Greenwich LifeSciences, Inc 10-K for FY2023

Greenwich LifeSciences, Inc. (GLSI)

10-K 2024-04-15 For: 2023-12-31

Added on April 11, 2026

About this 10-K

Greenwich LifeSciences, Inc filed this 10-K on April 15, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $8.89M; compared with a net loss of $7.83M a year earlier
Diluted EPS: -$0.69; compared with -$0.61 a year earlier

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3992 Bluebonnet Dr., Building 14, Stafford, Texas 77477		77477
(Address of principal executive offices)		(Zip Code)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		GLSI		The NASDAQ Capital Market LLC

		Page
	PART I
Item 1	Business	6
Item 1A	Risk Factors	22
Item 1B	Unresolved Staff Comments	51
Item 1C	Cybersecurity	51
Item 2	Properties	51
Item 3	Legal Proceedings	51
Item 4	Mine Safety Disclosures	51

	PART II
Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	52
Item 6	[Reserved]	52
Item 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	52
Item 7A	Quantitative and Qualitative Disclosures About Market Risk	55
Item 8	Financial Statements and Supplementary Data	55
Item 9	Changes In and Disagreements with Accountants on Accounting and Financial Disclosure	55
Item 9A	Controls and Procedures	55
Item 9B	Other Information	55
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	55

	PART III
Item 10	Directors, Executive Officers, and Corporate Governance	56
Item 11	Executive Compensation	60
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	61
Item 13	Certain Relationship and Related Transactions, and Director Independence	62
Item 14	Principal Accountant Fees and Services	63

	PART IV
Item 15	Exhibits	64
Item 16	Form 10-K Summary	64

SIGNATURES		65

	●	our projected financial position and estimated cash burn rate;

	●	our estimates regarding expenses, future revenues and capital requirements;

	●	our ability to continue as a going concern;

	●	our need to raise substantial additional capital to fund our operations;

	●	the success, cost and timing of our clinical trials;

	●	our dependence on third parties in the conduct of our clinical trial;

	●	our ability to obtain the necessary regulatory approvals to market and commercialize our product candidate;

	●	the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;

	●	the potential that results of preclinical and clinical trials indicate our current product candidate or any future product candidates we may seek to develop are unsafe or ineffective;

	●	the results of market research conducted by us or others;

	●	our ability to obtain and maintain intellectual property protection for our current product candidate;

	●	our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;

	●	the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;

	●	our reliance on third-party suppliers and manufacturers;

	●	the success of competing therapies and products that are or become available;

	●	our ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;

	●	the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our product candidate;

	●	market acceptance of our product candidate, the size and growth of the potential markets for our current product candidate and any future product candidates we may seek to develop, and our ability to serve those markets; and

	●	the successful development of our commercialization capabilities, including sales and marketing capabilities.

Clinical Trial Description		Status
GP2 Phase III Clinical Trial – Flamingo-01		Enrolling in US
●	A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Trastuzumab-based Therapy	and Europe

GP2 Phase IIb Clinical Trial		Trial Completed
●	Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A*02+ Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence
●	89 patients treated with GP2 + GM-CSF, 91 placebo patients treated with GM-CSF

GP2 Phase I Clinical Trial — Combination with AE37		Trial Completed
●	Phase I Safety Trial of the GP2 + GM-CSF Vaccine in Combination with the Helper Peptide AE37 + GM-CSF Vaccine
●	22 patients treated with GP2 + AE37 + GM-CSF

GP2 Phase I Clinical Trial — Combination with Trastuzumab		Trial Completed
●	Phase Ib Trial of Combination Immunotherapy with HER2/neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients
●	17 patients treated with GP2 + GM-CSF + trastuzumab

First GP2 Phase I Clinical Trial		Trial Completed
●	Phase Ib Trial of HER2/neu Peptide (GP2) Vaccine in Breast Cancer Patients
●	18 patients treated with GP2 + GM-CSF

	●	Prospective, randomized, single-blinded, placebo-controlled phase IIb clinical trial of GP2 + GM-CSF or GM-CSF alone in HER2/neu 1-3+, HLA-A*02 patients.

	●	High-risk breast cancer patients (Node Positive, High Risk Node Negative) who were disease-free and immunocompetent after having completed standard of care therapy.

	●	The primary endpoint was to determine if GP2 + GM-CSF reduces breast cancer recurrence rates versus GM-CSF alone. A recurrence is defined as either a pathologically confirmed recurrence or a new radiographic finding of recurrence during standard of care follow-up.

