ADDED
As of March 13, 2026, there were 4,336,029 shares of the registrant s Common stock outstanding.
All share and per share amounts in these consolidated financial statements and related footnotes have been retroactively adjusted to reflect the reverse stock split for all periods presented in the accompanying financial statements, unless otherwise indicated (the Reverse Stock Split ).
Overview We are a development-stage biopharmaceutical company dedicated to the research and development of nasal delivery pharmaceutical therapies targeting neurological conditions and infectious diseases.
The Company is currently focused on advancing the development and commercialization of its lead product candidate, ONP-002.
Our lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and we believe it can cross the blood-brain barrier with the goal of rapidly eliminating swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Our ONP-002 Neurology Asset for Brain Related Illness and Injury Our lead product and focus are on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury ( mTBI or Concussion ).
ONP-002, together with our other neurology assets, are referred to herein as the Neurology Assets.
The device is breath propelled and is designed to allow patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and effectively crosses the blood brain barrier.
Expected ONP-002 Product Development Timeline: Pre-clinical Animal Studies Phase 1 clinical trial Phase 2a clinical trial US based clinical trial Phase 3 clinical trial Complete Complete Q1 2026 Start Estimated Q1 2027 start Estimated Q1 2028 start This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
To date, national patents in 9 different countries have been granted, including European countries and Canada and Philippines.
REMOVED
As of March 10, 2025, there were 21,475,289 shares of the registrant s Common stock outstanding.
Overview We are a development-stage company dedicated to the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases.
Our lead product ONP-002 is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and is designed to cross the blood-brain barrier with the goal of rapidly reducing swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Our ONP-002 Neurology Asset for Brain Related Illness and Injury Following our December 2023 acquisition of certain assets from Odyssey Health, Inc.
( Odyssey ) related to the segment of Odyssey s business focused on developing medical products that treat brain related illnesses and diseases (the Neurology Assets ) our lead product and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury ( mTBI or Concussion ).
The device is breath-propelled and we expect it to allow patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and easily crosses the blood brain barrier.
Expected ONP-002 Product Development Timeline: Pre-clinical Animal Studies Phase 1 Phase 2a Australia Phase 2b Phase 3 Complete Complete Estimated Q1/Q2 2025 start Estimated Q1 2026 start Estimated Q1 2027 start This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
To date, national patents in 9 different countries have been granted, including European countries and Canada.
A bundle of patents under the European Patent Convention have also been granted.
Inventions relate to, inter alia, ONP-002 compositions, methods of use to treat, minimize and/or prevent traumatic brain injury (TBI), including severe TBI, moderate TBI, and mild TBI, including concussions, methods of manufacture and/or synthesis, products by process, and intermediates.