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What changed in ORAGENICS INC's 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of ORAGENICS INC's 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+529 added−808 removedSource: 10-K (2024-03-29) vs 10-K (2023-04-17)

Top changes in ORAGENICS INC's 2023 10-K

529 paragraphs added · 808 removed · 289 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

59 edited+63 added−173 removed220 unchanged
Biggest changeSuch restrictions under applicable federal and state healthcare laws and regulations, include the following: ● the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; ● the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; ● the federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests; and ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. 24 An increasing number of states have enacted legislation requiring pharmaceutical and biotechnology companies to file periodic reports of expenses relating to the marketing and promotion of drug products and gifts and payments to individual healthcare practitioners in these states; to make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities; to report information pertaining to and justifying price increases; or to register their sales representatives.
Biggest changeSuch restrictions under applicable federal and state healthcare laws and regulations, include the following: ● the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; ● the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 22 ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; ● the federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests; and ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
Additionally, during the term we will pay to Inspirevax a 7% royalty on net sales subject to certain gross revenue limitations at which time the royalty will decrease to 4%.
Additionally, during the term we will pay Inspirevax a 7% royalty on net sales subject to certain gross revenue limitations at which time the royalty will decrease to 4%.
They are distinguished individuals with expertise in numerous fields, including vaccine development and regulatory matters. We retain each consultant according to the terms of a consulting agreement. Under such agreements, we pay them a consulting fee and reimburse them for out-of-pocket expenses incurred in performing their services for us.
They are distinguished individuals with expertise in numerous fields, including vaccine development and regulatory matters. We retain each consultant according to the terms of the consulting agreement. Under such agreements, we pay them a consulting fee and reimburse them for out-of-pocket expenses incurred in performing their services for us.
Pursuant to Regulation (EC) No 726/2004, this procedure is mandatory for: ● medicinal products developed by means of one of the following biotechnological processes: ● recombinant DNA technology; ● controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and ● hybridoma and monoclonal antibody methods; ● advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 on advanced therapy medicinal products; 19 ● medicinal products for human use containing a new active substance that, on the date of effectiveness of this regulation, was not authorized in the European Union, and for which the therapeutic indication is the treatment of any of the following diseases: ● acquired immune deficiency syndrome; ● cancer; ● neurodegenerative disorder; ● diabetes; ● auto-immune diseases and other immune dysfunctions; and ● viral diseases; ● medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
Pursuant to Regulation (EC) No 726/2004, this procedure is mandatory for: ● medicinal products developed by means of one of the following biotechnological processes: ● recombinant DNA technology; ● controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and ● hybridoma and monoclonal antibody methods; ● advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 on advanced therapy medicinal products; ● medicinal products for human use containing a new active substance that, on the date of effectiveness of this regulation, was not authorized in the European Union, and for which the therapeutic indication is the treatment of any of the following diseases: ● acquired immune deficiency syndrome; ● cancer; ● neurodegenerative disorder; ● diabetes; ● auto-immune diseases and other immune dysfunctions; and ● viral diseases; ● medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves the following steps before a biological product or new drug may be marketed in the United States: ● pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s Good Laboratory Practice and Good Manufacturing Practice regulations; 10 ● submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may commence; ● performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication according to Good Clinical Practices; ● submission of an NDA or BLA to the FDA for review; ● random inspections of clinical sites to ensure validity of clinical safety and efficacy data; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practices; ● FDA approval of the NDA or BLA; and ● payment of user and establishment fees, if applicable.
Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves the following steps before a biological product or new drug may be marketed in the United States: ● pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s Good Laboratory Practice and Good Manufacturing Practice regulations; ● submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may commence; ● performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication according to Good Clinical Practices; 7 ● submission of an NDA or BLA to the FDA for review; ● random inspections of clinical sites to ensure validity of clinical safety and efficacy data; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practices; ● FDA approval of the NDA or BLA; and ● payment of user and establishment fees, if applicable.
The FDC Act provides a five-year period of non-patent exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity, or NCE. A drug is entitled to NCE exclusivity if it contains a drug substance no active moiety of which has been previously approved by the FDA.
The FDC Act provides a five-year period of non-patent exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity, or NCE. A drug is entitled to NCE exclusivity if it contains a drug substance with no active moiety of which has been previously approved by the FDA.
When an application is submitted for a marketing authorization in respect of a drug that is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may pursuant to Article 14(9) Regulation (EC) No 726/2004 request an accelerated assessment procedure.
When an application is submitted for a marketing authorization in respect of a drug that is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may be pursuant to Article 14(9) Regulation (EC) No 726/2004 request an accelerated assessment procedure.
In addition, in some countries cross-border imports from low-priced markets (parallel imports) exert a commercial pressure on pricing within a country. 23 In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed.
In addition, in some countries cross-border imports from low-priced markets (parallel imports) exert a commercial pressure on pricing within a country. In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed.
In addition, laws and regulations relating to environmental, health and safety matters are often subject to change. In the event of any changes or new laws or regulations, we could be subject to new compliance measures or to penalties for activities that were previously permitted. Competition Our industry is subject to rapid and intense technological change.
In addition, laws and regulations relating to environmental, health and safety matters are often subject to change. In the event of any changes or new laws or regulations, we could be subject to new compliance measures or to penalties for activities that were previously permitted. 23 Competition Our industry is subject to rapid and intense technological change.
We cannot assure you that we will be able to compete successfully. 25 Regardless of the disease, smaller or early-stage companies and research institutions also may prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical companies.
We cannot assure you that we will be able to compete successfully. Regardless of the disease, smaller or early-stage companies and research institutions also may prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical companies.
A single Phase 3 clinical trial with other confirmatory evidence may be sufficient in rare instances where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible. 11 The length of time and related costs necessary to complete clinical trials varies significantly and may be difficult to predict.
A single Phase 3 clinical trial with other confirmatory evidence may be sufficient in rare instances where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible. 8 The length of time and related costs necessary to complete clinical trials varies significantly and may be difficult to predict.
Such SPCs extend the rights under the basic patent for the drug. 21 Regulatory Requirements After a Marketing Authorization has been Obtained If we obtain authorization for a medicinal product in the European Union, we will be required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products: Pharmacovigilance and other requirements We will, for example, have to comply with the EU’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed.
Such SPCs extend the rights under the basic patent for the drug. 19 Regulatory Requirements After a Marketing Authorization has been Obtained If we obtain authorization for a medicinal product in the European Union, we will be required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products: Pharmacovigilance and other requirements We will, for example, have to comply with the EU’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed.
Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all the non-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. 15 Patent Term Extension After NDA approval, the owner of relevant drug patent may apply for up to a five-year patent term extension.
Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all the non-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. 12 Patent Term Extension After NDA approval, the owner of relevant drug patent may apply for up to a five-year patent term extension.
In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
In addition, there can be considerable pressure from governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers. 14 Disclosure of Clinical Trial Information Sponsors of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information.
Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers. 11 Disclosure of Clinical Trial Information Sponsors of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. 16 Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA or BLA.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. 13 Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA or BLA.
Regulation and Marketing Authorization in the European Union The process governing approval of medicinal products in the European Union follows essentially the same lines as in the United States and, likewise, generally involves satisfactorily completing each of the following: ● pre-clinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations; ● submission to the relevant national authorities of a clinical trial application, or CTA, which must be approved before human clinical trials may begin; ● performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication; ● submission to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labeling; ● satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced current cGMP; ● potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and ● review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
Regulation and Marketing Authorization in the European Union The process governing approval of medicinal products in the European Union follows essentially the same lines as in the United States and, likewise, generally involves satisfactorily completing each of the following: ● pre-clinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations; ● submission to the relevant national authorities of a clinical trial application, or CTA, which must be approved before human clinical trials may begin; ● performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication; ● submission to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labeling; ● satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced current cGMP; ● potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and ● review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product. 15 Pre-clinical Studies Pre-clinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies, in order to assess the potential safety and efficacy of the product.
In March 2022, following a positive assessment of a rabbit-based pilot study, we initiated a Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of NT-CoV2-1 in rabbits. This important preclinical study is designed to provide data required to advance our intranasal vaccine candidate into human clinical studies.
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.
Pediatric Studies Prior to obtaining a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included in an EMA-approved Pediatric Investigation Plan, or PIP, covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP.
A marketing authorization may be granted only to an applicant established in the European Union. 18 Pediatric Studies Prior to obtaining a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included in an EMA-approved Pediatric Investigation Plan, or PIP, covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP.
The companies formed a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. 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.
The companies formed a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. 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. We paid the upfront signing fee.
The FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be filed based on the agency’s threshold determination that it is sufficiently complete to permit substantive review.
The cost of preparing and submitting an NDA is substantial. 9 The FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be filed based on the agency’s threshold determination that it is sufficiently complete to permit substantive review.
Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as amended, a system for the approval of clinical trials in the European Union has been implemented through national legislation of the member states.
Clinical Trial Approval Requirements for the conduct of clinical trials in the European Union including GCP are implemented in the Clinical Trials Directive 2001/20/EC and the GCP Directive 2005/28/EC. Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as amended, a system for the approval of clinical trials in the European Union has been implemented through national legislation of the member states.
(“Inspirevax”) pursuant to which Inspirevax granted us an exclusive worldwide license to use Inspirevax’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based intranasal adjuvants, to make, research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”) to be used in an intranasal vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us.
Pursuant to the License Agreement Inspirevax granted us an exclusive worldwide license to use Inspirevax’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based intranasal adjuvants, to make, research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”) to be used in an intranasal vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us. 6 As consideration for the grant of the license, we paid an upfront signing fee of $50,000.
Large and established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson, AstraZeneca, and Moderna, among others, compete in the vaccine market.
Large and established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson, AstraZeneca, and Moderna, among others, compete in the same or similar markets.
The NDA or the BLA must include the results of all pre-clinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing and submitting an NDA is substantial.
The NDA or the BLA must include the results of all pre-clinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls.
The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a conditional marketing authorization. 20 Marketing Authorization under Exceptional Circumstances Under Article 14(8) Regulation (EC) No 726/2004, products for which the applicant can demonstrate that comprehensive data (in line with the requirements laid down in Annex I of Directive 2001/83/EC, as amended) cannot be provided (due to specific reasons foreseen in the legislation) might be eligible for marketing authorization under exceptional circumstances.
Marketing Authorization under Exceptional Circumstances Under Article 14(8) Regulation (EC) No 726/2004, products for which the applicant can demonstrate that comprehensive data (in line with the requirements laid down in Annex I of Directive 2001/83/EC, as amended) cannot be provided (due to specific reasons foreseen in the legislation) might be eligible for marketing authorization under exceptional circumstances.
The FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
FDA Regulation of Drugs-New Drug Approval Process Pharmaceutical products are subject to extensive regulation by the FDA. The FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
We will be required to use our best efforts to develop a product using the Inspirevax technology including the following: (a) first subject enrollment in first clinical study by December 31, 2023, (b) the first subject enrolled in a Phase 2a study by September 30, 2024, (c) first subject enrolled in a phase 3 registration trial by December 31, 2026, and (d) first marketing approval application submitted by June 30, 2028. 9 Pursuant to the License Agreement, Inspirevax is required to bear the responsibility and pay the costs to obtain and maintain patents related to the Inspirevax Technologies.
The Inspirevax License Agreement requires that we use our best efforts to develop a product using the Inspirevax technology including the following: (a) first subject enrollment in first clinical study by December 31, 2023, (b) the first subject enrolled in a Phase 2a study by September 30, 2024, (c) first subject enrolled in a phase 3 registration trial by December 31, 2026, and (d) first marketing approval application submitted by June 30, 2028.
We regard our trademarks and other proprietary rights as valuable assets and believe they have significant value to us. 27 Protection of Trade Secrets We attempt to protect our trade secrets, including the processes, concepts, ideas and documentation associated with our technologies, through the use of confidentiality agreements and non-competition agreements with our current employees and with other parties to whom we have divulged such trade secrets.
Protection of Trade Secrets We attempt to protect our trade secrets, including the processes, concepts, ideas and documentation associated with our technologies, through the use of confidentiality agreements and non-competition agreements with our current employees and with other parties to whom we have divulged such trade secrets.
