Shuttle Pharmaceuticals Holdings, Inc 10-K/A for FY2023

Shuttle Pharmaceuticals Holdings, Inc. (SHPH)

10-K/A 2024-09-04 For: 2023-12-31

Added on April 10, 2026

About this 10-K/A

Shuttle Pharmaceuticals Holdings, Inc filed this 10-K/A on September 4, 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: $6.59M; compared with a net loss of $5M a year earlier
Diluted EPS: -$3.53; compared with -$5.04 a year earlier

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Delaware		82-5089826
State or other jurisdiction of		(I.R.S. Employer
incorporation or organization		Identification Number)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		SHPH		The Nasdaq Stock Market LLC

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☒

	●	Part I, Item 1A. Risk Factors;

	●	Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations;

	●	Part II, Item 8. Financial Statements and Supplementary Data;

	●	Part II, Item 9A. Controls and Procedures; and

	●	Part III, Item 14. Principal Accountant Fees and Services.

		Page No.
	PART I
Item 1.	Business	4
Item 1A.	Risk Factors	24
Item 1B.	Unresolved Staff Comments	52
Item 1C.	Cybersecurity	52
Item 2.	Properties	53
Item 3.	Legal Proceedings	53
Item 4.	Mine Safety Disclosures	53

	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	54
Item 6.	[Reserved]	55
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	55
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	61
Item 8.	Financial Statements and Supplementary Data	62
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	63
Item 9A.	Controls and Procedures	63
Item 9B.	Other Information	63
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	63

	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	64
Item 11.	Executive Compensation	73
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	76
Item 13.	Certain Relationships and Related Transactions, and Director Independence	77
Item 14.	Principal Accountant Fees and Services	78

	PART IV
Item 15.	Exhibit and Financial Statement Schedules	79
Item 16.	Form 10–K Summary	81
SIGNATURES		82

	●	the initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and INDs, NDAs other regulatory submissions;

	●	our expected dependence on third party collaborators for developing, obtaining regulatory approval for and commercializing product candidates;

	●	our receipt and timing of any milestone payments or royalties under any research collaboration and license agreement we enter into;

	●	our ability to identify and develop product candidates;

	●	our or a collaborator’s ability to obtain and maintain regulatory approval of any of our product candidates;

	●	the rate and degree of market acceptance of any approved products candidates;

	●	the commercialization of any approved product candidates;

	●	our ability to establish and maintain additional collaborations and retain commercial rights for our product candidates subject to collaborations;

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

	●	our estimates of our expenses, ongoing losses, future revenue and capital requirements;

	●	our ability to obtain additional funds for our operations;

	●	our ability to obtain and maintain intellectual property protection for our technologies and product candidates and our ability to operate our business without infringing the intellectual property rights of others;

	●	our reliance on third parties to conduct our preclinical studies or any future clinical trials;

	●	our reliance on third party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development, preclinical and clinical trial drug supplies;

	●	our ability to attract and retain qualified key management and technical personnel;

	●	our use of net proceeds received by us from our initial public offering, or IPO, or any subsequent private placement;

	●	our expectations regarding the time during which we will be an emerging growth company under the JOBS Act;

	●	our financial performance; and

	●	developments relating to our competitors or our industry.

	1.	Sensitization of growing cancer cells, rendering them more susceptible to the effects of radiation therapy.

	2.	Activation of the DNA damage response pathway to kill cancer cells and protect adjacent normal cells.

	3.	Activation of the immune system to kill any remaining cells after RT.

	●	Ropidoxuridine and Tipiracil (IPdR/TPI) is a new combination formulation demonstrating extended bioavailability after oral administration in an animal model system. The IPdR/TPI formulation will undergo preclinical development for use as a radiation sensitizer of rectal cancers after the Phase II brain tumor clinical trial has been initiated.

	●	SP-1-161 is Shuttle Pharma’s pre-clinical candidate lead HDAC inhibitor, radiation sensitizing candidate product. This pan HDAC inhibitor initiates the mutated in ataxia-telangiectasia (ATM) response pathway. Using rational drug design, we discovered dual function molecules, HDAC inhibitors and ATM activators capable of sensitizing cancer cells to radiation and protecting normal cells. The drug candidate may serve as a direct chemotherapeutic agent or as radiation sensitizers for treating cancers.

