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Oragenics Inc. reports developments as a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The company’s lead candidate, ONP-002, is an investigational intranasal neurosteroid being evaluated for concussion and mild traumatic brain injury, with updates centered on clinical trial operations, regulatory clearances, site activity and dosing milestones.
Company news also covers annual-report disclosures, operating and financial results, capital-structure actions, material agreements, shareholder voting matters and governance updates. Oragenics’ communications frequently connect its CNS strategy, intranasal delivery platform and public-company reporting obligations as an NYSE American-listed biotechnology issuer.
Oragenics, Inc. (NYSE American: OGEN), a company developing intranasal pharmaceuticals for neurological disorders, has closed its public offering of 3,078,378 common stock shares and 5,028,206 pre-funded warrants. The offering price was $0.55 per share and $0.549 per pre-funded warrant, with a $0.001 exercise price for each warrant. The company raised approximately $4.45 million in gross proceeds before deducting fees and expenses. Oragenics plans to use the funds for the continued development of its ONP-002 product candidate and general corporate purposes. Post-offering, Oragenics has 8,659,071 outstanding common stock shares and 5,028,206 outstanding pre-funded warrants. Dawson James Securities, Inc. acted as the sole placement agent for this offering.
Oragenics, Inc. (NYSE American: OGEN), a company developing intranasal pharmaceuticals for neurological disorders, has announced the pricing of a public offering. The company plans to sell 8,106,584 shares of common stock (or pre-funded warrants) at $0.55 per share. The offering is expected to close around September 5, 2024, with anticipated gross proceeds of $4.45 million. Oragenics intends to use the net proceeds to fund the development of its ONP-002 product candidate and for general corporate purposes. Dawson James Securities, Inc. is acting as the sole placement agent for this offering, which is being made pursuant to an effective registration statement filed with the SEC.
Oragenics Inc. (NYSE American: OGEN) has completed the spray-dried formulation and nasal device filling for its lead candidate, ONP-002, in preparation for a Phase IIa clinical trial targeting concussion treatment. The trial, set to enroll 40 concussed patients in Australia, will evaluate the efficacy of ONP-002 administered intranasally within 8 hours of injury. This novel neurosteroid aims to reduce negative outcomes post-concussion through its anti-inflammatory effects.
Key developments include:
- Production of placebo and ONP-002 as spray-dried nanoparticle formulations
- Loading of the powder into Oragenics' proprietary breath-propelled intranasal device
- Initiation of a stability program for both the drug formula and device
The trial design involves twice-daily dosing for five consecutive days, with patient-reported outcomes and blood biomarkers expected to be part of the evaluation process.
Oragenics (NYSE American: OGEN) has provided an update on its drug ONP-002, intended to treat concussion, and its non-compliance with NYSE American continued listing standards. Key developments include:
1. Demonstrated stability of ONP-002 across a wide temperature range.
2. Preparation for Phase 2 clinical trials, expected to start in Q4 2024.
3. Improved drug formulation, increasing ONP-002 per dose by 4X.
4. Developed prototype for automated intranasal device.
5. Completed FDA-required cardiotoxicity and genotoxicity testing.
6. Raised $1.1 million through a public offering.
7. Appointed new medical advisors.
The company is currently not in compliance with NYSE American's continued listing standards but has an approved Plan of Compliance until October 18, 2025.
Oragenics Inc. (NYSE American: OGEN) has announced that its lead candidate for treating concussion, ONP-002, demonstrates stability across a wide temperature range (-20°C to 104°C). This eliminates the need for cold storage, making it suitable for field use in sports and military operations. Key points:
1. ONP-002 is a new chemical entity designed for intranasal delivery to treat concussions.
2. The drug maintains over 99% purity after 3 months at various temperatures.
3. Formulated as a spray-dried powder for improved stability.
4. No FDA-approved pharmaceutical treatment currently exists for concussions.
5. An estimated 69 million concussions are reported annually worldwide.
Oragenics aims to address the unmet medical need for concussion treatment, potentially impacting related neurological disorders like Alzheimer's, Parkinson's, and CTE.
Oragenics (NYSE American: OGEN) announced that its lead candidate for treating concussion, ONP-002, successfully completed an FDA-required genotoxicity study. The study showed that ONP-002 does not cause DNA damage or increase cancer risk in an animal model, even at high doses. This positive outcome clears a important safety hurdle for ONP-002, a new chemical entity designed for intranasal delivery to the brain.
Key points:
- ONP-002 showed no evidence of genetic mutations or cell cycle disruption
- The study was conducted under Good Laboratory (GLP) conditions
- Oragenics is planning a Phase II clinical trial for ONP-002
- Concussion affects an estimated 69 million people annually worldwide
- The company believes ONP-002 will be safe for concussed patients in the planned trial
Oragenics Inc. (NYSE American: OGEN) has announced that its lead candidate for treating concussion, ONP-002, has successfully completed FDA-required cardiotoxicity testing. The drug showed no signs of causing cardiac arrhythmia, demonstrating a strong safety margin for the heart. This clearance allows Oragenics to proceed with planning Phase II clinical trials for concussion treatment.
ONP-002 is a new chemical entity designed for intranasal delivery to target the brain. The potential addressable market for ONP-002 is significant, with an estimated 69 million concussions reported annually worldwide. The total annual healthcare cost for nonfatal traumatic brain injuries in the US exceeds $40.6 billion, highlighting the substantial market opportunity for effective concussion treatments.
Oragenics has developed a new formulation for its neurosteroid, ONP-002, designed for treating concussions via intranasal delivery. The formulation aims to enhance brain uptake and bioavailability, leading to longer absorption times. A Phase II study is planned to evaluate the drug's safety and effectiveness in concussed patients by examining blood biomarker profiles and functional outcomes. The improved formulation is part of Oragenics' platform for acute-field drug delivery, with the goal of reducing immediate and long-term concussion symptoms. Concussion, affecting 69 million people annually worldwide, is linked to various severe neurological disorders.
Oragenics (NYSE American: OGEN) has announced the development of an automated intranasal device for treating concussed patients. The new prototype is designed for initial use in acute settings where patients are confused, dazed, or unconscious. Oragenics' lead drug candidate, ONP-002, aims to target the brain through nasal delivery. A Phase II study will evaluate ONP-002's effectiveness on blood biomarkers and patient-reported outcomes. The automated device is particularly intended for patients unable to self-administer the drug due to mental impairment. Concussions, affecting around 69 million people annually, often result from falls, motor vehicle accidents, and contact sports.
Oragenics announced the closing of its public offering of 1,100,000 shares at $1.00 per share, raising approximately $1.1 million. The funds will support the development of their ONP-002 product candidate and cover general corporate expenses. Dawson James Securities acted as the sole placement agent, and the offering was made under a shelf registration statement filed with the SEC. Legal representation was provided by Shumaker, Loop & Kendrick, LLP for Oragenics and ArentFox Schiff LLP for the placement agent.