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Nasus Pharma (NSRX) reports positive NS003 preclinical results, plans 2026 human studies

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Rhea-AI Filing Summary

Nasus Pharma Ltd. reported positive preclinical results for NS003, its intranasal powder formulation of ondansetron for chemotherapy- and surgery-related nausea and vomiting. In an animal study, NS003 showed a pharmacokinetic profile comparable to intravenous ondansetron, with similar time to maximum concentration and area under the curve.

A separate toxicology study found a favorable safety profile at four times the test dose with no adverse effects. Based on these results, Nasus plans to start a first-in-human pharmacokinetic study of NS003 in the third quarter of 2026 and then advance NS002, its intranasal epinephrine candidate for anaphylaxis, to a pivotal study in the fourth quarter of 2026.

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Insights

Nasus reports encouraging preclinical NS003 data and outlines 2026 trial milestones.

Nasus Pharma announced that intranasal ondansetron candidate NS003 showed pharmacokinetic similarity to intravenous ondansetron in animals and a favorable safety profile at four times the test dose. This supports progression into a first-in-human pharmacokinetic study in Q3 2026.

The company also highlighted plans for a pivotal study of NS002, its intranasal epinephrine candidate for anaphylaxis, in Q4 2026. Both programs target conditions with large treated populations, but the data discussed are preclinical, so clinical efficacy and regulatory outcomes remain to be established.

The disclosed timelines mean upcoming human studies will be important future inflection points. For now, the update mainly clarifies development progress without providing financial metrics or late-stage clinical results that would directly reshape the investment view.

Ondansetron peak sales $1.5 billion Zofran (ondansetron) historical peak sales
Ondansetron prescriptions 2023 12 million prescriptions Prescriptions dispensed in 2023
Ondansetron patients 2023 6 million patients Patients receiving ondansetron in 2023
US chemotherapy patients annually 1 million patients Approximate annual chemotherapy patients in the U.S.
US radiotherapy patients annually 800,000 patients Approximate annual radiotherapy patients in the U.S.
Highly/moderately emetogenic regimens 60–80% Share of chemotherapy patients on such regimens
Breakthrough nausea and vomiting 15–20% Patients with symptoms not controlled by oral therapies
NS003 human PK study timing Q3 2026 Planned initiation of first-in-human NS003 PK study
pharmacokinetic medical
"positive results from a preclinical pharmacokinetic (“PK”) and safety study of NS003"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
area under the curve (AUC) medical
"similar time to maximum concentration (Tmax) and area under the curve (AUC) results"
Area under the curve (AUC) is a measurement of total drug exposure, calculated by adding up the drug concentration in the blood over time after a dose—think of it like totaling rainfall over a day to know how much water fell. Investors use AUC to judge how much of a medicine reaches the body, how long it lasts, and how it compares to alternatives, which affects dosing, safety, regulatory approval and commercial value.
emetogenic medical
"60–80% of whom undergo highly or moderately emetogenic regimens"
anaphylaxis medical
"NS002, Nasus Pharma’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative ... for patients with anaphylaxis"
Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.
pivotal study medical
"followed by the pivotal study of NS002 for anaphylaxis in the fourth quarter of 2026"
A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.
forward-looking statements regulatory
"This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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Form 6-K: How Foreign Companies Report to the SEC →

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of June 2026

 

Commission File Number: 001-42796

 

Nasus Pharma Ltd.

 

P.O. Box 284

Tel Aviv, Israel 6100201

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒ Form 40-F ☐

 

 

 

 

 

 

CONTENTS

 

Press Release

 

On June 9, 2026, Nasus Pharma Ltd. (the “Company”) issued a press release titled “Nasus Pharma Announces Positive Results from Preclinical Pharmacokinetic and Safety Study of Intranasal Ondansetron (NS003),” a copy of which is furnished as Exhibit 99.1 to this Report of Foreign Private Issuer on Form 6-K.

 

Investor Presentation

 

On June 9, 2026, the Company made available an updated corporate presentation on its website. A copy of the corporate presentation is attached hereto as Exhibit 99.2 to this Report of Foreign Private Issuer on Form 6-K.

 

Incorporation by Reference

 

Exhibit 99.1 to this Report on Foreign Private Issuer on Form 6-K (excluding the fourth paragraph included therein) is incorporated by reference into the Company’s Registration Statement on Form S-8 (File Nos. 333-296252), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press Release issued on June 9, 2026, by Nasus Pharma Ltd. titled “Nasus Pharma Announces Positive Results from Preclinical Pharmacokinetic and Safety Study of Intranasal Ondansetron (NS003).”
99.2   Corporate Presentation, dated June 2026.

