Nasus Pharma Ltd. (NSRX) - Form 20-F Summary
Business Context and Reporting Period
Company: Nasus Pharma Ltd.
Reporting Period: Fiscal year ended December 31, 2025.
Business Model: Clinical-stage specialty pharmaceutical company developing powder-based intranasal (PBI) drug delivery technology for emergency medical conditions.
Key Products:
- NS002 (Intranasal Epinephrine): Lead candidate for anaphylaxis. Completed Phase 2 studies showing faster absorption than IM EpiPen. Phase 3 pivotal study planned for Q4 2026.
- NS001 (Intranasal Naloxone): Candidate for opioid overdose. Development paused; company seeking partners.
- Pipeline: Preclinical candidates for seizures (Midazolam), organophosphate poisoning (Atropine), and vomiting (Ondansetron).
Corporate Status: Emerging Growth Company (EGC) and Foreign Private Issuer. Listed on NYSE American (Symbol: NSRX) since August 2025.
Key Financial Metrics
| Metric (in thousands USD) | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(5,856) | $(1,532) |
| Operating Expenses | $4,904 | $1,078 |
| Cash & Equivalents (Dec 31, 2025) | $1,291 | $311 |
| Short-Term Deposits (Dec 31, 2025) | $3,049 | $0 |
| Total Liquidity (Dec 31, 2025) | $4,340 | $311 |
| Accumulated Deficit | $(18,520) | $(12,664) |
Subsequent Liquidity Update: As of March 25, 2026, total cash and cash equivalents increased to approximately $15.0 million following a February 2026 private placement raising $15.0 million in gross proceeds.
Material Changes vs. Prior Period
- Operating Loss Expansion: Net loss increased 282% to $5.9 million in 2025, driven by a 568% increase in R&D expenses ($2.2M vs $0.3M) and a 259% increase in G&A expenses ($2.7M vs $0.7M) due to public company costs and clinical trial expansion.
- Capital Raising: Completed an IPO in August 2025 raising ~$10 million gross. Completed a private placement in February 2026 raising $15 million gross.
- Convertible Securities: Recognized a $0.95 million loss on the change in fair value of convertible securities (SAFEs) in 2025. All SAFEs converted to ordinary shares upon the IPO.
- Discontinued Operations: Reported a $51 thousand loss from discontinued operations (legacy Taffix product) in 2025, compared to $20 thousand income in 2024.
Guidance, Outlook, and Risks
Outlook & Guidance:
- Cash Runway: Management expects current cash ($15.0M as of March 2026) to fund operations through Q2 2027.
- Clinical Timeline: IND submission for NS002 planned for Q3 2026. Pivotal Phase 3 study initiation planned for Q4 2026. NDA submission targeted for H2 2027.
- Profitability: Company expects to continue incurring significant losses until regulatory approval and commercialization are achieved.
Material Risks & Contingencies:
- Going Concern: Auditors have issued a "substantial doubt" opinion regarding the company's ability to continue as a going concern due to recurring losses and lack of revenue, though recent financing mitigates immediate risk.
- Internal Controls: Material weaknesses in internal control over financial reporting were identified in 2023 and remain unremediated as of the filing date. A new CFO was hired in November 2025 to address this.
- Geopolitical Risk: Operations are based in Israel. Ongoing regional conflicts and potential mobilization of reserve personnel pose risks to operations and supply chains.
- Regulatory Uncertainty: Success depends on FDA approval of NS002 via the 505(b)(2) pathway, which is not guaranteed.
Investor Verification Checklist
- Remediation of Internal Controls: Verify the progress of remediation plans for the material weaknesses in internal controls over financial reporting.
- Cash Burn Rate: Monitor quarterly cash burn to confirm the runway extends through Q2 2027 as projected.
- Clinical Trial Enrollment: Track enrollment and interim data for the NS002 Phase 2 study in Canada and the upcoming Phase 3 pivotal study.
- Related Party Transactions: Review ongoing agreements with Formulex (owned by co-founders) and Aptar for terms and potential conflicts of interest.
- Geopolitical Impact: Assess the impact of the Israel-Iran/Hezbollah conflict on employee availability and supply chain logistics.