Core Insights - Palatin Technologies, Inc. is advancing multiple clinical programs targeting significant medical needs, including dry eye disease, obesity, male sexual dysfunction, and ulcerative colitis [1][2][3] Ocular Programs - The Phase 3 clinical program for PL9643 in treating dry eye disease (DED) is set to begin patient enrollment in Q4 2024, with topline results expected in Q4 2025 [1][3] - A positive Type C meeting with the FDA confirmed the trial protocols and endpoints for the MELODY-2 and MELODY-3 studies [2][3] - The successful completion of the Phase 3 MELODY-1 study demonstrated statistical significance for multiple symptom endpoints, indicating the efficacy of PL9643 [3][4] Obesity Program - A Phase 2 clinical study combining melanocortin-4 receptor (MC4R) agonist bremelanotide with GLP-1 (tirzepatide) commenced patient dosing in Q3 2024, with topline results expected in Q1 2025 [1][4] - The study aims to enroll up to 60 patients across four sites in the U.S., focusing on safety and efficacy in weight reduction [4] Male Sexual Dysfunction Program - Development of bremelanotide co-formulated with a PDE5 inhibitor for erectile dysfunction (ED) is underway, with a pharmacokinetics study expected to start in Q1 2025 and patient recruitment anticipated in H2 2025 [1][5] - Approximately 35% of men with ED do not respond adequately to PDE5i treatments, representing a significant market opportunity [5] Ulcerative Colitis Program - The Phase 2 clinical study of oral PL8177 for ulcerative colitis is ongoing, with an interim analysis expected in Q4 2024 and topline results anticipated in Q1 2025 [1][6] Financial and Strategic Developments - The company is engaged in discussions for potential collaborations and funding to support the development of its clinical programs [1][2][6] - An asset sale of Vyleesi® to Cosette Pharmaceuticals for up to $171 million was completed in December 2023, retaining rights for bremelanotide in obesity and male erectile dysfunction [6][7]

FDA & Palatin agree on clear regulatory path for PL9643 NDA submission in DED FDA confirms acceptability of protocols and endpoints for remaining MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Trials in DED Currently anticipate patient enrollment to start in 4Q calendar year 2024 Topline results currently expected in 4Q calendar year 2025 CRANBURY, N.J., Aug. 28, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molec ...

Core Insights - Palatin Technologies has initiated patient dosing for a Phase II clinical study (BMT-801) investigating the co-administration of Bremelanotide with Tirzepatide for obesity treatment, with full enrollment expected by Q3 2024 and topline results anticipated in Q1 2025 [1][3]. Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs and commercial potential [8]. Clinical Study Details - The Phase II study aims to enroll up to 60 patients across four sites in the U.S., with the primary endpoint being the safety and efficacy of the combination treatment in reducing body weight [2][3]. - Patients will initially receive Tirzepatide alone for four weeks before being randomized into one of four treatment regimens [2]. Mechanism of Action - The melanocortin 4 receptor (MCR4) is crucial for appetite regulation, and its agonists may provide a promising avenue for obesity treatment by promoting satiety [4][5]. - Combining MCR4 agonists with GLP-1 therapeutics like Tirzepatide may enhance weight loss effects while minimizing side effects, addressing the high discontinuation rates associated with current GLP-1 treatments [2]. Obesity Context - Obesity, defined as a BMI ≥30 kg/m², is a growing public health issue linked to various serious health conditions, with approximately 42% of U.S. adults and 20% of teens affected [7]. - The need for safe and effective obesity treatments is critical due to the associated economic burden on healthcare systems [7].

