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Polyrizon Announces Successful Study of its Naloxone Formulation Demonstrating Enhanced Nasal Deposition Profile Versus Commercial Reference Product
Globenewswire· 2026-02-26 13:12
Core Insights - Polyrizon Ltd. announced results from a comparative study showing its naloxone formulation has superior nasal deposition compared to a commercial reference product [1][6]. Study Overview - The study was conducted at the University of Parma's Biopharmanet-TEC research center under the supervision of Prof. Fabio Sonvico, focusing on intranasal technologies [2]. - A validated silicone nasal cast model was used for the evaluation, combined with quantitative image analysis [3]. Key Findings - Polyrizon's formulation achieved 94.6% (±4.0%) deposition in the nasal vestibule and upper turbinate, compared to 79.6% (±3.0%) for the commercial product [9]. - The formulation showed significantly lower deposition in the lower turbinate region (5.4% vs. 20.4% for the commercial product), which may enhance dosing consistency and systemic delivery efficiency [9]. - The upper/anterior nasal region is critical for rapid systemic drug absorption, and Polyrizon's technology enables controlled regional deposition [5]. Company Technology - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [7]. - The proprietary Capture and Contain™ hydrogel technology aims to improve bioadhesion and retention at the nasal site for drug delivery [7]. - The company is advancing its naloxone program as part of a broader intranasal platform strategy [6].
Nasus Pharma to Participate in Upcoming Investor Conferences
Globenewswire· 2026-02-20 13:00
Core Insights - Nasus Pharma Ltd. is a clinical-stage pharmaceutical company focused on developing innovative intranasal products, with management participating in investor conferences in February and March 2026 [1][2]. Group 1: Company Overview - Nasus Pharma is developing intranasal powder products aimed at addressing acute medical conditions, including NS002, an intranasal powder Epinephrine product candidate designed as a needle-free alternative for anaphylaxis treatment [3]. - The company's proprietary powder-based intranasal (PBI) technology allows for rapid and reliable drug delivery, utilizing the nasal cavity's vascular network for quick absorption [3]. Group 2: Upcoming Events - Nasus Pharma management will be available for one-on-one meetings during the Oppenheimer 36th Annual Healthcare Life Sciences Conference, BIO Investment & Growth Summit, and Citizens Life Sciences Conference [2]. - Key presentations by CEO Dan Teleman are scheduled for February 25, March 2, and March 11, 2026, with specific times and locations provided for each event [4].
Nasus Pharma Announces Closing of $15.0 Million Private Placement
Globenewswire· 2026-02-13 13:00
Core Viewpoint - Nasus Pharma Ltd. has successfully closed a private placement of ordinary shares and warrants, raising approximately $15.0 million to advance its clinical development programs, particularly the NS002 intranasal epinephrine product candidate [1][3]. Group 1: Private Placement Details - The private placement involved the sale of 2,695,425 ordinary shares and accompanying warrants at a combined purchase price of $5.565 per share [3][5]. - Citizens Capital Markets acted as the lead placement agent, with Laidlaw & Company (UK) Ltd. serving as the co-placement agent [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized to advance the pivotal clinical development of NS002 for anaphylaxis treatment, initiate first-in-human studies for other products, and for general corporate purposes [5]. Group 3: Product Development Focus - NS002 is being developed as a needle-free alternative to epinephrine autoinjectors, aimed at providing rapid drug delivery in emergency situations [8]. - The company is focused on leveraging its proprietary intranasal technology across various therapeutic areas to enhance clinical value [3][8]. Group 4: Financial Strengthening - The financing is expected to significantly strengthen the company's balance sheet and provide funding visibility for planned operations and development activities [3][5]. Group 5: Warrants Information - The warrants have an exercise price of $6.53 per share, are immediately exercisable, and will expire two years from issuance or 30 trading days after the announcement of NS002 pivotal study results [4].