	●	SP-2-225 is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitor that selectively affects histone deacetylase HDAC6. SP-2-225 has effects on the regulation of the immune system. The interactions of RT with the immune response for cancer treatment are of great current interest, offering insight into potential mechanisms for primary site and metastatic cancer treatment. For this reason, Shuttle Pharma has selected SP-2-225 as the candidate lead HDAC inhibitor for preclinical development. We have contracted with investigators at Georgetown University to perform preclinical studies of immune activation after radiation therapy in an animal tumor model. Requests for proposals for advancing drug manufacture and IND-enabling studies have been submitted and are under review to enable drug development to a Phase I clinical trial in 2024. With the introduction of check-point inhibitors, CAR-T therapies and personalized medicine in cancer, regulation of the immune response following RT is of significant clinical and commercial interest.

	●	SP-1-303 is Shuttle Pharma’s pre-clinical selective Class I HDAC inhibitor that preferentially affects histone deacetylases HDAC1 and HDAC3 members of the class I HDAC family of enzymes. SP-1-303 data show direct cellular toxicity in ER positive breast cancer cells. Furthermore, SP-1-303 increases PD-L1 expression. A manuscript reporting completed preclinical in vitro studies is in preparation. We plan to seek collaborations to complete SP-1-303 pre-clinical development in 2024.

	●	Develop IPdR as a radiation sensitizer for the treatment of gastro-intestinal cancers, in combination with radiation therapy. This funding provided partial support for the Phase I clinical trial of Ropidoxuridine and RT.

	●	Develop prostate cancer cell cultures from African-American men, with donor matched normal prostate cells, establishing 50 pairs for accelerating research to reduce prostate cancer health disparities in African-American men. This project was funded under “Moonshot” designation and Shuttle Pharma is eligible to submit an application for additional SBIR (Phase IIb) funding to establish the infrastructure required to expand and distribute cells for research purposes. Cells from African-American patients are distributed to investigators who are conducting health disparities research.

	●	Develop predictive biomarkers for determining outcomes for prostate cancer patients following treatment with SBRT. This SBIR-funded project was completed on March 15, 2022 and Shuttle Pharma is eligible to apply for additional funding through the SBIR (Phase IIb) mechanism The Phase IIb SBIR grant mechanism is designed to de-risk clinical validation to develop the predictive biomarkers to commercialization. Shuttle Pharma has licensed the intellectual property for the prostate cancer predictive biomarker test from Georgetown University and will seek additional investment from the public market to advance clinical development through its Shuttle Diagnostics entity.

	●	Capitalize on Ropidoxuridine as an orally available, small molecule radiation sensitizer. To date, there is one drug (Cetuximab, a monoclonal antibody) approved by the FDA specifically as a radiation sensitizer. If we are successful in developing Ropidoxuridine and obtaining FDA approval, a small molecule sensitizer would then be enabled for clinical applications for radiation sensitization indications.

	●	Expand our leadership position within radiation sensitizers. In addition to our traditional radiation sensitizers, we plan to advance our near-term pipeline to include radiation sensitizers for proton therapy. Proton Therapy is growing worldwide as a form of radiation therapy due to its unique beam shaping characteristics. As a result, this new technology offers a major opportunity for Shuttle Pharma to strive to develop an innovative and well-tolerated drug for proton therapy sensitization.

	●	Execute a disciplined business development strategy to strengthen our portfolio of product candidates. We have built our current product pipeline through in-house discovery, development, partnerships with leading academic institutions and through in-licensing. We will continue to evaluate new in-licensing opportunities and collaboration agreements with leading academic institutions and other biotechnology companies around programs that seek to address areas of high unmet need and for which we believe there is a high probability of clinical success, including programs beyond our target franchise areas and current technology footprint.

	●	Invest in our HDAC platform technology and maximize its utility across cancer therapies. We are initially applying the platform to develop drugs for cancer radiation sensitization, normal tissue radiation protection and post radiation immune stimulation. Based on the data we have obtained thus far, these drugs are immune regulatory. We intend to invest to develop other properties of our platform technology, as well.

	●	Enter into collaborations to realize the full potential of our platform. The breadth of our HDAC technology platform enables other therapeutic applications, including radiation sensitization and immune therapy. We intend to seek collaborations centered on our platform to maximize applications for cancer treatment.

Male				Female
Prostate	299,010	27	%	Breast	310,720	31	%
Lung & bronchus	116,310	12	%	Lung & bronchus	118,270	13	%
Colon & rectum	81,540	8	%	Colon & rectum	71,270	8	%
Urinary bladder	118,330	6	%	Uterine corpus	67,880	7	%
Melanoma of the skin	59,170	6	%	Melanoma of the skin	41,470	5	%
Kidney & renal pelvis	52,380	5	%	Thyroid	31,520	3	%
Non-Hodgkin lymphoma	44,590	4	%	Non-Hodgkin lymphoma	36,030	4	%
Oral cavity & pharynx	41,510	4	%	Kidney & renal pelvis	29,230	3	%
Leukemia	36,450	4	%	Pancreas	31,910	3	%
Pancreas	34,530	3	%	Leukemia	26,320	3	%
All sites	983,160			All sites	934,870

	●	Improvement in efficacy of radiation treatments as determined by overall survival, progression free survival and response rates in comparison to currently used “off-label” sensitizer drugs.

