Amylyx Stock is up a staggering 166% over the past year, and this biotech-focused hedge fund is still doubling down.On November 14, Austin-based Saturn V Capital Management disclosed a significant purchase of Amylyx Pharmaceuticals stock (AMLX 3.73%) that helped increase its position by $41.7 million quarter-over-quarter.What HappenedAccording to a Securities and Exchange Commission (SEC) filing dated November 14, Saturn V Capital Management LP increased its stake in Amylyx Pharmaceuticals (AMLX 3.73%) by 1 ...

Company Overview - Amylyx is presenting at the Citi Global Healthcare Conference, highlighting its lead asset, Avexitide, which is in a pivotal study for post-bariatric hypoglycemia (PBH) [3][4] - The company anticipates completion of enrollment for the study in the first quarter and expects top-line results in the third quarter of the year [4] Market Opportunity - PBH affects approximately 160,000 individuals in the U.S., with no approved treatments currently available, indicating a significant unmet medical need [4] - The company is planning for commercialization of Avexitide in 2027 following the study results [4] Future Developments - Amylyx is also exploring a potential long-acting formulation of Avexitide, which would be a daily subcutaneous treatment [4]

Amylyx Pharmaceuticals (NasdaqGS:AMLX) FY 2025 Conference December 03, 2025 04:00 PM ET Company ParticipantsJustin Klee - Co-CEo and Co-FounderConference Call ParticipantsGeoff Meacham - Senior AnalystGeoff MeachamAll right. Okay, welcome to the Citi Global Healthcare Conference. I'm Jeff Meacham.Global Head of Healthcare.Global Head of Healthcare, thank you. And Senior Analyst, big cap and mid-cap biotech and pharma. Obviously, Jarvis Fang is up here with me from my team. We're thrilled to have Amylyx. So ...

Financial Data and Key Metrics Changes - The company is excited about the upcoming pivotal study for Avexitide, targeting post-bariatric hypoglycemia (PBH), with an estimated 160,000 patients in the U.S. and no approved treatments [2][6][12] - Enrollment for the pivotal study is expected to complete in Q1 2026, with top-line results anticipated in Q3 2026, leading to potential commercialization in 2027 [2][3] Business Line Data and Key Metrics Changes - Avexitide is positioned as a competitive inhibitor of the GLP-1 receptor, with significant unmet needs in PBH and strong prior trial data supporting its efficacy [5][6] - The company is also developing a long-acting formulation of Avexitide, which is expected to enhance market appeal [3][21] Market Data and Key Metrics Changes - There is a growing awareness of PBH among endocrinologists, with initiatives for coverage and coding underway, including a petition for an ICD-10 code [9][36] - The company has identified a clear patient journey for PBH, which aids in diagnosis and treatment planning [34][41] Company Strategy and Development Direction - The company aims to leverage its experience in rare diseases to establish a robust commercialization strategy for Avexitide, focusing on patient connectivity and care pathways [30][32] - Future plans include exploring additional indications for Avexitide beyond Roux-en-Y gastric bypass patients, potentially expanding to sleeve gastrectomy and other surgeries [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming pivotal trial results and the potential impact of Avexitide on patient quality of life [12][14] - The company is preparing for a chronic treatment model, anticipating ongoing patient management needs [31][32] Other Important Information - The company is also advancing its ALS candidate AMX0114, with ongoing studies to assess its safety and efficacy [53][56] - AMX0035 for Wolfram syndrome is in the pipeline, with plans for a phase three trial pending FDA alignment [65][66] Q&A Session Summary Question: What is the expected timeline for Avexitide's pivotal study results? - The company anticipates completion of enrollment in Q1 2026 and top-line results in Q3 2026, with commercialization targeted for 2027 [2][3] Question: How does the company plan to raise awareness about PBH? - The company is working with the American Society of Metabolic and Bariatric Surgery to develop educational materials and increase awareness among healthcare providers [40][41] Question: What is the significance of the potential ICD-10 code for PBH? - While the ICD-10 code is seen as beneficial for claims databases and awareness, it is not deemed essential for diagnosis, as endocrinologists are already trained to recognize PBH [46][47]

One investor is making a bold bet on Amylyx just as its 2026 catalyst calendar starts to take shape.On November 14, New York City-based Commodore Capital disclosed a new position in Amylyx Pharmaceuticals (AMLX +2.76%), acquiring nearly 4.1 million shares valued at approximately $55 million, according to a recent SEC filing.What HappenedAccording to a filing with the U.S. Securities and Exchange Commission dated November 14, Commodore Capital LP disclosed a new stake in Amylyx Pharmaceuticals (AMLX +2.76%). ...

