What changed in this filing

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Item 9A. Controls and Procedures

2026-03-03 compared with 2025-03-04 · 198 added, 269 removed, 627 unchanged (43% of the section changed)

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Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Under the supervision and with the participation of the Company’s Chief Executive Officers and the Company’s Chief Financial Officer, we assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting under the 2013 “Internal Control—Integrated Framework”, issued by the

Committee of Sponsoring Organizations of the Treadway Commission, or COSO.

Under the supervision and with the participation of the Company’s Chief Executive Officers and the Company’s Chief Financial Officer, management assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting under the 2013 “Internal Control—Integrated Framework”, issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO.

Based on such assessment, our management concluded that we maintained effective internal control over financial reporting as of December 31, 2025.

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting pursuant to the requirements of Section 404(b) of the Sarbanes-Oxley Act as we qualify as a "non-accelerated filer" and as such, are exempt from such requirement.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the stockholders and the Board of Directors of Amylyx Pharmaceuticals, Inc.

Opinion on Internal Control over Financial Reporting

We have audited the internal control over financial reporting of Amylyx Pharmaceuticals, Inc.

and subsidiaries (the “Company”) as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2024, of the Company and our report dated March 4, 2025, expressed an unqualified opinion on those financial statements.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

/s/ Deloitte & Touche LLP

Boston, Massachusetts

March 4, 2025

There were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information.

Rule 10b5-1 Trading Arrangements

During the three months ended December 31, 2024 , no officers or directors of the Company (as defined in Rule 16a-1(f)) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(c) of Regulation S-K of the Exchange Act, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).

During the three months ended December 31, 2025 , no officers or directors of the Company (as defined in Rule 16a-1(f)) adopted , modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(c) of Regulation S-K of the Exchange Act, except as described below:

• Joshua Cohen , our Co-Chief Executive Officer and a member of our board of directors , adopted a new "non-Rule 10b5-1 trading arrangement" on November 12, 2025 , which is scheduled to expire on February 19, 2026 .

The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 200,000 .

This trading plan covers the exercise and sale of stock options, with such sales limited to an amount reasonably estimated such that the net proceeds from the sale are sufficient to cover the exercise cost and taxes associated with the exercise of the stock options.

• Justin Klee , our Co-Chief Executive Officer and a member of our board of directors , adopted a new "non-Rule 10b5-1 trading arrangement" on November 12, 2025 , which is scheduled to expire on February 19, 2026 .

The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 200,000 .

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

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333-261703) filed with the Securities and Exchange Commission on January 3, 2022).

Amended and Restated Non-Employee Director Compensation Policy (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2024).

Amended and Restated Non-Employee Director Compensation Policy

Executive Cash Incentive Bonus Plan (Incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1/A (File No.

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Form of Employment Agreement, between the Registrant and Gina Mazzariello (Incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2023).

Form of Employment Agreement, between the Registrant and Camille Bedrosian.

Form of Employment Agreement, between the Registrant and Camille Bedrosian (Incorporated by reference to Exhibit 10.15 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 22, 2024).

Form of Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1 (File No.

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Amylyx Pharmaceuticals, Inc.

Insider Trading Policy.

Insider Trading Policy (Incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2025).

List of Subsidiaries of Registrant.

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Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Compensation Recovery Policy.

Compensation Recovery Policy (Incorporated by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2025).

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

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Form 10-K Summary

Not applicable.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .

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Consolidated Statements of Operations

Consolidated Statements of Comprehensive Income (Loss )

Consolidated Statements of Stockholders’ Equity (Deficit )

Consolidated Statements of Comprehensive Loss

Consolidated Statements of Stockholders’ Equity

Consolidated Statements of Cash Flows

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We have audited the accompanying consolidated balance sheets of Amylyx Pharmaceuticals, Inc.

and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows, for each of the years then ended, and the related notes (collectively referred to as the "financial statements").

and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows, for each of the years then ended, and the related notes (collectively referred to as the "financial statements").

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 4, 2025 , expressed an unqualified opinion on the Company's internal control over financial reporting.

Basis for Opinion

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Our responsibility is to express an opinion on the Company's financial statements based on our audits.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

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Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.

Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

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Operating lease right-of-use assets

Long-term inventories

Deposits and other assets

Liabilities and Stockholders’ Equity

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Accumulated deficit

Accumulated other comprehensive (loss) income

Accumulated other comprehensive income (loss)

Total stockholders’ equity

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Total operating expenses

(Loss) income from operations

Loss from operations

Other income, net:

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Total other income, net

(Loss) income before income taxes

(Benefit) provision for income taxes

Net (loss) income

Net (loss) income per share

Weighted-average shares used in computing net (loss) income per share

Loss before income taxes

Provision (benefit) for income taxes

Net loss per share - basic and diluted

Weighted-average shares used in computing net loss per share - basic and diluted

The accompanying notes are an integral part of these consolidated financial statements.

AMYLYX PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

Year Ended December 31,

Net (loss) income

Other comprehensive (loss) income:

Foreign currency translation (loss) gain

Net unrealized gain on marketable securities

Other comprehensive (loss) income

Comprehensive (loss) income

Other comprehensive income (loss):

Foreign currency translation gain (loss)

Net unrealized (loss) gain on marketable securities

Other comprehensive income (loss)

Comprehensive loss

The accompanying notes are an integral part of these consolidated financial statements.

