MiNK Therapeutics(INKT) - 2023 Q4 - Annual Results

MiNK Therapeutics Fourth Quarter and Year-End 2023 Results Overview and Strategic Highlights MiNK Therapeutics advanced its iNKT cell programs in 2023, progressing agenT-797 to Phase 2 for gastroesophageal cancers and forming a key research partnership for TCR-based therapies - The company primarily focuses on advancing its lead program, agenT-797, in indications with promising proof-of-concept data[3] - A Phase 2 study of agenT-797 for gastroesophageal cancers has been initiated, with initial data expected later in the year[3][7] - A research collaboration with ImmunoScape was established to accelerate the development of TCR-based therapies for solid tumors[3][6] Clinical Program Updates MiNK advanced agenT-797 to Phase 2 for gastroesophageal cancers, showed high survival in ARDS, and progressed MiNK-215 with preclinical efficacy in NSCLC AgenT-797 in Solid Tumors A Phase 2 investigator-sponsored trial for agenT-797 in second-line gastroesophageal cancers is actively enrolling patients, evaluating a combination therapy regimen - A Phase 2 trial (NCT06251973) for second-line gastroesophageal cancers has launched and is actively enrolling patients[7][8] - The trial is led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center and supported by Stand Up To Cancer[8] - The combination therapy includes agenT-797, Agenus' botensilimab (CTLA-4), balstilimab (anti-PD-1), ramucirumab, and paclitaxel[8] AgenT-797 in Acute Respiratory Distress Syndrome (ARDS) A Phase 1/2 study of agenT-797 in ARDS demonstrated high survival rates and reduced secondary infections, with plans for further advancement in viral ARDS - A Phase 1/2 study published in Nature Communications demonstrated clinical activity in severe acute respiratory distress[7][8] - Survival rates exceeded 70% for patients on mechanical ventilation and over 80% for those on VV ECMO, significantly higher than the 10% control group survival[8] - AgenT-797 treatment led to an over 80% decrease in secondary bacterial and fungal infections in the highest dose cohort[8] Research and Preclinical Programs MiNK is expanding its early-stage pipeline via a collaboration with Immunoscape for TCR-based therapies and advancing preclinical candidate MiNK-215 for NSCLC with IND-enabling activities underway - The collaboration with Immunoscape aims to accelerate TCR-based therapies development against novel targets in T cells and iNKT cells for solid tumors[6][9] - Preclinical efficacy data for MiNK-215 presented at ASGCT 2023 showed activity in NSCLC models[17] - IND-enabling activities and supportive financing discussions for MiNK-215 are currently underway[17] Manufacturing Progress MiNK Therapeutics maintains internal, FDA-cleared, automated, and closed-system manufacturing for its allogeneic iNKT cells, supplying ongoing clinical trials - The company continued internal manufacturing of its allogeneic iNKT cells to supply ongoing clinical trials[10] - The manufacturing process is FDA-cleared, automated, and utilizes a closed-system[10] Financial Results MiNK ended 2023 with $3.4 million cash, secured an additional $5 million post-year-end, and reduced its full-year net loss to $22.5 million due to decreased R&D spending and improved operational efficiency Key Financial Position (Balance Sheet) As of December 31, 2023, MiNK's cash and cash equivalents were $3.4 million, a significant decrease from $19.6 million in 2022, with total assets also declining, though $5 million was received post-year-end via a convertible note - Ended 2023 with a cash balance of $3.4 million and received an additional $5 million after year-end under a convertible note agreement with Agenus Inc[11] Balance Sheet Summary (in thousands USD) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,367 | $19,636 | | Total assets | $4,552 | $21,472 | | Total stockholders' equity (deficit) | $(18,055) | $(401) | Statement of Operations For full year 2023, MiNK reported a net loss of $22.5 million ($0.65 per share), an improvement from $28.0 million in 2022, primarily due to decreased R&D expenses from $23.1 million to $15.5 million Statement of Operations Summary (in thousands USD, except per share data) | | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $15,490 | $23,115 | | General and administrative | $7,431 | $7,834 | | Operating loss | $22,921 | $30,949 | | Net loss | $22,458 | $27,991 | | Net loss per share | $0.65 | $0.83 | Cash Flow MiNK demonstrated improved cash management, with cash used in operations decreasing to $15.8 million for full year 2023 from $18.9 million in 2022, and $3.0 million for Q4 2023 from $4.4 million in Q4 2022 Cash Used in Operations (in thousands USD) | Period | 2023 | 2022 | | :--- | :--- | :--- | | Q4 | $3,025 | $4,431 | | Full Year | $15,752 | $18,867 |