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 Performance - MiNK Therapeutics reported a net loss of $10.8 million for the year ended December 31, 2024, or $2.86 per share, a significant improvement from a net loss of $22.5 million or $6.54 per share in 2023[8]. - Cash used in operations for the year was $9.6 million, down from $15.8 million in 2023, indicating improved operational efficiency[7]. - The company ended 2024 with a cash balance of $4.6 million, compared to $3.4 million at the end of 2023[10]. Fundraising and Financial Strategy - MiNK raised $5.8 million in private financing in 2024, focusing on externally funded clinical trials to advance its iNKT cell programs[6]. Clinical Trials and Research - AgenT-797 demonstrated an approximately 80% survival rate among VV ECMO patients in acute respiratory distress, compared to 10% in hospital controls[6]. - The Phase 2 trial for AgenT-797 in second-line advanced gastric cancer is actively enrolling, with promising early data from combination therapies[6]. - A research collaboration with Autonomous Therapeutics was established in October 2024 to develop precision RNA-iNKT therapies for metastatic tumors[6]. Manufacturing and Technology - MiNK's manufacturing process allows for the production of billions of donor-derived iNKT cells per run, enhancing scalability and patient access[6]. - The company is advancing next-generation iNKT treatments targeting challenging cancer types, supported by a rapid AI-driven drug discovery platform[2]. Strategic Vision - MiNK's operational strategy aims for value creation and collaboration opportunities, positioning the company for growth in 2025 and beyond[7].

Core Insights - MiNK Therapeutics, Inc. reported significant business progress and clinical advancements in its fourth quarter and full year 2024 financial results, emphasizing its commitment to developing allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies for challenging cancers and immune-related disorders [1][2] Operational Highlights - The company made substantial clinical strides, enhanced its manufacturing capabilities, and established strategic alliances throughout 2024 [2] - MiNK's rapid AI-driven drug discovery platform is generating a library of phosphorylated neoantigens and proprietary TCRs, positioning the company to set a new standard in oncology [2][6] Clinical Advancements - AgenT-797 demonstrated enhanced immune activation and improved efficacy of checkpoint inhibitors in heavily pretreated patients, with ongoing Phase 2 trials in advanced gastric cancer showing promising early data [7] - The therapy also showed an approximately 80% survival rate in acute respiratory distress patients compared to 10% in hospital controls, with late-stage trials planned [7] - MiNK's PRAME-TCR iNKTs exhibited high specificity and potent tumor-killing capabilities against resistant cancer targets [7] - MiNK-215 (IL-15 Armored CAR-iNKT) displayed robust anti-tumor activity in metastatic colorectal cancer models [7] Strategic Growth and Manufacturing Optimization - MiNK's advanced manufacturing process allows for the production of billions of donor-derived iNKT cells per run, facilitating rapid global distribution and enhancing patient access [7] - The company entered a research collaboration with Autonomous Therapeutics to develop precision RNA-iNKT therapies for metastatic tumors [7] Financial Highlights - MiNK raised $5.8 million in private financing in 2024 and ended the year with a cash balance of $4.6 million [8][9] - Cash used in operations decreased to $1.7 million for Q4 2024 from $3.0 million in Q4 2023, and for the full year, it decreased to $9.6 million from $15.8 million [8][10] - The net loss for 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 2023 [8][12]

Core Viewpoint - MiNK Therapeutics, Inc. has made significant progress in developing allogeneic iNKT cell therapies, reporting advancements in clinical trials and financial performance for the year 2024 [1][2]. Operational Highlights - The company has advanced its mission to provide off-the-shelf iNKT cell therapies for patients with difficult-to-treat cancers and severe immune-related disorders [2]. - MiNK has strengthened its manufacturing capabilities and established strategic alliances to enhance its operational efficiency and collaboration opportunities [2]. - The company is utilizing an AI-driven drug discovery platform to create a library of phosphorylated neoantigens and proprietary TCRs, positioning itself to set new standards in oncology [2][4]. Clinical Advancements - AgenT-797 has shown enhanced immune activation and improved efficacy in combination with checkpoint inhibitors and bispecific engagers in heavily pretreated patients [7]. - Early data from a Phase 2 trial in advanced gastric cancer suggest promising activity when combining AgenT-797 with other treatments [7]. - AgenT-797 demonstrated an approximately 80% survival rate in acute respiratory distress patients compared to 10% in hospital controls [7]. - MiNK's PRAME-TCR iNKTs have shown high specificity and potent tumor-killing capabilities against resistant cancer targets [7]. - MiNK-215 has exhibited robust anti-tumor activity in metastatic colorectal cancer models [7]. Financial Highlights - MiNK ended 2024 with a cash balance of $4.6 million, with cash used in operations decreasing to $1.7 million for Q4 and $9.6 million for the full year [8][10]. - The net loss for 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 2023 [8][12]. - Operating expenses for research and development decreased to $6.3 million in 2024 from $15.5 million in 2023 [11]. Strategic Growth and Manufacturing Optimization - MiNK's manufacturing process allows for the production of billions of donor-derived iNKT cells per run, facilitating rapid global distribution and enhancing patient access [7]. - The company raised $5.8 million in private financing in 2024 and is focusing on externally funded clinical trials to advance its iNKT cell programs [7].

