Palatin Technologies, Inc. - PTN STOCK NEWS

Palatin Technologies, Inc. (NYSE American: PTN) will announce its fourth quarter and fiscal year end 2024 operating results on Tuesday, October 1, 2024, before the U.S. financial markets open. The company will host a conference call and live audio webcast at 11:00 AM Eastern Time on the same day, featuring a review of operating results and updates on programs under development.

The press release will be available at 7:30 a.m. ET, followed by the live conference call at 11:00 a.m. ET. A replay of the call will be accessible from October 1 to October 15, 2024. Investors can access the webcast through Palatin's website.

Palatin is a biopharmaceutical company focusing on first-in-class medicines based on melanocortin receptor systems for treating diseases with significant unmet medical needs.

Palatin Technologies (NYSE American: PTN) provided an update on its clinical programs and anticipated milestones. Key highlights include:

• Dry Eye Disease: FDA confirmed protocols for MELODY-2 & MELODY-3 Phase 3 studies, targeting enrollment in Q4 2024
• Obesity: Phase 2 study of MC4R agonist + GLP-1 commenced patient dosing, results expected Q1 2025
• Male Sexual Dysfunction: Development of bremelanotide co-formulated with PDE5i for ED, Phase 3 study anticipated in 2H 2025
• Ulcerative Colitis: Oral PL8177 Phase 2 study interim analysis expected Q4 2024

The company is actively engaging in partnership discussions for its ocular and ulcerative colitis programs. Palatin's focus remains on developing melanocortin receptor system treatments for obesity and male sexual dysfunction.

Palatin Technologies (NYSE American: PTN) has received FDA confirmation for the protocols and endpoints of its remaining Phase 3 pivotal clinical trials for PL9643 in Dry Eye Disease (DED). The trials, MELODY-2 and MELODY-3, are set to begin patient enrollment in Q4 2024, with topline results expected by year-end 2025. If successful, an NDA submission is anticipated in H1 2026.

The company's first Phase 3 study, MELODY-1, completed in February 2024, showed promising results with rapid onset of efficacy and statistical significance in multiple symptom and sign endpoints. PL9643 demonstrated an excellent safety and tolerability profile, positioning it as a potentially highly differentiated product in the DED market, which affects an estimated 38 million adults in the US and 719 million globally.

Palatin Technologies (NYSE American: PTN) has initiated patient dosing in a Phase 2 clinical study of bremelanotide co-administered with tirzepatide for obesity treatment. The study, BMT-801, aims to enroll up to 60 patients across four U.S. sites, with full enrollment expected in Q3 2024 and topline results in Q1 2025. The primary endpoint is to demonstrate safety and increased efficacy of the co-administration on reducing body weight.

The company sees potential in combining MCR4 agonists with incretin therapeutics like tirzepatide for synergistic effects on weight loss, potentially allowing for increased weight loss at lower, better-tolerated doses. This approach aims to address the 67% discontinuation rate of GLP-1 agonists due to side effects and plateau effect in the first year.

Palatin Technologies, a biopharmaceutical company, announced a warrant inducement agreement with an institutional investor, resulting in the exercise of warrants for gross proceeds of approximately $6.1 million.

The agreement involves 3,233,277 shares of common stock at an amended price of $1.88 per share. The investor will receive unregistered Series A and Series B warrants, expiring five years from the closing date. The proceeds will support working capital and general corporate purposes.

The transaction is expected to close around June 24, 2024, pending customary conditions. The issued warrants are unregistered under the Securities Act of 1933.

Palatin Technologies has initiated a Phase 2 clinical study of bremelanotide (BMT) co-administered with a PDE5 inhibitor (PDE5i) for treating erectile dysfunction (ED) in patients unresponsive to PDE5i monotherapy. With 30-40% of ED patients not responding to current PDE5i treatments, this study aims to address significant unmet medical needs. The trial will involve around 50 patients and assess the safety and efficacy of the combination therapy. Topline data from the study is anticipated by the end of 2024. The study is FDA and IRB approved. Furthermore, a Phase 3 clinical study of a new co-formulated BMT plus PDE5i is expected to start in the first half of 2025. ED affects approximately 30 million men in the U.S., and current PDE5i monotherapy represents over $4 billion in annual sales but is ineffective for a significant portion of patients.

Palatin Technologies (NYSE American: PTN) has initiated a Phase 2 clinical study to evaluate the safety and efficacy of bremelanotide, a melanocortin 4 receptor (MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in obese patients. The trial aims to demonstrate the safety and improved efficacy of this combination in reducing body weight. The study, cleared by the FDA, involves 60 patients across five U.S. sites, with topline data expected by the end of 2024. Palatin believes this combination could lead to significant weight loss with improved tolerability, addressing the high discontinuation rates associated with current GLP-1 treatments. The company is also exploring additional studies for metabolic conditions and rare genetic diseases of obesity.

Palatin Technologies announced its Q3 FY2024 financial results and corporate updates. The company reported successful Phase 3 results for its dry eye treatment, PL9643, showing statistical significance in the co-primary endpoint of pain and several secondary endpoints. Interim analysis for their Phase 2 oral PL8177 study in ulcerative colitis is expected in Q2 2024, with topline results in 2H 2024. They plan to initiate Phase 2 trials in obesity and erectile dysfunction in Q2 2024. Revenue for the quarter ended March 31, 2024, was $0 due to the sale of Vyleesi rights. Operating expenses increased to $9.2 million, and net loss was $8.4 million. Cash position as of March 31, 2024, was $10 million. The company believes it has sufficient funds for its operations into the second half of 2024.

Palatin Technologies, Inc. (NYSE American: PTN) will report its third quarter fiscal year 2024 results on May 15, 2024, before the U.S. financial markets open. A conference call and webcast will follow at 11:00 a.m. ET to discuss the operating results and programs under development.