NEWS
Palatin Reports Fourth Quarter and Fiscal Year Ended 2024 Financial Results, Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones
• Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist plus Glucagon Like Peptide-1 (GLP-1)
◦ Patient Dosing Commenced 3Q Calendar Year 2024
◦ Patient Enrollment Expected to be Completed Early 4Q Calendar Year 2024
◦ Topline Results Expected 1Q Calendar Year 2025
• Dry Eye Disease (DED): PL9643
◦ MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies
▪ FDA Confirms Protocols and Endpoints
▪ Patient Enrollment Start Expected 1Q Calendar Year 2025
▪ Topline Results Anticipated 4Q Calendar Year 2025
◦ Potential Partner Collaboration and Funding Discussions Ongoing
• Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy
◦ Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025
◦ Patient Recruitment in Phase 2/3 Study Anticipated in 2H Calendar Year 2025
• Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients
◦ Interim Analysis Readout Expected 4Q Calendar Year 2024
◦ Topline Results Anticipated 1Q Calendar Year 2025
◦ Potential Partner Collaboration and Funding Discussions Ongoing
• Diabetic Nephropathy: Phase 2 BMT 701 Study in Patients with Diabetic Kidney Disease
◦ Topline Results Expected 4Q Calendar Year 2024
• Teleconference and Webcast to be held on October 1, 2024, at 11:00 AM ET
◦ Patient Dosing Commenced 3Q Calendar Year 2024
◦ Patient Enrollment Expected to be Completed Early 4Q Calendar Year 2024
◦ Topline Results Expected 1Q Calendar Year 2025
• Dry Eye Disease (DED): PL9643
◦ MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies
▪ FDA Confirms Protocols and Endpoints
▪ Patient Enrollment Start Expected 1Q Calendar Year 2025
▪ Topline Results Anticipated 4Q Calendar Year 2025
◦ Potential Partner Collaboration and Funding Discussions Ongoing
• Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy
◦ Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025
◦ Patient Recruitment in Phase 2/3 Study Anticipated in 2H Calendar Year 2025
• Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients
◦ Interim Analysis Readout Expected 4Q Calendar Year 2024
◦ Topline Results Anticipated 1Q Calendar Year 2025
◦ Potential Partner Collaboration and Funding Discussions Ongoing
• Diabetic Nephropathy: Phase 2 BMT 701 Study in Patients with Diabetic Kidney Disease
◦ Topline Results Expected 4Q Calendar Year 2024
• Teleconference and Webcast to be held on October 1, 2024, at 11:00 AM ET
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