Oragenics Inc 10-K for FY2022

Oragenics Inc (OGEN)

10-K 2023-04-17 For: 2022-12-31

Added on April 09, 2026

About this 10-K

Oragenics Inc filed this 10-K on April 17, 2023, covering the fiscal year ended December 31, 2022 (FY2022).

Headline figures

Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $131.52K; up 51.2% from $86.99K a year earlier
Net loss: $14.29M; compared with a net loss of $15.71M a year earlier

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Florida		59-3410522
(State or Other Jurisdiction of Incorporation or Organization)		(IRS Employer Identification No.)

4902 Eisenhower Blvd., Suite 125 Tampa, FL		33634
(Address of Principal Executive Offices)		(Zip Code)

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock $0.001 par value per share		OGEN		NYSE AMERICAN

☐	Large accelerated filer	☐	Accelerated filer
☒	Non-accelerated filer	☒	Smaller reporting company
		☐	Emerging growth company

FORWARD-LOOKING STATEMENTS AND CERTAIN CONSIDERATIONS		i

PART I
ITEM 1.	BUSINESS	1
ITEM 1A.	RISK FACTORS	29
ITEM 1B.	UNRESOLVED STAFF COMMENTS	77
ITEM 2.	PROPERTIES	77
ITEM 3.	LEGAL PROCEEDINGS	77
ITEM 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
ITEM 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	91
ITEM 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	91
ITEM 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	91
ITEM 9A.	CONTROLS AND PROCEDURES	92
ITEM 9B.	OTHER INFORMATION	94
ITEM 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	94

PART III
ITEM 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	95
ITEM 11.	EXECUTIVE COMPENSATION	99
ITEM 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS	112
ITEM 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	114
ITEM 14.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	115

PART IV
ITEM 15.	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	116
ITEM 16.	FORM 10-K SUMMARY	116

SIGNATURES		117
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM		F-2
CONSOLIDATED BALANCE SHEETS		F-3
CONSOLIDATED STATEMENTS OF OPERATIONS		F-4
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY		F-5
CONSOLIDATED STATEMENTS OF CASH FLOWS		F-6
CONSOLIDATED NOTES TO FINANCIAL STATEMENTS		F-7

	●	We have incurred significant operating losses since our inception and cannot assure you that we will generate revenues or achieve profitability;

	●	We will need to raise additional capital to continue to implement our business strategy and we may not be able to do so;

	●	Our financial capacity and performance, including our ability to obtain funding, non-dilutive or otherwise, 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 pre-clinical 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 including as to administration, distribution and storage;

	●	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, the NRC 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 and consultants;

	●	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 NT-CoV2-1 vaccine product candidate under the timelines and in accord with the milestones projected;

	●	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 pre-clinical 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 and the effects of our 1 for 60 reverse stock split on our price per share and the trading market of our common stock;

	●	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;

	●	We may be adversely impacted by any significant broad-based financial crises and its impact on consumers, retailers and equity and debt markets as well as our inability to obtain required additional funding to conduct our business;

	●	As a public company, we must implement additional and expensive finance and accounting systems, procedures and controls as we grow our business and organization to satisfy reporting requirements, which add to our costs and require additional management time and resources;

	●	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
NT-CoV2-1	Intranasal vaccine candidate (plasmid + adjuvant) to provide long lasting immunity against SARS-CoV-2	Broad, community-based vaccine immunity against SARS-CoV-2	Pre-clinical

Antibiotics	Semi-synthetic analogs of MU1140: Member of lantibiotic class of antibiotics	Healthcare-associated infections	Pre-clinical

(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.

	●	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.

●	We have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future.

●	The restatement of certain of our financial statements may subject us to risks and uncertainties, including the increased possibility of legal proceedings.

●	We have identified a material weakness in our internal control over financial reporting which could, if not remediated, adversely impact the reliability of our financial statements, result in material misstatements in our financial statements and cause current and potential stockholders to lose confidence in our financial reporting, which in turn could adversely affect the trading price of our common stock.

