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Palatin Reports Fourth Quarter and Fiscal Year Ended 2024 Financial Results, Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

Core Insights - Palatin Technologies is advancing multiple clinical programs with significant milestones expected in the near future, particularly in obesity, dry eye disease, male sexual dysfunction, ulcerative colitis, and diabetic nephropathy [1][2][3] Obesity Program - The Phase 2 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with GLP-1 agonist tirzepatide is set to enroll approximately 60 patients across four U.S. sites, with topline results expected in Q1 2025 [3][4] - The study aims to demonstrate the safety and increased efficacy of the combination therapy in reducing body weight, addressing the high discontinuation rates of GLP-1 monotherapy due to side effects [2][3] Dry Eye Disease (DED) Program - The Phase 3 clinical program for PL9643 in treating DED has received FDA agreement on trial protocols and endpoints, with patient enrollment expected to start in Q1 2025 and topline results anticipated in Q4 2025 [5][6] - The previous Phase 3 MELODY-1 study showed statistical significance in multiple symptom endpoints, indicating a strong potential for PL9643 in this indication [5] Male Sexual Dysfunction Program - A pharmacokinetics study for bremelanotide co-formulated with a PDE5 inhibitor for erectile dysfunction is expected to start in Q1 2025, with patient recruitment for a Phase 2/3 study anticipated in the second half of 2025 [6][7] - Historical data indicates that approximately 35% of men with erectile dysfunction do not respond adequately to PDE5 inhibitors, highlighting a significant market opportunity [6] Ulcerative Colitis Program - The Phase 2 study of oral PL8177 for active ulcerative colitis is set to provide interim analysis results in Q4 2024, with topline results expected in Q1 2025 [7] Diabetic Nephropathy Program - The Phase 2 BREAKOUT study of bremelanotide (BMT 701) in patients with diabetic kidney disease is expected to yield topline results in Q4 2024 [7] Financial Overview - For the fiscal year ended June 30, 2024, Palatin reported total revenues of $4.49 million, a decrease from $4.85 million in the previous year, primarily due to the sale of Vyleesi [9][11] - The company recorded a net loss of $29.7 million for the fiscal year, compared to a net loss of $24.0 million in the prior year, reflecting increased operational costs [19][21] - As of June 30, 2024, Palatin's cash and cash equivalents stood at $9.5 million, a slight decrease from $10.0 million as of March 31, 2024 [22]