Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 26, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-35342 | |
Entity Registrant Name | LUMOS PHARMA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 42-1491350 | |
Entity Address, Address Line One | 4200 Marathon Blvd #200 | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 78756 | |
City Area Code | 512 | |
Local Phone Number | 215-2630 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | LUMO | |
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 | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,124,037 | |
Entity Central Index Key | 0001126234 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 16,799 | $ 35,078 |
Short-term investments | 0 | 999 |
Prepaid expenses and other current assets | 3,925 | 3,748 |
Other receivables | 168 | 210 |
Total current assets | 20,892 | 40,035 |
Non-current assets: | ||
Right-of-use asset | 463 | 603 |
Total assets | 21,355 | 40,638 |
Current liabilities: | ||
Accounts payable | 337 | 890 |
Accrued expenses | 4,294 | 5,858 |
Current portion of lease liability | 304 | 282 |
Total current liabilities | 4,935 | 7,030 |
Long-term liabilities: | ||
Royalty obligation payable to Iowa Economic Development Authority | 6,000 | 6,000 |
Lease liability | 145 | 303 |
Total liabilities | 11,080 | 13,333 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Undesignated preferred stock, $0.01 par value: Authorized shares - 5,000,000 at June 30, 2024 and December 31, 2023; issued and outstanding shares - 0 at June 30, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.01 par value: Authorized shares - 75,000,000 at June 30, 2024 and December 31, 2023; issued shares - 8,151,900 and 8,125,728 at June 30, 2024 and December 31, 2023, respectively, and outstanding shares - 8,123,186 and 8,102,555 at June 30, 2024 and December 31, 2023, respectively | 81 | 81 |
Treasury stock, at cost, 28,714 and 23,173 shares at June 30, 2024 and December 31, 2023, respectively | (212) | (196) |
Additional paid-in capital | 189,915 | 188,937 |
Accumulated deficit | (179,509) | (161,517) |
Total stockholders' equity | 10,275 | 27,305 |
Total liabilities and stockholders' equity | $ 21,355 | $ 40,638 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Undesignated preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Undesignated preferred stock, authorized shares (in shares) | 5,000,000 | 5,000,000 |
Undesignated preferred stock, issued shares (in shares) | 0 | 0 |
Undesignated preferred stock, outstanding shares (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares (in shares) | 75,000,000 | 75,000,000 |
Common stock, issued shares (in shares) | 8,151,900 | 8,125,728 |
Common stock, outstanding shares (in shares) | 8,123,186 | 8,102,555 |
Treasury stock, shares (in shares) | 28,714 | 23,173 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues: | ||||
Royalty revenue | $ 488 | $ 527 | $ 653 | $ 1,218 |
Total revenues | 488 | 527 | 653 | 1,218 |
Operating expenses: | ||||
Research and development | 4,629 | 6,024 | 11,877 | 10,393 |
General and administrative | 3,682 | 4,146 | 7,461 | 8,503 |
Total operating expenses | 8,311 | 10,170 | 19,338 | 18,896 |
Loss from operations | (7,823) | (9,643) | (18,685) | (17,678) |
Other income and expense: | ||||
Other income, net | 202 | 124 | 465 | 243 |
Interest income | 70 | 559 | 228 | 1,129 |
Other income, net | 272 | 683 | 693 | 1,372 |
Net loss before taxes | (7,551) | (8,960) | (17,992) | (16,306) |
Income tax benefit | 0 | 29 | 0 | 29 |
Net loss | $ (7,551) | $ (8,931) | $ (17,992) | $ (16,277) |
Net loss per share: | ||||
Basic (in dollars per share) | $ (0.93) | $ (1.09) | $ (2.22) | $ (1.98) |
Diluted (in dollars per share) | $ (0.93) | $ (1.09) | $ (2.22) | $ (1.98) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 8,112,566 | 8,164,603 | 8,107,528 | 8,205,625 |
Diluted (in shares) | 8,112,566 | 8,164,603 | 8,107,528 | 8,205,625 |
Other comprehensive loss: | ||||
Unrealized loss on short-term investments | $ 0 | $ (6) | $ 0 | $ (2) |
Total comprehensive loss | $ (7,551) | $ (8,937) | $ (17,992) | $ (16,279) |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Common Stock, balance at beginning of period (in shares) at Dec. 31, 2022 | 8,267,968 | |||||
Treasury Stock, balance at beginning of period (in shares) at Dec. 31, 2022 | 15,740 | |||||
Balance at beginning of period at Dec. 31, 2022 | $ 59,584 | $ 82 | $ (170) | $ 187,164 | $ (127,483) | $ (9) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation | 586 | 586 | ||||
Stock issued upon vesting of restricted stock units (in shares) | 4,029 | |||||
Shares surrendered for tax withholding on vested awards (in shares) | (1,007) | (1,007) | ||||
Shares surrendered for tax withholding on vested awards | (4) | $ (4) | ||||
Repurchases of common stock (in shares) | (87,694) | |||||
Repurchases of common stock | (305) | $ (1) | (304) | |||
Other comprehensive income (loss) | 4 | 4 | ||||
Net loss | (7,346) | (7,346) | ||||
Common Stock, balance at end of period (in shares) at Mar. 31, 2023 | 8,183,296 | |||||
Treasury Stock, balance at end of period (in shares) at Mar. 31, 2023 | 16,747 | |||||
Balance at end of period at Mar. 31, 2023 | 52,519 | $ 81 | $ (174) | 187,446 | (134,829) | (5) |
Common Stock, balance at beginning of period (in shares) at Dec. 31, 2022 | 8,267,968 | |||||
Treasury Stock, balance at beginning of period (in shares) at Dec. 31, 2022 | 15,740 | |||||
Balance at beginning of period at Dec. 31, 2022 | 59,584 | $ 82 | $ (170) | 187,164 | (127,483) | (9) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (16,277) | |||||
Common Stock, balance at end of period (in shares) at Jun. 30, 2023 | 8,041,345 | |||||
Treasury Stock, balance at end of period (in shares) at Jun. 30, 2023 | 20,575 | |||||
Balance at end of period at Jun. 30, 2023 | 43,661 | $ 80 | $ (187) | 187,539 | (143,760) | (11) |
Common Stock, balance at beginning of period (in shares) at Mar. 31, 2023 | 8,183,296 | |||||
