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Nasus Pharma (NSRX) Earnings Call Presentation
2025-08-19 11:00
A NEW FRONTIER FOR INTRANASAL DRUG DELIVERY Company Presentation – August 2025 A clinical-stage pharmaceutical company leveraging its proprietary powder-based intranasal technology to develop innovative intranasal products to treat emergency medical conditions Ticker NSRX Exchange NYSE American 1 Experienced leadership team Strong IP protection to 2038 Forward Looking Statements This presentation of Nasus Pharma Ltd. contains "forward-looking statements" within the meaning of the Private Securities Litigati ...
Oragenics Selects Southern Star Research as Clinical Research Organization for ONP-002 Phase IIa Trial
Globenewswire· 2025-07-31 12:30
Core Viewpoint - Oragenics, Inc. has selected Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, aimed at treating concussion, highlighting the strategic partnership's importance for operational readiness and study initiation [1][2][3]. Group 1: Company Overview - Oragenics, Inc. is a clinical-stage biotechnology company focused on intranasal drug delivery for neurological conditions, with its lead candidate ONP-002 in clinical development for concussion treatment [7]. - Southern Star Research is a full-service CRO with expertise in early-phase trials across Australia and Asia-Pacific, known for its operational rigor and regulatory knowledge [2][8]. Group 2: Clinical Trial Details - The Phase IIa trial will be a randomized, double-blind, placebo-controlled study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI), assessing safety, tolerability, pharmacokinetics (PK), and early pharmacodynamic (PD) effects [5][6]. - The study has received Human Research Ethics Committee (HREC) approval, and patient enrollment and dosing are expected to begin shortly [3][4]. Group 3: Strategic Advantages - Conducting the study in Australia offers several advantages, including streamlined regulatory processes, access to experienced trial sites, and eligibility for Australia's R&D tax incentive program, enhancing cost-efficiency [9]. - ONP-002 is a proprietary intranasal neurosteroid designed to improve drug delivery to the brain while minimizing systemic exposure, showing promise in preclinical models for reducing brain inflammation and improving cognitive functions [4].
Branded Legacy, Inc. Signs Letter of Intent to Acquire Bio-Legacy Evaluative Group, Advancing Innovations in Intranasal Drug Delivery
Globenewswire· 2025-07-29 12:30
Strategic Acquisition Positions Branded Legacy to Enter the Growing Naloxone and Vaccine Markets, Enhancing Shareholder Value; Leadership Transition Planned with Amin Janmohamed as New CEO and Chairman MELBOURNE, Fla., July 29, 2025 (GLOBE NEWSWIRE) -- via IBN -- Branded Legacy, Inc. (OTC: BLEG), a diversified holdings company focused on innovative health and wellness solutions, today announced the execution of a non-binding Letter of Intent (LOI) to acquire Bio-Legacy Evaluative Group, a pioneering health ...
Oragenics Completes Approximately $16.5 Million Offering
Globenewswire· 2025-07-02 20:15
Core Viewpoint - Oragenics, Inc. successfully closed a public offering of Series H Convertible Preferred Stock and Warrants, raising approximately $16.5 million to advance its lead intranasal drug candidate, ONP-002, for mild traumatic brain injury [1][4][5] Group 1: Offering Details - The company issued 660,000 shares of Series H Convertible Preferred Stock along with Warrants to purchase an additional 660,000 shares, at a combined public offering price of $25.00 per unit [2][3] - If all Warrants are exercised, the company could raise an additional $16.5 million, totaling $33 million from the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the clinical development of ONP-002, support other R&D activities, repay a $3 million bridge note, and fund working capital and general corporate purposes [4] Group 3: Company Background - Oragenics is a clinical-stage biotechnology company focused on intranasal therapeutics for neurological disorders, with ONP-002 being developed for the treatment of mild traumatic brain injury [9]
Polyrizon Reports Promising Results Demonstrating Successful Internasal Delivery of its Innovative Hydrogel Formulation for CNS Therapeutics
Globenewswire· 2025-06-12 11:32
