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Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
US Market

Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

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AMLX

Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

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Neutral 56 (OpenAI - 5.2)
Rating:56Neutral
Price Target:
$15.00
▲(1.01% Upside)
The score is held back primarily by weak financial performance (negative TTM revenue, large losses, and heavy cash burn) despite low leverage. Technicals are supportive with an uptrend, but overbought momentum signals add near-term risk. Earnings call factors are moderately positive due to strong cash and pipeline progress, partially offset by a key trial timeline delay. Valuation is pressured by negative earnings and no dividend support.
Positive Factors
Low Leverage / Balance Sheet Flexibility
Extremely low debt provides durable financial flexibility to fund clinical programs and absorb trial setbacks without near-term insolvency risk. This reduces bankruptcy risk and preserves strategic optionality for partnerships or selective financing over the next 2–6 months.
Strong Cash Position and Recent Financing
A $344M cash balance, bolstered by a $191M offering, materially extends runway into 2028 per management, lowering near-term refinancing pressure. This supports multiple Phase III/Phase I activities and lowers the odds of disruptive dilutive funding needs in the medium term.
Regulatory Recognition for Lead Asset
Breakthrough designation signals expedited review and regulatory priority for avexitide, improving the odds of faster approval and market access if trials succeed. That structural regulatory support enhances the commercial potential and de-risks part of the clinical development path.
Negative Factors
High Ongoing Cash Burn
Sustained negative operating and free cash flow of ~-$154M TTM erodes cash reserves and increases dependency on external financing if burn continues. Over several quarters this pressures strategic flexibility and may force dilution or spending cuts that could delay programs.
Revenue Collapse and Large Losses
A swing from prior profitability to negative TTM revenue and large losses indicates fragile earnings quality and lack of durable product revenues. This structural weakness undermines self-funding, raises execution risk, and makes future operating plans contingent on financing or successful approvals.
Delay in Key Phase III Trial
Slower enrollment and a pushed topline to Q3 2026 delays potential approval and revenue realization for a core program. The structural impact includes prolonged development costs, longer uncertainty for commercialization timing, and greater exposure to competitive or regulatory changes.

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

Amylyx Pharmaceuticals Inc Business Overview & Revenue Model

Company DescriptionAmylyx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, engages in developing various therapeutics for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. The company's product pipeline includes AMX0035, a dual UPR-Bax apoptosis inhibitor composed of sodium phenylbutyrate and taurursodiol for the treatment of amyotrophic lateral sclerosis. It is also developing AMX0035 for other neurodegenerative diseases. The company was founded in 2013 and is headquartered in Cambridge, Massachusetts.
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
Balance sheet strength (very low leverage) is a key positive, but it is outweighed by sharply deteriorated operating results: TTM revenue turned negative, losses remain large, and cash flow is deeply negative with ongoing free-cash-flow burn.
Income Statement
18
Very Negative
Performance has deteriorated sharply. In TTM (Trailing-Twelve-Months), revenue turned negative (-$0.7M) versus $87.4M in 2024 and $380.8M in 2023, while losses remain very large (TTM net loss -$149.3M; 2024 net loss -$301.7M). Profitability is highly unstable year-to-year (2023 was profitable with $49.3M net income, but 2024 and TTM reverted to deep losses), suggesting weak earnings quality/visibility and a business model currently not covering its cost base.
Balance Sheet
72
Positive
Leverage is very low, which is a key strength: TTM debt is $5.9M against $332.0M of equity (debt-to-equity ~0.02), providing balance sheet flexibility. Assets remain sizable (TTM $362.7M), but profitability pressure is eroding returns (TTM return on equity about -0.69; 2024 about -1.83), so the main risk is continued losses reducing the equity cushion over time despite limited debt.
Cash Flow
24
Negative
Cash generation is weak and consistently negative. TTM operating cash flow is -$154.4M and free cash flow is -$154.5M, following -$167.6M and -$167.8M in 2024, indicating ongoing cash burn. Free cash flow has not shown sustained improvement (TTM free cash flow growth -6.7% after 2024 at -16.7%), which increases dependency on existing cash reserves and/or future financing if burn persists.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue-665.00K87.37M380.79M22.23M0.00650.00K
Gross Profit-20.66M45.22M355.35M19.24M0.00-23.94M
EBITDA-153.71M-290.98M39.89M-200.85M-82.64M-39.00M
Net Income-149.28M-301.74M49.27M-198.38M-87.93M-42.28M
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
Positive
Last Price14.85
Price Trends
50DMA
13.53
Positive
100DMA
13.49
Positive
200DMA
10.02
Positive
Market Momentum
MACD
0.70
Negative
RSI
55.94
Neutral
STOCH
41.14
Neutral
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 14.85 is above the 20-day moving average (MA) of 13.72, above the 50-day MA of 13.53, and above the 200-day MA of 10.02, indicating a bullish trend. The MACD of 0.70 indicates Negative momentum. The RSI at 55.94 is Neutral, neither overbought nor oversold. The STOCH value of 41.14 is Neutral, 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
81
Outperform
$2.12B11.6125.93%21.13%50.86%
56
Neutral
$1.59B-8.25-56.52%-100.34%52.85%
56
Neutral
$2.17B-15.28-28.57%-42.64%-39.78%
56
Neutral
$1.78B-8.64-51.81%-20.08%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$1.65B-141.0145.38%92.85%
48
Neutral
$1.77B-1.59-522.08%18.76%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
14.85
11.34
323.08%
BCRX
BioCryst
6.67
-1.20
-15.25%
DNTH
Dianthus Therapeutics
53.36
31.59
145.11%
HRMY
Harmony Biosciences Holdings
36.86
-2.68
-6.78%
PHVS
Pharvaris
27.79
10.06
56.74%
BHVN
Biohaven Ltd.
12.10
-26.90
-68.97%

Amylyx Pharmaceuticals Inc Corporate Events

Business Operations and StrategyProduct-Related Announcements
Amylyx Advances AMX0318 as New Rare-Disease Candidate
Positive
Jan 8, 2026

On January 8, 2026, Amylyx Pharmaceuticals selected AMX0318, a long-acting GLP-1 receptor antagonist discovered under its collaboration with peptide drug specialist Gubra A/S, as a development candidate for post-bariatric hypoglycemia and other rare diseases, triggering a $4 million milestone payment and positioning Gubra to earn more than $50 million in additional development and commercialization milestones plus mid-single-digit royalties on worldwide sales. The company also updated its corporate presentation in January 2026 to highlight a growing rare-disease pipeline led by avexitide, which is in a Phase 3 LUCIDITY trial for PBH with topline data expected in the third quarter of 2026 and a potential 2027 launch, while earlier clinical data have shown avexitide can sharply reduce hypoglycemic events in PBH patients, underscoring Amylyx’s strategic push to build a leading franchise in GLP-1 pathway modulation for underserved endocrine and neurodegenerative indications.

The most recent analyst rating on (AMLX) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Amylyx Pharmaceuticals Inc stock, see the AMLX Stock Forecast page.

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: Jan 21, 2026