Summary of Amylyx Pharmaceuticals FY Conference Call Company Overview - **Company**: Amylyx Pharmaceuticals (NasdaqGS:AMLX) - **Focus**: Development of innovative therapies, particularly in the area of post-bariatric hypoglycemia (PBH) and other rare diseases Key Points on Avexetide and PBH - **Avexetide**: A competitive inhibitor of the GLP-1 receptor currently in a phase three pivotal study for PBH, following five successful prior studies that supported FDA Breakthrough Therapy designation [1][2] - **Market Size**: Approximately 160,000 people in the U.S. are estimated to have PBH, a number expected to grow due to the increasing prevalence of bariatric surgeries [3][4] - **Bariatric Surgery**: About 270,000 bariatric surgeries are performed annually in the U.S., with a significant portion of patients potentially developing PBH [7][10] - **Awareness and Diagnosis**: PBH has historically been under-recognized, but awareness is increasing, with presentations at medical conferences and discussions about creating an ICD-10 code for PBH [5][16] Clinical Development and Pipeline - **AMX0035**: In clinical development for Wolfram syndrome, with positive phase two results and phase three design pending FDA alignment [2][25] - **Calpain-2 Antisense Oligonucleotide**: Currently in phase one study for ALS, with safety and tolerability data expected later this year [2][25] Market Dynamics and Adoption Drivers - **Patient Journey**: Diagnosis of PBH can take one to three years post-bariatric surgery, with a significant number of patients actively managed at specialized centers [12][13] - **Educational Efforts**: There is a need for increased education among general endocrinologists and surgeons to recognize PBH symptoms and refer patients appropriately [13][15] - **Launch Expectations**: Anticipation of a bolus effect of initial patients seeking treatment upon approval, followed by a typical S-shaped launch curve [14][15] Phase Three Study Design - **Study Duration**: The phase three study has a treatment period of 16 weeks, increased from 4 weeks in phase two, with no evidence of tachyphylaxis expected [18][19] - **Outcome Measurement**: Primary outcomes will measure hypoglycemic events using the same methods as in phase two, ensuring consistency [19][20] Future Opportunities - **Potential for Other Indications**: The mechanism of Avexetide may have applications in other conditions related to persistent hypoglycemia, such as congenital hyperinsulinism and complications from upper GI surgeries [23][24] - **Market Size for Wolfram Syndrome**: Estimated at about 3,000 people in the U.S., with a larger population outside the U.S. [25] Conclusion - **Financial Position**: Recent financing provides a cash runway into 2028, supporting ongoing clinical programs and market entry strategies [2] - **Outlook**: The company is optimistic about its pipeline and the potential for Avexetide to address an unmet medical need in the PBH market [2][26]

Core Points - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Amylyx Pharmaceuticals, Inc. [1] - Long-term shareholders of Amylyx may seek corporate governance reforms, financial incentives, or other benefits through legal action [2] - Shareholder involvement is emphasized as a means to improve company policies and enhance shareholder value [3] - Halper Sadeh LLC has a history of representing investors affected by securities fraud and corporate misconduct, recovering millions for defrauded investors [4]

Core Viewpoint - Rosen Law Firm is investigating potential breaches of fiduciary duties by the directors and officers of Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) [1] Company Summary - The investigation pertains to the actions of the directors and officers of Amylyx Pharmaceuticals, indicating possible misconduct or failure to act in the best interests of shareholders [1] - Shareholders of Amylyx Pharmaceuticals are encouraged to seek more information regarding the investigation through the law firm's website or by contacting them directly [1]

