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What changed in PALATIN TECHNOLOGIES INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of PALATIN TECHNOLOGIES INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+249 added−230 removedSource: 10-K (2025-09-23) vs 10-K (2024-09-30)

Top changes in PALATIN TECHNOLOGIES INC's 2025 10-K

249 paragraphs added · 230 removed · 183 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

56 edited+24 added−18 removed107 unchanged
Biggest changeThe research, development and approval process requires substantial time, effort and financial resources, and approvals may not be granted on a timely or commercially viable basis, if at all. 11 Table of Contents Preclinical testing includes laboratory evaluations to characterize the product’s composition, impurities, stability, and mechanism of its pharmacologic effect, as well as animal studies to assess the potential safety and efficacy of each product.
Biggest changePreclinical testing includes laboratory evaluations to characterize the product’s composition, impurities, stability, and mechanism of its pharmacologic effect, as well as animal studies to assess the potential safety and efficacy of each product. Preclinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practices and the U.S. Department of Agriculture’s Animal Welfare Act.
We rely on proprietary information, such as trade secrets and know-how, which is not patented. We have taken steps to protect our unpatented trade secrets and know-how, in part with confidentiality and intellectual property agreements with our employees, consultants and certain contractors.
Proprietary Information. We rely on proprietary information, such as trade secrets and know-how, which is not patented. We have taken steps to protect our unpatented trade secrets and know-how, in part with confidentiality and intellectual property agreements with our employees, consultants and certain contractors.
The laws and regulations that may affect our ability to operate include: · 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; 14 Table of Contents · 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.
The laws and regulations that may affect our ability to operate include: · 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; 9 Table of Contents · 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.
The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177 study, with once daily oral dosing in adult ulcerative colitis subjects. The study uses an adaptive design with an interim assessment by an independent drug monitoring committee after the initial 16 subjects have completed the 8-week evaluation visit. Diabetic Nephropathy Proof-of-Concept Study.
The Phase 2 study was a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177 study, with once daily oral dosing in adult ulcerative colitis subjects. The study uses an adaptive design with an interim assessment by an independent drug monitoring committee after the initial 16 subjects have completed the 8-week evaluation visit. Diabetic Nephropathy Proof-of-Concept Study.
The steps ordinarily required by the FDA before an innovative new drug product may be marketed in the United States are similar to steps required in most other countries and include, but are not limited to: · 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.
The steps ordinarily required by the FDA before an innovative new drug product may be marketed in the United States are similar to steps required in most other countries and include, but are not limited to: · 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; 6 Table of Contents · 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.
While competitors and potential competitors in treatment of refractory erectile dysfunction have substantially greater financial, technological, research and development, marketing and personnel resources than we do, there are no disclosed co-formulations of a melanocortin receptor 4 agonist and a PDE5i drug. PL9643 for Anti-Inflammatory Ocular Indications.
While competitors and potential competitors in treatment of refractory erectile dysfunction have substantially greater financial, technological, research and development, marketing and personnel resources than we do, there are no disclosed co-formulations of a melanocortin receptor 4 agonist and a PDE5i drug. 4 Table of Contents PL9643 for Anti-Inflammatory Ocular Indications.
PL9643, a peptide melanocortin agonist active at multiple MCrs, including MC1r and MC5r, is our lead clinical development candidate for anti-inflammatory ocular indications, including dry eye disease, which is also known as keratoconjunctivitis sicca. Dry eye disease is a syndrome with symptoms including irritation, redness, discharge and blurred vision.
PL9643, a peptide melanocortin agonist active at multiple melanocortin receptors, including MC1R and MC5R, is our lead clinical development candidate for anti-inflammatory ocular indications, including dry eye disease, which is also known as keratoconjunctivitis sicca. Dry eye disease is a syndrome with symptoms including irritation, redness, discharge and blurred vision.
Establishing relationships with new manufacturers or suppliers, any of whom must be FDA-approved, is a time-consuming and costly process. Product Liability and Insurance Our business may be affected by potential product liability risks that are inherent in the testing, manufacturing, marketing and use of our proposed products.
Establishing relationships with new manufacturers or suppliers, any of whom must be FDA-approved, is a time-consuming and costly process. 12 Table of Contents Product Liability and Insurance Our business may be affected by potential product liability risks that are inherent in the testing, manufacturing, marketing and use of our proposed products.
The FDA and other government agencies have broad postmarket regulatory and enforcement powers, including the ability to levy civil and criminal penalties, suspend or delay issuance of approvals, seize or recall products and revoke approvals. 12 Table of Contents Pharmaceutical manufacturers, distributors and their subcontractors are required to register their facilities with the FDA and state agencies.
The FDA and other government agencies have broad postmarket regulatory and enforcement powers, including the ability to levy civil and criminal penalties, suspend or delay issuance of approvals, seize or recall products and revoke approvals. Pharmaceutical manufacturers, distributors and their subcontractors are required to register their facilities with the FDA and state agencies.
FDA approval of the NDA is required before commercial marketing or non-investigational interstate shipment may begin in the United States. The FDA may also conduct an audit of the clinical trial data used to support the NDA. The FDA may deny or delay approval of an NDA that does not meet applicable regulatory criteria.
FDA approval of the NDA is required before commercial marketing or non-investigational interstate shipment may begin in the United States. The FDA may also conduct an audit of the clinical trial data used to support the NDA. 7 Table of Contents The FDA may deny or delay approval of an NDA that does not meet applicable regulatory criteria.
Manufacturing drug product, such as the oral formulation of PL8177, similarly may involve production, formulation and other problems not present in manufacturing at clinical trial or laboratory scale.
Manufacturing drug products, such as the oral formulation of PL8177, similarly may involve production, formulation and other problems not present in manufacturing at clinical trial or laboratory scale.
Computer-aided drug design models of receptors are optimized based on experimental results obtained with peptides and small molecules that we develop. With our approach, we believe we are developing an advanced understanding of the factors which drive agonism. Competition General.
Computer-aided drug design models of receptors are optimized based on experimental results obtained with peptides and small molecules that we develop. With our approach, we believe we are developing an advanced understanding of the factors which drive agonism. 3 Table of Contents Competition General.
The timing and extent of future generic competition is dependent upon both our intellectual property rights and the FDA regulatory process but cannot be accurately predicted. 8 Table of Contents The pharmaceutical and biotechnology industries are characterized by extensive research efforts and rapid technological change.
The timing and extent of future generic competition is dependent upon both our intellectual property rights and the FDA regulatory process but cannot be accurately predicted. The pharmaceutical and biotechnology industries are characterized by extensive research efforts and rapid technological change.
If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. 10 Table of Contents Generic Competition.
Prior clinical studies by Palatin have demonstrated the synergistic effects of combining bremelanotide with a PDE5i drug as a treatment for ED. 7 Table of Contents PL9643 for Dry Eye Disease and Anti-Inflammatory Ocular Indications.
Prior clinical studies by Palatin have demonstrated the synergistic effects of combining bremelanotide with a PDE5i drug as a treatment for ED. PL9643 for Dry Eye Disease and Anti-Inflammatory Ocular Indications.
Foreign regulatory bodies also strictly enforce these and other regulatory requirements and drug marketing may be prohibited in whole or in part in other countries. 13 Table of Contents We, our collaborators, licensees or third-party contract manufacturers may not be able to comply with the applicable regulations.
Foreign regulatory bodies also strictly enforce these and other regulatory requirements and drug marketing may be prohibited in whole or in part in other countries. We, our collaborators, licensees or third-party contract manufacturers may not be able to comply with the applicable regulations.
If such patents are valid and we do not obtain a license under any such patents, or we are found liable for infringement, we may be liable for significant monetary damages, may encounter significant delays in bringing products to market, or may be precluded from participating in the manufacture, use or sale of products or methods of treatment covered by such patents. 10 Table of Contents Proprietary Information.
If such patents are valid and we do not obtain a license under any such patents, or we are found liable for infringement, we may be liable for significant monetary damages, may encounter significant delays in bringing products to market, or may be precluded from participating in the manufacture, use or sale of products or methods of treatment covered by such patents.
Climate Change Related Regulation Our operations are focused on research and development of pharmaceutical products, and a significant portion of this research and development is conducted outside our facilities, including by outsourced contract research organizations or universities conduct research and studies at multiple sites.
Our operations are focused on research and development of pharmaceutical products, and a significant portion of this research and development is conducted outside our facilities, including by outsourced contract research organizations or universities conduct research and studies at multiple sites.
Even if the FDA approves a product, it may limit the approved uses for the product as described in the product labeling, require that contraindications, warning statements or precautions be included in the product labeling, require that additional studies be conducted following approval as a condition of the approval, impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a REMS, or otherwise limit the scope of any approval or limit labeling.
Even if the FDA approves a product, it may limit the approved uses for the product as described in the product labeling, require that contraindications, warning statements or precautions be included in the product labeling, require that additional studies be conducted following approval as a condition of the approval, impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a Risk Evaluation and Mitigation Strategy (“REMS”), or otherwise limit the scope of any approval or limit labeling.
A Phase 2 proof-of-concept study is ongoing for diabetic nephropathy, with topline results expected in the fourth quarter of calendar year 2024. Diabetic nephropathy, also called diabetic kidney disease, is the most common cause of end-stage renal disease in the United States and other developed countries.
A Phase 2 proof-of-concept study was conducted for diabetic nephropathy, with topline results announced in the fourth quarter of calendar year 2024. Diabetic nephropathy, also called diabetic kidney disease, is the most common cause of end-stage renal disease in the United States and other developed countries.
We will be required to assure product performance and manufacturing processes from one country to another.
We will be required to ensure product performance and manufacturing processes from one country to another.
Employees As of September 27, 2024, we employed 30 people full time, of whom 21 are engaged in research and development activities and 9 are engaged in administration and management, and did not have any part-time employees. While we have been successful in attracting skilled and experienced scientific personnel, competition for personnel in our industry is intense.
Employees As of September 19, 2025, we employed 29 people full-time, of whom 20 are engaged in research and development activities and 9 are engaged in administration and management, and did not have any part-time employees. While we have been successful in attracting skilled and experienced scientific personnel, competition for personnel in our industry is intense.
We have had a contract manufacturer make both the PL8177 and PL9643 peptides in suitable scale for toxicity studies and under GMP for clinical trial use. The PL8177 drug product oral formulation for ulcerative colitis has been manufactured for clinical trial use.
