TEL AVIV, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) ("Nasus Pharma" or the "Company"), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced the closing of its previously announced private placement of ordinary shares and warrants to purchase ordinary shares for aggregate gross proceeds of approximately $15.0 million, before deducting placement agent fees and other offering expenses. Citizens Capital Markets acted as lead ...

Core Insights - Nasus Pharma's NS002 shows significantly faster absorption and higher peak epinephrine levels compared to EpiPen, with 91% of participants achieving the 100 pg/ml plasma threshold at 5 minutes versus 67% for EpiPen [1][3] - The interim results indicate that NS002 is well-tolerated with no serious adverse events reported, and the pharmacodynamic response is comparable to EpiPen [1][5] - Full Phase 2 results are expected by the end of Q1 2026, with a pivotal study initiation planned for Q4 2026 [1][7] Study Design - The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis, divided into two cohorts [2] - The first cohort of 25 participants received NS002 or EpiPen with and without a nasal allergic challenge, while the second cohort received repeat doses under similar conditions [2] Key Interim Results - NS002 achieved a mean peak plasma concentration (Cmax) of 655 pg/ml compared to 548 pg/ml for EpiPen, with a peak concentration (Tmax) reached in 10.8 minutes versus 15 minutes for EpiPen [3] - Total epinephrine absorption in the critical 10-minute window was higher for NS002 (AUC: 55 h*pg/ml) compared to EpiPen (AUC: 32 h*pg/ml) [3] Safety and Tolerability - NS002 was well-tolerated, with 95% of treatment-emergent adverse events being mild and self-resolving, primarily local [5] - The pharmacodynamic response, including changes in blood pressure and pulse rate, remained within normal ranges and was comparable to EpiPen [5] Expert Commentary - Clinical experts highlight the potential of NS002 as a significant advancement in anaphylaxis treatment due to its faster delivery and higher concentrations of epinephrine [6] - The needle-free administration of NS002 could address compliance challenges associated with current treatments [6] Future Plans - Nasus Pharma aims to complete the Phase 2 study by the end of Q1 2026 and plans to initiate its pivotal clinical study in Q4 2026 [7]

Core Viewpoint - 2025 has been a transformational year for Nasus Pharma, marked by significant clinical advancements and the development of innovative intranasal products aimed at treating emergency medical conditions [2][3]. Group 1: Clinical Development - Nasus Pharma presented integrated data from two early clinical trials of NS002, an intranasal epinephrine powder formulation, which showed potential for faster and higher absorption compared to traditional injectable epinephrine [3]. - The company received authorization from Health Canada to initiate a Phase 2 clinical study of NS002, with the first patient dosed in an open-label trial comparing NS002 to EpiPen® [6]. - An interim analysis of the Phase 2 clinical study is expected to be reported in early Q1 2026 [8]. Group 2: Financial Position - The company successfully completed its initial public offering in August 2025, raising $10 million in gross proceeds, which strengthened its financial position [4]. Group 3: Collaborations and Technology - Nasus Pharma expanded collaboration agreements with Aptar France S.A.S. and AptarGroup Inc. to support the clinical development and commercialization of NS002, leveraging proven technology for faster market access [5]. - The proprietary Nasax powder technology offers a fast, needle-free, and portable method for delivering life-saving medications, with broad potential applications in emergency care [8]. Group 4: Future Plans - The company aims to initiate first-in-human studies for one or two additional pipeline products during 2026, while continuing to advance the NS002 program [7]. - Key regulatory and clinical milestones for NS002 include a planned IND submission in Q3 2026 and the initiation of pivotal and pediatric studies in Q3 and Q4 2026, respectively [8].

Core Insights - 2025 has been a transformational year for Nasus Pharma, focusing on developing innovative intranasal products for emergency medical conditions [2] - The company has made significant progress with its proprietary Nasax powder technology, which enhances intranasal drug absorption [2][8] Clinical Development - Nasus Pharma presented positive data from early clinical trials of NS002, an intranasal epinephrine powder formulation, showing faster and higher absorption compared to traditional injectables [3] - The company received authorization from Health Canada to initiate a Phase 2 clinical study of NS002, with the first patient dosed in an open-label trial [6] - An interim analysis of the Phase 2 study is expected to be reported in early Q1 2026 [6][10] Financial Position - The company successfully completed its initial public offering in August 2025, raising $10 million in gross proceeds, which strengthened its financial position [4] Collaborations and Partnerships - In October 2025, Nasus Pharma expanded collaboration agreements with Aptar France S.A.S. and AptarGroup Inc. to support the clinical development and commercialization of NS002 [5] Future Plans - The company aims to initiate first-in-human studies for one or two additional pipeline products in 2026 while continuing to advance NS002 [7] - Key regulatory and clinical milestones are planned for NS002, including an Investigational New Drug submission in Q3 2026 and pivotal study initiation in Q3 2026 [10]

