Beyond Cancer Reports Early Clinical Activity and Favorable Safety Profile with Interim Data from Phase 1 UNO Trial
Rhea-AI Summary
Beyond Cancer (NASDAQ: XAIR) reported interim Phase 1 UNO data showing early clinical activity and a favorable safety profile after a single intratumoral injection in ten heavily pretreated patients with cutaneous or subcutaneous tumors.
Key points: two triple negative breast cancer patients show no evidence of disease, seven patients alive 19–37 months post‑treatment, most adverse events Grade 1, one treatment‑related serious hypoxia event that resolved.
Positive
- Seven patients alive 19–37 months after one UNO injection
- Two triple negative breast cancer patients with no evidence of disease
- Majority of treatment‑related adverse events limited to Grade 1
Negative
- One treatment‑related serious adverse event (hypoxia) occurred during administration
- Trial enrolled only 10 patients, limiting statistical strength of conclusions
News Market Reaction – XAIR
In the Mar 18 session, XAIR gained 0.25%, reflecting a mild positive market reaction. Argus tracked a peak move of +14.9% during that session. Argus tracked a trough of -17.0% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.0x the daily average, suggesting notable buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 04 | AACR abstract selection | Positive | -5.2% | Selection of Phase 1 UNO data abstract for presentation at AACR 2026. |
| Sep 08 | Orphan drug designation | Positive | +49.8% | FDA Orphan Drug Designation for BA-101 in glioblastoma oncology program. |
| Dec 03 | Phase 1b trial approval | Positive | -8.7% | Israeli approval for Phase 1b LV UNO trial in combination with anti-PD-1. |
| Nov 11 | Preclinical LV UNO data | Positive | +7.6% | Promising preclinical LV UNO data showing enhanced tumor inhibition and survival. |
| Jul 31 | Pneumonia NO study | Positive | -5.2% | Peer‑reviewed data showing inhaled NO as safe and beneficial for viral pneumonia. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical and trial‑related catalysts have produced mixed reactions: two notable rallies on regulatory/clinical milestones and three sell‑offs despite ostensibly positive updates, suggesting investors often fade good news.
Over the past two years, XAIR has repeatedly highlighted nitric oxide as a therapeutic platform across oncology and respiratory disease. Clinical and regulatory milestones include peer‑reviewed pneumonia data (Jul 31, 2024), promising LV UNO preclinical results (Nov 11, 2024), Israeli approval for a Phase 1b LV UNO trial (Dec 3, 2024), FDA Orphan Drug Designation for GBM (Sep 8, 2025), and AACR Phase 1 UNO abstract selection (Feb 4, 2026). Today’s interim Phase 1 UNO data further extends this oncology narrative.
Key Terms
phase 1 medical
intratumoral medical
monotherapy medical
triple negative breast cancer medical
serious adverse event medical
hypoxia medical
anti‑pd‑1 therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data was published in the Online Itinerary Planner for the 2026 AACR Annual Meeting, and is scheduled to be presented at the meeting on April 19th
GARDEN CITY, N.Y., March 17, 2026 (GLOBE NEWSWIRE) -- 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.
“The combination of favorable safety and tolerability and early clinical activity strengthen our belief that UNO could serve as a differentiated complement to anti‑PD‑1 therapy in metastatic disease and perhaps as monotherapy prior to metastases,” said Steve Lisi, Chief Executive Officer of Beyond Air. “The duration of survival in this end-stage, heavily pre-treated population is compelling, and we look forward to future studies to better understand the potential of UNO therapy.”
| AACR Annual Meeting 2026 Poster Presentation Details: | |
| Session Category: | Experimental and Molecular Therapeutics |
| Session Title: | Innovative Therapeutic Modalities and Translational Platforms |
| Session Start: | April 19, 2026 at 5:00 PM ET / 2:00 PM PT |
| Session End: | April 19, 2026 at 8:00 PM ET / 5:00 PM PT |
| Location: | Poster Section 13, San Diego Convention Center |
| Poster Board Number: | 22 |
| Poster Number: | 304 |
The poster presentation at AACR will include data from an updated analysis of the ongoing Phase 1 trial beyond what is reflected in the published abstract referenced in this release.
About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately
About Beyond Cancer, Ltd.
Beyond Cancer, Ltd. is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. For more information, visit www.beyondcancer.com.
About Beyond Air®, Inc.
Beyond Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM).
Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety, tolerability and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include, but are not limited to, statements regarding the potential safety, tolerability, efficacy and therapeutic potential of ultra-high concentration nitric oxide (UNO”); the significance of interim clinical data from Beyond Cancer’s Phase 1 trial; the potential for UNO to be studied as a monotherapy, in combination with anti-PD-1 therapy, or in earlier lines of treatment; the expected content and timing of the AACR presentation; and the development, clinical, regulatory, and commercial prospects of Beyond Cancer’s and Beyond Air’s product candidates. Forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “look,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” and similar expressions, or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, many of which are outside the control of Beyond Air or Beyond Cancer, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
