Oral PL7737 significantly decreased food intake and body weight Oral small molecule melanocortin 4 agonist (MC4R) could address unmet needs and challenges of current obesity treatments Multiple clinical trials targeted in calendar year 2025 for the Company's obesity programsCRANBURY, N.J., Nov. 4, 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 (MC ...

Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesityCRANBURY, N.J., Oct. 31, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN ...

CRANBURY, N.J., Oct. 7, 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 it received a notice from the staff of NYSE American LLC (the "Exchange") that Palatin was not in compliance with the Exchange's continued listing standards under Section 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(iii) requires a lis ...

Financial Performance - Palatin reported total revenue of $4.5 million for the fiscal year ended June 30, 2024, down from $4.9 million in the previous fiscal year, with no product sales recorded in Q4 2024 due to the sale of Vyleesi's rights[10]. - Total revenues for the period were $4,853,678, a decrease from $4,990,090 in the previous period[23]. - The net loss for the period was $29,736,113, which is an increase from a net loss of $24,036,741 in the previous period[24]. - Basic and diluted net loss per common share was $2.02, compared to $2.21 in the prior period[24]. - Palatin's net loss for Q4 2024 was $8.6 million, or $(0.51) per share, compared to a net loss of $9.8 million, or $(0.84) per share, in Q4 2023[15]. Operating Expenses - Total operating expenses decreased to $27.0 million for the fiscal year ended June 30, 2024, compared to $37.3 million in the prior fiscal year, primarily due to a $7.8 million gain from the sale of Vyleesi[11]. - Research and development expenses amounted to $22,630,577, compared to $22,400,372 in the prior period, reflecting an increase of approximately 1%[23]. Cash and Assets - As of June 30, 2024, Palatin's cash and cash equivalents were $9.5 million, a decrease from $10.0 million as of March 31, 2024[16]. - Cash and cash equivalents as of June 30, 2024, were $9,527,396, an increase from $7,989,582 as of June 30, 2023[25]. - Total current assets decreased to $9,769,668 from $16,321,513 year-over-year[25]. - Total liabilities decreased to $10,853,763 from $19,655,911 year-over-year[25]. - The company reported a total stockholders' deficiency of $(111,497) compared to $(1,979,871) in the previous year[26]. Clinical Development - The Phase 2 clinical study for the MC4R agonist plus GLP-1 in obese patients is expected to complete patient enrollment by early Q4 2024, with topline results anticipated in Q1 2025[2]. - The MELODY-2 and MELODY-3 Phase 3 studies for PL9643 in dry eye disease are expected to begin patient enrollment in Q1 2025, with topline results anticipated in Q4 2025[5]. - The pharmacokinetics study for bremelanotide co-formulated with a PDE5 inhibitor is expected to start in Q1 2025, with patient recruitment in a Phase 2/3 study anticipated in 2H 2025[6]. - Interim analysis for the Phase 2 study of PL8177 in ulcerative colitis is expected in Q4 2024, with topline results anticipated in Q1 2025[7]. Funding and Future Plans - Palatin raised total gross proceeds of $21 million during the fiscal year ended June 30, 2024, through registered direct and warrant inducement offerings[9]. - The company is actively engaging with multiple parties for potential funding sources to support future operating cash needs[16]. - The company is focused on advancing its product candidates through clinical trials and regulatory approvals, with ongoing development programs[21].

Core Insights - Palatin Technologies is advancing multiple clinical programs with significant milestones expected in the near future, particularly in obesity, dry eye disease, male sexual dysfunction, ulcerative colitis, and diabetic nephropathy [1][2][3] Obesity Program - The Phase 2 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with GLP-1 agonist tirzepatide is set to enroll approximately 60 patients across four U.S. sites, with topline results expected in Q1 2025 [3][4] - The study aims to demonstrate the safety and increased efficacy of the combination therapy in reducing body weight, addressing the high discontinuation rates of GLP-1 monotherapy due to side effects [2][3] Dry Eye Disease (DED) Program - The Phase 3 clinical program for PL9643 in treating DED has received FDA agreement on trial protocols and endpoints, with patient enrollment expected to start in Q1 2025 and topline results anticipated in Q4 2025 [5][6] - The previous Phase 3 MELODY-1 study showed statistical significance in multiple symptom endpoints, indicating a strong potential for PL9643 in this indication [5] Male Sexual Dysfunction Program - A pharmacokinetics study for bremelanotide co-formulated with a PDE5 inhibitor for erectile dysfunction is expected to start in Q1 2025, with patient recruitment for a Phase 2/3 study anticipated in the second half of 2025 [6][7] - Historical data indicates that approximately 35% of men with erectile dysfunction do not respond adequately to PDE5 inhibitors, highlighting a significant market opportunity [6] Ulcerative Colitis Program - The Phase 2 study of oral PL8177 for active ulcerative colitis is set to provide interim analysis results in Q4 2024, with topline results expected in Q1 2025 [7] Diabetic Nephropathy Program - The Phase 2 BREAKOUT study of bremelanotide (BMT 701) in patients with diabetic kidney disease is expected to yield topline results in Q4 2024 [7] Financial Overview - For the fiscal year ended June 30, 2024, Palatin reported total revenues of $4.49 million, a decrease from $4.85 million in the previous year, primarily due to the sale of Vyleesi [9][11] - The company recorded a net loss of $29.7 million for the fiscal year, compared to a net loss of $24.0 million in the prior year, reflecting increased operational costs [19][21] - As of June 30, 2024, Palatin's cash and cash equivalents stood at $9.5 million, a slight decrease from $10.0 million as of March 31, 2024 [22]

Core Viewpoint - Palatin Technologies, Inc. will announce its fourth quarter and fiscal year end 2024 operating results on October 1, 2024, before the U.S. financial markets open [1]. Group 1: Operating Results Announcement - The press release for the Q4 and fiscal year end 2024 results will be issued on October 1, 2024, at 7:30 AM Eastern Time [3]. - A conference call and live audio webcast will take place on the same day at 11:00 AM Eastern Time, hosted by the executive management team [2][3]. - The conference call will include a review of the company's operating results and updates on development programs [2]. Group 2: Access Information - US Toll Free Dial-In Number for the conference call is 1-888-506-0062, and the International Dial-In Number is 1-973-528-0011, with a participant access code of 252326 [3]. - A replay of the conference call will be available from October 1, 2024, to October 15, 2024, with a US Toll Free Dial-In Number of 1-877-481-4010 and an International Dial-In Number of 1-919-882-2331, using participant access code 51290 [3]. - The audio webcast and replay can be accessed through the "Investors-Webcasts" section of Palatin's website [3]. Group 3: Company Overview - Palatin 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 [4]. - The company's strategy involves developing products and forming marketing collaborations with industry leaders to maximize commercial potential [4].

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].