Since the acquisition we have conducted testing in animal models, including SARS-CoV-2 challenge studies in hamsters, using specific formulations for intramuscular administration (our Terra CoV-2 vaccine candidate) and intranasal administration (our NT-CoV2-1 vaccine candidate), both based on the NIAID pre-fusion stabilized spike protein antigens.
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.
Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions and/or specific obligations.
Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a conditional marketing authorization.
Part II is assessed separately by each member state concerned. ● Strictly defined deadlines for the assessment of clinical trial application. ● The involvement of the ethics committees in the assessment procedure in accordance with the national law of the member state concerned but within the overall timelines defined by the Regulation (EU) No 536/2014.
Part II is assessed separately by each member state concerned. ● Strictly defined deadlines for the assessment of clinical trial application. ● The involvement of the ethics committees in the assessment procedure in accordance with the national law of the member state concerned but within the overall timelines defined by the Regulation (EU) No 536/2014. 16 Marketing Authorization Authorization to market a product in the member states of the European Union proceeds under one of four procedures: a centralized authorization procedure, a mutual recognition procedure, a decentralized procedure, or a national procedure.
The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission. 12 The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation and a recommendation as to whether the application should be approved.
The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation and a recommendation as to whether the application should be approved.
The centralized authorization procedure is optional for other medicinal products if they contain a new active substance or if the applicant shows that the medicinal product concerned constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization is in the interest of patients in the European Union.
The centralized authorization procedure is optional for other medicinal products if they contain a new active substance or if the applicant shows that the medicinal product concerned constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization is in the interest of patients in the European Union. 17 Administrative Procedure Under the centralized authorization procedure, the EMA’s Committee for Human Medicinal Products, or CHMP, serves as the scientific committee that renders opinions about the safety, efficacy, and quality of medicinal products for human use on behalf of the EMA.
This foreign regulatory approval process involves all of the risks associated with FDA approval discussed above and may also include additional risks. 13 The Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases and conditions affecting fewer than 200,000 persons in the United States at the time of application for orphan drug designation.
The Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases and conditions affecting fewer than 200,000 persons in the United States at the time of application for orphan drug designation.
Furthermore, the FDA may revoke an EUA for a variety of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorizations.
An EUA granted by the FDA would permit a drug candidate to be able to be distributed under the conditions set forth in the EUA prior to FDA approval. Furthermore, the FDA may revoke an EUA for a variety of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorizations.
Most of our competitors have substantially greater financial, marketing, technical and manufacturing resources than we have and we may not be profitable if our competitors are also able to take advantage of our trade secrets.
Most of our competitors have substantially greater financial, marketing, technical and manufacturing resources than we have and we may not be profitable if our competitors are also able to take advantage of our trade secrets. 25 We may find it necessary to initiate litigation to enforce our patent rights, to protect our intellectual property or to determine the scope and validity of the proprietary rights of others.
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 since the first lantibiotic, nisin, was discovered.
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.
The Biologics Price Competition and Innovation Act of 2009, or BPCIA, creates an abbreviated approval pathway for biological products shown to be highly similar to or interchangeable with an FDA-licensed reference biological product.
As with drugs, after approval of biologics, manufacturers must address any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval. 14 The Biologics Price Competition and Innovation Act of 2009, or BPCIA, creates an abbreviated approval pathway for biological products shown to be highly similar to or interchangeable with an FDA-licensed reference biological product.
However, a drug that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication, may also obtain approval in the United States during the seven-year exclusive marketing period.
However, a drug that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication, may also obtain approval in the United States during the seven-year exclusive marketing period. 10 Under the FDA Modernization Act of 1997, designation as a Fast-Track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product.
Our Intellectual Property We rely upon a combination of licenses, patents, trade secrets, know-how, and licensing opportunities to develop our business. Our future prospects depend on our ability to protect our intellectual property. We also need to operate without infringing the proprietary rights of third parties.
We have a limited ability to predict how competitive our products and product candidates will be in the marketplace. Our Intellectual Property We rely upon a combination of licenses, patents, trade secrets, know-how, and licensing opportunities to develop our business. Our future prospects depend on our ability to protect our intellectual property.
Public and private health care payers control costs and influence drug pricing through a variety of mechanisms, including through negotiating discounts with the manufacturers and through the use of tiered formularies and other mechanisms that provide preferential access to certain drugs over others within a therapeutic class.
The Affordable Care Act and further changes in the law or regulatory framework that reduce our revenues or increase our costs could also have a material adverse effect on our business, financial condition and results of operations and cash flows. 21 Public and private health care payers control costs and influence drug pricing through a variety of mechanisms, including through negotiating discounts with the manufacturers and through the use of tiered formularies and other mechanisms that provide preferential access to certain drugs over others within a therapeutic class.
We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates. 4 Our SARS-CoV-2 Vaccine Product Candidate-NT-CoV2-1 Market Opportunity The worldwide revenues for the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines in 2022 were $37.8 billion and $18.4 billion, respectively.
We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates.
Complexities associated with the larger, and often more complex, structures of biological products, as well as the process by which such products are manufactured, particularly with respect to interchangeability, are still being evaluated by the FDA. 17 A reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can be submitted for four years from the date of licensure of the reference product.
To date, only four biosimilar products and no interchangeable products have been approved under the BPCIA. Complexities associated with the larger, and often more complex, structures of biological products, as well as the process by which such products are manufactured, particularly with respect to interchangeability, are still being evaluated by the FDA.
We began pre-clinical studies in June of 2021 through our collaboration and material transfer agreement with the NRC. We initiated an immunogenicity study in mice to evaluate several adjuvant candidates. On August 30, 2021, we announced the successful completion of these mouse immunogenicity studies that supported further development using either the intramuscular or intranasal routes of administration.
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.
A hamster challenge study was initiated in September of 2021 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.
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.
These laws and regulations prescribe criminal and civil penalties that can be assessed, and violation of these laws and regulations can result in enforcement action by the FDA and other regulatory agencies. FDA Regulation of Drugs-New Drug Approval Process Pharmaceutical products are subject to extensive regulation by the FDA.
The FDC Act and other federal and state statutes and regulations govern, among other things, the manufacture, distribution and sale of these products. These laws and regulations prescribe criminal and civil penalties that can be assessed, and violation of these laws and regulations can result in enforcement action by the FDA and other regulatory agencies.
The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the first marketing authorization, minus five years, subject to a maximum term of five years. 22 A six-month pediatric extension of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information includes information on the results of the studies and the product is authorized in all member states of the European Union.
A six-month pediatric extension of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information includes information on the results of the studies and the product is authorized in all member states of the European Union. 20 Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.
Our SARS-CoV-2 Vaccine Product Candidate – NT-CoV2-1 Following our May 2020 acquisition of one hundred percent (100%) of the total issued and outstanding common stock of Noachis Terra, Inc. (“Noachis Terra”) we are focused on the development and commercialization of a vaccine product candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19.
Our SARS-CoV-2 Vaccine Product Candidate – NT-CoV2-1 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.
Patents We attempt to protect our technology and products through patents and patent applications pursuant to the terms of our license agreements.
We also need to operate without infringing the proprietary rights of third parties. Patents We attempt to protect our technology and products through patents and patent applications.
For biologics, priority review is further limited to drugs intended to treat a serious or life-threatening disease relative to the currently approved products.
For biologics, priority review is further limited to drugs intended to treat a serious or life-threatening disease relative to the currently approved products. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission.
In addition, some consultants hold options to purchase our common stock, subject to the vesting requirements contained in separate award agreements.
In addition, some consultants hold options to purchase our common stock, subject to the vesting requirements contained in separate award agreements. Our consultants may be employed by other entities and therefore may have commitments to their employer or may have other consulting or advisory agreements that may limit their availability to us.
Over 60 lantibiotics have been discovered, to date. We believe lantibiotics are generally recognized by the scientific community to be potent antibiotic agents. 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.
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-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Gram-negative bacteria.
The results of the pre-clinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA. 18 Clinical Trial Approval Requirements for the conduct of clinical trials in the European Union including GCP are implemented in the Clinical Trials Directive 2001/20/EC and the GCP Directive 2005/28/EC.
The conduct of the pre-clinical tests and formulation of the compounds for testing must comply with the relevant EU regulations and requirements. The results of the pre-clinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA.
Our Antibiotic Product Candidate – Oragenics Derived Compound (ODC-x) Members of our scientific team discovered that a certain bacterial strain of Streptococcus 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.
There can be no assurances that we will be able to secure any such opportunity or funding. 4 Our Lantibiotic Product Candidate Members of our scientific team discovered that a certain bacterial strain of Streptococcus mutans, produces Mutacin 1140 (MU1140), a molecule belonging to the novel class of antibiotics known as lantibiotics.
Litigation is costly and time-consuming, and there can be no assurance that our litigation expenses will not be significant in the future or that we will prevail in any such litigation. Government Grants We have previously received funding from government agencies under the National Science Foundation’s and National Institute of Health’s Small Business Innovation Research, or SBIR, grants.
Litigation is costly and time-consuming, and there can be no assurance that our litigation expenses will not be significant in the future or that we will prevail in any such litigation. Human Capital Employees We have five full-time employees. We enjoy good relations with our employees.
A high percentage of hospital-acquired infections are caused by highly antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Gram-negative bacteria. We believe the need for novel antibiotics is increasing as a result of the growing resistance of target pathogens to existing FDA approved antibiotics on the market.
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.
Government Regulations In the United States, foods (including dietary supplements), drugs (including biological products), medical devices, cosmetics, tobacco products and radiation-emitting products are subject to extensive regulation by the FDA. The FDC Act and other federal and state statutes and regulations govern, among other things, the manufacture, distribution and sale of these products.
However, none of the additional consideration milestones have been met, as of December 31, 2023, we have suspended all research and development activity for the COVID-19 vaccine candidate. Government Regulations In the United States, foods (including dietary supplements), drugs (including biological products), medical devices, cosmetics, tobacco products and radiation-emitting products are subject to extensive regulation by the FDA.
While we previously had a Type B Pre-IND Meeting with the FDA on our intramuscular vaccine product candidate, we again met with the FDA in a Type B Pre-IND Meeting request to discuss our intranasal vaccine product candidate.
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.
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Overview We are a development-stage company dedicated to the research and development of potential therapies to fight infectious diseases including coronaviruses and multidrug-resistant organisms. Our lead product (NT-CoV2-1) is an intranasal vaccine candidate to prevent coronavirus disease (“COVID-19”) from the SARS-CoV-2 virus and variants thereof.
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Overview 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 can cross the blood-brain barrier to rapidly reduce swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
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The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health and the National Research Council of Canada with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Our proprietary lantibiotics program features a novel class of antibiotics against bacteria our research has shown may be applicable to multiple antibiotic-resistant organisms.
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Our ONP-002 Neurology Asset for Brain Related Illness and Injury Following our December 2023 acquisition of certain assets from Odyssey Health, Inc.
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Noachis Terra is a party to a worldwide, nonexclusive intellectual property and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute within the National Institutes of Health (“NIH”), relating to certain research, patent applications and biological materials involving pre-fusion stabilized coronavirus spike proteins and their use in the development and commercialization of a vaccine to provide specific, long lasting immunity from SARS-CoV-2.
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(“Odyssey”) related to the segment of Odyssey’s business focused on developing medical products that treat brain related illnesses and diseases (the “Neurology Assets”) our lead product and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).
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Following consideration of a number of factors, including but not limited to the competitive landscape, we determined to bring the intranasal vaccine candidate NT-CoV2-1 into further development due to the greater differentiation versus current COVID-19 vaccines and the potential benefits of intranasal over intramuscular administration.
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ONP-002 to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled into the novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device is lightweight and easy to use in the field.
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We believe these benefits could include a higher reduction of transmission of SARS-CoV-2 and would offer a needle-free delivery option. We therefore are currently focusing our development efforts on our more highly differentiated NT-CoV2-1 vaccine candidate.
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We believe the proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain.
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On July 26, 2021, we entered into a licensing agreement with the National Research Council of Canada (“NRC”) that enables us to pursue the development of next-generation vaccines against the SARS-CoV-2 virus and its variants.
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The device is breath propelled and we expect 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.
