-- 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
-- Enrollment is ongoing in registration-enabling cohort of the Phase 1/2
Agni-01 multicenter study, with topline data expected by year-end 2027
-- Strengthened Board of Directors with appointment of Mark Reisenauer
-- Cash, cash equivalents, and marketable securities of $324.4 million as
of September 30, 2026, with expected cash runway into 2H 2028
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today reported financial results for the third quarter ended September 30, 2026, highlighting recent progress and business updates.
"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 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 $(SITC)$ 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.
About Obsidian Therapeutics
Obsidian 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's proprietary cytoDRiVE(R) 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.
About Amsokigene Autoleucel (amsoki-cel, formerly OBX-115)
Obsidian leverages its cytoDRiVE(R) platform to develop engineered TIL cell therapies. Obsidian's 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's 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).
Forward-Looking Statements
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