Palatin Technologies Inc 10-K for FY2022

Palatin Technologies Inc (PTN)

10-K 2022-09-22 For: 2022-06-30

Added on April 06, 2026

About this 10-K

Palatin Technologies Inc filed this 10-K on September 22, 2022, covering the fiscal year ended June 30, 2022 (FY2022).

Headline figures

Fiscal year ended June 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $1.47M; compared with -$188.6K a year earlier
Net loss: $36.2M; compared with a net loss of $33.6M a year earlier

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		Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	14
Item 1B.	Unresolved Staff Comments	37
Item 2.	Properties	37
Item 3.	Legal Proceedings	37
Item 4.	Mine Safety Disclosures	37
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	38
Item 6.	[Reserved]	38
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	38
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	42
Item 8.	Financial Statements and Supplementary Data	43
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	67
Item 9A.	Controls and Procedures	67
Item 9B.	Other Information	67
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	67
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	68
Item 11.	Executive Compensation	73
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	83
Item 13.	Certain Relationships and Related Transactions, and Director Independence	87
Item 14.	Principal Accounting Fees and Services	87
PART IV
Item 15.	Exhibits, Financial Statement Schedules	89
Item 16.	Form 10-K Summary	93

	·	our significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern;

	·	our expectation that we will incur losses for the foreseeable future and may never achieve or maintain profitability;

	·	our business, financial condition, and results of operations may be adversely affected by global health epidemics, including the COVID-19 pandemic, such as, for example, increase in costs of and delays in conducting human clinical trials and the performance of our contractors and suppliers, reduction in our productivity or the productivity of our contractors and suppliers, supply chain constraints, and labor shortages;

	·	our ability to successfully commercialize Vyleesi® (the trade name for bremelanotide) for the treatment of premenopausal women with hypoactive sexual desire disorder (“HSDD”) in the United States, which may be adversely affected by delays or disruptions related to the ongoing COVID-19 pandemic and economic disruptions, including a decrease in discretionary spending;

	·	our ability to manage the infrastructure to successfully manufacture, through contract manufacturers, Vyleesi, and to successfully market and distribute Vyleesi in the United States, including potentially qualifying a new contract manufacturer for the Vyleesi active drug ingredient;

	·	our ability to meet postmarketing commitments of the U.S. Food and Drug Administration (“FDA”);

	·	our expectations regarding the potential market size and market acceptance for Vyleesi for HSDD in the United States and elsewhere in the world;

	·	our expectations regarding performance of our exclusive licensees of Vyleesifor the treatment of premenopausal women with HSDD, which is a type of female sexual dysfunction (“FSD”), including:

	·	our expectations and the ability of our licensees to timely obtain approvals and successfully commercialize Vyleesi in countries other than the United States;

	·	the results of clinical trials with our late stage products, including PL9643, an ophthalmic peptide solution for dry eye disease (“DED”), which entered Phase 3 clinical trials in the fourth quarter of calendar year 2021, and PL8177, an oral peptide formulation for treatment of ulcerative colitis, which entered Phase 2 clinical trials in the third quarter of calendar year 2022;

	·	estimates of our expenses, future revenue and capital requirements;

	·	our ability to achieve profitability;

	·	our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of the ongoing COVID-19 pandemic and economic disruptions;

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

	·	the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs;

	·	the timing or likelihood of regulatory filings and approvals;

	·	our expectations regarding the clinical efficacy and utility of our melanocortin agonist product candidates for treatment of inflammatory and autoimmune related diseases and disorders, including ocular indications;

	·	our ability to compete with other products and technologies treating the same or similar indications as our product candidates;

	·	the ability of our third-party collaborators to timely carry out their duties under their agreements with us;

	·	the ability of our contract manufacturers to perform their manufacturing activities for us in compliance with applicable regulations;

	·	our ability to recognize the potential value of our licensing arrangements with third parties;

	·	the potential to achieve revenues from the sale of our product candidates;

	·	our ability to obtain adequate reimbursement from private insurers and other healthcare payers;

	·	our ability to maintain product liability insurance at a reasonable cost or in sufficient amounts, if at all;

	·	the performance and retention of our management team, senior staff professionals, other employees, and third-party contractors and consultants;

	·	the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology in the United States and throughout the world;

	·	our compliance with federal and state laws and regulations;

	·	the timing and costs associated with obtaining regulatory approval for our product candidates, including delays and additional costs related to the ongoing COVID-19 pandemic;

	·	the impact of fluctuations in foreign exchange rates;