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The license was subsequently amended to include the Omicron variant, broaden the non-exclusive field of use to include all diseases caused by coronaviruses and any genetic variants thereof, add research protocol developed by the NRC, and add reagents as part of the NRC technologies licensed by us. We extended the license in April 2022.
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This mechanism traps ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain.
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The NRC technologies, in combination with the licensed technologies from the U.S. NIH used in our NT-CoV2-1 vaccine candidate, provide us with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern.
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Expected ONP-002 Product Development Timeline: Pre-clinical Animal Studies Phase 1 Phase 2a Phase 2b Phase 3 Complete Complete Estimated Q2/Q3 2024 start Estimated Q4 2024 start Estimated Q4 2026 start This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
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This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge Program, are expected to enable expedited evaluation of SARS-CoV-2 antigen candidates in pre-clinical and clinical studies.
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Validation and Stability of ONP-002 A Certificate of Analysis (“COA”) was issued by the manufacturer of the drug, indicating that testing methods were standard and include appearance, identification by 1H NMR, identification by Mass Spectroscopy (MS), optical purity by HPLC, residual solvent analysis, elemental impurities, percent water, and residue on ignition.
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Coronaviruses are a family of viruses that can lead to upper-respiratory infections in humans. Recent clinical reports also suggest that the SARS-CoV-2 virus can affect other body-systems, including the nervous, cardiovascular, gastrointestinal and renal systems.
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The manufacturer has shown both the specifications and the results, indicating that the material supplied passes all criteria. ONP-002 is supplied in pure form. As such, no excipients are present. Stability studies were performed by storing samples under carefully controlled conditions with respect to temperature and humidity.
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Among the recent iterations of coronaviruses to move from animal to human carriers is SARS-CoV-2, which, beginning in Wuhan, China, in late 2019, caused a global pandemic due to its rapid spread and the relatively high mortality rate (as compared to the seasonal influenza). Pfizer-BioNTech received approval from the U.S.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Related to Our Common Stock ● The issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders. ● We cannot assure we will continue to be listed on the NYSE American. ● Our financial results could vary significantly from quarter to quarter and are difficult to predict. ● Our Series A and Series B preferred stock, if not converted into common stock, has a distribution and liquidation preference senior to our common stock in liquidation which could negatively affect the value of our common stock and impair our ability to raise additional capital. ● The conversion of our Series A Preferred Stock, and Series B Preferred Stock and the exercise of currently outstanding warrants and options could result in significant dilution to the holders of our common stock. ● Certain provisions of our articles of incorporation, bylaws, executive employment agreements and stock option plan may prevent a change of control of our company that a shareholder may consider favorable. ● The price and volume of our common stock has been volatile and fluctuates substantially, which could result in substantial losses for stockholders. 33 ● We may be subject to securities litigation, which is expensive and could divert management attention. ● Future sales or issuances of our common stock in the public markets, or the perception of such sales, could depress the trading price of our common stock. ● The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified members for our Board of Directors. ● If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline. ● We will continue to incur significant costs as a result of and devote substantial management time to operating as a public company listed on the NYSE American. ● If securities or industry analysts publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline. ● We may issue debt or debt securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock. ● We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors. ● We have never paid cash dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.
Biggest change“Licenses Agreements”. ● We may not be able to protect our intellectual property and if we are unable to protect our trademarks or other intellectual property from infringement, our business prospects may be harmed. ● We may be subject to claims challenging the inventorship of our patents and other intellectual property rights. ● If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming and an unfavorable outcome in that litigation could have a material adverse effect on our business. ● Our success will depend on our ability to partner or sub-license our product candidates. ● Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely on could compromise our information and expose us to liability, reputational damage, or other costs. 29 ● Our product candidates are subject to substantial government regulation. ● We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. ● Delays or difficulties in the enrollment of patients in clinical trials may result in additional costs and delays. ● Any product candidates that we commercialize will be subject to ongoing and continued regulatory review and we may also be subject to healthcare laws, regulation and enforcement. ● Our product candidates may cause serious or undesirable side effects. ● Our employees, independent contractors, principal investigators, consultants, vendors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. ● Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of health care payers, physician and patient adoption and use necessary for commercial success. ● We may not be able to satisfy the continued listing standards of the NYSE American and may be delisted from the NYSE American. 30 ● The issuance of additional equity securities by us in the future will result in dilution and the conversion of our outstanding preferred stock will result in significant dilution. ● Our Series A and Series B preferred stock, if not converted into common stock, has a distribution and liquidation preference senior to our common stock in liquidation which could negatively affect the value of our common stock and impair our ability to raise additional capital. ● Certain provisions of our articles of incorporation, bylaws, executive employment agreements and stock option plan may prevent a change of control of our company that a shareholder may consider favorable. ● The price and volume of our common stock has been volatile and fluctuates substantially. ● The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified members for our Board of Directors. ● If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud, we previously identified a material weakness in our internal control over financial reporting, which has been remediated during the year ended December 31, 2023.
We have also issued shares of common stock and warrants in connection with previous private placements. Such shares are available for resale as well as certain of the shares of common stock issuable upon exercise of the warrants.
We have also issued shares of common stock and warrants in connection with previous private placements. Such shares are available for resale as well as certain shares of common stock issuable upon exercise of the warrants.
The laws and regulations that may affect our ability to operate include: ● the federal healthcare program anti-kickback statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the United States False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HIPAA, which prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (i.e., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; 64 ● HIPAA and related implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or ACA, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members, with such information published on a searchable website on an annual basis; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
The laws and regulations that may affect our ability to operate include: ● the federal healthcare program anti-kickback statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the United States False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HIPAA, which prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (i.e., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; ● HIPAA and related implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or ACA, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members, with such information published on a searchable website on an annual basis; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
The degree and rate of physician and patient adoption of our current or future product candidates, if approved, will depend on a number of factors, including: ● the clinical indications for which the product is approved and patient demand for approved products that treat those indications; ● the effectiveness of our product as compared to other available therapies; ● the availability of coverage and adequate reimbursement from managed care plans and other healthcare payors for any of our product candidates that may be approved; ● the cost of treatment with our product candidates in relation to alternative treatments and willingness to pay for the product, if approved, on the part of patients; ● acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment; ● physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications; ● overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications; ● proper training and administration of our product candidates by physicians and medical staff; ● patient satisfaction with the results and administration of our product candidates and overall treatment experience; ● the willingness of patients to pay for certain of our product candidates relative to other discretionary items, especially during economically challenging times; ● the revenue and profitability that our product candidate may offer a physician as compared to alternative therapies; ● the prevalence and severity of side effects; ● limitations or warnings contained in the FDA-approved labeling for our product candidates; ● any FDA requirement to undertake a REMS; ● the effectiveness of our sales, marketing and distribution efforts; ● adverse publicity about our product candidates or favorable publicity about competitive products; and ● potential product liability claims.
The degree and rate of physician and patient adoption of our current or future product candidates, if approved, will depend on a number of factors, including: ● the clinical indications for which the product is approved and patient demand for approved products that treat those indications; ● the effectiveness of our product as compared to other available therapies; ● the availability of coverage and adequate reimbursement from managed care plans and other healthcare payors for any of our product candidates that may be approved; ● the cost of treatment with our product candidates in relation to alternative treatments and willingness to pay for the product, if approved, on the part of patients; 60 ● acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment; ● physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications; ● overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications; ● proper training and administration of our product candidates by physicians and medical staff; ● patient satisfaction with the results and administration of our product candidates and overall treatment experience; ● the willingness of patients to pay for certain of our product candidates relative to other discretionary items, especially during economically challenging times; ● the revenue and profitability that our product candidate may offer a physician as compared to alternative therapies; ● the prevalence and severity of side effects; ● limitations or warnings contained in the FDA-approved labeling for our product candidates; ● any FDA requirement to undertake a REMS; ● the effectiveness of our sales, marketing and distribution efforts; ● adverse publicity about our product candidates or favorable publicity about competitive products; and ● potential product liability claims.
If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may: ● impose restrictions on the marketing or manufacturing of the product, suspend or withdraw product approvals or revoke necessary licenses; ● issue warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; ● mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners; ● require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; commence criminal investigations and prosecutions; ● impose injunctions; ● impose other civil or criminal penalties; 62 ● suspend any ongoing clinical trials; ● delay or refuse to approve pending applications or supplements to approved applications filed by us; ● refuse to permit drugs or active ingredients to be imported or exported to or from the United States; ● suspend or impose restrictions on operations, including costly new manufacturing requirements; or ● seize or detain products or require us to initiate a product recall.
If we, our product candidates, or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may: ● impose restrictions on the marketing or manufacturing of the product, suspend or withdraw product approvals or revoke necessary licenses; 56 ● issue warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; ● mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners; ● require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; commence criminal investigations and prosecutions; ● impose injunctions; ● impose other civil or criminal penalties; ● suspend any ongoing clinical trials; ● delay or refuse to approve pending applications or supplements to approved applications filed by us; ● refuse to permit drugs or active ingredients to be imported or exported to or from the United States; ● suspend or impose restrictions on operations, including costly new manufacturing requirements; or ● seize or detain products or require us to initiate a product recall.
Patients are unlikely to use our prescription-only products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products. In addition, the market for certain of our product candidates will depend significantly on access to third-party payors’ drug formularies, or lists of medications for which third-party payors provide coverage and reimbursement.
Patients are unlikely to use our prescription-only products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products. 61 In addition, the market for certain of our product candidates will depend significantly on access to third-party payors’ drug formularies or lists of medications for which third-party payors provide coverage and reimbursement.
As a public company listed on the NYSE American, we incurred and will continue to incur significant legal, accounting and other expenses that we did not incur before when trading on the OTCQB Marketplace. For example, we are subject to the rules and regulations required by the NYSE American, including changes in corporate governance practices and minimum listing requirements.
As a public company listed on the NYSE American, we incur and will continue to incur significant legal, accounting and other expenses that we did not incur before when trading on the OTCQB Marketplace. For example, we are subject to the rules and regulations required by the NYSE American, including changes in corporate governance practices and minimum listing requirements.
Also, any collaborations, strategic alliances, and marketing, distribution, or licensing arrangements may require us to give up some or all of our rights to a product candidate, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of our vaccine candidates remains uncertain.
Also, any collaborations, strategic alliances, and marketing, distribution, or licensing arrangements may require us to give up some or all of our rights to a product candidate, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of our product candidates remains uncertain.
Further, market conditions could require us to accept less favorable terms for the issuance of our securities in the future. We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
Further, market conditions could require us to accept less favorable terms for the issuance of our securities in the future. 68 We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Achieving and sustaining compliance with these laws may prove costly.
In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. 59 Achieving and sustaining compliance with these laws may prove costly.
In that case, the trading price of our stock could decline, and you may lose all or part of your investment. Risk Factor Summary The below summary of risk factors provides an overview of many of the risks we are exposed to in the normal course of our business activities.
In that case, the trading price of our stock could decline, and you may lose all or part of your investment. 26 Risk Factor Summary The below summary of risk factors provides an overview of many of the risks we are exposed to in the normal course of our business activities.
Alternatively, or in addition to the above, we may enter into strategic alliances or partnership with other vaccine industry entities to utilize their research, development, manufacturing, testing, regulatory or commercialization skills, but we may be unable to enter into such agreements on favorable terms, if at all.
Alternatively, or in addition to the above, we may enter into strategic alliances or partnership with other industry entities to utilize their research, development, manufacturing, testing, regulatory or commercialization skills, but we may be unable to enter into such agreements on favorable terms, if at all.
These companies have greater experience and expertise in securing government contracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, manufacturing such products on a broad scale and marketing approved products.
In particular, these companies have greater experience and expertise in securing government contracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, manufacturing such products on a broad scale and marketing approved products.
In addition, from time to time, certain of our shareholders may be eligible to sell all or some of their restricted shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144, subject to certain limitations.
In addition, from time to time, certain of our shareholders may be eligible to sell all or some of their restricted shares of common stock by means of ordinary brokerage transactions on the open market pursuant to Rule 144, subject to certain limitations.
An adverse determination in such case could put one or more of our patents at risk of being invalidated, interpreted narrowly or amended such that they fail to cover or otherwise protect our product candidates.
