Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Annual Report on Form 10-K, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures.
Based on this evaluation, management concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.
Internal Control Over Financial Reporting
Management’s 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 system is designed to provide reasonable assurance to our management and Board regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Our management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO Framework”) in its 2013 Internal Control—Integrated Framework. Management believes that the COSO Framework is a suitable framework for its evaluation of financial reporting because it is free from bias, permits reasonably consistent qualitative and quantitative measurements of our internal control over financial reporting, is sufficiently complete so that those relevant factors that would alter a conclusion about the effectiveness of our internal control over financial reporting are not omitted and is relevant to an evaluation of internal control over financial reporting.
Based on this assessment, our management has concluded that as of December 31, 2025, our internal control over financial reporting was effective.
As a non-accelerated filer, this Annual Report on Form 10-K does not include an attestation report on our internal control over financial reporting issued by the Company’s independent registered public accounting firm.
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Completed Remediation of Prior Years' Material Weakness
In the course of preparing our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2025, our management concluded that the Series X and Series X 1 non-voting convertible preferred stock, $0.001 par value (“Preferred Stock”) should be treated as a separate class of common stock for purposes of calculating earnings per share in accordance with Accounting Standards Codification (“ASC”) 260-10, “Earnings Per Share” and the Company must instead present earnings per share under the two-class method. Additionally, our management concluded that the Preferred Stock does not meet the criteria for permanent equity classification and must be classified as temporary equity under ASC 480-10-S99-3A.
This determination resulted in the restatements of our financial statements in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 (as to the three and nine months ended September 30, 2024), our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 (as to the three and six months ended June 30, 2024), our Quarterly Report on Form 10-Q/A for the three months ended March 31, 2025, and our Annual Report on Form 10-K/A for the year ended December 31, 2024 (together, the “Impacted Reports”).
As a result, as previously disclosed in our Annual Report on Form 10-K/A for the year ended December 31, 2024, our management, including our principal executive officer and principal financial officer, determined that there existed a material weakness in our internal control over financial reporting related to our accounting for equity instruments for the periods covered by each of the Impacted Reports. A material weakness is a deficiency, or a combination of deficiencies, in the internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. Specifically, our management determined that we did not maintain effective controls to timely identify and account for equity instruments with complex terms, including certain provisions within our Preferred Stock. This material weakness resulted in the material misstatement of each of the Impacted Reports.
As previously disclosed, in August 2025, the Company immediately implemented a plan to address and remediate the material weakness described above and to improve our internal control over financial reporting. As part of the remediation plan, management identified and implemented a number of actions including, but not limited to, the following actions:
• Engaged with external technical accounting experts to advise and review all equity instruments, ensuring appropriate technical analysis, documentation, and oversight prior to the preparation of our financial statements.
• Implemented an accounting standards compliance process to ensure timely adoption and assessment of evolving accounting standards.
• Strengthened financial disclosure and technical guidance resources.
During the fourth quarter of the year ended December 31, 2025, we successfully completed the testing necessary to conclude that the material weakness has been remediated. As such, management, including our principal executive officer and principal financial officer, have concluded that the plan and actions described above were satisfactorily executed and the related policies, procedures and controls have been implemented, operated effectively and tested satisfactorily for a sufficient period of time to demonstrate that the previously identified material weakness has been remediated as of December 31, 2025. The Company is committed to evaluating and monitoring adherence to the established policies and procedures listed above.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act) during the quarter 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.
Insider Trading Arrangements
None .
Item 9C. Disclosure Regarding Foreign J urisdictions that Prevent Inspection.
Not applicable.
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PART III
Item 10. Directors, Executive Off icers and Corporate Governance.
The information required by this Item 10 is incorporated herein by reference to information in our proxy statement for our 2026 Annual Meeting of Stockholders (the “2026 Proxy Statement”), which we expect to be filed with the SEC within 120 days of the end of our fiscal year ended December 31, 2025, including under headings “ Proposal 1: Board of Directors and Corporate Governance—Election of Class III Directors,” “Executive Officers,” “Corporate Governance—Director Nomination Process,” “ Corporate Governance—Committees of the Board,” and “Corporate Governance—Insider Trading Policy and Procedures.”
We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of the code is available on the Corporate Governance section of our website, which is located at http://ir.eledon.com/corporate-governance/governance-overview . We intend to disclose on our website any amendments to, or waivers from, the code of business conduct and ethics that are required to be disclosed pursuant to the disclosure requirements of Item 5.05 of Form 8-K within four business days following the date of the amendment or waiver.
Item 11. Executive Compensation.
The information required by this Item 11 is incorporated herein by reference to information in our 2026 Proxy Statement, including under headings “Executive Compensation,” and “Director Compensation.”
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 is incorporated herein by reference to information in our 2026 Proxy Statement, including under headings “Stock Ownership and Reporting—Security Ownership of Certain Beneficial Owners and Management” and “Securities Authorized for Issuance Under Equity Compensation Plans.”
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 is incorporated herein by reference to information in our 2026 Proxy Statement, including under headings “Corporate Governance—Policies and Procedures for Related Person Transactions,” “Corporate Governance,” and “Corporate Governance—Committees of the Board.”
Item 14. Principal Accountant Fees and Services.
The information required by this Item 14 is incorporated herein by reference to information in our 2026 Proxy Statement, including under headings “Independent Registered Public Accounting Firm—Audit Fees and Services” and “Independent Registered Public Accounting Firm—Pre-Approval Policies and Procedures.”
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PART IV
Item 15. Exhibits and Financi al Statement Schedules.
(a) The following documents are filed as part of this Annual Report on Form 10-K:
(1) Financial Statements:
The Report of Independent Registered Public Accounting Firm, our consolidated financial statements and accompanying notes are set forth beginning on page F-1 immediately following the signature page of this Annual Report on Form 10-K.
(2) Financial Statement Schedules:
The financial statement schedules are omitted as they are either not applicable or the information required is presented in the financial statements and notes thereto under Part II, Item 8. Financial Statements and Supplementary Data .
