Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 13, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35890 | ||
Entity Registrant Name | Tempest Therapeutics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-1472564 | ||
Entity Address, Address Line One | 2000 Sierra Point Parkway | ||
Entity Address, Address Line Two | Suite 400 | ||
Entity Address, City or Town | Brisbane | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94005 | ||
City Area Code | (415) | ||
Local Phone Number | 798-8589 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 16 | ||
Entity Common Stock, Shares Outstanding | 22,192,026 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for its 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001544227 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Chicago, Illinois | ||
Common Stock | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | TPST | ||
Security Exchange Name | NASDAQ | ||
Series A Junior Participating Preferred Purchase Rights | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Series A Junior Participating Preferred Purchase Rights | ||
No Trading Symbol Flag | true | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 39,230 | $ 31,230 |
Insurance recovery of legal settlement | 450 | |
Prepaid expenses and other current assets | 1,133 | 1,270 |
Total current assets | 40,363 | 32,950 |
Property and equipment—net | 840 | 1,060 |
Operating lease right-of-use assets | 9,952 | 11,650 |
Other noncurrent assets | 448 | 429 |
Total assets | 51,603 | 46,089 |
Current liabilities: | ||
Accounts payable | 845 | 1,108 |
Accrued legal settlement | 450 | |
Accrued expenses | 1,673 | 2,961 |
Current loan payable (net of discount and issuance costs of $112 and nil, respectively) | 4,285 | |
Current operating lease liabilities | 952 | 1,413 |
Accrued compensation | 1,543 | 1,248 |
Interest payable | 113 | 97 |
Total current liabilities | 9,411 | 7,277 |
Loan payable (net of discount and issuance costs of $454 and $756, respectively) | 6,264 | 10,371 |
Operating lease liabilities, less current portion | 9,160 | 10,330 |
Total liabilities | 24,835 | 27,978 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized; 22,045,255 and 10,518,539 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 22 | 11 |
Additional paid-in capital | 192,009 | 153,872 |
Accumulated deficit | (165,263) | (135,772) |
Total stockholders' equity | 26,768 | 18,111 |
Total liabilities and stockholders' equity | $ 51,603 | $ 46,089 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Net of discount and issuance costs, Current | $ 112 | |
Net of discount and issuance costs | $ 164 | $ 454 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 22,045,255 | 10,518,539 |
Common stock, shares outstanding | 22,045,255 | 10,518,539 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 17,498,000 | $ 22,527,000 |
General and administrative | 11,659,000 | 12,113,000 |
Operating loss | (29,157,000) | (34,640,000) |
Other income (expense), net: | ||
Interest expense | (1,449,000) | (1,618,000) |
Interest income and other income (expense), net | 1,115,000 | 549,000 |
Other income (expense), net | (334,000) | (1,069,000) |
Provision for income taxes | 0 | 0 |
Net loss | $ (29,491,000) | $ (35,709,000) |
Net loss per share of common stock and pre-funded warrants, basic | $ (1.91) | $ (3.09) |
Net loss per share of common stock and pre-funded warrants, diluted | $ (1.91) | $ (3.09) |
Weighted-average shares of common stock and pre-funded warrants outstanding, basic | 15,416,203 | 11,548,907 |
Weighted-average shares of common stock and pre-funded warrants outstanding, diluted | 15,416,203 | 11,548,907 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Deficit Accumulated |
Beginning balance (in shares) at Dec. 31, 2021 | 6,910,324 | |||
Beginning balance at Dec. 31, 2021 | $ 36,117 | $ 7 | $ 136,173 | $ (100,063) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercised of stock options (in shares) | 0 | |||
Issuance of common stock for cash, net of issuance cost (in shares) | 3,608,215 | |||
Issuance of common stock for cash, net of issuance cost | $ 8,861 | $ 4 | 8,857 | |
Share-based compensation | 1,561 | 1,561 | ||
Issuance of common stock warrants | 7,281 | 7,281 | ||
Net loss | (35,709) | (35,709) | ||
Ending balance (in shares) at Dec. 31, 2022 | 10,518,539 | |||
Ending balance at Dec. 31, 2022 | $ 18,111 | $ 11 | 153,872 | (135,772) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercised of stock options (in shares) | 713 | 713 | ||
Exercised of stock options | $ 1 | 1 | ||
Issuance of common stock for cash, net of issuance cost (in shares) | 8,323,218 | |||
Issuance of common stock for cash, net of issuance cost | 35,598 | $ 8 | 35,590 | |
Exercise of pre-funded warrants(in shares) | 3,202,785 | |||
Exercise of pre-funded warrants | 3 | $ 3 | ||
Share-based compensation | 2,546 | 2,546 | ||
Net loss | (29,491) | (29,491) | ||
Ending balance (in shares) at Dec. 31, 2023 | 22,045,255 | |||
Ending balance at Dec. 31, 2023 | $ 26,768 | $ 22 | $ 192,009 | $ (165,263) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance costs | $ 1,105 | $ 489 |
Warrant issuance costs | $ 283 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||
Net loss | $ (29,491) | $ (35,709) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 381 | 638 |
Stock-based compensation expense | 2,546 | 1,561 |
Noncash lease expense | 1,698 | 1,176 |
Noncash interest and other expense, net | 186 | 394 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 193 | 915 |
Accounts payable | (263) | 1 |
Accrued expenses and other liabilities | (992) | 1,709 |
Interest payable | 16 | (256) |
Operating lease liabilities | (1,631) | (1,501) |
Cash used in operating activities | (27,357) | (31,072) |
Investing activities: | ||
Purchase of property and equipment | (170) | (562) |
Cash used in investing activities | (170) | (562) |
Financing activities: | ||
Proceeds from the issuance of common stock, net of issuance costs | 35,602 | 8,861 |
Proceeds from issuance of pre-funded warrants, net of issuance costs | 0 | 7,281 |
Repayment of loan | (4,739) | |
Cash provided by financing activities | 35,602 | 11,403 |
Net increase in cash and cash equivalents | 8,075 | (20,231) |
Cash, cash equivalents and restricted cash at beginning of period | 31,598 | 51,829 |
Cash, cash equivalents and restricted cash at end of period | 39,673 | 31,598 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 1,249 | 1,539 |
Cash paid for business taxes | 191 | 18 |
Operating lease right-of-use assets recognized in exchange for lease liabilities | 10,660 | |
Non-cash operating activities: | ||
Lease modification | 884 | |
Non-cash investing activities: | ||
Property and equipment in accounts payable | $ 0 | $ 93 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (29,491) | $ (35,709) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. ORGANIZATION AND DESCRIPTION OF BUSINESS Description of Business Tempest Therapeutics, Inc. (“Tempest” or the “Company”) is a clinical-stage oncology company advancing small molecules that combine both tumor-targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The Company’s two novel clinical programs are TPST-1120 and TPST-1495, antagonists of PPARα and EP2/EP4, respectively. Both programs are advancing through clinical trials designed to study the agents as monotherapies and in combination with other approved agents. Tempest is also developing other product candidates currently in our Discovery Research portfolio. Tempest is headquartered in Brisbane, California. Liquidity and Management Plans The accompanying financial statements have been prepared assuming the Company will continue as a going concern. The Company has incurred operating losses since inception. As of December 31, 2023 , the Company had cash and cash equivalents of $ 39.2 million, which is sufficient to fund operations beyond 12 months from the issuance of the financial statements. The Company’s ability to fund continued development will require additional capital, and Tempest intends to raise such capital through the issuance of additional debt or equity including in connection with potential merger opportunities, or through business development activities. The Company’s ability to continue as a going concern is dependent upon its ability to successfully accomplish these plans and secure sources of financing and ultimately attain profitable operations. If the Company are unable to obtain adequate capital, it could be forced to cease operations. ATM Program On July 23, 2021, the Company entered into a sales agreement with Jefferies LLC, pursuant to which the Company may sell, from time to time at its sole discretion through Jefferies, as its sales agent, shares of its common stock having, up to an aggregate sales price of $ 100.0 million of its common stock through Jefferies (the “ATM Program”). Any shares of its common stock sold will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-257990). The Company will pay Jefferies a commission up to 3.0 % of the gross sales proceeds of any shares of its common stock sold through Jefferies under the ATM Program and also has provided Jefferies with indemnification and contribution rights. As of December 31, 2023 , the Company has sold an aggregate of 8,960,822 shares of its common stock for net proceeds of approximately $ 41.2 million, after deducting commissions and expenses pursuant to the ATM Program. During the year ended December 31, 2023 , the Company has sold an aggregate of 8,260,479 shares of its common stock for net proceeds of approximately $ 35.6 million, after deducting commissions and expenses. As of December 31, 2023 , approximately $ 57.6 million remained available under the ATM Program. PIPE Financing On April 29, 2022, the Company completed a private investment in public equity (“PIPE”) financing from the sale of 3,149,912 shares of its common stock at a price per share of $ 2.36 and, and in lieu of shares of common stock, pre-funded warrants to purchase up to 3,206,020 shares of its common stock at a price per pre-funded warrant of $ 2.359 to EcoR1 Capital, LLC and Versant Venture Capital (the “PIPE Investors”). Net proceeds from the PIPE financings totaled approximately $ 14.5 million, after deducting offering expenses. The Company entered into a registration rights agreement with the PIPE Investors pursuant to which the Company filed a registration statement with the SEC registering the resale of the 3,149,912 shares common stock and the 3,206,020 shares of common stock underlying the pre-funded warrants issued in the PIPE financing. As of December 31, 2023 , all pre-funded warrants had been exercised. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation —The accompanying Consolidated Financial Statements have been prepared in accordance with US generally accepted accounting principles ("GAAP") and necessarily include amounts based on estimates and assumptions by management. Use of Estimates —The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development accruals, recoverability of long-lived assets, right-of-use assets, lease obligations, stock-based compensation and income taxes uncertainties and valuation allowances. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates. Segment Information —The Company operates and manages its business as one reportable and operating segment, which is the business of discovery and development of small molecule drugs to treat cancers. All assets and operations are in the U.S. The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Risks and Uncertainties —The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on single-source vendors, availability of raw materials, patentability of the Company’s products and processes and clinical efficacy and safety of the Company’s products under development, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval, prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale and, therefore, the Company has not generated any revenue from product sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. Concentration of Credit Risk —Financial instruments, which potentially subject the Company to concentration of risk, consist principally of cash and money market fund. All of the Company’s cash and money market fund are deposited in accounts with a major financial institution in excess of federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash equivalents to the extent recorded in the balance sheets. While the Company has not experienced any losses in such accounts, the recent failure of Silicon Valley Bank (SVB), at which the Company held cash and cash equivalents in multiple accounts, exposed the Company to significant credit risk prior to the completion by the Federal Deposit Insurance Corporation of the resolution of SVB in a manner that fully protected all depositors. The Company had subsequently transferred its accounts to one or more alternate depository institutions. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. Cash and Cash Equivalents —The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisitions to be cash equivalents. As of December 31, 2023 and 2022 , the Company’s cash and cash equivalents consisted of bank deposits and money market funds. Leases —The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the customer has the right to control the use of the identified asset. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments. When leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, including the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Property and Equipment —Property and equipment is recorded at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Upon disposal of an asset, the related cost and accumulated depreciation are removed from the asset accounts and any resulting gain or loss is included in the consolidated statements of operations. Repair and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. The estimated useful lives of the Company’s respective assets are as follows: Computer equipment and software 3 years Furniture and fixtures 7 years Laboratory equipment 5 years Leasehold improvements Shorter of the useful life of the asset or the life of the lease Impairment of Long-Lived Assets —Long-lived assets are reviewed for impairment if events or circumstances indicate the carrying amount of these assets may not be recoverable. If this review indicates that these assets will not be recoverable, based on the forecasted undiscounted future operating cash flows expected to result from the use of long-lived assets and their eventual disposition, the Company’s carrying value of the long-lived assets is reduced to fair value based on a discounted future cash flow approach or quoted market values. Research and Development Expenses and Accrued Research and Development —Research and development expenses are charged to expense as incurred. Research and development expenses include certain payroll and personnel expenses including stock-based compensation, laboratory supplies, consulting costs, external contract research and development expenses and facility or lease expenses. In-licensing fees and other costs to acquire technologies that are utilized in research and development, and that are not expected to have alternative future use, are expensed when incurred. Advance payments for goods or services for future research and development activities are deferred and expensed as the goods are delivered or the related services are performed. The Company estimates preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers, the Company’s estimates of accrued expenses and on information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. The estimates are trued up to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. Patent Costs —Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These patent-related legal costs are reported as a component of general and administrative expenses. General and Administrative Expenses —General and administrative costs are expensed as incurred and include employee-related expenses including salaries, benefits, travel and stock-based compensation for the Company’s personnel in executive, finance and accounting, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and patent costs. Fair Value Measurements —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 the Company’s financial instruments approximate fair value due to their short-term maturities. Stock-Based Compensation Expense —The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all share-based payments made to employees, directors and non-employees based on estimated grant-date fair values. The Company uses the straight-line method to allocate compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting period. The Company estimates the fair value of stock options to employees, directors and non-employees using the Black-Scholes option-valuation model. The Black-Scholes model requires the input of subjective assumptions, including expected volatility, expected dividend yield, expected term, risk-free rate of return, and the fair value of the underlying common stock on the date of grant. Due to the lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The group of representative companies have characteristics similar to the Company, including stage of product development and focus on the life science industry. The Company uses the simplified method to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The Company uses an assumed dividend yield of zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The Company accounts for forfeitures as they occur. Net Loss per Share Attributable to Common Stockholders —The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, convertible preferred stock and warrants to purchase shares of convertible preferred stock are considered potential dilutive common shares. 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 financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement 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, in the event that 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 earnings 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. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3 . FAIR VALUE MEASUREMENTS The following tables present the Company’s fair value hierarchy for assets and liabilities measured at fair value on a recurring basis (in thousands): As of December 31, 2023 Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 39,230 $ — $ — $ 39,230 Total $ 39,230 $ — $ — $ 39,230 As of December 31, 2022 Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 31,230 $ — $ — $ 31,230 Total $ 31,230 $ — $ — $ 31,230 |
Balance Sheet Items