An adverse determination in such a case could put one or more of our patents at risk of being invalidated, interpreted narrowly or amended such that they fail to cover or otherwise protect our product candidates.
There can be no assurance that our independent registered public accounting firm will not identify material weaknesses which could have an adverse effect on our stock price. 75 If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline.
There can be no assurance that our independent registered public accounting firm will not identify material weaknesses which could have an adverse effect on our stock price. 67 If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline.
Such competition could lead to reduced market share for our product candidates and contribute to downward pressure on the pricing of our product candidates, which could harm our business, financial condition, operating results and prospects.
Such competition could lead to a reduced market share for our product candidates and contribute to downward pressure on the pricing of our product candidates, which could harm our business, financial condition, operating results, and prospects.
In addition, a clinical trial may be suspended or terminated by us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring board, or DSMB, overseeing the clinical trial at issue, or other regulatory authorities due to a number of factors, including: ● failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; ● inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities; 59 ● inspection of manufacturing and drug packaging operations by regulatory authorities; ● unforeseen safety issues or lack of effectiveness; and ● lack of adequate funding to continue the clinical trial.
In addition, a clinical trial may be suspended or terminated by us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring board, or DSMB, overseeing the clinical trial at issue, or other regulatory authorities due to a number of factors, including: ● failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; ● inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities; 53 ● inspection of manufacturing and drug packaging operations by regulatory authorities; ● unforeseen safety issues or lack of effectiveness; and ● lack of adequate funding to continue the clinical trial.
Our new product development efforts may fail for many reasons, including: ● our recent entry into the vaccine research and development industry; ● failure of future tests at the research or development stages; ● lack of clinical validation data to support effectiveness; 41 ● delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner; ● regulatory delays at the FDA or from other independent oversight authorities, particularly in light of the demands placed on public health resources during and following the COVID-19 pandemic; ● failure to obtain or maintain necessary certifications, licenses, clearances or approvals to market or perform the test; or ● lack of commercial acceptance by the health care marketplace.
Our new product development efforts may fail for many reasons, including: ● our recent entry into the neurology research and development industry; ● failure of future tests at the research or development stages; ● lack of clinical validation data to support effectiveness; ● delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner; ● regulatory delays at the FDA or from other independent oversight authorities, particularly in light of the demands placed on public health resources during and following the COVID-19 pandemic; ● failure to obtain or maintain necessary certifications, licenses, clearances or approvals to market or perform the test; or ● lack of commercial acceptance by the health care marketplace.
Large and established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson, AstraZeneca, and Moderna, among others, compete in the vaccine market.
Large and established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson, AstraZeneca, and Moderna, among others, compete in the market.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed. 57 Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed. 51 Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs.
During our operating history, many essential responsibilities have been assigned to a relatively small number of individuals, and we currently depend heavily upon the efforts and abilities of our management team. However, as we advance into vaccine development, the demands on our key employees will expand and we will need to recruit additional qualified employees or consultants for our Company.
During our operating history, many essential responsibilities have been assigned to a relatively small number of individuals, and we currently depend heavily upon the efforts and abilities of our management team. However, as we advance into neurology development, the demands on our key employees will expand and we will need to recruit additional qualified employees or consultants for our Company.
In light of our recurring losses, accumulated deficit and negative cash flow as described in our notes to our audited consolidated financial statements, the report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2022 contained an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.
In light of our recurring losses, accumulated deficit and negative cash flow as described in our notes to our audited consolidated financial statements, the report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2023, contained an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.
Additionally, if we or others identify undesirable side effects, or other previously unknown problems, caused by our product candidates after obtaining U.S. or foreign regulatory approval or other products with the same or related active ingredients, a number of potentially negative consequences could result, including: ● regulatory authorities may withdraw their approval of the product; ● regulatory authorities may require a recall of the product or we may voluntarily recall a product; ● regulatory authorities may require the addition of warnings or contraindications in the product labeling, narrowing of the indication in the product label or issuance of field alerts to physicians and pharmacies; ● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or institute a REMS; ● we may be subject to limitations as to how we promote the product; ● we may be required to change the way the product is administered or modify the product in some other way; ● the FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product; ● sales of the product may decrease significantly; ● we could be sued and held liable for harm caused to patients; and ● our brand and reputation may suffer.
Additionally, if we or others identify undesirable side effects, or other previously unknown problems, caused by our product candidates after obtaining U.S. or foreign regulatory approval or other products with the same or related active ingredients, a number of potentially negative consequences could result, including: ● regulatory authorities may withdraw their approval of the product; ● regulatory authorities may require a recall of the product or we may voluntarily recall a product; ● regulatory authorities may require the addition of warnings or contraindications in the product labeling, narrowing of the indication in the product label or issuance of field alerts to physicians and pharmacies; 57 ● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or institute a risk evaluation and mitigation strategy, or REMS; ● we may be subject to limitations as to how we promote the product; ● we may be required to change the way the product is administered or modify the product in some other way; ● the FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product; ● sales of the product may decrease significantly; ● we could be sued and held liable for harm caused to patients; and ● our brand and reputation may suffer.
In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the scope and value of patents, once obtained. 53 For our U.S. patent applications containing a priority claim after March 16, 2013, there is a greater level of uncertainty in the patent law.
In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the scope and value of patents, once obtained. 47 For our U.S. patent applications containing a priority claim after March 16, 2013, there is a greater level of uncertainty in the patent law.
Limited data exist regarding the safety and efficacy of our vaccine product candidate, and we must conduct a substantial amount of additional research, development and clinical testing before any regulatory authority will approve our vaccine product candidate. The success of our efforts to develop and commercialize our product candidates could fail for a number of reasons.
Limited data exist regarding the safety and efficacy of our concussion product candidate, and we must conduct a substantial amount of additional research, development and clinical testing before any regulatory authority will approve our concussion product candidate. The success of our efforts to develop and commercialize our product candidates could fail for a number of reasons.
For example, we could experience delays in product development and clinical trials or unsatisfactory clinical trial results. In addition, adverse events, or the perception of adverse events, relating to a vaccine product candidate administered intranasally and delivery technologies may negatively impact our ability to develop commercially successful products.
For example, we could experience delays in product development and clinical trials or unsatisfactory clinical trial results. In addition, adverse events, or the perception of adverse events, relating to a concussion product candidate administered intranasally and delivery technologies may negatively impact our ability to develop commercially successful products.
To the extent that outstanding stock options or warrants have been or may be exercised or other shares issued, stockholders may experience further dilution. 74 If we make one or more significant acquisitions in which the consideration includes stock or other securities, our stockholders’ holdings may be significantly diluted.
To the extent that outstanding stock options or warrants have been or may be exercised or other shares issued, stockholders may experience further dilution. 66 If we make one or more significant acquisitions in which the consideration includes stock or other securities, our stockholders’ holdings may be significantly diluted.
These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 54 The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals.
These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 48 The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals.
The conversion of our Series A Preferred Stock and Series B Preferred Stock, as well as the exercise of our outstanding warrants could result in significant dilution to existing common shareholders, adversely affect the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities.
The conversion of our Series A Preferred Stock, Series B Preferred Stock, and Series F Preferred Stock; as well as the exercise of our outstanding warrants will result in significant dilution to existing common shareholders and could adversely affect the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities.
We may rely on government funding and collaboration with government entities for our vaccine development, which adds uncertainty to our research and development efforts and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
We may rely on government funding and collaboration with government entities for our product development, which adds uncertainty to our research and development efforts and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
If we cannot raise the additional funds required for our anticipated operations or to support our development efforts, we may be required to delay significantly, reduce the scope of or eliminate one or more of our research or development programs, downsize our organization, or seek alternative measures to avoid insolvency, including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies or our vaccine candidate.
If we cannot raise the additional funds required for our anticipated operations or to support our development efforts, we may be required to delay significantly, reduce the scope of or eliminate one or more of our research or development programs, downsize our organization, or seek alternative measures to avoid insolvency, including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies or our concussion drug candidate.
If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to progress at a slower pace, or not at all, and our business could be adversely affected.
If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our business could be adversely affected.
In order to effectively compete, we will have to make substantial investments in development, testing, manufacturing and sales and marketing or partner with one or more established companies. We may not be successful in gaining any market share for any vaccine.
In order to effectively compete, we will have to make substantial investments in development, testing, manufacturing and sales and marketing or partner with one or more established companies. We may not be successful in gaining any market share.
Any divestiture we undertake could adversely affect our results of operations. 49 We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
Any divestiture we undertake could adversely affect our results of operations. 43 We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
We cannot assure you that we will continue to be listed on the NYSE American. Our common stock commenced trading on the NYSE American formerly the NYSE MKT) on April 10, 2013, and we are subject to certain NYSE American continued listing requirements and standards.
Risks Related to Our Common Stock We cannot assure you that we will continue to be listed on the NYSE American. Our common stock commenced trading on the NYSE American (formerly the NYSE MKT) on April 10, 2013, and we are subject to certain NYSE American continued listing requirements and standards.
Decreased disclosures in our SEC filings due to our status a “smaller reporting company” may make it harder for investors to analyze our operating results and financial prospects. 76 We do not intend to pay cash dividends.
Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our operating results and financial prospects. We do not intend to pay cash dividends.
Our vaccine product candidate, even if safe and effective, could be difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their competing products. Accordingly, our inability to develop a commercially-successful vaccine product will materially harm our business.
Our concussion drug product candidate, even if safe and effective, could be difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their competing products. Accordingly, our inability to develop a commercially successful concussion product will materially harm our business.
Additionally, our ability to develop an effective vaccine will depend on our ability to work on an accelerated timeline, with uncertain access to financial resources beyond those that we currently possess, and in competition with a significant number of better-funded and more experienced vaccine-development companies.
Additionally, our ability to develop an effective concussion drug will depend on our ability to work on an accelerated timeline, with uncertain access to financial resources beyond those that we currently possess, and in competition with a significant number of better-funded and more experienced development companies.
The number of clinical trial participants in the United States, Europe, and elsewhere may turn out to be lower than expected, potential clinical trial participants may not be otherwise amenable to treatment with our products, or new clinical trial participants may become increasingly difficult to identify or gain access to, all of which would adversely affect our ability to conduct the research and development necessary to complete the vaccine product candidate.
The number of clinical trial participants in the United States, Australia, and elsewhere may turn out to be lower than expected, potential clinical trial participants may not be otherwise amenable to treatment with our products, or new clinical trial participants may become increasingly difficult to identify or gain access to, all of which would adversely affect our ability to conduct the research and development necessary to complete the concussion product candidate.
Regardless of the veracity of or the data supporting these claims, these and other claims may influence public perception of the use of vaccine product candidates and could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential vaccine product candidate.
Regardless of the veracity of or the data supporting these claims, these and other claims may influence public perception of the use of intranasal delivery product candidates and could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential product candidate.
In addition to our outstanding shares of preferred stock, as of December 31, 2022, there were currently outstanding warrants to purchase 275,990 shares of our common stock.
In addition to our outstanding shares of preferred stock, as of December 31, 2023, there were currently outstanding warrants to purchase 275,990 shares of our common stock.
We anticipate seeking such additional funds through a combination of public or private equity or debt financings, as well as potential collaborations, strategic alliances and marketing, distribution or licensing arrangements and non-dilutive funding from government and nongovernment funding entities, as well as other sources to further the research, development, manufacturing, testing, and regulatory approval of vaccine product candidates.
We anticipate seeking such additional funds through a combination of public or private equity or debt financings, as well as potential collaborations, strategic alliances and marketing, distribution or licensing arrangements and non-dilutive funding from government and nongovernment funding entities, as well as other sources to further the research, development, manufacturing, testing, and regulatory approval our concussion drug product.
We may not be able to initiate or continue, or complete in a timely fashion clinical trials for NT-CoV2-1 or our other product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States.
We may not be able to initiate, or continue, or complete in a timely fashion clinical trials for ONP-002 or our other product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States.
