Jasper Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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Jun 30, 2024 · Filed Aug 13, 2024
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Notes to Condensed Consolidated Financial Statements
NOTES TO UNAUDITED INTERIM CONDENSED
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, chronic inducible urticaria and asthma. 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.
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 and became a public company.
Liquidity and Going Concern
The Company has incurred significant losses and negative cash flows from operations since its inception. During the three and six months ended June 30, 2024, the Company incurred net losses of $14.6 million and $28.3 million, respectively. During the three and six months ended June 30, 2023, the Company incurred net losses of $16.1 million and $30.3 million, respectively. During the six months ended June 30, 2024 and 2023, the Company had negative cash flows from operations of $27.4 million and $23.6 million, respectively. As of June 30, 2024, the Company had an accumulated deficit of $197.9 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 June 30, 2024, the Company had cash and cash equivalents of $106.8 million. The Company’s management expects that the existing cash and cash equivalents will be sufficient to fund the Company’s operating plans for at least twelve months from the issuance date of these condensed 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.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The condensed consolidated financial statements and accompanying notes are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) regarding interim financial reporting.
The accompanying condensed financial statements are consolidated 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.
Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on the Form 10-K filed with the SEC on March 5, 2024. The information as of December 31, 2023, included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial statements. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other interim period or for any other future year.
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 condensed 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 condensed 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 condensed consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions made in the accompanying condensed 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 condensed consolidated balance sheets that sum to the total amount shown in the condensed consolidated statements of cash flows (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Cash and cash equivalents | $106,819 | $86,887 |
| Restricted cash | 417 | 417 |
| Total cash, cash equivalents and restricted cash | $107,236 | $87,304 |
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.
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. For performance stock units that are based on market conditions the estimated fair values of the awards are measured based on Monte Carlo simulation as of the grant date and is recorded over the vesting period derived from the simulation under the graded-vesting attribution method.
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 Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 the Company’s condensed 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 the Company’s condensed 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 June 30, 2024 and December 31, 2023.
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 earnout liability, which was recognized in connection with the business combination in 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 three and six months ended June 30, 2024 and 2023.
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 | $105,819 | $— | $— | $105,819 |
| Total fair value of assets | $105,819 | $— | $— | $105,819 |
| Financial liabilities | ||||
| Earnout liability | $— | $— | $20 | $20 |
| Total fair value of financial liabilities | $— | $— | $20 | $20 |
| 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 | $— | $— | $— | $— |
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, 2022 | $18 |
| Change in the fair value included in other expense | 764 |
| Fair Value as of March 31, 2023 | $782 |
| Change in the fair value included in other income | (420) |
| Fair Value as of June 30, 2023 | $362 |
| Fair Value as of December 31, 2023 | $— |
| Change in the fair value included in other expense | 20 |
| Fair Value as of March 31, 2024 | $20 |
| Change in the fair value included in other expense | — |
| Fair Value as of June 30, 2024 | $20 |
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.
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 June 30, 2024:
| Fair value (in thousands) · Valuation methodology · Significant unobservable input | ||||
|---|---|---|---|---|
| Earnout liability | $20 | Monte Carlo Simulation | Common stock price | $29.36 |
| Expected term (in years) | 0.23 | |||
| Expected volatility | 89.0% | |||
| Risk-free interest rate | 5.25% | |||
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 | $7.89 |
| Expected term (in years) | 0.73 | |||
| Expected volatility | 94.0% | |||
| Risk-free interest rate | 4.92% | |||
NOTE 4. CONDENSED 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):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Research and development prepaid expenses | $575 | $615 |
| Prepaid insurance | 466 | 877 |
| Payroll tax credit receivable | 250 | 250 |
| Prepaid travel expenses | 95 | 14 |
| Other prepaid expenses and current assets | 475 | 295 |
| Total | $1,861 | $2,051 |
Property and equipment, net
The following table summarizes the details of property and equipment, net as of the dates set forth below (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Leasehold improvements | $2,629 | $2,477 |
| Lab equipment | 2,037 | 1,973 |
| Office furniture & fixtures | 522 | 502 |
| Computer equipment | 207 | 145 |
| Capitalized software | 90 | 90 |
| Property and equipment, gross | 5,485 | 5,187 |
| Less: accumulated depreciation and amortization | (3,047) | (2,460) |
| Property and equipment, net | $2,438 | $2,727 |
Depreciation and amortization expense was $0.3 million for each of the three months ended June 30, 2024 and 2023, and $0.6 million and $0.5 million for the six months ended June 30, 2024 and 2023, 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):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Research and development accrued expenses | $3,998 | $5,169 |
| Accrued employee and related compensation expenses | 1,610 | 1,767 |
| Other | 447 | 317 |
| Total | $6,055 | $7,253 |
Other non-current liabilities
The following table summarizes the details of other non-current liabilities as of the dates set forth below (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| CIRM grant liability | $2,264 | $2,264 |
| Total | $2,264 | $2,264 |
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 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 June 30, 2024, of which $0.7 million was received during the year ended December 31, 2023. As of June 30, 2024, $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 $35,000 and $25,000 license maintenance fee in March 2024 and 2023, respectively, which was recognized as research and development expense in the condensed consolidated statements of operations and comprehensive loss for the six months ended June 30, 2024 and 2023.
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
Contingent Earnout Liability
Upon the closing of the business combination and pursuant 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., the Sponsor agreed to place the 105,000 earnout shares into escrow (the “Earnout Shares”), 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.
The estimated fair value of the earnout liability was less than $0.1 million as of June 30, 2024 and was minimal as of December 31, 2023. The fair value is estimated at the end of each reporting period using a Monte Carlo simulation model. Assumptions used in the valuations as of June 30, 2024 and December 31, 2023 are described in Note 3. No triggering event occurred as of each of June 30, 2024 and December 31, 2023. The Company recognized no loss or gain and a loss of less than $0.1 million for the three and six months ended June 30, 2024, respectively, and a gain of $0.4 million and a loss of $0.3 million for the three and six months ended June 30, 2023, respectively, classified within change in fair value of earnout liability in the condensed consolidated statements of operations and comprehensive loss.
NOTE 8. COMMITMENTS AND CONTINGENCIES
Operating Leases
As of June 30, 2024, the Company leased approximately 13,400 square feet of laboratory and office space in Redwood City, California, under an operating lease that expires 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 condensed 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.
The components of lease costs, which were included in the Company’s condensed consolidated statements of operations and comprehensive loss, are as follows (in thousands):
| Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Lease cost | ||
| Operating lease cost | $336 | $336 |
| Short-term lease cost | 1 | 1 |
| Total lease cost | $337 | $337 |
Supplemental information related to the Company’s operating leases is as follows:
| Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash paid for amounts included in the measurement of lease liabilities (in thousands) | $569 | $553 |
| Weighted average remaining lease term (years) | 2.11 | 3.11 |
| 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 June 30, 2024 (in thousands):
| Amount | |
|---|---|
| Year ending December 31, | |
| 2024 (remainder of the year) | $583 |
| 2025 | 1,187 |
| 2026 | 740 |
| Total undiscounted lease payments | 2,510 |
| Less imputed interest | (194) |
| Total discounted lease payments | 2,316 |
| Less current portion of lease liability | (1,029) |
| Noncurrent portion of lease liability | $1,287 |
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 June 30, 2024, 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 the third and final milestone in the amount of $0.3 million was achieved in July 2023. Each milestone was recognized as a research and development expense in the condensed consolidated statements of operations and comprehensive loss in the period in which the milestone was achieved.
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 June 30, 2024, and no royalties were due as of such date. The Company paid $35,000 and $25,000 license maintenance fee in March 2024 and 2023, respectively, and recognized this as a research and development expense in the condensed consolidated statements of operations and comprehensive loss for the six months ended June 30, 2024 and 2023, respectively. No expenses were recognized for each of the three months ended June 30, 2024 and 2023. As of June 30, 2024 and December 31, 2023, 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 six months ended June 30, 2024 and 2023, 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 June 30, 2024 and December 31, 2023, the Company did 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 15,105,300 shares of voting common stock, no shares of non-voting common stock and no shares of preferred stock issued and outstanding as of June 30, 2024.
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 June 30, 2024 and December 31, 2023, the Company had common stock reserved for future issuance as follows:
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Outstanding and issued common stock options | 1,543,752 | 1,040,875 |
| Shares issuable upon exercise of common stock warrants | 499,986 | 499,986 |
| Shares available for grant under Equity Incentive Plans | 1,880,221 | 119,014 |
| Shares available for grant under Employee Stock Purchase Plans | 1,000,000 | 111,958 |
| Shares available for grant under 2022 Inducement Equity Incentive Plan | 15,885 | 95,685 |
| Total shares of common stock reserved | 4,939,844 | 1,867,518 |
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 June 30, 2024, 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 June 30, 2024, $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 $96.9 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, related to an underwritten offering under the New S-3 of 3,900,000 shares of common stock. The Company received net proceeds of $47.2 million.
As of June 30, 2024, $124.5 million remained available and unallocated under the New S-3.
NOTE 10. STOCK-BASED COMPENSATION
On June 6, 2024, the Company’s 2024 Equity Incentive Plan (“2024 Plan”) and the 2024 Employee Stock Purchase Plan (“2024 ESPP”) were approved by its stockholders and became effective, superseding and replacing the Company’s 2021 Equity Incentive Plan (the “2021 Plan”) and the 2021 Employee Stock Purchase Plan (the “2021 ESPP”), respectively. No further awards or purchase rights will be granted under the 2021 Plan or the 2021 ESPP.
Under the 2024 Plan, the Company can grant incentive stock options, nonstatutory stock options, restricted stock awards, stock appreciation rights, restricted stock units (“RSUs”), performance restricted stock units (“PSUs”), and other stock-based awards to employees, directors, and consultants. Under the 2024 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.
On March 14, 2022, the 2022 Inducement Equity Incentive Plan became effective and it was amended on June 2, 2023 to increase the maximum number of shares available for grant thereunder (as amended, the “2022 Inducement Plan”). Under the 2022 Inducement Plan, the Company may 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.
Stock options under the 2024 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.
As of June 30, 2024,2,764,111 shares were reserved for issuance under the 2024 Plan, of which 1,880,221 shares were available for future grant and 883,890 shares were subject to outstanding awards including performance-based awards. As of June 30, 2024,29,802 shares have been issued under the 2021 ESPP and 1,000,000 shares were reserved and available for future issuance under the 2024 ESPP. As of June 30, 2024,550,000 shares were reserved for issuance under the 2022 Inducement Plan, of which 15,885 shares were available for future grant and 534,115 shares were subject to outstanding stock options.
Stock Option Activity
The following table summarizes the stock option activities, including performance-based stock options, under the 2024 Plan, 2021 Plan, the 2022 Inducement Plan and the Company’s 2019 Equity Incentive Plan for the six months ended June 30, 2024:
| Options Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Balance, December 31, 2023 | 1,040,875 | $19.82 | 8.55 | $237 |
| Options granted | 590,517 | $19.69 | ||
| Options exercised | (30,543) | $9.52 | ||
| Options cancelled/forfeited | (57,097) | $25.59 | ||
| Balance, June 30, 2024 | 1,543,752 | $19.76 | 8.63 | $8,091 |
| Vested and expected to vest, June 30, 2024 | 1,543,752 | $19.76 | 8.63 | $8,091 |
| Exercisable, June 30, 2024 | 452,181 | $20.88 | 7.27 | $2,840 |
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 three and six months ended June 30, 2024 was $0.1 million and $0.5 million, respectively, and during each of the three and six months ended June 30, 2023 was $0.4 million.
The total fair value of options that vested during the six months ended June 30, 2024 and 2023 was $3.2 million and $2.1 million, respectively. The weighted-average grant date fair value of options granted during the six months ended June 30, 2024 and 2023 was $16.88 and $14.45 per share, respectively.
Unrecognized stock-based compensation for stock options as of June 30, 2024 was $16.0 million, which is expected to be recognized over a weighted-average period of 3.0 years, including less than $0.1 million related to performance-based stock options, which is expected to be recognized over a weighted-average period of 0.5 years.
Performance-Based Stock Options
The following table summarizes the performance-based stock options activity under the 2024 Plan and 2021 Plan for the six months ended June 30, 2024:
| Options Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Balance, December 31, 2023 | 46,394 | $14.19 | 7.06 | $24 |
| Options granted | — | $ | ||
| Options cancelled/forfeited | — | $ | ||
| Balance, June 30, 2024 | 46,394 | $14.19 | 6.56 | $478 |
| Vested and expected to vest, June 30, 2024 | 46,394 | $14.19 | 6.56 | $478 |
| Exercisable, June 30, 2024 | 31,393 | $7.78 | 5.96 | $478 |
Restricted Stock Units (RSUs)
As of December 31, 2023 the Company had no unvested outstanding RSUs and no RSUs were granted during the six months ended June 30, 2024.
Performance Restricted Stock Units (PSUs)
The following table provides a summary of PSU activity under the 2024 Plan during the six months ended June 30, 2024:
| Number of Share | Weighted- Average Grant Date Fair Value | |
|---|---|---|
| Unvested performance-based restricted stock units at December 31, 2023 | — | $— |
| Granted | 20,000 | $21.90 |
| Unvested performance-based restricted stock units at June 30, 2024 | 20,000 | $21.90 |
| Outstanding performance-based restricted stock units at June 30, 2024 | 20,000 | $21.90 |
In June 2024, the Company granted PSUs for 20,000 shares that will vest in full if the closing price of the Company’s common stock on the Nasdaq Capital Market reaches or exceeds $35.00 per share (subject to adjustment for recapitalizations, stock splits and similar transactions) for thirty consecutive calendar days within two years from the grant date. If the vesting condition is not met within two years from the grant date, the PSUs will be forfeited. The Company concluded that issued PSUs are equity-based awards and include a market based vesting condition. The Company used a Monte Carlo simulation model to estimate the fair value of the PSUs with the following assumptions: common stock fair value of $23.95, which was the closing market price of the Company’s common stock at the grant date, volatility of 133.00%, risk free rate of 4.87%, vesting term of 2.0 years. Total estimated fair value of $0.4 million is recognized as stock-based compensation expense over the 0.4 years, the implied requisite service period from the grant date.
Employee Stock Purchase Plan
The Company issued 10,861 shares and 6,498 shares of common stock under the 2021 ESPP during the three and six months ended June 30, 2024 and 2023, respectively and recognized less than $0.1 million compensation expense related to the 2021 ESPP during each of the three and six months ended June 30, 2024 and 2023. The Company did not issue any shares of common stock under the 2024 ESPP during the three and six months ended June 30, 2024 and 2023 and did not recognize any compensation expense related to the 2024 ESPP during each of the three and six months ended June 30, 2024 and 2023. There was no unamortized stock-based compensation for shares issuable under the 2021 ESPP and 2024 ESPP as of June 30, 2024. The Company did not record any accrued expenses and other current liabilities related to contributions withheld as of June 30, 2024.*** ***
Stock-Based Compensation Expense
The following table presents stock-based compensation expenses related to options, PSUs and RSUs granted to employees and non-employees, employee stock purchase plan awards and restricted common stock shares issued to founders (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| General and administrative | $1,009 | $900 | $1,829 | $1,699 |
| Research and development | 473 | 491 | 822 | 959 |
| $1,482 | $1,391 | $2,651 | $2,658 | |
The Company recognized less than $0.1 million of stock-based compensation expense related to performance-based options, PSUs and RSUs during each of the three and six months ended June 30, 2024 and 2023.
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:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Expected term (in years) | 5.50-6.08 | 5.44-6.08 | 5.50-6.08 | 5.25-6.08 |
| Expected volatility | 116.56%-117.93% | 103.31%-108.98% | 112.09%-117.93% | 103.31%-108.98% |
| Risk-free interest rate | 4.23%-4.50% | 3.49% - 4.05% | 3.93%-4.50% | 3.45% - 4.25% |
| Expected dividend yield | — | — | — | — |
Valuation of Employee Stock Purchase Plan Awards
No 2021 ESPP and 2024 ESPP awards were granted during the three and six months ended June 30, 2024. The grant date fair value of 2021 ESPP awards granted during the three and six months ended June 30, 2023 was estimated using a Black-Scholes option-pricing model with the following assumptions:
| Three and Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Expected term (in years) | — | 0.5 |
| Expected volatility | — | 266.24% |
| Risk-free interest rate | — | 5.39% |
| 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):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator: | ||||
| Net loss attributable to common stockholders | $(14,583) | $(16,080) | $(28,311) | $(30,340) |
| Denominator: | ||||
| Weighted average common shares outstanding | 15,091,367 | 11,034,035 | 14,265,634 | 9,977,404 |
| Less: Weighted-average unvested restricted shares | — | (7,796) | — | (12,012) |
| Less: Shares subject to earnout | (105,000) | (105,000) | (105,000) | (105,000) |
| Weighted average shares used to compute basic and diluted net loss per share | 14,986,367 | 10,921,239 | 14,160,634 | 9,860,392 |
| Net loss per share attributable to common stockholders – basic and diluted | $(0.97) | $(1.47) | $(2.00) | $(3.08) |
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:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Outstanding and issued common stock options | 1,543,752 | 934,512 | 1,543,752 | 934,512 |
| Shares issuable upon exercise of common stock warrants | 499,986 | 499,986 | 499,986 | 499,986 |
| Unvested performance-based restricted stock units | 20,000 | — | 20,000 | — |
| Unvested restricted common stock | — | 5,882 | — | 5,882 |
| Unvested restricted stock units | — | 117,962 | — | 117,962 |
| Total | 2,063,738 | 1,558,342 | 2,063,738 | 1,558,342 |
NOTE 12. RELATED PARTIES
The Company entered into consulting agreements with two founders, one of whom is also a member of the Company’s Board of Directors (the “Board”), and each of whom also received founders’ common stock shares for services and assigned patents. The Company recorded $0.1 million for the founders’ advisory and consulting services performed for each of the three months ended June 30, 2024 and 2023. The Company recorded $0.1 million for advisory and consulting services performed by Professor Judith Shizuru, one of the founders of the Company and a member of the Board, for each of the six months ended June 30, 2024 and 2023. These expenses were recorded as research and development expenses in the condensed consolidated statements of operations and comprehensive loss. The Company recorded $0.1 million in accounts payable, accrued expenses and other current liabilities related to advisory and consulting services performed by Dr. Shizuru as of June 30, 2024. Also, the Company’s Licensed Technology from Stanford (see Note 6) was created in the Stanford laboratory of Dr. Shizuru.
In the first quarter of 2024, a senior executive of the Company joined the Board of Directors of an information technology service provider that the Company has historically utilized to support a broad array of the Company’s systems infrastructure as well as for general information technology support services. For the three and six months ended June 30, 2024, the Company paid that service provider $0.3 million and $0.9 million, respectively, for various information technology support services.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.