Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36296 | |
Entity Registrant Name | Carisma Therapeutics Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-2025616 | |
Entity Address, Address Line One | 3675 Market Street | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Philadelphia | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19104 | |
City Area Code | 267 | |
Local Phone Number | 491-6422 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | CARM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 40,284,845 | |
Entity Central Index Key | 0001485003 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 |
Unaudited Consolidated Balance
Unaudited Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 76,353 | $ 24,194 |
Marketable securities | 40,725 | 27,802 |
Prepaid expenses and other assets | 5,122 | 2,596 |
Total current assets | 122,200 | 54,592 |
Property and equipment, net | 7,590 | 8,628 |
Right of use assets – operating leases | 3,047 | 4,822 |
Restricted cash | 30 | 0 |
Deferred financing costs | 146 | 4,111 |
Total assets | 133,013 | 72,153 |
Current liabilities: | ||
Accounts payable | 2,487 | 1,728 |
Accrued expenses | 9,614 | 10,361 |
Deferred revenue | 1,416 | 2,459 |
Operating lease liabilities | 2,486 | 3,437 |
Finance lease liabilities | 1,215 | 1,162 |
Other current liabilities | 755 | 523 |
Total current liabilities | 17,973 | 19,670 |
Deferred revenue | 45,000 | 45,000 |
Convertible promissory note | 0 | 33,717 |
Derivative liability | 0 | 5,739 |
Operating lease liabilities | 920 | 976 |
Finance lease liabilities | 606 | 872 |
Other long-term liabilities | 1,809 | 1,041 |
Total liabilities | 66,308 | 107,015 |
Commitments and contingencies (Note 5) | ||
Convertible preferred stock | 0 | 107,808 |
Stockholders’ equity (deficit): | ||
Common stock $0.001 par value, 350,000,000 shares authorized, 40,269,576 and 2,217,737 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 40 | 2 |
Additional paid-in capital | 269,141 | 1,197 |
Accumulated other comprehensive income (loss) | 265 | (41) |
Accumulated deficit | (202,741) | (158,223) |
Total Carisma Therapeutics Inc. stockholders’ equity (deficit) | 66,705 | (157,065) |
Noncontrolling interests | 0 | 14,395 |
Total stockholders’ equity (deficit) | 66,705 | (142,670) |
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ 133,013 | $ 72,153 |
Unaudited Consolidated Balanc_2
Unaudited Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 |
Common stock, shares issued (in shares) | 40,269,576 | 2,217,737 |
Common stock, shares outstanding (in shares) | 40,269,576 | 2,217,737 |
Unaudited Consolidated Statemen
Unaudited Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Collaboration revenues | $ 3,560 | $ 2,703 | $ 6,803 | $ 3,525 |
Operating expenses: | ||||
Research and development | 18,518 | 14,212 | 35,159 | 22,979 |
General and administrative | 6,007 | 2,424 | 15,581 | 4,635 |
Total operating expenses | 24,525 | 16,636 | 50,740 | 27,614 |
Operating loss | (20,965) | (13,933) | (43,937) | (24,089) |
Change in fair value of derivative liability | 0 | (144) | (84) | (701) |
Interest income (expense), net | 1,177 | (771) | (300) | (1,370) |
Pre-tax loss | (19,788) | (14,848) | (44,321) | (26,160) |
Income tax expense | (88) | 0 | (197) | 0 |
Net loss | $ (19,876) | $ (14,848) | $ (44,518) | $ (26,160) |
Share information: | ||||
Net loss per share of common stock, basic (in usd per share) | $ (0.49) | $ (7.20) | $ (1.67) | $ (12.69) |
Net loss per share of common stock, diluted (in usd per share) | $ (0.49) | $ (7.20) | $ (1.67) | $ (12.69) |
Weighted-average shares of common stock outstanding, basic (in shares) | 40,258,107 | 2,061,643 | 26,596,712 | 2,060,819 |
Weighted-average shares of common stock outstanding, diluted (in shares) | 40,258,107 | 2,061,643 | 26,596,712 | 2,060,819 |
Comprehensive loss | ||||
Net loss | $ (19,876) | $ (14,848) | $ (44,518) | $ (26,160) |
Unrealized gain (loss) on marketable securities | 129 | (39) | 306 | (197) |
Comprehensive loss | $ (19,747) | $ (14,887) | $ (44,212) | $ (26,357) |
Unaudited Consolidated Statem_2
Unaudited Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Noncontrolling interests |
Beginning balance (in shares) at Dec. 31, 2021 | 8,700,885 | |||||
Beginning balance at Dec. 31, 2021 | $ 107,808 | |||||
Ending balance (in shares) at Mar. 31, 2022 | 8,700,885 | |||||
Ending balance at Mar. 31, 2022 | $ 107,808 | |||||
Beginning balance (in shares) at Dec. 31, 2021 | 2,059,072 | |||||
Beginning balance at Dec. 31, 2021 | (81,784) | $ 2 | $ 816 | $ 0 | $ (96,997) | $ 14,395 |
Stockholders' Equity (Deficit) | ||||||
Exercise of stock options (in shares) | 2,572 | |||||
Stock-based compensation | 89 | 89 | ||||
Unrealized gain (loss) on marketable securities | (158) | (158) | ||||
Net loss | (11,312) | (11,312) | ||||
Ending balance (in shares) at Mar. 31, 2022 | 2,061,644 | |||||
Ending balance at Mar. 31, 2022 | $ (93,165) | $ 2 | 905 | (158) | (108,309) | 14,395 |
Beginning balance (in shares) at Dec. 31, 2021 | 8,700,885 | |||||
Beginning balance at Dec. 31, 2021 | $ 107,808 | |||||
Ending balance (in shares) at Jun. 30, 2022 | 8,700,885 | |||||
Ending balance at Jun. 30, 2022 | $ 107,808 | |||||
Beginning balance (in shares) at Dec. 31, 2021 | 2,059,072 | |||||
Beginning balance at Dec. 31, 2021 | (81,784) | $ 2 | 816 | 0 | (96,997) | 14,395 |
Stockholders' Equity (Deficit) | ||||||
Net loss | (26,160) | |||||
Ending balance (in shares) at Jun. 30, 2022 | 2,061,644 | |||||
Ending balance at Jun. 30, 2022 | $ (107,994) | $ 2 | 963 | (197) | (123,157) | 14,395 |
Beginning balance (in shares) at Mar. 31, 2022 | 8,700,885 | |||||
Beginning balance at Mar. 31, 2022 | $ 107,808 | |||||
Ending balance (in shares) at Jun. 30, 2022 | 8,700,885 | |||||
Ending balance at Jun. 30, 2022 | $ 107,808 | |||||
Beginning balance (in shares) at Mar. 31, 2022 | 2,061,644 | |||||
Beginning balance at Mar. 31, 2022 | (93,165) | $ 2 | 905 | (158) | (108,309) | 14,395 |
Stockholders' Equity (Deficit) | ||||||
Stock-based compensation | 58 | 58 | ||||
Unrealized gain (loss) on marketable securities | (39) | (39,000) | ||||
Net loss | (14,848) | (14,848) | ||||
Ending balance (in shares) at Jun. 30, 2022 | 2,061,644 | |||||
Ending balance at Jun. 30, 2022 | $ (107,994) | $ 2 | 963 | (197) | (123,157) | 14,395 |
Beginning balance (in shares) at Dec. 31, 2022 | 8,700,885 | |||||
Beginning balance at Dec. 31, 2022 | $ 107,808 | |||||
Convertible preferred stock | ||||||
Conversion of convertible preferred stock and non-controlling interests to common stock (in shares) | (8,700,885) | |||||
Conversion of convertible preferred stock and non-controlling interests to common stock | $ (107,808) | |||||
Ending balance (in shares) at Mar. 31, 2023 | 0 | |||||
Ending balance at Mar. 31, 2023 | $ 0 | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 2,217,737 | |||||
Beginning balance at Dec. 31, 2022 | (142,670) | $ 2 | 1,197 | (41) | (158,223) | 14,395 |
Stockholders' Equity (Deficit) | ||||||
Stock-based compensation | 265 | 265 | ||||
Unrealized gain (loss) on marketable securities | 177 | 177 | ||||
Issuance of common stock for cash in pre-closing financing (in shares) | 3,730,608 | |||||
Issuance of common stock for cash in pre-closing financing | 30,640 | $ 4 | 30,636 | |||
Issuance of common stock upon settlement of convertible promissory note, accrued interest, and related derivative liability (in shares) | 5,059,338 | |||||
Issuance of common stock upon settlement of convertible promissory note, accrued interest, and related derivative liability | 42,447 | $ 5 | 42,442 | |||
Issuance of common stock to Sesen Bio shareholders in reverse capitalization (in shares) | 10,374,272 | |||||
Issuance of common stock to Sesen Bio shareholders in reverse capitalization | 72,044 | $ 10 | 72,034 | |||
Conversion of convertible preferred stock and non-controlling interests to common stock (in shares) | 18,872,711 | |||||
Conversion of convertible preferred stock and non-controlling interests to common stock | 107,809 | $ 19 | 122,185 | (14,395) | ||
Net loss | (24,642) | (24,642) | ||||
Ending balance (in shares) at Mar. 31, 2023 | 40,254,666 | |||||
Ending balance at Mar. 31, 2023 | $ 86,070 | $ 40 | 268,759 | 136 | (182,865) | 0 |
Beginning balance (in shares) at Dec. 31, 2022 | 8,700,885 | |||||
Beginning balance at Dec. 31, 2022 | $ 107,808 | |||||
Ending balance (in shares) at Jun. 30, 2023 | 0 | |||||
Ending balance at Jun. 30, 2023 | $ 0 | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 2,217,737 | |||||
Beginning balance at Dec. 31, 2022 | $ (142,670) | $ 2 | 1,197 | (41) | (158,223) | 14,395 |
Stockholders' Equity (Deficit) | ||||||
Exercise of stock options (in shares) | 14,910 | |||||
Net loss | $ (44,518) | |||||
Ending balance (in shares) at Jun. 30, 2023 | 40,269,576 | |||||
Ending balance at Jun. 30, 2023 | $ 66,705 | $ 40 | 269,141 | 265 | (202,741) | 0 |
Beginning balance (in shares) at Mar. 31, 2023 | 0 | |||||
Beginning balance at Mar. 31, 2023 | $ 0 | |||||
Ending balance (in shares) at Jun. 30, 2023 | 0 | |||||
Ending balance at Jun. 30, 2023 | $ 0 | |||||
Beginning balance (in shares) at Mar. 31, 2023 | 40,254,666 | |||||
Beginning balance at Mar. 31, 2023 | 86,070 | $ 40 | 268,759 | 136 | (182,865) | 0 |
Stockholders' Equity (Deficit) | ||||||
