Core Viewpoint - Palatin Technologies, Inc. is advancing its obesity program and strategic business development initiatives through a public offering, which is expected to resolve its delisting issue with NYSE American and accelerate the development of its obesity pipeline [1][2][3] Group 1: Financial Developments - The company announced a public offering consisting of $11.5 million upfront and up to an additional $11.5 million upon the cash exercise of milestone-related warrants, expected to close on May 8, 2025 [1] - Approximately $2.3 million in net proceeds were received in April 2025 under its at-the-market (ATM) facility, contributing to the financial resources needed to address the delisting determination [1] Group 2: Compliance and Listing Status - NYSE American determined that Palatin had not regained compliance with its continued listing standards by the end of its 18-month plan period, which expired on April 10, 2025 [2] - An appeal hearing regarding the delisting is scheduled for later this quarter, with the company expressing confidence in meeting the necessary listing requirements [2] Group 3: Product Development and Pipeline - The financing is expected to accelerate the development of the company's obesity pipeline, including next-generation MC4R-targeted long-acting peptides and oral small molecules, targeting various obesity-related conditions [3][6] - The company plans to submit Investigational New Drug (IND) applications in the fourth quarter of 2025, with initial clinical data anticipated in the first half of 2026 [3][6] - Strong interest is noted in the ocular portfolio, with ongoing discussions for collaborations and asset sales related to its Phase 3 dry eye disease program and preclinical glaucoma and retina programs, with potential deals expected in the second and third quarters of 2025 [3]

Core Viewpoint - Palatin Technologies, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $11.5 million, with potential additional proceeds of up to $11.5 million from the exercise of milestone-related warrants [1][3]. Group 1: Offering Details - The public offering includes 76,666,667 shares of common stock and Series F, G, and H warrants, priced at $0.15 per share [1][2]. - Series F Warrants have an exercise price of $0.30 per share, are immediately exercisable, and expire five years from the issuance date [2]. - Series G Warrants have an exercise price of $0.15 per share, are immediately exercisable, and expire either 24 months from issuance or at the end of the FDA Exercise Period [2]. - Series H Warrants will be issued upon the exercise of Series G Warrants, with an exercise price of $0.225 per share and expiring 24 months after issuance [2]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and general corporate purposes, particularly for the development of the company's obesity program [3]. Group 3: Closing and Agents - The closing of the offering is expected around May 8, 2025, pending customary closing conditions [3]. - A.G.P./Alliance Global Partners is the lead placement agent, with Laidlaw & Company (UK) Ltd. as the co-placement agent [4]. Group 4: Company Overview - Palatin Technologies is focused on developing first-in-class medicines targeting the melanocortin receptor system, addressing significant unmet medical needs [7]. - The company's strategy includes developing products and forming marketing collaborations to maximize commercial potential [7].

Core Insights - Palatin Technologies, Inc. announced new preclinical data for PL9588, a novel melanocortin receptor agonist, indicating its potential as a dual-action topical treatment for glaucoma, providing both intraocular pressure (IOP) reduction and neuroprotection [1][3][9] Company Overview - Palatin Technologies is focused on developing innovative treatments targeting the melanocortin receptor system, with PL9588 being a key candidate in their pipeline [1][11] - The company aims to address significant unmet medical needs in glaucoma therapy by combining IOP reduction with neuroprotective effects [4][11] Product Details - PL9588 is a synthetic peptide that activates melanocortin receptors 1 and 5 (MC1R and MC5R), designed to lower IOP and protect retinal cells [7][9] - Preclinical findings show that PL9588 reduces IOP by increasing aqueous outflow and demonstrates neuroprotection independent of IOP lowering, with a reduction in retinal cell stress/death by approximately 25% [10] Industry Context - Glaucoma affects around 79.6 million people globally and is a leading cause of preventable vision loss, highlighting the need for effective therapies beyond IOP reduction [5] - The global glaucoma market was valued at $5.71 billion in 2021 and is projected to reach $9.77 billion by 2030, driven by increasing prevalence and demand for innovative therapies [6]

