Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, are designed to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our co-Chief Executive Officers and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our principal executive officers and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our co-Chief Executive Officers and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
103
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d‑15(f) under the Exchange Act. Our 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. Our internal control over financial reporting include policies and procedures that:
• pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions relating to our business and dispositions of our assets;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our 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. 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, 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 year ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
(a)
None.
(b)
Rule 10b5-1 Trading Arrangements
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 . 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.
Item 9C . Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
104
PART III
Item 10 . Directors, Executive Officers and Corporate Governance.
The information required by this Item 10 will be included in the Proposal No. 1, Corporate Governance and Executive Officers section of our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 11 . Executive Compensation.
The information required by this Item 11 will be included in the Executive Compensation and Director Compensation sections (excluding the information under the heading “Pay Versus Performance”) of our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 12 . Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 will be included in the Security Ownership of Certain Beneficial Owners and Management sections of our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 13 . Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 will be included in the Certain Relationships and Related Party Transactions and Corporate Governance sections of our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 14 . Principal Accountant Fees and Services.
Our independent public accounting firm is Deloitte & Touche LLP , Boston, Massachusetts , PCAOB Auditor ID: 34 .
The information required by this Item 14 will be included in the Proposal No. 2 section of our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
105
PART IV
Item 15 . Exhibits, Financial Statement Schedules.
a) Financial Statements
For a list of the consolidated financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report, which is incorporated into this Item by reference.
b) Exhibits
Exhibit
Number
Description
2.1
Asset Purchase Agreement by and between the Company and Eiger Biopharmaceuticals, Inc., dated June 21, 2024 (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 21, 2024).
3.1
Fourth Amended and Restated Certificate of Incorporation of Amylyx Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 11, 2022).
3.2
Second Amended and Restated Bylaws of Amylyx Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 11, 2022).
4.1
Specimen Common Stock Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
4.2
Second Amended and Restated Investors’ Rights Agreement, dated as of July 1, 2021, among the Registrant and the parties thereto (Incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
4.3
Description of Securities (Incorporated by reference to Exhibit 4.3 to the Registrant’s Form 10-K filed with the Securities and Exchange Commission on March 31, 2022).
10.1#
2015 Stock Option and Incentive Plan, and form of award agreements thereunder (Incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.2#
2022 Stock Option and Incentive Plan, and form of award agreements thereunder (Incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.3#*
Amended and Restated Non-Employee Director Compensation Policy
10.4#
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. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.5#
2022 Employee Stock Purchase Plan (Incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.6#
Lease Agreement, dated as of October 23, 2018, as amended, by and between the Registrant and Bullfinch Square Limited Partnership (Incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
10.7#
Form of Employment Agreement, between the Registrant and Josh Cohen (Incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.8#
Form of Employment Agreement, between the Registrant and Justin Klee (Incorporated by reference to Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
10.9#
Form of Employment Agreement, between the Registrant and James Frates (Incorporated by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
106
10.10#
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).
10.11#
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).
10.12#
Form of Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
10.13
Master Manufacturing Services Agreement, dated as of November 12, 2019, by and between the Registrant and Patheon Inc. (Incorporated by reference to Exhibit 10.14 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
10.14
First Amendment, dated as of January 18, 2021, to Product Agreement, dated as of November 12, 2019, pursuant to the Master Manufacturing Services Agreement, dated as of November 12, 2019, by and between the Registrant and Patheon Inc. (Incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2023).
10.15
Second Amendment, dated as of March 20, 2023, to Product Agreement, dated as of November 12, 2019, as amended by Amendment No. 1, dated as of January 18, 2021, pursuant to the Master Manufacturing Services Agreement, dated as of November 12, 2019, by and between the Registrant and Patheon Inc. (Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2023).
10.16
Supply Agreement, dated as of October 29, 2019, by and between the Registrant and CU Chemie Uetikon GmbH (Incorporated by reference to Exhibit 10.15 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
10.17
First Amendment, effective as of January 1, 2023, to the Supply Agreement, dated as of October 29, 2019, by and between the Registrant and CU Chemie Uetikon GmbH (Incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2023).
10.18
Research, Development and Supply Agreement, dated as of December 9, 2019, and Deed of Amendment, dated as of July 26, 2021, by and between the Registrant and ICE S.p.A. (formerly Prodotti Chimici e Alimentari S.p.A.), as amended (Incorporated by reference to Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1 (File No. 333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
10.19
Commercial Supply Agreement, dated as of August 8, 2023, by and between the Registrant and ICE S.p.A. (formerly Prodotti Chimici e Alimentari S.p.A.) (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 August 10, 2023).
19.1
Amylyx Pharmaceuticals, Inc. 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).
21.1*
List of Subsidiaries of Registrant.
23.1*
Consent of Deloitte & Touche LLP, independent registered public accounting firm.
