Palatin Technologies, a biopharmaceutical company specializing in melanocortin receptor system modulation, announced its first quarter fiscal year 2025 operating and financial results, alongside updates on its key development programs. The company is prioritizing its obesity initiatives, with significant milestones expected in the coming year, while also exploring strategic options for its non-obesity assets.
Obesity Program Advancements
Palatin's core focus remains on addressing obesity through innovative therapies targeting the melanocortin-4 receptor (MC4R) pathway. Carl Spana, Ph.D., President and Chief Executive Officer of Palatin, emphasized the potential of their MC4R long-acting peptide and oral small molecule compounds to meet the unmet needs in obesity treatment, given the high discontinuation rates (67%) associated with current therapies due to side effects and weight-loss plateaus.
The Phase 2 clinical study of BMT-801, a co-administration of the MC4R agonist bremelanotide with the GLP-1/GIP dual agonist tirzepatide, has completed patient enrollment in October 2024. Topline results are anticipated in the first quarter of calendar year 2025. The study enrolled approximately twice the target of 60 patients.
Palatin is also planning multiple clinical trials in 2025, utilizing long-acting MC4R peptides and oral small molecule compounds to target general obesity, weight loss management, and rare MC4R pathway diseases such as hypothalamic obesity. Investigational new drug (IND) enabling activities are expected to commence in Q1 2025, with IND filings anticipated in the second half of the year and Phase 1 clinical studies targeted for Q4 2025.
Data presented at ObesityWeek® 2024 showcased the potential of the oral small molecule PL7737, demonstrating significant decreases in food intake and body weight. Selectivity for MC4R is designed to reduce the potential for skin pigmentation.
Strategic Review of Non-Obesity Programs
Palatin has engaged an investment bank to explore strategic options for its non-obesity programs, including those focused on dry eye disease (DED), glaucoma, retina, and ulcerative colitis (UC). There has been significant interest and ongoing discussions for these programs from multiple parties.
For the Phase 3 PL9643 clinical program for DED, the MELODY-1 pivotal study was successfully completed, meeting statistical significance (p<0.025) for the co-primary symptom endpoint of pain and statistical significance (p<0.05) for 7 of 11 secondary symptom endpoints at the 12-week treatment period. Subject to funding, patient enrollment for MELODY-2 & MELODY-3 clinical studies is ready to begin in Q1 2025.
The Phase 2 PL8177 oral formulation for UC has near complete enrollment, with an interim analysis expected in Q1 2025.
Financial Results
Palatin reported a net loss of $7.8 million, or $(0.39) per basic and diluted common share, for the quarter ended September 30, 2024, compared to a net loss of $5.2 million, or $(0.43) per basic and diluted common share, for the same period in 2023. As of September 30, 2024, Palatin's cash and cash equivalents were $2.4 million, compared to $9.5 million as of June 30, 2024. A scheduled $2.5 million deferred upfront payment was received in November 2024 related to the sale of Vyleesi to Cosette Pharmaceuticals.
The company is actively engaged with multiple potential funding sources for future operating cash needs.