Core Insights - Palatin Technologies has announced updated results from the Phase 3 MELODY-1 clinical trial for PL9643, indicating its potential as a first-in-class therapy for dry eye disease (DED) with full symptom resolution [2][3][4] Clinical Trial Results - The responder analysis showed statistically significant complete symptom resolution across multiple endpoints, with six out of thirteen symptom endpoints demonstrating a higher percentage of patients achieving resolution with PL9643 compared to placebo (p<0.05) [6][7] - The Symptom Composite Score for PL9643-treated patients indicated significant symptom resolution by week 2, with continued improvement through week 12, while the placebo group showed minimal improvement that plateaued early [6][7] - The Phase 3 MELODY-1 trial involved 575 patients and met statistical significance for the co-primary symptom endpoint of pain (P<0.025) and seven secondary symptom endpoints (P<0.05) [10] Regulatory and Market Context - The findings align with FDA approval guidance for dry eye drug development, which supports the use of responder analyses to demonstrate symptom improvement [9] - The dry eye disease market is projected to grow from an estimated $6.11 billion in 2024 to $7.46 billion by 2029, at a CAGR of 4.09% [11] Company Strategy and Future Plans - Palatin Technologies aims to finalize collaboration deals in the second half of the year and plans to begin patient enrollment for the remaining Phase 3 studies (MELODY-2 and MELODY-3) in the same timeframe [9][10] - The company focuses on developing first-in-class medicines targeting significant unmet medical needs, particularly in the area of dry eye disease [14]

Core Insights - Palatin Technologies, Inc. announced positive results from its BMT-801 Phase 2 obesity study, demonstrating effective appetite suppression with its drug bremelanotide in combination with tirzepatide [1][5] Study Results - The study included three arms: co-administered bremelanotide and tirzepatide, bremelanotide alone, and tirzepatide alone, all showing significant improvements in appetite suppression, fullness, and satiety [3][7] - Patients receiving co-administered bremelanotide and tirzepatide experienced a 71% increase in overall appetite suppression, while tirzepatide alone showed a 73% increase, and bremelanotide alone also showed a 71% increase [8] - Fullness increased by 65% in the co-administered group, 62% in the tirzepatide group, and 79% in the bremelanotide group [8] - Satiety increased by 56% in both the co-administered and tirzepatide groups, while the bremelanotide group showed a 68% increase [8] Weight Maintenance - Over 50% of lost weight was regained within two weeks after stopping tirzepatide, while patients transitioning to low-dose bremelanotide maintained their weight without significant regain, indicating its potential for long-term weight management [4][6] Pipeline Development - Palatin is advancing next-generation MC4R agonists, including long-acting peptides and oral small molecules, targeting various obesity indications and rare genetic obesity disorders, with IND filings expected by the end of Q4 2025 and initial clinical data anticipated in the first half of 2026 [6][11] Company Overview - Palatin Technologies focuses on developing first-in-class medicines that modulate the melanocortin receptor system, aiming to address significant unmet medical needs and maximize commercial potential through strategic collaborations [11]

CRANBURY, N.J., April 14, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (the "Company") (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced today that it has formally appealed the NYSE Regulation determination to delist its common stock. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc. Company working aggressively to r ...

Core Insights - Palatin Technologies, Inc. announced positive results from the Phase 2b BREAKOUT study, which evaluated the efficacy of bremelanotide in patients with Type 2 diabetic nephropathy [2][3] - The study demonstrated significant clinical improvements, indicating the potential of melanocortin agonists in treating various diseases [2][6] Company Overview - Palatin Technologies is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor system [11] - The company aims to address significant unmet medical needs and has a strategy to form marketing collaborations to maximize commercial potential [11] Study Details - The BREAKOUT study enrolled 16 patients with confirmed Type 2 diabetic nephropathy, with 8 patients completing a six-month treatment regimen [2][6] - Patients received bremelanotide subcutaneously twice daily alongside their maximum tolerated dose of RAAS inhibition therapy [2] Key Findings - 71% of patients achieved a greater than 30% reduction in urine protein to creatinine ratio (UP/Cr), a key indicator of kidney damage [6][7] - 71% demonstrated improved or stabilized estimated glomerular filtration rate (eGFR), indicating preserved kidney function [6][7] - 37.5% had increased urinary vascular endothelial growth factor (VEGF) levels, suggesting better blood vessel support in the kidneys [6][7] - 36% had reduced urinary synaptopodin losses, indicating healthier kidney cells and structure [6][7] Melanocortin Receptor System - The melanocortin receptor system consists of five receptors that influence inflammation, immune responses, metabolism, and other physiological functions [4][10] - Activation of these receptors can have significant pharmacological effects, particularly in maintaining podocyte viability, which is crucial for kidney function [9][10] Diabetic Nephropathy Context - Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries, affecting approximately 30 million patients in the U.S. [6][8] - Despite existing therapies, a significant portion of patients with Type 2 diabetic nephropathy progress to end-stage renal disease, highlighting the need for new treatment options [8]