Our MC1R and MCR agonist product candidates are synthetic peptides. We have had a contract manufacturer make both the PL8177 and PL9643 peptides in suitable scale for toxicity studies and under GMP for clinical trial use. The PL8177 drug product oral formulation for ulcerative colitis has been manufactured for clinical trial use.
Any drug products manufactured or distributed by us pursuant to FDA approvals, as well as the materials and components used in our products, are subject to pervasive and continuing regulation by the FDA, including: · 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.
Any drug products manufactured or distributed by us pursuant to FDA approvals, as well as the materials and components used in our products, are subject to pervasive and continuing regulation by the FDA, including: · 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. 8 Table of Contents Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or product removal.
We cannot guarantee that we will be able to compete successfully in the future or that developments by others will not render our proposed products under development or any future product candidates obsolete or noncompetitive or that our collaborators or customers will not choose to use competing technologies or products. Bremelanotide Co-administration with Tirzepatide (a GLP-1 agonist) to Treat Obesity.
We cannot guarantee that we will be able to compete successfully in the future or that developments by others will not render our proposed products under development or any future product candidates obsolete or noncompetitive or that our collaborators or customers will not choose to use competing technologies or products.
We have completed subcutaneous dosing of human subjects in a Phase 1 single and multiple ascending dose clinical safety study, and a human microdose pharmacokinetic study to evaluate a polymer-encapsulated, delayed-release, oral formulation of PL8177.
We have completed subcutaneous dosing of human subjects in a Phase 1 single and multiple ascending dose clinical safety study, and a human microdose pharmacokinetic study to evaluate a polymer-encapsulated, delayed-release, oral formulation of PL8177. Positive topline data was reported in the first quarter of calendar year 2025.
A large number of companies are developing products and therapies to combat obesity and diabetes, including Novo Nordisk, Sanofi, Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune.
Bremelanotide Co-administration with Tirzepatide (a GLP-1 agonist) to Treat Obesity. A large number of companies are developing products and therapies to combat obesity and diabetes, including Novo Nordisk, Sanofi, Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune.
We believe that PL8177 at MC1r in the bowel wall will maximize treatment effect while minimizing any systemic or off-target effects. A Phase 2 study in ulcerative colitis using our polymer-encapsulated, delayed-release, oral formulation of PL8177 initiated patent enrollment in September 2022, and topline date is expected in the first half of calendar year 2025.
We believe that PL8177 activating MC1R in the bowel wall will maximize treatment effect while minimizing any systemic or off-target effects. Topline data in a Phase 2 study in ulcerative colitis using our polymer-encapsulated, delayed-release, oral formulation of PL8177 was reported in the first quarter of calendar year 2025.
We have filed patent applications under the Patent Cooperation Treaty claiming PL9643 and other peptides in development for ocular and inflammatory disease indications and have entered national stage prosecution in the United States, European Patent Office, Eurasian Patent Office, and broadly throughout the world. If one or more patents are granted, the patents will have a presumptive term until 2041.
We have filed patent applications under the Patent Cooperation Treaty claiming PL9643 and other peptides in development for ocular and inflammatory disease indications and have entered national stage prosecution in the United States, European Patent Office, Eurasian Patent Office, and broadly throughout the world.
If one or more of the competing products under development are approved and can effectively treat ulcerative colitis with an acceptable side effect profile, such products could reduce the market for oral PL8177 for inflammatory bowel diseases, including ulcerative colitis. 9 Table of Contents Diabetic Retinopathy.
There are no reported MC1R agonist drugs in clinical trials for inflammatory bowel diseases, including ulcerative colitis. If one or more of the competing products under development are approved and can effectively treat ulcerative colitis with an acceptable side effect profile, such products could reduce the market for oral PL8177 for inflammatory bowel diseases, including ulcerative colitis.
Corporate Information We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996. Our corporate offices are located at 4B Cedar Brook Drive, Cranbury, New Jersey 08512 and our telephone number is (609) 495-2200.
Corporate Information We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996. Our executive offices are located at 103 Carnegie Center, Suite 300, Princeton, New Jersey 08540 and our telephone number is (609) 495-2200.
We believe that our agonist peptides regulate certain inflammatory cytokines, and modulate the activities of immune cells, such as monocytes and T cells, to reduce immune response, and may utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. Bremelanotide Co-administration with Tirzepatide (a GLP-1 agonist) to Treat Obesity .
We believe that our agonist peptides regulate certain inflammatory cytokines, and modulate the activities of immune cells, such as monocytes and T cells, to reduce immune response, and may utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. Oral Small Molecule PL7737 MC4R Agonist .
Key elements of our business strategy include: · 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 the sale of the Vyleesi product, including future milestone payments, as well as any future research, collaboration, or license agreements; and · Completing development and seeking regulatory approval of certain of our other product candidates. 6 Table of Contents Pipeline Overview The following chart illustrates the status of our drug development programs and Vyleesi, an FDA approved product for the treatment of premenopausal women with acquired, generalized HSDD acquired by Cosette in December, 2023. * These programs are planned but dependent on funding.
Key elements of our business strategy include: · 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 the sale of the Vyleesi product, including future milestone payments, as well as any future research, collaboration, or license agreements; and · Completing development and seeking regulatory approval of certain of our other product candidates.
An ANDA that contains a section (viii) statement to a method of use patent may be approved with labeling that omits the patented use before the use patent expires. Generic drugs approved with such a labeling carve out may be substituted by pharmacists for the original branded drug before the method of use patent expires. Section 505(b)(2) NDAs.
Generic drugs approved with such a labeling carve-out may be substituted by pharmacists for the original branded drug before the method of use patent expires. 11 Table of Contents Section 505(b)(2) NDAs. Most drug products obtain FDA marketing approval pursuant to an NDA or an ANDA.
We are also developing peptides that are active at more than one melanocortin receptor and small molecule MCr agonists. Our primary focus is on the development of melanocortin receptor system treatments for obesity and for male sexual dysfunction.
We are also developing peptides that are active at more than one melanocortin receptor and small molecule MCR agonists. Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
Many of these drugs address symptoms, but do not resolve the underlying inflammatory or autoimmune disease process. Patents and Proprietary Information Patent Protection. Our success will depend in substantial part on our ability to obtain, defend and enforce patents, maintain trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad.
Our success will depend in substantial part on our ability to obtain, defend and enforce patents, maintain trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad.
Third-party payers routinely limit the products that they will cover and the amount of money that they will pay and, in many instances, are exerting significant pressure on medical suppliers to lower their prices. Payers frequently employ a tiered system in reimbursing end users for pharmaceutical products, with tier designation affecting copay or deductible amounts.
Third-party payers routinely limit the products that they will cover and the amount of money that they will pay and, in many instances, are exerting significant pressure on medical suppliers to lower their prices.
The FDA also may impose other conditions, including labeling restrictions which can materially impact the potential market and profitability of a product.
As a condition of NDA approval, the FDA may require post-approval testing and surveillance to monitor a product’s safety or efficacy. The FDA also may impose other conditions, including labeling restrictions which can materially impact the potential market and profitability of a product.
Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).
Each of the identified patents are then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).
Generic Competition. Orange Book Listing. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product.
Orange Book Listing. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product. Upon approval of a drug, the applicant identifies all patents that claim the approved product’s active ingredient(s), the drug product’s approved formulation, or an approved method of use of the drug.
The presumptive term of the issued patents and pending patent applications is until 2030. Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments. 5 Table of Contents We have additional issued United States patents on melanocortin receptor specific peptides and small molecules, including patents on an alternative class of melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications.
If the ANDA contains one or more Paragraph III Certifications, the ANDA cannot not be approved until each listed patent for which a Paragraph III Certification was filed have expired. 15 Table of Contents If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA holder and patent owner once the ANDA has been accepted for filing by the FDA.
If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA holder and patent owner once the ANDA has been accepted for filing by the FDA.
The FDA is developing a national electronic drug safety tracking system known as SENTINEL that may impose additional safety monitoring burdens, and enhanced FDA enforcement authority, beyond the extensive requirements already in effect. As a condition of NDA approval, the FDA may require post-approval testing and surveillance to monitor a product’s safety or efficacy.
Product approvals may be revoked if compliance with regulatory requirements is not maintained or if problems concerning safety or effectiveness of the product occur following approval. The FDA is developing a national electronic drug safety tracking system known as SENTINEL that may impose additional safety monitoring burdens, and enhanced FDA enforcement authority, beyond the extensive requirements already in effect.
We cannot predict whether or when legislation or court decisions impacting our business will be enacted or issued, what FDA regulations, guidance or interpretations may change, or what the impact of such changes, if any, may be in the future. 16 Table of Contents Third-Party Reimbursements Successful sales of our proposed products in the United States and other countries depend, in large part, on the availability of adequate reimbursement from third-party payers such as governmental entities, managed care organizations, health maintenance organizations (“HMOs”), and private insurance plans.
Third-Party Reimbursements Successful sales of our proposed products in the United States and other countries depend, in large part, on the availability of adequate reimbursement from third-party payers, such as governmental entities, managed care organizations, health maintenance organizations (“HMOs”), and private insurance plans.
We are initiating Investigational New Drug (“IND”) enabling activities for a novel MC4r selective long-acting agonist later this year, and plan to file an IND in the second half of calendar year 2025. Bremelanotide Co-formulated with a PDE5i for the Treatment of ED in Patients Not Adequately Responsive to PDE5i Monotherapy.
We are advancing lead compound selection activities with a plan to initiate Investigational New Drug (“IND”) enabling activities for a novel MC4R selective long-acting agonist later this year, and plan to file an IND in the first quarter of calendar year 2026. Bremelanotide Co-administration with Tirzepatide (a GLP-1 agonist) to Treat Obesity.
We believe that use of two active agents may result in increased efficacy and decreased side effects. We are designing and developing potent and highly selective MC1r agonist peptides and agonist peptides specific for more than one melanocortin receptor for treatment of a variety of inflammatory and autoimmune indications.
We design and develop potent and highly selective MC1R agonist peptides and agonist peptides specific for more than one melanocortin receptor for treatment of a variety of inflammatory and autoimmune indications.
We do not have the facilities to manufacture any of our proposed products under GMP. We intend to rely on collaborators, licensees, or contract manufacturers for the commercial manufacture of our proposed products. Our MC1r and MCr agonist product candidates are synthetic peptides.
