Financial Performance - Research and development (R&D) expenses increased 111% to $1.1 million for Q3 2025 from $0.5 million in Q3 2024, primarily due to a $1.8 million gain from liability forgiveness in 2024 that did not recur in 2025 [81]. - General and administrative (G&A) expenses rose 59% to $1.8 million for Q3 2025 from $1.2 million in Q3 2024, mainly due to increased professional fees related to the implementation of the At Market Issuance Sales Agreement [82]. - R&D expenses decreased 14% to $4.2 million for the nine months ended September 30, 2025, down from $4.9 million for the same period in 2024, attributed to reduced clinical trial costs and personnel expenses [85]. - G&A expenses increased 42% to $5.0 million for the nine months ended September 30, 2025, compared to $3.5 million in the same period in 2024, driven by higher professional fees and share-based compensation [86]. - The company reported net cash used in operating activities of $3.9 million for the nine months ended September 30, 2025, compared to $7.8 million for the same period in 2024 [97]. Clinical Trials and Product Development - The company reported a survival benefit of 75% in a Phase 1 study of agenT-797 for viral ARDS, compared to 10-22% in an in-hospital control group [77]. - The median progression-free survival for patients in the Phase 1 trial of agenT-797 exceeded six months, with approximately 30% achieving durable disease stabilization [73]. - The company plans to submit an Investigational New Drug (IND) application for MiNK-215 to the FDA in 2025, following promising preclinical data [78]. - The collaboration with ImmunoScape aims to develop next-generation T-cell receptor therapies against solid tumors, leveraging both companies' proprietary technologies [79]. - The company’s future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of its product candidates [97]. Financial Position and Funding - The company had an accumulated deficit of $154.1 million as of September 30, 2025, and expects to incur losses in the coming years as it continues product development [91]. - The company entered into a Sales Agreement to sell shares of common stock with a maximum aggregate offering price of $50.0 million, with approximately $35.2 million remaining available under the agreement as of November 13, 2025 [92]. - As of September 30, 2025, the company had a cash and cash equivalents balance of $14.3 million, and after receiving $1.2 million from stock sales, it believes this will satisfy liquidity requirements for more than one year [95]. - The company has an outstanding Note of $5.0 million in principal plus accrued interest of approximately $154,000, which is payable on or after January 1, 2026 [93]. - The company plans to seek additional funding through strategic partnerships, collaborations, and potential equity or debt financing options to support liquidity requirements [96]. Going Concern and Regulatory Status - The company has substantial doubt about its ability to continue as a going concern for a period of one year after the filing of the Quarterly Report [95]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements [100].
MiNK Therapeutics(INKT) - 2025 Q3 - Quarterly Report