In addition to other risk factors discussed in this section, factors that may contribute to the variability of our quarterly results include: ● Our use of available cash resources; ● decisions by us to continue to pursue research and development and incur additional expenses, such as commencing a clinical trial or increases in research and development with our current product candidate; ● the timing of release of pre-clinical and clinical trial results and new products and services by our competitors, particularly those that may represent a significant portion of revenues in any given period; ● the popularity of new products, and products released in prior periods; ● changes by our competitors; 71 ● our success in entering new geographic markets; ● the level of expenses associated with our regulatory applications or compliance and clinical trials; and ● the timing of compensation expense associated with equity compensation grants.
In addition to other risk factors discussed in this section, factors that may contribute to the variability of our quarterly results include: ● Our use of available cash resources; ● decisions by us to continue to pursue research and development and incur additional expenses, such as commencing a clinical trial or increases in research and development with our current product candidate; ● the timing of release of pre-clinical and clinical trial results and new products and services by our competitors, particularly those that may represent a significant portion of revenues in any given period; ● changes by our competitors; ● the level of expenses associated with our regulatory applications or compliance and clinical trials; and ● the timing of compensation expense associated with equity compensation grants.
To successfully develop our NT-CoV2-1 vaccine product candidate, we will need to dedicate significant amounts of our limited financial and management resources to bolster our expertise in this area. Our success depends significantly on the continued contributions of our executive officers, financial, scientific and technical personnel and consultants, and on our ability to attract additional personnel.
To successfully develop our neurology product candidate, we will need to dedicate significant amounts of our limited financial and management resources to bolster our expertise in this area. Our success depends significantly on the continued contributions of our executive officers, financial, scientific and technical personnel and consultants, and on our ability to attract additional personnel.
The commencement or completion of nonclinical studies or clinical trials can be delayed or prevented for a number of reasons, including: ● an inability to raise sufficient capital to commence, conduct, or complete pre-clinical testing and clinical trials; ● insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials; ● difficulties in finding a partner with the resources to support large and expensive clinical development and commercialization costs; ● findings in nonclinical trials; ● difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial; ● delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● difficulties obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; ● challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including the size and nature of patient population, proximity of patients to clinical sites, eligibility criteria for the trial, nature of the trial protocol, the availability of approved effective treatments for the relevant condition and competition from other clinical trial programs for similar indications; ● limitations directly caused by, or restrictions imposed in response to, the COVID-19 pandemic, including our ability to conduct research and development and clinical trials, to engage or continue to engage with third-party contractors and suppliers or to comply with regulatory obligations relating to our business; ● severe or unexpected drug or biologic-related side effects experienced by patients in a clinical trial; and ● difficulties retaining patients who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the trial, lack of efficacy, side effects, or personal issues, or who are lost to further follow up.
The commencement or completion of nonclinical studies or clinical trials can be delayed or prevented for a number of reasons, including: ● an inability to raise sufficient capital to commence, conduct, or complete pre-clinical testing and clinical trials; ● insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials; ● difficulties in finding a partner with the resources to support large and expensive clinical development and commercialization costs; ● findings in nonclinical trials; ● difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial; ● delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● difficulties obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; ● challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including the size and nature of patient population, proximity of patients to clinical sites, eligibility criteria for the trial, nature of the trial protocol, the availability of approved effective treatments for the relevant condition and competition from other clinical trial programs for similar indications; ● severe or unexpected drug or biologic-related side effects experienced by patients in a clinical trial; and ● difficulties retaining patients who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the trial, lack of efficacy, side effects, or personal issues, or who are lost to further follow up.
In the event that any of the pre-clinical research or, if an IND is accepted by the FDA, the Phase 1 clinical trials for our SARS-CoV-2 vaccine product candidate are perceived to be successful, we may need to work toward the large-scale technical development, manufacturing scale-up and larger scale deployment of this potential vaccine through a variety of U.S. government-sponsored mechanisms, such as an Expanded Access Program or an Emergency Use Authorization program.
In the event that any of the pre-clinical research or, if an IND is accepted by the FDA, the Phase II clinical trials for our concussion treatment product candidate are perceived to be successful, we may need to work toward the large-scale technical development, manufacturing scale-up and larger scale deployment of this potential treatment through a variety of U.S. government-sponsored mechanisms, such as an Expanded Access Program or an Emergency Use Authorization program.
Our commercial success depends upon our ability to develop, manufacture, market, and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We cannot guarantee that marketing and selling such candidates and using such technologies will not infringe existing or future patents.
Our commercial success depends upon our ability to develop, manufacture, market, and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We cannot guarantee that engaging in such actions and using such technologies will not infringe existing or future patents.
We believe we can continue our current level of operations with the cash we have on hand without additional financing through 2023. Absent sufficient additional financing, we may be unable to remain a going concern.
We believe we can continue our current level of operations with the cash we have on hand without additional financing through the second quarter of 2024. Absent sufficient additional financing, we may be unable to remain a going concern.
We may be unable to obtain regulatory approval for our SARS-CoV-2 vaccine product candidate, or other early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates.
We may be unable to obtain regulatory approval for our concussion candidate, or other early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates.
We may be subject to securities litigation, which is expensive and could divert management attention. The market price of our common stock has been in the past and may continue to be volatile. In the past, other publicly-traded companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation.
We may be subject to securities litigation, which is expensive and could divert management attention. In the past, other publicly traded companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation.
In addition, if we are unable to successfully remediate the material weakness or if we are unable to produce accurate consolidated financial statements in the future, our stock price, liquidity and access to the capital markets may be adversely affected and we may be unable to maintain compliance with applicable stock exchange listing requirements.
In addition, if we are unable to produce accurate consolidated financial statements in the future, our stock price, liquidity and access to the capital markets may be adversely affected and we may be unable to maintain compliance with applicable stock exchange listing requirements.
We do not expect to generate revenue from product sales, licensing fees, royalties, milestones, contract research or other sources of funds in amounts sufficient to fully fund our operations for the foreseeable future, and we will therefore use our cash resources, and expect to require additional funds, to maintain our existing operations, continue our research and development programs, commence future pre-clinical studies and clinical trials for our NT-CoV2-1 vaccine product candidate, and to seek regulatory approvals.
We do not expect to generate revenue from product sales, licensing fees, royalties, milestones, contract research or other sources of funds in amounts sufficient to fully fund our operations for the foreseeable future, and we will therefore use our cash resources, and expect to require additional funds, to maintain our existing operations, continue our research and development programs, commence Phase II clinical studies and clinical trials for our ONP-002 product candidate, and to seek regulatory approvals.
Our management believes that, given the significance of these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued.
Our management believes that, given the significance of these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the d ate that these financials statements are issued.
Developing and commercializing biopharmaceutical products, including conducting nonclinical studies and clinical trials and establishing manufacturing capabilities, and the progress of our efforts to develop and commercialize our product candidates, is expensive, and can cause us to use our limited, available capital resources faster than we currently anticipate.
Developing and commercializing biopharmaceutical products, including Phase 2 work for our ONP-002 product candidate and conducting nonclinical studies and clinical trials and establishing manufacturing capabilities, and the progress of our efforts to develop and commercialize our product candidates, is expensive, and can cause us to use our limited, available capital resources faster than we currently anticipate.
The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates.
The FDA and foreign regulatory bodies have substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of product candidates for many reasons.
Any future determination as to the payment of cash dividends on our capital stock will be at our Board of Directors’ discretion and will depend on our financial condition, operating results, capital requirements and other factors that our Board of Directors considers to be relevant.
Any future determination as to the payment of cash dividends on our capital stock will be at our Board of Directors’ discretion and will depend on our financial condition, operating results, capital requirements and other factors that our Board of Directors considers to be relevant. ITEM 1B. UNRESOLVED STAFF COMMENTS. None.
Alternatively, even if a market exists, our vaccine product candidate could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances.
Even if a market exists, our concussion drug product candidate could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances.
Furthermore, if we raise additional capital by issuing equity securities, dilution to our existing stockholders would result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common stock.
Furthermore, if we raise additional funds by issuing equity securities, dilution to our existing stockholders could result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common and preferred stock.
If our future strategic collaborators do not commit sufficient resources to our alliances or partnerships and the progress of our vaccine development, if any, and we are unable to develop the necessary capabilities on our own, we may be unable to advance the development of our NT-CoV2-1 vaccine product candidate to the point of commercialization, even if we obtain regulatory approval.
If our future strategic collaborators do not commit sufficient resources to our alliances or partnerships and the progress of our development, if any, and we are unable to develop the necessary capabilities on our own, we may be unable to advance the development of our neurology asset product candidates to the point of commercialization, even if we obtain regulatory approval.
The outcome of any research and development program is highly uncertain. Only a small fraction of biotechnology and vaccine development programs ultimately result in commercial products or even product candidates and a number of events could delay our development efforts and negatively impact our ability to obtain regulatory approval for, and to manufacture, market and sell, a nasally administered vaccine.
Only a small fraction of biotechnology development programs ultimately result in commercial products or even product candidates and a number of events could delay our development efforts and negatively impact our ability to obtain regulatory approval for, and to manufacture, market and sell, a nasally administered vaccine.
These provisions include: ● authorization of the issuance of “blank check” preferred stock that could be issued by our Board of Directors without shareholder approval and that may be substantially dilutive or contain preferences or rights objectionable to an acquirer; ● the ability of our Board of Directors to amend the bylaws without shareholder approval; ● vacancies on our Board may only be filled by the remaining Directors and not our shareholders; 72 ● requirements that only our Board, our President or holders of more than 10% of our shares can call a special meeting of shareholders; ● obligations to make certain payments under executive employment agreements in the event of a change of control and termination of employment; and ● immediate vesting of all outstanding stock options.
These provisions include: ● authorization of the issuance of “blank check” preferred stock that could be issued by our Board of Directors without shareholder approval and that may be substantially dilutive or contain preferences or rights objectionable to an acquirer; ● the ability of our Board of Directors to amend the bylaws without shareholder approval; ● vacancies on our Board may only be filled by the remaining Directors and not our shareholders; ● requirements that only our Board, our President or holders of more than 10% of our shares can call a special meeting of shareholders; ● obligations to make certain payments under executive employment agreements in the event of a change of control and termination of employment; and ● immediate vesting of all outstanding stock options. 64 As a result, these provisions could discourage bids for our common stock at a premium and limit the price that investors are willing to pay in the future for shares of our common stock.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as our right to use intellectual property that is important to our NT-CoV2-1 vaccine product candidate.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as our right to use intellectual property that is important to our product candidate development and commercialization.
Our product and product candidates are protected by patents and patent applications. Our success depends in part on our ability to obtain patents or rights to patents, protect trade secrets, operate without infringing upon the proprietary rights of others, and prevent others from infringing on our patents, trademarks and other intellectual property rights.
Our success depends in part on our ability to obtain patents or rights to patents, protect trade secrets, operate without infringing upon the proprietary rights of others, and prevent others from infringing on our patents, trademarks and other intellectual property rights.
Our current projections of both the number of people who are or will be affected by this disease, as well as the subset of people who may be affected by this disease and who have the potential to benefit from immunity through our NT-CoV2-1 vaccine product candidate, are based on estimates.
Our current projections of both the number of people who are or will be affected by this disease, as well as the subset of people who may be affected by this disease and who have the potential to benefit from treatment through our ONP-002 product candidate are based on estimates.
Depending on the opportunities available, we may increase the amount of capital invested in such opportunities. We may not succeed in completing targeted transactions, including as a result of the market becoming increasingly competitive, or achieve desired results of operations. Furthermore, we face risks in successfully integrating any businesses we might acquire or create through a joint venture.
We may not succeed in completing targeted transactions, including as a result of the market becoming increasingly competitive, or achieve desired results of operations. Furthermore, we face risks in successfully integrating any businesses we might acquire or create through a joint venture.
Because our new NT-CoV2-1 vaccine product candidate is in early stages of development, and contemplates nasal administration it will require extensive pre-clinical and clinical testing, and we will need significant additional funding to conduct such research and testing.
Because our new ONP-002 concussion drug product candidate is in early stages of development and contemplates nasal administration it will require extensive pre-clinical and clinical testing, and we will need significant additional funding to conduct such research and testing.
Should we be affected by such an incident, we may incur substantial costs and suffer other negative consequences, which may include: ● investigation costs and costs to engage specialized consultants or costs of ransom demands; ● remediation costs, such as liability for stolen assets or information, repairs of system damage, and incentives to customers or business partners in an effort to maintain relationships after an attack; and ● litigation and legal risks, including regulatory actions by state and federal regulators.
