Document Information
Document Information | 6 Months Ended |
Jun. 30, 2024 | |
Document Information: | |
Document Type | 10-Q |
Amendment | false |
CIK | 0001526119 |
Registrant Name | Verastem, Inc. |
Period End Date | Jun. 30, 2024 |
Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 07, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2024 | |
Entity File Number | 001-35403 | |
Entity Registrant Name | Verastem, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-3269467 | |
Entity Address, Address Line One | 117 Kendrick Street, Suite 500 | |
Entity Address, City or Town | Needham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02494 | |
City Area Code | 781 | |
Local Phone Number | 292-4200 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | VSTM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 40,243,745 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001526119 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 83,371 | $ 77,909 |
Short-term investments | 59,220 | |
Grant receivable | 825 | |
Accounts receivable, net | 10,000 | |
Prepaid expenses and other current assets | 5,450 | 6,553 |
Total current assets | 99,646 | 143,682 |
Property and equipment, net | 46 | 37 |
Right-of-use asset, net | 816 | 1,171 |
Restricted cash | 241 | 241 |
Other assets | 4,998 | 4,587 |
Total assets | 105,747 | 149,718 |
Current liabilities: | ||
Accounts payable | 6,678 | 7,184 |
Accrued expenses | 17,195 | 17,928 |
Note Payable | 526 | |
Deferred Liabilities | 327 | |
Lease liability, short-term | 1,022 | 941 |
Current portion of long-term debt | 4,926 | |
Total current liabilities | 30,347 | 26,380 |
Non-current liabilities: | ||
Long-term debt | 35,390 | 40,086 |
Lease liability, long-term | 530 | |
Preferred stock tranche liability | 4,189 | |
Total liabilities | 65,737 | 71,185 |
Convertible Preferred Stock: | ||
Convertible preferred stock | 21,159 | 21,159 |
Stockholders' equity: | ||
Common stock, $0.0001 par value; 300,000 shares authorized, 25,308 and 25,281 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 3 | 3 |
Additional paid-in capital | 885,857 | 882,248 |
Accumulated other comprehensive income | 13 | |
Accumulated deficit | (867,009) | (824,890) |
Total stockholders' equity | 18,851 | 57,374 |
Total liabilities, convertible preferred stock and stockholders' equity | $ 105,747 | $ 149,718 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) | Jun. 30, 2024 $ / shares shares | Dec. 31, 2023 shares |
Preferred stock, shares authorized | 5,000,000 | |
Preferred stock, shares outstanding | 1,200,000 | |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |
Common stock, shares authorized | 300,000,000 | |
Common stock, shares issued | 26,876,000 | 25,281,000 |
Common stock, shares outstanding | 26,876,000 | 25,281,000 |
Series A Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 1,000,000 | |
Preferred stock, shares outstanding | 1,000,000 | |
Series B Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |
Preferred stock, shares authorized | 2,144,000 | |
Preferred stock, shares issued | 1,200,000 | 1,200,000 |
Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |
Preferred stock, shares authorized | 5,000,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue: | ||||
Sale of COPIKTRA license and related assets | $ 10,000 | $ 10,000 | ||
Total revenue | 10,000 | 10,000 | ||
Operating expenses: | ||||
Research and development | 18,062 | $ 12,893 | 35,769 | $ 24,908 |
Selling, general and administrative | 10,215 | 7,399 | 20,567 | 14,728 |
Total operating expenses | 28,277 | 20,292 | 56,336 | 39,636 |
Loss from operations | (18,277) | (20,292) | (46,336) | (39,636) |
Other expense | (24) | (40) | (54) | (47) |
Interest income | 983 | 1,122 | 2,350 | 2,098 |
Interest expense | (1,138) | (1,121) | (2,268) | (1,890) |
Change in fair value of preferred stock tranche liability | 10,200 | (3,950) | 4,189 | (520) |
Net loss | $ (8,256) | $ (24,281) | $ (42,119) | $ (39,995) |
Net loss per share-basic | $ (0.31) | $ (1.37) | $ (1.57) | $ (2.32) |
Net loss per share-diluted | $ (0.31) | $ (1.37) | $ (1.57) | $ (2.32) |
Weighted average common shares outstanding used in computing net loss per share - basic | 26,861 | 17,732 | 26,846 | 17,231 |
Net Income (Loss) | $ (8,256) | $ (24,281) | $ (42,119) | $ (39,995) |
Unrealized gain (loss) on available-for-sale securities | 4 | (5) | (13) | 1 |
Comprehensive loss | $ (8,252) | $ (24,286) | $ (42,132) | $ (39,994) |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Paranthetical) | May 31, 2023 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |
Reverse stock split ratio | 0.083 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Preferred stock Series A Preferred Stock | Preferred stock Series B Preferred Stock | Common Stock [Member] | Additional paid-in capital | Accumulated other comprehensive income/ (loss) | Accumulated deficit | Series A Preferred Stock | Series B Preferred Stock | Total |
Balance at Dec. 31, 2022 | $ 2 | $ 784,912 | $ (737,523) | $ 47,391 | |||||
Balance (in shares) at Dec. 31, 2022 | 16,711,761 | ||||||||
Balance (in shares, preferred) at Dec. 31, 2022 | 1,000,000 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | (15,714) | (15,714) | |||||||
Unrealized gain (loss) on available-for-sale marketable securities | $ 6 | 6 | |||||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 17,658 | ||||||||
Stock-based compensation expense | 1,313 | 1,313 | |||||||
Issuance of common stock under Employee Stock Purchase Plan | 29 | 29 | |||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 6,874 | ||||||||
Issuance of Series B Convertible Preferred Stock, net of issuance costs of $1,901 and preferred stock tranche liability of $6,940 | $ 21,159 | ||||||||
Issuance of Series B Convertible Preferred Stock, net of issuance costs of $1,901 and preferred stock tranche liability of $6,940, in shares | 1,200,000 | ||||||||
Balance at Mar. 31, 2023 | $ 21,159 | $ 2 | 786,254 | 6 | (753,237) | 33,025 | |||
Balance (in shares) at Mar. 31, 2023 | 16,736,293 | ||||||||
Balance (in shares, preferred) at Mar. 31, 2023 | 1,000,000 | 1,200,000 | |||||||
Balance at Dec. 31, 2022 | $ 2 | 784,912 | (737,523) | 47,391 | |||||
Balance (in shares) at Dec. 31, 2022 | 16,711,761 | ||||||||
Balance (in shares, preferred) at Dec. 31, 2022 | 1,000,000 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | (39,995) | ||||||||
Unrealized gain (loss) on available-for-sale marketable securities | 1 | ||||||||
Balance at Jun. 30, 2023 | $ 21,159 | $ 3 | 879,105 | 1 | (777,518) | 101,591 | |||
Balance (in shares) at Jun. 30, 2023 | 25,241,878 | ||||||||
Balance (in shares, preferred) at Jun. 30, 2023 | 1,000,000 | 1,200,000 | |||||||
Balance at Mar. 31, 2023 | $ 21,159 | $ 2 | 786,254 | 6 | (753,237) | 33,025 | |||
Balance (in shares) at Mar. 31, 2023 | 16,736,293 | ||||||||
Balance (in shares, preferred) at Mar. 31, 2023 | 1,000,000 | 1,200,000 | |||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | (24,281) | (24,281) | |||||||
Unrealized gain (loss) on available-for-sale marketable securities | (5) | (5) | |||||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 16,176 | ||||||||
Stock-based compensation expense | 1,432 | 1,432 | |||||||
Issuance of common stock, and pre-funded warrants | $ 1 | 91,419 | 91,420 | ||||||
Issuance of common stock, and pre-funded warrants (in shares) | 8,489,409 | ||||||||
Balance at Jun. 30, 2023 | $ 21,159 | $ 3 | 879,105 | 1 | (777,518) | 101,591 | |||
Balance (in shares) at Jun. 30, 2023 | 25,241,878 | ||||||||
Balance (in shares, preferred) at Jun. 30, 2023 | 1,000,000 | 1,200,000 | |||||||
Balance at Dec. 31, 2023 | $ 21,159 | $ 3 | 882,248 | 13 | (824,890) | $ 57,374 | |||
Balance (in shares) at Dec. 31, 2023 | 25,281,150 | 25,281,000 | |||||||
Balance (in shares, preferred) at Dec. 31, 2023 | 1,000,000 | 1,200,000 | 1,200,000 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | (33,863) | $ (33,863) | |||||||
Unrealized gain (loss) on available-for-sale marketable securities | (17) | (17) | |||||||
Issuance of common stock resulting from exercise of stock options | 36 | 36 | |||||||
Issuance of common stock resulting from exercise of stock options (in shares) | 4,600 | ||||||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 14,444 | ||||||||
Stock-based compensation expense | 1,483 | 1,483 | |||||||
Issuance of common stock under Employee Stock Purchase Plan | 49 | 49 | |||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 7,475 | ||||||||
Balance at Mar. 31, 2024 | $ 21,159 | $ 3 | 883,816 | (4) | (858,753) | 25,062 | |||
Balance (in shares) at Mar. 31, 2024 | 25,307,669 | ||||||||
Balance (in shares, preferred) at Mar. 31, 2024 | 1,000,000 | 1,200,000 | |||||||
Balance at Dec. 31, 2023 | $ 21,159 | $ 3 | 882,248 | 13 | (824,890) | $ 57,374 | |||
Balance (in shares) at Dec. 31, 2023 | 25,281,150 | 25,281,000 | |||||||
Balance (in shares, preferred) at Dec. 31, 2023 | 1,000,000 | 1,200,000 | 1,200,000 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | $ (42,119) | ||||||||
Unrealized gain (loss) on available-for-sale marketable securities | (13) | ||||||||
Balance at Jun. 30, 2024 | $ 21,159 | $ 3 | 885,857 | (867,009) | $ 18,851 | ||||
Balance (in shares) at Jun. 30, 2024 | 26,876,234 | 26,876,000 | |||||||
Balance (in shares, preferred) at Jun. 30, 2024 | 1,000,000 | 1,200,000 | 1,000,000 | 1,200,000 | |||||
Balance at Mar. 31, 2024 | $ 21,159 | $ 3 | 883,816 | (4) | (858,753) | $ 25,062 | |||
Balance (in shares) at Mar. 31, 2024 | 25,307,669 | ||||||||
Balance (in shares, preferred) at Mar. 31, 2024 | 1,000,000 | 1,200,000 | |||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net Income (Loss) | (8,256) | (8,256) | |||||||
Unrealized gain (loss) on available-for-sale marketable securities | $ 4 | 4 | |||||||
Issuance of common stock resulting from exercise of stock options | 136 | 136 | |||||||
Issuance of common stock resulting from exercise of stock options (in shares) | 17,378 | ||||||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 12,986 | ||||||||
Stock-based compensation expense | 1,905 | 1,905 | |||||||
Issuance of common stock, and pre-funded warrants (in shares) | 1,538,201 | ||||||||
Balance at Jun. 30, 2024 | $ 21,159 | $ 3 | $ 885,857 | $ (867,009) | $ 18,851 | ||||
Balance (in shares) at Jun. 30, 2024 | 26,876,234 | 26,876,000 | |||||||
Balance (in shares, preferred) at Jun. 30, 2024 | 1,000,000 | 1,200,000 | 1,000,000 | 1,200,000 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | |
Issuance of stock costs | $ 6,351 | |
Series B Preferred Stock | ||
Issuance of stock costs | $ 1,901 | |
Preferred stock tranche liability | $ 6,940 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities | ||
Net loss | $ (42,119) | $ (39,995) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 12 | 52 |
Non-cash operating lease cost | (94) | (82) |
Stock-based compensation expense | 3,388 | 2,745 |
Amortization of deferred financing costs, debt discounts and premiums and discounts on available-for-sale marketable securities | (413) | 76 |
Change in fair value of preferred stock tranche liability | (4,189) | 520 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (10,000) | 29 |
Grant receivable | (825) | |
Prepaid expenses, other current assets and other assets | (78) | (1,508) |
Accounts payable | (506) | (422) |
Accrued expenses and other liabilities | (726) | (1,639) |
Deferred liabilities | (327) | 34 |
Net cash used in operating activities | (55,877) | (40,190) |
Investing activities | ||
Purchases of property and equipment | (28) | |
Purchases of investments | (13,804) | |
Maturities of investments | 60,000 | 27,000 |
Net cash provided by investing activities | 59,972 | 13,196 |
Financing activities | ||
Payments for loan amendment | (150) | |
Proceeds from issuance of Series B Convertible Preferred Stock, net | 28,099 | |
Proceeds from long-term debt, net | 14,918 | |
Proceeds from insurance premium financing | 1,298 | 1,430 |
Payments on insurance premium financing | (772) | (851) |
Payments of deferred issuance costs | (156) | |
Proceeds from the exercise of stock options and employee stock purchase program | 221 | 29 |
Proceeds from the issuance of common stock, net | 91,906 | |
Net cash provided by financing activities | 441 | 135,531 |
Increase in cash, cash equivalents and restricted cash | 4,536 | 108,537 |
Cash, cash equivalents and restricted cash at beginning of period | 79,076 | 75,789 |
Cash, cash equivalents and restricted cash at end of period | 83,612 | 184,326 |
Supplemental disclosure of non-cash investing and financing activities | ||
Issuance of preferred stock tranche liability | 6,940 | |
Issuance costs included in accounts payable and accrued expenses | $ 263 | $ 486 |
Nature of business
Nature of business | 6 Months Ended |
Jun. 30, 2024 | |
Nature of business | |