Treasury Stock, balance at beginning of period (in shares) at Mar. 31, 2023 | 16,747 | |||||
Balance at beginning of period at Mar. 31, 2023 | 52,519 | $ 81 | $ (174) | 187,446 | (134,829) | (5) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation | 653 | 653 | ||||
Stock issued/sale under stock purchase plan (in shares) | 6,425 | |||||
Stock issued/sale under stock purchase plan | 18 | 18 | ||||
Stock issued upon vesting of restricted stock units (in shares) | 15,372 | |||||
Shares surrendered for tax withholding on vested awards (in shares) | (3,828) | (3,828) | ||||
Shares surrendered for tax withholding on vested awards | (13) | $ (13) | ||||
Repurchases of common stock (in shares) | (159,920) | |||||
Repurchases of common stock | (579) | $ (1) | (578) | |||
Other comprehensive income (loss) | (6) | (6) | ||||
Net loss | (8,931) | (8,931) | ||||
Common Stock, balance at end of period (in shares) at Jun. 30, 2023 | 8,041,345 | |||||
Treasury Stock, balance at end of period (in shares) at Jun. 30, 2023 | 20,575 | |||||
Balance at end of period at Jun. 30, 2023 | $ 43,661 | $ 80 | $ (187) | 187,539 | (143,760) | (11) |
Common Stock, balance at beginning of period (in shares) at Dec. 31, 2023 | 8,102,555 | 8,102,555 | ||||
Treasury Stock, balance at beginning of period (in shares) at Dec. 31, 2023 | 23,173 | 23,173 | ||||
Balance at beginning of period at Dec. 31, 2023 | $ 27,305 | $ 81 | $ (196) | 188,937 | (161,517) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation | 580 | 580 | ||||
Stock issued upon vesting of restricted stock units (in shares) | 6,279 | |||||
Shares surrendered for tax withholding on vested awards (in shares) | (1,713) | (1,713) | ||||
Shares surrendered for tax withholding on vested awards | (5) | $ (5) | ||||
Net loss | (10,441) | (10,441) | ||||
Common Stock, balance at end of period (in shares) at Mar. 31, 2024 | 8,107,121 | |||||
Treasury Stock, balance at end of period (in shares) at Mar. 31, 2024 | 24,886 | |||||
Balance at end of period at Mar. 31, 2024 | $ 17,439 | $ 81 | $ (201) | 189,517 | (171,958) | 0 |
Common Stock, balance at beginning of period (in shares) at Dec. 31, 2023 | 8,102,555 | 8,102,555 | ||||
Treasury Stock, balance at beginning of period (in shares) at Dec. 31, 2023 | 23,173 | 23,173 | ||||
Balance at beginning of period at Dec. 31, 2023 | $ 27,305 | $ 81 | $ (196) | 188,937 | (161,517) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | $ (17,992) | |||||
Common Stock, balance at end of period (in shares) at Jun. 30, 2024 | 8,123,186 | 8,123,186 | ||||
Treasury Stock, balance at end of period (in shares) at Jun. 30, 2024 | 28,714 | 28,714 | ||||
Balance at end of period at Jun. 30, 2024 | $ 10,275 | $ 81 | $ (212) | 189,915 | (179,509) | 0 |
Common Stock, balance at beginning of period (in shares) at Mar. 31, 2024 | 8,107,121 | |||||
Treasury Stock, balance at beginning of period (in shares) at Mar. 31, 2024 | 24,886 | |||||
Balance at beginning of period at Mar. 31, 2024 | 17,439 | $ 81 | $ (201) | 189,517 | (171,958) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation | 387 | 387 | ||||
Stock issued/sale under stock purchase plan (in shares) | 5,705 | |||||
Stock issued/sale under stock purchase plan | 11 | 11 | ||||
Stock issued upon vesting of restricted stock units (in shares) | 14,188 | |||||
Shares surrendered for tax withholding on vested awards (in shares) | (3,828) | (3,828) | ||||
Shares surrendered for tax withholding on vested awards | (11) | $ (11) | ||||
Net loss | $ (7,551) | (7,551) | ||||
Common Stock, balance at end of period (in shares) at Jun. 30, 2024 | 8,123,186 | 8,123,186 | ||||
Treasury Stock, balance at end of period (in shares) at Jun. 30, 2024 | 28,714 | 28,714 | ||||
Balance at end of period at Jun. 30, 2024 | $ 10,275 | $ 81 | $ (212) | $ 189,915 | $ (179,509) | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash Flows From Operating Activities | ||
Net loss | $ (17,992) | $ (16,277) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 967 | 1,239 |
Depreciation and amortization | 4 | 18 |
Other income, net | (1) | (271) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (177) | (474) |
Other receivables | 42 | (10) |
Accounts payable and accrued expenses | (2,117) | (107) |
Net cash used in operating activities | (19,274) | (15,882) |
Cash Flows From Investing Activities | ||
Purchases of marketable securities | 0 | (6,380) |
Maturities of marketable securities | 1,000 | 5,000 |
Net cash provided by (used in) investing activities | 1,000 | (1,380) |
Cash Flows From Financing Activities | ||
Sale of shares under stock purchase plan | 11 | 18 |
Payment for tax withholding on vested awards | (16) | (17) |
Repurchases of common stock | 0 | (884) |
Net cash used in financing activities | (5) | (883) |
Net decrease in cash and cash equivalents | (18,279) | (18,145) |
Cash and cash equivalents at beginning of period | 35,078 | 56,007 |
Cash and cash equivalents at end of period | $ 16,799 | $ 37,862 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | D escription of Business Organization and Nature of Operations Lumos Pharma, Inc. is a clinical-stage biopharmaceutical company. References in this Quarterly Report to “us,” “we,” “our,” the “Company,” or “Lumos” are to Lumos Pharma, Inc. and its wholly-owned subsidiaries. With our principal executive offices located in Austin, Texas and additional executive and administrative offices located in Ames, Iowa, we are engaged in advancing our clinical program and focused on identifying, acquiring, developing, and commercializing novel products and new therapies for people with rare diseases on a global level , for which there is currently a significant unmet need for safe and effective therapies. Our common stock is listed on the Nasdaq Global Market (“Nasdaq”) and trades under the ticker symbol “LUMO.” The Company entered into a business combination (the “Merger”) between the Company, formerly known as NewLink Genetics Corporation (“NewLink”), Cyclone Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of NewLink, and Lumos Pharma, Inc., which has since been renamed “Lumos Pharma Sub, Inc.” (“Private Lumos”). The Merger closed on March 18, 2020, and Merger Sub merged with and into Private Lumos, with Private Lumos surviving as a wholly-owned subsidiary of the Company. After the consummation of the Merger, the combined company has focused its efforts on the development of Private Lumos’ sole product candidate, secretagogue ibutamoren (“LUM-201”), a potential oral therapy for idiopathic pediatric growth hormone deficiency (“PGHD”) and other rare endocrine disorders. Liquidity and Going Concern The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements also do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company has historically devoted substantially all of its efforts toward research and development and has never earned revenue from commercial sales of its products. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. As of June 30, 2024 , the Company had approximately $16.8 million of cash and cash equivalents. The Company's accumulated deficit at June 30, 2024 was approximately $179.5 million . Given its current development plans and cash management efforts, the Company anticipates its cash resources will be sufficient to fund operations into the first quarter of 2025. However, based on the Company's current cash forecast and the Company’s dependence on its ability to obtain additional financing to fund its operations in advancing the PGHD program into a Phase 3 trial, the Company concluded that its available cash and cash equivalents as of June 30, 2024 may not be sufficient to fund its operations for at least 12 months from the filing date of this Quarterly Report, and thus substantial doubt exists as to the Company’s ability to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of Lumos and its wholly-owned subsidiaries and have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). All significant intercompany accounts and transactions are eliminated in consolidation . Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments of a normal and recurring nature considered necessary for a fair presentation have been included in the accompanying condensed consolidated financial statements. The results of operations for the interim period are not necessarily indicative of the results that will be realized for the entire fiscal year. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and accompanying notes thereto included in the Company’s 2023 Annual Report filed on Form 10-K with the SEC on March 7, 2024. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company ’s financial statements and accompanying notes. Significant management estimates that affect the reported amounts of assets and liabilities include stock-based compensation, accruals for clinical trials and deferred tax assets. While we believe that the estimates and assumptions used in preparation of our condensed consolidated financial statements based on our knowledge of current events and actions that we may undertake in the future are appropriate, actual results could differ from those estimates, and any such differences may be material. As of June 30, 2024, the Company’s significant accounting policies are consistent with those discussed in Note 2 - “ Summary of Significant Accounting Policies and Recent Accounting Pronouncements ” of its consolidated financial statements included in the Company’s 2023 Annual Report filed on Form 10-K with the SEC on March 7, 2024. Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures . This ASU requires interim and annual disclosure of significant segment expenses that are regularly provided to the chief operating decision-maker (“CODM”) and included within the reported measure of a segment’s profit or loss, requires interim disclosures about a reportable segment’s profit or loss and assets that are currently required annually, requires disclosure of the position and title of the CODM, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. This authoritative guidance is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures . This ASU requires that reporting entities disclose specific categories in the effective tax rate reconciliation as well as information about income taxes paid. The authoritative guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its consolidated financial statements. |
License and Asset Purchase Agre
License and Asset Purchase Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Asset Purchase Agreements | License and Asset Purchase Agreements License and LUM-201 Asset Purchase Agreements In July 2018, the Company entered into an asset purchase agreement (the “APA”) with Ammonett Pharma LLC (“Ammonett”) and acquired substantially all of the assets related to LUM-201, which Ammonett licensed from Merck in October 2013 (the “Lumos Merck Agreement”). The Lumos Merck Agreement, which grants Lumos (as successor in interest to Ammonett) worldwide, exclusive, sublicensable (subject to Merck’s consent in the United States, major European countries and Japan, such consent not to be unreasonably withheld) rights under specified patents and know-how to develop, manufacture and commercialize LUM-201 for any and all indications, excluding Autism Spectrum Disorders as defined in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders. On August 12, 2020, we entered into Amendment No. 1 to the Lumos Merck Agreement with Merck (the “Lumos Merck Agreement Amendment”). Pursuant to the Lumos Merck Agreement Amendment, we obtained from Merck a worldwide, non-exclusive, sublicensable (subject to Merck’s consent in the United States, specified major European countries and Japan, such consent not to be unreasonably withheld) license under the specified patents and know-how