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MiNK Reports Second Quarter 2024 Results and Business Update

Expanded Access to AgenT-797 in Severe ARDS Reinforces Clinical Efficacy; Data Highlighted at ATS 2024 Annual Meeting Phase 2 Study in 2L Gastric Cancer Advances; Early Clinical Data to be Presented at Upcoming Medical Conference Phase 1 Study in GvHD on Track for Activation in 2Q 2024 NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ:INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the second quarter 2024. MiNK executives will host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide a corporate update. "MiNK is making significant strides in advancing our iNKT programs as we pioneer this next generation of cell therapies for patients," said Dr. Jennifer Buell, CEO of MiNK Therapeutics. "Our lead program, agenT-797, is moving forward in a Phase 2 study for second-line gastric cancer, and we are fast-tracking IND-enabling activities for our FAP-expressing CAR-iNKT therapy, MiNK-215. Additionally, the expanded findings presented at the ATS annual meeting underscore the significant potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients. We are committed to expanding the development of agenT-797 in a non-dilutive manner, particularly in the areas of ARDS and GvHD, where unmet needs are critical." Business Updates: In May 2024, MiNK successfully closed a private placement financing (PIPE) agreement, raising $5.8 million at a 25% premium to a new investor. Increased efficiency and progress of externally funded trials enable cash runway into 2025. Clinical Programs: Acute Respiratory Distress (ARDS): Expanded access to agenT-797 in ARDS has deepened observations of clinical benefit. MiNK's recent presentation at the American Thoracic Society (ATS) 2024 annual meeting highlighted the activity of agenT-797 in treating ARDS. In a clinical case involving a renal transplant patient with severe COVID-19-induced respiratory distress, agenT-797 led to rapid cytokine reduction, successful extubation, and rapid discharge after just a single dose. These results underscore the potential of agenT-797 for severe respiratory conditions in immune-compromised patients. MiNK is committed to advancing agenT-797 in ARDS through a predominantly externally funded, large-scale platform trial. 2L Gastric Cancer: A Phase 2 Investigator-Sponsored Study of agenT-797 is progressing rapidly at Memorial Sloan Kettering Cancer Center (NCT06251973). The study's swift advancement and early signals of activity highlight the promising potential of agenT-797 in treating challenging cancers, with initial data at an upcoming conference. MiNK is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for 2Q 2024. This study aims to explore the potential of agenT-797 in mitigating GvHD, a severe and life-threatening complication following allogeneic stem cell transplantation. The unique immunomodulatory properties of iNKT cells offer a novel therapeutic approach to controlling GvHD by reducing inflammation and promoting immune tolerance - furthering MiNK's commitment to the application of agenT-797 beyond cancer. Preclinical Programs Advancing: MiNK-215 is an investigational IL-15 armored fibroblast activation protein (FAP) targeting CAR-iNKT cell therapy, that has demonstrated robust preclinical activity in solid tumor cancers, including MSS colorectal cancer liver metastases, and non-small-cell-lung cancer. Plans are in place to fast-track the IND filing to early 2025. Financial Results MiNK ended the quarter with a cash balance of $9.3 million reflecting cash used in operations for the quarter of $2.3 million, reduced from $2.6 million for the first quarter 2024. Net loss for the three and six months ended June 30, 2024, was $2.7 million, or $0.07 per share, and $6.5 million, or $0.18 per share, respectively. This compares to $6.2 million, or $0.18 per share, and $11.9 million, or $0.35 per share, for the same periods in 2023. Summary Consolidated Financial Information                           Condensed Consolidated Balance Sheet Data         (in thousands)         (unaudited)                             June 30, 2024   December 31, 2023                             Cash and cash equivalents $ 9,314     $ 3,367             Total assets   10,324       4,552                                                 Other Financial Information           (in thousands)         (unaudited)           Three months ended June 30,   Six months ended June 30,       2024       2023