MiNK Therapeutics Reports Third Quarter 2026 Results, First Pre-Commercial Product Revenue from agenT-797, Randomized ARDS Trial Advancing, and ARPA-H Selection for Deployable Cell Therapies

MiNK is concentrating its own investment on the randomized ARDS trial while using four sources of non-dilutive support to advance its pipeline.

Rhea-AI Summary

MiNK Therapeutics (NASDAQ: INKT) reported its first pre-commercial agenT-797 revenue of $0.2 million alongside third-quarter results and progress in its randomized ARDS trial. Net loss narrowed to $2.552 million, or $0.50 per share, from $2.888 million, or $0.65 per share, a year earlier. Cash totaled $7.471 million at September 30, 2026, versus $13.360 million at December 31, 2025.

The Phase 2 trial in acute respiratory distress syndrome continued enrolling in Ukraine. MiNK expects U.S. dosing before year-end 2026 and initial randomized data in the second half of 2027; it is seeking FDA feedback on an adaptive design. AgenT-797 was selected for the Draper-led ARPA-H team, with up to $87 million in program-wide funding over four years, not an award solely to MiNK. Paid named-patient access operates outside the United States with case-by-case health authority authorization.

14 points · 0 major

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0 major · 7 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Initial randomized ARDS readout is expected in 2H2027, with 124 patients planned for the initial stage.
• Minor pointFirst pre-commercial revenue of $0.2 million came from paid agenT-797 named-patient access during the third quarter.
• Minor pointQuarterly net loss narrowed to $2.552 million, or $0.50 per share, versus $2.888 million, or $0.65, a year earlier.
• Minor pointNine-month net loss narrowed to $8.423 million, or $1.69 per share, versus $9.892 million, or $2.39, a year earlier.
• Minor pointGeneral and administrative expense declined 44% to $1.0 million, reflecting lower professional fees and stock compensation.

9 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Randomized Phase 2 ARDS enrollment continued in Ukraine; MiNK expects U.S. dosing before year-end 2026.
• Minor pointInitial treated ARDS patients showed clinical recovery; no serious adverse events were attributed to agenT-797.
• Minor pointARPA-H selection adds fixed-fee participation in a Draper-led program supported by up to $87 million program-wide over four years.
• Minor pointFour sources of non-dilutive support are advancing pipeline programs alongside MiNK's internally funded ARDS trial.
• Minor pointScripps investigator-sponsored Phase 2 study is evaluating agenT-797 with botensilimab and balstilimab in colorectal cancer with liver metastases.
• Minor point. Forward-looking: it has not happened yet and may not happen.Wisconsin GvHD-prevention Phase 1 study is moving toward dosing; the university expects first-patient scheduling by December 2026.
• Minor pointPreclinical colorectal cancer organoids showed tumor-cell killing when agenT-797 was added to botensilimab and balstilimab.
• Minor pointPreclinical senescence findings showed agenT-797 and MiNK-215 clearing senescent cells; MiNK-215 also eliminated FAP-expressing fibroblasts.
• Minor point. Forward-looking: it has not happened yet and may not happen.Named-patient access expansion is planned in additional markets where regulations allow.

Negative

• Moderate pointCash declined to $7.471 million at September 30, 2026, from $13.360 million at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Additional financing is being pursued, including potential equity or debt, to prioritize funding the randomized study through readout.
• Minor pointQuarterly operating cash use was $1.276 million, versus $941,000 a year earlier, but down from approximately $2.1 million sequentially.
• Minor pointNine-month operating cash use increased to $5.091 million from $3.851 million in the prior-year period.
• Minor pointResearch and development expense increased to $1.8 million from $1.1 million, reflecting trial activity and translational analyses.

2 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Named-patient revenue is expected to vary quarterly, depending on physician requests and case-by-case regulatory authorizations.
• Minor pointFDA feedback is still being sought on the proposed adaptive ARDS development design.

News Explained

The company is pursuing potential equity or debt financing to strengthen its balance sheet and fund the randomized study through readout, but discloses no amount or transaction terms; the release describes a financing objective, not committed proceeds or a quantifiable ownership effect.

