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].

Financial Data and Key Metrics Changes - For Q2 2025, Palatin Technologies did not record any product sales due to the completion of the sale of worldwide rights for female sexual dysfunction to CoSette Pharmaceuticals, resulting in gross product sales of $4.3 million and net product revenue of $2 million for Q2 2024 [6] - Total operating expenses for Q2 2025 were $2.6 million, net of a $2.5 million gain on the sale by lessee, compared to $0.9 million net of a $7.8 million gain for the same quarter in 2024 [6][7] - The net loss for Q2 2025 was $2.4 million, a decrease from a net loss of $7.8 million in Q2 2024, primarily driven by changes in fair values of warrant liabilities and the elimination of leasing net product revenue [8][9] - Cash and cash equivalents as of December 31, 2024, were $3.4 million, an increase from $2.4 million at September 30, 2024, but down from $9.5 million as of June 30, 2024 [10] Business Line Data and Key Metrics Changes - The company is focusing on its obesity and weight loss management portfolio, which includes both long-acting monoclonal 4 receptor selective peptide agonists and orally active small molecules [12][14] - The phase two signal detection study for BMP 801 has been completed, with top-line data expected later this month [12] Market Data and Key Metrics Changes - The market for pharmacological treatment of obesity is projected to exceed $100 billion annually, indicating significant growth potential for the company's products [20] Company Strategy and Development Direction - The company is concentrating its research and development efforts on melanocortin-4 receptor agonists, believing they will play a critical role in obesity treatment and weight loss management [21] - Palatin Technologies is actively engaged in discussions for out-licensing its programs and seeking strategic partnerships to enhance its market position [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data releases and the potential for significant advancements in obesity treatment [22][42] - The company is preparing for an exciting 2025, with expectations for substantial developments in its clinical programs [42] Other Important Information - The company is exploring opportunities in rare and orphan syndromic diseases related to melanocortin-4 receptor agonists, which could provide additional market opportunities [35][36] Q&A Session Summary Question: Focus on upcoming obesity data and benchmarks - Analyst inquired about the expected weight loss benchmarks in comparison to tirzepatide data and what would be considered a win for the study [24][25] Response: - Management clarified that they are looking for a clear signal rather than a specific percentage, focusing on the percentage of patients achieving clinically meaningful weight loss [26][27][30] Question: Additional indications beyond general weight loss - Analyst asked if there are other indications being considered for melanocortin-4 receptor agonists [34] Response: - Management acknowledged the potential for using these agonists in rare and orphan diseases, highlighting hypothalamic obesity as a significant market opportunity [35][36]

Financial Data and Key Metrics Changes - For Q2 2025, Palatin did not record any product sales due to the sale of Vyleesi's rights, compared to gross product sales of $4.3 million and net product revenue of $2 million in Q2 2024 [4] - Total operating expenses for Q2 2025 were $2.6 million, net of a $2.5 million gain, compared to $900,000 net of a $7.8 million gain in Q2 2024 [4] - Net loss for Q2 2025 was $2.4 million, a decrease from a net loss of $7.8 million in Q2 2024, primarily due to changes in fair values of warrant liabilities and the elimination of leasing net product revenue [5] - Cash and cash equivalents as of December 31, 2024, were $3.4 million, an increase from $2.4 million at September 30, 2024, but down from $9.5 million at June 30, 2024 [5][6] Business Line Data and Key Metrics Changes - The Phase two study BMP-801 evaluating the co-administration of bremelanotide with drocepatide has been completed, with top-line data expected later this month [7][8] - The obesity and weight loss management portfolio includes long-acting and orally active melanocortin four receptor compounds, with plans to move both into IND enabling activities and clinical studies in 2025 [9] - A Phase two study for OP08177 for ulcerative colitis remains on track for top-line data release in Q1 2025, with increased business development discussions anticipated [10] Market Data and Key Metrics Changes - The pharmacological treatment of obesity is projected to have a market value exceeding $100 billion annually, with a focus on melanocortin four receptor agonists as a key treatment option [12] - The company is exploring opportunities in rare and orphan syndromic diseases, which may present significant market potential [22][23] Company Strategy and Development Direction - The company is concentrating its R&D efforts on melanocortin four receptor obesity assets, believing it will play a crucial role in future obesity treatment [12] - Palatin is actively engaged in discussions for out-licensing programs and seeking funding for further development [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming quarter and 2025, highlighting the excitement surrounding their ongoing projects and potential market opportunities [28] Other Important Information - The detailed results of the Phase two breakout study for Bremelanotide in diabetic kidney disease have been accepted for presentation at a medical meeting, indicating the program's potential [10][11] Q&A Session Summary Question: Focus on upcoming obesity data and benchmarks - Management clarified that they are looking for a clear signal in the study rather than a specific percentage weight loss benchmark, emphasizing the importance of clinical meaningfulness [15][16][17] Question: Consideration of additional indications beyond weight loss - Management acknowledged the potential for melanocortin four receptor agonists in rare and orphan syndromic diseases, indicating a strategic focus on this area [21][22][24]