Manufacturing and Marketing To be successful, our proposed products will need to be manufactured in commercial quantities under GMP prescribed by the FDA and at acceptable costs. We do not have the facilities to manufacture any of our proposed products under GMP. We intend to rely on collaborators, licensees, or contract manufacturers for the commercial manufacture of our proposed products.
Preclinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practices and the U.S. Department of Agriculture’s Animal Welfare Act. Violations of these laws and regulations can, in some cases, lead to invalidation of the tests, requiring such tests to be repeated and delaying approval of the NDA.
Violations of these laws and regulations can, in some cases, lead to invalidation of the tests, requiring such tests to be repeated and delaying approval of the NDA.
Many inflammatory disease-related indications are treated using systemic steroids or immunosuppressant drugs, all of which have side effects that can be dose limiting. There are a number of approved biological drugs and other biological drugs under development for treatment of inflammatory disease-related indications, which typically affect only one pathway in the inflammatory response.
Melanocortin Receptor 1 Agonist Drug Products for Inflammatory and Autoimmune Diseases. Many inflammatory disease-related indications are treated using systemic steroids or immunosuppressant drugs, all of which have side effects that can be dose limiting.
For combination products, CDER will consult with the Center for Devices and Radiological Health to ensure that the device components of the product meet all applicable device requirements.
For combination products, CDER will consult with the Center for Devices and Radiological Health to ensure that the device components of the product meet all applicable device requirements. The research, development and approval process requires substantial time, effort and financial resources, and approvals may not be granted on a timely or commercially viable basis, if at all.
We are conducting research in several additional ocular areas, including both front of the eye and back of the eye indications, exploring use of our compounds to treat additional indications. Technologies We Use We used a rational drug design approach to discover and develop proprietary peptide, peptide mimetic and small molecule agonist compounds, focusing on the melanocortin receptor system.
A melanocortin pan agonist is administered by subcutaneous injection to patients taking conventional renin-angiotensin-aldosterone system (“RAAS”) inhibitors. Technologies We Use We used a rational drug design approach to discover and develop proprietary peptide, peptide mimetic and small molecule agonist compounds, focusing on the melanocortin receptor system.
Full patient enrollment in this Phase 2 trial is excepted later in calendar year 2024, with topline date readout expected in the first half of calendar year 2025.
Full patient enrollment in this Phase 2 trial was completed in calendar year 2024, with topline data readout in the first quarter of calendar year 2025. Bremelanotide Co-formulated with a PDE5i for the Treatment of ED in Patients Not Adequately Responsive to PDE5i Monotherapy.
Our new product development activities in inflammation disease indications focus primarily on development of MCr peptides for ocular conditions, but also include conditions in the gut and kidney.
This includes a modified MC4R peptide with an extended drug residency time and minimal blood pressure effects and a MC4R selective oral small molecule. Activities in inflammation disease indications focus primarily on development of MCR peptides for ocular conditions, and in the gut and kidney.
In the second quarter of calendar year 2024 we initiated a Phase 2 clinical study for the treatment of obesity with co-administration of the melanocortin agonist bremelanotide with tirzepatide, a GLP-1 (glucagon-like peptide-1) agonist, and plan to enroll up to 60 patients who are actively on tirzepatide with the primary endpoint of the trial to demonstrate safety and increased efficacy of co-administration of bremelanotide with tirzepatide in reducing body weight.
In the first quarter of calendar year 2025, we reported positive topline data in a Phase 2 clinical study for the treatment of obesity with co-administration of the melanocortin agonist bremelanotide with tirzepatide, a GLP-1 (glucagon-like peptide-1) agonist. Our new product development strategy focuses on development of MC4R selective agonists with improved pharmacokinetic properties.
Vyleesi is the first FDA-approved melanocortin agent and the first and only FDA-approved as-needed treatment for premenopausal women with HSDD. Our Business Strategy.
Vyleesi is the first FDA-approved melanocortin agent and the first and only FDA-approved as-needed treatment for premenopausal women with HSDD. Our program for treatment of retinal diseases and glaucoma culminated in an agreement with Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”), which acquired certain Palatin patent applications to first-in-class melanocortin receptor-targeted peptides developed by Palatin in August 2025.
There are other melanocortin agonists marketed in the United States, including Imcivree®, the melanocortin agonist setmelanotide, marketed by Rhythm Pharmaceutical for chronic weight management.
There are other melanocortin agonists marketed in the United States, including Imcivree®, the melanocortin agonist setmelanotide, marketed by Rhythm Pharmaceuticals and which is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity, and a number of compounds under development for various obesity related treatments, including Rhythm Pharmaceuticals’ Bivamelagon, in Phase 2 clinical trials for hypothalamic obesity.
Removed
We have initiated a clinical program for the evaluation of bremelanotide co-formulated with a phosphodiesterase type 5 inhibitor (PDE5i) for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.
Added
The Company is developing MC4R peptides and small molecule agonists with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Removed
A pharmacokinetics study is targeted for the first half of calendar year 2025, with a Phase 3 clinical trial in PDE5i non-responder ED patients expected to commence in the second half of calendar year 2025.
Added
We are also developing, dependent on resources for development activities, MC1R agonist products, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease.
Removed
Melanocortin Receptor Programs Our Current Product Development Strategy.
Added
The Company believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
Removed
We are developing products which incorporate a melanocortin agonist with another pharmaceutical agent, with an initial focus on an MC4r agonist plus a GLP-1 drug for use in obese patients, and on an MC4r agonist plus a PDE5i for use in treatment of erectile dysfunction in patients who do not respond to PDE5i monotherapy.
Added
The Company is also developing, dependent on resources for development activities, peptides and small molecules that are active at more than one melanocortin receptor, with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Removed
We have co-formulated bremelanotide with a PDE5i drug and anticipate commencing a Phase 3 clinical study in PDE5i monotherapy non-responder ED patients in the second half of calendar year 2025.
Added
We retain rights to PL9643, which has successfully completed a first Phase 3 clinical trial for dry eye disease. 1 Table of Contents Our Business Strategy.
Removed
A melanocortin pan agonist is administered by subcutaneous injection to patients taking conventional renin-angiotensin-aldosterone system (“RAAS”) inhibitors. Melanocortin Peptides for Diabetic Retinopathy. We conducted preclinical studies with melanocortin peptides in diabetic retinopathy models and have selected a peptide candidate for further development work. We are working on a formulation for intravitreal and subcutaneous administration.
Added
Pipeline Overview The following chart illustrates the status of our drug development programs. Melanocortin Receptor Programs Our Current Product Development Strategy. Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
Removed
If results support advancing the program, we will conduct required safety studies and manufacture drug product under Good Manufacturing Practices (“GMP”) regulations needed to file an IND and initiating clinical studies. Ocular Research Programs.
Added
The Company is developing MC4R peptides and small molecule agonists with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Removed
There are no reported MC1r agonist drugs in clinical trials for inflammatory bowel diseases, including ulcerative colitis.
Added
We are also developing, dependent on resources for development activities, MC1R agonist products, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease.
Removed
FDA-approved drugs used in treatment of diabetic retinopathy include steroids and anti-vascular endothelial growth factor compounds. At least two different antibody fragment products are marketed in the United States in which either aflibercept or ranibizumab is the active pharmaceutical ingredient. Additional vascular endothelial growth factor inhibitors are in clinical trials or in preclinical development.
Added
The Company believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
Removed
There are no reported MC1r agonist drugs in clinical trials for diabetic retinopathy. If one or more of the competing product candidates under development is approved and can treat diabetic retinopathy with an acceptable side effect profile, it could reduce the market for MC1r peptide products for this indication. Melanocortin Receptor 1 Agonist Drug Products for Inflammatory and Autoimmune Diseases.
Added
The Company is also developing, dependent on resources for development activities, peptides and small molecules that are active at more than one melanocortin receptor, with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Removed
We have additional issued United States patents on melanocortin receptor specific peptides and small molecules, including patents on an alternative class of melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications, and on natriuretic peptide receptor agonist compounds, but we are not actively developing any product candidate covered by a claim of any of these patents.
Added
We are advancing Investigational New Drug (“IND”) enabling activities for a novel MC4R selective long-acting agonist later this year, and plan to file an IND in the first quarter of calendar year 2026. 2 Table of Contents Long-acting Peptide MC4R Agonists .
Removed
Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or product removal. Product approvals may be revoked if compliance with regulatory requirements is not maintained or if problems concerning safety or effectiveness of the product occur following approval.
Added
Oral Small Molecule PL7737 MC4R Agonist and Long-acting Peptide MC4R Agonists to Treat Obesity and Metabolic-Related Disorders, Rare MC4R Pathway Diseases, Such as Hypothalamic Obesity, and Orphan Indications. A large number of companies are developing products and therapies to combat obesity and diabetes, including Novo Nordisk, Sanofi, Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

91 edited+28 added−19 removed176 unchanged
Biggest changeAs of September 27, 2024, holders of our outstanding dilutive securities had the right to acquire the following amounts of underlying common stock: · 5,333 shares issuable on the conversion of our immediately convertible Series A Preferred Stock, subject to adjustment, for no further consideration; · 2,249,102 shares issuable upon exercise of stock options with a weighted-average exercise price of $6.12 per share; · 859,613 shares issuable under restricted stock units which will vest on dates between June 22, 2025 and June 4, 2028, subject to the fulfillment of service or performance conditions; · 279,700 shares of common stock which have vested under restricted stock unit agreements, but are subject to provisions to delay delivery; · 66,666 shares of common stock issuable upon exercise of warrants at an exercise price of $12.50 per share, and expire on May 11, 2026; · 2,727,273 shares of common stock issuable upon exercise of Series A warrants at an exercise price of $1.88 per share, and expire on June 24, 2029; · 2,122,642 shares of common stock issuable upon exercise of Series B warrants at an exercise price of $1.88 per share. 498,441 Series B warrants expire June 24, 2024 and 1,624,201 Series B warrants are subject to stockholder approval and will expire on the five-year anniversary from the date of stockholder approval; · 1,831,503 shares of common stock issuable upon exercise of common warrants at an exercise price of $5.46 per share, and that expire on February 1, 2028; · 91,575 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the Company’s February 1, 2024 offering, with an exercise price of $6.825 per share, and an expiration date of February 1, 2028; · 90,909 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the Company’s October 2022 offering, with an exercise price of $6.875 per share, and an expiration date of October 31, 2027; · 943,396 shares issuable upon exercise of warrants issued in the Company’s October 2023 Offering, with an exercise price of $2.12 per share, and that expire on April 24, 2029; · 117,925 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the October 2023 Offering, with an exercise price of $2.65 per share, and an expiration date of October 20, 2028; and · 223,538 shares of common stock available for future issuance under our 2011 Stock Incentive Plan. 38 Table of Contents If the holders convert, exercise, or receive these securities, or similar dilutive securities we may issue in the future, stockholders may experience dilution in the net book value of their common stock.
