20-F: Nasus Pharma Advances Epinephrine Program, Secures New Funding

Nasus Pharma reports positive Phase 2 clinical results for its intranasal Epinephrine candidate, NS002, and successfully raises $15 million in a private placement, despite continued operating losses and going concern doubts.

Summary

• Nasus Pharma is a clinical-stage specialty pharmaceutical company focused on developing intranasal drugs for emergency medical conditions using its proprietary powder-based intranasal (PBI) technology.
• The company's primary product candidate, NS002 (Intranasal Epinephrine), is being developed for severe allergic reactions and anaphylactic shock.
• Topline results from a comprehensive Phase 2 clinical study of NS002 demonstrated significantly faster and higher early epinephrine absorption compared to intramuscular EpiPen, with a median time to therapeutic threshold (T100) of 1.69 minutes for NS002 versus 3.42 minutes for EpiPen (p=0.033).
• At 2.5 minutes, 67.4% of NS002 participants reached the therapeutic threshold compared to 27.1% with EpiPen (p=0.0001), and at 5 minutes, 88.4% of NS002 subjects reached the threshold compared to 64.6% with EpiPen (p=0.0081).
• Total epinephrine absorption in the critical 10-minute therapeutic window was approximately 50% higher with NS002, with AUC statistically significantly higher in the first 5-10 minutes compared to EpiPen.
• NS002 demonstrated a favorable safety and tolerability profile consistent with previous studies, with no serious adverse events reported.
• Development of NS001 (Intranasal Naloxone) has been paused, with plans to pursue partnering opportunities for its further advancement.
• The company incurred a net loss of $5.856 million for the year ended December 31, 2025, an increase of 282% from $1.532 million in 2024, and has an accumulated deficit of approximately $18.5 million.
• As of December 31, 2025, cash and cash equivalents, restricted cash, and short-term deposits totaled $4.34 million, increasing to approximately $15.0 million by March 25, 2026, following a private placement.
• Management believes existing cash will fund operations through the second quarter of 2027, but substantial additional funding will be required for commercialization, raising substantial doubt about the company's ability to continue as a going concern.
• The company settled outstanding disputes with Aptar, its inhaler manufacturer, for $300,000 and entered into new agreements for NS002 development and exclusive supply of UDSp devices.
• The company is also exploring other preclinical pipeline programs, including intranasal midazolam, atropine, and ondansetron powder nasal sprays.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a positive development, driven by strong Phase 2 clinical data for NS002 and successful capital raises. However, the company's early stage, ongoing operating losses, and stated 'going concern' doubt temper the overall sentiment, indicating significant risks remain.

Positives

• NS002 Phase 2 clinical study demonstrated significantly faster and higher early epinephrine absorption compared to intramuscular EpiPen, reaching the critical 100 pg/mL plasma threshold with a median T100 of 1.69 minutes versus 3.42 minutes for EpiPen (p=0.033).
• At 2.5 minutes, 67.4% of NS002 participants reached the therapeutic threshold compared to 27.1% with EpiPen (p=0.0001), indicating rapid onset of action.
• Total epinephrine absorption in the critical 10-minute therapeutic window was approximately 50% higher with NS002, with AUC statistically significantly higher in the first 5-10 minutes compared to EpiPen.
• NS002 showed a favorable safety and tolerability profile with no serious adverse events reported in the Phase 2 study.
• The company successfully completed an IPO in August 2025, raising approximately $10 million in gross proceeds.
• A private placement in February 2026 secured an additional $15.0 million in gross proceeds, extending the funding runway through Q2 2027.
• The proprietary powder-based intranasal (PBI) technology has demonstrated long-term enantiomeric stability for Epinephrine, with 100% active form compared to EpiPen devices showing up to 5.7% inactive form even within shelf life.
• The company has a strong intellectual property position with multiple granted patents for dry powder formulations and intranasal Epinephrine, and many pending applications worldwide.
• Successful tech transfer and scalability for commercial production of powder-based products have been achieved, leveraging prior experience from the Naloxone program.

Negatives

• The company has not generated revenues from its product candidates and incurred a net loss of $5.856 million in 2025, a 282% increase from 2024.
• An accumulated deficit of approximately $18.5 million as of December 31, 2025, raises substantial doubt about the company's ability to continue as a going concern.
• Earlier NS002 pilot and Phase 2 studies were not powered for statistical significance, meaning observed effects may not be accurate due to small sample sizes.
• Development of NS001 (Intranasal Naloxone) has been paused, with the company seeking partnering opportunities, indicating a delay in its direct commercialization.
• The company has identified material weaknesses in its internal control over financial reporting as of December 31, 2023, which have not yet been remediated.
• Competition in the pharmaceutical industry is intense, with many competitors possessing greater resources, experience, and market presence, potentially limiting market share for new products.
• The company's current cash on hand is only sufficient to fund operations through the second quarter of 2027, necessitating substantial additional funding.