(3) Exhibits:
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
3.1
Restated Certificate of Incorporation of Novus Therapeutics, Inc., a Delaware corporation, dated September 22, 2014
8-K
001-36620
3.1
September 26, 2014
3.2
Certificate of Amendment to Certificate of Incorporation of Novus Therapeutics, Inc. (effecting, among other things a reverse stock-split), filed with the Secretary of the State of Delaware on May 9, 2017
8-K
001-36620
3.1
May 15, 2017
3.3
Certificate of Amendment to Certificate of Incorporation of Novus Therapeutics, Inc. (effecting, among other things a change in the corporation’s name to “Novus Therapeutics, Inc.”), filed with the Secretary of the State of Delaware on May 9, 2017
8-K
001-36620
3.2
May 15, 2017
3.4
Certificate of Amendment to the Restated Certificate of Incorporation of Novus Therapeutics, Inc., (effecting, among other things a reverse stock-split) effective as of October 5, 2020
8-K
001-36620
3.1
October 6, 2020
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3.5
Certificate of Amendment to the Restated Certificate of Incorporation of Novus Therapeutics, Inc., (effecting, among other things a change in the corporation’s name to “Eledon Pharmaceuticals, Inc.”) effective as of January 5, 2021
8-K
001-36620
3.1
January 5, 2021
3.6
Certificate of Amendment to the Restated Certificate of Incorporation, as amended, of Eledon Pharmaceuticals, Inc., (effecting an increase in authorized shares of common stock)
8-K
001-36620
3.1
June 12, 2025
3.7
Certificate of Amendment to the Restated Certificate of Incorporation, as amended, of Eledon Pharmaceuticals, Inc., (providing for exculpation of certain officers)
8-K
001-36620
3.2
June 12, 2025
3.8
Amended and Restated Bylaws of Eledon Pharmaceuticals, Inc.
8-K
001-36620
3.4
January 5, 2021
3.9
Certificate of Designations of Series X Convertible Preferred Stock
8-K
001-36620
3.1
February 19, 2020
3.10
Certificate of Designations of Series X 1 Convertible Preferred Stock
8-K
001-36620
3.1
September 15, 2020
4.1
Form of Common Stock Purchase Warrant
8-K
001-36620
4.1
January 16, 2020
4.2
Form of Pre-Funded Warrant to Purchase Common Stock
8-K
001-36620
4.1
May 1, 2023
4.3
Form of Tranche A Warrant to Purchase Common Stock or Pre-Funded Warrants
8-K
001-36620
4.2
May 1, 2023
4.4
Form of Pre-Funded Warrant to Purchase Common Stock
8-K
001-36620
4.1
May 7, 2024
4.5
Form of Pre-Funded Warrant to Purchase Common Stock
8-K
001-36620
4.1
October 30, 2024
4.6
Form of Pre-Funded Warrant to Purchase Common Stock
8-K
001-36620
4.1
November 13, 2025
4.7
Form of Exchange Warrant
8-K
001-36620
4.1
January 2, 2026
4.8
Description of Securities
X
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10.1
Open Market Sales Agreement by and between the Registrant and Guggenheim Securities, LLC dated September 20, 2024
S-3
333-282260
1.2
September 20, 2024
10.2 *
Form of Indemnification Agreement to be entered into with each of the directors and officers of Eledon
8-K
001-36620
10.1
September 21, 2023
10.3
Fourth Amendment to Lease Agreement, dated March 12, 2024, by and between Newport Gateway Office LLC and Eledon Pharmaceuticals, Inc.
10-K
001-36620
10.7
March 20, 2025
10.4
Lease Agreement, dated September 4, 2024, by and between Blanchard Group LLC and Eledon Pharmaceuticals, Inc.
10-K
001-36620
10.8
March 20, 2025
10.5 *
Tokai Pharmaceuticals, Inc. 2014 Stock Incentive Plan
10-Q
001-36620
10.2
August 7, 2018
10.6 *
Novus Therapeutics, Inc., 2014 Employee Stock Purchase Plan
10-Q
001-36620
10.3
August 7, 2018
10.7 *
Executive Employment Agreement, dated September 9, 2020, between Novus Therapeutics, Inc. and David-Alexandre C. Gros, M.D.
10-K
001-36620
10.8
March 31, 2021
10.8 *
David-Alexandre Gros, M.D. Letter Agreement, dated April 27, 2023
8-K
001-36620
10.3
May 1, 2023
10.9 *
David-Alexandre Gros, M.D. Letter Agreement, dated December 16, 2024
10-K
001-36620
10.14
March 20, 2025
10.10 *
Executive Employment Agreement, dated March 15, 2021, between Eledon Pharmaceuticals, Inc. and Paul Little
10-K
001-36620
10.10
March 31, 2021
10.11 *
Steve Perrin, Ph.D. Letter Agreement, dated April 27, 2023
8-K
001-36620
10.4
May 1, 2023
10.12 *
Novus Therapeutics, Inc., 2020 Long Term Incentive Plan
10-K
001-36620
10.11
March 31, 2021
10.13 *
Eledon Pharmaceuticals, Inc. 2020 Long Term Incentive Plan, as amended
8-K
001-36620
10.1
July 10, 2024
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10.14*
Performance Stock Option Agreement, dated February 1, 2022, between Eledon Pharmaceuticals, Inc. and David-Alexandre C. Gros, M.D.
10-K
001-36620
10.12
March 24, 2022
10.15
Amended and Restated License Agreement by and between ALS Therapy Development Foundation, Inc. and Anelixis Therapeutics, Inc, dated February 18, 2020
10-Q
001-36620
10.1
August 11, 2022
10.16
First Amendment to Restated License Agreement between ALS Therapy Development Foundation, Inc. and Anelixis Therapeutics, Inc. dated September 5, 2020
10-Q
001-36620
10.2
August 11, 2022
10.17
License Agreement between Lonza Sales AG and Anelixis Therapeutics, LLC, dated September 11, 2018
10-Q
001-36620
10.3
August 11, 2022
10.18*
Form of Stock Option Agreement, dated May 1, 2023, between Eledon Pharmaceuticals, Inc. and each of David-Alexandre C. Gros, M.D., Steve Perrin, Ph D., Bryan Smith and Paul Little
10-K
001-36620
10.22
March 28, 2024
10.19*
Form of Amendment to Stock Option Agreement, dated December 30, 2023, between Eledon Pharmaceuticals, Inc. and David-Alexandre C. Gros, M.D., Steve Perrin, Ph D., Bryan Smith and Paul Little
10-K
001-36620
10.23
March 28, 2024
10.20*
Form of Amendment to Stock Option Agreement, dated June 13, 2024, between Eledon Pharmaceuticals, Inc. and David-Alexandre C. Gros, M.D., Steve Perrin, Ph D., Bryan Smith and Paul Little
10-K
001-36620
10.25
March 20, 2025
10.21*
Form of Amendment to Stock Option Agreement, dated November 20, 2024, between Eledon Pharmaceuticals, Inc. and David-Alexandre C. Gros, M.D., Steve Perrin, Ph D., Bryan Smith and Paul Little
10-K
001-36620
10.26
March 20, 2025
10.22*
Stock Option Forfeiture Agreement date December 30, 2025, between Eledon Pharmaceuticals, Inc. and David-Alexandre C. Gros, M.D.