Biggest changeAs of September 19, 2025, 202 holders of our outstanding dilutive securities had the right to acquire the following amounts of underlying common stock: · 78 shares issuable on the conversion of our immediately convertible Series A Preferred Stock, subject to adjustment, for no further consideration; · 61,816 shares issuable on the conversion of our immediately convertible Series D Preferred Stock, subject to adjustment, for no further consideration; · 44,233 shares issuable upon exercise of stock options with a weighted-average exercise price of $305.92 per share; · 12,570 shares issuable under restricted stock units which will vest on dates between June 24, 2026 and June 4, 2028, subject to the fulfillment of service or performance conditions; · 9,980 shares of common stock which have vested under restricted stock unit agreements, but are subject to provisions to delay delivery; · 1,333 shares of common stock issuable upon exercise of warrants at an exercise price of $625.00 per share, which expire on May 11, 2026; · 37,712 shares of common stock issuable upon exercise of Series B warrants at an exercise price of $94.00 per share. 5,228 Series B warrants expire on June 24, 2024 and 32,484 Series B warrants expire on July 25, 2030, the five-year anniversary from the date of stockholder approval; 34 Table of Contents · 36,630 shares of common stock issuable upon exercise of common warrants at an exercise price of $273.00 per share, which expire on February 1, 2028; · 1,831 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the Company’s February 1, 2024 offering, with an exercise price of $341.25 per share, which expire on February 1, 2028; · 1,818 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the Company’s October 2022 offering, with an exercise price of $343.75 per share, which expire on of October 31, 2027; · 78,153 shares of common stock issuable upon exercise of Series C warrants issued in the Company’s December 2024 Offering, with an exercise price of $43.75 per share, which expire on December 17, 2029; · 2,358 shares of common stock issuable upon exercise of the placement agent warrants issued to the placement agent or its designees as compensation in connection with the October 2023 Offering, with an exercise price of $132.50 per share, which expire on October 20, 2028; · 39,076 shares of common stock issuable upon exercise of Series D warrants issued in the Company’s December 2024 Offering, with an exercise price of $43.75 per share, which expire on July 25, 2030, the five-year anniversary from the date of stockholder approval; · 93,760 shares of common stock issuable upon exercise of Series E warrants issued in the Company’s February 2025 Offering, with an exercise price of $50.00 per share, which expire on August 12, 2030; · 146,479 shares of common stock issuable upon exercise of Series F warrants issued in the Company’s May 2025 Offering, with an exercise price of $15.00 per share, which expire on May 8, 2030; · 102,720 shares of common stock issuable upon exercise of Series G warrants issued in the Company’s May 2025 Offering, with an exercise price of $7.50 per share, which expire on the earlier of the 31 st calendar day following the date the Company receives the U.S.
If we identify side effects or other problems occur in future clinical trials, we may be required to terminate or delay clinical development of the product candidate.
If we identify side effects or if other problems occur in future clinical trials, we may be required to terminate or delay clinical development of the product candidate.
These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property.
These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees, royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property.
Upon (i) liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, (ii) sale or other disposition of all or substantially all of the assets of the Company, or (iii) any consolidation, merger, combination, reorganization or other transaction in which the Company is not the surviving entity or in which the shares of common stock constituting in excess of 50% of the voting power of the Company are exchanged for or changed into other stock or securities, cash and/or any other property, after payment or provision for payment of the debts and other liabilities of the Company, the holders of Series A Preferred Stock will be entitled to receive, pro rata and in preference to the holders of any other capital stock, an amount per share equal to $100 plus accrued but unpaid dividends, if any 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.
Upon (i) liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, (ii) sale or other disposition of all or substantially all of the assets of the Company, or (iii) any consolidation, merger, combination, reorganization or other transaction in which the Company is not the surviving entity or in which the shares of common stock constituting in excess of 50% of the voting power of the Company are exchanged for or changed into other stock or securities, cash and/or any other property, after payment or provision for payment of the debts and other liabilities of the Company, the holders of Series A Preferred Stock and Series D Preferred Stock will be entitled to receive, pro rata and in preference to the holders of any other capital stock, an amount per share equal to $100 plus accrued but unpaid dividends, if any 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.
The clinical and commercial success of Vyleesi by Cosette and our product candidates will depend on a number of factors, including the following: · 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; · Cosette’s ability to successfully manufacture Vyleesi; · Cosette’s success in educating physicians and patients about the benefits, administration and use of Vyleesi for HSDD; 21 Table of Contents · 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; · Cosette’s 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 for 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.
The clinical and commercial success of Vyleesi by Cosette and our product candidates will depend on a number of factors, including the following: · 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; · Cosette’s ability to successfully manufacture Vyleesi; · Cosette’s success 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; · Cosette’s 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 for any future product candidates; · our ability to avoid third-party patent interference or intellectual property infringement claims; 17 Table of Contents · 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.
The clinical and commercial success of our product candidates will depend on a number of factors, including the following: · 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; 20 Table of Contents · 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.
The clinical and commercial success of our product candidates will depend on a number of factors, including the following: · 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.
Potential delaying events include: · 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; 23 Table of Contents · 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.
Potential delaying events include: · 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.
If any of our products candidates are approved by the FDA or other regulatory authorities, we must enter into agreements with third parties to market these product candidates or develop marketing, distribution and selling capacity and expertise, which will be costly and time consuming, or enter into agreements with other companies to provide these capabilities.
If any of our product candidates are approved by the FDA or other regulatory authorities, we must enter into agreements with third parties to market these product candidates or develop marketing, distribution and selling capacity and expertise, which will be costly and time-consuming, or enter into agreements with other companies to provide these capabilities.
These include, but are not limited to: 35 Table of Contents · 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.
These include, but are not limited to: · 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.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology, intellectual property, research and development or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be delayed. 27 Table of Contents We may use artificial intelligence in our business, and challenges with properly managing its use, as well as uncertainty regarding the legal landscape surrounding the use of artificial intelligence ("AI”) could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology, intellectual property, research and development or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be delayed. 23 Table of Contents We may use artificial intelligence in our business, and challenges with properly managing its use, as well as uncertainty regarding the legal landscape surrounding the use of artificial intelligence ("AI”) could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.
At present, foreign marketing authorizations are applied for at a national level, although within the European Community (“EC”), registration procedures are available to companies wishing to market a product to more than one EC member state. If the regulatory authority is satisfied that adequate evidence of safety, quality and efficiency has been presented, a marketing authorization will be granted.
At present, foreign marketing authorizations are applied for at a national level, although within the European Community (“EC”), registration procedures are available to companies wishing to market a product to more than one EC member state. If the regulatory authority is satisfied that adequate evidence of safety, quality and efficacy has been presented, a marketing authorization will be granted.
The laws that may affect our ability to operate include: · 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.
The laws that may affect our ability to operate include: · 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; 24 Table of Contents · HIPAA, as amended by the Health Information Technology and Clinical Health Act, and its implementing regulations, which impose 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.
Our independent registered public accounting firm has issued their report, which includes an explanatory paragraph for going concern uncertainty on our consolidated financial statements as of and for the year ended June 30, 2024. The existence of a “going concern” conclusion may hinder our ability to obtain additional financing in the future.
Our independent registered public accounting firm has issued their report, which includes an explanatory paragraph for going concern uncertainty on our consolidated financial statements as of and for the year ended June 30, 2025. The existence of a “going concern” conclusion may hinder our ability to obtain additional financing in the future.
Risks Related to Our Business, Strategy, and Industry The commercial success of Vyleesi for HSDD is a component of our corporate strategy, but we may not receive significant milestone payments under our purchase agreement with Cosette. In December 2023 we sold Vyleesi to Cosette under a purchase agreement providing for contingent, sales-base milestone payments of up to $159 million.
Risks Related to Our Business, Strategy, and Industry The commercial success of Vyleesi for HSDD is a component of our corporate strategy, but we may not receive significant milestone payments under our purchase agreement with Cosette. In December 2023 we sold Vyleesi to Cosette under a purchase agreement providing for contingent, sales-based milestone payments of up to $159 million.
We may not be able to secure and maintain suitable research institutions or organizations to conduct our clinical trials. Even if our product candidates receive regulatory approval, they may never achieve market acceptance, in which case our business, financial condition and results of operation will be materially adversely affected.
We may not be able to secure and maintain suitable research institutions or organizations to conduct our clinical trials. Even if our product candidates receive regulatory approval, they may never achieve market acceptance, in which case our business, financial condition and results of operations will be materially adversely affected.
If one or more equity research analysts ceases coverage of us, or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline. Holders of our Series A Preferred Stock may have interests different from our common stockholders.
If one or more equity research analysts ceases coverage of us, or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline. Holders of our Series A Preferred Stock and Series D Preferred Stock may have interests different from our common stockholders.
Our internal computer systems, or those of our third-party contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs. In the ordinary course of our business, we collect, store and transmit confidential information.
Our internal computer systems, or those of our third-party contractors or consultants, may fail or suffer security breaches, that could result in a material disruption of our product development programs. In the ordinary course of our business, we collect, store and transmit confidential information.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting, and defending patents for product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.
Moreover, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. 32 Table of Contents Legally mandated price controls on payment amounts by governmental and private third-party payers or other restrictions could harm our business, results of operations, financial condition, and prospects.
Moreover, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. Legally mandated price controls on payment amounts by governmental and private third-party payers or other restrictions could harm our business, results of operations, financial condition, and prospects.
For example, at the federal level, during the former Trump administration there were multiple executive orders issued, initiatives implemented and calls for legislation from Congress to reduce drug prices, increase competition and reduce out of pocket costs of drugs for patients.
For example, at the federal level, during both the former and current Trump administration there were multiple executive orders issued, initiatives implemented and calls for legislation from Congress to reduce drug prices, increase competition and reduce out of pocket costs of drugs for patients.
