Strengthening Leadership to Accelerate iNKT Therapies into Immune-Mediated Disease, Pulmonary Disorders, and Global Health Security Colonel (Ret.) John B. Holcomb, MD Colonel (Ret.) John B. Holcomb, MD NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage biopharmaceutical company pioneering invariant natural killer T (iNKT) cell therapies, today announced the appointment of Colonel (Ret.) John B. Holcomb, MD, FACS to its Board of Directors. Dr. Holcomb is ...

NEW YORK, Sept. 25, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage biopharmaceutical company pioneering invariant natural killer T (iNKT) cell therapies, today announced that its President and Chief Executive Officer, Dr. Jennifer Buell, will deliver a featured plenary address at the 10th Annual CAR-TCR Summit, taking place September 23–26, 2025, in Boston, MA. The CAR-TCR Summit is one of the industry’s most influential gatherings of academic, clinical, and biopharma lead ...

Core Insights - MiNK Therapeutics has appointed Dr. Terese C. Hammond as Head of Inflammatory and Pulmonary Diseases, which is expected to enhance the company's focus on innovative therapies for severe pulmonary and inflammatory diseases [1][3]. Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company specializing in invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies [6]. - The company's lead asset, AgenT-797, is an allogeneic iNKT cell therapy currently in clinical development for graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [6][9]. Leadership and Expertise - Dr. Hammond is a recognized leader in pulmonary and critical care medicine, with over two decades of experience and a history of advancing registration-stage programs in severe diseases [2][5]. - She has served as principal investigator on pivotal studies for major pharmaceutical companies and is the lead author of significant publications related to MiNK's iNKT cell therapy [2][3]. Clinical Programs - Dr. Hammond will lead MiNK's inflammatory and pulmonary disease portfolio, which includes a grant-supported clinical trial in GvHD and a planned late-stage trial in severe pulmonary disease [3][7]. - These programs are positioned as substantial, low-risk opportunities supported by strong biological rationale and peer-reviewed data [3]. Research and Development - iNKT therapies have shown promising results in acute respiratory distress syndrome (ARDS) and other severe pulmonary diseases, indicating a substantial opportunity for near-term pivotal advancement [4][9]. - The unique biology of iNKTs allows for a robust immune response against difficult-to-treat tumors, enhancing the potential for transformative treatment options [9].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-40908 MiNK Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-2142067 (Sta ...

Financial Data and Key Metrics Changes - The company ended the quarter with a cash balance of $1.7 million and raised an additional $13 million through equity sales, extending the cash runway through mid-2026 [18] - The net loss for Q2 2025 was $4.2 million or $1.06 per share, compared to $2.7 million or $0.73 per share for Q2 2024 [18] - For the six months ended June 2025, the net loss was $7 million or $1.76 per share, compared to $6.5 million or $1.82 per share for the same period in 2024 [19] Business Line Data and Key Metrics Changes - The company achieved significant clinical milestones, including a complete clinical response in a patient with metastatic testicular cancer, highlighting the potential of the INKT platform [5][7] - The Q2 operating cash burn was reduced by over 30% year over year, reflecting operational efficiencies [6] Market Data and Key Metrics Changes - The company is in active discussions for strategic partnerships, with increased market capitalization following the publication in Nature's Oncogene, indicating growing investor confidence in INKT therapies [6][7] Company Strategy and Development Direction - The company is focusing on advancing its INKT platform for oncology and immune-related diseases, with plans to apply INKTs to hematopoietic stem cell transplantation and severe inflammatory syndromes [10][12] - Upcoming trials include a Phase I trial for GVHD and a Phase II trial for gastric cancer, with expectations for top-line data by 2025 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INKT therapies to address unmet needs in cancer and other immune-related diseases, emphasizing the unique capabilities of INKTs [4][10] - The company is well-positioned to advance multiple programs in parallel while preserving shareholder value, supported by a lean cost structure and a strong balance sheet [17] Other Important Information - The company is advancing its engineered INKT programs, with a focus on CAR INKT, which has shown promising preclinical results [15][31] - The company has received funding from the Department of Defense and the University of Wisconsin Cancer Center to support its clinical trials [14][41] Q&A Session Summary Question: Could you talk about the preventative GVHD trial design? - The trial is designed as a Phase I with a run-in for safety, starting with a lower dose and expanding to a target dose of one billion cells per patient [22][24] Question: Updates on the gastric cancer study? - The company has mature clinical follow-up data and plans to present survival follow-up and immune-modifying properties of the cells in a peer-reviewed journal [26][28] Question: Information on the grants and their impact on clinical trial costs? - The trials are fully funded, allowing flexibility to interrogate additional biomarkers without capital infusion from the company [40][41] Question: Details on the Phase II/III trial for ARDS? - The trial will focus on primary endpoints for FDA registration, including 28-day mortality and prevention of secondary infections, with promising preliminary results [46][47]