	●	HER2/neu 3+ Positive Over Expressors: In the 96 HER2/neu 3+, HLA-A*02 patients, a substantial reduction in recurrences was observed in the efficacy population. A patient was in the efficacy population if they were treated, followed, and remained disease free over the first 6 months, which is the time we believe is required to reach peak immunity and thus maximum efficacy and protection. This patient population was treated with GLSI-100 following the first year of trastuzumab treatment, which followed surgery.

	●	HER2/neu 1-2+ Low to Intermediate Expressors: In the 72 HER2/neu 1-2+, HLA-A*02 patients, no reduction in recurrence rates were observed, but trastuzumab was not administered to these patients. Thus, we may pursue a future trial with GP2 in combination with trastuzumab based therapy and other synergistic agents.

	●	completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices, or GLP, regulations;

	●	submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made;

	●	approval by an independent IRB or ethics committee at each clinical site before the trial is begun;

	●	performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of product;

	●	manufacture of product with adequate controls so that the product has the purity and potency of the proposed biologic product candidate for its intended purpose;

	●	preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials;

	●	satisfactory completion of an FDA Advisory Committee review, if applicable;

	●	a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

	●	satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigations to assess compliance with GCP; and

	●	FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the U.S., which must be updated annually when significant changes are made.

	●	Phase 2 — The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

	●	Phase 3 — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

	●	Phase 4 — In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 clinical trials may be made a condition to approval of the BLA.

	●	conduct clinical trials of our lead product candidate, GP2;

	●	in-license or acquire the rights to, and pursue development of, other products, product candidates or technologies;

	●	hire additional clinical, manufacturing, quality control, quality assurance and scientific personnel;

	●	seek marketing approval for any product candidates that successfully complete clinical trials;

	●	develop our outsourced manufacturing and commercial activities and establish sales, marketing and distribution capabilities, if we receive, or expect to receive, marketing approval for any product candidates;

	●	maintain, expand and protect our intellectual property portfolio; and

	●	add operational, financial and management information systems and personnel.

	●	the scope, progress, results and costs of our ongoing and planned development programs for our product candidate, as well as any additional clinical trials we undertake to obtain data sufficient to seek marketing approval for our product candidate;

	●	the timing of, and the costs involved in, obtaining regulatory approvals for our product candidate if our clinical trials are successful;

	●	the cost of commercialization activities for our product candidate, if our product candidate is approved for sale, including marketing, sales and distribution costs;

	●	the cost of manufacturing our product candidate for clinical trials in preparation for regulatory approval, including the cost and timing of process development, manufacturing scale-up and validation activities;

	●	our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;

	●	the costs to in-license future product candidates or technologies;

	●	the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;

	●	the costs in defending and resolving future derivative and securities class action litigation;

	●	our operating expenses; and

	●	the emergence of competing technologies or other adverse market developments.

	●	successfully complete development activities, including the necessary clinical trials;

	●	complete and submit either Biologics License Applications, or BLAs, or New Drug Applications, or NDAs, to the FDA and obtain U.S. regulatory approval for indications for which there is a commercial market;

	●	complete and submit applications to foreign regulatory authorities;

	●	obtain regulatory approval in territories with viable market sizes;

	●	obtain coverage and adequate reimbursement from third parties, including government and private payors;

	●	set commercially viable prices for our product, if any;

	●	establish and maintain supply and manufacturing relationships with reliable third parties and/or build our own manufacturing facility and ensure adequate, legally globally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

	●	develop distribution processes for our product candidate;

	●	develop commercial quantities of our product candidate, once approved, at acceptable cost levels; obtain additional funding, if required to develop and commercialize our product candidate;

	●	develop a commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves, in the markets in which we choose to commercialize on our own;

	●	achieve market acceptance of our product;

	●	attract, hire and retain qualified personnel; and

	●	protect our rights in our intellectual property portfolio.

	●	designing, conducting and successfully completing preclinical development activities, including preclinical efficacy and IND-enabling studies, for our product candidate or product candidates we may, in the future, in-license or acquire;

	●	designing, conducting and completing clinical trials for our product candidate with positive results;

	●	receipt of regulatory approvals from applicable authorities;

	●	obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidate;

	●	making arrangements with third-party manufacturers, receiving regulatory approval of our manufacturing processes and our third-party manufacturers’ facilities from applicable regulatory authorities and ensuring adequate supply of drug product;

	●	manufacturing our product candidate at an acceptable cost;

	●	effectively launching commercial sales of our product candidate, if approved, whether alone or in collaboration with others;

	●	achieving acceptance of our product candidate, if approved, by patients, the medical community and third-party payors;

	●	effectively competing with other therapies;

	●	if our product candidate is approved, obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our product candidate;

	●	complying with all applicable regulatory requirements, including FDA current Good Clinical Practices (“GCP”), current Good Manufacturing Practices (“cGMP”), and standards, rules and regulations governing promotional and other marketing activities;

	●	maintaining a continued acceptable safety profile of the product during development and following approval; and

	●	maintaining and growing an organization of scientists and business people who can develop and commercialize our product and technology.