Nature of business | 1. Nature of business Verastem, Inc. (the “Company”) is a late-stage development biopharmaceutical company, with an ongoing registration directed trial, committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. The Company’s pipeline is focused on ras sarcoma (“RAS”)/ mitogen activated pathway kinase (“MAPK”) driven cancers, specifically novel drug candidates that inhibit signaling pathways critical to cancer cell survival and tumor growth, particularly RAF/MEK inhibition and FAK inhibition. The Company’s most advanced product candidates, avutometinib and defactinib, are being investigated in both preclinical and clinical studies for the treatment of various solid tumors, including, but not limited to low-grade serous ovarian cancer (“LGSOC”), non-small cell lung cancer (“NSCLC”), pancreatic cancer, colorectal cancer (“CRC”), and thyroid. The Company believes that avutometinib may be beneficial as a therapeutic as a single agent or when used together in combination with defactinib, other pathway inhibitors or other current and emerging standard of care treatments in cancers that do not adequately respond to currently available therapies. The condensed consolidated financial statements include the accounts of Verastem Securities Company and Verastem Europe GmbH, wholly-owned subsidiaries of the Company. All financial information presented has been consolidated and includes the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company is subject to the risks associated with other life science companies, including, but not limited to, possible failure of preclinical testing or clinical trials, competitors developing new technological innovations, inability to obtain marketing approval of the Company’s product candidates, avutometinib and defactinib, market acceptance and commercial success of the Company’s product candidates, avutometinib and defactinib, following receipt of regulatory approval, and, protection of proprietary technology and the continued ability to obtain adequate financing to fund the Company’s future operations. If the Company does not obtain marketing approval and successfully commercialize its product candidates, avutometinib and defactinib, following regulatory approval, it will be unable to generate product revenue or achieve profitability and may need to raise additional capital. As of June 30, 2024, the Company had cash, cash equivalents, and investments of $83.4 million. On July 25, 2024, the Company received net proceeds of approximately $51.1 million from the sale of 13,333,334 shares of common stock and accompanying warrants to purchase up to 13,333,334 shares of common stock and the sale of pre-funded warrants to purchase an aggregate of 5,000,000 shares of common stock and accompanying warrants to purchase up to 5,000,000 shares of common stock. Refer to Note 16. Subsequent Events The Company expects to finance its operations with its existing cash, cash equivalents and investments, through potential future milestones and royalties received pursuant to the asset purchase agreement dated August 10, 2020, between the Company and Secura (the “Secura APA”), through the loan and security agreement with Oxford Finance LLC (“Oxford”), or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, future offerings of its equity, or the incurrence of debt. However, given the risks associated with these potential strategic or financing opportunities, they are not deemed probable for purposes of the going concern assessment. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. Reverse Stock Split On May 30, 2023, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation, as amended to date, with the Secretary of State of the State of Delaware to effect a reverse stock split of the Company’s issued and outstanding common stock, par value $0.0001 at a ratio of 1-for-12 one The Company has retroactively restated the share and per share amounts in the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2023, to give retroactive effect to the Reverse Stock Split. Proportionate adjustments were made to the per share exercise price and number of shares of common stock issuable under all outstanding stock options, convertible notes and preferred stock. In addition, proportionate adjustments have been made to the number of shares of common stock issuable upon vesting of the restricted stock units and the number of shares of common stock reserved for the Company’s equity incentive compensation plans. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01 under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, or any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2024. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 14, 2024. Significant Accounting Policies No te 2 . Significant accounting policies in the Recently issued accounting standards updates In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and by extending the disclosure requirements to entities with a single reportable segment. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. ASU 2023-07 is to be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the potential impact of adopting this new guidance on the Company’s condensed consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its condensed consolidated financial statements and related disclosures. Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the condensed consolidated financial statements upon future adoption. Concentrations of credit risk and off-balance sheet risk Cash, cash equivalents, investments and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk. The Company mitigates this risk by maintaining its cash and cash equivalents and investments with high quality, accredited financial institutions. The management of the Company’s investments is not discretionary on the part of these financial institutions. As of June 30, 2024, the Company’s cash, cash equivalents and investments were deposited at four financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. As of June 30, 2024, Secura made up all of the Company’s account receivable balance. The Company assesses the creditworthiness of all its customers and sets and reassesses customer credit limits to ensure the collectability of any accounts receivable balances are assured. For the six months ended June 30, 2024, there was one customer, Secura, who individually accounted for all of the Company’s revenue. Refer to Note 13. License, collaboration and commercial agreements Proceeds from Grants In May 2022, the Company was awarded the “Therapeutic Accelerator Award” grant from Pancreatic Cancer Network (“PanCAN”) for up to $3.8 million (the “ PanCAN Grant ”). In August 2022, PanCAN agreed to provide the Company with an additional $0.5 million for the collection and analysis of patient samples. The grant is supporting a Phase 1b/2 clinical trial of GEMZAR (gemcitabine) and ABRAXANE (Nab-paclitaxel) in combination with avutometinib and defactinib entitled RAMP 205. The RAMP 205 trial is evaluating whether combining avutometinib (to target mutant Kirsten rat sarcoma viral oncogene homolog (“KRAS”), which is found in more than 90% of pancreatic adenocarcinomas, and defactinib (to reduce stromal density and adaptive resistance to avutometinib) to the standard GEMZAR/ABRAXANE regimen improves outcomes for patients with such pancreatic cancers. The Company recognizes grants as contra research and development expense in the consolidated statement of operations and comprehensive loss on a systematic basis over the periods in which the Company recognizes as expenses the related costs for which the grants are intended to compensate. Eligible expenses incurred in excess of grant payments received up to the total amount of the PanCAN Grant are recorded as a grant receivable. Through June 30, 2024, the Company has received $3.5 million of cash proceeds which was initially recorded as deferred liabilities on the balance sheet. The Company recorded $ 0.6 million and $2.0 million of the proceeds as a reduction of research and development expense during the three and six months ended June 30, 2024, respectively. As of June 30, 2024, the company recorded $0.8 million as a grant receivable related to the PanCAN Grants in the condensed consolidated balance sheet. As of December 31, 2023, the Company recorded $0.3 million as deferred liabilities related to the PanCAN Grant in the condensed consolidated balance sheet . |
Cash, cash equivalents and rest
Cash, cash equivalents and restricted cash | 6 Months Ended |
Jun. 30, 2024 | |
Cash, cash equivalents and restricted cash | |
Cash, cash equivalents and restricted cash | 3. Cash, cash equivalents and restricted cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): June 30, 2024 December 31, 2023 Cash and cash equivalents $ 83,371 $ 77,909 Restricted cash 241 1,167 Total cash, cash equivalents and restricted cash $ 83,612 $ 79,076 Amounts included in restricted cash as of June 30, 2024 is cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $0.2 million. Amounts included in restricted cash as of December 31, 2023 represent (i) cash received pursuant to the PanCAN Grant restricted for expenditures for specific research and development activities of $0.9 million and (ii) cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $0.2 million. The letters of credit are included in non-current restricted cash on the condensed consolidated balance sheets as of June 30, 2024, and December 31, 2023. Cash received pursuant to the PanCAN Grant is included in prepaid expenses and other current assets on the condensed consolidated balance sheets as of December 31, 2023. |
Fair value of financial instrum
Fair value of financial instruments | 6 Months Ended |
Jun. 30, 2024 | |
Fair value of financial instruments | |
Fair value of financial instruments | 4. Fair value of financial instruments The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 inputs Quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date. Level 2 inputs Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3 inputs Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Items Measured at Fair Value on a Recurring Basis The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands): June 30, 2024 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 75,424 $ 75,424 $ — $ — Total financial assets $ 75,424 $ 75,424 $ — $ — Preferred stock tranche liability $ — $ — $ — $ — December 31, 2023 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 46,093 $ 46,093 $ — $ — Short-term investments 59,220 5,992 53,228 — Total financial assets $ 105,313 $ 52,085 $ 53,228 $ — Preferred stock tranche liability $ 4,189 $ — $ — $ 4,189 The Company’s cash equivalents and short-term investments consist of U.S. Government money market funds, corporate bonds, agency bonds and commercial paper of publicly traded companies. The investments and cash equivalents have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2024, or December 31, 2023. A preferred stock tranche liability was recorded as a result of the entry into the Securities Purchase Agreement (defined herein) (see Note 10. Capital Stock) Below are the inputs used to value the preferred stock tranche liability at June 30, 2024, and December 31, 2023: June 30, 2024 December 31, 2023 Risk-free interest rate 5.47 % 5.13 5.52 % Volatility 90 % 75 % Dividend yield — — Remaining term (years) 0.1 0.6 The following table represents a reconciliation of the preferred stock right liability recorded in connection with the entry into the Securities Purchase Agreement (in thousands): January 1, 2024 $ 4,189 Fair value adjustment (4,189) June 30, 2024 $ — Fair Value of Financial Instruments The fair value of the Company’s long-term debt was determined using a discounted cash flow analysis with current applicable rates for similar instruments as of the condensed consolidated balance sheet dates. The Company estimates that the fair value of its long-term debt was approximately $40.1 million as of June 30, 2024, which differs from the carrying value of $40.3 million. The Company estimates that the fair value of its long-term debt was approximately $39.6 million as of December 31, 2023, which differs from the carrying value of $ 40.1 million. The fair value of the Company’s long-term debt was determined using Level 3 inputs. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2024 | |
Investments | |