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Stock-based compensation expense

Other comprehensive income

Other comprehensive loss

Balance as of December 31, 2024

Issuance of common stock upon financing, net of issuance costs

Issuance of common stock upon exercise of stock options

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Stock-based compensation expense

Other comprehensive loss

Other comprehensive income

Balance as of December 31, 2025

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Year Ended December 31,

Cash flows (used in) provided by operating activities:

Net (loss) income

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:

Cash flows used in operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense

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Inventory impairment and loss on firm purchase commitments

Property and equipment impairment

Charge for purchase of IPR&D assets

Other non-cash items

Changes in operating assets and liabilities:

Accounts receivable, net

Prepaid expenses and other assets

Interest receivable

Prepaid expenses and other current assets

Operating lease right-of-use assets

Deposits and other assets

Accounts payable

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Operating lease liabilities

Net cash (used in) provided by operating activities

Net cash used in operating activities

Cash flows provided by investing activities:

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Cash flows provided by financing activities:

Follow-on offering costs paid

Proceeds from financings, net of issuance costs

Proceeds from exercise of stock options and RSUs vesting

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Effect of exchange rate changes on cash, cash equivalents and restricted cash equivalents

Net (decrease) increase in cash, cash equivalents and restricted cash equivalents

Net increase (decrease) in cash, cash equivalents and restricted cash equivalents

Cash, cash equivalents and restricted cash equivalents, beginning of year

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Supplemental disclosure of cash flow information:

Taxes withheld on stock-based awards included in accrued expenses

Purchases of property and equipment included in accounts payable

Income taxes paid

Other assets included in accounts payable and accrued expenses

Right-of-use assets obtained in exchange for new operating lease liabilities

The accompanying notes are an integral part of these consolidated financial statements.

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Nature of Business

Amylyx Pharmaceuticals, Inc., together with its wholly-owned subsidiaries, known as Amylyx or the Company, is a biotechnology company that is committed to the discovery and development of new treatment options for communities with high unmet needs, including people living with serious and fatal neurodegenerative diseases and endocrine conditions.

Amylyx Pharmaceuticals, Inc., together with its wholly-owned subsidiaries, known as Amylyx or the Company, is a clinical-stage pharmaceutical company with a mission to develop novel therapies for communities with high unmet medical needs.

The Company has preclinical and clinical development programs underway in endocrine conditions and neurodegenerative diseases.

The Company is currently developing four investigational therapies for potential impact across several diseases:

avexitide in PBH, AMX0035 in Wolfram syndrome, AMX0114 in ALS, and AMX0318 in PBH and other rare diseases.

Risks and Uncertainties

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, potential difficulties with or delays in timing with respect to regulatory approval processes, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the economic challenges caused by economic uncertainty in various global markets caused by geopolitical instability and conflict.

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 avexitide, AMX0035 and any additional or future product candidates.

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.

The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.

The Company expects to continue to generate operating losses for the foreseeable future.

In January 2025, the Company received gross proceeds of $ 69 million in a public offering of the Company's common stock (see Note 18 Subsequent events ).

The Company expects that its cash, cash equivalents, marketable securities and the proceeds from the January 2025 Offering will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance of these consolidated financial statements.

To continue its development efforts, the Company will 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.

The Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance of these consolidated financial statements.

To continue its development efforts, 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.

The Company may not be able to obtain financing on acceptable terms, when needed or at all, and the Company may not be able to enter into collaborations, strategic alliances or licensing arrangements.

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Use of Estimates— The preparation of the consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period.

Actual results could differ

from those estimates.

Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the financial statements.

Actual results could differ from those estimates.

Management considers many factors in selecting appropriate financial accounting policies in

developing the estimates and assumptions that are used in the preparation of the financial statements.

Management must apply significant judgment in this process.

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in October 2022.

In April 2024, the Company announced that it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO and ALBRIOZA (AMX0035) for ALS and remove the product from the market based on topline results from the global Phase 3 PHOENIX trial, which did not meet its prespecified primary and secondary endpoints.

In 2024, the Company voluntarily discontinued the marketing authorizations for RELYVRIO and ALBRIOZA (AMX0035) for ALS and removed the product from the market based on topline results from the global Phase 3 PHOENIX trial, which did not meet its prespecified primary and secondary endpoints.

Amylyx wound down the Open Label Extension as planned.

The Company entered into arrangements with wholesalers, specialty pharmacies and specialty distributors, or customers, to distribute ALBRIOZA, RELYVRIO, prior to voluntary discontinuation.

In accordance with ASC Topic 606 - Revenue from Contracts with Customers , or Topic 606, revenue is recognized when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.

At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Product Revenue, Net

The Company sold its approved products to its customers.

These customers subsequently resold our products to specialty pharmacy providers, specialty distributors, health care providers, certain medical centers or hospitals, and patients.

In addition to agreements with the customers, the Company entered into arrangements with specialty pharmacies, health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of our products.

The Company’s customer identification process considered a number of factors, including contractual and legal factors, and who controls the Company’s product and bears inventory risk.

The Company evaluated these factors on a customer-by-customer basis to determine the appropriate customer for revenue recognition purposes.

In some cases, the Company used a third-party logistics providers to deliver the Company’s product to its customers, but the Company recognized revenue upon delivery to the customer, as it was determined that the third-party logistics provider was acting as our agent.

