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Nasus Pharma Advances NS002 Towards Pivotal Study Following Positive Phase 2; Reports Annual Results and Provides Business Update

(Positive)

Nasus Pharma (NYSE: NSRX) reported positive Phase 2 topline results for NS002, showing faster early epinephrine absorption versus EpiPen and consistent absorption under nasal allergic challenge. The company plans a pivotal study to start in Q4 2026 with a planned readout in Q1 2027, and believes results support a potential NDA filing.

Nasus is advancing NS003 and NS004 toward first-in-human studies in H2 2026 and is advancing NS005. As of Dec 31, 2025, cash and equivalents were $4.3 million; R&D was $2.4M, G&A $2.7M, and net loss $5.9M. Shares outstanding: 9,015,383.

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Positive

  • NS002 Phase 2 showed faster early absorption vs EpiPen
  • Consistent absorption under nasal allergic challenge
  • Pivotal study planned to start in Q4 2026
  • First-in-human studies for NS003/NS004 expected H2 2026
  • Company reports being well-funded to complete NS002 pivotal study

Negative

  • Cash, cash equivalents and marketable securities were $4.3M as of Dec 31, 2025
  • Net loss increased to $5.9M for year ended Dec 31, 2025
  • R&D expenses rose to $2.4M and G&A to $2.7M in 2025

News Market Reaction – NSRX

+10.84%
7 alerts
+10.84% Session close to close
+8.9% Peak Tracked
-11.5% Trough Tracked
$32.32M Market Cap
0.0x Rel. Volume

In the Mar 25 session, NSRX gained 10.84%, reflecting a significant positive market reaction. Argus tracked a peak move of +8.9% during that session. Argus tracked a trough of -11.5% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +10.8% in the session following this news. A strong positive reaction aligns with t...
Analysis

The stock surged +10.8% in the session following this news. A strong positive reaction aligns with the company’s ongoing clinical progress, but it would contrast with prior NS002 news that saw average moves of -16.05% after clinical updates. Investors reviewing such a move might weigh the expanded pipeline and improved cash of $4.3 million against rising R&D and G&A costs, as well as the historical tendency for enthusiasm around NS002 data to fade after initial headlines.

Key Figures

Cash & securities: $4.3 million Cash & equivalents: $0.3 million Research & development: $2.4 million +5 more
8 metrics
Cash & securities $4.3 million As of Dec 31, 2025
Cash & equivalents $0.3 million As of Dec 31, 2024
Research & development $2.4 million Year ended Dec 31, 2025
Research & development $0.3 million Year ended Dec 31, 2024
General & administrative $2.7 million Year ended Dec 31, 2025
Net loss $5.9 million Year ended Dec 31, 2025
Net loss $1.5 million Year ended Dec 31, 2024
Shares outstanding 9,015,383 shares As of Dec 31, 2025

Previous Clinical trial Reports

4 past events · Latest: Mar 16 (Positive)
Same Type Pattern 4 events
Date Event Sentiment 24h Move Catalyst
Mar 16 Phase 2 topline data Positive -40.6% Reported full positive Phase 2 results with faster NS002 epinephrine delivery vs EpiPen®.
Mar 09 Data presentation plan Positive -15.4% Announced webcast to present NS002 Phase 2 topline analysis and hold Q&A session.
Jan 20 Interim Phase 2 data Positive -7.5% Shared positive interim NS002 Phase 2 PK data vs EpiPen® with no serious AEs.
Nov 06 Phase 2 approval Positive -0.7% Received Health Canada no‑objection letter clearing initiation of NS002 Phase 2 study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Across recent NS002 clinical-trial milestones, positive updates have repeatedly coincided with negative one-day price reactions, indicating a pattern of the stock selling off into or after favorable data.

Recent Company History

Over the last few quarters, Nasus has steadily advanced NS002 through Phase 2, from Health Canada’s Nov 6, 2025 approval to initiate the trial to interim and then full positive Phase 2 results reported on Jan 20, 2026 and Mar 16, 2026. Each clinical milestone highlighted superior pharmacokinetics vs. EpiPen® and plans for a pivotal study in Q4 2026, yet the stock showed negative single-day moves after these events, underscoring a consistent divergence between data strength and immediate market reaction.

