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].

Mink Therapeutics (INKT) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Zack Armen - Head of IR & Corporate DevelopmentJennifer Buell - President and CEOChristine Klaskin - CFOThiago Favano - Senior Director, Portfolio Operations Conference Call Participants Emily Bodnar - Biotech Equity Research AnalystMatthew Phipps - Equity Research Analyst Operator Thank you for standing by. My name is Roselle, and I will be your conference operator today. At this time, I would like to welcome every ...

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 [22] - 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 [22] 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][11] - 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) [16][19] 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 [10] - The company has observed promising survival rates exceeding 70% in critically ill ventilated patients with ARDS, indicating the potential to change 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 [19][20] - The company aims to diversify capital, reduce dilution, and accelerate development through external partnerships, reflecting strong external conviction in the value of its INKT platform [10] 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 [20] Other Important Information - The company has been able to reduce its operating cash burn by about 47% year on year, preserving its ability to invest in core programs [6] - The company expects to receive formal funding from the National Institute of Allergy and Infectious Diseases (NIAID) by June, which would provide critical non-dilutive funding [20] Q&A Session Summary Question: Regarding the testicular cancer patient, how long after treatment was the complete response observed? - The complete response was formally designated at month 24 after the initial treatment of AGENT-797, with disease stabilization observed during the 12-month follow-up period [25][27] Question: Is the company still on track for initial efficacy data in the phase two gastric trial in the second half of this year? - The company is on target to present initial efficacy data by the end of this year, with ongoing enrollment in the trial [30][31] Question: Any updates on government funding from NIAID? - The company has received reassurance from NIAID regarding probable funding and expects to hear conclusively in June, indicating that NIAID has not been heavily impacted by recent delays [32][33] Question: Can the company provide details on the GVHD trial and patient enrollment? - The company plans to study GVHD in both steroid refractory acute patients and in prophylaxis settings, with discussions with regulators imminent [37][39]

Financial Performance - MiNK Therapeutics reported a cash balance of $3.2 million at the end of Q1 2025, down from $4.6 million at the end of Q4 2024[10] - Cash used in operations for Q1 2025 was $1.3 million, a decrease of 48% compared to $2.5 million in Q1 2024[8] - The net loss for Q1 2025 was $2.8 million, or $0.70 per share, compared to a net loss of $3.8 million, or $1.10 per share, in Q1 2024[8] - Research and development expenses decreased to $1.3 million in Q1 2025 from $2.6 million in Q1 2024, reflecting a reduction of 50%[14] Clinical Development - MiNK is actively enrolling patients in a Phase 2 trial for gastric cancer, with new data showing promising results in PD-1–resistant tumors[6] - The company is pursuing broader patient access through clinical trials and compassionate use programs for its iNKT therapy in ARDS[6] - A peer-reviewed publication is expected in the first half of 2025 detailing a complete remission case in a patient with metastatic testicular cancer treated with agenT-797[6] Strategic Initiatives - MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in GvHD, with a formal award expected by June 2025[6] - The company is engaged in advanced discussions for strategic partnerships in oncology, immune-mediated diseases, and next-generation engineered cell therapies[3] - MiNK's iNKT platform is positioned to deliver off-the-shelf therapies to patients with urgency, focus, and scale, leveraging clinical advances and expanded access to non-dilutive capital[2]

Core Viewpoint - MiNK Therapeutics is making significant progress in its clinical-stage biopharmaceutical development of allogeneic invariant natural killer T (iNKT) cell therapies, with a focus on oncology and immune-mediated diseases, while also enhancing its financial position through strategic partnerships and non-dilutive capital [2][3][6]. Financial Highlights - As of March 31, 2025, MiNK Therapeutics reported a cash balance of $3.2 million, with cash used in operations amounting to $1.3 million, a decrease from $2.5 million in the same period of 2024 [6][10]. - The net loss for Q1 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 Q1 2024 [6][10]. Clinical Progress - MiNK is advancing its iNKT platform in treating solid tumors and immune-mediated diseases, with notable developments including a complete remission case in metastatic testicular cancer and ongoing enrollment in a Phase 2 gastric cancer trial [8][12]. - The company presented new data at AACR IO and ASCO GI, demonstrating the efficacy of agenT-797 in combination with other therapies for PD-1–resistant gastroesophageal cancers [8][12]. - MiNK's iNKT therapy has shown survival benefits in acute respiratory distress syndrome (ARDS) and is pursuing broader patient access through clinical trials [8][12]. Strategic Developments - The company is engaged in late-stage strategic discussions to expand its reach in oncology, immune-mediated diseases, and next-generation engineered cell therapies, aiming to enhance shareholder value [2][3]. - MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in graft-versus-host disease (GvHD), expected to provide critical non-dilutive capital [8][12].