Risks

• The company has not generated revenues from its continued activities, has incurred significant losses since inception, and anticipates continued losses, raising substantial doubt about its ability to continue as a going concern.
• Additional funding will be required to complete research and development, clinical trials, attain regulatory approvals, and commercialize products, and there is no assurance that such funding will be available on acceptable terms or at all.
• Clinical drug development is a lengthy, expensive, and uncertain process, and there is no guarantee that product candidates will receive regulatory approval or be commercially viable.
• The results of pre-clinical studies and early-stage clinical trials may not be indicative of results in future clinical trials, and observed effects in small sample sizes may not be accurate.
• Product candidates may lack sufficient efficacy or cause undesirable side effects not previously identified, which could delay or prevent regulatory approval or commercialization.
• The company relies on third-party manufacturers and suppliers for Epinephrine and other formulations, and any delays, price increases, or unavailability could adversely affect clinical trials and commercialization.
• Intellectual property protection may be limited, as there is no assurance that all patent applications will result in issued patents or that existing patents will be broad or strong enough to prevent competition.
• The company's future success depends on its ability to retain key personnel and to attract, retain, and motivate qualified personnel in a highly competitive environment.
• Geopolitical conditions in Israel and the Middle East, including ongoing conflicts, may adversely affect operations, and commercial insurance does not cover war-related losses.
• The company is exposed to fluctuations in currency exchange rates, which could adversely affect results of operations.
• Changes in regulatory requirements and guidance or unanticipated events during clinical trials may result in increased costs or delays.
• Failure to comply with post-marketing regulatory requirements could subject the company to enforcement actions, including substantial penalties.
• Unstable market and economic conditions, including inflation and interest rates, may have serious adverse consequences on the business, financial condition, and share price.
• The company may be subject to litigation for various claims, including product liability, which could be expensive and divert management attention.
• The company's management team has limited experience managing a U.S. reporting company, which could lead to difficulties in compliance and oversight.
• The business and operations might be adversely affected by security breaches, including cybersecurity incidents, leading to data loss, regulatory investigations, and reputational damage.

Future Outlook

The company intends to initiate an additional Phase 2 study for NS002 evaluating self-administration in the second quarter of 2026, followed by a pivotal clinical Phase 3 study in the fourth quarter of 2026, with an Investigational New Drug (IND) submission planned for the third quarter of 2026 and a New Drug Application (NDA) submission for marketing approval by the second half of 2027. The company plans to pursue partnering opportunities for the further development of NS001 and explore regulatory approval of its products outside the United States, while also developing additional preclinical pipeline programs.

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.
• 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 believe that PBI may be superior over liquid-based solutions due to potentially significantly higher dispersion of powder throughout the nasal cavity, thus creating a larger absorption area and enabling more rapid and higher drug absorption.

Industry Context

StockSavvy.ai notes that Nasus Pharma operates in the rapidly growing intranasal drug delivery market, estimated at $59 billion in 2022 and projected to reach $93.7 billion by 2029. The company's focus on emergency medical conditions like anaphylaxis and opioid overdose places it in a competitive landscape with established players like ADAPT Pharma (Neffy), Bryn Pharma, Orexo, and Aquestive Therapeutics, who are also developing alternative Epinephrine delivery methods. The market for Naloxone is also seeing new entrants and generic versions, highlighting the need for differentiated products with superior pharmacokinetic profiles.

Comparison to Industry Standards

• NS002 demonstrated a median time to therapeutic threshold (T100) of 1.69 minutes, significantly faster than EpiPen's 3.42 minutes, and faster than reported mean T100 values for competitors like ARS Pharmaceuticals' Neffy (10-21 minutes) and Aquestive Therapeutics (10 minutes), and Orexo (5 minutes).
• NS002 achieved approximately 50% higher total epinephrine absorption (AUC) in the critical 10-minute therapeutic window compared to EpiPen, and its AUC in the first 5-10 minutes was statistically significantly higher than EpiPen, outperforming ARS Neffy (712 h/pg/ml) and Bryn Pharma (1,130 h/pg/ml) in early exposure.
• NS002's peak concentration (Cmax) was comparable to EpiPen, with repeat dosing showing strong performance, and its median Tmax of 15 minutes was faster than EpiPen's 19.8 minutes, and comparable to Aquestive (15 minutes), and faster than ARS Neffy (30 minutes), Bryn Pharma (20 minutes), and Orexo (25 minutes).
• The company's PBI technology for Epinephrine showed 100% enantiomeric stability, meaning no loss of active compound, which is a significant advantage over liquid-based EpiPen devices that showed up to 5.7% inactive enantiomers even before expiration.
• NS001 (Intranasal Naloxone) pilot study results showed significantly faster absorption and higher plasma levels compared to Narcan, with partial AUC0-4 minutes approximately 7-fold higher, partial AUC0-10 minutes approximately 4-fold higher, and peak systemic exposure approximately 1.6-fold higher, with a median Tmax occurring approximately 5 minutes earlier.

