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 ...

Mink Therapeutics (INKT) Q2 2025 Earnings Call August 14, 2025 08:30 AM ET Speaker0Good morning, and welcome to Mink Therapeutics Second Quarter twenty twenty five Conference Call and Webcast. All participants will be in a listen only mode until the question and answer session. Please note that this event is being recorded. If anyone has any objections, you may disconnect at this time. I would now like to turn the conference over to Zach Arman from Minx Investor Relations.Zach, please go ahead.Speaker1Thank ...

EXHIBIT 99.1 MiNK Therapeutics Reports Clinical and Strategic Milestones and Second Quarter 2025 Results NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting major clinical achievements, a strengthened balance sheet, and expanded ...

Cash runway extended to deliver clinical program in GVHD and Ph2 results in 2L Gastric CancerDepartment of Defense STTR Grant to advance INKTs in GVHD announced; program advancingNew clinical grant awarded to launch AgenT-797 in GvHD clinical trial; target initiation 2H2025 NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financi ...

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]

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]

Core Insights - MiNK Therapeutics has published a significant case study demonstrating the efficacy of its allogeneic iNKT cell therapy, agenT-797, in achieving complete and durable remission in a patient with metastatic testicular cancer who had previously failed multiple treatments [1][2][3] Group 1: Clinical Evidence - The case study published in Nature's Oncogene details a patient who achieved complete clinical, radiologic, and biochemical remission after receiving a single infusion of agenT-797 alongside nivolumab, with no evidence of disease over two years later [2] - The patient had previously undergone multiple lines of therapy, including platinum-based chemotherapy and various immune checkpoint inhibitors, highlighting the potential of iNKT cell therapy in heavily pre-treated patients [2][3] - MiNK presented additional data at the 2025 AACR Immuno-Oncology meeting, showing immune activation and early signals of tumor control in patients with gastric cancer who were previously refractory to checkpoint inhibitors [3][4] Group 2: Mechanism and Development - AgenT-797 is designed to harness both innate and adaptive immunity, functioning as a "master regulator" that combines the cytotoxic capabilities of NK cells with T-cell-like antigen recognition [7] - The therapy is scalable and off-the-shelf, aimed at providing accessible treatment options for patients with solid tumors and severe pulmonary inflammation [8] - MiNK is actively enrolling patients in an ongoing Phase 2 trial for gastric cancer, with further readouts expected in the coming months [4]

Core Insights - MiNK Therapeutics has received a non-dilutive grant from the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of its allogeneic invariant natural killer T (iNKT) cell therapy platform for preventing and treating graft-versus-host disease (GvHD) in high-risk hematopoietic stem cell transplantation (HSCT) settings [1][2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision-targeted immune technologies [4] - The company's lead asset, AGENT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and critical pulmonary immune collapse [4] - MiNK is advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools aimed at enabling tumor- and tissue-specific immune activation [4] Research and Development - The collaboration with the University of Wisconsin aims to leverage expertise in transplant immunology to enhance the efficacy of iNKT cells in managing GvHD while preserving the patient's ability to fight infections [3] - iNKT cells are recognized for their potential to regulate immune responses, promote tissue repair, and suppress inflammatory pathways, making them suitable for addressing GvHD complications [2][3] Market Need - Nearly 50% of patients undergoing allogeneic stem cell transplants are at risk for GvHD, highlighting a significant unmet medical need in this area [2]