	●	Reduction in radiation doses needed to affect a positive clinical response for the patient.

	●	Reduction in the surgical extent that is needed to remove residual cancer.

	●	Improvement in quality-of-life outcomes.

	●	GMP manufacture and formulation of 24 kg of Ropidoxuridine for use in clinical trials has been completed.

	●	The IND for a Phase II clinical trial of Ropidoxuridine and RT in glioblastoma has been approved for the study to proceed.

	●	The contract research organizations (CRO), Theradex Oncology has been engaged to assist in the performance the Phase II clinical trial.

	●	Completion of the Phase II clinical trial in glioblastomas to determine appropriate dosing, effectiveness and tolerability of the treatment.

	●	SP-1-161, a candidate lead of compounds demonstrating activation of the “ATM” gene product (mutated in Ataxia-Telangiectasia). Ataxia-Telangiectasia is a human genetic disease characterized by neurological, immunological and radiobiological clinical features.

	●	SP-2-225, a candidate lead of compounds demonstrating Class II (HDAC6) selective inhibition. HDAC6 is a molecule integral to the presentation of antigens by macrophages to T-lymphocytes.

	●	SP-1-303 is a candidate Class I HDAC inhibitor with preferential efficacy against ER positive cancers.

	○	Sub-contractor for the SBIR supported African American prostate cancer patient health disparities project (completed). The conditional reprogramming of cells (CRC) technology was invented at Georgetown University and Georgetown University owns the intellectual property. Propagenix holds the license for the intellectual property for the CRC technology from Georgetown University. The intellectual property for cells derived from African American patients under the Georgetown University subcontract belong to Shuttle Pharmaceuticals, Inc. based on our sub-licensing agreement with Propagenix.
	○	Sub-contractor for the SBIR supported metabolomic predictive biomarker project (completed). The metabolomic biomarker intellectual property belongs to Georgetown University and Shuttle Pharma holds an exclusive option to license the intellectual property.
		Exclusive licensing agreement with Georgetown University pursuant to which Georgetown University agreed to license the intellectual property known as “Predictive Biomarkers for Adverse Effects of Radiation Therapy” (U.S. Patent Application No. 17/476,184, filed on September 15, 2021) (the “Patent Rights”), which was developed by Dr. Anatoly Dritschilo, the Company’s Chief Executive Officer, Dr. Scott Grindrod, the Company’s Principal Scientist, and Drs. Amrita Cheema and Yaoxiang Li, employees of Georgetown. The Patent Rights will be available for the Company’s use worldwide.
		Shuttle Pharma entered into a research agreement (the “Research Agreement”) with Georgetown University for testing small molecule radiation sensitizers and immune activation candidates discovered and developed by Shuttle Pharma in cell-based and animal xenograft models.
	○	In conjunction with the Research Agreement, Shuttle Pharma also entered into a material transfer agreement (the “MTA”), dated March 21, 2023, with Georgetown University. Under the MTA, Shuttle Pharma agreed to transfer research quantities of candidate drug molecules to Georgetown University, which materials will be used by Georgetown University solely to carry out additional research for Shuttle Pharma and which materials shall at all times remain the property of Shuttle Pharma.

	○	Material transfer agreement for testing HDAC inhibitor effects in immune model systems
	○	The material transfer agreement that protects our HDAC inhibitor intellectual property is with George Washington University, transferring drugs for research purposes and sharing authorship on publications. There is no transfer of funds related to such activities.

**	IUdR continuous IV infusion (1000 mg/m2/ day/ 14 days), Total of 39 patients (F. Sullivan, et al. Int J Radiat Oncol Biol Phys. 1994; 30(3):583-90)

*	IUdR continuous IV infusion (2000 mg/m2/ 4 day infusion/ 6 week treatment), Total of 21 patients (R. Urtasun, et al. Int J Radiat Oncol Biol Phys. 1996;36(5):1163-7.)

	●	SBIR contract #261201400013C: Phase I ($191,971) and Phase II ($1,428,117) for Clinical Development of IPdR for Radiosensitization, dates September 19, 2014 through August 3, 2017. Subcontract to Brown University/LifeSpan Rhode Island Hospital. No related intellectual property.
	●	SBIR contracts # HHSN261201600038C; Phase I ($224,687) and #261201800016C: Cell-Based Models for Prostate Cancer Health Disparity Research - Moonshot Project (Phase II), award amount $1,484,350, dates September 19, 2016 through September 16, 2021. Subcontract to Georgetown University. Intellectual property consists of cell cultures and is property of Shuttle Pharmaceuticals, Inc. via licensing agreement.
	●	SBIR contracts #HHSN261201600027C ($299,502) and #75N81018C00031: Predictive Biomarkers of Prostate Cancer Patient Sensitivity for Radiation Late Effects, award amount $1,903,015, dates September 16, 2019 through March 15, 2022. Subcontract to Georgetown University. Intellectual property is owned by subcontractor Georgetown University with option to license to Shuttle Pharmaceuticals, Inc.

	●	Our ability to continue as a going concern in the near term is dependent upon us successfully raising additional equity or debt financing to fund our operations.
	●	Our success is primarily dependent on the successful development, regulatory approval and commercialization of our product candidates, all of which are in the early stages of development.
	●	We currently have no source of product sales revenue.
	●	We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours. If these companies develop technologies or product candidates more rapidly than we do or their technologies, including delivery technologies, are more effective, our ability to develop and commercialize product candidates may be adversely affected.
	●	If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
	●	If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
	●	If we are not able to obtain and enforce patent protection for our technologies or product candidates, development and commercialization of our product candidates may be adversely affected.
	●	We or our licensors, or any future collaborators or a strategic partners may become subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other proprietary rights, all of which could be costly, time consuming, delay or prevent the development and commercialization of our product candidates, or put our patents and other proprietary rights at risk.
	●	If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
	●	We may be unable to obtain U.S. or foreign regulatory approval and, as a result, unable to commercialize our product candidates.
	●	Any drugs we develop may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.
	●	Our ability to obtain services, reimbursement or funding from the federal government may be impacted by possible reductions in federal spending.
	●	If any of our product candidates receives marketing approval and we or others later identify undesirable side effects caused by the product candidate, our ability to market and derive revenue from the product candidates could be compromised.
	●	On August 13, 2024, we effected a 1-for-8 reverse split of our common stock in order to bring our stock price above $1.00 in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”); as a result, Nasdaq notified us that we had regained compliance with the Minimum Bid Price Requirement on August 27, 2024.
	●	Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.
	●	The future issuance of equity or of debt securities that are convertible into common stock will dilute our share capital.
	●	If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
	●	The restatement of our financial statements and identification of material weaknesses in our internal controls may result in additional risks and uncertainties, including regulatory, stockholder or other actions, loss of investor and counterparty confidence and negative impacts on our stock price.

	●	building on favorable results from our Phase I clinical trial for IPdR and proceeding to Phase II and Phase III clinical trials, which may be slower or cost more than we currently anticipate;

	●	our ability to demonstrate safety and efficacy of our product candidates, which are ongoing determinations that are solely within the authority of the FDA;

	●	even if our clinical trials are completed, there can be no assurance that the FDA will agree that we have satisfactorily demonstrated safety or efficacy or that the FDA will not raise new issues regarding the design of our clinical trials;

	●	whether we are required by the FDA to conduct additional clinical trials to support the approval of our product candidates;

	●	the acceptance by the FDA of our proposed parameters for regulatory approval, including our proposed indication, endpoints and endpoint measurement tools relating to our product candidates;

	●	the incidence, duration and severity of adverse side effects;

	●	the timely receipt of necessary marketing approvals from the FDA;

	●	whether we are able to secure collaborations for completing the development and, if approved, commercialization of our product candidates;

	●	the effectiveness of our and our potential collaborators’ marketing, sales and distribution strategy and operations of product candidates that are approved;

	●	our success in educating physicians and patients about the benefits, administration and use of our product candidates;

	●	the ability of our third-party manufacturers and potential collaborators to manufacture clinical trial and commercial supplies of our product candidates to remain in good standing with regulatory bodies, and to develop, validate and maintain commercially viable manufacturing processes that are compliant with current Good Manufacturing Practices (“cGMP”) regulations;

	●	our ability to commercialize our product candidates, if approved for marketing;

	●	our ability to enforce our intellectual property rights;

	●	our ability to avoid third-party patent interference or patent infringement claims;

	●	acceptance of our product candidates as safe and effective by patients and the medical community; and

	●	a continued acceptable quality profile of our product candidates following approval.