The sponsor would be required to evaluate and monitor the various REMS activities and adjust them if need be. The FDA also may impose various civil or criminal sanctions for failure to comply with regulatory requirements, including withdrawal of product approval.
The sponsor would be required to evaluate and monitor the various REMS activities and adjust them if needed. The FDA also may impose various civil or criminal sanctions for failure to comply with regulatory requirements, including withdrawal of product approval.
Obtaining reimbursement from governmental payers, insurance companies, HMOs and other third-party payers of healthcare costs is a time-consuming and expensive process. 26 Table of Contents Even if we receive regulatory approval for our products in Europe, we may not be able to secure adequate pricing and reimbursement in Europe for us or any strategic partner to achieve profitability.
Obtaining reimbursement from governmental payers, insurance companies, HMOs and other third-party payers of healthcare costs is a time-consuming and expensive process. Even if we receive regulatory approval for our products in Europe, we may not be able to secure adequate pricing and reimbursement in Europe for us or any strategic partner to achieve profitability.
Similarly, the inflammatory bowel disease and ulcerative colitis markets are highly competitive, with a number of marketed products and products reported to be in late-stage clinical trials. In general, the biopharmaceutical industry is highly competitive. We are likely to encounter significant competition with respect to MC1r product candidates and MCr product candidates.
Similarly, the inflammatory bowel disease and ulcerative colitis markets are highly competitive, with a number of marketed products and products reported to be in late-stage clinical trials. 21 Table of Contents In general, the biopharmaceutical industry is highly competitive. We are likely to encounter significant competition with respect to MC1R product candidates and MCR product candidates.
Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 27, 2024, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock.
Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 19, 2025, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock.
Our future capital requirements depend on many factors, including: · 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. 19 Table of Contents We have a limited operating history upon which to base an investment decision.
Our future capital requirements depend on many factors, including: · 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.
Smaller reporting companies are able to provide simplified executive compensation disclosures in their filings and have certain other decreased disclosure obligations in their SEC filings. We cannot predict whether investors will find our common stock less attractive because of our reliance on the smaller reporting company exemption.
We are currently a “smaller reporting company” as defined in the Exchange Act. Smaller reporting companies are able to provide simplified executive compensation disclosures in their filings and have certain other decreased disclosure obligations in their SEC filings. We cannot predict whether investors will find our common stock less attractive because of our reliance on the smaller reporting company exemption.
Currently, we have no commitments to obtain any additional financing, and there can be no assurance that financing will be available in amounts or on terms acceptable to us, if at all. We have a history of substantial net losses, including a net loss of $29.7 million for the year ended June 30, 2024.
Currently, we have no commitments to obtain any additional financing, and there can be no assurance that financing will be available in amounts or on terms acceptable to us, if at all. 13 Table of Contents We have a history of substantial net losses, including a net loss of $17.3 million for the year ended June 30, 2025.
To commercialize our product candidates, we will need to hire or contract with experienced sales and marketing personnel to sell and market those product candidates that we decide to commercialize, and we will need to expand the number of our managerial, operational, financial and other employees to support commercialization. Competition exists for qualified personnel in the biopharmaceutical field.
To commercialize our product candidates, we will need to hire or contract with experienced sales and marketing personnel to sell and market those product candidates that we decide to commercialize, and we will need to expand the number of our managerial, operational, financial and other employees to support commercialization.
We expect to incur substantial net losses over the next few years, and we may never achieve or maintain profitability. As of June 30, 2024, we had an accumulated deficit of $441.8 million.
We expect to incur substantial net losses over the next few years, and we may never achieve or maintain profitability. As of June 30, 2025, we had an accumulated deficit of $459.1 million.
If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including: · 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. 29 Table of Contents Changes in the regulatory approval policy during the development period, changes in or the enactment of additional regulations or statutes, or changes in the regulatory review for each submitted product application may cause delays in the approval or rejection of an application.
If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including: · 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.
The steps ordinarily required by the FDA before a new drug may be marketed in the United States include: · 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. 30 Table of Contents Satisfaction of FDA pre-market approval requirements for new drugs typically takes a number of years and the actual time required for approval may vary substantially based upon the type, complexity and novelty of the product or disease to be treated by the drug.
The steps ordinarily required by the FDA before a new drug may be marketed in the United States include: · completion of non-clinical tests including preclinical laboratory and formulation studies and animal testing and toxicology; 26 Table of Contents · 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.
Our product candidates, including the combination products bremelanotide and a PDE5i agent and bremelanotide and tirzepatide or another GLP-1 agonist, PL9643 for dry eye disease, and PL8177 for the treatment of ulcerative colitis, are at various stages of research and development, will require regulatory approval, and may never be successfully developed or commercialized.
Our product candidates, including the combination products bremelanotide and a PDE5i agent and bremelanotide and tirzepatide or another GLP-1 agonist, an extended half-life peptide for treatment of obesity, an orally available small molecule for treatment of obesity, PL9643 for dry eye disease, and PL8177 for the treatment of ulcerative colitis, are at various stages of research and development, will require regulatory approval, and may never be successfully developed or commercialized.
Several provisions of the law have affected us and increased certain of our costs. Since its enactment, there have been executive, judicial, and congressional challenges to certain aspects of the PPACA. In addition, other legislative changes have been adopted since the PPACA was enacted. Some of these changes have resulted in additional reductions in Medicare and other healthcare funding.
Several provisions of the law have affected us and increased certain of our costs. Since its enactment, there have been executive, judicial, and congressional challenges to certain aspects of the PPACA. In addition, other legislative changes have been adopted since the PPACA was enacted.
Failure to timely file will cause us to be ineligible to utilize short-form registration statements, which may impair our ability to obtain capital in a timely fashion to execute our business strategies or issue shares to effect an acquisition.
In either case, this could result a material adverse effect on our business. Failure to timely file will cause us to be ineligible to utilize short-form registration statements, which may impair our ability to obtain capital in a timely fashion to execute our business strategies or issue shares to effect an acquisition.
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. 28 Table of Contents Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
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.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. As of September 27, 2024, there were 11,385,637 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. As of September 19, 2025, there were 838,142 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants.
We may not achieve or sustain profitability in future years, depending on numerous factors, including whether and when development and product commercialization milestones are met, whether and when we enter into license agreements for any of our products under development, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products. 18 Table of Contents We expect to incur significant expenses as we continue our development of MC1r and MCr products.
We may not achieve or sustain profitability in future years, depending on numerous factors, including whether and when development and product commercialization milestones are met, whether and when we enter into license agreements for any of our products under development, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products.
In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.
For example, the Affordable Care Act, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, which could adversely affect our competitive position. 34 Table of Contents While we cannot predict with certainty the impact the Leahy-Smith Act or any potential future changes to the U.S. or foreign patent systems will have on the operation of our business, the Leahy-Smith Act and such future changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, results of operations, financial condition and cash flows and future prospects.
While we cannot predict with certainty the impact the Leahy-Smith Act or any potential future changes to the U.S. or foreign patent systems will have on the operation of our business, the Leahy-Smith Act and such future changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, results of operations, financial condition and cash flows and future prospects.
These outside contractors are not our employees and may terminate their engagements with us at any time. In addition, we have limited control over the resources that these contractors devote to our programs, and they may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves.
In addition, we have limited control over the resources that these contractors devote to our programs, and they may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves.
Failure of third-party companies to supply the devices, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required approvals or clearances of the devices, and maintain compliance with all regulatory requirements, could result in increased development costs, delays in or failure to obtain regulatory approval and delays in product candidates reaching the market or in gaining approval or clearance for expanded labels for new indications.
Failure of third-party companies to supply the devices, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required approvals or clearances of the devices, and maintain compliance with all regulatory requirements, could result in increased development costs, delays in or failure to obtain regulatory approval and delays in product candidates reaching the market or in gaining approval or clearance for expanded labels for new indications. 27 Table of Contents Upon approval, a product candidate may be marketed only in those dosage forms and for those indications approved by the FDA.
We anticipate that the PPACA, as well as other healthcare reform measures that may be adopted in the future in the U.S. or abroad, may result in more rigorous coverage criteria and an additional downward pressure on the reimbursement our customers may receive for our products.
Some of these changes have resulted in additional reductions in Medicare and other healthcare funding. 28 Table of Contents We anticipate that the PPACA, as well as other healthcare reform measures that may be adopted in the future in the U.S. or abroad, may result in more rigorous coverage criteria and an additional downward pressure on the reimbursement our customers may receive for our products.
Based on our available cash, cash equivalents and marketable securities, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued and we are seeking additional funding to complete development activities and required clinical trials for our MC1r product candidates and, if those clinical trials are successful (which we cannot predict), to complete submission of required regulatory applications to the FDA.
Based on our available cash and cash equivalents, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued and we are seeking additional funding to complete development activities and required clinical trials for our MC1R product candidates and, if those clinical trials are successful (which we cannot predict), to complete submission of required regulatory applications to the FDA. 14 Table of Contents We may raise additional funds through public or private equity or debt financings, collaborative arrangements on our product candidates, or other sources.
The degree of market acceptance of any such product will depend on a number of factors, including: · 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.
The degree of market acceptance of any such product will depend on a number of factors, including: · 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. 20 Table of Contents Even if our product candidates receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.
We had $29.7 million in net loss for the year ended June 30, 2024, compared to $24.0 million in net loss for the year ended June 30, 2023.
We had $17.3 million in net loss for the year ended June 30, 2025, compared to $29.7 million in net loss for the year ended June 30, 2024.
Litigation or USPTO proceedings brought by us may fail or may be invoked against us by third parties. Even if we are successful, domestic, or foreign litigation or USPTO or foreign patent office proceedings may result in substantial costs and distraction to our management.
Even if we are successful, domestic, or foreign litigation or USPTO or foreign patent office proceedings may result in substantial costs and distraction to our management.
For the 12-month period ended June 30, 2024, the price of our stock has been volatile, ranging from a high of $5.65 per share to a low of $1.43 per share.
For the 12-month period ended June 30, 2025, the price of our stock has been volatile, ranging from a high of $99.00 per share to a low of $2.00 per share.
In addition, the sale or availability for sale of the underlying shares in the marketplace could depress our stock price. We have registered or agreed to register for resale substantially all of the underlying shares listed above. Holders of registered underlying shares could resell the shares immediately upon issuance, which could result in significant downward pressure on our stock price.
