Six-month open-label study showed clinically meaningful improvements in kidney function and disease in patients with Type 2 diabetic nephropathy. 71% achieved a >30% reduction in UP/Cr, a key indicator of kidney damage. 71% demonstrated improved or stabilized eGFR, signaling preserved kidney function. 37.5% had increased urinary VEGF levels, suggesting better blood vessel support in the kidneys. 36% had reduced urinary synaptopodin losses, indicating healthier kidney cells and structure. CRANBURY, N.J., A ...

CRANBURY, N.J., March 31, 2025 /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 that its BMT-801 Phase 2 obesity co-administration study met its primary endpoint and was highly statistically significant. The Company reported positive topline data with co-administered melanocortin-4 receptor (MC4R) agonist bremelanotide plus glucago ...

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]

Initiated IND-enabling toxicology program IND submission planned for 4Q25; Clinical data expected in 1H26 CRANBURY, N.J., March 25, 2025 /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 the US Food & Drug Administration (FDA) has granted "orphan drug" designation to PL7737, an oral treatment that activates the melanocortin-4 rece ...

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]

Palatin (PTN) Q2 2025 Earnings Call February 13, 2025 11:00 AM ET Company Participants Carl Spana - Co-Founder, President, CEO & DirectorStephen Wills - Executive Vice President, Chief Financial Officer and Chief Operating OfficerJoe Pantginis - Managing Director Operator Greetings. Welcome to Palatin's Second Quarter Fiscal Year twenty twenty five Operating Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal As a reminder, ...

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 December 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 (Sta ...

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].

Group 1 - Palatin Technologies, Inc. will announce its second quarter fiscal year 2025 operating results on February 13, 2025, before the U.S. financial markets open [1] - A conference call and live audio webcast will be held on February 13, 2025, at 11:00 a.m. ET to review the operating results and provide updates on development programs [1][2] - The company is focused on developing first-in-class medicines targeting melanocortin receptor systems for diseases with significant unmet medical needs [3] Group 2 - The press release for the Q2 fiscal year 2025 results will be available at 7:30 a.m. ET on February 13, 2025 [2] - The conference call will be accessible via US toll-free and international dial-in numbers, with a participant access code provided [2] - Palatin's strategy includes forming marketing collaborations with industry leaders to enhance the commercial potential of its products [3]

CRANBURY, N.J., Feb. 7, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) ("Palatin" or the "Company"), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered into definitive agreements with a single healthcare focused institutional investor for the purchase and sale of 4,688,000 shares of its common stock (or common stock equivalents in lieu thereof) in a regist ...