31.1*
Certification of Co-Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Co-Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.3*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1 +
Certification of Co-Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2 +
Certification of Co-Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.3 +
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
107
97.1
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).
101.INS*
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.
101.SCH*
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Filed herewith.
+ Furnished herewith. This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, except to the extent specifically incorporated by reference into such filing.
# Indicates a management contract or any compensatory plan, contract or arrangement.
Portions of this exhibit (indicated by asterisks) have been omitted in accordance with Item 601(b)(10) of Regulation S-K.
c) Financial Statement Schedules
No financial statements have been submitted because they are not required or are not applicable or because the information required is included in the consolidated financial statements or the notes thereto.
Item 16 . Form 10-K Summary
Not applicable.
108
SIGNATURES
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 .
AMYLYX PHARMACEUTICALS, INC.
Date: March 3, 2026
By:
/s/ Joshua B. Cohen
Joshua B. Cohen
Co-Chief Executive Officer
Date: March 3, 2026
By:
/s/ Justin B. Klee
Justin B. Klee
Co-Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ Joshua B. Cohen
Co-Chief Executive Officer and Director (Principal Executive Officer)
March 3, 2026
Joshua B. Cohen
/s/ Justin B. Klee
Co-Chief Executive Officer and Director (Principal Executive Officer)
March 3, 2026
Justin B. Klee
/s/ James M. Frates
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
March 3, 2026
James M. Frates
/s/ George Mclean Milne Jr.
Director
March 3, 2026
George Mclean Milne Jr. Ph.D.
/s/ Paul Fonteyne
Director
March 3, 2026
Paul Fonteyne, M.S., M.B.A.
/s/ Daphne Quimi
Director
March 3, 2026
Daphne Quimi
/s/ Karen Firestone
Director
March 3, 2026
Karen Firestone
/s/ Bernhardt Zeiher
Director
March 3, 2026
Bernhardt Zeiher, MD.
109
Amylyx Pharmaceuticals, Inc.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB Auditor ID: 34)
F- 2
Consolidated Balance Sheets
F- 3
Consolidated Statements of Operations
F- 4
Consolidated Statements of Comprehensive Loss
F- 5
Consolidated Statements of Stockholders’ Equity
F- 6
Consolidated Statements of Cash Flows
F- 7
Notes to Consolidated Financial Statements
F- 8
F- 1
REPORT of independent registered public accounting firm
To the stockholders and the Board of Directors of Amylyx Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Amylyx Pharmaceuticals, Inc. 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.
Basis for Opinion
These financial statements are the responsibility of the Company's management. 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 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.
We conducted our audits in accordance with the standards of the PCAOB. 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. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 3, 2026
We have served as the Company’s auditor since 2020.
F- 2
AMYLYX PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
226,651
$
77,391
Marketable securities
90,328
99,110
Accounts receivable, net
88
447
Prepaid expenses and other current assets
6,604
12,484
Total current assets
323,671
189,432
Property and equipment, net
310
961
Restricted cash equivalents
985
1,446
Operating lease right-of-use assets
5,181
1,771
Deposits and other assets
2,498
24
Total assets
$
332,645
$
193,634
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
3,519
$
2,939
Accrued expenses
17,910
23,949
Operating lease liabilities, current portion
1,259
1,518
Total current liabilities
22,688
28,406
Operating lease liabilities, net of current portion
4,698
463
Total liabilities
27,386
28,869
Commitments and contingencies (Note 16)
Stockholders’ equity:
Common stock, $ 0.0001 par value; 300,000,000 shares authorized; 109,884,502 and 68,629,738 shares issued and outstanding as of December 31, 2025 and 2024, respectively
11
7
Additional paid-in capital
1,056,271
771,542
Accumulated deficit
( 751,427
)
( 606,692
)
Accumulated other comprehensive income (loss)
404
( 92
)
Total stockholders’ equity
305,259
164,765
Total liabilities and stockholders' equity
$
332,645
$
193,634
The accompanying notes are an integral part of these consolidated financial statements.