We have registered or agreed to register for resale substantially all of the underlying shares listed above. Holders of registered underlying shares could resell the shares immediately upon issuance, which could result in significant downward pressure on our stock price. Our common stock has been suspended from trading on the NYSE American.
The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks.
The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks.
As of September 27, 2024, there are 4,030 shares of Series A Preferred Stock outstanding. Each share of Series A Preferred Stock is convertible at any time, at the option of the holder, and such conversion could dilute the value of our common stock to current stockholders and could adversely affect the market price of our common stock.
Each share of Series A Preferred Stock and Series D Preferred Stock is convertible into common stock at any time, at the option of the holder, and such conversion could dilute the value of our common stock to current stockholders and could adversely affect the market price of our common stock.
The successful commercialization of our product candidates will require us to perform a variety of functions, including: · 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 successful commercialization of our product candidates will require us to perform a variety of functions, including: · 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. 15 Table of Contents If we are unable to obtain regulatory approval of any of our product candidates, to successfully commercialize any products for which we receive regulatory approval or to obtain additional capital, we may not be able to recover our investment in our development efforts.
Raising additional capital may cause dilution to existing stockholders, restrict our operations, or require us to relinquish rights. We will seek the additional capital necessary to fund our operations through public or private equity offerings, collaboration agreements, debt financings, licensing arrangements or combinations of the foregoing.
We will seek the additional capital necessary to fund our operations through public or private equity offerings, collaboration agreements, debt financings, licensing arrangements or combinations of the foregoing.
We have limited research and development staff. We rely on third parties and independent contractors, such as researchers at CROs and universities, in certain areas that are particularly relevant to our research and product development plans. We engage such researchers to conduct our preclinical studies, clinical trials and associated tests.
We rely on third parties and independent contractors, such as researchers at CROs and universities, in certain areas that are particularly relevant to our research and product development plans. We engage such researchers to conduct our preclinical studies, clinical trials and associated tests. These outside contractors are not our employees and may terminate their engagements with us at any time.
Further, if we were no longer listed on the NYSE American, our common stock would not be deemed covered securities and we would be subject to regulation in each state in which we offer our securities. 39 Table of Contents Item 1B. Unresolved Staff Comments None.
If we were to be delisted from the NYSE American, ,our common stock will not be deemed to be covered securities, and we will be subject to regulation in each state in which we offer our securities. Item 1B. Unresolved Staff Comments None.
Our ability to achieve revenues from the sale of our products will depend, in part, on our ability to obtain adequate reimbursement from private insurers and other healthcare payers.
Our future financial performance and our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively. Our ability to achieve revenues from the sale of our products will depend, in part, on our ability to obtain adequate reimbursement from private insurers and other healthcare payers.
Ineffective internal control could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our securities. 36 Table of Contents We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of these controls.
We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of these controls.
In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover its technology or that the factors necessary to grant an injunction against an infringer are not satisfied.
In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover its technology or that the factors necessary to grant an injunction against an infringer are not satisfied. 29 Table of Contents An adverse determination of any litigation or other proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.
To the extent that we sell or otherwise issue authorized but currently unissued shares, this could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock. 37 Table of Contents Our charter authorizes us to issue up to 10,000,000 shares of preferred stock and to determine the terms of those shares of stock without any further action by our stockholders.
Our charter authorizes us to issue up to 10,000,000 shares of preferred stock and to determine the terms of those shares of stock without any further action by our stockholders. If we exercise this right, it could be more difficult for a third party to acquire a majority of our outstanding voting stock.
Risks Related to Government Regulation 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.
Our failure to attract and retain such personnel, contractors and consultants could have a material adverse effect on our business, results of operations and financial condition. 25 Table of Contents Risks Related to Government Regulation 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.
Likewise, if our financial statements are not filed on a timely basis, we could be subject to sanctions or investigations by the stock exchange on which our ordinary shares are listed, the SEC or other regulatory authorities. In either case, there could result a material adverse effect on our business.
If our financial statements are not accurate, investors may not have a complete understanding of our operations. Likewise, if our financial statements are not filed on a timely basis, we could be subject to sanctions or investigations by the stock exchange on which our ordinary shares are listed, the SEC or other regulatory authorities.
Failure to obtain regulatory approval in other countries or any delay or setbacks in obtaining such approval would impair our ability to develop foreign markets for our product candidates and may have a material adverse effect on our results of operations and financial condition. 24 Table of Contents If side effects emerge that can be linked to 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.
If side effects emerge that can be linked to 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.
Our operations are primarily focused on acquiring, developing and securing our proprietary technology, conducting preclinical and clinical studies and formulating and manufacturing, through contract manufacturers, our principal product candidates on a small-scale basis. These operations provide a limited basis for stockholders to assess our ability to commercialize our product candidates.
We have a limited operating history upon which to base an investment decision. Our operations are primarily focused on acquiring, developing and securing our proprietary technology, conducting preclinical and clinical studies and formulating and manufacturing, through contract manufacturers, our principal product candidates on a small-scale basis.
The foreign regulatory approval process generally includes all of the risks associated with FDA approval described above. The requirements governing the conduct of clinical trials and marketing authorization vary widely from country to country.
Outside the United States, our ability to market our product candidates will also depend on receiving marketing authorizations from the appropriate regulatory authorities. The foreign regulatory approval process generally includes all of the risks associated with FDA approval described above. The requirements governing the conduct of clinical trials and marketing authorization vary widely from country to country.
If we exercise this right, it could be more difficult for a third party to acquire a majority of our outstanding voting stock. In addition, our equity incentive plans generally permit us to accelerate the vesting of options and other stock rights granted under these plans in the event of a change of control.
In addition, our equity incentive plans generally permit us to accelerate the vesting of options and other stock rights granted under these plans in the event of a change of control. If we accelerate the vesting of options or other stock rights, this action could make an acquisition more costly.
However, we do not anticipate receiving significant milestone payments for at least the next year from the issuance of this Annual Report and may never receive significant milestone payments.
We sold our Vyleesi product to Cosette in December 2023 and have the potential to receive milestone payments based on sales of Vyleesi by Cosette. However, we do not anticipate receiving significant milestone payments for at least the next year from the issuance of this Annual Report and may never receive significant milestone payments.
Consequently, our pending patent applications may not be allowed and, if allowed, may not contain the type and extent of patent claims that will be adequate to conduct our business as planned.
The standards that the USPTO and foreign patent offices use to grant patents are not always applied predictably or uniformly and can change. Consequently, our pending patent applications may not be allowed and, if allowed, may not contain the type and extent of patent claims that will be adequate to conduct our business as planned.
Upon approval, a product candidate may be marketed only in those dosage forms and for those indications approved by the FDA. Once approved, the FDA may withdraw the product approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the marketplace.
Once approved, the FDA may withdraw the product approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the marketplace.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition, or results of operations.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.
Risks Related to the Ownership of Our Common Stock 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.
In addition, our competitors may independently develop substantially equivalent technologies and processes or gain access to our trade secrets or technology, either of which could materially or adversely affect our competitive position. 31 Table of Contents Risks Related to the Ownership of Our Common Stock 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.
Even if our product candidates receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States. In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy.
In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods.
Anti-takeover provisions of Delaware law and our charter documents may make potential acquisitions more difficult and could result in the entrenchment of management. We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our charter documents may make a change in control or efforts to remove management more difficult.
Anti-takeover provisions of Delaware law and our charter documents may make a change in control or efforts to remove management more difficult. Also, under Delaware law, our board of directors may adopt additional anti-takeover measures.
Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or in product removal.
Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or in product removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.
You should evaluate us in light of these uncertainties, difficulties and expenses commonly experienced by early stage biopharmaceutical companies, as well as unanticipated problems and additional costs relating to: · product approval or clearance; · regulatory compliance; · good manufacturing practices; · intellectual property rights; · product introduction; and · marketing and competition.
You should evaluate us in light of these uncertainties, difficulties and expenses commonly experienced by early stage biopharmaceutical companies, as well as unanticipated problems and additional costs relating to: · product approval or clearance; · regulatory compliance; · good manufacturing practices; · intellectual property rights; · product introduction; and · marketing and competition. 19 Table of Contents 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.
In addition, there is a risk that one or more of our current service providers, manufacturers, or other partners may be adversely impacted by deteriorating economic conditions, which could directly affect our ability to attain our operating goals and to accurately forecast and plan our future business activities. 22 Table of Contents Our product candidates including our combination products for treatment of obesity and ED, as well as 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.
In addition, there is a risk that one or more of our current service providers, manufacturers, or other partners may be adversely impacted by deteriorating economic conditions, which could directly affect our ability to attain our operating goals and to accurately forecast and plan our future business activities.
While we have processes to identify and appropriately apply applicable accounting requirements, we plan to enhance these processes to better evaluate our research and understanding of the nuances of the complex accounting standards that apply to our financial statements.
While we have processes to identify and appropriately apply applicable accounting requirements, we plan to enhance these processes to better evaluate our research and understanding of the nuances of the complex accounting standards that apply to our financial statements. 32 Table of Contents Any failure to maintain such internal control could adversely impact our ability to report our financial position and results from operations on a timely and accurate basis.
Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly, we cannot assure our investors that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue our business.
Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates.
As of June 30, 2024, we had cash, cash equivalents and marketable securities of $9.5 million, with current liabilities of $9.7 million.
As of June 30, 2025, we had cash and cash equivalents of $2.6 million, with current liabilities of $8.0 million.
We may seek to license, sell or otherwise dispose of our product candidates, technologies and contractual rights on the best possible terms available.
If we are unable to raise sufficient additional funds when needed, we may be required to curtail operations significantly, cease clinical trials and decrease staffing levels. We may seek to license, sell or otherwise dispose of our product candidates, technologies and contractual rights on the best possible terms available.
If the NYSE American de-lists our securities for trading on its exchange, we could face significant material adverse consequences, including: · a limited availability of market quotations for our securities; · reduced liquidity with respect to our securities; · a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock; · a limited amount of news and analyst coverage for our company; and · a decreased ability to issue additional securities or obtain additional financing in the future.
However, there can be no assurance that we will be able to timely resolve the NYSE American listing deficiencies 35 Table of Contents Because our common stock has been suspended from trading on the NYSE American exchange, we face significant material adverse consequences, including: · a limited availability of market quotations for our securities; · reduced liquidity with respect to our securities; · a limited amount of news and analyst coverage for our company; and · a decreased ability to issue additional securities or obtain additional financing in the future.
These expenses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity, total assets and working capital. We sold our Vyleesi product to Cosette in December 2023 and have the potential to receive milestone payments based on sales of Vyleesi by Cosette.
We expect to incur significant expenses as we continue our development of MC1R and MCR products. These expenses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity, total assets and working capital.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties Our corporate offices are located at 4B Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury, NJ 08512, where we lease approximately 10,000 square feet of office space under a lease that expires in June 2025.
Biggest changeItem 2. Properties Our corporate offices are located at 103 Carnegie Center Drive, Suite 300, Princeton, New Jersey, where we have office and coworking space under an agreement that expires in January 2026, subject to automatic renewal provisions.
We also lease approximately 3,600 square feet of laboratory space in the Township of South Brunswick, NJ under a lease that expires in October 2026. We believe our present facilities are adequate for our current needs.
We also lease approximately 3,600 square feet of laboratory space in Monmouth Junction, the Township of South Brunswick, New Jersey under a lease that expires in October 2026. We believe our present facilities are adequate for our current needs.
The corporate offices include private offices, meeting rooms and workspaces for all administrative personnel and over half of the research and development personnel, with the remainder of research and development personnel stationed at the laboratory facility. We do not own any real property.
The corporate offices include private offices, meeting rooms and workspaces for executive officers and administrative personnel, with research and development personnel stationed at the laboratory facility. We do not own any real property. 36 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings We are involved, from time to time, in various claims and legal proceedings arising in the ordinary course of our business. As of the date of this filing, we are not aware that we are a party to any pending or threatened legal proceeding or proceeding by a governmental authority.
Biggest changeWe plan to vigorously defend against the lawsuit and the action will proceed next to the discovery stage and for further proceedings. As of the date of this filing, we are not aware that we are a party to any pending or threatened legal proceeding or proceeding by a governmental authority. Item 4.
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Item 3. Legal Proceedings We are involved, from time to time, in various claims and legal proceedings arising in the ordinary course of our business, including a complaint filed in the Supreme Court of the State of New York, County of New York, on February 13, 2025, captioned H.C. Wainwright & Co., LLC (“Wainwright”) v.
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Palatin Technologies, Inc., Case No: 650878/2025. The complaint names the Company as defendant, asserting three causes of action for breach of contract and seeking monetary damages and the award of warrants allegedly due under the parties’ agreement.
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The breach of contract claims each relate to the engagement agreement entered into by the Company and Wainwright on or about January 29, 2024. On March 20, 2025, we filed our answer in response to the complaint, in which we denied all liability and asserted several affirmative defenses.
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Mine Safety Disclosures Not applicable. 37 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock has been listed on NYSE American under the symbol “PTN” since December 21, 1999.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock traded on NYSE American under the symbol “PTN” from December 21, 1999 to May 8, 2025, and since May 8, 2025 has traded on the OTCQB® Venture Market operated by OTC Markets Group, Inc. under the symbol “PTNT”.
There were no shares withheld during the quarter ended June 30, 2024, at the direction of the employees as permitted under the 2011 Stock Incentive Plan, in order to pay the minimum amount of tax liability owed by the employee from the vesting of those units and options. Dividends and dividend policy .
There were no shares withheld during the quarter ended June 30, 2025, at the direction of the employees as permitted under the 2011 Stock Incentive Plan, in order to pay the minimum amount of tax liability owed by the employee from the vesting of those units and options. Dividends and dividend policy .
Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 27, 2024, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock. Equity compensation plan information.
Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 19, 2025, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock. Equity compensation plan information.
The aggregate market value of the common and non-voting common equity held by non-affiliates on such date, computed by reference to the closing sales price of our common stock on that date, was $16,051,587. Issuer purchases of equity securities.
The aggregate market value of the common and non-voting common equity held by non-affiliates on such date, computed by reference to the closing sales price of our common stock on that date, was $8,346,059 Issuer purchases of equity securities.
It previously traded on The Nasdaq SmallCap Market under the symbol “PLTN.” On September 27, 2024 we had approximately 90 record holders of common stock and the closing sales price of our common stock as reported on the NYSE American was $0.84 per share.
On September 19, 2025 we had approximately 50 record holders of common stock and the closing sales price of our common stock as reported on the OTCQB was $8.64 per share.
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Since August 8, 2025, when the reverse stock split of our shares at a ratio of 1-for-50 was effective, our shares have traded under the symbol “PTNTD”, which continued for 20 trading dates, ending on September 10, 2025. Over-the-counter market quotations or prices represent inter-dealer prices without retail mark-ups, mark-downs or commissions, and may not necessarily represent actual transactions.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe are also developing MC1r agonists, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, uveitis, diabetic retinopathy, and inflammatory bowel disease. 41 Table of Contents Critical Accounting Policies and Estimates Our significant accounting policies are described in Note 2 to the consolidated financial statements included in this Annual Report.
Biggest changeThe Company is developing MC4R peptides and small molecule agonists with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications. 38 Table of Contents We are also developing, dependent on resources for development activities, MC1R agonist products, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease.
We may experience uncertainties, delays, difficulties, and expenses commonly experienced by early-stage biopharmaceutical companies, which may include unanticipated problems and additional costs relating to: · the development and testing of products in animals and humans; · dependance on third party contractors and collaborators for part of our research and development; · ability to attract and retain experienced personnel; · product approval or clearance; · regulatory compliance; · good manufacturing practices (“GMP”) compliance; · intellectual property rights; · product introduction; · marketing, sales, and competition; and · obtaining sufficient capital.
We may experience uncertainties, delays, difficulties, and expenses commonly experienced by early-stage biopharmaceutical companies, which may include unanticipated problems and additional costs relating to: · the development and testing of products in animals and humans; · dependence on third party contractors and collaborators for part of our research and development; · ability to attract and retain experienced personnel; · product approval or clearance; · regulatory compliance; · good manufacturing practices (“GMP”) compliance; · intellectual property rights; · product introduction; · marketing, sales, and competition; and · obtaining sufficient capital.
Certain of these allowances represent estimates of the related obligations and, as such, knowledge and judgement are required when estimating the impact of these allowances on gross product sales for a reporting period. If any of our judgments made during a reporting period are not indicative or accurate estimates of our future experience, our results could be materially affected.
Certain of these allowances represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these allowances on gross product sales for a reporting period. If any of our judgments made during a reporting period are not indicative or accurate estimates of our future experience, our results could be materially affected.
Cumulative spending from inception to June 30, 2024 was approximately $311,900,000 on our Vyleesi program and approximately $234,000,000 on all our other programs (which include PL8177, PL9643, other melanocortin receptor agonists and terminated programs).
Cumulative spending from inception to June 30, 2024 was approximately $311,900,000 on our Vyleesi program and approximately $250,700,000 on all our other programs (which include PL8177, PL9643, other melanocortin receptor agonists and terminated programs).
Food and Drug Administration (“FDA”) in June 2019 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. This product was acquired by Cosette Pharmaceuticals, Inc. (“Cosette”) on December 19, 2023.
Food and Drug Administration (“FDA”) in June 2019 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. This product was acquired by Cosette Pharmaceuticals, Inc.
However, the COVID-19 pandemic and its resulting impact to economic conditions may negatively impact our operations, including possible effects on our financial condition, ability to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce.
However, uncertain economic conditions may negatively impact our operations, including possible effects on our financial condition, ability to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce.
Any of these possibilities could materially and adversely affect our operations and require us to curtail or cease certain programs. During fiscal 2024, net cash used in operating activities was $31,461,441 compared to net cash used in operating activities of $29,271,346 in fiscal 2023.
Any of these possibilities could materially and adversely affect our operations and require us to curtail or cease certain programs. During fiscal 2025, net cash used in operating activities was $21,306,637 compared to net cash used in operating activities of $31,461,441 in fiscal 2024.
We had a net loss for fiscal 2024 of $29,736,113. We may not attain profitability in future years, which is dependent on numerous factors, including, but not limited to whether and when development and sales milestones are met, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products.
We may not attain profitability in future years, which is dependent on numerous factors, including, but not limited to whether and when development and sales milestones are met, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products.
Based on our current existing cash and cash equivalents as of the date of this filing will be sufficient to fund currently anticipated operating expenses through the second half of calendar year 2024.
Based on our current operating and development plans, we expect that our existing cash and cash equivalents as of the date of this filing will be sufficient to fund currently anticipated operating expenses through the second half of calendar year 2025.
During fiscal 2024, net cash provided by financing activities was $20,548,891 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs of $14,693,779 and the exercise of outstanding warrants of $6,045,642 offset by payment of withholding taxes related to restricted stock units of $56,401, and payment of finance lease obligations of $106,392.
During fiscal 2024, net cash provided by financing activities was $20,548,891 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs, of $14,666,042 and the exercise of outstanding warrants of $6,045,642 offset by payment of withholding taxes related to restricted stock units of $56,401, and payment of finance lease obligations of $106,392. 41 Table of Contents We had a net loss for fiscal 2025 of $17,307,349.
Introduction Palatin Technologies, Inc. is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system. The Company’s product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Our prior commercial product, Vyleesi®, was approved by the U.S.
Introduction Palatin Technologies, Inc. is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system. The Company’s product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
The amounts of program spending above exclude general research and development spending, which were $6,888,233 for fiscal 2024 compared to $6,428,145 for fiscal 2023. The increase in general research and development spending is primarily attributable to increased compensation costs.
The amounts of program spending above exclude general research and development spending, which were $6,349,878 for fiscal 2025, compared to $6,888,233 for fiscal 2024. The decrease in general research and development spending is primarily attributable to decreased compensation costs.
Research and development expenses related to our Vyleesi, MCr programs, and other preclinical programs were $15,512,149 for fiscal 2024 compared to $16,202,432 for fiscal 2023. The decrease is primarily related to a decrease in spending on our MCr programs.
The decrease is a result of lower spending on our MCR programs. Research and development expenses related to our MCR programs and other preclinical programs were $8,548,616 for fiscal 2025, compared to $15,512,149 for fiscal 2024. The decrease is primarily related to a decrease in spending on our MCR programs.
Based on our June 30, 2024, cash and cash equivalents, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued.
Based on our June 30, 2025, cash and cash equivalents and approximately $2,000,000 we received in September 2025 as a result of the Research Collaboration agreement with Boehringer Ingleheim, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued.
