F-1: Nasus Pharma Files F-1 for Resale, Details Clinical Progress & Funding

Nasus Pharma Ltd. filed an F-1 registration statement for the resale of up to 5.39 million ordinary shares by selling shareholders, outlining clinical progress for its intranasal drug candidates and recent financing activities.

Summary

• The F-1 registration statement covers the resale of up to 5,390,850 Ordinary Shares by selling shareholders, including shares issued and those issuable upon warrant exercise.
• Nasus Pharma is a clinical-stage specialty pharmaceutical company focused on developing intranasal drugs for emergency medical conditions using its unique powder-based intranasal (PBI) technology.
• The primary product candidate is NS002 (Intranasal Epinephrine) for severe allergies and anaphylaxis, which has completed Phase 2 studies.
• Development of NS001 (Intranasal Naloxone) for opioid overdose has been paused, with plans to pursue partnering opportunities.
• The company has incurred significant operating losses since inception, with an accumulated deficit of $13.9 million as of June 30, 2025.
• An Initial Public Offering (IPO) in August 2025 raised approximately $10 million in gross proceeds.
• A private placement in February 2026 generated $15.0 million in gross proceeds from the sale of 2,695,425 Ordinary Shares and warrants.
• Interim results from the Phase 2 study for NS002 in Canada, initiated in November 2025, showed faster systemic absorption and higher peak epinephrine concentrations compared to EpiPen.
• The company expects its existing cash and cash equivalents of $16.2 million (as of March 2, 2026) to fund operations through May 2027.
• Material weaknesses in internal control over financial reporting were identified as of December 31, 2023, and remediation plans are underway, including the appointment of a CFO and internal auditor.

Sentiment

Score: 4

Explanation: StockSavvy.ai views this filing with cautious optimism. While positive clinical data for NS002 and recent capital raises are encouraging, the significant accumulated losses, ongoing 'going concern' warning, and substantial future funding requirements present considerable financial risk. The pause in NS001 development also adds uncertainty.

Positives

• Successful initiation of a Phase 2 clinical study for NS002 in Canada in November 2025.
• Interim Phase 2 results for NS002 demonstrated faster systemic absorption and higher peak epinephrine concentrations compared to EpiPen, with most participants reaching clinically meaningful plasma levels within five minutes.
• NS002 was well tolerated in trials, with no serious adverse events reported and a pharmacodynamic profile comparable to EpiPen.
• The company completed an IPO in August 2025, raising approximately $10 million in gross proceeds.
• A private placement in February 2026 raised $15.0 million in gross proceeds, with potential for an additional $17.6 million from warrant exercises.
• Appointment of Mr. Eyal Rubin as Chief Financial Officer and Executive Vice President in November 2025, bringing over two decades of financial leadership experience.
• The company possesses a strong intellectual property position with several granted patents for its dry powder formulations and intranasal delivery technology.
• Successful completion of scalability and technology transfer to a European GMP FDA approved manufacturing facility for commercial size production.

Negatives

• The company has not generated revenues from its continued activities and has incurred significant operating losses since inception.
• As of June 30, 2025, the accumulated deficit was $13.9 million, and the company had only $0.2 million in cash and cash equivalents.
• A 'substantial doubt about our ability to continue as a going concern' has been raised by management and noted by auditors.
• Development of NS001 (Intranasal Naloxone) has been paused, with the company seeking partnering opportunities for its further development.
• None of the company's product candidates have received FDA approval to date.
• Clinical trials conducted thus far have involved relatively small patient populations, and some were not powered for statistical significance, meaning observed effects may not be accurate.
• Identified material weaknesses in internal control over financial reporting as of December 31, 2023, which have not yet been remediated.
• The company operates in an intensely competitive pharmaceutical industry with many competitors possessing greater resources and market presence.
• The current cash on hand is not believed to be sufficient to fund all projected operating requirements, including the completion of all R&D activities necessary to commercialize product candidates.

