SARASOTA, Fla., May 22, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William "Frank" Peacock as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency Department ("ED"). Oragenics' lead drug candidate, ONP-002, is combined with its intranasal device intended for the treatment of mil ...

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]

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 ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Oragenics, Inc.'s September 30, 2023, unaudited financial statements reflect significant asset declines, ongoing net losses, and substantial going concern doubt, alongside a strategic shift to neurological drug therapies [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets decreased to **$7.9 million** from **$14.8 million** at year-end 2022, primarily due to reduced cash and a decline in shareholders' equity Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,766,644 | $11,426,785 | | Total current assets | $7,814,092 | $14,271,583 | | **Total assets** | **$7,899,428** | **$14,758,025** | | **Liabilities & Equity** | | | | Total current liabilities | $1,402,107 | $1,596,284 | | **Total liabilities** | **$1,402,107** | **$1,748,723** | | **Total shareholders' equity** | **$6,497,321** | **$13,009,302** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and nine months ended September 30, 2023, net losses significantly decreased to **$2.0 million** and **$7.9 million**, respectively, primarily due to reduced research and development expenses Condensed Consolidated Statements of Operations (Unaudited, in $) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Grant Revenue | 7,466 | 86,047 | 37,653 | 131,521 | | Research and Development | 769,350 | 2,777,068 | 4,448,623 | 8,660,761 | | General and Administrative | 1,332,562 | 1,215,498 | 3,697,609 | 3,592,361 | | Loss from Operations | (2,094,446) | (3,906,519) | (8,108,579) | (12,121,601) | | **Net Loss** | **(2,012,885)** | **(3,870,113)** | **(7,908,308)** | **(12,050,649)** | | **Net Loss Per Share** | **(0.85)** | **(1.99)** | **(3.70)** | **(6.21)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities significantly decreased to **$6.2 million**, with overall cash and cash equivalents declining by **$5.7 million** Cash Flow Summary (Unaudited, for the nine months ended September 30) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,188,335) | $(12,795,647) | | Net cash provided by (used in) investing activities | $63,715 | $(112,081) | | Net cash provided by (used in) financing activities | $464,479 | $(406,921) | | **Net decrease in cash and cash equivalents** | **$(5,660,141)** | **$(13,314,649)** | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Key notes detail the company's strategic shift to neurological drug therapies, ongoing COVID-19 vaccine focus, critical going concern doubt beyond Q1 2024, and recent financing activities - The company's lead product is an intranasal vaccine candidate, **NT-CoV2-1**, for SARS-CoV-2[20](index=20&type=chunk) - On October 4, 2023, the company signed a definitive agreement to acquire proprietary assets from **Odyssey Health, Inc.** related to **neurological drug therapies**, including treatments for concussion and Niemann Pick Disease Type C[21](index=21&type=chunk)[70](index=70&type=chunk) - There is **substantial doubt** about the company's ability to continue as a **going concern** beyond the **first quarter of 2024**, as current working capital is insufficient to fund operations past that point[25](index=25&type=chunk) - To **conserve cash**, the company terminated its Alachua research facility lease in September 2023, and research activities for its lantibiotic program are currently **inactive**[22](index=22&type=chunk)[25](index=25&type=chunk) - A **1-for-60 reverse stock split** was effected on January 20, 2023 All historical share and per-share amounts have been adjusted[5](index=5&type=chunk)[42](index=42&type=chunk) - In August 2023, the company raised gross proceeds of **$850,000** through a **private placement** of common and preferred stock[44](index=44&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to neurological drug assets, ongoing COVID-19 vaccine development, significant R&D expense reductions, and critical liquidity challenges raising substantial going concern doubt [Overview and Product Candidates](index=23&type=section&id=Overview%20and%20Product%20Candidates) Oragenics, a development-stage company, is strategically expanding into neurological drug therapies via acquisition while continuing its intranasal COVID-19 vaccine development and pausing its lantibiotic program to conserve cash - The company's lead product is the intranasal vaccine candidate **NT-CoV2-1**, which is currently in pre-clinical development[81](index=81&type=chunk)[107](index=107&type=chunk) - The company has **paused its lantibiotic program** and closed its Alachua research facility to **conserve cash** resources[104](index=104&type=chunk)[109](index=109&type=chunk) - A definitive agreement was signed to acquire assets from **Odyssey Health, Inc.