Core Insights - Palatin Technologies, Inc. announced that its BMT-801 Phase 2 obesity co-administration study met its primary endpoint with highly statistically significant results, demonstrating the effectiveness of combining melanocortin-4 receptor (MC4R) agonist bremelanotide with GLP-1/GIP tirzepatide [1][2][4] Group 1: Study Results - The co-administered group experienced a 4.4% reduction in weight compared to a 1.6% reduction in the placebo group (p<0.0001) [4][5] - 40% of patients in the co-administered group achieved a 5% reduction in body weight, compared to 27% for the tirzepatide alone group (p<0.05) [5] - The study indicated that low-dose bremelanotide effectively halted weight regain after the cessation of tirzepatide treatment [4][6] Group 2: Future Developments - Palatin is advancing the development of next-generation MC4R long-acting peptides and oral small molecules, with IND applications planned for Q4 2025 and clinical data expected in H1 2026 [4][8] - The company is focusing on treatments for general obesity, weight loss management, and hypothalamic obesity, addressing significant unmet medical needs in a multi-billion-dollar market [9] Group 3: Mechanism and Market Context - The MC4R pathway is crucial for appetite regulation, and genetic mutations affecting this pathway can lead to obesity, highlighting the therapeutic potential of MC4R agonists [10] - Current GLP-1 receptor agonists face challenges such as side effects and treatment discontinuation, creating a demand for alternative therapies like MC4R agonists [9]

Core Insights - Palatin Technologies announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, for treating active ulcerative colitis (UC) [1][2][6] - The study demonstrated significant clinical remission and response rates, indicating PL8177 could be a viable alternative to current immunosuppressive and steroid therapies [2][4][6] Study Results - Clinical remission was achieved in 33% of PL8177-treated patients compared to 0% in the placebo group after eight weeks [4][5] - Clinical response was observed in 78% of PL8177-treated patients versus 33% in the placebo group, with a p-value of less than 0.005 [4][5] - Symptomatic remission occurred in 56% of PL8177-treated patients compared to 33% in the placebo group [4][5] Safety and Tolerability - PL8177 was well tolerated with no treatment-related adverse events reported during the study [4][6] Licensing and Market Potential - Discussions for licensing PL8177 are advancing with multiple large pharmaceutical companies, indicating strong interest in the UC program [4][6] Mechanism of Action - PL8177 targets melanocortin-1 receptors on colon cells, which may help improve colon health and reduce inflammation [8][12][13] Background on Ulcerative Colitis - Ulcerative colitis affects approximately 1.25 million individuals in the U.S., with a significant portion suffering from moderate-to-severe disease [14][15]

Core Viewpoint - Palatin Technologies, Inc. has received FDA orphan drug designation for PL7737, an oral treatment for leptin receptor deficiency-related obesity, which could offer a more convenient option compared to the current injectable treatment [1][2]. 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 [6]. - The company is exploring PL7737 for hypothalamic obesity and plans to initiate a Phase 1 study in late 2025 [2]. Clinical Development - The FDA orphan drug designation is a significant milestone for Palatin's MC4R receptor agonists aimed at rare obesity conditions [2]. - Palatin has completed statistical analysis for its Phase 2 clinical studies involving MC4R bremelanotide and GLP-1/GIP tirzepatide for obesity, as well as PL8177 for ulcerative colitis, with topline data expected to be released soon [2]. Mechanism of Action - PL7737 acts as an MC4R agonist, designed to restore impaired signaling due to genetic mutations in the LEPR gene, which is crucial for regulating hunger and body weight [2][4]. - The melanocortin receptor system plays a vital role in various physiological processes, including metabolism and food intake, making it a promising target for obesity treatments [5]. Regulatory Insights - The FDA's orphan drug designation provides several incentives, including tax credits for clinical trials, exemption from user fees, and potential market exclusivity for seven years post-approval [7].