Amylyx Pharmaceuticals, Inc. (AMLX) SEC Filings & Earnings Calls
EquiReason read 15 Amylyx Pharmaceuticals, Inc. SEC filings in the last 12 months. Latest: 8-K on 2026-09-08 — Amylyx entered manufacturing and supply agreements with Bachem and Polypeptide for avexitide drug substance; $30M upfront fee to Polypeptide for capacity reservation..
Source: SEC EDGAR filings · figures as of 2026-06-30 · read by EquiReason
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Every filing, read
last 12 months · SECWhat happened, the numbers inside, guidance and risks. The original is one click away.
8 Sep 20268-K · 1.01Amylyx entered manufacturing and supply agreements with Bachem and Polypeptide for avexitide drug substance; $30M upfront fee to Polypeptide for capacity reservation.open
Figures in the filing · each found in the filing text
| upfront fee · 2026-09-01 | $30M |
Risks flagged
Dependence on avexitide regulatory approval; manufacturing agreements are contingent on commercialization.
“Manufacturing agreements for avexitide drug substance for commercial use, if approved.”
18 Aug 20268-K · 8.01Positive topline results from LUCIDITY Phase 3 trial of avexitide in post-bariatric hypoglycemia; investor presentation attached.open
Risks flagged
Regulatory and commercial risk for avexitide approval and market adoption
“Phase 3 results positive but regulatory approval and commercialization still pending”
18 Aug 20268-K · 7.01, 8.01Amylyx announced positive Phase 3 LUCIDITY topline results for avexitide in post-bariatric hypoglycemia: met primary endpoint with 55% reduction in hypoglycemic events (p=0.000003); all secondary endpoints met; NDA submission planned by yeaopen
Figures in the filing · each found in the filing text
| reduction in composite rate of Level 2 and Level 3 hypoglycemic events · avexitide · Q3-2026 | 55.0% |
Risks flagged
Regulatory and commercial risks remain; NDA approval not guaranteed; competition from other GLP-1 therapies.
“Amylyx plans to submit an NDA for avexitide with the FDA by year-end; avexitide has Breakthrough Therapy and Orphan Drug Designations.” · word for word
6 Aug 202610-QAmylyx reported Q2 2026 net loss of $43.4M, slightly wider than prior year, with significant cash burn and no revenue.earningsopen
Figures in the filing · each found in the filing text
| Net loss · Q2-2026 | $-43M | +5% y/y |
| Cash and cash equivalents · Q2-2026 | $49M | -78% y/y |
| Research and development expense · Q2-2026 | $24M | -13% y/y |
| Selling, general and administrative expense · Q2-2026 | $22M | +40% y/y |
| Interest income · Q2-2026 | $2M | +19% y/y |
| Net loss per share - basic and diluted · Q2-2026 | $-0.39 | -15% y/y |
Risks flagged
Cash runway risk
“Cash and cash equivalents decreased from $226.7M to $49.3M in six months; operating cash flow used $68.3M in H1 2026.”
Litigation risk
“Securities class action and derivative lawsuits pending; settlement reached for $6.5M for class claims, but derivative suits not yet resolved.”
Clinical trial risk
“Phase 3 LUCIDITY trial topline data expected Q3 2026; failure would be material.”
No approved products
“Company is a clinical-stage pharmaceutical company with no approved products and no revenue.”
6 Aug 20268-K · 2.02Research and development expenses $24M (-12% y/y)earningsopen
Figures in the filing · each found in the filing text
| Research and development expenses · Q2-2026 | $24M | -13% y/y |
Risks flagged
Clinical trial risk: Phase 3 LUCIDITY topline data pending; failure could impact pipeline value.
“Topline data readout for the Phase 3 LUCIDITY clinical trial of avexitide in PBH is on track and anticipated in late August or early September 2026” · word for word
Pre-revenue biotech with no approved products; dependent on clinical success and regulatory approval.
“If approved, commercial launch of avexitide is anticipated in 2027” · word for word
7 May 20268-K · 2.02Net loss $-41M (+15% y/y); Research and development expenses $28M (+25% y/y); Selling, general, and administrative expenses $16M (+3% y/y)earningsopen
Figures in the filing · each found in the filing text
| Net loss · Q1-2026 | $-41M | +15% y/y |
| Research and development expenses · Q1-2026 | $28M | +25% y/y |
| Selling, general, and administrative expenses · Q1-2026 | $16M | +3% y/y |
| Cash, cash equivalents, and short-term investments · Q1-2026 | $280M |
Risks flagged
Clinical trial risk: Phase 3 LUCIDITY topline data pending; failure could impact pipeline value.
“Topline data readout for Phase 3 LUCIDITY clinical trial of avexitide in PBH is on track and anticipated in the third quarter of 2026” · word for word
Pre-revenue biotech with no approved products; dependent on clinical success and regulatory approval.