The Company recognizes revenue on product sales when the customer obtains control of our product, which occurs at a point in time (upon delivery).

Product revenues are recorded net of applicable GTN adjustments, which are described below.

Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenue.

The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less.

However, no such costs were incurred during the years ended December 31, 2024 and 2023.

GTN Adjustments

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration related to certain GTN adjustments.

Components of GTN adjustments include trade discounts and allowances, product returns, third-party payor rebates, and other allowances that are offered within contracts between the Company, its customers and payors relating to the sale of our products.

These GTN adjustments, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer).

These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as historical experience, payer channel mix (e.g., Medicare or

Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.

In certain circumstances, the Company applies the most likely method in Topic 606.

The determination to use the expected value method or the most likely method is based on the type of GTN adjustment and what method better predicts the amount of consideration we expect to be entitled to.

Overall, these GTN adjustments reflect in the transaction price the amount of consideration to which the Company expects to be entitled to in exchange for transferring promised goods or services to its customers.

The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period.

Actual amounts of consideration ultimately received may differ from our estimates.

If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect product revenue, net and earnings in the period such variances become known.

Trade Discounts and Allowances

The Company generally provides customers with prompt payment discounts and pay fees for distribution services and for certain data that distributors provide to us that are explicitly stated in our contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.

Payment from customers is typically due within 30 calendar days of the invoice date, without consideration to the prompt payment discounts.

Product Returns

Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date, which is set to lapse within a specified period stated in the contract.

Additionally, our limited right of return policy allows for eligible returns from customers in circumstances where product was shipped in error or was damaged in shipping, or product was returned pursuant to an official drug recall.

The Company estimates the amount of product sales that may be returned by our customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net on the consolidated balance sheets.

Provider Chargebacks and Discounts

Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company.

Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers.

These GTN adjustments are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net.

GTN adjustments for chargebacks consist of credits that customers have not claimed, but for which we expect to issue a credit.

Payor Rebates

The Company contracts with certain government and private payor organizations, primarily government and commercial health insurance companies, for the payment of rebates with respect to utilization of our products.

The Company is subject to discount obligations under state Medicaid programs and Medicare.

These GTN adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets.

For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program.

The Company's liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.

Other Incentives

Other incentives which the Company offers include voluntary patient assistance programs, such as its co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors.

The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue for each reporting period.

The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the consolidated balance sheets.

Comprehensive Income (Loss)— Comprehensive income (loss) includes net loss, as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders.

Comprehensive income (loss) is composed of net income (loss) and other comprehensive (loss) income.

Other comprehensive (loss) income consists of unrealized gains and losses on marketable securities and foreign currency translation.

As a result, the Company does not expect to generate revenue from the sale of RELYVRIO and ALBRIOZA in future periods.

Comprehensive Loss— Comprehensive loss includes net loss, as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders.

Comprehensive loss is composed of net loss and other comprehensive (loss) income.

Other comprehensive income (loss) consists of unrealized gains and losses on marketable securities and foreign currency translation.

Cash and Cash Equivalents— The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents.

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Marketable Securities— Marketable securities are composed of U.S.

treasury bills and U.S.

agency bonds.

treasury bills.

The Company classifies all of its marketable securities as available-for-sale.

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There were no impairment charges on marketable securities in the periods presented.

Concentrations of Credit Risk— Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities and accounts receivable, net.

Concentrations of Credit Risk— Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities.

The Company maintains its cash in financial institutions that management believes have high credit quality.

The Company has not experienced any losses on such accounts, and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

The Company’s accounts receivable, net represents amounts due to the Company from customers.

Amylyx performs ongoing credit evaluations of its customers and generally does not require collateral.

The Company monitors its exposure and records a reserve against uncollectible amounts as necessary.

Five and three customers individually accounted for approximately 89 % and 81 % in the aggregate of gross product revenue in 2024 and 2023, respectively.

One and three customers individually accounted for approximately 100 % and 81 % of total accounts receivable, net as of December 31, 2024 and 2023 , respectively.

Fair Value Measurements— Assets and liabilities recorded at fair value on a recurring basis on the consolidated balance sheet are categorized based upon the level of judgment associated with the inputs used to measure fair values.

value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

Valuation techniques used to measure fair value must maximize the use of observable inputs and

minimize the use of unobservable inputs.

The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

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The remaining financial instruments are stated at their respective carrying amounts, which approximate fair value due to the short-term nature of these assets and liabilities.

Inventories— The Company values its inventories at the lower of cost or estimated net realizable value.

The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis.

The Company classifies inventory as long-term when consumption or sale of the inventory is expected beyond its normal operating cycle of twelve months.

The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified.

Such impairment charges are recorded within cost of sales.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.

Inventory acquired prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred.

Inventory that can be used in either the production of clinical or commercial product is initially capitalized and subsequently expensed as research and development expense when identified for use in the manufacture of drugs still in development.

Property and Equipment, net— Property and equipment are stated at cost, net of accumulated depreciation.

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Impairment of Long-Lived Assets— The Company evaluates assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable.

Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to

Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate.

If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book values of the assets exceed fair value.

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Contingent consideration obligations are recorded when it is probable that they will occur and they can be reasonably estimated.

Sales and Marketing Costs— Sales and marketing expenses consist primarily of wages and benefits for sales and marketing personnel, professional and consulting fees, administrative travel expenses, and marketing and advertising costs such as marketing literature, promotional activities, conferences and seminars and branding.

