreement over the six years from execution of the Stanford License Agreement and must notify Stanford in writing as each milestone is met.
The Company is obligated to pay annual license maintenance fees, beginning on the first anniversary of the effective date of the agreement and ending upon the first commercial sale of a product, method, or service in the licensed field of use, as follows: $25,000 for each first and second year, $35,000 for each third and fourth year and $50,000 at each anniversary thereafter ending upon the first commercial sale. The Company is also obligated to pay late-stage clinical development milestone payments and first commercial sales milestone payments of up to $9.0 million in total. The Company will also pay low single-digit royalties on net sales of licensed products, if approved. The Company paid a $25,000 license maintenance fee in each of March 2023 and 2022, which was recognized as research and development expense in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2023 and 2022.
The Stanford License Agreement expires on a country-by-country basis on the last-to-expire valid claim of a licensed patent in such country. The Company may terminate the agreement by giving Stanford written notice at least 12 months in advance of the effective date of termination. The Company may also terminate the agreement solely with respect to any particular patent application or patent by giving Stanford written notice at least 60 days in advance of the effective date of termination. Stanford may terminate the agreement after 90 days from a written notice by Stanford, specifying a problem, including a delinquency on any report required pursuant to the agreement or any payment, missing a milestone or a material breach, unless the Company remediates the problem in that 90-day period.
NOTE 7. DERIVATIVE FINANCIAL INSTRUMENTS
Common Stock Warrants
The warrants to purchase shares of the Company’s common stock (the “Common Stock Warrants”) assumed in the Business Combination are traded on the Nasdaq Capital Market and may only be exercised for a whole number of shares. The Common Stock Warrants became exercisable on October 24, 2021 and will expire on September 24, 2026, unless early redeemed or if the Company extends the exercise period.
As long as the Company continued to have shares of non-voting common stock outstanding, the Common Stock Warrants did not meet the equity classification guidance and were accounted for as liabilities at fair value. In January 2023, a holder converted all of the 91,102 outstanding shares of non-voting common stock into shares of voting common stock and thereafter the Company no longer had any outstanding shares of non-voting common stock. As a result, in January 2023, all outstanding Common Stock Warrants for 499,986 shares of common stock met equity classification criteria and were reclassified to equity at the fair value of $0.7 million at the reclassification date.
The Company recognized a loss of $0.6 million and a gain of $7.2 million for the years ended December 31 2023, and 2022, respectively classified within change in fair value of common stock warrant liability in the consolidated statements of operations and comprehensive loss. The Common Stock Warrants’ fair value was $0.2 million as of December 31, 2022. As of December 31, 2023, the Company has 4,999,863 outstanding Common Stock Warrants to purchase an aggregate of 499,986 shares of common stock and recorded in equity.
Contingent Earnout Liability
Upon the closing of the business combination and pursuant to the Sponsor Support Agreement, the Sponsor agreed to place the 105,000 Earnout Shares into escrow, which will be released as follows: (a) 25,000 Earnout Shares will be released if, during the period from and after September 24, 2021 until September 24, 2024 (the “Earnout Period”), over any twenty trading days within any thirty day consecutive trading day period, the volume-weighted average price of the Company’s common stock (the “Applicable VWAP”) is greater than or equal to $115.00, (b) 50,000 Earnout Shares will be released if, during the Earnout Period, the Applicable VWAP is greater than or equal to $150.00 and (c) 30,000 Earnout Shares will be released if, during the Earnout Period, the Applicable VWAP is greater than or equal to $180.00 (the “triggering events”).
The Earnout Shares placed in escrow are legally issued and outstanding shares that participate in voting and dividends. The Earnout Shares (along with related escrowed dividends, if any) will be forfeited and not released from escrow at the end of the Earnout Period unless the triggering events described above are achieved during the Earnout Period. Upon the closing of the Business Combination, the contingent obligation to release the Earnout Shares was accounted for as a liability-classified financial instrument upon their initial recognition because the triggering events that determine the number of shares required to be released from escrow include events that were not solely indexed to the common stock of the Company. The earnout liability is remeasured each reporting period with changes in fair value recognized in earnings.
