Core Insights - Oragenics, Inc. has appointed Dr. William "Frank" Peacock as Chief Clinical Officer to lead its Phase II clinical trial for ONP-002, aimed at treating concussions in emergency departments [1][4] - ONP-002 is a new chemical entity designed for intranasal delivery to treat mild Traumatic Brain Injury (mTBI), with a completed Phase I study indicating it is safe and well-tolerated [1][5] - The global incidence of concussions is significant, with an estimated 69 million cases reported annually, highlighting an unmet medical need in this area [6] Company Overview - Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceuticals for neurological disorders and infectious diseases, including treatments for mTBI and Niemann Pick Disease Type C [7] - The company is collaborating with Avance Clinical, a Contract Research Organization (CRO), for its Phase II trial [4] Clinical Development - The Phase II trial for ONP-002 will assess the timing of the first dose, the relationship between drug application and blood biomarker levels, and the evaluation of patient symptom severity shortly after injury [5] - Dr. Peacock's expertise in emergency medicine and blood biomarkers is expected to enhance the success of the clinical trials [4][3]

SARASOTA, Fla., May 17, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical company specializing in intranasal treatments for neurological disorders, today announced that the company will host a webinar panel on Neurotrauma Medicine Monday, May 20, 2024, at 12:00 PM ET. The discussion will address the unmet medical need in Traumatic Brain Injury (TBI), commonly known as concussion, explore common causes, and examine its association with other long-term neurological di ...

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com. Webinar Topic: Neurotrauma Medicine When: Monday, May 20, 2024 Time: 1 ...

Research and Development - Research and development expenses for the three months ended March 31, 2024, were $663,414, a decrease of 60% from $1,672,576 in the same period of 2023[88]. - The company has paused research and development activities related to its vaccine product candidate and lantibiotics program due to limited resources and is focusing on the development of ONP-002[85]. - ONP-002 has completed Phase 1 clinical trials, demonstrating safety and tolerability in 40 human subjects[78][81]. - The anticipated timeline for ONP-002 includes Phase 2a trials starting in Q2/Q3 2024 and Phase 2b trials expected to begin in Q4 2024[74][82]. - The ONP-002 product development plan is subject to change based on funding, technical risks, and regulatory approvals[74]. - The company is focusing on preclinical research and Phase 2 clinical trials for its ONP-002 concussion drug[125]. Financial Performance - Research and development expenses decreased by $1,009,162 or 60.3%, totaling $663,414 for the three months ended March 31, 2024, compared to $1,672,576 for the same period in 2023[100]. - General and administrative expenses increased by approximately $547,426 or 43.8%, totaling $1,796,689 for the three months ended March 31, 2024[102]. - The company reported no grant revenue for the three months ended March 31, 2024, compared to $17,024 for the same period in 2023[99]. - Operating activities used cash of $3,062,249 for the three months ended March 31, 2024, compared to $2,108,695 for the same period in 2023[103]. - The company had a working capital surplus of $1,534,515 as of March 31, 2024, down from $2,067,593 at December 31, 2023[103]. - The company reported stockholders' equity of $2.6 million as of March 31, 2024, below the NYSE American's required minimum of $4 million[116]. Funding and Compliance - The company intends to use net proceeds from the offering to fund the continued development of ONP-002 and for general corporate purposes[92]. - The company has federal and state tax net operating loss carryforwards of $153,575,836 and $137,731,183, respectively[96]. - The company must submit a compliance plan by May 18, 2024, to address its non-compliance with NYSE American listing standards[117]. - The company is preparing a Plan for submission to the NYSE American by the May 18, 2024 deadline to maintain its listing status[118]. - If the Plan is not accepted or compliance is not achieved by October 18, 2025, the company may face delisting procedures[118]. - Current cash and cash equivalents are limited, expected to fund operations through Q3 2024, leading to cost-saving initiatives[123]. - The company anticipates substantial expenditures for research, nonclinical testing, and clinical trials, requiring additional capital[122]. - There is uncertainty regarding the availability of additional financing, which may impact the company's ability to execute its business plan[124]. - The company has no committed sources of financing at this time, and future funding requirements are uncertain[124]. - The company is exploring non-dilutive funding opportunities for COVID-19 research and development[123]. Market and Business Development - The global market for concussion treatment was valued at $6.9 billion in 2020 and is projected to reach $8.9 billion by 2027[70]. - The company has filed patents for ONP-002 and its nasal delivery device, with U.S. patent expiration dates set for 2035 and 2040[75]. - The company views business development activities, including potential mergers and acquisitions, as essential for enhancing shareholder value[84]. - The company closed a public offering of 1.4 million shares at $1.50 per share, raising gross proceeds of $2.1 million[91]. - The ONP-002 drug candidate is designed for intranasal administration, allowing for rapid and direct accessibility to the brain[73]. - The common stock will continue to trade under the symbol "OGEN" with a designation of ".BC" indicating "below compliance" status[120]. - Delisting could reduce liquidity and market price of the common stock, impacting the ability to raise equity financing[121].

SARASOTA, Fla., May 07, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a pioneer in developing innovative intranasal pharmaceuticals for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct a Phase II clinical trial in Australia. This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion. ONP-002, a novel chemical entity (NCE), is delivered th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from__________ to ___________ Commission file number 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) Florida 59-3410522 (State or Other Jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ________ Commission File Number: 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) FLORIDA 59-3410522 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURIT ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ________ Commission File Number: 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) FLORIDA 59-3410522 (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ________ Commission File Number: 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) FLORIDA 59-3410522 (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from__________ to ___________ Commission file number 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) Florida 59-3410522 (State or Other Jurisdiction ...