Risks

• Inability to achieve or maintain profitability due to significant operating losses and lack of revenue from existing products.
• Substantial doubt about the company's ability to continue as a going concern, potentially preventing new financing on reasonable terms.
• Clinical drug development is lengthy, expensive, and uncertain, with potential for prolonged delays or unsuccessful outcomes.
• Denial of regulatory approval for NS002 or NS001 could delay or cease operations and impact revenue generation.
• Results from pre-clinical studies and early-stage clinical trials may not be indicative of results in future clinical trials.
• Product candidates may lack sufficient efficacy or cause undesirable side effects not previously identified, delaying or preventing regulatory approval.
• Reliance on third-party manufacturers for Epinephrine and other formulations, with risks of delays, price increases, or unavailability.
• Reliance on a limited number of single suppliers for laboratory instruments and materials, posing replacement or transition challenges.
• Dependence on third parties to conduct pre-clinical and clinical studies, with risks of non-compliance or missed deadlines.
• Limited manufacturing experience and reliance on third-party manufacturers for commercial-scale production, leading to potential production problems.
• Inability to obtain or maintain effective intellectual property rights, including patents, which could limit competitive advantage.
• Potential for third parties to initiate legal proceedings alleging infringement of their intellectual property rights.
• Challenges in retaining key executives and attracting/retaining qualified personnel.
• Intense competition in the pharmaceutical industry, with competitors potentially developing superior or less costly products.
• Exposure to substantial volatility in share price, with shareholders potentially losing all or a substantial part of their investment.
• Sales of a substantial number of Ordinary Shares by existing shareholders could depress the market price.
• Raising additional capital would cause dilution to existing shareholders.
• Principal shareholders and management own a significant percentage of Ordinary Shares, exerting influence over shareholder approval matters.
• Operations in Israel expose the company to geopolitical, economic, and military instability.
• Exposure to fluctuations in currency exchange rates, which could adversely affect results of operations.
• Termination or reduction of tax and other incentives from the Israeli government could increase costs and taxes.
• Potential requirement to pay monetary remuneration to Israeli employees for their inventions, even if rights are assigned to the company.
• Difficulty enforcing non-compete covenants under Israeli law, potentially leading to increased competition.
• Provisions of Israeli law and articles of association may delay or prevent mergers or acquisitions.
• Difficulty enforcing U.S. court judgments against the company and its executive officers/directors in Israel.
• Shareholder rights and responsibilities governed by Israeli laws, which differ from U.S. companies.
• Risk of security breaches, including cybersecurity incidents, affecting business operations and data integrity.
• Unsuccessful compliance with European privacy regulations (GDPR) could adversely affect business and reputation.
• Changes in regulatory requirements and guidance or unanticipated events during clinical trials may increase costs or delay development.
• FDA may not agree that product candidates satisfy requirements for the Section 505(b)(2) regulatory approval pathway, leading to longer, costlier, and riskier approval processes.
• Failure to obtain designations like Fast Track or Breakthrough Therapy, or inability to realize their intended benefits.
• Preliminary data from clinical trials may change, potentially harming business prospects.
• Ongoing regulatory oversight post-approval, with risks of enforcement actions for non-compliance.
• Failure to achieve market acceptance by physicians, patients, and third-party payors, even if products are approved.
• Lack of internal marketing and sales organization, requiring reliance on third parties.
• Unfavorable pricing regulations or third-party coverage and reimbursement policies.
• Legislative or regulatory healthcare reforms in the U.S. and EU could increase costs or limit market access.
• Inadequate funding for the FDA and other government agencies could hinder timely product review and approval.

Future Outlook

Nasus Pharma expects to continue incurring significant operating losses and will require substantial additional funding to complete the development and commercialization of its product candidates, particularly NS002. The company plans to initiate an additional Phase 2 study for NS002 in Q1 2026, submit an IND application in Q3 2026, and begin a pivotal Phase 3 study in Q4 2026, with an NDA submission targeted for H2 2027. NS001 development is paused, with a focus on seeking partnering opportunities. The company anticipates its current cash will fund operations through May 2027, but further capital raises will be necessary.

Management Comments

• Our mission is to offer better protection to patients during acute, severe and life-threatening medical conditions by an effective, user-friendly and immediately active PBI specialized products.
• To help achieve this we are focused on developing NS002, an Intranasal Epinephrine, and we have also been developing NS001, an Intranasal Naloxone, which we have paused, planning to pursue partnering opportunities for further development of NS001.
• We expect that we will need to raise substantial additional funding in the future.

Industry Context

StockSavvy.ai notes that Nasus Pharma operates in the highly competitive intranasal drug delivery market, which was estimated at $59 billion globally in 2022 and is projected to grow to $93.7 billion by 2029. The company's focus on powder-based intranasal (PBI) technology aims to differentiate it from predominantly liquid-based solutions offered by major competitors like ADAPT Pharma (Neffy), Bryn Pharma, Orexo, and Aquestive Therapeutics in the Epinephrine space, and Emergent BioSolutions (Narcan), Teva, Sandoz, and Hikma (Kloxxado) in the Naloxone market. The market is driven by the need for rapid, user-friendly, non-invasive treatments for emergency conditions like anaphylaxis and opioid overdose, where current injectable solutions face challenges such as needle fear, stability issues, and high costs. Nasus's PBI technology, with its demonstrated faster and higher drug absorption in early trials, positions it to potentially capture market share if it can overcome significant regulatory and commercialization hurdles.