At each of December 31, 2023 and 2022, the estimated fair value of the earnout liability was less than $0.1 million based on a Monte Carlo simulation model. Assumptions used in the valuations as of December 31, 2023 and 2022 are described in Note 3. No triggering event occurred as of each of December 31, 2023 and 2022. The Company recognized a gain of less than $0.1 million and $5.7 million for the years ended December 31, 2023 and 2022, respectively, classified within change in fair value of earnout liability in the consolidated statements of operations and comprehensive loss.
NOTE 8. COMMITMENTS AND CONTINGENCIES
Operating Leases
In August 2020, the Company leased 7,781 square feet and in January 2022, the Company leased an additional 5,611 square feet of laboratory and office space in Redwood City, California. The Company’s operating lease will expire in August 2026.
In conjunction with signing the lease, the Company secured a letter of credit in favor of the lessor in the amount of $0.4 million. The funds related to this letter of credit are presented as restricted cash on the Company’s consolidated balance sheets. The lease agreement includes an escalation clause for increased base rent and a renewal provision allowing the Company to extend this lease for an additional 60 months at the prevailing rental rate, which the Company is not reasonably certain to exercise. In addition to base rent, the Company pays its share of operating expenses and taxes.
To complete certain leasehold improvements, the lessor agreed to provide the Company a tenant improvement allowance of $1.5 million as well as an option to take an additional allowance of $0.4 million to be repaid over the lease term at an interest rate of 9% per annum, which the Company exercised. The Company recognized the full $1.9 million in leasehold improvements covered by these allowances during the 2021 and 2022 fiscal years. In accordance with the lease agreement, the lessor managed and supervised the construction of the improvements. In exchange for these services, the Company paid the lessor a fee equal to 5% of total construction costs. The leasehold improvements constructed are presented under property and equipment on the Company’s consolidated balance sheets and depreciated on a straight-line basis over the remaining lease term.
The Company also pays variable costs related to its share of operating expenses and taxes. These variable costs are recorded as lease expense as incurred and presented as operating expenses in the consolidated statements of operations and comprehensive loss.
The components of lease costs, which were included in the Company’s consolidated statements of operations and comprehensive loss, are as follows (in thousands):
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Lease cost | ||
| Operating lease cost | $672 | $622 |
| Short-term lease cost | 2 | 129 |
| Total lease cost | $674 | $751 |
Supplemental information related to the Company’s operating leases is as follows:
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Cash paid for amounts included in the measurement of lease liabilities (in thousands) | $1,119 | $870 |
| Weighted average remaining lease term (years) | 2.6 | 3.6 |
| Weighted average discount rate | 8.00% | 8.00% |
The following table summarizes a maturity analysis of the Company’s operating lease liabilities showing the aggregate lease payments as of December 31, 2023 (in thousands):
| Amount | |
|---|---|
| Year ending December 31, | |
| 2024 | $1,153 |
| 2025 | 1,187 |
| 2026 | 740 |
| Total undiscounted lease payments | 3,080 |
| Less imputed interest | (294) |
| Total discounted lease payments | 2,786 |
| Less current portion of lease liability | (972) |
| Noncurrent portion of lease liability | $1,814 |
Stanford Sponsored Research Agreement
In September 2020, the Company entered into a sponsored research agreement with Stanford for a research program related to the treatment of Fanconi Anemia patients in Bone Marrow Failure requiring allogeneic transplant with non-sibling donors at Stanford Lucile Packard Children’s Hospital using briquilimab (the “Research Project”). Stanford will perform the Research Project and is fully responsible for costs and operations related to the Research Project. In addition, Stanford owns the entire right, title, and interest in and to all technology developed using Stanford facilities and by Stanford personnel through the performance of the Research Project under this agreement (the “Fanconi Anemia Research Project IP”). Under this agreement, Stanford granted the Company an exclusive option to license Stanford’s rights in the Fanconi Anemia Research Project IP (the “Fanconi Anemia Option”) in the field of commercialization of briquilimab. There is no license granted or other intellectual property transferred under this agreement until the Fanconi Anemia Option is exercised. As of December 31, 2023, the Company has not yet exercised the Fanconi Anemia Option.
