Beyond Cancer Reports Updated Survival and Safety Data from Phase 1 UNO Trial Presented at AACR 2026
Rhea-AI Summary
Beyond Cancer (NASDAQ: XAIR) reported updated Phase 1 UNO data and a U.S. patent allowance on April 20, 2026. Follow-up shows 6 of 10 heavily pretreated patients alive 22–40 months after a single intratumoral UNO injection; median overall survival not reached. Two triple negative breast cancer patients show no evidence of disease. Safety was generally favorable; one treatment-related serious adverse event (hypoxia) resolved. The USPTO issued a Notice of Allowance for a gas-delivery patent that will strengthen the UNO intellectual property portfolio.
AI-generated analysis. Not financial advice.
Positive
- Survival: 6 of 10 patients alive 22–40 months after single injection
- Median OS: Not reached because >50% of patients remain alive
- Durable responses: 2 triple negative breast cancer patients show no evidence of disease
- Safety: Most treatment-related adverse events Grade 1–2; one resolved SAE
- IP: U.S. Notice of Allowance for gas-delivery patent supporting UNO platform
Negative
- Small sample: Phase 1 enrolled only 10 heavily pretreated patients
- No control arm: Study design limits efficacy interpretation and comparison
- Early-stage: Results are preliminary and not conclusive for clinical benefit
- One SAE: Treatment-related hypoxia occurred during administration (resolved)
News Market Reaction – XAIR
On the day this news was published, XAIR gained 0.18%, reflecting a mild positive market reaction. Argus tracked a peak move of +11.7% during that session. Argus tracked a trough of -5.4% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $11K to the company's valuation, bringing the market cap to $6.14M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Sector peers show mixed moves (e.g., AIMD +18.67%, INBS -5%, SINT -0.37%), and momentum scanner flags CODX and SINT moving up on no news, supporting this as a stock-specific reaction to XAIR’s clinical update.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 17 | Phase 1 interim data | Positive | +0.3% | Interim UNO Phase 1 data showed early activity and favorable safety profile. |
| Feb 04 | AACR abstract selection | Positive | -5.2% | AACR 2026 abstract acceptance for Phase 1 UNO data in solid tumor metastases. |
| Sep 08 | Orphan Drug Designation | Positive | +49.8% | FDA Orphan Drug Designation granted for BA-101 in glioblastoma. |
| Dec 03 | Phase 1b trial approval | Positive | -8.7% | Israeli approval for Phase 1b LV UNO trial with anti-PD-1 in solid tumors. |
| Nov 11 | Preclinical LV UNO data | Positive | +7.6% | Preclinical LV UNO plus checkpoint therapy doubled tumor growth inhibition in models. |
Clinical/oncology updates have produced mixed reactions: several modest moves (around ±5–9%) and one large spike of +49.77% on Orphan Drug Designation, indicating occasional strong sensitivity to positive clinical milestones.
Over the past 18 months, XAIR’s oncology and nitric oxide programs have advanced through preclinical and early clinical stages. Events include promising LV UNO preclinical data on Nov 11, 2024, Phase 1b LV UNO trial approval on Dec 3, 2024, and FDA Orphan Drug Designation for GBM on Sep 8, 2025, which drew a +49.77% move. More recently, UNO Phase 1 interim data on Mar 17, 2026 produced a small +0.25% gain. Today’s AACR survival update extends that same clinical narrative.
Historical Comparison
In the past 5 clinical/oncology updates, XAIR’s average move was 8.75%. Today’s +22.19% reaction to updated UNO Phase 1 survival data stands well above that norm.
Clinical news shows a progression from preclinical LV UNO synergy data to regulatory clearances and early-phase trials, now extending to longer-term survival and safety follow-up in the Phase 1 UNO study.
Regulatory & Risk Context
An effective S-3 shelf filed on Jan 30, 2026 covers resale of 524,990 existing shares plus shares from pre-funded and common warrants exercisable at $0.0001 and $1.147 per share through Jan 16, 2031. Beyond Air would receive cash only upon warrant exercise; a 424B3 usage was filed on Feb 10, 2026.
Market Pulse Summary
This announcement updates Phase 1 UNO data, highlighting 6 of 10 heavily pretreated patients alive 22–40 months after a single intratumoral dose, with mostly Grade 1–2 adverse events and one resolving serious hypoxia event. Two triple negative breast cancer patients maintain no evidence of disease. These findings build on prior clinical and preclinical UNO milestones but remain early-stage and uncontrolled. Investors should also monitor Nasdaq listing risk, ongoing losses, and use of the effective S-3 resale registration when assessing the broader risk profile.
Key Terms
intratumoral medical
triple negative breast cancer medical
adverse events medical
serious adverse event medical
hypoxia medical
Phase 1 medical
immune checkpoint inhibitors medical
Notice of Allowance regulatory
AI-generated analysis. Not financial advice.
Updated AACR poster data show continued survival follow-up in heavily pre‑treated patients following a single intratumoral UNO injection
Received US patent allowance covering proprietary gas delivery technology for UNO
GARDEN CITY, N.Y., April 20, 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 updated follow-up data from its Phase 1 UNO trial, which are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 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 median of 4 prior systemic therapies and 11 total cancer-directed treatments. Six patients received 25,000 ppm UNO and four patients received 50,000 ppm UNO.
As of February 2, 2026, six of ten patients remain alive between 22 to 40 months following a single UNO injection. While the study was not designed to assess efficacy and lacks a control arm, these observations may suggest prolonged survival in this heavily pretreated population. Interpretation of these results is limited by the small sample size and early-stage design. Two patients with triple negative breast cancer continue to demonstrate no evidence of disease, based on available imaging, testing, and clinical examinations. Treatment demonstrated a generally favorable safety and tolerability profile, with most treatment‑related adverse events predominantly Grade 1 or Grade 2. One treatment-related serious adverse event (hypoxia) occurred during administration at 25,000 ppm; the event was not considered dose-limiting and resolved fully. Median overall survival had not yet been reached at last follow-up because more than
“We are pleased to present these updated and promising data from the UNO study at AACR,” said Robert Goodman, Chief Executive Officer of Beyond Air. “What stands out is not only the durability of survival, but the context in which it is occurring. These observations are notable in a salvage‑stage population with few therapeutic alternatives, where enrolled patients had exhausted standard treatment options and received a median of four prior systemic therapies. Observing prolonged survival following a single localized UNO injection reinforces our conviction that UNO has meaningful therapeutic potential and supports further development, including evaluation in combination with immune checkpoint inhibitors and in earlier lines of disease.”
In addition, the company announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application titled, “System and Method for Delivery of Gas to a Tissue.” Once issued, the patent will further strengthen the company’s intellectual property portfolio supporting its UNO platform.
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