Core Insights - The Phase 2 clinical study of NS002, an intranasal epinephrine powder formulation, has been successfully initiated in Canada, aiming to compare its bioavailability and pharmacokinetics against EpiPen for anaphylaxis treatment [2][3][4] - Interim results from the Phase 2 study are expected in the first quarter of 2026, which will provide insights into the efficacy and safety of NS002 [3][4] Group 1: Study Details - The Phase 2 study is an open-label, fixed-sequence trial involving 50 healthy adults with a history of allergic rhinitis [3] - The study is designed to evaluate pharmacokinetic parameters and hemodynamic responses of NS002 compared to EpiPen [3] Group 2: Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing innovative intranasal products for emergency medical conditions [5] - The company's proprietary powder-based intranasal (PBI) technology aims for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network for quick absorption [5] Group 3: Market Need - The development of NS002 addresses the need for user-friendly treatment options for patients with severe allergies, particularly those who fear needles or find traditional autoinjectors cumbersome [4]

Core Insights - Nasus Pharma Ltd. has received a No-Objection Letter from Health Canada for its planned Phase 2 clinical study of NS002, an intranasal epinephrine powder formulation aimed at treating anaphylaxis [1][2]. Regulatory Milestone - The Health Canada authorization is a significant regulatory milestone for the NS002 development program, confirming the trial design, safety data, and manufacturing information [2]. Product Development - NS002 is being developed as a needle-free alternative to traditional epinephrine autoinjectors, addressing the challenges of needle fear and the inconvenience of carrying autoinjectors for patients with severe allergies [3][4]. - The proprietary Nasax® technology aims to deliver epinephrine effectively through a simple nasal spray, enhancing patient compliance and potentially improving treatment outcomes [3][4]. Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing intranasal powder products for acute medical conditions, leveraging its proprietary powder-based intranasal (PBI) technology for rapid drug delivery [4].

Core Insights - Nasus Pharma has entered into a strategic collaboration with Aptar, a leading global manufacturer of drug delivery systems, to enhance the clinical and commercial development of its intranasal powder epinephrine product candidate, NS002 [1][2] Group 1: Collaboration Details - The collaboration provides Nasus Pharma with access to Aptar's proven Unit Dose System technology, which will support the development and commercialization of NS002 [2] - This partnership aims to leverage Aptar's regulatory pathways, manufacturing capabilities, and supply chain to accelerate NS002's market entry while minimizing development risks [2] Group 2: Product Information - NS002 is being developed as a needle-free alternative to traditional epinephrine autoinjectors for patients experiencing anaphylaxis, focusing on rapid drug delivery in emergency situations [3] - The proprietary powder-based intranasal (PBI) technology is designed for quick absorption through the nasal cavity, utilizing uniform spherical powder particles for enhanced dispersion and absorption compared to liquid-based products [3]

Core Insights - Nasus Pharma Ltd. has entered into comprehensive agreements with Aptar France S.A.S. and AptarGroup, Inc. to support the clinical development and commercialization of its intranasal powder epinephrine product candidate, NS002 [1][2] - The collaboration is expected to provide Nasus Pharma with a validated dosing infrastructure and access to Aptar's technical expertise, which will help accelerate NS002's path to market while reducing development risks [2] Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing intranasal powder products for acute medical conditions, with NS002 being a needle-free alternative to epinephrine autoinjectors for anaphylaxis [3] - The company's proprietary powder-based intranasal (PBI) technology is designed for rapid drug delivery, utilizing the nasal cavity's vascular network for quick absorption, and aims to offer potentially faster and higher absorption compared to liquid-based nasal products [3]

Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on intranasal drug delivery for emergency medical conditions[1] - The company's proprietary Nasax® technology aims to enhance intranasal drug absorption and potentially offer longer shelf-life[6, 4] - Nasus has strong IP protection extending to 2038[6] NS002 (Intranasal Epinephrine) - NS002 is in Phase 2 development for anaphylaxis and has demonstrated faster epinephrine absorption compared to EpiPen in studies[7] - A pilot study showed NS002 epinephrine absorbed into the bloodstream faster than EpiPen[37] - Phase 2 study results showed that 91% of patients reached the clinical threshold of 100pg/mL at 6 minutes with NS002 4mg, compared to 55% with EpiPen[53] - NS002 4mg achieved a mean Cmax of 477 pg/mL, while EpiPen achieved 360 pg/mL[63] - NS002 4mg achieved a median Tmax of 10 minutes, while EpiPen achieved 15 minutes[63] Market Opportunity - The global epinephrine market was approximately $2.3 billion in 2024[34] - Anaphylaxis affects an estimated 1-3% of the global population[33]