Exercise of stock options (in shares) | 14,910 | |||||
Exercise of stock options | 52 | 52 | ||||
Stock-based compensation | 330 | 330 | ||||
Unrealized gain (loss) on marketable securities | 129 | 129 | ||||
Net loss | (19,876) | (19,876) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 40,269,576 | |||||
Ending balance at Jun. 30, 2023 | $ 66,705 | $ 40 | $ 269,141 | $ 265 | $ (202,741) | $ 0 |
Unaudited Consolidated Statem_3
Unaudited Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (44,518) | $ (26,160) |
Adjustment to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation and amortization expense | 1,420 | 463 |
Stock-based compensation expense | 595 | 147 |
Reduction in the operating right of use assets | 2,683 | 1,620 |
Amortization of debt discount | 1,283 | 1,305 |
Change in fair value of derivative liability | 84 | 701 |
Accretion on marketable securities | (569) | 0 |
Non-cash interest expense | 68 | 4 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,210) | (1,324) |
Accounts payable | 659 | 674 |
Accrued expenses | (1,618) | (484) |
Deferred revenue | (1,043) | 45,447 |
Operating lease liabilities | (1,915) | (2,088) |
Net cash (used in) provided by operating activities | (44,081) | 20,305 |
Cash flows from investing activities: | ||
Purchase of marketable securities | (34,460) | (42,103) |
Proceeds from the sale of marketable securities | 67,000 | 0 |
Purchases of property and equipment | (382) | (2,038) |
Net cash provided by (used in) investing activities | 32,158 | (44,141) |
Cash flows from financing activities: | ||
Cash, cash equivalents and restricted cash acquired in connection with the reverse recapitalization | 37,903 | 0 |
Payment of reverse recapitalization finance costs | (5,202) | 0 |
Proceeds from the issuance of common stock in pre-closing financing | 30,640 | 0 |
Payment of principal related to finance lease liabilities | (213) | (17) |
Proceeds from failed sale-leaseback arrangement | 1,020 | 0 |
Payment of finance liability from failed sale-leaseback arrangement | (88) | 0 |
Proceeds from issuance of convertible promissory note | 0 | 35,000 |
Proceeds from the exercise of stock options | 52 | 0 |
Net cash provided by financing activities | 64,112 | 34,983 |
Net increase in cash, cash equivalents and restricted cash | 52,189 | 11,147 |
Cash, cash equivalents and restricted cash at beginning of the period | 24,194 | 28,551 |
Cash, cash equivalents and restricted cash at end of the period | 76,383 | 39,698 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 88 | 0 |
Supplemental disclosure of non-cash financing and investing activities: | ||
Conversion of convertible preferred stock and non-controlling interests upon Merger | 122,204 | 0 |
Conversion of convertible promissory note, accrued interest and derivative liability upon Merger | 42,447 | 0 |
Reverse recapitalization costs in accrued expenses | 611 | 0 |
Unrealized gain (loss) on marketable securities | 306 | (197) |
Deferred financing costs in accounts payable | 86 | 0 |
Deferred financing costs in accrued expenses | 60 | 0 |
Right-of-use assets obtained in exchange for new operating lease liabilities | 908 | 6,437 |
Right-of-use assets obtained in exchange for new financing lease liabilities | 0 | 268 |
Allocation of debt proceeds to derivative liability | 0 | 3,820 |
Property and equipment in accounts payable | $ 0 | $ 993 |
Background
Background | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background | Background Carisma Therapeutics Inc., a Delaware Corporation (collectively with its subsidiaries, the Company), is a clinical-stage cell therapy company focused on utilizing the Company’s proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. The Company has created a comprehensive cell therapy platform to enable the therapeutic use of engineered macrophages and monocytes, which belong to a subgroup of white blood cells called myeloid cells. The Company’s initial focus is its proprietary Chimeric Antigen Receptor Macrophage (CAR-M) cell therapy platform, which redirects macrophages against specific tumor associated antigens and enables targeted anti-tumor immunity by utilizing genetically modifying myeloid cells (macrophages and monocytes) to express chimeric antigen receptors (CARs), enabling the potent innate immune cells to recognize specific tumor-associated antigens on the surface of tumor cells. The Company’s initial product candidates, CT-0508 and CT-0525 are ex vivo autologous cell therapy product candidates, wherein immune cells from blood drawn from a patient are engineered outside of the body and reinfused into the same patient. The Company also has research programs to develop allogeneic and in vivo cell therapy macrophage products. The Company’s lead product candidate, CT-0508, is the first CAR-M to be evaluated in a human clinical trial and is intended to treat solid tumors that overexpress HER2, a protein that is overexpressed on the surface of a variety of solid tumors, including breast cancer, gastric cancer, esophageal cancer, salivary gland cancer, and numerous others. It has been granted “Fast Track” status for the treatment of patients with HER2 overexpressing solid tumors by the United States Food and Drug Administration (FDA). CT-0508 is currently being studied in a multi-center open label Phase 1 clinical trial in the United States (U.S.). This ongoing first-in-human study evaluates the safety, tolerability and manufacturing feasibility of CT-0508 along with several customary exploratory secondary endpoints. The Company has completed enrollment of the first group of patients in this trial, with nine patients having been successfully dosed over a five-day dosing schedule. In November 2022, the Company presented preliminary clinical results from the first group of patients. CT-0508 was successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and has shown high CAR expression, viability, and purity. In addition, CT-0508 has been generally well-tolerated after infusion with no dose-limiting toxicities reported to date from the nine patients enrolled in the first group. While the results from this early clinical trial data are both preliminary and limited, the Company believes the results indicate that CT-0508 can be detected within the tumor microenvironment (TME), lead to remodeling and activation of the TME, and potentially induce anti-tumor adaptive immunity. In addition to the first group of patients in this study, the Company initiated a second group to evaluate bolus dosing of patients with data anticipated from this group in the second half of 2023. The Company has also initiated several additional sub-studies evaluating CT-0508 in the clinical setting. In addition to monotherapy treatment, the Company has observed synergistic potential of CT-0508 with a PD1 blocking T-cell checkpoint inhibitor in multiple pre-clinical models. As a result of those studies and the preliminary results from group 1 in the Company’s clinical trial, the Company initiated a sub-study to evaluate at least nine patients with the co-administration of CT-0508 and pembrolizumab in the first half of 2023. The Company anticipates the initial data from this sub-study in the second half of 2023. The Company's second product candidate, CT-0525, which also is intended to treat solid tumors that overexpress HER2, is in pre-clinical development and utilizes a novel approach to CAR-M therapy that engineers patients’ monocytes directly, without ex vivo differentiation into macrophages, as the Company currently does for CT-0508. The Company refers to this CAR-Monocyte approach as CAR-Mono. This process enables a single day manufacturing process, enables the ability to manufacture up to ten billion cells from a single apheresis, and leverages an automated, closed-system manufacturing process. In addition, CAR-Mono has the potential to improve upon the potential anti-tumor effect of a CAR-Macrophage. By increasing the cell yield, the CAR-Mono approach enables a larger dose than a CAR-Macrophage. In addition, CT-0525 has the potential for improved persistence and trafficking, all observed pre-clinically. The increased cell yield and the improved persistence and trafficking may improve tumor control. The Company expects to submit an Investigational New Drug Application (IND) to the FDA for CT-0525 in the second half of 2023, initiate clinical development shortly thereafter, and treat the Company's first patient in the first half of 2024. Beyond CT-0508 and CT-0525, the Company has a broad pipeline of cell therapy assets in various stages of pre-clinical development. In addition to the development of ex vivo CAR-M cell therapies, the Company is developing in vivo CAR-M gene therapies, wherein immune cells are directly engineered within the patient’s body. To advance the Company’s in vivo CAR-M therapeutics, the Company established a strategic collaboration with ModernaTX Inc. (Moderna) (Note 10). Reverse Merger with Sesen Bio On March 7, 2023, the Company (formerly publicly-held Sesen Bio, Inc.) consummated a merger with CTx Operations, Inc. (formerly privately-held CARISMA Therapeutics Inc.) (Legacy Carisma) pursuant to an Agreement and Plan of Merger and Reorganization, as amended (the Merger Agreement), by and among the Company, Legacy Carisma and Seahawk Merger Sub, Inc. (Merger Sub), a Delaware corporation and wholly-owned subsidiary of the Company. The Merger Agreement provided for the merger of Merger Sub with and into Legacy Carisma, with Legacy Carisma continuing as a wholly-owned subsidiary of the Company and the surviving corporation of the merger (the Merger). Pursuant to the Merger Agreement, the Company changed its name from “Sesen Bio, Inc.” to “Carisma Therapeutics Inc.” At the closing of the Merger, (a) each then outstanding share of Legacy Carisma common stock and convertible preferred stock (including shares of Legacy Carisma common stock issued in connection with the pre-closing financing transaction described below) were converted into shares of Sesen Bio common stock at an exchange ratio of 1.8994 shares of Sesen Bio for each share of Legacy Carisma (the Exchange Ratio), and (b) each then outstanding stock option to purchase Legacy Carisma common stock was assumed by Sesen Bio, with necessary adjustments to reflect the Exchange Ratio. Except as otherwise indicated, references herein to “Carisma,” the “Company,” or the “Combined Company,” refer to Carisma Therapeutics Inc. on a post-Merger basis, and references to “Legacy Carisma” refer to the business of privately-held CARISMA Therapeutics Inc. prior to the completion of the Merger. References to “Sesen Bio” refer to Sesen Bio, Inc. prior to the completion of the Merger. Following the Merger, the shareholders of Legacy Carisma held 74.2% of the Combined Company and the shareholders of Sesen Bio held 25.8% of the Combined Company. Basis of Presentation and Exchange Ratio As discussed in Note 3, the Merger was accounted for as reverse capitalization under which the historical financial statements of the Company prior to the Merger are Legacy Carisma. All common stock, per share and related information presented in the consolidated financial statements and notes prior to the Merger has been retroactively adjusted to reflect the Exchange Ratio. |
Development-Stage Risks and Liq
Development-Stage Risks and Liquidity | 6 Months Ended |
Jun. 30, 2023 | |
Development-Stage Risks and Liquidity | |
Development-Stage Risks and Liquidity | Development-Stage Risks and Liquidity The Company has incurred losses since inception and has an accumulated deficit of $202.7 million as of June 30, 2023. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales from its product candidates currently in development. Management believes that cash, cash equivalents and marketable securities of $117.1 million as of June 30, 2023 are sufficient to sustain planned operations through the end of 2024. The Company is subject to those risks associated with any specialty biotechnology company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Interim Financial Statements The summary of significant accounting policies included in the Company’s audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 filed as Exhibit 99.4 to the Company’s Current Report on Form 8-K/A filed with the SEC on April 4, 2023. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). Any references in these notes to applicable guidance is meant to refer to GAAP as found in Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) promulgated by the Financial Accounting Standards Board (FASB). The accompanying unaudited interim consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. In the opinion of management, the accompanying interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the consolidated financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2023 and its results of operations for the three and six months ended June 30, 2023 and 2022. Operating results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The interim consolidated financial statements, presented herein, do not contain all of the required disclosures under GAAP for annual financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 filed as Exhibit 99.4 to the Company’s Current Report on Form 8-K/A filed with the SEC on April 4, 2023. Use of Estimates The preparation of unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include the fair value of the Company’s common stock and the derivative liability prior to the Merger, stock-based compensation assumptions, the estimated useful lives of property and equipment, and accrued research and development expenses. Fair Value of Financial Instruments Management believes that the carrying amounts of the Company’s financial instruments, including cash equivalents and accounts payable, approximate fair value due to the short-term nature of those instruments. The Company considered the carrying value of its convertible promissory note (Note 6) as of December 31, 2022 to approximate fair value due to its short-term nature. The derivative liability was recorded at its estimated fair value prior to its derecognition in March 2023 upon conversion of the associated convertible promissory notes. Fair Value Measurements The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: • Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. • Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The following fair value hierarchy table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: (in thousands) Fair value measurement at reporting date using (Level 1) (Level 2) (Level 3) June 30, 2023 Assets: Cash equivalents – money markets accounts $ 55,217 $ — $ — Marketable securities – U.S. Treasuries $ 40,725 $ — $ — December 31, 2022 Assets: Cash equivalents – money markets accounts $ 7,794 $ — $ — Marketable securities – U.S. Treasuries $ 27,802 $ — $ — Liability: Derivative liability – redemption feature on convertible promissory note $ — $ — $ 5,739 The following is a summary of the Company’s marketable securities as of June 30, 2023: Amortized Gross Fair value Available-for-sale marketable securities U.S. Treasury securities $ 40,460 $ 265 $ 40,725 The table presented below is a summary of the changes in fair value of the Company’s derivative liability associated with the redemption feature of the Company’s convertible promissory note (Level 3 measurement): (in thousands) Six Months Ended June 30, 2023 2022 Balance at the beginning of the period $ 5,739 $ — Balance at issuance — 3,820 Change in fair value 84 701 Derecognition upon conversion of convertible promissory note (5,823) — Balance at the end of the period $ — $ 4,521 During the six months ended June 30, 2023 and 2022, there were no transfers between Level 1, Level 2 and Level 3. Concentration of credit risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents. Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. Net loss per share Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock and stock options, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, potentially dilutive securities are not included in the calculation as their impact is anti-dilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2023 2022 Convertible preferred stock and exchangeable shares — 9,936,148 Stock options 6,655,749 3,610,376 Conversion of convertible promissory note — 3,173,635 6,655,749 16,720,159 Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13 Financial Instruments - Credit Losses , which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. This standard is effective for fiscal years beginning after December 15, 2022. The Company adopted the guidance using a modified retrospective approach as of January 1, 2023 which resulted in no cumulative-effect adjustment to accumulated deficit and did not have a material impact on the Company’s consolidated financial statements. |
Merger with Sesen Bio
Merger with Sesen Bio | 6 Months Ended |
Jun. 30, 2023 | |
Business Combinations [Abstract] | |
Merger with Sesen Bio | Merger with Sesen Bio On March 7, 2023, Legacy Carisma completed the Merger with Sesen Bio as discussed in Note 1. The Merger was accounted for as a reverse recapitalization under GAAP because the primary assets of Sesen Bio were cash, cash equivalents and marketable securities. For financial reporting purposes Legacy Carisma was determined to be the accounting acquirer based upon the terms of the Merger and other factors, including: (i) Legacy Carisma stockholders own approximately 74.2% of the Combined Company, (ii) Legacy Carisma holds the majority (six of seven) of board seats of the Combined Company and (iii) Legacy Carisma management holds all key positions of management. Accordingly, the Merger was treated as the equivalent of Legacy Carisma issuing stock to acquire the net assets of Sesen Bio. As a result of the Merger, the net assets of Sesen Bio were recorded at their acquisition-date fair value in the consolidated financial statements and the reported operating results prior to the Merger are those of Legacy Carisma. Immediately after the Merger, there were 40,254,666 shares of the Company’s common stock outstanding. The following table shows the net assets acquired in the Merger (in thousands): March 7, 2023 Cash and cash equivalents $ 37,873 Marketable securities 44,588 Prepaid expenses and other assets 1,316 Restricted cash 30 Accounts payable and accrued expenses (3,499) Total net assets acquired 80,308 Less: Transaction costs (8,264) Total net assets acquired less transaction costs $ 72,044 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases The Company has operating