Welcome back. Novo Nordisk gaining FDA approval for the first oral weight loss drug. Our Anakah Constantino spoke with the CEO and joins us this morning.Hey, Anakah. >> Hi, Carl. That's right.So, we're all familiar with Novo's Blockbuster Weekly injection, Mgoi. But for the very first time, patients will be able to access an oral version of that drug. It's the first ever GLP-1 pill specifically approved for obesity, and it's launching early in 2026.And Novo says it's priced at a significant discount to what ...

Wegovy maker Novo Nordisk filed for U.S. FDA approval of CagriSema, a once-weekly shot that combines two compounds to treat obesity. https://t.co/XJjvikIDWU ...

Core Insights - Aligos Therapeutics has a significant Phase II pipeline, with a focus on hepatitis B treatment through its lead program, pevifoscorvir (previously known as ALG-184) [2][3] - The company is also developing a beta thyroid agonist, ALG-009, which has completed Phase IIa testing, along with preclinical results in obesity [2] - Additionally, Aligos is working on a pan-coronavirus protease inhibitor currently in a Phase II study funded by the MRC in the U.K. [3] Company Pipeline - The lead program, pevifoscorvir, targets chronic hepatitis B virus (HBV) infection, which is recognized as the largest chronic viral infection globally [2][3] - The beta thyroid agonist, ALG-009, has shown promising results in Phase IIa testing [2] - The preclinical portfolio includes an antisense oligonucleotide targeting both hepatitis B and hepatitis delta viruses [3]

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]