KAPA 10-K

Kairos Pharma, LTD. (KAPA)

10-K 2025-04-15 For: 2024-12-31

View Original

Added on April 08, 2026

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		KAPA		NYSE American

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


PART I		3
Item 1	Business	4
Item 1A	Risk Factors	25
Item 1B	Unresolved Staff Comments	101
Item 1C	Cybersecurity	102
Item 2	Properties	102
Item 3	Legal Proceedings	102
Item 4	Mine Safety Disclosures	102
PART II		102
Item 5	Market for the Registrant’s Common Equity, Related Shareholder Maters, and Issuer Purchases of Equity Securities	102
Item 6	Reserved	103
Item 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	103
Item 7A	Quantitative and Qualitative Disclosures About Market Risk	115
Item 8	Financial Statements and Supplementary Data	116
Item 9	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	117
Item 9A	Controls and Procedures	117
Item 9B	Other Information	117
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	117
PART III		118
Item 10	Directors, Executive Officers and Corporate Governance	118
Item 11	Executive Compensation	118
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	118
Item 13	Certain Relationships and Related Transactions, and Director Independence	118
Item 14	Principal Accountant Fees and Services	118
PART IV		119
Item 15	Exhibits and Financial Statement Schedules	119
Item 16	Form 10-K Summary	122

Signatures		123

	●	the initiation, timing, progress, and results of our preclinical and nonclinical studies and clinical trials, and our research and development programs, including the manufacture of clinical trial material and drug product for launch;

	●	our ability to successfully complete our ongoing and planned for clinical trials and obtain regulatory approval in the United States for our target drugs;

	●	our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals as needed;

	●	our ability to advance product candidates into, and successfully complete, clinical trials;

	●	the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;

	●	the ability to commercialize our product candidates, if approved;

	●	the ability of our current in-development products, if approved, to successfully compete with other therapies, including therapies currently in development;

	●	the pricing, coverage and reimbursement of our product candidates, if approved;

	●	the implementation of our business model, strategic plans for our business, and product candidates;

	●	the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;

	●	our ability to identify additional product candidates and advance them into clinical development;

	●	our estimates regarding expenses, capital requirements and needs for additional financing;

	●	our financial performance; and

	●	developments relating to our competitors and our industry.

	●	Five pre-clinical or clinical-trial stage drug candidates developed by us and designed to target immune response.

	●	Two therapeutic agents developed by our Enviro Therapeutics, Inc. subsidiary and designed to increase anti-tumor response in conjunction with cancer therapies by addressing resistance to these agents.

	●	A variety of technologies licensed by our Enviro Therapeutics, Inc. subsidiary and consisting of compositions and methods for treating diseases and conditions by targeting CD105 and depleting mitochondrial DNA from the circulation.

	●	A multi-pronged toolkit of potent and life changing therapeutics with differing modalities, targets, and stages of development. Their commonality is targeting key mechanisms of drug resistance and immune suppression by cancer.

	●	Leverage our academic research and clinical connections with our industry collaborations.

	●	Complete enrollment of prostate patients in a randomized multi-institutional Phase 2 trial of ENV 105.

	●	Complete enrollment in a Phase 1 trial of ENV105 for patients with non-small lung cancer on Tagrisso.

	●	Initiate a Phase 1 trial of activated T cell therapy for KROS 201 in patients with glioblastoma.

	●	Complete pre-IND studies for the checkpoint inhibitor KROS 101.

	●	Continue to advance our pipeline of immunotherapeutics for clinical trials.

	●	Maintain a portfolio of innovative therapeutics to mitigate risk.

	●	Leverage virtual infrastructure for efficient execution of collaborative clinical and translational research.

	●	Utilize internal development capabilities to leverage close academic partnerships.

	●	*Strategic Partnerships* – We will focus on expanding our existing pipeline through establishing strategic partnerships with companies that have interesting products and technologies. We intend to focus on novel, early-stage and preclinical assets in a variety of therapeutic areas.

	●	*Commercial Development* – We expect to participate and assist in the commercial development activities of its assets with our strategic partners. Commercial development activities may include, but are not limited to, clinical development, market research, healthcare economics, market access, sales/marketing, and commercial launch strategies.

	●	*Portfolio Optimization* – We will continue to evaluate, prioritize, optimize, and make appropriate changes in our pipeline portfolio as market development dynamics and/or product opportunities change.

	1.	Method of generating activated T cells for cancer therapy, invented by Dr. John S. Yu and others.

	2.	Methods of use of compounds that bind to RelA of NFkB, invented by Dr. Ramanchandran Murali and others.

	3.	Composition and methods for treating fibrosis, invented by Dr. Ramanchandran Murali and others.

	4.	Compositions and methods for treating cancer and autoimmune diseases, invented by Dr. Ramanchandran Murali and others.

