Jupiter Neurosciences, Inc 10-K for FY2024

Jupiter Neurosciences, Inc. (JUNS)

10-K 2025-03-28 For: 2024-12-31

Added on April 05, 2026

About this 10-K

Jupiter Neurosciences, Inc filed this 10-K on March 28, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $2.44M; compared with a net loss of $4.78M a year earlier
Diluted EPS: -$0.08; compared with -$0.18 a year earlier

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

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

		Page
Part I

Item 1.	Business	1
Item 1A.	Risk Factors	16
Item 1B.	Unresolved Staff Comments	80
Item 1C.	Cybersecurity	80
Item 2.	Properties	81
Item 3.	Legal Proceedings	81
Item 4.	Mine Safety Disclosures	81

Part II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	82
Item 6.	[Reserved]	83
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	83
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	92
Item 8.	Financial Statements and Supplementary Data	93
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	93
Item 9A.	Controls and Procedures	93
Item 9B.	Other Information	94
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	94

Part III

Item 10.	Directors, Executive Officers and Corporate Governance	94
Item 11.	Executive Compensation	103
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	116
Item 13.	Certain Relationships and Related Transactions, and Director Independence	118
Item 14.	Principal Accountant Fees and Services	120

Part IV

Item 15.	Exhibit and Financial Statement Schedules	121
Item 16.	Form 10-K Summary	124

	Signatures	125

	●	the ability of our preclinical studies and planned clinical trials to demonstrate safety and efficacy of our product candidate JOTROL, and other positive results;
	●	the timing, progress and results of preclinical studies and clinical trials for JOTROL and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and our research and development programs;
	●	the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs and final FDA approval of JOTROL and any other future product candidates;
	●	the timing, scope or likelihood of foreign regulatory filings and approvals;
	●	our ability to develop and advance our current product candidate JOTROL and programs into, and successfully complete, clinical studies;
	●	our manufacturing, commercialization, and marketing capabilities and strategy;
	●	our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
	●	the need to hire additional personnel and our ability to attract and retain such personnel;
	●	the size of the market opportunity for our product candidate JOTROL, including our estimates of the number of patients who suffer from the diseases we are targeting;
	●	our expectations regarding the approval and use of our product candidate JOTROL in combination with other drugs;
	●	our competitive position and the success of competing therapies that are or may become available;
	●	our estimates of the number of patients that we will enroll in our clinical trials;
	●	the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidate JOTROL;
	●	our ability to obtain and maintain regulatory approval of our product candidate JOTROL;
	●	our plans relating to the further development of our product candidate JOTROL, including additional indications we may pursue;
	●	existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
	●	our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering JOTROL and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
	●	our continued reliance on third parties to conduct additional preclinical studies and planned clinical trials of our product candidate JOTROL, and for the manufacture of our product candidate JOTROL for preclinical studies and clinical trials;
	●	our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors;

	●	our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidate JOTROL;
	●	the pricing and reimbursement of JOTROL and other product candidates we may develop, if approved;
	●	the rate and degree of market acceptance and clinical utility of JOTROL and other product candidates we may develop;
	●	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

	●	our financial performance;
	●	the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
	●	the impact of laws and regulations;
	●	our expectations regarding the period during which we will qualify as an emerging growth company under The Jumpstart Our Business Startups Act of 2012 and a smaller reporting company under the Securities Exchange Act of 1934, as amended;
	●	our anticipated use of our existing resources and the proceeds from our initial public offering; and
	●	the price of our common stock could be subject to rapid and substantial volatility. As a relatively small-capitalization company with relatively small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies. In addition, if the trading volumes of our common stock are low, persons buying or selling in relatively small quantities may easily influence prices of our common stock. This low volume of trades could also cause the price of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading; and
	●	other risks and uncertainties, including those listed under the captions “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

	○	To assess safety and tolerability of JOTROL in AD-MCI patients by monitoring adverse events (AEs) and serious adverse events (SAEs) and assessing their relationship to the study drug. Tolerability will be measured by subjects’ ability to remain on treatment. Overall tolerability of the drug will be defined as fewer than 25% discontinuations due to drug-related AEs and SAEs
	○	A first efficacy indicator will be stabilization of Abeta 40/42.