Should we be affected by such an incident, we may incur substantial costs and suffer other negative consequences, which may include: ● investigation costs and costs to engage specialized consultants or costs of ransom demands; ● remediation costs, such as liability for stolen assets or information, repairs of system damage, and incentives to customers or business partners in an effort to maintain relationships after an attack; and ● litigation and legal risks, including regulatory actions by state and federal regulators. 52 Risks Related to Government Regulations Our product candidates are subject to substantial government regulation, including the regulation of nonclinical testing and clinical trials.
Although, in connection with the acquisition, we added experienced vaccine researchers and consultants and appointed an experienced vaccine industry professional to our Board of Directors, given our size and current pre-clinical stage of development, we still have limited vaccine-specific research, development, manufacturing, testing, regulatory, commercialization, sales, distribution, and marketing experience.
Although, in connection with the acquisition, we added experienced neurology researchers and consultants, given our size and current pre-clinical stage of development, we still have limited neurology-specific research, development, manufacturing, testing, regulatory, commercialization, sales, distribution, and marketing experience.
If our remedial measures are insufficient to address the material weakness, or if additional material weaknesses or significant deficiencies in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements may contain misstatements and we could be required to restate our financial results.
Although we have completed our remediation of the material weakness, if additional material weaknesses or significant deficiencies in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements may contain misstatements and we could be required to restate our financial results.
We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of approximately $14.3 million and $15.7 million for the years ended December 31, 2022, and 2021, respectively. As of December 31, 2022, our accumulated deficit was approximately $185.6 million.
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.
If we raise additional funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock, and the terms of the debt securities issued could impose significant restrictions on our operations.
If we raise additional funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock, and the terms of the debt securities issued could impose significant restrictions on our operations. Additionally, future offerings also could have a material and adverse effect on the price of our common stock.
The conversion of our Series A Preferred Stock, and Series B Preferred Stock and the exercise of currently outstanding warrants could result in significant dilution to the holders of our common stock. The holders of our Series A Preferred Stock and Series B Preferred Stock may convert their shares of preferred stock into shares of common stock.
The conversion of our Series A Preferred Stock, Series B Preferred Stock, Series F Preferred Stock, and the exercise of currently outstanding warrants could result in significant dilution to the holders of our common stock.
These factors include: ● results of preclinical and clinical studies of our product candidates or those of our competition; ● regulatory or legal developments in the U.S. and other countries, especially changes in laws and regulations applicable to our product candidates; ● actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and marketing terms; ● introductions and announcements of new products by us or our competitors, and the timing of these introductions or announcements; ● announcements by us or our competitors of significant acquisitions or other strategic transactions or capital commitments; ● fluctuations in our quarterly operating results or the operating results of our competitors; ● variance in our financial performance from the expectations of investors; ● changes in the estimation of the future size and growth rate of our markets; ● changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results; ● failure of our products to achieve or maintain market acceptance or commercial success; ● conditions and trends in the markets we serve; ● changes in general economic, industry and market conditions; ● changes in legislation or regulatory policies, practices or actions; ● the commencement or outcome of litigation involving our company, our general industry or both; 73 ● recruitment or departure of key personnel; ● changes in our capital structure, such as future issuances of securities, redemption or conversion of preferred stock or the incurrence of additional debt; ● actual or expected sales of our common stock by our stockholders; ● acquisitions and financings; and ● the trading volume of our common stock; Our stock price has been, and in the future may be, subject to substantial volatility.
Factors that impact our trading price include: ● results of preclinical and clinical studies of our product candidates or those of our competition, including i nformation related to our development, manufacturing, and distribution efforts with respect to ONP-002, or information regarding such efforts by competitors with respect to their products, may also impact our stock price; ● regulatory or legal developments in the U.S. and other countries, especially changes in laws and regulations applicable to our product candidates; ● actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and marketing terms; ● introductions and announcements of new products by us or our competitors, and the timing of these introductions or announcements; ● announcements by us or our competitors of significant acquisitions or other strategic transactions or capital commitments; ● fluctuations in our quarterly operating results or the operating results of our competitors; ● variance in our financial performance from the expectations of investors; ● changes in the estimation of the future size and growth rate of our markets; ● changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results; ● failure of our products to achieve or maintain market acceptance or commercial success; ● conditions and trends in the markets we serve; ● changes in general economic, industry and market conditions; ● changes in legislation or regulatory policies, practices or actions; ● the commencement or outcome of litigation involving our company, our general industry or both; ● recruitment or departure of key personnel; 65 ● changes in our capital structure, such as future issuances of securities, redemption or conversion of preferred stock or the incurrence of additional debt; ● actual or expected sales of our common stock by our stockholders; ● acquisitions and financings; and ● the trading volume of our common stock; The stock markets, in general, NYSE American and the market for biotech companies in particular, may experience a loss of investor confidence.
Accordingly, there can be no assurance that we will be able to successfully establish a competitive market share for our NT-CoV2-1 vaccine product candidate.
Accordingly, there can be no assurance that we will be able to successfully establish a competitive market share for our concussion treatment product candidate.
We also accumulated U.S. federal and state research tax credits of approximately $4,834,850 as of December 31, 2022 Under Sections 382 and 383 of the Internal Revenue Code (the “Code”), if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research tax credits, to offset its post-ownership change income and taxes may be limited.
Under Sections 382 and 383 of the Internal Revenue Code (the “Code”), if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research tax credits, to offset its post-ownership change income and taxes may be limited.
For example, our stock traded within a range of a high volume of 3,900,007 and a low volume of 7,362 per share for the period of January 1, 2022, through December 31, 2022. As a result of this volatility, our stockholders could incur substantial losses.
Furthermore, our stock traded within a range of a high volume of 313,400 and a low volume of 900 per share for the period of January 1, 2023, through December 31, 2023. As a result of this volatility, our stockholders could incur substantial losses.
Our present and future funding requirements will depend on many factors, including: ● the level of research and development investment budgeted to develop our current and future product candidates through each phase of development; ● the timing, scope, progress, results and cost of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials, including any impacts related to the COVID-19 pandemic; ● costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; ● our need or decision to acquire or license complementary technologies or acquire complementary businesses; ● changes in test development plans needed to address any difficulties in product candidate selection for commercialization; ● competing vaccines and technological and market developments; ● our interaction and relationship with the FDA, or other, regulatory agencies; and ● changes in regulatory policies or laws that affect our operations.
Our present and future funding requirements will depend on many factors, including: ● the level of research and development investment budgeted to develop our current and future product candidates through each phase of development; ● the timing, scope, progress, results and cost of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials. ● costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; ● our need or decision to acquire or license complementary technologies or acquire complementary businesses; ● changes in test development plans needed to address any difficulties in product candidate selection for commercialization; ● competing neurological, vaccine and technological and market developments; ● our interaction and relationship with the FDA, or other, regulatory agencies; and ● changes in regulatory policies or laws that affect our operations. 32 In addition, we have previously discontinued and could be forced to discontinue future product development and commercialization of one or more of our product candidates, curtail or forego sales and marketing efforts, and/or forego licensing attractive business opportunities.
We have no control or input over whether an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide investors with any assurances that we will receive such funding. 36 Similar to the requirements imposed by our new NIH license, contracts and grants funded by the U.S. government and its agencies, contain provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: ● reduce or modify the government’s obligations under such agreements without the consent of the other party; ● claim rights, including IP rights, in products and data developed under such agreements; ● audit contract-related costs and fees, including allocated indirect costs; ● suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations; ● impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; ● suspend or debar the contractor or grantee from doing future business with the government; ● control and potentially prohibit the export of products; ● pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and ● limit the government’s financial liability to amounts appropriated by the U.S.
Additionally, contracts and grants funded by the U.S. or foreign governments and their agencies, contain provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: ● reduce or modify the government’s obligations under such agreements without the consent of the other party; ● claim rights, including IP rights, in products and data developed under such agreements; ● audit contract-related costs and fees, including allocated indirect costs; ● suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations; ● impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; 33 ● suspend or debar the contractor or grantee from doing future business with the government; ● control and potentially prohibit the export of products; ● pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and ● limit the government’s financial liability to amounts appropriated by the U.S.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe lease expires on February 29, 2024. In addition to our Tampa location, we continue to lease our research facility located at 13700 Progress Boulevard, Alachua, Florida 32615. The facility is approximately 5,300 square feet of which approximately 60% is laboratory space and the remainder is office space and common areas.
Biggest changeThe facility was approximately 5,300 square feet of which approximately 60% was used for laboratory space and the remainder was used as office space and common areas. In September of 2023, we terminated the lease for the Alachua facility.
ITEM 2. PROPERTIES. We lease approximately 2,207 square feet for our corporate offices located at 4902 Eisenhower Boulevard, Suite 125, Tampa, Florida 33634. Lease payments range from $4,138 per month to $4,392 per month inclusive of insurance, taxes and utilities. The lease costs for the year ended December 31, 2022 were approximately $65,000 which includes insurance, taxes and utilities.
ITEM 2. PROPERTIES. We leased approximately 2,207 square feet for our corporate offices located at 4902 Eisenhower Boulevard, Suite 125, Tampa, Florida 33634. Lease payments per month are inclusive of insurance, taxes and utilities. The lease expired on February 28, 2024, as we elected not to renew it.
The lease costs for the year ended December 31, 2022 were approximately $166,000 which includes insurance, taxes and utilities. Lease payments are capped during the term.
Lease costs for the Alachua facility for the year ended December 31, 2023, include insurance, taxes, utilities, and a one-time early termination fee of approximately $162,000.
Removed
In November of 2019, the Company entered into an amendment for the office space in Tampa to extend the term for an additional three years beginning in March of 2020. Under the amended lease agreement, the rental payments are expected to range from $4,524 per month to $4,800 per month.
Added
In addition to our Tampa location, we leased space at 13700 Progress Boulevard, Alachua, Florida 32615, the space was used as our research facility where some of the research and development for our lantibiotics program was completed.
Removed
In August of 2022, the Company entered into an amendment for the leased office space for corporate personnel located in Tampa, FL. The amended lease is for approximately 2,207 square feet. The lease period for the office space is for twelve months commencing on March 1, 2023. Lease payments are $4,944 per month inclusive of insurance, taxes and utilities.
Removed
In June of 2019, the Company entered into an amendment to our lease for the Alachua facility to provide for a term of five years beginning at the end of the existing lease term in December of 2019. Under the amended lease agreement, the rental payments range from $12,870 per month to $13,338 per month.
Removed
The lease may be terminated prior to its stated expiration date upon the payment of nine-months rent.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeITEM 4. MINE SAFETY DISCLOSURES 77 PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 78 ITEM 6. RESERVED 78 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 79
Biggest changeITEM 4. MINE SAFETY DISCLOSURES 69 PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 70 ITEM 6. RESERVED 70 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 70

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeUnregistered Sale Of Equity Securities And Use Of Proceeds None. Stock Repurchases in the Fourth Quarter There were no purchases of our common stock during the three months ended December 31, 2022.
Biggest changeUnregistered Sale of Equity Securities and Use of Proceeds None, other than reported in Current Reports on Form 8-K. Stock Repurchases in the Fourth Quarter There were no purchases of our common stock during the three months ended December 31, 2023.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our common stock is quoted on the NYSE American under the ticker symbol “OGEN”. The last price of our common stock as reported on the NYSE American on April 14, 2023 was $3.14 per share.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our common stock is quoted on the NYSE American under the ticker symbol “OGEN”. The last price of our common stock as reported on the NYSE American on March 26, 2024 was $1.41 per share.
As of April 14, 2023, there were approximately 66 stockholders of record of our common stock. This number does not include beneficial owners from whom shares are held by nominees in street name such as banks and brokerage firms.
As of March 26, 2024, there were approximately 40 stockholders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name such as banks and brokerage firms.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe recorded grant revenue of $131,521 for the year ended December 31, 2022 compared to $86,987 for the year ended December 31, 2021; an increase of $44,534, or 100.0%. This increase was attributable to the award of a small business innovation research grant and periodic drawdowns against the grant. Research and Development.
