Oragenics Inc 8-K, filed May 8, 2020

Oragenics Inc (OGEN)

8-K 2020-05-08 For: 2020-05-08

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Added on April 09, 2026

About this 8-K

Oragenics Inc filed this 8-K on May 8, 2020.

Items reported

Item 7.01: Regulation FD disclosure
Item 8.01: Other events
Item 9.01: Financial statements and exhibits

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[ ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		OGEN		NYSE American

	●	our financial capacity and performance, including our ability to obtain funding necessary to do the research, development, manufacture and commercialization of any one or all of our product candidates;

	●	the timing, progress and results of clinical trials of our product candidates, including statements regarding the timing of initiation and completion of preclinical studies or clinical trials or related preparatory work, the period during which the results of the trials will become available and our research and development programs;

	●	the timing of any submission of filings for regulatory approval of our product candidates and our ability to obtain and maintain regulatory approvals for our product candidates for any indication;

	●	our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates;

	●	our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if approved for commercial use;

	●	our manufacturing capabilities and strategy, including the, scalability and commercial viability of our manufacturing methods and processes, and those of our contractual partners;

	●	our expectations regarding the scope of any approved indications for our product candidates;

	●	our ability to successfully commercialize our product candidates;

	●	the potential benefits of and our ability to maintain our relationships and collaborations with the NIAID, the NIH, Precigen, ILH Holdings and other potential collaboration or strategic relationships;

	●	our ability to use our Lantibiotic platform to develop future product candidates;

	●	our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional funding, including any application for future grants or funding;

	●	our ability to identify, recruit and retain key personnel;

	●	our ability to obtain, retain, protect and enforce our intellectual property position for our product candidates, and the scope of such protection;

	●	our ability to advance the development of our new TerraCoV2 vaccine product candidate under the timelines and in accord with the milestones it projects;

	●	our inability to achieve success in our identification of lantibiotic homologs or the manufacture and nonclinical testing of our lantibiotic product candidates;

	●	our need to comply with extensive and costly regulation by worldwide health authorities, who must approve our product candidates prior to substantial research and development and could restrict or delay the future commercialization of certain of our product candidates;

	●	our ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all;

	●	the safety, efficacy and benefits of our product candidates;

	●	the content and timing of submissions to and decisions made by the FDA, other regulatory agencies and nongovernmental bodies and actors, such as investigational review boards;

	●	the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements;

	●	the capacities and performance of our suppliers and manufacturers and other third parties over whom we have limited control;

	●	our ability to maintain our listing on the NYSE American;

	●	the impact of the COVID-19 pandemic on our financial condition and business operations and our ability to continue research and development for existing product candidates on previously-projected timelines or in accord with ordinary practices, as well as the broader governmental, global health and macro- and microeconomic responses to and consequences of the pandemic;

	●	our competitive position and the development of and projections relating to our competitors or our industry; and

	●	the impact of laws and regulations, including those that may not yet exist.

Product/Candidate	Description	Application	Status
TerraCoV2	Vaccine candidate (plasmid + adjuvant) to provide lifetime immunity from SARS-CoV-2	Broad, community-based vaccine immunity and/or therapeutic	Pre-clinical

AG013	Lactococcus lacti bacterial strain genetically modified to include the gene for hTTF1	Treatment of oral mucositis in cancer patients	Phase 2 completed. Awaiting full results analysis.

OG716	A homolog of MU1140: Member of lantibiotic class of antibiotics	Healthcare-associated infections	Nonclinical testing

	(i)	We become insolvent or the subject of a bankruptcy petition;

	(ii)	We fail to follow the commercial development plan, fail to achieve certain commercial development and sales-related benchmarks or cannot otherwise demonstrate progress toward a practical application of the Licensed Products or Licensed Processes;

	(iii)	We fail to keep any Licensed Products or Licensed Processes reasonably available to the public following the commencement of commercial use or fail to reasonably justify noncompliance with its domestic production obligation;

	(iv)	We cannot reasonably satisfy public health and safety needs; or

	(v)	The NIAID determines termination or modification is necessary because we cannot meet federal public use regulatory requirements, as issued after the effective date of the License Agreement.