Comparison to Industry Standards

• NS002 (Nasus Pharma) demonstrated faster systemic absorption and higher peak epinephrine concentrations compared to EpiPen in its Phase 2 study, with the majority of participants reaching clinically meaningful plasma levels within the first five minutes. The median time to clinical threshold (T100pg) was about 3.6 minutes, compared to 9 minutes for IM EpiPen.
• ARS Pharmaceuticals' Neffy showed a Cmax of 341 pg/ml and a median Tmax of 30 minutes, with 15% of subjects reaching 100 pg/ml at 5 minutes and 60% at 10 minutes.
• Bryn Pharma's intranasal Epinephrine achieved a Cmax of 429 pg/ml and a Tmax of 20 minutes, with 17% of subjects reaching 100 pg/ml at 5 minutes and 60% at 10 minutes.
• Orexo's intranasal Epinephrine formulation exhibited a Cmax of 377 pg/ml and a Tmax of 25 minutes, with a mean time to 100 pg/ml of 5 minutes.
• Aquestive Therapeutics' sublingual film of Epinephrine demonstrated a Cmax of 497 pg/ml and a Tmax of 15 minutes, with 82% of subjects reaching 100 pg/ml at 10 minutes and 91% at 15 minutes.
• Nasus's NS001 (Naloxone) pilot study showed significantly faster absorption rates in the immediate critical period (7-fold higher partial AUC0-4 minutes, 4-fold higher partial AUC0-10 minutes) and higher peak systemic exposure (1.6-fold higher) compared to Narcan (4 mg), with a median Tmax approximately 5 minutes earlier.

Management Changes

Corporate Governance

Legal Proceedings

• A legal dispute with Aptar Group Inc. regarding alleged breach of contractual obligations and outstanding payments was settled on October 6, 2025, with the company agreeing to pay $300,000 in full settlement.
• A legal proceeding in the magistrate court of Tel Aviv initiated by a Taffix supplier for $92,000 was settled on July 17, 2025, with the company agreeing to pay $94,000 in installments.

Related Party Transactions

• License agreement with Formulex Pharma Innovations Ltd. (owned by co-founders Mr. Ehud Gilboa, Dr. Dalia Megiddo, and director Dr. Ronnie Hershman) for dry powder compositions, with royalties capped at $100,000.
• Previous services agreement with Formulex for R&D services at a fixed monthly cost of $5,000, terminated and replaced by a new development services agreement on September 8, 2025, for $10,000 per month.
• Subcontractor agreement with Formulex (December 5, 2024) for potential tender participation, with maximum consideration not exceeding $800,000.
• Services agreement with Topnotch Consultancy (2009) Ltd. (owned by Mr. Udi Gilboa) for secretarial and administrative services, with a monthly fee of NIS 15,000 ($4,119) as of April 2024.
• Previous office lease agreement with Topnotch, terminated on September 13, 2025.
• Co-founders and directors (Mr. Udi Gilboa, Dr. Dalia Megiddo, Dr. Ronnie Hershman) participated in 2022, 2023, and 2024 Simple Agreements for Future Equity (SAFEs).
• Loans received from Dr. Ronnie Hershman and Michael Gibber (July 2022 Loan) and from Mr. Udi Gilboa, Dr. Dalia Megiddo, and Dr. Ronnie Hershman (February 2023 Loan), which were later converted into 2024 SAFEs.

Stakeholder Impact

• Shareholders face significant dilution risk from future equity financings and potential loss of investment due to the company's 'going concern' status and share price volatility.
• Employees and consultants benefit from the 2019 Incentive Option Plan, providing equity-based compensation.
• Customers and patients could benefit from the development of user-friendly, rapidly acting intranasal drugs for emergency medical conditions, if regulatory approvals are obtained.
• Suppliers and creditors face risks related to the company's financial position and ability to meet obligations, as evidenced by past disputes and the 'going concern' warning.
• Management and key personnel are incentivized through compensation packages, including equity awards and performance bonuses, tied to clinical milestones and financing success.

Next Steps

• Conduct an additional Phase 2 study for NS002 in the first quarter of 2026 to evaluate self-administration.
• Submit an Investigational New Drug (IND) application for NS002 in the third quarter of 2026.
• Initiate a pivotal clinical Phase 3 study for NS002 in the fourth quarter of 2026.
• Perform various stability, reliability, usability, preclinical, and pediatric studies for NS002.
• Submit a New Drug Application (NDA) dossier for marketing approval of NS002 by the second half of 2027.
• Pursue partnering opportunities for the further development of NS001 (Intranasal Naloxone).
• Explore regulatory approval of products outside the United States, including seeking scientific advice from European countries.
• Utilize platform technology to develop additional pipeline programs for other indications (e.g., intranasal midazolam, atropine, ondansetron).
• Continue to develop and implement a plan to remediate identified material weaknesses in internal control over financial reporting.

Key Dates

Recommendation

The company's recent IPO and private placement have significantly bolstered its cash position, providing runway through May 2027. Positive interim Phase 2 results for NS002 are encouraging, suggesting potential for a differentiated product in a critical market. However, the company remains in a clinical stage with no FDA-approved products, faces intense competition, and carries a 'going concern' warning from its auditors. The long and expensive path to regulatory approval and commercialization, coupled with the need for substantial additional funding, introduces considerable risk. A 'hold' recommendation is appropriate, acknowledging the promising clinical progress and improved liquidity, but also reflecting the high execution risk and financial uncertainty inherent in a development-stage pharmaceutical company.

Keywords

Intranasal Epinephrine, NS002, Anaphylaxis, Powder-Based Intranasal Technology, Clinical Stage Pharmaceutical, SEC F-1, Biotechnology, Drug Development, Epinephrine, Naloxone, Opioid Overdose, Emergency Medicine, FDA Approval, Clinical Trials, Pharmacokinetics, Corporate Governance, Capital Raise, Israel