MiNK Therapeutics Reports Q3 2025 Results and Accelerates iNKT Platform Toward Pivotal Development Across Oncology, Pulmonary Disease, and Transplantation
MiNK Therapeutics (NASDAQ: INKT) reported Q3 2025 results and clinical progress on its allogeneic iNKT platform. Key clinical highlights include durable responses with agenT-797 in checkpoint- and chemotherapy-refractory solid tumors, including complete remissions >2 years and multi-year survivors, with no ≥Grade 3 CRS or neurotoxicity reported.
The company launched an NIH- and philanthropically funded GvHD collaboration with UW–Madison and plans a Phase 2+ severe pulmonary disease trial using FDA-validated endpoints. Leadership additions target pulmonary, trauma, and biodefense expertise. Cash was $14.3M at 9/30/25 (plus $1.2M subsequent raise), providing runway through 2026.
MiNK Therapeutics (NASDAQ: INKT) ha riportato i risultati del terzo trimestre 2025 e i progressi clinici sulla sua piattaforma allogenica iNKT. Evidenze cliniche chiave includono risposte durevoli con agenT-797 in tumori solidi resistenti sia ai checkpoint sia alla chemioterapia, inclusi remissions complete >2 anni e sopravvissuti pluriennali, senza segnalazioni di CRS di grado ≥3 né neurotossicità.
L’azienda ha avviato una collaborazione per GvHD finanziata dal NIH e da donatori privati con UW–Madison e prevede uno studio di fase 2+ per una malattia polmonare grave utilizzando endpoint validati dalla FDA. Le aggiunte al management mirano a competenze in polmone, trauma e biosicurezza. La liquidità ammontava a 14,3 milioni di dollari al 30/09/25 (più 1,2 milioni di raccolta successiva), fornendo una runway fino al 2026.
MiNK Therapeutics (NASDAQ: INKT) informó los resultados del tercer trimestre de 2025 y el progreso clínico de su plataforma iNKT alogénica. Los aspectos clínicos clave incluyen respuestas duraderas con agenT-797 en tumores sólidos refractarios a checkpoint y a la quimioterapia, incluidas remisiones completas de >2 años y pacientes que han sobrevivido varios años, sinCRS ≥Grado 3 ni neurotoxicidad reportados.
La empresa lanzó una colaboración para GvHD financiada por el NIH y donantes privados con UW–Madison y planea un ensayo de fase 2+ para una enfermedad pulmonar severa utilizando endpoints validados por la FDA. Las incorporaciones en la dirección buscan experiencia en pulmonar, trauma y defensa biológica. La liquidez fue de 14,3 millones de USD al 30/09/25 (más 1,2 millones de recaudación posterior), asegurando viabilidad hasta 2026.
MiNK Therapeutics (NASDAQ: INKT)는 2025년 3분기 실적과 동종 iNKT 플랫폼의 임상 진전을 발표했습니다. 주요 임상 하이라이트로는 checkpoint 및 화학요법에 저항하는 고형 종양에서 agenT-797로 인한 지속 가능한 반응, 2년 이상 지속된 완전 관해 및 다년 생존자가 포함되며, Grade ≥3의 CRS나 신경독성은 보고되지 않았습니다.
회사는 NIH 및 자선체가 자금을 제공하는 UW–Madison과의 GvHD 협력을 시작했고 FDA가 검증한 엔드포인트를 사용한 중증 폐질환에 대한 2상 이상(Fase 2+) 시험을 계획하고 있습니다. 경영진 보강은 폐질환, 외상 및 생물방위 전문 지식을 목표로 합니다. 현금 보유액은 2025년 9월 30일 기준 1430만 달러(추가로 120만 달러의 자금 조달), 2026년까지 운영 여정을 확보합니다.
MiNK Therapeutics (NASDAQ: INKT) a publié les résultats du troisième trimestre 2025 et les progrès cliniques de sa plateforme iNKT allogénique. Parmi les points forts cliniques, on note des réponses durables avec agenT-797 dans des tumeurs solides réfractaires aux contrôles (checkpoint) et à la chimiothérapie, y compris des rémissions complètes de >2 ans et des survivants de longue durée, sans CRS de grade ≥3 ni neurotoxicité signalés.
L’entreprise a lancé une collaboration GvHD financée par le NIH et des donateurs privés avec UW–Madison et prévoit un essai de phase 2+ pour une maladie pulmonaire grave utilisant des critères terminologiques validés par la FDA. Des renforcements de l’équipe dirigeante visent des compétences en pulmonaire, trauma et biosécurité. La trésorerie s’élevait à 14,3 M$ au 30/09/25 (avec 1,2 M$ levés ultérieurement), assurant une runway jusqu’en 2026.
MiNK Therapeutics (NASDAQ: INKT) hat die Ergebnisse des 3. Quartals 2025 und den klinischen Fortschritt ihrer allogenen iNKT-Plattform berichtet. Zu den wichtigsten klinischen Highlights gehören dauerhafte Reaktionen mit agenT-797 bei checkpoint- und chemotherapy-resistenten soliden Tumoren, darunter komplette Remissionen >2 Jahre und mehrjährige Überlebende, ohne Berichte von CRS Grad ≥3 oder Neurotoxizität.
Das Unternehmen initiierte eine NIH- und philanthropisch finanzierte GvHD-Kollaboration mit UW–Madison und plant eine Phase-2+-Studie zu einer schweren Lungenerkrankung unter Verwendung FDA-validierter Endpunkte. Führungsberatungen zielen auf Expertise in Lunge, Trauma und Biowaffenschutz. Die Liquidität belief sich zum 30.09.2025 auf 14,3 Mio. USD (plus 1,2 Mio. USD aus einer nachfolgendem Finanzierung), was eine Laufzeit bis 2026 sicherstellt.
MiNK Therapeutics (NASDAQ: INKT) أعلنت نتائج الربع الثالث من 2025 والتقدم السريري في منصتها iNKT المتوافقة جميعياً. تشمل النقاط الرئيسية السريرية استجابات دائمة مع agenT-797 في الأورام الصلبة المقاومة لعلاج التثبيت (checkpoint) والكيميائي، بما في ذلك تحرّرات كاملة تزيد عن عامين ومصابون بانتظام لسنوات، دون تقارير CRS بدرجة ≥3 أو سمية عصبية.
أطلقت الشركة تعاوناً مع NIH ومتبرعين خاصين لعلاج GvHD مع UW–Madison وتخطط لتجربة في مرحلة 2+ لمرض رئوي حاد باستخدام نقاط نهاية معتمدة من FDA. التعيينات القيادية الجديدة تستهدف خبرة في الرئة والصدمة والدفاع الحيوي. بلغت السيولة 14.3 مليون دولار أمريكي في 30/09/2025 (مع زيادة 1.2 مليون دولار من جولة تمويل لاحقة)، مما يوفر مساراً زمنياً حتى 2026.
- Complete remissions >2 years reported with agenT-797
- No ≥Grade 3 CRS or neurotoxicity observed
- NIH and philanthropic funding secured for GvHD study
- Cash balance $14.3M at September 30, 2025
- Phase 2+ trial planned in severe pulmonary disease (FDA endpoints)
- Nine-month net loss of $9.9M through Q3 2025
- Q3 2025 net loss $2.9M, higher than Q3 2024 $1.8M
- Runway extends only through 2026, requiring future funding
Insights
Durable clinical remissions, grant‑funded GvHD trial, and extended runway through
agenT-797 shows notable durability with complete remissions beyond two years and survival past two and three years in checkpoint- and chemotherapy-refractory cancers; safety reportedly lacked ≥ Grade 3 CRS or neurotoxicity. These facts support a credible path toward pivotal development because they demonstrate both efficacy signals and a manageable acute safety profile in heavily pretreated patients.
Program expansion received non-dilutive NIH and philanthropic support for a GvHD study and plans for a Phase 2+ pulmonary trial with FDA-validated endpoints. The company ended Q3 with
Key dependencies and risks include the need for reproducible, controlled data in randomized or pivotal‑enabling settings and confirmation of long-term safety and durability across broader cohorts. Monitor the initiation of the NIH- and philanthropy-supported Phase 1 GvHD study in
- New clinical data show durable remissions and long-tail survivors including >2-year complete remissions in chemotherapy- and checkpoint-refractory cancers
- GVHD trial launching through non-dilutive funding from NIH- and philanthropic grants
- Launching Phase 2+ trial in severe pulmonary disease in US population with FDA-validated endpoints
- Added national leaders in pulmonary medicine, trauma, and biodefense join MiNK management (Dr. Hammond) and Board (Dr. Holcomb) to drive pivotal development
- Cash runway extended through 2026, enabling multiple inflection points
NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to reconstitute immunity to treat cancer and immune disorders, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update highlighting durable clinical responses with agenT-797, expansion of its iNKT platform across oncology, inflammation and transplantation, and strengthening of its leadership team as the company advances toward pivotal development.