Key Terms

phase 2, pivotal study, first-in-human, nda submission, +3 more
7 terms
phase 2 medical
"Recent Phase 2 topline results demonstrate NS002’s potential for best-in-class..."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.
pivotal study medical
"...intranasal epinephrine powder formulation towards a pivotal study planned to initiate..."
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.
first-in-human medical
"...toward first-in-human studies expected to start in the second half of 2026..."
A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.
nda submission regulatory
"...complete NS002’s pivotal study and see through a potential NDA filing."
An NDA submission is the formal application a drug developer files with a medicines regulator seeking permission to market a new prescription drug. Think of it as the final product pitch that compiles all clinical trial results, safety data and manufacturing details so the regulator can decide whether the drug can be sold. For investors, an NDA submission is a major milestone because acceptance or approval can unlock sales and revenue, while delays or rejections create uncertainty and financial risk.
chemotherapy-induced nausea and vomiting medical
"NS003 (Ondansetron for chemotherapy-induced nausea and vomiting) and NS004..."
Chemotherapy-induced nausea and vomiting is the upset stomach and vomiting that many patients experience as a side effect of cancer drugs; think of it as severe motion sickness caused by treatment rather than by travel. It matters to investors because the condition affects how well patients can stay on therapy, drives additional medical visits and supportive-care spending, and creates demand for anti-nausea drugs and services—factors that influence healthcare costs, drug sales and clinical trial outcomes.
intranasal medical
"...a clinical-stage pharmaceutical company focused on the development of innovative intranasal products..."
Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.
form 20-f regulatory
"...announced the filing of its annual report on Form 20-F for the year ended..."
Form 20-F is the standardized annual disclosure that non-U.S. companies must file with the U.S. securities regulator when their shares are traded in the U.S.; it contains audited financial statements, a plain-language description of the business, management discussion, governance details and key risk factors. It matters to investors because it provides a consistent, comparable company “report card” and rulebook, helping buyers assess financial health, governance and risks before investing.

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Recent Phase 2 topline results demonstrate NS002’s potential for best-in-class epinephrine delivery, with statistically significant improvements in early absorption compared to EpiPen®; pivotal study planned for Q4 2026

Company advancing pipeline assets NS003 (Ondansetron for chemotherapy-induced nausea and vomiting) and NS004 (metabolic) toward first-in-human studies expected to start in the second half of 2026, significantly expanding the Company’s intranasal product portfolio into additional high value therapeutic areas

Company well funded through planned NS002 pivotal study and potential NDA submission

TEL AVIV, Israel, March 25, 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 the filing of its annual report on Form 20-F for the year ended December 31, 2025, and provided a business update highlighting recent Phase 2 results for NS002 and upcoming clinical milestones.

"With positive Phase 2 data for NS002 and a strong cash position, we believe Nasus is well positioned to deliver on multiple clinical inflection points in 2026," said Dan Teleman, Chief Executive Officer of Nasus Pharma. "Following the compelling topline Phase 2 results of NS002, we are advancing our intranasal epinephrine powder formulation towards a pivotal study planned to initiate in the fourth quarter of this year. The Company is well-funded to complete NS002’s pivotal study and see through a potential NDA filing. In addition, we plan to progress our earlier pipeline assets, Ondansetron for chemotherapy induced nausea and vomiting, and NS004 targeting metabolic disorders, into first-in-human studies in the second half of the year and are also advancing NS005 targeting cardiovascular diseases. We believe our pipeline of innovative intranasal products, leveraging our proprietary powder platform technology, can deliver significant clinical benefits to patients and could unlock substantial value to our shareholders. We are committed to executing on this vision.”

Business Update

NS002 – Intranasal powder Epinephrine for Anaphylaxis

  • Completed Phase 2 single and repeat dose clinical study, with topline results demonstrating statistically significant improvements in time to therapeutic threshold (T100) and a higher proportion of participants reaching therapeutic epinephrine levels within the first minutes following administration, compared to EpiPen®. The data also demonstrated NS002’s consistent absorption across real-world conditions, including under a nasal allergic challenge designed to simulate anaphylaxis scenarios.

