INKT

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MiNK Therapeutics Reports First Quarter 2026 Financial Results and Advances iNKT Cell Therapy Platform Into Randomized Clinical Validation

• Randomized Phase 2 trial initiated for agenT-797 in severe acute lung injury and respiratory distress, with preliminary data expected in the second half of 2026

• AACR and ASGCT presentations showcase durable survival and context-dependent iNKT activity in cancer and inflammatory lung disease

• Non-dilutive collaborations expand MiNK’s platform and potentiate meaningful commercial revenue potential, while preserving focus on lead clinical programs

• Company continues disciplined execution with reduced operating burn and focused advancement of high-priority programs

• New clinical data to be presented at the ATS conference on May 20, 2026

NEW YORK, NY — May 15, 2026 (Globe Newswire) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today reported financial results for the first quarter ending March 31, 2026, and provided a corporate update.

“MiNK entered 2026 focused on converting a growing body of clinical and translational evidence into prospective validation,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “During the first quarter and subsequent period, we advanced agenT-797 into a randomized Phase 2 study in acute lung injury and critical illness, presented data that further support the context-dependent biology of iNKT cells, and continued to expand the platform through selective, non-dilutive collaborations. This is the next phase of MiNK’s strategy: disciplined clinical execution, rigorous translational validation, and capital-efficient expansion of a broadly deployable cell therapy platform.”

Dr. Buell continued, “What continues to distinguish agenT-797 is both its biology and its practicality. As an off-the-shelf iNKT cell therapy administered without lymphodepletion or HLA matching, agenT-797 is designed for settings where immune dysfunction drives poor outcomes and where speed, tolerability and deployability matter. We believe this is particularly relevant in severe acute lung injury and critical illness, where patients often face a cascade of respiratory failure, secondary infection and organ dysfunction with limited therapeutic options.”

Recent Business and Development Highlights

agenT-797 Advanced into Randomized Phase 2 Clinical Evaluation in Acute Lung Injury and Critical Illness

MiNK initiated a randomized Phase 2 clinical trial evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with severe acute lung injury and critical

illness, including moderate to severe acute hypoxemic respiratory failure due to severe pneumonia, who meet Global ARDS criteria and are admitted to the ICU. The study is being designed with a seamless Phase 2/3 operational framework intended to support efficient transition into later-stage development if findings from the randomized Phase 2 portion are prospectively confirmed.

The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation. Preliminary data are expected in the second half of 2026.

Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million patients globally and approximately 200,000 patients annually in the United States, accounting for nearly 25% of mechanically ventilated ICU patients. Mortality remains high, approximately 40% to 50%, and there are currently no approved pharmacologic therapies shown to reduce mortality in ARDS. The trial is designed to prospectively evaluate agenT-797 in a clearly defined, critical care population where ventilator-free days, secondary infection, respiratory recovery and survival can be assessed within clinically meaningful and regulatory-aligned endpoints.

Recent Data at AACR and ASGCT Strengthen the Biologic Rationale for Context-Dependent iNKT Activity

Recent clinical and translational presentations at the American Association for Clinical Research (AACR) Annual Meeting and the American Society of Gene and Cell Therapy Meeting (ASGCT) reinforced the potential of MiNK’s iNKT platform to generate disease-relevant immune activity across distinct clinical settings.

In PD-1 refractory gastroesophageal cancer, investigator-sponsored Phase 2 data showed disease control and longer-term survival in a subset of heavily pretreated patients, supported by evidence of immune activation and tumor microenvironment remodeling. The study achieved a 77% disease control rate, with long-term survival beyond 20 months observed in a subset of patients with immune-induction prior to chemother

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MiNK Therapeutics Reports Q4 and Full Year 2025 Results; Phase 2 Programs Advance with Impactful Non-Dilutive Momentum

• ARDS / hypoxemic pneumonia Phase 2 trial initiation 1H 2026; early data by year end; market opportunity of ~200,000–300,000 patients annually in US/EU

• C-Further Consortium collaboration adds to growing non-dilutive funding for PRAME-TCR iNKT in pediatric oncology

• NIH STTR grant and Mary Gooze philanthropic award fully fund graft-versus-host disease (GVHD) preclinical data with clinical trial launch in 1H 2026

• Keystone Symposia data report iNKT depletion in end-stage Pulmonary Fibrosis (IPF); underscores pipeline expansion

• Portfolio focused on high-value immune restoration with multiple 2026 clinical catalysts

NEW YORK, NY — March 31, 2026 (Globe Newswire) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2025.

