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Palatin Technologies, Inc. (NYSE American: PTN) is a specialized biopharmaceutical company based in Cranbury, New Jersey. The company focuses on developing first-in-class medicines that target the melanocortin and natriuretic peptide receptor systems. These therapies are aimed at treating a variety of diseases with significant unmet medical needs and commercial potential.
The company's lead product is Vyleesi, a melanocortin receptor agonist for premenopausal women suffering from hypoactive sexual desire disorder (HSDD). Recently, Palatin announced the divestiture of Vyleesi to better focus on its robust development and clinical pipeline.
Palatin is also advancing several promising candidates through clinical trials:
- PL9643: A melanocortin receptor agonist for treating dry eye disease (DED). The company recently reported successful results from its Phase 3 MELODY-1 trial, demonstrating significant efficacy and safety.
- PL8177: This selective melanocortin receptor 1 (MC1R) agonist peptide has completed Phase 1 trials for inflammatory bowel diseases and systemic non-infectious uveitis. It is being further developed for treating COVID-19.
- PL3994: A natriuretic peptide receptor (NPR)-A agonist aimed at treating cardiovascular diseases and other conditions.
Palatin’s strategic focus is on developing targeted, receptor-specific product candidates and forming marketing collaborations with industry leaders to maximize their commercial potential. The company's research and development efforts are guided by a commitment to innovative science and a focus on areas with high probability of success and differentiation.
Financially, Palatin has shown strong operational progress. As of the latest fiscal quarter, the company announced a substantial cash position, ensuring the funding of its ongoing projects into the second half of 2024. The company's leadership believes that their internal research and development efforts, concentrating on melanocortin receptor-based therapies, hold significant promise for the treatment of various conditions, including obesity and erectile dysfunction.
Palatin’s approach to biopharmaceutical development underscores a commitment to addressing significant medical needs through innovative receptor-specific therapies. For more information, visit www.Palatin.com and follow them on Twitter at @PalatinTech.
Palatin Technologies (NYSE: PTN) reported Q1 FY2025 financial results and provided updates on its obesity programs. The company completed patient enrollment in October 2024 for its Phase 2 BMT-801 clinical study, combining MC4R agonist bremelanotide with GLP-1/GIP dual agonist tirzepatide, with topline results expected in Q1 2025. Net loss for Q1 was $7.8 million ($0.39 per share), compared to $5.2 million ($0.43 per share) in Q1 FY2024. Cash position as of September 30, 2024, was $2.4 million. The company has engaged an investment bank to explore strategic options for non-obesity programs, including its Phase 3 DED program and Phase 2 UC program.
Palatin Technologies (NYSE American: PTN) has announced it will release its first quarter fiscal year 2025 financial results on November 14, 2024, before U.S. markets open. The company will host a conference call and webcast at 11:00 a.m. ET the same day, featuring executive management's review of operating results and development program updates. The earnings release is scheduled for 7:30 a.m. ET, with a conference call replay available until November 28, 2024. Palatin is a biopharmaceutical company focused on developing first-in-class medicines based on melanocortin receptor systems.
Palatin Technologies (NYSE American: PTN) presented preclinical data for PL7737, their oral melanocortin 4 receptor (MC4R) selective agonist for obesity treatment. Studies showed that PL7737 significantly reduced food intake and body weight in diet-induced obese mice, validating its MC4R-mediated effects. The compound demonstrated promising oral bioavailability and lacked erectogenic activity, making it potentially suitable for obesity treatment.
The company plans multiple clinical trials in 2025 for its obesity programs, including novel long-acting MC4R peptide and small molecule compounds. Additionally, Palatin is conducting a Phase 2 trial combining bremelanotide with tirzepatide, with topline results expected in Q1 2025.
Palatin Technologies (NYSE American: PTN) has completed enrollment in its Phase 2 clinical study evaluating bremelanotide co-administered with tirzepatide for obesity treatment. The study enrolled approximately 120 patients, double the target, across four US sites. Topline results are expected by March 2025.
The study aims to demonstrate that combining an MC4R agonist with GLP-1/GIP may produce synergistic effects on weight loss at lower, better-tolerated doses. This research addresses the current challenges with GLP-1/GIP therapies, where 67% of patients discontinue treatment due to side effects and experience weight rebound after plateauing in the first year.
Palatin Technologies (NYSE American: PTN) presented clinical and preclinical data on three melanocortin agonists at the 19th Annual Peptide Therapeutics Symposium. The presentation highlighted: PL9643 showing statistical significance in treating dry eye disease; PL8177 demonstrating effectiveness in reducing colonic damage and inflammation in ulcerative colitis models; and PL9654 showing promise in treating retinal diseases by reducing vision loss and photoreceptor degeneration. The data supports using melanocortin agonists to treat inflammatory diseases without immunosuppression.
Palatin Technologies (NYSE American: PTN) presented foundational data on novel and highly selective Melanocortin 4 Receptor (MC4R) agonists at the 19th Annual Peptide Therapeutics Symposium. The company has identified specific structural components responsible for MC1R agonism, which causes increased skin pigmentation, and modified them to optimize MC4R activity while reducing MC1R activity. This breakthrough could potentially eliminate skin color changes in obesity treatments.
The company plans to begin clinical development in 2025, targeting obesity treatment. Currently, Palatin is conducting a Phase 2 clinical trial combining bremelanotide with tirzepatide in obese patients, with results expected in Q1 2025.
Palatin Technologies, Inc. (NYSE American: PTN) has received a notice of non-compliance from NYSE American regarding continued listing standards. The company does not meet the requirement of having stockholders' equity of $6 million or more, as specified in Section 1003(a)(iii) of the NYSE American Company Guide. This is in addition to previously reported non-compliance with Sections 1003(a)(i) and (ii).
Palatin has submitted a plan to regain compliance by April 10, 2025, which has been accepted by the Exchange. The company can continue its listing during this period, subject to periodic reviews. Palatin is exploring multiple funding avenues to achieve compliance. The notice does not immediately affect the listing or trading of Palatin's common stock, nor does it impact the company's business operations or SEC reporting requirements.
Palatin Technologies, Inc. (NYSE American: PTN) reported financial results for Q4 and fiscal year 2024, ending June 30. Key highlights include:
Clinical Programs:
- Obesity: Phase 2 study of MC4R agonist plus GLP-1 ongoing, topline results expected Q1 2025
- Dry Eye Disease: FDA agreement on Phase 3 protocols, patient enrollment to start Q1 2025
- Male Sexual Dysfunction: PK study for bremelanotide + PDE5i to start Q1 2025
- Ulcerative Colitis: Phase 2 interim analysis expected Q4 2024
- Diabetic Nephropathy: Phase 2 topline results expected Q4 2024
Financial Results:
- Q4 net loss: $8.6 million, or $(0.51) per share
- FY2024 net loss: $29.7 million, or $(2.02) per share
- Cash position: $9.5 million as of June 30, 2024
The company is pursuing potential funding sources and partnership opportunities for its clinical programs.
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.
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