• Obesity programs:
  • Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide
    • Topline results expected 1Q calendar year 2025
  • General obesity, weight loss management, and rare neuroendocrine and genetic diseases, including hypothalamic obesity
    • Multiple clinical trials targeted to commence 2H calendar year 2025 with long-acting MC4R peptide and/or MC4R oral small molecule compounds
• Dry eye disease and other ocular programs, ulcerative colitis, and diabetic nephropathy programs:
  • Program specific licensing/collaboration and spinout discussions ongoing with multiple deals targeted for calendar year 2025

CRANBURY, N.J., Jan. 28, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system (MCRS), today provided an update on anticipated corporate milestones expected to occur in calendar year 2025.

"We are poised for a transformational and defining year in 2025, focusing on reporting the topline data of our Phase 2 BMT-801 clinical study evaluating the co-administration of bremelanotide with tirzepatide on reducing body weight, with the readout expected later this quarter," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The high discontinuation rate (67%) of obese patients on currently approved therapies resulting from side effects and a weight-loss plateau effect in the first year, points to a need for additional safe and effective treatments for obesity. We are targeting to start multiple clinical trials in the second half of calendar year 2025 with a novel and proprietary long-acting MC4R peptide and/or an MC4R selective oral small molecule compound for the treatment of general obesity and weight loss management, as well as obesity associated with rare neuroendocrine and genetic diseases."

"The central melanocortin system has a fundamental role in regulating energy storage and feeding behaviors. MC4R is a well validated target for treating obesity with MC4R agonists having demonstrated in multiple clinical studies significant reductions in caloric intake and weight loss," continued Dr. Spana. "As the leading MCRS development company, Palatin has unique expertise, broad intellectual property coverage and an extensive library of compounds from which to draw to develop MC4R agonists for the treatment of obesity. Our novel MC4R agonists could play a vital role in treating obesity as monotherapy or in combination with existing treatments."

Expected 2025 Milestones

Obesity Programs

• Topline results from our Phase 2 BMT-801 'signal detection' clinical study with MC4R agonist bremelanotide plus a glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist tirzepatide, expected in the first quarter of calendar year 2025.
  • Primary objective: Demonstrate that co-administration of bremelanotide with tirzepatide is safe and has a significant effect on reducing body weight.
• General obesity, weight loss management, and orphan/rare neuroendocrine and genetic diseases, including hypothalamic obesity:
  • Potential for monotherapy or combination (with a GLP-1 agonist) therapy.
  • Investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025.
  • Filing of INDs anticipated 2H of calendar year 2025.
  • Commencement of Phase 1 clinical studies targeted for 4Q calendar year 2025.

Dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), and diabetic nephropathy programs

• Program specific licensing/collaboration and spinout activities ongoing with multiple deals targeted for calendar year 2025.
• DED
  • Concluded positive Type C meeting with the FDA and reached agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols, with patient enrollment prepared to commence 1H calendar year 2025.
• UC
  • Report topline results from our Phase 2 clinical study of PL8177 oral formulation for the treatment of UC later this quarter.

About Melanocortin 4 Receptor Agonists Effect on Obesity

Genetic analysis has identified the melanocortin 4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MC4R therefore represents an attractive target for potential obesity treatments.

About Melanocortin Receptor Agonists

The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

About Palatin

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.

Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.

Palatin Technologies^® is a registered trademark of Palatin Technologies, Inc.