	·	the impact of any geopolitical instability, economic uncertainty, financial markets volatility, or capital markets disruption resulting from the ongoing military conflict between Russia and Ukraine, and any resulting effects on our revenue, financial condition or results of operations;

	·	the impact of legislative or regulatory healthcare reforms in the United States;

	·	our ability to adapt to changes in global economic conditions as well as competing products and technologies; and

	·	our ability to remain listed on the NYSE American stock exchange.

	o	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (“Fosun”), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., for the territories of the People’s Republic of China, Taiwan, Hong Kong S.A.R. and Macau S.A.R. (collectively, “China”), and

	o	Kwangdong Pharmaceutical Co., Ltd. (“Kwangdong”) for the Republic of Korea (“Korea”);

	·	Our management has determined that there is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.

	·	We have a history of substantial net losses, including a net loss of $36.2 million for the year ended June 30, 2022, and expect to incur substantial net losses over the next few years, and we may never achieve or maintain profitability.

	·	We will need additional funding, including funding to complete clinical trials for our product candidates, which additional funding may not be available on acceptable terms, if at all.

	·	We have a limited operating history upon which to base an investment decision.

	·	Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights.

	·	The commercial success of Vyleesi for HSDD is a component of our corporate strategy, but we and our licensees may never successfully commercialize Vyleesi for HSDD or obtain approvals in countries other than the United States.

	·	Production and supply of Vyleesi and our product supplies depend on contract manufacturers over whom we do not have any control, and there may not be adequate supplies of Vyleesi.

	·	Our agreement with Lonza Ltd. (“Lonza”) to manufacturer the Vyleesi active drug ingredient expires December 31, 2022, and Lonza has advised us that they will not renew our contract, but we remain in discussions with Lonza on contract manufacturing. We are actively evaluating potential new contract manufacturers for the Vyleesi active drug ingredient, but selecting and validating a new contract manufacturer will be a time consuming and costly process.

	·	The effect of COVID-19 and other possible pandemics and outbreaks could result in material adverse effects on our clinical trials, business, financial condition, and results of operations.

	·	Our product candidates other than Vyleesi, including PL9643 for dry eye disease and PL8177 for the treatment of ulcerative colitis, are still in the early stages of development and remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our product candidates, we will not be successful.

	·	If clinical trials for our product candidates are prolonged or delayed, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.

	·	Even if our product candidates receive regulatory approval in the United States, they may never achieve market acceptance in the United States or approval outside the United States, in which case our business, financial condition and results of operations will be materially adversely affected.

	·	If side effects emerge that can be linked to Vyleesi or any of our product candidates (either while they are in development or after they are approved and on the market), we may be required to perform lengthy additional clinical trials, change the labeling of any such products, or withdraw such products from the market, any of which would hinder or preclude our ability to generate revenues.

	·	Both before and after marketing approval, our product candidates are subject to ongoing regulatory requirements and, if we fail to comply with these continuing requirements, we could be subject to a variety of sanctions and the sale of any approved commercial products could be suspended.

	·	The FDA has required that two postmarketing studies and a clinical trial be conducted on Vyleesi, and our failure to timely complete studies or the clinical trial, and any adverse outcomes of the studies or trial, could result in withdrawal of Vyleesi from the market.

	·	Our stock price is volatile and may fluctuate in a way that is disproportionate to our operating performance and we expect it to remain volatile, which could limit investors’ ability to sell stock at a profit.

	·	Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gains.

	·	As of September 21, 2022 there were 3,173,338 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants. Stockholders may experience dilution from the conversion of preferred stock, exercise of outstanding options and warrants and vesting and delivery of restricted stock units.

	·	Maximizing revenue from Vyleesi by marketing Vyleesi in the United States, supporting our existing licensees for China and Korea, and licensing Vyleesi for the United States and additional regions;

	·	Maintaining a team to create, develop and commercialize MCr products addressing unmet medical needs;

	·	Entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale, and distribution of product candidates that we are developing;

	·	Partially funding our product development programs with the cash flow generated from Vyleesi and existing license agreements, as well as any future research, collaboration, or license agreements; and

	·	Completing development and seeking regulatory approval of certain of our other product candidates.

	·	completion of preclinical laboratory tests, preclinical animal testing and formulation studies;

	·	submission to the FDA of an IND, which must be in effect before clinical trials may commence;

	·	clinical studies to evaluate safety and efficacy;

	·	submission to the FDA of an NDA that includes preclinical data, clinical trial data and manufacturing information;

	·	payment of substantial user fees for filing the NDA and other recurring user fees;

	·	FDA review of the NDA;

	·	satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities; and

	·	FDA approval of the NDA, including approval of all product labeling.

