Group 1 - Palatin Technologies, Inc. announced a reverse stock split at a ratio of 1-for-50, effective on August 8, 2025, with trading on a split-adjusted basis starting August 11, 2025 [1][2] - The primary goal of the reverse stock split is to increase the per-share market price to comply with NYSE American's Listing Qualifications due to the low selling price of the company's common shares [2] - Stockholders approved the reverse stock split at a ratio of 1-for-50 to 1-for-100 during the annual meeting on July 25, 2025, with the final ratio to be determined by the Board of Directors [3] Group 2 - As of the effective time, every 50 shares of the company's common stock will be combined into one share, with cash provided for any fractional shares [4] - The par value and other terms of the common stock will remain unaffected by the reverse stock split, and the new CUSIP number for the post-split common stock will be 696077 601 [4] - Palatin is a biopharmaceutical company focused on developing first-in-class medicines targeting melanocortin receptor systems for diseases with significant unmet medical needs [5]

Core Insights - Palatin Technologies, Inc. announced strong preclinical results for PL7737, an oral selective melanocortin-4 receptor (MC4R) agonist, demonstrating effectiveness in rodent models of obesity [1][2] - The company plans to initiate a Phase 1 clinical trial for PL7737 in late 2025, with data expected in the first half of 2026 [2][5] Group 1: Preclinical Study Results - The preclinical study evaluated the weight loss effects of PL7737 in a diet-induced obese rat model, showing statistically significant weight loss after 4 days of treatment [2] - PL7737 monotherapy resulted in a 5% weight loss at the middle dose and 10% at the high dose, while the combination with tirzepatide led to an 11% and 15% weight loss, respectively [6] Group 2: Mechanism and Pipeline - MC4R agonists, like PL7737, offer a unique mechanism of action for obesity treatment, differing from incretin-based therapies [2] - Palatin is developing a pipeline of novel MC4R agonists, including both oral and long-acting peptide candidates, targeting general obesity and rare forms of the disease [2][9] Group 3: Regulatory and Market Potential - The FDA granted orphan drug designation to PL7737 for treating leptin receptor deficiency-related obesity, a rare genetic disorder [2] - There are currently no approved pharmacologic treatments specifically indicated for hypothalamic obesity, highlighting a significant unmet medical need [7]

Revenue and Sales - For the nine months ended March 31, 2025, the company recognized $0 in product revenue, a decrease from $4,140,090 for the same period in 2024 due to the sale of worldwide rights to Vyleesi[152]. - The company reported a gain of $2,500,000 on the sale of Vyleesi for the nine months ended March 31, 2025, compared to a gain of $7,798,280 for the same period in 2024[159]. - The company has no recurring source of revenue following the sale of worldwide rights to Vyleesi[171]. Research and Development - Research and development expenses for the nine months ended March 31, 2025, were $12,928,391, down from $17,728,516 in the prior year, primarily due to reduced spending on MCr programs[154]. - The Phase 2 clinical trial for PL8177, an oral peptide formulation for ulcerative colitis, reported that one-third of patients achieved clinical remission, while the placebo group saw no clinical remission[143]. - The company plans to file an IND for a novel once-weekly peptide MC4R agonist in 2025, with CMC activities expected to be completed in the first quarter of 2025[145]. - The company intends to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of its MC1r and MC4r programs[170]. Financial Performance - Selling, general and administrative expenses decreased to $5,176,794 for the nine months ended March 31, 2025, from $8,266,267 in the prior year, due to the elimination of selling expenses related to Vyleesi[158]. - Net cash used in operating activities was $17,217,595 for the nine months ended March 31, 2025, a decrease from $24,988,985 in the prior year, attributed to a reduction in net loss and working capital changes[164]. - For the nine months ended March 31, 2025, net cash provided by investing activities was $2,500,000, a decrease from $12,455,275 for the same period in 2024[165]. - Net cash provided by financing activities for the nine months ended March 31, 2025, was $7,710,261, down from $14,558,216 in the prior year[166]. Liquidity and Funding - As of March 31, 2025, the company had cash and cash equivalents of $2,520,062 and current liabilities of $10,048,349, indicating a significant liquidity challenge[168]. - The company has incurred cumulative negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern for the next year[171]. - Additional funding will be required to complete clinical trials and regulatory submissions, with current economic conditions posing risks to financial stability and capital access[172]. - The company is evaluating strategies for obtaining additional funding, including equity financing and cost reductions, to sustain operations[171]. - The existing cash and cash equivalents are expected to fund operations into the second half of calendar year 2025, contingent on successful funding efforts[171]. Strategic Partnerships - The company is actively engaged in discussions with potential partners for ocular conditions to progress product development and commercialization[143]. - The company aims to maintain strategic alliances and partnerships to facilitate the development and commercialization of its product candidates[146].