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NASUS PHARMA LTD.
     
Date: June 9, 2026 By: /s/ Dan Teleman
  Name: Dan Teleman
  Title: Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Nasus Pharma Announces Positive Results from Preclinical Pharmacokinetic and Safety Study of Intranasal Ondansetron (NS003)

 

Study Comparing Intranasal Powder Formulation of Ondansetron Demonstrates Comparable Pharmacokinetic Profile to Intravenous Ondansetron in Animal Study;
Program to Advance to First-in-Human PK Study in Third Quarter of 2026

 

Tel Aviv, Israel, June 9 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 positive results from a preclinical pharmacokinetic (“PK”) and safety study of NS003, the Company’s proprietary intranasal powder formulation of ondansetron being developed for chemotherapy and post-operative nausea and vomiting.

 

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

 

The study compared NS003 to the intravenous (“IV”) formulation in an animal study. Data showed that NS003 had a PK profile comparable to IV, with similar time to maximum concentration (Tmax) and area under the curve (AUC) results. In a separate toxicology study, NS003 demonstrated a favorable safety profile at four times the test dose, with no adverse effects observed. With this milestone achieved, Nasus Pharma is now preparing to initiate a first-in-human PK study in the third quarter of 2026.

 

“These results represent a significant milestone for our pipeline programs as well as a further demonstration of the potential of our Nasax platform,” said Dan Teleman, Chief Executive Officer of Nasus Pharma. “Approximately 1 million patients in the United States receive chemotherapy annually, 60–80% of whom undergo highly or moderately emetogenic regimens, while an additional 800,000 patients undergo radiotherapy each year, with more than half experiencing radiotherapy-induced nausea and vomiting. Our market research indicates that 15–20% of these patients experience breakthrough nausea and vomiting not adequately controlled by oral therapies, often requiring a return to the clinic for intravenous anti-emetic treatment. Intranasal administration of NS003 has the potential to address this unmet need by offering a convenient, fast-onset alternative that may reduce avoidable clinic visits. We look forward to advancing NS003 to a first-in-human trial during the third quarter of 2026, followed by the pivotal study of NS002 for anaphylaxis in the fourth quarter of 2026, supporting the continued expansion of our intranasal product portfolio.”

 

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 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

 

 

 

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What did Nasus Pharma (NSRX) announce about its NS003 intranasal ondansetron program?

Nasus Pharma reported positive preclinical pharmacokinetic and safety results for NS003, its intranasal ondansetron powder. In animals, NS003 showed a pharmacokinetic profile comparable to intravenous ondansetron and a favorable safety profile, supporting advancement into a first-in-human pharmacokinetic study in the third quarter of 2026.

How does Nasus Pharma’s NS003 compare to intravenous ondansetron in preclinical testing?

In the reported animal study, NS003’s pharmacokinetic profile was comparable to intravenous ondansetron. The company highlighted similar time to maximum concentration (Tmax) and area under the curve (AUC), suggesting intranasal delivery achieved exposure characteristics in line with the established intravenous formulation.

What safety data did Nasus Pharma provide for NS003 intranasal ondansetron?

Nasus Pharma described a separate toxicology study where NS003 was tested at four times the test dose. The company reported a favorable safety profile in this setting, with no adverse effects observed, which supports moving the program into first-in-human pharmacokinetic evaluation in 2026.

What are Nasus Pharma’s planned next steps and timelines for NS003 development?

Nasus Pharma plans to initiate a first-in-human pharmacokinetic study of NS003 in the third quarter of 2026. This study follows the positive preclinical pharmacokinetic and safety results and is designed to evaluate intranasal ondansetron’s behavior in humans after the encouraging animal data.

Which additional pipeline program and timeline did Nasus Pharma highlight alongside NS003?

Alongside NS003, Nasus Pharma highlighted NS002, its intranasal powder epinephrine candidate for anaphylaxis. The company stated it looks forward to starting a pivotal study of NS002 in the fourth quarter of 2026, supporting expansion of its intranasal product portfolio targeting acute medical conditions.

How large is the potential treatment market described for Nasus Pharma’s nausea and vomiting focus?

Nasus Pharma noted that approximately 1 million U.S. patients receive chemotherapy annually and 800,000 receive radiotherapy, with a substantial portion experiencing nausea and vomiting. Its market research suggests 15–20% of these patients have breakthrough symptoms not controlled by oral therapies, often requiring intravenous treatment.

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