1.	Preclinical studies conducted at University of Miami in MPS I mice results showed that a high dose of resveratrol increased the alpha-L-iduronidase which is the critical enzyme that is too low in these patients.
2.	IND application for Phase I study was approved by the FDA and the clinical trial is completed. Results documented in the section JOTROL Phase I Pharmacokinetic (“PK”) and Safety Study.
3.	Final study details and start to be determined by consultation with the FDA and supportive additional financing.

5.	Secondary endpoints to include (subject to FDA acceptance)

	i.	Improvement in 6-minute walk distance
	ii.	Forced vital capacity
	iii.	Biomarkers, such as alpha-L-iduronidase levels
	iv.	MPS I validated pain survey

	1.	Show superior efficacy;
	2.	Avoid serious side effects of the available therapy;
	3.	Decrease clinically significant toxicity of an available therapy; and
	4.	Address an emerging or anticipated public health need

	●	The Company’s strategy is to partner with organizations in the territory that can execute much more efficiently than trying to manage the process from USA.

	●	We have already received interest for our JOTROL product in the Asian market since resveratrol is listed as a Traditional Chinese Medicine.

	●	The need for a set up that can service this market is imperative for success.

	●	Strategic collaboration agreements have been executed to facilitate an expedited execution of an out-licensing agreement with one or more Chinese or other SE Asian pharmaceutical companies.

	●	The Company is too small, both financially as well as internal manpower, to manage developments in the territory.

	●	The Company has a history of poor financial status and not being able to fulfill commitments and finalize clinical studies.

	●	By utilizing equity as service payments, the company believes that it can get projects finalized without any significant cash outflow.

	●	The service agreements are therefore designed to be a win for both parties, assuming an increase in equity value, in case clinical studies and out-licensing activities will be successful in the territory.

	●	We are early in our development efforts, with a limited operating history, and have no products approved for commercial sale.

	●	We have not generated any revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.

	●	Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of our product candidate.

	●	We will require substantial additional capital to finance our operations.

	●	Our substantial amount of indebtedness may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.

	●	We are substantially dependent on the success of our product candidate, JOTROL. If we are unable to complete development of, obtain approval for and commercialize JOTROL for one or more indications in a timely manner, our business will be harmed.

	●	Our prospects depend upon developing product candidate JOTROL for particular indications and possibly discovering, developing other product candidates in future programs.

	●	Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The clinical trials of our product candidate JOTROL may not demonstrate safety and efficacy to the satisfaction of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results.

	●	We have limited resources and are currently focusing the majority of our efforts on developing JOTROL for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

	●	We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted. In particular, we face competition for patients with MPS-I, Friedreich’s ataxia, MELAS, Parkinson’s Disease, Mild Cognitive Impairment, and early Alzheimer’s disease from companies that produce drugs to treat such diseases. For more information regarding competition we face, see the section titled “Business — Competition.

	●	We rely on third parties to conduct our preclinical studies, clinical trials, and manufacturing and these third parties may not perform satisfactorily.

	●	If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

	●	We rely on our management team and other key employees, and the loss of one or more key employees could harm our business.

	●	The failure to attract and retain additional qualified personnel could prevent us from executing our business strategy.

	●	There can be no assurance that we will be able to comply with Nasdaq Capital Market’s continued listing standards.

	●	The price of our common stock could be subject to rapid and substantial volatility. As a relatively small-capitalization company with relatively small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies. Such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock. In addition, if the trading volumes of our common stock are low, persons buying or selling in relatively small quantities may easily influence prices of our common stock. This low volume of trades could also cause the price of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading.