that are the subject of our exclusive license to develop, manufacture and commercialize LUM-201 for diagnostic purposes, excluding Autism Spectrum Disorders. Under the APA, the Company paid Ammonett an upfront fee of $3.5 million which was recorded as research and development expense in 2018. The Company may also incur development milestone payments totaling up to $17.0 million for achievement of specified milestones on the first indication that Lumos pursues, of which $2.0 million was paid in March 2024, and up to $14.0 million for achievements of specified milestones on the second indication that Lumos pursues, sales milestone payments totaling up to $55.0 million on worldwide product sales, and royalty payments based on worldwide product sales, as discussed below. Under the Lumos Merck Agreement, Lumos will be required to pay Merck substantial development milestone payments for achievement of specified milestones relating to each of the first and second indications. Total potential development milestone payments are required of up to $14 million for the first indication that Lumos pursues and up to $8.5 million for the second indication that Lumos pursues. Tiered sales milestone payments totaling up to $80.0 million are required on worldwide net product sales up to $1.0 billion, and royalty payments based on product sales are required if product sales are achieved. If product sales are ever achieved, Lumos is required to make royalty payments under both the APA and the Lumos Merck Agreement collectively of 10% to 12% of total annual product net sales, subject to standard reductions for generic erosion. The royalty obligations under the Lumos Merck Agreement are on a product-by-product and country-by-country basis and will last until the later of expiration of the last licensed patent covering the product in such country and expiration of regulatory exclusivity for such product in such country. The royalty obligations under the APA are on a product-by-product and country-by-country basis for the duration of the royalty obligations under the Merck license and thereafter until the expiration of the last patent assigned to Lumos under the APA covering such product in such country. The Lumos Merck Agreement shall continue in force until the expiration of royalty obligations on a country-by-country and product-by-product basis, or unless terminated by Lumos at will by submitting 180 days’ advance written notice to Merck or by either party for the other party’s uncured material breach or specified bankruptcy events. Upon expiry of the royalty obligations the Lumos Merck Agreement converts to a fully paid-up, perpetual non-exclusive license. If the Lumos Merck Agreement is terminated, and upon Merck’s written request, Lumos is obligated to use reasonable and diligent efforts to assign to Merck any sublicenses previously granted by Lumos. License and PRV Asset Purchase Agreements In November 2014, NewLink entered into a worldwide license and collaboration agreement (the “NewLink Merck Agreement”), with Merck, to develop and potentially commercialize its Ebola vaccine rVSV∆G-ZEBOV that it licensed from the Public Health Agency of Canada (“ PHAC ”). rVSV∆G-ZEBOV was also eligible to receive a PRV if approval was granted by the U.S. Food and Drug Administration (the “FDA”), with the Company entitled to 60% and Merck entitled to the remaining 40% of the PRV value obtained through sale, transfer or other disposition of the PRV. On December 20, 2019, Merck announced that the FDA approved its application for ERVEBO® (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire Ebola virus in individuals 18 years of age and older and grant of the PRV. Under the NewLink Merck Agreement, as amended , the Company has earned and has the potential to continue to earn royalties on sales of the vaccine in certain countries. However, we believe that the market for the vaccine will be limited primarily to areas in the developing world that are excluded from royalty payment or where the vaccine is donated or sold at low or no margin, and therefore we do not expect to receive material royalty payments from Merck in the foreseeable future. For each of the three months ended June 30, 2024 and 2023, the Company recognized revenues of $0.5 million, and recognized revenues of $0.7 million and $1.2 million, respectively, for the six months ended June 30, 2024 and 2023, for royalties related to royalty-bearing commercial sales of the vaccine. Additionally, per the terms of the licensing agreement with the PHAC, the Company has an obligation to pay a royalty fee to the PHAC for any royalty amounts earned. For each of the three months ended June 30, 2024 and 2023, the Company incurred royalty expense of $0.3 million, and incurred royalty expense of $0.4 million and $0.8 million, respectively, for the six months ended June 30, 2024 and 2023, for royalties related to royalty-bearing commercial sales of the vaccine. Royalty expenses are included within general and administrative expenses in the consolidated statements of operations. |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments | Financial Instruments Fair Value The fair values of the Company’s financial instruments are recorded using a hierarchical disclosure framework based upon the level of subjectivity of the inputs used in measuring assets and liabilities. The three levels are described below: • Level 1: Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date . • Level 2: Inputs other than Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities and quoted prices in less active markets. • Level 3: Inputs are unobservable for the asset or liability and are developed based on the best information available in the circumstances, which might include the Company’s own data. The following summarizes the valuation of the Company’s financial instruments (in thousands). The tables do not include either cash on hand or assets