Core Insights - Polyrizon Ltd. announced positive preclinical results for its hydrogel-based Trap & Target (T&T) platform, indicating effective drug delivery to the upper nasal cavity, which is crucial for central nervous system (CNS) applications [1][4] Group 1: Study Results - The study, conducted with the University of Parma, showed that Polyrizon's hydrogel formulation achieved over 60% preferential accumulation in the middle and upper turbinates, enhancing nose-to-brain transport [3] - The results suggest potential applications for CNS indications, such as opioid overdose treatment and seizure management, where rapid brain access is critical [3][4] Group 2: Technology Validation - The CEO of Polyrizon emphasized the validation of the T&T technology's ability to achieve localized deposition in favorable nasal regions, which could lead to new therapies for acute neurological and psychiatric conditions [4] - The hydrogel demonstrated consistent delivery to upper nasal segments while maintaining favorable handling characteristics, supporting further preclinical development [4] Group 3: Future Plans - Polyrizon plans to validate these preclinical results in animal models and initiate safety studies as part of its translational roadmap for the T&T technology [5]
Oragenics, Inc. Participates in the 3rd Nasal Formulation & Delivery Summit
Newsfilter· 2025-04-07 20:30
Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly targeting mild traumatic brain injury (mTBI) or concussion [1][4] - The company’s lead candidate, ONP-002, utilizes intranasal administration for rapid absorption and targeted delivery to the brain [3][4] Industry Developments - The 3rd Nasal Formulation & Delivery Summit highlighted innovations in intranasal drug delivery, emphasizing CNS therapeutics, emergency-use treatments, and applications for infectious diseases [2] - Dr. James Kelly, Chief Medical Officer of Oragenics, participated in a panel discussion, sharing insights on optimizing intranasal drug delivery and its benefits for neurological treatments [2][3] Company Commitment - Oragenics' involvement in the summit reflects its dedication to advancing non-invasive CNS therapeutics and engaging with the intranasal research community [3]
Oragenics, Inc. Participates in the 3rd Nasal Formulation & Delivery Summit
Globenewswire· 2025-04-07 20:30
Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly its lead candidate ONP-002 for mild traumatic brain injury (mTBI) [1][4] - The company participated in the 3rd Nasal Formulation & Delivery Summit, highlighting its commitment to innovation in non-invasive CNS therapeutics [1][3] Company Developments - Dr. James Kelly, Chief Medical Officer of Oragenics, shared insights on optimizing intranasal drug delivery and its advantages in neurological treatment during the summit [2] - ONP-002 is designed for rapid absorption and targeted brain delivery through intranasal administration, aiming to improve outcomes for concussion patients [3][4] Industry Context - The summit gathered industry leaders to discuss innovations in intranasal drug delivery, focusing on CNS therapeutics, emergency-use treatments, and infectious disease applications [2]
Polyrizon Signs Non– Binding LOI to Expand its Innovative Intranasal Drug Delivery Platform for Psychedelic-Based Treatments
Globenewswire· 2025-03-14 12:35
Core Viewpoint - Polyrizon Ltd. has signed a non-binding Letter of Intent with a biotech company focused on psychedelic-derived therapeutics to develop a novel intranasal formulation for psychedelic-based treatment applications [1][2]. Group 1: Collaboration Details - The agreement aims to leverage Polyrizon's proprietary platform to optimize the delivery of innovative psychedelic treatments, emphasizing the potential of intranasal drug delivery in enhancing bioavailability, efficacy, and patient accessibility [2][4]. - Polyrizon will lead the formulation's development using its mucoadhesive drug delivery technology, while the psychedelic company will fund the research and development process, including feasibility studies [4]. Group 2: Technology and Innovation - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a barrier in the nasal cavity to protect against viruses and allergens [5]. - The company's proprietary Capture and Contain (C&C) hydrogel technology aims to improve bioadhesion and prolonged retention at the nasal deposition site for drug delivery [5]. Group 3: Future Prospects - If the collaboration is successful, it could lead to further clinical development and commercialization, with plans to negotiate a definitive agreement outlining intellectual property ownership, commercialization rights, and financial terms [4]. - Polyrizon is expected to receive royalty payments for any future commercialization of the product by the psychedelic company [4].