Amylyx Pharmaceuticals Inc (AMLX) Q3 2024 Earnings Call Highlights: Strategic Advances Amid ...

GuruFocus.com11-08

Cash and Investments: $234.4 million at the end of Q3 2024. Net Product Revenues: $400,000 for the third quarter. Cost of Sales: $800,000 related to discontinued commercial sales. Research and ...

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About 8% of these patients have persistent PBH. Camille L. Bedrosian, Chief Medical Officer, added that they are actively working w","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":["earning"],"viewcount":null,"language":"en","relate_stocks":{"AMLX":"Amylyx Pharmaceuticals, Inc."},"translate_title":"Amylyx Pharmaceuticals Inc(AMLX)2024年第三季度收益看涨期权亮点：战略进展...","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AMLX":1},"content_text":"Cash and Investments: $234.4 million at the end of Q3 2024.\nNet Product Revenues: $400,000 for the third quarter.\nCost of Sales: $800,000 related to discontinued commercial sales.\nResearch and Development Expenses: $21.2 million for Q3 2024, down from $30 million in Q3 2023.\nSelling, General and Administrative Expenses: $17.8 million for Q3 2024, down from $48.7 million in Q3 2023.\nAcquisition Expense: $36.2 million related to the avexitide acquisition.\nNet Loss: $72.7 million or $7 per share for the third quarter.\nCash Runway: Expected to extend into 2026.\n\n\nWarning! GuruFocus has detected 3 Warning Signs with AMLX.\n\nRelease Date: November 07, 2024\nFor the complete transcript of the earnings call, please refer to the full earnings call transcript.\n Positive Points \n\nAmylyx Pharmaceuticals Inc (NASDAQ:AMLX) reported positive top-line data from the Phase II HELIOS trial of AMX0035 in Wolfram syndrome, showing improvement in pancreatic function and stabilization across secondary endpoints.\nThe company is on track to initiate a Phase III trial for avexitide in post-bariatric hypoglycemia (PBH) in Q1 2025, with FDA breakthrough therapy and orphan drug designations.\nAmylyx Pharmaceuticals Inc (NASDAQ:AMLX) has a strong financial position with a cash runway expected to last into 2026.\nThe ORION trial of AMX0035 in progressive supranuclear palsy (PSP) is recruiting well, with interim analysis data expected in mid-2025.\nThe company has received clearance from Health Canada for a Phase I trial of AMX0114 in ALS, with early cohort data expected in 2025.\n\n Negative Points \n\nThe FDA has placed a clinical hold on the AMX0114 trial in the US, citing concerns over the proposed starting dose, which could delay US-based trials.\nNet product revenues were only $400,000 for the third quarter, while the cost of sales was $800,000, indicating a financial loss from discontinued commercial sales.\nThe company recorded a net loss of $72.7 million for the third quarter, highlighting ongoing financial challenges.\nResearch and development expenses decreased, primarily due to a decline in clinical expenses and restructuring, which may impact future innovation and development.\nThe company faces challenges in balancing cash among its lead program avexitide and other programs, which may have a lower probability of success.\n\n Q & A Highlights \nQ: How should we think about the market size for PBH patients that are officially managed by existing therapy? And what are the gating factors to initiating the phase III PBH study? A: Joshua Cohen, Co-CEO, explained that there are approximately 160,000 people living with PBH, based on literature suggesting 20% to 40% of bariatric surgery patients show abnormal glycemic control. About 8% of these patients have persistent PBH. Camille L. Bedrosian, Chief Medical Officer, added that they are actively working with clinical sites to initiate the trial in Q1 2025, with significant enthusiasm from the clinical community.\nQ: What are the considerations for the phase III trial design for PBH, and is there potential for an earlier readout in 2026? A: Camille L. Bedrosian, Chief Medical Officer, stated that the trial will use a 90 mg dose with a primary endpoint of composite level II and III hypoglycemia. The study is expected to begin in Q1 2025, with data anticipated in 2026. The design is based on previous significant results in phase II studies.\nQ: How do you address the risk of hyperglycemia with avexitide, and why did the FDA deem the 12.5 mg dose of AMX0114 too high? A: Camille L. Bedrosian, Chief Medical Officer, clarified that avexitide is a GLP-1 receptor antagonist, returning glycemic control to homeostasis without causing hyperglycemia. Regarding AMX0114, they are confident in its safety profile and are addressing FDA concerns, with plans to proceed with trials in Canada.\nQ: Why include level II hypoglycemia in the primary endpoint for the PBH trial? A: Camille L. Bedrosian, Chief Medical Officer, explained that including level II hypoglycemia captures all clinically meaningful events. The composite endpoint is well-established in anti-diabetic drug trials and provides a comprehensive measure of efficacy.\nQ: How do you plan to balance cash among your lead program and other projects? A: James Frates, CFO, emphasized that avexitide is their lead asset due to its clinical data and market opportunity. They are committed to advancing all programs but will prioritize avexitide, ensuring cash runway through its phase III data.\nFor the complete transcript of the earnings call, please refer to the full earnings call transcript.This article first appeared on \nGuruFocus.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2481974145"}