ORAGENICS INC

Previous wording

Concussions are an unmet medical need that affects millions worldwide. Repetitive concussions are thought to increase the risk of developing Chronic Traumatic Encephalopathy (“CTE”) and other neuropsychiatric disorders. It is estimated that 5 million concussions occur in the U.S. annually and that as many as 50% go unreported. The worldwide incidence of concussion is estimated at 69 million. The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027, according to Grandview Research. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.

Current wording

Concussions are an unmet medical need that affects millions worldwide. Repetitive concussions are thought to increase the risk of developing Chronic Traumatic Encephalopathy (“CTE”) and other neuropsychiatric disorders. It is estimated that between 3.5 million and 5 million concussions occur in the U.S. annually and that as many as 50% go unreported. The worldwide incidence of concussion is estimated at 69 million. The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027, according to Grandview Research. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.

Previous wording

In the six months ended June 30, 2024, we executed agreements with several vendors to advance our efforts toward starting Phase 2 clinical trials, including a contract with Avance Clinical to conduct Phase 2 clinical trials in Australia.

Current wording

In the nine months ended September 30, 2024, we executed agreements with several vendors to advance our efforts toward starting Phase 2 clinical trials, including a contract with Avance Clinical to conduct Phase 2 clinical trials in Australia.

Previous wording

Our research and development expenses were $1,570,193 and $3,679,272 for the six months ended June 30, 2024 and 2023, respectively. In 2023 our research and development costs consisted of our COVID vaccine program and our lantibiotics program, which were paused in 2023. For the six months ended June 30, 2024, our research and development expenses consisted of the costs related to the development of our ONP-002 neurologya sset. Due to limited resources, while we continue our development efforts, we have focused our research and development expenses to our ONP-002 drug and paused further development of our vaccine product and lantibiotics research until we can raise additional capital.

Current wording

Our research and development expenses were $2,449,234 and $4,448,623 for the nine months ended September 30, 2024 and 2023, respectively. In 2023 our research and development costs consisted of our COVID vaccine program and our lantibiotics program, which were paused in 2023. For the nine months ended September 30, 2024, our research and development expenses consisted of the costs related to the development of our ONP-002 neurology asset. Due to limited resources, while we continue our development efforts, we have focused our research and development expenses to our ONP-002 drug and paused further development of our vaccine product and lantibiotics research until we can raise additional capital.

Previous wording

On June 26, 2024, we announced the sale of 1.1 million shares of our common stock, par value $0.001, through a placement agreement with Dawson James Securities, Inc. (“Dawson James”) at an offering price per share of common stock of $1.00. The offering resulted in gross proceeds of $1.1 million before deducting placement agent fees and other estimated offering expenses payable by the Company. We also agreed to issue placement agent warrants (“Dawson James Warrants”) to purchase up to 5% of the aggregate number of securities sold in the offering with an exercise price 125% of the offering price of the common stock in the offering. The Dawson James Warrants are exercisable for five years from the date of closing the offering and are initially exercisable six months from the closing of the Offering.

Current wording

On September 4, 2024, we announced the sale of 3 million shares of our common stock and Pre-Funded Warrants to purchase 5 million shares of common stock, par value $0.001, through a placement agreement with Dawson James Securities, Inc. (“Dawson James”) at an offering price per share of common stock of $0.55. The offering resulted in gross proceeds of $4.45 million before deducting placement agent fees and other estimated offering expenses payable by the Company. We also agreed to issue placement agent warrants (“Dawson James Warrants”) to purchase up to 5% of the aggregate number of securities sold in the offering with an exercise price 125% of the offering price of the common stock in the offering. The Dawson James Warrants are exercisable for five years from the date of closing the offering and are initially exercisable six months from the closing of the Offering.

Previous wording

Results of Operations for the Three and Six Months Ended June 2024 and 2023

Current wording

Results of Operations for the Three and Nine Months Ended September 2024 and 2023

Previous wording

Grant revenue. There was no grant revenue for the three and six-month periods ended June 30, 2024. For the comparable three and six-month periods in 2023, there was $13,163 and $30,187 in grant revenue, respectively. This decrease was attributable to awards received for a small business innovation research grant that expired in the three-month period ended September 30, 2023.

Current wording

Grant revenue. There was no grant revenue for the three and nine month periods ended September 30, 2024. For the comparable three and nine month periods in 2023, there was $7,466 and $37,653 in grant revenue, respectively. This decrease was attributable to awards received for a small business innovation research grant that expired in the three-month period ended September 30, 2023.

Previous wording

Research and Development. Research and development expenses were $906,779 and $1,570,193, respectively, for the three and six-month periods ended June 30, 2024, compared to $2,006,696 and $3,679,272 for the comparable three and six-month periods ended June 30, 2023. This is a decrease of 54.8% and 57.3% for the comparable three and six-month periods ended June 30, 2024.

