Financial Performance - Net product revenue for Q3 2024 was $0.4 million, primarily due to adjustments related to prior sales of RELYVRIO and ALBRIOZA[6] - Net loss for Q3 2024 was $72.7 million, or $1.07 per share, compared to net income of $20.9 million, or $0.30 per diluted share for the same period in 2023[7] - For the three months ended September 30, 2024, product revenue was $416,000, a significant decrease from $102.693 million in the same period of 2023[30] - The net loss for the three months ended September 30, 2024, was $72.704 million, compared to a net income of $20.893 million in the same period of 2023[30] - Cash, cash equivalents, and marketable securities totaled $234.4 million as of September 30, 2024, down from $309.8 million as of June 30, 2024, with a cash runway expected into 2026[7] - Cash, cash equivalents, and short-term investments decreased to $234.395 million as of September 30, 2024, from $371.362 million as of December 31, 2023[29] - The company reported a total asset value of $250.713 million as of September 30, 2024, down from $517.454 million as of December 31, 2023[29] - Stockholders' equity decreased to $196.203 million as of September 30, 2024, from $433.432 million as of December 31, 2023[29] Research and Development - Acquired in-process research and development expenses were $36.2 million for Q3 2024, compared to zero for the same period in 2023, due to the acquisition of avexitide[6] - Research and development expenses decreased to $21.2 million in Q3 2024 from $30.0 million in Q3 2023, attributed to reduced clinical expenses and personnel costs[7] - Positive topline data from the Phase 2 HELIOS trial of AMX0035 showed improvement in pancreatic function after 24 weeks of treatment[3] - The company plans to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia in Q1 2025, with topline data anticipated in 2026[5] - Interim data from the Phase 2b/3 ORION trial of AMX0035 in progressive supranuclear palsy is expected in mid-2025[5] - The ORION trial is a Phase 2b/3 clinical trial assessing the efficacy and safety of AMX0035 in patients with progressive supranuclear palsy (PSP)[19] - The company is exploring the potential of AMX0035 for the treatment of Wolfram syndrome and PSP, with ongoing discussions with regulatory authorities planned[25] - The company is engaging with the FDA to inform the Phase 3 program for AMX0035 in Wolfram syndrome and expects to provide updates in 2025[3] Operational Expenses - Selling, general and administrative expenses were $17.8 million in Q3 2024, down from $48.7 million in Q3 2023, mainly due to reduced payroll and consulting costs[7] - Total operating expenses for the three months ended September 30, 2024, were $76.077 million, down from $83.973 million in the same period of 2023, reflecting a reduction of approximately 9%[30] Strategic Initiatives - Amylyx Pharmaceuticals is committed to developing new treatment options for serious neurodegenerative diseases, with a focus on addressing high unmet medical needs[24] - The company anticipates potential expansion into the U.S. for AMX0114 as a treatment for ALS, with a trial initiation planned[25]

Core Viewpoint - Amylyx Pharmaceuticals has achieved significant progress with its drug AMX0035, targeting the rare genetic disorder Wolfram Syndrome, leading to a notable increase in its stock price [1][2]. Group 1: Drug Development - The drug AMX0035 has shown positive results in a phase 2 clinical trial involving 12 adults, meeting its primary efficacy endpoint of improving pancreatic function [2]. - Long-term data from the trial indicate sustained improvement in patients while on the drug, and it was well tolerated [2]. - The company plans to engage with the U.S. Food and Drug Administration (FDA) to advance AMX0035 to phase 3 testing [2]. Group 2: Market Context - Wolfram Syndrome is a rare disorder affecting approximately 3,000 individuals in the U.S., which has led to AMX0035 receiving orphan drug status in both the U.S. and the European Union [3]. - Despite the limited patient population, the drug's performance is promising, making Amylyx's stock a noteworthy investment opportunity [3].