	(1)	an Exclusive License Agreement for Enviro to develop, manufacture, use and sell products utilized or derived from patent rights worldwide, which include one patent application in the United States related to the “Compositions and Methods for Treating Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented by Dr. Neil Bhowmick and others; and

	(2)	an Exclusive License Agreement for Enviro to develop, manufacture, use and sell products utilized or derived from the patent rights and technical information worldwide, which include six patent applications in the United States, Australia, Canada, China, Europe and Japan related to the “Sensitization of Tumors to Therapies Through Endoglin Antagonism” invented by Dr. Neil Bhowmick and others.

	1.	Completion of preclinical studies within two years of the effective date, as stipulated in the agreement thereof (the “Effective Date”);
	2.	Completion of toxicology studies within two and a half years of the Effective Date;
	3.	Obtaining IND within three years of the Effective Date; and
	4.	Beginning the Phase 1 trial within four years of the Effective Date.

	●	*Talent development, compensation, and retention:* We strive to provide our employees with a rewarding work environment, including the opportunity for growth, success, and professional development. We provide a competitive compensation and benefits package, including bonus and equity incentive plans, a 401(k) plan—all designed to attract and retain a skilled and diverse workforce.

	●	*Health and safety:* We support the health and safety of our employees by providing comprehensive insurance benefits, an employee assistance program, company-paid holidays, a personal time-off program, and other additional benefits which are intended to assist employees to manage their well-being.

	●	*Inclusion and diversity:* We are committed to efforts to increase diversity and foster an inclusive work environment that supports our workforce.

	●	the timing, progress, and results of our ongoing and future clinical trials of our current in-development products;
	●	the costs, timing, and outcome of regulatory review of our current in-development products and any of our future product candidates;
	●	the scope, progress, results, and costs of identifying, obtaining, and conducting preclinical development, laboratory testing, and clinical trials of future product candidates that we may pursue;
	●	the cost and timetable of manufacturing processes for development, clinical trials, and potential commercial use;
	●	the number and development requirements of future product candidates that we may pursue;
	●	the amount of funding that we receive under our non-dilutive funding opportunities, including government awards and government awards, if any, that we may apply for;
	●	the costs and timing of future commercialization activities, including product manufacturing, marketing, sales, and distribution, for our current in-development products or any future product candidates that receive marketing approval;
	●	the pricing and revenue, if any, received from commercial sales of our current in-development products or any future product candidates that receive marketing approval;
	●	the costs and timing of preparing, filing, and prosecuting patent applications, maintaining, and enforcing our intellectual property rights, and defending any intellectual property-related claims;
	●	the costs of operating as a public company; and
	●	the extent to which we acquire or in-license other product candidates and technologies.

	●	disagreement with the design or implementation of our clinical trials;
	●	negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval (for example, otherwise positive clinical results may be called into question if patient reported outcomes introduce ambiguity due to factors such as co-morbidities and other underlying patient issues);
	●	serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates;
	●	our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that our product candidates are safe and effective for the proposed indication;
	●	disagreement with the interpretation of data from nonclinical studies or clinical trials;
	●	our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks;
	●	requirements for additional nonclinical studies or clinical trials;
	●	disagreement regarding the formulation, labeling, and/or the specifications we propose for our product candidates; or
	●	changes in a policies, requirements, or regulations rendering our clinical data insufficient for approval.

	●	the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies;
	●	obtaining regulatory approval to commence and/or continue to conduct a trial, including but not limited to obtaining IND approval by FDA;
	●	reaching an agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
	●	obtaining Institutional Review Board, or IRB, approval at each site, or Independent Ethics Committee, or IEC, approval at sites outside the United States;
	●	recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers;
	●	having patients complete a trial or return for post-treatment follow-up;
	●	imposition of a clinical hold by regulatory authorities, or IRBs, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols;
	●	clinical sites deviating from trial protocol, failing to adequately enroll study subjects, committing fraud or other violations of regulatory requirements, or dropping out of a trial, which can render data from that site unusable in support of regulatory approval;
	●	addressing patient safety concerns that arise during the course of a trial;
	●	adding a sufficient number of clinical trial sites; or
	●	manufacturing sufficient quantities of our drug therapies for use in clinical trials.

	●	regulatory authorities may suspend, withdraw or limit approvals of such product, or seek an injunction against its manufacture or distribution;
	●	regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, “Dear Healthcare Provider” letters, press releases or other communications containing warnings or other safety information about the product;
	●	we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
	●	we may be required to change the way a product is administered or conduct additional clinical trials;
	●	the product may become less competitive, and our reputation may suffer;
	●	we may decide to remove the product from the marketplace; and
	●	we may be subject to fines, injunctions or the imposition of civil or criminal penalties.