	(i)	commercialized by us;

	(ii)	approved by regulatory authorities;

	(iii)	a subject of an application for regulatory approval that is pending before the applicable regulatory authority; or

	(iv)	the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the Field (in the case of a termination by our Collaboration Partner due to an uncured material breach by the Company or a voluntary termination by us).

	(i)	a one-time payment of twenty-five million United States dollars ($25,000,000) within six (6) months of the achievement of the Regulatory Approval Milestone Event meaning receiving approval from the FDA of a New Product Application (or equivalent regulatory action in a foreign jurisdiction) for an Oragenics Product;

	(ii)	a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Indication Milestone Event meaning receiving approval from the FDA of a Supplemental FDA Application (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of the Oragenics Product other than the current regulatory-approved indication; and

	(iii)	a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Product Milestone Event meaning the receiving of approval from the FDA of a New Product that is deemed to be a different drug product that the first Oragenics Product that was clinically pursued under the Lantibiotics Program.

	(i)	the particular Oragenics Product is being sold by us triggering profit sharing payments under the Oral Mucositis ECC to Precigen;

	(ii)	the particular Oragenics Product has received regulatory approval;

	(iii)	the particular Oragenics Product is a subject of an application for regulatory approval in the Field covered by the ECC that is pending before the applicable regulatory authority;

	(iv)	the particular Oragenics Product is AG013, and such Oragenics Product has been the subject of at least one completed Phase 2 clinical trial (as such is defined by relevant FDA guidelines) during the Term; or

	(v)	the particular Oragenics Product other than AG013 and such Oragenics Product is the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the Field.

	(i)	a one-time payment of twenty-seven million five hundred thousand United States dollars ($27,500,000) within six (6) months of the achievement of the Regulatory Approval Milestone Event meaning receiving approval from the FDA of a New Product Application for an Oragenics Product (or equivalent regulatory action in a foreign jurisdiction);

	(ii)	a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Indication Milestone Event meaning receiving approval from the FDA of a Supplemental FDA Application (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of the Oragenics Product other than the current regulatory-approved indication; and

	(iii)	a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Product Milestone Event meaning receiving approval from the FDA of a New Product that is deemed to be a different drug product that the first Oragenics Product that was clinically pursued under the Program.

	●	preclinical 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 Investigational New Drug application (IND) 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 Biologics License Application (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.

	●	interruptions to or limitations on our ability to conduct preclinical research and development and clinical trials due to the COVID-19 pandemic and government restrictions in response to the pandemic, including difficulties identifying capable research and testing partners, lack of available subjects and supplies for preclinical or clinical research and testing, limitations on work schedules for government regulators and their employees, slow or delayed patient enrollment because of an inability to access testing or research facilities, or other financial costs implicated by a global economic slowdown;

	●	slow patient enrollment due to the nature of the protocol, the proximity of patients to clinical sites, the eligibility criteria for the trial, competition with clinical trials for other drug candidates or other factors;

	●	inadequately trained or insufficient personnel at the trial site to assist in overseeing and monitoring clinical trials;

	●	delays in approvals from a trial site’s contracts office and/or IRB;

	●	longer than anticipated treatment time required to demonstrate effectiveness or determine the appropriate product dose;

	●	lack of sufficient supplies of the drug candidate for use in clinical trials;

	●	adverse medical events or side effects in treated patients; and

	●	lack of effectiveness of the drug candidate being tested.

	●	preclinical 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.

	●	A streamlined application procedure via a single-entry point, the EU portal.

	●	A single set of documents to be prepared and submitted for the application as well as simplified reporting procedures that will spare sponsors from submitting broadly identical information separately to various bodies and different member states.

	●	A harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed jointly by all member states concerned. 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.

	●	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.

	●	The decentralized procedure allows applicants to file identical applications to several EU member states and receive simultaneous national approvals based on the recognition by EU member states of an assessment by a reference member state.

	●	The national procedure is only available for products intended to be authorized in a single EU member state.

	●	A mutual recognition procedure similar to the decentralized procedure is available when a marketing authorization has already been obtained in at least one E.U. member state.

	●	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.

	●	conduct preclinical research for our TerraCoV2 vaccine product candidate, file an IND with the FDA and, if approved, engage in Phase 1 clinical trials;

	●	engage in GMP and non-GMP manufacturing for our product candidates at the preclinical research and clinical trial stages;

	●	expand our clinical laboratory operations;

	●	fund our clinical validation study activities;

	●	expand our research and development activities; and

	●	finance our capital expenditures and general and administrative expenses.

	●	the current and continued microeconomic impact of the COVID-19 pandemic on our ability, the ability of our third-party contractors and suppliers, and the ability of government regulators to conduct ordinary business operations in a timely and efficient manner, as well as the pandemic’s broader, macroeconomic impact on the U.S., foreign and global economic markets;

	●	the level of research and development investment budgeted to develop our current and future product candidates;

	●	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 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.

	●	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. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.

	●	specialized accounting systems unique to government contracts and grants;

	●	mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;

	●	public disclosures of certain contract and grant information, which may enable competitors to gain insights into our research program; and

	●	mandatory socioeconomic compliance requirements, including labor standards, non-discrimination, and affirmative action programs, and environmental compliance requirements.

	●	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;

	●	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.

	●	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 in pricing policies by us or our competitors;

	●	our success in entering new geographic markets;

	●	decisions by us to incur additional expenses, such as commencing a clinical trial or increases in research and development;

	●	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.

	●	we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development and commercialization of our vaccine product candidate, in a timely manner or at all;

	●	such partners may not devote sufficient resources to our vaccine product candidate or properly maintain or defend our intellectual property rights;

	●	any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our vaccine product candidate and affect our ability to realize product revenue; and

	●	disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals and commercialization activities.

	●	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;

	●	an inability to raise sufficient capital to commence, conduct, or complete 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;

	●	insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;

	●	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.

	●	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;

	●	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.

	●	disagree with the design or implementation of one or more clinical trials;

	●	decline to deem a product candidate safe and effective for its proposed indication, or deem a product candidate’s safety or other perceived risks to outweigh its clinical or other benefits.

	●	find the data from preclinical studies and clinical trials does not sufficiently support approval, or the results of clinical trials may not meet the level of statistical or clinical significance required for approval;

	●	disagree with our interpretation of data from preclinical studies or clinical trials performed by us or third parties;

	●	determine the data collected from clinical trials are insufficient to support the submission or approval of an NDA or other applicable regulatory filing.

	●	require additional preclinical studies or clinical trials;

	●	identify deficiencies in the formulation, quality control, labeling or specifications of our current or future product candidates;

	●	grant approval contingent on the performance of costly additional post-approval clinical trials;

	●	approve our current or any future product candidates for a more limited indication or a narrower patient population than we originally requested or with strong warnings that may affect marketability;

	●	decline to approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates;

	●	require a Risk Evaluation and Mitigation Strategy, or REMS, with monitoring requirements or distribution limitations. For example, it is possible that the FDA could require distribution controls in the approval, if any, of our product candidates to prevent inadvertent exposure to pregnant women;

	●	decline to approve of the manufacturing processes, controls or facilities of third-party manufacturers or testing labs with whom we contract; or

	●	change its approval policies or adopt new regulations in a manner rendering our clinical data or regulatory filings insufficient for approval.

	●	the severity of the disease under investigation;

	●	the eligibility criteria for the study in question;

	●	the perceived risks and benefits of the product candidate under study;

	●	the efforts to facilitate timely enrollment in clinical trials;

	●	the patient referral practices of physicians;

	●	the ability to monitor patients adequately during and after treatment; and

	●	the proximity and availability of clinical trial sites for prospective patients.

	●	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;

	●	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.

	●	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.