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]

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 public offering that provided approximately $191 million in net proceeds [12] - 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 Avexitide incurred in Q3 2024 [12][13] - Research and development expenses decreased to $19.9 million from $21.2 million in Q3 2024, mainly due to reduced spending on AMX0035 for PSP and ALS [13] - Selling, general, and administrative expenses were $16.2 million, down from $17.8 million in Q3 2024, attributed to decreased consulting and professional services expenses [13] Business Line Data and Key Metrics Changes - The lead program, Avexitide, is focused on post-bariatric hypoglycemia (PBH) and has shown statistically significant reductions in hypoglycemic events across five clinical trials [4][8] - The pivotal phase 3 Lucidity Trial is designed to replicate previous trial results, with a focus on enrolling a similar patient population and collecting data consistently [4][9] - The company anticipates completing recruitment for the Lucidity Trial in Q1 2026, with top-line data expected in Q3 2026 [5][12] Market Data and Key Metrics Changes - The company estimates approximately 160,000 individuals in the U.S. suffer from PBH, highlighting a significant unmet need for treatment options [6][17] - The ongoing market research and claims analysis support the understanding of the burden of PBH and the urgent need for an FDA-approved treatment [6][17] Company Strategy and Development Direction - The company is preparing for a potential launch of Avexitide in 2027, pending FDA approval, and is building its medical affairs and commercial organizations [5][6] - The company is also advancing the clinical development of AMX0035 for Wolfram syndrome, with plans to initiate a pivotal phase 3 trial in the second half of 2026 [6][55] - The research collaboration with Gubra is progressing well, with new molecules demonstrating strong potency and extended half-lives [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the Lucidity Trial and the potential of Avexitide to be the first approved therapy for PBH [10][18] - The company remains focused on addressing the significant unmet need in the PBH market, with ongoing engagement from clinical trial sites and high participant interest [9][51] - Management acknowledged the steady enrollment rate in the Lucidity Trial and emphasized the importance of quality in participant selection and data collection [22][51] Other Important Information - The company is preparing for early NDA submission efforts for Avexitide, with a focus on market research and disease education [5][6] - The anticipated cash runway extends into 2028, supporting the company's strategic initiatives and potential product launch [12] Q&A Session Summary Question: Enrollment update and operational dynamics affecting the study - Management acknowledged the importance of site startup and participant commitment to dietary restrictions, noting a steady enrollment rate and the focus on quality [20][22] Question: Phase 3 study patient history and screen failure rates - Management indicated that most patients would have been on dietary therapy for several years prior to entering the study, but did not disclose specific screen failure rates [27][28] Question: Addressable market for PBH and patient eligibility - Management reiterated the estimate of 160,000 PBH patients, emphasizing that this figure includes those not controlled on diet and experiencing significant hypoglycemic events [31][36] Question: Differences in site enrollment rates and engagement - Management confirmed that differences in enrollment rates across sites are common, but overall engagement from sites remains high [51] Question: Manufacturing and CMC processes for Avexitide - Management stated that registration batches have been manufactured and are undergoing stability testing, with a focus on quality and inspection readiness [49] Question: Measuring diet adherence in the Lucidity trial - Management confirmed that diet adherence is monitored through blinded continuous glucose monitoring (CGM) data, with interventions possible if significant deviations are observed [44] Question: Future regulatory path for Avexitide in other GI surgeries - Management indicated that while the current phase 3 study focuses on Roux-en-Y gastric bypass, there is interest in exploring other surgical types in the future [46]

