Financial Data and Key Metrics Changes - The company ended 2024 with a solid cash position of $176.5 million, excluding approximately $65.5 million in net proceeds from a public offering that closed on January 13, 2025 [28] - Total operating expenses for Q4 were $39.9 million, down 62% from the same period in 2023 [29] - Research and development expenses were $22.9 million compared to $44.9 million in Q4 2023, primarily due to decreased spending on AMX0035 and other cost reductions [29] - Selling, general and administrative expenses were $17.1 million compared to $52.2 million in Q4 2023, reflecting a decrease in payroll and consulting costs [29] Business Line Data and Key Metrics Changes - The lead asset, avexitide, is in a pivotal Phase III clinical trial targeting post-bariatric hypoglycemia (PBH) with top line results expected in the first half of 2026 [6][7] - AMX0035 is being evaluated in Wolfram syndrome and progressive supranuclear palsy (PSP), with ongoing trials showing promising early data [9][12] - AMX0114 is in a Phase I trial for ALS, with recruitment expected to begin in March or April [16][17] Market Data and Key Metrics Changes - There are approximately 160,000 people in the U.S. living with PBH, a condition with no approved treatments [8][36] - The company estimates that about 8% of individuals who undergo Roux-en-Y gastric bypass will develop PBH, indicating a substantial market opportunity [46] Company Strategy and Development Direction - The company is focused on executing clinical trials and preparing for a potential commercial launch of avexitide in PBH, with a target launch anticipated in 2027 [34][39] - A collaboration with Gubra aims to develop a novel long-acting GLP-1 receptor antagonist, indicating a strategic expansion of the company's pipeline [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the potential impact of avexitide as the first approved treatment for PBH [19][39] - The company is preparing for significant milestones in 2025 and 2026, including data from multiple ongoing trials [32][40] Other Important Information - The company has approximately $7.8 million in obligations remaining from previously recognized items related to the discontinuation of RELYVRIO/ALBRIOZA, expected to be paid through 2025 [31][32] - The company appointed Dan Monahan as Chief Commercial Officer to lead commercialization efforts, highlighting a strengthened leadership team [35] Q&A Session Summary Question: Why limit the entry criteria to just Roux-en-Y gastric bypass procedures for the PBH Phase III trial? - Management noted that they have the most experience with avexitide in patients who have undergone Roux-en-Y gastric bypass, but they recognize the pathophysiology is consistent across bariatric surgeries [45] Question: How will efficacy be interpreted in the PSP ORION study across regions? - Management indicated that both the 10-item and 28-item PSP rating scales will be analyzed, and they expect similar results from both [48] Question: What is the target profile for the long-acting GLP-1? - Management clarified that avexitide is a GLP-1 antagonist, which has shown reductions in insulin and hypoglycemia, differentiating it from GLP-1 agonists [51] Question: How is the market for PBH forecasted to change over time? - Management believes the market will continue to grow due to the chronic nature of PBH and ongoing demand for bariatric surgeries [55][59] Question: What are the expectations for the week 48 data in the Wolfram syndrome trial? - Management is looking for sustained improvements in C-peptide response and visual acuity, which would support regulatory confidence in AMX0035 [64] Question: Is there potential for avexitide to be developed for other indications beyond PBH? - Management acknowledged the potential for avexitide in other diseases characterized by hyperinsulinemic hypoglycemia but emphasized that the current focus remains on PBH [65]

Financial Performance - Product revenue, net for the year ended December 31, 2024, was $87.4 million, a decrease of 77% from $380.8 million in 2023[506]. - Net loss for the year ended December 31, 2024, was $301.7 million, compared to a net income of $49.3 million in 2023, representing a 712% decline[505]. - Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $176.5 million, supplemented by net proceeds of $65.5 million from a January 2025 offering[490]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $176.5 million, with an accumulated deficit of $606.7 million[517]. - Net cash used in operating activities was $167.6 million in 2024, compared to a cash provided of $11.9 million in 2023, reflecting a change of $179.6 million[524][525]. - Net cash provided by investing activities decreased to $75.7 million in 2024 from $92.1 million in 2023, a decline of $16.4 million or 18%[529][530]. Operating Expenses - Total operating expenses increased by 18% to $402.1 million in 2024, compared to $342.0 million in 2023[505]. - Research and development expenses decreased by 19% to $104.1 million in 2024, down from $128.2 million in 2023[505]. - Selling, general and administrative expenses decreased by 39% to $114.3 million in 2024, compared to $188.4 million in 2023, following a restructuring plan that reduced the workforce by approximately 70%[502]. - Direct research and development expenses for AMX0035 - ALS dropped by $24.1 million (40%) to $36.7 million, while expenses for AMX0035 - PSP increased by $10.5 million (164%) to $16.9 million[510][511]. - Restructuring expenses amounted to approximately $22.9 million in 2024, including $21.9 million for employee severance and termination benefits[513]. Product Discontinuation - The RELYVRIO/ALBRIOZA product was discontinued in April 2024 following the failure of the Phase 3 PHOENIX trial to meet its primary and secondary endpoints[492]. - The company recorded approximately $118.7 million in charges related to inventory write-downs and losses on firm purchase commitments due to the discontinuation of RELYVRIO/ALBRIOZA[507]. Future Outlook - The company anticipates that existing cash and proceeds will be sufficient to meet operating and capital expenditure requirements through 2026[490]. - The company expects to finance near-term operations through existing cash and potential equity or debt financing, with no assurances of additional funding availability[519][523]. - The January 2025 Offering is expected to generate approximately $65.5 million in proceeds, which will support ongoing operations[516]. Accounting and Reporting - The company prepares its consolidated financial statements in accordance with U.S. GAAP, requiring estimates and judgments that affect reported amounts of assets and liabilities[534]. - Revenue recognition prior to the discontinuation of RELYVRIO®/ALBRIOZA™ involved significant estimates related to gross-to-net adjustments, which have not materially differed from actual activity to date[536]. - The company estimates accrued research and development expenses based on open contracts and service provider communications, with adjustments made as necessary[539]. - The estimate of accrued research and development expenses relies on timely reporting from third-party service providers, with no material adjustments to prior estimates reported[540]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[543].