F- 3
AMYLYX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Year Ended December 31,
2025
2024
Product revenue, net
$
—
$
87,371
Operating expenses:
Cost of sales
—
5,953
Cost of sales - inventory impairment and loss on firm purchase commitments
—
118,680
Acquired in-process research and development
—
36,203
Research and development
90,404
104,084
Selling, general and administrative
62,887
114,331
Restructuring expenses
—
22,851
Total operating expenses
153,291
402,102
Loss from operations
( 153,291
)
( 314,731
)
Other income, net:
Interest income
9,302
13,809
Other expense, net
( 700
)
( 1,214
)
Total other income, net
8,602
12,595
Loss before income taxes
( 144,689
)
( 302,136
)
Provision (benefit) for income taxes
46
( 393
)
Net loss
$
( 144,735
)
$
( 301,743
)
Net loss per share - basic and diluted
$
( 1.53
)
$
( 4.43
)
Weighted-average shares used in computing net loss per share - basic and diluted
94,565,567
68,142,158
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
AMYLYX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Year Ended December 31,
2025
2024
Net loss
$
( 144,735
)
$
( 301,743
)
Other comprehensive income (loss):
Foreign currency translation gain (loss)
627
( 396
)
Net unrealized (loss) gain on marketable securities
( 131
)
107
Other comprehensive income (loss)
496
( 289
)
Comprehensive loss
$
( 144,239
)
$
( 302,032
)
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
AMYLYX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance as of January 1, 2024
67,707,432
$
7
$
738,177
$
197
$
( 304,949
)
$
433,432
Issuance of common stock upon exercise of stock options
210,088
—
327
—
—
327
Issuance of common stock upon vesting of RSUs
712,218
—
—
—
—
—
Stock-based compensation expense
—
—
33,038
—
—
33,038
Other comprehensive loss
—
—
—
( 289
)
—
( 289
)
Net loss
—
—
—
—
( 301,743
)
( 301,743
)
Balance as of December 31, 2024
68,629,738
$
7
$
771,542
$
( 92
)
$
( 606,692
)
$
164,765
Issuance of common stock upon financing, net of issuance costs
39,839,285
4
$
256,310
$
—
$
—
$
256,314
Issuance of common stock upon exercise of stock options
213,090
—
774
—
—
774
Issuance of common stock upon vesting of RSUs
1,202,389
—
—
—
—
—
Stock-based compensation expense
—
—
27,645
—
—
27,645
Other comprehensive income
—
—
—
496
—
496
Net loss
—
—
—
—
( 144,735
)
( 144,735
)
Balance as of December 31, 2025
109,884,502
$
11
$
1,056,271
$
404
$
( 751,427
)
$
305,259
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
AMYLYX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2025
2024
Cash flows used in operating activities:
Net loss
$
( 144,735
)
$
( 301,743
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
27,645
33,038
Depreciation expense
525
904
Accretion of investment discounts, net
( 5,526
)
( 9,856
)
Inventory impairment and loss on firm purchase commitments
—
118,680
Charge for purchase of IPR&D assets
—
36,203
Other non-cash items
( 169
)
958
Changes in operating assets and liabilities:
Accounts receivable, net
359
39,602
Inventories
—
( 9,253
)
Interest receivable
24
359
Prepaid expenses and other current assets
5,960
1,998
Operating lease right-of-use assets
1,730
1,954
Deposits and other assets
( 1,976
)
677
Accounts payable
580
( 19,102
)
Accrued expenses
( 6,598
)
( 59,810
)
Operating lease liabilities
( 1,162
)
( 2,256
)
Net cash used in operating activities
( 123,343
)
( 167,647
)
Cash flows provided by investing activities:
Purchases of property and equipment
( 138
)
( 157
)
Purchases of IPR&D assets, including transaction costs
—
( 36,203
)
Purchases of investments
( 231,823
)
( 231,986
)
Proceeds from maturities of marketable securities
246,000
344,000
Net cash provided by investing activities
14,039
75,654
Cash flows provided by financing activities:
Proceeds from financings, net of issuance costs
256,313
—
Proceeds from exercise of stock options and RSUs vesting
4,077
2,132
Withholding taxes paid on stock-based awards
( 3,361
)
( 1,784
)
Net cash provided by financing activities
257,029
348
Effect of exchange rate changes on cash, cash equivalents and restricted cash equivalents
1,074
( 438
)
Net increase (decrease) in cash, cash equivalents and restricted cash equivalents
148,799
( 92,083
)
Cash, cash equivalents and restricted cash equivalents, beginning of year
78,837
170,920
Cash, cash equivalents and restricted cash equivalents, end of year
$
227,636
$
78,837
Reconciliation of cash, cash equivalents and restricted cash equivalents:
Cash and cash equivalents
$
226,651
$
77,391
Restricted cash equivalents
985
1,446
Total cash, cash equivalents and restricted cash equivalents:
$
227,636
$
78,837
Supplemental disclosure of cash flow information:
Other assets included in accounts payable and accrued expenses
$
500
$
—
Right-of-use assets obtained in exchange for new operating lease liabilities
$
5,140
$
—
The accompanying notes are an integral part of these consolidated financial statements.
F- 7
AMYLYX PHARMACEUTICALS, INC.
NOTES TO Consolidated FINANCIAL STATEMENTS
1. Nature of 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 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. 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.
2. Summary of Significant Accounting Policies
Basis of Presentation and Consolidation— The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, and include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB.
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
F- 8
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.
Revenue recognition— In June 2022, AMX0035 received marketing authorization with conditions as ALBRIOZA by Health Canada for the treatment of ALS, and the Company launched ALBRIOZA in Canada in July 2022. In September 2022, AMX0035 received approval as RELYVRIO by the FDA for the treatment of ALS in adults, and the Company launched RELYVRIO in the U.S. in October 2022. 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. 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. Cash equivalents represent funds invested in readily available checking and money market funds.
