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Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
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Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

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AMLX

Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

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Neutral 57 (OpenAI - 4o)
Rating:57Neutral
Price Target:
$9.50
▼(-31.26% Downside)
Amylyx Pharmaceuticals' overall stock score is primarily impacted by its financial performance challenges, including declining revenues and operational losses. While technical analysis shows positive momentum, the company's valuation is weak due to a negative P/E ratio and lack of dividends. The recent halt of the ORION program further adds to the uncertainty, despite some positive developments in other clinical trials.
Positive Factors
Pipeline Expansion
The Fast Track designation for AMX0114 indicates regulatory support and could expedite the development process, enhancing long-term growth prospects.
Strong Financial Position
A robust cash position ensures operational stability and supports ongoing R&D efforts, crucial for future product development and market expansion.
Clinical Trial Progress
Advancement in clinical trials like LUCIDITY for Avexitide demonstrates progress in expanding the product pipeline, essential for long-term revenue growth.
Negative Factors
Revenue Decline
A sharp decline in revenue suggests challenges in product sales and market penetration, impacting the company's ability to sustain operations long-term.
Discontinuation of ORION Program
Halting the ORION program reduces the company's potential product offerings and revenue streams, affecting future growth and market competitiveness.
Cash Flow Challenges
Persistent cash flow issues indicate operational inefficiencies and may limit the company's ability to invest in R&D and other growth initiatives.

Amylyx Pharmaceuticals Inc (AMLX) vs. SPDR S&P 500 ETF (SPY)

Amylyx Pharmaceuticals Inc Business Overview & Revenue Model

Company DescriptionAmylyx Pharmaceuticals Inc (AMLX) is a biotechnology company focused on developing innovative therapies for neurodegenerative diseases, with a primary emphasis on conditions such as amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The company is committed to advancing its lead product, AMX0035, which aims to slow the progression of neurodegenerative disorders by targeting multiple pathways involved in cellular stress and neuroinflammation. Through its scientific expertise and dedication to addressing unmet medical needs, Amylyx is positioned at the forefront of neurotherapeutics.
How the Company Makes MoneyAmylyx Pharmaceuticals generates revenue primarily through the commercialization of its therapeutic products, particularly AMX0035, which has received regulatory approval for use in ALS patients. The company may also explore partnerships with larger pharmaceutical firms for co-development or licensing agreements to expand its product offerings and market reach. Additionally, revenue can be supplemented through grants and funding from governmental and non-governmental organizations aimed at fostering innovation in the biotech sector. As Amylyx progresses through clinical trials and achieves regulatory milestones, it may also benefit from milestone payments from partners, further contributing to its earnings.

Amylyx Pharmaceuticals Inc Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Positive
The earnings call was overall positive, with significant progress reported in clinical trials and pipeline expansion. Financial management shows a strong cash position, although there are challenges related to market education and cash flow reduction.
Q2-2025 Updates
Positive Updates
Progress in Avexitide Clinical Trials
The Phase III LUCIDITY trial for Avexitide is underway, with recruitment expected to be completed by year-end and data expected in the first half of 2026.
Strong Financial Position
The company ended the second quarter with $180.8 million in cash, down from $204.1 million, but sufficient to fund operations through 2026.
Pipeline Expansion
AMX0114 received Fast Track designation from the FDA and is progressing in the Phase I LUMINA trial for ALS.
Phase IIb/III ORION Trial for AMX0035
The trial is ongoing for progressive supranuclear palsy, with top-line data expected this quarter.
Reduction in Operating Expenses
Operating expenses were significantly reduced by 43% compared to the same period in 2024.
Negative Updates
Decrease in Cash Position
Cash decreased from $204.1 million to $180.8 million during the quarter.
Operating Losses
The company reported total operating expenses of $42.9 million, which, while reduced, still represents a significant expenditure.
Challenges in Market Education
The need for further education of primary care physicians and the lack of an ICD-10 code for PBH were identified as challenges.
Company Guidance
During the Amylyx Pharmaceuticals Second Quarter 2025 earnings call, guidance was provided on several key metrics and timelines. The company plans to complete recruitment for the Phase III LUCIDITY trial of Avexitide by the end of 2025, with top-line data expected in the first half of 2026. The trial focuses on post-bariatric hypoglycemia, a condition affecting an estimated 160,000 individuals in the U.S. Additionally, the company anticipates top-line data from the Phase IIb portion of the ORION trial for progressive supranuclear palsy (PSP) this quarter, a condition affecting approximately 23,000 people in the U.S. Amylyx also expects early cohort data from the Phase I LUMINA trial of AMX0114, targeting amyotrophic lateral sclerosis, by the end of the year. Financially, the company reported a cash position of $180.8 million at the end of Q2, with operating expenses of $42.9 million, and anticipates a cash runway through the end of 2026.

Amylyx Pharmaceuticals Inc Financial Statement Overview

Summary
Amylyx Pharmaceuticals faces significant financial challenges, with declining revenues and substantial operational losses reflected in negative profit margins. The balance sheet shows a relatively low level of debt and strong equity ratio, although historical negative equity points to potential financial instability. Cash flow analysis reveals persistent cash generation issues, which could impact future operational sustainability.
Income Statement
40
Negative
The company's revenue showed a significant decrease from 2023 to 2024, indicating a revenue growth rate of -77.05%. Despite having a gross profit margin of 51.76% in 2024, the net profit margin was highly negative at -345.20%, reflecting substantial operational losses. The EBIT and EBITDA margins were also negative, highlighting ongoing profitability challenges.
Balance Sheet
55
Neutral
Amylyx Pharmaceuticals maintains a low debt-to-equity ratio of 0.01, suggesting minimal reliance on debt. However, the company has a strong equity ratio of 85.10%, indicating that a majority of the assets are financed by shareholders' equity. Despite this, the company has consistently reported negative equity in previous years, pointing to financial instability risks.
Cash Flow
35
Negative
The company experienced a decline in free cash flow from 2023 to 2024, with a negative growth rate of -1671.46%. The operating cash flow to net income ratio is negative, reflecting operational inefficiencies. This indicates ongoing cash flow challenges, as the company is not generating sufficient cash from operations to cover its expenses.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue-249.00K87.37M380.79M22.23M285.00K650.00K
Gross Profit-1.36M-37.26M355.35M19.24M233.00K-23.94M
EBITDA-194.88M-290.98M39.89M-200.85M-82.64M-39.00M
Net Income-187.60M-301.74M49.27M-198.38M-87.88M-44.84M
Balance Sheet
Total Assets194.60M193.63M517.45M391.45M105.61M14.10M
Cash, Cash Equivalents and Short-Term Investments180.83M176.50M371.36M346.94M96.12M12.88M
Total Debt5.96M1.98M4.24M6.28M0.001.43M
Total Liabilities26.72M28.87M84.02M50.85M256.78M80.83M
Stockholders Equity167.88M164.76M433.43M340.61M-151.17M-66.72M
Cash Flow
Free Cash Flow-165.68M-167.80M10.68M-182.40M-75.15M-36.85M
Operating Cash Flow-165.65M-167.65M11.92M-179.87M-74.80M-36.70M
Investing Cash Flow83.13M75.65M92.05M-238.99M-46.41M-151.00K
Financing Cash Flow65.82M348.00K3.54M431.79M158.51M46.82M

Amylyx Pharmaceuticals Inc Technical Analysis

Technical Analysis Sentiment
Positive
Last Price13.82
Price Trends
50DMA
9.58
Positive
100DMA
7.64
Positive
200DMA
5.73
Positive
Market Momentum
MACD
1.30
Negative
RSI
84.99
Negative
STOCH
90.15
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Positive. The current price of 13.82 is above the 20-day moving average (MA) of 11.63, above the 50-day MA of 9.58, and above the 200-day MA of 5.73, indicating a bullish trend. The MACD of 1.30 indicates Negative momentum. The RSI at 84.99 is Negative, neither overbought nor oversold. The STOCH value of 90.15 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AMLX.

Amylyx Pharmaceuticals Inc Risk Analysis

Amylyx Pharmaceuticals Inc disclosed 89 risk factors in its most recent earnings report. Amylyx Pharmaceuticals Inc reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Amylyx Pharmaceuticals Inc Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
67
Neutral
534.47M-130.86-15.65%85.40%40.95%
58
Neutral
854.00M-4.40-50.24%
57
Neutral
$1.48B-87.42%-100.08%-2.45%
47
Neutral
369.87M-10.9183.28%
46
Neutral
272.91M-1.08-61.01%-100.00%30.91%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
13.82
10.74
348.70%
BNTC
Benitec Biopharma
13.80
4.57
49.51%
CKPT
Checkpoint Therapeutics
4.26
2.01
89.33%
ALLO
Allogene Therapeutics
1.20
-1.71
-58.76%
ETON
Eton Pharmaceuticals
20.14
14.34
247.24%
ZBIO
Zenas BioPharma, Inc.
18.62
1.48
8.63%

Amylyx Pharmaceuticals Inc Corporate Events

Product-Related Announcements
Amylyx Pharmaceuticals Halts ORION Program for AMX0035
Negative
Aug 27, 2025

On August 27, 2025, Amylyx Pharmaceuticals announced the discontinuation of its ORION program for AMX0035 in adults with progressive supranuclear palsy, as the drug showed no significant differences compared to placebo in primary or secondary outcomes at Week 24. Consequently, the company will halt the Phase 2b trial and open-label extension, and will not proceed with the Phase 3 portion, although safety data remained consistent with previous studies.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 28, 2025