Sales and marketing, and advertising costs are expensed as incurred and included in selling, general and administrative expenses in the accompanying consolidated statements of operations.

The Company considers advertising costs as expenses related to the promotion of the Company's commercial products.

For the years ended December 31, 2024 and 2023, advertising costs were $ 2.7 million and $ 9.5 million , respectively.

Patent-Related Costs— Patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure.

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Generally, the Company issues stock awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.

For awards subject to performance conditions, the Company recognizes stock-based compensation expense over the requisite service period using an accelerated recognition method when it is probable that the performance condition will be achieved.

The Company classifies stock-based compensation expense in the same manner in which the award recipient’s payroll costs are classified.

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For each of the Company’s lease arrangements, the Company records a right-of-use asset representing the Company’s right to use an underlying asset for the lease term and a lease liability representing the Company’s obligation to make lease payments.

Operating lease right-of-use assets and operating lease liabilities are recognized at the lease commencement date based on the net present value of the remaining future minimum lease payments over the lease term.

Operating lease right-of-use assets and operating lease liabilities are recognized at the lease commencement date based on the

net present value of the remaining future minimum lease payments over the lease term.

If the interest rate implicit in the Company’s leases is not readily determinable, in determining the weighted-average discount rate used to calculate the net present value of lease payments, the Company utilizes an estimate of its incremental borrowing rate based on market sources including interest rates for companies with similar credit quality for agreements of similar duration to discount the lease payments.

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New Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740):

Improvement to Income Tax Disclosures , or ASU 2023-09, to enhance the transparency and decision usefulness of income tax disclosures.

ASU 2023-09 is effective for the Company beginning January 1, 2025 on a prospective basis.

The impact of this ASU on the tax disclosures is not expected to be material.

In November 2024, the FASB issued ASU No.

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The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.

Recently Adopted Accounting Pronouncements

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740):

Improvement to Income Tax Disclosures , or ASU 2023-09, to enhance the transparency and decision usefulness of income tax disclosures.

ASU 2023-09 is effective for the Company beginning January 1, 2025 on a prospective basis.

The Company adopted ASU 2023-09, which did not have a material impact on its consolidated financial statements and related disclosures.

PRODUCT REVENUE, NET

To date, the Company’s only source of product revenue had been from the sales of RELYVRIO, known as ALBRIOZA in Canada.

In April 2024, the Company announced it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA and remove the product from the market in the U.S.

In 2024, the Company voluntarily discontinued the marketing authorizations for RELYVRIO/ALBRIOZA and removed the product from the market in the U.S.

and Canada based on topline results from the Phase 3 PHOENIX trial.

The following table reconciles gross product revenue to net product revenue:

Year Ended December 31,

(in thousands)

Product revenue, gross

GTN adjustments

Product revenue, net

The activity and ending reserve balance for GTN adjustments were as follows for the periods indicated:

Chargebacks and Cash Discounts

Medicaid and Medicare Rebates

Other Rebates, Returns, Discounts and Adjustments

(in thousands)

Balance at January 1, 2022

Provision related to sales in the current year

Adjustments related to prior period sales

Credits and payments made

Balance at December 31, 2023

Provision related to sales in the current year

Adjustments related to prior period sales

Credits and payments made

Balance at December 31, 2024

Included in the ending reserve balance for GTN adjustments are chargebacks resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company, rebates and estimates for product returns.

Chargebacks, discounts and returns are recorded as reductions of accounts receivable, net on the condensed consolidated balance sheets to the extent there are receivable balances to reduce.

If there are net balances owed to customers, they are recorded as a component of accrued expenses on the consolidated balance sheets.

As a result, the Company did no t generate revenue from the sale of RELYVRIO/ALBRIOZA during the year ended December 31, 2025.

During the year ended December 31, 2024, the Company recognized $ 87.4 million of net product revenue that related to units of RELYVRIO and ALBRIOZA sold in the U.S.

and Canada, respectively, prior to the discontinuation of RELYVRIO/ALBRIOZA.

The ending reserve balance for gross-to-net adjustments are immaterial as of December 31, 2025 .

MARKETABLE SECURITIES

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Total marketable securities

Inventories consisted of the following:

(in thousands)

Raw materials

Work in process

Finished goods

Total inventories

In April 2024, the Company announced it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO ® /ALBRIOZA and remove the product from the market in the U.S.

and Canada based on topline results from the global Phase 3 PHOENIX trial.

As a result, the Company recorded approximately $ 92.5 million of charges associated with the write-down of inventory for the year ended December 31, 2024.

For the year ended December 31, 2023, the Company recognized inventory write-downs of $ 3.3 million .

Inventory amounts written down as a result of obsolescence or other reasons are charged to cost of sales.

Property and equipment, net

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Accrued external research and development

Accrued benefits and incentive compensation

Accrued employee compensation and benefits

Accrued manufacturing

Accrued consulting and other professional fees

Accrued returns, rebates and co-pay assistance

Accrued royalties

Accrued rebates

Accrued loss on future purchase commitments

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Cash equivalents

Marketable securities:

Treasury bills

Total marketable securities

Restricted cash equivalents

Treasury bills

Total financial assets

The Company classifies its money market funds and treasury bills as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices for identical assets in active markets without any valuation adjustment.