X
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10.23*
Stock Option Forfeiture Agreement date December 30, 2025, between Eledon Pharmaceuticals, Inc. and Steve Perrin, Ph.D
X
10.24
Underwriting Agreement, dated November 12, 2025, by and between Eledon Pharmaceuticals, Inc. and Leerink Partners LLC, as representative of the several underwriters named therein
8-K
001-36620
1.1
November 13, 2025
19.1
Eledon Pharmaceuticals, Inc. Insider Trading Policy
10-K
001-36620
19.1
March 20, 2025
21.1
Subsidiaries of the Registrant
10-K
001-36620
21.1
March 17, 2020
23.1
Consent of Deloitte & Touche LLP, independent registered public accounting firm
X
23.2
Consent of Crowe LLP, independent registered public accounting firm
X
31.1
Certification of 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
X
31.2
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
X
32.1#
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2 #
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
X
97.1 *
Incentive Compensation Recoupment Policy
10-K
001-36620
97.1
March 28, 2024
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101.INS
INLINE XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
X
101.SCH
INLINE XBRL Taxonomy Extension Schema with Embedded Linkbase Documents
X
104
Cover page formatted as INLINE XBRL and contained in Exhibit 101
X
*
Indicates a management contract or compensatory plan
#
These certifications are not deemed filed by the SEC and are not to be incorporated by reference in any filing we make under the Securities Act of 1933 or the Securities Exchange Act of 1934, irrespective of any general incorporation language in any filings.
Item 16. Form 10-K Summary.
None.
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SIGNAT URES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Eledon Pharmaceuticals, Inc.
Date: March 19, 2026
By:
/s/ David-Alexandre C. Gros, M.D.
David-Alexandre C. Gros, M.D.
Chief Executive Officer
and Director (Principal
Executive Officer and Duly Authorized Officer)
Date: March 19, 2026
By:
/s/ Paul Little
Paul Little
Chief Financial Officer
(Principal Financial and Accounting 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/ David-Alexandre C. Gros, M.D.
Chief Executive Officer and Director
March 19, 2026
David-Alexandre C. Gros, M.D.
( Principal Executive Officer)
/s/ Paul Little
Chief Financial Officer
March 19, 2026
Paul Little
(Principal Financial and Accounting Officer)
/s/ Keith A. Katkin
Chairman of the Board of Directors
March 19, 2026
Keith A. Katkin
/s/ Jan Hillson, M.D.
Director
March 19, 2026
Jan Hillson, M.D.
/s/ James Robinson
Director
March 19, 2026
James Robinson
/s/ Allan Kirk, M.D.
Director
March 19, 2026
Allan Kirk, M.D.
/s/ John S. McBride
Director
March 19, 2026
John S. McBride
/s/ June Lee, M.D.
Director
March 19, 2026
June Lee, M.D.
/s/ Steven Perrin
President, Director
March 19, 2026
Steven Perrin
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ELEDON PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANC IAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm ( Deloitte & Touche LLP PCAOB ID#: 34 )
F- 2
Report of Independent Registered Public Accounting Firm (Crowe LLP PCAOB ID# : 173 )
F- 4
Consolidated Balance Sheets as of December 31, 2025 and 2024
F- 6
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2025 and 2024
F- 7
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity for the Years Ended December 31, 2025 and 2024
F- 8
Consolidated Statements of Cash Flows for the Years Ended December 31, 2025 and 2024
F- 9
Notes to Consolidated Financial Statements
F- 10
F- 1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Eledon Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Eledon Pharmaceuticals, Inc. (the "Company") as of December 31, 2025, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders' equity, and cash flows, for the year ended December 31, 2025, 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 the results of its operation and its cash flows for the year ended December 31, 2025, 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 audit. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether 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 audit, 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Classification of Pre-Funded Warrants – Refer to Notes 2 and 9 to the financial statements
Critical Audit Matter Description
On November 13, 2025, the Company closed an underwritten offering, which included the sale of pre-funded warrants (the “2025 Offering Pre-Funded Warrants”), and on December 30, 2025, the Company entered into an agreement to exchange shares of the Company's common stock for pre-funded warrants (the “2025 Warrant Exchange Agreement”). The Company accounts for pre-funded warrants as either a liability or equity in accordance with Accounting Standards Codification (ASC) Topic 480-10, Distinguishing liabilities from equity, and ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity.
We identified the assessment of the classification of the 2025 Offering Pre-Funded Warrants and the 2025 Warrant Exchange Agreement (collectively, the “2025 Pre-Funded Warrant Agreements”) as a critical audit matter. The assessment of the terms and provisions to determine the classification of the 2025 Pre-Funded Warrant Agreements as a liability or equity is complex
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and required a high extent of effort, including the need for us to involve professionals in our firm with expertise in accounting for financial instruments.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the classification of the 2025 Pre-Funded Warrant Agreements, included the following, among others:
• We read the 2025 Pre-Funded Warrant Agreements, and compared the terms and provisions to the Company’s accounting analysis.
• With the assistance of professionals in our firm having expertise in accounting for financial instruments, we evaluated the terms and provisions of the 2025 Pre-Funded Warrant Agreements to assess the appropriate classification as a liability or equity.
/s/ Deloitte & Touche LLP
Costa Mesa, CA
March 19, 2026
We have served as the Company's auditor since 2025.
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Shareholders and the Board of Directors of Eledon Pharmaceuticals, Inc.
Irvine, California
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Eledon Pharmaceuticals, Inc. (the "Company") as of December 31, 2024, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity, and cash flows, 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, 2024, and the results of its operations and its cash flows for the year 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 audit. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether 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 audit 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 audit 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 audit 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 audit provided a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Classification and Valuation of Pre-Funded Warrants
As described in Note 2, Summary of Significant Accounting Policies, and Note 9, Stockholder’s Equity, to the consolidated financial statements, the Company accounts for issued pre-funded warrants either as a liability or equity in accordance with ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period with any change in the fair value of the warrants recorded in the consolidated statements of operations and comprehensive loss as a gain or loss. The Common Warrants and the Subsequent Closing Warrants (as defined in Note 9) issued in the 2023 Private Placement are liability classified and recorded at fair value using the Black-Scholes option-pricing model at issuance, with any subsequent changes in fair value recognized in the consolidated statements of operations. Determining the proper classification of pre-funded warrants as either a derivative liability or as equity instruments requires significant management judgment in assessing the specific terms and conditions. The
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valuation of the derivative liability for liability classified pre-funded warrants also requires management judgment in determining the fair value.