Balance Sheet Items | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Items | 4 . BALANCE SHEET ITEMS Prepaid expenses and other current asset consist of the following as of December 31, 2023 and 2022 (in thousands): 2023 2022 Prepaid expenses $ 700 $ 703 Prepaid research and development costs 337 304 Other current assets 96 263 Total $ 1,133 $ 1,270 Property and equipment, net, consists of the following as of December 31, 2023 and 2022 (in thousands): 2023 2022 Computer equipment and software $ 169 $ 168 Furniture and fixtures 328 310 Lab equipment 1,133 1,061 Leasehold improvements 235 882 Property and equipment 1,865 2,421 Less accumulated depreciation ( 1,025 ) ( 1,361 ) Property and equipment—net $ 840 $ 1,060 Depreciation expense for the years ended December 31, 2023 and 2022 were $ 381 and $ 638 , respectively. Accrued liabilities as of December 31, 2023 and 2022 consist of the following (in thousands): 2023 2022 Accrued other liabilities $ 626 $ 756 Accrued clinical trial liability 1,047 2,205 Total $ 1,673 $ 2,961 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5 . COMMITMENTS AND CONTINGENCIES Facilities Lease Agreements —In February 2019, the Company entered into a 5-year office lease agreement for a 9,780 square feet facility in South San Francisco, California. The original lease term expires on February 29, 2024 . In June 2022, the lease was amended to terminate early on January 31, 2023 . The amendment was not accounted for as a separate contract and the lease liability and the right-of-use asset were remeasured on the lease modification date. In January 2022, the Company entered into a new 8-year office lease agreement for a 20,116 square feet facility in Brisbane, California ("Brisbane Lease"). The lease commenced in December 2022. As of December 31, 2023 and 2022 , the balance of the operating lease right of use assets were $ 9,952 and $ 11,650 , respectively, and the related operating lease liability were $ 10,112 and $ 11,744 , respectively, as shown in the accompanying consolidated balance sheets. Rent expense was $ 2,738 and $ 1,445 for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, future minimum annual lease payments under the Company’s operating lease liabilities were as follows: Total Commitment Year Ending (in thousands) 2024 $ 2,100 2025 1,861 2026 1,926 2027 1,994 2028 and beyond 6,410 Total minimum lease payments 14,291 Less: imputed interest ( 4,179 ) Present value of operating lease obligations 10,112 Less: current portion ( 952 ) Noncurrent operating lease obligations $ 9,160 Related to this Brisbane Lease agreement, the Company entered into a letter of credit with a bank to deposit $ 388 in a separate account that is restricted cash to serve as security rent deposit. This amount is included in other noncurrent assets in the accompanying Consolidated Balance Sheets as of December 31, 2023. 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. Legal Proceedings —Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. As a result of the merger with Millendo, the Company is party to various litigation matters given Millendo’s role as successor to OvaScience, Inc. (“OvaScience”). OvaScience merged with Millendo in 2018. Prior to the merger with Millendo, OvaScience was sued in three matters that are disclosed below. On November 9, 2016, a purported shareholder derivative action was filed in Massachusetts State court (Cima v. Dipp) against OvaScience and certain former officers and directors of OvaScience and OvaScience alleging breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement and waste of corporate assets for purported actions related to OvaScience’s January 2015 follow-on public offering. As of September 12, 2022, the parties have reached an agreement in principle and have executed a term sheet in connection with a settlement. On September 13, 2022, the parties filed a joint motion to stay the case pending settlement. On September 15, 2022, the court issued a 90-day nisi order. On December 14, 2022, the court extended that order for 60 days to February 20, 2023. On February 17, 2023, the court extended the order until March 22, 2023 and set a court appearance for March 23, 2023. On March 23, 2023, the court granted preliminary approval of the settlement and set a final fairness hearing for June 12, 2023. By order dated June 12, 2023, the court granted final approval of the settlement. On July 27, 2017, a purported shareholder derivative complaint was filed in Massachusetts Federal court (Chiu v. Dipp) against OvaScience and certain former officers and directors of OvaScience alleging breach of fiduciary duties, unjust enrichment and violations of Section 14(a) of the Exchange Act. related to OvaScience’s January 2015 follow-on public offering and other public statements concerning OvaScience’s AUGMENT treatment. Following the court’s dismissal of an amended complaint, the parties agreed that plaintiffs could file a second amended complaint and that the case would be stayed pending the resolution of the Dahhan Action. In May 2018, the court entered an order staying this case pending the resolution of the Dahhan Action. As of September 12, 2022, the parties have reached an agreement in principle and have executed a term sheet in connection with the settlement. On February 14, 2023, the parties informed the court that, subject to court approval, they had reached an agreement to settle Chiu v. Dipp as well as Cima v. Dipp. The parties requested a 90-day stay in order to present the settlement to the state court in Cima v. Dipp first. On February 16, 2023, the court granted the 90-day stay. On May 2, 2023, the court extended the stay through July 12, 2023. After final approval of the Cima settlement, the parties filed a stipulation and proposed order to dismiss the Chiu Action with prejudice on June 27, 2023. By order dated July 5, 2023, the court dismissed the Chiu Action with prejudice. |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loan Payable | 6 . LOAN PAYABLE On January 15, 2021, the Company entered into a loan agreement with Oxford Finance LLC (the "Lender") to borrow a term loan amount of $ 35,000 to be funded in three tranches. Tranche A of $ 15,000 was wired to the Company on January 15, 2021. Tranche B of $ 10,000 expired on March 31, 2022 . Tranche C of $ 10,000 is available at the Lender’s option. On December 23, 2022, the Company entered into a First Amendment to the loan agreement. The amendment modified the agreement as follows: (i) each of the Company and Millendo, were joined as co-borrowers under the Loan Agreement; (ii) the interest-only repayment period was extended through December 31, 2023 (which interest-only period may be further extended through June 30, 2024 under certain circumstances); and (iii) a security interest in all of the assets of the Company, TempestTx and Millendo, including any intellectual property, was granted to the Lender. In addition, the Lender permitted a one-time prepayment in the amount of $ 5.0 million, which the Company paid on December 23, 2022. Following the amendment to the loan agreement, the term loan matures on August 1, 2025 and has an annual floating interest rate of 7.15 % which is an Index Rate plus 7.10 %. Index Rate is the greater of (i) 1-Month CME Term SOFR or (ii) 0.05 %. In the fourth quarter of 2023, the Company achieved the circumstances necessary to extend the interest-only repayment period through June 30, 2024. Monthly principal payments of $ 733 are required to begin on July 1, 2024. Related to this borrowing, the Company recorded loan discounts totaling $ 898 and paid $ 95 of debt issuance costs. These amounts would be amortized as additional interest expense over the life of the loan. As of December 31, 2023 , the balance of the loan payable (net of debt issuance costs) was $ 10.5 million. The carrying value of the loan approximates fair value (Level 2). For the years ended December 31, 2023 and 2022 , total interest expense was $ 1,449 and $ 1,618 , respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Temporary Equity Disclosure [Abstract] | |
Stockholders' Equity | 7 . STOCKHOLDERS' EQUITY Common Stock On March 29, 2021, TempestTx, Inc. (“Private Tempest”) entered into an Agreement and Plan of Merger (with Millendo Therapeutics, Inc. upon completion of the merger on June 25, 2021, the Company issued an aggregate of approximately 5,365,899 shares of its common stock to Private Tempest stockholders, based on an exchange ratio of 0.0322 shares of the Company’s common stock for each share of Private Tempest common stock outstanding immediately prior to the merger, including those shares of common stock issued upon conversion of the Private Tempest preferred stock ( 3,692,912 common shares) and those shares of common stock issued with its pre-merger financing of $ 30.0 million ( 1,136,849 common shares). As of December 31, 2023 and December 31, 2022, the Company was authorized to issue 100,000,000 shares of common stock and 5,000,000 shares of preferred stock, each with a par value of $ 0.001 per share. Of the common stock shares authorized, 22,045,255 and 10,518,539 were issued and outstanding at December 31, 2023 and December 31, 2022, respectively. There were no shares subject to repurchase due to remaining vesting requirements. There was no preferred stock issued nor outstanding as of December 31, 2023 and December 31, 2022. Common stockholders are entitled to dividends as declared by the Board of Directors, subject to rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. The holders of each share of common stock are entitled to one vote. Except for effecting or validating certain specific actions intended to protect the preferred stockholders, the holders of common stock vote together with preferred stockholders and have the right to elect one member of the Company’s Board of Directors. Rights Plan On October 10, 2023, the Company’s Board of Directors adopted a limited duration stockholder rights plan (the “Rights Plan”), effective immediately, and declared a dividend of one preferred share purchase right (a “Right”) for each outstanding share of the common stock, par value $ 0.001 per share (the “Common Shares”), of the Company. The dividend was effective as of October 23, 2023 (the “Record Date”) with respect to stockholders of record on that date. The Rights will also attach to new Common Shares issued after the Record Date. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $ 0.001 per share, (the “Preferred Shares”), of the Company at a price of $ 25.00 per one one-thousandth of a Preferred Share, subject to adjustment. The descriptions and terms of the Rights are set forth in a Rights Agreement, dated as of October 10, 2023 (the “Rights Agreement"), between the Company and Computershare Trust Company, NA. The Rights will expire on October 10, 2024 , or, if the Company’s stockholders approve the Rights plan, on October 10, 2026 , unless the Rights are earlier redeemed or exchanged by the Company. ATM Program On July 23, 2021, the Company entered into a sales agreement with Jefferies LLC, pursuant to which the Company may sell, from time to time, up to an aggregate sales price of $ 100,000,000 of its common stock through Jefferies LLC (the "ATM Program"). Our ability to sell securities under the ATM program will be limited until we are no longer subject to the SEC’s “baby shelf” limitations. Pre-Funded Warrants In April 2022, the Company completed a PIPE financing, which included the issuance of pre-funded warrants to purchase up to 3,206,020 shares of its common stock at a price per pre-funded warrant of $ 2.359 to the PIPE Investors. As of December 31, 2023, all pre-funded warrants had been exercised. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8 . STOCK-BASED COMPENSATION Equity Plans In 2011, Private Tempest adopted the 2011 Equity Incentive Plan (the “2011 Plan), and in 2017, Private Tempest adopted the 2017 Equity Incentive Plan (the “2017 Plan”), and together with the 2011 Plan, the “Tempest Prior Plans.” The Tempest Prior Plans have been terminated and no additional grants may be made under either plan. All stock awards granted under the Tempest Prior Plans will remain subject to the terms of the applicable prior plan. As a result of the merger with Millendo, the Tempest Prior Plans were assumed by the Company. On April 29, 2019, the Board of Millendo adopted the 2019 Equity Incentive Plan (the “2019 Plan”), subject to approval by the Company’s stockholders, and became effective with such stockholder approval on June 11, 2019. On June 17, 2022, the Company’s stockholders approved the Amended and Restated 2019 Equity Incentive Plan (the “A&R 2019 Plan”), which amended and restated the 2019 Plan and will be a successor to, and replacement of, the 2019 Plan. The Board of Tempest adopted the Amended and Restated 2023 Equity Incentive Plan (the “2023 Plan”) on April 30, 2023, subject to approval by the Company’s stockholders. On June 15, 2023, the Company’s stockholders approved the 2023 Plan, which amended and restated the A&R 2019 Plan and will be a successor to, and replacement of, the A&R 2019 Plan. The number of shares of the Company's common stock reserved for issuance under the 2023 Plan will automatically increase on January 1st of each year, for a period of 10 years, from January 1, 2024 continuing through January 1, 2033, by 4 % of the total number of shares of the Company's common stock outstanding on December 31 st of the preceding calendar year, or a lesser number of shares as may be determined by the Board of Directors. Accordingly, on January 1, 2024, the common stock reserved for issuance was increased by 881,810 shares. As of December 31, 2023 , there were 233,708 shares available for future grant under the 2023 Plan. The 2023 Plan allows the Company to grant stock awards to employees, directors and consultants of the Company, including incentive stock options (“ISOs”), non-qualified stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock awards. The Board of Tempest adopted the 2023 Inducement Plan (“2023 Inducement Plan”) on June 21, 2023, pursuant to which the Company reserved 1,150,000 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2023 Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance with such rule. As of December 31, 2023 , there were 1,142,350 shares available for future grant under the 2023 Inducement Plan. The Company measures employee and non-employee stock-based awards at grant date fair value and records compensation expense on a straight-line basis over the vesting period of the award. Employee Stock Ownership Plan The Board of Millendo adopted the 2019 Employee Stock Purchase Plan on April 29, 2019, which became effective upon stockholder approval on June 11, 2019. On June 17, 2022, the Company’s stockholders approved the Amended and Restated 2019 Employee Stock Purchase Plan (the “2019 ESPP”). The 2019 ESPP enables employees to purchase shares of the Company's common stock through offerings of rights to purchase the Company's common stock to all eligible employees. The 2019 ESPP provides that the number of shares of common stock reserved for issuance under the 2019 ESPP will automatically increase on January 1, 2023 and continuing through (and including) January 1, 2029, by the lesser of 1.5 % of the total number of shares of Common Stock outstanding on December 31 st of the preceding calendar year, (ii) 500,000 shares of Common Stock, or (iii) such lesser number of shares of Common Stock as determined by the Board of Directors (which may be zero). On January 1, 2024, the common stock reserved for issuance was increased by 330,678 shares. As of December 31, 2023 , 232,136 shares of common stock remained available for future issuance under the 2019 ESPP. During the year ended December 31, 2023 , 62,739 shares of common stock had been issued under the 2019 ESPP. Stock Options Options to purchase the Company’s common stock may be granted at a price not less than the fair market value in the case of both NSOs and ISOs, except for an options holder who owns more than 10% of the voting power of all classes of stock of the Company, in which case the exercise price shall be no less than 110 % of the fair market value per share on the grant date. Stock options granted under the Plans generally vest over four years and expire no later than ten ( 10 ) years from the date of grant. Vested options can be exercised at any time. Prior to the merger with Millendo, the grant date fair market value of the shares of common stock underlying stock options was determined by the Company’s Board of Directors. Up until the merger, there had been no public market for the Company’s common stock, and therefore the Board of Directors exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate of the fair market value, which included valuations performed by an independent third-party, important developments in the Company’s operations, sales of convertible preferred stock, actual operating results, financial performance, the conditions in the life sciences industry, the economy in general, the stock price performance and volatility of comparable public companies, and the lack of liquidity of the Company’s common stock. The following shows the stock option activities for the years ended December 31, 2023 and 2022: Total Options Outstanding Weighted-Average Exercise Price Balance—December 31, 2021 790,637 $ 32.82 Granted 909,527 3.34 Exercised — — Cancelled and forfeited ( 147,123 ) 128.79 Balance—December 31, 2022 1,553,041 $ 6.66 Granted 2,308,800 7.26 Exercised ( 713 ) 1.23 Cancelled and forfeited ( 307,016 ) 3.97 Balance—December 31, 2023 3,554,112 7.28 The following table summarizes information about stock options outstanding at December 31, 2023: Shares Weighted Average Remaining Contractual Life (In Years) Weighted Average Exercise Price Aggregate Intrinsic Value Options outstanding 3,554,112 8.79 $ 7.28 $ 2,737,358 Vested and expected to vest 3,554,112 8.79 $ 7.28 $ 2,737,358 Exercisable 1,041,752 7.42 $ 6.52 $ 906,002 During the years ended December 31, 2023 and 2022 , the Company granted employees and non-employees stock options to purchase 2,308,800 and 909,527 shares of common stock with a weighted-average grant date fair value of $ 6.05 and $ 2.82 per share, respectively. As of December 31, 2023 and 2022 , total unrecognized compensation costs related to unvested employee stock options were $ 14,703 and $ 4,012 , respectively. These costs are expected to be recognized over a weighted-average period of approximately 3.5 years and 2.6 years, respectively. The Company estimated the fair value of stock options using the Black-Scholes option pricing valuation model. The fair value of employee stock options is being amortized on the straight-line basis over the requisite service period of the awards. The fair value of employee stock options was estimated using the following assumptions for the years ended December 31, 2023 and 2022: 2023 2022 Expected term (in years) 5.5 - 6.1 5.5 - 6.1 Expected volatility 106 % - 111 % 109 % - 112 % Risk-free interest rate 3.4 % - 4.5 % 1.5 % - 3.9 % Dividends — % — % Expected Term —The expected term of options granted represents the period of time that the options are expected to be outstanding. Due to the lack of historical exercise history, the expected term of the Company’s employee stock options has been determined utilizing the simplified method for awards that qualify as plain-vanilla options. Expected Volatility —The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company did not have any trading history for the Company’s common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the