Restricted Cash Equivalents— Restricted cash equivalents consist of cash serving as collateral for a letter of credit issued for the Company’s office spaces and collateral for a corporate credit card program.
Accounts receivable, net— The Company’s accounts receivable consists of amounts due from customers related to product sales and have standard payment terms. The Company analyzes accounts that are past due for collectability and provides reserves against accounts receivable for expected credit losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are written-off against the established reserve. The credit losses were not material in the periods presented.
Marketable Securities— Marketable securities are composed of U.S. treasury bills. The Company classifies all of its marketable securities as available-for-sale. Accordingly, these investments are recorded at fair value, which is determined based on quoted market prices. Unrealized gains and losses on available-for-sale securities are included as a separate component of other accumulated comprehensive loss. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts. Such amortization and accretion are included in interest income. Realized gains and losses are included in other expense, net. The Company evaluates marketable securities for other-than-temporary impairment at the balance sheet date. Declines in fair value, if any, determined to be other than temporary-than-temporary are also included in other income, net.
When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, and the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. 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 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.
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. 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
F- 9
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:
• Level 1 —Quoted prices in active markets for identical assets or liabilities.
• Level 2 —Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
• Level 3 —Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The Company’s financial instruments consist of cash, cash equivalents, restricted cash, marketable securities, accounts receivable, net, accounts payable and accrued expenses. The Company’s marketable securities are carried at fair value, determined according to Level 1 and Level 2 inputs to the fair value hierarchy described above. 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.
Property and Equipment, net— Property and equipment are stated at cost, net of accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repairs that do not improve or extend the life of the assets are expensed when incurred. Upon sale or retirement of assets, the cost and accumulated depreciation are removed from the consolidated balance sheets and any resulting gain or loss is reflected in the consolidated statements of operations in the period realized. The range of useful lives of property and equipment is as follows:
Estimated Useful Life
Leasehold improvements
Lesser of the estimated life or remaining lease term
Furniture and fixtures
4 years
Computer hardware and software
3 years
Construction in progress
Not depreciated
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 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.
Business Combinations and Asset Acquisitions— The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the requirements of a business. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. In-process research and development, or IPR&D, projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated.
F- 10
Research and Development— Research and development expenses include costs directly attributable to the conduct of research and development activities. Expenditures relating to research and development are expensed in the period incurred. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In addition, research and development-related salaries and benefits, facility, and overhead costs, supplies and other related costs are included in research and development expense.
License and Collaboration Agreements — The Company analyzes license and collaboration arrangements pursuant to ASC Topic 808 - Collaborative Arrangement Guidance and Considerations , or ASC 808, to assess whether such arrangements, or transactions between arrangement participants, involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities.
Collaboration arrangements often require upfront payments and may include additional milestone, research and development cost sharing, royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development and commercialization. Upfront payments associated with collaborative arrangements and subsequent payments made to the partner for the achievement of development milestones prior to regulatory approval are expensed to acquired IPR&D expense as incurred. Contingent consideration obligations are recorded when it is probable that they will occur and they can be reasonably estimated.
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. Amounts incurred are classified as selling, general and administrative expenses in the accompanying consolidated statements of operations.
Stock-Based Compensation Expense— Stock-based compensation is recognized in the consolidated statements of operations based on the fair value on the date of grant over the requisite service period, which is generally equal to the vesting period of the respective award. Forfeitures are accounted for as incurred. 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.
The fair value of each restricted common stock award is measured based on the fair value of the Company’s common stock on the grant date.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends. The Company estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. There is no expected dividend yield since the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The stock price of the Company is based on the closing price on the date of grant.
Contingencies— From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues for loss contingencies when losses become probable and are reasonably estimable. If the reasonable estimate of the loss is a range and no amount within the range is a better estimate, the minimum amount of the range is recorded as a liability on the Company’s consolidated balance sheets. The Company does not accrue for contingent losses that, in its judgment, are considered to be reasonably possible, but not probable; however, it discloses the range of reasonably possible losses.
Leases— The Company leases its offices, and may from time to time, enter into other lease agreements in conducting its business. The Company determines if an arrangement includes a lease at the inception of the agreement. 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
F- 11
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. Lease expense for the Company’s operating leases is recognized on a straight-line basis over the lease term and variable lease costs are expensed as incurred. The Company did not have financing leases as of December 31, 2025 and 2024.