Investments | 5. Investments Cash, cash equivalents, restricted cash and investments consist of the following (in thousands): June 30, 2024 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 83,612 $ — $ — $ 83,612 Total cash, cash equivalents & restricted cash: $ 83,612 $ — $ — $ 83,612 December 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 79,076 $ — $ — $ 79,076 Total cash, cash equivalents & restricted cash: $ 79,076 $ — $ — $ 79,076 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 59,208 $ 13 (1) $ 59,220 Total investments $ 59,208 $ 13 $ (1) $ 59,220 Total cash, cash equivalents, restricted cash and investments $ 138,284 $ 13 $ (1) $ 138,296 There were no realized gains or losses on investments for the three or six months ended June 30, 2024, or 2023. Accrued interest receivable is excluded from the amortized cost and estimated fair value of the Company's investments. Accrued interest receivable of $0.1 million is presented within prepaid expenses and other current assets on the condensed consolidated balance sheets at each June 30, 2024 and December 31, 2023. There were zero and two debt securities in an unrealized loss position as of June 30, 2024, and December 31, 2023, respectively. None of these investments had been in an unrealized loss position for more than 12 months as of December 31, 2023. The Company considered the decline in the market value for these securities to be primarily attributable to current economic conditions and not credit related. At December 31, 2023, the Company had the intent and ability to hold such securities until recovery. As a result, the Company did not record any charges for credit-related impairments for its investments as of December 31, 2023. The following is a summary of available-for-sale securities with unrealized losses for less than 12 months as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Fair Unrealized Fair Unrealized Value Losses Value Losses Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ — $ — $ 8,896 $ (1) Total available-for-sale securities in an unrealized loss position $ — $ — $ 8,896 $ (1) |
Accrued expenses
Accrued expenses | 6 Months Ended |
Jun. 30, 2024 | |
Accrued expenses | |
Accrued expenses | 6. Accrued expenses Accrued expenses consist of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical trial expenses $ 7,608 $ 6,518 Accrued contract manufacturing expenses 2,760 2,010 Accrued other research and development expenses 1,184 1,043 Accrued compensation and related benefits 3,089 4,796 Accrued professional fees 547 637 Accrued consulting fees 1,202 1,078 Accrued interest 306 316 Accrued commercialization costs 362 453 Accrued other 137 1,077 Total accrued expenses $ 17,195 $ 17,928 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Long-term debt | |
Debt | 7. Debt On March 25, 2022 (the “Closing Date”), the Company entered into a loan and security agreement (the “Original Loan Agreement”) with Oxford, as collateral agent and a lender, and Oxford Finance Credit Fund III LP, as a lender (“OFCF III” and together with Oxford, the “Lenders”), pursuant to which the Lenders have agreed to lend the Company up to an aggregate principal amount of $150.0 million in a series of term loans (the “Term Loans”). On January 4, 2024, the Company amended the Original Loan Agreement (as amended, the “Loan Agreement”) to extend the date by which it may draw down the Term C Loan from March 31, 2024, to March 31, 2025. Pursuant to the Loan Agreement, the Company received an initial Term Loan of $25.0 million on the Closing Date, and drew down the second term loan of $15.0 million (the “Term B Loan”) on March 22, 2023, and may borrow an additional $110.0 million of Term Loans at its option upon the satisfaction of certain conditions as follows: i. $25.0 million (the “Term C Loan”), when the Company has received accelerated or full approval from the FDA of avutometinib for the treatment of LGSOC (the “Term C Milestone”). The Company may draw the Term C Loan within 60 days after the occurrence of the Term C Milestone, but no later than March 31, 2025. ii. $35.0 million (the “Term D Loan”), when the Company has achieved at least $50.0 million in gross product revenue calculated on a trailing six-month basis (the “Term D Milestone”). The Company may draw the Term D Loan within 30 days after the occurrence of the Term D Milestone, but no later than March 31, 2025. iii. $50.0 million (the “Term E Loan”), at the sole discretion of the Lenders. The Term Loans bear interest at a floating rate equal to (a) the greater of (i) the one-month CME Secured Overnight Financing Rate and (ii) 0.13% plus (b) 7.37% , which is subject to an overall floor and cap. Interest is payable monthly in arrears on the first calendar day of each calendar month. As a result of the Term B Loan drawdown, beginning (i) April 1, 2025, or (ii) April 1, 2026, if either (A) as received FDA approval for the treatment of LGSOC or (B) COPIKTRA has received FDA approval for the treatment of peripheral T-cell lymphoma, the Company shall repay the Term Loans in consecutive equal monthly payments of principal, together with applicable interest, in arrears. All unpaid principal and accrued and unpaid interest with respect to each Term Loan is due and payable in full on March 1, 2027. The Company is required to make a final payment of 5.0% of the original principal amount of the Term Loans that are drawn, payable at maturity or upon any earlier acceleration or prepayment of the Term Loans (the “Final Payment Fee”). The Company may prepay all, but not less than all, of the Term Loans, subject to a prepayment fee equal to (i) 3.0% of the principal amount of the applicable Term Loan if prepaid on or before the first anniversary date of the funding date of such Term Loan, (ii) 2.0% of the principal amount of the applicable Term Loan if prepaid after the first anniversary and on or before the second anniversary of the funding date of such Term Loan, and (iii) 1.0% of the principal amount of the applicable Term Loan if prepaid after the second anniversary of the applicable funding date of such Term Loan. All Term Loans are subject to a facility fee of 0.5% of the principal amount. The Loan Agreement contains no financial covenants. The Loan Agreement includes customary events of default, including, among others, payment defaults, breach of representations and warrants, covenant defaults, judgment defaults, insolvency and bankruptcy defaults, and a material adverse change. The occurrence of an event of default could result in the acceleration of the obligations under the Loan Agreement, termination of the Term Loan commitments and the right to foreclose on the collateral securing the obligations. During the existence of an event of default, the Term Loans will accrue interest at a rate per annum equal to 5.0% above the otherwise applicable interest rate. In connection with the Loan Agreement, the Company granted Oxford a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property (but including the right to payments and proceeds of intellectual property), and a negative pledge on intellectual property. The Company assessed all terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the Loan Agreement, including put and call features. The Company determined that all features of the Loan Agreement were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. There have been no changes to the Company assessment through June 30, 2024. The debt issuance costs and the Final Payment Fee have been recorded as a debt discount which are being accreted to interest expense through the maturity date of the Term Loan using the effective interest method . June 30, 2024 December 31, 2023 Principal loan balance $ 40,000 $ 40,000 Final Payment Fee 907 661 Debt issuance costs, net of accretion (591) (575) Total Long-term debt, net of discount 40,316 40,086 Current portion of long-term debt 4,926 — Long-term debt, net of current portion $ 35,390 $ 40,086 The following table sets forth total interest expense for the three-month and six-month periods ended June 30, 2024 and 2023 (in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Contractual Interest $ 945 $ 949 $ 1,889 $ 1,581 Amortization of debt discount and issuance costs 68 57 133 115 Amortization of Final Payment Fee 125 115 246 194 Total $ 1,138 $ 1,121 $ 2,268 $ 1,890 As of June 30, 2024, future principal payments due are as follows (in thousands): 2024 — 2025 15,000 2026 20,000 2027 5,000 Total principal payments $ 40,000 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases | |
Leases | 8. Leases On April 15, 2014, the Company entered into a lease agreement for approximately 15,197 square feet of office and laboratory space in Needham, Massachusetts. Effective February 15, 2018, the Company amended its lease agreement to relocate within the facility to another location consisting of 27,810 square feet of office space (the “Amended Lease Agreement”). The Amended Lease Agreement extends the expiration date of the lease from September 2019 through June 2025. Pursuant to the Amended Lease Agreement, the initial annual base rent amount is approximately $0.7 million, which increases during the lease term to $1.1 million for the last twelve-month period. The Company accounted for its Needham, Massachusetts office space as an operating lease. The Company’s lease contains an option to renew and extend the lease terms and an option to terminate the lease prior to the expiration date. The Company has not included the lease extension or the termination options within the right-of-use asset and lease liability on the condensed consolidated balance sheets as neither option is reasonably certain to be exercised. The Company’s lease includes variable non-lease components (e.g., common area maintenance, maintenance, consumables, etc.) that are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. The Company does not have any other operating or finance leases. As of June 30, 2024, a right-of-use asset of $0.8 million and lease liability of $1.0 million are reflected on the condensed consolidated balance sheets. The elements of lease expense were as follows (dollar amounts in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Lease Expense Operating lease expense $ 221 $ 221 $ 442 $ 442 Total Lease Expense $ 221 $ 221 $ 442 $ 442 Other Information - Operating Leases Operating cash flows paid for amounts included in measurement of lease liabilities $ 268 $ 262 $ 535 $ 525 June 30, 2024 Other Balance Sheet Information - Operating Leases Weighted average remaining lease term (in years) 1.0 Weighted average discount rate 14.6% Maturity Analysis 2024 546 2025 546 Total $ 1,092 Less: Present value discount (70) Lease Liability $ 1,022 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2024 | |
Notes Payable [Abstract] | |
Notes Payable | 9. Notes Payable |
Capital stock
Capital stock | 6 Months Ended |
Jun. 30, 2024 | |
Capital stock | |
Capital stock | 10. Capital stock June 2023 Public Offering On June 15, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets, LLC and Cantor Fitzgerald & Co. (“Cantor”), as representatives of several underwriters (the “Underwriters”) to offer 7,181,409 shares of the Company’s common stock, at a price to the public of $9.75 per share, less the underwriting discounts and commissions, and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 1,538,591 shares of common stock at a price to the public of $9.749 per share of common stock underlying a pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $0.001 per share exercise price for each such share of common stock underlying a pre-funded warrant (the “June 2023 Offering”). In addition, the Company granted the Underwriters an option to purchase, at the public offering price less any underwriting discounts and commissions, an additional 1,308,000 shares of common stock, exercisable for 30 days from the date of the Underwriting Agreement, which the Underwriters exercised in full on June 16, 2023. The June 2023 Offering closed on June 21, 2023. The Company could not have effected the exercise of any pre-funded warrant, and a holder was not entitled to exercise any portion of any pre-funded warrant if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) would have exceeded 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage could have been increased or decreased at the holder’s election upon 61 days ’ notice to the Company subject to the terms of such pre-funded warrant, provided that such percentage in no event exceeded 19.99% . Each pre-funded warrant had an exercise price equal to $0.001 per share of common stock. The exercise price and the number of shares of common stock issuable upon exercise of each pre-funded warrant was subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Company’s common stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The pre-funded warrants were exercisable as of June 21, 2023, did not expire and were exercisable in cash or by means of a cashless exercise. In addition, upon the consummation of an acquisition (as described in the pre-funded warrant agreements), each pre-funded warrant would have automatically been converted into the right of the holder of such pre-funded warrant to receive the kind and amount of securities, cash or other property that such holders would have received had they exercised such pre-funded warrant immediately prior to such acquisition, without regard to any limitations on exercise contained in the pre-funded warrants. The pre-funded warrants could not have required cash settlement, were freestanding financial instruments that were legally detachable and separately exercisable from the shares of common stock with which they were issued, were immediately exercisable, and did not embody an obligation for the Company to repurchase its common stock shares and permitted the holders to receive a fixed number of shares of common stock