The classification and valuation of warrants was determined to be a critical audit matter because of the complexity and significant judgment involved in determining the accounting for the pre-funded warrants and the significant audit effort, including the use of specialists, in assessing management’s conclusions and inputs to its calculation of fair value.
Our audit procedures to evaluate the classification and fair market value of the pre-funded warrants included:
• Obtaining and inspecting the securities purchase agreements to evaluate the contractual terms of the pre-funded warrants.
• Evaluating management's technical accounting analysis on the classification of the pre-funded warrants.
• Consulting with specialists on the classification and valuation of the pre-funded warrants.
• Developing an independent expectation of the valuation of the liability-classified warrants to compare to management’s valuation.
/s/ Crowe LLP
We served as the Company's auditor from 2024 to 2024.
Los Angeles, California
March 20, 2025, Except for Note 9, as to which the date is August 14, 2025
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Table of Contents
ELEDON PHARMACEUTICALS, INC.
CONSOLIDA TED BALANCE SHEETS
(In thousands, except share and per share data)
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
22,808
$
20,549
Short-term investments
110,528
119,629
Prepaid expenses and other current assets
2,352
3,552
Total current assets
135,688
143,730
Operating lease right-of-use asset, net
613
926
In-process research and development
32,386
32,386
Other assets
322
363
Total assets
$
169,009
$
177,405
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
3,627
$
5,833
Current operating lease liability
358
314
Accrued expenses and other liabilities
14,359
5,430
Total current liabilities
18,344
11,577
Deferred tax liability
2,187
2,183
Non-current operating lease liability
283
640
Warrant liabilities
11,416
44,865
Total liabilities
32,230
59,265
Commitments and contingencies (Note 7)
Convertible preferred stock, 5,000,000 shares authorized at December 31, 2025 and 2024:
Series X non-voting convertible preferred stock, $ 0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at December 31, 2025 and 2024
2,151
2,151
Series X 1 non-voting convertible preferred stock, $ 0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at December 31, 2025 and 2024
53,543
53,543
Stockholders’ equity:
Common stock, $ 0.001 par value, 300,000,000 and 200,000,000 shares authorized at December 31, 2025 and 2024, respectively; 75,430,033 and 59,789,275 shares issued and outstanding at December 31, 2025 and 2024, respectively
75
60
Additional paid-in capital
482,189
417,946
Accumulated other comprehensive income
24
26
Accumulated deficit
( 401,203
)
( 355,586
)
Total stockholders’ equity
81,085
62,446
Total liabilities, convertible preferred stock and stockholders’ equity
$
169,009
$
177,405
See accompanying notes to consolidated financial statements.
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Table of Contents
ELEDON PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended
December 31,
2025
2024
Operating expenses
Research and development
$
66,267
$
51,964
General and administrative
16,984
18,613
Total operating expenses
83,251
70,577
Other income, net
4,220
3,924
Change in fair value of warrant liabilities
33,449
30,900
Loss before income taxes
( 45,582
)
( 35,753
)
Provision for income taxes
( 35
)
( 431
)
Net loss
$
( 45,617
)
$
( 36,184
)
Other comprehensive loss:
Unrealized loss on available-for-sale securities, net
( 2
)
—
Comprehensive loss
$
( 45,619
)
$
( 36,184
)
Basic and diluted earnings per share of common stock
$
( 0.52
)
$
( 0.66
)
Weighted-average common shares outstanding, basic and diluted
81,836,246
48,543,787
Basic and diluted earnings per share of Series X and Series X 1 non-voting convertible preferred stock
$
( 28.73
)
$
( 36.61
)
Weighted-average shares outstanding of Series X and Series X 1 non-voting convertible preferred stock, basic and diluted
114,508
114,508
See accompanying notes to consolidated financial statements.
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Table of Contents
ELEDON PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE STOCK AND ST OCKHOLDERS’ EQUITY
(In thousands, except share data)
Convertible Preferred Stock
Stockholders' Equity
Series X 1 Non-Voting
Convertible
Preferred Stock
Series X Non-Voting
Convertible
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders'
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Income
Deficit
Equity
Balance as of December 31, 2023
110,086
$
53,543
4,422
$
2,151
24,213,130
$
24
$
270,892
$
—
$
( 319,402
)
$
( 48,486
)
Issuance of common stock and pre-funded warrants in connection with 2024 Securities Purchase Agreement, net of issuance costs
—
—
—
—
13,110,484
13
48,051
—
—
48,064
Issuance of common stock with the completion of the Second Closing and Third Closing in connection with 2023 Securities Purchase Agreement, net of issuance costs
—
—
—
—
2,636,488
3
6,152
—
—
6,155
Issuance of common stock in connection with exercise of pre-funded warrants
—
—
—
—
1,423,000
1
—
—
—
1
Issuance of common stock and pre-funded warrants in connection with 2024 Underwritten Offering, net of issuance costs.
—
—
—
—
18,356,173
18
79,515
—
—
79,533
Stock option exercise
—
—
—
—
50,000
1
214
—
—
215
Share-based compensation
—
—
—
—
—
—
13,122
—
—
13,122
Accumulated other comprehensive income
—
—
—
—
—
—
—
26
—
26
Net loss
—
—
—
—
—
—
—
—
( 36,184
)
( 36,184
)
Balance as of December 31, 2024
110,086
$
53,543
4,422
$
2,151
59,789,275
$
60
$
417,946
$
26
$
( 355,586
)
$
62,446
Issuance of common stock and pre-funded warrants in connection with 2025 Underwritten Offering, net of issuance costs
—
—
—
—
19,698,085
19
53,558
—
—
53,577
Cancellation of common stock in exchange of common stock for pre-funded warrants
—
—
—
—
( 4,203,764
)
( 4
)
4
—
—
—
Issuance of common stock in connection with vesting of restricted stock units
—
—
—
—
46,000
—
—
—
—
—
Stock option exercise
—
—
—
—
100,437
—
230
—
—
230
Share-based compensation
—
—
—
—
—
—
10,451
—
—
10,451
Accumulated other comprehensive loss
—
—
—
—
—
—
—
( 2
)
—
( 2
)
Net loss
—
—
—
—
—
—
—
—
( 45,617
)
( 45,617
)
Balance as of December 31, 2025
110,086
$
53,543
4,422
$
2,151
75,430,033
$
75
$
482,189
$
24
$
( 401,203
)
$
81,085
See accompanying notes to consolidated financial statements.
