Amylyx Pharmaceuticals, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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Jun 30, 2026 · Filed Aug 6, 2026
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Notes to Condensed Consolidated Financial Statements
(unaudited)
- Nature of the Business
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 also experience disruptions in supply of its products, if approved, or its current or future product candidates and other items that are essential for its research, development, and commercialization activities.
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. 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. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Any collaborations, strategic alliances or licensing arrangements may require the Company to relinquish rights to certain of its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company. If the Company is unable to obtain funding, the Company could be forced to delay, limit, reduce or eliminate some or all of its research and development programs, pipeline expansion or future commercialization efforts or grant rights to develop and market product candidates, which could adversely affect its business prospects. Although management will continue to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations when needed or at all.
- Summary of Significant Accounting Policies
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2025 and the notes thereto, which are included in the Company’s most recent Annual Report on Form 10-K. There have been no material changes to its significant accounting policies since the date of those consolidated financial statements.
Basis of Presentation and Consolidation
The accompanying condensed consolidated financial statements and the related interim disclosures are unaudited and have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, and pursuant to the rules and regulations of the SEC for the interim financial information. These unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted as permitted by the SEC’s rules and regulations for interim reporting. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
In the opinion of the Company’s management, all normal and recurring adjustments necessary for a fair presentation have been reflected. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB.
Use of Estimates
The preparation of the condensed 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. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates.
New Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires new financial statement disclosures in tabular format, in the notes to financial statements, of specified information about certain costs and expenses. The amendments in this update do not change or remove current expense disclosure requirements. The amendments in this update are effective for the Company's annual financial statement disclosure beginning December 31, 2027, and interim periods within the years beginning January 1, 2028. Early adoption is permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.
- MARKETABLE SECURITIES
The Company has classified all of its marketable securities at June 30, 2026 as “available-for-sale”. The Company records available-for-sale securities at fair value, with the unrealized gains and losses included as a separate component of other accumulated comprehensive loss. There wereno realized gains or losses recognized during thethree and six months ended June 30, 2026 and 2025.
The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific identification method. The Company includes interest and dividends on securities classified as available-for-sale in interest income. Accrued interest receivable relating to the Company’s available-for-sale securities is presented within prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets, and amounted to$0.5 million and less than$0.1 million at June 30, 2026 and December 31, 2025, respectively.
As of June 30, 2026, there wereno securities in an unrealized loss position for greater than 12 months. The Company does not intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases. The Company did not record an allowance for credit losses as of June 30, 2026.
Marketable securities, which are classified as available-for-sale, consisted of the following (in thousands):
| Balance at June 30, 2026: | AmortizedCost Basis | UnrealizedGain | UnrealizedLoss | FairValue |
|---|---|---|---|---|
| Treasury bills | $94,665 | $— | $(9) | $94,656 |
| Treasury notes | 99,073 | — | (163) | 98,910 |
| Commercial paper | 7,882 | — | (14) | 7,868 |
| Total marketable securities | $201,620 | $— | $(186) | $201,434 |
| Balance at December 31, 2025: | AmortizedCost Basis | UnrealizedGain | UnrealizedLoss | FairValue |
|---|---|---|---|---|
| Treasury bills | $90,288 | $40 | $— | $90,328 |
| Total marketable securities | $90,288 | $40 | $— | $90,328 |
- Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| June 30, 2026 | December 31, 2025 | |
|---|---|---|
| Accrued external research and development | $6,216 | $5,355 |
| Accrued employee compensation and benefits | 5,625 | 10,055 |
| Accrued consulting and other professional fees | 2,556 | 1,855 |
| Other accrued expenses | 212 | 645 |
| Total accrued expenses | $14,609 | $17,910 |
- FAIR VALUE MEASUREMENTS
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | $24,525 | $— | $— | $24,525 |
| Restricted cash equivalents | 986 | — | — | 986 |
| Marketable securities: | ||||
| Treasury bills | 94,656 | — | — | 94,656 |
| Treasury notes | 98,910 | — | — | 98,910 |
| Commercial paper | — | 7,868 | — | 7,868 |
| Total marketable securities | 193,566 | 7,868 | — | 201,434 |
| Total financial assets | $219,077 | $7,868 | $— | $226,945 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | $207,599 | $— | $— | $207,599 |
| Restricted cash equivalents | 985 | — | — | 985 |
| Treasury bills | 90,328 | — | — | 90,328 |
| Total financial assets | $298,912 | $— | $— | $298,912 |
The Company classifies its cash equivalents, treasury bills, and treasury notes 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 commercial paper 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.