Core Viewpoint - MiNK Therapeutics, Inc. is set to release its first quarter 2025 financial results on May 15, 2025, and will host a conference call to discuss these results and provide a corporate update [1]. Group 1: Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune-mediated diseases [3]. - The company is advancing a pipeline of both native and next-generation engineered iNKT programs, emphasizing scalable and reproducible manufacturing for off-the-shelf delivery [3]. - MiNK Therapeutics is headquartered in New York, NY, and provides regular updates on important information for investors through its website and social media channels [3]. Group 2: Conference Call Details - The conference call will take place on May 15, 2025, at 8:30 a.m. ET, following the release of the financial results [1]. - Dial-in numbers for the conference call include 646-307-1963 for New York and 800-715-9871 for USA & Canada, with a conference ID of 9822477 [2]. - A live webcast and replay of the conference call will be available on the company's Events & Presentations page [2].

Financial Performance - MiNK Therapeutics reported a 59% decrease in research and development expenses, down to $6.3 million for the year ended December 31, 2024, from $15.5 million in 2023[383]. - General and administrative expenses decreased by 42% to $4.3 million for the year ended December 31, 2024, compared to $7.4 million in 2023[384]. - The company has an accumulated deficit of $144.2 million as of December 31, 2024[382]. - As of December 31, 2024, the cash and cash equivalents balance was $4.6 million, with substantial doubt about the ability to continue as a going concern for the next year[393]. - 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[392]. Clinical Trials and Research - The clinical trial of agenT-797 in solid tumors showed a median progression-free survival exceeding six months, with approximately 30% of patients experiencing durable disease stabilization[377]. - In a Phase 1 study of agenT-797 in viral ARDS, the survival benefit was reported at 75%, compared to 10-22% in the control group[378]. - MiNK Therapeutics has established in-house iNKT cell manufacturing capacity capable of supplying over 5,000 doses annually[375]. - The company plans to submit an Investigational New Drug (IND) application to the FDA for MiNK-215 in 2025[380]. - MiNK Therapeutics announced a collaboration with ImmunoScape to develop next-generation T-cell receptor therapies against solid tumors[381]. Regulatory and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[401]. - The company can 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[402]. - The company has elected not to "opt out" of the extended transition period for complying with new or revised accounting standards, delaying adoption until private companies are required to comply[403]. - The reported results of operations may not be directly comparable to those of other public companies due to the accounting standards adopted[403].

