- \n
- Presented positive updated efficacy and pooled safety data on amsoki-cel in advanced melanoma at the 41st Annual SITC Meeting, including a 67% ORR (n=10\/15), median PFS of 8.3 months and median DOR not yet reached at 14.3 months median study follow-up<\/i><\/li>\n
- Enrollment is ongoing in registration-enabling cohort of the Phase 1\/2 Agni-01 multicenter study, with topline data expected by year-end 2027<\/i><\/li>\n
- Strengthened Board of Directors with appointment of Mark Reisenauer<\/i><\/li>\n
- Cash, cash equivalents, and marketable securities of $324.4 million as of September 30, 2026, with expected cash runway into 2H 2028<\/i><\/li>\n<\/ul>\n
CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nObsidian Therapeutics, Inc. (\u201cObsidian\u201d) (Nasdaq: OBX), a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, today reported financial results for the third quarter ended September 30, 2026, highlighting recent progress and business updates.<\/p>\n\n\u201c2026 has been a transformative year so far for Obsidian. In the third quarter, we closed an oversubscribed $350 million financing, completed our transaction with Galera Therapeutics, and debuted on Nasdaq as a publicly traded company,\u201d said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. \u201cWe have made substantial progress advancing amsoki-cel, with enrollment ongoing in the registration-enabling immune checkpoint inhibitor-resistant advanced melanoma cohort of our Agni-01 study. The updated data we presented at SITC further strengthen our belief in the program, highlighting amsoki-cel\u2019s consistent, favorable safety profile and encouraging clinical activity in patients with advanced melanoma, including an objective response rate of 67%, median progression-free survival of 8.3 months, and median duration of response not yet reached at median study follow-up of 14.3 months. We remain on track to complete enrollment in the registration-enabling cohort by the end of the first quarter of 2027 and report topline data by year-end 2027.\u201d<\/p>\n
Third Quarter 2026 and Recent Updates<\/b><\/p>\n
Amsokigene autoleucel (amsoki-cel, formerly OBX-115)<\/b><\/p>\n
- \n
- \nEnrollment in the registration-enabling cohort of the Phase 1\/2 Agni-01 multicenter study of amsoki-cel in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma is expected to be completed by the end of the first quarter of 2027, with topline data expected by the end of 2027.<\/p>\n
- \n
- \nThe Company announced initiation of enrollment in August 2026. The single-arm registration-enabling cohort is part of the ongoing Agni-01 study (NCT06060613<\/a>), which is a multicenter Phase 1\/2 study, designed to further evaluate the safety and efficacy of amsoki-cel at the recommended phase 2 dose (RP2D) in patients with ICI-resistant advanced melanoma. The primary endpoint is objective response rate (ORR) as measured per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by a blinded independent central review (BICR).<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nUpdated amsoki-cel results presented at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting continued to suggest encouraging efficacy, durable clinical benefit and a consistent, favorable safety profile in patients with ICI-resistant advanced melanoma. The presentation included updated efficacy data from the single-arm, open-label Phase 1\/2 Agni-01 multicenter study as of a September 25, 2026, data cutoff in 15 patients treated at the RP2D. Additional data included pooled safety data across 37 patients from the Phase 1 first-in-human (FIH) single-center study and the Phase 1\/2 Agni-01 multicenter study as of a May 5, 2026, data cutoff.<\/p>\n
- \n
- \nIn the efficacy set (n=15), a 67% ORR, per RECIST v1.1, was observed, including 2 confirmed complete responses (CR) and 8 confirmed partial responses (PR). 2 of the 8 patients who achieved a PR demonstrated a 100% reduction in the sum of diameters (SOD) of target lesions. Data demonstrated a durable clinical benefit, including 5 of 10 responses ongoing as of the median 14.3-month study follow-up, median progression-free survival (PFS) of 8.3 months, and 33% of all treated patients (5\/15) remained in deep, ongoing response at the 12-month post-infusion landmark. The median duration of response (mDOR) was not reached.<\/p>\n<\/li>\n
- \nIn the pooled safety set (n=37), there were no dose-limiting toxicities (DLT), treatment-related mortality (TRM), immune effector cell-associated neurotoxicity syndrome (ICANS) or ICU transfers, and the majority of non-hematologic treatment-emergent adverse events (TEAEs) occurring in \u226530% of patients were Grade 2 or less, with one reported Grade 3 cytokine release syndrome (CRS).<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nThe Company also announced a publication in Nature Medicine<\/i> summarizing safety and efficacy data as of a May 5, 2026, data cutoff from the FIH and ongoing Agni-01 studies. The publication, \u201cRegulatable Membrane-Bound IL-15 Engineered TIL Cell Therapy for Immune Checkpoint Inhibitor-Resistant Advanced Melanoma: Pooled Analysis of Phase 1 and 1\/2 Trials,\u201d is available online here<\/a>.<\/p>\n<\/li>\n
- \nObsidian is also investigating amsoki-cel in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.<\/p>\n<\/li>\n<\/ul>\n
Corporate Updates<\/b><\/p>\n
- \n
- \nObsidian completed its transaction with Galera Therapeutics and began trading on Nasdaq on August 4, 2026, under the ticker symbol \u201cOBX.\u201d The Company also closed a previously announced oversubscribed private placement of $350 million in gross proceeds.<\/p>\n<\/li>\n
- \nIn November 2026, Obsidian appointed Mark Reisenauer to the Board of Directors. Mr. Reisenauer brings more than 30 years of experience successfully commercializing and launching products in the oncology space. Most recently, he served as Chief Executive Officer and a director of Assertio, which was acquired by Zydus Lifesciences. Previously, he served as President of U.S. Commercial at Astellas Pharmaceuticals Inc., where he grew sales to nearly $5 billion while overseeing Marketing, Sales, Policy and Government Affairs and Market Access teams. Earlier in his career, he served as Senior Vice President and Chief Commercial Officer at Micromet, Inc., which was acquired by Amgen, where he led commercial launch activities and pipeline development. He also held senior roles at Abbott Laboratories, where he led global commercialization, licensing, and R&D strategy for oncology products and co-chaired the Oncology Therapeutic Executive Committee.<\/p>\n<\/li>\n<\/ul>\n
Third Quarter 2026 Financial Results<\/b><\/p>\n
- \n
- \nCash, cash equivalents, and marketable securities were $324.4 million as of September 30, 2026. Obsidian expects that its current cash, cash equivalents, and marketable securities will support planned operations into the second half of 2028.<\/p>\n<\/li>\n
- \nResearch and development expenses were $27.5 million for the three months ended September 30, 2026.<\/p>\n<\/li>\n
- \nGeneral and administrative expenses were $10.3 million for the three months ended September 30, 2026.<\/p>\n<\/li>\n
- \nAcquired in-process research and development expense associated with the Galera transaction was $15.1 million for the three months ended September 30, 2026.<\/p>\n<\/li>\n
- \nNet loss was $50.7 million, or $1.23 per basic and diluted share, for the three months ended September 30, 2026.<\/p>\n<\/li>\n<\/ul>\n
About Obsidian Therapeutics<\/b><\/p>\n
\nObsidian Therapeutics, Inc. is a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered TIL cell therapies for the treatment of patients with solid tumors. Obsidian\u2019s proprietary cytoDRiVE\u00ae technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian has offices in Cambridge and Bedford, MA. For more information, please visit www.obsidiantx.com<\/a>.<\/p>\n
About Amsokigene Autoleucel (amsoki-cel, formerly OBX-115)<\/b><\/p>\n
\nObsidian leverages its cytoDRiVE\u00ae platform to develop engineered TIL cell therapies. Obsidian\u2019s lead investigational TIL program, amsoki-cel, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). Amsoki-cel has the potential, if approved, to become a meaningful therapeutic option for patients with advanced (unresectable or metastatic) melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian\u2019s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating amsoki-cel in the Phase 1\/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613<\/a>).<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201caim,\u201d \u201cmay,\u201d \u201congoing,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould\u201d or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Such statements include, but are not limited to, implied and express statements concerning beliefs and expectations regarding: future clinical development activities, therapeutic potential, clinical benefits and safety of Obsidian\u2019s product candidates; potential indications and patient populations for amsoki-cel, if approved; the expected benefits of mbIL15, Obsidian’s manufacturing process and its cytoDRiVE\u00ae platform; the anticipated timing of completion of enrollment in the registration-enabling cohort of the Agni-01 study by the end of the first quarter of 2027 and availability of topline data by year-end 2027 as well as availability of NSCLC Phase 1 data in the first half of 2027; Obsidian’s expected cash runway and the sufficiency of its cash, cash equivalents and marketable securities to fund planned operations; anticipated contributions by members of Obsidian\u2019s Board and management team;and expectations regarding timing, progress, objectives or plans for Obsidian\u2019s development of its clinical pipeline and interactions with regulatory agencies.<\/p>\n
\nThese forward-looking statements relate to Obsidian, its business, prospects and results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause Obsidian\u2019s actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: Obsidian\u2019s ability to advance amsoki-cel through clinical development, and to obtain regulatory approval of amsoki-cel; the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the possibility that updated or additional data from the Agni-01 study may differ from results reported to date; the initiation, timing, progress and results of clinical trials, including the timing of completion of enrollment and data readouts; Obsidian\u2019s ability to fund its development activities and achieve development goals; the accuracy of Obsidian’s estimates of its expenses, capital requirements and the period over which its cash resources will be sufficient to fund operations; Obsidian\u2019s dependence on third parties to conduct clinical trials and manufacture amsoki-cel; Obsidian\u2019s ability to attract, hire and retain key personnel, and protect its intellectual property; Obsidian\u2019s financial condition and need for substantial additional funds in order to complete development activities and commercialize amsoki-cel, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Obsidian\u2019s competitors and industry; and other risks and uncertainties described under the heading \u201cRisk Factors\u201d included in the Quarterly Report on Form 10-Q for the quarter ended September30, 2026. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. These forward-looking statements are based upon Obsidian\u2019s current expectations and involve assumptions that may never materialize or may prove to be incorrect. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise, except as required by applicable law.<\/p>\n
\nObsidian intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Obsidian\u2019s Investor Relations website, in addition to following Obsidian\u2019s press releases, SEC filings, public conference calls, presentations, and webcasts.<\/p>\n
\n
\n \u00a0<\/td>\n<\/tr>\n \n \n OBSIDIAN THERAPEUTICS, INC.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
\n
<\/b>(IN THOUSANDS)<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n (UNAUDITED)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n <\/tr>\n \n \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n Three months ended
\n
September 30,<\/b><\/p>\n<\/td>\n\n \n Nine months ended
\n
September 30,<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n 2026<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2025<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2026<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2025<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nOperating expenses:<\/p>\n<\/td>\n
\n \n \n \n \n \n <\/tr>\n \n \n \nResearch and development<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n27,547<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n25,046<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n64,828<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n69,123<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGeneral and administrative<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n10,316<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n4,588<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n19,455<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n15,372<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAcquired in-process research and development<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n15,052<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n15,052<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal operating expenses<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n52,915<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n29,634<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n99,335<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n84,495<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLoss from operations<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(52,915<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(29,634<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(99,335<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(84,495<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nOther income, net:<\/p>\n<\/td>\n
\n \n \n \n \n \n <\/tr>\n \n \n \nInterest and other income<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n2,259<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n1,166<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n3,182<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n4,145<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal other income<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n2,259<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n1,166<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n3,182<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n4,145<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLoss before income tax expense<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(50,656<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(28,468<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(96,153<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(80,350<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nIncome tax benefit (expense)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet Loss<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(50,656<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(28,468<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(96,153<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(80,350<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n <\/tr>\n<\/table>\n \n
\n \n OBSIDIAN THERAPEUTICS, INC.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n CONDENSED CONSOLIDATED BALANCE SHEETS
\n
<\/b>(IN THOUSANDS)<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n (UNAUDITED)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n September 30, 2026<\/b><\/p>\n<\/td>\n
\n \n December 31, 2025<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \nCash, cash equivalents, and marketable securities<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n324,354<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n80,486<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal assets<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n340,744<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n88,580<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal liabilities<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n20,163<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n16,589<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nConvertible preferred stock<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n338,028<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal stockholders’ equity (deficit)<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n320,581<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(266,037<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
\n\u00a0<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261112501893\/en\/<\/a><\/span><\/p>\n
Inquiries:
\n
<\/b>Caroline Code
\n
VP Corporate Development and Investor Relations
\n
ir@obsidiantx.com<\/a><\/p>\nKEYWORDS:<\/b> United States North America Massachusetts<\/p>\n
INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n
- \nObsidian is also investigating amsoki-cel in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.<\/p>\n<\/li>\n<\/ul>\n
- \nUpdated amsoki-cel results presented at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting continued to suggest encouraging efficacy, durable clinical benefit and a consistent, favorable safety profile in patients with ICI-resistant advanced melanoma. The presentation included updated efficacy data from the single-arm, open-label Phase 1\/2 Agni-01 multicenter study as of a September 25, 2026, data cutoff in 15 patients treated at the RP2D. Additional data included pooled safety data across 37 patients from the Phase 1 first-in-human (FIH) single-center study and the Phase 1\/2 Agni-01 multicenter study as of a May 5, 2026, data cutoff.<\/p>\n
- \nThe Company announced initiation of enrollment in August 2026. The single-arm registration-enabling cohort is part of the ongoing Agni-01 study (NCT06060613<\/a>), which is a multicenter Phase 1\/2 study, designed to further evaluate the safety and efficacy of amsoki-cel at the recommended phase 2 dose (RP2D) in patients with ICI-resistant advanced melanoma. The primary endpoint is objective response rate (ORR) as measured per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by a blinded independent central review (BICR).<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- Enrollment is ongoing in registration-enabling cohort of the Phase 1\/2 Agni-01 multicenter study, with topline data expected by year-end 2027<\/i><\/li>\n
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