The Company classifies its U.S.

agency bonds as Level 2 assets under the fair value hierarchy, as these assets have been valued using information obtained through a third-party pricing service at each balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.

The Company leases its office facilities under non-cancelable operating leases that expire at various dates through October 2026.

On September 12, 2024, the Company entered into a new office lease in Cambridge, Massachusetts for office space for its headquarters facility.

The lease commencement date is expected to be June 1, 2025 when the premises are expected to be available for occupancy and, therefore, as the office lease has not commenced, the related operating lease right-of-use assets and liabilities are not recorded in the Company's consolidated balance sheet as of December 31, 2024.

Components of lease expense required by ASC 842 are presented below for the years ended December 31, 2024 and 2023:

Year Ended December 31,

(in thousands)

Operating lease cost

Total lease cost

The Company classifies its cash equivalents and marketable securities as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices for identical assets in active markets without any valuation adjustment.

The Company leases its office facilities under non-cancelable operating leases that expire at various dates through December 2030.

On September 12, 2024, the Company entered into a lease agreement for the lease of approximately 15,000 square feet of office space in Cambridge, Massachusetts, which serves as the Company's corporate headquarters facility.

The lease commenced on June 1, 2025, at which time the Company recognized a right-of-use, or ROU, asset and corresponding lease liability of $ 5.1 million.

The initial lease term is approximately 67 months with rental payments beginning seven months after the lease commencement.

In addition to base rent, the Company will reimburse the landlord for certain operating expenses under the terms of the lease.

The Company has the option to extend the lease one time for an additional five-year period, subject to the terms therein; however, the exercise of the option to extend the lease term was not determined to be reasonably certain , and the Company will therefore recognize lease expense through the expiration of the initial lease term ending in December 2030.

Operating lease expense totaled $ 2.2 million and $ 2.2 million for the years ended December 31, 2025 and 2024, respectively.

Lease liabilities are measured by calculating the present value of remaining lease payments under the lease arrangement.

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The total purchase consideration of $ 36.2 million was composed of cash paid at closing of $ 35.1 million and direct transaction costs of $ 1.1 million.

The fair value was allocated to in-process research and development (IPR&D) assets with no alternative future use for these assets at the closing of the acquisition.

As a result, the Company recorded a charge of $ 36.2 million related to acquired in-process research and development expense on the consolidated statements of operations in 2024.

As part of the transaction, the Company assumed certain contractual obligations from Eiger, including royalty obligations between 4 % and 7 % on future sales owed to certain academic institutions and individuals.

The fair value was allocated to acquired in-process research and development, or IPR&D, assets with no alternative future use for these assets at the closing of the acquisition.

As a result, the Company recorded a charge of $ 36.2 million related to acquired IPR&D expense on the consolidated statements of operations during the year ended December 31, 2024, and no IPR&D expense was recorded during the year ended December 31, 2025.

As part of the transaction, the Company assumed royalty obligations between 4 % and 7 % on future sales owed to certain academic institutions and individuals.

The Company will recognize these royalty payments related to avexitide in the period in which the achievement of the underlying milestones becomes probable.

There were no other contingent obligations or assumed liabilities from the acquisition as of December 31, 2025 or December 31, 2024.

Gubra A/S Collaboration and License Agreement

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Gubra is eligible to receive an additional $ 53.5 million upon the achievement of certain development, regulatory and commercial milestones, as well as tiered royalties on future sales from any products that result from the agreement.

None of these payments are deemed probable at December 31, 2024 and have not been recognized.

Certain milestones were met and paid in the first quarter of 2026, specifically the selection and handover of the development candidate, which provided a milestone payment of $ 4 million to Gubra.

The Company has agreed to make quarterly payments to fund Gubra's ongoing research activities, which are not expected to be material.

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Under the 2022 Plan, the Company may grant incentive stock options, or ISOs, non-statutory stock options, stock appreciation rights, restricted stock units, restricted stock awards and other stock-based awards.

As of December 31, 2024 , there were 7,080,463 shares available for future issuance under the 2022 Plan.

As of December 31, 2025, there were 4,815,653 s hares available for future issuance under the 2022 Plan.

The options issued under the 2022 Plan expire 10 years following the date of grant.

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Number of shares

Weighted Average Grant Date Fair Value

Weighted Average

Nonvested as of January 1, 2025

Nonvested as of December 31, 2025

Performance-Based Restricted Stock Unit Activity

In 2025, the Company granted performance-based restricted stock units, or PSUs, whereby vesting depends upon the occurrence of certain milestone events, or the 2025 PSUs.

When achievement of milestone events, which include certain clinical milestones related to PBH, becomes probable, compensation cost will be recognized from the grant date over the requisite service period and a cumulative catch-up adjustment will be recorded to reflect the portion of the employees' requisite service that has been provided to date.

As of December 31, 2025, none of the milestone events related to the 2025 PSUs had been deemed probable of being achieved.

A summary of PSU activity for the year ended December 31, 2025, is as follows:

Number of Shares

Weighted Average

Nonvested as of December 31, 2024

Nonvested as of December 31, 2025

Stock-Based Compensation Expense— The Company recorded stock-based compensation expense in the following expense categories of its statements of operations:

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Restricted stock units

The components of net (loss) income before the provision for income taxes are as follows:

Under the Company’s Fourth Amended and Restated Certificate of Incorporation, or the certificate of incorporation, each share of common stock entitles the holder to one vote on all matters submitted to the stockholders for a vote provided, however, that, except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Company’s certificate of incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to the certificate of incorporation or pursuant to the Delaware General Corporation Law.