Company Overview - MiNK Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies aimed at treating cancer and other immune-mediated diseases [3] Upcoming Financial Results - The company will release its fourth quarter and year-end 2024 financial results before the market opens on March 18, 2025 [1] - MiNK executives will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the results and provide a corporate update [1] Conference Call Details - Dial-in numbers for the conference call include 646-307-1963 (New York) and 800-715-9871 (USA & Canada) [2] - A live webcast and replay of the conference call will be available on the company's Events & Presentations page [2]

Core Points - MiNK Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune-mediated diseases [1][3] - The company will release its fourth quarter and year-end 2024 financial results on March 18, 2025, before the market opens [1] - A conference call and webcast will be held at 8:30 a.m. ET on the same day to discuss the results and provide a corporate update [1][2] Company Overview - MiNK Therapeutics is advancing a pipeline of both native and next-generation engineered iNKT programs [3] - The company aims to facilitate scalable and reproducible manufacturing for off-the-shelf delivery of its therapies [3] - MiNK Therapeutics is headquartered in New York, NY, and provides information relevant to investors on its website and social media channels [3]

Core Insights - MiNK Therapeutics presented new data on its allo-iNKT cell therapy, agenT-797, demonstrating its potential to enhance immune activation in patients with refractory gastroesophageal cancer when combined with checkpoint inhibitors and chemotherapy [1][2][3] Combination Therapy Efficacy - The combination of agenT-797 with botensilimab and balstilimab showed significant immune reactivation, leading to improved clinical activity in tumors that typically do not respond to treatment [2][3] - Early induction of agenT-797 resulted in a notable increase in interferon-gamma (IFNγ) levels and enhanced tumor infiltration by T cells and antigen-presenting cells, indicating robust systemic immune engagement [3] Treatment Sequencing Importance - The most effective immune response was observed when agenT-797 was administered concurrently with checkpoint inhibitors and prior to standard chemotherapy, highlighting the significance of treatment sequencing [4] Strategic Advantages - MiNK's scalable manufacturing process allows for the generation of billions of donor-derived iNKT cells in a single run, facilitating rapid global distribution and reducing logistical challenges [6] - The company’s differentiated pipeline supports expansion into additional hard-to-treat cancers, presenting significant opportunities for growth and partnerships [6] Product Overview - AgenT-797 is designed to leverage both innate and adaptive immunity, functioning as a "master regulator" to enhance immune responses against difficult tumors [9][10] - Botensilimab and balstilimab are designed to improve anti-tumor immune responses, particularly in "cold" tumors that are less responsive to conventional therapies [11][12]

Group 1 - MiNK Therapeutics, Inc. has regained compliance with Nasdaq listing requirements, confirming it meets the minimum bid price and market value of listed securities [1] - The company specializes in the development of allogeneic invariant natural killer T (iNKT) cell therapies aimed at treating cancer and immune-mediated diseases [2] - MiNK is advancing a pipeline of both native and engineered iNKT programs, focusing on scalable and reproducible manufacturing for off-the-shelf delivery [2] Group 2 - The company is headquartered in New York, NY, and provides information relevant to investors through its website and social media channels [2] - The press release includes forward-looking statements regarding the potential benefits of iNKT cell therapies and future program goals, which are subject to various risks and uncertainties [3] - Investor and media contact information is provided for further inquiries [4]

Core Viewpoint - MiNK Therapeutics, Inc. has been selected for an oral presentation at the AACR IO Annual Meeting, showcasing interim data from its Phase 2 study of AgenT-797 in combination with botensilimab and balstilimab for treating refractory gastric cancer [1][2]. 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 [1][2]. - The company is advancing a pipeline of both native and engineered iNKT programs, emphasizing scalable and reproducible manufacturing for off-the-shelf delivery [2]. Product Information - AgenT-797 is an allogeneic iNKT cell therapy that combines the cytotoxic capabilities of natural killer cells with the adaptive memory of T cells, allowing for a broad range of immune responses [3]. - The product is designed to be a scalable, "off-the-shelf" cell therapy, manufactured in Lexington, MA [4]. Presentation Details - The oral presentation will focus on biomarker analysis from the Phase 2 study of AgenT-797 in combination with botensilimab and balstilimab for PD-1 refractory gastroesophageal cancer [2]. - The presentation is scheduled for February 25, 2025, from 1:00 to 1:45 p.m. PST [2].