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Jun 30, 2024
Palatin Technologies Q4 2024 Earnings Report
Palatin Technologies reported financial results for the fourth quarter and fiscal year ended June 30, 2024.
Key Takeaways
Palatin Technologies reported a net loss of $8.6 million for the fourth quarter ended June 30, 2024, compared to a net loss of $9.8 million for the same period in 2023. The decrease in net loss was mainly due to the decrease in Vyleesi operating expenses, offset by the elimination of net product revenue of Vyleesi and the recognition of the change in fair value of warrant liabilities for the quarter ended June 30, 2023.
Patient enrollment is expected to be completed early in the fourth quarter of calendar year 2024 for the Phase 2 clinical study of the MC4R agonist plus a GLP-1 agonist in obese patients.
Topline data from the Phase 2 clinical study of the MC4R agonist plus a GLP-1 agonist in obese patients is expected early in the first quarter of calendar year 2025.
Patient enrollment for the MELODY-2 and MELODY-3 studies of PL9643 is expected to begin in the first quarter of calendar year 2025.
Interim analysis readout for the Phase 2 PL8177 oral formulation study for ulcerative colitis is expected in the fourth quarter of calendar year 2024.
Palatin Technologies
Palatin Technologies
Forward Guidance
Palatin Technologies is progressing with its clinical development programs and anticipates several key milestones over the coming quarters.
Positive Outlook
- Completion of enrollment expected this month in Phase 2 clinical study of MC4R agonist plus a GLP-1 agonist in obese patients.
- Topline data expected early in the first quarter of calendar year 2025 for the obesity program.
- Agreement with the FDA on the remaining PL9643 Phase 3 DED trial protocols and endpoints.
- MELODY-2 and MELODY-3 studies of PL9643 are expected to begin patient enrollment in the first quarter of calendar year 2025.
- Actively engaging in collaboration and funding discussions with potential partners for PL9643 for DED.
Challenges Ahead
- Potential for discontinuance of GLP-1 agonist use due to side effects and plateau effect.
- Reliance on potential collaborations and funding for advancing PL9643 for DED.
- Uncertainties related to clinical trial results and regulatory actions.
- Dependence on ability to fund development and complete clinical trials.
- Risks associated with commercial acceptance of Palatin's products.