upon exercise. Additionally, the pre-funded warrants did not provide any guarantee of value or return. Accordingly, the pre-funded warrants were classified as a component of permanent equity. After deducting for commissions and other offering expenses, the Company received net proceeds of approximately $91.4 million from the sale of 8,489,409 shares of common stock and pre-funded warrants to purchase up to 1,538,591 shares of common stock. During the quarter ended June 30, 2024, the holders exercised pre-funded warrants representing 1,538,591 underlying shares of common stock, exercise price $0.0001 per share, via cashless exercise resulting in the issuance of 1,538,201 shares of common stock. As of June 30, 2024, there were no pre-funded warrants outstanding. Series B Convertible Preferred Stock Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by the stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding. On January 24, 2023, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain purchasers pursuant to which the Company agreed to sell and issue to the purchasers in a private placement (the “Private Placement”) up to 2,144,160 shares of its Series B convertible preferred stock, par value $0.0001 per share (the “Series B Convertible Preferred Stock”), in two tranches. On January 24, 2023, the Company filed the Certificate of Designation of the Preferences, Rights and Limitations of the Series B Convertible Preferred Stock (the “Series B Convertible Preferred Stock Certificate of Designation”) setting forth the preferences, rights and limitations of the Series B Convertible Preferred Stock with the Secretary of State of the State of Delaware. The Series B Convertible Preferred Stock Certificate of Designation became effective upon filing. Each share of the Series B Convertible Preferred Shares is convertible into 3.5305 shares of the Company’s common stock, such conversion rate reflects an adjustment to account for the Reverse Stock Split, at the option of the holders at any time, subject to certain limitations, including that the holder will be prohibited from converting Series B Convertible Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above a conversion blocker, which is initially set at 9.99% (the “Conversion Blocker”) of the total common stock then issued and outstanding immediately following the conversion of such shares of Series B Convertible Preferred Stock. Holders of the Series B Convertible Preferred Stock are permitted to increase the Conversion Blocker to an amount not to exceed 19.99% upon 60 days ’ notice. The Company agreed to sell and issue in the first tranche of the Private Placement 1,200,000 shares of Series B Convertible Preferred Stock at a purchase price of $25.00 per share of Series B Convertible Preferred Stock (equivalent to $7.0812 per share of common stock on a post-Reverse Stock Split basis). The first tranche of the Private Placement closed on January 27, 2023. The Company received gross proceeds from the first tranche of the Private Placement of approximately $30.0 million, before deducting fees to the placement agent and other offering expenses payable by the Company (“Series B Convertible Preferred Stock Proceeds”). In addition, the Company agreed to sell and issue in the second tranche of the Private Placement 944,160 shares of Series B Convertible Preferred Stock at a purchase price of $31.77 per share of Series B Convertible Preferred Stock (equivalent to $9.00 per share of common stock on a post-Reverse Stock Split basis) if at any time within 18 months following the closing of the first tranche the 10-day volume weighted average price of the Company’s common stock (as quoted on Nasdaq and as calculated by Bloomberg) should reach at least $13.50 per share, such threshold reflects an adjustment to account for the Reverse Stock Split (which may be further adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as needed) with aggregate trading volume during the same 10-day period of at least $25 million (the “Second Tranche Right”). The second tranche of the Private Placement is expected to close within seven trading days of meeting the second tranche conditions and will be subject to additional, customary closing conditions. If the Second Tranche Right conditions are satisfied, the Company anticipates receiving gross proceeds from the second tranche of the Private Placement of approximately $30.0 million, before deducting fees to the placement agent and other offering expenses payable by the Company. The Series B Convertible Preferred Stock ranks (i) senior to the common stock; (ii) senior to all other classes and series of equity securities of the Company that by their terms do not rank senior to the Series B Convertible Preferred Stock; (iii) senior to all shares of the Company’s Series A Convertible Preferred Stock the equity securities described in (i)-(iii), the “Junior Stock”); (iv) on parity with any class or series of capital stock of the Company hereafter created specifically ranking by its terms on parity with the Series B Convertible Preferred Stock (the “Parity Stock”); (v) junior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms senior to any Series B Convertible Preferred Stock (“Senior Stock”); and (vi) junior to all of the Company’s existing and future debt obligations, including convertible or exchangeable debt securities, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily and as to the right to receive dividends. In the event of the liquidation, dissolution or winding up of the affairs of the Company, whether voluntary or involuntary, after payment or provision for payment of the debts and other liabilities of the Company, and subject to the prior and superior rights of any Senior Stock, each holder of shares of Series B Convertible Preferred Stock will be entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of the common stock and any of the Company’s securities that are Junior Stock and pari passu with any distribution to the holders of any Parity Stock, an amount equal to $1.00 per share of Series B Convertible Preferred Stock, plus an additional amount equal to any dividends declared but unpaid on such shares, before any payments shall be made or any assets distributed to holders of the common stock or any of our securities that Junior Stock. So long as any shares of the Series B Convertible Preferred Stock remain outstanding, the Company cannot without the affirmative vote or consent of the holders of majority of the shares of the Series B Convertible Preferred Stock then-outstanding, in which the holders of the Series B Convertible Preferred Stock vote separately as a class: (a) amend, alter, modify or repeal (whether by merger, consolidation or otherwise) the Series B Convertible Preferred Stock Certificate of Designation, the Company’s certificate of incorporation, or the Company’s bylaws in any manner that adversely affects the rights, preferences, privileges or the restrictions provided for the benefit of, the Series B Convertible Preferred Stock; (b) issue further shares of Series B Convertible Preferred Stock or increase or decrease (other than by conversion) the number of authorized shares of Series B Convertible Preferred Stock; (c) authorize or issue any Senior Stock; or (d) enter into any agreement to do any of the foregoing that is not expressly made conditional on obtaining the affirmative vote or written consent of the majority of then-outstanding Series B Convertible Preferred Stock. Holders of Series B Convertible Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis. Shares of Series B Convertible Preferred Stock are otherwise not entitled to dividends. The Company classified the first tranche of the Series B Convertible Preferred Stock as temporary equity in the condensed consolidated balance sheets as the Company could be required to redeem the Series B Convertible Preferred Stock if the Company cannot convert the Series B Convertible Preferred Stock into shares of common stock for any reason including due to any applicable laws or by the rules or regulations of any stock exchange, interdealer quotation system, or other self-regulatory organization with jurisdiction over the Company which is not solely in the control of the Company. If the Company were required to redeem the Series B Convertible Preferred Stock, it would be based upon the volume-weighted-average price of common stock on an as converted basis on the date the holders provided a conversion notice to the Company. As of June 30, 2024, the Company did not adjust the carrying value of the Series B Convertible Preferred Stock since it was not probable the holders would be unable to convert the Series B Convertible Preferred Stock into shares of common stock due to any reason including due to any applicable laws or by the rules or regulations of any stock exchange, interdealer quotation system, or other self-regulatory organization with jurisdiction over the Company. The Company evaluated the Second Tranche Right under Accounting Standard Codification 480, Distinguishing Liabilities from Equity The Company determined that all other features of the securities offered pursuant to the Securities Purchase Agreement were clearly and closely associated with the equity host and did not require bifurcation or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. There have been no changes to the Company’s original assessment through June 30, 2024. Series A Convertible Preferred Stock On November 4, 2022, the Company e ntered into an exchange agreement (the “Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS LP and MSI BVF SPV, LLC (collectively referred to as “BVF”), pursuant to which BVF exchanged 833,333 shares of the Company’s common stock for 1,000,000 shares of newly designated Series A convertible preferred stock, par value $0.0001 per share (the “Series A Convertible Preferred Stock”) (the “Exchange”). Each share of the Series A Convertible Preferred Stock is convertible into 0.833 shares of the Company’s common stock at the option of the holder at any time, subject to certain limitations, including that the holder will be prohibited from converting Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above the Conversion Blocker, initially set at 9.99% , of the total common stock then issued and outstanding immediately following the conversion of such shares of Preferred Stock. Holders of the Series A Convertible Preferred Stock are permitted to increase the Conversion Blocker to an amount not to exceed 19.99% upon 60 days ’ notice. Shares of Series A Convertible Preferred Stock generally have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Series A Convertible Preferred Stock will be required to amend the terms of the Series A Convertible Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Convertible Preferred Stock will participate pari passu with any distribution of proceeds to holders of common stock. Holders of Series A Convertible Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis. Shares of Series A Convertible Preferred Stock are otherwise not entitled to dividends. The Series A Convertible Preferred Stock (i) senior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms junior to the Series A Convertible Preferred Stock; (ii) on parity with the common stock and any class or series of capital stock of the Company created specifically ranking by its terms on parity with the Series A Convertible Preferred Stock; and (iii) junior to the Series B Convertible Preferred Stock and to any class or series of capital stock of the Company created specifically ranking by its terms senior to any Series A Convertible Preferred Stock, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily. The Company evaluated the Series A Convertible Preferred Stock for liability or equity classification under ASC 480, and determined that equity treatment was appropriate because the Series A Convertible Preferred Stock did not meet the definition of the liability under ASC 480. Additionally, the Series A Convertible Preferred Stock is not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, or (iii) upon the occurrence of an event that is not solely within control of the Company. As such, the Company recorded the Series A Convertible Preferred Stock as permanent equity. |
Stock-based compensation
Stock-based compensation | 6 Months Ended |
Jun. 30, 2024 | |
Stock-based compensation | |