	●	our inability to design such product candidates with the properties that we desire; or
	●	potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance.

	●	we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a candidate is safe and effective for its proposed indication;
	●	serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our candidates, or other products containing the active ingredient in our candidates;
	●	negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
	●	we may be unable to demonstrate that a candidate’s clinical and other benefits outweigh its safety risks;
	●	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
	●	the data collected from clinical trials of our development candidates may not be acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials;
	●	the FDA or comparable foreign authorities may disagree regarding the formulation, labeling and/or the specifications of our candidates;
	●	the FDA or comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

	●	the FDA or comparable foreign regulatory authorities may inspect and find deficiencies at the clinical trial sites we use to conduct our clinical studies; and
	●	the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

	●	the patient eligibility criteria defined in the protocol;
	●	the size of the patient population required for analysis of the trial’s primary endpoints;
	●	the nature of the trial protocol;
	●	the existing body of safety and efficacy data with respect to the product candidate;
	●	the proximity of patients to clinical sites;
	●	our ability to recruit clinical trial investigators with the appropriate competencies and experience;
	●	clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;
	●	competing clinical trials being conducted by other companies or institutions;
	●	our ability to maintain patient consents;
	●	the risk that patients enrolled in clinical trials will drop out of the trials before completion; and
	●	delays or difficulties in enrollment and completion of studies due to any pandemic, epidemic or outbreak of an infectious disease.

	●	regulatory authorities may withdraw approvals of such product;
	●	regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;
	●	additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
	●	we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a medication guide outlining the risks of such side effects for distribution to patients;
	●	we could be sued and held liable for harm caused to patients;
	●	the product may become less competitive; and
	●	our reputation may suffer.

	●	litigation involving patients taking our product candidates;
	●	restrictions on such products, manufacturers, or manufacturing processes;
	●	restrictions on the labeling or marketing of products;
	●	restrictions on product distribution or use;
	●	requirements to conduct post-marketing studies or clinical trials;
	●	warning letters or untitled letters;
	●	withdrawal of the products from the market;
	●	refusal to approve pending applications or supplements to approved applications that we submit;
	●	recall of products;
	●	fines, restitution or disgorgement of profits or revenues;
	●	suspension or withdrawal of marketing approvals;
	●	refusal to permit the import or export of our products;
	●	damage to relationships with any potential collaborators;
	●	unfavorable press coverage and damage to our reputation;
	●	refusal to permit the import or export of our product candidates;
	●	product seizure; or
	●	injunctions or the imposition of civil or criminal penalties.

	●	our inability to recruit, train, and retain adequate numbers of effective sales and marketing personnel;
	●	the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products;
	●	the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage compared to companies with more extensive product lines;
	●	unforeseen costs and expenses associated with creating an independent sales and marketing organization; and
	●	unforeseen costs and limitations with regard to setting up a distribution network.

	●	impairment of our business
	●	reputation and significant negative media attention;
	●	withdrawal of participants from our clinical trials;
	●	significant costs to defend the litigation;
	●	distraction of management’s attention from our primary business;
	●	substantial monetary awards to patients or other claimants;
	●	inability to commercialize THIO or any other product candidate;
	●	product recalls, withdrawals or labeling, marketing or promotional restrictions;
	●	decreased market demand for any product; and
	●	loss of revenue.

	●	differing regulatory requirements and reimbursement landscapes in foreign countries;
	●	the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market with low or lower prices rather than buying them locally;
	●	unexpected changes in tariffs, trade barriers, price and exchange controls, and other regulatory requirements;
	●	economic weakness, including inflation, or political instability in particular foreign economies and markets;
	●	compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
	●	foreign taxes, including withholding of payroll taxes;
	●	foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
	●	difficulties staffing and managing foreign operations;
	●	workforce uncertainty in countries where labor unrest is more common than in the United States;
	●	potential liability under the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, or comparable foreign regulations;
	●	challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
	●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
	●	business interruptions resulting from geo-political actions, including war and terrorism.