	·	recordkeeping requirements;

	·	periodic reporting requirements;

	·	GMP requirements related to all stages of manufacturing, testing, storage, packaging, labeling and distribution of finished dosage forms of the product;

	·	monitoring and reporting of adverse experiences with the product; and

	·	advertising and promotional reporting requirements and restrictions.

	·	restrictions on the marketing or manufacturing of a product;

	·	Warning Letters or Untitled Letters from the FDA asking us, our collaborators or third-party contractors to take or refrain from taking certain actions;

	·	withdrawal of the product from the market;

	·	the FDA’s refusal to approve pending applications or supplements to approved applications;

	·	voluntary or mandatory product recall;

	·	fines or disgorgement of profits or revenue;

	·	suspension or withdrawal of regulatory approvals;

	·	refusals to permit the import or export of products;

	·	product seizure; and

	·	injunctions or the imposition of civil or criminal penalties.

	·	the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs;

	·	federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

	·	the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

	·	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

	·	the federal physician sunshine requirements under the Patient Protection and Affordable Care Act (“Affordable Care Act”), which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; and

	·	state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

	·	our ability to develop and maintain manufacturing, marketing and distribution capability for sales of Vyleesi in the United States, including our ability to enter into agreements with one or more third parties to conduct activities relating to the commercialization of Vyleesi;

	·	our ability to enter into one or more licensing or similar agreements for Vyleesi outside of Korea and China;

	·	the timing of obtaining regulatory approvals for Vyleesi for HSDD in markets outside the United States;

	·	the expense and timing of obtaining regulatory approvals for our other product candidates;

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

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

	·	the cost of commercialization activities if any future product candidates are approved for sale, including marketing, sales and distribution costs;

	·	the cost of manufacturing any future product candidates and any products we successfully commercialize;

	·	our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms and timing of such arrangements;

	·	the degree and rate of market acceptance of any future approved products;

	·	the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;

	·	any product liability or other lawsuits related to our products;

	·	the expenses needed to attract and retain skilled personnel;

	·	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, future approved products, if any.

	·	continuing to conduct preclinical development and clinical trials;

	·	participating in regulatory approval processes;

	·	formulating and manufacturing products, or having third parties formulate and manufacture products;

	·	post-approval monitoring and surveillance of our products;

	·	conducting sales and marketing activities, either alone or with a partner; and

	·	obtaining additional capital.

	·	the ability to raise additional capital on acceptable terms, or at all;

	·	timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

	·	whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;

	·	acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities;

	·	our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product candidates or any future product candidates;

	·	the prevalence, duration and severity of potential side effects experienced with our product candidates or future approved products, if any;

	·	the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

	·	achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any;

	·	the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with the FDA’s current GMP regulations;

	·	a continued acceptable safety profile and efficacy during clinical development and following approval of our product candidates or any future product candidates;

	·	our ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others;

	·	acceptance by physicians and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments;

	·	our and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates;

	·	our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and

	·	our ability to develop, in-license or acquire additional product candidates or commercial-stage products that we believe can be successfully developed and commercialized.

	·	timely completion of, or need to conduct additional clinical trials and studies, for our product candidates, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the accurate and satisfactory performance of third-party contractors;

	·	the ability to demonstrate to the satisfaction of the FDA the safety and efficacy of future product candidates through clinical trials;

	·	whether we or our licensees are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of Vyleesi and future product candidates;

	·	our ability to successfully manufacture Vyleesi for worldwide markets;

	·	our success and the success of our licensees in educating physicians and patients about the benefits, administration and use of Vyleesi for HSDD;

	·	the prevalence and severity of adverse events experienced with Vyleesi for HSDD or any future product candidates or approved products;

	·	the adequacy and regulatory compliance of the autoinjector device, supplied by an unaffiliated third party, used as part of the Vyleesi combination product;

	·	the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

	·	our ability to raise additional capital on acceptable terms to achieve our goals;

	·	achieving and maintaining compliance with all regulatory requirements applicable to Vyleesi for HSDD or any future product candidates or approved products;

	·	the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;

	·	the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations;

	·	the ability to manufacture clinical trial supplies of any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current GMP;

	·	our ability to successfully commercialize Vyleesi for HSDD in the United States;

	·	our ability to successfully commercialize any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;

	·	our ability to enforce our intellectual property rights in and to Vyleesi for HSDD or any future product candidates;

	·	our ability to avoid third-party patent interference or intellectual property infringement claims;

	·	acceptance of Vyleesi for HSDD or any future product candidates, if approved, as safe and effective by patients and the medical community; and

	·	a continued acceptable safety profile and efficacy of Vyleesi for HSDD or any future product candidates following approval.