- Stock-BASED COMPENSATION
Stock Incentive Plan
General Option Information
A summary of option activity for thesix months ended June 30, 2026 is as follows:
| Number ofOptions · Weighted-AverageExercisePrice · Weighted-AverageRemainingContractualTerm(in years) · AggregateIntrinsicValue(in thousands) | |||||
|---|---|---|---|---|---|
| Outstanding at December 31, 2025 | 9,407,851 | $11.93 | 7.2 | $42,967 | |
| Granted | 2,770,780 | $14.03 | |||
| Exercised | (721,933) | $6.32 | $6,011 | ||
| Cancelled or forfeited | (125,492) | $14.44 | |||
| Outstanding at June 30, 2026 | 11,331,206 | $12.77 | 7.7 | $78,565 | |
| Options exercisable as of June 30, 2026 | 5,797,526 | $14.73 | 6.5 | $35,686 | |
| Options unvested as of June 30, 2026 | 5,533,680 | $10.72 | 8.9 | $42,880 | |
| Weighted average grant-date fair value of options granted during the period | $11.72 | ||||
The aggregate intrinsic value of options exercised during the six months ended June 30, 2026 and 2025 was$6.0 million and$0.1 million, respectively.
The total fair value of stock options vested during the six months ended June 30, 2026 and 2025 was$7.9 million and$10.6 million, respectively.
Restricted Stock Unit Activity
A summary of restricted stock unit, or RSU, activity for thesix months ended June 30, 2026 is as follows:
| Number of Shares | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested as of December 31, 2025 | 2,725,084 | $8.12 |
| Granted | 2,040,947 | $14.04 |
| Vested | (761,848) | $10.18 |
| Forfeited | (143,077) | $8.26 |
| Nonvested as of June 30, 2026 | 3,861,106 | $10.84 |
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 the achievement of milestone events, which include certain clinical milestones related to avexitide for the treatment of 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 June 30, 2026, none of the milestone events related to the 2025 PSUs had been deemed probable of being achieved.
A summary of PSU activity for thesix months ended June 30, 2026, is as follows:
| Number of Shares | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested as of December 31, 2025 | 2,089,494 | $6.01 |
| Granted | — | $— |
| Vested | — | $— |
| Forfeited | (75,475) | $7.20 |
| Nonvested as of June 30, 2026 | 2,014,019 | $5.96 |
Summary of Stock-Based Compensation Expense
Stock-based compensation expense for thethree and six months ended June 30, 2026 and 2025, is as follows (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $2,472 | $1,960 | $4,227 | $3,782 |
| Selling, general and administrative | 5,846 | 5,390 | 10,211 | 10,401 |
| Total stock-based compensation expense | $8,318 | $7,350 | $14,438 | $14,183 |
The following table summarizes unrecognized stock-based compensation expense as of June 30, 2026, by type of awards (in thousands), and the weighted-average period over which that expense is expected to be recognized (in years). The total unrecognized stock-based compensation expense will be adjusted for actual forfeitures as they occur.
| Unrecognized Expense | Weighted-average Recognition Period | |
|---|---|---|
| Stock options | $42,385 | 2.89 |
| Restricted stock units | $36,876 | 3.17 |
| Performance-based restricted stock units | $12,013 | — |
- STOCKHOLDERS’ EQUITY
Common Stock
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 thesix months ended June 30, 2026 and 2025.
- 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. 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, unvested RSUs and unvested PSUs. In computing diluted earnings per share, the Company utilizes the treasury stock method.
Because the Company reports a net loss attributable to common stockholders, basic and diluted net loss per share attributable to common stockholders 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 three and six months ended June 30, 2026. 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:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Options to purchase common stock | 11,331,206 | 9,815,940 | 11,331,206 | 9,815,940 |
| Restricted stock units | 3,861,106 | 3,139,802 | 3,861,106 | 3,139,802 |
| Performance-based restricted stock units | 2,014,019 | 1,392,632 | 2,014,019 | 1,392,632 |
| Total excluded common stock equivalents | 17,206,331 | 14,348,374 | 17,206,331 | 14,348,374 |
- Commitments and Contingencies
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 June 30, 2026 and December 31, 2025, the Company’s restricted cash equivalents balance was$1.0 million on its condensed consolidated balance sheets.
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 reached an agreement in principle to settle the class claims, subject to court approval, for $6.5 million, a significant portion of which was funded by insurance proceeds. On May 19, 2026, the court issued an order preliminarily approving the settlement and scheduled a final settlement approval hearing for September 10, 2026.