leases for its laboratory and office space in Philadelphia, Pennsylvania. The Company’s operating leases have term end dates ranging from 2023 to 2029. The Company also has obligations under an arrangement for the use of certain laboratory equipment that are classified as finance leases that commenced in 2022 and have end dates ranging from 2024 to 2025. The Company’s operating and finance lease right-of-use (ROU) assets and the related lease liabilities are initially measured at the present value of future lease payments over the lease term. The Company is responsible for payment of certain real estate taxes, insurance and other expenses on certain of its leases. These amounts are generally considered to be variable and are not included in the measurement of the ROU assets and lease liability. The Company accounts for non-lease components, such as maintenance, separately from lease components. The Company carries laboratory equipment from failed sale leasebacks, as property and equipment, net on the accompanying consolidated balance sheets. The ongoing lease payments are recorded as reductions to the finance liability and interest expense. As of June 30, 2023, the Company had a $2.6 million financing liability recorded in other current liabilities and other long-term liabilities on the unaudited consolidated balance sheet. The elements of the lease costs were as follows (in thousands): Six Months Ended June 30, 2023 2022 Operating lease cost $ 2,875 $ 1,898 Finance lease cost: Amortization of lease assets 593 15 Interest on lease liabilities 88 4 Total finance lease cost 681 19 Total lease cost $ 3,556 $ 1,917 Lease term and discount rate information related to leases was as follows: June 30, 2023 2022 Weighted-average remaining lease term (in years) Operating leases 2.2 2.2 Finance leases 1.7 2.8 Weighted-average discount rate Operating leases 9.6 % 9.3 % Finance leases 9.0 % 9.0 % Supplemental cash flow information was as follows (in thousands): Six Months Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash used in operating leases $ 2,584 $ 2,367 Operating cash used in finance leases $ 88 $ 4 Financing cash used in finance leases $ 213 $ 17 Future maturities of lease liabilities were as follows as of June 30, 2023 (in thousands): Operating Finance Fiscal year ending: 2023 (remaining six months) $ 2,344 $ 1,001 2024 403 600 2025 219 338 2026 226 — 2027 233 — Thereafter 424 — Total future minimum payments 3,849 1,939 Less imputed interest (443) (118) Present value of lease liabilities $ 3,406 $ 1,821 Licensing and Sponsored Research Agreements Under a license agreement with The Trustees of the University of Pennsylvania (Penn), entered into in November 2017 (Penn License Agreement), the Company is required to make annual payments of $10,000 through 2021 and $25,000 in annual payments thereafter. Penn is eligible to receive up to $10.9 million per product in development upon the achievement of certain clinical, regulatory and commercial milestone events. There are additional milestone payments required to be paid of up to $30.0 million per product in commercial milestones and up to an additional $1.7 million in development and regulatory milestone payments for the first CAR-M product directed to mesothelin. Additionally, the Company is obligated to pay Penn single-digit royalties based on its net sales. In March 2023, the Company entered into a manufacturing and supply agreement (Novartis Agreement) with Novartis Pharmaceuticals Corporation (Novartis) for the manufacturing of the Company’s CT-0508 product candidate. The Novartis Agreement is for five years and shall renew automatically for additional one-year periods unless and until terminated by either party. In addition to paying to manufacture the product, the Company will also pay $1.0 million per calendar year, payable in quarterly payments, for reserved capacity starting on the date on which the Novartis site is declared ready to produce CT-0508 as determined by the Company. In the event of termination without cause by the Company, a termination fee equal to $4.0 million will be payable by Carisma to Novartis which, pursuant to the terms of the agreement, can be credited in full against amounts due for a substitute product. Contingencies Liabilities for loss contingencies, arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment and/or remediation can be reasonably estimated. On February 3, 2023, a purported stockholder filed a complaint in the United States District Court for the District of Delaware against Sesen Bio and its board of directors, captioned Plumley v. Sesen Bio, Inc., et al. , Case No. 1:23-cv-00131 (D. Del.) (the Plumley Complaint). The Plumley Complaint asserts claims under Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder for allegedly false and misleading statements in the proxy statement/prospectus filed as part of the Registration Statement in connection with the Merger and under Section 20(a) of the Exchange Act for alleged “control person” liability with respect to such allegedly false and misleading statements and seeks, among other relief, an order enjoining the Merger and an award for plaintiffs’ fees and costs. On February 7, 2023, another purported stockholder filed a complaint in the United States District Court for the Southern District of New York against Sesen Bio and its board of directors, captioned Franchi v. Sesen Bio, Inc., et al. , 1:23-cv-01041 (S.D.N.Y.) (the Franchi Complaint). The Franchi Complaint contains substantially similar allegations and claims and seeks substantially similar relief as the Plumley Complaint. Additionally, on February 9, 2023, another purported stockholder filed a complaint in the United States District Court for the Southern District of New York against Sesen Bio and its board of directors, captioned Menzer v. Sesen Bio, Inc. , et al., 23-cv-01119 (S.D.N.Y.) (the Menzer Complaint). The Menzer Complaint contains substantially similar allegations and claims and seeks substantially similar relief as the Plumley Complaint and the Franchi Complaint. In April 2023, the Company executed a confidential fee agreement to resolve the stockholders’ claim for attorney’s fees and expenses in connection with the Plumley Complaint, Franchi Complaint, and Menzer Complaint. The amount of the confidential fee agreement was reasonably estimated and probable to be incurred as of June 30, 2023, resulting in $0.2 million of claim expenses incurred during the six months ended June 30, 2023. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ Equity On March 7, 2023, in connection with the closing of the Mer ger, the following is reflected on the consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the six months ended June 30, 2023: (i) the sale of 3,730,608 shares of common stock in a pre-closing funding at $8.21 per share for total proceeds of $30.6 million, (ii) the issuance of 5,059,338 shares of common stock upon the settlement of the Company’s $35.0 million convertible promissory note, accrued interest and related derivative liability, (iii) the conversion of convertible preferred stock and exchangeable shares previously presented as noncontrolling interests into 18,872,711 shares of common stock, (iv) the issuance of 10,374,272 shares of common stock to Sesen Bio stockholders as consideration for the Merger. On June 6, 2023, the Company's stockholders approved an amendment to the Company's Restated Certificate of Incorporation to increase the number of authorized shares of the Company's common stock, $0.001 par value, from 100,000,000 shares to 350,000,000 shares. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation 2017 Stock Incentive Plan Legacy Carisma adopted the CARISMA Therapeutics Inc. 2017 Stock Incentive Plan, as amended (the Legacy Carisma Plan), that provided for the grant of incentive stock options to employees, directors, and consultants. The maximum term of options granted under the Legacy Carisma Plan was ten years, and stock options typically vested over a four-year period. The Company’s stock options vest based on the terms in the awards agreements and generally vest over four years. Upon completion of the Merger, the Company assumed the Legacy Carisma Plan and the outstanding and unexercised options issued thereunder, and ceased granting awards under the Legacy Carisma Plan. 2014 Stock Incentive Plan The Sesen Bio, Inc. Amended and Restated 2014 Stock Incentive Plan, as amended (the Sesen Bio 2014 Plan), provides for the grant of incentive and non-qualified stock options, restricted stock awards and restricted stock units, stock appreciation rights and other stock-based awards to the Compan y’s employees, officers, directors, consultants, and advisors, with amounts and terms of grants determined by the Company’s board of directors at the time of grant. Stock options outstanding under the Sesen Bio 2014 Plan generally vest over a four-year period at the rate of 25% of the grant vesting on the first anniversary of the date of grant and 6.25% of the grant vesting at the end of each successive three-month period thereafter. Stock options granted under the Sesen Bio 2014 Plan are exercisable for a period of ten years from the date of grant. On March 7, 2023, the Company amended and restated the Sesen Bio 2014 Plan to (i) change the name of the plan to the Carisma Therapeutics Inc. 2014 Amended and Restated Stock Incentive Plan (the 2014 Plan) and (ii) adopt a new form of stock option agreement and a new form of restricted stock unit agreement for the grant of options and restricted stock units under the 2014 P lan. On June 6, 2023, the Company’s stockholders approved an amendment and restatement of the Company’s 2014 Plan, which amendment and restatement had previously been adopted by the Company’s board of directors, subject to stockholder approval. As of June 30, 2023, approximately 7.0 million shares of common stock remained available for issuance. 2014 Employee Stock Purchase Plan The Sesen Bio 2014 Employee Stock Purchase Plan (the Sesen Bio 2014 ESPP) provides employees with the opportunity to purchase shares of common stock at a 15% discount to the market price through payroll deductions or lump sum cash investments. The purpose of the Sesen Bio 2014 ESPP is to enhance employee interest in the success and progress of the Company by encouraging employee ownership of common stock. On March 7, 2023, the Company amended and restated the Sesen Bio 2014 ESPP to (i) change the name of the plan to Carisma Therapeutics Inc. 2014 Employee Stock Purchase Plan and (ii) restate and integrate a ll prior amendments thereto. As of June 30, 2023, 0.2 million shares of common stock remained available for issuance. The following table summarizes stock option activity for the six months ended June 30, 2023: Options Weighted Weighted Aggregate Outstanding as of December 31, 2022 3,356,937 $ 1.01 Sesen Bio options assumed in the Merger 765,223 27.94 Exercised (14,910) 3.07 Granted 2,747,152 7.17 Forfeited (87,275) 1.46 Expired (111,378) 23.52 Outstanding as of June 30, 2023 6,655,749 $ 6.26 7.5 $ 29,956 Exercisable as of June 30, 2023 2,961,132 $ 6.98 5.2 $ 18,575 Vested and expected to vest at June 30, 2023 6,655,749 $ 6.26 7.5 $ 29,956 The weighted-average grant-date per share fair values of options granted during the six months ended June 30, 2023 and 2022 were $4.43 and $0.75, respectively. The fair values in the six months ended June 30, 2023 and 2022 were estimated using the Black-Scholes option-pricing model based on the following assumptions: Six Months Ended June 30, 2023 2022 Risk-free interest rate 2.92% - 4.03% 2.40% - 3.05% Expected term 6 years 6 years Expected volatility 57.77% - 65.00% 54.54% - 56.50% Expected dividend yield — — Stock-Based Compensation Expense The Company recorded stock-based compensation expense in the following expense categories in its accompanying unaudited consolidated statements of operations: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 24 $ 36 $ 34 $ 77 General and administrative $ 306 $ 22 $ 561 $ 70 $ 330 $ 58 $ 595 $ 147 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesBased on taxable income projections for 2023, the Company expects to have federal and state income tax liabilities for the year. For tax years beginning on or after January 1, 2022, the Tax Cuts and Jobs Act of 2017 (TCJA) eliminates the option to currently deduct research and development expenses and requires taxpayers to capitalize and amortize them over five years for research activities performed in the U.S. and 15 years for research activities performed outside the U.S. pursuant to Section 174 of the Internal Revenue Code (the Code). In addition, the Company is required to recognize tax revenue of $45.0 million in 2023, related to cash received under the Collaboration and License Agreement entered into with Moderna in 2022 (the Moderna License Agreement), for tax purposes in advance of GAAP recognition. The Company also expects limitations on utilization of net operating losses and tax credits under TCJA and/or Sections 382 and 383 of the Code. These requirements temporarily increase the Company’s U.S. federal and state cash tax payments and reduces cash flows in 2023. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related-Party Transactions The Company has outstanding licensing and scientific research agreements with Penn, a significant shareholder (Note 5). The Company recognized $0.2 million of research and development expenses for the three months ended June 30, 2022 related to the Penn License Agreement. No expense was recognized for the three months ended June 30, 2023. The Company recognized $0.3 million and $0.4 million of research and development expenses for the six months ended June 30, 2023 and 2022, respectively, related to the Penn License Agreement. The Company has a collaboration and license agreement with Moderna, a significant shareholder (Note 10). The Company recognized revenue of $3.6 million and $2.7 million for the three months ended June 30, 2023 and 2022, respectively, related to the Moderna License Agreement. The Company recognized revenue of $6.8 million and $3.5 million for the six months ended June 30, 2023 and 2022, respectively, related to the Moderna License Agreement. |
Moderna Collaboration and Licen
Moderna Collaboration and License Agreement | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Moderna Collaboration and License Agreement | Moderna Collaboration and License Agreement In January 2022, the Company entered into the Moderna License Agreement to develop and commercialize in vivo engineered CAR-M therapeutics for different forms of cancer. The Moderna License Agreement allows Moderna to develop and commercialize product candidates for up to twelve research targets. The Company is responsible for discovering and optimizing development candidates, and Moderna is responsible for the clinical development thereafter. Pursuant to the Moderna License Agreement, the Company and Moderna formed a joint steering committee (JSC) that is responsible for the coordination and oversight of all research activities to which the Company is responsible for providing. The JSC is comprised of three representatives each from the Company and Moderna and with Moderna having final decision-making authority, subject to customary exclusions. During the research term of the Moderna License Agreement, the Company has granted Moderna an exclusive worldwide royalty free license to the Company’s intellectual property associated with the product candidates that permits Moderna to conduct its research and development activities. Upon Moderna’s election of a development target (and payment of a related development target designation milestone) for commencement of pre-clinical development of a product candidate, the Company will grant Moderna an exclusive worldwide, sublicensable royalty bearing license to develop, manufacture and commercialize the product candidate. Upon execution of the Moderna License Agreement, Moderna made an upfront non-refundable payment of $45.0 million to the Company. Moderna also will reimburse the Company for all costs incurred by the Company in connection with its research and development activities under the Moderna License Agreement plus a reasonable margin for the respective services performed (with a minimum commitment to reimburse $10.0 million in research and development costs over the first three years from execution of the Moderna License Agreement). In addition, assuming Moderna develops and commercializes 12 products, each directed to a different development target, the Company is eligible to receive up to between $247.0 million and $253.0 million per product in development target designation, development, regulatory and commercial milestone payments. The Company is also eligible to receive tiered mid-to-high single digit royalties of net product sales, subject to adjustment. In addition, Moderna will repay the Company for certain development, regulatory and commercial milestone payments and certain royalty payments pursuant to the Company’s license agreement with the University of Pennsylvania. The Moderna License Agreement terminates on a product-by-product basis upon the latest of expiration of the applicable product patents, expiration of regulatory exclusivity and the tenth anniversary of first commercial sale, unless terminated earlier by the Company or Moderna. At commencement, the Company identified several potential performance obligations within the Moderna License Agreement, including research and development services on research targets, option rights held by Moderna, a non-exclusive royalty-free license to use the Company’s intellectual property to conduct research and development activities and participation on the JSC. The Company determined that there were 2 performance obligations comprised of (i) research and development services and (ii) option rights. For the research and development services, the stand-alone selling price was determined considering the expected passthrough costs and cost of the research and development services and a reasonable margin for the respective services. The material rights from the option rights were valued based on the estimated discount at which the option is priced and the Company’s estimated probability of the options’ exercise as of the time of the agreement. The transaction price allocated to research and development services is recognized as collaboration revenues as the research and development services are provided to satisfy the underlying obligation related to the research and development