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 ...

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].