	·	our ability to recruit subjects for clinical trials and studies for our product candidates and to timely complete clinical trials and other studies;

	·	our ability to successfully market Vyleesi, given significant limitations in person-to-person marketing and contacts, including limitations in educating physicians and other health care professionals about the benefits, administration and use of Vyleesi for HSDD;

	·	adverse impacts on our ability to manufacture and distribute Vyleesi, including due to the negative impact of COVID-19 on air travel, as well as temporary disruptions, restrictions or closures of facilities of our suppliers and contract manufacturers in the Vyleesi manufacturing chain;

	·	adverse impacts of COVID-19 on our ability to successful manufacture product candidates for clinical trials and to successfully manufacture Vyleesi for the United States market and clinical trials elsewhere in the world;

	·	adverse impacts on our operations resulting from remote working arrangements;

	·	limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families, delays or difficulties in conducting site visits and other required travel, and the desire of employees to avoid contact with large groups of people;

	·	the inability of global suppliers of raw materials or components used in the manufacture of our products, or contract manufacturers of our products, to supply and/or transport those raw materials, components and products to us in a timely and cost effective manner due to shutdowns, interruptions or delays, limiting and precluding the production of our finished products, impacting our ability to supply customers, reducing our sales, increasing our costs of goods sold, and reducing our absorption of overhead;

	·	the illiquidity or insolvency of our suppliers, vendors and customers, or their inability to pay our invoices in full or in a timely manner, due to the reduction in their revenues caused by the cancellation or delay of procedures and other factors, which could potentially reduce our cash flow and our liquidity;

	·	delays in our ability, and the ability of our development partners, to conduct, enroll and complete clinical development programs;

	·	the instability to worldwide economies, financial markets, social institutions, labor markets and the healthcare systems as a result of the COVID-19 pandemic, which could result in an economic downturn that could adversely impact our business, results of operations and financial condition, as well as that of our investors, suppliers, customers or other business partners;

	·	changes in customer behavior and preferences for Vyleesi, as customers may experience financial difficulties or may delay or reduce their spending in light of COVID-19; and

	·	the continuation or exacerbation of the COVID-19 pandemic after social distancing and other similar measures have been relaxed.

	·	lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints;

	·	failure to design appropriate clinical trial protocols;

	·	uncertainty regarding proper dosing;

	·	for injectable products, inability to develop or obtain a supplier for a suitable autoinjector device that meets the FDA’s medical device requirements;

	·	insufficient data to support regulatory approval;

	·	inability or unwillingness of medical investigators to follow our clinical protocols;

	·	inability to add a sufficient number of clinical trial sites; or

	·	the availability of sufficient capital to sustain operations and clinical trials.

	·	product approval or clearance;

	·	regulatory compliance;

	·	good manufacturing practices;

	·	intellectual property rights;

	·	product introduction; and

	·	marketing and competition.

	·	discovery of serious or unexpected toxicities or side effects experienced by study participants or other safety issues;

	·	slower than expected rates of subject recruitment and enrollment rates in clinical trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment;

	·	difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

	·	difficulty in obtaining IRB approval for studies to be conducted at each site;

	·	delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;

	·	inadequacy of or changes in our manufacturing process or the product formulation or method of delivery;

	·	changes in applicable laws, regulations and regulatory policies;

	·	delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research organizations (“CROs”), clinical trial sites and other third-party contractors;

	·	failure of our CROs or other third-party contractors to comply with contractual and regulatory requirements or to perform their services in a timely or acceptable manner;

	·	failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug, medical device and biologic products;

	·	delays in the scheduling and performance by the FDA of required inspections of us, our CROs, our suppliers, or our clinical trial sites, and violations of law or regulations discovered in the course of FDA inspections;

	·	scheduling conflicts with participating clinicians and clinical institutions; or

	·	difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data.

	·	perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of any such product;

	·	cost-effectiveness relative to competing products and technologies;

	·	availability of reimbursement for our products from third-party payers such as health insurers, HMOs and government programs such as Medicare and Medicaid; and

	·	advantages over alternative treatment methods.

	·	regulatory authorities may withdraw their approval of the product;

	·	we may be required to reformulate such products or change the way the product is manufactured;

	·	we may become the target of lawsuits, including class action suits; and

	·	our reputation in the marketplace may suffer resulting in a significant drop in the sales of such products.

