Durable survival and deep, lasting remissions in checkpoint-refractory, heavily pretreated cancers with median OS of ~23 months with agenT-797 plus anti-PD-1Evidence of immune activation and tumor-immune remodeling underscore agenT-797’s potential to restore responsiveness in PD-1–resistant diseaseFavorable safety and reproducible activity reinforce MiNK’s leadership in allogeneic iNKT cell therapy NEW YORK, Nov. 07, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharma ...

Core Insights - MiNK Therapeutics, Inc. is set to release its Q3 2025 financial results on November 14, 2025, before market opening [1] - The company recently presented new clinical data for its agenT-797 iNKT cell therapy at the 2025 SITC Annual Meeting, showing durable immune reconstitution and activity in patients with advanced solid tumors [2] - A conference call and webcast will be held on the same day to discuss financial results, clinical progress, and upcoming milestones [2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators [4] - The 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 [5] - The company aims to deliver durable, accessible, and globally deployable immune reconstitution therapies through a scalable manufacturing process [5]

Core Insights - MiNK Therapeutics is set to present late-breaking data on AgenT-797, an allogeneic invariant natural killer T (iNKT) cell therapy, demonstrating durable clinical activity in advanced solid tumors at the upcoming SITC meeting [1][2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision immune modulators aimed at restoring immune balance and achieving durable cytotoxic responses [4] - The company's lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently undergoing clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure [5] - MiNK's pipeline includes TCR-based and neoantigen-targeted iNKT programs, which are designed for tissue-specific immune activation, showcasing a scalable manufacturing process and broad therapeutic potential [5]

Core Insights - MiNK Therapeutics, Inc. has appointed Colonel (Ret.) John B. Holcomb, MD, FACS to its Board of Directors, enhancing its leadership as it advances iNKT cell therapies for immune-mediated diseases and public health security [1][3][4]. Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies [6]. - The company's lead asset, AGENT-797, is in clinical development for treating graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [6]. Leadership Appointment - Dr. Holcomb brings over 23 years of military experience and is recognized for his innovations in trauma care and transfusion medicine, which have significantly impacted global health protocols [2]. - His expertise is expected to guide MiNK in advancing its iNKT cell therapies into late-stage development, addressing critical health challenges such as cancer and pulmonary diseases [4][5]. Strategic Focus - The appointment of Dr. Holcomb, alongside pulmonary critical care expert Dr. Terese Hammond, underscores MiNK's commitment to tackling diseases with significant epidemiological burdens [3][5]. - MiNK aims to develop therapies that restore immune balance and drive cytotoxic immune responses across various conditions, leveraging a scalable manufacturing process [6].

Core Insights - MiNK Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing invariant natural killer T (iNKT) cell therapies and will present at the 10th Annual CAR-TCR Summit [1][2] Company Overview - MiNK Therapeutics is pioneering allogeneic iNKT cell therapies and precision-targeted immune technologies aimed at restoring immune balance and driving cytotoxic immune responses across various diseases [5] - The company's lead asset, agenT-797, is currently in clinical development for treating graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [5] - MiNK is also advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools for tumor- and tissue-specific immune activation [5] Industry Context - The CAR-TCR Summit is a significant global forum for cell therapy, gathering over 800 stakeholders, including executives, scientists, investors, and regulators [4] - The summit features over 100 speakers and multiple content tracks, showcasing breakthroughs in CAR-T, TCR, and iNKT cell therapies across oncology and autoimmune diseases [4] - Dr. Jennifer Buell, CEO of MiNK, will discuss the potential of iNKT cells in restoring immune balance in diseases with limited treatment options [3][2]

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].

Financial Performance - Research and development expenses decreased by 29% to $3.1 million for the six months ended June 30, 2025, down from $4.4 million for the same period in 2024[86]. - General and administrative expenses increased by 33% to $3.1 million for the six months ended June 30, 2025, compared to $2.3 million for the same period in 2024[87]. - The company had an accumulated deficit of $151.2 million as of June 30, 2025, and expects to incur losses over the next several years[92]. - Net cash used in operating activities for the six months ended June 30, 2025, was $2.9 million, compared to $4.8 million for the same period in 2024, indicating a reduction in cash burn[99]. Funding and Liquidity - In July 2025, the company sold approximately 478,000 shares of common stock under a Sales Agreement, resulting in net proceeds of approximately $13.0 million[93]. - As of June 30, 2025, the company's cash and cash equivalents balance was $1.7 million, with an additional $13.0 million received from common stock sales post-quarter[96]. - The company anticipates that its current cash balance, along with expected funding, will be sufficient to meet liquidity requirements for over one year[96]. - Management is actively seeking additional funding through strategic partnerships, collaborations, and non-dilutive financing options[97][98]. - The company has expressed substantial doubt about its ability to continue as a going concern for one year following the filing of its Quarterly Report[96]. Clinical Development - The company reported a median progression-free survival exceeding six months in a Phase 1 trial of agenT-797, with approximately 30% of patients achieving durable disease stabilization[74]. - In a Phase 1 study of agenT-797 for viral ARDS, the survival benefit was reported at 75%, compared to approximately 10-22% in a control group[78]. - MiNK Therapeutics is advancing next-generation engineered iNKT programs, including MiNK-215 and MiNK-413, with IND submissions expected in 2025[79]. - A collaboration with ImmunoScape was announced to develop next-generation T-cell receptor therapies against novel targets in solid tumors[80]. - Future cash generation will depend on achieving regulatory approval and market acceptance of product candidates[99]. Corporate Structure and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[102]. - The company plans to rely on exemptions from certain disclosure requirements as long as it remains an emerging growth company[103]. - The company has not opted out of the extended transition period for complying with new accounting standards, which may affect comparability with other public companies[104]. Manufacturing Capacity - MiNK Therapeutics has established in-house iNKT cell manufacturing capacity capable of supplying over 5,000 doses annually through a fully automated process[72].

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].