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Palatin’s Corporate Outlook and Strategic Focus for 2024 Unveiled

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By manpreet maan

Palatin Technologies, Inc. (NYSE American: PTN) Corporate Update and Key Development Milestones for 2024

Palatin Technologies, a biopharmaceutical company specializing in melanocortin receptor system-based medicines, announced its achievements in 2023 and outlined the anticipated clinical development milestones for 2024. Carl Spana, Ph.D., President and CEO of Palatin, expressed confidence in making 2024 a transformative year.

Clinical Development Milestones for 2024:

  1. Dry Eye Disease (DED) – PL9643 MELODY-1 Phase 3 Study:
  • Patient enrollment completed (n=570)
  • Data Base Lock 2H January 2024
  • Topline Data Readout Expected Early 1Q Calendar Year 2024
  • Phase 3 safety and efficacy studies MELODY-2 and MELODY-3 to commence patient enrollment in 2H 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 Targeted to 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 Targeted to Start 1Q Calendar Year 2024
  • Topline Results Expected in 2H Calendar Year 2024
  1. Vyleesi®:
  • Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million
  • $12 Million Upfront Plus Sales-Based Milestones of up to $159 Million

Program Updates and Milestones:

  • Anti-Inflammatory / Autoimmune Programs:
  • PL9643 melanocortin agonist Phase 3 study for DED: Patient enrollment completed, Data base lock in January 2024, Topline data readout expected in early 1Q 2024.
  • PL8177 oral melanocortin agonist Phase 2 study for UC: Interim assessment in 1Q 2024, Topline data readout in 2Q 2024.
  • Bremelanotide BREAKOUT Phase 2 study in patients with diabetic kidney disease: Topline data readout in 2Q 2024.
  • Metabolic Program (Obesity):
  • Positive data presented for bremelanotide + GLP-1 in obesity treatment.
  • Phase 2 clinical study targeted to start in 1Q 2024, Topline data readout in 2H 2024.
  • IND enabling activities for a novel MCR4 selective long-acting agonist expected in 2H 2024.
  • Sexual Health Program (Male Sexual Dysfunction):
  • Initiated a clinical development program for bremelanotide co-formulated with PDE5i.
  • Phase 2 clinical study in PDE5i non-responder ED patients expected to commence in 1Q 2024, Topline data readout in 2H 2024.

Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD):

  • Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023.
  • $12 million upfront, plus potential sales-based milestones of up to $159 million.
  • Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications.

About Melanocortin Receptor Agonists and Inflammation:
The melanocortin receptor system modulates inflammation, immune responses, metabolism, food intake, and sexual function. Palatin focuses on developing selective and efficacious melanocortin-based therapeutics to address significant unmet medical needs.

About Palatin:
Palatin Technologies develops first-in-class medicines based on molecules modulating the melanocortin receptor systems, aiming to address diseases with unmet medical needs. The company collaborates with industry leaders to maximize commercial potential.

Forward-looking Statements:
Palatin acknowledges that forward-looking statements involve risks and uncertainties that could differ materially from historical results. Factors include clinical trial results, regulatory actions, funding, and market acceptance. Palatin is not responsible for updating events post this press release.

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