For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you discuss the benchmarks of success for your weight loss program with GLP-1? Are you looking for a minimum or limit of weight loss to move to the next stage, and what impacts on lean muscle mass are you expecting? Also, how are you addressing pigmentation issues? A: The primary goal is to determine if there is an additive effect when co-administering bremelanotide with tirzepatide. We expect to see a measurable separation in weight loss, even if it's modest over the short term. Regarding pigmentation, we are developing next-generation compounds that are highly selective for the MCR4 receptor and devoid of MCR1 activity, which should eliminate skin darkening issues. Carl Spana, CEO
Q: How mature are your discussions on business development for the dry eye program, and what guidance have you received from the FDA? A: We have FDA concurrence on the primary endpoints for the next Phase 3 trials. Our protocols, statistical analysis plans, and CROs are ready. We are in active discussions with potential corporate collaborators and funding partners, and we are optimistic about securing the necessary funding to move forward. Carl Spana, CEO
Q: Do you see the potential to co-formulate your MCR4 agonists with drugs like tirzepatide for weight loss treatment? A: While we haven't done this work yet, it is highly feasible. The formulations for these compounds are soluble, and combining them should be relatively straightforward. Carl Spana, CEO
Q: Can you provide more details on the financial impact of the Vyleesi asset sale to Cosette Pharmaceuticals? A: The sale included $12 million upfront and potential milestones up to $159 million based on annual net sales. This transaction significantly reduced our operating expenses and contributed to a $7.8 million gain. Stephen Wills, CFO
Q: What are the next steps for your PL9643 dry eye disease program following the positive Phase 3 MELODY-1 trial results? A: We plan to complete the remaining Phase 3 trials (MELODY-2 and MELODY-3) in 2025 and file a new drug application with the FDA in the first half of 2026. We are also in discussions with potential collaborators to support this program. Carl Spana, CEO
Q: How is Palatin addressing the high discontinuation rates seen with current obesity treatments like GLP-1 receptor agonists? A: We believe that combining MCR4 receptor agonists with GLP-1 receptor agonists may result in synergistic effects, allowing for increased or sustained weight loss at lower and better-tolerated doses. Our ongoing Phase 2 study aims to demonstrate this potential. Carl Spana, CEO
Q: What progress has been made in your ocular programs, specifically for glaucoma and retinopathies? A: PL9588 for glaucoma has shown promising preclinical results, including lowering intraocular pressure and providing neuroprotection. PL9654 for retinopathies has demonstrated the ability to preserve vision and protect the retina from damage. Both programs are ready to enter IND-enabling studies in 2025. Carl Spana, CEO
Q: Can you provide an update on your PL8177 program for ulcerative colitis? A: The Phase 2 study is nearly complete, and we expect interim analysis data later this quarter. Preclinical studies have shown that PL8177 can resolve inflammation and improve diseased colons towards a healthy state. Carl Spana, CEO
Q: What are the key milestones for Palatin in the upcoming year? A: We aim to complete the Phase 2 study for our obesity program, advance our selective MCR4 peptide agonists to first-in-human studies, start and complete Phase 3 trials for our dry eye disease program, and initiate clinical studies for our male sexual dysfunction program. Carl Spana, CEO
Q: How is Palatin positioned financially to support its ongoing and future programs? A: We are actively engaged with multiple parties for potential funding sources, including business development efforts and collaborations. Our cash and cash equivalents were $9.5 million as of June 30, 2024, and we are optimistic about securing additional funding to support our programs. Stephen Wills, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.