●	We will need to raise additional capital in the future to complete the development and commercialization of our product candidates and operate our business.

●	We have a limited number of authorized shares of common stock and may be unable to achieve the requisite approval for an increase of such authorized shares.

●	Substantial uncertainties regarding future funding and financial performance presents uncertainty as a going concern.

●	We were denied funding from the Biomedical Advanced Research and Development Authority (“BARDA”) and we may be unable to win any government contracts, grants, agreement or other funding in the future. Even if we are successful in obtaining such contracts, grants, agreements or other funding, we cannot assure the success of our NT-CoV2-1 vaccine product candidate, that it will be approved by the FDA or other public health regulatory authority or that any funding provided will be sufficient to complete development and successful commercialization.

●	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 have limited vaccine-specific research, development, manufacturing, testing, regulatory, commercialization, sales, distribution, and marketing experience, and we may need to invest significant financial and management resources to establish these capabilities. Despite such investments and our best efforts, our strategic acquisition of Noachis Terra may turn out to be unsuccessful.

●	We have limited financial resources and we may not be able to maintain our current level of operations or be able to fund the further development of our new NT-CoV2-1 vaccine product candidate.

●	Our vaccine product candidate is at the pre-clinical stage and has not been approved for sale. We have not conducted substantial research and development for a vaccine product candidate, and we may be unable to produce a vaccine that successfully prevents the virus in a timely and economical manner, if at all.

●	Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities.

●	The market opportunities for our vaccine product candidate may be smaller than we believe them to be. Moreover, any pandemic threat may abate, the underlying virus may mutate, or alternative vaccines or technologies may be adopted, before our vaccines achieve regulatory approval.

●	If we are unable to successfully develop our product candidates, our operating results and competitive position could be harmed. Research and development involves a lengthy and complex process, and we may not be successful in our efforts to develop and commercialize our product candidates. The further development and ultimate commercialization of product candidates for SARS-CoV-2 and COVID-19, as well as our other product candidates, are keys to our strategy.

●	If we are successful in producing a vaccine against SARS-CoV-2, we may need to devote significant resources to its scale-up and development, including for use by the U.S. government or other foreign authorities. Moreover, government involvement may limit the commercial success of our vaccine product candidate.

●	Our product candidates, if approved, will face significant competition and our failure to compete effectively may prevent us from achieving significant market penetration.

●	Because our vaccine product development efforts depend on new and rapidly evolving technologies, we cannot be certain that our efforts will be successful.

●	Our SARS-CoV-2 vaccine product candidate may face competition from biosimilars approved through an abbreviated regulatory pathway.

●	We may be unable to refine a method to produce MU1140 homologs in large-scale commercial quantities. If we cannot, we will be unable to generate significant revenues from sales of a MU1140 homolog product candidate.

●	Our success will depend on our ability to obtain regulatory approval of our product candidate under our Lantibiotics Program and its successful commercialization.

●	We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates.

●	We have limited experience in the conduct of clinical trials. We have never initiated a vaccine-related clinical trial. We have never obtained approval of any product candidates. We may be unable to undertake any of those actions successfully.

●	We cannot assure you that the market and consumers will accept our products or product candidates. If they do not, we will be unable to generate significant revenues from our products or product candidates and our business, financial condition and results of operations will be materially adversely affected.

●	Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.

●	We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing our growth.

●	If our manufacturers and suppliers in general fail to meet our requirements and the requirements of regulatory authorities, our research and development may be materially adversely affected.

●	We rely on the significant experience and specialized expertise of our senior management and scientific team and the loss of any of our key personnel or our inability to successfully hire their successors could harm our business.

●	We need to hire and retain additional qualified scientists and other highly skilled personnel to maintain and grow our business.

●	If any of our product candidates are shown to be ineffective or harmful in humans, we will be unable to generate revenues from these product candidates.