and liabilities that are measured at historical cost or any basis other than fair value. As of June 30, 2024 Level 1 Level 2 Total Cash equivalents: Money market funds $ 15,857 $ — $ 15,857 Total cash equivalents $ 15,857 $ — $ 15,857 As of December 31, 2023 Level 1 Level 2 Total Cash equivalents: Money market funds $ 34,741 $ — $ 34,741 Total cash equivalents $ 34,741 $ — $ 34,741 Short-term investments: U.S. government and agency securities — 999 999 Total short-term investments $ — $ 999 $ 999 Total $ 34,741 $ 999 $ 35,740 As of June 30, 2024 and December 31, 2023, the Company had no Level 3 assets or liabilities. The Company’s other financial instruments, including cash, receivables and accounts payable, are recorded at amounts that approximate their fair values due to their short maturities. The Company is unable to estimate the fair value of the royalty obligation to Iowa Economic Development Authority based on future product sales, as the timing of payments, if any, is uncertain. Contractual Maturities of Investments As of June 30, 2024, all of the Company's available-for-sale investments were due within one year or less. Available-for-sale Investments The following table summarizes the Company's available-for-sale securities by security type: As of June 30, 2024 Amortized Cost Unrealized Losses Fair Value Cash equivalents: Money market funds $ 15,857 $ — $ 15,857 Total cash equivalents $ 15,857 $ — $ 15,857 As of December 31, 2023 Amortized Cost Unrealized Losses Fair Value Cash equivalents: Money market funds $ 34,741 $ — $ 34,741 Total cash equivalents $ 34,741 $ — $ 34,741 Short-term investments: U.S. government and agency securities 999 — 999 Total short-term investments $ 999 $ — $ 999 Total $ 35,740 $ — $ 35,740 As of June 30, 2024 and December 31, 2023, there were no material unrealized gains associated with the Company’s available-for-sale investments. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses are comprised of the following (in thousands): June 30, 2024 December 31, 2023 Compensation and related benefits $ 2,507 $ 3,472 Clinical and contract manufacturing expenses 1,181 1,790 Other 606 596 Total accrued expenses $ 4,294 $ 5,858 |
Stock-Based Compensation and Em
Stock-Based Compensation and Employee Benefit Plans | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation and Employee Benefit Plans | Stock-Based Compensation and Employee Benefit Plans Stock Options and Performance Stock Options In 2012, Private Lumos adopted the 2012 Equity Incentive Plan (“2012 Plan”), and in 2016 it adopted the 2016 Stock Plan (“2016 Plan” and together with the 2012 Plan, the “Plans”). In connection with the Merger, all outstanding options under the Plans were assumed and such assumed options may be exercised to purchase common stock of the Company after the Merger. Subsequent to the Merger, the Plans were terminated as to future awards . In connection with the Merger, the Company assumed NewLink’s 2009 Equity Incentive Plan which was effective since July 2009 and was subsequently amended on May 9 , 2019 (the “2019 Plan”) . The 2019 Plan has a 10 year term from the Board adoption date of March 22, 2019 and on January 1 of each year through January 1, 2029, in accordance with an “evergreen provision”, a number of shares of common stock in an amount equal to 3% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year or such lesser amount of shares (or no shares) approved by the Board, will be added to the shares reserved under the 2019 Plan. The 2019 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock awards and stock appreciation rights to officers, employees, members of the Board, advisors, and consultants to the Company . As of June 30, 2024, we had 688,134 shares available for grant under the 2019 Plan. 2010 Non-Employee Directors' Stock Award Plan In connection with the Merger , the Company assumed NewLink’s 2010 Non-Employee Directors’ Stock Award Plan (the Directors’ Plan) which was effective on November 10, 2011. As of June 30, 2024, 5,624 shares remain available for grant under the Directors' Plan. 2010 Employee Stock Purchase Plan In connection with the Merger, the Company assumed NewLink’s 2010 Employee Stock Purchase Plan, as amended (the “2010 Purchase Plan”), which was effective on November 10, 2011. As of June 30, 2024, 30,241 shares remain available for issuance under the 2010 Purchase Plan. On July 22, 2021, the Board approved an amendment and restatement of the 2010 Purchase Plan (the “A&R ESPP”), and established a special offering period under the A&R ESPP beginning September 1, 2021 and lasting until June 30, 2023, subject to restart provisions as described within the A&R ESPP. The special offering period under the A&R ESPP was fully contingent upon stockholder approval of the A&R ESPP at the 2022 Annual Meeting of Stockholders. The A&R ESPP provided for an increase in the number of shares reserved for issuance under the A&R ESPP by 60,000 shares. On May 4, 2022, at the 2022 Annual Meeting of Stockholders, the A&R ESPP was approved. On June 30, 2022, December 30, 2022, June 30, 2023, and June 30, 2024, the restart provision was triggered, resulting in new offering periods. The current offering period is from July 1, 2024 through June 30, 2026. Share-Based Compensation Expense Stock-based compensation expenses included in the Company’s condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 were (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 102 $ 192 $ 244 $ 349 General and administrative 285 461 723 890 Total $ 387 $ 653 $ 967 $ 1,239 As of June 30, 2024, we had unrecognized compensation cost of $2.3 million and the weighted-average period over which it is expected to be recognized is 2.2 years. |
Long-Term Debt and Conversion t
