Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Entity File Number | 001-40315 | |
Entity Registrant Name | Reneo Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-2309515 | |
Entity Address, Address Line One | 18575 Jamboree Road, Suite 275-S | |
Entity Address, City or Town | Irvine | |
Entity Address State Or Province | CA | |
Entity Address, Postal Zip Code | 92612 | |
City Area Code | 858 | |
Local Phone Number | 283-0280 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | RPHM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 33,800,788 | |
Entity Central Index Key | 0001637715 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 9,081 | $ 19,927 |
Short-term investments | 133,596 | 81,246 |
Prepaid expenses and other current assets | 3,643 | 5,180 |
Total current assets | 146,320 | 106,353 |
Property and equipment, net | 554 | 453 |
Right-of-use assets | 1,086 | 1,292 |
Other non-current assets | 79 | 84 |
Total assets | 148,039 | 108,182 |
Current liabilities: | ||
Accounts payable | 1,828 | 1,893 |
Accrued expenses | 11,592 | 4,827 |
Operating lease liabilities, current portion | 318 | 404 |
Total current liabilities | 13,738 | 7,124 |
Operating lease liabilities, less current portion | 897 | 1,059 |
Performance award | 876 | 29 |
Total liabilities | 15,511 | 8,212 |
Commitments and contingencies | ||
Stockholders' equity (deficit): | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2023 and December 31, 2022; 33,800,788 and 24,699,553 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 3 | 3 |
Additional paid-in capital | 303,877 | 236,693 |
Accumulated deficit | (171,321) | (136,683) |
Accumulated other comprehensive loss | (31) | (43) |
Total stockholders' equity | 132,528 | 99,970 |
Total liabilities and stockholders' equity | $ 148,039 | $ 108,182 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, Par value | $ 0.0001 | $ 0.0001 |
Common stock, authorized | 200,000,000 | 200,000,000 |
Common stock, issued | 33,800,788 | 24,699,553 |
Common stock, outstanding | 33,800,788 | 24,699,553 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 14,400 | $ 8,132 | $ 25,389 | $ 17,410 |
General and administrative | 6,639 | 4,299 | 11,771 | 8,036 |
Total operating expenses | 21,039 | 12,431 | 37,160 | 25,446 |
Loss from operations | (21,039) | (12,431) | (37,160) | (25,446) |
Other income: | ||||
Other income | 1,508 | 119 | 2,522 | 98 |
Net loss | (19,531) | (12,312) | (34,638) | (25,348) |
Unrealized (loss) gain on short-term investments | (43) | 104 | 12 | 134 |
Comprehensive loss | $ (19,574) | $ (12,208) | $ (34,626) | $ (25,214) |
Net loss per share attributable to common stockholders, basic | $ (0.65) | $ (0.5) | $ (1.25) | $ (1.04) |
Net loss per share attributable to common stockholders, diluted | $ (0.65) | $ (0.5) | $ (1.25) | $ (1.04) |
Weighted-average shares used in computing net loss per share, basic | 30,215,321 | 24,463,824 | 27,640,172 | 24,461,085 |
Weighted-average shares used in computing net loss per share, diluted | 30,215,321 | 24,463,824 | 27,640,172 | 24,461,085 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Public Offering [Member] | At-The-Market Facility [Member] | Private Placement [Member] | Common Stock [Member] | Common Stock [Member] Public Offering [Member] | Common Stock [Member] At-The-Market Facility [Member] | Common Stock [Member] Private Placement [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] Public Offering [Member] | Additional Paid-in Capital [Member] At-The-Market Facility [Member] | Additional Paid-in Capital [Member] Private Placement [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2021 | $ 147,211 | $ 3 | $ 231,902 | $ 34 | $ (84,728) | |||||||||
Beginning Balance (in shares) at Dec. 31, 2021 | 24,455,390 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Stock based compensation | 1,107 | 1,107 | ||||||||||||
Issuance of common stock in connection with equity plans | 6 | 6 | ||||||||||||
Issuance of common stock in connection with equity plans (in shares) | 3,160 | |||||||||||||
Other comprehensive income (loss) | 30 | 30 | ||||||||||||
Net loss | (13,036) | (13,036) | ||||||||||||
Ending Balance at Mar. 31, 2022 | 135,318 | $ 3 | 233,015 | 64 | (97,764) | |||||||||
Ending Balance (in shares) at Mar. 31, 2022 | 24,458,550 | |||||||||||||
Beginning Balance at Dec. 31, 2021 | 147,211 | $ 3 | 231,902 | 34 | (84,728) | |||||||||
Beginning Balance (in shares) at Dec. 31, 2021 | 24,455,390 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Net loss | (25,348) | |||||||||||||
Ending Balance at Jun. 30, 2022 | 124,157 | $ 3 | 234,062 | 168 | (110,076) | |||||||||
Ending Balance (in shares) at Jun. 30, 2022 | 24,479,646 | |||||||||||||
Beginning Balance at Mar. 31, 2022 | 135,318 | $ 3 | 233,015 | 64 | (97,764) | |||||||||
Beginning Balance (in shares) at Mar. 31, 2022 | 24,458,550 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Stock based compensation | 1,006 | 1,006 | ||||||||||||
Issuance of common stock in connection with equity plans | 41 | 41 | ||||||||||||
Issuance of common stock in connection with equity plans (in shares) | 21,096 | |||||||||||||
Other comprehensive income (loss) | 104 | 104 | ||||||||||||
Net loss | (12,312) | (12,312) | ||||||||||||
Ending Balance at Jun. 30, 2022 | 124,157 | $ 3 | 234,062 | 168 | (110,076) | |||||||||
Ending Balance (in shares) at Jun. 30, 2022 | 24,479,646 | |||||||||||||
Beginning Balance at Dec. 31, 2022 | 99,970 | $ 3 | 236,693 | (43) | (136,683) | |||||||||
Beginning Balance (in shares) at Dec. 31, 2022 | 24,699,553 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Stock based compensation | 1,157 | 1,157 | ||||||||||||
Issuance of common stock, net of issuance costs | $ 1,009 | $ 1,009 | ||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 407,877 | |||||||||||||
Other comprehensive income (loss) | 55 | 55 | ||||||||||||
Net loss | (15,107) | (15,107) | ||||||||||||
Ending Balance at Mar. 31, 2023 | 87,084 | $ 3 | 238,859 | 12 | (151,790) | |||||||||
Ending Balance (in shares) at Mar. 31, 2023 | 25,107,430 | |||||||||||||
Beginning Balance at Dec. 31, 2022 | 99,970 | $ 3 | 236,693 | (43) | (136,683) | |||||||||
Beginning Balance (in shares) at Dec. 31, 2022 | 24,699,553 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Net loss | (34,638) | |||||||||||||
Ending Balance at Jun. 30, 2023 | 132,528 | $ 3 | 303,877 | (31) | (171,321) | |||||||||
Ending Balance (in shares) at Jun. 30, 2023 | 33,800,788 | |||||||||||||
Beginning Balance at Mar. 31, 2023 | 87,084 | $ 3 | 238,859 | 12 | (151,790) | |||||||||
Beginning Balance (in shares) at Mar. 31, 2023 | 25,107,430 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Stock based compensation | 1,207 | 1,207 | ||||||||||||
Issuance of common stock, net of issuance costs | $ 58,862 | $ 4,667 | $ 58,862 | $ 4,667 | ||||||||||
Issuance of common stock, net of issuance costs (in shares) | 7,906,250 | 625,000 | ||||||||||||
Issuance of common stock in connection with equity plans | 282 | 282 | ||||||||||||
Issuance of common stock in connection with equity plans (in shares) | 162,108 | |||||||||||||
Other comprehensive income (loss) | (43) | (43) | ||||||||||||
Net loss | (19,531) | (19,531) | ||||||||||||
Ending Balance at Jun. 30, 2023 | $ 132,528 | $ 3 | $ 303,877 | $ (31) | $ (171,321) | |||||||||
Ending Balance (in shares) at Jun. 30, 2023 | 33,800,788 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (34,638) | $ (25,348) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,364 | 2,113 |
Depreciation and amortization | 83 | 41 |
Amortization/accretion on short-term investments | (2,011) | (22) |
Changes in the fair value of performance award | 847 | (389) |
Non-cash lease expense | 241 | 241 |
Loss on disposal of fixed asset | 3 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,542 | 905 |
Accounts payable and accrued expenses | 6,690 | 1,726 |
Operating lease liabilities | (283) | (222) |
Net cash used in operating activities | (25,162) | (20,955) |
Cash flows from investing activities | ||
Purchases of property and equipment | (177) | (68) |
Purchase of available-for-sale short-term investments | (132,327) | (15,922) |
Proceeds from maturities of available-for-sale short-term investments | 82,000 | 30,500 |
Net cash (used in) provided by investing activities | (50,504) | 14,510 |
Cash flows from financing activities | ||
Proceeds from private placement of common stock, net of offering costs | 4,667 | |
Proceeds from issuance of common stock in connection with equity plans | 282 | 49 |
Net cash provided by financing activities | 64,820 | 49 |
Net decrease in cash and cash equivalents | (10,846) | (6,396) |
Cash and cash equivalents, beginning of period | 19,927 | 124,660 |
Cash and cash equivalents, end of period | 9,081 | 118,264 |
Supplemental cash flow information: | ||
Right-of-use assets obtained in exchange for lease obligations | $ 1,524 | |
Property and equipment in accounts payable | 10 | |
At-The-Market Facility [Member] | ||
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of offering costs | 1,009 | |
Public Offering [Member] | ||
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of offering costs | $ 58,862 |
Organization and Business
Organization and Business | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | 1. Organization and Business Organization Reneo Pharmaceuticals, Inc. (Reneo or the Company) commenced operations on September 22, 2014 as a clinical-stage pharmaceutical company focused on the development of therapies for patients with rare genetic mitochondrial diseases. In December 2017, the Company in-licensed mavodelpar (REN001), a novel oral peroxisome proliferator-activated receptor delta (PPARδ) agonist. Liquidity From its inception in 2014, the Company has incurred significant losses and negative cash flows from operations. For the three and six months ended June 30, 2023, the Company had a net loss of $ 19.5 million and $ 34.6 million, respectively, and used $ 25.2 million cash in operating activities during the six months ended June 30, 2023. Since inception through June 30, 2023, the Company had an accumulated deficit of $ 171.3 million. The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern , which requires that management perform a two-step analysis over its ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern and to meet its obligations as they become due within one year after the date that the consolidated financial statements are issued (step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (step 2). As of June 30, 2023, the Company had cash, cash equivalents and short-term investments of $ 142.7 million, which the Company expects are sufficient to fund operations beyond the potential submission of a new drug application for mavodelpar for treatment of primary mitochondrial myopathies in the United States anticipated in the first half of 2024. However, based on the anticipated increase in sales and marketing expenses for mavodelpar, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for more than one year from the date of the filing of this Quarterly Report on Form 10-Q. Management plans to alleviate this risk by raising additional capital through public or private equity offerings or debt financings, credit or loan facilities, collaborations, strategic alliances, licensing arrangements or a combination of one or more of these funding sources. In addition, the Company has the ability to defer certain commercial activities until additional capital is received. There can be no assurance that the Company will be successful in obtaining additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could negatively impact the Company’s business, results of operations, and future prospects. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, disruptions to, and volatility in, financial markets in the United States and worldwide, including those resulting from infectious diseases, bank failures, actual or perceived changes in interest rates and economic inflation. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. In addition, successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The Company has prepared the accompanying unaudited consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. In the opinion of management, all adjustments, including normal recurring adjustments, considered necessary for a fair statement of the financial statements, have been included in the accompanying unaudited financial statements. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of June 30, 2023 ; all intercompany transactions and balances have been eliminated. Summary of Significant Accounting Policies The significant accounting policies used in the preparation of these consolidated financial statements for the six months ended June 30, 2023 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. New Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standard Board (FASB) issued Accounting Standard Update (ASU) 2016-13, Financial Instruments - Credit Losses (ASC 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in the carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance was effective for the Company as of January 1, 2023. The Company adopted the guidance as of January 1, 2023 , with no material impact on its financial statements and related disclosures. Recent Accounting Pronouncements Not Yet Adopted In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (ASC 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . The ASU clarifies that (1) a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value, (2) an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction, and (3) new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with ASC 820. The new guidance is effective for the Company for fiscal years beginning after December 15, 2023. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 3. Net Loss Per Share The Company computes basic loss per share by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock shares to be issued upon exercise of all outstanding stock options and restricted stock units were excluded from the diluted net loss per share calculation for the three and six months ended June 30, 2023 and 2022 because such shares are anti-dilutive. Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: As of June 30, 2023 2022 Common stock options outstanding 6,001,185 4,400,561 Unvested restricted stock units 364,500 284,500 Total 6,365,685 4,685,061 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements ASC Topic 820, Fair Value Measurement , establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC Topic 820 identifies fair value as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes between the following: • Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities. • Level 2 – Inputs, other than quoted prices in active markets, which are observable for the asset or liability, either directly or indirectly. • Level 3 – Unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s financial assets are subject to fair value measurements on a recurring basis. The Company categorizes its money market funds as Level 1, using the quoted prices in active markets. Commercial paper and U.S. treasury securities are categorized as Level 2, using significant other observable inputs. The fair value of the Company’s investments in certain money market funds is their face value and such instruments are classified as Level 1 and are included in cash and cash equivalents on the consolidated balance sheets. In connection with the Company’s chief executive officer’s (CEO) employment agreement, he is entitled to receive a special performance bonus in the amount of $ 7.5 million (Performance Award), payable in cash, common stock or a combination of cash and common stock, at the election of the Company, based on achievement of certain conditions as described in more detail in Note 9. The Company estimated the fair value of the Performance Award using a Monte Carlo simulation, which incorporates the stock price at the date of the valuation and utilizes Level 3 inputs such as volatility, probabilities of success, and other inputs that are not observable in active markets. The Performance Award is required to be measured at fair value on a recurring basis each reporting period, with changes in the fair value recognized in general and administrative expense in the consolidated statements of operations and comprehensive loss over the derived service period of the award. No assets or liabilities were transferred into or out of their classifications during the six months ended June 30, 2023. The recurring fair value measurement of the Company’s assets and liabilities measured at fair value at June 30, 2023 consisted of the following (in thousands): Quoted Prices in Significant Other Significant Total Assets Cash and cash equivalents: Money market investments $ 5,552 $ — $ — $ 5,552 Short-term investments: U.S. treasury securities — 133,596 — 133,596 Total $ 5,552 $ 133,596 $ — $ 139,148 Liabilities Performance award $ — $ — $ 876 $ 876 Total $ — $ — $ 876 $ 876 The recurring fair value measurement of the Company’s assets and liabilities measured at fair value at December 31, 2022 consisted of the following (in thousands): Quoted Prices in Significant Other Significant Total Assets Cash and cash equivalents: Money market investments $ 9,365 $ — $ — $ 9,365 Commercial paper — 4,978 — 4,978 Short-term investments: U.S. treasury securities — 76,253 — 76,253 Commercial paper — 4,993 — 4,993 Total $ 9,365 $ 86,224 $ — $ 95,589 Liabilities Performance award $ — $ — $ 29 $ 29 Total $ — $ — $ 29 $ 29 The following table summarizes changes in fair value measurements of the Performance Award during the six months ended June 30, 2023 (in thousands): Performance Balance as of January 1, 2023 $ 29 Change in fair value 847 Balance as of June 30, 2023 $ 876 |
Marketable Debt Securities
Marketable Debt Securities | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Debt Securities | 5. Marketable Debt Securities The Company’s investments in debt securities are carried at fair value and classified as current assets available-for-sale as they mature within 12 months and represent the investment of funds available for current operations. Unrealized gains and losses on available-for-sale debt securities are included in other comprehensive income or loss, and charged to income or expense in the period when realized. The following tables summarize the gross unrealized gains and losses of the Company’s available-for-sale securities (in thousands): As of June 30, 2023 Amortized Gross Gross Fair Available-for-sale securities: U.S. treasury securities $ 133,627 $ 6 $ ( 37 ) $ 133,596 Total $ 133,627 $ 6 $ ( 37 ) $ 133,596 As of December 31, 2022 Amortized Gross Gross Fair Available-for-sale securities: U.S. treasury securities $ 76,297 $ 2 $ ( 46 ) $ 76,253 Commercial paper 4,993 — — 4,993 Total $ 81,290 $ 2 $ ( 46 ) $ 81,246 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following (in thousands): As of June 30, 2023 As of December 31, 2022 Accrued clinical and regulatory $ 6,242 $ 1,872 Accrued contract manufacturing cost 1,535 1,583 Accrued compensation 2,525 807 Accrued other 1,290 565 Total accrued expenses $ 11,592 $ 4,827 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company’s headquarters are located in Irvine, California, where it leases office space. As of June 30, 2023, the Company leased additional office space located in San Diego, California and in Sandwich, United Kingdom. The lease terms for the Irvine, San Diego, and Sandwich offices extend through November 30, 2026, July 31, 2023, and October 23, 2027, respectively. The Company did not renew the office space located in San Diego upon the expiration of the lease. Other information related to the Company ’s operating leases as of the balance sheet dates presented are as follows: As of June 30, 2023 2022 Weighted incremental borrowing rate 5 % 5 % Weighted average remaining lease term (in years) 3.7 4.0 Cash paid for amounts included in the measurement of lease liabilities (in thousands) $ 142 $ 266 Lease expense (in thousands) $ 241 $ 241 Maturities of lease liabilities by fiscal year for the Company ’s operating leases are as follows (in thousands): As of June 30, 2023 2023 (remaining six months) $ 187 2024 381 2025 381 2026 343 2027 34 Total lease payments 1,326 Less: Imputed interest ( 111 ) Present value of lease liabilities $ 1,215 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity On May 8, 2023, the Company completed a public offering in which it sold an aggregate of 7,906,250 shares of common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,031,250 shares of common stock, at a price of $ 8.00 per share. The Company received total net proceeds from the offering of approximately $ 58.9 million, after deducting underwriting discounts and commissions and offering expenses. On May 9, 2023, the Company completed a concurrent private placement in which it sold an aggregate of 625,000 shares of common stock to Abingworth Bioventures 8 L.P., a holder of more than 5 % of the Company’s common stock, at a price of $ 8.00 per share. The Company received total net proceeds of approximately $ 4.7 million, after deducting advisor fees and other estimated fees and expenses. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation In March 2021, the Company’s board of directors adopted the Company’s 2021 Equity Incentive Plan (2021 Plan), which is the successor to the Company’s 2014 Equity Incentive Plan (2014 Plan). As of the effective date of the 2021 Plan, awards granted under the 2014 Plan that are forfeited or otherwise become available under the 2014 Plan will be included and available for issuance under the 2021 Plan. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other awards to individuals who are employees, officers, directors or consultants of the Company and its affiliates. Under the 2014 Plan, certain employees were granted the ability to early exercise their options. The shares of common stock issued pursuant to the early exercise of unvested stock options are restricted and continue to vest over the requisite service period after issuance. The Company has the option to repurchase any unvested shares at the original purchase price upon any voluntary or involuntary termination. The shares purchased by the employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares vest. As of June 30, 2023 , there were no unvested shares of common stock outstanding that were issued pursuant to the early exercise of stock options. Shares Reserved for Future Issuance As of June 30, 2023, the Company had reserved shares of its common stock for future issuance as follows: Shares Common stock options outstanding 6,001,185 Unvested restricted stock units 364,500 Available for future grants under the 2021 Equity Incentive Plan 1,543,869 Available for future grants under the 2021 Employee Stock Purchase Plan 546,341 Total shares of common stock reserved 8,455,895 Stock Options A summary of the Company’s stock option activity and related information during the six months ended June 30, 2023 is as follows: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2022 5,877,745 $ 4.47 8.2 $ 907 Granted 382,915 $ 6.83 Exercised ( 77,812 ) $ 1.97 Forfeited/Expired ( 181,663 ) $ 5.60 Outstanding at June 30, 2023 6,001,185 $ 4.62 8.0 $ 14,005 Vested at June 30, 2023 2,692,861 $ 4.93 7.1 $ 5,566 Exercisable at June 30, 2023 3,263,418 $ 4.92 7.2 $ 6,509 Options exercisable at June 30, 2023 include vested options and options eligible for early exercise. All outstanding options as of June 30, 2023 are expected to vest. Unrecognized stock-based compensation expense at June 30, 2023 was $ 9.9 million, which is expected to be recognized over a weighted-average vesting term of 2.6 years. The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Risk-free interest rate 3.8 % 3.0 % 3.8 % 2.3 % Expected volatility 88.4 % 84.4 % 87.2 % 84.9 % Expected term (in years) 5.8 5.8 5.9 5.9 Expected dividend yield — % — % — % — % Risk-free interest rate. The Company bases the risk-free interest rate assumption on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. Expected volatility. Since the Company does not have sufficient trading history for its common stock the expected volatility assumption is based on a blend of volatilities of the Company’s share price and a peer group of similar companies whose share prices are publicly available. For awards granted prior to April 2023, the expected volatility assumption was based on the volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry. Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its vesting period. Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Restricted Stock Units (RSUs) RSUs consist of performance-based units (PSUs) and market-based units (MSUs). The following table summarizes RSU activity during the six months ended June 30, 2023: Number of Weighted-Average Unvested at December 31, 2022 329,500 $ 5.70 Granted 40,000 $ 3.63 Cancelled ( 5,000 ) $ 2.14 Unvested at June 30, 2023 364,500 $ 5.52 Performance-Based Units The vesting of the PSUs is based on the Company achieving certain regulatory milestones and are subject to the employee’s continued employment with the Company through the achievement date. The fair value of the awards was based on the value of the Company’s common stock at the grant date of the award and expense recognition is based on the probability of achieving the performance conditions. Stock-based compensation expense is adjusted in future periods for subsequent changes in the expected outcome of the performance conditions. The Company had 244,500 unvested shares underlying PSUs as of June 30, 2023. The Company concluded that achievement of the performance conditions was not probable as of June 30, 2023 , and therefore no stock-based compensation expense was recognized for the three and six months ended June 30, 2023. As of June 30, 2023, there was $ 1.6 million of unrecognized stock-based compensation expense related to the PSUs that were deemed not probable of vesting. Market-Based Units The vesting of the MSUs is based on the Company’s closing stock price trading above $ 20 per share for 30 consecutive trading days subject to the employee’s continued employment with the Company through the date of achievement. The fair value was based on Monte Carlo simulation model on the grant date. Stock-based compensation expense is recognized over the derived service period of approximately 3 years. The Company had 120,000 unvested shares underlying MSUs as of June 30, 2023. Stock-based compensation expense related to the MSUs during the three and six months ended June 30, 2023 was immaterial. As of June 30, 2023, there was $ 0.2 million of unrecognized stock-based compensation expense related to MSUs. Performance Award In connection with the CEO’s employment agreement, he is entitled to receive a Performance Award in the amount of $ 7.5 million, payable in cash, common stock or a combination of cash and common stock, at the election of the Company, in the event that (i) the Company’s market value exceeds $ 750.0 million utilizing the volume-weighted average of the closing sale price of its common stock on the Nasdaq Stock Market or other principal exchange for each of the 30 trading days immediately prior to the measurement date, or (ii) the fair market value of the net proceeds available for distribution to the Company’s stockholders in connection with a change in control as defined in the Company’s severance benefit plan, as determined in good faith by its board of directors, exceeds $ 750.0 million. The Company has determined that the Performance Award is subject to ASC 718, Compensation – Stock Compensation and includes both market and performance conditions. Since the Company’ s initial public offering (IPO), neither of the events have yet been satisfied. The Company estimated the fair value of the Performance Award at each reporting period using the Monte Carlo simulation (Note 4), which is recognized as stock-based compensation expense over the derived service period. The Company recognized approximately $ 0.6 million and $ 0.8 million in compensation expense related to the change in the fair value of the Performance Award for the three and six months ended June 30, 2023, respectively. The expense is reflected in consolidated statements of operations and comprehensive loss in the general and administrative expense. 2021 Employee Stock Purchase Plan (ESPP) In March 2021, the Company’s board of directors adopted the ESPP, which became effective immediately prior to the execution of the underwriting agreement in connection with the Company’s IPO. During the six months ended June 30, 2023, 84,296 shares of common stock were purchased under the ESPP. In September 2021, the Company’s board of directors adopted the Company’s 2021 United Kingdom Sharesave Sub-plan (SAYE). An allocation of 25,875 shares of common stock from the ESPP reserve pool was approved and reserved for issuance under the SAYE. No shares have been issued under the SAYE through June 30, 2023. Stock-Based Compensation Expense The following table summarizes stock-based compensation expense, including expense associated with award modifications for unvested options, reflected in the consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 494 $ 386 $ 967 $ 773 General and administrative 713 620 1,397 1,340 Total $ 1,207 $ 1,006 $ 2,364 $ 2,113 |
License Agreement
License Agreement | 6 Months Ended |
Jun. 30, 2023 | |
License Agreement | |
License Agreement | 10. License Agreement In December 2017, the Company entered into a license agreement with vTv Therapeutics LLC (vTv Therapeutics) (the vTv License Agreement), under which the Company obtained an exclusive, worldwide, sublicensable license under certain vTv Therapeutics intellectual property to develop, manufacture and commercialize PPARδ agonists and products containing such PPARδ agonists, including mavodelpar, for any therapeutic, prophylactic or diagnostic application in humans. Under the terms of the vTv License Agreement, the Company paid vTv Therapeutics an initial upfront license fee of $ 3.0 million and issued an aggregate of 576,443 shares of its common stock to vTv Therapeutics. Upon the achievement of certain pre-specified development and regulatory milestones, the Company is also required to pay vTv Therapeutics milestone payments totaling up to $ 64.5 million. The Company is also required to pay vTv Therapeutics up to $ 30.0 million in total sales-based milestones upon achievement of certain sales thresholds of the licensed product. As of June 30, 2023 , the Company has paid an aggregate of $ 2.0 million in development and regulatory milestone payments. In addition, the Company is obligated to make royalty payments to vTv Therapeutics at mid-single digit to low teen percentage royalty rates, based on tiers of annual net sales of licensed products, subject to certain customary reductions. There were no milestone payments achieved or recorded for the three and six months ended June 30, 2023 and 2022 . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The Company has prepared the accompanying unaudited consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. In the opinion of management, all adjustments, including normal recurring adjustments, considered necessary for a fair statement of the financial statements, have been included in the accompanying unaudited financial statements. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of June 30, 2023 ; all intercompany transactions and balances have been eliminated. |
New Accounting Pronouncements | New Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standard Board (FASB) issued Accounting Standard Update (ASU) 2016-13, Financial Instruments - Credit Losses (ASC 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in the carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance was effective for the Company as of January 1, 2023. The Company adopted the guidance as of January 1, 2023 , with no material impact on its financial statements and related disclosures. Recent Accounting Pronouncements Not Yet Adopted In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (ASC 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . The ASU clarifies that (1) a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value, (2) an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction, and (3) new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with ASC 820. The new guidance is effective for the Company for fiscal years beginning after December 15, 2023. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive securities not included in diluted net loss per share calculation | Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: As of June 30, 2023 2022 Common stock options outstanding 6,001,185 4,400,561 Unvested restricted stock units 364,500 284,500 Total 6,365,685 4,685,061 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of recurring fair value measurement of the Company's assets and liabilities | The recurring fair value measurement of the Company’s assets and liabilities measured at fair value at June 30, 2023 consisted of the following (in thousands): Quoted Prices in Significant Other Significant Total Assets Cash and cash equivalents: Money market investments $ 5,552 $ — $ — $ 5,552 Short-term investments: U.S. treasury securities — 133,596 — 133,596 Total $ 5,552 $ 133,596 $ — $ 139,148 Liabilities Performance award $ — $ — $ 876 $ 876 Total $ — $ — $ 876 $ 876 The recurring fair value measurement of the Company’s assets and liabilities measured at fair value at December 31, 2022 consisted of the following (in thousands): Quoted Prices in Significant Other Significant Total Assets Cash and cash equivalents: Money market investments $ 9,365 $ — $ — $ 9,365 Commercial paper — 4,978 — 4,978 Short-term investments: U.S. treasury securities — 76,253 — 76,253 Commercial paper — 4,993 — 4,993 Total $ 9,365 $ 86,224 $ — $ 95,589 Liabilities Performance award $ — $ — $ 29 $ 29 Total $ — $ — $ 29 $ 29 |
Schedule Changes in fair value measurements of the performance award | The following table summarizes changes in fair value measurements of the Performance Award during the six months ended June 30, 2023 (in thousands): Performance Balance as of January 1, 2023 $ 29 Change in fair value 847 Balance as of June 30, 2023 $ 876 |
Marketable Debt Securities (Tab
Marketable Debt Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Gross Unrealized Gains and Losses of Available-for-Sale Securities | The following tables summarize the gross unrealized gains and losses of the Company’s available-for-sale securities (in thousands): As of June 30, 2023 Amortized Gross Gross Fair Available-for-sale securities: U.S. treasury securities $ 133,627 $ 6 $ ( 37 ) $ 133,596 Total $ 133,627 $ 6 $ ( 37 ) $ 133,596 As of December 31, 2022 Amortized Gross Gross Fair Available-for-sale securities: U.S. treasury securities $ 76,297 $ 2 $ ( 46 ) $ 76,253 Commercial paper 4,993 — — 4,993 Total $ 81,290 $ 2 $ ( 46 ) $ 81,246 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued expenses | Accrued expenses consisted of the following (in thousands): As of June 30, 2023 As of December 31, 2022 Accrued clinical and regulatory $ 6,242 $ 1,872 Accrued contract manufacturing cost 1,535 1,583 Accrued compensation 2,525 807 Accrued other 1,290 565 Total accrued expenses $ 11,592 $ 4,827 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Schedule of Other Information Related to Operating Leases | Other information related to the Company ’s operating leases as of the balance sheet dates presented are as follows: As of June 30, 2023 2022 Weighted incremental borrowing rate 5 % 5 % Weighted average remaining lease term (in years) 3.7 4.0 Cash paid for amounts included in the measurement of lease liabilities (in thousands) $ 142 $ 266 Lease expense (in thousands) $ 241 $ 241 |
Schedule of Maturities of lease liabilities by fiscal year for operating leases | Maturities of lease liabilities by fiscal year for the Company ’s operating leases are as follows (in thousands): As of June 30, 2023 2023 (remaining six months) $ 187 2024 381 2025 381 2026 343 2027 34 Total lease payments 1,326 Less: Imputed interest ( 111 ) Present value of lease liabilities $ 1,215 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of common stock reserved for future issuance | As of June 30, 2023, the Company had reserved shares of its common stock for future issuance as follows: Shares Common stock options outstanding 6,001,185 Unvested restricted stock units 364,500 Available for future grants under the 2021 Equity Incentive Plan 1,543,869 Available for future grants under the 2021 Employee Stock Purchase Plan 546,341 Total shares of common stock reserved 8,455,895 |
Summary of the Company's stock option activity | A summary of the Company’s stock option activity and related information during the six months ended June 30, 2023 is as follows: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2022 5,877,745 $ 4.47 8.2 $ 907 Granted 382,915 $ 6.83 Exercised ( 77,812 ) $ 1.97 Forfeited/Expired ( 181,663 ) $ 5.60 Outstanding at June 30, 2023 6,001,185 $ 4.62 8.0 $ 14,005 Vested at June 30, 2023 2,692,861 $ 4.93 7.1 $ 5,566 Exercisable at June 30, 2023 3,263,418 $ 4.92 7.2 $ 6,509 |
Summary of weighted-average assumptions to determine the fair value of the employee stock option | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Risk-free interest rate 3.8 % 3.0 % 3.8 % 2.3 % Expected volatility 88.4 % 84.4 % 87.2 % 84.9 % Expected term (in years) 5.8 5.8 5.9 5.9 Expected dividend yield — % — % — % — % |
Summary of RSU activity | RSUs consist of performance-based units (PSUs) and market-based units (MSUs). The following table summarizes RSU activity during the six months ended June 30, 2023: Number of Weighted-Average Unvested at December 31, 2022 329,500 $ 5.70 Granted 40,000 $ 3.63 Cancelled ( 5,000 ) $ 2.14 Unvested at June 30, 2023 364,500 $ 5.52 |
Summary of Non-cash stock-based compensation expense recorded | The following table summarizes stock-based compensation expense, including expense associated with award modifications for unvested options, reflected in the consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 494 $ 386 $ 967 $ 773 General and administrative 713 620 1,397 1,340 Total $ 1,207 $ 1,006 $ 2,364 $ 2,113 |
Organization and Business (Narr
Organization and Business (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Cash, cash equivalents and short term investments | $ 142,700 | $ 142,700 | |||||
Accumulated deficit | 171,321 | 171,321 | $ 136,683 | ||||
Net loss | $ 19,531 | $ 15,107 | $ 12,312 | $ 13,036 | 34,638 | $ 25,348 | |
Cash used for operating activities | $ 25,162 | $ 20,955 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Right-of-use assets | $ 1,086 | $ 1,292 |
Operating Lease, Liability | $ 1,215 | |
Accounting Standards Update 2016-13 [Member] | ||
Change in accounting principle, accounting standards update, adopted | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | |
Change in accounting principle, accounting standards update, immaterial effect | true |
Net Loss Per Share - Anti-dilut
Net Loss Per Share - Anti-dilutive securities not included in diluted net loss per share calculation (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,365,685 | 4,685,061 |
Common Stock Options Outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,001,185 | 4,400,561 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 364,500 | 284,500 |
Fair Value Measurements - Narra
Fair Value Measurements - Narratives (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Assets transferred into L3 | $ 0 |
Assets transferred out of L3 | 0 |
Liabilities transferred into L3 | 0 |
Liabilities transferred out of L3 | 0 |
Performance Shares [Member] | Chief Executive Officer [Member] | |
Special performance bonus payable | $ 7,500 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring fair value measurement of the Company's assets and liabilities (Detail) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 139,148 | $ 95,589 |
Total | 876 | 29 |
Quoted Prices in Active Markets For Identical Items (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 5,552 | 9,365 |
Significant Other Observable Inputs (Level 2)[Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 133,596 | 86,224 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 876 | 29 |
Performance Award Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 876 | 29 |
Performance Award Liability [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 876 | 29 |
Money market investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,552 | 9,365 |
Money market investments [Member] | Quoted Prices in Active Markets For Identical Items (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,552 | 9,365 |
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 133,596 | 76,253 |
US Treasury Securities [Member] | Significant Other Observable Inputs (Level 2)[Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 133,596 | 76,253 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 4,978 | |
Short-term investments | 4,993 | |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2)[Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 4,978 | |
Short-term investments | $ 4,993 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule Changes in fair value measurements of the performance award (Detail) - Performance Award [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | $ 29 |
Change in fair value | 847 |
Ending Balance | $ 876 |
Marketable Debt Securities - Su
Marketable Debt Securities - Summary of Gross Unrealized Gains and Losses of Available-for-Sale (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 133,627 | $ 81,290 |
Gross Unrealized Gains | 6 | 2 |
Gross Unrealized Losses | (37) | (46) |
Fair Market Value | 133,596 | 81,246 |
US Treasury Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 133,627 | 76,297 |
Gross Unrealized Gains | 6 | 2 |
Gross Unrealized Losses | (37) | (46) |
Fair Market Value | $ 133,596 | 76,253 |
Commercial Paper [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 4,993 | |
Fair Market Value | $ 4,993 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued clinical and regulatory | $ 6,242 | $ 1,872 |
Accrued contract manufacturing cost | 1,535 | 1,583 |
Accrued compensation | 2,525 | 807 |
Accrued other | 1,290 | 565 |
Total accrued expenses | $ 11,592 | $ 4,827 |
Leases - Schedule of Other Info
Leases - Schedule of Other Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Leases [Abstract] | ||
Weighted average incremental borrowing rate | 5% | 5% |
Weighted average remaining lease term | 3 years 8 months 12 days | 4 years |
Cash paid for amounts included in the measurement of lease liabilities | $ 142 | $ 266 |
Lease expense | $ 241 | $ 241 |
Leases - Maturities of lease li
Leases - Maturities of lease liabilities (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Leases [Abstract] | |
2023 (remaining six months) | $ 187 |
2024 | 381 |
2025 | 381 |
2026 | 343 |
2027 | 34 |
Total lease payments | 1,326 |
Less: Imputed interest | (111) |
Present value of lease liabilities | $ 1,215 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narratives (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
May 09, 2023 | May 08, 2023 | Jun. 30, 2023 | |
Class of Stock [Line Items] | |||
Net proceeds from private placement | $ 4,667 | ||
Public Offering [Member] | |||
Class of Stock [Line Items] | |||
Common stock issued and sold, Shares | 7,906,250 | ||
Option to purchase shares of common stock | 1,031,250 | ||
Share price | $ 8 | ||
Net proceeds from offering | $ 58,900 | $ 58,862 | |
Private Placement [Member] | |||
Class of Stock [Line Items] | |||
Common stock issued and sold, Shares | 625,000 | ||
Share price | $ 8 | ||
Net proceeds from private placement | $ 4,700 | ||
Private Placement [Member] | Minimum [Member] | |||
Class of Stock [Line Items] | |||
Percentage of common stock held by affiliate | 5% |
Stock-Based Compensation - Equi
Stock-Based Compensation - Equity Incentive Plans (Details) | 6 Months Ended |
Jun. 30, 2023 shares | |
Equity Incentive Plan 2014 | Common Stock | |