Key Figures

Pre-commercial product revenue: $0.2 million Cash and cash equivalents: $7.5 million Net loss: $2.6 million vs. $2.9 million +4 more

Pre-commercial product revenue

$0.2 million

Q3 2026; first revenue from agenT-797 named-patient access

Cash and cash equivalents

$7.5 million

At September 30, 2026

Net loss

$2.6 million vs. $2.9 million

Q3 2026 vs. prior-year quarter

Net loss per share reduction

23%

Q3 2026 vs. prior-year quarter

Initial randomized stage

124 patients

Phase 2 ARDS trial; initial readout expected in 2H2027

Initial readout

2H2027

Randomized ARDS trial

Program-wide funding

Up to $87 million over four years

ARPA-H BoSS program-wide funding; no MiNK-specific amount disclosed

Previous Earnings Reports

1 past event · Latest: May 15

Same Type 1 event

1. May 15

   Q1 2026 earnings

   24h Move

   +2.0%

   Initiated the randomized Phase 2 agenT-797 trial in severe acute lung injury.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ards, allogeneic, hla matching, lymphodepletion, +1 more

5 terms

ards medical

"acute respiratory distress syndrome (ARDS) is advancing"

Acute respiratory distress syndrome (ARDS) is a sudden, severe failure of the lungs where fluid and inflammation prevent oxygen from getting into the bloodstream, like heavy wet balloons that won’t inflate properly. It matters to investors because ARDS represents a serious unmet medical need that drives demand for new therapies, influences clinical trial size and risk, affects regulatory scrutiny and reimbursement, and can significantly impact the valuation of companies developing treatments or diagnostics.

allogeneic medical

"off-the-shelf allogeneic invariant natural killer T"

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

hla matching medical

"without apheresis, HLA matching or lymphodepletion"

HLA matching is the process of comparing specific immune-system markers on donor and recipient cells to see how closely they align, much like checking whether two puzzle pieces or a lock and key fit. For investors, HLA compatibility matters because it strongly influences the success and complication risk of transplants and some cell therapies, which affects clinical outcomes, regulatory decisions, treatment demand, and the likely costs and timelines for related medical products.

lymphodepletion medical

"without apheresis, HLA matching or lymphodepletion"

Lymphodepletion is a short medical treatment that lowers a patient’s lymphocytes, the immune cells that can interfere with certain cell-based therapies, to create a more supportive environment for the new therapy to work. Think of it like clearing a crowded garden bed before planting seeds: by temporarily reducing competing cells, the engineered therapy can take hold more effectively. Investors watch lymphodepletion because it affects clinical trial results, safety profiles, treatment adoption, and overall commercial potential.

veno-venous ecmo medical

"advancing to veno-venous ECMO and all-cause mortality through Day 28"

Veno-venous ECMO (VV ECMO) is an extracorporeal life-support technique that temporarily takes over the gas-exchange function of the lungs by circulating a patient’s blood through an external oxygenator and returning it to the venous system. Blood is drained from a large vein, passed through a pump and membrane oxygenator to remove carbon dioxide and add oxygen, and then returned to a central vein; because the returned blood goes into the venous circulation, VV ECMO provides respiratory support only and does not provide direct cardiac (pump) support, which is the role of veno-arterial ECMO. It is used when the heart can still pump adequately but the lungs cannot oxygenate blood or remove carbon dioxide sufficiently despite conventional ventilation.

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• Patients with serious unmet medical need access agenT-797 through physician-requested named-patient access; generating the Company’s first product revenue
• Selected as the cell therapy for the Draper-led team in ARPA-H’s BoSS program (up to $87 million in program wide funding) to move living medicines toward room temperature deployability
• Randomized Phase 2 ARDS trial of agenT-797 plus standard of care (SOC) enrolling with U.S. dosing expected before year-end in patients with ~40% 28-day mortality, no effective approved therapies (estimated 93,000 U.S. patients annually)
• Data presented at SITC 2026: agenT-797 and MiNK-215 acted as “living senolytics,” clearing senescent cells chemotherapy leaves behind – cells that fuel treatment resistance and fibrotic lung disease; agenT-797 also unlocked tumor-cell killing with BOT/BAL in LM MSS CRC  organoids
• Disciplined execution: 23% year-over-year improvement in net loss per share, 44% G&A efficiency gain and the most capital-efficient quarter of 2026

