MiNK Therapeutics (NASDAQ:INKT) outlined progress across its allogeneic invariant natural killer T-cell (iNKT) platform during its fourth quarter and year-end 2025 financial results conference call, highlighting updated clinical observations in solid tumors, plans to initiate randomized testing in severe hypoxemic pneumonia/acute respiratory distress syndrome (ARDS), and externally funded work in graft-versus-host disease (GVHD).
President and CEO Dr. Jennifer Buell described MiNK’s iNKT cells as an “off-the-shelf” approach that is administered “without lymphodepletion” and “without HLA matching.” Buell said the company has observed clinical activity with a favorable safety profile and is advancing programs in both oncology and immune-mediated inflammatory conditions.
Updated observations in solid tumors and immune mechanism
On mechanism, Buell said the company has seen signs of coordinated immune activation, including “activation and expansion” of immune cell populations such as dendritic cells, repolarization of macrophages toward “pro-inflammatory antitumor states,” and “reinvigorated” exhausted T-cells. She also cited “controlled increases in cytokines” including interferon gamma, IL-2, and TNF alpha, which she said were consistent with a productive immune response “without systemic toxicity.”
ARDS/hypoxemic pneumonia program moving into randomized testing
A major focus of the call was MiNK’s pulmonary program in severe hypoxemic pneumonia/ARDS. Buell described ARDS as affecting “approximately 200–300,000 patients annually” with a “mortality rate of 30%–40%” and “no approved disease-modifying therapies.”
Discussing results from a prior phase I/II trial in critically ill patients, Buell said patients were on “mechanical ventilation and/or VV ECMO,” and the company demonstrated it could deliver cells in community hospitals. She said MiNK dosed “to 1 billion cells” and that the cells were “tolerated quite well,” adding that the company did not observe cytokine release and instead “dampened pro-inflammatory signals.”
Buell also cited outcomes from the trial, including “prolonged survival,” stating that “70% of patients” were alive compared to “10% of patients within hospital controls.” She said the company observed local immune modulation in the lung, improved endothelial function and oxygenation, “rapid extubation,” and patients coming off VV ECMO. Buell added that MiNK observed pathogen clearance and “a reduction in the onset of secondary infections.”
Based on those findings, Buell said MiNK expects to begin dosing patients “imminently” in a MiNK-sponsored randomized phase II study designed to expand to a phase II/III study. She described it as a global program planned to launch with centers in Ukraine and in the U.S., and said the company is working with the Ministry of Health in Ukraine and the U.S. FDA. With dosing expected to start soon, Buell said MiNK anticipates initial clinical data in the “second half of this year.”
In the Q&A session, Buell provided additional detail on the intended control approach. She said that in this disease setting, patients are treated with standard of care—often steroids and anti-infectives—reflecting “physician’s choice.” She said MiNK plans to evaluate its cells “added on top of standard of care versus the cells alone,” and emphasized the company has observed the cells appear to clear pathogens and modulate immune function “independent of steroids being on board,” describing the cells as appearing “steroid resistant.”
Buell also highlighted the role of Dr. Terese Hammond, MiNK’s Head of Development, in leading the pulmonary program, noting Hammond’s clinical background in pulmonary critical care and ongoing ICU practice.
GVHD trial backed by non-dilutive funding
MiNK also discussed its plans in GVHD in the setting of hematopoietic stem cell transplantation. Buell said the company’s intent is to improve engraftment success and prevent acute GVHD. She said the work has support from two sources of non-dilutive funding: an NIH/NIAID STTR award for preclinical and translational work and the Mary Goos Clinical Trial Award to fund clinical trial execution at the University of Wisconsin.
According to Buell, the GVHD clinical trial is in “final review at the university,” with clinical initiation targeted for the first half of the year and dosing expected “very soon.”
Pipeline expansion and collaboration commentary
Buell highlighted additional non-dilutive funding obtained in 2025, including consortium funding through C-Further. She said the C-Further collaboration includes “over $1 million” to support IND-enabling studies and provides “meaningful double-digit downstream economics” to MiNK. Buell described the program as focused on a PRAME-targeting iNKT TCR and said it was selected as one of the first programs within the C-Further Consortium, which she described as an international pediatric oncology initiative supported by Cancer Research Horizons, LifeArc, and Great Ormond Street Hospital.
Buell also referenced MiNK-215, a CAR-iNKT program “targeting stromal resistance,” saying the company is building translational data as it moves responsibly toward IND-enabling work. She said there was not a “specific near-term catalyst,” but added the company would “expect to be announcing some within the next 3–5 months” for the 215 program.
On potential partnerships, Buell said MiNK has seen increased external interest in “797 and iNKT biology” but had “not formally announced any of our strategic collaborations yet.” In response to a question about an IL-15 superagonist combination trial appearing on ClinicalTrials.gov, Buell said MiNK “has not formally announced any collaboration or any clinical trials with the IL-15 superagonist.” She added that the company has ongoing discussions involving clinical trial combinations and broader strategic collaborations, as well as potential minority financial investments, but said none had been publicly disclosed.
Financial results and 2026 milestones
Melissa Orilall, Principal Financial and Accounting Officer, reported that MiNK ended 2025 with a cash balance of $13.4 million after executing an at-the-market (ATM) facility “in a disciplined manner.” Orilall added that since year-end the company raised an additional $3 million through the ATM, which she said extends runway through 2026 and supports key clinical milestones.
Orilall said MiNK’s net loss for the fourth quarter of 2025 was $2.6 million, or $0.56 per share, compared with a net loss of $2.5 million, or $0.62 per share, in the fourth quarter of 2024. For the full year, net loss was $12.5 million, or $2.93 per share, compared with $10.8 million, or $2.86 per share, in 2024. She attributed the results to continued investment in the company’s AGENT-797 clinical programs alongside “disciplined control” of operational spending.
Looking ahead, Buell outlined milestones the company expects to pursue in 2026, including initiating the randomized phase II/III ARDS/hypoxemic pneumonia study and activating and dosing the GVHD trial in the first half of the year, followed by initial clinical data from both programs in the second half. She also said MiNK expects multiple data presentations and peer-reviewed publications in the first half of 2026, extending data sets discussed from SITC and Keystone.
About MiNK Therapeutics (NASDAQ:INKT)
MiNK Therapeutics, Inc is a clinical-stage biotechnology company developing exosome-based immunotherapies for the treatment of solid tumors. The company’s proprietary platform isolates and engineers naturally occurring extracellular vesicles, or exosomes, to deliver therapeutic payloads—such as mRNA, proteins and modulatory factors—directly into the tumor microenvironment. By leveraging the innate cell‐to‐cell communication properties of exosomes, MiNK aims to reprogram immune cells and overcome immune suppression within solid tumors.
MiNK’s preclinical pipeline features multiple lead candidates designed to repolarize tumor‐associated macrophages and boost T cell–mediated tumor clearance.