Holders of common stock are entitled to receive dividends, as may be declared by the Company’s Board of Directors, if any, subject to the preferential dividend rights of the preferred stock.

No dividends were declared or paid during the years ended December 31, 2025 and 2024.

On January 13, 2025, the Company closed an underwritten public offering of 19,714,285 shares of its common stock at a public offering price of $ 3.50 per share.

The net proceeds from this offering were approximately $ 65.5 million, after deducting underwriting discounts and commissions and offering expenses.

On September 10, 2025, the Company closed an underwritten public offering of 20,125,000 shares of its common stock at a public offering price of $ 10.00 per share.

The net proceeds from this offering were approximately $ 190.7 million, after deducting underwriting discounts and commissions and offering expenses.

The components of net loss before the provision for income taxes are as follows:

(in thousands)

(Loss) income before income taxes

Loss before income taxes

The (benefit) provision for income taxes is as follows:

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Deferred income tax provision

Provision for income taxes

Provision (benefit) for income taxes

A reconciliation of the Company’s effective income tax rate to the U.S.

statutory federal income tax rate of 21 % for the years ended December 31, 2025 and 2024 is as follows:

statutory tax rate

State income tax benefit

federal statutory tax rate

State and local income taxes, net of federal income tax

Foreign tax effects (aggregate)

Research and development tax credits

Executive Compensation

Uncertain Tax Positions

Valuation allowances

Changes in valuation allowance

Nontaxable or nondeductible items

Stock-based compensation

Executive compensation

Effective income tax rate

(1) State taxes in Illinois contributed to the majority of the tax effect in this category.

Deferred tax assets and liabilities were as follows:

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Of the $ 306.5 million state NOL carryforwards, $ 201.0 million relate to Massachusetts and begin to expire in 2040 .

As of December 31, 2024 and 2023, the Company also had federal tax credits of $ 13.4 million and $ 6.8 million , respectively, and state tax credits of $ 3.3 million and $ 1.6 million , respectively.

As of December 31, 2025 and 2024, the Company also had federal tax credits of $ 16.1 million and $ 13.4 million , respectively, and state tax credits of $ 3.3 million .

The tax credit carryforwards will expire at various dates beginning in 2035.

The utilization of NOL and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the IRC.

Ownership changes occurred in the years ended December 31, 2016 and 2023.

These ownership changes do not impact the Company’s overall ability to utilize NOL carryforwards and research and development tax credit carryforwards but may limit the amount that can be utilized annually to offset future taxable income.

The utilization of NOL and tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the IRC.

No ownership changes have occurred that would impact the Company’s overall ability to utilize NOL carryforwards and research and development tax credit carryforwards but application of IRC sections 382 and 383 may limit the amount of NOL and tax credit carryforwards that can be utilized annually to offset future taxable income.

The following table reflects the roll-forward of the Company’s valuation allowance for the years ended December 31, 2025 and 2024:

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The Company accounts for uncertainty in income taxes under the provisions of ASC 740 which defines the thresholds for recognizing the benefits of tax return positions in the consolidated financial statements as “more likely than not” to be sustained by the taxing authority.

The tax benefit is measured based on the largest benefit that has a greater than 50%

likelihood of being realized upon ultimate settlemen t.

The tax benefit is measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlemen t.

A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows:

1 unchanged sentence

Balance at beginning of the period

Increases related to tax positions taken during prior years

(Decreases) Increases related to tax positions taken during prior years

Increases related to tax positions taken during the current year

2 unchanged sentences

All uncertain tax benefits, if recognized, would impact the effective tax rate if recognized, offset by changes to the Company’s valuation allowance which also would impact the effective tax rate.

The Company does not expect the amount of unrecognized tax benefits to materially change over next 12 months.

The Company accrues interest and penalties related to unrecognized tax benefits as a component of its provision for income taxes.

4 unchanged sentences

There are currently no federal or state audits or examinations in process.

Cash paid for income taxes, net of refunds received, by jurisdiction for the years ended December 31, 2025 and 2024 is as follows:

(in thousands)

US state and local

United Kingdom

Total income taxes paid, net of refunds received

* The amount of income taxes paid during the year does not meet the 5% disaggregation threshold.

EMPLOYEE BENEFIT PLANS

3 unchanged sentences

The Company made $ 1.5 million and $ 2.8 million of contributions for the years ended December 31, 2025 and 2024 , respectively.

NET (LOSS) INCOME PER SHARE

Net (Loss) Income per Share

Basic earnings per share is computed by dividing net (loss) income by the weighted average number of common shares outstanding during the period.

Diluted earnings per share is calculated based on the combined weighted average number of common shares and potentially dilutive shares, which include the assumed exercise of employee stock options and unvested restricted stock units.

NET Loss PER SHARE

Net Loss per Share

Basic earnings per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period.

In computing diluted earnings per share, the Company utilizes the treasury stock method.

A summary of the numerator and denominators used in the computation of earnings per share follows (in thousands, except share and per share data:

Net (loss) income

Weighted-average shares used to compute basic net (loss) income per share

Dilutive effect of employee stock options and restricted stock units

Weighted-average shares used to compute diluted net (loss) income per share

Net (loss) income per share

All stock options and restricted stock units were excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact for the year ended December 31, 2024 .