Summary of Amylyx Pharmaceuticals FY Conference Call Company Overview - **Company**: Amylyx Pharmaceuticals (NasdaqGS:AMLX) - **Event**: FY Conference on November 10, 2025 - **Key Speakers**: Co-CEOs Josh Cohen and Justin Klee Key Points Drug Candidates and Clinical Programs - Amylyx has three drug candidates in clinical development, with Evexetide as the lead candidate targeting post-bariatric hypoglycemia (PBH) [2][3] - Evexetide is a GLP-1 receptor competitive inhibitor, currently in a pivotal phase three study for PBH, which affects approximately 160,000 people in the U.S. [2][3][14] - No FDA-approved treatments exist for PBH, highlighting a significant unmet medical need [3][15] - Other candidates include a small molecule for Wolfram syndrome and Amylyx 114, an antisense oligonucleotide for ALS [3][4] Clinical Trial Details - The phase three study for Evexetide is expected to complete enrollment in Q1 2026, with top-line results anticipated in Q3 2026 [3][38] - Previous studies have shown positive results, including FDA Breakthrough Therapy Designation [3][8] - The phase three trial aims to replicate the success of earlier trials, focusing on reducing level two and level three hypoglycemic events [21][29] Market Opportunity and Unmet Need - PBH is a rare complication following bariatric surgery, with an estimated 8% of patients developing the condition [14] - The condition leads to severe hypoglycemia, which can result in medical emergencies, emphasizing the need for effective treatment [12][13] - The majority of PBH cases are linked to Roux-en-Y gastric bypass surgery, with an estimated 120,000 cases from this procedure [15] Regulatory and Market Considerations - An ICD-10 code for PBH is being considered, which could aid in tracking and diagnosing patients, but is not deemed essential for Evexetide's success [17][19] - The treating community is actively working to elevate awareness of PBH, with recent discussions at medical conferences [18] Financial Position - As of Q3 2025, Amylyx reported $344 million in cash, providing a runway into 2028 [38] - The company anticipates completing enrollment in the lucidity trial in Q1 2026, with potential data release in Q3 2026 and a possible product launch in 2027 [38] Conclusion - Amylyx Pharmaceuticals is focused on addressing significant unmet needs in the treatment of PBH through its lead candidate Evexetide, with ongoing clinical trials and a strong financial position to support its initiatives [4][38]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a strong cash position of $344 million, compared to $181 million at the end of Q2 2025, reflecting a recent public offering that provided approximately $191 million in net proceeds [16] - Total operating expenses for the quarter were $36 million, down 53% from the same period in 2024, primarily due to one-time expenses related to the acquisition of Avexatide incurred in Q3 2024 [17] - Research and development expenses decreased to $19.9 million from $21.2 million in Q3 2024, mainly due to reduced spending on AMX-35 for PSP and ALS, offset by increased spending on Avexatide [17][18] Business Line Data and Key Metrics Changes - The pivotal Phase III lucidity trial for Avexatide is focused on post-bariatric hypoglycemia (PBH), with high participant interest and engagement across clinical trial sites [5][6] - The company anticipates completing recruitment for the lucidity trial in Q1 2026, with top-line data expected in Q3 2026, a slight delay from previous guidance [6][7] - The clinical development of AMX-35 for Wolfram syndrome is advancing, with plans to initiate a pivotal Phase III trial in 2026 pending FDA alignment [8][9] Market Data and Key Metrics Changes - The company estimates approximately 160,000 individuals in the U.S. suffer from PBH, with ongoing market research supporting this estimate [8][21] - The company is preparing for a potential launch of Avexatide in 2027, pending FDA approval, and is investing in market research and commercial infrastructure [7][16] Company Strategy and Development Direction - The company remains focused on executing the lucidity trial with high quality and preparing for a successful launch of Avexatide [7][19] - The research collaboration with GUBRA is progressing, with encouraging proof of concept data for new GLP-1 receptor antagonists [20] - The company is committed to addressing the significant unmet need in the PBH market, as evidenced by ongoing claims-based analyses and direct feedback from clinics [21][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the lucidity trial and the potential for Avexatide to be the first approved therapy for PBH [14][22] - The company acknowledges the challenges in enrollment rates but emphasizes the importance of quality over speed in participant selection [30][31] - Management highlighted the urgency of addressing the unmet need for patients experiencing frequent hypoglycemic events [41][42] Other Important Information - The company is focused on building its medical affairs and commercial organizations in preparation for the potential launch of Avexatide [7][19] - The FDA has granted Breakthrough Therapy designation to Avexatide, underscoring its potential significance in treating PBH [14] Q&A Session Summary Question: Enrollment update and operational dynamics affecting the lucidity trial - Management acknowledged the steady enrollment rate and emphasized the focus on quality participant selection and data collection [29][30] Question: Clarification on ALS program presentation and biomarker data - Management confirmed that early biomarker data will be presented in the first half of the coming year, with safety data shared at an upcoming symposium [36][38] Question: Addressable market for PBH and patient eligibility - Management reiterated the estimate of 160,000 PBH patients, emphasizing that this figure includes those uncontrolled on diet [40][46] Question: Differences in enrollment rates across clinical sites - Management noted that differences in enrollment rates are common in clinical trials and that they are learning from sites with faster enrollment [70] Question: Manufacturing and CMC processes for Avexatide - Management confirmed that registration batches are manufactured and stability testing is underway, with a focus on quality and inspection readiness [66] Question: Measurement of dietary adherence in the lucidity trial - Management stated that dietary adherence is monitored through blinded continuous glucose monitoring (CGM) and that interventions can be made if necessary [58][59] Question: Potential for Avexatide use in other GI surgeries - Management expressed interest in pursuing regulatory discussions for Avexatide's use in other surgical populations, noting similarities in pathophysiology [60][61]