Q3 2025 Highlights
- Durable clinical responses in refractory solid tumors with agenT-797
At SITC 2025, MiNK reported updated clinical data showing sustained tumor regression and immune reprogramming with its lead asset agenT-797 across checkpoint-refractory cancers, including complete remissions lasting more than two years and survival exceeding two and three years in late stage, refractory cancers. Safety profile was favorable with no ≥ Grade 3 CRS or neurotoxicity. - Ongoing publication and translational momentum
Peer-reviewed publications in Oncogene and Frontiers in Immunology further validated agenT-797’s ability to reinvigorate immune-exhausted T cells and reduce pulmonary inflammation without lymphodepletion, providing mechanistic and clinical rationale for pivotal-enabling trials across oncology and inflammatory diseases. - Launch of federally and philanthropically funded collaboration with the University of Wisconsin Carbone Cancer Center (UWCCC) in GvHD with agent-797
In collaboration with the University of Wisconsin Carbone Cancer Center–Madison, MiNK initiated a preclinical and Phase 1 study of agenT-797 with the goal of preventing GvHD and reduce relapse in stem-cell transplant patients. The study, led by Dr. Hongtao Liu and Dr. Jenny Gumperz, is supported by the Mary Gooze Clinical Trial and Translation Award and an NIH STTR grant from NIAID.
“This trial reflects the broader momentum of our iNKT platform as we expand into diseases marked by profound immune dysregulation,” said Dr. Terese Hammond, Head of Inflammatory and Pulmonary Diseases at MiNK Therapeutics. “Whether in transplantation, severe pulmonary inflammation, or systemic immune collapse, the ability of iNKT cells to rebalance immunity creates a compelling opportunity to change outcomes across multiple high-need conditions. With strong support from NIH and our philanthropic partners, we are advancing a development program with meaningful potential across several disease areas.”
- Strengthened leadership
- Dr. Terese C. Hammond, a nationally recognized expert in pulmonary and critical care medicine, joined MiNK as Head of Inflammatory and Pulmonary Diseases to lead the Company’s late-stage ARDS and GvHD programs.
- Colonel (Ret.) John B. Holcomb, MD, FACS joined MiNK’s Board of Directors, bringing global expertise in trauma and critical care to advance iNKT therapies in immune-mediated and pulmonary diseases.
“This quarter, MiNK achieved meaningful clinical and organizational milestones as we continue our disciplined path toward pivotal development,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “The durability and mechanistic depth of our off-the-shelf iNKT cell therapy, agenT-797 results, paired with the launch of our grant supported GvHD study and new leadership in critical care, underscore the breadth of our platform and the momentum driving MiNK forward. We believe our iNKT therapies can restore immune balance across settings where current treatments have failed — in cancer, transplant, and severe inflammation, where we prepare for the next phase of clinical expansion.”
Financial Highlights
- Cash Position: MiNK ended Q3 2025 with approximately
$14.3 million in cash and cash equivalents and subsequently raised$1.2 million through equity sales, providing expected runway through 2026. - Net Loss: Net loss for Q3 2025 was
$2.9 million , or$0.65 per share, compared to$1.8 million , or$0.46 per share for Q3 2024. For the nine-months ended Q3 2025, net loss was$9.9 million , or$2.39 per share compared to$8.3 million or$2.24 per share for the same period in 2024. Current period results reflect ongoing activity supporting our agent-797 programs.
| Summary Consolidated Financial Information | |||||||||||
| Condensed Consolidated Balance Sheet Data | |||||||||||
| (in thousands) | |||||||||||
| (unaudited) | |||||||||||
| September 30, 2025 | December 31, 2024 | ||||||||||
| Cash and cash equivalents | $ | 14,281 | $ | 4,577 | |||||||
| Other Financial Information | |||||||||||
| (in thousands) | |||||||||||
| (unaudited) | |||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||
| Net loss | $ | 2,888 | $ | 1,807 | $ | 9,892 | $ | 8,322 | |||
| Net loss per share | 0.65 | 0.46 | 2.39 | 2.24 | |||||||
| Cash used in operations | $ | 941 | $ | 2,995 | $ | 3,851 | $ | 7,828 | |||
Future Catalysts
- Q1 2026: Initiation of the NIH- and philanthropy-supported Phase 1 GvHD study with UW–Madison
- 2026: Early data from our randomized Phase 2 trial in severe pulmonary inflammatory disease
- 2026: Clinical and translational updates from agenT-797 oncology and inflammatory cohorts, including early signals from transplant, GVHD, and pulmonary programs
- 2026: Continued progress on strategic partnerships and manufacturing optimization to support multi-program clinical execution
Taken together, these milestones position MiNK to have multiple studies enrolling, early clinical readouts emerging, and increasing clarity on pivotal-enabling paths across our oncology, inflammatory, and critical-illness portfolio over the next 12 months.
Conference Call and Webcast Information
MiNK executives will host a conference call and webcast at 8:30 a.m. ET on Friday, November 14, 2025 to discuss results and corporate updates.
Conference Participant Dial Information
United States - New York (646) 307-1963
USA & Canada - Toll-Free (800) 715-9871
Conference ID: 3474114
Webcast & Replay Information
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website following the event.
Live event link: https://edge.media-server.com/mmc/p/4bufw45x
Webcast Replay: https://investor.minktherapeutics.com/events-and-presentations
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse.
Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for agenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law.
Contacts
Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
Source: MiNK Therapeutics
FAQ
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