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Table of Contents
ELEDON PHARMACEUTICALS, INC.
CONSOLIDATED S TATEMENTS OF CASH FLOWS
(In thousands)
Year Ended
December 31,
2025
2024
Cash flows used in operating activities:
Net loss
$
( 45,617
)
$
( 36,184
)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on lease termination
—
( 10
)
Non-cash lease expense
313
359
Accretion of investment discounts
( 1,696
)
( 2,799
)
Stock-based compensation
10,451
13,122
Change in fair value of warrant liabilities
( 33,449
)
( 30,900
)
Deferred tax provision
5
431
Changes in operating assets and liabilities:
Prepaid expenses and other assets
1,241
1,298
Accounts payable, accrued expenses and other liabilities
6,724
7,751
Operating lease liabilities
( 313
)
( 339
)
Net cash used in operating activities
( 62,341
)
( 47,271
)
Cash flows from investing activities:
Purchase of available-for-sale short-term investments
( 161,132
)
( 156,131
)
Proceeds from maturities of available-for-sale short-term investments
171,925
85,817
Net cash provided by (used in) investing activities
10,793
( 70,314
)
Cash flows from financing activities:
Proceeds from issuances of common stock and pre-funded warrants, net
53,577
133,307
Proceeds from exercise of stock options
230
215
Net cash provided by financing activities
53,807
133,522
Net change in cash and cash equivalents
2,259
15,937
Cash and cash equivalents at beginning of year
20,549
4,612
Cash and cash equivalents at end of year
$
22,808
$
20,549
Supplemental disclosure of non-cash investing and financing activities
Non-cash activities:
Unrealized gain (loss) on available-for-sale securities
$
( 2
)
$
26
Common stock exchange for warrants
$
4
$
—
Offering costs accrued but not yet paid
$
4
$
—
Increase in operating right-of-use lease asset and liability due to new lease
$
—
$
920
Settlement of warrant liability into common stock due to exercise
$
—
$
446
See accompanying notes to consolidated financial statements.
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Table of Contents
ELEDON PHARMACEUTICALS, INC.
NOTES TO CONSOLID ATED FINANCIAL STATEMENTS
Note 1. Description of Business
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company using its immunology expertise in targeting the CD40 Ligand (“CD40L”) pathway to develop therapies to protect transplanted organs and prevent rejection, and to treat amyotrophic lateral sclerosis (“ALS”). The Company’s lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40L, a well-validated biological target that we believe has broad therapeutic potential. Unless otherwise indicated, references to the terms “Eledon,” “our,” “us,” “we,” or the “Company” refer to Eledon Pharmaceuticals, Inc. and its wholly owned subsidiaries, on a consolidated basis.
On September 14, 2020 , Eledon acquired Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40L antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. The Company maintains its corporate headquarters in Irvine, California and has research and development facilities in Burlington, Massachusetts.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States ( “ GAAP ” ). Eledon, a Delaware corporation, owns 100 % of the issued and outstanding common stock or other ownership interest in Anelixis Therapeutics, LLC, a Delaware limited liability company, and Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100 % of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation.
Reclassifications
Certain reclassifications have been made to the prior year balances in Note 5. Prepaid Expenses and Other Current Assets and Note 6. Accrued Expenses and Other Liabilities to conform to the current year presentation . These reclassifications had no impact on prior period results.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation expense, warrant liabilities, the fair value of right-of-use (“ROU”) assets and liabilities, accruals for liabilities, impairment of long-lived assets, and other matters that affect the consolidated financial statements and related disclosures. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to significant concentration of credit risk consists of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured institutions in excess of federally insured limits and invests in short-term investments with the primary objective of seeking to preserve principal, achieve liquidity requirements and safeguard invested funds. We believe that the Company is not exposed to significant credit risk due to the financial position of the depository institution in which those deposits are held and the nature, including the credit ratings, of our cash equivalents and short-term investments, but we have not eliminated all credit risk.
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Table of Contents
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, U.S. government securities and U.S. government agency securities. Cash and cash equivalents are valued at cost, which approximates their fair value due to the short-term maturities of these investments.
Risks and Liquidity
Since inception, the Company devoted substantially all of its resources to its research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. The Company’s net loss for the year ended December 31, 2025 is $ 45.6 million. As of December 31, 2025, the Company had cash and cash equivalents and short-term investments of $ 133.3 million, working capital of $ 117.3 million and an accumulated deficit of $ 401.2 million. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. In order to continue these activities, the Company will need to raise additional funds through public or private debt and equity financings including the possible issuance of shares of common stock pursuant to the Company’s “at-the-market” equity offering program, and may need to pursue strategic collaboration and licensing arrangements. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets.
The Company expects that, based on its current operating plans, the Company’s existing cash, cash equivalents and marketable securities will be sufficient to fund its currently planned operations for at least the next 12 months from the filing date of these consolidated financial statements. The Company anticipates it will require additional financing to fund its future operations. Even if the Company believes it has sufficient funds for its current or future operating plans, the Company may seek to raise additional capital if market conditions are favorable or in light of other strategic considerations.
Reportable Segments
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company operates as one operating and one reportable segment, focused on the development of tegoprubart, to develop therapies to protect transplanted organs and prevent rejection, and to treat ALS. The Company’s measure of segment profit or loss is net loss. The CODM is the chief executive officer . The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with the Company’s long-term company wide strategic goals. Consistent with this decision-making process, the CODM uses consolidated net income for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The measure of segment assets is reported on the balance sheet as total consolidated assets.
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Table of Contents
The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to the consolidated net loss for the years ended December 31, 2025 and 2024 is included at the bottom of the table below (in thousands):
Year Ended
December 31,
2025
2024
Operating expenses:
Tegoprubart - kidney transplantation programs
$
35,994
$
27,452
Tegoprubart - other development programs
$
( 168
)
306
Manufacturing
$
14,974
12,448
Personnel-related expenses
$
14,526
10,706
Stock-based compensation
$
10,451
13,122
Other segment items*
$
7,474
6,543
Other income, net
$
4,220
3,924
Change in fair value of warrant liabilities
$
33,449
30,900
Provision for income taxes
$
( 35
)
( 431
)
Net loss
$
( 45,617
)
$
( 36,184
)
* Other segment items included in total operating expenses primarily consist of consulting, professional fees, facilities, insurance and information technology.