Financial Data and Key Metrics Changes - For the quarter ended March 31, 2025, Palatin reported total operating expenses of $4.8 million, a decrease from $9.2 million in the same quarter last year, primarily due to reduced spending on MCR programs [5][6] - The net loss for the quarter was $4.8 million, down from $8.4 million for the same period in 2024, driven by decreased operating expenses [6] - Cash and cash equivalents as of March 31, 2025, were $2.5 million, down from $9.5 million as of June 30, 2024 [7] Business Line Data and Key Metrics Changes - Palatin did not record any product sales for the quarter due to the completion of the sale of Vyleesi's worldwide rights for up to $171 million in December 2023 [5] - Positive top-line data was reported for the Phase II study of the melanocortin-four receptor obesity program, showing a weight reduction of 4.4% for the combined treatment compared to 1.6% for the placebo [10] Market Data and Key Metrics Changes - The FDA granted orphan drug status to PL7737 for treating patients with obesity due to leptin receptor deficiency, indicating potential market opportunities [11] - The obesity treatment market is expected to exceed $100 billion annually, highlighting significant growth potential for melanocortin-four receptor agonists [15][16] Company Strategy and Development Direction - The company is focusing on research and development of melanocortin-four receptor obesity assets, believing it to be in the early stages of a multi-year innovation cycle [15] - Palatin aims to eliminate MCR-one activity in its next-generation compounds to reduce skin darkening side effects, enhancing patient compliance [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the operating results, describing the quarter as phenomenal despite challenges with the NYSE delisting [27] - The company is actively engaging with multiple funding sources to address future operating cash requirements [7] Other Important Information - Trading of Palatin's common stock was suspended on the NYSE American due to low selling prices, and the stock began trading on the OTC Pink market [4] Q&A Session Summary Question: Will a higher dose of remelanotide increase weight loss? - Management indicated that higher doses of bremelanotide could yield comparable weight loss to single-agent treatments like Wegovy [18] Question: Will weight maintenance become a focus in future generations of treatments? - Management confirmed that newer compounds will be evaluated for long-term weight maintenance, addressing rebound weight regain [20][21] Question: What benefits will separate the next generation of MC4Rs from the first generation? - Management highlighted improvements such as reduced pigmentation side effects and more patient-friendly dosing schedules for the next-generation compounds [22][24]

