ORAGENICS INC
For the period ended Dec 31, 2024. Filed Mar 14, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 14, 2025
OGEN$0.35+0.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-29.
0001493152-24-011979
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-14.
0001493152-25-010389
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 118 previous paragraphs and 86 current paragraphs.
26 unchanged; 15 reworded; 35 added; 76 removed; 1 previous and 10 current paragraphs rearranged.
Tables are not compared: 15 previous and 15 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (35)
Current report
For a discussion of the related intellectual property and clinical trials, refer to Item 1. Business.
Current report
Business Development Strategy
Current report
Recent Funding
Current report
In February 2025, we sold 7.8 million shares of our common stock pursuant to our ATM agreement with Dawson James for gross proceeds of $2.75 million before deducting commission and legal expenses. See Note 7 of Notes to Consolidated Financial Statements for additional information.
Current report
On March 13, 2025, the Company entered into and consummated a note securities purchase agreement (the “Purchase Agreement”) with a single investor (the “Purchaser”) pursuant to which the Company sold, in a private placement (the “Offering”), to the Purchaser a promissory note with an aggregate principal amount of $3,000,000 (the “Note”) and 1,000,000 shares of Series G Mirroring Preferred Stock of the Company (the “Series G Preferred Stock”). The aggregate gross proceeds to the Company are expected to be $2,500,000 million, before deducting placement agent fees and expenses. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes. Dawson James Securities, Inc. served as the placement agent in the Offering, pursuant to the terms of a placement agent agreement dated February 26, 2024 and received 6% of the gross proceeds of the Offering and reimbursement of the legal fees of its counsel. The Note and Series G Preferred Stock sold in the Offering were issued in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, have not been registered under the Act, or applicable state securities laws. Accordingly, the Note and Series G Preferred Stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
Current report
Going Concern
Current report
Our current available cash and cash equivalents provide us with limited liquidity. We believe our existing cash and cash equivalents of $0.8 million at December 31, 2024 will allow us to fund our operating plan through the first quarter of 2025. Subsequent to December 31, 2024, in February 2025, we sold 7.8 million shares of common stock from our ATM program. The gross proceeds before commission and expenses from the February 2025 ATM sales were $2.75 million. Additionally, on March 13, 2025, the Company entered into and consummated a note securities purchase agreement (the “Purchase Agreement”) with a single investor (the “Purchaser”) pursuant to which the Company sold, in a private placement (the “Offering”), to the Purchaser a promissory note with an aggregate principal amount of $3,000,000 (the “Note”) and 1,000,000 shares of Series G Mirroring Preferred Stock of the Company (the “Series G Preferred Stock”). The aggregate gross proceeds to the Company were $2,500,000 million, before deducting placement agent fees and expenses. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes. We believe that these additional cash resources will allow us to fund our operating plan through the third quarter of 2025.
Current report
Research and Development
Current report
We do not manufacture or have the capacity to manufacture any of our drug candidates and have one manufacturer as our current partner in the development of synthetic chemistry and manufacturing of the ONP-002 (Molecular Formula: C20H28O2, Molecular Weight: 300.14 g/mol). Our ability to successfully develop our ONP-002 product candidates, and to ultimately supply our commercial products in quantities sufficient to meet the market demand, depends in part on our ability to obtain the drug product and drug substance for our product candidates in accordance with regulatory requirements and in sufficient quantities for commercialization and clinical testing. We do not currently have arrangements in place for a redundant or second-source supply of any products or substances in the event our current supplier ceases their operations or stops offering us sufficient quantities of these materials for any reason.
Current report
We are not certain that our single-source supplier will be able to meet our demand, either because of the nature of our agreement with the supplier, our limited experience with the supplier or our relative importance as a customer to the supplier. It may be difficult for us to assess its ability to timely meet our demand in the future based on past performance. While our supplier has generally met our demand on a timely basis in the past, they may subordinate our needs in the future to their other customers.
Current report
General and Administrative
Current report
Income Taxes
Current report
At December 31, 2024, the Company has federal and state tax net operating loss carry forwards of $159,358,389 and $142,594,207, respectively. The State of Pennsylvania tax net operating loss carryforwards will expire through 2036. Federal and Florida tax net operating loss carryforwards generated prior to December 31, 2017 will expire through 2037 and are not subject to taxable income limitations. Federal and Florida tax net operating loss carryforwards generated subsequent to December 31, 2017, do not expire but may be subject to taxable income limitation pursuant to the Tax Cuts and Jobs Act that was enacted on December 22, 2017. The Company also has federal research and development tax credit carryforwards of $4,041,694 of which are included as an uncertain tax position. The federal tax credit carryforward will expire beginning in 2021 and continuing through 2043 unless utilized.