“If approved, commercial launch of avexitide is anticipated in 2027” · word for word
7 May 202610-QCash and cash equivalents $229M; Marketable securities $51M; Net loss $-41Mopen
Figures in the filing · each found in the filing text
| Cash and cash equivalents · Q1-2026 | $229M | |
| Marketable securities · Q1-2026 | $51M | |
| Net loss · Q1-2026 | $-41M | |
| Net loss per share — basic and diluted · Q1-2026 | $-0.37 | |
| Research and development expenses · Q1-2026 | $28M | |
| Selling, general and administrative expenses · Q1-2026 | $16M | |
| Interest income · Q1-2026 | $3M | |
| Operating cash flow · Q1-2026 | $-37M | |
| Free cash flow · Q1-2026 | $-37M |
Risks flagged
Clinical trial failure risk
“The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the outcome of preclinical studies and clinical trials.” · word for word
Regulatory approval risk
“Potential difficulties with or delays in timing with respect to regulatory approval processes.” · word for word
Funding risk
“The Company may need to obtain substantial additional funding through public or private equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements in order to fund its research and development and ongoing operating expenses.” · word for word
Litigation risk
“The parties have reached an agreement in principle to settle the class claims, subject to court approval, for $6.5 million, a significant portion of which will be funded by insurance proceeds.” · word for word
Supply chain risk
“The Company and its contractors may experience disruptions in supply of items that are essential for its research and development activities, including, for example, raw materials and bulk drug substances that the Company imports from Europe and Canada used in the manufacturing of AMX0035 and any additional or future product candidates.” · word for word
23 Apr 2026DEF 14ANet Income $-145M; Net Income $-302M; Net Income $49Mopen
Figures in the filing · each found in the filing text
| Net Income · FY2025 | $-145M | |
| Net Income · FY2024 | $-302M | |
| Net Income · FY2023 | $49M | |
| Total Shareholder Return · FY2025 | $67.00 | |
| Total Shareholder Return · FY2024 | $21.00 | |
| Total Shareholder Return · FY2023 | $81.00 |
24 Mar 20268-K · 7.01Issued a Regulation FD disclosure (forward guidance or material update); filed financial statements and exhibits with this reportopen
Risks flagged
Clinical trial risk; no new financial data.
“No financial metrics or guidance provided.”
3 Mar 202610-KRisks named: Clinical trial failure risk, Patent expiration riskopen
Risks flagged
Clinical trial failure risk
“Our ability to obtain regulatory approvals of avexitide in post-bariatric hypoglycemia, or PBH, or any other indications...” · word for word
Patent expiration risk
“The issued patents and others that issue from this family may first begin to expire as early as May 23, 2026...” · word for word
3 Mar 20268-K · 2.02Released earnings results and quarterly financials; filed financial statements and exhibits with this reportearningsopen
Risks flagged
Clinical trial risk: Phase 3 LUCIDITY trial results are pivotal for regulatory approval and commercialization.
“topline data anticipated in Q3 2026” · word for word
8 Jan 20268-K · 7.01, 8.01Milestone payments $4Mopen
Figures in the filing · each found in the filing text
| milestone payments | $4M |
Risks flagged
Development candidate still preclinical; regulatory and clinical risks ahead.
“AMX0318 expected to advance into IND-enabling studies in 2026, IND expected in 2027.”
6 Nov 202510-QNet loss $-34M; Cash and cash equivalents $225M; Marketable securities $119Mopen
Figures in the filing · each found in the filing text
| Net loss · Q3-2025 | $-34M | |
| Cash and cash equivalents · 2025-09-30 | $225M | |
| Marketable securities · 2025-09-30 | $119M | |
| Research and development expenses · Q3-2025 | $20M | -7% y/y |
| Selling, general and administrative expenses · Q3-2025 | $16M | -9% y/y |
| Net cash used in operating activities · 9M-2025 | $-95M | |
| Net cash provided by financing activities · 9M-2025 | $257M | |
| Weighted-average shares outstanding - basic and diluted · Q3-2025 | 93,332,930 | +37% y/y |
| Interest income · Q3-2025 | $2M | -41% y/y |
Risks flagged
Clinical trial failure risk
“The Company is a clinical-stage pharmaceutical company with no approved products and relies on successful clinical trials for avexitide, AMX0035, and AMX0114.” · word for word
Supply chain disruption risk
“The Company and its contractors may experience disruptions in supply of items that are essential for its research and development activities, including raw materials and bulk drug substances imported from Europe and Canada.” · word for word
Litigation risk
“A putative class action lawsuit and derivative complaints have been filed alleging false and misleading statements related to RELYVRIO; the motion to dismiss was denied in part.”
Funding risk
“The Company expects to continue to generate operating losses and may need additional funding; however, current cash is sufficient for at least 12 months.” · word for word
6 Nov 20258-K · 2.02Net loss $-41M; Cash, cash equivalents, and investments $277M; Research and development expenses $20M; Guidance: Cash runway into 2028earningsopen
Figures in the filing · each found in the filing text
| Net loss · Q3-2025 | $-41M | |
| Cash, cash equivalents, and investments · Q3-2025 | $277M | |
| Research and development expenses · Q3-2025 | $20M |
Guidance
Cash runway into 2028
Cash runway guidance reaffirmed; no revenue guidance.
Risks flagged
Clinical-stage biotech with no approved products; significant reliance on pipeline success.
“Pre-revenue; net loss $41.4M; cash burn significant.”
Amylyx Pharmaceuticals, Inc. — questions
- What did Amylyx Pharmaceuticals, Inc. file recently?
- 15 SEC filings in the last 12 months. Latest: 8-K on 2026-09-08 — Amylyx entered manufacturing and supply agreements with Bachem and Polypeptide for avexitide drug substance; $30M upfront fee to Polypeptide for capacity reservation.
Every figure on this page comes from Amylyx Pharmaceuticals, Inc.'s own SEC filings — see them on SEC EDGAR. Price data is licensed and shown only inside the product.
How these figures are read: methodology · EquiReason.