Stock-based compensation | 11. Stock-based compensation Option Exchange Program On January 17, 2024, the Company’s stockholders, upon recommendation of the board of directors, approved a one-time stock option exchange program (the “Option Exchange Program”) for certain employees, executive officers and non-employee directors of the Company who held certain underwater options and remained employed or otherwise engaged by the Company through the completion of the Exchange Offer. The Company’s offer to participate in the Option Exchange Program commenced on February 8, 2024, and expired on March 8, 2024 (the “Exchange Offer”). Pursuant to the Exchange Offer, 42 eligible holders elected to exchange, and the Company accepted for cancellation, eligible options to purchase an aggregate of 603,330 shares of the Company’s common stock (the “Exchanged Options”). On March 11, 2024, promptly following the expiration of the Exchange Offer, the Company granted new options to purchase 603,330 shares of common stock (the “New Options”), pursuant to the terms of the Exchange Offer and the Amended and Restated 2021 Equity Incentive Plan (the “2021 Plan”). The exercise price of the New Options granted was $11.44 per share, which was the closing price of the Company’s common stock on the Nasdaq Capital Market on the grant date of the New Options. The exchange of stock options was treated as a modification for accounting purposes. As a result of the Option Exchange Program, the Company will recognize incremental stock-based compensation expense of $1.7 million over the requisite service period of the New Options, which is two or four years depending on whether the Exchanged Options were vested at the time of exchange. Since the Exchanged Options were not at-the-money on the modification date, the Company was precluded from utilizing the simplified method as described in SEC Staff Accounting Bulletin Topic 14.D.2 to calculate the expected term as a key assumption in the Black-Scholes pricing model. Therefore, the Company utilized the binomial lattice model to calculate the fair value of the Exchanged Options immediately prior to the exchange. The Company utilized the Black-Scholes option-pricing model to calculate the fair value of the New Options on the modification date. The Company will recognize the remaining unamortized stock compensation expense for the Exchanged Options on the modification date over the original requisite service period of the Exchanged Options. Stock options A summary of the Company’s stock option activity and related information for the six months ended June 30, 2024 is as follows: Shares Weighted-average exercise price per share Weighted-average remaining contractual term (years) Aggregate intrinsic value (in thousands) Outstanding at December 31, 2023 2,270,359 $ 19.81 7.8 $ 559 Granted 179,251 6.07 Exercised (21,978) 7.84 Forfeited/cancelled (184,122) 15.41 Expired (23,677) 162.38 Cancelled under the Option Exchange Program (603,330) 30.58 Granted under the Option Exchange Program 603,330 11.44 Outstanding at June 30, 2024 2,219,833 $ 12.46 8.6 $ — Vested at June 30, 2024 594,357 $ 19.22 7.2 $ — The fair value of each stock option granted during the six months ended June 30, 2024 and 2023 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions: Six months ended June 30, 2024 2023 Risk-free interest rate 4.11 % 3.56 % Volatility 97 % 90 % Dividend yield — — Expected term (years) 5.8 6.1 Restricted stock units A summary of the Company’s restricted stock unit activity and related information for the six months ended June 30, 2024 is as follows: Shares Weighted-average grant date fair value per share Outstanding at December 31, 2023 209,289 $ 18.05 Granted 950,371 $ 5.07 Vested (33,511) $ 21.66 Forfeited/cancelled (28,127) $ 16.80 Outstanding at June 30, 2024 1,098,022 $ 6.74 Employee stock purchase plan Six months ended June 30, 2024 2023 Risk-free interest rate 5.24 % 4.77 % Volatility 60 % 106 % Dividend yield — — Expected term (years) 0.5 0.5 |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2024 | |
Net loss per share | |
Net loss per share | 12. Net loss per share Basic loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period. For purposes of calculating net loss per share, weighted-average number of common shares outstanding includes the weighted average effect of the pre-funded warrants issued in June 2023, the exercise of which required little or no consideration for the delivery of shares of common stock. Diluted net loss per common share is calculated by increasing the denominator by the weighted-average number of additional shares that could have been outstanding from securities convertible into common stock, such as stock options, restricted stock units, and employee stock purchase plan shares (using the “treasury stock” method), and the 5.00% Convertible Senior Notes due 2048 (the “ The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Outstanding stock options 2,219,833 2,007,023 2,219,833 2,007,023 Outstanding restricted stock units 1,098,022 142,333 1,098,022 142,333 2018 Notes — 3,489 — 3,489 Employee stock purchase plan 7,756 7,396 7,756 7,396 Series A Convertible Preferred Stock 833,333 833,333 833,333 833,333 Series B Convertible Preferred Stock 4,236,570 4,236,570 4,236,570 4,236,570 Total potentially dilutive securities 8,395,514 7,230,144 8,395,514 7,230,144 |
License, collaboration and comm
License, collaboration and commercial agreements | 6 Months Ended |
Jun. 30, 2023 | |
License, collaboration and commercial agreements | |
License, collaboration and commercial agreements | 13. License, collaboration and commercial agreements Secura On August 10, 2020, the Company and Secura signed the Secura APA and on September 30, 2020, the transaction closed. Pursuant to the Secura APA, the Company sold to Secura its exclusive worldwide license, including related assets, for the research, development, commercialization, and manufacture in oncology indications of products containing duvelisib. The sale included certain intellectual property related to duvelisib in oncology indications, certain existing duvelisib inventory, claims and rights under certain contracts pertaining to duvelisib. Pursuant to the Secura APA, Secura assumed all operational and financial responsibility for activities that were part of the Company’s duvelisib oncology program, including all commercialization efforts related to duvelisib in the United States and Europe, as well as the Company’s ongoing duvelisib clinical trials. Further, Secura assumed all obligations with existing collaboration partners developing and commercializing duvelisib, which include Yakult Honsha Co., Ltd. (“Yakult”), CSPC Pharmaceutical Group Limited (“CSPC”), and Sanofi. Additionally, Secura assumed all royalty payment obligations due under the amended and restated license agreement with Infinity Pharmaceuticals, Inc. Pursuant to the terms of the Secura APA, Secura has paid the Company an up-front payment of $70.0 million in September 2020 and has agreed to pay the Company (i) regulatory milestone payments up to $45.0 million, consisting of a payment of $35.0 million upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma and a payment of $10.0 million upon receipt of the first regulatory approval for the commercial sale of COPIKTRA in the European Union for the treatment of peripheral T-cell lymphoma, (ii) sales milestone payments of up to $50.0 million, consisting of $10.0 million when total worldwide net sales of COPIKTRA exceed $100.0 million, $15.0 million when total worldwide net sales of COPIKTRA exceed $200.0 million and $25.0 million when total worldwide net sales of COPIKTRA exceed $300.0 million, (iii) low double-digit royalties on the annual aggregate net sales above $100.0 million in the United States, European Union, and the United Kingdom of Great Britain and Northern Ireland and (iv) 50% of all royalty, milestone and sublicense revenue payments payable to Secura under the Company’s existing license agreements with Sanofi, Yakult, and CSPC, and 50% of all royalty and milestone payments payable to Secura under any license or sublicense agreement entered into by Secura in certain jurisdictions. The Company evaluated the Secura APA in accordance with ASC 606 as the Company concluded that the counterparty, Secura, is a customer. The Company identified a bundled performance obligation consisting of delivery of the duvelisib global license and intellectual property, certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approvals, and certain regulatory documentation and books and records (the “Bundled Secura Performance Obligation”). The Company concluded that the duvelisib global license and intellectual property were not distinct within the context of the contract (i.e. separately identifiable) because the other assets including certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approval, and certain regulatory documentation and books and records do not have stand-alone value from other duvelisib global license and intellectual property and Secura could not benefit from them without the duvelisib global license and intellectual property. Consistent with the guidance under ASC 606-10-25-16A, the Company disregarded immaterial promised goods and services when determining performance obligations. The Company has determined that the upfront payment of $70.0 million, future potential milestone payments and royalties including from Secura’s sublicensees should be allocated to the delivery of the Bundled Secura Performance Obligation. During the three and six months ended June 30, 2024, Secura achieved $100.0 million of total worldwide net sales of COPIKTRA which triggered a $10.0 million sales milestone payment to the Company under the Secura APA. The Company recognized $10.0 million of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss for the three and six months ended June 30, 2024. The Company determined all other future potential milestones and royalties were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of June 30, 2024. As part of the Company’s evaluation of the constraint, the Company considered several factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors included: the likelihood and magnitude of revenue reversals related to future milestones, the amount of variable consideration that is highly susceptible to factors outside of the Company’s influence and the uncertainty about the consideration is not expected to be resolved for an extended period of time. All future potential milestone payments were fully constrained as the risk of significant revenue reversal related to these amounts has not yet been resolved. The Company received the $10.0 million milestone payment in July 2024. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income taxes | |
Income taxes | 14. Income taxes |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and contingencies | |
Commitments and contingencies | 15. Commitments and contingencies The Company has no other commitments other than minimum lease payments as disclosed in Note 8 Leases. |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent events. | |
Subsequent events | 16. Subsequent events The Company reviews all activity subsequent to the end of the quarter but prior to issuance of the condensed consolidated financial statements for events that could require disclosure or that could impact the carrying value of assets or liabilities as of the balance sheet date. The Company is not aware of any material subsequent events other the following: July 2024 Public Offering On June 23, 2024, the Company entered into an underwriting agreement with Guggenheim Securities, LLC and Cantor, as representatives of several underwriters to offer 13,333,334 shares of the Company’s common stock and accompanying warrants to purchase up to 13,333,334 shares of its common stock at a combined offering price to the public of $3.00 per share and accompanying warrant. In lieu of common stock to certain investors, the Company offered pre-funded warrants to purchase up to an aggregate of 5,000,000 shares of its common stock and accompanying warrants to purchase up to 5,000,000 shares of its common stock at a combined offering price to the public of $2.999 per share of common stock underlying a pre-funded warrant and accompanying warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such share of common stock underlying the pre-funded warrants (the offering shares of common stock, pre-funded warrants, collectively, the “July 2024 Offering”). The pre-funded warrants do not expire. The warrants have an exercise price of $3.50 per share, are exercisable immediately and expire 18 months from the date of issuance. The warrants are exercisable, at the option of each holder, in whole or in part by delivering a duly executed exercise notice and by payment in full of the exercise price for the number of shares of common stock purchased upon such exercise. Cashless exercise of the warrants are limited to certain circumstances as defined within the warrant. The net proceeds from the offering, after deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $51.1 million. The offering closed on July 25, 2024. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ 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 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (8,256) | $ (33,863) | $ (24,281) | $ (15,714) | $ (42,119) | $ (39,995) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 6 Months Ended | 9 Months Ended |
Jun. 30, 2024 | Sep. 30, 2023 | |
Summary of significant accounting policies | ||
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01 under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, or any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2024. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 14, 2024. | |
Significant Accounting Policies | Significant Accounting Policies No te 2 . Significant accounting policies in the | |
Recently issued accounting standards updates | Recently issued accounting standards updates In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and by extending the disclosure requirements to entities with a single reportable segment. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. ASU 2023-07 is to be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the potential impact of adopting this new guidance on the Company’s condensed consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its condensed consolidated financial statements and related disclosures. Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the condensed consolidated financial statements upon future adoption. | |
Concentrations of credit risk and off-balance sheet risk | Concentrations of credit risk and off-balance sheet risk Cash, cash equivalents, investments and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk. The Company mitigates this risk by maintaining its cash and cash equivalents and investments with high quality, accredited financial institutions. The management of the Company’s investments is not discretionary on the part of these financial institutions. As of June 30, 2024, the Company’s cash, cash equivalents and investments were deposited at four financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. | |
Proceeds from Grants | Proceeds from Grants In May 2022, the Company was awarded the “Therapeutic Accelerator Award” grant from Pancreatic Cancer Network (“PanCAN”) for up to $3.8 million (the “ PanCAN Grant ”). In August 2022, PanCAN agreed to provide the Company with an additional $0.5 million for the collection and analysis of patient samples. The grant is supporting a Phase 1b/2 clinical trial of GEMZAR (gemcitabine) and ABRAXANE (Nab-paclitaxel) in combination with avutometinib and defactinib entitled RAMP 205. The RAMP 205 trial is evaluating whether combining avutometinib (to target mutant Kirsten rat sarcoma viral oncogene homolog (“KRAS”), which is found in more than 90% of pancreatic adenocarcinomas, and defactinib (to reduce stromal density and adaptive resistance to avutometinib) to the standard GEMZAR/ABRAXANE regimen improves outcomes for patients with such pancreatic cancers. The Company recognizes grants as contra research and development expense in the consolidated statement of operations and comprehensive loss on a systematic basis over the periods in which the Company recognizes as expenses the related costs for which the grants are intended to compensate. Eligible expenses incurred in excess of grant payments received up to the total amount of the PanCAN Grant are recorded as a grant receivable. Through June 30, 2024, the Company has received $3.5 million of cash proceeds which was initially recorded as deferred liabilities on the balance sheet. The Company recorded $ 0.6 million and $2.0 million of the proceeds as a reduction of research and development expense during the three and six months ended June 30, 2024, respectively. As of June 30, 2024, the company recorded $0.8 million as a grant receivable related to the PanCAN Grants in the condensed consolidated balance sheet. As of December 31, 2023, the Company recorded $0.3 million as deferred liabilities related to the PanCAN Grant in the condensed consolidated balance sheet . |
Cash, cash equivalents and re_2
Cash, cash equivalents and restricted cash (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Cash, cash equivalents and restricted cash | |
Schedule of reconciliation of cash, cash equivalents and restricted cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): June 30, 2024 December 31, 2023 Cash and cash equivalents $ 83,371 $ 77,909 Restricted cash 241 1,167 Total cash, cash equivalents and restricted cash $ 83,612 $ 79,076 |
Fair value of financial instr_2
Fair value of financial instruments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair value of financial instruments | |
Schedule of financial instruments measured at fair value on a recurring basis | The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands): June 30, 2024 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 75,424 $ 75,424 $ — $ — Total financial assets $ 75,424 $ 75,424 $ — $ — Preferred stock tranche liability $ — $ — $ — $ — December 31, 2023 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 46,093 $ 46,093 $ — $ — Short-term investments 59,220 5,992 53,228 — Total financial assets $ 105,313 $ 52,085 $ 53,228 $ — Preferred stock tranche liability $ 4,189 $ — $ — $ 4,189 |
Schedule of inputs used to value the preferred stock tranche liability | June 30, 2024 December 31, 2023 Risk-free interest rate 5.47 % 5.13 5.52 % Volatility 90 % 75 % Dividend yield — — Remaining term (years) 0.1 0.6 |
Schedule of reconciliation of the preferred stock right liability | January 1, 2024 $ 4,189 Fair value adjustment (4,189) June 30, 2024 $ — |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments | |
Schedule of cash, cash equivalents and investments | Cash, cash equivalents, restricted cash and investments consist of the following (in thousands): June 30, 2024 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 83,612 $ — $ — $ 83,612 Total cash, cash equivalents & restricted cash: $ 83,612 $ — $ — $ 83,612 December 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 79,076 $ — $ — $ 79,076 Total cash, cash equivalents & restricted cash: $ 79,076 $ — $ — $ 79,076 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 59,208 $ 13 (1) $ 59,220 Total investments $ 59,208 $ 13 $ (1) $ 59,220 Total cash, cash equivalents, restricted cash and investments $ 138,284 $ 13 $ (1) $ 138,296 |
Summary of available-for-sale securities with unrealized losses for less than 12 months | The following is a summary of available-for-sale securities with unrealized losses for less than 12 months as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Fair Unrealized Fair Unrealized Value Losses Value Losses Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ — $ — $ 8,896 $ (1) Total available-for-sale securities in an unrealized loss position $ — $ — $ 8,896 $ (1) |
Accrued expenses (Tables)
Accrued expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accrued expenses | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical trial expenses $ 7,608 $ 6,518 Accrued contract manufacturing expenses 2,760 2,010 Accrued other research and development expenses 1,184 1,043 Accrued compensation and related benefits 3,089 4,796 Accrued professional fees 547 637 Accrued consulting fees 1,202 1,078 Accrued interest 306 316 Accrued commercialization costs 362 453 Accrued other 137 1,077 Total accrued expenses $ 17,195 $ 17,928 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Long-term debt | |
Schedule of carrying value of debt | June 30, 2024 December 31, 2023 Principal loan balance $ 40,000 $ 40,000 Final Payment Fee 907 661 Debt issuance costs, net of accretion (591) (575) Total Long-term debt, net of discount 40,316 40,086 Current portion of long-term debt 4,926 — Long-term debt, net of current portion $ 35,390 $ 40,086 |
Schedule of interest expenses | June 30, 2024 December 31, 2023 Principal loan balance $ 40,000 $ 40,000 Final Payment Fee 907 661 Debt issuance costs, net of accretion (591) (575) Total Long-term debt, net of discount 40,316 40,086 Current portion of long-term debt 4,926 — Long-term debt, net of current portion $ 35,390 $ 40,086 |
Schedule of future principal payments under the Loan Agreement | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Contractual Interest $ 945 $ 949 $ 1,889 $ 1,581 Amortization of debt discount and issuance costs 68 57 133 115 Amortization of Final Payment Fee 125 115 246 194 Total $ 1,138 $ 1,121 $ 2,268 $ 1,890 As of June 30, 2024, future principal payments due are as follows (in thousands): 2024 — 2025 15,000 2026 20,000 2027 5,000 Total principal payments $ 40,000 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases | |
Summary of elements of lease expenses | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Lease Expense Operating lease expense $ 221 $ 221 $ 442 $ 442 Total Lease Expense $ 221 $ 221 $ 442 $ 442 Other Information - Operating Leases Operating cash flows paid for amounts included in measurement of lease liabilities $ 268 $ 262 $ 535 $ 525 June 30, 2024 Other Balance Sheet Information - Operating Leases Weighted average remaining lease term (in years) 1.0 Weighted average discount rate 14.6% Maturity Analysis 2024 546 2025 546 Total $ 1,092 Less: Present value discount (70) Lease Liability $ 1,022 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stock-based compensation | |
Summary of stock option activity and related information | A summary of the Company’s stock option activity and related information for the six months ended June 30, 2024 is as follows: Shares Weighted-average exercise price per share Weighted-average remaining contractual term (years) Aggregate intrinsic value (in thousands) Outstanding at December 31, 2023 2,270,359 $ 19.81 7.8 $ 559 Granted 179,251 6.07 Exercised (21,978) 7.84 Forfeited/cancelled (184,122) 15.41 Expired (23,677) 162.38 Cancelled under the Option Exchange Program (603,330) 30.58 Granted under the Option Exchange Program 603,330 11.44 Outstanding at June 30, 2024 2,219,833 $ 12.46 8.6 $ — Vested at June 30, 2024 594,357 $ 19.22 7.2 $ — |
Schedule of assumptions used to estimate fair value of each stock option on grant date | The fair value of each stock option granted during the six months ended June 30, 2024 and 2023 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions: Six months ended June 30, 2024 2023 Risk-free interest rate 4.11 % 3.56 % Volatility 97 % 90 % Dividend yield — — Expected term (years) 5.8 6.1 |
Schedule of restricted stock units | A summary of the Company’s restricted stock unit activity and related information for the six months ended June 30, 2024 is as follows: Shares Weighted-average grant date fair value per share Outstanding at December 31, 2023 209,289 $ 18.05 Granted 950,371 $ 5.07 Vested (33,511) $ 21.66 Forfeited/cancelled (28,127) $ 16.80 Outstanding at June 30, 2024 1,098,022 $ 6.74 |
Schedule of assumptions used to estimate fair value of each employee stock purchase plan on grant date | Six months ended June 30, 2024 2023 Risk-free interest rate 5.24 % 4.77 % Volatility 60 % 106 % Dividend yield — — Expected term (years) 0.5 0.5 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Net loss per share | |
Schedule of potentially dilutive securities were excluded from the calculation of diluted net loss per share | The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Outstanding stock options 2,219,833 2,007,023 2,219,833 2,007,023 Outstanding restricted stock units 1,098,022 142,333 1,098,022 142,333 2018 Notes — 3,489 — 3,489 Employee stock purchase plan 7,756 7,396 7,756 7,396 Series A Convertible Preferred Stock 833,333 833,333 833,333 833,333 Series B Convertible Preferred Stock 4,236,570 4,236,570 4,236,570 4,236,570 Total potentially dilutive securities 8,395,514 7,230,144 8,395,514 7,230,144 |
Nature of business (Details)
Nature of business (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Nature of business | |
Cash, cash equivalents, and investments | $ 83.4 |
Nature of business - Sale of co
Nature of business - Sale of common stock (Details) - USD ($) $ in Millions | Jul. 25, 2024 | Jun. 23, 2024 |
Common stock | ||
Nature of business | ||
Common stock sold | 13,333,334 | |
Pre-funded warrants | ||
Nature of business | ||
Number of common stock warrants can purchase | 5,000,000 | |
Subsequent events | ||
Nature of business | ||
Gross proceeds | $ 51.1 | |
Subsequent events | Common stock | ||
Nature of business | ||
Common stock sold | 13,333,334 | |
Subsequent events | Pre-funded warrants | ||
Nature of business | ||
Common stock sold | 5,000,000 | |
Number of common stock warrants can purchase | 5,000,000 |
Nature of business - Reverse St
Nature of business - Reverse Stock Split (Details) | 1 Months Ended | ||
May 31, 2023 $ / shares shares | May 31, 2023 $ / shares shares | Jun. 30, 2024 $ / shares shares | |
Nature of business | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||
Reverse stock split ratio | 0.083 | ||
Common stock, shares authorized | shares | 300,000,000 | ||
Certificate of Amendment | |||
Nature of business | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |
Reverse stock split ratio | 0.083 | ||
Common stock, shares authorized | shares | 300,000,000 | 300,000,000 |
Summary of significant accoun_3
Summary of significant accounting policies - Concentrations of credit risk and off-balance sheet risk (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) customer | |
Concentrations of credit risk and off-balance sheet risk | |
Accounts Receivable, Net | $ | $ 10,000 |
Off-balance sheet concentrations of credit risk description | As of June 30, 2024, the Company’s cash, cash equivalents and investments were deposited at four financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Revenue | Customer Concentration Risk | Secura | |
Concentrations of credit risk and off-balance sheet risk | |
Number of customer | customer | 1 |
Summary of significant accoun_4
Summary of significant accounting policies - Proceeds from Grants (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | Aug. 31, 2022 | May 31, 2022 | |
Accounting Policies [Line Items] | |||||
Grant awarded, amount | $ 3,500 | $ 3,500 | $ 3,800 | ||
Government Assistance, Statement of Income or Comprehensive Income [Extensible Enumeration] | Research and Development Expense | ||||
Reduction of research and development expense | 600 | $ 2,000 | |||
Grant receivable | 825 | 825 | |||
Grant, grants receivable | $ 800 | $ 800 | |||
Government Assistance, Asset, Current, Statement of Financial Position [Extensible Enumeration] | Grant receivable | Grant receivable | |||
Grants, deferred liability | $ 300 | ||||
Government Assistance, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Deferred Revenue, Current | ||||
Additional funding | |||||
Accounting Policies [Line Items] | |||||
Grant awarded, amount | $ 500 |
Cash, cash equivalents and re_3
Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 83,371 | $ 77,909 | ||
Restricted cash | 241 | 241 | ||
Restricted cash | 241 | 1,167 | ||
Total cash, cash equivalents and restricted cash | 83,612 | 79,076 | $ 184,326 | $ 75,789 |
Restricted Cash and Cash Equivalents [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Restricted cash | 900 | |||
Letter of credit | Office and Laboratory Space in Needham, Massachusetts | Restricted Cash and Cash Equivalents [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Restricted cash | $ 200 | $ 200 |
Fair value of financial instr_3
Fair value of financial instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Financial liabilities | ||
Long-term debt | $ 40,316 | $ 40,086 |
Level 3 | ||
Financial liabilities | ||
Fair value of long-term debt | 40,100 | 39,600 |
Long-term debt | $ 40,300 | $ 40,100 |
Fair value of financial instr_4
Fair value of financial instruments - Financial instruments measured at fair value on a recurring basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Financial assets | ||
Preferred stock tranche liability | $ 4,189 | |
Level 3 | ||
Financial assets | ||
Preferred stock tranche liability | 4,189 | |
Recurring basis | ||
Financial assets | ||
Cash equivalents | $ 75,424 | 46,093 |
Short-term investments | 59,220 | |
Total financial assets | 75,424 | 105,313 |
Preferred stock tranche liability | 4,189 | |
Recurring basis | Level 1 | ||
Financial assets | ||
Cash equivalents | 75,424 | 46,093 |
Short-term investments | 5,992 | |
Total financial assets | $ 75,424 | 52,085 |
Recurring basis | Level 2 | ||
Financial assets | ||
Short-term investments | 53,228 | |
Total financial assets | 53,228 | |
Recurring basis | Level 3 | ||
Financial assets | ||
Preferred stock tranche liability | $ 4,189 |
Fair value of financial instr_5
Fair value of financial instruments - Inputs used to value the preferred stock tranche liability (Details) | Jun. 30, 2024 | Dec. 31, 2023 |
Risk-free interest rate | ||
Financial liabilities | ||
Debt Instrument, Measurement Input | 5.47 | |
Risk-free interest rate | Maximum | ||
Financial liabilities | ||
Debt Instrument, Measurement Input | 0.0494 | |
Risk-free interest rate | Minimum | ||
Financial liabilities | ||
Debt Instrument, Measurement Input | 0.0445 | |
Volatility | ||
Financial liabilities | ||
Debt Instrument, Measurement Input | 90 | 0.95 |
Remaining term | ||
Financial liabilities | ||
Remaining term (years) | 1 month 6 days | 7 months 6 days |
Fair value of financial instr_6
Fair value of financial instruments - Reconciliation of the preferred stock tranche liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Financial liabilities | ||||
January 1, 2024 | $ 4,189 | |||
Fair value adjustment | $ 10,200 | $ (3,950) | 4,189 | $ (520) |
Level 3 | ||||
Financial liabilities | ||||
January 1, 2024 | 4,189 | |||
Fair value adjustment | $ (4,189) |
Investments (Details)
Investments (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) position | Jun. 30, 2023 USD ($) | Dec. 31, 2023 position item | |
Investments | |||||
Realized gains or losses on investments | $ 0 | $ 0 | $ 0 | $ 0 | |
Accrued interest receivable | $ 100 | ||||
Number of investments in unrealized loss position | position | 0 | 2 | |||
Number of investments in unrealized loss position for more than 12 months | item | 0 |
Investments - Cash, cash equiva
Investments - Cash, cash equivalents, restricted cash and investments (Details) - USD ($) $ in Thousands | 12 Months Ended | 18 Months Ended | |
Dec. 31, 2023 | Jun. 30, 2024 | Dec. 31, 2022 | |
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | $ 77,909 | $ 83,371 | |
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Gains | $ 13 | ||
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Losses | (1) | ||
Total cash, cash equivalents, restricted cash and investments, Fair Value | $ 83,400 | ||
Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Total cash, cash equivalents, restricted cash and investments, Amortized Cost | 138,284 | ||
Total | |||
Schedule of Investments [Line Items] | |||
Total cash, cash equivalents, restricted cash and investments, Fair Value | $ 138,296 | ||
Corporate bonds, agency bonds and commercial paper (due within 1 year) | |||
Schedule of Investments [Line Items] | |||
Maturity period, investments | 1 year | 1 year | |
Gross Unrealized Gains | 13 | ||
Gross Unrealized Losses | (1) | ||
Corporate bonds, agency bonds and commercial paper (due within 1 year) | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Due within 1 year, Amortized Cost | $ 59,208 | ||
Corporate bonds, agency bonds and commercial paper (due within 1 year) | Total | |||
Schedule of Investments [Line Items] | |||
Due within 1 year, Fair Value | 59,220 | ||
Total investments | |||
Schedule of Investments [Line Items] | |||
Gross Unrealized Gains | 13 | ||
Gross Unrealized Losses | $ (1) | ||
Total investments | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Investments, Amortized Cost | 59,208 | ||
Total investments | Total | |||
Schedule of Investments [Line Items] | |||
Investments, Fair Value | 59,220 | ||
Cash and money market accounts. | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 79,076 | $ 83,612 | |
Cash and money market accounts. | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | 79,076 | 83,612 | |
Cash, cash equivalents & restricted cash | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 79,076 | ||
Total cash, cash equivalents, restricted cash and investments, Amortized Cost | 83,612 | ||
Cash, cash equivalents & restricted cash | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | $ 79,076 | ||
Total cash, cash equivalents, restricted cash and investments, Fair Value | $ 83,612 |
Investments - Available-for-sal
Investments - Available-for-sale securities with unrealized losses for less than 12 months (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Schedule of Investments [Line Items] | |
Unrealized loss of available-for-sale securities with unrealized losses for less than 12 months | $ 1 |
Total fair value of available-for-sale securities in an unrealized loss position for less than 12 months | 8,896 |
Corporate bonds, agency bonds and commercial paper (due within 1 year) | |
Schedule of Investments [Line Items] | |
Fair value of available-for-sale securities with unrealized losses for less than 12 months | 8,896 |
Unrealized loss of available-for-sale securities with unrealized losses for less than 12 months | $ 1 |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued expenses | ||
Accrued clinical trail expenses | $ 7,608 | $ 6,518 |
Accrued contract manufacturing expenses | 2,760 | 2,010 |
Accrued other research and development expenses | 1,184 | 1,043 |
Accrued compensation and related benefits | 3,089 | 4,796 |
Accrued professional fees | 547 | 637 |
Accrued consulting fees | 1,202 | 1,078 |
Accrued interest | 306 | 316 |
Accrued commercialization costs | 362 | 453 |
Accrued other | 137 | 1,077 |
Total accrued expenses | $ 17,195 | $ 17,928 |
Debt (Details)
Debt (Details) - USD ($) $ in Millions | Mar. 25, 2024 | Mar. 22, 2023 | Mar. 25, 2022 |
Long-term debt | |||
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] | us-gaap:SecuredOvernightFinancingRateSofrMember | ||
Financial covenants | The Loan Agreement contains no financial covenants. | ||
Loan Agreement | |||
Long-term debt | |||
Accrued interest rate | 5% | ||
Term loan | |||
Long-term debt | |||
Aggregate principal amount | $ 150 | ||
Issuance of debt | $ 25 | ||
Current borrowing capacity | 110 | ||
Interest rate | 7.37% | ||
Basis spread | 0.13% | ||
Percentage of final prepayment fee | 5% | ||
Additional interest rate in an event of default | 0.50% | ||
Term loan | If prepaid on or before the first anniversary | |||
Long-term debt | |||
Percentage of final prepayment fee | 3% | ||
Term loan | If prepaid after the first anniversary and on or before the second anniversary | |||
Long-term debt | |||
Percentage of final prepayment fee | 2% | ||
Term loan | If prepaid after the second anniversary | |||
Long-term debt | |||
Percentage of final prepayment fee | 1% | ||
Term B Loan | |||
Long-term debt | |||
Issuance of debt | $ 15 | ||
Term C Loan | |||
Long-term debt | |||
Aggregate principal amount | $ 25 | ||
Debt instrument period to draw loan, Minimum | 60 days | ||
Term D Loan | |||
Long-term debt | |||
Aggregate principal amount | $ 35 | ||
Debt instrument period to draw loan, Minimum | 30 days | ||
Gross product revenue to be achieved | $ 50 | ||
Term E Loan | |||
Long-term debt | |||
Aggregate principal amount | $ 50 |
Debt - Components of carrying v
Debt - Components of carrying value of debt (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Long-term debt | ||
Principal loan balance | $ 40,000 | $ 40,000 |
Final Payment Fee | 907 | 661 |
Debt issuance costs, net of accretion | (591) | (575) |
Long-term debt, net of discount | 40,316 | 40,086 |
Current portion of long-term debt | 4,926 | |
Long-term debt, net of current portion | $ 35,390 | $ 40,086 |
Debt - Schedule of interest exp
Debt - Schedule of interest expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Long-term debt | ||||
Contractual Interest | $ 945 | $ 949 | $ 1,889 | $ 1,581 |
Amortization of debt discount and issuance costs | 68 | 57 | 133 | 115 |
Amortization of Final Payment Fee | 125 | 115 | 246 | 194 |
Interest Expense, Total | $ 1,138 | $ 1,121 | $ 2,268 | $ 1,890 |
Debt - Future principal payment
Debt - Future principal payments (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Future principal payments | |
2025 | $ 15,000 |
2026 | 20,000 |
2027 | 5,000 |
Total principal payments | $ 40,000 |
Leases (Details)
Leases (Details) - Office and Laboratory Space in Needham, Massachusetts $ in Millions | Feb. 15, 2018 USD ($) ft² | Apr. 15, 2014 ft² |
Leases | ||
Area of space | ft² | 27,810 | 15,197 |
Minimum | ||
Leases | ||
Operating lease expense | $ 0.7 | |
Maximum | ||
Leases | ||
Operating lease expense | $ 1.1 |
Leases - Balance sheet and othe
Leases - Balance sheet and other information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Leases | |||||
Right-of use asset | $ 816 | $ 816 | $ 1,171 | ||
Lease liability | 1,022 | 1,022 | |||
Lease Expense | |||||
Operating lease expense | 221 | $ 221 | 442 | $ 442 | |
Total Lease Expense | 221 | 221 | 442 | 442 | |
Other Information - Operating Leases | |||||
Operating cash flows paid for amounts included in measurement of lease liabilities | $ 268 | $ 262 | $ 535 | $ 525 | |
Weighted average remaining lease term (in years) | 1 year | 1 year | |||
Weighted average discount rate | 14.60% | 14.60% | |||
Maturity Analysis | |||||
2024 | $ 546 | $ 546 | |||
2025 | 546 | 546 | |||
Total | 1,092 | 1,092 | |||
Less: Present value discount | (70) | (70) | |||
Lease Liability | $ 1,022 | $ 1,022 |
Notes Payable (Details)
Notes Payable (Details) - AFCO - USD ($) $ in Millions | 1 Months Ended | |
Feb. 29, 2024 | Jun. 30, 2024 | |
Short-Term Debt [Line Items] | ||
Aggregate principal amount | $ 1.3 | |
Interest rate (as a percent) | 8.30% | |
Monthly payments | $ 0.1 | |
Note Payable | $ 0.5 |
Capital stock - June 2023 Publi
Capital stock - June 2023 Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 23, 2024 | Jun. 15, 2023 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | |
Class of Stock [Line Items] | ||||||
Stock Issued, Pre Funded Warrants, Net of Issuance Costs | $ 91,420 | |||||
Pre-funded warrants outstanding | 0 | 0 | ||||
Underwriting Agreement | ||||||
Class of Stock [Line Items] | ||||||
Period options are exercisable | 30 days | |||||
Stock Issued, Pre Funded Warrants, Net of Issuance Costs | $ 91,400 | |||||
Underwriting Agreement | Public | ||||||
Class of Stock [Line Items] | ||||||
Common shares, offered | 7,181,409 | |||||
Sale price of the Common Stock | $ 9.75 | |||||
Underwriting Agreement | Underwriters | ||||||
Class of Stock [Line Items] | ||||||
Common shares, offered | 1,308,000 | |||||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Share price (in dollars per share) | $ 2.999 | |||||
Stock Issued, Pre Funded Warrants, Net of Issuance Costs | $ 1 | |||||
Shares exercised | 17,378 | 4,600 | ||||
Issuance of common stock, and pre-funded warrants (in shares) | 1,538,201 | 8,489,409 | ||||
Common Stock [Member] | Underwriting Agreement | ||||||
Class of Stock [Line Items] | ||||||
Shares issued | 8,489,409 | |||||
Pre-Funded Warrant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of shares of common stock in the warrant issued (in dollars per share) | $ 0.001 | |||||
Shares issued | 5,000,000 | |||||
Pre-Funded Warrant [Member] | Underwriting Agreement | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of shares of common stock in the warrant issued (in dollars per share) | $ 0.001 | $ 0.0001 | $ 0.0001 | |||
Maximum amount of common stock owned, as a percentage, that would prevent exercise | 9.99% | |||||
Days of notice for increase/decrease to maximum percentage owned | 61 days | |||||
Upper limit of maximum amount of common stock owned by a holder, as a percentage | 19.99% | |||||
Shares issued | 1,538,591 | |||||
Shares exercised | 1,538,591 | |||||
Issuance of common stock, and pre-funded warrants (in shares) | 1,538,201 | |||||
Pre-Funded Warrant [Member] | Underwriting Agreement | Investors | ||||||
Class of Stock [Line Items] | ||||||
Common shares, offered | 1,538,591 | |||||
Sale price of the Common Stock | $ 9.749 | |||||
Exercise price of shares of common stock in the warrant issued (in dollars per share) | $ 0.001 |
Capital Stock - Convertible Pre
Capital Stock - Convertible Preferred Stock (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jan. 24, 2023 USD ($) tranche D $ / shares shares | Nov. 04, 2022 $ / shares shares | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 23, 2024 $ / shares | Dec. 31, 2023 USD ($) | |
Class of Stock [Line Items] | ||||||||
Preferred Stock, Shares Authorized | shares | 5,000,000 | 5,000,000 | ||||||
Preferred stock tranche liability | $ | $ 4,189 | |||||||
Common Stock [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Share price (in dollars per share) | $ 2.999 | |||||||
SeriesA Convertible Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Convertible preferred stock, shares issued upon conversion | shares | 0.833 | |||||||
Conversion of preferred stock, conversion blocker, percent | 9.99% | |||||||
Conversion of Preferred Stock, Conversion Blocker, Percent, Upon Giving Notice | 19.99% | |||||||
Conversion of Preferred Stock, Conversion Blocker, Notice Period | 60 days | |||||||
Shares issued on conversion | shares | 1,000,000 | |||||||
Series B Convertible Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Convertible preferred stock, shares issued upon conversion | shares | 3.5305 | |||||||
Conversion of preferred stock, conversion blocker, percent | 9.99% | |||||||
Conversion of Preferred Stock, Conversion Blocker, Notice Period | 60 days | |||||||
Threshold share price | $ 31.77 | |||||||
Expected closing period of issuance | 10 days | |||||||
Liquidation preference per share | $ 1 | |||||||
Fair value of the Second Tranche Right | $ | $ 6,900 | $ 0 | $ 0 | $ 4,200 | ||||
Preferred stock tranche liability | $ | $ 6,900 | |||||||
Mark-to-market adjustment under change in fair value of preferred stock tranche liability | $ | $ 10,200 | $ 4,000 | $ 4,200 | $ 500 | ||||
Series B Convertible Preferred Stock | Private placement | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issued | shares | 944,160 | |||||||
Conversion price | $ 7.0812 | |||||||
Gross proceeds | $ | $ 30,000 | |||||||
Threshold share price | $ 13.50 | |||||||
Share price (in dollars per share) | $ 9 | |||||||
Share issue period | 10 days | |||||||
Threshold trading volume | $ | $ 25,000 | |||||||
Trading days | D | 7 | |||||||
Maximum | Series B Convertible Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate shares to be sold | shares | 2,144,160 | |||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||||||
Number of tranches | tranche | 2 | |||||||
Conversion of Preferred Stock, Conversion Blocker, Percent, Upon Giving Notice | 19.99% | |||||||
Shares issued | shares | 1,200,000 | |||||||
Share price (in dollars per share) | $ 25 | |||||||
BVF | SeriesA Convertible Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||||||
Conversion of stock, shares converted | shares | 833,333 |
Stock-based compensation - Opti
Stock-based compensation - Option Exchange Program (Details) - Option Exchange Program $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jan. 17, 2024 item shares | Jun. 30, 2024 USD ($) | Mar. 11, 2024 $ / shares shares | |
Stock-based compensation | |||
Number of eligible stockholders | item | 42 | ||
Number of shares reserved | shares | 603,330 | 603,330 | |
Exercise price of new options | $ / shares | $ 11.44 | ||
Stock-based compensation expense | $ | $ 1.7 |
Stock-based compensation - Stoc
Stock-based compensation - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Stock options | |||
Shares | |||
Outstanding at the beginning of the period (in shares) | 2,270,359 | ||
Granted (in shares) | 179,251 | ||
Exercised (in shares) | (21,978) | ||
Forfeited/cancelled (in shares) | (184,122) | ||
Expired | (23,677) | ||
Outstanding at the end of the period (in shares) | 2,219,833 | 2,270,359 | |
Vested at the end of the period (in shares) | 594,357 | ||
Weighted-average exercise price per share | |||
Outstanding at the beginning of the period (in dollars per share) | $ 19.81 | ||
Granted (in dollars per share) | 6.07 | ||
Exercised (in dollars per share) | 7.84 | ||
Forfeited/cancelled (in dollars per share) | 15.41 | ||
Expired (in dollars per share) | 162.38 | ||
Outstanding at the end of the period (in dollars per share) | 12.46 | $ 19.81 | |
Vested at the end of the period (in dollars per share) | $ 19.22 | ||
Weighted-average remaining contractual term | |||
Outstanding at the end of the period | 8 years 7 months 6 days | 7 years 9 months 18 days | |
Vested at the end of the period | 7 years 2 months 12 days | ||
Aggregate intrinsic value | |||
Outstanding at the beginning of the period (in dollars) | $ 559 | ||
Outstanding at the end of the period (in dollars) | $ 559 | ||
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Risk-free interest rate (as a percent) | 4.11% | 3.56% | |
Volatility (as a percent) | 97% | 90% | |
Expected term (years) | 6 years 2 months 5 days | 5 years 7 months 6 days | |
Option Exchange Program | |||
Additional disclosures | |||
Stock-based compensation expense | $ 1,700 | ||
Option Exchange Program | Stock options | |||
Shares | |||
Granted (in shares) | 603,330 | ||
Forfeited/cancelled (in shares) | (603,330) | ||
Weighted-average exercise price per share | |||
Granted (in dollars per share) | $ 11.44 | ||
Forfeited/cancelled (in dollars per share) | $ 30.58 |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units (Details) - Restricted stock units | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Shares | |
Outstanding at the beginning of the period (in shares) | shares | 209,289 |
Granted (in shares) | shares | 950,371 |
Vested (in shares) | shares | (33,511) |
Forfeited/cancelled (in shares) | shares | (28,127) |
Outstanding at the end of the period (in shares) | shares | 1,098,022 |
Weighted-average grant date fair value | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 18.05 |
Granted (in dollars per share) | $ / shares | 5.07 |
Vested (in dollars per share) | $ / shares | 21.66 |
Forfeited/cancelled (in dollars per share) | $ / shares | 16.80 |
Outstanding at the end of the period (in dollars per share) | $ / shares | $ 6.74 |
Stock-based compensation - Empl
Stock-based compensation - Employee stock purchase plan (Details) $ in Thousands | 6 Months Ended | ||
Jun. 21, 2019 item | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | |
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Proceeds from the exercise of stock options and employee stock purchase program | $ 221 | $ 29 | |
Employee Stock [Member] | |||
Stock-based compensation | |||
Percent of common stock at market price to be purchased | 85% | ||
Number of vesting periods | item | 2 | ||
Vesting period | 6 months | ||
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Risk-free interest rate (as a percent) | 5.24% | 4.77% | |
Volatility (as a percent) | 60% | 106% | |
Dividend yield (as a percent) | 0% | 0% | |
Expected term (years) | 6 months | 6 months | |
Stock-based compensation expense | $ 100 | $ 100 | |
Issuance of common stock under ESPP | shares | 7,475 | ||
Proceeds from the exercise of stock options and employee stock purchase program | $ 100 |
Net loss per share (Details)
Net loss per share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 8,395,514 | 7,230,144 | 8,395,514 | 7,230,144 |
Employee Stock Option [Member] | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 2,219,833 | 2,007,023 | 2,219,833 | 2,007,023 |
Restricted stock units | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 1,098,022 | 142,333 | 1,098,022 | 142,333 |
2018 Notes | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 3,489 | 3,489 | ||
Employee stock purchase plan | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 7,756 | 7,396 | 7,756 | 7,396 |
Series A Preferred Stock | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 833,333 | 833,333 | 833,333 | 833,333 |
Series B Preferred Stock | ||||
Net loss per share | ||||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 4,236,570 | 4,236,570 | 4,236,570 | 4,236,570 |
License, collaboration and co_2
License, collaboration and commercial agreements - Secura (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 54 Months Ended | |
Sep. 30, 2020 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Jul. 31, 2024 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenue recognized | $ 10,000 | $ 10,000 | |||
License and Collaboration Agreement | Secura | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Upfront payment | $ 70,000 | ||||
Regulatory milestone payments | 45,000 | ||||
Milestone payments receivable upon approval of COPIKTRA | 35,000 | ||||
Milestone payments receivable upon approval for commercial sale | 10,000 | ||||
Threshold sales to trigger royalty payments | $ 100,000 | ||||
Percentage of all royalty, milestone and sublicense revenue payments payable | 50% | ||||
Percentage of all royalty and milestone payments payable under certain jurisdictions | 50% | ||||
License and Collaboration Agreement | Secura | Sales Exceeds $100 Million | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Sales milestone receivable | $ 10,000 | $ 10,000 | 10,000 | $ 10,000 | |
Threshold sales to trigger milestone payments | 100,000 | $ 100,000 | |||
Revenue recognized | $ 10,000 | ||||
Sales milestone received | $ 10,000 | ||||
License and Collaboration Agreement | Secura | Sales Exceeds $200 Million | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Sales milestone receivable | 15,000 | ||||
Threshold sales to trigger milestone payments | 200,000 | ||||
License and Collaboration Agreement | Secura | Sales Exceeds $300 Million | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Sales milestone receivable | 25,000 | ||||
Threshold sales to trigger milestone payments | 300,000 | ||||
License and Collaboration Agreement | Secura | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Sales milestone receivable | $ 50,000 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income taxes | ||||
Income tax expense | $ 0 | $ 0 | $ 0 | $ 0 |
Commitments and contingencies (
Commitments and contingencies (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Commitments and contingencies | |
Other commitments | $ 0 |
Subsequent events (Details)
Subsequent events (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 25, 2024 | Jun. 23, 2024 |
Common stock | ||
Subsequent events | ||
Common stock sold | 13,333,334 | |
Share price (in dollars per share) | $ 2.999 | |
Pre-funded warrants | ||
Subsequent events | ||
Shares issued | 5,000,000 | |
Number of common stock warrants can purchase | 5,000,000 | |
Exercise price of shares of common stock in the warrant issued under the license agreement (in dollars per share) | $ 0.001 | |
Warrants | ||
Subsequent events | ||
Exercise price of shares of common stock in the warrant issued under the license agreement (in dollars per share) | $ 3.50 | |
Subsequent events | ||
Subsequent events | ||
Gross proceeds | $ 51.1 | |
Subsequent events | Common stock | ||
Subsequent events | ||
Common stock sold | 13,333,334 | |
Subsequent events | Pre-funded warrants | ||
Subsequent events | ||
Number of common stock warrants can purchase | 5,000,000 | |
Common stock sold | 5,000,000 |