The following stock options and restricted stock units outstanding at each period end have been excluded from the calculation of diluted net (loss) income per share because their inclusion would have been antidilutive:

Because the Company reports a net loss, basic and diluted net loss per share are the same for both periods presented.

All stock options, RSUs and PSUs units were excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact for the years ended December 31, 2025 and 2024.

The following stock options, RSUs and PSUs outstanding at each period end have been excluded from the calculation of diluted net loss per share because their inclusion would have been antidilutive:

Options to purchase common stock

Restricted stock units

Performance-based restricted stock units

Total excluded common stock equivalents

The Company has one operating segment which is the business of researching and developing therapeutics for neurodegenerative diseases and endocrine conditions.

Our operating segments are determined based on how our Co-Chief Executive Officers , Justin Klee and Joshua Cohen, who collectively serve as our chief operating decision makers ("CODM") manages our business, regularly accesses discrete financial information, and evaluates performance for operating decision-making purposes, including allocation of resources or capital to specific compounds or projects in line with the Company’s overall strategies and goals.

The Company views its operations and manages its business as one operating segment and reporting unit.

Our operating segments are determined based on how our Co-Chief Executive Officers , who collectively serve as our chief operating decision makers, or CODM, manage our business, regularly access discrete financial information, and evaluate performance for operating decision-making purposes, including allocation of resources or capital to specific compounds or projects in line with the Company’s overall strategies and goals.

The Company’s entire business is managed by a single management team, which reports to the CODM.

The accounting policies of the Company's segment are the same as those described in Note 2 Significant Accounting Policies .

The CODM assesses segment performance and decides how to allocate resources based on consolidated net (loss) income that also is reported on the consolidated statement of operations.

The CODM uses net income to monitor budget and forecast versus actual results in assessing segment performance and to evaluate income generated from segment assets in deciding how to allocate resources.

The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.

The CODM assess segment performance and decide how to allocate resources based on consolidated net loss.

The CODM use net loss to monitor budget and forecast versus actual results in assessing segment performance and to determine how to allocate resources.

The measure of segment assets used in determining how to manage and allocate resources is reported on the consolidated balance sheets as total assets.

For the years ended December 31, 2025 and 2024, all of the Company's long-lived assets were held within the U.S.

The following table reconciles segment revenue and expenses to consolidated net loss (income) for the year ended December 31, 2024 and 2023 (in thousands):

The following table reconciles segment revenue and expenses to consolidated net loss (income) for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

2 unchanged sentences

Direct research and development expenses by program:

AMX0035 - ALS

AMX0035 - PSP

AMX0035 - ALS

Other programs

6 unchanged sentences

Other segment items 4

Net (loss) income

The significant expense categories and amounts align with the segment-level information that is regularly provided to the CODM.

As the Company has one reportable segment, there were no intersegment eliminations for the year ended December 31, 2024 and 2023.

Includes inventory impairment and loss on firm purchase commitments of $ 118.7 million and zero during year ended December 31, 2024 and 2023, respectively.

As the Company has one reportable segment, there were no intersegment eliminations for the years ended December 31, 2025 and 2024 .

Includes inventory impairment and loss on firm purchase commitments of zero and $ 118.7 million during years ended December 31, 2025 and 2024 , respectively.

The Company does not allocate personnel and other similar costs to specific programs because these costs are deployed across multiple programs.

Other segment items primarily consists of net realized and unrealized losses on foreign exchange transactions

Depreciation and amortization expense of $ 0.9 million and $ 1.1 million durin g the years ended December 31, 2024 and 2023, respectively, are allocated across the significant expense captions.

Depreciation and amortization expense of $ 0.5 million and $ 0.9 million durin g the years ended years ended December 31, 2025 and 2024 , respectively, are allocated across the significant expense captions.

Commitments and Contingencies

Legal Proceedings— As of December 31, 2024, the Company is not a party to any legal proceedings that are expected to have a material impact on the Company's consolidated financial statements.

The Company recognizes expenses for its costs related to its legal proceedings, as incurred.

Royalty Payments— Between August 2016 and February 2019, the Company entered into grant agreements with the ALS Association, ALS Finding a Cure Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and Cure Alzheimer’s Fund, or Grantors.

Pursuant to the terms of the grant agreements, the Company has certain payment obligations that are contingent upon future events such as the achievement of commercialization or the receipt of proceeds from a revenue generating transaction resulting from the projects for which the grants are used for.

The Company does not expect to incur any costs under the agreements given the discontinuation of sales of RELYVRIO®/ALBRIOZA.

As disclosed in Note 10 Asset Acquisitions and Collaboration Agreements, the Company assumed royalty obligations from Eiger related to the acquisition of avexitide and Gubra A/S related to a collaboration arrangement.

As the conditions that would trigger royalty payments under the agreements have not occurred, no amounts have been recorded in the consolidated financial statements.

Purchase Commitments— The Company enters into agreements in the normal course of business with contract manufacturing organizations for raw material purchases and manufacturing services.

As of December 31, 2024, the amounts committed under these agreements are not material.

Following the discontinuation of the sales of RELYVRIO®/ALBRIOZA in 2024, the Company recognized a loss on purchase commitments of $ 26.1 million , which was recorded to cost of sales on the condensed consolidated statement of operations.