●	Because we are new to vaccine development, we must identify vaccines for development with our technologies and establish successful third-party relationships.

●	We intend to seek licensing partners to cover a portion of the costs associated with obtaining regulatory approval for, and manufacturing and marketing of, our product candidates. If we are unable to obtain agreements with third parties to fund these costs, we will have to fund such costs ourselves or we may be unable to extract any value from these technologies.

●	We might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses.

●	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 may be adversely affected by natural disasters, pandemics and other catastrophic events, and by man-made problems such as terrorism, that could disrupt our business operations and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

●	Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited, each of which could harm our business.

●	Our auditor has previously expressed substantial doubt about our ability to continue as a going concern and absent additional financing we may be unable to remain a going concern.

●	Our vaccine research and development efforts are to a large extent dependent upon our intellectual property and biologicals materials license with the NIAID, the NIH, and the NRC(“Licensors”).

●	We may incur additional expenses and obligations in connection with our NIH and NRC licenses (“Licenses Agreements”).

●	The intellectual property covered by our License Agreements concerns patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.

●	We cannot prevent the Licensors or other companies, including our competitors, from licensing the same intellectual property and biological materials that we have licensed or from otherwise duplicating our business model and operations.

●	Our Lantibiotic Development program development efforts are to a large extent dependent upon our intellectual property and is based on early-stage technology in its field.

●	We may be subject to claims challenging the inventorship of our patents and other intellectual property.

●	Changes in patent law or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

●	If we are unable to protect our trademarks or other intellectual property from infringement, our business prospects may be harmed.

●	We may not be able to protect our intellectual property rights throughout the world.

●	If we fail to comply with our obligations under our intellectual property license agreements, we could lose our license rights that are important to our business and development of our product candidates.

●	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.

●	We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.

●	Our success will depend on our ability to partner or sub-license our product candidates and their subsequent successful commercialization.

●	If our intellectual property rights do not adequately protect our products or product candidates, or if third parties claim we are infringing their intellectual property rights, others could compete against us more directly or we could be subject to significant litigation. Such results could prevent us from marketing our products or product candidates and hurt our profitability.

●	Our business and operations would suffer in the event of cybersecurity/information systems risk.

●	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.

●	We may incur costs of addressing a cybersecurity incident.

●	Our business and operations would suffer in the event of failures in our internal computer systems or those of our collaborators.

●	Our product candidates are subject to substantial government regulation, including the regulation of nonclinical testing and clinical trials. If we are unable to obtain regulatory approval for our product candidates, we will be unable to generate revenues.

●	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. The delay, limitation or denial of any regulatory approval would adversely impact commercialization, our potential to generate revenue, our business and our operating results.

●	Delays or difficulties in the enrollment of patients in clinical trials may result in additional costs and delays in our ability to generate significant revenues, and may delay or prevent our receipt of any regulatory approvals necessary to commercialize our planned and future products.

●	Any product candidates that we commercialize will be subject to ongoing and continued regulatory review.

●	Our product candidates may cause serious or undesirable side effects or possess other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of approved labeling or result in post-approval regulatory action.

●	If any of our product candidates are approved for marketing and we are found to have improperly promoted off-label uses, or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.

●	We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.

●	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.

●	If we are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered.

●	If our products do not receive favorable third-party reimbursement, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not generate significant revenues.

●	Our business is subject to risks arising from public health crises, epidemic or pandemic diseases, such as the recent global outbreak of the coronavirus disease (COVID-19).

●	Our ability to conduct clinical trials may be impeded, delayed, limited or prevented entirely due to the spread of COVID-19, the imposition of government restrictions and the concurrent disruptions to ordinary business activities globally.

●	Our business involves international components, and we are exposed to various global and local risks related to the coronavirus disease 2019 (COVID-19) that could have a material adverse effect on our financial condition and results of operations.

●	Macroeconomic pressures in the markets in which we operate, including, but not limited to, the effectives of the coronavirus disease (COVID-19) may alter the ways in which we conduct our business operations and manage our financial capacities.

