Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an investigational immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ:XAIR), today announced early signs of clinical activity and a favorable safety and tolerability profile from its Phase 1 clinical trial evaluating a single intratumoral UNO injection administered as monotherapy. These data were included in an Online Itinerary Planner issued today for the American Association for Cancer Research (AACR) Annual Meeting 2026, which is scheduled to be held from April 17-22, 2026 at the San Diego Convention Center in San Diego, California.

The Phase 1 trial (NCT05351502) was a clinical proof-of-concept trial that assessed the intratumoral administration of UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions. The trial enrolled ten heavily pretreated patients, including breast cancer (n=6), squamous cell carcinoma (n=2), and melanoma (n=2). Patients received a mean of 5.5 prior systemic therapies and 10.3 total cancer-directed treatments. Six patients received 25,000 ppm UNO and four patients received 50,000 ppm UNO.

As of October 1, 2025, seven of ten patients remain alive between 19 to 37 months following a single UNO injection. One patient died of disease progression 25 months after treatment. Two patients with triple negative breast cancer have no evidence of disease. No deaths occurred within 12 weeks after treatment. Treatment demonstrated a favorable safety and tolerability profile, with most treatment‑related adverse events limited to Grade 1. One treatment-related serious adverse event (hypoxia) occurred during administration at 25,000 ppm; the event was not considered dose-limiting and resolved fully.