In-Process Research and Development
Amounts allocated to in-process research and development (“IPR&D”) in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs when regulatory approval to market a product is obtained, the associated assets are deemed finite-lived and amortized over a period that best reflects the economic benefits provided by these assets. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested annually for impairment or more frequently if indicators of impairment exist.
The Company first assesses qualitative factors to determine whether it is more likely than not that the fair value of the IPR&D is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative assessment. If, after assessing qualitative factors, the Company determines it is not more likely than not that the fair value is less than its carrying amount, then a quantitative assessment is unnecessary. If the quantitative assessment is deemed necessary, the excess of the carrying value over fair value will be recorded as an impairment. The qualitative assessment focuses on the key inputs, assumptions and rationale utilized in the establishment of the carrying value and related changes since the last quantitative assessment. Based on the results of the Company’s annual qualitative assessment, the Company concluded that it is not more likely than not that IPR&D was impaired for any of the periods presented.
Research and Development Expenses
Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed.
The Company contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The
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Table of Contents
Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time.
Net Loss Per Share
Basic and diluted net loss per share are calculated using the two-class method in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings Per Share. The two-class method allocates undistributed losses to the Company’s outstanding common stock, and the Series X and Series X 1 non-voting convertible preferred stock, $ 0.001 par value (the “Preferred Stock”), based on each class’s proportionate share of the total weighted-average shares outstanding. Since the Company has never declared dividends, net loss and undistributed losses are equi valent. The process is used for both common stock and Preferred Stock.
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. As the rights and preferences of the Preferred Stock are substantially identical to each other, they are considered a single class of common stock for earnings per share purposes.
For purposes of the diluted net loss per share calculation, incentive stock options, restricted stock units and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Basic weighted average shares outstanding for the years ended December 31, 2025 and 2024 include 36,629,572 and 12,443,755 respectively, shares underlying pre-funded warrants to purchase common shares. As the shares underlying these pre-funded warrants can be issued for little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share.
Employee Benefit Plan
The Company maintains a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code covering all employees who meet eligibility requirements. Participants may contribute a portion of their compensation subject to IRS limitations. The Company provides matching contributions in accordance with the terms of the plan.
The Company recognized expense related to employer contributions to the plan of $ 0.5 million and $ 0.3 million for the years ended December 31, 2025 and 2024 , respectively.
Stock-Based Compensation
The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value.
The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on publicly traded biotechnology and pharmaceutical companies with comparable business characteristics, clinical stages of development, and organizational scale, including employee headcount, primarily consisting of companies with Phase II or Phase III clinical programs. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation.
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Table of Contents
Restricted Stock Units (“RSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant.
Income Taxes
Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a valuation allowance on our deferred tax assets as of December 31, 2025 and 2024 because we believe it is more likely than not that a majority of our deferred tax assets will not be realized as of this date.
The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2025 and 2024. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized.
The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50 % likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 8. Income Taxes of the Notes to Financial Statements.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act 2017, including 100 % bonus depreciation and immediate expensing of domestic research and development costs, among other tax changes. The Company had no impact on its consolidated financial statements as a result of the enactment of OBBBA.
Common Stock Warrants and Pre-Funded Warrants
The Company accounts for issued common stock warrants and pre-funded warrants either as a liability or equity in accordance with ASC 480-10, Distinguishing Liabilities from Equity (“ASC 480-10”) and ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (“ASC 815-40”). The Company first evaluates the warrants under ASC 480-10 to determine whether the instruments should be classified as liabilities, including whether the warrants embody an obligation to repurchase the Company's shares, require or may require cash settlement, or represent obligations to issue a variable number of shares with a monetary value that is fixed or indexed to something other than the Company's stock. If liability classification is not required under ASC 480-10, the Company then applies ASC 815-40. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations and comprehensive loss as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
F- 14
Table of Contents
Recent Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-09, effective December 31, 2025 , in these consolidated financial statements. ASU 2023-09 only impacted the disclosures and did no t impact the consolidated financial statements. See Note 8 , Income Taxes , for disclosures related to the adoption of ASU 2023-09.
Recent Accounting Pronouncements Issued But Not 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 disaggregated disclosure of income statement expenses for public business entities (“PBEs”). In January 2025, the FASB issued ASU No. 2025-01 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40),” which clarified the effective date for ASU 2024-03. These amendments are intended to provide more information about types of expenses in commonly presented expense captions. The amendments in this update are effective for annual periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, and early adoption is permitted. The Company is currently evaluating the impact on its consolidated financial statements and related disclosures.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission ( “SEC”) did not, or are not believed by management to, have a material impact on the Company’s present or future financial position, results of operations or cash flows.
Note 3. Short-Term Investments
The objectives of the Company’s investment policy are to preserve principal, meet the Company's liquidity requirements and safeguard invested funds. Short-term investments consist of U.S. treasuries and U.S. government securities. The Company has classified these investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investments with maturity dates beyond three months at the date of purchase as current assets in the accompanying consolidated balance sheets. Any premium or discount arising at purchase is amortized and/or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. Investments are reported at their estimated fair value. Unrealized gains and losses are included in accumulated other comprehensive loss as a component of stockholders' equity until realized.
The following is a summary of short-term investments, which were classified as available-for-sale securities as of December 31, 2025 and 2024 (in thousands):
December 31, 2025
Amortized Cost
Unrealized Gains
Unrealized Losses
Fair Value
U.S. treasuries
$
59,839
$
27
$
( 5
)
$
59,861
U.S. government securities
50,667
9
( 9
)
50,667
Total short-term investments
$
110,506
$
36
$
( 14
)
$
110,528
December 31, 2024
Amortized Cost
Unrealized Gains
Unrealized Losses
Fair Value
U.S. government securities
$
119,603
$
55
$
( 29
)
$
119,629
Total short-term investments
$
119,603
$
55
$
( 29
)
$
119,629
All of the Company's available-for-sale securities have a stated maturity of less than one year.
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Note 4. Fair Value Measurements
Financial assets and liabilities are recorded at fair value.
The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
• Level 1—Quoted market prices (unadjusted) in active markets for identical assets and liabilities.
• Level 2—Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active 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 and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. These fair values are obtained from independent pricing services which utilize Level 1 and Level 2 inputs.
Financial Assets
The following table summarizes the Company's financial asset instruments measured at fair value on a recurring basis as of December 31, 2025 and 2024 (in thousands). Included within cash and cash equivalents on the consolidated balance sheets, but excluded from the fair value hierarchy table, are cash deposits held at financial institutions.