Biggest changeThis decrease was attributable to a small business innovation research grant awarded in 2021 that expired in July of 2023 generating 7 months of revenue for the year ended December 31, 2023, as compared to 12 months of revenue for year ended December 31, 2022. Research and Development.
The Series A and Series B Preferred Stock is classified as permanent equity. Each of the Series A and Series B Preferred Stock have redemption rights to the extent we have funds legally available therefore, at any time after the fifth anniversary of the original issue date of the applicable Series A and Series B Preferred Stock.
The Preferred Stock is classified as permanent equity. Each of the Series A and Series B Preferred Stock have redemption rights to the extent we have funds legally available therefore, at any time after the fifth anniversary of the original issue date of the applicable series of Preferred Stock.
To the extent the stock option grants or warrants do not vest at the grant date they are subject to forfeiture. Stock-Based Compensation U.S. Generally Accepted Accounting Principles (“US GAAP”) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date.
To the extent the stock option grants or warrants do not vest at the grant date they are subject to forfeiture. 77 Stock-Based Compensation U.S. Generally Accepted Accounting Principles (“US GAAP”) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date.
We expense research and development costs as incurred. 83 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.
We expense research and development costs as incurred. 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.
Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designations), the holders of Series A and Series B Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares of Series A and Series B Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation (as defined in the Certificate of Designations) in respect of Common Stock issuable upon conversion of such shares of Series A and Series B Preferred Stock if all outstanding shares of Series A and Series B Preferred Stock were converted into Common Stock immediately prior to the Liquidation.
Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designation), the holders of the Series A and Series B Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares of preferred stock then held by such holder, multiplied by the Original Issue Price of such series of stock; and (ii) the amount that would be payable to such holder in the Liquidation (as defined in the Certificate of Designation) in respect of Common Stock issuable upon conversion of such shares of Preferred Stock if all outstanding shares of the Preferred Stock were converted into Common Stock immediately prior to the Liquidation.
However, as long as any shares of Series A and Series B Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A and Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A or Series B Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A and Series B Preferred Stock, (c) increase the number of authorized shares of Series A and Series B Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing.
However, as long as any shares of the Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders the Preferred Stock, (c) increase the number of authorized shares of Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing.
A high percentage of hospital-acquired infections are caused by highly antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Gram-negative bacteria. We believe the need for novel antibiotics is increasing as a result of the growing resistance of target pathogens to existing FDA approved antibiotics on the market.
A high percentage of hospital-acquired infections are caused by highly antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus 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.
Financial Overview Grant revenue The Company was awarded a small business innovation research grant during the third quarter of 2021 in the amount of $250,000 (“Computer-aided Design for Improved Lantibiotics” R41GM136034) for the Company’s continued research and development of lantibiotics, including its collaborative program with the Biomolecular Sciences Institute at FIU.
Grant revenue The Company was awarded a small business innovation research grant during the third quarter of 2021 in the amount of $250,000 (“Computer-aided Design for Improved Lantibiotics” R41GM136034) for the Company’s continued research and development of lantibiotics, including its collaborative program with the Biomolecular Sciences Institute at FIU.
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. 89 Our current available cash and cash equivalents provide us with limited liquidity.
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. 81 Our current available cash and cash equivalents provide us with limited liquidity.
Sales of the Shares may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including, without limitation, sales made directly on or through the NYSE American.
Sales of the Shares could be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including, without limitation, sales made directly on or through the NYSE American.
Future Capital Requirements Our capital requirements for 2023 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.
Future Capital Requirements 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.
Directors’ and Officers’ Insurance On August 5, 2022, The Company entered into a short-term note payable for $528,429 bearing interest at 6.24% to finance a portion of the Directors’ and officers’ liability insurance and employment practices liability insurance premiums.
On August 5, 2022, we entered into a short-term note payable for $528,429 bearing interest at 6.24% to finance a portion of the Directors’ and officers’ liability insurance and employment practices liability insurance premiums.
In March 2022, following a positive assessment of a rabbit-based pilot study, we initiated a Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of NT-CoV2-1 in rabbits. This important preclinical study is designed to provide data required to advance our intranasal vaccine candidate into human clinical studies.
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.
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 will pursue the development of NT-CoV2-1 with Inspirevax’s novel BDX301 intranasal mucosal adjuvant.
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.
Over 60 lantibiotics have been discovered, to date. We believe lantibiotics are generally recognized by the scientific community to be potent antibiotic agents. 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.
We believe lantibiotics are generally recognized by the scientific community to be potent antibiotic agents. 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.
On February 24, 2023, we entered into an At the Market Offering Agreement with Ladenburg, Thalmann & Co., Inc. (the “Agent”), pursuant to which we may issue and sell, from time to time, shares of its common stock (the “Shares”), depending on market demand, with the Agent acting as the sales agent or principal (the “Offering”).
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 view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates. Recent Developments Positive Lantibiotics Results.
We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates. Recent Developments Odyssey Neurology Assets.
We believe our existing cash and cash equivalents, can allow us to fund our operating plan through the end of 2023. 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.
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.
We will need to raise additional capital to fund our operations. We anticipate that our cash resources as of December 31, 2022, will be sufficient to fund our operations as presently structured through the fourth quarter of 2023. There can be no assurance that additional capital will be available to us on acceptable terms, if at all.
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.
Our future funding requirements will depend on many factors, including, but not limited to: ● conduct pre-clinical research for our NT-CoV2-1 vaccine product candidate, file an IND with the FDA and, if approved, engage in Phase 1 clinical trials; ● identifying and securing clinical sites for the conduct of human trials for our product candidates; ● the determination to redeem all or any portion of our outstanding Series C Preferred Stock; ● the number and characteristics of the product candidates we pursue; ● the scope, progress, results and costs of researching and developing our product candidates, and conducting nonclinical and clinical trials including the research and development expenditures we expect to make in connection with agreements with third parties we put in place to advance our research and development efforts; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates; ● our ability to maintain current research and development licensing agreements and to establish new strategic partnerships, licensing or other arrangements and the financial terms of such agreements; ● our ability to achieve our milestones under our ECC agreement and licensing arrangements and the payment obligations we may have; ● the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and ● the timing, receipt and amount of sales of, or royalties on, our products and future products, if any.
Our future funding requirements will depend on many factors, including, but not limited to: ● conduct Phase II clinical trials for our ONP-002 product candidate, file an IND with the FDA and, if approved, engage in Phase III clinical trials; ● identifying and securing clinical sites for the conduct of human trials for our product candidates; ● the number and characteristics of the product candidates we pursue; ● the scope, progress, results, and costs of researching and developing our product candidates, and conducting nonclinical and clinical trials including the research and development expenditures we expect to make in connection with agreements with third parties we put in place to advance our research and development efforts; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates; ● our ability to maintain current research and development licensing agreements and to establish new strategic partnerships, licensing or other arrangements and the financial terms of such agreements; ● our ability to achieve our milestones under our ECC agreement and licensing arrangements and the payment obligations we may have; ● the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and ● the timing, receipt and amount of sales of, or royalties on, our products and future products, if any.
In recent years, inflation has been modest but has recently increased. High energy costs and fluctuations in commodity prices can affect the cost of all raw materials and components. Although we cannot precisely determine the effects of inflation on our business, it is management’s belief that the effects on operating results will not be significant.
High energy costs and fluctuations in commodity prices can affect the cost of all raw materials and components. Although we cannot precisely determine the effects of inflation on our business, it is management’s belief that the effects on operating results will not be significant.
The net change was primarily attributable to an increase in interest income and gain on sale of property and equipment of $60,053 and $10,912, offset by a decrease in local business tax of $3,783. 87 Liquidity and Capital Resources 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.
The net change was primarily attributable to an increase in interest income and gain on sale of property and equipment of $74,494 and $52,399, offset by a decrease in local business tax of $3,008. 79 Liquidity and Capital Resources 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.
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 working capital surplus of $12,693,239 and $26,262,129 as of December 31, 2022 and 2021, 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.
We anticipate that our general and administrative expenses may remain flat, but be subject to variability for, among others, the following reasons: ● to support our research and development activities, which, subject to available capital, we expect to expand as we continue the development of our product candidates; ● the efforts we undertake from, time to time, to raise additional capital; and ● the increased payroll, and stock-based compensation, expanded infrastructure and consulting, legal, accounting and investor relations costs associated with being a public company.
We anticipate that our general and administrative expenses to increase, but be subject to variability for, among others, the following reasons: ● to support our research and development activities, which, subject to available capital, we expect to expand as we continue the development of our product candidates; with a focus on ONP-002; ● the efforts we undertake from, time to time, to raise additional capital; ● the increased payroll, and stock-based compensation, expanded infrastructure and consulting, legal, accounting and investor relations costs associated with being a public company; and ● The additional staff hired or retained, as part of the purchase of the Neurology Assets.
Our Antibiotic Product Candidate - Oragenics Derived Compound (ODC-x) Members of our scientific team discovered that a certain bacterial strain of Streptococcus 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.
Our Lantibiotic Product Candidate Members of our scientific team discovered that a certain bacterial strain of Streptococcus 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.
Subject to available capital, we expect overall research and development expenses to increase as a result of our vaccine product candidate and to remain relatively constant with respect to our lantibiotic program. Our research and development projects are currently expected to be taken to the point where they can be licensed or partnered with larger pharmaceutical companies.
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.
As of December 31, 2022 our outstanding Series A and Series B Preferred Stock and the amount of common stock that may be issued upon conversion is set forth below: Preferred Stock Series Outstanding Shares Common Stock Equivalents Series A Preferred 5,417,000 9,028 Series B Preferred 4,050,000 13,500 In addition, we issued warrants to purchase shares of Common Stock to the Series A holders, and (ii) shares of Common Stock to the Series B holders in connection with the Preferred Stock Financing.
As of December 31, 2023 our outstanding Series A, Series B, and Series F Preferred Stock and the amount of common stock that may be issued upon conversion is set forth below: Preferred Stock Series Outstanding Shares Common Stock Equivalents Series A Preferred 5,417,000 9,028 Series B Preferred 4,050,000 13,500 Series F Preferred 7,488,197 7,488,197 In addition, as of December 31, 2023, we have outstanding warrants for the Series A and Series B holders to purchase an aggregate 19,915 shares of our common stock.
They will also form a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. We will make clinical, regulatory and commercial milestone payments, as well as tiered royalty payments.
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.
Since the acquisition we have conducted testing in animal models, including SARS-CoV-2 challenge studies in hamsters, using specific formulations for intramuscular administration (our Terra CoV-2 vaccine candidate) and intranasal administration (our NT-CoV2-1 vaccine candidate), both based on the NIAID pre-fusion stabilized spike protein antigens.
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.
Our research and development expenses were $10,072,684 and $10,586,144 for the years ended December 31, 2022 and 2021, respectively.
Our research and development expenses were $15,490,604 and $10,072,684 for the years ended December 31, 2023 and 2022, respectively.
The following table sets forth the primary sources and uses of cash for each of the periods indicated: Years ended December 31, 2022 2021 Net cash used in operating activities $ (15,228,483 ) $ (13,470,212 ) Net cash used by investing activities (115,519 ) (43,876 ) Net cash provided by financing activities (494,916 ) 23,140,216 Net decrease in cash and cash equivalents $ (15,838,918 ) $ 9,626,128 During the years ended December 31, 2022 and 2021, our operating cash flows from operations used cash of $(15,228,483) and $(13,470,212), respectively.
The following table sets forth the primary sources and uses of cash for each of the periods indicated: Years Ended December 31, 2023 2022 Net cash used in operating activities $ (7,290,880 ) $ (15,228,483 ) Net cash used in investing activities (936,285 ) (115,519 ) Net cash provided by (used in) financing activities 283,880 (494,916 ) Net decrease in cash and cash equivalents $ (7,943,285 ) $ (15,838,918 ) 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.
We will require substantial funds to conduct research and development and nonclinical and Phase 1 and Phase 2 clinical testing of our licensed, patented technologies and to develop sublicensing relationships for the Phase 2 and 3 clinical testing and manufacture and marketing of any products that are approved for commercial sale.
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.