Current report
Utilization of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or, could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by IRC Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. The Company has completed several financings since its inception, which may result in a change in ownership as defined by IRC Section 382, or could result in a change in control in the future. In each period since our inception, we have recorded a 100% valuation allowance for the full amount of our deferred tax asset, as the realization of the deferred tax asset is uncertain. As a result, we have not recorded any federal tax benefit in our statements of operations.
Current report
At December 31, 2024 and 2023, we included a full valuation allowance against our deferred tax assets of approximately $46,958,449 and $41,166,891, respectively, as our management believes it is uncertain that they will be fully realized. If we determine in the future that we will be able to realize all or a portion of our net operating loss carryforwards, an adjustment to our net operating loss carryforwards would increase net income in the period in which we make such a determination.
Current report
Income Taxes
Current report
See Note 2 of Notes to Consolidated Financial Statements for additional information.
Current report
The decrease in Grant revenue in 2024 compared to 2023 was attributable to awards received for a small business innovation research grant that expired September 30, 2023.
Current report
Research and Development
Current report
The decrease in research and development in 2024 compared to 2023 was mainly attributed to In process research and development expensed in connection with the acquisition of our concussion asset in 2023 of $10.3 million and decreased development costs. Development costs associated with the development of our ONP-002 concussion drug in 2024 were $2.8 million compared to development costs associated with our vaccine product and our lantibiotics program of $1.3 million. Research and development expense in 2024 related to our vaccine product and lantibiotics program are associated with contract terminations.
Current report
General and Administrative
Current report
The increase in General and administrative in 2024 compared to 2023 was primarily due to the following:
Current report
Other Income (Expense)
Current report
The decrease in other income (expense) in 2024 compared to 2023 was attributed to decreased interest income generated from cash balances held in our money market account, the sale of fixed assets in 2023 related to the closing of our laboratory in Alachua Florida and foreign currency exchange in 2024 related to payments made to foreign vendors.
Current report
Operating Activities
Current report
Cash used in operating activities in 2024 resulted from our net loss adjusted for non-cash items and changes in operating assets and liabilities. Significant items included a non-cash charge of $0.5 million for stock-based compensation and a $1.1 million decrease in Prepaid research and development.
Current report
Significant items affecting cash used in operations in 2023 included non-cash charges of $10.3 million for In process research and development and $1.0 million for stock-based compensation and a $2.0 million decrease in Prepaid expenses and other current assets.
Current report
Investing Activities
Current report
There were no investing activities in 2024.
Current report
Investing activities in 2023 primarily related to $1.0 million used for the purchase of In process research and development as part of the Neurology Assets purchase in December 2023.
Current report
Financing Activities
Current report
Cash provided by financing activities in 2024 was primarily related to $6.7 million received from sales of our common stock, this was offset by $0.7 million in payments on our short-term note payable for financed insurance premiums.
Current report
Cash provided by financing activities in 2023 was primarily related to $0.8 million received in sales of our common stock partially offset by $0.6 million used for payments on our short-term notes payable.
Current report
Short-Term Notes Payable
Current report
We had the following short-term notes payable outstanding:
Removed paragraphs (76)
Previous report
Intellectual Property
Previous report
Patents on ONP-002 have been filed and/or issued and a patent has been filed on the nasal delivery device as follows:
Previous report
An issued U.S. patent expiration - 10/19/2042.
Previous report
ONP-002 Clinical Trials
Previous report
ONP-002 has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated.
Previous report
Safety studies have established a dosing regimen of 2X/day for fourteen days. The Phase I clinical trial was performed in Melbourne, Australia with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty Ltd. The country of Australia provides a currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia.
Previous report
The Phase 1 study was double-blinded, randomized and placebo controlled (3:1, drug: placebo). Phase 1 used a Single Ascending/Multiple Ascending (SAD/MAD) drug administration design. The SAD component was a 1X treatment (low, medium, or high dose) and the MAD component was a 1X/day treatment for five consecutive days (low and medium dose). Blood and urine samples were collected at multiple time points for safety pharmacokinetics. Standard safety monitoring was provided for each body system.