	●	eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;

	●	design of the clinical trial;

	●	size and nature of the patient population;

	●	patients’ perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

	●	the availability and efficacy of competing therapies and clinical trials;

	●	pendency of other trials underway in the same patient population;

	●	ability of clinical sites to staff sufficiently for the start-up and conduct of our clinical trial;

	●	willingness of physicians to participate in our planned clinical trials;

	●	severity of the disease under investigation;

	●	proximity of patients to clinical sites;

	●	patients who do not complete the trials for personal reasons; and

	●	issues with CROs and/or with other vendors that handle our clinical trials.

	●	delay or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that we are able to execute;

	●	delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;

	●	delay or failure in reaching agreement on acceptable terms with prospective 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;

	●	delay or failure in obtaining IRB approval or the approval of other reviewing entities, including comparable foreign regulatory authorities, to conduct a clinical trial at each site;

	●	withdrawal of clinical trial sites from our clinical trials or the ineligibility of a site to participate in our clinical trials;

	●	delay or failure in recruiting and enrolling suitable patients to participate in a clinical trial;

	●	delay or failure in patients completing a clinical trial or returning for post-treatment follow-up;

	●	clinical sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance with regulatory requirements, or dropping out of a clinical trial;

	●	inability to identify and maintain a sufficient number of clinical trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication;

	●	failure of our third-party clinical trial managers, CROs, clinical trial sites, contracted laboratories or other third-party vendors to satisfy their contractual duties, meet expected deadlines or return trustworthy data;

	●	delay or failure in adding new clinical trial sites;

	●	interim results or data that are ambiguous or negative or are inconsistent with earlier results or data;

	●	alteration of clinical trial design necessitated by re-evaluation of design assumptions based upon observed data;

	●	feedback from the FDA, the IRB or a comparable foreign regulatory authority, or results from earlier stage or concurrent preclinical studies and clinical trials, that might require modification to the protocol for a clinical trial;

	●	a decision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend or terminate clinical trials at any time for safety issues or for any other reason;

	●	unacceptable risk-benefit profile, unforeseen safety issues or adverse side effects;

	●	failure to demonstrate a benefit from using a product candidate;

	●	difficulties in manufacturing or obtaining from third parties sufficient quantities of a product candidate to start or to use in clinical trials;

	●	lack of adequate funding to continue a clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical trials or increased expenses associated with the services of our CROs and other third parties; or

	●	changes in governmental regulations or administrative actions or lack of adequate funding to continue a clinical trial.

	●	failure to obtain regulatory approval or intellectual property rights in any country which could lead to the termination of a licensing transaction in that country;

	●	the inability to obtain the issuance of patent claims or regulatory status in a foreign country that provide periods of market exclusivity or data exclusivity prior to the entry of generic or biosimilar forms of our products;

	●	the difficulty of pursuing legal remedies to disputes or to secure monetary damages in foreign countries;

	●	the inability to repatriate income from a licensing transaction in a foreign country to the U.S. or to other foreign countries where cash is needed; and

	●	The potential to not realize or to delay development or commercialization milestone payments due to unanticipated outcomes that prevent or delay the milestone.

	●	differing regulatory requirements for drug approvals and regulation of approved drugs in foreign countries; more stringent privacy requirements for data to be supplied to our operations in the U.S., e.g., General Data Protection Regulation in the European Union;

	●	unexpected changes in tariffs, trade barriers and 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;

	●	differing payor reimbursement regimes, governmental payors or patient self-pay systems and price controls;

	●	foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating in another country;

	●	workforce uncertainty in countries where labor unrest is more common than in the U.S.;

	●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

	●	business interruptions resulting from geopolitical actions, including war and terrorism.

	●	we may be forced to suspend marketing of such product;

	●	regulatory authorities may withdraw their approvals of such product;

	●	regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of such product;

	●	we may be required to conduct post-marketing clinical trials;

	●	we may be required to change the way the product is administered;

	●	we could be sued and held liable for harm caused to patients; and

	●	our reputation may suffer.