Letter of Credit

Restricted cash equivalents consist of $ 0.9 million of cash serving as collateral for a letter of credit issued for the Company’s office spaces, and $ 0.1 million as collateral for a corporate credit card program.

As of December 31, 2025 and December 31, 2024, the Company’s restricted cash equivalents balance was $ 1.0 million and $ 1.4 million on its consolidated balance sheets, respectively.

Legal Proceedings

On February 9, 2024, a putative class action lawsuit was filed in the U.S.

District Court for the Southern District of New York against us and certain of our current and former officers (Shih v.

Amylyx Pharmaceuticals, Inc., et al., Case Number 1:24-CV-00988, or the Shih Complaint).

Plaintiff filed an amended complaint on June 24, 2024.

The Shih Complaint asserts a claim against all defendants for alleged violations of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder and a claim under Section 20(a) against certain current and former officers as alleged controlling persons.

The Shih Complaint alleges that defendants made materially false and misleading statements related to the commercial results and prospects for RELYVRIO.

The Shih Complaint seeks unspecified damages, interest, costs and attorneys’ fees, and other unspecified relief that the court deems appropriate.

On August 12, 2024, the case was transferred from the U.S.

District Court for the Southern District of New York to the U.S.

District Court for the District of Massachusetts, or the Court, and assigned docket number 1:24-CV-12068.

Following the transfer, on September 6, 2024, defendants moved to dismiss the Shih Complaint.

On September 30, 2025, the Court issued an order finding that the majority of the alleged misstatements are inactionable, but ultimately denied the motion to dismiss.

The Company filed an answer on October 30, 2025.

The parties have agreed to participate in a confidential mediation, currently scheduled for March 12, 2026, in an attempt to resolve this action, and will provide a status update to the court by April 12, 2026.

In addition to the Shih Complaint, on October 2, 2024, a derivative complaint was filed in the U.S.

District Court for the District of Massachusetts against certain current and former director and officer defendants, or the Individual Defendants, naming us as a nominal defendant (Jones v.

Cohen, et al., 1:24-CV-12527, or the Jones Derivative Complaint).

The substantive allegations mirror those of the Shih Complaint but also include claims for alleged violations of Section 14(a) of the Exchange Act, breach of fiduciary duty, insider trading, and unjust enrichment against the Individual Defendants.

The Jones Derivative Complaint seeks unspecified damages to be awarded to the Company along with interest, restitution, unspecified corporate governance and internal procedural reforms and improvements, and plaintiff's attorneys' fees and costs.

On October 31, 2024, the Court entered an order staying the action until the earlier of the dismissal of the Shih Complaint with prejudice, including the exhaustion of all appeals, or defendants file an answer to the Shih Complaint.

On July 2, 2025, a second derivative complaint was filed in the Court against certain current and former directors and officer defendants, naming the Company as nominal defendant (Hassine v.

Cohen, et al., 1:25-CV-11879, or the Hassine Derivative Complaint and, together with the Jones Derivative Complaint, the Derivative Complaints).

The substantive allegations mirror those of the Shih Complaint but also include claims for alleged violations of Sections 14(a), 10(b), and 21D of the Exchange Act, breach of fiduciary duty, and certain other common law claims.

The Hassine Derivative Complaint seeks unspecified damages to be awarded to the Company along with interest, costs, and attorneys’ fees, restitution, and certain corporate governance and internal procedural reforms and improvements.

On July 16, 2025, the parties to both Derivative Complaints moved the Court to consolidate the Hassine Derivative Complaint with the Jones Derivative Complaint and stay the action according to the terms of the previously-entered stay of the Jones Derivative Complaint.

The Court approved the motion on July 22, 2025.

Due to the above-referenced mediation currently scheduled for March 12, 2026, the previously-entered stay has been extended through April 30, 2026, at which point the parties will determine whether to enter a proposed case schedule or further extend the stay.

We intend to defend against the Shih Complaint and Derivative Complaints vigorously.

At this time, an estimate of the impact, if any, of the claims made in the Shih Complaint and Derivative Complaints cannot be made.

Royalty Payments

The Company has entered into a limited number of grant and royalty agreements that include payment obligations contingent upon future events, such as commercialization or the receipt of proceeds from revenue-generating transactions related to the underlying technologies.

As the conditions that would trigger royalty payments have not been met, no amounts have been recorded in the consolidated financial statements.

Purchase Commitments

The Company enters into agreements in the normal course of business with CMOs for raw material purchases and manufacturing services.

As of December 31, 2025 , there are no amounts committed under these agreements.

Restructuring

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Restructuring expenses for the year ended December 31, 2024 included $ 21.8 million of severance and employee benefit costs and $ 1.0 million of other contract termination costs and impairment charges.

All costs related to this restructuring activity were paid as of December 31, 2024 , and the Company does not expect to incur costs in future periods for the Restructuring Plan.

Subsequent Events

On January 13, 2025, the Company closed an underwritten public offering of 19,714,285 shares of its common stock at a public offering price of $ 3.50 per share.

The net proceeds from this offering were approximately $ 65.5 million, after deducting underwriting discounts and commissions and offering expenses.

Al l costs related to this restructuring activity were paid as of December 31, 2024 , and the Company does not expect to incur costs in future periods for the Restructuring Plan.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures