GICS Sector : Healthcare
Amylyx 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.
Amylyx Pharmaceuticals reported a loss per share of $0.37 in Q3 2025, beating the estimated loss of $0.43 per share. Total operating expenses for the quarter were $36 million, down 53% from the same period in 2024, driven by decreases in both research and development expenses, and selling, general, and administrative expenses, which were $19.9 million and $16.2 million, respectively. The company ended Q3 2025 with $344 million in cash, following a public offering in early September that provided approximately $191 million in net proceeds.
Publication Date: Nov -17
The significant increase in cash is expected to support the potential launch of avexitide in 2027 and provides an anticipated cash runway into 2028. This financing will be crucial as the company advances its lead program, avexitide, through the pivotal Phase III LUCIDITY trial for post-bariatric hypoglycemia (PBH).
The LUCIDITY trial is expected to complete enrollment in Q1 2026, with top-line data anticipated in Q3 2026. Avexitide has FDA breakthrough therapy designation and has shown significant reductions in hypoglycemic events in a Phase IIb trial. The company is also advancing AMX0035 for Wolfram syndrome, with plans to initiate a focused pivotal Phase III trial in the second half of 2026, and AMX0114 for ALS, with Cohort 1 in the Phase I LUMINA trial fully enrolled in September.
The estimated addressable market for PBH patients is 160,000, who are not controlled on diet and experience unacceptable and clinically problematic hypoglycemic events. With a current P/S Ratio of -1586.25, the market is pricing in significant uncertainty around the company's ability to generate revenue. The EV/EBITDA ratio stands at -5.37, indicating that the company's enterprise value is not justified by its current EBITDA, highlighting the need for successful clinical trials and subsequent commercialization.
The company is also exploring the potential use of avexitide for hypoglycemia associated with other GI surgeries, which could potentially expand its market. Analysts estimate next year's revenue growth at -99.9%, indicating a challenging year ahead in terms of revenue generation. However, the successful execution of the LUCIDITY study and potential approval of avexitide could significantly change the company's prospects.
Amylyx Pharmaceuticals, Inc. (AMLX) Presents at Citi Annual Global Healthcare Conference 2025 Transcript
Dec -04
With a 150% Rally and Big 2026 Catalysts Ahead, Is Amylyx Stock Getting a Second Chance?
Dec -03
HALPER SADEH LLC ENCOURAGES GLOBE LIFE INC. SHAREHOLDERS TO CONTACT THE FIRM TO DISCUSS THEIR RIGHTS
Nov -28
This Biotech Fund Has an $85 Million Bet on Amylyx as Stock Surges 180% and Co-CEOs Tease 'Transformational' Year Ahead
Nov -17
Rosen Law Firm Announces Investigation of Breaches of Fiduciary Duties by the Directors and Officers of Amylyx Pharmaceuticals, Inc. – AMLX
Nov -11
Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2025 Earnings Call Transcript
Nov -06
Amylyx Pharmaceuticals Reports Third Quarter 2025 Financial Results
Nov -06
Notice to Long-Term Shareholders of Amylyx Pharmaceuticals, Inc. (AMLX): Grabar Law Office is Investigating Claims on Your Behalf as Securities Fraud Class Action Survives Motion to Dismiss
Nov -04
Relyvrio's 10.27% growth driven by increasing ALS patient adoption, expanded insurance coverage, and strong marketing efforts. Amylyx's strategic partnerships and investments in clinical trials also contribute to growth. Additionally, the drug's unique mechanism of action and favorable safety profile support its rising demand.
AMX0035 is an oral fixed-dose combination of sodium phenylbutyrate and taurursodiol for the treatment of amyotrophic lateral sclerosis (ALS).
AMX0035 is being explored for its potential to treat other neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and Huntington's disease.
Amylyx Pharmaceuticals, Inc. has a moderate threat of substitutes due to the availability of alternative treatments for ALS and other neurodegenerative diseases.
Patients and healthcare providers have limited bargaining power due to the lack of effective treatment options for ALS, giving Amylyx Pharmaceuticals, Inc. an upper hand in pricing and negotiations.
Amylyx Pharmaceuticals, Inc. relies on a few key suppliers for raw materials and manufacturing services, giving them some bargaining power, but the company's strong financial position and diversified supply chain mitigate this risk.
The biotechnology industry is highly competitive, and new entrants with innovative treatments for ALS and other neurodegenerative diseases could potentially disrupt Amylyx Pharmaceuticals, Inc.'s market share.
The biotechnology industry is highly competitive, with multiple companies vying for market share and patent protection for their treatments, leading to a high intensity of rivalry.
| Value | |
|---|---|
| Debt Weight | 0.97% |
| Debt Cost | 3.95% |
| Equity Weight | 99.03% |
| Equity Cost | 0.53% |
| WACC | 0.57% |
| Leverage | 0.98% |
Value: 7.4
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