As consideration for the services performed by Stanford under this sponsored research agreement, the Company agreed to pay Stanford a total of $0.9 million over approximately three years upon the achievement of development and clinical milestones, including the FDA filings and patient enrollment. The first milestone in the amount of $0.3 million was achieved in 2020. The second milestone in the amount of $0.3 million was achieved in February 2022 and recognized as a research and development expense in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2022. The third and final milestone in the amount of $0.3 million was achieved in July 2023 and recognized as a research and development expense in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2023.
License Agreements
In March 2021, the Company entered into the Stanford License Agreement (Note 6), which was amended in July 2023, pursuant to which the Company is required to pay annual license maintenance fees, clinical development and commercial sales milestone payments of up to an aggregate of $9.0 million, and low single-digit royalties on net sales of licensed products. All products were in development as of December 31, 2023, and no royalties were due as of such date. The Company paid a $25,000 license maintenance fee in each of March 2023 and 2022 and recognized this as a research and development expense in the consolidated statements of operations and comprehensive loss for each of the years ended December 31, 2023 and 2022. As of December 31, 2023 and 2022, no milestones were probable to be achieved and payable.
Legal Proceedings
The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings during the years ended December 31, 2023 and 2022, and, to the best of its knowledge, no material legal proceedings are currently pending.
Guarantees and Indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of December 31, 2023 and 2022, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
NOTE 9. COMMON STOCK
The Company is authorized to issue 490,000,000 shares of voting common stock,2,000,000 shares of non-voting common stock, and 10,000,000 shares of undesignated preferred stock. There were 11,163,896 shares of voting common stock, no shares of non-voting common stock and no shares of preferred stock issued and outstanding as of December 31, 2023.
Holders of the voting common stock and the non-voting common stock have similar rights, except that non-voting stockholders are not entitled to vote, including for the election of directors. Holders of voting common stock do not have conversion rights, while holders of non-voting common stock have the right to convert each share of non-voting common stock held by such holder into one share of voting common stock at such holder’s election by providing written notice to the Company, provided that as a result of such conversion, such holder, together with its affiliates, would not beneficially own in excess of 9.9% of the Company’s voting common stock following such conversion. On January 31, 2023,91,102 shares of the Company’s non-voting common stock were fully converted into 91,102 shares of the voting common stock per the holder’s request, and no shares of non-voting common stock remained outstanding after such conversion.
As of December 31, 2023 and 2022, the Company had common stock reserved for future issuance as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Outstanding and issued common stock options | 1,040,875 | 616,897 |
| Shares issuable upon exercise of common stock warrants | 499,986 | 499,986 |
| Outstanding restricted stock units | — | 261,729 |
| Shares available for grant under 2021 Equity Incentive Plan | 119,014 | 138,388 |
| Shares available for grant under 2022 Inducement Equity Incentive Plan | 95,685 | 129,568 |
| Shares available for grant under 2021 Employee Stock Purchase Plan | 111,958 | 86,913 |
| Total shares of common stock reserved | 1,867,518 | 1,733,481 |
Shelf Registration Statement
On October 7, 2022, the Company filed a shelf registration statement on Form S-3 (the “Prior S-3”) with the Securities and Exchange Commission (the “SEC”), which was declared effective on October 18, 2022. The Company could sell from time to time up to $150.0 million of common stock, preferred stock, debt securities, warrants, rights, units or depositary shares comprised of any combination of these securities, for the Company’s own account in one or more offerings under the Prior S-3. On April 28, 2023, the Company filed a new shelf registration statement on Form S-3 (“New S-3”) with the SEC, which was declared effective on May 5, 2023 and superseded the Prior S-3. As of December 31, 2023, the Company can sell from time to time up to $250.0 million of common stock, preferred stock, debt securities, warrants, rights, units or depositary shares comprised of any combination of these securities, for the Company’s own account in one or more offerings under the New S-3. The terms of any offering under the New S-3 will be established at the time of such offering and will be described in a prospectus supplement to the New S-3 filed with the SEC prior to the completion of any such offering.
ATM Offering
In November 2022, the Company entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent, as sales agent or principal, shares of the Company’s common stock from time to time (the “ATM Offering”). On November 10, 2022, the Company filed with the SEC a prospectus supplement under the Prior S-3 in connection with the ATM Offering, pursuant to which the Company could offer and sell shares of common stock having an aggregate offering price of up to $15.5 million. In January 2023, the Company issued and sold an aggregate of 233,747 shares of common stock for net proceeds of $4.5 million.