December 31, 2025
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
6,734
$
—
$
—
$
6,734
U.S. treasuries
—
14,955
—
14,955
Total cash equivalents
6,734
14,955
—
21,689
Short-term investments:
U.S. treasuries
—
59,861
—
59,861
U.S. government securities
—
50,667
—
50,667
Total short-term investments
—
110,528
—
110,528
Total financial assets
$
6,734
$
125,483
$
—
$
132,217
December 31, 2024
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
1,215
$
—
$
—
$
1,215
U.S. treasuries
—
17,464
—
17,464
Total cash equivalents
1,215
17,464
—
18,679
Short-term investments:
U.S. government securities
—
119,629
—
119,629
Total short-term investments
—
119,629
—
119,629
Total financial assets
$
1,215
$
137,093
$
—
$
138,308
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Warrant Liabilities
The following table summarizes the Company's warrant liabilities (see Note 9. Preferred Stock and Stockholders' Equity ) measured at fair value on a recurring basis as of December 31, 2025 and 2024 (in thousands) and was based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.
December 31, 2025
Level 1
Level 2
Level 3
Total
Warrant liabilities
$
—
$
—
$
11,416
$
11,416
December 31, 2024
Level 1
Level 2
Level 3
Total
Warrant liabilities
$
—
$
—
$
44,865
$
44,865
The following table provides a roll-forward of the aggregate fair value of the warrant liabilities categorized with Level 3 inputs (in thousands):
Warrant Liability
Balance as of December 31, 2024
$
44,865
Change in fair value of warrant liabilities
( 33,449
)
Settlement of warrant liability
—
Balance as of December 31, 2025
$
11,416
Note 5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of December 31, 2025 and 2024 (in thousands):
Year Ended
December 31,
2025
2024
Prepaid clinical
$
578
$
1,768
Interest income receivable
514
625
Prepaid insurance
688
693
Prepaid other
221
215
Prepaid manufacturing
340
147
Other current assets
11
104
Total prepaid expenses and other current assets
$
2,352
$
3,552
Note 6. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following as of December 31, 2025 and 2024 (in thousands):
Year Ended
December 31,
2025
2024
Accrued clinical
$
6,531
$
3,021
Accrued compensation and related expenses
4,176
1,601
Accrued manufacturing
2,525
621
Accrued professional services
495
140
Accrued other
632
47
Total accrued expenses and other liabilities
$
14,359
$
5,430
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Note 7. Commitments and Contingencies
Contract Obligations
As of December 31, 2025 , the Company has non-cancelable purchase obligations related to manufacturing totaling $ 9.3 million. The Company expects to fulfill its commitments within the next twelve months under these agreements in the normal course of business, therefore, no related liability has been recorded on the consolidated balance sheets as of that date.
Operating Leases
The Company leases office space under various operating leases. Total rent expense for all operating leases in the consolidated statements of operations and comprehensive loss was $ 0.4 million for each of the years ended December 31, 2025 and 2024.
On April 19, 2024, the Company entered into a 38-month operating lease for 5,817 square feet of office space in Irvine, California, that expires on June 30, 2027 (the “Irvine Lease Agreement”). On April 19, 2024, in conjunction with the Irvine Lease Agreement, the Company terminated an existing operating lease for 5,197 square feet of office space in Irvine, California, that was set to expire on December 31, 2024 . On April 19, 2024, the effective date of the Irvine Lease Agreement, the Company recognized additional net ROU assets and lease liabilities in the amount of $ 0.5 million .
On September 4, 2024, the Company entered into a 36-month operating lease for 6,138 square feet of office space in Burlington, Massachusetts, that expires on November 21, 2027 (the “Burlington Lease Agreement”). The prior lease expired on November 20, 2024. On November 21, 2024, the effective date of the Burlington Lease Agreement, the Company recognized additional net ROU assets and lease liabilities in the amount of $ 0.5 million.
The Company determines if a contract contains a lease at inception. Our office leases have a remaining term of approximately 2 years and do not include options to extend the leases for additional periods.
Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities as adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we estimate incremental secured borrowing rates corresponding to the maturities of the leases. As we have no outstanding debt nor committed credit facilities, secured or otherwise, we estimate this rate based on prevailing financial market conditions, comparable company and credit analysis, and management’s judgment.
Our leases contain rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term. Additionally, tenant incentives used to fund leasehold improvements are recognized when earned and reduce our ROU asset related to the lease. These are amortized through the ROU asset as reductions of expense over the lease term. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants.
While we do not currently have any lease agreement with lease and non-lease components, we elected to account for lease and non-lease components as separate components.
We have elected the short-term lease recognition exemption for all applicable classes of underlying assets. Short-term disclosures include only those leases with a term greater than one month and 12 months or less, and expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less, that do not include an option to purchase the underlying asset that we are reasonably certain to exercise, are not recorded on the consolidated balance sheet.
The components of lease expense were as follows (in thousands):
Year Ended
December 31,
2025
2024
Operating lease cost (a)
$
394
$
407
(a) Includes variable operating lease expenses, which are immaterial.
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Other supplemental cash flow information related to leases were as follows (in thousands):
Year Ended
December 31,
2025
2024
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$
391
$
378
Other supplemental balance sheet information related to our operating leases (in thousands, except lease term and discount rate):
Year Ended
December 31,
2025
2024
Operating leases
Operating lease right-of-use assets
$
613
$
926
Operating lease liabilities (current)
( 358
)
( 314
)
Operating lease liabilities (non-current)
( 283
)
( 640
)
Total lease obligations under operating leases
$
( 641
)
$
( 954
)
Weighted-average remaining lease term (in years)
1.7
2.7
Weighted-average discount rate
9.44
%
9.46
%
As of December 31, 2025, future minimum payments under non-cancelable operating leases, were as follows (in thousands):
Year Ended
December 31,
2025
2026
$
403
2027
294
Total minimum lease payments
697
Less imputed interest
( 56
)
Present value of lease liabilities
641
Less current portion of operating lease liabilities
( 358
)
Non-current operating lease liabilities
$
283
Grants and Licenses
ALS Therapy Development Foundation, Inc. License Agreement
In May 2015, Anelixis executed a License Agreement (the “Agreement”), which is an exclusive patent rights agreement with ALS Therapy Development Foundation, Inc. (“ALS TDI”) for certain patents and “know-how” of ALS TDI. This Agreement continues until the licensee terminates the agreement with ninety days written notice. The Agreement requires license fees payable to ALS TDI, subject to the achievement of certain milestones and other conditions.