Investigational Therapies - The company is developing three investigational therapies: avexitide for PBH, AMX0035 for Wolfram syndrome, and AMX0114 for ALS[80]. - Avexitide has received Breakthrough Therapy Designation from the FDA for both PBH and congenital hyperinsulinism, with no FDA-approved therapies currently available for PBH[81]. - The pivotal Phase 3 LUCIDITY trial for avexitide began in April 2025, with approximately 75 participants expected to complete recruitment by Q1 2026 and topline data anticipated in Q3 2026[83]. - In the Phase 2 PREVENT trial, avexitide demonstrated a 21% and 26% increase in mean plasma glucose nadir after treatment with 30 mg twice daily and 60 mg once daily, respectively, compared to placebo[84]. - AMX0035 is being investigated for its potential to slow neurodegeneration in Wolfram syndrome, a rare disorder affecting approximately 3,000 people in the U.S.[89]. - The Phase 2 HELIOS trial of AMX0035 showed sustained improvements in pancreatic function and glycemic control through Week 48, with all adverse events being mild or moderate[93]. - AMX0114 has received Fast Track designation from the FDA for ALS, with the first participant dosed in the Phase 1 LUMINA trial in April 2025[95][97]. - The company plans to initiate a pivotal Phase 3 trial for AMX0035 in Wolfram syndrome in the second half of 2026, pending FDA alignment[94]. - The company announced the discontinuation of the ORION program for AMX0035 in progressive supranuclear palsy due to lack of efficacy[98]. Financial Performance - For the three months ended September 30, 2025, product revenue was $0, a decrease of 100% compared to $416,000 in the same period of 2024[108]. - Research and development expenses for the three months ended September 30, 2025 were $19.9 million, down 7% from $21.2 million in 2024[111]. - The decrease in research and development expenses was primarily due to a $1.9 million reduction related to AMX0035 for PSP and a $4.1 million decrease for ALS, offset by a $4.8 million increase for avexitide[112]. - Selling, general and administrative expenses decreased to $16.2 million for the three months ended September 30, 2025, a 9% decline from $17.8 million in 2024[113]. - Total operating expenses for the three months ended September 30, 2025 were $36.0 million, a 53% decrease from $76.1 million in 2024[108]. - For the nine months ended September 30, 2025, product revenue was $0, a decrease of 100% from $88.0 million in the same period of 2024[114]. - Research and development expenses for the nine months ended September 30, 2025 were $69.2 million, down 15% from $81.2 million in 2024[114]. - The company recorded approximately $118.7 million in charges related to inventory write-downs and losses on firm purchase commitments for the nine months ended September 30, 2024[116]. - Selling, general and administrative expenses fell to $47.5 million for the nine months ended September 30, 2025, compared to $97.2 million in 2024, a decrease of 51%[119]. Cash and Financing - The company raised approximately $65.5 million from the January 2025 Offering and $190.7 million from the September 2025 Offering, totaling $257.2 million in financing activities for the nine months ended September 30, 2025[121][122]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $344.0 million, with an accumulated deficit of $718.4 million[123]. - The net cash used in operating activities was $95.4 million for the nine months ended September 30, 2025, compared to $108.6 million in 2024, a decrease of 12%[130]. - The company expects to finance near-term operations through existing cash and potential equity or debt financing, with no assurances that additional funding will be available on acceptable terms[126]. - The company anticipates an increase in expenses related to ongoing research and development activities, particularly for avexitide and AMX0035, as well as potential acquisitions or in-licensing of new product candidates[127]. - The net cash used in investing activities was $15.4 million for the nine months ended September 30, 2025, primarily due to $201.4 million in purchases of marketable securities[135]. Restructuring and Workforce - The restructuring plan announced in April 2024 resulted in a workforce reduction of approximately 70% and a decrease in external financial commitments[105]. - The company did not recognize any restructuring expenses for the nine months ended September 30, 2025, following approximately $22.9 million in restructuring costs in the same period of 2024[120]. Research and Development Focus - Research and development expenses primarily consist of costs related to avexitide, AMX0035, AMX0114, and other potential future product candidates[99]. - The significant decrease in R&D expenses was primarily due to a $26.6 million reduction in spending on AMX0035 for ALS treatment following the PHOENIX trial results[118].

