Financial Data and Key Metrics Changes - For Q1 2026, Palatin reported approximately $8.8 million in collaboration license revenue, a significant increase from zero in the same quarter last year, primarily due to the agreement with Boehringer Ingelheim [9] - Total operating expenses decreased to $4.2 million from $7.8 million in the comparable quarter last year, mainly due to reduced spending on development programs [10] - The company reported a net income of $4.7 million for the quarter, compared to a net loss of $7.8 million in the same quarter last year, driven by the revenue from the BI agreement and lower operating expenses [11] - Cash and cash equivalents as of September 30, 2025, were $1.3 million, down from $2.6 million as of June 30, 2025, but this does not include a $6.5 million milestone payment received in October 2025 [11] Business Line Data and Key Metrics Changes - The increase in collaboration license revenue is attributed entirely to the Boehringer Ingelheim agreement, which included an upfront payment and milestone achievements [9] - The company is focusing on the development of melanocortin-4 receptor agents for obesity treatment, with a proprietary portfolio that includes both orally active small molecules and long-acting peptides [13][15] Market Data and Key Metrics Changes - The collaboration with Boehringer Ingelheim validates the potential of targeting the melanocortin system, with expectations for additional development and regulatory milestones [16] - The company anticipates a multi-billion-dollar market for obesity treatments, indicating a competitive landscape with room for multiple players [25] Company Strategy and Development Direction - Palatin's R&D efforts will concentrate on melanocortin-4 receptor agents for syndromic and genetic obesity, aiming to improve dosing profiles and reduce side effects compared to current treatments [13][15] - The company plans to initiate IND-enabling studies for its compounds in the first half of 2026, with first-in-human studies expected in the second half of 2026 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made with the Boehringer Ingelheim collaboration and the successful public offering, which has improved the company's financial standing and compliance with NYSE American listing standards [8][12] - The company expects a cash runway beyond December 31, 2026, indicating a stable financial outlook for ongoing operations [11] Other Important Information - The company executed an $18.2 million equity offering, which has provided significant non-dilutive capital and allowed for the resumption of trading on the NYSE American under the PTN ticker symbol [17] - The company is also exploring licensing opportunities for other melanocortin receptor system programs, including candidates for dry eye disease and ulcerative colitis [16] Q&A Session Summary Question: Can you highlight the ideal target profile for PL7737 and the long-acting peptides? - Management emphasized the importance of minimizing activity at the melanocortin-1 receptor and achieving a flat pharmacokinetic curve for effective obesity treatment [19][20] Question: How do these next-generation compounds address hyperpigmentation side effects? - The company has developed selective agonists that significantly reduce activity at the melanocortin-1 receptor, potentially eliminating skin darkening side effects [23] Question: How does the company position itself against competitors in the obesity treatment market? - Management believes that the quality of their compounds, which reduce potential side effects and maximize efficacy, will allow them to compete effectively in a multi-billion-dollar market [25] Question: When might we see the next collaboration from other pipeline compounds? - Management anticipates near-term resource development milestones of approximately $15 million within the next 12 months following the successful collaboration with Boehringer Ingelheim [27]

Core Insights - Palatin Technologies, Inc. is making significant advancements in its obesity pipeline, particularly with the oral small molecule PL7737, which is expected to enter clinical studies in the first half of 2026 [2][8] - The company has strengthened its financial position through an $18.2 million public offering and has resumed trading on the NYSE American [5][10] - Collaboration with Boehringer Ingelheim is progressing, with milestones achieved and additional potential payments outlined [7][8] Obesity Program Update - PL7737 has shown robust weight loss and safety in preclinical models, with IND-enabling toxicology studies ongoing [8] - The U.S. FDA has granted Orphan Drug Designation for PL7737 for treating leptin receptor deficiency-related obesity [8] - Next-generation selective peptide MC4R agonists are planned for mid-2026 clinical trials [8] Financial Results - For the fiscal first quarter ended September 30, 2025, Palatin reported collaboration and license revenue of $8,847,550, a significant increase from $0 in the same quarter last year [11] - Total operating expenses decreased to $4.2 million from $7.8 million year-over-year, primarily due to reduced spending on MCR development programs [12] - The company reported a net income of $4.7 million for the quarter, compared to a net loss of $7.8 million in the prior year [15] Cash Position - As of September 30, 2025, Palatin had cash and cash equivalents of $1.3 million, down from $2.6 million as of June 30, 2025 [16] - The company expects a cash runway beyond December 31, 2026, factoring in upcoming milestone payments and proceeds from the recent public offering [17] Corporate Developments - The company regained compliance with NYSE American listing standards following the public offering, allowing its common stock to resume trading under the symbol "PTN" [10] - A teleconference and webcast are scheduled for November 13, 2025, to discuss operational results and corporate updates [18]

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]

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 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 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]