[Introduction and Q2 2025 Overview](index=1&type=section&id=Introduction%20and%20Q2%202025%20Overview) [Q2 2025 Business Update](index=1&type=section&id=Q2%202025%20Business%20Update) MiNK Therapeutics reported Q2 2025 results, highlighting clinical achievements, a strengthened balance sheet, and extended cash runway - MiNK Therapeutics reported **Q2 2025 financial results** and a business update, emphasizing **major clinical achievements**, a **strengthened balance sheet**, and **expanded funding** for oncology and immunology programs[1](index=1&type=chunk) - CEO Jennifer Buell highlighted the platform's power with **high-impact clinical results**, publication of key clinical findings, and competitive, **non-dilutive federal funding**, extending the **cash runway beyond mid-2026**[2](index=2&type=chunk) [Q2 2025 Highlights](index=1&type=section&id=Highlights%20from%20Q2%202025) [Clinical and Strategic Milestones](index=1&type=section&id=Clinical%20and%20Strategic%20Milestones) MiNK Therapeutics achieved durable complete remission in testicular cancer and secured non-dilutive grants for GvHD programs - Achieved **durable complete remission** in **metastatic testicular cancer** with a **single infusion** of **agenT-797** in combination with checkpoint blockade, with the patient remaining disease-free for **over two years**[7](index=7&type=chunk) - Awarded a **competitive Department of Defense STTR Grant** to advance iNKTs for **graft-versus-host disease (GvHD) prevention and treatment**, with the program launched[6](index=6&type=chunk)[7](index=7&type=chunk) - Received an **additional clinical competitive grant** to initiate a **first-in-human clinical trial** of **iNKTs in GvHD**, targeting initiation in **2H2025**[6](index=6&type=chunk)[7](index=7&type=chunk) - Anticipates **additional clinical readouts in 2025** for the **Phase 2 trial** of **agenT-797** in **second-line gastric cancer**[6](index=6&type=chunk)[7](index=7&type=chunk) - MiNK's **iNKT cell therapy platform** was featured in a Frontiers in Immunology review, highlighting its ability to **remodel the tumor microenvironment** and **overcome therapeutic resistance**[7](index=7&type=chunk) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) The company strengthened its balance sheet, extended cash runway beyond mid-2026, and reported an increased net loss - **Strengthened balance sheet** with **increased cash reserves**, extending the **cash runway beyond mid-2026** to advance clinical programs[6](index=6&type=chunk)[7](index=7&type=chunk) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | $4.2 million | $2.7 million | +$1.5 million | | Net Loss per Share | $1.06 | $0.73 | +$0.33 | | H1 2025 Net Loss | $7.0 million | $6.5 million | +$0.5 million | | H1 2025 Net Loss per Share | $1.76 | $1.82 | -$0.06 | - Ended Q2 2025 with approximately **$1.6 million in cash and cash equivalents**, and subsequently **raised $13 million through equity sales**, providing an expected **runway into mid-2026**[7](index=7&type=chunk) [Condensed Consolidated Financial Information](index=1&type=section&id=Summary%20Consolidated%20Financial%20Information) [Condensed Consolidated Balance Sheet Data](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, MiNK Therapeutics reported **$1.682 million** in cash, with **$13.012 million** raised post-quarter | Metric | June 30, 2025 (in thousands) | | :--- | :--- | | Cash and cash equivalents | $1,682 | | Cash raised since quarter end | $13,012 | [Other Financial Information](index=2&type=section&id=Other%20Financial%20Information) Q2 2025 showed decreased cash used in operations, increased non-cash expenses, and a higher net loss year-over-year | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Cash used in operations | $1,569 | $2,291 | $2,910 | $4,833 | | Non-cash expenses | $1,501 | $491 | $2,336 | $1,141 | | Net loss | $4,237 | $2,702 | $7,004 | $6,515 | | Net loss per share | $1.06 | $0.73 | $1.76 | $1.82 | [Additional Information](index=2&type=section&id=Additional%20Information) [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) MiNK Therapeutics hosted a conference call and webcast on August 14, 2025, with access details provided for live and replay - A conference call and webcast were held on **August 14, 2025**, at **8:30 a.m. ET**[12](index=12&type=chunk) - Access to the **live call** was available via specific dial-in numbers and a conference ID, with a **replay accessible on MiNK's investor website**[12](index=12&type=chunk) [About MiNK Therapeutics](index=2&type=section&id=About%20MiNK%20Therapeutics) MiNK Therapeutics is a clinical-stage biopharmaceutical company developing allogeneic iNKT cell therapies for cancer and immune diseases - MiNK Therapeutics is a **clinical-stage biopharmaceutical company** pioneering **allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies** to treat **cancer and other immune-mediated diseases**[13](index=13&type=chunk) - The company is advancing a pipeline of both **native and next-generation engineered iNKT programs**, with a platform designed to facilitate **scalable and reproducible manufacturing** for **off-the-shelf delivery**[13](index=13&type=chunk) [Forward Looking Statements](index=2&type=section&id=Forward%20Looking%20Statements) This press release contains forward-looking statements subject to risks, with investors cautioned against undue reliance - This press release contains **forward-looking statements** that are subject to **risks and uncertainties** that could cause **actual results to differ materially**[14](index=14&type=chunk) - MiNK cautions investors **not to place considerable reliance** on the forward-looking statements, which speak only as of the date of this press release, and undertakes **no obligation to update or revise** them, other than to the extent required by law[14](index=14&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) Contact details for investor relations and media inquiries were provided - **Investor Contact**: **917-362-1370** | **investor@minktherapeutics.com**[15](index=15&type=chunk) - **Media Contact**: **781-674-4422** | **communications@minktherapeutics.com**[15](index=15&type=chunk)

Core Viewpoint - MiNK Therapeutics, Inc. reported significant clinical advancements and financial results for Q2 2025, highlighting a strengthened balance sheet and expanded funding to support its oncology and immunology programs [1][2]. Group 1: Clinical Achievements - The company demonstrated impactful clinical results, including a landmark case of durable complete remission in a patient with treatment-refractory metastatic testicular cancer following a single infusion of agenT-797 [6]. - MiNK's platform was featured in a peer-reviewed review, showcasing the potential of iNKT cells to remodel the tumor microenvironment and overcome therapeutic resistance [6]. Group 2: Financial Highlights - MiNK ended Q2 2025 with approximately $1.6 million in cash and cash equivalents, and raised an additional $13 million through equity sales, extending its cash runway beyond mid-2026 [6][7]. - The net loss for Q2 2025 was $4.2 million, or $1.06 per share, compared to a net loss of $2.7 million, or $0.73 per share for Q2 2024 [8]. - For the first half of 2025, the net loss was $7 million, or $1.76 per share, compared to $6.5 million, or $1.82 per share for the first half of 2024 [8]. Group 3: Funding and Grants - The company announced a Department of Defense STTR grant to advance the development of iNKTs for graft-versus-host disease (GvHD) prevention and treatment [5][6]. - A new clinical grant was awarded to initiate a first-in-human clinical trial of iNKTs in GvHD, with a target initiation in the second half of 2025 [5][6]. Group 4: Future Outlook - The company anticipates additional clinical readouts in 2025 from its Phase 2 trial of agenT-797 in second-line gastric cancer [6].

Core Insights - MiNK Therapeutics is pioneering allogeneic invariant natural killer T (iNKT) cell therapies, with a focus on treating solid tumors where conventional therapies have struggled [1][2] - The company’s lead product, agenT-797, has shown durable responses in patients with treatment-refractory solid tumors, demonstrating its potential as a next-generation therapy [3][4] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing iNKT cell therapies and precision-targeted immune technologies [7] - The company’s proprietary platform aims to restore immune balance and drive cytotoxic immune responses across various diseases, including cancer and immune-mediated disorders [7][9] Clinical Data - In a recent case, a patient with metastatic testicular cancer achieved complete remission after treatment with agenT-797 combined with anti–PD-1 therapy, remaining disease-free for over two years [3] - Ongoing Phase 2 trials in gastric cancer have shown that agenT-797 can activate the immune system, enhance tumor infiltration, and provide durable disease control in patients who previously failed immunotherapy [4] Unique Mechanism of Action - iNKT cells, when engineered with CARs, maintain their innate tumor-homing and immunomodulatory features while gaining antigen-specific precision, allowing for both direct tumor killing and broad immune reprogramming [5] - MiNK-215, an IL-15–armored, FAP-targeting CAR-iNKT therapy, is designed to penetrate fibrotic tumors and has shown promise in preclinical studies by enhancing T cell infiltration and depleting stromal barriers [6][8] Manufacturing and Scalability - The iNKT platform allows for scalable and cost-effective manufacturing, with the potential for off-the-shelf therapies that do not require complex conditioning or lymphodepletion [8][9]

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 100 points on Monday [1] - Ultragenyx Pharmaceutical Inc. shares fell 8% to $27.15 after receiving a Complete Response Letter from the FDA for its gene therapy UX111 [1] Company-Specific Movements - MiNK Therapeutics, Inc. shares dropped 31% to $44.25 after a significant 730% increase on Friday due to a publication announcement [3] - Above Food Ingredients Inc. shares decreased 21.3% to $2.84 following a 134% rise on Friday after announcing a merger agreement [3] - Newegg Commerce, Inc. shares fell 11.3% to $43.66 after a 71% gain on Friday [3] - CEL-SCI Corporation shares declined 11% to $3.08 after an 8% drop on Friday, following a partnership announcement with a Saudi Arabian company [3] - Unusual Machines, Inc. shares slipped 8% to $11.13 after a 39% increase on Friday [3] - Gossamer Bio, Inc. shares fell 6.6% to $1.2700 after completing enrollment in a Phase 3 study for pulmonary arterial hypertension [3] - Gilat Satellite Networks Ltd. shares decreased 4.1% to $7.22 after announcing over $22 million in orders from satellite operators [3] - KalVista Pharmaceuticals, Inc. shares dipped 4% to $13.94 after reporting a wider-than-expected quarterly loss [3] - Apple Inc. shares fell 1% to $209.22 amid a significant management reshuffle, with CEO Tim Cook remaining in charge despite challenges [3]

Core Insights - MiNK Therapeutics, Inc. is experiencing a significant increase in stock price, with INKT stock rising 471.3% to $44.16 [7] - The company is focused on developing allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, with promising clinical results reported [2] Clinical Developments - A landmark case published in Nature's Oncogene reported a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer after receiving a single infusion of agenT-797 combined with Bristol-Myers Squibb's Opdivo [2][3] - The patient showed no evidence of disease over two years, with donor iNKT cells detectable for up to six months post-infusion, and the treatment was well-tolerated without severe side effects [4] - Data from a Phase 2 trial in 2L gastric cancer presented at the 2025 AACR Immuno-Oncology meeting indicated immune activation and early signs of tumor control in patients previously resistant to checkpoint inhibitors, with some patients surviving beyond 12 months [5] - A separate peer-reviewed case report noted a patient with metastatic gastric cancer achieving a 42% tumor reduction and over nine months of progression-free survival following a single infusion of agenT-797 combined with nivolumab [6] Market Activity - The trading volume for INKT stock reached 20.2 million, significantly higher than the average volume of 7.5 million [1]