	●	successful and timely completion of clinical development of JOTROL research program, and our other future product candidates and programs;

	●	establishing and maintaining relationships with CROs and clinical sites for the clinical development of JOTROL and any other future product candidates and programs;

	●	the initiation and successful patient enrollment and completion of additional clinical trials on a timely basis;

	●	acceptable frequency and severity of adverse events in the clinical trials;

	●	the efficacy and safety profiles that are satisfactory to the U.S. Food and Drug Administration (FDA) or any comparable foreign regulatory authority for marketing approval;

	●	timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;

	●	complying with any required post-marketing approval commitments to applicable regulatory authorities;

	●	developing an efficient and scalable manufacturing process for our product candidates;

	●	establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidate, if approved;

	●	successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;

	●	a continued acceptable safety profile following any marketing approval of our product candidate;

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

	●	satisfying any required post-marketing approval commitments to applicable regulatory authorities;

	●	identifying, assessing and developing new product candidates;

	●	obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

	●	protecting our rights in our intellectual property portfolio;

	●	defending against third-party infringement claims, if any;

	●	entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidate;

	●	obtaining coverage and adequate reimbursement by third-party payors for our products and patients’ willingness to pay in the absence of such coverage and adequate reimbursement;

	●	obtaining additional funding to develop and potentially manufacture and commercialize our product candidates;

	●	addressing any competing therapies and technological and market developments;

	●	managing costs, including any unforeseen costs, that we may incur as a result of nonclinical study or clinical trial delays; and

	●	attracting, hiring and retaining qualified personnel including clinical, scientific, management and administrative personnel.

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

	●	the costs, timing and outcome of regulatory review of our product candidates;

	●	the number and characteristics of other product candidates that we pursue;

	●	the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

	●	the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

	●	the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

	●	the cost and timing of hiring new employees to support our continued growth;

	●	the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

	●	the effect of competing products that may limit market penetration of our products;

	●	the ability to establish and maintain collaborations on favorable terms, if at all;

	●	the extent to which we acquire or in-license other product candidates and technologies;

	●	the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any;

	●	our need to implement additional internal systems and infrastructure, including financial and reporting systems;

	●	the compliance and administrative costs associated with being a public company; and

	●	the extent to which we acquire or invest in businesses, products, or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

	●	make it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the debt instruments;

	●	make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation;

	●	require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes;

	●	limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

	●	place us at a competitive disadvantage compared to our competitors that have less debt; and

	●	limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business strategy or other purposes.

	●	the initiation and successful patient enrollment and completion of additional clinical trials of JOTROL on a timely basis;

	●	maintaining and establishing relationships with CROs and clinical sites for the clinical development of JOTROL;

	●	the frequency and severity of adverse events in clinical trials;

	●	demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval;

	●	the timely receipt of marketing approvals for JOTROL from applicable regulatory authorities;

	●	the extent of any required post-marketing approval commitments to applicable regulatory authorities;

	●	the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of JOTROL;

	●	obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

	●	protecting our rights in our intellectual property portfolio;

	●	our ability to expand JOTROL into multiple indications;

	●	our ability to find partners handling all aspects of commercialization;

	●	the successful launch of commercial sales following any marketing approval;

	●	a continued acceptable safety profile following any marketing approval;

	●	the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected;

	●	commercial acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be novel; and

	●	our ability to compete with other therapies.

	●	generating sufficient data to support the initiation or continuation of clinical trials;

	●	obtaining regulatory permission to initiate clinical trials;

	●	contracting with the necessary parties to conduct clinical trials;

	●	successful enrollment of patients in, and the completion of, clinical trials on a timely basis;

	●	the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and

	●	adverse events in clinical trials.

	●	receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials;

	●	clinical trial observations or results that require us to modify the design of our clinical trials;

	●	negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development programs;

	●	obtaining approval from one or more institutional review boards (IRB);

	●	the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated;

	●	any failure or delay in reaching an agreement with 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;

	●	the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks;

	●	changes to clinical trial protocol;

	●	clinical sites deviating from trial protocol or dropping out of a trial;

	●	the cost of clinical trials of our product candidates being greater than anticipated;

	●	the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate;

	●	subjects experiencing severe or unexpected drug-related adverse selection of clinical end points that require prolonged periods of clinical observation or analysis of the resulting data;

	●	a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of current good manufacturing practice (cGMPs), regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;

	●	any changes to our manufacturing process that may be necessary or desired;

	●	third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices (GCP) or other regulatory requirements;

	●	third-party contractors not performing data collection or analysis in a timely or accurate manner;

	●	third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications; and

	●	regulators revising the requirements for approving our product candidates.