Financial Data and Key Metrics Changes - The company ended the year with a cash balance of $4.6 million, with cash used in operations for Q4 2024 at $1.7 million and for the full year at $9.6 million, compared to $3 million and $15.8 million for the same periods in 2023, reflecting efforts to contain spending while advancing programs [27][28] - The net loss for the year ended 2024 was $10.8 million or $2.86 per share, a significant reduction from a net loss of $22.5 million or $6.54 per share in the prior year [28] Business Line Data and Key Metrics Changes - The company made strong progress in its clinical programs, particularly with the iNKT cell therapy, which has shown effectiveness in treating solid tumors and immune-driven diseases [11][12] - The collaboration with Autonomous Therapeutics aims to enhance the efficacy of iNKT cell therapy by integrating their encrypted RNA technology, targeting metastatic cancer with greater precision [9][10] Market Data and Key Metrics Changes - The company presented data at major conferences, demonstrating that its iNKT cell therapy enhances immune activation and overcomes resistance in challenging cancers, including gastric cancer [12][13] - The Phase 1 study of AgenT-797 in patients with severe acute respiratory distress showed an 80% survival rate in patients on life support, compared to just 10% of in-hospital controls, highlighting the potential of iNKT cells in addressing high-impact health challenges [20][21] Company Strategy and Development Direction - The company is focused on bringing scalable, durable, and effective allogeneic iNKT cell therapy to patients, with plans to advance multiple clinical programs in 2025, including gastric cancer and GvHD [5][31] - The addition of Dr. Robert Kadlec to the Board of Directors is expected to enhance the company's strategic depth in biodefense and pandemic preparedness [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's momentum entering 2025, with a differentiated technology and a clear plan to reach the next value inflection point [26][32] - The company remains committed to operational efficiency and fiscal responsibility while advancing its innovative therapies [32] Other Important Information - The company is advancing its PRAME-TCR program, which targets intracellular tumor antigens, demonstrating high specificity and potent tumor killing [15][18] - The Phase 1 trial of 797 in patients undergoing allogeneic bone marrow transplant for GvHD is expected to be conducted with external support to offset development costs [22][24] Q&A Session Summary Question: Status of the Phase 2 study and focus for 2025 - Management confirmed that the majority of patients are enrolled in the Phase 2 study for gastric cancer, with data expected in the second half of the year, and emphasized the importance of advancing both gastric cancer and GvHD studies in 2025 [41][37] Question: KOL investigator feedback and approval prospects - Management noted positive feedback from KOLs and highlighted the potential for the program to be registrational, with ongoing data accumulation to demonstrate clinical benefits [49][53] Question: Timing of funding for GvHD study and cash runway - Management indicated that funding from NIAID is fluid but expressed optimism about securing it, while also stating that the company has cash runway through the end of 2025 [66][78]

Financial Data and Key Metrics Changes - The company ended the year with a cash balance of $4.6 million, with cash used in operations for Q4 2024 at $1.7 million and for the full year at $9.6 million, compared to $3 million and $15.8 million for the same periods in 2023, reflecting efforts to contain spending while advancing programs [27][28] - The net loss for the year ended 2024 was $10.8 million or $2.86 per share, compared to a net loss of $22.5 million or $6.54 per share in the prior year [28] Business Line Data and Key Metrics Changes - The company made significant progress in its clinical programs, particularly with the iNKT cell therapy, which has shown effectiveness in treating solid tumors and immune-driven diseases [11][12] - The collaboration with Autonomous Therapeutics aims to enhance the efficacy of iNKT cell therapy by integrating their encrypted RNA technology, targeting metastatic cancer with greater precision [9][10] Market Data and Key Metrics Changes - The company presented data at major conferences, demonstrating that its iNKT cell therapy enhances immune activation and overcomes resistance in challenging cancers, including gastric cancer [12][13] - The Phase 1 study of AgenT-797 in patients with severe acute respiratory distress showed an 80% survival rate, significantly higher than the 10% survival rate of in-hospital controls [20][21] Company Strategy and Development Direction - The company is focused on delivering scalable, durable, and effective allogeneic iNKT cell therapy to patients, with plans to advance multiple clinical programs in 2025, including gastric cancer and GvHD [5][31] - The addition of Dr. Robert Kadlec to the Board of Directors is expected to enhance the company's strategic depth in biodefense and pandemic preparedness [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's momentum entering 2025, highlighting a differentiated technology and a clear plan to reach the next value inflection point [26][32] - The company remains committed to operational efficiency and fiscal responsibility while advancing its innovative therapies [32] Other Important Information - The company has received probable funding from the National Institute of Allergy and Infectious Diseases (NIAID) to explore the activity of 797 in acute GvHD, with plans for a Phase 1 trial [23][24] - The company is advancing its PRAME-TCR program, which targets intracellular tumor antigens, demonstrating high specificity and potent tumor killing [15][18] Q&A Session Summary Question: Status of the Phase 2 study and focus for 2025 - Management confirmed that the majority of patients are enrolled in the Phase 2 study for gastric cancer, with data expected in the second half of the year, and emphasized the importance of advancing both gastric cancer and GvHD programs in 2025 [36][41] Question: KOL investigator feedback and potential for approval - Management noted positive feedback from key opinion leaders and emphasized the goal of accumulating data to demonstrate clinical benefits, with plans for regulatory discussions [47][53] Question: Timing of funding for GvHD study and cash runway - Management indicated that funding for the GvHD study is fluid but expressed optimism about securing it, while confirming that the company has cash runway through the end of 2025 [66][78]