On May 5, 2023, the Company filed with the SEC a prospectus under the New S-3 in connection with the ATM Offering (the “ATM Prospectus”), pursuant to which the Company can now offer and sell shares of common stock having an aggregate offering price of up to $75.0 million.
As of December 31, 2023, $175.0 million remained available and unallocated under the New S-3 and $75.0 million remained available under the ATM Prospectus.
Public Offering
In January 2023, the Company entered into an underwriting agreement with Credit Suisse Securities (USA) LLC, William Blair & Company, L.L.C. and Oppenheimer & Co. Inc., as the representatives of the several underwriters named therein (the “2023 Underwriters”), relating to an underwritten public offering under the Prior S-3 of 6,900,000 shares of common stock, including 900,000 shares issued as a result of the exercise of the 2023 Underwriters’ option to purchase 900,000 shares. The Company received net proceeds of $97.0 million.
Underwritten Offering
In February 2024, the Company entered into an underwriting agreement with Cowen and Company, LLC and Evercore Group L.L.C., as the representatives of the several underwriters named therein (the “Underwriters”), related to an underwritten offering under the New S-3 of 3,900,000 shares of common stock. The total estimated net proceeds of the offering were $47.2 million.
As of December 31, 2023, $175.0 million remained available and unallocated under the New S-3 and $75.0 million remained available under the ATM Prospectus. After the February 2024 underwritten offering, approximately $124.5 million remained available and unallocated under the New S-3.
NOTE 10. STOCK-BASED COMPENSATION
On September 23, 2021, the 2021 Equity Incentive Plan (“2021 Plan”) and the 2021 Employee Stock Purchase Plan (“ESPP”) became effective. The 2021 Plan and ESPP provide for annual automatic increases in the number of shares reserved under each plan on January 1 of each year, beginning on January 1, 2022 and through January 1, 2031. The number of shares available for issuance under the 2021 Plan will increase annually in an amount equal to the least of (i) 275,000 shares, (ii) a number of shares equal to 4% of the total number of shares of all classes of common stock of the Company outstanding on the last day of the immediately preceding fiscal year, or (iii) such lesser number of shares determined by the Company’s Board of Directors (the “Board”) no later than the last day of the immediately preceding fiscal year. The number of shares of common stock available for issuance under the ESPP will increase annually in an amount equal to the least of (i) 55,000 shares of common stock, (ii) a number of shares of common stock equal to 1% of the total number of shares of all classes of common stock of the Company on the last day of the immediately preceding fiscal year, or (iii) such number of shares determined by the Board. As of December 31, 2023, 537,688 shares were reserved for issuance under the 2021 Plan, of which 119,014 shares were available for future grant and 418,674 shares were subject to outstanding options, including performance-based awards. As of December 31, 2023, 18,941 shares have been issued under the ESPP and 111,958 shares were reserved and available for future issuance.
On March 14, 2022, the Compensation Committee of the Board (the “Compensation Committee”) adopted the 2022 Inducement Equity Incentive Plan (the “2022 Inducement Plan”) and on June 2, 2023, the Compensation Committee approved an amendment and restatement of the 2022 Inducement Plan. Under the 2022 Inducement Plan, the Company may grant equity awards to new employees. The only persons eligible to receive grants under the 2022 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq guidance. As of December 31, 2023,550,000 shares were reserved for issuance under the 2022 Inducement Plan, of which 95,685 shares were available for future grant and 454,315 shares were subject to outstanding stock options.
Under the 2021 Plan, the Company can grant incentive stock options, nonstatutory stock options, restricted stock awards, stock appreciation rights, restricted stock units (“RSUs”), performance awards and other awards to employees, directors and consultants. Under the 2022 Inducement Plan, the Company can grant nonstatutory stock options, restricted stock awards, stock appreciation rights, RSUs, performance awards and other awards, but only to an individual, as a material inducement to such individual to enter into employment with the Company or an affiliate of the Company, who (i) has not previously been an employee or director of the Company or (ii) is rehired following a bona fide period of non-employment with the Company. Under the ESPP, the Company can grant purchase rights to employees to purchase shares of common stock at a purchase price which is equal to 85% of the fair market value of common stock on the offering date or on the exercise date, whichever is lower.