Previous report
Forty human subjects (31 males, 9 females) were successfully enrolled in Phase I. The Safety Review Board, made up of medical doctors, has reviewed the trial data and has determined the drug is safe and well tolerated at all dosing levels.
Previous report
We anticipate preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase I data, we plan to apply for an Investigational New Drug application with the FDA and conduct a Phase II trial in the United States.
Previous report
We anticipate a Phase 2 clinical trial will be performed administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen days. The Phase 2a feasibility study will be performed in Australia with a target initiation date in the second or third quarter of 2024 to be followed closely by a Phase 2b proof of concept study in the US.
Previous report
Our SARS-CoV-2 Vaccine Product Candidate – NT-CoV2-1
Previous report
Prior to the purchase of the Neurology Assets, starting in May 2020 with the acquisition of one hundred percent (100%) of the total issued and outstanding common stock of Noachis Terra, Inc. (“Noachis Terra”) and through December 31, 2023, we were focused on the development and commercialization of a vaccine produce candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19. During that time, we conducted testing in animal models, including SARS-CoV-2 challenge studies in hamsters, using specific formulations for intramuscular administration and intranasal administration, both based on the NIAID pre-fusion stabilized spike protein antigens.
Previous report
In June of 2021 we initiated an immunogenicity study in mice and on August 30, 2021, we announced the successful completion of the mouse studies that supported further development using either intramuscular or intranasal routes of administration. In September of 2021 we initiated a hamster challenge to assess inhibition of viral replication using adjuvants specific for intramuscular and intranasal administration. In December of 2021, we announced that both formulations generated robust immune responses and reduced the SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge. On June 14, 2022, we announced that the results of these studies were published in Nature Scientific Reports.
Previous report
In March of 2022, following a positive assessment of a rabbit-based pilot study, we initiated a Good Laboratory Practice toxicology study to evaluate the safety profile and immunogenicity of NT-CoV2-1 in rabbits. This preclinical study was designed to provide data required to advance our intranasal vaccine candidate into human clinical studies.
Previous report
Following the successful results of the animal studies previously referenced and a Type B Pre-IND meeting with the FDA we determined to focus our development efforts and financial resources on the intranasal delivery vaccine produce candidate, NT-CoV2-1. As part of this intranasal development focus, during 2023 we entered into strategic license agreements and announced an award of a grant from CQDM.
Previous report
However, due to lack of financial resources our research and development activities for our NT-CoV2-1 vaccine product were suspended as of December 31, 2023, and are not currently active. We will continue to evaluate opportunities and funding resources for our SARS-CoV-2 and NT-CoV2-1 candidate products in the future, of which there can be no assurances. These opportunities and funding resources could include; without limitations: sublicensing agreements, joint ventures or partnerships, sales or licensing of technology, government grants, the sale of additional debt or equity securities, and lines of credit or other loans. There are no assurances that we will be able to secure any such opportunity or funding.
Previous report
Our Lantibiotic Product Candidate
Previous report
Members of our scientific team discovered that a certain bacterial strain ofStreptococcus mutans, produces Mutacin 1140 (MU1140), a molecule belonging to the novel class of antibiotics known as lantibiotics. Lantibiotics, such as MU1140, are highly modified peptide antibiotics made by a small group of Gram-positive bacterial species. Over 60 lantibiotics have been discovered, to date. We believe lantibiotics are generally recognized by the scientific community to be potent antibiotic agents.
Previous report
In nonclinical testing, MU1140 has shown activity against all Gram-positive bacteria against which it has been tested, including those responsible for a number of healthcare associated infections, or HAIs. A high percentage of hospital-acquired infections are caused by highly antibiotic-resistant bacteria such as methicillin-resistantStaphylococcus aureus (MRSA) or multidrug-resistant Gram-negative bacteria. We believe the need for novel antibiotics is increasing because of the growing resistance of target pathogens to existing FDA approved antibiotics on the market.
Previous report
Lantibiotics have been difficult to investigate for their clinical usefulness as therapeutic agents in the treatment of infectious diseases due to a general inability to produce or synthesize sufficient quantities of pure amounts of these molecules. Traditional fermentation methods can only produce minute amounts of the lantibiotic.
Previous report
While lantibiotics are promising, in 2023 we concluded we needed to make several changes to reduce the cash used in operations. In September of 2023, we terminated our lease for the building where some of the research and development activities for the lantibiotic program were undertaken. The closing of the laboratory was part of the continued focus on preserving cash resources while seeking additional funding through various mechanisms.
Previous report
As of December 31, 2023, research and development activities related to the lantibiotic program are inactive. We will evaluate opportunities for the lantibiotic program; however, moving forward our focus is to strengthen our focus and expertise on developing our intranasal drug delivery platform and drug candidates that treat brain related illnesses and diseases.
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Our Business Development Strategy
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Recent Developments
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*Odyssey Neurology Assets.*On December 28, 2023 (“the “Closing Date”) we closed the transactions contemplated by the Asset Purchase Agreement (the “Purchase Agreement”) between us and Odyssey Health, Inc. (“Odyssey”). We originally entered into the Purchase Agreement on October 4, 2023 (the “Signing Date”); the closing was subject to the satisfaction of certain closing conditions which were satisfied or waived prior to the Closing Date. At the Closing Date we purchased and assumed, and Odyssey sold and assigned, all assets (and assumed certain liabilities) related to the segment of Odyssey’s business focused on developing medical products that treat brain related illnesses and diseases (the “Neurology Assets”). The Neurology Assets include 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 Odyssey’s proprietary powder formulation and its nasal delivery device.
Previous report
In consideration for the Neurology Assets, we paid Odyssey $1 million in cash and issued 8 million shares of convertible Series F Preferred Stock to Odyssey. The Series F Preferred Stock is convertible into common stock on a one-to-one basis. Additional information related to the Purchase Agreement and the Series F Preferred Stock can be found in the Form 8-K filed with the Securities and Exchange Commission on October 5, 2023, December 8, 2023, and December 29, 2023.
Previous report
New President. In connection with the closing and as contemplated in the Purchase Agreement, effective as of the Closing Date, we entered into an Executive Employment Agreement with Joseph Michael Redmond, pursuant to which he will serve as the President of the Company. Additional information related to Mr. Redmond and his employment with the Company can be found in our Forms 8-K filed with the Securities and Exchange Commission on December 29, 2023.
Previous report
New Directors. On October 4, 2023, our Board of Directors (the “Board”) approved an increase in the size of the board of directors from five (5) to seven (7) individuals. Following the increase in the size of the board of directors, the Board appointed Mr. Bruce Cassidy and Mr. John Gandolfo to our Board. Mr. Cassidy and Mr. Gandolfo were chosen to serve as members of our Board due to their extensive leadership and business experience as well as their prior experience serving on other boards of publicly traded companies. Additional information regarding Mr. Cassidy and Mr. Gandolfo can be found in the Form 8-K filed with the Securities and Exchange Commission on October 5, 2023, and the press release filed October 18, 2023.
Previous report
Material Transfer Agreement. On September 26, 2023, we completed the sale and transfer of certain materials and data to a third-party (the “Purchaser”) pursuant to a Material Transfer Agreement (the “Transfer Agreement”). Under the terms of the Transfer Agreement, we transferred certain biological samples/strains (referred to as “Samples”) and associated data, including but not limited to testing, assays, and stability data (“Data”) (collectively, the “Transferred Assets”) to the Purchaser, following the Purchaser’s successful testing and verification of the Samples viability. In exchange for the transfer, the Purchaser; (i) paid us $50,000 in cash, and (ii) granted us an option to purchase 1,000,000 shares of the Purchaser’s equity for a total consideration of $1.00, additionally the Purchaser agreed to pay us a royalty equal to ten percent (10%) of the net income from any products developed or derived from the Transferred Assets. The duration of the royalty payments spans a ten (10) year term. The Samples were not connected to any of our current or ongoing research and development projects and were initially developed as part of a research and development project that we had previously halted and preserved until a suitable use could be identified. As of the date of this filing we have not exercised our option to purchase shares of the Purchaser’s company. The agreement did not involve the transfer of any licenses or ownership of intellectual property form the Company to the Purchaser. Additional information regarding the transaction can be found in the Form 8-K filed with the Securities and Exchange Commission on September 29, 2023.
Previous report
Lease Termination. On September 13, 2023, we exercised our option to terminate our lease agreement for the facility located at 13,700 Progress Boulevard, Alachua, Florida 32615 (the “Lease”). To terminate the Lease, we paid nine (9) months of advance rent, plus prorated rent for the month of September, plus applicable sales tax. In addition, we agreed with the landlord that the security deposit would be retained by the landlord as consideration for accepting the property in “AS IS” condition. We have no further obligations under the Lease. The Alachua Lease contained the laboratory where some of the research and development for the lantibiotic program was undertaken. The lantibiotic program is now on hold.
Previous report
In addition to the termination of the Lease, the Company eliminated two staff positions and Dr. Martin Handfield transitioned from an employee of the Company to a consultant. Dr. Handfield continues to be available to provide support services on an hourly basis through a consulting agreement. Dr. Handfield’s employment agreement was terminated in accordance with its terms.
Previous report
Change in Certifying Accountant. On August 15, 2023, upon the completion of a comprehensive selection process, the Audit Committee of the Board of Directors (the “Audit Committee”) approved the dismissal of Mayer Hoffman McCann P.C (“MHM”) and engaged Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2023. Additional information can be found in the Form 8-K filed with the Securities and Exchange Commission on August 18, 2023.
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Executive Officer and Director Equity Awards. On August 8, 2023, the Compensation Committee and the Board of Directors approved restricted awards to certain executive officers and directors. Under the 2021 Equity Incentive Plan 40,000 shares of restricted stock was awarded to the Chief Executive Officer, Ms. Kimberly Murphy, and the Chief Financial Officer, Ms. Janet Huffman. Approximately 30,000 of the 40,000 shares vested immediately and the remaining shares vested within six (6) months from the date of the award. Additional information regarding the equity awards can be found in the Form 8-K filed with the Securities and Exchange Commission on August 10, 2023.
Previous report
Securities Purchase Agreement. On August 4, 2023, we entered into a Securities Purchase Agreement (the “Securities Agreement”) with two healthcare-focused investors. Pursuant to the Securities Agreement we agreed to issue in a private placement (the “Offering”), an aggregate of (i) 404,728 shares of our common stock, $0.001 par value (the “Common Stock”), and (ii) 404,728 shares of Series E Mirroring Preferred Stock (the “Series E Preferred Stock”), the rights and preferences of which are set forth in the Certificate of Designation filed with the Secretary of State for the State of Florida. Gross proceeds from the offering were approximately $850,000. Upon the approval of the Company’s Articles of Amendment to increase its authorized shares of common stock on December 14, 2023, each share of Series E Preferred Stock was automatically transferred to the Company and cancelled for no consideration with no action on behalf of the holders of Series E Preferred Stock. Such shares resumed the status of authorized but unissued preferred stock and will no longer be designated as Series E Mirroring Preferred Stock. Additional information can be found regarding the transaction in the Form 8-K filed with the Securities and Exchange Commission on August 4, 2023.
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Three-Way Collaborative Agreement. On June 5, 2023, we announced the award of a grant from CQDM, a Canadian bioresearch consortium, for the collaborative development of a variant-agnostic COVID-19 protein subunit vaccine candidate. The project is a collaboration with the National Research Council of Canada and Inspirevax.
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*New Chief Financial Officer, Secretary and Treasurer.*On March 8, 2023, we announced the appointment of Ms. Janet Huffman as our Chief Financial Officer, Secretary and Treasurer.
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Ladenburg ATM Offering Sales Agreement. On February 24, 2023, we entered into an At the Market Offering Agreement with Ladenburg, Thalmann & Co., Inc., pursuant to which would issue and sell, from time to time, shares of its common stock, depending on market demand, with the Agent acting as the sales agent or principal. We terminated the At The Market Offering Agreement effective January 30, 2024. During the 12 months ended December 31, 2023, no shares were sold from the ATM.
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*Global Commercial License Agreement—Inspirevax.*On February 23, 2023, we entered into a Commercial License Agreement with Inspirevax, Inc. for its novel intranasal mucosal adjuvant, BDX301, for the development of NT-CoV2-1, our lead intranasal COVID-19 vaccine candidate. Under the exclusive licensing agreement, we contemplated pursuing the development of NT-CoV2-1 with Inspirevax’s novel BDX301 intranasal mucosal adjuvant. In connection therewith, we also formed a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. Under the agreement, we are required to make clinical, regulatory, and commercial milestone payments, as well as tiered royalty payments. Additionally, the agreement provides a certain period of time for the companies to expand their collaboration to pursue the development of additional intranasal vaccine candidates using Inspirevax’s adjuvants.
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*Reverse Stock Split.*On January 20, 2023, we effectuated a one for sixty reverse stock split of our authorized and issued and outstanding shares of common stock pursuant to the Florida Business Corporation Act, which our Board of Directors approved in December 2022 to expeditiously meet the continued listing standards of the NYSE American, LLC and to reduce the risk of being automatically delisted from the NYSE American due to the trading price of our common stock falling below the price that the NYSE American views as low.
Previous report
Financial Overview
Showing the first 40 of 76 passages. Open the source sections for the rest.
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Previous wording
We are a development-stage company dedicated to the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases. Our lead product ONP-002 is a fully synthetic, nonnaturally occurring neurosteroid, is lipophilic, and can cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Current wording
We are a development-stage company dedicated to the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases. Our lead product ONP-002 is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and is designed to can cross the blood-brain barrier with the goal of rapidly reducing swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Previous wording
The proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The device is breath propelled and Oragenics expects it to allow patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and easily crosses the blood brain barrier. This mechanism traps ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain.
Current wording
The proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The device is breath propelled and allows patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and easily crosses the blood brain barrier. This mechanism is designed to trap ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain.
Previous wording
We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of approximately $21 million and $14 million for the years ended December 31, 2023, and 2022, respectively. As of December 31, 2023, our accumulated deficit was approximately $206 million. We have devoted a significant amount of our financial resources to research and development, including our nonclinical development activities and clinical trials. We expect that the costs associated with our plans to begin Phase 2 work on ONP-002 will be significant. Additionally, our License Agreements also require the payment of certain recurring and performance-based royalties that may negatively impact our financial capabilities. In addition, Ladenburg Thalmann has sent us an invoice and demand letter claiming it is owed $2,500,000 in connection with our purchase of the Neurology Assets (the “Ladenburg Claim”). While we strongly disagree with such claim and have filed a confidential action for arbitration against Ladenburg through FINRA on March 12, 2024, seeking, among other things, a declaratory action ruling that no such fee is owed, the litigation expenses related thereto will put further strain on our limited resources. As a result, we expect to continue to incur substantial net losses and negative cash flow for the foreseeable future. These losses and negative cash flows have had, and will continue to have, an adverse effect on our shareholders’ equity and working capital. Because of the numerous risks and uncertainties associated with product development and commercialization, we may not be able to continue as a going concern and are unable to accurately predict the timing or amount of substantial expenses or when, or if, we will be able to generate the revenue necessary to achieve or maintain profitability.
Current wording
We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of $10.6 million and $20.7 million for the years ended December 31, 2024 and 2023 respectively. As of December 31, 2024, our accumulated deficit was $216.8 million.
Previous wording
Our capital requirements for 2024 will depend on numerous factors, including the success of our commercialization efforts and of our research and development, the resources we devote to develop and support our technologies and our success in pursuing strategic licensing and funded product development relationships with external partners. Subject to our ability to raise additional capital including through possible joint ventures and/or partnerships, we expect to incur substantial expenditures to further commercialize or develop our technologies including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company. We will require substantial funds to conduct research and development and nonclinical and Phase 2 and Phase 3 clinical testing of our product candidates, and in particular ONP-002, as well as for the manufacture and marketing of any products that are approved for commercial sale. Our plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.
Current wording
Our capital requirements for 2025 will depend on numerous factors, including the success of our commercialization efforts and of our research and development, the resources we devote to develop and support our technologies and our success in pursuing strategic licensing and funded product development relationships with external partners.
Previous wording
Our current available cash and cash equivalents provide us with limited liquidity. We believe our existing cash and cash equivalents on December 31, 2023, can allow us to fund our operating plan through the second quarter of 2024. We expect to continue to seek additional funding for our operations. Any such required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which could harm our business. The sale of additional equity or debt securities may result in additional dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations. We also will require additional capital beyond our currently forecasted amounts. For example, as we continue to work on the development of our product candidates and enter into third party agreements in connection therewith, we will require additional capital.
Current wording
Required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which could harm our business.
Previous wording
We have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts than we currently anticipate. Potential sources of financing include strategic relationships, public or private sales of our shares or debt and other sources. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations and our business, financial condition and results of operations would be materially harmed.
Current wording
We have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts than we currently anticipate.
Previous wording
Research and development consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses consist primarily of employee-related expenses, which include salaries and benefits and attending science conferences; expenses incurred under our License Agreements with third parties and under other agreements with contract research organizations, investigative sites and consultants that conduct our clinical trials and a substantial portion of our nonclinical studies; the cost of acquiring and manufacturing clinical trial materials; facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, and depreciation of fixed assets; license fees, for and milestone payments related to, in-licensed products and technology; stock-based compensation expense; and costs associated with nonclinical activities and regulatory approvals. We expense research and development costs as incurred.
Current wording
Research and development consist of expenses incurred in connection with the discovery and development of our product candidates and are divided into (i) clinical research and (ii) nonclinical research and development activities.
Previous wording
Our research and development expenses can be divided into (i) clinical research and (ii) nonclinical research and development activities. Clinical research costs consist of clinical trials, manufacturing services and regulatory activities, all of which are largely provided by third parties. Nonclinical research and development costs consist of our research activities, research activities provided by third parties, our own nonclinical studies, nonclinical studies provided by third parties, the acquisition of in process research and development, related personnel costs and laboratory supplies, and other costs such as rent, utilities, depreciation and stock-based compensation and research expenses we incur associated with the development of our product candidates. While we are currently focused on advancing our product development programs, our future research and development expenses will depend on the clinical success of our product candidates, as well as ongoing assessments of each product candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans, research expenses and capital requirements.
Current wording
Clinical research activities consist of clinical trials, manufacturing services and regulatory activities, all of which are largely provided by third parties. Nonclinical research and development activities consist of our own research activities, research activities provided by third parties, our own nonclinical studies, nonclinical studies provided by third parties and the acquisition of in process research and development.
Previous wording
Our plan is to budget and manage expenditures in research and development such that they are undertaken in a cost-effective manner yet still advance the research and development efforts focused on ONP-002. Subject to available capital, we expect overall research and development expenses to increase as a result of our ONP-002 product candidate. Our research and development projects focused on ONP-002 are currently expected to be taken to the point where they can be licensed or partnered with larger pharmaceutical companies. Our research and development projects related to other product candidates currently are on hold.
Current wording
Our current product development strategy contemplates (i) an expected increase in our research and development expenses in the future as we continue the advancement of our product development program for our ONP-002 and (ii) a continued attempt to decrease expenses related to our other product candidates, as we have paused our lantibiotics program and COVID-19 vaccine program pending additional financing and other developments. Our research and development projects focused on ONP-002 are currently expected to be taken to the point where they can be licensed or partnered with larger pharmaceutical companies.
Previous wording
Our current product development strategy contemplates (i) an expected increase in our research and development expenses in the future as we continue the advancement of our product development program for our ONP-002 and (ii) a continued attempt to decrease expenses related to our other product candidates, as we have paused our lantibiotics program and COVID-19 vaccine program pending additional financing and other developments. The lengthy process of completing pre-clinical studies, clinical trials; seeking regulatory approval for our product candidates; and expanding the potential claims we are able to make, requires expenditure of substantial resources. Any failure or delay in completing pre-clinical studies, clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenues and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Our current product candidates are not expected to be commercially available until we are able to obtain regulatory approval from the FDA or the regulatory authority in other jurisdictions where we may seek approval.
Current wording
The lengthy process of completing pre-clinical studies and clinical trials, seeking regulatory approval for our product candidates and expanding the potential claims we are able to make requires expenditure of substantial resources. Any failure or delay in completing pre-clinical studies, clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenues and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations and financial position.
Previous wording
Other income (expense) includes local business taxes, as well as interest income and expense. Interest income consists of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our indebtedness.
Current wording
Other income (expense) includes local business taxes, as well as interest income and expense, and realized gains and losses related to foreign currency exchange rates with our vendors. Interest income consists of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our indebtedness.
Previous wording
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires public entities to disclose consistent categories and greater disaggregation of information in the rate reconciliation and for income taxes paid. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is required to adopt this standard prospectively in fiscal year 2026 for the annual reporting period ending September 30, 2026. The accounting pronouncement is not expected to have a material impact on the Company’s related disclosures.
Current wording
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires public entities to disclose consistent categories and greater disaggregation of information in the rate reconciliation and for income taxes paid. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2024, with early adoption permitted. The accounting pronouncement is not expected to have a material impact on the Company’s related disclosures.
Previous wording
Effective January 1, 2023, repurchases are subject to a nondeductible excise tax under the Inflation Reduction Act of 2022 equal to 1.0% of the fair market value of the shares repurchased, subject to certain limitations. The Company did not have an impact to our financial condition or results of operations in 2023 as a result of the excise tax.
Current wording
Effective January 1, 2023, repurchases are subject to a non-deductible excise tax under the Inflation Reduction Act of 2022 equal to 1.0% of the fair market value of the shares repurchased, subject to certain limitations. The Company did not have an impact to the financial condition or results of operations in 2023 as a result of the excise tax.
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 and public offerings, debt financing, warrant exercises and grants. As of December 31, 2023, we had an accumulated deficit of $(206,218,254) and we have yet to achieve profitability. We incurred net losses of $(20,655,737) and $(14,288,389) for the years ended December 31, 2023 and 2022, respectively. We expect to incur significant and increasing operating losses for the foreseeable future as we seek to advance our product candidates through nonclinical testing and clinical trials to ultimately obtain regulatory approval and eventual commercialization. We will need to raise additional capital to fund our operations. We anticipate that our cash resources as of December 31, 2023, will be sufficient to fund our operations as presently structured through the second quarter of 2024. There can be no assurance that additional capital will be available to us on acceptable terms, if at all. Adequate additional funding may not be available to us on acceptable terms, or at all. Assuming we can raise additional capital, we expect that research and development expenses will increase along with general and administrative costs, as we grow and operate our business. The following table sets forth the primary sources and uses of cash for each of the periods indicated:
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 and public offerings, debt financing, warrant exercises and grants. As of December 31, 2024, we had an accumulated deficit of $216.8 million and we have yet to achieve profitability. We incurred net losses of $10.6 million and $20.7 million for the years ended December 31, 2024 and 2023 respectively. We expect to incur significant and increasing operating losses for the foreseeable future as we seek to advance our Neurology Assets through nonclinical testing and clinical trials to ultimately obtain regulatory approval and eventual commercialization.
Previous wording
During the years ended December 31, 2023 and 2022, our cash flows from operations used cash of $(7,290,880) and $(15,228,483), respectively. The use of cash in all periods primarily resulted from our net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $2,067,593 and $12,693,239 as of December 31, 2023, and 2022, respectively.
Current wording
We had a working capital deficit of $211,885 at December 31, 2024 compared to a working capital surplus of $2,067,593 at December 31, 2023.
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
We have devoted a significant amount of our financial resources to research and development, including our nonclinical development activities and clinical trials. We expect that the costs associated with our plans to begin Phase 2 work on ONP-002 will be significant. Additionally, our License Agreements also require the payment of certain recurring and performance-based royalties that may negatively impact our financial capabilities.
Current report — wording carried from elsewhere
In addition, Ladenburg Thalmann has sent us an invoice and demand letter claiming we owe them $2.5 million in connection with our purchase of the Neurology Assets (the “Ladenburg Claim”). See Item 3. Legal Proceedings for additional information.
Current report — wording carried from elsewhere
We expect to continue to incur substantial net losses and negative cash flows for the foreseeable future. These losses and negative cash flows have had, and will continue to have, an adverse effect on our shareholders’ equity and working capital. Because of the numerous risks and uncertainties associated with product development and commercialization, we may not be able to continue as a going concern and are unable to accurately predict the timing or amount of substantial expenses or when, or if, we will be able to generate the revenue necessary to achieve or maintain profitability.
Current report — wording carried from elsewhere
Subject to our ability to raise additional capital including through possible joint ventures and/or partnerships, we expect to incur substantial expenditures to further commercialize or develop our Neurology Assets, including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company.
Current report — wording carried from elsewhere
Our plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.
Current report — wording carried from elsewhere
The sale of additional equity or debt securities may result in dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations.
Current report — wording carried from elsewhere
Research and development expenses consist primarily of:
Current report — wording carried from elsewhere
We expense research and development costs as incurred.
Current report — wording carried from elsewhere
Our current product candidates are not expected to be commercially available until we are able to obtain regulatory approval from the FDA or the regulatory authority in other jurisdictions where we may seek approval.
Current report — wording carried from elsewhere
The following table sets forth the primary sources and uses of cash for each of the periods indicated:
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
For the Years Ended December 31, 2023 and 2022