Oragenics Inc 10-K for FY2025

Oragenics Inc (OGEN)

10-K 2026-03-16 For: 2025-12-31

Added on April 09, 2026

About this 10-K

Oragenics Inc filed this 10-K on March 16, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $9.84M; compared with a net loss of $10.57M a year earlier
Diluted EPS: -$4.56; compared with -$47.88 a year earlier

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

9015 Town Center Parkway, Suite 143, Lakewood Ranch, FL		34202
(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		ii

PART I
ITEM 1.	BUSINESS	1
ITEM 1A.	RISK FACTORS	21
ITEM 1B.	UNRESOLVED STAFF COMMENTS	54
ITEM 1C.	CYBERSECURITY	54
ITEM 2.	PROPERTIES	55
ITEM 3.	LEGAL PROCEEDINGS	55
ITEM 4.	MINE SAFETY DISCLOSURES	55

PART II
ITEM 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	56
ITEM 6.	RESERVED	56
ITEM 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	56
ITEM 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	63
ITEM 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	63
ITEM 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	63
ITEM 9A.	CONTROLS AND PROCEDURES	63
ITEM 9B.	OTHER INFORMATION	64
ITEM 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	64

PART III
ITEM 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	65
ITEM 11.	EXECUTIVE COMPENSATION	68
ITEM 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS	80
ITEM 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	81
ITEM 14.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	82

PART IV
ITEM 15.	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	83
ITEM 16.	FORM 10-K SUMMARY	83

SIGNATURES		84

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’ (DEFICIT) 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 need to raise additional capital to continue to implement our business strategy and we may not be able to do so;
●	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;
●	Our ability to maintain compliance with the continued listing requirements of the NYSE American;
●	The timing, progress and results of clinical trials of our product candidates;
●	Uncertainties regarding submission, approval and scope 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;
●	Uncertainties regarding the potential benefits, activity, effectiveness and safety of our product candidates including as to administration, distribution and storage;
●	Uncertainties 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 ability to successfully commercialize our product candidates;
●	Uncertainties regarding our expenses, ongoing losses, future revenue, capital requirements;
●	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 and existing product candidate under the timelines and in accord with the milestones projected;
●	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 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; and
●	Our competitive position and the development of and projections relating to our competitors or our industry.

Pre-clinical Animal Studies		Phase 1 clinical trial		Phase 2a clinical trial		US based clinical trial		Phase 3 clinical trial
Complete		Complete		Q1 2026 Start		Estimated Q1 2027 start		Estimated Q1 2028 start

	○	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 and/or, minimize 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.

	○	Breath-Powered Nasal Devices and Uses Thereof for, inter alia, treatment of TBI, Including Concussion, and Methods.
	○	Inventions relate to, inter alia, breath-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 CNS injury, disease or disorder with such devices.
	○	An exemplary issued U.S. patent expiration - 10/19/2042.

1)	Distribution or License Agreements. Once any of our products in development are approved by the appropriate regulatory agency, we plan to enter into distribution agreements with companies that have sales professionals with experience selling through a variety of sales methods. These distribution agreements should allow us to achieve sales and revenue more quickly in the medical products industries.
2)	Identify and develop our products for additional proprietary uses. When funding allows, we intend to utilize our proprietary nasal delivery system to deliver other drugs to the brain to treat brain-related medical issues.
3)	The development and acquisition of new products. We intend to pursue the development and acquisition of other product candidates and market any new products, if cleared or approved. We intend, as capital resources permit, to develop such opportunities if and when they present themselves.
4)	Seek partners to assist in the further development of our drug device combination products. We intend to seek partners to assist with the further development and clinical trials of ONP-002. Partnerships could be in the form of government grants or from industry pharmaceutical companies who have an interest in brain-related drug therapies.

●	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;
●	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.

●	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 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.

●	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.

●	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 into 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;
●	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;
●	viral diseases; and
●	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 prohibit 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.

	●	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 healthcare marketplace.

	●	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 expertise of the 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.

	●	Withdrawal of clinical trial participants;
	●	Termination of clinical trial sites or entire 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 claim 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 up to treble damages. In addition, the court may award attorneys’ fees to the third party if the court deems the case to be “exceptional” under 35 U.S.C § 285;
	●	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 in the United States;
	●	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 expenditure 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;

	●	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 pre-clinical 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 pre-clinical 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 pre-clinical 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 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.

	●	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 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.

	●	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.