The Company elected the practical expedient not to apply the recognition and measurement requirements to short-term leases, which is any lease with a term of one year or less as of the lease commencement date. The lease may require the Company to pay additional amounts for maintenance and other expenses, which are generally referred to as non-lease components. Non-lease components (e.g., common area maintenance) are paid separately from rent based on actual costs incurred and therefore are not included in the operating lease right-of-use assets and lease liabilities and are reflected as an expense in the period incurred. If a lease includes options to extend the lease term, the Company does not assume the option will be exercised in its initial lease term assessment unless there is reasonable certainty that the Company will renew based on an assessment of economic factors present as of the lease commencement date.
Income Taxes— The Company accounts for income taxes using the asset and liability approach. Deferred tax assets and liabilities represent future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of assets and liabilities and for loss carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is established to reduce deferred tax assets to the amounts expected to be realized. The Company also recognizes a tax benefit from uncertain tax positions only if it is “more likely than not” that the position is sustainable based on its technical merits. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. To date, the Company has not incurred material interest and penalties related to income tax positions.
Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of December 31, 2025 , we continued to maintain a full valuation allowance against all of our deferred tax assets based on management’s evaluation of all available evidence, including our history of incurring significant losses from operations.
Recent Accounting Pronouncements
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.
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.
3. 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 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. 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 .
F- 12
4. MARKETABLE SECURITIES
The Company has classified all of its marketable securities 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 income (loss). There were no realized gains or losses recognized in the periods presented.
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 consolidated balance sheets, and amounted to $ 0.1 million and $ 0.1 million at December 31, 2025 and 2024, respectively.
Marketable securities, which are classified as available-for-sale, consisted of the following (in thousands):
December 31, 2025
Amortized
Cost Basis
Unrealized
Gain
Unrealized
Loss
Fair
Values
(in thousands)
Treasury bills
$
90,288
$
40
$
—
$
90,328
Total marketable securities
$
90,288
$
40
$
—
$
90,328
December 31, 2024
Amortized
Cost Basis
Unrealized
Gain
Unrealized
Loss
Fair
Values
(in thousands)
Treasury bills
$
98,939
$
171
$
—
$
99,110
Total marketable securities
$
98,939
$
171
$
—
$
99,110
5. Property and equipment, net
Property and equipment, net consisted of the following:
December 31,
2025
2024
(in thousands)
Furniture and fixtures
$
160
$
382
Computer hardware and software
1,531
1,541
Leasehold improvements
154
176
Construction in progress
19
221
Total property and equipment
1,864
2,320
Less: accumulated depreciation
( 1,554
)
( 1,359
)
Total property and equipment, net
$
310
$
961
6. Accrued Expenses
Accrued expenses consisted of the following:
December 31,
2025
2024
(in thousands)
Accrued external research and development
$
5,355
$
4,353
Accrued employee compensation and benefits
10,055
9,992
Accrued manufacturing
—
500
Accrued consulting and other professional fees
1,855
1,974
Accrued rebates
—
5,334
Accrued loss on future purchase commitments
—
1,538
Other accrued expenses
645
258
Total accrued expenses
$
17,910
$
23,949
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7. 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:
December 31, 2025
Level 1
Level 2
Level 3
Total
(in thousands)
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
December 31, 2024
Level 1
Level 2
Level 3
Total
(in thousands)
Assets:
Cash equivalents
$
37,550
$
—
$
—
$
37,550
Restricted cash equivalents
1,446
—
—
1,446
Treasury bills
99,110
—
—
99,110
Total financial assets
$
138,106
$
—
$
—
$
138,106
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.
8. LEASES
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. Since the rates implicit in our leases are not readily determinable, the Company uses estimated incremental borrowing rates in determining the discount rate used to calculate the present value of remaining lease payments. The incremental borrowing rate is the rate of interest that the Company would have to pay to borrow, on a collateralized basis, an amount equal to the lease payments over a similar term equal to the lease term in a similar economic environment. The incremental borrowing rate is based on the information available at commencement date. As the Company has no recent external borrowings, the incremental borrowing is a hypothetical rate based on our understanding of what our credit rating would be and adjusted to reflect a collateralized borrowing.
The Company’s leases contain renewal options that can extend the lease for additional years. Because the Company is not reasonably certain to exercise these renewal options, they are not considered in determining the lease terms, and associated potential additional payments are excluded from lease payments. The Company has existing net leases in which the non-lease components (e.g., common area maintenance) are paid separately from rent based on actual costs incurred and therefore are not included in the operating lease right-of-use assets and lease liabilities and are reflected as an expense in the period incurred. Variable lease payments during the years ended December 31, 2025 and 2024 were not material.
