Nasus Pharma CEO Issues 2025 Letter to Shareholders

Rhea-AI Summary

Nasus Pharma (NYSE: NSRX) issued a 2025 shareholder letter outlining clinical and corporate milestones. The company completed an IPO in August 2025, raising $10 million in gross proceeds, and described progress advancing NS002, an investigational intranasal epinephrine powder based on its proprietary Nasax technology.

Key 2025 developments include expanded collaboration agreements with Aptar, Health Canada authorization to start a Phase 2 trial, and dosing of the first patient in October 2025. Near-term milestones include an interim analysis expected early Q1 2026 and a topline Phase 2 readout planned for end of Q1 2026, with IND, pivotal, and pediatric study initiations targeted in Q3–Q4 2026.

Positive

• IPO raised $10 million gross proceeds (August 2025)
• Health Canada authorized Phase 2 trial for NS002 (Oct 2025)
• First patient dosed in NS002 Phase 2 study (Oct 2025)
• Expanded collaboration with Aptar for unit dose technology

Negative

• NS002 remains pre-pivotal; pivotal study initiation planned Q3 2026
• Company is clinical-stage with no marketed products yet

Key Figures

IPO gross proceeds $10 million Initial public offering completed in August 2025

Phase 2 status Phase 2 clinical study NS002 study authorized by Health Canada and initiated in 2025

Planned enrollment up to 50 adults Open-label NS002 vs EpiPen trial in healthy adults

Topline timing end of Q1 2026 Planned topline readout from NS002 Phase 2 study

IND submission Q3 2026 Planned NS002 Investigational New Drug filing

Pivotal study start Q3 2026 Planned initiation of NS002 pivotal study

Pediatric study start Q4 2026 Planned initiation of NS002 pediatric study

Pipeline first-in-human 1–2 products in 2026 Goal to start first-in-human studies for pipeline programs

Market Reality Check

$7.08 Last Close

Volume Volume 6,650 vs 3,017 20-day average (~2.2x), indicating elevated interest ahead of this update. high

Technical Price $7.58 is trading slightly below the 200-day MA ($7.60), near longer-term trend levels.

Peers on Argus 2 Down

While NSRX showed a positive pre-news move of 18.92%, momentum peers like INCR and RMTI appeared in scanners moving down (median about -6.4%), pointing to stock-specific strength rather than a broad sector lift.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Oct 08	NS002 collaboration	Positive	+0.8%	Expanded Aptar agreements to support NS002 development and commercialization.
Sep 02	Investor conference	Neutral	-0.7%	Announcement of CEO presentation at H.C. Wainwright investor conference.
Aug 26	Listing milestone	Positive	+0.5%	NYSE American listing marked with bell-ringing ceremony highlighting intranasal platform.
Aug 14	IPO completion	Positive	+0.6%	Completion of IPO raising funds to advance intranasal epinephrine program.

Pattern Detected

Recent news and IPO-related events have produced modest, mostly positive moves (within about ±1%), generally aligning with constructive company updates.

Recent Company History

Over the past several months, Nasus Pharma has moved from IPO to execution on its intranasal epinephrine strategy. The August 2025 IPO raised $10 million, followed by NYSE American listing celebrations and increased investor outreach, including the H.C. Wainwright conference on September 5, 2025. A key operational milestone came on October 8, 2025 with expanded Aptar agreements to support NS002’s development and commercialization. Those events saw small, mostly positive price reactions, suggesting a pattern of measured market responses to corporate progress heading into this 2025 shareholder letter.

Market Pulse Summary

This announcement outlines a year of transition from IPO funding to active clinical execution for NS002, supported by Aptar collaborations and Health Canada authorization for a Phase 2 study in up to 50 adults. The letter also details a roadmap of 2026 milestones, including Phase 2 topline data, IND submission, and pivotal and pediatric study initiations. Investors may monitor delivery on these timelines and progress of additional Nasax-based candidates planned for first-in-human studies.

Key Terms

intranasal medical

"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.

epinephrine medical

"intranasal epinephrine powder formulation, designed to address limitations of injectable Epinephrine"

Epinephrine, also known as adrenaline, is a fast-acting hormone and medication used to stimulate the heart, open airways and tighten blood vessels during life-threatening emergencies like severe allergic reactions, asthma attacks and cardiac arrest. Investors care because its clinical use and demand drive sales of drug products and delivery devices, influence regulatory approvals and supply chains, and can quickly affect revenue and stock value when shortages, new formulations or policy changes occur.

anaphylaxis medical

"As anaphylaxis represents a time-critical medical emergency, faster epinephrine delivery"

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.

pharmacokinetic medical

"trial designed to evaluate the pharmacokinetic parameters and hemodynamic responses of NS002"

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.

investigational new drug regulatory

"NS002 Investigational New Drug (“IND”) submission planned for the third quarter of 2026"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

phase 2 medical

"authorization from Health Canada ... to initiate our planned Phase 2 clinical study of NS002"

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.

AI-generated analysis. Not financial advice.

TEL AVIV, Israel, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) ("Nasus Pharma", “Nasus” or the "Company"), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products to treat emergency medical conditions, today issued a letter to its shareholders from its Chief Executive Officer, Dan Teleman.

