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]

Group 1 - Palatin Technologies, Inc. has entered into definitive agreements for the purchase and sale of 4,688,000 shares of its common stock at a price of $1.00 per share in a registered direct offering [1][3] - The company will also issue warrants to purchase up to an aggregate of 4,688,000 shares of common stock in a concurrent private placement, with an exercise price of $1.00 per share [2] - The gross proceeds from the offering are expected to be approximately $4.7 million, which will be used for general corporate purposes [3] Group 2 - The registered direct offering is made pursuant to the company's shelf registration statement filed with the SEC, and a prospectus supplement will be available [4] - The private placement of the warrants will rely on an exemption from registration under the Securities Act, meaning the securities may not be offered or sold in the U.S. without an effective registration statement [5] - Palatin is focused on developing first-in-class medicines targeting the melanocortin receptor system for diseases with significant unmet medical needs [7]

Core Insights - Palatin Technologies, Inc. has completed its Phase 2 clinical study (BMT-801) for the co-administration of MC4R bremelanotide and GLP-1/GIP tirzepatide aimed at treating obesity, with final data collection expected soon [1][2][3] Group 1: Clinical Study Details - The Phase 2 BMT-801 study enrolled 113 patients, with 96 patients randomized, exceeding the initial target of 60 patients due to strong demand [2] - The primary endpoint of the study is to demonstrate the safety and efficacy of the combination treatment in reducing body weight [3] - Topline data results from the study are anticipated to be released later this quarter [2][3] Group 2: Mechanism and Importance - The melanocortin 4 receptor (MC4R) is crucial for appetite regulation, and its modulation may provide new treatment avenues for obesity [4] - MC4R agonists are seen as a promising target for obesity treatments, potentially offering additive and synergistic effects when combined with GLP-1/GIP agonists [3][4] Group 3: Company Overview - Palatin Technologies focuses on developing first-in-class medicines that modulate the melanocortin receptor system, addressing significant unmet medical needs [6] - The company aims to form marketing collaborations with industry leaders to maximize the commercial potential of its products [6]

Core Insights - Palatin Technologies, Inc. is preparing for a significant year in 2025, focusing on the topline data from its Phase 2 BMT-801 clinical study, which evaluates the combination of bremelanotide and tirzepatide for obesity treatment, with results expected in the first quarter of 2025 [2][5][6] - The company aims to initiate multiple clinical trials in the second half of 2025 for a long-acting MC4R peptide and/or an MC4R selective oral small molecule targeting general obesity and related conditions [2][5] - Palatin has a strong position in the melanocortin receptor system (MCRS) development, with extensive intellectual property and a library of compounds for developing MC4R agonists [2][8] Obesity Programs - The Phase 2 BMT-801 clinical study is designed to demonstrate the safety and efficacy of bremelanotide combined with tirzepatide in reducing body weight, with topline results anticipated in Q1 2025 [5][6] - The company is targeting general obesity, weight loss management, and rare neuroendocrine and genetic diseases, including hypothalamic obesity, with plans for IND enabling activities to start in Q1 2025 and IND filings expected in the second half of 2025 [6][8] - Multiple clinical trials for new MC4R compounds are planned to commence in the second half of 2025 [5][6] Other Programs - Ongoing discussions for licensing and collaboration related to dry eye disease, ulcerative colitis, and diabetic nephropathy programs, with multiple deals targeted for 2025 [5][6] - Positive outcomes from a Type C meeting with the FDA regarding endpoints for Phase 3 trials in dry eye disease, with patient enrollment set to begin in the first half of 2025 [6][7]

Core Insights - The BREAKOUT study demonstrated that bremelanotide therapy resulted in significant improvements in patients with Type 2 diabetic nephropathy, with 71% achieving a greater than 30% reduction in urine protein to creatinine ratio and 71% showing improved or stabilized estimated glomerular filtration rate [1][3][4] Company Overview - Palatin Technologies, Inc. is focused on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs [12] - The company has a pipeline that includes positive clinical results in diabetic nephropathy and other conditions, indicating a strong potential for future therapeutic options [4][12] Study Details - The BREAKOUT study enrolled 16 patients with confirmed Type 2 diabetic nephropathy, with 8 completing the six-month treatment regimen [2] - Patients received bremelanotide subcutaneously twice daily alongside their maximum tolerated dose of RAAS inhibition therapy [2] Efficacy Results - Bremelanotide therapy led to increased urinary VEGF levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients [1][3] - The study's findings support the potential of melanocortin receptor modulation as a new therapeutic strategy for diabetic nephropathy [4][6] Safety Profile - Bremelanotide was well tolerated, with no serious adverse events attributed to the treatment; the most common adverse event was skin hyperpigmentation, occurring in 71% of patients [4]

Core Viewpoint - Palatin Technologies, Inc. has entered into a warrant exercise inducement agreement with an institutional investor to exercise outstanding warrants, resulting in gross proceeds of approximately $3.4 million [1][2]. Group 1: Warrant Exercise Agreement - The investor will exercise a total of 2,964,283 shares from June 2024 warrants and 943,396 shares from October 2023 warrants at an amended exercise price of $0.875 per share [2]. - In exchange for the immediate exercise of the warrants, the company will issue unregistered Series C and Series D warrants, allowing the purchase of an aggregate of 3,907,679 and 1,953,839 shares, respectively, at the same exercise price of $0.875 per share [2]. Group 2: Transaction Details - The transaction is expected to close around December 17, 2024, pending customary closing conditions [3]. - The net proceeds from the warrant exercise will be used for working capital and general corporate purposes [3]. Group 3: Company Overview - Palatin Technologies is focused on developing first-in-class medicines targeting the melanocortin receptor system, addressing diseases with significant unmet medical needs [6]. - The company's strategy includes developing products and forming marketing collaborations with industry leaders to enhance commercial potential [6].

Core Insights - Palatin Technologies has completed enrollment in its Phase 2 study of oral PL8177 for ulcerative colitis, which is expected to provide a safe and effective treatment option compared to existing therapies [1][2][3] - The study aims to evaluate the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of PL8177 in adult patients with active ulcerative colitis, with topline data anticipated in early 2025 [1][2][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 [10] - The company aims to out-license its ulcerative colitis program, having received significant interest from multiple parties [2][3] Product Details - PL8177 is a potent melanocortin-1 receptor (MC1R) agonist that has shown promise in preclinical studies for resolving inflammation in ulcerative colitis [1][4][7] - The oral formulation of PL8177 demonstrated sustained delivery to the colon without systemic exposure, indicating a favorable safety profile [2][8] Clinical Study Design - The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled trial with a planned enrollment of 28 subjects, but was concluded early with 13 subjects due to strategic decisions [3] - The primary efficacy endpoint is the Mayo Endoscopic Subscore, which assesses the level of disease in the colon mucosa [3] Disease Context - Ulcerative colitis is a chronic inflammatory bowel disease affecting over 1 million people in the U.S., with existing treatments often ineffective for moderate-to-severe cases [2][9] - The disease can lead to severe complications, including surgery or cancer, highlighting the need for effective treatment options [2][9]

Financial Data and Key Metrics - For Q1 FY2025, the company did not record any product sales to pharmacy distributors due to the sale of Vyleesi's worldwide rights in December 2023 [4] - Gross product sales for Q1 FY2024 were $4.6 million, with net product revenue of $2.1 million [5] - Total operating expenses for Q1 FY2025 were $7.8 million, down from $8.2 million in the same period last year, primarily due to the elimination of Vyleesi selling expenses [5] - Net cash used in operations for Q1 FY2025 was $7 million, compared to $5.9 million in Q1 FY2024, mainly due to increased net loss [6] - Net loss for Q1 FY2025 was $7.8 million, up from $5.2 million in Q1 FY2024, primarily due to the elimination of Vyleesi net product revenue [7] - Cash and cash equivalents as of September 30, 2024, were $2.4 million, down from $9.5 million as of June 30, 2024 [8] Business Line Data and Key Metrics - The company is focusing its future investment and activities on its core obesity programs, while exploring strategic options for non-obesity programs [9] - The Phase 2 study BMT-801, evaluating the combination of bremelanotide and tirzepatide for obesity, is fully enrolled with top-line results expected in Q1 2025 [10][11] - The obesity and weight loss management portfolio includes novel Melanocortin-4 receptor peptide agonists and orally active MCR4 selective small molecule agonists, with IND-enabling activities and clinical studies planned for 2025 [12] - The Phase 2 study for PL8177, an orally selective MCR1 treatment for ulcerative colitis, is expected to have top-line data in Q1 2025 [14] Market Data and Key Metrics - The pharmacological treatment of obesity is in the early stages of a multiyear cycle of innovation, with a market value expected to exceed $100 billion annually [16] - The Melanocortin system plays a critical role in regulating stored energy and food intake, and Melanocortin-4 receptor agonists are expected to be an important part of future obesity treatment [16] Company Strategy and Industry Competition - The company is focusing its research and development efforts on MCR-4 obesity assets to drive substantial shareholder value [18] - The company is exploring multiple strategic options for its non-obesity programs, including out-licensing, engagement with investors, and potential business combinations [19] - The company believes its ocular assets, including the Phase 3 dry eye disease program and lead compounds in glaucoma and retinal diseases, have significant value and are worthy of continued investment [18] Management Commentary on Operating Environment and Future Outlook - The company is optimistic about its position in the obesity treatment market, with high interest in its Melanocortin-based therapeutics [44] - The company is actively engaging in business development discussions for its ulcerative colitis program, with significant interest from multiple large companies [21] Other Important Information - The company received a $2.5 million deferred payment in November 2024 from Cosette Pharmaceuticals related to the sale of Vyleesi, which is not included in the September 30, 2024, cash balance [8] Q&A Session Summary Question: Options for the ulcerative colitis program following data - The company is exploring typical partnering discussions with larger companies, with significant interest from multiple parties under CDA [21] Question: Success criteria for the BMT-801 study and next steps - The study aims to demonstrate increased weight loss by combining Melanocortin mechanism with incretin therapy, with additional focus on weight loss maintenance and lean muscle mass preservation [22][23][24][25][26][27][28] Question: Potential for MCR-4 long-acting peptide and oral small molecule approaches - The company views these approaches as having broad applicability, including weight loss maintenance, add-on therapy, and potential monotherapy for patients failing other treatments [29][30][31][32][33] Question: Position in the broader obesity market, particularly hypothalamic obesity - The company believes its Melanocortin approaches have broad applicability and are evaluating their role in hypothalamic obesity [34][35][36] Question: Mix of financial approaches for business development opportunities - The company is considering a variety of financial approaches, including out-licensing, corporate combinations, and project finance, depending on the specific program and potential return [38][39][40][41] Closing Remarks - The company is excited about its position in the obesity treatment market and the potential of its Melanocortin-based therapeutics to build substantial value [44][45]

Obesity programs: Core focus on obesity includes exploratory co-administration BMT-801 study and two novel development drug candidates Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide Patient enrollment completed October 2024 Topline results expected 1Q calendar year 2025 Multiple clinical trials targeted in calendar year 2025 with long-acting MC4R peptide and oral small molecule compounds General obesity, weight loss management, and rare MC4R pathw ...

CRANBURY, N.J., Nov. 8, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its first quarter fiscal year 2025 operating results on Thursday, November 14, 2024, before the open of the U.S. financial markets.Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 14, 2024, at 11:00 a.m. ET. The conference call will include a review of the company's operating results and an update on programs under development. Sch ...