INKT

• Clinical Development Progress for Agent 797 (ARDS/Acute Lung Injury)

  • Initiated the randomized Phase II C1300-02 study, comparing Agent 797 plus standard of care to placebo plus standard of care in adult patients meeting the global definition of ARDS with moderate to severe hypoxemic respiratory failure. The study opened at a site in Lviv, Ukraine, in collaboration with Unbroken Ukraine, and the first patient was dosed shortly after regulatory authorization during active conflict.
  • Presented initial non-comparative data from the first two run-in patients at the Military Health System Research Symposium: both patients survived to day 28, achieved improved oxygenation, resolved ARDS, were weaned from ventilation and vasopressor support, controlled baseline multi-drug resistant infections, and showed reduced inflammatory markers consistent with immune and tissue repair. No serious adverse events were attributed to Agent 797. Management emphasized these are early small-sample results that require confirmation from the randomized trial.
  • U.S. site activation is ongoing, with enrollment expected to start in September 2026, and additional data readouts are expected in early 2027.

• Named Patient Access Program

  • Launched the company's first international paid named patient access program for Agent 797 in Brazil, in partnership with local consultants. The program allows treating physicians to request the investigational therapy for individual patients with serious unmet medical needs, subject to case-by-case regulatory approval.
  • This program establishes cross-border operational infrastructure for cell therapy delivery (including regulatory submission, import logistics, and pharmacovigilance) and generates modest per-patient revenue to support ongoing clinical development, while enabling responsible access outside of formal clinical trials.

• Pipeline and Scientific Progress

  • Agent 797 is an off-the-shelf allogeneic invariant natural killer T (INKT) cell therapy, designed to restore immune regulation without requiring patient-specific manufacturing, HLA matching, or lymphodepletion, with no graft-versus-host disease risk.
  • Additional preclinical and early clinical data was presented at multiple 2026 medical conferences, supporting the INKT cell mechanism of action across indications: immune activation in cancer, and inflammation regulation and tissue repair in acute and chronic lung disease. Phase two data in PD-1 refractory gastroesophageal cancer showed a 77% disease control rate and durable survival in a subset of patients treated with combination therapy.

• Financial and Operational Strategy

  • Management maintains financial discipline, with a deliberately lean operating footprint, no added fixed infrastructure, and an inventory-based manufacturing model rather than patient-specific production. The company prioritizes non-dilutive funding, with two ongoing programs (graft versus host disease trial at University of Wisconsin, and the pediatric PRAME program) fully externally funded.

• Enrollment in the randomized portion of the Phase II C1300-02 ARDS study is ongoing, with U.S. sites expected to start enrolling in September 2026. Once all sites are active, management expects enrollment of 4 to 8 patients per site per month, with seasonal upticks in acute respiratory cases expected to boost enrollment.
• Preliminary data readouts from the randomized Phase II portion of the C1300-02 study are expected in the first half of 2027, with full additional data expected in early 2027. Positive results would allow rapid transition directly to a confirmatory Phase III trial.
• The Brazil paid named patient access program is active, and further geographic expansions will be announced as regulatory approvals are secured in additional territories. Updates on program metrics and financial contributions will be provided in the Q3 2026 earnings update.

NK Therapeutics is a clinical-stage biotech with no commercial product segments launched as of Q2 2026. All revenue to date is nominal, generated from the newly launched paid named patient access program for the still-investigational Agent 797, which did not contribute material revenue in the quarter. Aggregate corporate financials for Q2 2026: cash and cash equivalents totaled $8.8 million, down from $9.5 million at the end of Q1 2026 and up from $3.4 million at year-end 2025. Net loss for the quarter narrowed to $3.1 million (62 cents per share), compared to $4.2 million ($1.06 per share) in Q2 2025. Year-to-date net loss through the first half of 2026 was $5.9 million ($1.20 per share), compared to $7 million ($1.76 per share) in the same period of 2025. Cash used in operations was $2.1 million for the quarter, up from $1.6 million in Q2 2025, with the increase driven by deliberate investments in the Agent 797 Phase II trial.

• All results for Agent 797 to date are early, non-comparative, and from a small number of patients. There is no guarantee that the observed positive early clinical and biological signals will be confirmed in the larger randomized Phase II study, which is required to prove the therapy improves patient outcomes.
• Agent 797 remains an investigational product, and there is no guarantee it will receive regulatory marketing approval in any indication.
• Cross-border delivery of cell therapy is operationally complex, and many cell therapy programs fail at this stage. There is risk that the company's operational infrastructure will not scale reliably to support expanded access or future commercialization.
• The Phase II ARDS study is being conducted partially in an active conflict zone in Ukraine, which creates inherent operational and patient safety risks.
• Multi-drug resistant pathogens are an emerging global public health threat, but there is no guarantee that Agent 797 will demonstrate a clinically meaningful benefit for these infections that leads to regulatory approval or widespread use.
• The company has a limited cash balance, and will require additional funding to advance its pipeline through late-stage clinical development and potential commercialization.

Q: How many run-in patients were included in the initial presented data, what are their baseline characteristics, and what is the expected 28-day mortality for this patient population on standard of care? / A: Management presented data from the first 2 treated run-in patients. Both met global ARDS criteria and had multi-drug resistant pneumonia from intubation; the first was a 41-year-old woman with poorly controlled diabetes and pneumococcal sepsis. Patients with moderate to severe ARDS, especially those with complex multi-drug resistant infections, have a 30% to 50% 28-day mortality risk in the ICU. The 100% 28-day survival seen in these initial patients is provocative, but management stresses these are unrandomized, preliminary results that require confirmation.

Q: How many patients have been dosed and randomized to date, what is the expected enrollment rate, and how will the U.S. patient population differ from the cohort treated in Ukraine? / A: Management did not disclose current specific enrollment numbers, only confirmed enrollment is ongoing at the Ukraine site, with U.S. sites launching in September 2026. The expected enrollment rate is 4 to 8 patients per active site per month, with seasonal increases in acute respiratory cases boosting enrollment. Most patients treated in Ukraine have pan-resistant multi-drug organisms that are already widespread in conflict zones and spreading across Europe; while U.S. sites will see fewer of these virulent community-acquired resistant infections currently, this is expected to become a growing problem globally.

Q: What is the rationale for launching the paid named patient program in Brazil, and can you share early updates on demand and pricing? / A: The program launched in Brazil due to strong physician inquiries and rapid regulatory review from local authorities. The company will not disclose pricing details at this stage. The program became active just after the end of Q2, with the first patients already enrolled, and further details on program metrics will be shared in the Q3 2026 update. NK plans to expand the program to additional regions as regulatory approvals are secured, with requests already received for both cancer and critical illness patients.