Financial Performance - Net loss for Q4 2024 was $37.5 million, or $0.55 per share, compared to a net income of $4.7 million, or $0.07 per share in Q4 2023; for the full year, net loss was $301.7 million, or $4.43 per share, compared to a net income of $49.3 million, or $0.70 per share in 2023[11] - Product revenue for the three months ended December 31, 2024, was $(665,000), compared to $108,449,000 in the same period of 2023, indicating a significant decrease[24] - The net loss for the year ended December 31, 2024, was $(301,743,000), compared to a net income of $49,271,000 in 2023, marking a substantial decline[24] - The company reported a basic net loss per share of $(0.55) for the three months ended December 31, 2024, compared to a profit of $0.07 in the same period of 2023[24] Expenses - Research and development expenses for Q4 2024 were $22.9 million, down from $44.9 million in Q4 2023, and total R&D expenses for the year were $104.1 million compared to $128.2 million in 2023[9] - Selling, general, and administrative expenses for Q4 2024 were $17.1 million, a decrease from $52.2 million in Q4 2023, with total SG&A expenses for the year at $114.3 million compared to $188.4 million in 2023[10] - Total operating expenses for the year ended December 31, 2024, were $402,102,000, up from $341,984,000 in 2023, reflecting an increase of approximately 17.5%[24] - Research and development expenses for the three months ended December 31, 2024, were $22,892,000, compared to $44,914,000 in the same period of 2023, showing a decrease of approximately 48.9%[24] Cash Position - Cash position at December 31, 2024, was $176.5 million, down from $234.4 million at September 30, 2024; the company raised $65.5 million in January 2025, extending the cash runway through the end of 2026[12] - Cash, cash equivalents, and marketable securities decreased to $176,501,000 as of December 31, 2024, down from $371,362,000 in 2023, a decline of approximately 52.5%[22] Clinical Trials and Development - The pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia is underway, with completion of recruitment expected in 2025 and topline data anticipated in the first half of 2026[5] - The LUCIDITY trial will evaluate the FDA-agreed-upon primary outcome of reducing hypoglycemic events through Week 16, with a total of approximately 75 participants[18] - Amylyx appointed Dan Monahan as Chief Commercial Officer to lead the commercialization strategy for avexitide, which is expected to launch in 2027 if approved[6] - The company began the Phase 1 LUMINA clinical trial of AMX0114 for ALS, with dosing expected to begin in March or April 2025[6] - Amylyx plans to share Week 48 data from the ongoing Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in the coming months[12] - The company anticipates the announcement of Week 48 data from the Phase 2 HELIOS trial of AMX0035 for the treatment of Wolfram syndrome in the near future[20] - Amylyx is currently conducting a Phase 3 trial of avexitide for PBH, with expectations regarding recruitment completion and topline data readout[20] - The company is exploring the potential of AMX0114 as a treatment for ALS, with an expected timeline for data readout forthcoming[20] Asset Position - As of December 31, 2024, total assets decreased to $193,634,000 from $517,454,000 in 2023, representing a decline of approximately 62.6%[22] - The company entered into a collaboration with Gubra A/S to develop a novel long-acting GLP-1 receptor antagonist, aiming to identify a lead development candidate for IND-enabling studies[6]

Core Viewpoint - Amylyx Pharmaceuticals, Inc. (AMLX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook driven by an upward trend in earnings estimates [1][4]. Earnings Estimates and Stock Price Impact - The Zacks rating system is primarily based on a company's changing earnings picture, which is crucial for stock price movements [2][5]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, influenced by institutional investors [5][6]. Recent Performance and Analyst Sentiment - Amylyx Pharmaceuticals is projected to earn -$4.29 per share for the fiscal year ending December 2024, reflecting a year-over-year change of -712.9% [9]. - Over the past three months, the Zacks Consensus Estimate for Amylyx has increased by 10.7%, indicating a positive shift in analyst sentiment [9]. Zacks Rating System Overview - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with a proven track record of performance [8][10]. - Only the top 20% of Zacks-covered stocks receive a 'Strong Buy' or 'Buy' rating, highlighting their superior earnings estimate revision features [10][11]. Conclusion - The upgrade of Amylyx Pharmaceuticals to Zacks Rank 2 positions it favorably for potential stock price increases in the near term due to improved earnings outlook [11].

Financial Data and Key Metrics Changes - The company ended Q3 2024 with $234.4 million in cash and investments, maintaining a cash runway expected to last into 2026 [27] - Net product revenues were $400,000 for Q3, with cost of sales at $800,000, both related to discontinued sales of RELYVRIO and ALBRIOZA [28] - Research and development expenses decreased to $21.2 million from $30 million in the same period in 2023, primarily due to reduced clinical expenses and restructuring [28] - Selling, general and administrative expenses were $17.8 million for Q3, down from $48.7 million in the same period in 2023, attributed to lower payroll and consulting costs [29] - The company recorded a net loss of $72.7 million or $1.07 per share for Q3 [31] Business Line Data and Key Metrics Changes - The lead asset, avexitide, is on track for a Phase III trial in post-bariatric hypoglycemia (PBH) expected to start in Q1 2025 [9][15] - Positive topline data from the Phase II HELIOS trial of AMX0035 in Wolfram syndrome showed improvement in pancreatic function and stabilization across secondary endpoints [10][20] - The ORION trial of AMX0035 in progressive supranuclear palsy (PSP) is recruiting well, with interim analysis data expected in mid-2025 [11][23] - The Phase I clinical trial of AMX0114 in ALS is set to begin soon, with early cohort data anticipated in 2025 [24][26] Market Data and Key Metrics Changes - The estimated market size for PBH patients is approximately 160,000, based on literature suggesting that 20% to 40% of bariatric surgery patients may experience abnormal glycemic control [34] - The company plans to engage with the FDA regarding the Phase III program for AMX0035 in Wolfram syndrome, with updates expected in 2025 [22][32] Company Strategy and Development Direction - The company’s pipeline strategy focuses on addressing orphan conditions with clear mechanistic rationales and measurable biomarkers [12] - The acquisition of avexitide is viewed as a significant opportunity, with the company prioritizing its development due to its late-stage status and market potential [60] - The company aims to manage its cash runway effectively to support critical milestones across its pipeline programs [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s financial position and ability to deliver on key milestones ahead [31] - The company remains focused on progressing its pipeline and addressing high unmet needs in neurodegenerative diseases and endocrine conditions [12][32] Other Important Information - The company completed its restructuring plan and does not expect to incur material restructuring expenses going forward [30] - The FDA has provided breakthrough therapy designation and orphan drug designation for avexitide, indicating regulatory support for its development [8] Q&A Session Summary Question: Market size for PBH patients and gating factors for Phase III study - The estimated market for PBH is about 160,000 individuals, with ongoing preparations for the Phase III trial expected to start in Q1 2025 [34][35] Question: Trial design considerations for avexitide - The trial will focus on a composite endpoint of Level 2 and Level 3 hypoglycemia, with a well-established rationale for including both measures [36][47] Question: Concerns about hyperglycemia with avexitide - Management clarified that avexitide is designed to block excess GLP-1 activity, thus not expected to cause hyperglycemia [40][41] Question: FDA's concerns regarding AMX0114 dosing - The FDA deemed the proposed starting dose too high, but the company is confident in the safety profile and plans to address FDA concerns [42][43] Question: Go/no-go decision criteria for PSP trial - The interim analysis will focus on clinical activity in PSP, with established benchmarks for comparison against placebo [50][51]

Drug Development and Clinical Trials - Avexitide has received breakthrough therapy designation from the FDA for both post-bariatric hypoglycemia and congenital hyperinsulinism, impacting approximately 160,000 people in the U.S.[68] - The Phase 3 program for avexitide in post-bariatric hypoglycemia is expected to begin in Q1 2025, with topline data anticipated in 2026[69] - AMX0035 has shown the ability to reduce tau and YKL-40 markers associated with neurodegenerative diseases in clinical trials[70] - The HELIOS trial for AMX0035 in Wolfram syndrome demonstrated a C-peptide response change from baseline of +3.8 min*ng/mL in the Intent to Treat group at Week 24[75] - In the HELIOS trial, 100% of participants met responder criteria for both Clinician Reported Global Impression of Change and Patient Reported Global Impression of Change[76] - The ORION trial for AMX0035 in progressive supranuclear palsy is ongoing, with interim analysis data expected in mid-2025[79] - AMX0114, targeting Calpain-2 for ALS, has shown potent knockdown of CAPN2 mRNA expression in preclinical studies[81] - A Phase 1 trial for AMX0114 in ALS is planned to begin by the end of 2024 or early 2025, evaluating safety and biological activity in approximately 48 adults[82] Financial Performance - Product revenue, net for the three months ended September 30, 2024, was $416,000, a decrease of 100% from $102.7 million in 2023[103] - Total operating expenses for the three months ended September 30, 2024, were $76.1 million, a decrease of 9% from $84.0 million in 2023[103] - Net loss for the three months ended September 30, 2024, was $72.7 million, compared to a net income of $20.9 million in 2023, representing a decrease of 448%[103] - Research and development expenses for the three months ended September 30, 2024, were $21.2 million, down 29% from $30.0 million in 2023[107] - Selling, general and administrative expenses for the three months ended September 30, 2024, were $17.8 million, a decrease of 63% from $48.7 million in 2023[109] - Product revenue, net for the nine months ended September 30, 2024, was $88.0 million, a decrease of 68% from $272.3 million in 2023[113] - Total operating expenses for the nine months ended September 30, 2024, were $362.1 million, an increase of 54% from $235.5 million in 2023[112] - Net loss for the nine months ended September 30, 2024, was $264.2 million, compared to a net income of $44.5 million in 2023, representing a decrease of 693%[112] Restructuring and Financial Strategy - The company announced a restructuring plan in April 2024, reducing its workforce by approximately 70% to focus financial resources on upcoming clinical milestones[87] - The company anticipates a decrease in selling, general, and administrative expenses in 2024 compared to 2023 due to the restructuring plan[98] - The company plans to finance near-term operations through existing cash and may consider equity or debt financing if necessary[89] - The company is exposed to interest rate risk, with cash, cash equivalents, and marketable securities decreasing from $371.4 million as of December 31, 2023, to $234.4 million as of September 30, 2024[140] Research and Development Expenses - Research and development expenses are expected to continue increasing as the company advances AMX0035, avexitide, and AMX0114 through clinical development[96] - The company will continue to incur significant expenses related to the development of avexitide, AMX0035, and AMX0114, including hiring additional personnel and seeking regulatory approval[88] - The company expects to incur significant expenses related to ongoing research and development activities, including clinical trials for AMX0035 and avexitide[124] - Acquired in-process research and development expenses recorded in the three and nine months ended September 30, 2024, were approximately $36.2 million due to the Eiger Acquisition[106][115] Cash and Marketable Securities - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $234.4 million[87] - Operating activities used $108.6 million of cash during the nine months ended September 30, 2024, primarily due to a net loss of $264.2 million[130] - Net cash provided by investing activities was $10.7 million for the nine months ended September 30, 2024, down from $71.1 million in the same period of 2023[129] - The company anticipates that existing cash and marketable securities will be sufficient to meet operating and capital expenditure requirements for at least twelve months following the filing of the Quarterly Report[122] - The company had approximately $27.2 million of remaining obligations under agreements with contract manufacturing organizations as of September 30, 2024[136] Regulatory and Market Changes - The company will not generate revenue from the sale of RELYVRIO/ALBRIOZA in future periods due to the voluntary discontinuation of marketing authorizations based on the failed Phase 3 PHOENIX trial[90] - The NDA for RELYVRIO/ALBRIOZA is now on the Discontinued Drug Product List of the Orange Book, and the company will continue to collect data on survival from the PHOENIX trial[85] - The company has placed AMX0114 on clinical hold due to FDA comments and is working to address these issues[83] - The company recorded an income tax provision of $0.2 million for the nine months ended September 30, 2024, compared to an income tax benefit of $3.3 million for the same period in 2023[120] - Cost of sales for the nine months ended September 30, 2024, were $124.6 million, compared to $16.1 million in 2023, primarily due to inventory write-downs and losses on firm purchase commitments[114] - Restructuring expenses for the nine months ended September 30, 2024, totaled approximately $22.9 million, including $21.9 million for employee severance and termination benefits[119]

Amylyx Pharmaceuticals Reports Third Quarter 2024 Financial Results Exhibit 99.1 • On track to initiate a Phase 3 program for Company's lead asset avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations, in post-bariatric hypoglycemia (PBH) in the first quarter of 2025 • Reported positive topline data from Phase 2 HELIOS clinical trial of AMX0035 in Wolfram syndrome demonstrating improvement or stabilization across all disease measures at Week 24 and sustained impro ...

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]