NEW YORK, Nov. 11, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering unmodified, off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapies, reported financial results for the third quarter ended September 30, 2026, and highlighted a quarter in which agenT-797 realized pre-commercial revenue, its randomized trial in acute respiratory distress syndrome (ARDS) is advancing , and an ARPA-H program selected the Company’s cells to generate living medicines can be delivered without a freezer. Full financial results will be reported on Thursday, November 12, 2026.

iNKT cells coordinate the immune response a tissue requires: resolving infection and inflammation in severe lung injury, overcoming treatment resistance in cancer and clearing the senescent cells that sustain progression and fibrotic scarring. agenT-797 delivers from inventory – without apheresis, HLA matching or lymphodepletion. MiNK is concentrating its own investment on the randomized ARDS trial and using non-dilutive partners to advance key platform programs.

“We now have a randomized trial running in critical illness, multiple clinical programs enrolling and a path toward pivotal development. This quarter, physicians outside our trials began requesting agenT-797 for their patients, bringing our first pre-commercial revenue,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “The same unmodified iNKT cells, from the same donor, that drove a 77% disease control rate in PD-1-refractory gastroesophageal cancer are now in a placebo-controlled trial in ARDS, where nearly four in ten patients die and no effective approved drug changes that outcome. Our focus now is delivering the randomized readout designed to show what these cells can do for these patients.”

Third Quarter 2026 and Recent Highlights

Named-Patient Access Reaches Patients in Multiple Countries, Generating First Pre-commercial Revenue

In the third quarter, MiNK recognized its first pre-commercial product revenue from agenT-797 supplied on a paid, per-patient basis under its international named-patient access program, in collaboration with Orphan Drug Consulting and BAP. The program is now open in multiple countries outside the United States. Every request originates with a treating physician for an individually identified patient with serious unmet medical need and is authorized case by case by the applicable health authority; agenT-797 remains investigational.

The program shows that MiNK’s inventory can supply trials and physician-directed access at the same time; that MiNK can move a living cell therapy across borders with full regulatory and safety oversight; and that physicians are requesting it. MiNK intends to expand this access in all markets where regulations allow. 

Randomized ARDS Trial Advancing 

MiNK’s randomized, placebo-controlled Phase 2 study of agenT-797 plus standard of care in adults with acute lung injury and moderate-to-severe hypoxemic respiratory failure (C-1300-02) continued enrolling in Lviv, Ukraine during the quarter. U.S. dosing is expected before year-end, with data expected 2H2027.

MiNK plans to advance C-1300-02 as an adaptive trial. The initial randomized stage would enroll 124 patients for initial readout in 2H2027 for the potential to expand. MiNK is pursuing a hierarchical design which will evaluate prevention of patients advancing to veno-venous ECMO and all-cause mortality through Day 28. MiNK is seeking FDA feedback on the development plans for the program.

In August, MiNK presented initial Day 28 observations from the first agenT-797-treated patients at the Military Health System Research Symposium. These very sick patients, several with multidrug-resistant infections, demonstrated resolution of fever, improved oxygenation, resolution of ARDS and recovery from ventilator and vasopressor support, with immune markers in blood and lung fluid tracking recovery. No serious adverse events were attributed to agenT-797. 

MiNK estimates that approximately 93,000 U.S. patients annually fall within its initial target population of ventilated, pneumonia-associated moderate-to-severe ARDS. Nearly four in ten patients die within 28 days, and no effective FDA-approved drug has been shown to reduce that mortality. 

“I treat ARDS in the ICU, and it is the condition I see most often and can do the least about. We keep patients alive and wait for the immune system to right itself, and too often it does not,” said Terese Hammond, M.D., Head of Inflammatory and Pulmonary Diseases at MiNK Therapeutics. “Because agenT-797 comes from inventory, with no matching or conditioning, it can be given in the window when it matters, in any ICU that can thaw and infuse it. That is why we are running the randomized trial.”