** for treating mild traumatic brain injury (concussion) and Niemann Pick Disease Type C, signaling a **strategic expansion into neurological therapies**[110](index=110&type=chunk) - In September 2023, the company partnered with Lantern Bioworks, transferring certain lantibiotic-related assets for a **$50,000 cash payment** and a **10% royalty** on future net income[105](index=105&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) For the three and nine months ended September 30, 2023, the company significantly reduced its net loss, primarily driven by a **72%** and **49%** decrease in Research and Development expenses, respectively Comparison of Results for the Three Months Ended September 30, (in $) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Grant Revenue | $7,466 | $86,047 | -91.3% | | R&D Expenses | $769,353 | $2,777,068 | -72.0% | | G&A Expenses | $1,332,562 | $1,215,498 | +10.0% | Comparison of Results for the Nine Months Ended September 30, (in $) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Grant Revenue | $37,653 | $131,521 | -71.4% | | R&D Expenses | $4,448,623 | $8,660,761 | -49.0% | | G&A Expenses | $3,697,609 | $3,592,361 | +3.0% | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critical, with current cash sufficient only through Q1 2024, requiring substantial additional capital to fund future operations and development programs - The company believes its current cash resources will only be sufficient to fund its operating plan through the **first quarter of 2024**[139](index=139&type=chunk)[148](index=148&type=chunk) - Working capital decreased from **$12.7 million** at Dec 31, 2022, to **$6.4 million** at Sep 30, 2023[136](index=136&type=chunk) - The company raised approximately **$850,000** in gross proceeds from a **private placement** in August 2023[121](index=121&type=chunk)[144](index=144&type=chunk) - Future capital requirements are **substantial**, particularly if the Odyssey asset purchase is completed The company will need to **raise additional funds** to continue development programs[147](index=147&type=chunk)[149](index=149&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Oragenics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a **smaller reporting company** and is **not required** to provide quantitative and qualitative disclosures about market risk[157](index=157&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified a material weakness in internal controls related to R&D contract accounting, leading to financial statement restatements for 2022, and is actively pursuing remediation - A **material weakness** was identified in **internal controls** related to the review of research and development contracts[163](index=163&type=chunk) - This control deficiency resulted in errors in accounting for R&D prepayments and required the **restatement** of the unaudited financial statements for **Q1, Q2, and Q3 of 2022**[153](index=153&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - Due to this material weakness, management concluded that the company's disclosure controls and procedures were **not effective** as of the reporting date[163](index=163&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material pending legal proceedings impacting its financial condition or business - The company reports **no material pending legal proceedings**[171](index=171&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section highlights critical risks including significant losses, substantial going concern doubt, uncertainties surrounding the Odyssey Health asset purchase, and the need for substantial additional capital to fund development programs - **Going Concern Risk:** The company has incurred significant losses and its existing cash will only fund operations through Q1 2024, raising substantial doubt about its ability to continue as a going concern[173](index=173&type=chunk)[174](index=174&type=chunk) - **Acquisition Risk:** The closing of the Odyssey Asset Purchase is subject to numerous conditions, including shareholder approvals, and there is no assurance it will be consummated Failure could result in the loss of cash payments already made[175](index=175&type=chunk) - **Capital Needs:** The company requires significant additional capital to fund its business plan, especially if the Odyssey acquisition proceeds Difficulty in raising funds could force it to scale back or delay R&D on all its programs[176](index=176&type=chunk)[178](index=178&type=chunk) - **Development Risk:** The product candidates to be acquired from Odyssey are in early stages and require extensive testing, with no guarantee of regulatory approval or commercial success[180](index=180&type=chunk)[183](index=183&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reports no new unregistered sales of equity securities during the period beyond prior disclosures - **No new unregistered sales** of equity securities were reported in this filing[192](index=192&type=chunk) [Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[193](index=193&type=chunk) [Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[194](index=194&type=chunk) [Other Information](index=44&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[195](index=195&type=chunk) [Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including corporate governance documents, material contracts, and officer certifications

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 ...