Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
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, $0.0001 par value per share | |
Trading Symbol | VSTM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 200,861,380 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001526119 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 97,260 | $ 74,933 |
Short-term investments | 13,944 | 12,961 |
Accounts receivable, net | 31 | |
Prepaid expenses and other current assets | 7,689 | 4,945 |
Total current assets | 118,893 | 92,870 |
Property and equipment, net | 62 | 92 |
Right-of-use asset, net | 1,645 | 1,789 |
Restricted cash | 241 | 241 |
Other assets | 36 | 58 |
Total assets | 120,877 | 95,050 |
Current liabilities: | ||
Accounts payable | 4,903 | 4,901 |
Accrued expenses | 13,938 | 14,983 |
Note Payable | 1,004 | |
Deferred liabilities | 1,403 | 710 |
Lease liability, short-term | 829 | 794 |
Convertible senior notes | 282 | 275 |
Total current liabilities | 22,359 | 21,663 |
Non-current liabilities: | ||
Long-term debt | 39,574 | 24,526 |
Lease liability, long-term | 1,250 | 1,470 |
Preferred stock tranche liability | 3,510 | |
Total liabilities | 66,693 | 47,659 |
Stockholders' equity: | ||
Preferred Stock, $0.0001 par value; 1,856 and 4,000 shares authorized, 0 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively. | ||
Common stock, $0.0001 par value; 300,000 shares authorized, 200,836 and 200,541 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 20 | 20 |
Additional paid-in capital | 786,236 | 784,894 |
Accumulated other comprehensive income | 6 | |
Accumulated deficit | (753,237) | (737,523) |
Total stockholders' equity | 33,025 | 47,391 |
Total liabilities and stockholders' equity | 120,877 | $ 95,050 |
Series B Preferred Stock [Member] | ||
Convertible Preferred Stock: | ||
Convertible Preferred Stock | $ 21,159 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Preferred stock, shares authorized | 5,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 200,836,000 | 200,541,000 |
Common stock, shares outstanding | 200,541,000 | 200,541,000 |
Series A Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |
Preferred stock, shares authorized | 1,000,000 | |
Preferred stock, shares issued | 1,000,000 | |
Preferred stock, shares outstanding | 1,000,000 | |
Series B Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |
Preferred stock, shares authorized | 2,144,000 | 0 |
Preferred stock, shares issued | 1,200,000 | |
Preferred stock, shares outstanding | 0 | |
Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Total revenue | $ 2,596 | |
Operating expenses: | ||
Research and development | $ 12,015 | 13,642 |
Selling, general and administrative | 7,329 | 5,934 |
Total operating expenses | 19,344 | 19,576 |
Loss from operations | (19,344) | (16,980) |
Other income (expense) | (7) | 28 |
Interest income | 976 | 46 |
Interest expense | (769) | (56) |
Change in fair value of preferred stock tranche liability | 3,430 | |
Net loss | $ (15,714) | $ (16,962) |
Net loss per share-basic | $ (0.08) | $ (0.09) |
Net loss per share-diluted | $ (0.08) | $ (0.09) |
Weighted average common shares outstanding used in computing net loss per share - basic | 200,679 | 186,264 |
Weighted average common shares outstanding used in computing net loss per share - diluted | 200,679 | 186,264 |
Net loss | $ (15,714) | $ (16,962) |
Unrealized gain (loss) on available-for-sale securities | 6 | (147) |
Comprehensive loss | $ (15,708) | $ (17,109) |
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 | Additional paid-in capital | Accumulated other comprehensive income/ (loss) | Accumulated deficit | Total |
Balance at Dec. 31, 2021 | $ 19 | $ 751,217 | $ 34 | $ (663,711) | $ 87,559 | ||
Balance (in shares) at Dec. 31, 2021 | 185,286,480 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (16,962) | (16,962) | |||||
Unrealized (loss) on available-for-sale marketable securities | (147) | (147) | |||||
Issuance of common stock resulting from exercise of stock options | 575 | 575 | |||||
Issuance of common stock resulting from exercise of stock options (in shares) | 285,900 | ||||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 699,635 | ||||||
Stock-based compensation expense | 1,646 | 1,646 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 100 | 100 | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 57,636 | ||||||
Balance at Mar. 31, 2022 | $ 19 | 753,538 | (113) | (680,673) | 72,771 | ||
Balance (in shares) at Mar. 31, 2022 | 186,329,651 | ||||||
Balance at Dec. 31, 2022 | $ 20 | 784,894 | (737,523) | $ 47,391 | |||
Balance (in shares) at Dec. 31, 2022 | 1,000,000 | 200,540,946 | 200,541,000 | ||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (15,714) | $ (15,714) | |||||
Unrealized (loss) on available-for-sale marketable securities | 6 | 6 | |||||
Issuance of common stock resulting from vesting of restricted stock units (in shares) | 212,075 | ||||||
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) | 82,496 | ||||||
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 | $ 20 | $ 786,236 | $ 6 | $ (753,237) | $ 33,025 | |
Balance (in shares) at Mar. 31, 2023 | 1,000,000 | 1,200,000 | 200,835,517 | 200,836,000 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY | |
Issuance of Series B Convertible Preferred Stock, issuance costs | $ 1,901 |
Preferred stock tranche liability | $ 6,940 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (15,714) | $ (16,962) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 30 | 30 |
Amortization of right-of-use asset and lease liability | (41) | (37) |
Stock-based compensation expense | 1,313 | 1,646 |
Amortization of deferred financing costs, debt discounts and premiums and discounts on available-for-sale marketable securities | (36) | 17 |
Change in fair value of preferred stock tranche liability | (3,430) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 31 | (2,128) |
Prepaid expenses, other current assets and other assets | (2,089) | 510 |
Accounts payable | 2 | 92 |
Accrued expenses and other liabilities | (1,045) | (2,449) |
Deferred liabilities | 693 | |
Net cash used in operating activities | (20,286) | (19,281) |
Investing activities | ||
Purchases of investments | (13,804) | (4,986) |
Maturities of investments | 13,000 | 24,250 |
Net cash provided by (used in) investing activities | (804) | 19,264 |
Financing activities | ||
Proceeds from issuance of Series B Convertible Preferred Stock, net | 28,099 | |
Proceeds from long-term debt, net | 14,918 | 24,772 |
Proceeds from insurance premium financing | 1,430 | |
Payments on insurance premium financing | (426) | |
Proceeds from the exercise of stock options and employee stock purchase program | 29 | 100 |
Proceeds from the issuance of common stock, net | 580 | |
Net cash provided by financing activities | 44,050 | 25,452 |
Increase (decrease) in cash, cash equivalents and restricted cash | 22,960 | 25,435 |
Cash, cash equivalents and restricted cash at beginning of period | 75,789 | 21,493 |
Cash, cash equivalents and restricted cash at end of period | 98,749 | 46,928 |
Supplemental disclosure of non-cash investing and financing activities | ||
Issuance of preferred stock tranche liability | $ 6,940 | |
Conversion of notes into common stock | $ 624 |
Nature of business
Nature of business | 3 Months Ended |
Mar. 31, 2023 | |
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 advancing new medicines for patients battling cancer. The Company’s pipeline is focused on novel anticancer agents that inhibit critical signaling pathways in cancer that promote 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”), colorectal cancer (“CRC”), pancreatic cancer, and melanoma. The Company believes that avutometinib may be beneficial as a therapeutic as a single agent or when used together in combination with defactinib, other agents, other pathway inhibitors or other current and emerging standard of care treatments in cancers that do not adequately respond to currently available therapies. On September 24, 2018, the Company’s first commercial product, COPIKTRA® (duvelisib), was approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of adult patients with certain hematologic cancers including relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma after at least two prior therapies and relapsed or refractory follicular lymphoma after at least two prior systemic therapies. On August 10, 2020, the Company and Secura Bio, Inc. (“Secura”) entered into an asset purchase agreement (“Secura APA”). Pursuant to the Secura APA, the Company sold to Secura its exclusive worldwide license, including certain related assets for the research, development, commercialization, and manufacture in oncology indications of products containing COPIKTRA (duvelisib). The transaction closed on September 30, 2020. Refer to Note 14. License, collaboration, and commercial agreements 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. The Company has historical losses from operations and anticipates that it may continue to incur operating losses as it continues the research and development of its product candidates. As of March 31, 2023, the Company had cash, cash equivalents, and investments of $111.2 million, and an accumulated deficit of $753.2 million. The Company expects its existing cash resources will be sufficient to fund its planned operations through at least 12 months from the date of issuance of these condensed consolidated financial statements. The Company expects to finance the future development costs of its clinical product portfolio with its existing cash, cash equivalents, and investments, through potential future milestones and royalties received pursuant to the Secura APA, through the loan and security agreement with Oxford Finance LLC (“Oxford”), executed or executed on favorable terms, and some could be dilutive to existing stockholders. 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. |
Summary of significant accounti
Summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2023 | |
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 months ended March 31, 2023 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2023. 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, 2022, as filed with the Securities and Exchange Commission (“SEC”) on March 14, 2023. Significant Accounting Policies No te 2 . Significant accounting policies in the Recently Adopted Accounting Standards Updates In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will replace the incurred loss impairment methodology under current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Effective January 1, 2023, the Company adopted the provisions of ASU 2016-13. The adoption did not have a material impact on the Company's condensed consolidated financial statements or related financial statement disclosures. In August 2020, the FASB issued No. ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The ASU also simplifies the diluted earnings per share calculation in certain areas. The Company elected to adopt this standard on January 1, 2023 under the modified retrospective transition method. The adoption did not have a material impact on the Company's condensed consolidated financial statements or related financial statement disclosures. In September 2022, the FASB issued ASU 2022-04, Liabilities—Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations (“ASU 2022-04”). ASU 2022-04 requires the buyer in a supplier finance program to disclose information about the key terms of the program, outstanding confirmed amounts as of the end of the period, a rollforward of such amounts during each annual period, and a description of where in the financial statements outstanding amounts are presented. This guidance is effective for fiscal years beginning after December 15, 2022. We adopted this guidance as of January 1, 2023, on a prospective basis. The adoption of the standard only resulted in new disclosures for amounts presented within Notes Payable and did not affect the Company’s recognition, measurement, or financial statement presentation of supplier finance program obligations on the condensed consolidated financial statements. For additional information on the new disclosures, see Note 9 , Notes Payable . 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 March 31, 2023, 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 March 31, 2023, the Company did not have an accounts receivable balance. For the three months ended March 31, 2023, the Company did not record any revenue. 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 expected to support 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 will evaluate whether combining avutometinib (to target mutant 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. Through March 31, 2023, the Company has received $1.8 million of cash proceeds in which was initially recorded as deferred liabilities on the balance sheet. 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 entity recognizes as expenses the related costs for which the grants are intended to compensate. The Company recorded $0.1 million of the proceeds as a reduction of research and development expense during the three months ended March 31, 2023. As of March 31, 2023, the Company recorded $1.4 million as deferred liabilities in the consolidated balance sheet related to the PanCAN Grant. |
Cash, cash equivalents and rest
Cash, cash equivalents and restricted cash | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, 2023 December 31, 2022 Cash and cash equivalents $ 97,260 $ 74,933 Restricted cash 1,489 856 Total cash, cash equivalents and restricted cash $ 98,749 $ 75,789 Amounts included in restricted cash as of March 31, 2023 and December 31, 2022 represent (i) cash received pursuant to the PanCAN Grant restricted for future expenditures for specific research and development activities of $1.2 million and $0.6 million, respectively, 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. Cash received pursuant to the PanCAN Grant is included in prepaid expenses and other current assets on the condensed consolidated balance sheets as of March 31, 2023 and December 31, 2022. The letters of credit are included in non-current restricted cash on the condensed consolidated balance sheets as of March 31, 2023 and December 31, 2022. |
Fair value of financial instrum
Fair value of financial instruments | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, 2023 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 78,301 $ 70,824 $ 7,477 $ — Short-term investments 13,944 — 13,944 — Total financial assets $ 92,245 $ 70,824 $ 21,421 $ — Preferred stock tranche liability $ 3,510 $ — $ — $ 3,510 December 31, 2022 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 73,613 $ 72,617 $ 996 $ — Short-term investments 12,961 — 12,961 — Total financial assets $ 86,574 $ 72,617 $ 13,957 $ — 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 March 31, 2023 or December 31, 2022. A preferred stock tranche liability was recorded as a result of the entry into the Securities Purchase Agreement (defined herein) (see Note 11. Capital Stock) Below are the inputs used to value the preferred stock tranche liability at January 24, 2023 and March 31, 2023: March 31, 2023 January 24, 2023 Risk-free interest rate 4.45 4.94 % 4.41 4.84 % Volatility 95 % 90 % Dividend yield — — Remaining term (years) 1.3 1.5 The following table represents a reconciliation of the preferred stock right liability recorded in connection with the entry into the Securities Purchase Agreement: January 1, 2023 $ — Fair value recognized upon entering into Securities Purchase Agreement 6,940 Fair value adjustment (3,430) March 31, 2023 $ 3,510 Fair Value of Financial Instruments The fair value of the Company’s 2018 issued 5.00% Convertible Senior Notes due 2048 (the “2018 Notes”) was approximately $0.3 million as of March 31, 2023 and December 31, 2022, which equals the carrying value of the 2018 Notes on each date. The fair value of the 2018 Notes is influenced by the Company’s stock price, stock price volatility, and current market yields and was determined using Level 3 inputs. The fair value of the Company’s long-term debt is 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 $39.1 million as of March 31, 2023, which differs from the carrying value of $39.6 million. The Company estimates that the fair value of its long-term debt was approximately $24.9 million as of December 31, 2022, which differs from the carrying value of $24.5 million. The fair value of the Company’s long-term debt was determined using Level 3 inputs. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments | |
Investments | 5. Investments Cash, cash equivalents, restricted cash and investments consist of the following (in thousands): March 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 91,271 $ — $ — $ 91,271 Corporate bonds, agency bonds and commercial paper (due within 90 days ) 7,476 2 — 7,478 Total cash, cash equivalents & restricted cash: $ 98,747 $ 2 $ — $ 98,749 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 13,940 $ 4 $ — $ 13,944 Total investments $ 13,940 $ 4 $ — $ 13,944 Total cash, cash equivalents, restricted cash and investments $ 112,687 $ 6 $ — $ 112,693 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 74,794 $ — $ — $ 74,794 Corporate bonds, agency bonds and commercial paper (due within 90 days ) 995 — $ — 995 Total cash, cash equivalents & restricted cash: $ 75,789 $ — $ — $ 75,789 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 12,961 $ 2 $ (2) $ 12,961 Total investments $ 12,961 $ 2 $ (2) $ 12,961 Total cash, cash equivalents, restricted cash and investments $ 88,750 $ 2 $ (2) $ 88,750 There were no realized gains or losses on investments for the three months ended March 31, 2023 or 2022. 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 separately within the prepaid expenses and other current assets on the condensed consolidated balance sheets at March 31, 2023 and December 31, 2022. There were no investments in an unrealized loss position as of March 31, 2023. There were two debt securities in an unrealized loss position as of December 31, 2022. None of these investments had been in an unrealized loss position for more than 12 months as of December 31, 2022. The fair value of these securities as of December 31, 2022 was $6.0 million and the aggregate unrealized loss was immaterial. 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, 2022, the Company has 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, 2022. |
Accrued expenses
Accrued expenses | 3 Months Ended |
Mar. 31, 2023 | |
Accrued expenses | |
Accrued expenses | 6. Accrued expenses Accrued expenses consist of the following (in thousands): March 31, 2023 December 31, 2022 Research and development expenses $ 8,952 $ 8,535 Compensation and related benefits 1,786 3,844 Professional fees 972 469 Consulting fees 991 902 Interest 204 192 Commercialization costs 90 148 Other 943 893 Total accrued expenses $ 13,938 $ 14,983 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2023 | |
Long-term debt | |
Debt | 7. Debt On March 25, 2022 (the “Closing Date”), the Company entered into a loan and security agreement (the “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”). Pursuant to the Loan Agreement, the Company received an initial Term Loan of $25.0 million on the Closing Date and may borrow an additional $125.0 million of Term Loans at its option upon the satisfaction of certain conditions as follows: i. $15.0 million (the “Term B Loan”), when the Company has either (a) received the Regulatory Milestone Payment (as defined in the Secura APA) from Secura of $35.0 million which is due upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma (“PTCL”) or (b) received at least $50.0 million in unrestricted cash proceeds from the sale or issuance of equity securities after the Closing Date (the “Term B Milestones”). The Company may draw the Term B Loan within 60 days after the occurrence of one of the Term B Milestones, but no later than March 31, 2023. ii. $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, 2024. iii. $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. iv. $50.0 million (the “Term E Loan”), at the sole discretion of the Lenders. On March 22, 2023, the Company elected to draw down the $15.0 million Term B Loan, having received at least $50.0 million in unrestricted cash proceeds from the sale or issuance of equity securities. 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 PTCL, 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 March 31, 2023. 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 . March 31, 2023 December 31, 2022 Principal loan balance $ 40,000 $ 25,000 Final Payment Fee 304 225 Debt issuance costs, net of accretion (730) (699) Long-term debt, net of discount $ 39,574 $ 24,526 Three months ended March 31, 2023 2022 Contractual Interest $ 632 $ 41 Amortization of debt discount and issuance costs 58 10 Amortization of Final Payment Fee 79 5 Total $ 769 $ 56 As of March 31, 2023, future principal payments due are as follows (in thousands): 2023 — 2024 — 2025 15,000 2026 20,000 2027 5,000 Total principal payments $ 40,000 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023, a right-of-use asset of $1.6 million and lease liability of $2.1 million are reflected on the condensed consolidated balance sheets. The elements of lease expense were as follows (dollar amounts in thousands): Three months ended March 31, 2023 2022 Lease Expense Operating lease expense $ 221 $ 221 Total Lease Expense $ 221 $ 221 Other Information - Operating Leases Operating cash flows paid for amounts included in measurement of lease liabilities $ 262 $ 257 March 31, 2023 Other Balance Sheet Information - Operating Leases Weighted average remaining lease term (in years) 2.3 Weighted average discount rate 14.6% Maturity Analysis 2023 798 2024 1,081 2025 546 Total $ 2,425 Less: Present value discount (346) Lease Liability $ 2,079 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable [Abstract] | |
Notes Payable | 9. Notes Payable |
Convertible senior notes
Convertible senior notes | 3 Months Ended |
Mar. 31, 2023 | |
Convertible Senior Notes | |
Convertible Senior Notes | 10. Convertible Senior Notes 2018 Notes approximately $7.16 per share of common stock. Upon conversion, converting noteholders will be entitled to receive accrued interest on their converted 2018 Notes. The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends, but will not be adjusted for any accrued and unpaid interest. Prior to November 1, 2022, the Company did not have the right to redeem the 2018 Notes. After November 1, 2022, the Company may elect to redeem the 2018 Notes, in whole or in part, at a cash redemption price equal to the principal amount of the 2018 Notes to be redeemed, plus accrued and unpaid interest, if any. Unless the Company has previously called all outstanding 2018 Notes for redemption, the 2018 Notes will be subject to repurchase by the Company at the holders’ option on each of November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043 (or, if any such date is not a business day, on the next business day) at a cash repurchase price equal to the principal amount of the 2018 Notes to be repurchased, plus accrued and unpaid interest, if any. If a “Fundamental Change” (as defined in the 2018 Indenture) occurs at any time, subject to certain conditions, holders may require the Company to purchase all or any portion of their 2018 Notes at a purchase price equal to 100% of the principal amount of the 2018 Notes to be purchased, plus accrued and unpaid interest. The 2018 Indenture includes customary covenants and set forth certain events of default after which the 2018 Notes may be declared immediately due and payable and set forth certain types of bankruptcy or insolvency events of default involving the Company or certain of its subsidiaries after which the 2018 Notes become automatically due and payable. The Company determined that the expected life of the 2018 Notes was equal to the period through November 1, 2023, as this represents the point at which the 2018 Notes are subject to repurchase by the Company at the option of the holders. Accordingly, for the 2018 Notes, the total debt discount, inclusive of the fair value of the embedded conversion feature derivative at issuance is being amortized using the effective interest method through November 1, 2023 at the effective interest rate of 15.65% . March 31, 2023 December 31, 2022 2018 Notes principal balance $ 300 $ 300 Debt issuance costs, net of accretion (18) (25) 2018 Notes, net $ 282 $ 275 2019 Notes 2020 Notes |
Capital stock
Capital stock | 3 Months Ended |
Mar. 31, 2023 | |
Capital stock | |
Capital stock | 11. Capital 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. Series B Convertible Preferred Stock 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 42.3657 shares of the Company’s common stock, 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 $0.5901 per share of common stock). 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 $0.75 per share of common stock) 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 $1.125 per share (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 within 18 months from the closing date of the initial tranche. (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 March 31, 2023, 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 ASC 480 and determined that it met the requirements for separate accounting from the initial issuance of Series B Convertible Preferred Stock as a freestanding financial instrument. The Company then determined the Second Tranche Right should be liability classified pursuant to ASC 480. As a result, the Company classified the Second Tranche Right as a non-current liability within the condensed consolidated balance sheets and the Second Tranche Right was initially recorded at fair value and is subsequently re-measured at fair value at the end of each reporting period. The fair value of the Second Tranche Right on the date of issuance was determined to be $6.9 million based on a Monte-Carlo valuation and the Company allocated $6.9 million of the Series B Convertible Preferred Stock Proceeds to this liability and recorded this amount as preferred stock tranche liability. On March 31, 2023, the fair value of the Second Tranche Right was determined to be $3.5 million, and the Company recorded this amount as preferred stock tranche liability on the condensed consolidated balance sheets. The Company recorded the mark-to-market adjustment of $3.4 million under change in fair value of preferred stock tranche liability within the condensed consolidated statements of operations and loss. 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 March 31, 2023. 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 10,000,000 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 10 shares of 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 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 Preferred Stock. Holders of the Series A 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 will 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 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. |
Stock-based compensation
Stock-based compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-based compensation | |
Stock-based compensation | 12. Stock-based compensation Stock options A summary of the Company’s stock option activity and related information for the three months ended March 31, 2023 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, 2022 14,018,610 $ 2.80 7.1 $ 18 Granted 9,925,247 0.66 Forfeited/cancelled (98,248) 2.21 Expired (130,000) 9.80 Outstanding at March 31, 2023 23,715,609 $ 1.87 8.1 $ 20 Vested at March 31, 2023 9,132,740 $ 3.09 6.1 $ 5 The fair value of each stock option granted during the three months ended March 31, 2023 and 2022 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions: Three months ended March 31, 2023 2022 Risk-free interest rate 3.56 % 2.18 % Volatility 90 % 87 % Dividend yield — — Expected term (years) 6.2 5.6 Restricted stock units A summary of the Company’s restricted stock unit activity and related information for the three months ended March 31, 2023 is as follows: Shares Weighted-average grant date fair value per share Outstanding at December 31, 2022 2,074,967 $ 2.09 Granted 96,700 $ 0.54 Vested (228,824) $ 2.18 Forfeited/cancelled (15,000) $ 1.13 Outstanding at March 31, 2023 1,927,843 $ 2.08 Employee stock purchase plan Three months ended March 31, 2023 2022 Risk-free interest rate 4.77 % 0.22 % Volatility 106 % 50 % Dividend yield — — Expected term (years) 0.5 0.5 $0.1 |
Net loss per share
Net loss per share | 3 Months Ended |
Mar. 31, 2023 | |
Net loss per share | |
Net loss per share | 13. 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. 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 2018 Notes, Series A Convertible Preferred Stock, and Series B Convertible Preferred Stock (using the “if-converted” method), unless their effect on net loss per share is anti-dilutive. 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 March 31, 2023 2022 Outstanding stock options 23,715,609 15,943,060 Outstanding restricted stock units 1,927,843 2,599,205 2018 Notes 41,873 41,873 Employee stock purchase plan 81,629 51,050 Series A Convertible Preferred Stock 10,000,000 — Series B Convertible Preferred Stock 50,838,840 — Total potentially dilutive securities 86,605,794 18,635,188 |
License, collaboration and comm
License, collaboration and commercial agreements | 3 Months Ended |
Mar. 31, 2023 | |
License, collaboration and commercial agreements | |
License, collaboration and commercial agreements | 14. 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 PTCL 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 PTCL, (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 the following bundled performance obligation under the Secura APA: ● 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. The Company determined $0.1 million of future potential royalties the Company expects to receive pursuant to the Secura APA were not constrained as of March 31, 2023. When estimating the amount of royalties to be received that were not constrained, the Company used the expected value method as there are a range of possible outcomes. When estimating royalties to be received, the Company used a combination of internal projections and forecasts and data from external sources. The Company determined that all other future potential royalties were constrained under the guidance as of March 31, 2023. As part of the Company’s evaluation of the constraint on future royalties, the Company considered a number of factors in determining whether there is significant uncertainty associated with future events that would result in royalty payments. Those factors include: the likelihood and magnitude of revenue reversals related to future royalties, the amount of variable consideration is highly susceptible to factors outside of the Company’s influence, the amount of time to resolve the uncertainty, and lack of significant history of selling COPIKTRA outside of the United States. As the consideration for future royalties is conditional, the Company recorded a corresponding contract asset for the expected royalties. Portions of the contract asset are reclassified to accounts receivable when the right to consideration becomes unconditional. As of March 31, 2023 and December 31, 2022, the contract asset has been recorded within prepaid and other current assets on the condensed consolidated balance sheets. The following table presents changes in the Company’s contract asset for the three months ended March 31, 2023 (in thousands): Contract Asset: December 31, 2022 Additions Reclassification to receivable March 31, 2023 Contract asset - Secura $ 96 $ — $ (34) $ 62 Total $ 96 $ — $ (34) $ 62 During the first quarter of 2023, the Company determined all future potential milestones were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of March 31, 2023. As part of the Company’s evaluation of the constraint, the Company considered a number of 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. During the three months ended March 31, 2022, the Company recognized $2.6 million of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss. The sale of COPIKTRA license and related assets revenue for the three months ended March 31, 2022 primarily related to one regulatory milestone for $2.5 million achieved by Secura’s sublicensee, CSPC, and $0.1 million related to royalties on COPIKTRA sales in the three months ended March 31, 2022 and future royalties expected to be received pursuant to the Secura APA that were not constrained. |
Income taxes
Income taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income taxes | |
Income taxes | 15. Income taxes |
Commitments and contingencies
Commitments and contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and contingencies | |
Commitments and contingencies | 16. Commitments and contingencies The Company has no other commitments other than minimum lease payments as disclosed in Note 8 Leases. |
Subsequent events
Subsequent events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent events. | |
Subsequent events | 17. 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. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 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 months ended March 31, 2023 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2023. 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, 2022, as filed with the Securities and Exchange Commission (“SEC”) on March 14, 2023. |
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 expected to support 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 will evaluate whether combining avutometinib (to target mutant 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. Through March 31, 2023, the Company has received $1.8 million of cash proceeds in which was initially recorded as deferred liabilities on the balance sheet. 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 entity recognizes as expenses the related costs for which the grants are intended to compensate. The Company recorded $0.1 million of the proceeds as a reduction of research and development expense during the three months ended March 31, 2023. As of March 31, 2023, the Company recorded $1.4 million as deferred liabilities in the consolidated balance sheet related to the PanCAN Grant. |
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 March 31, 2023, 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 March 31, 2023, the Company did not have an accounts receivable balance. For the three months ended March 31, 2023, the Company did not record any revenue. |
Recently Issued Accounting Standards Updates | Recently Adopted Accounting Standards Updates In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will replace the incurred loss impairment methodology under current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Effective January 1, 2023, the Company adopted the provisions of ASU 2016-13. The adoption did not have a material impact on the Company's condensed consolidated financial statements or related financial statement disclosures. In August 2020, the FASB issued No. ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The ASU also simplifies the diluted earnings per share calculation in certain areas. The Company elected to adopt this standard on January 1, 2023 under the modified retrospective transition method. The adoption did not have a material impact on the Company's condensed consolidated financial statements or related financial statement disclosures. In September 2022, the FASB issued ASU 2022-04, Liabilities—Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations (“ASU 2022-04”). ASU 2022-04 requires the buyer in a supplier finance program to disclose information about the key terms of the program, outstanding confirmed amounts as of the end of the period, a rollforward of such amounts during each annual period, and a description of where in the financial statements outstanding amounts are presented. This guidance is effective for fiscal years beginning after December 15, 2022. We adopted this guidance as of January 1, 2023, on a prospective basis. The adoption of the standard only resulted in new disclosures for amounts presented within Notes Payable and did not affect the Company’s recognition, measurement, or financial statement presentation of supplier finance program obligations on the condensed consolidated financial statements. For additional information on the new disclosures, see Note 9 , Notes Payable . |
Significant Accounting Policies | Significant Accounting Policies No te 2 . Significant accounting policies in the |
Cash, cash equivalents and re_2
Cash, cash equivalents and restricted cash (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, 2023 December 31, 2022 Cash and cash equivalents $ 97,260 $ 74,933 Restricted cash 1,489 856 Total cash, cash equivalents and restricted cash $ 98,749 $ 75,789 |
Fair value of financial instr_2
Fair value of financial instruments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, 2023 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 78,301 $ 70,824 $ 7,477 $ — Short-term investments 13,944 — 13,944 — Total financial assets $ 92,245 $ 70,824 $ 21,421 $ — Preferred stock tranche liability $ 3,510 $ — $ — $ 3,510 December 31, 2022 Description Total Level 1 Level 2 Level 3 Financial assets Cash equivalents $ 73,613 $ 72,617 $ 996 $ — Short-term investments 12,961 — 12,961 — Total financial assets $ 86,574 $ 72,617 $ 13,957 $ — |
Schedule of derivative liability reconciliation | March 31, 2023 January 24, 2023 Risk-free interest rate 4.45 4.94 % 4.41 4.84 % Volatility 95 % 90 % Dividend yield — — Remaining term (years) 1.3 1.5 |
Schedule of reconciliation of derivative liability | January 1, 2023 $ — Fair value recognized upon entering into Securities Purchase Agreement 6,940 Fair value adjustment (3,430) March 31, 2023 $ 3,510 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments | |
Schedule of cash, cash equivalents and investments | Cash, cash equivalents, restricted cash and investments consist of the following (in thousands): March 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 91,271 $ — $ — $ 91,271 Corporate bonds, agency bonds and commercial paper (due within 90 days ) 7,476 2 — 7,478 Total cash, cash equivalents & restricted cash: $ 98,747 $ 2 $ — $ 98,749 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 13,940 $ 4 $ — $ 13,944 Total investments $ 13,940 $ 4 $ — $ 13,944 Total cash, cash equivalents, restricted cash and investments $ 112,687 $ 6 $ — $ 112,693 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Cash, cash equivalents & restricted cash: Cash and money market accounts $ 74,794 $ — $ — $ 74,794 Corporate bonds, agency bonds and commercial paper (due within 90 days ) 995 — $ — 995 Total cash, cash equivalents & restricted cash: $ 75,789 $ — $ — $ 75,789 Investments: Corporate bonds, agency bonds and commercial paper (due within 1 year ) $ 12,961 $ 2 $ (2) $ 12,961 Total investments $ 12,961 $ 2 $ (2) $ 12,961 Total cash, cash equivalents, restricted cash and investments $ 88,750 $ 2 $ (2) $ 88,750 |
Accrued expenses (Tables)
Accrued expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued expenses | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): March 31, 2023 December 31, 2022 Research and development expenses $ 8,952 $ 8,535 Compensation and related benefits 1,786 3,844 Professional fees 972 469 Consulting fees 991 902 Interest 204 192 Commercialization costs 90 148 Other 943 893 Total accrued expenses $ 13,938 $ 14,983 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Long-term debt | |
Schedule of carrying value of debt | March 31, 2023 December 31, 2022 Principal loan balance $ 40,000 $ 25,000 Final Payment Fee 304 225 Debt issuance costs, net of accretion (730) (699) Long-term debt, net of discount $ 39,574 $ 24,526 |
Schedule of interest expenses | Three months ended March 31, 2023 2022 Contractual Interest $ 632 $ 41 Amortization of debt discount and issuance costs 58 10 Amortization of Final Payment Fee 79 5 Total $ 769 $ 56 |
Schedule of future principal payments under the Loan Agreement | As of March 31, 2023, future principal payments due are as follows (in thousands): 2023 — 2024 — 2025 15,000 2026 20,000 2027 5,000 Total principal payments $ 40,000 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases | |
Summary of elements of lease expenses | Three months ended March 31, 2023 2022 Lease Expense Operating lease expense $ 221 $ 221 Total Lease Expense $ 221 $ 221 Other Information - Operating Leases Operating cash flows paid for amounts included in measurement of lease liabilities $ 262 $ 257 March 31, 2023 Other Balance Sheet Information - Operating Leases Weighted average remaining lease term (in years) 2.3 Weighted average discount rate 14.6% Maturity Analysis 2023 798 2024 1,081 2025 546 Total $ 2,425 Less: Present value discount (346) Lease Liability $ 2,079 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 three months ended March 31, 2023 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, 2022 14,018,610 $ 2.80 7.1 $ 18 Granted 9,925,247 0.66 Forfeited/cancelled (98,248) 2.21 Expired (130,000) 9.80 Outstanding at March 31, 2023 23,715,609 $ 1.87 8.1 $ 20 Vested at March 31, 2023 9,132,740 $ 3.09 6.1 $ 5 |
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 three months ended March 31, 2023 and 2022 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions: Three months ended March 31, 2023 2022 Risk-free interest rate 3.56 % 2.18 % Volatility 90 % 87 % Dividend yield — — Expected term (years) 6.2 5.6 |
Schedule of restricted stock units | A summary of the Company’s restricted stock unit activity and related information for the three months ended March 31, 2023 is as follows: Shares Weighted-average grant date fair value per share Outstanding at December 31, 2022 2,074,967 $ 2.09 Granted 96,700 $ 0.54 Vested (228,824) $ 2.18 Forfeited/cancelled (15,000) $ 1.13 Outstanding at March 31, 2023 1,927,843 $ 2.08 |
Schedule of assumptions used to estimate fair value of each employee stock purchase plan on grant date | Three months ended March 31, 2023 2022 Risk-free interest rate 4.77 % 0.22 % Volatility 106 % 50 % Dividend yield — — Expected term (years) 0.5 0.5 |
Net loss per share (Tables)
Net loss per share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 2022 Outstanding stock options 23,715,609 15,943,060 Outstanding restricted stock units 1,927,843 2,599,205 2018 Notes 41,873 41,873 Employee stock purchase plan 81,629 51,050 Series A Convertible Preferred Stock 10,000,000 — Series B Convertible Preferred Stock 50,838,840 — Total potentially dilutive securities 86,605,794 18,635,188 |
License, collaboration and co_2
License, collaboration and commercial agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
License, collaboration and commercial agreements | |
Schedule of contract assets | The following table presents changes in the Company’s contract asset for the three months ended March 31, 2023 (in thousands): Contract Asset: December 31, 2022 Additions Reclassification to receivable March 31, 2023 Contract asset - Secura $ 96 $ — $ (34) $ 62 Total $ 96 $ — $ (34) $ 62 |
Nature of business (Details)
Nature of business (Details) - USD ($) $ in Thousands | Mar. 25, 2022 | Mar. 31, 2023 | Dec. 31, 2022 |
Nature of business | |||
Cash, cash equivalents, and investments | $ 111,200 | ||
Accumulated deficit | $ 753,237 | $ 737,523 | |
Term loan | |||
Nature of business | |||
Issuance of debt | $ 25,000 |
Summary of significant accoun_3
Summary of significant accounting policies - Proceeds from grants (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Aug. 31, 2022 | May 31, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | |
Summary of significant accounting policies | ||||
Grant awarded, amount | $ 3,800 | |||
Cash proceeds | $ 500 | $ 1,800 | ||
Reduction of research and development expense | 100 | |||
Deferred liabilities | $ 1,403 | $ 710 |
Summary of significant accoun_4
Summary of significant accounting policies - Concentrations of credit risk and off-balance sheet risk (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Aug. 31, 2022 | May 31, 2022 | Mar. 31, 2023 | |
Concentrations of credit risk and off-balance sheet risk | |||
Off-balance sheet concentrations of credit risk description | As of March 31, 2023, 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 March 31, 2023, the Company did not have an accounts receivable balance. For the three months ended March 31, 2023, the Company | ||
Grant awarded, amount | $ 3,800 | ||
Cash proceeds | $ 500 | $ 1,800 | |
Reduction of research and development expense | 100 | ||
Deferred liabilities | $ 693 |
Cash, cash equivalents and re_3
Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 97,260 | $ 74,933 | ||
Restricted cash | 241 | 241 | ||
Restricted cash | 1,489 | 856 | ||
Total cash, cash equivalents and restricted cash | 98,749 | 75,789 | $ 46,928 | $ 21,493 |
Prepaid Expenses and Other Current Assets | ||||
Property, Plant and Equipment [Line Items] | ||||
Restricted cash | 1,200 | $ 600 | ||
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 |
Fair value of financial instr_3
Fair value of financial instruments - Financial Instruments Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Financial assets | ||
Preferred stock tranche liability | $ 3,510 | |
Level 3 | ||
Financial assets | ||
Preferred stock tranche liability | 3,510 | |
Recurring basis | ||
Financial assets | ||
Cash equivalents | 78,301 | $ 73,613 |
Short-term investments | 13,944 | 12,961 |
Total financial assets | 92,245 | 86,574 |
Preferred stock tranche liability | 3,510 | |
Recurring basis | Level 1 | ||
Financial assets | ||
Cash equivalents | 70,824 | 72,617 |
Total financial assets | 70,824 | 72,617 |
Recurring basis | Level 2 | ||
Financial assets | ||
Cash equivalents | 7,477 | 996 |
Short-term investments | 13,944 | 12,961 |
Total financial assets | 21,421 | $ 13,957 |
Recurring basis | Level 3 | ||
Financial assets | ||
Preferred stock tranche liability | $ 3,510 |
Fair value of financial instr_4
Fair value of financial instruments (Details) $ in Thousands | Nov. 30, 2023 | Mar. 31, 2023 USD ($) | Jan. 24, 2023 | Dec. 31, 2022 USD ($) | Oct. 17, 2018 |
Financial liabilities | |||||
Long-term debt | $ 39,574 | $ 24,526 | |||
Debt, carrying value | $ 40,000 | 25,000 | |||
2018 Notes principle balance | |||||
Financial liabilities | |||||
Interest rate (as a percent) | 15.65% | 5% | 5% | ||
Debt, carrying value | $ 300 | 300 | |||
Level 3 | 2018 Notes principle balance | |||||
Financial liabilities | |||||
Fair value of long-term debt | 24,900 | ||||
Debt, fair value | 300 | ||||
Long-term debt | 39,600 | $ 24,500 | |||
Level 3 | Term loan | |||||
Financial liabilities | |||||
Fair value of long-term debt | $ 39,100 | ||||
Risk-free interest rate | Maximum | |||||
Financial liabilities | |||||
Debt Instrument, Measurement Input | 0.0494 | 0.0484 | |||
Risk-free interest rate | Minimum | |||||
Financial liabilities | |||||
Debt Instrument, Measurement Input | 0.0445 | 0.0441 | |||
Volatility | |||||
Financial liabilities | |||||
Debt Instrument, Measurement Input | 0.95 | 0.9 | |||
Remaining term | |||||
Financial liabilities | |||||
Remaining term (years) | 1 year 4 months | 1 year 6 months |
Fair value of financial instr_5
Fair value of financial instruments - Preferred stock right liability (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Financial assets | |
Fair value recognized upon entering into Securities Purchase Agreement | $ 6,940 |
Fair value adjustment | 3,430 |
March 31, 2023 | 3,510 |
Level 3 | |
Financial assets | |
Fair value recognized upon entering into Securities Purchase Agreement | 6,940 |
Fair value adjustment | (3,430) |
March 31, 2023 | $ 3,510 |
Investments (Details)
Investments (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) item | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) item | |
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | $ 97,260 | $ 74,933 | |
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Gains | 6 | 2 | |
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Losses | $ (2) | ||
Total cash, cash equivalents, restricted cash and investments, Fair Value | 111,200 | ||
Accrued interest receivable | 100 | ||
Realized gains or losses on investments | $ 0 | $ 0 | |
Number of investments in unrealized loss position | item | 2 | ||
Number of investments in unrealized loss position for more than 12 months | item | 0 | 0 | |
Fair value less than 12 months | $ 6,000 | ||
Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Total cash, cash equivalents, restricted cash and investments, Amortized Cost | $ 112,687 | 88,750 | |
Total | |||
Schedule of Investments [Line Items] | |||
Total cash, cash equivalents, restricted cash and investments, Fair Value | $ 112,693 | $ 88,750 | |
Corporate bonds, agency bonds and commercial paper (due within 90 days) | |||
Schedule of Investments [Line Items] | |||
Original maturity period, cash and cash equivalents | 90 days | 90 days | |
Gross Unrealized Gains | $ 2 | ||
Corporate bonds, agency bonds and commercial paper (due within 90 days) | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 7,476 | ||
Corporate bonds, agency bonds and commercial paper (due within 90 days) | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | $ 7,478 | ||
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 | $ 4 | $ 2 | |
Gross Unrealized Losses | (2) | ||
Corporate bonds, agency bonds and commercial paper (due within 1 year) | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Due within 1 year, Amortized Cost | 13,940 | 12,961 | |
Corporate bonds, agency bonds and commercial paper (due within 1 year) | Total | |||
Schedule of Investments [Line Items] | |||
Due within 1 year, Fair Value | 13,944 | 12,961 | |
Investments. | |||
Schedule of Investments [Line Items] | |||
Gross Unrealized Gains | 4 | 2 | |
Gross Unrealized Losses | (2) | ||
Investments. | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Investments, Amortized Cost | 13,940 | 12,961 | |
Investments. | Total | |||
Schedule of Investments [Line Items] | |||
Investments, Fair Value | 13,944 | 12,961 | |
Cash and money market accounts. | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 91,271 | 74,794 | |
Cash and money market accounts. | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | 91,271 | 74,794 | |
Corporate bonds, agency bonds and commercial paper | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 995 | ||
Corporate bonds, agency bonds and commercial paper | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | 995 | ||
Cash, cash equivalents & restricted cash | |||
Schedule of Investments [Line Items] | |||
Gross Unrealized Gains | 2 | ||
Cash, cash equivalents & restricted cash | Amortized Cost | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Amortized Cost | 98,747 | 75,789 | |
Cash, cash equivalents & restricted cash | Total | |||
Schedule of Investments [Line Items] | |||
Cash, cash equivalents & restricted cash, Fair Value | $ 98,749 | $ 75,789 |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued expenses | ||
Research and development expenses | $ 8,952 | $ 8,535 |
Compensation and related benefits | 1,786 | 3,844 |
Professional fees | 972 | 469 |
Consulting fees | 991 | 902 |
Interest | 204 | 192 |
Commercialization costs | 90 | 148 |
Other | 943 | 893 |
Total accrued expenses | $ 13,938 | $ 14,983 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Millions | Mar. 22, 2023 | Mar. 25, 2022 |
Loan Agreement | ||
Long-term debt | ||
Financial covenants | $ 0 | |
Accrued interest rate | 5% | |
Term loan | ||
Long-term debt | ||
Aggregate principal amount | $ 150 | |
Issuance of debt | 25 | |
Current borrowing capacity | $ 125 | |
Percentage of final prepayment fee | 5% | |
Additional interest rate in an event of default | 0.50% | |
Term loan | Secured Overnight Financing Rate | ||
Long-term debt | ||
Interest rate | 7.37% | |
Basis spread | 0.13% | |
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 | ||
Aggregate principal amount | $ 15 | $ 15 |
Regulatory milestone payments | 35 | |
Minimum unrestricted cash proceeds from sale or issuance of equity securities | $ 50 | $ 50 |
Debt instrument period to draw loan, Minimum | 60 days | |
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 |
Long-term debt - Components of
Long-term debt - Components of carrying value of debt (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Long-term debt | ||
Principal loan balance | $ 40,000 | $ 25,000 |
Final Payment Fee | 304 | 225 |
Debt issuance costs, net of accretion | (730) | (699) |
Long-term debt, net of discount | $ 39,574 | $ 24,526 |
Debt - Schedule of interest exp
Debt - Schedule of interest expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Long-term debt | ||
Contractual Interest | $ 632 | $ 41 |
Amortization of debt discount and issuance costs | 58 | 10 |
Amortization of Final Payment Fee | 79 | 5 |
Interest Expense, Total | $ 769 | $ 56 |
Long-term debt - Future princip
Long-term debt - Future principal payments (Details) $ in Thousands | Mar. 31, 2023 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 | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Leases | |||
Right-of use asset | $ 1,645 | $ 1,789 | |
Lease liability | 2,079 | ||
Lease Expense | |||
Operating lease expense | 221 | $ 221 | |
Total Lease Expense | 221 | 221 | |
Other Information - Operating Leases | |||
Operating cash flows paid for amounts included in measurement of lease liabilities | $ 262 | $ 257 | |
Weighted average remaining lease term (in years) | 2 years 3 months 18 days | ||
Weighted average discount rate | 14.60% | ||
Maturity Analysis | |||
2023 | $ 798 | ||
2024 | 1,081 | ||
2025 | 546 | ||
Total | 2,425 | ||
Less: Present value discount | (346) | ||
Lease Liability | $ 2,079 |
Notes Payable (Details)
Notes Payable (Details) - AFCO - USD ($) $ in Millions | 1 Months Ended | |
Feb. 28, 2023 | Mar. 31, 2023 | |
Short-Term Debt [Line Items] | ||
Aggregate principal amount | $ 1.4 | |
Interest rate (as a percent) | 7.40% | |
Monthly payments | $ 0.1 | |
Note Payable | $ 1 |
Convertible Senior Notes - Sche
Convertible Senior Notes - Schedule of Notes Carrying Value (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Convertible Notes | |||
Debt, carrying value | $ 40,000 | $ 25,000 | |
Amortization of debt discount and issuance costs | (58) | $ (10) | |
2018 Notes principle balance | |||
Convertible Notes | |||
Debt, carrying value | 300 | 300 | |
Amortization of debt discount and issuance costs | (18) | (25) | |
Convertible senior notes | $ 282 | $ 275 |
Convertible Senior Notes (Detai
Convertible Senior Notes (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||||
Nov. 06, 2020 USD ($) | Oct. 17, 2018 USD ($) D $ / shares | Mar. 31, 2023 USD ($) $ / shares | Mar. 31, 2022 USD ($) | Dec. 31, 2019 USD ($) | Nov. 30, 2023 | Dec. 31, 2022 USD ($) $ / shares | Mar. 31, 2020 USD ($) | |
Convertible Notes | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Percentage price of principal amount to be purchased plus accrued and unpaid interest | 100% | |||||||
Other Nonoperating Income (Expenses) | $ (7) | $ 28 | ||||||
Notes outstanding | 39,574 | $ 24,526 | ||||||
Debt, carrying value | $ 40,000 | 25,000 | ||||||
2018 Notes principle balance | ||||||||
Convertible Notes | ||||||||
Aggregate principal amount | $ 150,000 | |||||||
Interest rate (as a percent) | 5% | 5% | 15.65% | |||||
Net proceeds | $ 145,300 | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Initial conversion rate | 139.5771 | |||||||
Initial conversion price of Common Stock | $ / shares | $ 7.16 | |||||||
Percentage of stock price trigger for conversion | 130% | |||||||
Trading days | D | 20 | |||||||
Consecutive trading days | D | 30 | |||||||
Debt, carrying value | $ 300 | $ 300 | ||||||
2019 Notes | ||||||||
Convertible Notes | ||||||||
Debt Conversion, Original Debt, Amount | $ 121,700 | |||||||
Debt Conversion, Converted Instrument, Amount | 66,900 | |||||||
Repayments of Convertible Debt | $ 12,100 | |||||||
Interest rate (as a percent) | 5% | |||||||
Debt, carrying value | $ 0 | |||||||
2018 Notes, net | ||||||||
Convertible Notes | ||||||||
Aggregate principal amount | $ 28,000 | |||||||
Debt Conversion, Converted Instrument, Amount | $ 28,000 | |||||||
Interest rate (as a percent) | 5% |
Capital stock (Details)
Capital stock (Details) $ / shares in Units, $ in Thousands | Mar. 31, 2023 USD ($) shares | Jan. 24, 2023 USD ($) tranche D $ / shares shares | Nov. 04, 2022 $ / shares shares |
Class of Stock [Line Items] | |||
Preferred Stock, Shares Authorized | shares | 5,000,000 | ||
Preferred stock tranche liability | $ | $ 3,510 | ||
SeriesA Convertible Preferred Stock | |||
Class of Stock [Line Items] | |||
Convertible preferred stock, shares issued upon conversion | shares | 10 | ||
Conversion of preferred stock, conversion blocker, percent | 9.99% | ||
Conversion of Preferred Stock, Conversion Blocker, Notice Period | 60 days | ||
Series B Convertible Preferred Stock | |||
Class of Stock [Line Items] | |||
Convertible preferred stock, shares issued upon conversion | shares | 42.3657 | ||
Conversion of preferred stock, conversion blocker, percent | 9.99% | ||
Conversion of Preferred Stock, Conversion Blocker, Notice Period | 60 days | ||
Threshold share price | $ / shares | $ 31.77 | ||
Expected closing period of issuance | 10 days | ||
Liquidation preference per share | $ / shares | $ 1 | ||
Fair value of the Second Tranche Right | $ | 3,500 | $ 6,900 | |
Preferred stock tranche liability | $ | $ 6,900 | ||
Mark-to-market adjustment under change in fair value of preferred stock tranche liability | $ | $ 3,400 | ||
Series B Convertible Preferred Stock | Private placement | |||
Class of Stock [Line Items] | |||
Shares issued | shares | 944,160 | ||
Conversion price | $ / shares | $ 0.5901 | ||
Gross proceeds | $ | $ 30,000 | ||
Threshold share price | $ / shares | $ 1.125 | ||
Share price (in dollars per share) | $ / shares | $ 0.75 | ||
Share issue period | 10 days | ||
Threshold trading volume | $ | $ 25,000 | ||
Trading days | D | 7 | ||
Maximum | SeriesA Convertible Preferred Stock | |||
Class of Stock [Line Items] | |||
Conversion of Preferred Stock, Conversion Blocker, Percent, Upon Giving Notice | 19.99% | ||
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) | $ / shares | $ 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) | $ / shares | $ 25 | ||
BVP | Common stock | |||
Class of Stock [Line Items] | |||
Conversion of stock, shares converted | shares | 10,000,000 | ||
BVP | SeriesA Convertible Preferred Stock | |||
Class of Stock [Line Items] | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||
Shares issued on conversion | shares | 1,000,000 |
Stock-based compensation - Stoc
Stock-based compensation - Stock Options (Details) - Stock options - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Shares | |||
Outstanding at the beginning of the period (in shares) | 14,018,610 | ||
Granted (in shares) | 9,925,247 | ||
Forfeited/cancelled (in shares) | (98,248) | ||
Expired | (130,000) | ||
Outstanding at the end of the period (in shares) | 23,715,609 | 14,018,610 | |
Vested at the end of the period (in shares) | 9,132,740 | ||
Weighted-average exercise price per share | |||
Outstanding at the beginning of the period (in dollars per share) | $ 2.80 | ||
Granted (in dollars per share) | 0.66 | ||
Forfeited/cancelled (in dollars per share) | 2.21 | ||
Expired (in dollars per share) | 9.80 | ||
Outstanding at the end of the period (in dollars per share) | 1.87 | $ 2.80 | |
Vested at the end of the period (in dollars per share) | $ 3.09 | ||
Weighted-average remaining contractual term | |||
Outstanding at the end of the period | 8 years 1 month 6 days | 7 years 1 month 6 days | |
Vested at the end of the period | 6 years 1 month 6 days | ||
Aggregate intrinsic value | |||
Outstanding at the beginning of the period (in dollars) | $ 18 | ||
Outstanding at the end of the period (in dollars) | 20 | $ 18 | |
Vested at the end of the period (in dollars) | $ 5 | ||
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Risk-free interest rate (as a percent) | 3.56% | 2.18% | |
Volatility (as a percent) | 90% | 87% | |
Expected term (years) | 6 years 2 months 12 days | 5 years 7 months 6 days |
Stock-based compensation - Rest
Stock-based compensation - Restricted Stock (Details) - Restricted stock units | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Shares | |
Outstanding at the beginning of the period (in shares) | shares | 2,074,967 |
Granted (in shares) | shares | 96,700 |
Vested (in shares) | shares | (228,824) |
Forfeited/cancelled (in shares) | shares | (15,000) |
Outstanding at the end of the period (in shares) | shares | 1,927,843 |
Weighted-average grant date fair value | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 2.09 |
Granted (in dollars per share) | $ / shares | 0.54 |
Vested (in dollars per share) | $ / shares | 2.18 |
Forfeited/cancelled (in dollars per share) | $ / shares | 1.13 |
Outstanding at the end of the period (in dollars per share) | $ / shares | $ 2.08 |
Stock-based compensation - Empl
Stock-based compensation - Employee Stock Purchase Plan (Details) $ in Thousands | 3 Months Ended | ||
Jun. 21, 2019 item shares | Mar. 31, 2023 USD ($) shares | Mar. 31, 2022 USD ($) | |
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 | $ 29 | $ 100 | |
Employee Stock purchase plan | |||
Stock-based compensation | |||
Percent of common stock at market price to be purchased | 85% | ||
Number of vesting periods | item | 2 | ||
Vesting period | 6 months | ||
Shares reserved for issuance | shares | 2,000,000 | ||
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Risk-free interest rate (as a percent) | 4.77% | 0.22% | |
Volatility (as a percent) | 106% | 50% | |
Dividend yield (as a percent) | 0% | 0% | |
Expected term (years) | 6 months | 6 months | |
Issuance of common stock under ESPP | shares | 82,496 | ||
Proceeds from the exercise of stock options and employee stock purchase program | $ 29 | ||
Employee Stock purchase plan | Maximum | |||
Assumptions used to estimate fair value of each stock-based award on the grant date | |||
Stock-based compensation expense | $ 100 | $ 100 |
Net loss per share - Potentiall
Net loss per share - Potentially dilutive securities were excluded from the calculation of diluted net loss per share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 86,605,794 | 18,635,188 |
Outstanding stock options | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 23,715,609 | 15,943,060 |
Restricted stock units | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 1,927,843 | 2,599,205 |
2018 Notes. | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 41,873 | 41,873 |
Employee Stock Purchase Plan | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 81,629 | 51,050 |
Series A Preferred Stock | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 10,000,000 | |
Series B Preferred Stock | ||
Net loss per share | ||
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares) | 50,838,840 |
License, collaboration and co_3
License, collaboration and commercial agreements - Secura (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Sep. 30, 2020 USD ($) | Mar. 31, 2022 USD ($) Milestone | Mar. 31, 2023 USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Revenue recognized | $ 2,596 | ||
License and Collaboration Agreement | Secura | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Upfront payment | $ 70,000 | ||
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% | ||
Future potential royalties expected to be received | $ 100 | ||
Revenue recognized | 2,600 | ||
License and Collaboration Agreement | Secura | Sale of COPIKTRA license and related assets | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Regulatory milestone payments | 2,500 | ||
Proceeds related to royalties | $ 100 | ||
Number of regulatory milestone achieved | Milestone | 1 | ||
License and Collaboration Agreement | Secura | Sales Exceeds $100 Million | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Sales milestone receivable | $ 10,000 | ||
Threshold sales to trigger milestone payments | 100,000 | ||
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] | |||
Regulatory milestone payments | 45,000 | ||
Sales milestone receivable | $ 50,000 |
License, collaboration and co_4
License, collaboration and commercial agreements - Secura - Contract asset (Details) - License and Collaboration Agreement $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Balance at the beginning of period | $ 96 |
Reclassification to receivable | (34) |
Balance at the end of period | 62 |
Secura | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Balance at the beginning of period | 96 |
Reclassification to receivable | (34) |
Balance at the end of period | $ 62 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income taxes | ||
Income tax expense | $ 0 | $ 0 |
Commitments and contingencies (
Commitments and contingencies (Details) $ in Millions | Mar. 31, 2023 USD ($) |
Commitments and contingencies | |
Other commitments | $ 0 |