Stock options under the 2021 Plan and the 2022 Inducement Plan may be granted for periods of up to 10 years and at prices no less than 100% of the fair market value of the shares on the date of grant, provided, however, that the exercise price of an incentive stock option (which cannot be granted pursuant to the 2022 Inducement Plan) granted to a 10% stockholder may not be less than 110% of the fair market value of the shares. Stock options granted to employees and non-employees generally vest ratably over four years.
Stock Option Activity
The following table summarizes the stock option activities, including performance-based stock options, under the 2021 Plan, the 2022 Inducement Plan and the 2019 Plan for the year ended December 31, 2023:
| Options Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Balance, December 31, 2022 | 616,897 | $22.51 | 7.80 | $— |
| Options granted | 603,054 | $15.53 | ||
| Options exercised | (54,580) | $7.10 | ||
| Options cancelled/forfeited | (124,496) | $17.95 | ||
| Balance, December 31, 2023 | 1,040,875 | $19.82 | 8.55 | $237 |
| Vested and expected to vest, December 31, 2023 | 1,040,875 | $19.82 | 8.55 | $237 |
| Exercisable, December 31, 2023 | 324,645 | $20.79 | 7.33 | $125 |
The aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise price of outstanding, in-the-money options. The total intrinsic value of the options exercised during the years ended December 31, 2023 and 2022 was $0.4 million and $0.1 million, respectively.
The total fair value of options that vested during the years ended December 31, 2023 and 2022 was $3.4 million and $1.8 million, respectively. The weighted-average grant date fair value of options granted during the years ended December 31, 2023 and 2022 was $12.82 and $23.76 per share, respectively.
Future stock-based compensation for unvested options as of December 31, 2023 was $9.4 million, which is expected to be recognized over a weighted-average period of 2.83 years, including $0.1 million related to performance-based stock options, which is expected to be recognized over a weighted-average period of 0.25 years.
Performance-based stock options
The following table summarizes the performance-based stock options activity under the 2021 Plan and the 2019 Plan for the year ended December 31, 2023:
| Options Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Balance, December 31, 2022 | 46,394 | $14.19 | 8.06 | $— |
| Options granted | 5,000 | $19.20 | ||
| Options cancelled/forfeited | (5,000) | $19.20 | ||
| Balance, December 31, 2023 | 46,394 | $14.19 | 7.06 | $24 |
| Vested and expected to vest, December 31, 2023 | 46,394 | $14.19 | 7.06 | $24 |
| Exercisable, December 31, 2023 | 31,393 | $7.78 | 6.46 | $24 |
Restricted Stock Units (RSUs)
The following table provides a summary of RSUs activity under the 2021 Plan during the year ended December 31, 2023:
| Number of Shares | Weighted Average Grant date Fair Value | |
|---|---|---|
| Unvested restricted stock units at December 31, 2022 | 261,729 | $7.91 |
| Granted | 5,000 | $15.00 |
| Vested | (238,605) | $7.91 |
| Forfeited | (28,124) | $9.16 |
| Unvested restricted stock units at December 31, 2023 | — | $— |
| Outstanding restricted stock units at December 31, 2023 | — | $— |
The total fair value of RSUs that vested during the year ended December 31, 2023 was $1.9 million. There was no unamortized stock-based compensation for RSUs as of December 31, 2023.
Employee Stock Purchase Plan
The Company issued 12,999 and 5,942 shares of common stock under the ESPP during the years ended December 31, 2023 and 2022, respectively, and recognized $0.1 million compensation expense related to the ESPP during each of the years ended December 31, 2023 and 2022. Unamortized stock-based compensation for shares issuable under the ESPP as of December 31, 2023 was less than $0.1 million, which is expected to be recognized over a weighted-average period of 0.44 years. The Company recorded less than $0.1 million in accrued expenses and other current liabilities related to contributions withheld as of December 31, 2023.
Stock-Based Compensation Expense
The following table presents stock-based compensation expenses related to options and RSUs granted to employee and non-employees, ESPP awards and restricted common stock shares issued to founders (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| General and administrative | $3,607 | $2,668 |
| Research and development | 1,604 | 1,423 |
| Total | $5,211 | $4,091 |
The Company recognized less than $0.1 million and $0.2 million of stock-based compensation expense related to performance-based options and RSUs during the years ended December 31, 2023 and 2022, respectively.
