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 ...

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 September 30, 2022. 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 ...

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, 2022. 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 juri ...

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, 2022. 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 jur ...