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The following table summarizes the presentation in the Company’s consolidated balance sheet of its operating leases:
December 31,
2025
2024
(in thousands)
Assets
Operating lease right-of-use assets
$
5,181
$
1,771
Liabilities
Operating lease right-of-use liabilities, current
$
1,259
$
1,518
Operating lease right-of-use liabilities, net of current portion
4,698
463
Total operating lease liabilities
$
5,957
$
1,981
During the years ended December 31, 2025 and 2024, the Company made cash payments for operating leases of $ 1.6 million and $ 2.5 million , respectively. Future minimum lease payments under non-cancelable leases as of December 31, 2025, were as detailed below (in thousands):
As of
December 31, 2025
2026
$
1,850
2027
1,408
2028
1,444
2029
1,480
2030
1,516
Total undiscounted lease payments
7,698
Less: imputed interest
( 1,741
)
Total operating lease liabilities
$
5,957
As of December 31, 2025 and 2024, the weighted average remaining lease term was 4.7 years and 1.2 years , respectively. As of December 31, 2025 and 2024, the weighted average incremental borrowing rate used to determine the operating lease right-of-use assets was 11.3 % and 7.4 % , respectively.
9. aSSET aCQUISITIONS AND COLLABORATION AGREEMENTS
Eiger Asset Acquisition
On July 9, 2024, the Company completed the acquisition of substantially all the assets and interests in the development, manufacture and commercialization of avexitide from Eiger BioPharmaceuticals, Inc., or Eiger, for $ 35.1 million, or the Eiger Acquisition. The Eiger Acquisition includes the acquisition of all of Eiger’s owned and co-owned patents and applications directed to avexitide, as well as the assumption of Eiger’s licenses to patents and applications directed to avexitide and owned and co-owned by other entities, and the samples, retains, raw materials and active pharmaceutical ingredients in Eiger’s possession and control.
The transaction was accounted for as an asset acquisition as the acquired assets did not meet the definition of a business. The Company did not acquire any outputs and there was not an acquired substantive process in place to create outputs. 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 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.
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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 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. 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. 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.
10. Stock Option and Grant PlanS
Stock Incentive Plan— In January 2022, the Company’s board of directors adopted, and its stockholders approved the 2022 Stock Option and Incentive Plan, or 2022 Plan. 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, 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. Stock options and restricted stock units typically vest over 4 years. We recognize the compensation cost of awards subject to service-based vesting conditions over the requisite service period, which is generally equal to the vesting period of the respective award.
Initially, subject to adjustment as provided in the 2022 Plan, the aggregate number of shares of the Company’s common stock available for issuance under the 2022 Plan is 7,650,000 . The number of shares of the Company’s common stock reserved for issuance under the 2022 Plan will automatically increase on January 1 of each year commencing January 1, 2023, by 5 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s board of directors.
Inducement Plan— In July 2023, the Company’s board of directors adopted the Amylyx Pharmaceuticals, Inc. 2023 Inducement Plan, or the Inducement Plan, to grant equity awards to induce highly-qualified prospective officers and employees who are not currently employed by the Company to accept employment and provide them with a proprietary interest in the Company. The Company has reserved 750,000 shares of its common stock that may be issued under the Inducement Plan. As of December 31, 2025, there were 360,167 shares available for future issuance under the Inducement Plan.
Employee Stock Purchase Plan— In January 2022, the Company’s board of directors adopted the 2022 Employee Stock Purchase Plan, or ESPP, which was subsequently approved by the Company's stockholders. The ESPP initially reserves and authorizes the issuance of up to a total of 605,000 shares of common stock to participating employees. The ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2023 and each January 1 thereafter through January 1, 2032, by the least of (i) 1 % of the outstanding number of shares of our common stock on the immediately preceding December 31, (ii) 1,210,000 shares or (iii) such number of shares of common stock as determined by the ESPP administrator. The initial purchase period under the ESPP has not yet commenced. As of December 31, 2025, there were 2,633,491 shares available for future issuance under the ESPP.
The Company estimates the fair value of stock option awards on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions:
Year Ended December 31,
2025
2024
Risk-free interest rate
4.07
%
4.44
%
Expected term (in years)
6.01
6.08
Expected volatility
109.09
%
69.17
%
Dividend yield
0.00
%
0.00
%
F- 16
The weighted average grant date fair value of stock options granted during the year ended December 31, 2025 and 2024 was $ 3.46 per share and $ 5.61 per share, respectively.
A summary of option activity for the year ended December 31, 2025, is as follows:
Number of
Options
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
(in thousands)
Outstanding at January 1, 2025
7,728,707
$
14.34
7.5
$
3,584
Granted
2,474,549
$
4.15
Exercised
( 213,090
)
$
3.63
Cancelled or forfeited
( 582,315
)
$
13.89
Outstanding at December 31, 2025
9,407,851
$
11.93
7.2
$
42,967
Exercisable at December 31, 2025
5,250,970
$
15.13
6.1
$
15,416
Unvested at December 31, 2025
4,156,881
$
7.88
8.6
$
27,551
The aggregate intrinsic value of options exercised during the years ended December 31, 2025 and 2024 was $ 1.8 million and $ 1.0 million , respectively.
The total fair value of stock options vested during the years ended December 31, 2025 and 2024 was $ 18.5 million and $ 32.5 million , respectively.