Other Income (Expense) – Total other income (expense), net was ($7,239,992) for fiscal 2024 compared to $3,747,143 for fiscal 2023. For fiscal 2024, we recognized an increase in the fair value of warrant liabilities of $6,962,562, offering expense of $696,912 and interest expense of $17,114 offset by investment income of $376,843 and unrealized foreign currency gain of $59,753.
For fiscal 2025, we recognized investment income of $167,665 offset by foreign currency transaction losses of $50 and interest expense of $15,025. For fiscal 2024, we recognized an increase in the fair value of warrant liabilities of $6,962,562, offering expense of $696,912 and interest expense of $17,114 offset by investment income of $376,843 and unrealized foreign currency gain of $59,753.
Our product candidates are at various stages of development and will require significant further research, development, and testing and some may never be successfully developed or commercialized.
We have financed our net operating losses primarily through debt and equity financings and amounts received under collaborative and license agreements. Our product candidates are at various stages of development and will require significant further research, development, and testing and some may never be successfully developed or commercialized.
During fiscal 2023, net cash provided by financing activities was $10,748,591 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs of $10,995,497 and the exercise of outstanding warrants of $78 offset by payment of withholding taxes related to restricted stock units of $146,062, and payment of finance lease obligations of $100,922.
During fiscal 2025, net cash provided by financing activities was $11,213,506 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs, of $7,960,765 and the exercise of outstanding warrants of $3,398,237 offset by payment of withholding taxes related to restricted stock units of $99,482, and payment of finance lease obligations of $46,014.
Selling, General and Administrative – Selling, general and administrative expenses, which consist of costs related to Vyleesi in addition to compensation and related costs, were $12,270,046 for fiscal 2024, compared to $15,290,836 for fiscal 2023.
Selling, General and Administrative – Selling, general and administrative expenses, which consist of costs related to Vyleesi in addition to compensation and related costs, were $7,809,345 for fiscal 2025, compared to $12,270,046 for fiscal 2024. The decrease is primarily attributable to $1,912,243 of selling expenses related to Vyleesi in fiscal 2024 and decreased compensation costs.
As a result of the transaction, the Company recorded a gain of $7,781,844 on the sale of Vyleesi for the year ended June 30, 2024. The gain represents the upfront purchase price of $9,500,000 less the cost of net assets transferred to the purchaser.
For fiscal 2024, we recorded a gain of $7,781,844 on the sale of Vyleesi. The gain represents the upfront purchase price of $9,500,000 less the cost of net assets transferred to the purchaser. Other Income (Expense) – Total other income (expense), net was $152,590 for fiscal 2025 compared to ($7,239,992) for fiscal 2024.
Cost of Products Sold – Cost of products sold was $97,637 for fiscal 2024 compared to $418,470 for fiscal 2023. The decrease in cost of products sold is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
Cost of products sold was $97,637 for fiscal 2024. The decrease in cost of products sold is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024. Research and Development – Total research and development expenses, including general research and development spending, were $14,898,494 for fiscal 2025 compared to $22,400,372 for fiscal 2024.
Estimating the value or stage of completion of certain services requires judgment based on available information. If we do not identify services performed for us but not billed by the service-provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated.
If we do not identify services performed for us but not billed by the service-provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated. 39 Table of Contents Stock-Based Compensation We expense the fair value of stock options and other equity awards granted to employees and nonemployees for services.
For the fiscal year ended June 30, 2023 (“fiscal 2023”) we recognized $4,850,678 of product revenue, net of allowances, and $3,000 in license and contract revenue pursuant to our license agreement with Fosun. The decrease in net revenue is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
For the fiscal year ended June 30, 2024 (“fiscal 2024”) we recognized $4,490,090 of product revenue, net of allowances. The decrease in net revenue is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024. Cost of Products Sold – We did not recognize cost of products sold for fiscal 2025.
Compensation expense is not adjusted for subsequent changes in the estimates used to calculate fair value or for actual experience. Forfeitures are recognized as they occur.
Compensation expense is not adjusted for subsequent changes in the estimates used to calculate fair value or for actual experience. Forfeitures are recognized as they occur. As the amount and timing of compensation expense to be recorded in future periods may be affected by the achievement of performance conditions and employee terminations, stock-based compensation may vary significantly period to period.
The increase in cash used in operations in fiscal 2024 compared with fiscal 2023 was a result of a higher net loss in fiscal 2023 due to a change in fair value off warrant liabilities, offset by the gain on the sale of Vyleesi and working capital changes.
The decrease in cash used in operations in fiscal 2025 compared with fiscal 2024 was a result of a lower net loss in fiscal 2024 due to reduced program expenses and a gain on the sale of Vyleesi and a gain on purchase commitments.
Income Tax Benefit – Income tax benefit for fiscal 2023 was $4,674,999 as a result of the Company selling New Jersey state net operating losses (“NOLs”) and R&D credits . 43 Table of Contents Effects of Inflati on - We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented.
Effects of Inflati on - We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented. Liquidity and Capital Resources Since inception, we have generally incurred net operating losses, primarily related to spending on our research and development programs.
Gain on Purchase Commitment - Gain on purchase commitments was $1,027,322 for fiscal 2023 as a result of the Company amending the minimum purchase commitment that was previously reserved under the Lonza Agreement.
Gain on Purchase Commitment - Gain on purchase commitments was $2,117,900 for fiscal 2025 as a result of the Company amending the minimum purchase commitment that was previously reserved under the Catalent and Ypsomed agreements. 40 Table of Contents Gain on Sale of Vyleesi – For fiscal 2025, we recorded a gain of $3,130,000 on the sale of Vyleesi as a result of the settlement of sales-based milestone payments and certain purchase commitments.
As of June 30, 2024, our cash, cash equivalents and marketable securities were $9,527,396 with current liabilities of $9,657,681. 44 Table of Contents Our obligations include aggregate lease obligations of $426,556 for the year ending June 30, 2025 and $163,782 for the years ending June 30, 2026 and 2027, and aggregate inventory purchase commitments of $1,976,450 which include $944,150 in current liabilities as of June 30, 2024 and $1,032,300 included in other long-term liabilities.
As of June 30, 2025, our cash, cash equivalents and marketable securities were $2,564,265 with current liabilities of $8,010,030. Our obligations include aggregate lease obligations of $129,812 for the year ending June 30, 2026 and $33,969 for the year ending June 30, 2027.
Removed
Our new product development activities focus primarily on use of bremelanotide, or other MC4r agonists, with tirzepatide, a GLP-1 agonist for treatment of obesity, which entered Phase 2 in the second quarter of calendar year 2024, and a co-formulation of bremelanotide with a PDE5i for treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy.
Added
The Company believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
Removed
Stock-Based Compensation We expense the fair value of stock options and other equity awards granted to employees and nonemployees for services.
Added
The Company is also developing, dependent on resources for development activities, peptides and small molecules that are active at more than one melanocortin receptor, with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications. Our prior commercial product, Vyleesi®, was approved by the U.S.
Removed
As the amount and timing of compensation expense to be recorded in future periods may be affected by the achievement of performance conditions and employee terminations, stock-based compensation may vary significantly period to period. 42 Table of Contents See Note 3 to the consolidated financial statements included in this Annual Report for a description of recent accounting pronouncements that affect us.
Added
(“Cosette”) on December 19, 2023, and is still marketed by Cosette, with a release and settlement agreement on June 5, 2025 Critical Accounting Policies and Estimates Our significant accounting policies are described in Note 2 to the consolidated financial statements included in this Annual Report.
Removed
Results of Operations Year Ended June 30, 2024 Compared to the Year Ended June 30, 2023: Revenue – For the fiscal year ended June 30, 2024 (“fiscal 2024”) we recognized $4,490,090 of product revenue, net of allowances.
Added
Estimating the value or stage of completion of certain services requires judgment based on available information.
Removed
Research and Development – Total research and development expenses, including general research and development spending, were $22,400,372 for fiscal 2024 compared to $22,630,577 for fiscal 2023. The decrease is a result of lower spending on our MCr programs.
Added
See Note 3 to the consolidated financial statements included in this Annual Report for a description of recent accounting pronouncements that affect us. Results of Operations Year Ended June 30, 2025 Compared to the Year Ended June 30, 2024: Revenue – We did not recognize product revenue for the fiscal year ended June 30, 2025 (“fiscal 2025”).
Removed
The decrease is primarily attributable to $1,912,243 of selling expenses related to Vyleesi in fiscal 2024 compared to $4,621,001 of selling expenses related to Vyleesi in fiscal 2023.
Added
During fiscal 2025, net cash provided by investing activities was $3,130,000 related to proceeds from the sale of Vyleesi.
Removed
Gain on Sale of Vyleesi – On December 19, 2023, the Company entered into an asset purchase agreement (the “Cosette Purchase Agreement”) with Cosette pursuant to which Cosette acquired from the Company worldwide rights to Vyleesi.
Added
On August 14, 2025, we entered into a Research Collaboration, License and Patent Assignment Boehringer Ingelheim to research, develop and commercialize first-in-class melanocortin receptor-targeted peptides developed by the Company for the treatment of retinal diseases, including diabetic retinopathy.
Removed
For fiscal 2023, we recognized a decrease in the fair value of warrant liabilities of $4,620,911 and investment income of $691,981 offset by $1,115,765 of offering expenses, $429,971 of unrealized foreign currency loss and $20,013 of interest expense.
Added
Under the terms of the Agreement, we received an upfront payment of $2,300,000 (received September 2025) and may receive up to $21,200,000 in near-term research milestone payments and up to $307,000,000 in success-based development, regulatory, and commercial milestone payments, plus tiered royalties on net commercial sales of Products.
Removed
Liquidity and Capital Resources Since inception, we have generally incurred net operating losses, primarily related to spending on our research and development programs. We have financed our net operating losses primarily through debt and equity financings and amounts received under collaborative and license agreements.
Added
On September 22, 2025, we announced the achievement of a research milestone under its collaboration with Boehringer Ingelheim. This milestone triggers a payment to us of approximately $6,500,000 (expected to be received in October 2025).
Removed
During fiscal 2023, net cash used in investing activities was $3,426,757 which consisted of $2,992,830 used for the purchase of marketable securities and $433,927 of leasehold improvements.

Other PTN 10-K year-over-year comparisons