“2025 was a foundational year in which we sharpened our focus on immune restoration in auto-immune and inflammatory diseases and began to see the power of strategic, non-dilutive partnerships accelerate our progress,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “We are deliberately building a pipeline where iNKT cells address serious auto-immune and inflammatory conditions — from acute critical care in ARDS to chronic fibrotic disease in IPF and immune dysregulation in GVHD. The C-Further collaboration, together with the NIH NIAID STTR grant and Mary Gooze philanthropic award secured in 2025 for our GVHD program, reflects growing recognition of our platform’s potential. We enter 2026 with strong momentum and multiple near-term opportunities to demonstrate clinical value.”

Terese Hammond, MD, Head of Pulmonary and Inflammatory Diseases at MiNK, added: “There is a clear continuum from acute inflammation and autoimmune dysregulation to chronic fibrotic diseases like IPF and even immune-resistant cancers. MiNK’s iNKT platform is uniquely suited to address this spectrum because of its ability to deliver context-dependent immune modulation — activating anti-tumor responses in cancer while restoring balance and suppressing harmful inflammation in acute and chronic lung disease.”

2025 Achievements and 2026 Milestones

Pulmonary & Critical Care: Large Market Opportunity with Near-Term Catalysts

agenT-797 advances in randomized Phase 2 in hypoxemic pneumonia/ARDS, a severe inflammatory condition affecting ~200,000–300,000 patients annually in the U.S. and major European markets. With mortality rates of 30–40% and no approved disease-modifying

therapies, ARDS represents a substantial commercial opportunity with strong government and biodefense alignment.

• Phase 2 clinical readouts planned for 2H 2026

• Expanded development into end stage pulmonary fibrosis (IPF)

• Data presented at Keystone Symposia demonstrated significant iNKT cell depletion in end-stage IPF

• Strategic discussions to advance agent-797 in IPF are actively underway

Oncology: Durable Responses in Checkpoint-Resistant Tumors

Data presented at SITC 2025 reinforced agenT-797’s ability to deliver durable clinical benefit in heavily pretreated, checkpoint-refractory solid tumors.

• Median OS in R/R cancers exceeded 23 months in combo with commercial PD-1 therapy

• Complete remissions lasting beyond two years, long-term survival across multiple tumors

• Translational analyses showed iNKT cells actively reprogramming the tumor microenvironment through dendritic cell activation, macrophage repolarization, and reinvigoration of exhausted T cells

Transplantation: Externally Funded GVHD Program Advancing

NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID) supports development and evaluation of agenT-797 in preclinical models while The Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison directly funds enrollment, immune monitoring, and operations for the Phase 1.

• Trial is advancing through university approval with first dosing expected May 2026

• Preliminary clinical data expected 2H 2026

• Program represents clinically meaningful opportunity with minimal capital burden.

Expanding Pipeline: Targeting Resistance and Expanding Reach

• PRAME-TCR-engineered iNKT advancing under the C-Further Consortium collaboration

o Collaboration provides up to $1.1 million in non-dilutive funding plus meaningful double-digit percentage revenue share.

Leadership and Operational Readiness

• Dr. Terese Hammond appointed Head of Pulmonary and Inflammatory Diseases

• Col. (Ret.) John Holcomb, MD added to the Board of Directors and Scientific Advisory Board

• Melissa Orilall appointed Principal Financial Officer

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8-K

0001840229false00018402292025-11-142025-11-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 14, 2025

MiNK Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-40908

82-2142067

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

149 Fifth Avenue Suite 500

New York, New York

10010

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 212 994-8250

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.00001 per share

INKT

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On November 14, 2025, MiNK Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025. The Company inadvertently did not timely file a Current Report on Form 8-K for such press release. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The Company also hosted a live conference call on November 14, 2025 at 8:30 AM EST to discuss its financial and operating results for the period. A transcript of the conference call is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

There are no revisions to the results that were presented in the foregoing press release and conference call.

The information set forth under Item 2.02 and in Exhibits 99.1 and 99.2 attached hereto is in each case intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibit The following exhibits are furnished herewith:

99.1 Press Release dated November 14, 2025 99.2 Transcript of Conference Call dated November 14, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:

December 8, 2025

By:

/s/ Christine M. Klaskin

Christine M. Klaskin, Treasurer