Valuation of Stock Options
The grant date fair value of stock options was estimated using a Black-Scholes option-pricing model with the following assumptions:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Expected term (in years) | 5.25 – 6.08 | 1.00 – 6.08 |
| Expected volatility | 103.31% – 112.30% | 63.41% – 106.03% |
| Risk-free interest rate | 3.45% – 4.71% | 1.40% – 3.62% |
| Expected dividend yield | — | — |
The determination of the fair value of stock options on the date of grant using a Black-Scholes option-pricing model is affected by the estimated fair value of the Company’s common stock, as well as assumptions regarding a number of variables that are complex, subjective and generally require significant judgment to determine. The Company estimates the fair value of its common stock based on the closing quoted market price of its common stock as reported on the Nasdaq Capital Market.
Expected Term
The expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as the Company has concluded that its stock option exercise history does not provide a reasonable basis upon which to estimate expected term.
Expected Volatility
The Company derived the expected volatility from the average historical volatilities over a period approximately equal to the expected term of comparable publicly traded companies within its peer group that were deemed to be representative of future stock price trends as the Company does not have any trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.
Risk-Free Interest Rate
The risk-free interest rate is based on the U.S. Treasury rate, with maturities similar to the expected term of the stock options.
Expected Dividend Yield
The Company does not anticipate paying any dividends in the foreseeable future and, therefore, uses an expected dividend yield ofzero.
Valuation of ESPP Awards
The grant date fair value of ESPP awards was estimated using a Black-Scholes option-pricing model with the following assumptions:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Expected term (in years) | 0.50 | 0.50 |
| Expected volatility | 77.80% - 266.24% | 75.61% - 78.89% |
| Risk-free interest rate | 5.39% - 5.40% | 1.81% - 4.72% |
| Expected dividend yield | — | — |
NOTE 11. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Numerator: | ||
| Net loss attributable to common stockholders | $(64,465) | $(37,685) |
| Denominator: | ||
| Weighted average common shares outstanding | 10,551,290 | 3,793,375 |
| Less: Weighted-average unvested restricted shares | (7,256) | (40,235) |
| Less: Shares subject to earnout | (105,000) | (105,000) |
| Weighted average shares used to compute basic and diluted net loss per share | 10,439,034 | 3,648,140 |
| Net loss per share attributable to common stockholders – basic and diluted | $(6.18) | $(10.33) |
The potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have had an antidilutive effect were as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Outstanding and issued common stock options | 1,040,875 | 616,897 |
| Shares issuable upon exercise of common stock warrants | 499,986 | 499,986 |
| Outstanding RSUs | — | 261,729 |
| Unvested restricted common stock | — | 25,884 |
| Total | 1,540,861 | 1,404,496 |
NOTE 12. INCOME TAXES
During the years ended December 31, 2023 and 2022, the Company did not incur any tax expense or benefit as the Company operated with taxable losses and provided a full valuation allowance.
The provision for income taxes differs from the amount computed by applying the federal statutory income tax rate to loss before taxes as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Federal tax benefit at statutory rate | $(13,538) | $(7,914) |
| State taxes | 1,112 | (4,518) |
| Change in fair value of warrant liability | 121 | (1,512) |
| Change in fair value of earnout liability | (4) | (1,202) |
| Non-deductible expenses | (38) | (108) |
| Research and development credits | (1,628) | (1,835) |
| Change in valuation allowance | 12,539 | 16,243 |
| Stock-based compensation | 822 | — |
| Other | 614 | 846 |
| Provision for income taxes | $— | $— |
The Inflation Reduction Act 2022 (the “IRA”), which incorporates a Corporate Alternative Minimum Tax, was signed into law on August 16, 2022. The changes affect the tax years beginning after December 31, 2022. The tax requires companies to compute two separate calculations for federal income tax purposes and pay the greater of the new minimum tax or their regular tax liability. The Company does not expect the IRA to have a material impact on the Company’s consolidated financial statements.
