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We are also developing peptides that are active at more than one melanocortin receptor and small molecule MCR agonists.
−Removed: Our primary focus is on the development of melanocortin receptor system treatments for obesity and for male sexual dysfunction.
−Removed: 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.
−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.
−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.
−Removed: 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.
+Added: Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
+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.
+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.
+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.
+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.
+Added: 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.
+Added: Our new product development strategy focuses on development of MC4R selective agonists with improved pharmacokinetic properties.
+Added: This includes a modified MC4R peptide with an extended drug residency time and minimal blood pressure effects and a MC4R selective oral small molecule.
+Added: Activities in inflammation disease indications focus primarily on development of MCR peptides for ocular conditions, and in the gut and kidney.
Utilizing peptides which are agonists at MC1R, and in some instances agonists at additional melanocortin receptors, we are developing products to treat inflammatory and autoimmune diseases such as dry eye disease (also known as keratoconjunctivitis sicca), uveitis, diabetic retinopathy, and inflammatory bowel disease.
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Vyleesi is the first FDA-approved melanocortin agent and the first and only FDA-approved as-needed treatment for premenopausal women with HSDD.
+Added: 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.
+Added: We retain rights to PL9643, which has successfully completed a first Phase 3 clinical trial for dry eye disease.
Our Business Strategy.
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Pipeline Overview
−Removed: 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.
−Removed: * These programs are planned but dependent on funding.
+Added: The following chart illustrates the status of our drug development programs.
Melanocortin Receptor Programs
Our Current Product Development Strategy.
−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.
−Removed: We believe that use of two active agents may result in increased efficacy and decreased side effects.
−Removed: 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.
+Added: Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
+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.
+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.
+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.
+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.
+Added: 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 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.
+Added: Oral Small Molecule PL7737 MC4R Agonist .
+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.
+Added: Long-acting Peptide MC4R Agonists .
+Added: 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.
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Prior clinical studies have demonstrated the role of bremelanotide in the regulation of energy storage and food intake, resulting in weight loss.
−Removed: 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.
−Removed: 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.
+Added: 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.
−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.
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.
−Removed: 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.
+Added: 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.
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The remaining Phase 3 clinical trial program consists of two Phase 3 studies, MELODY-2 and MELODY-3, and include sign and symptom endpoints in each study.
+Added: Additional Phase 3 studies could start as early as the first half of calendar year 2026.
Oral PL8177 for Inflammatory Bowel Diseases.
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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.
+Added: Positive topline data was reported in the first quarter of calendar year 2025.
For ulcerative colitis and other inflammatory bowel diseases, we administer PL8177 in our oral formulation to deliver PL8177 to the interior wall of the diseased bowel.
PL8177 activates MC1R present on the interior wall of the bowel in ulcerative colitis and other inflammatory bowel diseases.
−Removed: We believe that PL8177 at MC1r in the bowel wall will maximize treatment effect while minimizing any systemic or off-target effects.
−Removed: 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.
−Removed: 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.
+Added: We believe that PL8177 activating MC1R in the bowel wall will maximize treatment effect while minimizing any systemic or off-target effects.
+Added: 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.
+Added: 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.
−Removed: A Phase 2 proof-of-concept study is ongoing for diabetic nephropathy, with topline results expected in the fourth quarter of calendar year 2024.
+Added: 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.
A melanocortin pan agonist is administered by subcutaneous injection to patients taking conventional renin-angiotensin-aldosterone system (“RAAS”) inhibitors.
−Removed: Melanocortin Peptides for Diabetic Retinopathy.
−Removed: We conducted preclinical studies with melanocortin peptides in diabetic retinopathy models and have selected a peptide candidate for further development work.
−Removed: We are working on a formulation for intravitreal and subcutaneous administration.
−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.
−Removed: Ocular Research Programs.
−Removed: 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
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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.
+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.
+Added: 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.
+Added: The recent extensive use of both Food and Drug Administration-approved and compounded versions of GLP-1 receptor agonist drug products, such as Wegovy and Ozempic (semaglutide) for the treatment of obesity, has significantly increased the competition in the obesity market.
+Added: 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.
+Added: Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do.
+Added: We cannot, with any accuracy, forecast when or if these companies are likely to bring their products and therapies to market in competition with those that we are pursuing.
Bremelanotide Co-administration with Tirzepatide (a GLP-1 agonist) to Treat Obesity.
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Other therapies, including various devices and drugs, are in development.
−Removed: There are other melanocortin agonists marketed in the United States, including Imcivree®, the melanocortin agonist setmelanotide, marketed by Rhythm Pharmaceutical for chronic weight management.
