On November 12, 2026 Obsidian Therapeutics, Inc. ("Obsidian") (Nasdaq: OBX), a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported financial results for the third quarter ended September 30, 2026, highlighting recent progress and business updates.
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"2026 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," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "We 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 (Free SITC Whitepaper) further strengthen our belief in the program, highlighting amsoki-cel’s 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."
Third Quarter 2026 and Recent Updates
Amsokigene autoleucel (amsoki-cel, formerly OBX-115)
Enrollment 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.
The Company announced initiation of enrollment in August 2026. The single-arm registration-enabling cohort is part of the ongoing Agni-01 study (NCT06060613), 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).
Updated amsoki-cel results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 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.
In 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.
In 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 ≥30% of patients were Grade 2 or less, with one reported Grade 3 cytokine release syndrome (CRS).
The Company also announced a publication in Nature Medicine summarizing safety and efficacy data as of a May 5, 2026, data cutoff from the FIH and ongoing Agni-01 studies. The publication, "Regulatable Membrane-Bound IL-15 Engineered TIL Cell Therapy for Immune Checkpoint Inhibitor-Resistant Advanced Melanoma: Pooled Analysis of Phase 1 and 1/2 Trials," is available online here.
Obsidian 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.
Corporate Updates
Obsidian completed its transaction with Galera Therapeutics and began trading on Nasdaq on August 4, 2026, under the ticker symbol "OBX." The Company also closed a previously announced oversubscribed private placement of $350 million in gross proceeds.
In 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.
Third Quarter 2026 Financial Results
Cash, 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.
Research and development expenses were $27.5 million for the three months ended September 30, 2026.
General and administrative expenses were $10.3 million for the three months ended September 30, 2026.
Acquired in-process research and development expense associated with the Galera transaction was $15.1 million for the three months ended September 30, 2026.
Net loss was $50.7 million, or $1.23 per basic and diluted share, for the three months ended September 30, 2026.
(Press release, Obsidian Therapeutics, NOV 12, 2026, View Source [SID1234674705])