	●	complete research and clinical development of current and future product candidates, either directly or through collaborative relationships;

	●	establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

	●	obtain regulatory approval from relevant regulatory authorities in jurisdictions where we intend to market our product candidates, either directly or through collaborative relationships;

	●	launch and commercialize future product candidates for which we obtain marketing approval, if any, through collaborative partners;

	●	obtain coverage and adequate product reimbursement from third-party payors, including government payors;

	●	achieve market acceptance for our products, if any;

	●	establish, maintain and protect our intellectual property rights; and

	●	attract, hire and retain qualified personnel.

	●	terms of any approvals and the countries in which approvals are obtained;

	●	safety and efficacy of our product candidates, which are determinations solely within the authority of the FDA;

	●	prevalence and severity of any adverse side effects associated with our product candidates;

	●	warnings contained in any labeling approved by the FDA or other regulatory authority;

	●	convenience and ease of administration of our product candidates;

	●	success of our physician education programs;

	●	availability of adequate government and third-party payor reimbursement;

	●	pricing of our products, particularly as compared to alternative treatments; and

	●	availability of alternative effective products for indications our product candidates are intended to treat.

	●	the scope, progress, results and costs of researching and developing our current product candidates, future product candidates and conducting preclinical and clinical trials;

	●	the cost of commercialization activities if our current product candidates and future product candidates are approved for sale, including securing collaborative ventures for completing development of, securing marketing approval for and ultimately marketing, selling and distributing our product candidates, if approved or building a corporate infrastructure if we have to undertake these activities directly;

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

	●	the number and characteristics of any additional product candidates we may develop or acquire;

	●	any product liability or other lawsuits related to our products or commenced against us;

	●	the expenses needed to attract and retain skilled personnel;

	●	the costs associated with being a public company;

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

	●	the timing, receipt and amount of sales of, or royalties on, any future approved products, if any.

	●	delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for our current product candidates or future product candidates, if any;

	●	delay, limit, reduce or terminate our research and development activities; or

	●	delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize our current or future product candidates.

	●	negative or inconclusive results from our clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;

	●	serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates;

	●	delays in submitting an Investigational New Drug application (“IND”) or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

	●	conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

	●	delays in enrolling research subjects in clinical trials;

	●	high drop-out rates of research subjects;

	●	greater than anticipated clinical trial costs;

	●	poor effectiveness of our product candidates during clinical trials;

	●	unfavorable FDA or other regulatory agency inspection and review of a clinical trial site;

	●	failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;

	●	delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or

	●	varying interpretations of data by the FDA and similar foreign regulatory agencies.

	●	an inability to initiate or continue clinical trials of product candidates under development;

	●	delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates;

	●	loss of the cooperation of a collaborator;

	●	subjecting our product candidates to additional inspections by regulatory authorities;

	●	requirements to cease distribution or to recall batches of our product candidates; and

	●	in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.

	●	others will not or may not be able to make, use or sell compounds that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own or license;

	●	we or our licensors, collaborators or any future collaborators are the first to make the inventions covered by each of our issued patents and pending patent applications that we own or license;

	●	we or our licensors, collaborators or any future collaborators are the first to file patent applications covering certain aspects of our inventions;

	●	others will not independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

	●	A third party may not challenge our patents and, if challenged, a court may not hold that our patents are valid, enforceable and infringed;

	●	any issued patents that we own or have licensed will provide us with any competitive advantages, or will not be challenged by third parties;

	●	we may develop additional proprietary technologies that are patentable;

	●	the patents of others will not have an adverse effect on our business; and

	●	our competitors do not conduct research and development activities in countries where we do not have enforceable patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets.

	●	the U.S. federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;

	●	the U.S. federal false claims law, which prohibits, among other things, individuals or entities from knowingly presenting or causing to be presented, claims for payment by government funded programs such as Medicare or Medicaid that are false or fraudulent, and which may apply to us by virtue of statements and representations made to customers or third parties;

	●	the U.S. federal Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act, which prohibit executing a scheme to defraud healthcare programs, impose requirements relating to the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;

	●	the federal Open Payments regulations under the National Physician Payment Transparency Program have been issued under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, and will require that manufacturers of pharmaceutical and biological drugs covered by Medicare, Medicaid, and Children’s Health Insurance Programs report all consulting fees, travel reimbursements, research grants, and other payments or gifts with values over $10 made to physicians and teaching hospitals; and

	●	state laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws applicable to commercial insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security.

	●	adverse regulatory inspection findings;

	●	warning letters;

	●	voluntary or mandatory product recalls or public notification or medical product safety alerts to healthcare professionals;

	●	restrictions on, or prohibitions against, marketing our products;