Financial Performance - Research and development (R&D) expenses decreased by 51% to $1.3 million for the three months ended March 31, 2025, down from $2.5 million for the same period in 2024, primarily due to reduced clinical trial costs and personnel expenses [72]. - The total accumulated deficit as of March 31, 2025, was $146.9 million, with expectations of continued losses in the coming years [77]. - Cash and cash equivalents as of March 31, 2025, were $3.2 million, with substantial doubt about the ability to continue as a going concern for the next year [80]. Clinical Trials and Research - The company reported a median progression-free survival exceeding six months in a Phase 1 trial of agenT-797, with approximately 30% of patients experiencing durable disease stabilization [66]. - In a Phase 1 study of agenT-797 for viral acute respiratory distress syndrome (ARDS), a survival benefit of 75% was observed, compared to 10-22% in the control group [67]. - The company plans to advance agenT-797 in viral ARDS through strategic collaborations and non-dilutive external financing into a randomized Phase 2 trial [68]. - The company has two advanced engineered iNKT programs, MiNK-215 and MiNK-413, with IND submissions expected in 2025 [69]. Manufacturing and Collaboration - The company has established in-house iNKT cell manufacturing capacity capable of supplying over 5,000 doses annually through a fully automated process [64]. - A collaboration with ImmunoScape was announced in December 2023 to develop next-generation T-cell receptor therapies against solid tumors [70]. Regulatory and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements [85]. - The company will remain an emerging growth company until it exceeds $1.235 billion in annual revenue or $700 million in market value of stock held by non-affiliates [86]. - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, delaying adoption until private companies are required to comply [88]. - The reported results of operations may not be directly comparable to those of other public companies due to the extended transition period [88]. - The company intends to rely on exemptions from certain disclosure requirements applicable to other public companies [87]. Financing Activities - The company entered into a stock purchase agreement in May 2024, issuing 464,000 shares at $12.50 per share, raising approximately $5.8 million [79].

Financial Data and Key Metrics Changes - The company ended the quarter with a cash balance of $3.2 million, with cash used in operations for the three months ended March 31, 2025, at $1.3 million, reduced from $2.5 million for the same period in 2024 [21] - The net loss for the first quarter of 2025 was $2.8 million or $0.70 per share, compared to a net loss of $3.8 million or $1.10 per share for the first quarter of 2024 [21] Business Line Data and Key Metrics Changes - The company made significant progress in clinical trials, particularly in solid tumors, with new data presented at the AACR IO conference showing immune activation and early clinical activity in patients with second-line gastric cancer [6][10] - The company is advancing its INKT cell therapies in multiple areas, including solid tumors and immune-related diseases, with a focus on acute respiratory distress syndrome (ARDS) and graft versus host disease (GVHD) [15][18] Market Data and Key Metrics Changes - The company is engaging in confidential discussions for proposals that could extend its runway and accelerate its impact in oncology and immunology [7][9] - The company has observed promising survival rates exceeding 70% in critically ill ventilated patients with ARDS, indicating a potential shift in treatment paradigms [16] Company Strategy and Development Direction - The company is focused on advancing its INKT platform in oncology and immunology, with plans to initiate a phase one trial for GVHD and continue developing its CAR NKT and TCR NKT therapies [8][18] - The company aims to diversify capital and reduce dilution through strategic partnerships, which are essential for unlocking the full potential of its technology [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the regulatory path forward, particularly with the FDA's increased receptivity to novel immune-based approaches [17] - The company is committed to advancing its programs rapidly, guided by scientific conviction and a mandate to bring transformative immune-based therapies to patients in need [19] Other Important Information - The company has been selected for probable funding by the National Institute of Allergy and Infectious Diseases, which is expected to provide critical non-dilutive funding [19] - The company is working to make its therapies accessible through well-designed clinical trials and compassionate use programs [17] Q&A Session Summary Question: Duration until complete response observed in testicular cancer patient - Management indicated that the complete response was formally designated at month 24 after the initial treatment, with disease stabilization observed during the 12-month follow-up period [25][26] Question: Status of phase two gastric trial and expected data release - Management confirmed that they are on track for initial efficacy data in the second half of the year, with updates expected by early next year at the latest [29][30] Question: Updates on government funding and potential delays - Management reassured that while there were delays expected, they received formal notification from NIAID regarding probable funding, which remains a high priority for the agency [31][33] Question: Details on GVHD trial and patient enrollment - Management outlined plans to study GVHD in both steroid refractory acute patients and prophylaxis settings, with discussions with regulators imminent [37][39]