Financial Performance - The company reported a net loss of $34.4 million, or $0.37 per share, for Q3 2025, compared to a net loss of $72.7 million, or $1.07 per share, for the same period in 2024[11]. - Net loss for the three months ended September 30, 2025, was $34.386 million, an improvement from a net loss of $72.704 million in the same period of 2024[26]. - Loss before income taxes for the nine months ended September 30, 2025, was $111.736 million, compared to a loss of $263.955 million in the same period of 2024, indicating a reduction of 57.6%[26]. - The net loss per share for the three months ended September 30, 2025, was $0.37, an improvement from $1.07 in the same period of 2024[26]. Expenses - Research and development expenses for Q3 2025 were $19.9 million, a decrease from $21.2 million in Q3 2024, primarily due to reduced spending on AMX0035[9]. - Selling, general, and administrative expenses for Q3 2025 were $16.2 million, down from $17.8 million in Q3 2024, mainly due to lower consulting and professional service costs[10]. - Total operating expenses for the nine months ended September 30, 2025, were $116.686 million, a decrease of 67.7% compared to $362.113 million in the same period of 2024[26]. - Research and development expenses for the nine months ended September 30, 2025, totaled $69.191 million, down from $81.192 million in the same period of 2024, representing a decrease of 14.7%[26]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $344.0 million as of September 30, 2025, up from $180.8 million at June 30, 2025, reflecting net proceeds of approximately $191 million from a public offering[12]. - Cash, cash equivalents, and marketable securities increased significantly to $343.990 million as of September 30, 2025, compared to $176.501 million at the end of 2024, marking a growth of 94.8%[24]. - Total assets increased to $362.741 million as of September 30, 2025, compared to $193.634 million on December 31, 2024, reflecting a growth of 87.5%[24]. - Total liabilities increased slightly to $30.745 million as of September 30, 2025, from $28.869 million on December 31, 2024, reflecting a growth of 6.1%[24]. - Stockholders' equity rose to $331.996 million as of September 30, 2025, compared to $164.765 million at the end of 2024, representing an increase of 101.5%[24]. Clinical Trials and Development - Recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide is expected to be completed in Q1 2026, with topline data anticipated in Q3 2026[6]. - The company plans to initiate a pivotal Phase 3 trial for AMX0035 in Wolfram syndrome in the second half of 2026, pending FDA alignment[13]. - Avexitide demonstrated a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in the Phase 2b trial, with a p-value of 0.0031[7]. - Early cohort data from the Phase 1 LUMINA trial of AMX0114 in ALS will be presented at the 36th International Symposium on ALS/MND in December 2025[4]. - Amylyx is advancing a collaboration with Gubra A/S for a novel long-acting GLP-1 receptor antagonist, with a decision on a potential development candidate expected soon[13].

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Amylyx Pharmaceuticals, Inc. [1] Company Summary - The investigation focuses on whether the actions of Amylyx's leadership have harmed shareholder interests [1] - Long-term shareholders of Amylyx may have the opportunity to pursue corporate governance reforms and seek financial restitution [1]

Core Viewpoint - Amylyx Pharmaceuticals Inc. is recognized as a small-cap stock with significant upside potential, particularly following a price target increase by Bank of America Securities from $14 to $16 while maintaining a 'Buy' rating [1][2]. Financial Performance - The price target increase is attributed to Amylyx raising $175 million through the issuance of 17.5 million shares, with net proceeds amounting to $163 million, which extends the company's cash runway beyond 2027 [2][3]. Strategic Initiatives - The strengthened balance sheet allows the company to invest in commercial ramp-up activities, including pivotal Phase 3 LUCIDITY trial results for avexitide in post-bariatric hypoglycemia, expected in the first half of 2026 [3]. - Additionally, Amylyx is on track to deliver cohort data from the AMX0114 program in ALS by the end of the year [3]. Company Overview - Amylyx Pharmaceuticals Inc. focuses on discovering and developing novel treatments for neurodegenerative diseases and other serious conditions with high unmet medical needs, including amyotrophic lateral sclerosis (ALS) [4].

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Amylyx Pharmaceuticals, Inc. (AMLX) - AMLX currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3] - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for outperformance in the market [4] Performance Metrics - Over the past week, AMLX shares increased by 4.84%, while the Zacks Medical - Drugs industry remained flat [6] - In the last quarter, AMLX shares rose by 78.21%, and over the past year, they increased by 192.04%, significantly outperforming the S&P 500, which rose by 6.22% and 17.55% respectively [7] - The average 20-day trading volume for AMLX is 2,035,068 shares, indicating strong trading activity [8] Earnings Outlook - In the past two months, two earnings estimates for AMLX have been revised upwards, with the consensus estimate improving from -$1.71 to -$1.58 [10] - For the next fiscal year, two estimates have also moved upwards, with no downward revisions during the same period [10] Conclusion - Given the strong performance metrics and positive earnings outlook, AMLX is identified as a promising momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [12]

Core Viewpoint - Shares of Amylyx Pharmaceuticals, Inc. (AMLX) have increased by 3.6% over the past four weeks, closing at $14.31, with a potential upside indicated by Wall Street analysts' mean price target of $18.5, suggesting a 29.3% increase [1] Price Targets and Analyst Estimates - The mean estimate consists of eight short-term price targets with a standard deviation of $3.85, where the lowest estimate is $12.00 (indicating a 16.1% decline) and the highest is $25.00 (indicating a 74.7% increase) [2] - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price movement [2][9] Earnings Estimates and Analyst Agreement - Analysts have shown increasing optimism about AMLX's earnings prospects, as indicated by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has risen by 8.8% over the past month, with two estimates increasing and no negative revisions [12] Zacks Rank and Investment Potential - AMLX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a strong potential upside [13] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a useful guide for potential investment [14]