Stock-Based Compensation | |
Share options exercised unvested shares outstanding | 0 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Shares Reserved for Future Issuance (Details) | Jun. 30, 2023 shares |
Class of Stock [Line Items] | |
Total shares of common stock reserved | 8,455,895 |
Common Stock Options Outstanding | |
Class of Stock [Line Items] | |
Total shares of common stock reserved | 6,001,185 |
Unvested Restricted Stock Units | |
Class of Stock [Line Items] | |
Total shares of common stock reserved | 364,500 |
Equity Incentive Plan 2021 | |
Class of Stock [Line Items] | |
Total shares of common stock reserved | 1,543,869 |
Employee Stock Purchase Plan (ESPP) 2021 | |
Class of Stock [Line Items] | |
Total shares of common stock reserved | 546,341 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Options Outstanding | ||
Outstanding at beginning of period (in shares) | 5,877,745 | |
Granted (in shares) | 382,915 | |
Exercised (in shares) | (77,812) | |
Forfeited/Expired (in shares) | (181,663) | |
Outstanding at end of period (in shares) | 6,001,185 | 5,877,745 |
Vested (in shares) | 2,692,861 | |
Exercisable (in shares) | 3,263,418 | |
Weighted-Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 4.47 | |
Granted (in dollars per share) | 6.83 | |
Exercised (in dollars per share) | 1.97 | |
Forfeited/Expired (in dollars per share) | 5.6 | |
Outstanding at end of period (in dollars per share) | 4.62 | $ 4.47 |
Vested (in dollars per share) | 4.93 | |
Exercisable (in dollars per share) | $ 4.92 | |
Weighted-Average Remaining Contractual Term (in years) / Aggregate Intrinsic Value | ||
Weighted Average Remaining Contractual Term (in years), Options Outstanding | 8 years | 8 years 2 months 12 days |
Weighted Average Remaining Contractual Term (in years), Vested | 7 years 1 month 6 days | |
Weighted Average Remaining Contractual Term (in years), Exercisable | 7 years 2 months 12 days | |
Aggregate Intrinsic Value, Outstanding | $ 14,005 | $ 907 |
Aggregate Intrinsic Value, Vested | 5,566 | |
Aggregate Intrinsic Value, Exercisable | 6,509 | |
Unrecognized stock-based compensation expense | $ 9,900 | |
Weighted-average vesting term | 2 years 7 months 6 days |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Weighted-average assumptions | ||||
Risk-free interest rate | 3.80% | 3% | 3.80% | 2.30% |
Expected volatility | 88.40% | 84.40% | 87.20% | 84.90% |
Expected term (in years) | 5 years 9 months 18 days | 5 years 9 months 18 days | 5 years 10 months 24 days | 5 years 10 months 24 days |
Expected dividend yield | 0% | 0% | 0% | 0% |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units (RSUs) (Details) - Restricted Stock Units (RSUs) - Equity Incentive Plan 2021 | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Number of PSUs | |
Unvested at Beginning | shares | 329,500 |
Granted | shares | 40,000 |
Cancelled | shares | (5,000) |
Unvested at End | shares | 364,500 |
Weighted Average Grant Date Fair Value | |
Unvested at Beginning | $ / shares | $ 5.7 |
Granted | $ / shares | 3.63 |
Cancelled | $ / shares | 2.14 |
Unvested at End | $ / shares | $ 5.52 |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance-Based Units (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,207,000 | $ 1,006,000 | $ 2,364,000 | $ 2,113,000 |
Unrecognized compensation expense | $ 9,900,000 | $ 9,900,000 | ||
Performance-based Restricted Units | Equity Incentive Plan 2021 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Unvested shares | 244,500 | 244,500 | ||
Stock-based compensation expense | $ 0 | $ 0 | ||
Unrecognized compensation expense | $ 1,600,000 | $ 1,600,000 |
Stock-Based Compensation - Mark
Stock-Based Compensation - Market-Based Units (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) Days $ / shares shares | |
Stock-Based Compensation | |
Unrecognized stock-based compensation expense | $ 9.9 |
Equity Incentive Plan 2021 | Market-Based Units | |
Stock-Based Compensation | |
Unrecognized stock-based compensation expense | $ 0.2 |
Equity Incentive Plan 2021 | Market-Based Units | Employee | |
Stock-Based Compensation | |
Threshold share price for vesting of shares | $ / shares | $ 20 |
Consecutive trading days | Days | 30 |
Unvested shares | shares | 120,000 |
Service period | 3 years |
Stock-Based Compensation - Appo
Stock-Based Compensation - Appointment of CEO (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) Days | Jun. 30, 2022 USD ($) | |
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 1,207 | $ 1,006 | $ 2,364 | $ 2,113 |
Chief executive officer | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | 600 | 800 | ||
Chief executive officer | Performance Shares [Member] | ||||
Stock-Based Compensation | ||||
Special performance bonus payable | 7,500 | 7,500 | ||
Threshold market value | 750,000 | $ 750,000 | ||
Number of trading days | Days | 30 | |||
Threshold fair market value of the net proceeds | $ 750,000 | $ 750,000 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) | 6 Months Ended |
Jun. 30, 2023 shares | |
2021 Employee Stock Purchase Plan | Common Stock | |
Stock-Based Compensation | |
Number of shares purchased | 84,296 |
UK Sharesave Sub-plan (SAYE) | |
Stock-Based Compensation | |
Options authorized | 25,875 |
Number of shares purchased | 0 |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-cash stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 1,207 | $ 1,006 | $ 2,364 | $ 2,113 |
Research and development | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | 494 | 386 | 967 | 773 |
General and administrative | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 713 | $ 620 | $ 1,397 | $ 1,340 |
License Agreement (Details)
License Agreement (Details) - vTv Therapeutics - USD ($) | 1 Months Ended | 6 Months Ended | |
Dec. 31, 2017 | Jun. 30, 2023 | Jun. 30, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payments | $ 0 | $ 0 | |
Development and regulatory milestone payments | $ 2,000,000 | ||
Milestone payments payable on achievement of sales thresholds of the licensed product | $ 30,000,000 | ||
Research and development | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Upfront license fee payment | $ 3,000,000 | ||
Common stock issued, Shares | 576,443 | ||
Milestone payments payable on achievement of development and regulatory milestones | $ 64,500,000 |