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CRANBURY, N.J. - Palatin Technologies (NYSE:PTN), Inc. (NYSE American: PTN), a biopharmaceutical company, has commenced patient dosing in a Phase II clinical trial for a potential obesity treatment, the company announced today. This study is evaluating the safety and effectiveness of Bremelanotide when used in combination with Tirzepatide, a GLP-1/GIP therapy.
The trial, identified as BMT-801, is a randomized, double-blind, placebo-controlled study that aims to enroll up to 60 participants across four U.S. sites. It will initially treat patients with Tirzepatide alone for four weeks before randomizing them into one of four treatment regimens to assess the combined effects on body weight reduction.
Palatin's CEO, Carl Spana, Ph.D., expressed optimism about the study's commencement and noted the significant patient and physician interest. Spana highlighted the need for diverse therapeutic options in the treatment of obesity, emphasizing the potential role of Melanocortin 4 Receptor (MCR4) agonists in future combination therapies. He also pointed out the limitations of current GLP-1 agonists and the potential benefits of combining these with MCR4 agonists for better-tolerated doses and increased weight loss.
The primary endpoint of the trial is to demonstrate the safety and increased efficacy of the co-administration of Bremelanotide with Tirzepatide. Full patient enrollment is expected by the third quarter of 2024, with topline results anticipated in the first half of 2025.
MCR4 agonists have been identified as playing a central role in regulating appetite and energy storage, making them a promising target for obesity treatments. The MCR system, which includes five receptors, influences various physiological responses, including metabolism and food intake.
Obesity is a growing global health concern, linked to numerous health risks and a substantial economic burden on healthcare systems. In the United States, approximately 42% of adults are considered obese.
Palatin Technologies focuses on developing novel treatments by modulating the melanocortin receptor system and aims to establish marketing collaborations to maximize the commercial potential of its products. This announcement is based on a press release statement from Palatin Technologies.
In other recent news, Palatin Technologies reported Q3 fiscal year 2024 results, recording a net loss of $8.4 million with no gross product sales following the sale of Vyleesi's worldwide rights. However, a fair value adjustment gain of $0.4 million was noted, indicating an improvement from the previous year's loss. The company's operating expenses surged to $9.2 million due to investments in Melanocortin receptor programs.
Recently, Palatin secured approximately $6.1 million from the exercise of warrants issued in November 2022 and October 2023. This resulted in the issuance of over 3.2 million shares of common stock. The transaction is expected to close around June 24, 2024, with the net proceeds allocated for working capital and other general corporate purposes.
In other developments, the company's annual stockholders' meeting saw the election of seven directors, the ratification of KPMG LLP as the public accounting firm for the fiscal year ending June 30, 2024, and approval of an amendment to its 2011 Stock Incentive Plan.
H.C. Wainwright maintained its Buy rating for Palatin following the commencement of a Phase 2 clinical trial focused on the co-administration of bremelanotide and a phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction. Topline data from this trial is expected by the end of 2024. Palatin also plans to submit an Investigational New Drug application for a new co-formulation combining bremelanotide with a PDE5i, with a potential Phase 3 clinical trial projected to begin in the first half of 2025. These recent developments highlight Palatin's commitment to advancing its clinical programs and engaging with regulatory authorities.
InvestingPro Insights
As Palatin Technologies (NYSE American: PTN) embarks on a new phase of clinical trials for its obesity treatment, investors and industry observers are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, Palatin Technologies has reported a revenue of $5.9 million over the last twelve months as of Q3 2024, which marks a significant growth of 52.8% in the same period. Despite this revenue growth, the company faces challenges as indicated by a gross profit margin of -329.27% and an operating income margin of -555.24%, reflecting substantial costs exceeding revenues.
InvestingPro Tips highlight some concerns for Palatin Technologies, as analysts have revised their earnings downwards for the upcoming period and anticipate a sales decline in the current year. These concerns are compounded by the fact that the company has not been profitable over the last twelve months, and analysts do not expect it to be profitable this year. With a moderate level of debt and no dividend payouts to shareholders, the company's stock has experienced a significant downturn, with a six-month price total return of -53.92%.
Investors considering Palatin Technologies should note that there are 7 additional InvestingPro Tips available, which could provide further insights into the company's performance and potential. These additional tips are accessible through InvestingPro and could be particularly valuable in light of the company's next earnings date scheduled for September 12, 2024.
Understanding the financial metrics and market performance of Palatin Technologies is crucial for stakeholders as the company progresses with its clinical trials and seeks to innovate in the treatment of obesity.
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