Revenue and Financial Performance - For the six months ended December 31, 2024, the company recognized $0 in product revenue, a decrease from $4,140,090 for the same period in 2023 due to the sale of worldwide rights to Vyleesi[149]. - Selling, general and administrative expenses decreased to $3,702,775 for the six months ended December 31, 2024, from $6,232,857 in the same period of 2023, primarily due to the elimination of selling expenses related to Vyleesi[155]. - The company recorded a gain of $7,823,482 on the sale of worldwide rights to Vyleesi for the six months ended December 31, 2024[156]. - Net cash used in operating activities for the six months ended December 31, 2024, was $11,863,319, a decrease from $16,382,079 for the same period in 2023[162]. - Net cash provided by investing activities was $2,500,000 for the six months ended December 31, 2024, compared to $12,455,275 for the same period in 2023[163]. Research and Development - Research and development expenses for the six months ended December 31, 2024, were $9,173,233, compared to $10,568,830 for the same period in 2023, reflecting a decrease in spending on MCr programs[151]. - The Phase 2 clinical trial for the co-administration of bremelanotide with tirzepatide for obesity has completed patient enrollment, with topline results expected in Q1 2025[141]. - The company is actively engaged in discussions with potential partners for the development and commercialization of products targeting ocular conditions[141]. - The company aims to maintain strategic alliances with pharmaceutical companies to facilitate the development and commercialization of its product candidates[145]. Financial Position and Liquidity - As of December 31, 2024, the company had cash and cash equivalents of $3,416,604 and current liabilities of $9,558,756[165]. - The company has incurred cumulative negative cash flows from operations since inception and is dependent on equity or debt financing for continued operations[165]. - The company has short-term lease obligations totaling $257,673 and long-term lease liabilities of $100,071 as of December 31, 2024[166]. - The company has received $4,309,641 in February 2025, which will support product development and testing[168]. - There is substantial doubt about the company's ability to continue as a going concern for one year from the issuance of its consolidated financial statements[169]. - The company expects existing cash and cash equivalents will fund operations into the second half of calendar year 2025[169]. - Additional funding will be needed to complete required clinical trials and regulatory submissions for product candidates[170]. - Current economic conditions may negatively impact the company's financial condition and ability to access capital markets[170]. Cumulative Spending - Cumulative spending on the Vyleesi program from inception to December 31, 2024, was approximately $311,900,000[154].

Core Insights - Palatin Technologies, Inc. announced financial results for its fiscal second quarter ended December 31, 2024, and completed database lock for its Phase 2 obesity co-administration study involving MC4R agonist bremelanotide and GLP-1/GIP dual agonist tirzepatide [1][5]. Financial Results - The company did not record any product sales for the second quarter ended December 31, 2024, following the sale of Vyleesi's worldwide rights for up to $171 million in December 2023. In the same quarter of 2023, gross product sales were $4.3 million, with net product revenue of $2.0 million [7]. - Total operating expenses for the quarter were $2.6 million, net of a $2.5 million gain on the sale of Vyleesi, compared to $0.9 million in the same quarter of the previous year, which included a $7.8 million gain on the sale of Vyleesi [8]. - The net loss for the quarter was $2.4 million, or $(0.12) per share, a decrease from a net loss of $7.8 million, or $(0.56) per share, in the same period of 2023 [11][12]. - As of December 31, 2024, cash and cash equivalents were $3.4 million, an increase from $2.4 million at September 30, 2024, but down from $9.5 million as of June 30, 2024 [13]. Obesity Programs - The completion of database lock for the Phase 2 obesity study is seen as a significant advancement in providing alternative treatments for obesity, with topline results expected later this month [2][5]. - The company is developing next-generation selective MC4R long-acting peptides and oral small molecules, targeting general obesity, weight loss management, and rare conditions like hypothalamic obesity [6]. - Investigational new drug (IND) enabling activities are expected to commence in the first quarter of 2025, with IND filings anticipated in the second half of 2025 [6]. Other Programs - The company is also advancing programs for dry eye disease, ulcerative colitis, and diabetic nephropathy, with topline data readouts expected for the ulcerative colitis treatment later this quarter [4][14].