-- First patients treated in randomized Phase 2 trial C-1300-02 were alive
at Day 28, with improved oxygenation, resolution of ARDS with return to
spontaneous breathing and liberation from vasopressor support
-- Clinical recovery and biologic readouts moved in the same direction;
serum and bronchoalveolar lavage analyses showed reduced inflammatory
markers and biologic changes associated with immune recovery and tissue
repair; no major serious adverse events were attributed to agenT-797
-- Launched international paid named-patient access program established for
physicians to request access to agenT-797, subject to per-patient
regulatory authorization; building cross-border infrastructure and access
NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, today reported financial results for the second quarter ended June 30, 2026, and provided an update on the clinical advancement of its lead candidate, agenT-797.
The second quarter marked MiNK's advancement to randomized clinical validation. The Company dosed its first patient in C-1300-02 within days of Ministry of Health authorization in Ukraine, and has since reported Day 28 observations in ventilated, critically ill patients treated in an active conflict environment -- a pace made possible by a therapy that ships from inventory and requires no apheresis, patient-specific manufacturing, HLA matching, or lymphodepletion.
"We are building cell therapy for the real world--off the shelf, available from inventory, and deployable where patients receive care," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. "This quarter, we put that mission into action. We moved agenT-797 into randomized Phase 2 evaluation and delivered it to mechanically ventilated patients within days of regulatory authorization--even in an active conflict environment. The initial clinical course and mechanistic readouts moved in the same direction over the same interval, consistent with the host-directed immune regulation our study was designed to evaluate. These observations are early, and we look forward to sharing additional data from the randomized trial in 2027."
"In parallel, we are building a new model for responsible access," Buell continued. "Our paid named-patient program enables physician-directed access, generates program support from product supplied, and establishes the cross-border infrastructure required to deliver agenT-797 beyond clinical trials. Together, these advances are moving cell therapy beyond specialized cancer centers and toward a readily available treatment that can reach patients when and where it is needed."
Second Quarter 2026 and Recent Highlights
Randomized Phase 2 Trial in Acute Lung Injury and ARDS
-- Targets a high-mortality unmet need in critical care. Acute lung injury
and ARDS remain among the most serious unresolved conditions in critical
care, with mortality exceeding 40-50% and no approved therapies shown to
reduce mortality.i Critically ill patients often deteriorate because
severe lung injury can trigger broader immune dysfunction, including
impaired pathogen control, infection susceptibility, and organ
dysfunction.
-- Randomized Phase 2 dosing initiated in May 2026. MiNK began dosing at
First Lviv Territorial Medical Union in Lviv, Ukraine, in collaboration
with UNBROKEN Ukraine, within days of receiving Ministry of Health
authorization. C-1300-02 (NCT07615010) is evaluating agenT-797 plus
standard of care versus placebo plus standard of care in adults with
acute lung injury and moderate-to-severe hypoxemic respiratory failure
meeting Global ARDS Definition criteria. The study is being conducted
under an active U.S. IND.
-- Initial Day 28 observations presented at the Military Health System
Research Symposium (MHSRS). Dr. Terese C. Hammond, M.D., Head of
Inflammatory and Pulmonary Diseases at MiNK, presented initial
observations with co-authors from First Lviv Territorial Medical Union.
The initial agenT-797--treated patients were alive and afebrile at Day
28, with improved oxygenation, resolution of ARDS with return to
spontaneous breathing and liberation from vasopressor support.
Microbiologic findings indicated control of baseline infections. Serum
and bronchoalveolar lavage analyses showed reduced inflammatory markers
and biologic changes associated with immune recovery, epithelial repair
and pulmonary vascular recovery. No major serious adverse events were
attributed to agenT-797 in these initial patients.
-- U.S. expansion in progress. Enrollment continues in Lviv, and activation
of U.S. clinical centers is underway. Additional data are expected in
early 2027.
Paid International Named-Patient Access
-- First paid international access program established. MiNK is
collaborating with Orphan Drug Consulting $(ODC)$ to support
physician-initiated requests for agenT-797 for individually identified
patients. The program expands access for patients with serious unmet
medical need and provides MiNK with program revenue for product supplied.
Each request is initiated by the treating physician and remains subject
to case-by-case Brazilian regulatory authorization. The program does not
represent a commercial launch or marketing authorization.
-- Access, revenue and scalable international infrastructure. ODC supports
local regulatory submissions, importation, logistics and
pharmacovigilance. Product will be supplied on a paid, per-patient basis
in accordance with applicable Brazilian access regulations. The program
may result in non-promotional income to MiNK while establishing the
operational infrastructure needed to support responsible access to
agenT-797 in additional international markets.
Translational and Scientific Progress
-- ATS 2026 and peer-reviewed publication (May 2026). Data presented at the
American Thoracic Society International Conference and published
concurrently in Clinical Immunology Communications showed pathogen
suppression, lung immune restoration and activation of tissue-repair
pathways following administration of agenT-797 and an IL-15 super agonist
(N-803), in Coccidioides infection.
-- ASGCT 2026 (May 2026). MiNK presented clinical evidence at the American
Society for Gene and Cell Therapy Meeting that a single off-the-shelf
iNKT-cell product manufactured from the same donor batch produced
context-dependent immune activity--immune activation in cancer and
anti-inflammatory activity in ARDS--without genetic engineering.
Financial Results
Cash and cash equivalents were $8.8 million as of June 30, 2026, compared with $9.5 million as of March 31, 2026, and $13.4 million as of December 31, 2025. Net loss for the second quarter of 2026 was $3.1 million, or $0.62 per share, compared with $4.2 million, or $1.06 per share, for the second quarter of 2025. For the six months ended June 30, 2026, net loss was $5.9 million, or $1.20 per share, compared with $7.0 million, or $1.76 per share, for the same period in 2025. The year-over-year improvement reflects continued expense discipline.
Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) December June 30, 2026 31, 2025 --------------- ----------- Cash and cash equivalents $ 8,807 $ 13,360 Other Financial Information (in thousands) (unaudited) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 ------ ------- ------- --- ------- -------- Net loss $ 3,128 $ 4,238 $ 5,871 $ 7,004 Net loss per share 0.62 1.06 1.20 1.76 Cash used in operations $ 2,082 $ 1,569 $ 3,815 $ 2,910
Second Quarter 2026 Financial Results Conference Call and Webcast
MiNK will host a conference call and webcast today at 8:30 a.m. ET to discuss its financial results, provide clinical updates on agenT-797 in lung injury and highlight important business updates.
Conference Participant Dial Information ------------------------------------------ United States - New York (646) 307-1963 -------------------------- -------------- USA & Canada - Toll-Free (800) 715-9871 -------------------------- -------------- Conference ID - 8767945 -------------------------- --------------
Webcast & Replay Information
Live event link: https://edge.media-server.com/mmc/p/zkuebhpc
Webcast Replay: https://investor.minktherapeutics.com/events-and-presentations
About Mink Therapeutics