Company’s common stock becomes available. Risk-Free Interest Rate —The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. Dividends —The Company has not paid any cash dividends on common stock since inception and does not anticipate paying any dividends in the foreseeable future. Consequently, an expected dividend yield of zero was used. Restricted Stock Units The Company granted 125,000 restricted stock units ("RSUs") with a fair value of $ 0.60 per share during the year ended December 31, 2023 . The RSUs vest on February 25, 2024 . Stock-Based Compensation Expense The following table summarizes the components of stock-based compensation expense recognized in the Company’s consolidated statements of operations for the years ended December 31, 2023 and 2022: 2023 2022 Research and development $ 899 $ 517 General and administrative 1,647 1,044 Total $ 2,546 $ 1,561 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9 . INCOME TAXES There was no provision for income taxes for the years ended December 31, 2023 and 2022, because the Company has incurred losses since inception. At December 31, 2023 and 2022 the Company concluded it was not more likely than not that it would realize its deferred tax assets, and therefore has recorded a full valuation allowance. For the years ended December 31, 2023 and 2022, income tax provision (benefit) related to continuing operations differ from the amounts computed by applying the statutory income tax rate of 21% to pre-tax loss as follows (in thousands): 2023 2022 U.S. federal provision (benefit) At statutory rate $ ( 6,192 ) $ ( 7,497 ) State taxes ( 2,492 ) ( 2,733 ) Valuation allowance 9,129 8,581 Tax credits ( 836 ) ( 1,173 ) Stock-based compensation 371 2,606 Permanent differences 20 216 Total $ — $ — Significant components of the Company’s deferred tax assets at December 31, 2023 and 2022 are shown below. 2023 2022 Deferred tax assets: Net operating losses $ 136,901 $ 131,346 Research and development tax credits 19,240 18,122 Amortization 730 916 Lease liability 3,018 3,504 Stock based compensation 809 576 Other 449 378 Capitalized R&D 6,466 4,138 Fixed assets — 10 Total gross deferred tax assets 167,613 158,990 Less: valuation allowance ( 164,643 ) ( 155,514 ) Total deferred tax assets 2,970 3,476 Deferred tax liability: Right-of-use assets ( 2,970 ) ( 3,476 ) Total gross deferred tax liabilities ( 2,970 ) ( 3,476 ) Net deferred tax assets $ — $ — The valuation allowance increased by $ 9.1 million from December 31, 2022 to December 31, 2023 due primarily to the generation of net operating losses and research and development credits. As of December 31, 2023, the Company has net operating loss carryforwards for federal and state income tax purposes of approximately $ 482.1 million and $ 457.8 million, respectively. As of December 31, 2022 , the Company has net operating loss carryforwards for federal and state income tax purposes of approximately $ 466.0 million and $ 434.4 million, respectively. The federal and state net operating loss carryforwards begin to expire in 2031 and 2023, respectively, if not utilized. Federal net operating losses of $ 260.9 million are not subject to expiration. As of December 31, 2023 , the Company has federal and state research and development carryforwards of approximately $ 12.7 million and $ 4.0 million, respectively. The Company also has $ 7.4 million of Orphan Drug Credit. As of December 31, 2022 , the Company has federal and state research and development carryforwards of approximately $ 11.7 million and $ 3.6 million, respectively. The federal and state credits begin to expire in 2031 and 2029, respectively, if not utilized; $ 2.9 million of the state credits can be carried forward indefinitely. Utilization of some of the federal and state net operating loss and credit carryforwards may be subject to annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986 and similar state provisions. The annual limitations may result in the expiration of net operating losses and credits before utilization. The Company has not performed a Section 382 study as of December 31, 2023 . At least $ 455.8 thousand of legacy Millendo federal net operating losses are expected to expire unused due to prior ownership changes. The Company has the following activity relating to unrecognized tax benefits as of December 31, 2023 and 2022: 2023 2022 Beginning balance $ 4,650 $ 4,293 Gross increase - tax position in current period 273 357 Ending balance $ 4,923 $ 4,650 As of December 31, 2023 and 2022, none of the unrecognized tax benefits would impact the Company's effective tax rate due to the valuation allowance. The Company does not anticipate the uncertain tax positions will materially change in the next 12 months. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest and penalties on the accompanying consolidated balance sheets as of December 31, 2023 and 2022, respectively, and has not recognized penalties and/or interest in the accompanying statements of operations for the years ended December 31, 2023 and 2022, respectively. The Company is subject to taxation in the United States, California, Massachusetts, and Michigan. The Company’s tax years from inception are subject to examination by the IRS and state tax authorities due to the carryforward of unutilized net operating losses and research and development credits. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement Plan | 10. RETIREMENT PLAN The Company participates in a qualified 401(k) Plan sponsored by its professional service organization. The retirement plan is a defined contribution plan covering eligible employees. Participants may contribute a portion of their annual compensation limited to a maximum annual amount set by the Internal Revenue Service. During the year ended December 31, 2023 , the Company contributed $ 147 to the 401(k) Plan. During the year ended December 31, 2022 , the Company contributed $ 126 to the 401(k) Plan. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. NET LOSS PER SHARE The following table sets forth the computation of the Company’s basic and diluted net loss per share for the years ended December 31, 2023 and 2022 (in thousands, except share and per share amounts): 2023 2022 Numerator: Net loss $ ( 29,491 ) $ ( 35,709 ) Denominator: Weighted-average common shares outstanding 15,416,203 11,548,907 Less: Weighted-average unvested restricted shares and shares subject to repurchase — — Weighted-average shares used in computing basic and diluted net loss per share 15,416,203 11,548,907 Net loss per share attributable to common stockholders—basic and diluted $ ( 1.91 ) $ ( 3.09 ) As of December 31, 2023 and 2022 , the Company’s potentially dilutive securities included unvested stock warrants and stock options, which have been excluded from the computation of diluted net loss per share attributable to common stockholders as the effect would be anti-dilutive. The issuance of pre-funded warrants have been included in the computation of basic and diluted net loss per share attributable to common stockholders. Based on the amounts outstanding as of December 31, 2023 and 2022, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect: 2023 2022 Options to purchase common stock 3,554,112 1,553,041 Restricted stock units 125,000 — Common stock warrants 6,036 6,036 3,685,148 1,559,077 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation —The accompanying Consolidated Financial Statements have been prepared in accordance with US generally accepted accounting principles ("GAAP") and necessarily include amounts based on estimates and assumptions by management. |
Use of Estimates | Use of Estimates —The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development accruals, recoverability of long-lived assets, right-of-use assets, lease obligations, stock-based compensation and income taxes uncertainties and valuation allowances. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates. |
Segment Information | Segment Information —The Company operates and manages its business as one reportable and operating segment, which is the business of discovery and development of small molecule drugs to treat cancers. All assets and operations are in the U.S. The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. |
Risks and Uncertainties | Risks and Uncertainties —The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on single-source vendors, availability of raw materials, patentability of the Company’s products and processes and clinical efficacy and safety of the Company’s products under development, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval, prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale and, therefore, the Company has not generated any revenue from product sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. |
Concentration of Credit Risk | Concentration of Credit Risk —Financial instruments, which potentially subject the Company to concentration of risk, consist principally of cash and money market fund. All of the Company’s cash and money market fund are deposited in accounts with a major financial institution in excess of federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash equivalents to the extent recorded in the balance sheets. While the Company has not experienced any losses in such accounts, the recent failure of Silicon Valley Bank (SVB), at which the Company held cash and cash equivalents in multiple accounts, exposed the Company to significant credit risk prior to the completion by the Federal Deposit Insurance Corporation of the resolution of SVB in a manner that fully protected all depositors. The Company had subsequently transferred its accounts to one or more alternate depository institutions. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Cash and Cash Equivalents | Cash and Cash Equivalents —The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisitions to be cash equivalents. As of December 31, 2023 and 2022 , the Company’s cash and cash equivalents consisted of bank deposits and money market funds. |