As of December 31, 2022, we had an accumulated deficit of $(185,562,517) and we have yet to achieve profitability. We incurred net losses of $(14,288,389) and $(15,711,614) for the years ended December 31, 2022 and 2021, respectively.
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.
On February 24, 2023, we entered into an At the Market Offering Agreement with Ladenburg, Thalmann & Co., Inc. (the “Agent”), pursuant to which we may issue and sell, from time to time, shares of its common stock (the “Shares”), depending on market demand, with the Agent acting as the sales agent or principal (the “Offering”).
(the “Agent”), pursuant to which we may 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.
General and Administrative Expenses General and administrative expenses consist principally of salaries and related costs for personnel in executive, finance, business development, marketing, information technology, legal and human resources functions. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, patent filing, and professional fees for legal, consulting, auditing and tax services.
Other general and administrative expenses include facility costs not otherwise included in research and development expenses, patent filing, and professional fees for legal, consulting, auditing, and tax services.
Other Income (Expense) 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.
The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our indebtedness.
We account for forfeitures of stock-based awards as a component of compensation expense as the forfeitures occur. 85 New Accounting Pronouncements There are no additional accounting pronouncements issued or effective during the twelve months ended December 31, 2022 that have had or are expected to have an impact on our financial statements.
New Accounting Pronouncements There are no additional accounting pronouncements issued or effective during the twelve months ended December 31, 2023, that have had or are expected to have a material impact on our financial statements.
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, as well as a result of our restatement of the financial statements in our Q1 2022 10-Q, Q2 2022 10-Q, and Q3 2022 10-Q.
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.
Principal and interest payments on this note began August 24, 2021 and were made evenly based on a straight-line amortization over a 10-month period the final payment was made on May 24, 2022. Our Outstanding Preferred Stock During 2017, we issued shares of Series A and Series B Preferred Stock in financing transactions (the “Preferred Stock Financings”).
Principal and interest payments on this note began August 24, 2022 and were made evenly based on a straight-line amortization over a 10-month period, with the final payment being made in May 2023.
We began pre-clinical studies in June of 2021 through our collaboration and material transfer agreement with the NRC. We initiated an immunogenicity study in mice to evaluate several adjuvant candidates. On August 30, 2021, we announced the successful completion of these mouse immunogenicity studies that supported further development using either the intramuscular or intranasal routes of administration.
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.
A hamster challenge study was initiated in September of 2021 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.
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.
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.
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. 76 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.
Other Financings We enter into short term financing arrangements for the payment of our annual insurance premiums for our Directors and officers and employment practices insurance.
We terminated the At The Market Offering Agreement on August 15, 2023. 80 Other Financings We entered into short term financing arrangements for the payment of our annual insurance premiums, including our insurance policies for our Directors and Officers, Employment Practices Liability, Products Liability, Property coverage, and other coverages.
Additional details of our financing activities for the periods reflected in this report as well as certain information on our outstanding shares of preferred stock are provided below: Financings At-the-Market Program (“ATM Program”) During the three months ended December 31, 2022, we issued 6,544 shares of common stock under our ATM Program, which generated gross proceeds of approximately $72,000.
Additional details of our financing activities for the periods reflected in this report as well as certain information on our outstanding shares of preferred stock are provided below: Financings At-the-Market Program (“ATM Program”) On February 24, 2023, we entered into an At the Market Offering Agreement (“ATM”) with Ladenburg, Thalmann & Co., Inc.
Principal and interest payments on this note began August 24, 2022 and are made evenly based on a straight-line amortization over a 10-month period with the final payment being due on May 24, 2023. 88 On July 24, 2021, the Company entered into a short-term note payable for $600,169 bearing interest at 5.34% to finance a portion of the Directors’ and officers’ liability insurance and employment practices liability insurance premiums.
Principal and interest payments on this note began August 24, 2023, and are made evenly based on a straight-line amortization over a 10-month period with the final payment being made in May 24, 2024.
Our SARS-CoV-2 Vaccine Product Candidate - NT-CoV2-1 Following our May 2020 acquisition of one hundred percent (100%) of the total issued and outstanding common stock of Noachis Terra, Inc. (“Noachis Terra”) we are focused on the development and commercialization of a vaccine product candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19.
(“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.
As of December 31, 2022, there are 11,828 and 11,720 shares of common stock held by our Series A and Series B holders respectively. Except as otherwise required by law, the Series A and Series B Preferred Stock have no voting rights.
Except as otherwise required by law, the Series A, Series B, and Series F Preferred Stock (collectively referred to as the “Preferred Stock”) have no voting rights.
As a result, we may have to significantly limit our operations and our business, financial condition and results of operations would be materially harmed. Off-Balance Sheet Arrangements We have no off-balance sheet arrangements. 90 Tax Loss and Credit Carryforwards At December 31, 2022, the Company has federal and state tax net operating loss carryforwards of $150,083,903.
As a result, we may have to significantly limit our operations and our business, financial condition and results of operations would be materially harmed. 82 Off-Balance Sheet Arrangements We have no off-balance sheet arrangements. Inflation Inflation affects the cost of raw materials, goods, and services that we use. In recent years, inflation has been modest but has recently increased.
Our current product development strategy contemplates an expected increase in our research and development expenses in the future as we continue the advancement of our product development programs for our vaccine and lantibiotic product candidates, with greater near-term emphasis on our vaccine product candidate.
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.
While we previously had a Type B Pre-IND Meeting with the FDA on our intramuscular vaccine product candidate, we again met with the FDA in a Type B Pre-IND Meeting request to discuss our intranasal vaccine product candidate.
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.
We remain committed to fighting infectious diseases through the development of our lantibiotics pipeline against MRSA and VRE pathogens. 82 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. Ladenburg ATM Offering Sales Agreement.
Janet Huffman as our Chief Financial Officer, Secretary and Treasurer. Ladenburg ATM Offering Sales Agreement.
Research and development expenses were $10,072,684 for the year ended December 31, 2022 compared to $10,586,144 for the year ended December 31, 2021; a decrease of $513,461 or 4.85%.
Research and development expenses were $15,490,604 for the year ended December 31, 2023, compared to $10,072,684 for the year ended December 31, 2022; an increase of $5,417,920 or 53.8%. Research and development expenses increased by approximately $10.3 million due to the purchase of the Neurology Assets and the amount of IPR&D expense recorded.
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Overview We are a development-stage company dedicated to the research and development of potential therapies to fight infectious diseases including coronaviruses and multidrug-resistant organisms. Our lead product (NT-CoV2-1) is an intranasal vaccine candidate to prevent coronavirus disease (“COVID-19”) from the SARS-CoV-2 virus and variants thereof.
Added
Overview 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.
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The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health and the National Research Council of Canada with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Our proprietary lantibiotics program features a novel class of antibiotics against bacteria our research has shown may be applicable to multiple antibiotic-resistant organisms.
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Our ONP-002 Neurology Asset for Brain Related Illness and Injury Following our December 2023 acquisition of the assets of Odyssey Health, Inc (“Odyssey”) related to the segment of its business focused on developing medical products that treat brain related illnesses and diseases (the “Neurology Assets”) our lead product and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).
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Noachis Terra is a party to a worldwide, nonexclusive intellectual property and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute within the National Institutes of Health (“NIH”), relating to certain research, patent applications and biological materials involving pre-fusion stabilized coronavirus spike proteins and their use in the development and commercialization of a vaccine to provide specific, long lasting immunity from SARS-CoV-2.
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ONP-002 to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled into the novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device is lightweight and easy to use in the field.
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Following consideration of a number of factors, including but not limited to the competitive landscape, we determined to bring the intranasal vaccine candidate NT-CoV2-1 into further development due to the greater differentiation versus current COVID-19 vaccines and the potential benefits of intranasal over intramuscular administration.
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The proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain.
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We believe these benefits could include a higher reduction of transmission of SARS-CoV-2 and would offer a needle-free delivery option. We therefore are currently focusing our development efforts on our more highly differentiated NT-CoV2-1 vaccine candidate.
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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.
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On July 26, 2021, we entered into a licensing agreement with the National Research Council of Canada (“NRC”) that enables us to pursue the development of next-generation vaccines against the SARS-CoV-2 virus and its variants.
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This mechanism traps ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain. 70 Expected ONP-002 Product Development Timeline: Pre-clinical Animal Studies Phase 1 Phase 2a Phase 2b Phase 3 Complete Complete Estimated Q2/Q3 2024 start Estimated Q4 2024 start Estimated Q4 2026 start This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
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The license was subsequently amended to include the Omicron variant, broaden the non-exclusive field of use to include all diseases caused by coronaviruses and any genetic variants thereof, add research protocol developed by the NRC, and add reagents as part of the NRC technologies licensed by us. We extended the license in April 2022.
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Intellectual Property Patents on ONP-002 have been filed and/or issued and a patent has been filed on the nasal delivery device as follows: ● New chemical entity patent filing concerning the C-20 Steroid compounds has been filed with the USPTO and is pending in the U.S. and approved in Europe and Canada. ○ C-20 steroid compounds, composition and uses thereof to treat traumatic brain injury (TBI), including concussion. ○ Inventions relate to, inter alia , ONP-002 compositions, methods of use to treat, minimize and/or prevent traumatic brain injury (TBI), including severe TBI, moderate TBI, and mild TBI, including concussions, methods of manufacture and/or synthesis, products by process, and intermediates. ○ An issued U.S. patent expiration with 5-year maximum patent term extension - 9/17/2040. ○ An issued U.S. patent expiration without patent term extension - 9/17/2035. ● New nasal delivery device filing concerning the Breadth-Powered Nasal Devices has been filed with the USPTO as a utility patent application and with the USPTO PCT Receiving Office as a PCT application. ○ Breadth-Powered Nasal Devices for Treatment of Traumatic Brain Injury (TBI), Including Concussion, and Methods. ○ Inventions relate to, inter alia , breadth-powered nasal devices, single-directional breath-powered nasal devices for providing dual airflow for propelling a drug substance into a nasal cavity for targeted delivery to the olfactory region in high drug substance concentration for rapid diffusion into the brain for the treatment of local or systemic and/or central nervous system (“CNS”) injury, disease or disorder, and methods of treating local or systemic and/or central nervous system (“CNS”) injury, disease or disorder with such devices.
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The NRC technologies, in combination with the licensed technologies from the U.S. NIH used in our NT-CoV2-1 vaccine candidate, provide us with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern.
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An issued U.S. patent expiration - 10/19/2042. 71 ONP-002 Clinical Trials ONP-002 has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated. Safety studies have established a dosing regimen of 2X/day for fourteen days.
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This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge Program, are expected to enable expedited evaluation of SARS-CoV-2 antigen candidates in pre-clinical and clinical studies.
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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.
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Coronaviruses are a family of viruses that can lead to upper-respiratory infections in humans. Recent clinical reports also suggest that the SARS-CoV-2 virus can affect other body-systems, including the nervous, cardiovascular, gastrointestinal and renal systems.
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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).
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Among the recent iterations of coronaviruses to move from animal to human carriers is SARS-CoV-2, which, beginning in Wuhan, China, in late 2019, caused a global pandemic due to its rapid spread and the relatively high mortality rate (as compared to the seasonal influenza). Pfizer-BioNTech received approval from the U.S.
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Blood and urine samples were collected at multiple time points for safety pharmacokinetics. Standard safety monitoring was provided for each body system. Forty human subjects (31 males, 9 females) were successfully enrolled in Phase I.
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Food and Drug Administration (“FDA”) for their COVID-19 vaccines in August of 2021 and the Moderna vaccine in January 2022. The Janssen vaccine is currently available in the United States under Emergency Use Authorizations (“EUA”) by the FDA. In July 2022, the FDA granted EUA for the Novavax COVID-19 vaccine as well.
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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. We anticipate preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy.
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Current vaccines have reduced the rates of hospitalization and death due to COVID-19 in vaccinated individuals, but the transmission levels, even in vaccinated individuals, has allowed SARS-CoV-2 variants to continue to circulate.
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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. 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.
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We believe, given the size of the worldwide spread of COVID-19, that even with additional vaccines available, there will be demand for the highly differentiated NT-CoV2-1 vaccine once development is successfully completed.
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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. 72 Our SARS-CoV-2 Vaccine Product Candidate – NT-CoV2-1 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.

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