Palatin Announces Q3 FY 2024 Financial Results and Corporate Update

Palatin Technologies, Inc., a biopharmaceutical company advancing novel treatments, has announced significant achievements in its fiscal third quarter ending March 31, 2024. The company specializes in developing drugs that target the melanocortin receptor system, and its advancements span several therapeutic areas, including dry eye disease (DED), ulcerative colitis, obesity, and male sexual dysfunction.

A major highlight is the successful completion of the Phase 3 MELODY-1 study for dry eye disease using PL9643. The study demonstrated a rapid onset of efficacy, with the co-primary symptom endpoint of pain and seven of eleven secondary symptom endpoints achieving statistical significance within a 12-week treatment period. Notably, significant improvements were observed as early as two weeks. The treatment also proved to have an excellent safety and tolerability profile. These positive outcomes offer promising potential for PL9643 as a highly differentiated treatment for DED. Palatin is currently in discussions with potential partners and preparing for an FDA meeting to discuss the next steps for the PL9643 program, aiming for an NDA submission by the second half of 2025.

In the realm of autoimmune and anti-inflammatory treatments, Palatin is progressing with its oral Phase 2 study for PL8177 in patients with ulcerative colitis. An interim analysis is expected in the second quarter of 2024, with topline results anticipated later in the year.

Additionally, Palatin is set to launch a Phase 2 study targeting obesity using a combination of a Melanocortin Receptor 4 (MCR4) agonist and Glucagon-Like Peptide-1 (GLP-1). This study is slated to begin in the second quarter of 2024, with data expected by the year's end. Another Phase 2 study will assess bremelanotide co-formulated with a PDE5 inhibitor (PDE5i) for treating erectile dysfunction in patients unresponsive to PDE5i monotherapy, also beginning in the second quarter of 2024.

Financially, Palatin reported no product sales for the quarter, following the sale of worldwide rights for Vyleesi to Cosette Pharmaceuticals in December 2023. Operating expenses increased to $9.2 million, primarily due to higher spending on MCR programs, while net cash used in operations rose to $8.6 million from $1.4 million the previous year. The company ended the quarter with $10 million in cash and marketable securities, affirming that existing funds should cover anticipated expenses until the second half of 2024.

Palatin hosted a teleconference and webcast on May 15, 2024, to discuss these results and provide further updates on their corporate developments. This session was accessible through their website, with replay options available post-event.

The advancements in Palatin's clinical programs highlight their commitment to addressing significant unmet medical needs through innovative therapies. With the progression of multiple studies and the potential for new treatments in various fields, the company continues to solidify its position in the biopharmaceutical landscape.

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