●	Economic uncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled.

●	Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

●	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.

●	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.

	●	May have the effect of eroding the investor confidence in us and our financial reporting and accounting practice and processes;
	●	May negatively impact the trading price of our common stock;
	●	Diverted, and may continue to divert management’s attention from the operation of our business;
	●	Requiring that we incur additional expenses and may require that we incur significant expenses relating to any litigation or regulatory examinations, investigations, proceedings or orders;
	●	May make it more difficult, expensive and time consuming for us to raise capital, if necessary, on acceptable terms, if at all; and
	●	May make it more difficult to pursue transactions or implement business strategies that might otherwise be beneficial to our business.

	●	expand our clinical laboratory operations and conduct further research and development in lantibiotics;

	●	fund our clinical validation study activities;

	●	expand our research and development activities; and

	●	finance our capital expenditures and general and administrative expenses.

	●	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.

	●	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.

	●	research and development;

	●	pre-clinical testing;

	●	designing and implementing clinical trials;

	●	regulatory processes and approvals;

	●	production and manufacturing; and

	●	sales and marketing of approved products.

	●	the quality and breadth of an organization’s technology;

	●	management of the organization and the execution of the organization’s strategy;

	●	the skill and experience of an organization’s employees and its ability to recruit and retain skilled and experienced employees;

	●	an organization’s intellectual property portfolio;

	●	the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and

	●	the availability of substantial capital resources to fund discovery, development and commercialization activities.

	●	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.

	●	Our SARS-CoV-2 vaccine product candidate or technologies, any or all of the products based on such technologies or any manufacturing process will be ineffective or unsafe, or otherwise fail to receive necessary regulatory approvals or achieve commercial viability;

	●	third-party supplier or manufacturer facilities will be unable or unwilling to provide necessary supplies or scale-up manufacturing capabilities for our products in a cost-effective manner or at all;

	●	the products, if safe and effective, may be difficult to manufacture on a large-scale or uneconomical to market;

	●	third-party manufacturing facilities will fail to continue to pass regulatory inspections;

	●	proprietary rights of third-parties will prevent us or our collaborators from exploiting technologies, and manufacturing or marketing products; and

	●	third-party competitors with approval or Emergency Use Authorization from the FDA and use of vaccines will gain greater market share and limit or impair development efforts.

	●	continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

	●	attract and retain sufficient numbers of talented employees;

	●	develop a plan for marketing, sales, and distribution capability;

	●	manage our commercialization activities for our product candidates effectively;

	●	establish and maintain relationships with development and commercialization partners;

	●	manage our pre-clinical and clinical trials effectively;

	●	manage our third-party supply and manufacturing operations effectively and in a cost-effective manner, while increasing production capabilities for our current product candidates to commercial levels; and

	●	manage our development efforts effectively while carrying out our contractual obligations to partners and other third parties.

	●	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.

	●	withdrawal of clinical trial participants;

	●	termination of clinical trial sites or entire trial programs;

	●	the inability to commercialize our product candidates;

	●	decreased demand for our product candidates;

	●	impairment of our brand and/or reputation;

	●	product recall or withdrawal from the market or labeling, marketing or promotional restrictions;

	●	substantial costs of any related litigation or similar disputes;

	●	distraction of management’s attention and other resources from our primary business;

	●	substantial monetary awards to patients or other claimants against us that may not be covered by insurance; or

	●	loss of potential revenue.

	●	infringement and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business;

	●	substantial damages for infringement, which we may have to pay if a court decides that the product or technology at issue infringes or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

	●	a court prohibiting us from selling or licensing the product or using the technology unless the third party licenses its intellectual property rights to us, which it is not required to do;

	●	if a license is available from a third party, we may have to pay substantial royalties or upfront fees or grant cross-licenses to intellectual property rights for our products or technologies; and

	●	redesigning our products or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.

	●	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.

	●	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.

	●	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;