Management Changes

Corporate Governance

Legal Proceedings

• Resolved outstanding disputes with Aptar Group Inc. through a Termination and Settlement Agreement on October 6, 2025, agreeing to a total settlement of $300,000.

Related Party Transactions

• Loans totaling $560,000 (July 2022 Loan) and $67,000 (February 2023 Loan) from directors and shareholders were converted into Simple Agreements for Future Equity (SAFEs) in August 2024.
• Formulex Pharma Innovations Ltd., owned by co-founders and a director, granted the company an exclusive license for dry powder compositions and know-how, with royalties capped at $100,000.
• A prior services agreement with Formulex for $5,000 monthly was terminated in December 2025, with Formulex waiving $225,000 in prior obligations.
• A new development services agreement was entered with Formulex on September 8, 2025, for $10,000 monthly for preclinical pipeline development and consulting.
• Formulex also provided one-time development services for additional fees of $167,000 in 2025 and $22,000 in 2023.
• A subcontractor agreement with Formulex was entered in December 2024, with $219,000 paid for services in 2025.
• A consulting agreement with Capital Point Ltd., a shareholder, was entered on August 7, 2025, for business development and strategic consulting services for $600,000 through June 2026.
• Secretarial and administrative services from Topnotch Consultancy (owned by co-founder Udi Gilboa) for NIS 15,000 per month were terminated in September 2025.
• Office space lease from Topnotch (owned by co-founder Udi Gilboa) for NIS 12,000 per month was terminated on September 13, 2025.
• Co-founders and directors (Udi Gilboa, Dr. Dalia Megiddo, Dr. Ronnie Hershman) participated in the 2022, 2023, and 2024 SAFEs, and the February 2026 private placement.
• Executive officers received bonuses in connection with the IPO and the February 2026 private placement, including $293,000 for Mr. Gilboa and $235,000 for Dr. Megiddo for the IPO, and $277,200 for Mr. Gilboa and $100,000 for Mr. Rubin for the private placement (partially subject to shareholder approval).

Stakeholder Impact

• Shareholders: Dilution from recent equity offerings (IPO and private placement) and potential future capital raises. Share price volatility is a risk. Principal shareholders and management exert significant influence.
• Employees: Increased payroll and related expenses due to new hires and management bonuses. Share-based compensation plans provide incentives. Geopolitical conditions in Israel could impact employees.
• Customers/Patients: Potential for new, user-friendly, and effective intranasal treatments for emergency medical conditions (anaphylaxis, opioid overdose) if products receive regulatory approval and market acceptance.
• Suppliers/Manufacturers: Continued reliance on third-party manufacturers and suppliers (e.g., Aptar) for product components and manufacturing, with new agreements in place for NS002.
• Creditors: The company's going concern doubt and need for additional financing pose risks to creditors, though recent capital raises provide some liquidity.

Next Steps

• Initiate an additional Phase 2 study for NS002 evaluating self-administration in the second quarter of 2026.
• 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.
• Initiate pediatric studies for NS002 in the fourth quarter of 2026.
• 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.
• Continue to develop additional preclinical pipeline programs (NS005 Intranasal Midazolam, NS004 Intranasal Atropine, NS003 Intranasal Ondansetron).

Key Dates

Recommendation

The strong, statistically significant Phase 2 results for NS002, demonstrating superior early absorption compared to EpiPen, represent a critical de-risking event and a significant competitive advantage in a large, unmet medical need market. The successful IPO and recent $15 million private placement provide a runway for advancing NS002 into pivotal Phase 3 trials. While the company faces ongoing losses and 'going concern' uncertainty, the clear development pathway, proprietary technology, and potential for a differentiated product in emergency medicine make it an attractive 'buy' for investors with a higher risk tolerance seeking exposure to a promising clinical-stage pharmaceutical company.

Keywords

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