MiNK Therapeutics, Inc. (NASDAQ:INKT) is a clinical-stage biopharmaceutical company pioneering the discovery, development, and manufacturing of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. The company's proprietary platform is designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery, positioning it as a highly versatile application for therapeutic development.

Business Overview

MiNK's lead product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy that has demonstrated promising results in its Phase 1 clinical trial for solid tumor cancers. The therapy has shown durable clinical benefit and a tolerable safety profile across various heavily pre-treated solid tumors, including non-small cell lung cancer, testicular cancer, and gastric cancer. Notably, the median progression-free survival exceeded six months, and approximately 30% of patients experienced durable disease stabilization, even in cancers that were refractory to all prior therapies.

Building on these encouraging results, MiNK plans to conduct a randomized Phase 1/2 expansion trial to assess the efficacy of agenT-797 in combination with standard-of-care chemotherapy and immune therapy, with or without Agenus' multifunctional anti-CTLA-4 agent, botensilimab, in relapsed/refractory gastric cancer.

In addition to its work in oncology, MiNK has also reported positive data from a Phase 1 clinical trial of agenT-797 for the treatment of viral acute respiratory distress syndrome (ARDS). The company reported an encouraging 75% survival benefit, compared to approximately 10-22% in control and time-matched data, as well as observations that agenT-797 improved lung function and significantly reduced inflammation and secondary infections.

MiNK is also advancing a pipeline of next-generation allogeneic, engineered iNKT programs, including MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT, and MiNK-413, an IL-15 armored CAR-iNKT program targeting BCMA. These programs have demonstrated promising preclinical results, and the company expects to submit Investigational New Drug (IND) applications to the FDA in 2024.

Financials

For the fiscal year ended December 31, 2023, MiNK reported an annual net loss of $22.5 million and no revenue. The company's annual operating cash flow was -$15.8 million, and its annual free cash flow was -$15.8 million. These financial results reflect the company's ongoing investment in research and development activities to advance its pipeline of iNKT cell therapies.

In the first quarter of 2024, MiNK reported a net loss of $3.8 million, or $0.11 per share, compared to a net loss of $5.7 million, or $0.17 per share, in the same period of the prior year. The company's research and development expenses decreased by 39% to $2.5 million, while general and administrative expenses decreased by 23% to $1.3 million, primarily due to decreased share-based compensation expense.

As of March 31, 2024, MiNK had a cash and cash equivalents balance of $5.8 million. Subsequent to the quarter end, the company announced a $5.8 million investment from a new investor, which will be used to support the advancement of the MiNK-215 program.

Liquidity

MiNK has incurred annual operating losses since its inception in 2017 and had an accumulated deficit of $137.2 million as of March 31, 2024. The company expects to continue incurring losses as it advances the development of its technologies and product candidates, manages regulatory processes, initiates and continues clinical trials, and prepares for potential commercialization.

To support its liquidity requirements, MiNK is exploring various funding sources, including seeking strategic partnerships and collaborations, securing non-dilutive financing such as grants and collaborations, and potential equity or debt financing options. The company's parent, Agenus Inc., has also indicated a willingness to provide additional funding to finance MiNK's operations.

Risks and Challenges

As a clinical-stage biopharmaceutical company, MiNK faces several risks and challenges, including the inherent uncertainties of the drug development process, the need to obtain regulatory approvals for its product candidates, and the competition from other therapies in the oncology and immune-mediated disease markets. The company's reliance on its parent, Agenus, for certain services and deferral of related payments also presents a risk, as Agenus has recently disclosed the existence of a substantial doubt about its ability to continue as a going concern.

Outlook

MiNK is focused on advancing its clinical-stage programs, strengthening its financial foundation, and delivering innovative medicines to patients with cancer and other immune-mediated diseases. The company expects to report initial data from the Phase 2 gastric cancer trial of agenT-797 in the second half of 2024 and plans to submit IND applications for its next-generation iNKT programs, MiNK-215 and MiNK-413, in 2024.

Conclusion

MiNK Therapeutics is a promising biotech company with a unique platform for developing allogeneic, off-the-shelf iNKT cell therapies. The company's lead program, agenT-797, has demonstrated encouraging clinical results in solid tumor cancers and severe respiratory distress, while its pipeline of next-generation engineered iNKT programs, such as MiNK-215 and MiNK-413, hold significant potential. With a focus on advancing its clinical-stage assets and strengthening its financial position, MiNK is well-positioned to drive transformative growth and deliver innovative treatments to patients in need.