Core Viewpoint - Palatin Technologies, Inc. has entered into a warrant inducement agreement with an institutional investor to exercise outstanding warrants, resulting in gross proceeds of approximately $6.1 million from the issuance of 3,233,277 shares of common stock [1]. Group 1: Warrant Inducement Agreement - The agreement involves the exercise of November 2022 and October 2023 outstanding warrants, totaling 1,818,812 and 1,415,095 shares respectively, at an amended exercise price of $1.88 per share [9]. - In exchange for the immediate exercise of these warrants, the company will issue unregistered Series A and Series B warrants, allowing the purchase of an additional 2,727,273 and 2,122,642 shares respectively, also at an exercise price of $1.88 per share [9]. - The Series A and B warrants will expire five years from the closing date, with certain portions of the Series B warrants exercisable only after stockholder approval [9]. Group 2: Financial Implications - The net proceeds from the exercise of the warrants are intended for working capital and general corporate purposes [5]. - The transaction is expected to close on or about June 24, 2024, pending customary closing conditions [5]. Group 3: Company Overview - Palatin Technologies is focused on developing first-in-class biopharmaceuticals that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs [3]. - The company's strategy includes forming marketing collaborations with industry leaders to maximize the commercial potential of its products [3].

Core Insights - Approximately 30-40% of erectile dysfunction (ED) patients do not respond to phosphodiesterase-5 inhibitors (PDE5i) monotherapy, which includes drugs like Viagra, Cialis, and Levitra, indicating a significant unmet medical need for more effective treatments [2][4] - Palatin Technologies is developing a new co-formulation of bremelanotide (BMT) and a PDE5i, which is expected to be more effective for ED patients who do not respond to existing PDE5i therapies [3][8] - A Phase 2 clinical study of this co-formulation is currently underway, with topline data expected by the end of 2024, and a Phase 3 study anticipated to start in the first half of 2025 [1][9] Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor systems, targeting diseases with significant unmet medical needs [5] - The company aims to maximize the commercial potential of its products through marketing collaborations with industry leaders [5] Clinical Study Details - The Phase 2 clinical trial is designed to enroll approximately 50 patients who are non-responders to PDE5i monotherapy, assessing the safety and efficacy of BMT co-administered with a PDE5i [9] - Previous studies have shown that bremelanotide has statistically significant and clinically meaningful effects on improving erectile function [10]

Core Insights - The article discusses the initiation of a Phase 2 clinical study by Palatin Technologies to evaluate the co-administration of bremelanotide, an MC4R agonist, with tirzepatide (GLP-1/GIP) for obesity treatment, with topline data expected by the end of 2024 [1][8] Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate melanocortin receptor systems, targeting diseases with significant unmet medical needs and commercial potential [5][8] Clinical Study Details - The Phase II study, titled "BMT-801," has FDA clearance and aims to enroll up to 60 patients currently on tirzepatide across five trial sites in the U.S. The study will assess the safety and efficacy of bremelanotide as a standalone treatment or in conjunction with GLP-1/GIP therapy [2][8] Obesity Context - Obesity, defined as a BMI ≥30 kg/m², is a growing public health concern linked to increased mortality and serious health conditions, with approximately 42% of U.S. adults and one in five teens affected [4][8] Mechanism of Action - Genetic analysis highlights the melanocortin 4 receptor (MC4R) as crucial in appetite regulation, with mutations leading to obesity. MC4R agonists are seen as promising targets for obesity treatments due to their role in promoting satiety [3][9]

Investors might want to bet on Palatin Technologies, Inc. (PTN) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

Palatin Technologies, Inc. (NYSE:PTN) Q3 2024 Earnings Conference Call May 15, 2024 11:00 AM ET Company Participants Carl Spana - President, CEO & Director Stephen Wills - CFO, COO, EVP, Treasurer & Secretary Conference Call Participants Joe Pantginis - H.C. Wainwright & Co. Operator Greetings. Welcome to Palatin's Third Quarter Fiscal Year 2024 Operating Results Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remi ...

Palatin Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update EX-99.1 2 ptn_ex991.htm PRESS RELEASE EXHIBIT 99.1 CRANBURY, NJ – May 15, 2024 /PRNewswire/ – Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced financial results for its fiscal third quarter ended March 31, 2024. "Study results of our successful Phase 3 M ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number: 001-15543 PALATIN TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 95-4078884 (State ...