Nasus Pharma Announces Enrollment and Dosing of First Patient in Phase 1 Study of NS003 Intranasal Formulation of Ondansetron

TEL AVIV, Israel, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced that the first patient has been enrolled and dosed in the Company’s Phase 1 pharmacokinetic (PK) trial of NS003, its proprietary intranasal powder formulation of ondansetron being developed for chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV).

In a recent pre-clinical study comparing NS003 to the intravenous (“IV”) formulation of ondansetron in animals, results showed that NS003 had a PK profile comparable to the IV formulation, with similar time to maximum concentration (Tmax) and area under the curve (AUC) results. In a separate safety study, NS003 demonstrated a favorable safety profile at four times the test dose, with no adverse effects observed. The current Phase 1 PK study will assess the pharmacokinetic and safety profile of NS003 in human patients for the first time.

"Enrolling and dosing our first patient in this Phase 1 study of NS003 demonstrates our ability to execute on previous guidance, and we are very pleased to achieve this milestone," said Brendan O'Grady, Chief Executive Officer of Nasus. "Ondansetron remains one of the most widely prescribed anti-emetics, with significant usage of the IV formulation in the hospital setting. A fast-onset, needle-free option could offer real value for patients who aren't fully controlled on oral therapy. Intranasal administration of NS003 has the potential to address these unmet needs by offering a convenient, fast-onset alternative that may reduce avoidable clinic visits. We look forward to announcing topline PK data from this study before year-end, along with the initiation of our pivotal NS002 study for anaphylaxis, also targeted for the fourth quarter."

Ondansetron is one of the most widely used therapies for chemotherapy-induced nausea and vomiting. In 2023, more than 12 million prescriptions for orally administered were dispensed to over 6 million patients. Zofran ®(ondansetron) peak sales exceeded $1.5 billion.

About Nasus Pharma

Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus Pharma’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle-free, easy-to-use alternatives. Nasus Pharma’s proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws. Words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will”, “would,” or the negative of these words, similar expressions or variations of such words are intended to identify forward-looking statements. For example, Nasus Pharma is using forward-looking statements in this press release when it discusses: the planned initiation and timing of a first-in-human PK study and Phase 1 trial for NS003, the timing of the NS002 pivotal study, expected clinical and development milestones, and the expansion of the Company’s product portfolio. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Forward-looking statements are based on the Company’s current expectations and are subject to uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2026. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Corporate Contact

Nasus Pharma Ltd. Israel

info@nasuspharma.com

Investors Contact

Mike Moyer

LifeSci Advisors

+1-617-308-4306

mmoyer@lifesciadvisors.com