Calendar Year 2024: Palatin’s Comprehensive Corporate Update and Strategic Emphasis

Palatin Technologies Provides 2024 Clinical Development Milestones Update

Palatin Technologies, Inc. (NYSE American: PTN), a leading biopharmaceutical company specializing in melanocortin receptor system modulation, announced key accomplishments from 2023 and outlined anticipated clinical development milestones for 2024.

Clinical Programs Overview:

  1. Dry Eye Disease (DED) – PL9643 MELODY-1 Phase 3 Study:
  • Data Base Lock: 2H January 2024
  • Topline Data Readout: Expected Early 1Q Calendar Year 2024
  1. Ulcerative Colitis (UC) – Oral PL8177 Phase 2 Clinical Study:
  • Interim Analysis Data Readout: On Track for 1Q Calendar Year 2024
  • Topline Results: Expected in 2Q Calendar Year 2024
  1. Obesity – Melanocortin Receptor 4 (MCR4) Agonist + GLP-1:
  • Phase 2 Clinical Study Start: 1Q Calendar Year 2024
  • Topline Results: Expected in 2H Calendar Year 2024
  1. Male Sexual Dysfunction – Bremelanotide Co-Formulated with PDE5i:
  • Phase 2 Clinical Study Start: 1Q Calendar Year 2024
  • Topline Results: Expected in 2H Calendar Year 2024
  1. Vyleesi® Asset Sale:
  • Completed Sale to Cosette Pharmaceuticals for up to $171 Million
  • $12 Million Upfront Plus Sales-Based Milestones of up to $159 Million

Corporate Update:

  • Carl Spana, Ph.D., President and CEO of Palatin, expressed confidence in the company’s progress during 2023 and highlighted the focus on making 2024 transformative.
  • Phase 3 PL9643 DED study with a data readout expected early in 1Q 2024.
  • Phase 2 study of oral PL8177 in UC patients with an interim analysis in 1Q and topline results in 2Q 2024.
  • Initiation of a Phase 2 study for MCR4 agonist plus GLP-1 in obese patients in 1Q 2024.
  • Phase 2 clinical study for bremelanotide co-formulated with a PDE5i in male sexual dysfunction patients starting in 1Q 2024.

Financial Highlights:

  • Completed the asset sale of Vyleesi® to Cosette Pharmaceuticals for up to $171 million.
  • $12 million upfront payment, with potential sales-based milestones reaching up to $159 million.
  • Retained rights and usage of bremelanotide for obesity and male erectile dysfunction indications.

Future Outlook:

  • Emphasis on melanocortin-based therapeutics for obesity treatment.
  • Focus on developing selective and efficacious MCR4 long-acting peptides and orally active small molecules.
  • Anticipated initiation of IND enabling activities for a novel MCR4 selective long-acting agonist in 2H 2024.

About Palatin Technologies:

  • Palatin is dedicated to developing first-in-class medicines based on molecules modulating the melanocortin receptor systems.
  • Strategy involves forming collaborations with industry leaders to maximize commercial potential.

Forward-looking Statements:

  • Palatin’s President and CEO, Dr. Carl Spana, highlighted the company’s focus on areas with high success probability, product differentiation, and a substantial return on investment.
  • Topline data readout for PL9643 expected early 1Q 2024.
  • Interim analysis for oral PL8177 in UC patients targeted for 1Q 2024.
  • Phase 2 clinical study for obesity and male sexual dysfunction expected to commence in 1Q 2024.

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