	●	reliance on the third party for regulatory compliance and quality assurance;
	●	the possible breach of the manufacturing agreement by the third party;
	●	the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
	●	the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

	●	We did not design and maintain an effective control environment commensurate with our financial reporting requirements. Specifically, we lacked a sufficient complement of resources with (i) an appropriate level of accounting knowledge, experience and training to appropriately analyze, record and disclose accounting matters timely and accurately, and (ii) an appropriate level of knowledge and experience to establish effective processes and controls. Additionally, the lack of a sufficient number of professionals resulted in an inability to consistently establish appropriate authorities and responsibilities in pursuit of our financial reporting objectives, as demonstrated by, among other things, insufficient segregation of duties in our finance and accounting functions. This material weakness contributed to the following additional material weaknesses.
	●	We did not design and maintain effective controls related to the period-end financial reporting process, including designing and maintaining formal accounting policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures. Additionally, we did not design and maintain controls over the preparation and review of account reconciliations and journal entries, including maintaining appropriate segregation of duties.
	●	We did not design and maintain effective controls related to the accounting for certain non-routine or complex transactions, including the proper application of U.S. GAAP to such transactions.
	●	Additionally, these material weaknesses could result in a misstatement of substantially all of our accounts or disclosures that would result in a material misstatement to the annual or interim financial statements that would not be prevented or detected.
	●	We did not design and maintain effective controls over information technology, or IT, general controls for information systems that are relevant to the preparation of our financial statements. Specifically, we did not design and maintain (i) program change management controls to ensure that information technology program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized and implemented appropriately, (ii) user access controls to ensure appropriate segregation of duties and that adequately restrict user and privileged access to financial applications, programs, and data to appropriate Company personnel, (iii) computer operations controls to ensure that critical batch jobs are monitored and data backups are authorized and monitored, and (iv) testing and approval controls for program development to ensure that new software development is aligned with business and IT requirements.

	●	increased operating expenses and cash requirements;
	●	the assumption of additional indebtedness or contingent liabilities;

	●	assimilation of operations, intellectual property, and drug products of an acquired company, including difficulties associated with integrating new personnel;
	●	the diversion of our management’s attention from our existing drug programs and initiatives in pursuing such a strategic partnership, merger, or acquisition;
	●	retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
	●	risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or drug candidates and regulatory approvals; and
	●	our inability to generate revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

	●	the scope of rights granted under the license agreement and other interpretation-related issues;
	●	the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
	●	the sublicensing of patent and other rights under our collaborative development relationships;
	●	our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
	●	the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
	●	the priority of invention of patented technology.

	●	the federal civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;

	●	the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit 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 whether the payor is 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, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” and their respective subcontractors 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 Payments Sunshine Act, created under Section 6002 of Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, and its implementing regulations, created annual reporting requirements for manufacturers of drugs, devices, biologicals, and medical supplies for certain payments and “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. As of January 1, 2022, these reporting obligations will extend to include transfers of value made in the previous year to certain non-physician providers such as physician assistants and nurse practitioners; and

	●	analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state and local laws requiring the licensure of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

	●	collaborators may not perform their obligations as expected;

	●	collaborators may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

	●	collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

	●	collaborators could fail to make timely regulatory submissions for a product candidate;

	●	collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements, which could subject them or us to regulatory enforcement actions;

	●	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

	●	product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;

	●	a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product candidate or product;

	●	disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time consuming and expensive;

	●	collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; and

	●	collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.

	●	Successfully completing our Phase 1 and Phase 2 clinical trials and obtaining FDA approval for our product candidates;

	●	launching commercial sales of such products, whether alone or in collaboration with others;

	●	receiving approved labels with claims that are necessary or desirable for successful marketing, and that do not contain safety or other limitations that would impede our ability to market such products;

	●	creating market demand for such products through marketing, sales and promotion activities;

	●	hiring, training, and deploying a sales force or contracting with third parties to commercialize such products in the United States;

	●	creating partnerships with, or offering licenses to, third parties to promote and sell such products in foreign markets where we receive marketing approval;

	●	manufacturing such products in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter;

	●	establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms;

	●	maintaining patent and trade secret protection and regulatory exclusivity for such products;

	●	achieving market acceptance of such products by patients, the medical community, and third-party payors;

	●	achieving coverage and adequate reimbursement from third-party payors for such products;

	●	achieving patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors;

	●	competing effectively with other therapies; and

	●	maintaining a continued acceptable safety profile of such products following launch.

	●	the inability to recruit, train, manage, and retain adequate numbers of effective sales and marketing personnel;

	●	the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing our product candidates;

	●	our inability to effectively oversee a geographically dispersed sales and marketing team;

	●	the costs associated with training personnel, including sales and marketing personnel, on compliance matters and monitoring their actions;

	●	an inability to secure coverage and adequate reimbursement by third-party payors, including government and private health plans;

	●	the unwillingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement from third-party payors;

	●	the clinical indications for which the products are approved and the claims that we may make for the products;

	●	limitations or warnings, including distribution or use restrictions, contained in the products’ approved labeling;

	●	any distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities or to which we agree as part of a mandatory REMS or voluntary risk management plan;

	●	liability for our personnel, including sales or marketing personnel, who fail to comply with applicable law;

	●	the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

	●	unforeseen costs and expenses associated with creating an independent sales and marketing organization or engaging a contract sales organization.