Financial Data and Key Metrics Changes - For the fiscal third quarter ended March 31, 2025, Palatin reported total operating expenses of $4.8 million, a decrease from $9.2 million in the same quarter last year, primarily due to reduced spending on MCR programs [6][7] - The net loss for the quarter was $4.8 million, down from $8.4 million for the same period in 2024, driven by decreased operating expenses [7] - Cash and cash equivalents as of March 31, 2025, were $2.5 million, down from $9.5 million as of June 30, 2024 [8] Business Line Data and Key Metrics Changes - Palatin did not record any product sales for the quarter due to the completion of the sale of Vyleesi's worldwide rights for up to $171 million in December 2023 [6] - Positive top-line data was reported for the Phase II study of the melanocortin-four receptor obesity program, showing a weight reduction of 4.4% for the combined treatment compared to 1.6% for the placebo [10] - The Phase II study of PL-8177 for ulcerative colitis showed clinical remission in 33% of treated patients versus 0% for placebo, indicating significant efficacy [12] Market Data and Key Metrics Changes - The company is actively engaged in business development discussions for its obesity and ulcerative colitis programs, which aligns with its strategy to out-license these programs [12][13] - The pharmacological treatment of obesity is expected to enter a multi-year cycle of innovation, with a market value projected to exceed $100 billion annually [15] Company Strategy and Development Direction - The company is focusing its R&D efforts on melanocortin-four receptor obesity assets, believing they will play a critical role in future obesity treatment [15] - The next-generation melanocortin-four receptor compounds aim to eliminate skin darkening side effects and improve dosing convenience, with a goal of once-weekly or once-daily administration [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the NYSE's decision to suspend trading and delist the company's stock, indicating they are assessing all available options [5] - The management believes the recent positive clinical data will enhance business development opportunities and is optimistic about future partnerships [12][14] Other Important Information - The company is actively seeking multiple funding sources to address future operating cash requirements [8] - The FDA granted orphan drug status to PL-7737 for treating obesity due to leptin receptor deficiency, which is expected to support its development [11] Q&A Session Summary Question: Will a higher dose of remelanotide increase weight loss? - Management indicated that higher doses of bremelanotide have been studied and can achieve weight loss comparable to single-agent treatments like Wegovy [17] Question: Will weight maintenance become a focus in future generations of treatments? - Management confirmed that newer compounds will be evaluated for long-term weight maintenance, addressing the rebound weight regain issue [19][20] Question: What benefits will the next generation of MC4Rs have over the first generation? - Management highlighted that the next generation aims to eliminate pigmentation issues and improve dosing frequency, making them more competitive in the market [21][22]

Core Insights - Palatin Technologies, Inc. announced promising preclinical data for its melanocortin agonists PL9654 and PL9655, which show potential in treating diabetic retinopathy through inflammation resolution, vascular stabilization, and neuroprotection [1][4] Group 1: Findings on PL9654 and PL9655 - The compounds demonstrated the ability to resolve inflammation, stabilize the blood-retinal barrier, reduce VEGF signaling, and protect retinal ganglion cells, which are critical in preventing vision loss in diabetic retinopathy [2][4] - Efficacy was observed across multiple models and administration routes, including topical delivery [2][4] - The research highlights the unique capability of Palatin's melanocortin data in demonstrating multi-pathway inflammation resolution [4] Group 2: Diabetic Retinopathy Overview - Diabetic retinopathy is a progressive complication of diabetes that damages retinal blood vessels, leading to vision loss and is a leading cause of vision impairment among adults aged 20 to 64 [5] - The prevalence of diabetic retinopathy is projected to increase significantly, with estimates indicating that 11.3 million people in the U.S. will be affected by 2030, rising to 14.6 million by 2050 [8] Group 3: Melanocortin Receptor System - The melanocortin receptor system is crucial for regulating inflammation, immune response, and tissue repair, with agonists showing promise in restoring tissue homeostasis in various diseases [6] - PL9654 and PL9655 are positioned as a new class of anti-inflammatory and neuroprotective therapeutics, with the potential for earlier intervention compared to current therapies [7] Group 4: Company Strategy and Future Outlook - Palatin is focused on developing first-in-class medicines that modulate inflammatory pathways and preserve retinal structure and function [7] - The company aims to form marketing collaborations to maximize the commercial potential of its products [9]

Company Overview - Palatin Technologies, Inc. is a biopharmaceutical company focused on developing first-in-class medicines that modulate the melanocortin receptor system [6] - The company aims to address diseases with significant unmet medical needs and commercial potential through targeted, receptor-specific product candidates [6] Recent Offering - The company announced the closing of a public offering consisting of 7,324,119 shares of common stock and accompanying warrants at a combined public offering price of $0.15 per share [1] - The offering generated approximately $1.1 million in gross proceeds, which will primarily be used for working capital and general corporate purposes [3] Warrants Details - The Series F Warrants have an exercise price of $0.30 per share, are immediately exercisable, and expire five years from the issuance date [2] - The Series G Warrants have an exercise price of $0.15 per share, are immediately exercisable, and expire either 24 months from the issuance date or at the end of the FDA Exercise Period [2] - The Series H Warrants will be issued upon the exercise of the Series G Warrants, with an exercise price of $0.225 per share and expiring 24 months after issuance [2] Placement Agents - A.G.P./Alliance Global Partners acted as the lead placement agent, while Laidlaw & Company (UK) Ltd. served as the co-placement agent for the offering [3]

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]