Lessee, Leases | Leases —The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the customer has the right to control the use of the identified asset. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments. When leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, including the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
Property and Equipment | Property and Equipment —Property and equipment is recorded at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Upon disposal of an asset, the related cost and accumulated depreciation are removed from the asset accounts and any resulting gain or loss is included in the consolidated statements of operations. Repair and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets —Long-lived assets are reviewed for impairment if events or circumstances indicate the carrying amount of these assets may not be recoverable. If this review indicates that these assets will not be recoverable, based on the forecasted undiscounted future operating cash flows expected to result from the use of long-lived assets and their eventual disposition, the Company’s carrying value of the long-lived assets is reduced to fair value based on a discounted future cash flow approach or quoted market values. |
Research and Development Expense and Accrued Research and Development | Research and Development Expenses and Accrued Research and Development —Research and development expenses are charged to expense as incurred. Research and development expenses include certain payroll and personnel expenses including stock-based compensation, laboratory supplies, consulting costs, external contract research and development expenses and facility or lease expenses. In-licensing fees and other costs to acquire technologies that are utilized in research and development, and that are not expected to have alternative future use, are expensed when incurred. Advance payments for goods or services for future research and development activities are deferred and expensed as the goods are delivered or the related services are performed. The Company estimates preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers, the Company’s estimates of accrued expenses and on information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. The estimates are trued up to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. |
Patent Costs | Patent Costs —Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These patent-related legal costs are reported as a component of general and administrative expenses. |
General and Administrative Expenses | General and Administrative Expenses —General and administrative costs are expensed as incurred and include employee-related expenses including salaries, benefits, travel and stock-based compensation for the Company’s personnel in executive, finance and accounting, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and patent costs. |
Fair Value Measurements | Fair Value Measurements —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 the Company’s financial instruments approximate fair value due to their short-term maturities. |
Share-based Compensation Expense | Stock-Based Compensation Expense —The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all share-based payments made to employees, directors and non-employees based on estimated grant-date fair values. The Company uses the straight-line method to allocate compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting period. The Company estimates the fair value of stock options to employees, directors and non-employees using the Black-Scholes option-valuation model. The Black-Scholes model requires the input of subjective assumptions, including expected volatility, expected dividend yield, expected term, risk-free rate of return, and the fair value of the underlying common stock on the date of grant. Due to the lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The group of representative companies have characteristics similar to the Company, including stage of product development and focus on the life science industry. The Company uses the simplified method to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The Company uses an assumed dividend yield of zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The Company accounts for forfeitures as they occur. |
Net Loss Per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders —The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, convertible preferred stock and warrants to purchase shares of convertible preferred stock are considered potential dilutive common shares. |
Income Taxes | 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 financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement 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, in the event that 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 earnings 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Property, Plant and Equipment | The estimated useful lives of the Company’s respective assets are as follows: Computer equipment and software 3 years Furniture and fixtures 7 years Laboratory equipment 5 years Leasehold improvements Shorter of the useful life of the asset or the life of the lease |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following tables present the Company’s fair value hierarchy for assets and liabilities measured at fair value on a recurring basis (in thousands): As of December 31, 2023 Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 39,230 $ — $ — $ 39,230 Total $ 39,230 $ — $ — $ 39,230 As of December 31, 2022 Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 31,230 $ — $ — $ 31,230 Total $ 31,230 $ — $ — $ 31,230 |
Balance Sheet Items (Tables)
Balance Sheet Items (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Prepaid Expenses and Other Current Asset | Prepaid expenses and other current asset consist of the following as of December 31, 2023 and 2022 (in thousands): 2023 2022 Prepaid expenses $ 700 $ 703 Prepaid research and development costs 337 304 Other current assets 96 263 Total $ 1,133 $ 1,270 |
Summary of Property and Equipment, Net | Property and equipment, net, consists of the following as of December 31, 2023 and 2022 (in thousands): 2023 2022 Computer equipment and software $ 169 $ 168 Furniture and fixtures 328 310 Lab equipment 1,133 1,061 Leasehold improvements 235 882 Property and equipment 1,865 2,421 Less accumulated depreciation ( 1,025 ) ( 1,361 ) Property and equipment—net $ 840 $ 1,060 |
Schedule of Accrued Liabilities | Accrued liabilities as of December 31, 2023 and 2022 consist of the following (in thousands): 2023 2022 Accrued other liabilities $ 626 $ 756 Accrued clinical trial liability 1,047 2,205 Total $ 1,673 $ 2,961 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Rental Payments under Operating Leases with Noncancelable Terms | As of December 31, 2023, future minimum annual lease payments under the Company’s operating lease liabilities were as follows: Total Commitment Year Ending (in thousands) 2024 $ 2,100 2025 1,861 2026 1,926 2027 1,994 2028 and beyond 6,410 Total minimum lease payments 14,291 Less: imputed interest ( 4,179 ) Present value of operating lease obligations 10,112 Less: current portion ( 952 ) Noncurrent operating lease obligations $ 9,160 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Stock Options | The following shows the stock option activities for the years ended December 31, 2023 and 2022: Total Options Outstanding Weighted-Average Exercise Price Balance—December 31, 2021 790,637 $ 32.82 Granted 909,527 3.34 Exercised — — Cancelled and forfeited ( 147,123 ) 128.79 Balance—December 31, 2022 1,553,041 $ 6.66 Granted 2,308,800 7.26 Exercised ( 713 ) 1.23 Cancelled and forfeited ( 307,016 ) 3.97 Balance—December 31, 2023 3,554,112 7.28 |
Summary of Information About Stock Options Outstanding | The following table summarizes information about stock options outstanding at December 31, 2023: Shares Weighted Average Remaining Contractual Life (In Years) Weighted Average Exercise Price Aggregate Intrinsic Value Options outstanding 3,554,112 8.79 $ 7.28 $ 2,737,358 Vested and expected to vest 3,554,112 8.79 $ 7.28 $ 2,737,358 Exercisable 1,041,752 7.42 $ 6.52 $ 906,002 |
Schedule of Stock Based Compensation Expense | Company’s consolidated statements of operations for the years ended December 31, 2023 and 2022: 2023 2022 Research and development $ 899 $ 517 General and administrative 1,647 1,044 Total $ 2,546 $ 1,561 |