	●	size and nature of the patient population;

	●	perceived risks and benefits of novel, unproven approaches;

	●	severity of the disease under investigation;

	●	availability and efficacy of approved drugs for the disease under investigation;

	●	patient eligibility criteria for the trial in question as defined in the protocol;

	●	perceived risks and benefits of the product candidates under study;

	●	clinicians’ and patients’ perceptions as to the potential advantages of the product candidates being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating;

	●	patient referral practices of physicians;

	●	the ability to monitor patients adequately during and after treatment;

	●	the activities of key opinion leaders (KOLs) and patient advocacy groups;

	●	proximity and availability of clinical trial sites for prospective patients; and

	●	the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may have an advanced disease, will not survive the full terms of the clinical trials.

	●	the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;

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

	●	the clinical indications for which a product candidate is approved;

	●	restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products;

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

	●	the cost of treatment in relation to alternative treatments;

	●	the availability of an approved product candidate for use as a combination therapy;

	●	relative convenience and ease of administration;

	●	the willingness of the target patient population or their caregivers to try new therapies and of physicians to prescribe these therapies;

	●	the availability of coverage and adequate reimbursement by third-party payors, including government authorities;

	●	patients’ willingness to pay for these therapies in the absence of such coverage and adequate reimbursement;

	●	the effectiveness of sales and marketing efforts;

	●	support from KOLs and patient advocacy groups;

	●	unfavorable publicity relating to our product candidates; and

	●	the approval of other new therapies for the same indications.

	●	delays in the development of our product candidates;

	●	FDA, EMA or other regulatory authority investigation of the safety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs;

	●	decreased or interrupted demand for our products;

	●	injury to our reputation;

	●	withdrawal of clinical trial participants and inability to continue clinical trials;

	●	initiation of investigations by regulators;

	●	costs to defend the related litigation;

	●	a diversion of management’s time and our resources;

	●	substantial monetary awards to trial participants or patients;

	●	product recalls, withdrawals or labeling, marketing, or promotional restrictions;

	●	loss of revenue;

	●	exhaustion of any available insurance and our capital resources; and

	●	the inability to commercialize any products.

	●	the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

	●	the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;

	●	the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

	●	we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable;

	●	the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

	●	the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

	●	restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;

	●	restrictions on the products, manufacturers or manufacturing process;

	●	warning or untitled letters;

	●	civil and criminal penalties;

	●	injunctions;

	●	suspension or withdrawal of regulatory approvals;

	●	product seizures, detentions or import bans;

	●	voluntary or mandatory product recalls and publicity requirements;

	●	total or partial suspension of production; and

	●	imposition of restrictions on operations, including costly new manufacturing requirements.

	●	the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

	●	the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

	●	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

	●	the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians, defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, reporting obligations with respect to covered recipients will be expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during the previous year; and

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

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

	●	managing our internal development efforts effectively, including the clinical, FDA, EMA and other comparable foreign regulatory agencies’ review process for JOTROL and any other product candidates, while complying with any contractual obligations to contractors and other third parties we may have; and

	●	improving our operational, financial and management controls, reporting systems and procedures.

	●	differing regulatory requirements and reimbursement regimes in foreign countries;

	●	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 revenue, 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 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.

	●	the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;

	●	patent applications may not result in any patents being issued;

	●	patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

	●	our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;

	●	there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and

	●	countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

	●	others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license;

	●	we or our licensor or collaborators might not have been the first to make the inventions covered by the patent applications that we own or license;

	●	we or our licensor or collaborators might not have been the first to file patent applications covering certain of our inventions;

	●	others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

	●	it is possible that the pending patent applications we own or license will not lead to issued patents;

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

	●	we may not develop additional proprietary technologies that are patentable;

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

	●	we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such intellectual property.

	●	result in costly litigation that may cause negative publicity;

	●	divert the time and attention of our technical personnel and management;

	●	cause development delays;

	●	prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;

	●	require us to develop non-infringing technology, which may not be possible on a cost-effective basis;

	●	subject us to significant liability to third parties; or

	●	require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology.