Announcement • Mar 25
Nasus Pharma Ltd Advances NS002 And Expands Intranasal Product Portfolio Nasus Pharma Ltd. 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. 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 the fourth quarter of 2026. 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. 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. Announcement • Mar 16
Nasus Pharma Ltd Announces Positive Top Line Data from Phase 2 Clinical Study of NS002 Nasus Pharma Ltd. announced positive top line results from its Phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. NS002 demonstrated significantly faster time to the critical 100 pg/mL epinephrine threshold compared to EpiPen®, with a median T100 of 1.69 minutes versus 3.42 minutes (p=0.033). At 5 minutes, 88.4% of subjects receiving NS002 reached the threshold compared to 64.6% with EpiPen®. NS002 continued to demonstrate a favorable safety profile with no serious adverse events reported and comparable pharmacodynamic response to EpiPen® across all participants. The Company plans to initiate its pivotal clinical study in fourth quarter of 2026. The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis. All subjects received a single and repeat dose of NS002 and intramuscular EpiPen® with and without a nasal allergic challenge (“NAC”). This robust study design provided comprehensive data supporting NS002's clinical utility across multiple administration scenarios that patients may encounter during actual anaphylactic emergencies. The top line Phase 2 analysis demonstrated multiple significant advantages for NS002 across key pharmacokinetic and pharmacodynamic parameters: Speed to Therapeutic Threshold: After a single administration, NS002 achieved the critical 100 pg/mL plasma epinephrine 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 participants receiving NS002 reached the therapeutic threshold compared to 27.1% with EpiPen® (p=0.0001). At 5 minutes, 88.4% of NS002 subjects reached the threshold compared to 64.6% with EpiPen® (p=0.0081). By 10 minutes, approximately 95% of participants receiving NS002 reached the therapeutic threshold. Time to Peak Concentration: NS002 reached peak concentration (“Tmax”) in a median of 15 minutes compared to 19.8 minutes with EpiPen®, demonstrating consistently faster epinephrine delivery. Critical Window Drug Exposure: Total epinephrine absorption in the critical 10-minute therapeutic window following administration was approximately 50% higher with NS002, with AUC statistically significantly higher in the first 5–10 minutes compared to EpiPen®. Repeat Dose Performance: Repeat administration of NS002 with or without a NAC maintained consistent pharmacokinetic advantages over EpiPen®, a clinically significant finding given that patients experiencing severe anaphylaxis may require a repeat dose to fully resolve symptoms. Peak Plasma Concentrations: Across multiple scenarios, NS002 demonstrated comparable peak plasma concentration (“Cmax”) compared to EpiPen®, with repeat dosing showing particularly strong performance. Safety and Tolerability Profile: NS002 demonstrated a favorable safety and tolerability profile consistent with previous studies, with no serious adverse events reported. These results demonstrated that NS002 has the potential to exceed EpiPen® performance across the full spectrum of real-world conditions, including the challenging NAC environment that simulates scenarios patients may encounter during actual allergic reactions. The analysis showed statistically significant improvements in time to therapeutic threshold (T100) and in the proportion of subjects reaching the therapeutic epinephrine threshold within the first minutes following administration. Nasus Pharma will host a conference call and webcast at 8:00 a.m. EDT to review and discuss the final analysis data from the Phase 2 repeated dose clinical study. New Risk • Feb 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-US$4.3m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Market cap is less than US$100m (US$69.4m market cap). 
