お知らせ • Jun 12
Nasus Pharma Ltd. Announces Positive Results From Preclinical Pharmacokinetic And Safety Study Of Intranasal Ondansetron (NS003) Nasus Pharma Ltd. announced positive results from a preclinical pharmacokinetic (PK) and safety study of NS003, the Company's proprietary intranasal powder formulation of ondansetron being developed for chemotherapy and post-operative nausea and vomiting. The study compared NS003 to the intravenous (IV) formulation in an animal study. Data showed that NS003 had a PK profile comparable to IV, with similar time to maximum concentration (Tmax) and area under the curve (AUC) results. In a separate toxicology study, NS003 demonstrated a favorable safety profile at four times the test dose, with no adverse effects observed. With this milestone achieved, Nasus Pharma is now preparing to initiate a first-in-human PK study in the third quarter of 2026. Ondansetron is one of the most widely used therapies for chemotherapy-induced nausea and vomiting. In 2023, more than 12 million prescriptions were dispensed to over 6 million patients. Zofran (ondansetron) peak sales exceeded $1.5 billion. Approximately 1 million patients in the United States receive chemotherapy annually, 60-80% of whom undergo highly or moderately emetogenic regimens, while an additional 800,000 patients undergo radiotherapy each year, with more than half experiencing radiotherapy-induced nausea and vomiting. Market research indicates that 15-20% of these patients experience breakthrough nausea and vomiting not adequately controlled by oral therapies, often requiring a return to the clinic for intravenous anti-emetic treatment. Intranasal administration of NS003 has the potential to address this unmet need by offering a convenient, fast-onset alternative that may reduce avoidable clinic visits. NS002, Nasus Pharma'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 Pharma's 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. お知らせ • 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. お知らせ • 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). お知らせ • Feb 13
Nasus Pharma Ltd. announced that it has received $15.00004 million in funding On February 13, 2026, the Nasus Pharma Ltd closed the transaction. お知らせ • Feb 11
Nasus Pharma Ltd. announced that it expects to receive $15.00004 million in funding Nasus Pharma Ltd. announced that it has entered into a securities purchase agreement for a private placement of 2,695,425 ordinary shares no par value at an issue price of $5.565 per share and accompanying ordinary warrants to purchase up to 2,695,425 Ordinary Shares and a warrant for aggregate gross proceeds of approximately $15,000,040.125 before deducting placement agent fees and other offering expenses on February 10, 2026. The private placement includes participation from both new and existing investors, certain members of the Company’s Board of Directors, certain institutional and accredited investors. The per share and accompanying Warrant price of the securities sold in the private placement was priced at a premium to the last closing price of Nasus Pharma’s Ordinary Shares on the NYSE American. The Warrants will have an exercise price of $6.53 per share, are immediately exercisable, and will expire upon the earlier of two years from the date of issuance. The private placement is expected to close on or about February 12, 2026, subject to satisfaction of customary closing conditions. The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. お知らせ • Jan 20
Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder Nasus Pharma Ltd. announced positive interim results from its Phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. The data demonstrated that NS002 achieved faster absorption, higher peak concentrations, and greater early epinephrine exposure compared to intramuscular EpiPen autoinjector. The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis across two cohorts. At the interim analysis, the first cohort of 25 participants received NS002 or intramuscular EpiPen with and without a nasal allergic challenge. The second cohort of 25 participants received repeat doses of NS002 or intramuscular EpiPen with and without a nasal allergic challenge, evaluating real-world scenarios where multiple administrations may be necessary. The final analysis will include results of all 50 subjects who will have received all treatments. Key Interim Results: NS002 demonstrated a higher mean peak plasma concentration (“Cmax”) of 655 pg/ml compared to 548 pg/ml for EpiPen, and achieved peak concentration (“Tmax”) in 10.8 minutes compared to 15 minutes with EpiPen. Critically, 91% of participants administered NS002 reached the epinephrine plasma threshold of 100 pg/ml at 5 minutes, compared to 67% of those administered EpiPen. Total epinephrine absorption in the 10 minute period following administration—the critical window for resolving anaphylaxis—was higher in participants administered NS002 (AUC: 55 hpg/ml) compared to EpiPen (AUC: 32 hpg/ml). Repeat administration of NS002 with or without nasal allergic challenge demonstrated consistent pharmacokinetic advantages over EpiPen. This is a clinically relevant finding, as patients experiencing severe anaphylaxis may require repeat doses to fully resolve symptoms. The interim analysis includes safety data on all 50 subjects who completed all treatment arms. NS002 was well-tolerated, with no serious adverse events reported. The majority (95%) of treatment-emergent adverse events were mild and self-resolving, mostly local. The pharmacodynamic response, including changes from baseline in systolic and diastolic blood pressure and pulse rate, was comparable to that of EpiPen and remained within the normal range. Nasus Pharma expects to complete the Phase 2 study by the end of the first quarter of 2026. The Company plans to initiate its pivotal clinical study in fourth quarter of 2026. New Risk • Dec 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$3.2m). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$57.7m market cap). Board Change • Dec 12
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO & Director Dan Teleman was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. お知らせ • Nov 19
Nasus Pharma Ltd. Announces Initiation of Phase 2 Clinical Study of NS002 with First Participant Dosed Nasus Pharma Ltd. announced the successful initiation of the Company's Phase 2 clinical study with dosing of the first participant in Canada. The trial aims to evaluate NS002, the Company's investigational intranasal epinephrine powder formulation, compared to EpiPen for the treatment of anaphylaxis. NS002 could potentially offer patients a needle-free alternative to traditional epinephrine autoinjectors. The Phase 2 study is an open-label, fixed- sequence trial designed to evaluate the pharmacokinetic parameters and hemodynamic responses of NS002 compared to EpiPen in 50 healthy adults with a history of allergic rhinitis. Interim results from this trial are expected in the first quarter of 2026. お知らせ • Nov 07
Nasus Pharma Announces Approval from Health Canada to Initiate Planned Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder Nasus Pharma Ltd. announced that it recently received a No-Objection Letter from Health Canada, the country's primary regulatory authority for drugs and medical products, for the Company's planned Phase 2 clinical study of NS002, its investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. The Health Canada authorization marks an important regulatory milestone in the NS002 development program. This clearance confirms the acceptability of the proposed trial design, supporting safety data, and manufacturing information, and enables Nasus to advance towards its planned Phase 2 clinical study. New Risk • Oct 07
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$3.2m). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Market cap is less than US$100m (US$63.9m market cap). Board Change • Aug 14
High number of new directors Independent Director Sharon Shacham was the last director to join the board, commencing their role in 2025.