Acquisition and Clinical Trials - The company completed the acquisition of avexitide for $35.1 million, which has received breakthrough therapy designation from the FDA for hyperinsulinemic hypoglycemia and congenital hyperinsulinism [83]. - Avexitide has shown statistically significant reductions in hypoglycemic events in previous clinical trials, with a Phase 3 program expected to begin in Q1 2025 and topline data anticipated in 2026 [84]. - AMX0035, a treatment for neurodegenerative diseases, has demonstrated the ability to reduce markers associated with such diseases, including tau and YKL-40, in clinical trials [85]. - Interim data from the HELIOS trial indicated that AMX0035 had a clinically meaningful effect on glucose control and visual acuity in participants with Wolfram syndrome [89]. - The ORION trial for AMX0035 in PSP is ongoing, with interim analysis data expected in mid-2025 [91]. - The company plans to initiate a clinical trial for AMX0114 in ALS patients in the second half of 2024, following successful IND-enabling studies [94]. Financial Performance - Product revenue, net for the three months ended June 30, 2024, was $(1,023) thousand, a decrease of $(99,239) thousand or (101%) compared to $98,216 thousand in 2023 [112]. - Product revenue, net decreased to $87.6 million for the six months ended June 30, 2024, down 48% from $169.6 million in the same period of 2023 [124]. - The company reported a net loss of $(72,700) thousand for the three months ended June 30, 2024, compared to a net income of $22,074 thousand in 2023, reflecting a decrease of $(94,774) thousand or (429%) [112]. - The company recorded a net loss of $191.5 million for the six months ended June 30, 2024, compared to a net income of $23.6 million in 2023, representing a 910% decline [124]. Expenses and Cost Management - Research and development expenses totaled $23,347 thousand for the three months ended June 30, 2024, down from $29,044 thousand in 2023, representing a decrease of $(5,697) thousand or (20%) [116]. - Selling, general and administrative expenses were $21,647 thousand for the three months ended June 30, 2024, a decrease of $(21,744) thousand or (50%) from $43,391 thousand in 2023 [119]. - Restructuring expenses for the three months ended June 30, 2024, amounted to approximately $22,851 thousand, primarily due to employee severance and termination benefits [120]. - Research and development expenses rose to $60.0 million for the six months ended June 30, 2024, a 13% increase from $53.2 million in 2023, driven by increased spending on AMX0035 and personnel-related costs [129]. - Selling, general and administrative expenses decreased to $79.4 million for the six months ended June 30, 2024, down from $87.4 million in 2023, mainly due to reduced payroll and consulting costs [131]. - Restructuring expenses totaled approximately $22.9 million for the six months ended June 30, 2024, including $21.8 million in employee severance and termination benefits [132]. Cash and Funding - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $309.8 million, following a restructuring that reduced the workforce by approximately 70% [97]. - 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 [99]. - For the six months ended June 30, 2024, the company used $67.1 million in cash from operating activities, primarily due to a net loss of $191.5 million [142]. - The company reported a net cash used by investing activities of $28.1 million, mainly from $232.0 million in purchases of short-term investments [143]. - Net cash provided by financing activities was $0.2 million, consisting primarily of proceeds from stock options and awards [144]. - The company experienced a 151% decrease in cash, cash equivalents, and restricted cash equivalents, totaling a net decrease of $95.2 million for the six months ended June 30, 2024 [142]. - The company has committed approximately $195.0 million under agreements with contract manufacturing organizations, expected to be paid through 2028 [145]. Restructuring and Future Outlook - The company announced the voluntary discontinuation of marketing authorizations for RELYVRIO/ALBRIOZA due to the failure of the Phase 3 PHOENIX trial to meet its primary and secondary endpoints [95]. - The company has initiated a process with the FDA and Health Canada to voluntarily discontinue marketing authorizations for RELYVRIO®/ALBRIOZA™ [114]. - The company announced a restructuring plan aimed at reducing its workforce by approximately 70% to focus resources on key clinical and preclinical programs [134]. - The company plans to continue significant investments in research and development, particularly for AMX0035 and avexitide, while also managing costs associated with being a public company [136][137]. - Future funding requirements may increase significantly due to various factors, including the need for additional capital for product development and commercialization efforts [139]. Market and Economic Conditions - The company is exposed to interest rate risk, but does not expect a 100 basis point change in interest rates to materially affect the fair market value of its investment portfolio [149]. - The company does not believe inflation had a material effect on its financial condition during the six months ended June 30, 2024 [151].