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.
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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.
−Removed: Diabetic Retinopathy.
−Removed: FDA-approved drugs used in treatment of diabetic retinopathy include steroids and anti-vascular endothelial growth factor compounds.
−Removed: At least two different antibody fragment products are marketed in the United States in which either aflibercept or ranibizumab is the active pharmaceutical ingredient.
−Removed: Additional vascular endothelial growth factor inhibitors are in clinical trials or in preclinical development.
−Removed: There are no reported MC1r agonist drugs in clinical trials for diabetic retinopathy.
−Removed: 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.
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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.
+Added: On August 14, 2025, we assigned this patent to Boehringer Ingelheim an irrevocable, royalty-free license for PL9643.
If one or more patents are granted, the patents will have a presumptive term until 2041.
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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.
−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 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.
In the event that a third party has also filed a patent application relating to an invention we claimed in a patent application, we may be required to participate in an interference proceeding adjudicated by the United States Patent and Trademark Office (“USPTO”) to determine priority of invention.
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Similar types of regulatory processes will be encountered as efforts are made to market any drug internationally.
−Removed: We will be required to assure product performance and manufacturing processes from one country to another.
−Removed: 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.
+Added: We will be required to ensure product performance and manufacturing processes from one country to another.
+Added: 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.
Once it approves an NDA, the FDA may revoke or suspend the product approval if compliance with postmarketing regulatory commitments is not maintained or if problems occur after the product reaches the marketplace.
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If the application contains only Paragraph I or Paragraph II Certifications, the ANDA may be approved as soon as FDA completes its review and concludes that all approval requirements have been met.
−Removed: 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.
+Added: If the ANDA contains one or more Paragraph III Certifications, the ANDA cannot be approved until each listed patent for which a Paragraph III Certification was filed have expired.
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.
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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.
−Removed: Payers frequently employ a tiered system in reimbursing end users for pharmaceutical products, with tier designation affecting copay or deductible amounts.
−Removed: Vyleesi is classified as a Tier 3 drug by insurers covering Vyleesi.
−Removed: Thus, reimbursement is limited for Vyleesi for treatment of premenopausal women with HSDD.
−Removed: Flibanserin, sold under the trade name Addyi, is similarly classified as a Tier 3 drug.
−Removed: Less than full reimbursement by third-party payers may adversely affect the market acceptance of Vyleesi.
−Removed: Further, healthcare reimbursement systems vary from country to country, and third-party reimbursement might not be made available for Vyleesi for HSDD under other reimbursement systems.
Manufacturing and Marketing
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Additionally, scaling up to commercial quantities may involve production, purification, formulation and other problems not present in the scale of manufacturing done to date.
−Removed: 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.
+Added: 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.
The failure of any manufacturer or supplier to comply with FDA regulations, including GMP or medical device quality systems regulations (“QSR”), or to supply the device component or drug substance and services as agreed, would force us or our licensees to seek alternative sources of supply and could interfere with our and our licensees’ ability to deliver product on a timely and cost-effective basis or at all.
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We have liability insurance providing $10 million coverage in the aggregate as to certain product liability and commercialization risks and certain clinical trial risks.
−Removed: Climate Change Related Regulation
+Added: Compliance with Environmental Laws
+Added: We are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting emissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor or in possession.
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.
−Removed: We do not anticipate any regulation regarding climate change to impact our operations.
−Removed: There is the potential for more frequent and severe weather events that may impact the facilities of our contractors and suppliers.
−Removed: We cannot provide assurance that physical risks to the facilities of our contractors, suppliers and supply chain due to climate change will not occur in the future, but do not believe these potential risks are material to our operations at this time.
+Added: We do not expect that compliance with such environmental laws will have a material effect on our capital expenditures, earnings, or competitive position in the foreseeable future.
+Added: There can be no assurance, however, that future changes in environmental laws or regulations, administrative actions or enforcement actions, or remediation obligations arising under environmental laws will not have a material adverse effect on our capital expenditures, earnings, or competitive position.
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.
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We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996.
−Removed: Our corporate offices are located at 4B Cedar Brook Drive, Cranbury, New Jersey 08512 and our telephone number is (609) 495-2200.
+Added: Our executive offices are located at 103 Carnegie Center, Suite 300, Princeton, New Jersey 08540 and our telephone number is (609) 495-2200.
+Added: Our mailing address is 11 Deer Park Drive, Suite 204, Monmouth Junction, New Jersey 08852, which is our research laboratory.
We maintain an Internet site at www.palatin.com , where among other things, we make available free of charge on and through this website our Forms 3, 4 and 5, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) and Section 16 of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.