Long-Term Debt and Conversion to Royalty Obligation | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Long-Term Debt and Conversion to Royalty Obligation | Long-Term Debt and Conversion to Royalty Obligation In March 2005, NewLink entered into a $6.0 million forgivable loan agreement with the Iowa Department of Economic Development (the “IDED”). Under the agreement, in the absence of default, there were no principal or interest payments due until the completion date for the project. This loan was converted into a royalty obligation under the terms of a settlement agreement entered into on March 26, 2012 (the “IEDA Agreement”), with the Iowa Economic Development Authority (the “IEDA”), as successor in interest to the IDED. As no payments are expected in the next 12 months, the entire royalty obligation of $6.0 million, which we assumed in connection with the Merger, is classified as a long-term liability as of June 30, 2024. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the three months ended June 30, 2024 and 2023, the Company recorded an income tax benefit of $0 and $29,000, respectively. For the six months ended June 30, 2024 and 2023, the Company recorded an income tax benefit of $0 and $29,000, respectively. The income tax amount for each of the three and six months ended June 30, 2024 and 2023 differs from the amount that would be expected after applying the statutory U.S. federal income tax rate primarily due to an increase in the valuation allowance. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Due to the uncertainty of the Company’s ability to realize the benefit of the deferred tax assets, the net deferred tax assets are fully offset by a valuation allowance at June 30, 2024. Based on Section 382 ownership change analyses through March 18, 2020, as a result of the Merger, both historical NewLink and Private Lumos experienced Section 382 ownership changes on March 18, 2020. These ownership changes limit our ability to utilize federal net operating loss carryforwards and certain other tax attributes that accrued prior to the respective ownership changes of us and our subsidiaries and may continue to limit our ability to utilize such attributes in the future. Based on subsequent analyses, we did not experience a Section 382 ownership change from March 19, 2020 through December 31, 2022. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Net Loss per Share of Common Stock Basic loss per share is based upon the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted loss per share is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common stock equivalents during the period when the effect is dilutive. The following table presents the computation of basic and diluted loss per share of common stock (in thousands, except share and per share data) and the number of unexercised stock options and restricted stock units, which are common stock equivalents, that have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented. Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Net loss $ (7,551) $ (8,931) $ (17,992) $ (16,277) Weighted-average shares outstanding – Basic and diluted 8,112,566 8,164,603 8,107,528 8,205,625 Net loss per share – Basic and diluted $ (0.93) $ (1.09) $ (2.22) $ (1.98) Anti-dilutive stock options 1,640,843 1,488,088 1,640,843 1,488,088 Anti-dilutive restricted stock units 57,113 53,868 57,113 53,868 Total anti-dilutive common stock equivalents excluded 1,697,956 1,541,956 1,697,956 1,541,956 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of Lumos and its wholly-owned subsidiaries and have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). All significant intercompany accounts and transactions are eliminated in consolidation . |
Liquidity and Going Concern/ Basis of Presentation | Liquidity and Going Concern The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements also do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company has historically devoted substantially all of its efforts toward research and development and has never earned revenue from commercial sales of its products. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. As of June 30, 2024 , the Company had approximately $16.8 million of cash and cash equivalents. The Company's accumulated deficit at June 30, 2024 was approximately $179.5 million . Given its current development plans and cash management efforts, the Company anticipates its cash resources will be sufficient to fund operations into the first quarter of 2025. However, based on the Company's current cash forecast and the Company’s dependence on its ability to obtain additional financing to fund its operations in advancing the PGHD program into a Phase 3 trial, the Company concluded that its available cash and cash equivalents as of June 30, 2024 may not be sufficient to fund its operations for at least 12 months from the filing date of this Quarterly Report, and thus substantial doubt exists as to the Company’s ability to continue as a going concern. If the Company is not able to raise additional funding and its available liquidity becomes insufficient to meet the Company’s obligations as they come due, management's plan is to raise additional equity or financing to fund the Company's future operations. There can be no assurances that such financing will be available on terms that are favorable to the Company, or at all. The Company has taken certain steps to delay or reduce the scope of its research programs and limit its operations until it is able to obtain additional funding. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to further delay or reduce the scope of its research programs, including its LUM-201 Phase 3 trial, and/or limit or cease its operations. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments of a normal and recurring nature considered necessary for a fair presentation have been included in the accompanying condensed consolidated financial statements. The results of operations for the interim period are not necessarily indicative of the results that will be realized for the entire fiscal year. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and accompanying notes thereto included in the Company’s 2023 Annual Report filed on Form 10-K with the SEC on March 7, 2024. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company ’s financial statements and accompanying notes. Significant management estimates that affect the reported amounts of assets and liabilities include stock-based compensation, accruals for clinical trials and deferred tax assets. While we believe that the estimates and assumptions used in preparation of our condensed consolidated financial statements based on our knowledge of current events and actions that we may undertake in the future are appropriate, actual results could differ from those estimates, and any such differences may be material. As of June 30, 2024, the Company’s significant accounting policies are consistent with those discussed in Note 2 - “ Summary of Significant Accounting Policies and Recent Accounting Pronouncements ” of its consolidated financial statements included in the Company’s 2023 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures . This ASU requires interim and annual disclosure of significant segment expenses that are regularly provided to the chief operating decision-maker (“CODM”) and included within the reported measure of a segment’s profit or loss, requires interim disclosures about a reportable segment’s profit or loss and assets that are currently required annually, requires disclosure of the position and title of the CODM, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. This authoritative guidance is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures . This ASU requires that reporting entities disclose specific categories in the effective tax rate reconciliation as well as information about income taxes paid. The authoritative guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its consolidated financial statements. |
Fair Value | Fair Value The fair values of the Company’s financial instruments are recorded using a hierarchical disclosure framework based upon the level of subjectivity of the inputs used in measuring assets and liabilities. The three levels are described below: • Level 1: Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date . • Level 2: Inputs other than Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities and quoted prices in less active markets. • Level 3: Inputs are unobservable for the asset or liability and are developed based on the best information available in the circumstances, which might include the Company’s own data. |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Summarizes the Valuation of the Company’s Financial Instruments | The following summarizes the valuation of the Company’s financial instruments (in thousands). The tables do not include either cash on hand or assets and liabilities that are measured at historical cost or any basis other than fair value. As of June 30, 2024 Level 1 Level 2 Total Cash equivalents: Money market funds $ 15,857 $ — $ 15,857 Total cash equivalents $ 15,857 $ — $ 15,857 As of December 31, 2023 Level 1 Level 2 Total Cash equivalents: Money market funds $ 34,741 $ — $ 34,741 Total cash equivalents $ 34,741 $ — $ 34,741 Short-term investments: U.S. government and agency securities — 999 999 Total short-term investments $ — $ 999 $ 999 Total $ 34,741 $ 999 $ 35,740 The following table summarizes the Company's available-for-sale securities by security type: As of June 30, 2024 Amortized Cost Unrealized Losses Fair Value Cash equivalents: Money market funds $ 15,857 $ — $ 15,857 Total cash equivalents $ 15,857 $ — $ 15,857 As of December 31, 2023 Amortized Cost Unrealized Losses Fair Value Cash equivalents: Money market funds $ 34,741 $ — $ 34,741 Total cash equivalents $ 34,741 $ — $ 34,741 Short-term investments: U.S. government and agency securities 999 — 999 Total short-term investments $ 999 $ — $ 999 Total $ 35,740 $ — $ 35,740 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised of the following (in thousands): June 30, 2024 December 31, 2023 Compensation and related benefits $ 2,507 $ 3,472 Clinical and contract manufacturing expenses 1,181 1,790 Other 606 596 Total accrued expenses $ 4,294 $ 5,858 |
Stock-Based Compensation and _2
Stock-Based Compensation and Employee Benefit Plans (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Expense | Stock-based compensation expenses included in the Company’s condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 were (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 102 $ 192 $ 244 $ 349 General and administrative 285 461 723 890 Total $ 387 $ 653 $ 967 $ 1,239 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss per Share of Common Stock | The following table presents the computation of basic and diluted loss per share of common stock (in thousands, except share and per share data) and the number of unexercised stock options and restricted stock units, which are common stock equivalents, that have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented. Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Net loss $ (7,551) $ (8,931) $ (17,992) $ (16,277) Weighted-average shares outstanding – Basic and diluted 8,112,566 8,164,603 8,107,528 8,205,625 Net loss per share – Basic and diluted $ (0.93) $ (1.09) $ (2.22) $ (1.98) Anti-dilutive stock options 1,640,843 1,488,088 1,640,843 1,488,088 Anti-dilutive restricted stock units 57,113 53,868 57,113 53,868 Total anti-dilutive common stock equivalents excluded 1,697,956 1,541,956 1,697,956 1,541,956 |
Description of Business (Detail
Description of Business (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 16,799 | $ 35,078 |
Accumulated deficit | $ 179,509 | $ 161,517 |
License and Asset Purchase Ag_2
License and Asset Purchase Agreements (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2018 | Nov. 30, 2014 | |
Asset Acquisition [Line Items] | ||||||