Financial Performance - Net product revenue for Q2 2024 was $(1.0) million, a significant decrease from $98.2 million in Q2 2023 due to the discontinuation of RELYVRIO and ALBRIOZA[5] - The company reported a net loss of $72.7 million, or $1.07 per share, for Q2 2024, compared to a net income of $22.1 million, or $0.31 per diluted share, in Q2 2023[5] - Product revenue for the three months ended June 30, 2024, was $1,023,000, a significant decrease from $98,216,000 in the same period of 2023, representing a decline of approximately 98.96%[27] - Net loss for the three months ended June 30, 2024, was $72,700,000, compared to a net income of $22,074,000 for the same period in 2023[27] - Total operating expenses for the six months ended June 30, 2024, were $286,036,000, compared to $151,496,000 for the same period in 2023, an increase of approximately 88.8%[27] Research and Development - Research and development expenses decreased to $23.3 million in Q2 2024 from $29.0 million in Q2 2023, primarily due to reduced payroll and clinical expenses[5] - Research and development expenses for the three months ended June 30, 2024, were $23,347,000, down from $29,044,000 in the same period of 2023, a decrease of approximately 19.5%[27] - The company is conducting the Phase 2b/3 ORION trial to assess the efficacy and safety of AMX0035 in patients with progressive supranuclear palsy (PSP)[17] - The company plans to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia (PBH) in Q1 2025, with topline data anticipated in 2026[1] - Updated data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome will be presented at ISPAD 2024, including data from all 12 participants at Week 24[1] - A multiple ascending dose clinical trial of AMX0114 in ALS is expected to begin in the second half of 2024[4] - The company plans to initiate discussions with regulatory authorities regarding the potential Phase 3 trial for AMX0035 for Wolfram syndrome[22] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $309.8 million as of June 30, 2024, down from $373.3 million at March 31, 2024, with a cash runway expected into 2026[5] - Cash, cash equivalents, and short-term investments decreased to $309,812,000 from $371,362,000, a decline of approximately 16.6%[26] Company Overview - Amylyx Pharmaceuticals is focused on developing treatments for neurodegenerative diseases, including ongoing clinical programs for ALS and Wolfram syndrome[21] - The company received Orphan Drug Designation from the European Commission for AMX0035 for the treatment of Wolfram syndrome[3] - Approximately 160,000 individuals in the U.S. are estimated to be affected by symptomatic PBH, highlighting a significant unmet medical need[1] Administrative Expenses - Selling, general and administrative expenses were $21.6 million in Q2 2024, down from $43.4 million in Q2 2023, reflecting a decrease in personnel costs and consulting services[6] - The company reported a total liabilities of $70,853,000 as of June 30, 2024, down from $84,022,000 at the end of 2023, a decrease of approximately 15.5%[26] - The weighted-average shares used in computing net loss per share for the three months ended June 30, 2024, were 68,024,929[27]

Core Viewpoint - Kuehn Law is investigating potential breaches of fiduciary duties by officers and directors of Amylyx Pharmaceuticals, Inc. related to misrepresentation of the company's drug RELYVRIO's commercial prospects [1] Group 1: Allegations Against Amylyx Pharmaceuticals - Insiders allegedly overstated the commercial prospects of RELYVRIO [1] - Patients reportedly discontinued treatment with RELYVRIO after six months [1] - The rate of new patients starting treatment with RELYVRIO was decreasing [1] - Consequently, the prescription rate for RELYVRIO was also overstated [1] - Insiders are accused of attempting to conceal these negative trends from investors by blocking analysts from accessing prescription data [1] - As a result, the company's public statements were materially false and misleading [1]

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Avexitide Acquisition Conference Call July 10, 2024 8:00 AM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer Joshua Cohen - Co-Chief Executive Officer Camille Bedrosian - Chief Medical Officer James Frates - Chief Financial Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Michael DiFiore - Evercore ISI Graig Suvannavejh - Mizuho Securities Charlie Yang - Bank of Americ ...

Summary of Amylyx Pharmaceuticals Conference Call on Avexitide Acquisition Company and Industry Overview - **Company**: Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) - **Industry**: Pharmaceuticals, specifically focusing on treatments for hyperinsulinemic hypoglycemia Key Points and Arguments 1. **Acquisition Announcement**: Amylyx Pharmaceuticals announced the acquisition of Avexitide, a novel GLP-1 receptor antagonist aimed at treating hyperinsulinemic hypoglycemia [5][7][11] 2. **Target Conditions**: Avexitide is being developed for two primary indications: post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism, both of which have no approved treatment options [8][10][11] 3. **FDA Breakthrough Therapy Designation**: Avexitide has received FDA breakthrough therapy designation for both PBH and congenital hyperinsulinism, indicating its potential significance in treating these conditions [11][22] 4. **Clinical Readiness**: Avexitide is considered Phase III-ready, having met primary outcomes in previous Phase II studies, specifically in reducing hypoglycemic events [9][22] 5. **Market Potential**: There are approximately 160,000 individuals in the U.S. currently affected by PBH, highlighting a significant unmet medical need [10][15][29] 6. **Mechanism of Action**: Avexitide works by antagonizing the GLP-1 receptor, which is involved in insulin secretion, thereby stabilizing glucose levels and mitigating hypoglycemia [18][19][20] 7. **Clinical Data**: Phase II studies showed that Avexitide significantly reduced insulin levels and improved glucose nadir, with reductions in severe hypoglycemic events by over 50% [21][24][27] 8. **Safety Profile**: Avexitide has demonstrated a favorable safety profile in clinical studies, with no serious adverse events reported [26][29] 9. **Financial Terms of Acquisition**: The acquisition cost was $35.1 million, with a 3% royalty on future sales if approved [29] 10. **Future Plans**: The Phase III program is expected to initiate in Q1 2025, with topline data anticipated in 2026 and a potential commercial launch in 2027 [29][32] Additional Important Content 1. **Bariatric Surgery Context**: Over the past decade, approximately 2 million people in the U.S. have undergone bariatric surgery, with PBH developing in a subset of these patients [12][14] 2. **Patient Impact**: PBH can lead to severe cognitive impairment and life-threatening events, emphasizing the need for effective treatment options [14][15][32] 3. **Commercialization Strategy**: The company plans to target endocrinologists as the primary audience for Avexitide, leveraging existing relationships from their Wolfram syndrome program [45][46] 4. **Competitive Landscape**: Avexitide is positioned as the only Phase III candidate for PBH, with growing interest in the treatment of this debilitating condition [41][43] 5. **Long-term Outlook**: The company acknowledges the potential impact of next-generation GLP-1 therapies on bariatric surgery rates but believes that the need for Avexitide will remain due to the specific nature of PBH [74][75] This summary encapsulates the critical insights from the conference call regarding Amylyx Pharmaceuticals' acquisition of Avexitide and its implications for the treatment of hyperinsulinemic hypoglycemia.

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q1 2024 Results Conference Call May 9, 2024 8:00 AM ET Company Participants Lindsey Allen - Head, IR & Communications Justin Klee - Co-CEO Camille Bedrosian - CMO Jim Frates - CFO Josh Cohen - Co-CEO Conference Call Participants Corinne Jenkins - Goldman Sachs Graig Suvannavejh - Mizuho Operator Good morning. My name is Morgan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals First Quarter 20 ...

Amylyx Pharmaceuticals, Inc. (AMLX) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of $0.24. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -291.67%. A quarter ago, it was expected that this company would post earnings of $0.20 per share when it actually produced earnings of $0.07, delivering a surprise of -65%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition peri ...