Share-based Payment Arrangement, Employee | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Grant Date Fair Value | The fair value of employee stock options was estimated using the following assumptions for the years ended December 31, 2023 and 2022: 2023 2022 Expected term (in years) 5.5 - 6.1 5.5 - 6.1 Expected volatility 106 % - 111 % 109 % - 112 % Risk-free interest rate 3.4 % - 4.5 % 1.5 % - 3.9 % Dividends — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | For the years ended December 31, 2023 and 2022, income tax provision (benefit) related to continuing operations differ from the amounts computed by applying the statutory income tax rate of 21% to pre-tax loss as follows (in thousands): 2023 2022 U.S. federal provision (benefit) At statutory rate $ ( 6,192 ) $ ( 7,497 ) State taxes ( 2,492 ) ( 2,733 ) Valuation allowance 9,129 8,581 Tax credits ( 836 ) ( 1,173 ) Stock-based compensation 371 2,606 Permanent differences 20 216 Total $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets at December 31, 2023 and 2022 are shown below. 2023 2022 Deferred tax assets: Net operating losses $ 136,901 $ 131,346 Research and development tax credits 19,240 18,122 Amortization 730 916 Lease liability 3,018 3,504 Stock based compensation 809 576 Other 449 378 Capitalized R&D 6,466 4,138 Fixed assets — 10 Total gross deferred tax assets 167,613 158,990 Less: valuation allowance ( 164,643 ) ( 155,514 ) Total deferred tax assets 2,970 3,476 Deferred tax liability: Right-of-use assets ( 2,970 ) ( 3,476 ) Total gross deferred tax liabilities ( 2,970 ) ( 3,476 ) Net deferred tax assets $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | The Company has the following activity relating to unrecognized tax benefits as of December 31, 2023 and 2022: 2023 2022 Beginning balance $ 4,650 $ 4,293 Gross increase - tax position in current period 273 357 Ending balance $ 4,923 $ 4,650 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Basis in Diluted Net Loss Per Share | The following table sets forth the computation of the Company’s basic and diluted net loss per share for the years ended December 31, 2023 and 2022 (in thousands, except share and per share amounts): 2023 2022 Numerator: Net loss $ ( 29,491 ) $ ( 35,709 ) Denominator: Weighted-average common shares outstanding 15,416,203 11,548,907 Less: Weighted-average unvested restricted shares and shares subject to repurchase — — Weighted-average shares used in computing basic and diluted net loss per share 15,416,203 11,548,907 Net loss per share attributable to common stockholders—basic and diluted $ ( 1.91 ) $ ( 3.09 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Based on the amounts outstanding as of December 31, 2023 and 2022, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect: 2023 2022 Options to purchase common stock 3,554,112 1,553,041 Restricted stock units 125,000 — Common stock warrants 6,036 6,036 3,685,148 1,559,077 |
Organization and Description _2
Organization and Description of Business - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | 29 Months Ended | ||||
Apr. 29, 2022 | Jul. 23, 2021 | Jun. 25, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Class of Stock [Line Items] | ||||||
Cash and cash equivalents | $ 39,230 | $ 31,230 | $ 39,230 | |||
Aggregate sales price of common stock | $ 35,598 | $ 8,861 | ||||
Issuance of common stock for cash, net of issuance cost (in shares) | 5,365,899 | |||||
PIPE Financing | ||||||
Class of Stock [Line Items] | ||||||
Consideration received | $ 14,500 | |||||
Shares issued in transaction | 3,149,912 | |||||
Stock price (in dollars per share) | $ 2.36 | |||||
Number of warrants issued | 3,206,020 | |||||
PIPE Financing | EcoR1 Capital, LLC and Versant Venture Capital | ||||||
Class of Stock [Line Items] | ||||||
Pre-funded warrant price (in dollars per share) | 2.359 | |||||
At-The-Market Program | ||||||
Class of Stock [Line Items] | ||||||
Shares issued | 8,960,822 | 8,960,822 | ||||
Issuance of common stock for cash, net of issuance cost (in shares) | 8,260,479 | |||||
Net proceeds from sales of common stock | $ 35,600 | $ 41,200 | ||||
Remained available for issuance of common stock | $ 57,600 | $ 57,600 | ||||
At-The-Market Program | Jefferies LLC | Maximum | ||||||
Class of Stock [Line Items] | ||||||
Aggregate sales price of common stock | $ 100,000 | |||||
Percentage of commission on sale of stock | 3% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives of Property, Plant and Equipment (Details) | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | Leasehold improvements |
Computer equipment and software | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) | 12 Months Ended |
Dec. 31, 2023 Segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and cash equivalents | $ 39,230 | $ 31,230 |
Total | 39,230 | 31,230 |
Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and cash equivalents | 39,230 | 31,230 |
Total | 39,230 | 31,230 |
Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Total | 0 | 0 |
Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Total | $ 0 | $ 0 |
Balance Sheet Items - Schedule
Balance Sheet Items - Schedule of Prepaid Expenses and Other Current Asset (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid expenses | $ 700 | $ 703 |
Prepaid research and development costs | 337 | 304 |
Other current assets | 96 | 263 |
Total | $ 1,133 | $ 1,270 |
Balance Sheet Items - Summary o
Balance Sheet Items - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,865 | $ 2,421 |
Less accumulated depreciation | (1,025) | (1,361) |
Property and equipment—net | 840 | 1,060 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 169 | 168 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 328 | 310 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 1,133 | 1,061 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 235 | $ 882 |
Balance Sheet Items - Narrative
Balance Sheet Items - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Depreciation expense | $ 381 | $ 638 |
Balance Sheet Items - Schedul_2
Balance Sheet Items - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued other liabilities | $ 626 | $ 756 |
Accrued clinical trial liability | 1,047 | 2,205 |
Total | $ 1,673 | $ 2,961 |
Commitment and Contingencies -
Commitment and Contingencies - Narrative (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jan. 31, 2022 USD ($) ft² | Feb. 28, 2019 ft² | |
Loss Contingencies [Line Items] | |||||
Operating lease right-of-use assets | $ 9,952 | $ 11,650 | |||
Letter of Credit | |||||
Loss Contingencies [Line Items] | |||||
Borrowing capacity | $ 388 | ||||
South San Francisco, California | |||||
Loss Contingencies [Line Items] | |||||
Term of contract | 5 years | ||||
Area of property (in sqft) | ft² | 9,780 | ||||
Expiration date | Jan. 31, 2023 | Feb. 29, 2024 | |||
Operating lease right-of-use assets | $ 9,952 | 11,650 | |||
Present value of operating lease obligations | 10,112 | 11,744 | |||
Rent expense | $ 2,738 | $ 1,445 | |||
Brisbane, California | |||||
Loss Contingencies [Line Items] | |||||
Term of contract | 8 years | ||||
Area of property (in sqft) | ft² | 20,116 |
Commitment and Contingencies _2
Commitment and Contingencies - Future Minimum Rental Payments under Operating Leases with Noncancelable Terms (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Loss Contingencies [Line Items] | ||
Less: current portion | $ (952) | $ (1,413) |
Noncurrent operating lease obligations | 9,160 | $ 10,330 |
Brisbane, California and Ann Arbor Michigan | ||
Loss Contingencies [Line Items] | ||
2024 | 2,100 | |
2025 | 1,861 | |
2026 | 1,926 | |
2027 | 1,994 | |
2028 and beyond | 6,410 | |
Total minimum lease payments | 14,291 | |
Less: imputed interest | (4,179) | |
Present value of operating lease obligations | 10,112 | |
Less: current portion | (952) | |
Noncurrent operating lease obligations | $ 9,160 |
Loan Payable - Narrative (Detai
Loan Payable - Narrative (Details) $ in Thousands | 12 Months Ended | |||
Dec. 23, 2022 USD ($) | Jan. 15, 2021 USD ($) Tranche | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | ||||
Long-term debt | $ 10,500 | |||
Term Loan | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 35,000 | |||
Loan mature date | Aug. 01, 2025 | |||
Number of tranches | Tranche | 3 | |||
Debt instrument interest term | the interest-only repayment period was extended through December 31, 2023 (which interest-only period may be further extended through June 30, 2024 under certain circumstances); | |||
Prepayment amount | $ 5,000 | |||
Annual floating interest rate | 7.15% | |||
Debt instrument, basis spread on variable rate | 7.10% | |||
Thershold index rate | 0.05% | |||
Monthly principal payments | $ 733 | |||
Loan discounts | $ 898 | |||
Payments of debt issuance costs | 95 | |||
Interest expense | $ 1,449 | $ 1,618 | ||
Tranche A Term Loan | ||||
Debt Instrument [Line Items] | ||||
Loan amount | 15,000 | |||
Tranche B Term Loan | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 10,000 | |||
Loan mature date | Mar. 31, 2022 | |||
Tranche C Term Loan | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 10,000 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) | 12 Months Ended | |||||
Oct. 10, 2023 $ / shares shares | Jul. 23, 2021 USD ($) | Jun. 25, 2021 USD ($) shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | Apr. 29, 2022 $ / shares shares | |
Class of Stock [Line Items] | ||||||
Issuance of common stock for cash (in shares) | 5,365,899 | |||||
Stock split exchange ratio | 0.0322 | |||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||
Preferred stock, par or stated value per share | $ / shares | $ 0.001 | $ 0.001 | ||||
Common stock, shares issued | 22,045,255 | 10,518,539 | ||||
Common stock, shares outstanding | 22,045,255 | 10,518,539 | ||||
Preferred stock, shares issued | 0 | 0 | ||||
Preferred stock, shares outstanding | 0 | 0 | ||||
Dividends | $ | $ 0 | |||||
Voting rights of common stock | one | |||||
Rights Plan | ||||||
Class of Stock [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | |||||
Dividend record date | Oct. 23, 2023 | |||||
Rights Expiration Date | Oct. 10, 2024 | |||||
Approve date of rights plan | Oct. 10, 2026 | |||||