Polyrizon Signs an Agreement to Develop Intranasal Proprietary Non-Hallucinogenic Neuroplastogen Formulation
Globenewswire· 2026-02-06 12:55
Core Viewpoint - Polyrizon Ltd. has entered into a development agreement with Clearmind Medicine Inc. to leverage Polyrizon's intranasal delivery platform for the clinical development of Clearmind's drug candidate MEAI, aimed at treating addiction-related and other CNS conditions [1][2][3] Group 1: Collaboration Details - The collaboration aims to advance an intranasal formulation of MEAI to support Clearmind's future clinical development programs [2] - Polyrizon's proprietary intranasal technology is designed to enable targeted and efficient delivery of drugs, potentially offering significant value in Clearmind's clinical pathway [3] Group 2: Polyrizon's Technology - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [4] - The company's Capture and Contain TM hydrogel technology is designed to enhance bioadhesion and prolong retention at the nasal site for drug delivery [4][6] Group 3: Clearmind's Focus - Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on developing novel psychedelic-derived therapeutics to address underserved health issues, including alcohol use disorder [7] - The company holds a portfolio of nineteen patent families, including 31 granted patents, and aims to expand its intellectual property [8]
Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program
Globenewswire· 2026-02-03 13:30
Core Insights - Oragenics, Inc. has engaged DUCK FLATS Pharma to support its U.S. Investigational New Drug (IND) readiness and regulatory execution for its novel intranasal concussion therapy, ONP-002, as it prepares for clinical trials in the U.S. [1][2] - The collaboration aims to ensure regulatory diligence and trial integrity, aligning the upcoming Phase 2a clinical trial in Australia with U.S. regulatory strategies [1][2][3] Company Overview - Oragenics, Inc. is a clinical-stage biotechnology company focused on developing brain-targeted therapeutics using proprietary intranasal delivery technology [5] - The lead candidate, ONP-002, is being advanced as a potential first-in-class treatment for concussion and mild traumatic brain injury, with ongoing Phase 2a trials in Australia and plans for U.S. Phase 2b trials [5] Market Potential - The global concussion market is projected to exceed $9 billion by 2027, indicating significant growth potential for innovative therapies in this area [4] - The nasal drug delivery market is expected to reach over $125 billion by 2030, highlighting the broader market opportunity for intranasal therapeutics [4] Collaboration Details - DUCK FLATS Pharma has a strong track record, having contributed to the development and approval of approximately 40 drug programs, including notable intranasal therapies [2][3] - The firm has extensive experience in regulatory and drug development, having managed over 400 regulatory documents and served as project lead on more than 60 FDA-approved New Drug Applications [2]
Nasus Pharma CEO Issues 2025 Letter to Shareholders - Nasus Pharma (AMEX:NSRX)
Benzinga· 2025-12-22 13:00
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]
Polyrizon Reports Positive Mucoadhesion Results for Intranasal Naloxone Hydrogel Compared to Marketed Intranasal Naloxone product
Globenewswire· 2025-12-03 14:28
Core Insights - Polyrizon Ltd. has announced new preclinical data indicating that its proprietary naloxone hydrogel demonstrates superior mucoadhesion compared to an existing intranasal naloxone spray product, which may enhance opioid overdose reversal in real-world emergencies [1][5]. Group 1: Product Performance - The study utilized an ex-vivo rabbit nasal mucosa model to compare the persistence of Polyrizon's hydrogel formulation against a commercial product, revealing that Polyrizon's hydrogel maintained significantly higher levels of a fluorescence marker, indicating stronger and more durable mucosal retention (p < 0.0001) [2]. - Polyrizon's Trap and Target ™ (T&T) hydrogel exhibited significantly higher mucoadhesion levels, suggesting prolonged contact at the nasal deposition site and potentially improved bioavailability [3]. Group 2: Importance of Mucoadhesion - Enhanced mucoadhesion is critical for intranasal drug delivery, especially for emergency treatments like opioid overdose reversal, as it supports more reliable absorption and potentially faster onset of action [4]. Group 3: Company Perspective - The CEO of Polyrizon emphasized that the results validate the potential of the T&T hydrogel platform and highlight its advantages in intranasal drug delivery, marking an important milestone in advancing the Naloxone program [5]. - The new dataset builds on previously reported stability results, reinforcing the robustness of Polyrizon's formulation under various storage conditions, which collectively supports the potential for a safer and more effective intranasal naloxone product [5]. Group 4: Company Overview - Polyrizon is a development-stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens while also enhancing drug delivery through improved bioadhesion and retention [6].
Nasus Pharma Strengthens Leadership Team, Appointing Eyal Rubin as Executive Vice President and Chief Financial Officer
Globenewswire· 2025-11-20 13:15
Core Insights - The appointment of Eyal Rubin as Executive Vice President and Chief Financial Officer highlights the Company's commitment to strengthening its leadership team while advancing its clinical and commercial strategy [1][3] Company Overview - Nasus Pharma Ltd. is a clinical-stage pharmaceutical company focused on developing innovative intranasal products for emergency medical conditions [4] - The Company is developing NS002, an intranasal powder Epinephrine product candidate, as a needle-free alternative for patients experiencing anaphylaxis [4] Leadership Appointment - Eyal Rubin brings over 20 years of financial leadership experience in the biotechnology and pharmaceutical industries to Nasus Pharma [1][2] - Mr. Rubin will oversee financial operations, including corporate finance, financial planning, capital strategy, and investor relations [2] - The CEO and Executive Chairman expressed confidence in Mr. Rubin's ability to enhance the Company's financial and operational capabilities during a critical growth phase [3] Product Development - The Company's proprietary powder-based intranasal (PBI) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network for quick absorption [4] - The PBI formulation utilizes uniform spherical powder particles for broad dispersion and potentially faster absorption compared to liquid-based nasal products [4]
Nasus Pharma Strengthens Leadership Team, Appointing Eyal Rubin as Executive Vice President and Chief Financial Officer - Nasus Pharma (AMEX:NSRX)
Benzinga· 2025-11-20 13:15
Core Insights - Nasus Pharma Ltd. has appointed Eyal Rubin as Executive Vice President and Chief Financial Officer, bringing over 20 years of financial leadership experience in the biotechnology and pharmaceutical industries [1][2][3] - Mr. Rubin will oversee financial operations, including corporate finance, financial planning, capital strategy, and investor relations, as the company advances its pipeline of intranasal therapeutics [2][3] - The leadership team believes Mr. Rubin's expertise will be crucial as the company enters a significant growth phase [3] Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing innovative intranasal products for emergency medical conditions [4] - The company's lead product candidate, NS002, is an intranasal powder formulation of Epinephrine, designed as a needle-free alternative for treating anaphylaxis [4] - The proprietary powder-based intranasal (PBI) technology aims for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network for quick absorption [4]
Nasus Pharma (NSRX) Earnings Call Presentation
2025-08-19 11:00
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]