Dear Shareholders, 2025 has been a transformational year for Nasus Pharma. We’ve made considerable progress building a strong, focused company with significant clinical impact, by developing drug delivery products based on our proprietary Nasax powder technology, which has the potential to enhance intranasal drug absorption for improved outcomes.

We began 2025 by presenting integrated data from two early clinical trials of NS002, our investigational intranasal epinephrine powder formulation, designed to address limitations of injectable Epinephrine, developed as a needle-free, easy-to-administer alternative to traditional epinephrine autoinjectors. The positive results show NS002 has demonstrated the potential for faster and higher absorption of epinephrine in a clinic setting. As anaphylaxis represents a time-critical medical emergency, faster epinephrine delivery can make the difference between life and death.

To progress towards fulfilling our mission to innovate the field of life-saving medications, we successfully completed our initial public offering in August 2025, raising $10 million in gross proceeds and strengthening Nasus Pharma’s financial position.

We have carried this positive momentum forward by advancing NS002’s clinical development alongside our goal to ultimately bring a fast-acting, intranasal epinephrine delivery product to market. In October 2025, we announced our expanded collaboration agreements with Aptar France S.A.S. and AptarGroup Inc. to support ongoing clinical development and planned commercialization of NS002. These agreements provide Nasus with a commercially proven Unit Dose System technology, which has the potential to accelerate NS002’s path to market with established regulatory avenues, as well as validated manufacturing and supply chain capabilities.

We have concluded the year by further advancing NS002’s development program. In October 2025, we received authorization from Health Canada, the country’s primary regulatory authority for drugs and medical products, to initiate our planned Phase 2 clinical study of NS002. Shortly after receiving this approval, we dosed the first patient in an open-label, fixed-sequence trial designed to evaluate the pharmacokinetic parameters and hemodynamic responses of NS002 compared to EpiPen® in up to 50 healthy adults with a history of allergic rhinitis. We expect to report an interim analysis early in the first quarter of 2026.

We’ve made significant headway this year in our mission to transform anaphylaxis treatment and deliver epinephrine effectively while offering patients the ease and convenience of a simple nasal spray. We’ve steered Nasus toward meaningful progress in 2026, driven by the achievement of key planned regulatory and clinical milestones:

• topline readout from NS002’s Phase 2 clinical study planned for the end of the first quarter of 2026
• NS002 Investigational New Drug (“IND”) submission planned for the third quarter of 2026
• NS002 pivotal study initiation planned for the third quarter of 2026
• NS002 pediatric study initiation planned for the fourth quarter in 2026

While we are advancing our NS002 program, we are also working to develop further drug candidates based on our Nasax technology. Our goal is to initiate first-in-human studies in one or two of our pipeline products during 2026. As we commit to this planned progress in 2026, we remain focused on advancing our pipeline led by NS002, expanding our reach, and continuing to develop drug delivery products that are fast, easy to use, and ready for when they’re needed most.

Our proprietary Nasax powder technology has the potential to offer an improved way to deliver life-saving medications: fast, needle-free, portable, and stable without refrigeration. This platform has broad potential across emergency care, and we are just beginning to unlock it.

We thank our employees, partners, and shareholders for the continued trust and support -- all of which have made 2025 a year of excellence for Nasus.

Sincerely,

Dan Teleman
Chief Executive Officer

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’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 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. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including statements regarding: the Company’s expectations regarding its growth, the advancement of its clinical programs, and anticipated clinical and commercial milestones for NS002 and other product candidates; expectations regarding interim analyses, top-line data readouts, and future clinical milestones; plans and timelines for regulatory submissions and clinical milestones, including IND applications and potential regulatory approvals; expectations regarding the initiation and progression of pivotal and pediatric clinical studies; the potential safety, efficacy, pharmacokinetic profile, and clinical benefits of NS002 and other product candidates; the potential advantages, applications, and commercial viability of the Company’s proprietary Nasax powder technology; the ability to advance product candidates toward commercialization; expectations regarding collaborations, including anticipated benefits related to manufacturing, regulatory pathways, and supply chain capabilities; future pipeline development and plans to initiate first-in-human studies for additional candidates; and the Company’s strategy, business plans, objectives, and expectations for future growth, and value creation. Forward-looking statements contained in this press release may be identified by the use of 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 or other similar expressions, although not all forward-looking statements contain these words. 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 prospectus filed with the U.S. Securities and Exchange Commission dated August 12, 2025. 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) raise in its August 2025 IPO?

Nasus completed an IPO in August 2025, raising $10 million in gross proceeds.

What is the status of NS002 intranasal epinephrine (NSRX) as of Dec 22, 2025?

NS002 is in clinical development with Health Canada authorization for a Phase 2 study and the first patient dosed in October 2025.

When does Nasus Pharma (NSRX) expect Phase 2 NS002 results?

The company expects an interim analysis early in Q1 2026 and a topline Phase 2 readout by the end of Q1 2026.

What regulatory and clinical milestones does NSRX target in 2026?

Nasus plans an IND submission in Q3 2026, pivotal study initiation in Q3 2026, and a pediatric study initiation in Q4 2026.

What collaboration supports NS002 commercialization for NSRX?

Expanded agreements with Aptar provide a commercially proven Unit Dose System for clinical development and planned commercialization.

Will Nasus (NSRX) advance other programs in 2026?

The company plans to initiate first-in-human studies for one or two additional Nasax-based pipeline candidates during 2026.