	●	disagreement with the regulatory authorities regarding the scope, design or implementation of our clinical trials;

	●	failure to demonstrate that a product candidate is safe and effective for our proposed indication;

	●	failure of clinical trials to meet the level of statistical significance required for approval;

	●	failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

	●	disagreement with our interpretation of data from preclinical studies or clinical trials;

	●	the insufficiency of data collected from clinical trials of our product candidate to support the submission and filing of a BLA, NDA or other submission or to obtain regulatory approval;

	●	failure to obtain approval of our manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies or our own manufacturing facility; or

	●	changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.

	●	issue warning letters or untitled letters;

	●	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;

	●	seek an injunction or impose civil or criminal penalties or monetary fines;

	●	suspend or withdraw regulatory approval;

	●	suspend any ongoing clinical trials;

	●	refuse to approve pending applications or supplements to applications filed by us;

	●	suspend or impose restrictions on operations, including costly new manufacturing requirements; or

	●	seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.

	●	product loss due to contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error;

	●	reduced production yields, product defects, and other supply disruptions due to deviations, even minor, from normal manufacturing and distribution processes;

	●	unexpected product defects; and

	●	microbial, viral, or other contaminations in our product candidate or in the manufacturing facilities in which our product candidate is made, which may result in the closure of such manufacturing facilities for an extended period of time to allow for the investigation and remediation of the contamination.

	●	others may be able to make compounds that are similar to our product candidate, but that are not covered by the claims of our licensed patents;

	●	HJF might not have been the first to make the inventions covered by its pending patent applications;

	●	we or HJF might not have been the first to file patent applications for these inventions;

	●	HJF’s pending patent applications may not result in issued patents;

	●	the claims of HJF’s issued patents or patent applications when issued may not cover our product or product candidate;

	●	any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;

	●	any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and

	●	the patents of others may have an adverse effect on our business.

	●	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;

	●	our diligence obligations under the license agreement and what activities satisfy those obligations;

	●	if a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required to sublicense rights in that area to a third party, and that sublicense could harm our business; and

	●	the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

	●	some patent applications in the U.S. may be maintained in secrecy until the patents are issued;

	●	patent applications in the U.S. are typically not published until 18 months after the priority date; and

	●	publications in the scientific literature often lag behind actual discoveries.

	●	paying monetary damages related to the legal expenses of the third party;

	●	facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product; and

	●	restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

	●	the efficacy and safety of such product candidates as demonstrated in clinical trials;

	●	the clinical indications and patient populations for which the product candidate is approved;

	●	acceptance by physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;

	●	the adoption of novel immunotherapies by physicians, hospitals and third-party payors;

	●	the potential and perceived advantages of product candidates over alternative treatments;

	●	the safety of product candidates seen in a broader patient group, including our use outside the approved indications;

	●	any restrictions on use together with other medications;

	●	the prevalence and severity of any side effects;

	●	product labeling or product insert requirements of the FDA or other regulatory authorities;

	●	the timing of market introduction of our product as well as competitive products;

	●	the development of manufacturing and distribution processes for commercial scale manufacturing for our current product candidate and any future product candidates;

	●	the cost of treatment in relation to alternative treatments;

	●	the availability of coverage and adequate reimbursement from third-party payors and government authorities;

	●	relative convenience and ease of administration; and

	●	the effectiveness of our sales and marketing efforts and those of our collaborators.

	●	the demand for our product candidate, if we obtain regulatory approval;

	●	our ability to receive or set a price that we believe is fair for our product;

	●	our ability to generate revenue and achieve or maintain profitability;

	●	the level of taxes that we are required to pay; and

	●	the availability of capital.

	●	a covered benefit under its health plan;

	●	safe, effective and medically necessary;

	●	appropriate for the specific patient;

	●	cost-effective; and

	●	neither experimental nor investigational.

	●	the federal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

	●	federal civil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or qui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment or approval 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 (“HIPAA”) which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on entities subject to the law, such as certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable health information;

	●	the federal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical supplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members and applicable group purchasing organizations;

	●	decreased demand for any product candidates or products that we may develop;

	●	termination of clinical trial sites or entire clinical trial programs;

	●	injury to our reputation and significant negative media attention;

	●	withdrawal of clinical trial participants;

	●	significant costs to defend the related litigation;

	●	substantial monetary awards to clinical trial patients;

	●	loss of revenue;

	●	diversion of management and scientific resources from our business operations; and

	●	the inability to commercialize any products that we may develop.

	●	managing our clinical trials effectively;

	●	identifying, recruiting, maintaining, motivating and integrating additional employees;

	●	managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

	●	improving our managerial, development, operational, information technology, and finance systems; and

	●	expanding our facilities.