Restricted Stock Unit Activity
A summary of restricted stock unit activity for the year ended December 31, 2025, is as follows:
Number of shares
Weighted Average
Grant Date
Fair Value
Nonvested as of January 1, 2025
2,212,905
$
10.96
Granted
1,994,637
$
4.21
Vested
( 1,202,389
)
$
7.14
Forfeited
( 280,069
)
$
6.73
Nonvested as of December 31, 2025
2,725,084
$
8.12
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
Grant Date
Fair Value
Nonvested as of December 31, 2024
—
$
—
Granted
2,189,724
$
5.92
Vested
—
$
—
Forfeited
( 100,230
)
$
4.09
Nonvested as of December 31, 2025
2,089,494
$
6.01
F- 17
Stock-Based Compensation Expense— The Company recorded stock-based compensation expense in the following expense categories of its statements of operations:
Year Ended December 31,
2025
2024
(in thousands)
Research and development expenses
$
6,961
$
8,758
Selling, general and administrative expenses
20,684
24,280
Total stock-based compensation
$
27,645
$
33,038
The following table summarizes unrecognized stock-based compensation expense as of December 31, 2025, by type of awards, and the weighted-average period over which that expense is expected to be recognized. The total unrecognized stock-based compensation expense will be adjusted for actual forfeitures as they occur.
As of December 31, 2025
Unrecognized Expense
Weighted-average Recognition Period
(in thousands)
(in years)
Stock options
$
19,596
1.96
Restricted stock units
$
15,166
2.41
11. 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 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.
12. Income Taxes
The components of net loss before the provision for income taxes are as follows:
Year Ended
December 31,
2025
2024
(in thousands)
U.S.
$
( 144,577
)
$
( 301,757
)
Non-U.S.
( 112
)
( 379
)
Loss before income taxes
$
( 144,689
)
$
( 302,136
)
F- 18
The (benefit) provision for income taxes is as follows:
Year Ended
December 31,
2025
2024
(in thousands)
Current income tax provision
U.S. - Federal
$
—
$
130
U.S. - State
46
23
Non-U.S.
—
( 770
)
$
46
$
( 617
)
Deferred income tax provision
Non-U.S.
$
—
$
224
Provision (benefit) for income taxes
$
46
$
( 393
)
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:
Year Ended
December 31,
2025
2024
U.S. federal statutory tax rate
$
( 30,384
)
21.0
%
$
( 63,449
)
21.0
%
State and local income taxes, net of federal income tax
effect (1)
37
( 0.0
)%
18
( 0.1
)%
Foreign tax effects (aggregate)
—
—
%
( 430
)
0.1
%
Tax credits
Research and development tax credits
( 2,726
)
1.9
%
( 7,053
)
2.3
%
Changes in valuation allowance
28,332
( 19.6
)%
64,916
( 21.4
)%
Nontaxable or nondeductible items
Stock-based compensation
1,670
( 1.2
)%
4,047
( 1.3
)%
Executive compensation
2,971
( 2.1
)%
2,557
( 0.8
)%
Other
146
( 0.1
)%
( 999
)
0.3
%
Effective income tax rate
$
46
( 0.0
)%
$
( 393
)
0.1
%
(1) State taxes in Illinois contributed to the majority of the tax effect in this category.
Deferred tax assets and liabilities were as follows:
Year Ended
December 31,
2025
2024
(in thousands)
Deferred tax assets:
Federal net operating loss carryforwards
$
76,043
$
55,174
State net operating loss carryforwards
19,576
7,881
Capitalized research and development costs
67,557
61,280
Tax credits
18,705
16,005
Stock Based Compensation
4,221
3,396
Intangibles
7,526
7,507
Accruals and other
7,396
7,906
Total deferred tax assets
$
201,024
$
159,149
Valuation allowance
( 199,595
)
( 158,542
)
Net total deferred tax assets
$
1,429
$
607
Deferred tax liabilities:
Other
( 1,429
)
( 607
)
Total deferred tax liabilities
$
( 1,429
)
$
( 607
)
Net deferred tax assets
$
—
$
—
F- 19
On a periodic basis the Company reassess the valuation allowance that has been established, weighing all positive and negative evidence. As of December 31, 2025, the Company maintained a full valuation against net deferred tax assets.
As of December 31, 2025 and 2024, the Company had federal NOL loss carryforwards of approximately $ 362.1 million and $ 262.7 million , respectively, and state NOL loss carryforwards of approximately $ 306.5 million and $ 126.9 million , respectively, which are available to reduce future taxable income. All U.S. federal NOL carryforwards as of December 31, 2025 carry forward indefinitely. Of the $ 306.5 million state NOL carryforwards, $ 201.0 million relate to Massachusetts and begin to expire in 2040 . 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 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:
Year Ended
December 31,
2025
2024
(in thousands)
Valuation allowance at beginning of year
$
158,542
$
83,922
Increases (decreases) recorded to income tax provision
41,053
74,620
Valuation allowance at end of year
$
199,595
$
158,542
The increase in the valuation allowance recorded during the year was primarily due to the increase in net operating loss generated by the Company in 2025 and required capitalization of research and development costs.
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. A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows:
Year Ended
December 31,
2025
2024
(in thousands)
Balance at beginning of the period
$
3,762
$
2,209
(Decreases) Increases related to tax positions taken during prior years
( 169
)
55
Increases related to tax positions taken during the current year
725
1,498
Balance at end of the period
$
4,318
$
3,762
The Company has reviewed the tax positions taken, or to be taken, in its tax returns for all tax years currently open to examination by a taxing authority. 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 accrues interest and penalties related to unrecognized tax benefits as a component of its provision for income taxes. The Company did no t recognize any material interest or penalties related to uncertain tax positions during the years ended December 31, 2025 and 2024.
The Company files U.S. federal, foreign and state income tax returns in various jurisdictions. The status of limitations varies by jurisdiction. There are currently no federal or state audits or examinations in process.
F- 20
Cash paid for income taxes, net of refunds received, by jurisdiction for the years ended December 31, 2025 and 2024 is as follows:
Year Ended
December 31,
2025
2024
(in thousands)
US Federal
$
( 96
)
$
—
US state and local
Florida
*
52
Illinois
( 281
)
*
Texas
*
140
Other
( 21
)
2
Foreign
Canada
( 223
)
62
Germany
*
35
Ireland
*
( 61
)
Netherlands
( 546
)
( 56
)
Switzerland
*
57
United Kingdom
78
*
Other
51
4
Total income taxes paid, net of refunds received
$
( 1,038
)
$
235
* The amount of income taxes paid during the year does not meet the 5% disaggregation threshold.
13. EMPLOYEE BENEFIT PLANS
The Company maintains a tax-qualified retirement plan that provides eligible U.S. employees with an opportunity to save for retirement on a tax-advantaged basis. Plan participants are able to defer eligible compensation subject to applicable annual IRC limits. The Company made $ 1.5 million and $ 2.8 million of contributions for the years ended December 31, 2025 and 2024 , respectively.
14. 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, 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:
December 31,
2025
2024
Options to purchase common stock
9,407,851
7,728,707
Restricted stock units
2,725,084
2,212,905
Performance-based restricted stock units
2,089,494
—
Total excluded common stock equivalents
14,222,429
9,941,612
F- 21
15. Segments
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 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 years ended December 31, 2025 and 2024 (in thousands):
Year Ended December 31,
2025
2024
Product revenue, net
$
—
$
87,371
Less 1,5 :
Cost of sales 2
—
124,633
Direct research and development expenses by program:
Avexitide
24,100
2,766
AMX0035 - PSP
17,260
16,917
AMX0035 - ALS
1,756
36,727
Other programs
15,004
8,698
Acquired in-process research and development
—
36,203
Personnel-related research and development 3
32,284
38,976
Selling, general and administrative
62,887
114,331
Restructuring expenses
—
22,851
(Benefit) provision for income taxes
46
( 393
)
Interest income
( 9,302
)
( 13,809
)
Other segment items 4
700
1,214
Net loss
$
( 144,735
)
$
( 301,743
)
1 . 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 years ended December 31, 2025 and 2024 .
2. Includes inventory impairment and loss on firm purchase commitments of zero and $ 118.7 million during years ended December 31, 2025 and 2024 , respectively.
3. The Company does not allocate personnel and other similar costs to specific programs because these costs are deployed across multiple programs.
4. Other segment items primarily consists of net realized and unrealized losses on foreign exchange transactions
5. 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.
F- 22
16. 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 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.
F- 23
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.
17. Restructuring
In April 2024, the Company announced a restructuring plan designed to focus the Company’s resources on key clinical and preclinical programs, or the Restructuring Plan. The Restructuring Plan included a reduction in force which reduced the Company’s workforce by approximately 70 % and decreased external financial commitments outside of its priority areas. The Company completed the Restructuring Plan in 2024.
Restructuring expenses consists primarily of employee severance and termination benefits, contract termination costs, impairment of long-lived assets and other costs. Liabilities for costs associated with a restructuring activity are recognized when the liability is incurred and are measured at fair value. One-time employee severance and termination benefits are expensed at the date the entity notifies the employee of the plan. One-time termination benefits primarily include severance, continuation of health insurance coverage, and other benefits such as outplacement support services for a specified period of time.
In connection with the Restructuring Plan, the Company performed an impairment evaluation of its long-lived assets resulting in an impairment charge of $ 0.9 million during the year ended December 31, 2024 related to the impairment of capitalized internal-use software.
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. 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.
F- 24