Payments for royalties | $ 0.3 | $ 0.3 | $ 0.4 | $ 0.8 | ||
Merck | Royalty revenue | ||||||
Asset Acquisition [Line Items] | ||||||
Grant revenue | 0.5 | $ 0.5 | 0.7 | $ 1.2 | ||
License and Collaborative Arrangement | Merck | ||||||
Asset Acquisition [Line Items] | ||||||
Collaborative arrangement development milestone payments | 14 | 14 | ||||
Collaborative arrangement second indication development milestone payments | 8.5 | 8.5 | ||||
Collaborative arrangement tiered sales milestone payments | 80 | 80 | ||||
Net product sales milestone | 1,000 | $ 1,000 | ||||
Value of PRV company is entitled to | 60% | |||||
Value of PRV liability | 40% | |||||
License and Collaborative Arrangement | Merck | Minimum | ||||||
Asset Acquisition [Line Items] | ||||||
Royalty obligation percent of annual product net sales | 10% | |||||
License and Collaborative Arrangement | Merck | Maximum | ||||||
Asset Acquisition [Line Items] | ||||||
Royalty obligation percent of annual product net sales | 12% | |||||
Ammonett | ||||||
Asset Acquisition [Line Items] | ||||||
Upfront payments | $ 3.5 | |||||
Acquisition development milestone payments | 17 | |||||
Acquisition specific milestone payments | $ 2 | $ 2 | 14 | |||
Acquisition sales milestone payments | $ 55 |
Financial Instruments - Summary
Financial Instruments - Summary of the Valuation of the Company’s Financial Instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | $ 15,857 | $ 34,741 |
Short-term investments: | 999 | |
Total | 35,740 | |
U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 999 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 15,857 | 34,741 |
Short-term investments: | 0 | |
Total | 34,741 | |
Level 1 | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Short-term investments: | 999 | |
Total | 999 | |
Level 2 | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 999 | |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 15,857 | 34,741 |
Money market funds | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 15,857 | 34,741 |
Money market funds | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | $ 0 | $ 0 |
Financial Instruments - Schedul
Financial Instruments - Schedule of Available for Sale by Security Type (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 35,740 | |
Unrealized Losses | 0 | |
Fair Value | 35,740 | |
Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 15,857 | 34,741 |
Unrealized Losses | 0 | 0 |
Fair Value | 15,857 | 34,741 |
Cash Equivalents | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 15,857 | 34,741 |
Unrealized Losses | 0 | 0 |
Fair Value | $ 15,857 | 34,741 |
Short-Term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 999 | |
Unrealized Losses | 0 | |
Fair Value | 999 | |
Short-Term Investments | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 999 | |
Unrealized Losses | 0 | |
Fair Value | $ 999 |
Accrued Expenses - Summary (Det
Accrued Expenses - Summary (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued expenses | ||
Compensation and related benefits | $ 2,507 | $ 3,472 |
Clinical and contract manufacturing expenses | 1,181 | 1,790 |
Other | 606 | 596 |
Total accrued expenses | $ 4,294 | $ 5,858 |
Stock-Based Compensation and _3
Stock-Based Compensation and Employee Benefit Plans - Narrative (Details) - USD ($) $ in Millions | 6 Months Ended | |
May 09, 2019 | Jun. 30, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Unrecognized compensation cost | $ 2.3 | |
Weighted average vesting period for non-vested option awards (in years) | 2 years 2 months 12 days | |
2009 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Plan term | 10 years | |
Evergreen increase (percent) | 3% | |
Number of shares remained available for issuance (in shares) | 688,134 | |
2010 Non-Employee Directors' Stock Option Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Number of shares remained available for issuance (in shares) | 5,624 | |
2010 Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Number of shares remained available for issuance (in shares) | 30,241 | |
2010 Employee Stock Purchase Plan | ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Increase in shares reserved for future issuance (in shares) | 60,000 |
Stock-Based Compensation and _4
Stock-Based Compensation and Employee Benefit Plans - Allocated Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 387 | $ 653 | $ 967 | $ 1,239 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | 102 | 192 | 244 | 349 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 285 | $ 461 | $ 723 | $ 890 |
Long-Term Debt and Conversion_2
Long-Term Debt and Conversion to Royalty Obligation (Details) - IDED - Loans payable - USD ($) $ in Millions | Jun. 30, 2024 | Mar. 31, 2005 |
Debt Instrument [Line Items] | ||
Loan available balance | $ 6 | |
Outstanding balance | $ 6 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | ||||
Income tax benefit | $ 0 | $ 29 | $ 0 | $ 29 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock - Net Loss Per Share Computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Net loss | $ (7,551) | $ (10,441) | $ (8,931) | $ (7,346) | $ (17,992) | $ (16,277) |
Weighted-average shares outstanding - Basic (in shares) | 8,112,566 | 8,164,603 | 8,107,528 | 8,205,625 | ||
Weighted-average shares outstanding - Diluted (in shares) | 8,112,566 | 8,164,603 | 8,107,528 | 8,205,625 | ||
Net loss per share - Basic (in dollars per share) | $ (0.93) | $ (1.09) | $ (2.22) | $ (1.98) | ||
Net loss per share - Diluted (in dollars per share) | $ (0.93) | $ (1.09) | $ (2.22) | $ (1.98) | ||
Antidilutive securities (in shares) | 1,697,956 | 1,541,956 | 1,697,956 | 1,541,956 | ||
Stock Option | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Antidilutive securities (in shares) | 1,640,843 | 1,488,088 | 1,640,843 | 1,488,088 | ||
Restricted Stock | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Antidilutive securities (in shares) | 57,113 | 53,868 | 57,113 | 53,868 |