Current wording

Research and Development. Research and development expenses were $879,041 and $2,449,234, respectively, for the three and nine month periods ended September30, 2024, compared to $769,350 and $4,448,623 for the comparable three and nine month periods ended September 30, 2023. This is an increase 14% and a decrease of 45% for the comparable three and nine month periods ended September 30, 2024.

Previous wording

This decrease was mainly driven by decreased costs associated with the development of our COVID vaccine product and our lantibiotics program. For the three months ended June 30, 2023, research and development expenses for our COVID vaccine and lantibiotics programs were approximately $2.0 million and primarily associated with costs for outside consultants. For the three-month period ended June 30, 2024, research and development expense related to ONP-002 was approximately $0.9 million. For the six-month period ended June 30, 2024 and 2023, respectively our research and development expenses were approximately $1.4 million for our ONP-002 product and $0.1 million for our vaccine product, and approximately $3.7 million for our vaccine and lantibiotics programs.

Current wording

This decrease for the nine month comparable periods was mainly driven by decreased costs associated with the development of our ONP-002 concussion drug as compared to development costs associated with our COVID vaccine product and our lantibiotics program. For the three months ended September 30, 2023, research and development expenses for our COVID vaccine and lantibiotics programs were approximately $0.8 million and primarily associated with costs for outside consultants. For the three-month period ended September 30, 2024, research and development expense related to ONP-002 was approximately $0.9 million. For the nine month period ended September 30, 2024 and 2023, respectively our research and development expenses were approximately $2.4 million for our ONP-002 product and $4.4 million for our vaccine product and lantibiotics programs.

Previous wording

General and Administrative. General and administrative expenses were $1,399,221 for the three months ended June 30, 2024, compared to $1,115,785 for three months ended June 30, 2023, an increase of approximately $283,436 or 25.4%. General and administrative expenses for the six-month period ended June 30, 2024, were approximately $3,195,910 compared to $2,365,048 for the comparable six-month period in 2023, an increase of $830,862 or 35.1%. This increase was primarily due to increased expenses related to:

Current wording

General and Administrative. General and administrative expenses were approximately $1.6 million and $1.3 million for the three months ended September 30, 2024 and 2023 respectively. General and administrative expenses for the nine month period ended September 30, 2024, were approximately $4.8 million compared to $3.7 million for the comparable nine month period in 2023, an increase of approximately $1 million or 29%. This increase was primarily due to increased expenses related to:

Previous wording

Other Income (Expense). Other income, net, was $910 for the three months ended June 30, 2024, compared to $58,732 for the three months ended June 30, 2023. For the six-month period ended June 30, 2024 and 2023, other income, net, was $10,180 and $118,710 respectively, resulting in a decrease of $108,530 or 91.4% for the comparable six-month periods. The net change was primarily attributable to a reduction in interest income due to lower cash balances in interest earning accounts for the comparable periods.

Current wording

Other Income (Expense). Other income and expense, net, was $(25,590) for the three months ended September 30, 2024, compared to $81,561 for the comparable three months in 2023. For the nine month period ended September 30, 2024 and 2023, other income and expense, net, was $(15,412) and $200,271 respectively, resulting in a change of $215,683 or 108% for the comparable nine month periods. The net change was primarily attributable to a reduction in interest income due to lower cash balances in interest earning accounts for the comparable periods.

Previous wording

Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the six months ended June 30, 2024 and 2023, our operating activities used cash of $4,608,778 and $4,685,323 respectively. The decrease is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $235,646 and $2,067,593 at June 30, 2024 and December 31, 2023, respectively.

Current wording

Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the nine months ended September 30, 2024 and 2023, our operating activities used cash of $6,579,029 and $6,188,335 respectively. The change is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $1,986,837 and $2,067,593 at September 30, 2024 and December 31, 2023, respectively.

Previous wording

During the six months ended June 30, 2024 and 2023, our financing activities provided cash of $2,473,898 and used cash of $267,640 respectively. The cash provided by financing activities during the six months ended June 30, 2024 was primarily due to net proceeds from our underwritten public offerings.

Current wording

During the nine months ended September 30, 2024 and 2023, our financing activities provided cash of $6,239,577 and $464,479 respectively. The cash provided by financing activities during the nine months ended September 30, 2024 was primarily due to net proceeds from our underwritten public offerings.

Previous wording

On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the six-month periods ended June 30, 2024 and 2023. The Company did not sell any shares through the ATM program while it was active. The ATM program with Ladenburg terminated on January 30, 2024.

