Palatin Technologies, a biopharmaceutical company specializing in melanocortin receptor system modulation, announced its fiscal first quarter 2025 operating and financial results, emphasizing advancements in its obesity and ocular programs. The company anticipates topline data from its Phase 2 BMT-801 clinical study in the first quarter of calendar year 2025.
Obesity Program Updates
Palatin's core focus remains on obesity, with the Phase 2 BMT-801 clinical study evaluating the co-administration of bremelanotide, a melanocortin-4 receptor (MC4R) agonist, with tirzepatide, a GLP-1/GIP dual agonist. Patient enrollment concluded in October 2024, exceeding the initial target with approximately twice the planned 60 patients across four U.S. sites. The primary endpoint assesses the safety and increased efficacy of the combination in reducing body weight.
Carl Spana, Ph.D., President and CEO of Palatin, stated, "We believe our MC4R long-acting peptide and oral small molecule compounds could address the unmet needs and challenges of these treatments," highlighting the potential of their compounds to overcome limitations of existing obesity therapies, such as high discontinuation rates due to side effects and weight-loss plateaus.
In addition to BMT-801, Palatin is developing novel MC4R selective long-acting peptide and oral small molecule agonists, with investigational new drug (IND) enabling activities expected to commence in the first quarter of calendar year 2025. The company anticipates filing INDs in the second half of 2025 and initiating Phase 1 clinical studies in the fourth quarter of 2025. These agonists are being developed for potential use as monotherapy or in combination with GLP-1 agonists.
Ocular and Other Programs
Palatin is also exploring strategic options for its non-obesity programs, including those focused on dry eye disease (DED), glaucoma, retina-related conditions and ulcerative colitis (UC). According to the company, there has been significant interest and ongoing discussions from multiple parties regarding these programs.
The Phase 3 PL9643 clinical program for DED has shown promise, with the MELODY-1 pivotal study successfully completed, demonstrating 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 the MELODY-2 & MELODY-3 clinical studies is ready to begin in the first quarter of calendar year 2025.
Financial Highlights
For the fiscal first quarter ended September 30, 2024, Palatin reported a net loss of $7.8 million, or $(0.39) per basic and diluted common share, compared to a net loss of $5.2 million, or $(0.43) per basic and diluted common share, for the same period in 2023. The increase in net loss was primarily attributed to the elimination of Vyleesi net product revenue, offset by the elimination of Vyleesi selling expenses and the recognition of the change in fair value of warrant liabilities for the quarter ended September 30, 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. The company received a scheduled $2.5 million deferred upfront payment in November 2024 related to the sale of Vyleesi to Cosette Pharmaceuticals and is actively engaged with multiple potential funding sources for future operating cash needs.