target. The transfer of control occurs over this period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation. The transaction price allocated to the options rights, which are considered material rights, will be recognized in the period that Moderna elects to exercise or elects to not exercise its option right to license and commercialize the underlying research and development target. The Company included the $45.0 million up-front and nonrefundable payment and $73.9 million of variable consideration for expected research and development services to be performed during the five-year contract term, inclusive of passthrough costs, in the transaction price as of the outset of the arrangement. During the three months ended June 30, 2023 and 2022 the Company recognized $3.6 million and $2.7 million, respectively, of research and development services as collaboration revenues as the Company is the principal in providing such services. During the six months ended June 30, 2023 and 2022 the Company recognized $6.8 million and $3.5 million, respectively, of research and development services as collaboration revenues. The Company recognized $16.6 million of collaboration revenues since inception of the Moderna License Agreement through June 30, 2023. The following table includes estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied as of June 30, 2023 (in thousands): Transaction Performance obligations: Research and development $ 57,816 Option rights 45,000 Total performance obligations $ 102,816 Amounts due to the Company for satisfying the revenue recognition criteria or that are contractually due based upon the terms of the collaboration agreements are recorded as accounts receivable in the Company’s consolidated balance sheet. Contract liabilities consist of amounts received prior to satisfying the revenue recognition criteria, which are recorded as deferred revenue in the Company’s consolidated balance sheet. The following table summarizes the changes in deferred revenue (in thousands): Six Months Ended June 30, 2023 2022 Balance at the beginning of the period $ 47,459 $ — Deferral of revenue 5,760 48,972 Recognition of unearned revenue (6,803) (3,525) Balance at the end of the period $ 46,416 $ 45,447 The current portion of deferred revenue represents advanced payments received from Moderna for costs expected to be incurred by the Company within the next twelve months. The noncurrent portion of deferred revenue represents the $45.0 million upfront, non-refundable and non-creditable payment allocated to customer option right which is not expected to be recognized within the next 12 months. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsThe Company has evaluated subsequent events from the balance sheet date through August 10, 2023, the issuance date of these unaudited interim consolidated financial statements, and has not identified any requiring disclosure. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Interim Financial Statements | Interim Financial Statements The summary of significant accounting policies included in the Company’s audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 filed as Exhibit 99.4 to the Company’s Current Report on Form 8-K/A filed with the SEC on April 4, 2023. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). Any references in these notes to applicable guidance is meant to refer to GAAP as found in Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) promulgated by the Financial Accounting Standards Board (FASB). |
Use of Estimates | Use of Estimates The preparation of unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include the fair value of the Company’s common stock and the derivative liability prior to the Merger, stock-based compensation assumptions, the estimated useful lives of property and equipment, and accrued research and development expenses. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Management believes that the carrying amounts of the Company’s financial instruments, including cash equivalents and accounts payable, approximate fair value due to the short-term nature of those instruments. The Company considered the carrying value of its convertible promissory note (Note 6) as of December 31, 2022 to approximate fair value due to its short-term nature. The derivative liability was recorded at its estimated fair value prior to its derecognition in March 2023 upon conversion of the associated convertible promissory notes. |
Fair Value Measurements | Fair Value Measurements The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: • Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. • Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The following fair value hierarchy table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: (in thousands) Fair value measurement at reporting date using (Level 1) (Level 2) (Level 3) June 30, 2023 Assets: Cash equivalents – money markets accounts $ 55,217 $ — $ — Marketable securities – U.S. Treasuries $ 40,725 $ — $ — December 31, 2022 Assets: Cash equivalents – money markets accounts $ 7,794 $ — $ — Marketable securities – U.S. Treasuries $ 27,802 $ — $ — Liability: Derivative liability – redemption feature on convertible promissory note $ — $ — $ 5,739 The following is a summary of the Company’s marketable securities as of June 30, 2023: Amortized Gross Fair value Available-for-sale marketable securities U.S. Treasury securities $ 40,460 $ 265 $ 40,725 The table presented below is a summary of the changes in fair value of the Company’s derivative liability associated with the redemption feature of the Company’s convertible promissory note (Level 3 measurement): (in thousands) Six Months Ended June 30, 2023 2022 Balance at the beginning of the period $ 5,739 $ — Balance at issuance — 3,820 Change in fair value 84 701 Derecognition upon conversion of convertible promissory note (5,823) — Balance at the end of the period $ — $ 4,521 During the six months ended June 30, 2023 and 2022, there were no transfers between Level 1, Level 2 and Level 3. |
Concentration of credit risk | Concentration of credit risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents. |
Segment information | Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. |
Net loss per share | Net loss per share Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock and stock options, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, potentially dilutive securities are not included in the calculation as their impact is anti-dilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2023 2022 Convertible preferred stock and exchangeable shares — 9,936,148 Stock options 6,655,749 3,610,376 Conversion of convertible promissory note — 3,173,635 6,655,749 16,720,159 |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13 Financial Instruments - Credit Losses , which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. This standard is effective for fiscal years beginning after December 15, 2022. The Company adopted the guidance using a modified retrospective approach as of January 1, 2023 which resulted in no cumulative-effect adjustment to accumulated deficit and did not have a material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value Hierarchy of Assets and Liabilities Measured on Recurring Basis | The following fair value hierarchy table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: (in thousands) Fair value measurement at reporting date using (Level 1) (Level 2) (Level 3) June 30, 2023 Assets: Cash equivalents – money markets accounts $ 55,217 $ — $ — Marketable securities – U.S. Treasuries $ 40,725 $ — $ — December 31, 2022 Assets: Cash equivalents – money markets accounts $ 7,794 $ — $ — Marketable securities – U.S. Treasuries $ 27,802 $ — $ — Liability: Derivative liability – redemption feature on convertible promissory note $ — $ — $ 5,739 |
Schedule of Marketable Securities | The following is a summary of the Company’s marketable securities as of June 30, 2023: Amortized Gross Fair value Available-for-sale marketable securities U.S. Treasury securities $ 40,460 $ 265 $ 40,725 |
Schedule of The Changes in Fair Value of Derivative Liability Associated With The Redemption Feature of Convertible Promissory Note | The table presented below is a summary of the changes in fair value of the Company’s derivative liability associated with the redemption feature of the Company’s convertible promissory note (Level 3 measurement): (in thousands) Six Months Ended June 30, 2023 2022 Balance at the beginning of the period $ 5,739 $ — Balance at issuance — 3,820 Change in fair value 84 701 Derecognition upon conversion of convertible promissory note (5,823) — Balance at the end of the period $ — $ 4,521 |
Schedule of Anti-Dilutive Securities | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2023 2022 Convertible preferred stock and exchangeable shares — 9,936,148 Stock options 6,655,749 3,610,376 Conversion of convertible promissory note — 3,173,635 6,655,749 16,720,159 |
Merger with Sesen Bio (Tables)
Merger with Sesen Bio (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Business Combinations [Abstract] | |
Schedule of Net Assets Acquired in the Merger | The following table shows the net assets acquired in the Merger (in thousands): March 7, 2023 Cash and cash equivalents $ 37,873 Marketable securities 44,588 Prepaid expenses and other assets 1,316 Restricted cash 30 Accounts payable and accrued expenses (3,499) Total net assets acquired 80,308 Less: Transaction costs (8,264) Total net assets acquired less transaction costs $ 72,044 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Costs | The elements of the lease costs were as follows (in thousands): Six Months Ended June 30, 2023 2022 Operating lease cost $ 2,875 $ 1,898 Finance lease cost: Amortization of lease assets 593 15 Interest on lease liabilities 88 4 Total finance lease cost 681 19 Total lease cost $ 3,556 $ 1,917 |
Schedule of Lease Term and Discount Rate Information | Lease term and discount rate information related to leases was as follows: June 30, 2023 2022 Weighted-average remaining lease term (in years) Operating leases 2.2 2.2 Finance leases 1.7 2.8 Weighted-average discount rate Operating leases 9.6 % 9.3 % Finance leases 9.0 % 9.0 % |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information was as follows (in thousands): Six Months Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash used in operating leases $ 2,584 $ 2,367 Operating cash used in finance leases $ 88 $ 4 Financing cash used in finance leases $ 213 $ 17 |
Schedule of Future Maturities of Lease Liabilities | Future maturities of lease liabilities were as follows as of June 30, 2023 (in thousands): Operating Finance Fiscal year ending: 2023 (remaining six months) $ 2,344 $ 1,001 2024 403 600 2025 219 338 2026 226 — 2027 233 — Thereafter 424 — Total future minimum payments 3,849 1,939 Less imputed interest (443) (118) Present value of lease liabilities $ 3,406 $ 1,821 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes stock option activity for the six months ended June 30, 2023: Options Weighted Weighted Aggregate Outstanding as of December 31, 2022 3,356,937 $ 1.01 Sesen Bio options assumed in the Merger 765,223 27.94 Exercised (14,910) 3.07 Granted 2,747,152 7.17 Forfeited (87,275) 1.46 Expired (111,378) 23.52 Outstanding as of June 30, 2023 6,655,749 $ 6.26 7.5 $ 29,956 Exercisable as of June 30, 2023 2,961,132 $ 6.98 5.2 $ 18,575 Vested and expected to vest at June 30, 2023 6,655,749 $ 6.26 7.5 $ 29,956 |
Schedule of Estimated Using The Black-Scholes Option-Pricing Model | The fair values in the six months ended June 30, 2023 and 2022 were estimated using the Black-Scholes option-pricing model based on the following assumptions: Six Months Ended June 30, 2023 2022 Risk-free interest rate 2.92% - 4.03% 2.40% - 3.05% Expected term 6 years 6 years Expected volatility 57.77% - 65.00% 54.54% - 56.50% Expected dividend yield — — |
Schedule of Stock-based Compensation Expense | The Company recorded stock-based compensation expense in the following expense categories in its accompanying unaudited consolidated statements of operations: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 24 $ 36 $ 34 $ 77 General and administrative $ 306 $ 22 $ 561 $ 70 $ 330 $ 58 $ 595 $ 147 |
Moderna Collaboration and Lic_2
Moderna Collaboration and License Agreement (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Estimated Revenue Expected to be Recognized in The Future Related to Performance Obligations | The following table includes estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied as of June 30, 2023 (in thousands): Transaction Performance obligations: Research and development $ 57,816 Option rights 45,000 Total performance obligations $ 102,816 |
Schedule of Changes in Deferred Revenue | The following table summarizes the changes in deferred revenue (in thousands): Six Months Ended June 30, 2023 2022 Balance at the beginning of the period $ 47,459 $ — Deferral of revenue 5,760 48,972 Recognition of unearned revenue (6,803) (3,525) Balance at the end of the period $ 46,416 $ 45,447 |
Background (Details)
Background (Details) | Mar. 07, 2023 |
CARISMA Therapeutics Inc, Legacy, Stockholders | Carisma Therapeutics Inc. | |
Background | |
Exchange ratio of shares of Sesen Bio for each share of Legacy Carisma | 0.742 |
CARISMA Therapeutics Inc, Legacy, Stockholders | Sesen Bio, Inc. | Carisma Therapeutics Inc. | |
Background | |
Common stock at an exchange ratio | 1.8994 |
Sesen Bio Stockholders | Sesen Bio, Inc. | |
Background | |
Ownership interest held after the merge | 25.80% |
Development-Stage Risks and L_2
Development-Stage Risks and Liquidity (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Development-Stage Risks and Liquidity | ||
Accumulated deficit | $ 202,741 | $ 158,223 |
Cash, cash equivalents and marketable securities | $ 117,100 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Fair Value Hierarchy of Assets and Liabilities Measured on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Level 1 | ||
Assets: | ||
Cash equivalents – money markets accounts | $ 55,217 | $ 7,794 |
Marketable securities – U.S. Treasuries | 40,725 | 27,802 |
Liability: | ||
Derivative liability – redemption feature on convertible promissory note | 0 | |
Level 2 | ||
Assets: | ||
Cash equivalents – money markets accounts | 0 | 0 |
Marketable securities – U.S. Treasuries | 0 | 0 |
Liability: | ||
Derivative liability – redemption feature on convertible promissory note | 0 | |
Level 3 | ||
Assets: | ||
Cash equivalents – money markets accounts | 0 | 0 |
Marketable securities – U.S. Treasuries | $ 0 | 0 |
Liability: | ||
Derivative liability – redemption feature on convertible promissory note | $ 5,739 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Marketable Securities (Details) - U.S. Treasury securities $ in Thousands | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Available-for-sale marketable securities | |
Amortized cost | $ 40,460 |
Gross unrealized gain | 265 |
Fair value | $ 40,725 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of The Changes in Fair Value of Derivative Liability Associated With The Redemption Feature of Convertible Promissory Note (Details) - Derivative liability - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Changes in fair value of derivative liabilities | ||
Balance at the beginning of the period | $ 5,739 | $ 0 |
Balance at issuance | 0 | 3,820 |
Change in fair value | 84 | 701 |
Derecognition upon conversion of convertible promissory note | (5,823) | 0 |
Balance at the end of the period | $ 0 | $ 4,521 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Narrative (Details) | 6 Months Ended |
Jun. 30, 2023 segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Anti-Dilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Net loss per share | ||
Anti-dilutive securities (in shares) | 6,655,749 | 16,720,159 |
Convertible preferred stock and exchangeable shares | ||
Net loss per share | ||
Anti-dilutive securities (in shares) | 0 | 9,936,148 |
Stock options | ||
Net loss per share | ||
Anti-dilutive securities (in shares) | 6,655,749 | 3,610,376 |
Conversion of convertible promissory note | ||
Net loss per share | ||
Anti-dilutive securities (in shares) | 0 | 3,173,635 |
Merger with Sesen Bio - Schedul
Merger with Sesen Bio - Schedule of Net Assets Acquired in the Merger (Details) $ in Thousands | 4 Months Ended | ||
Jun. 30, 2023 USD ($) seat shares | Mar. 07, 2023 USD ($) shares | Dec. 31, 2022 shares | |
Merger with Sesen Bio | |||
Number of board seats | seat | 7 | ||
Entity common stock, shares outstanding immediately after merger | shares | 40,269,576 | 2,217,737 | |
Cash and cash equivalents | $ 37,873 | ||
Marketable securities | 44,588 | ||
Prepaid expenses and other assets | 1,316 | ||
Restricted cash | 30 | ||
Accounts payable and accrued expenses | (3,499) | ||
Total net assets acquired | 80,308 | ||
Less: Transaction costs | (8,264) | ||
Total net assets acquired less transaction costs | $ 72,044 | ||
Carisma Therapeutics Inc. | |||
Merger with Sesen Bio | |||
Severance and personnel costs paid | $ 4,600 | ||
CARISMA Therapeutics Inc, Legacy, Stockholders | Carisma Therapeutics Inc. | |||
Merger with Sesen Bio | |||
Business acquisition percentage of voting interests acquired | 74.20% | ||
Entity common stock, shares outstanding immediately after merger | shares | 40,254,666 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Lease Costs (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 2,875 | $ 1,898 |
Finance lease cost: | ||
Amortization of lease assets | 593 | 15 |
Interest on lease liabilities | 88 | 4 |
Total finance lease cost | 681 | 19 |
Total lease cost | $ 3,556 | $ 1,917 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Lease Term and Discount Rate Information (Details) | Jun. 30, 2023 | Jun. 30, 2022 |
Weighted-average remaining lease term (in years) | ||
Operating leases | 2 years 2 months 12 days | 2 years 2 months 12 days |
Finance leases | 1 year 8 months 12 days | 2 years 9 months 18 days |
Weighted-average discount rate | ||
Operating leases | 9.60% | 9.30% |
Finance leases | 9% | 9% |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash used in operating leases | $ 2,584 | $ 2,367 |
Operating cash used in finance leases | 88 | 4 |
Financing cash used in finance leases | $ 213 | $ 17 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Maturities of Lease Liabilities (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Operating Leases | |
2023 (remaining six months) | $ 2,344 |
2024 | 403 |
2025 | 219 |
2026 | 226 |
2027 | 233 |
Thereafter | 424 |
Total future minimum payments | 3,849 |
Less imputed interest | (443) |
Present value of lease liabilities | 3,406 |
Finance Leases | |
2023 (remaining six months) | 1,001 |
2024 | 600 |
2025 | 338 |
Total future minimum payments | 1,939 |
Less imputed interest | (118) |
Present value of lease liabilities | $ 1,821 |
Commitments and Contingencies_5
Commitments and Contingencies - Narratives (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2021 | Mar. 01, 2023 | |
Commitments and Contingencies | ||||
Financing liability | $ 1,821 | |||
Accrued settlement | 200 | |||
Penn License Agreement | Penn | ||||
Commitments and Contingencies | ||||
Annual payments to be made | 25,000 | $ 10,000 | ||
Additional milestone payments for first CAR-M product | 1,700 | |||
Penn License Agreement | Penn | Maximum | ||||
Commitments and Contingencies | ||||
Milestone payments | 10,900 | |||
Additional milestone payments | 30,000 | |||
Novartis Agreement | ||||
Commitments and Contingencies | ||||
Agreement term | 5 years | |||
Renewal term | 1 year | |||
Amount payable per calendar year for reserved capacity | $ 1,000 | |||
Termination fee payable | $ 4,000 | |||
Lab Equipment | ||||
Commitments and Contingencies | ||||
Financing liability | $ 2,600 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||
Mar. 07, 2023 | Mar. 31, 2023 | Jun. 30, 2023 | Jun. 06, 2023 | Jun. 05, 2023 | Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | ||||||
Shares issued in a pre-closing funding (in shares) | 3,730,608 | |||||
Issue price per share (in USD per share) | $ 8.21 | |||||
Value of shares issued in a pre-closing funding | $ 30,600 | |||||
Issuance of common stock upon settlement of convertible promissory note, accrued interest, and related derivative liability (in shares) | 5,059,338 | |||||
Issuance of common stock upon settlement of convertible promissory note, accrued interest, and related derivative liability | $ 35,000 | $ 42,447 | ||||
Shares issued upon conversion of convertible preferred stock and exchangeable shares previously presented as noncontrolling interests (in shares) | 18,872,711 | |||||
Issuance of common stock to Sesen Bio shareholders in reverse capitalization (in shares) | 10,374,272 | |||||
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 | ||||
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 | 100,000,000 | 350,000,000 |
Stock-based Compensation - Narr
Stock-based Compensation - Narratives (Details) shares in Millions | 6 Months Ended |
Jun. 30, 2023 shares | |
Two Thousand Seventeen Stock Incentive Plan | Stock options | |
Stock-based Compensation | |
Vesting period | 4 years |
Two Thousand Seventeen Stock Incentive Plan | Stock options | Maximum | |
Stock-based Compensation | |
Terms | 10 years |
Two Thousand Fourteen Stock Incentive Plan | |
Stock-based Compensation | |
Vesting period | 4 years |
Vesting on first anniversary (as a percent) | 25% |
Vesting at the end of each three-month period after first anniversary (as a percent) | 6.25% |
Shares available for issuance | 7 |
Two Thousand Fourteen Stock Incentive Plan | Stock options | |
Stock-based Compensation | |
Vesting period | 10 years |
Two Thousand Fourteen Employee Stock Purchase Plan | |
Stock-based Compensation | |
Shares available for issuance | 0.2 |
Discount to the market price (as a percent) | 15% |
Stock-based Compensation -Sched
Stock-based Compensation -Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 $ / shares | |
Options | ||
Outstanding as of December 31, 2022 (in shares) | shares | 3,356,937 | |
Sesen Bio options assumed in the Merger (in shares) | shares | 765,223 | |
Exercised (in shares) | shares | (14,910) | |
Granted (in shares) | shares | 2,747,152 | |
Forfeited (in shares) | shares | (87,275) | |
Expired (in shares) | shares | (111,378) | |
Outstanding as of June 30, 2023 (in shares) | shares | 6,655,749 | |
Exercisable as of June 30, 2023 (in shares) | shares | 2,961,132 | |
Vested and expected to vest at June 30, 2023 (in shares) | shares | 6,655,749 | |
Weighted average exercise price | ||
Outstanding as of December 31, 2022 (in USD per share) | $ 1.01 | |
Sesen Bio options assumed in the Merger (in USD per share) | 27.94 | |
Exercised (in USD per share) | 3.07 | |
Granted (in USD per share) | 7.17 | |
Forfeited (in USD per share) | 1.46 | |
Expired (in USD per share) | 23.52 | |
Outstanding as of June 30, 2023 (in USD per share) | 6.26 | |
Exercisable as of June 30, 2023 (in USD per share) | 6.98 | |
Vested and expected to vest at June 30, 2023 (in USD per share) | 6.26 | |
Share based compensation arrangement by share based payment award options grants in period weighted average grant date fair value (in USD per share) | $ 4.43 | $ 0.75 |
Weighted average remaining contractual term (years) | ||
Outstanding as of June 30, 2023 | 7 years 6 months | |
Exercisable as of June 30, 2023 | 5 years 2 months 12 days | |
Vested and expected to vest at June 30, 2023 | 7 years 6 months | |
Aggregate Intrinsic Value | ||
Outstanding as of June 30, 2023 | $ | $ 29,956 | |
Exercisable as of June 30, 2023 | $ | 18,575 | |
Vested and expected to vest at June 30, 2023 | $ | $ 29,956 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Estimated Using The Black-Scholes Option-Pricing Model (Details) - Stock options | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based Compensation | ||
Expected term | 6 years | 6 years |
Expected dividend yield | 0% | 0% |
Minimum | ||
Stock-based Compensation | ||
Risk-free interest rate | 2.92% | 2.40% |
Expected volatility | 57.77% | 54.54% |
Maximum | ||
Stock-based Compensation | ||
Risk-free interest rate | 4.03% | 3.05% |
Expected volatility | 65% | 56.50% |
Stock-based Compensation - Sc_2
Stock-based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based Compensation | ||||
Stock-based compensation expense | $ 330 | $ 58 | $ 595 | $ 147 |
Future compensation cost for awards not vested | 12,700 | $ 12,700 | ||
Weighted-average period compensation cost of unvested awards to be expensed | 3 years 9 months 18 days | |||
Sesen Bio, Inc. | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | $ 200 | |||
Research and development | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | 24 | 36 | 34 | 77 |
General and administrative | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | $ 306 | $ 22 | $ 561 | $ 70 |
Income Taxes (Details)
Income Taxes (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Income Tax Disclosure [Abstract] | |
Tax revenue related to Moderna cash received | $ 45 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Related-Party Transactions | ||||
Research and development | $ 18,518 | $ 14,212 | $ 35,159 | $ 22,979 |
Collaboration revenues | 3,560 | 2,703 | 6,803 | 3,525 |
Penn | ||||
Related-Party Transactions | ||||
Research and development | $ 0 | $ 200 | $ 300 | $ 400 |
Moderna Collaboration and Lic_3
Moderna Collaboration and License Agreement - Narratives (Details) $ in Millions | 1 Months Ended | 6 Months Ended |
Jan. 31, 2022 USD ($) target product representative | Jun. 30, 2023 USD ($) obligation | |
Collaboration and License Agreement | Research and Development Services | ||
Moderna Collaboration and License Agreement | ||
Upfront payment | $ 45 | |
Variable consideration | $ 73.9 | |
Term of contract | 5 years | |
Noncurrent portion of deferred revenue | $ 45 | |
Collaboration and License Agreement | Moderna | ||
Moderna Collaboration and License Agreement | ||
Maximum of Research Targets | target | 12 | |
Number of representatives from each company in joint steering committee | representative | 3 | |
Collaboration and License Agreement | Moderna | Research and Development Services | ||
Moderna Collaboration and License Agreement | ||
Upfront non-refundable payment received | $ 45 | |
Minimum commitment to reimburse research and development costs | $ 10 | |
Period of reimbursement of research and development costs | 3 years | |
Number of products developed and commercialized | product | 12 | |
Number of performance obligations | obligation | 2 | |
Collaboration and License Agreement | Moderna | Minimum | Research and Development Services | ||
Moderna Collaboration and License Agreement | ||
Amount receivable per product | $ 247 | |
Collaboration and License Agreement | Moderna | Maximum | Research and Development Services | ||
Moderna Collaboration and License Agreement | ||
Amount receivable per product | $ 253 | |
Moderna License Agreement | ||
Moderna Collaboration and License Agreement | ||
Collaboration revenues | $ 16.6 |
Moderna Collaboration and Lic_4
Moderna Collaboration and License Agreement - Schedule of Estimated Revenue Expected to be Recognized in The Future Related to Performance Obligations (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Performance obligations: | |
Research and development | $ 57,816 |
Option rights | 45,000 |
Total performance obligations | $ 102,816 |
Moderna Collaboration and Lic_5
Moderna Collaboration and License Agreement - Schedule of Changes in Deferred Revenue (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Balance at the beginning of the period | $ 47,459 | $ 0 |
Deferral of revenue | 5,760 | 48,972 |
Recognition of unearned revenue | (6,803) | (3,525) |
Balance at the ending of the period | $ 46,416 | $ 45,447 |