  • Advancing toward pivotal development, with a pivotal clinical study expected to initiate in the fourth quarter of 2026 and a planned readout in the first quarter of 2027, subject to regulatory alignment. The Company believes the positive Phase 2 results support continued development toward a potential NDA submission.

Early Pipeline

Nasus is advancing its earlier-stage pipeline programs, which leverage the Company’s proprietary intranasal powder platform:

  • NS003 – Ondansetron for chemotherapy-induced nausea and vomiting
  • NS004 – targeting metabolic disorders
  • NS005 – targeting cardiovascular diseases

All programs are currently in preclinical development, with first-in-human Phase 1 studies expected to initiate in the second half of 2026 for NS003 and NS004, supporting the continued expansion of the Company’s intranasal product portfolio.

Financial Results

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Nasus had cash, cash equivalents and marketable securities of $4.3 million, compared with cash and cash equivalents of $0.3million as of December 31, 2024. The increase in cash, cash equivalents and short term deposits was primarily a result of our IPO. Following our $15 private placement, which closed in February 2026, Nasus expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the second quarter of 2027.

Research and Development Expenses: Research and development expenses were $2.4 million for the year ended December 31, 2025, compared with $0.3 million for the year ended December 31, 2024. The increase was primarily attributable to expenses paid in connection with the development of NS002.

General and Administrative Expenses: General and administrative expenses were $2.7 million for the year ended December 31, 2025, compared with $0.7 million for the year ended December 31, 2024. The increase was mainly due to the company’s transition to a public company.

Net Loss: For the year ended December 31, 2025, net loss was $5.9 million compared with a net loss of $1.5 million for the year ended December 31, 2024. The total number of shares outstanding as of December 31, 2025 was 9,015,383.

The Company has filed its Annual Report on Form 20-F for the year ended December 31, 2025 (the “Annual Report”) with the U.S. Securities and Exchange Commission (“SEC”), which can be accessed on its website at https://www.nasuspharma.com.  Shareholders may request, free of charge, a hard copy of the Annual Report, which includes the Company’s complete audited consolidated financial statements for the year ended December 31, 2025, by contacting ir@nasuspharma.com.

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 timing and results of planned clinical studies, including the NS002 pivotal study, potential regulatory submissions, including a potential NDA, the development and timing of pipeline programs, including NS003, NS004 and NS005, expected clinical and development milestones, expansion of the Company’s product portfolio, and the Company’s financial position and expected cash runway.  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.

Company Contact
Nasus Pharma Ltd.
info@nasuspharma.com

Investor Contact
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com 


FAQ

What did Nasus Pharma (NSRX) report about NS002 Phase 2 results on March 25, 2026?

NS002 showed statistically significant faster early absorption versus EpiPen, reaching therapeutic levels more quickly. According to the company, Phase 2 also showed consistent absorption under a nasal allergic challenge, supporting advancement toward a pivotal study planned for Q4 2026.

When will Nasus Pharma (NSRX) start the NS002 pivotal study and when is the readout expected?

The pivotal study for NS002 is expected to initiate in the fourth quarter of 2026. According to the company, a planned readout is targeted for the first quarter of 2027, subject to regulatory alignment and study execution timelines.

How is Nasus Pharma (NSRX) funded to complete the NS002 pivotal study?

The company says it is well funded to complete NS002’s pivotal study and pursue a potential NDA filing. According to the company, cash and marketable securities were $4.3 million at Dec 31, 2025 and funding increased after a $15 private placement.

What near-term clinical milestones does Nasus Pharma (NSRX) expect for its pipeline in 2026?

Nasus expects first-in-human Phase 1 studies for NS003 and NS004 in the second half of 2026. According to the company, these milestones expand its intranasal powder portfolio into antiemetic and metabolic programs.

What were Nasus Pharma (NSRX) key financial results for the year ended December 31, 2025?

For 2025, Nasus reported cash and marketable securities of $4.3M and a net loss of $5.9M. According to the company, R&D expenses were $2.4M and G&A expenses were $2.7M for the year.