ARPA-H Selects agenT-797 to Prove Cell Therapy Can Be Deployed Without a Freezer

In September, MiNK’s agenT-797 was selected as the therapeutic cell system for the Draper-led Reversible Ambient Biostabilization team under ARPA-H’s BioStabilization Systems (BoSS) program. Supported by up to $87 million in program-wide funding over four years for performers; the initiative seeks to move living medicines from cryogenic storage toward room temperature.

Cold chain is the single largest barrier to taking an allogeneic cell therapy beyond specialized centers. MiNK has already delivered cryopreserved agenT-797 to ventilated patients within days of authorization in a conflict zone; removing the freezer would allow a living immune therapy to be stocked like a conventional drug in community hospitals and austere settings. MiNK participates on a fixed-fee basis, complementing its internally funded clinical priorities.

SITC 2026: One Biology from Oncology to Fibrotic Lung Disease

At SITC 2026, MiNK presented new preclinical findings demonstrating the potential of unmodified and engineered iNKT therapies to address two mechanisms that defeat current treatments: tumor resistance and cellular senescence.

In a human organoid model of microsatellite-stable (MSS) colorectal cancer with liver metastases – a setting with no approved immunotherapy – botensilimab and balstilimab alone produced no significant tumor-cell killing. Adding agenT-797 shifted suppressive macrophages toward an antigen-presenting phenotype and unlocked killing, providing mechanistic support for the ongoing investigator-sponsored Phase 2 study at Scripps (NCT07550088).

With Imperial College London, MiNK showed that agenT-797 and MiNK-215, the Company’s FAP-targeted, IL-15-armored CAR-iNKT candidate, act as living senolytics, clearing the therapy-induced senescent cells that chemotherapy and radiation leave behind. MiNK-215 also eliminated FAP-expressing fibroblasts that shield tumors and drive scarring. These same cells fuel treatment resistance in cancer and progression in fibrotic lung disease – including in ARDS survivors whose lungs continue to scar after leaving the ICU – giving MiNK a single thread from oncology to the lung. The Company intends to earn it in sequence: randomized evidence first, then senescence and fibrosis in the clinic.

Externally Funded Clinical Programs Advance Alongside the Randomized Trial

An investigator-sponsored Phase 2 study at Scripps is evaluating agenT-797 with botensilimab and balstilimab in patients with MSS colorectal cancer and liver metastases, building on clinical observations in refractory gastrointestinal cancers, including the disease control rate in PD-1-refractory gastroesophageal cancer reported by Memorial Sloan Kettering investigators at AACR 2026.

At the University of Wisconsin–Madison, an investigator-sponsored Phase 1 study of agenT-797 for graft-versus-host disease (GvHD) prevention, funded by an NIAID STTR award and the Mary Gooze Clinical Trial Award, is moving toward first dosing; the University has informed MiNK that it expects the first patient to be scheduled by December 2026.

Together with the C-Further program in pediatric patients with blood cancers and the ARPA-H BoSS participation, MiNK now has four sources of non-dilutive support advancing its pipeline, allowing the Company to concentrate its own resources on the randomized ARDS readout.

Priorities and Anticipated Milestones into 2027

• Activate U.S. ICU sites and begin U.S. dosing in C-1300-02 before year-end 2026; sustain enrollment
• Meet with FDA before year-end on the adaptive Phase 2b/3 design and discuss supportive regulatory designations
• Report comparative data from the randomized ARDS trial in second half of 2027
• Support first patient dosing in the University of Wisconsin GvHD prevention study
• Extend named-patient access to additional markets where regulations allow
• Advance the ARPA-H BoSS deployability program

Third Quarter 2026 Financial Results

MiNK ended the quarter with $7.5 million in cash and cash equivalents, compared with $8.8 million at June 30, 2026. The Company recognized $0.2 million in pre-commercial product revenue – its first – from agenT-797 supplied through the named-patient access program. Because the program is new, revenue is expected to vary from quarter to quarter based on physician requests and case-by-case regulatory authorizations.