	·	the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs;

	·	federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

	·	HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

	·	HIPAA, as amended by the Health Information Technology and Clinical Health Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information;

	·	The federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S. Department of Health and Human Services 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; and

	·	state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

	·	restrictions on the products or manufacturing process;

	·	warning letters;

	·	civil or criminal penalties;

	·	fines;

	·	injunctions;

	·	imposition of a Corporate Integrity Agreement requiring heightened monitoring of our compliance functions, overseen by outside monitors, and enhanced reporting requirements to, and oversight by, the FDA and other government agencies;

	·	product seizures or detentions and related publicity requirements;

	·	suspension or withdrawal of regulatory approvals;

	·	regulators or IRBs may not authorize us or any potential future collaborators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

	·	total or partial suspension of production; and

	·	refusal to approve pending applications for marketing approval of new product candidates.

	·	completion of non-clinical tests including preclinical laboratory and formulation studies and animal testing and toxicology;

	·	submission to the FDA of an IND application, which must become effective before clinical trials may begin, and which may be placed on “clinical hold” by the FDA, meaning the trial may not commence, or must be suspended or terminated prior to completion;

	·	performance of adequate and well-controlled Phase 1, 2 and 3 human clinical trials to establish the safety and efficacy of the drug for each proposed indication, and potentially post-approval or Phase 4 studies to further define the drug’s efficacy and safety, generally or in specific patient populations;

	·	submission to the FDA of an NDA that must be accompanied by a substantial “user fee” payment;

	·	FDA review and approval of the NDA before any commercial marketing or sale; and

	·	compliance with post-approval commitments and requirements.

	·	require changes to manufacturing methods;

	·	require recall, replacement or discontinuance of one or more of our products;

	·	require additional recordkeeping;

	·	limit or restrict our ability to engage in certain types of marketing or promotional activities;

	·	alter or eliminate the scope or terms of any currently available regulatory exclusivities; and

	·	restrict or eliminate our ability to settle any patent litigation we may bring against potential generic competitors.

	·	the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;

	·	if and when patents will be issued;

	·	whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; and

	·	whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose.

	·	obtain licenses, which may not be available on commercially reasonable terms, if at all;

	·	redesign our products or processes to avoid infringement;

	·	stop using the subject matter claimed in the patents held by others;

	·	pay damages; or

	·	defend litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion of our management resources.

	·	publicity regarding actual or potential clinical results relating to products under development by our competitors or us;

	·	delay or failure in initiating, completing or analyzing preclinical or clinical trials or unsatisfactory designs or results of these trials;

	·	interim decisions by regulatory agencies, including the FDA, as to clinical trial designs, acceptable safety profiles and the benefit/risk ratio of products under development;

	·	achievement or rejection of regulatory approvals by our competitors or by us;

	·	announcements of technological innovations or new commercial products by our competitors or by us;

	·	developments concerning proprietary rights, including patents;

	·	developments concerning our collaborations;

	·	regulatory developments in the United States and foreign countries;

	·	economic or other crises and other external factors;

	·	period-to-period fluctuations in our revenue and other results of operations;

	·	changes in the structure of healthcare payment systems or other actions that affect the effective reimbursement rates for treatment regimens containing our products;

	·	changes in financial estimates and recommendations by securities analysts following our business or our industry;

	·	sales of our common stock, or the perception that such sales could occur; and

	·	the other factors described in this “Risk Factors” section.

	·	2,629 shares issuable on the conversion of our immediately convertible Series A Preferred Stock, subject to adjustment, for no further consideration;

	·	1,200,000 shares issuable on the conversion of our immediately convertible Series B Preferred Stock, subject to adjustment, for no further consideration;

	·	133,333 shares issuable on the conversion of our immediately convertible Series C Preferred Stock, subject to adjustment, for no further consideration;

	·	1,143,774 shares issuable upon the exercise of stock options at a weighted-average exercise price of $15.95 per share;

	·	282,774 shares issuable under restricted stock units which vested or will vest on dates between June 16, 2022 and June 22, 2026, subject to the fulfillment of service or performance conditions;

	·	344,162 shares of common stock which have vested under restricted stock unit agreements, but are subject to provisions to delay delivery; and

	·	66,666 shares issuable upon the exercise of warrants at an exercise price of $12.50 per share, issued in conjunction with the Series B and Series C Preferred Stock, of which 33,333 are currently exercisable and expire on May 11, 2026, and the remaining are exercisable only in the event that a Redemption Consideration Election is made and expire on May 11, 2026.