Series A Junior Participating Preferred Stock | Rights Plan | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, par or stated value per share | $ / shares | $ 0.001 | |||||
Preferred stock price per share | $ / shares | $ 25 | |||||
Number of shares purchase from preferred stock | 0.001 | |||||
At-The-Market Program | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock for cash (in shares) | 8,260,479 | |||||
At-The-Market Program | Jefferies LLC | ||||||
Class of Stock [Line Items] | ||||||
Sale of Stock, Amount Authorized | $ | $ 100,000,000 | |||||
PIPE Financing | ||||||
Class of Stock [Line Items] | ||||||
Number of warrants issued | 3,206,020 | |||||
PIPE Financing | EcoR1 Capital, LLC and Versant Venture Capital | ||||||
Class of Stock [Line Items] | ||||||
Pre-funded warrant price (in dollars per share) | $ / shares | 2.359 | |||||
Private Tempest Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Conversion of preferred stock to common stock (in shares) | 3,692,912 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock for cash (in shares) | 8,323,218 | 3,608,215 | ||||
Conversion of preferred stock to common stock (in shares) | 1,136,849 | |||||
Conversion of preferred stock to common stock | $ | $ 30,000,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Jan. 01, 2024 | Jun. 15, 2023 | Jun. 17, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 21, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, purchase price of common stock, percent | 110% | |||||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | |||||
Granted (in shares) | 2,308,800 | 909,527 | ||||
Granted (in dollars per share) | $ 7.26 | $ 3.34 | ||||
2019 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, percentage of outstanding stock maximum | 1.50% | |||||
Share-based compensation arrangement by share-based payment award, shares issued in period | 62,739 | |||||
Share-based compensation arrangement by share-based payment award, maximum number of shares available for grant per year | 500,000 | |||||
Common stock, capital shares reserved for future issuance | 232,136 | |||||
2019 Employee Stock Purchase Plan | Subsequent Event | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, shares issued in period | 330,678 | |||||
Amended and Restated 2023 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, percentage of outstanding stock maximum | 4% | |||||
Share-based compensation arrangement by share-based payment award, period of automatic increase to outstanding stock maximum | 10 years | |||||
Common stock, capital shares reserved for future issuance | 233,708 | |||||
Amended and Restated 2023 Equity Incentive Plan | Subsequent Event | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, shares issued in period | 881,810 | |||||
2023 Inducement Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, capital shares reserved for future issuance | 1,142,350 | |||||
Restricted Stock Units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, number of shares granted | 125,000 | |||||
Share-based compensation arrangement by share-based payment award, share fair value | $ 0.6 | |||||
Share-based compensation arrangement by share-based payment award, vesting date | Feb. 25, 2024 | |||||
Individuals who were not Previously Employees or Directors of Company | 2023 Inducement Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, capital shares reserved for future issuance | 1,150,000 | |||||
Share-based Payment Arrangement, Employee | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 2,308,800 | 909,527 | ||||
Granted (in dollars per share) | $ 6.05 | $ 2.82 | ||||
Share-based payment arrangement, nonvested award, option, cost not yet recognized, amount | $ 14,703 | $ 4,012 | ||||
Share-based payment arrangement, nonvested award, cost not yet recognized, period for recognition | 3 years 6 months | 2 years 7 months 6 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding at beginning (in shares) | 1,553,041 | 790,637 |
Granted (in shares) | 2,308,800 | 909,527 |
Exercised (in shares) | (713) | 0 |
Cancelled and forfeited (in shares) | (307,016) | (147,123) |
Outstanding at end (in shares) | 3,554,112 | 1,553,041 |
Outstanding at beginning (in dollars per share) | $ 6.66 | $ 32.82 |
Granted (in dollars per share) | 7.26 | 3.34 |
Exercised (in dollars per share) | 1.23 | 0 |
Cancelled and forfeited (in dollars per share) | 3.97 | 128.79 |
Outstanding at end (in dollars per share) | $ 7.28 | $ 6.66 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Information About Stock Options Outstanding (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 3,554,112 | 1,553,041 | 790,637 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 9 months 14 days | ||
Outstanding (in dollars per share) | $ 7.28 | $ 6.66 | $ 32.82 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 2,737,358 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 3,554,112 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Weighted Average Remaining Contractual Term | 8 years 9 months 14 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Weighted Average Exercise Price | $ 7.28 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Aggregate Intrinsic Value | $ 2,737,358 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,041,752 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 7 years 5 months 1 day | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 6.52 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 906,002 |
Stock-Based Compensation - Gran
Stock-Based Compensation - Grant Date Fair Value of Option (Details) - Share-based Payment Arrangement, Employee | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividends | 0% | 0% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 6 months |
Expected volatility | 106% | 109% |
Risk-free interest rate | 3.40% | 1.50% |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected volatility | 111% | 112% |
Risk-free interest rate | 4.50% | 3.90% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 2,546 | $ 1,561 |
Research and Development Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 899 | 517 |
General and Administrative Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,647 | $ 1,044 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax [Line Items] | ||
Provision for income taxes | $ 0 | $ 0 |
Operating loss carryforwards, federal | 482,100,000 | 466,000,000 |
Operating loss carryforwards, state | 457,800,000 | 434,400,000 |
Increase in valuation allowance | 9,100,000 | |
Legacy Millendo | ||
Income Tax [Line Items] | ||
Operating loss carryforwards, federal | 455,800 | |
Orphan Drug Credit | ||
Income Tax [Line Items] | ||
Tax credit carryforwards | 7,400,000 | |
Not Subject to Expiration | ||
Income Tax [Line Items] | ||
Operating loss carryforwards, federal | 260,900,000 | |
United States | Research Tax Credit Carryforward | ||
Income Tax [Line Items] | ||
Tax credit carryforwards | 12,700,000 | 11,700,000 |
State and Local Jurisdiction | Research Tax Credit Carryforward | ||
Income Tax [Line Items] | ||
Tax credit carryforwards | 4,000,000 | $ 3,600,000 |
State and Local Jurisdiction | Not Subject to Expiration | Research Tax Credit Carryforward | ||
Income Tax [Line Items] | ||
Tax credit carryforwards | $ 2,900,000 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
At statutory rate | $ (6,192,000) | $ (7,497,000) |
State taxes | (2,492,000) | (2,733,000) |
Valuation allowance | 9,129,000 | 8,581,000 |
Tax credits | (836,000) | (1,173,000) |
Stock-based compensation | 371,000 | 2,606,000 |
Permanent differences | 20,000 | 216,000 |
Total | $ 0 | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating losses | $ 136,901 | $ 131,346 |
Research and development tax credits | 19,240 | 18,122 |
Amortization | 730 | 916 |
Lease liability | 3,018 | 3,504 |
Stock based compensation | 809 | 576 |
Other | 449 | 378 |
Capitalized R&D | 6,466 | 4,138 |
Fixed Assets | 0 | 10 |
Total gross deferred tax assets | 167,613 | 158,990 |
Less: valuation allowance | (164,643) | (155,514) |
Total deferred tax assets | 2,970 | 3,476 |
Deferred tax liability: | ||
Right-of-use assets | (2,970) | (3,476) |
Total gross deferred tax liabilities | (2,970) | (3,476) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Chan
Income Taxes - Schedule of Changes in Tax Reserve (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Reserve [Roll Forward] | ||
Beginning balance | $ 4,650 | $ 4,293 |
Gross increase - tax position in current period | 273 | 357 |
Ending balance | $ 4,923 | $ 4,650 |
Retirement Plan - Narrative (De
Retirement Plan - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 147 | $ 126 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Basis in Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||
Net loss | $ (29,491) | $ (35,709) |
Denominator: | ||
Weighted-average common shares outstanding | 15,416,203 | 11,548,907 |
Less: Weighted-average unvested restricted shares and shares subject to repurchase | 0 | 0 |
Weighted-average shares used in computing basic net loss per share | 15,416,203 | 11,548,907 |
Weighted-average shares used in computing diluted net loss per share | 15,416,203 | 11,548,907 |
Net loss per share attributable to common stockholders - basic | $ (1.91) | $ (3.09) |
Net loss per share attributable to common stockholders - diluted | $ (1.91) | $ (3.09) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings | 3,685,148 | 1,559,077 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings | 3,554,112 | 1,553,041 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings | 125,000 | |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings | 6,036 | 6,036 |