In addition to the Shih Complaint, two derivative complaints were filed in the U.S. District Court for the District of Massachusetts on October 2, 2024, Jones v. Cohen, et al., 1:24-cv-12527, and on July 2, 2025, Hassine v. Cohen, et al., 1:25-CV-11879 (together, the Massachusetts Derivative Complaints) against certain current and former director and officer defendants (and naming the company as a nominal defendant). The substantive allegations in the Massachusetts Derivative Complaints mirror those of the Shih Complaint but assert claims for alleged violations of the Exchange Act, breach of fiduciary duty, insider trading, and unjust enrichment (among other common law claims) and seek 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 July 16, 2025, the parties to both Massachusetts Derivative Complaints moved the Court to consolidate the two actions and stay the consolidated action, which the Court approved on July 22, 2025. On June 12, 2026, following the lifting of the stay, plaintiffs filed an amended complaint. On July 14, 2026, the parties filed a stipulation with the court informing it that they were engaged in the negotiation of as settlement term sheet and seeking an extension to existing deadlines to allow the parties to finalize the term sheet and negotiate a formal settlement agreement, which the court granted on July 15, 2026. In the event that a settlement cannot be reached, Defendants’ deadline to file a motion to dismiss the amended complaint is currently August 13, 2026.
On April 7, 2026, a third derivative complaint was filed in Delaware Court of Chancery against certain current and former directors and officer defendants, naming the Company as nominal defendant, Schweitzer v. Klee, et al., 2026-0459-BWD (the Schweitzer Complaint and, together with the Massachusetts Derivative Complaints, the Derivative Complaints). Like the Massachusetts Complaints, the substantive allegations of the Schweitzer Complaint mirror those of the Shih Complaint and allege breach of fiduciary duty and other common law claims and seeks unspecified damages with interest, costs, and attorneys’ fees, restitution, and certain corporate governance and internal procedural reforms and improvements. The Schweitzer Complaint plaintiff is participating in the above-referenced settlement negotiations to attempt to resolve the Derivative Complaints. To the extent a resolution of the Derivative Complaints cannot be reached, we intend to defend against the Derivative Complaints vigorously. At this time, an estimate of the impact, if any, of the claims made in the 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 contract manufacturing organizations, or CMOs, for raw material purchases and manufacturing services. As of June 30, 2026, the Company had approximately$35.0 million of remaining unconditional purchase obligations that are expected to be paid through 2028. Of this amount, approximately$13.6 million is expected to be paid within the next 12 months, and approximately$21.5 million is expected to be paid thereafter through 2028.
- asset aCQUISITIONS and collaboration agreements
Gubra A/S Collaboration and License Agreement
On December 23, 2024, the Company entered into a collaboration and license agreement, or the Gubra Agreement, with Gubra A/S, or Gubra, pursuant to which the parties will perform research and discovery activities for the development of a potential novel long-acting GLP-1 receptor antagonist, under the oversight of a joint research committee. The collaboration provides the Company an exclusive license to develop, manufacture, commercialize and otherwise exploit any development candidate and product(s) arising in the performance of activities under the agreement.
The Company made an immaterial upfront payment in January 2025, which became due upon the effective date of the Gubra Agreement. Since the payment was made for the use of Gubra’s intellectual property and research and development services and there is no alternative use, the Company recorded the upfront payment to research and development expense on the consolidated statements of operations in 2024. 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. Gubra is eligible to receive an additional $49.5 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 milestone payments are deemed probable at June 30, 2026 and have not been recognized.
- Segments
The Company views its operations and manages its business asone 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 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. 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 for thethree and six months ended June 30, 2026 and 2025 (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Direct research and development expenses by program1,2: | ||||
| Avexitide | $9,358 | $7,105 | $19,348 | $12,531 |
| AMX0035 - PSP | 36 | 7,146 | 685 | 11,709 |
| Other programs3 | 4,632 | 4,759 | 12,609 | 8,531 |
| Personnel-related research and development4 | 9,742 | 8,207 | 18,737 | 16,565 |
| Selling, general and administrative | 21,925 | 15,640 | 38,093 | 31,324 |
| Interest income | (2,323) | (1,960) | (4,893) | (4,191) |
| Other segment items5 | 53 | 546 | 128 | 881 |
| Net loss | $(43,423) | $(41,443) | $(84,707) | $(77,350) |
The significant expense categories and amounts align with the segment-level information that is regularly provided to the CODM. As the Company hasone reportable segment, there wereno intersegment eliminations for thethree and six months ended June 30, 2026 and 2025.
Depreciation and amortization expenseof less than 0.1 million and$0.1 million during the three and six months ended June 30, 2026, respectively, and$0.1 million and$0.3 million during the three and six months ended June 30, 2025, respectively, are allocated across the significant expense captions.
Other programs includes milestone payments totaling $4.0 million made to Gubra following the selection and handover of AMX0318 as a development candidate for PBH and other rare diseases during thesix months ended June 30, 2026.
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.