MiNK Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Recognized $0.2 million in pre-commercial product revenue for the three months ended September 30, 2026, marking the company's first product revenue from the named-patient access program for agenT-797.
• Reported a net loss of $2.6 million ($0.50 per share) for the quarter, compared to a net loss of $2.9 million ($0.65 per share) in the prior-year quarter, representing a 23% year-over-year improvement in net loss per share.
• For the nine months ended September 30, 2026, net loss was $8.4 million ($1.69 per share), compared to $9.9 million ($2.39 per share) in the prior-year period.
• General and administrative expenses declined 44% to $1.0 million, driven by lower professional fees and stock compensation expense.
• Research and development expenses increased to $1.8 million from $1.1 million in the prior-year quarter, reflecting randomized Phase 2 activity and translational analyses.
• Cash used in operations was approximately $1.3 million for the quarter, down from $2.1 million in the second quarter of 2026.
• Ended the quarter with $7.5 million in cash and cash equivalents, down from $8.8 million at June 30, 2026.
• Total operating expenses for the quarter were $2.8 million, compared to $3.2 million in the prior-year quarter.

Guidance and Future Outlook:

• U.S. dosing for the randomized Phase 2 ARDS trial (C-1300-02) is expected to begin before year-end 2026, with data anticipated in the second half of 2027.
• Plans to advance the C-1300-02 trial as an adaptive study, with an initial randomized stage enrolling 124 patients.
• Management intends to meet with the FDA before year-end to discuss the adaptive Phase 2b/3 design and supportive regulatory designations.
• First patient dosing for the University of Wisconsin GvHD prevention study is expected by December 2026.
• Company aims to extend named-patient access to additional markets where regulations allow.
• Revenue from the named-patient program is expected to vary quarter-to-quarter based on physician requests and regulatory authorizations.

Business Segments and Product Lines:

• agenT-797: The lead candidate is an off-the-shelf iNKT cell therapy currently in development for GvHD, solid tumors, and severe pulmonary inflammation.
• Named-Patient Access: The program is now open in multiple countries outside the U.S., allowing physicians to request agenT-797 for patients with serious unmet medical needs on a paid, per-patient basis.
• MiNK-215: An FAP-targeted, IL-15-armored CAR-iNKT candidate demonstrated the ability to eliminate FAP-expressing fibroblasts and act as a living senolytic in preclinical models.
• Clinical Programs:
  • Randomized Phase 2 ARDS trial (C-1300-02) is enrolling in Lviv, Ukraine, with U.S. site activation planned.
  • Investigator-sponsored Phase 2 study at Scripps evaluating agenT-797 with botensilimab and balstilimab in MSS colorectal cancer.
  • Investigator-sponsored Phase 1 study at University of Wisconsin–Madison for GvHD prevention, funded by NIAID STTR and Mary Gooze Clinical Trial Awards.
  • C-Further program in pediatric patients with blood cancers.

Market and Competitive Landscape:

• The initial target population for the ARDS trial is estimated at approximately 93,000 U.S. patients annually with ventilated, pneumonia-associated moderate-to-severe ARDS.
• Nearly 40% of patients in this population die within 28 days, and no effective FDA-approved drug currently exists to reduce mortality.
• The MSS colorectal cancer setting with liver metastases currently has no approved immunotherapy options.
• Cold chain logistics remain the single largest barrier to commercializing allogeneic cell therapies beyond specialized centers.

Risks and Challenges:

• Clinical outcomes from early observations and preclinical findings may not be predictive of results in controlled studies.
• Revenue from the named-patient program is subject to variability based on regulatory authorizations and physician requests.
• The company faces risks associated with the development of room-temperature stabilization technologies and the execution of clinical trials.
• Forward-looking statements regarding therapeutic potential, clinical development timelines, and capital resources involve uncertainties detailed in SEC filings.

Management Commentary and Tone:

• CEO Jennifer Buell, Ph.D., stated the company has a randomized trial running in critical illness, multiple programs enrolling, and a path toward pivotal development.
• Buell highlighted that the same unmodified iNKT cells driving a 77% disease control rate in PD-1-refractory gastroesophageal cancer are now in a placebo-controlled ARDS trial.
• Dr. Terese Hammond, Head of Inflammatory and Pulmonary Diseases, emphasized the ability to administer agenT-797 from inventory without matching or conditioning in the ICU window when it matters most.
• Management described the quarter as the "most capital-efficient quarter of 2026" with a 44% G&A efficiency gain.

Other Key Points:

• ARPA-H Selection: agenT-797 was selected for the Draper-led Reversible Ambient Biostabilization team under ARPA-H's BoSS program, which offers up to $87 million in program-wide funding to move living medicines toward room temperature deployability.
• SITC 2026 Presentations: Data showed agenT-797 and MiNK-215 act as "living senolytics," clearing senescent cells left behind by chemotherapy and radiation, and unlocked tumor-cell killing in MSS CRC organoids when combined with botensilimab and balstilimab.
• Non-Dilutive Funding: The company now has four sources of non-dilutive support (C-Further, ARPA-H, Scripps study, and University of Wisconsin study) to advance the pipeline while concentrating internal resources on the randomized ARDS readout.
• Conference Call: A conference call and webcast were scheduled for November 11, 2026, at 8:30 a.m. Eastern Time.