tiprankstipranks
Trending News
More News >
Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
US Market
Advertisement

Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

Compare
641 Followers

Top Page

AMLX

Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

Select Model
Select Model
Select Model
Neutral 47 (OpenAI - 4o)
Rating:47Neutral
Price Target:
$13.00
▲(5.61% Upside)
The overall stock score is primarily influenced by significant financial challenges, including declining revenues and operational losses. While the technical analysis shows some potential for upward momentum, the valuation remains unattractive due to a negative P/E ratio and no dividend yield. The earnings call provided some positive sentiment, but operational delays pose risks. The company's financial instability and cash flow issues are the most significant factors impacting the score.
Positive Factors
Strong Cash Position
A robust cash position provides financial stability and flexibility to fund ongoing R&D and operational activities, supporting long-term growth.
FDA Breakthrough Therapy Designation
This designation can expedite the development and review process, potentially accelerating time to market and enhancing competitive positioning.
Decrease in Operating Expenses
Reduced operating expenses improve financial efficiency, allowing more resources to be allocated to strategic initiatives and R&D.
Negative Factors
Declining Revenue
A sharp decline in revenue growth can hinder the ability to fund operations and innovation, posing a risk to long-term sustainability.
Operational Losses
Sustained operational losses can erode financial health, limiting the company's ability to invest in growth and respond to market changes.
Cash Flow Challenges
Persistent cash flow issues can strain financial resources, affecting the company's ability to sustain operations and invest in future growth.

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:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Apr 01, 2026
Earnings Call Sentiment Positive
The earnings call reflects a generally positive sentiment with strong financial performance and progress across multiple programs. However, there is a noted delay in the LUCIDITY trial enrollment, indicating some operational challenges. The urgency and unmet need in the PBH market further underscore the importance of avexitide's development.
Q3-2025 Updates
Positive Updates
Strong Financial Position
Amylyx Pharmaceuticals ended the third quarter with a cash position of $344 million, up from $181 million at the end of the second quarter, due to the completion of a public offering in September which provided approximately $191 million of net proceeds.
Advancement in ALS Program
The company fully enrolled Cohort 1 in the Phase I LUMINA trial for AMX0114 and plans to share safety data at an upcoming ALS and MMD symposium. Biomarker data is anticipated to be available in the coming months.
Decrease in Operating Expenses
Total operating expenses for the quarter were $36 million, down 53% from the same period in 2024, primarily due to decreased onetime expenses related to the acquisition of avexitide.
FDA Breakthrough Therapy Designation for Avexitide
Avexitide, the company's investigational inhibitor of GLP-1 receptor activity, continues to progress with high participant interest in the LUCIDITY trial, and has FDA breakthrough therapy designation.
Negative Updates
Delay in Avexitide LUCIDITY Trial Enrollment
The completion of recruitment for the LUCIDITY trial is now expected in Q1 2026, delayed from the original timeline of the end of 2025, due to a slower than anticipated ramp in enrollment rate.
Unmet Needs in PBH Market
Despite the identified market of approximately 160,000 individuals with PBH in the U.S., there is a significant unmet need due to the lack of an FDA-approved therapy, highlighting the urgency for avexitide's approval.
Company Guidance
During the Amylyx Pharmaceuticals third quarter earnings call, the company provided updated guidance on several key metrics and timelines. They announced a delay in the completion of recruitment for the Phase III LUCIDITY trial of avexitide for post-bariatric hypoglycemia (PBH) to Q1 2026, with top-line data now expected in Q3 2026, instead of the previously anticipated end of 2025. They remain on track for a potential launch of avexitide in 2027, pending FDA approval. The company reported a strong cash position of $344 million, bolstered by a public offering that raised $191 million, and an anticipated cash runway into 2028. Operating expenses for Q3 were $36 million, down 53% from the same period in 2024, primarily due to one-time expenses incurred in the prior year. Additionally, Amylyx plans to initiate a Phase III trial for AMX0035 in Wolfram syndrome in the second half of 2026, and they are progressing with the Phase I LUMINA trial for AMX0114 in ALS, with early cohort safety data expected to be presented in December.

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. The company needs to address its declining revenue and improve operational efficiency to enhance financial health.
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-665.00K87.37M380.79M22.23M285.00K650.00K
Gross Profit-966.00K45.22M355.35M19.24M233.00K-23.94M
EBITDA-155.47M-290.98M39.89M-200.85M-82.64M-39.00M
Net Income-149.28M-301.74M49.27M-198.38M-87.88M-44.84M
Balance Sheet
Total Assets362.74M193.63M517.45M391.45M105.61M14.10M
Cash, Cash Equivalents and Short-Term Investments343.99M176.50M371.36M346.94M96.12M12.88M
Total Debt5.93M1.98M4.24M6.28M0.001.43M
Total Liabilities30.75M28.87M84.02M50.85M256.78M80.83M
Stockholders Equity332.00M164.76M433.43M340.61M-151.17M-66.72M
Cash Flow
Free Cash Flow-154.52M-167.80M10.68M-182.40M-75.15M-36.85M
Operating Cash Flow-154.45M-167.65M11.92M-179.87M-74.80M-36.70M
Investing Cash Flow49.55M75.65M92.05M-238.99M-46.41M-151.00K
Financing Cash Flow257.35M348.00K3.54M431.79M158.51M46.82M

Amylyx Pharmaceuticals Inc Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price12.31
Price Trends
50DMA
13.19
Negative
100DMA
10.43
Positive
200DMA
7.30
Positive
Market Momentum
MACD
-0.12
Positive
RSI
35.93
Neutral
STOCH
12.90
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Neutral. The current price of 12.31 is below the 20-day moving average (MA) of 14.20, below the 50-day MA of 13.19, and above the 200-day MA of 7.30, indicating a neutral trend. The MACD of -0.12 indicates Positive momentum. The RSI at 35.93 is Neutral, neither overbought nor oversold. The STOCH value of 12.90 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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
83
Outperform
$1.78B9.9025.93%21.13%50.86%
55
Neutral
$1.32B-10.20-28.57%-42.64%-39.78%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$1.33B-56.52%-100.34%52.85%
46
Neutral
$1.48B45.38%92.85%
42
Neutral
$1.40B-63.96%-36.92%
40
Underperform
$902.40M-295.94%16.36%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
12.31
5.28
75.11%
BCRX
BioCryst
7.09
-1.10
-13.43%
DNTH
Dianthus Therapeutics
36.28
8.53
30.74%
HRMY
Harmony Biosciences Holdings
31.43
-4.48
-12.48%
PHVS
Pharvaris
21.59
0.34
1.60%
BHVN
Biohaven Ltd.
8.26
-44.17
-84.25%

Amylyx Pharmaceuticals Inc Corporate Events

Amylyx Pharmaceuticals Advances Phase 3 Study for Post-Bariatric Hypoglycemia Treatment
Oct 27, 2025

Amylyx Pharmaceuticals, Inc. is conducting a Phase 3 study titled A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia. The study aims to assess the efficacy and safety of avexitide, a treatment for post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass, by measuring the reduction of hypoglycemic events.

Amylyx Pharmaceuticals Advances ALS Treatment with Promising Study Update
Oct 27, 2025

Study Overview: Amylyx Pharmaceuticals, Inc. is conducting a Phase 1 study titled Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis. The primary aim is to assess the safety and tolerability of AMX0114, a promising treatment for ALS, a debilitating neurodegenerative disease.

Private Placements and Financing
Amylyx Pharmaceuticals Announces $164 Million Stock Offering
Neutral
Sep 10, 2025

On September 9, 2025, Amylyx Pharmaceuticals, Inc. announced an underwriting agreement to issue and sell 17,500,000 shares of its common stock at $10.00 per share, potentially raising approximately $164.0 million. The proceeds are intended for advancing avexitide commercial readiness, research and development, and general corporate purposes, with the offering expected to close on September 11, 2025.

The most recent analyst rating on (AMLX) stock is a Buy with a $12.00 price target. To see the full list of analyst forecasts on Amylyx Pharmaceuticals Inc stock, see the AMLX Stock Forecast page.

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.

The most recent analyst rating on (AMLX) stock is a Hold with a $8.00 price target. To see the full list of analyst forecasts on Amylyx Pharmaceuticals Inc stock, see the AMLX Stock Forecast page.

Amylyx Pharmaceuticals Advances Phase 3 Study on Avexitide for Post-Bariatric Hypoglycemia
Aug 22, 2025

Amylyx Pharmaceuticals, Inc. is conducting a Phase 3 study titled A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia. The study aims to assess the efficacy and safety of avexitide, a treatment for post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery, by comparing it to a placebo. The significance lies in addressing PBH, a condition affecting patients post-surgery, by reducing hypoglycemic events.

Amylyx Pharmaceuticals’ Promising Earnings Call Highlights
Aug 13, 2025

Amylyx Pharmaceuticals’ latest earnings call paints a promising picture for the company’s future. The sentiment expressed during the call was largely positive, highlighting significant progress in clinical trials for their key drugs, Avexitide and AMX0035, as well as financial stability through reduced expenses. Despite some challenges in cash management and market education, the overall outlook remains optimistic, driven by advancements in drug development and effective financial management.

Amylyx Pharmaceuticals: Progress in Trials and Financials
Aug 8, 2025

Amylyx Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing innovative therapies for neurodegenerative and endocrine diseases. The company is known for its investigational therapies such as avexitide and AMX0035.

Amylyx Pharmaceuticals Advances ALS Treatment with AMX0114 Clinical Trial
Aug 7, 2025

Amylyx Pharmaceuticals, Inc. is conducting a Phase 1 clinical trial titled Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis. The study aims to assess the safety and tolerability of AMX0114, an antisense oligonucleotide, in adults with amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease.

Amylyx Pharmaceuticals’ Phase 3 Study on Avexitide: A Potential Game-Changer for Post-Bariatric Hypoglycemia
Aug 7, 2025

Amylyx Pharmaceuticals, Inc. (AMLX) is conducting a Phase 3 study titled A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia. The study aims to assess the safety and efficacy of avexitide in reducing hypoglycemic events in patients who have undergone Roux-en-Y gastric bypass surgery and suffer from post-bariatric hypoglycemia (PBH). This study holds significant potential for improving patient outcomes in this niche but impactful area.

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: Nov 06, 2025