Net loss was $2.6 million, or $0.50 per share, compared with $2.9 million, or $0.65 per share, in the prior-year quarter – a 23% reduction in net loss per share. Cash used in operations decreased to approximately $1.3 million from $2.1 million in the second quarter, the lowest quarterly operating cash use of 2026. For the nine months ended September 30, 2026, net loss was $8.4 million, or $1.69 per share, compared with $9.9 million, or $2.39 per share, in the prior-year period.

General and administrative expense declined 44% to $1.0 million, primarily reflecting lower professional fees and stock compensation expense. Research and development expense increased to $1.8 million from $1.1 million, reflecting randomized Phase 2 activity and the translational analyses presented at scientific meetings during the quarter – spending directed where the randomized trial requires it.

MiNK is prioritizing investment in its randomized clinical program while holding other operating expenses down. The Company is pursuing partnerships and licensing, non-dilutive funding such as its ARPA-H BoSS participation, and potential equity or debt financing to strengthen its balance sheet, with the priority of funding the randomized study through its readout.

Summary Consolidated Financial Information
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
	September 30, 2026			December 31, 2025
Cash and cash equivalents	$	7,471		$	13,360
Other Financial Information
(in thousands)
(unaudited)
	Three months ended September 30,						Nine months ended September 30,
	2026			2025			2026			2025
Pre-commercial product revenue	$	200		$	-		$	200		$	-
Total operating expenses	$	2,837		$	3,184		$	8,936		$	9,937
Net loss	$	2,552		$	2,888		$	8,423		$	9,892
Net loss per share		0.50			0.65			1.69			2.39
Cash used in operations	$	1,276		$	941		$	5,091		$	3,851

Third Quarter 2026 Conference Call and Webcast

MiNK will host a conference call and webcast on Wednesday, November 11, 2026, at 8:30 a.m. Eastern Time to discuss financial results and provide a corporate update.

The live webcast will be accessible at MiNK Therapeutics Investor Relations, with a replay available following the call.

About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK’s proprietary platform is designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. MiNK’s lead candidate, agenT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and severe pulmonary inflammation. With a scalable cryopreserved manufacturing process and differentiated biology bridging innate and adaptive immunity, MiNK is committed to developing next-generation immune reconstitution therapies. For more information, visit www.minktherapeutics.com or follow us on X @MiNK_iNKT.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, safety, anticipated benefits and clinical development of agenT-797, MiNK-215 and other iNKT-based therapies; the design, enrollment, U.S. site activation and dosing, endpoints, proposed adaptive Phase 2b/3 design, FDA engagement and timing of data from C-1300-02; the timing and results of investigator-sponsored studies; potential applications of preclinical findings, including in senescence and fibrotic disease; the possible development of room-temperature stabilization technologies; the scope, expansion and continued operation of named-patient access and any revenue from it; estimates of patient populations and market opportunity; and MiNK’s capital resources, financing plans and anticipated milestones. Early clinical observations and preclinical findings may not be predictive of outcomes in controlled studies or patients. Such statements involve risks and uncertainties, including those detailed in MiNK’s most recent filings with the Securities and Exchange Commission. Actual results may differ materially from those expressed or implied. MiNK cautions investors not to place undue reliance on forward-looking statements, which speak only as of the date of this release, and undertakes no obligation to update them except as required by law.

Contacts
Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com

Source: MiNK Therapeutics

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much first product revenue did MiNK Therapeutics report for agenT-797?

MiNK recognized $0.2 million in first pre-commercial product revenue in the third quarter of 2026. AgenT-797 was supplied on a paid, per-patient basis through its international named-patient access program, with each case authorized by the applicable health authority.

When does MiNK Therapeutics expect randomized agenT-797 ARDS trial data?

MiNK expects the initial randomized ARDS readout in 2H2027. The initial stage would enroll 124 patients, with potential expansion under an adaptive design. U.S. dosing is expected before year-end 2026.

What outcomes does MiNK plan to evaluate in its adaptive ARDS trial?

MiNK is pursuing a hierarchical design evaluating prevention of progression to veno-venous ECMO, an external blood-oxygenation treatment, and all-cause mortality through Day 28. The company plans to meet with the FDA before year-end 2026 about the adaptive Phase 2b/3 design and supportive regulatory designations.