Significant components of the Company’s net deferred tax assets (liabilities) as of December 31, 2023 and 2022 were as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Accrued expenses and other | $477 | $1,281 |
| Intangibles | 313 | 484 |
| Net operating losses | 25,146 | 20,669 |
| Research and development credits | 4,873 | 3,245 |
| Stock-based compensation | 676 | 985 |
| Lease liability | 585 | 1,090 |
| Section 195 start-up amortization | 229 | 351 |
| Fixed assets | — | 99 |
| Capitalized section 174 | 14,308 | 6,284 |
| Other | 346 | — |
| Total deferred tax assets | 46,953 | 34,488 |
| Valuation allowance | (46,465) | (33,925) |
| Total net deferred tax assets | 488 | 563 |
| Deferred tax liabilities: | ||
| Right-of-use asset | (308) | (563) |
| Fixed assets | (180) | — |
| Total deferred tax liabilities | (488) | (563) |
| Net deferred tax assets | $— | $— |
A valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized. The Company believes that, based on a number of factors such as the history of operating losses, it is more likely than not that the deferred tax assets will not be fully realized, such that a full valuation allowance has been recorded. The valuation allowance increased by $12.5 million and $16.2 million for the years ended December 31, 2023 and 2022, respectively.
The following table sets forth the Company’s federal and state net operating loss carryforwards as of December 31, 2023 (in thousands):
| Amount | Expiration Years | |
|---|---|---|
| Net operating losses, Federal | $91,357 | Do not expire |
| Net operating losses, states primarily California | $131,895 | 2038-2042 |
As of December 31, 2023, the Company had research and development credit carryforwards of approximately $3.8 million and $3.2 million available to reduce future taxable income, if any, for both federal and California state income tax purposes, respectively. The federal research and development credit carryforwards begin expiring in 2040, and California credits carryforward indefinitely.
Utilization of the net operating loss carryforwards and research credit carryforwards may be subject to an annual limitation due to the ownership percentage change limitations provided by the Internal Revenue Code, as amended (“IRC”), and similar state provisions. Annual limitations may result in the expiration of the net operating losses and tax credit carryforwards before they are utilized. The Company has completed an IRC Section 382 analysis from inception through the year ended December 31, 2022. During this period, the Company experienced two ownership changes, on November 21, 2019 and September 24, 2021, resulting in $2.9 million of net operating losses becoming permanently limited for California tax purposes. The Company reduced its California net operating loss deferred tax assets balance by the permanently limited amount of $0.6 million. The federal net operating losses are not limited as they can be carried forward indefinitely. The Company does not expect there to be additional tax attributes that will expire unused before the expiration periods.
Uncertain Tax Positions
A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the periods ended December 31, 2023 and 2022 is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Balance at beginning of year | $1,722 | $828 |
| Additions based on tax positions related to current year | 698 | 894 |
| Balance at end of year | $2,420 | $1,722 |
The Company recognizes interest accrued related to unrecognized tax benefits and penalties as income tax expense. Related to the unrecognized tax benefits noted above, the Company did not accrue any penalties or interest during tax years 2023 and 2022. The Company does not expect its unrecognized tax benefit to change materially over the next twelve months.
The Company is subject to examination by the United States federal and state tax authorities for the tax years 2019 and later. State income tax returns are generally subject to examination for a period of four years after filing of the respective return. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service and state tax authorities to the extent utilized in a future period. No income tax returns are currently under examination by taxing authorities.
NOTE 13. 401(K) SAVINGS PLAN
The Company has a retirement and savings plan under Section 401(k) of the IRC (the “401(k) Plan”), covering all U.S. employees. The 401(k) Plan allows employees to make pre-tax contributions up to the maximum allowable amount set by the Internal Revenue Service. The Company may make contributions to the 401(k) Plan at its discretion. $0.1 million contributions were made to the 401(k) Plan by the Company for each of the years ended December 31, 2023 and 2022.
NOTE 14. RELATED PARTIES
The Company entered into consulting agreements with two founders, one of whom is also a member of the Board, and each of whom also received founders’ common stock shares for services and assigned patents. The Company recorded $0.3 million and $0.5 million for the founders’ advisory and consulting services performed for the years ended December 31, 2023 and 2022, respectively. These expenses were recorded as research and development expenses in the consolidated statements of operations and comprehensive loss. Also, the Company’s Licensed Technology from Stanford (see Note 6) was created in the Stanford laboratory of Professor Judith Shizuru, one of the Company’s founders and a member of the Board.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.