Current wording

On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the nine month periods ended September 30, 2024 and 2023. The Company did not sell any shares through the ATM program while it was active. The ATM program with Ladenburg terminated on January 30, 2024.

Previous wording

On August 8, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, as sales agent (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent (the “ATM”) up to $10.0 million in shares of its common stock (the “Shares”) at-the-market. Shares offered and sold in the Offering are anticipated to be issued pursuant to the Company’s universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”). Under the terms of the Sales Agreement, the Agent is entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares under the Agreement. There can be no assurances the Company will be able to raise any funds under the Sales Agreement.

Current wording

On August 8, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, as sales agent (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent (the “ATM”) up to $10.0 million in shares of its common stock (the “Shares”) at-the-market. Shares offered and sold in the Offering are anticipated to be issued pursuant to the Company’s universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”). Under the terms of the Sales Agreement, the Agent is entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares under the Agreement. On October 9, 2024 the Company terminated the Sales Agreement with Ascendiant Capital, and there were no shares sold under the Sales Agreement with Ascendiant Capital in the nine months ended September 30, 2024.

Previous wording

In July of 2023, we entered into a short-term note payable for $611,109 bearing interest at a rate of 9.55% to finance the renewals of the directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability policies. Principal and interest payments on the note began in August of 2023 and continued through May of 2024 based on straight-line amortization over the 10-month period.

Current wording

In July of 2024, we entered into a short-term note payable for $636,972 bearing interest at a rate of 9.55% to finance the renewals of the directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability policies. Principal and interest payments on the note began in August of 2024 and continue through May of 2025 based on straight-line amortization over the 10-month period.

Previous wording

On June 25, 2024, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Dawson James Securities Inc. (“Dawson James” or the “Placement Agent”) pursuant to which the Company engaged Dawson James as the placement agent for a registered public offering (the “Offering”) of an aggregate of 1,100,000 shares of the Company’s common stock, par value $0,001 (“Common Stock”). The offering price per share of Common Stock was $1.00. The Company agreed to pay the Placement Agent a placement agent fee in cash equal to 7.00% of the gross proceeds from the Offering, and to reimburse for certain out of pocket expenses, including legal fees not to exceed $75,000. In addition, the Company agreed to issue to the Placement Agent warrants to purchase up to five percent 5% of the aggregate number of securities sold in the Offering (“Dawson James Warrants”) with an exercise price of 125% of the offering price of the Common Stock in the Offering and exercisable for five years from the date of the closing of the Offering and are initially exercisable six months from the closing of the Offering.

Current wording

On September 4, 2024, we announced the sale of 3 million shares of our common stock and Pre-Funded Warrants to purchase 5 million shares of common stock, par value $0.001, through a placement agreement with Dawson James Securities, Inc. (“Dawson James”) at an offering price per share of common stock of $0.55. The offering resulted in gross proceeds of $4.45 million before deducting placement agent fees and other estimated offering expenses payable by the Company. We also agreed to issue placement agent warrants (“Dawson James Warrants”) to purchase up to 5% of the aggregate number of securities sold in the offering with an exercise price 125% of the offering price of the common stock in the offering. The Dawson James Warrants are exercisable for five years from the date of closing the offering and are initially exercisable six months from the closing of the Offering.

Previous wording

On April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. We reported stockholders’ equity of $3.2 million as of December 31, 2023, and $1.3 million as of June 30, 2024. Additionally, we have reported losses from continuing operations and/or net losses in our five most recent fiscal years ended December 31, 2023.

Current wording

On April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. Subsequently, the NYSE American notified the Company that it also is not in compliance with subsection (i) Section 1003(a), which requires stockholders’ equity of no less than $2,000,000 if the Company has sustained losses from continuing operations and/or net losses in two of its three most recent fiscal years.

Previous wording

We submitted the Plan by the Deadline and on June 18, 2024 we were notified by the NYSE American that our Plan to regain compliance with NYSE American’s continued listing standards had been accepted, as part of the acceptance we were granted a plan period through October 18, 2025. During the plan period, we will be subject to quarterly monitoring for compliance with the plan. If we do not regain compliance with NYSE American’s listing standards by October 18, 2025, or if we do not make progress consistent with our plan, the NYSE American may initiate delisting proceedings.

Current wording

We submitted the Plan by the Deadline and on June 18, 2024 we were notified by the NYSE American that our Plan to regain compliance with NYSE American’s continued listing standards had been accepted. As part of the acceptance we were granted a plan period through October 18, 2025 to regain compliance. During the plan period, we will be subject to quarterly monitoring for compliance with the plan. If we do not regain compliance with NYSE American’s listing standards by October 18, 2025, or if we do not make progress consistent with our plan, the NYSE American may initiate delisting proceedings.