The first and second milestones of the Agreement are the dosing of the first subjects in a first toxicity study in non-human primates and the dosing of the first patient in a Phase I Clinical Trial, respectively. Both of these milestones were achieved prior to 2024. The fee due upon achievement of each milestone was $ 1.0 million, and as the payments became due, the Company settled the obligations through the issuance of common stock in lieu of cash payments.
The Agreement was amended and restated in February 2020, and a first amendment to the restated license agreement was executed in September 2020. As amended in September 2020, the remaining milestone payments for a first licensed
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product total $ 6.0 million. In the event that the Company develops a second licensed product, the Company is obligated to pay up to $ 2.5 million in additional milestone payments.
In addition to the milestone payments, the Company is required to pay ALS TDI an amended annual license maintenance fee of $ 0.1 million beginning on the earlier of January 1, 2022, the Company’s first sublicense, or change in control, as defined in the Agreement. The Company has made a $ 0.1 million annual license maintenance fee each year since 2022.
Furthermore, the Company is required to pay ALS TDI fees based on reaching certain levels of annual net sales of any product produced with the patent rights. A royalty in the low single digits will be due on aggregate net sales. Upon the first calendar year of reaching $ 500.0 million in aggregate net sales, the Company will be required to pay ALS TDI a one-time milestone payment of $ 15.0 million. Upon the first calendar year of reaching $ 1.0 billion in aggregate net sales, the Company is obligated to pay ALS TDI a one-time milestone payment of $ 30.0 million.
There were no milestones achieved during the years ended December 31, 2025 or 2024.
Lonza Sales AG Inc. License Agreement
In September 2018, Anelixis executed a License Agreement (the “Lonza Agreement”), which is a manufacturing know-how rights agreement with Lonza Sales AG Inc. (“Lonza”) for the use of certain processes and know-how related to the manufacture of tegoprubart. The Lonza Agreement continues until the later of the last Valid Claim (as defined therein) or ten years from the First Commercial Sale of tegoprubart, as defined and subject to the conditions therein. A royalty in the low single digits will be due on aggregate net sales of tegoprubart that is manufactured by Lonza or any other third-party or licensee. For the years ended December 31, 2025 and 2024 , the Company has no t paid any royalties under the Lonza Agreement.
Legal Matters
The Company and its subsidiaries are not a party to or the subject of any claim or lawsuit that individually or in the aggregate is anticipated to have a material effect on the Company’s results of operations, financial condition or cash flows.
Indemnifications
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future because of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual at December 31, 2025 and 2024 .
Note 8. Income Taxes
Loss before income taxes are as follows (in thousands):
Year Ended
December 31,
2025
2024
Losses before income taxes:
U.S.
$
( 45,781
)
$
( 35,951
)
Non-U.S.
199
198
Total
$
( 45,582
)
$
( 35,753
)
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The provision for income taxes are as follows (in thousands):
Year Ended
December 31,
2025
2024
Current:
Federal
$
—
$
—
State
30
—
Foreign
—
—
Total current income tax provision
30
—
Deferred:
Federal
—
—
State
5
431
Foreign
—
—
Total deferred income tax provision
5
431
Total provision for income taxes
$
35
$
431
Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting.
Based on its review, the Company concluded that it was more likely than not that they would not realize the benefit of a portion of its deferred tax assets in the future. This conclusion was based on historical and projected operating performance, as well as the Company’s expectation that its operations will not generate sufficient taxable income in future periods to realize the tax benefits associated with the deferred tax assets within the statutory carryover periods. Therefore, the Company has a valuation allowance on its deferred tax assets as of December 31, 2025.
The Company will continue to assess the need for a valuation allowance on its deferred tax assets by evaluating both positive and negative evidence that may exist. Any adjustment to the net deferred tax asset valuation allowance would be recorded in the statement of operations for the period that the adjustment is determined to be required.
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):
Year Ended
December 31, 2025
$
%
Expected benefit at statutory federal income tax rate
$
( 9,572
)
21.00
%
State income taxes, net of federal tax benefits*
35
- 0.08
%
Tax credits:
Research and development credits
( 3,512
)
7.70
%
Nontaxable and nondeductible items:
Stock-based compensation
3,574
- 7.84
%
Other permanent items
19
- 0.04
%
Change in fair value of warrant liabilities
( 7,024
)
15.41
%
Changes in unrecognized tax benefits
1,756
- 3.85
%
Other
12
- 0.03
%
Change in valuation allowance
14,747
- 32.35
%
Total provision for income taxes
$
35
- 0.08
%
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*State taxes in Massachusetts made up the majority (greater than 50%) of the tax effect in this category. The Company paid a majority of cash taxes in Massachusetts.
As previously disclosed for the years ended December 31, 2024, prior to the adoption of ASU 2023-09, the table below is a reconciliation of the components that caused the Company's provision (benefit) for income taxes to differ from amounts computed by applying the U.S. Federal statutory rate of 21 % (in thousands):
Year Ended
December 31, 2024
Statutory federal income tax rate
$
( 7,508
)
State income taxes, net of federal tax benefits
( 908
)
Tax credits
( 2,358
)
Stock-based compensation
2,819
Permanent items
12
Change in fair value of warrant liabilities
( 7,273
)
State rate differential
490
Net operating loss true-up
( 4
)
Other
24
Change in valuation allowance
15,137
Total provision for income taxes
$
431
Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2025 and 2024 consisted of the following (in thousands):
Year Ended
December 31,
2025
2024
Net operating loss carryforwards
$
29,509
$
22,740
Research and development tax credits
7,616
5,560
Accruals and reserves
699
366
Research expenditures
28,232
18,809
Stock-based compensation
1,591
3,281
Depreciation and amortization
795
1,056
Lease liability
151
225
Total deferred tax assets
68,593
52,037
Right-of-use asset
( 144
)
( 218
)
Acquired IPR&D
( 7,628
)
( 7,623
)
Total deferred tax liabilities
( 7,772
)
( 7,841
)
Less: valuation allowance
( 63,008
)
( 46,379
)
Net deferred tax liabilities
$
( 2,187
)
$
( 2,183
)
The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands):
Year Ended
December 31,
2025
2024
Gross unrecognized tax benefits at the beginning of the year
$
6,232
$
3,636
Additions from tax positions taken in the current year
2,017
2,596
Additions from tax positions taken in prior years
12
—
Prior year adjustment
( 238
)
—
Gross unrecognized tax benefits at the end of the year
$
8,023
$
6,232
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The following table summarizes the income taxes paid, net of refunds, for the year ended December 31, 2025 (in thousands).
Year Ended
December 31, 2025
U.S. Federal
$
—
Massachusetts
26
Other
2
Total income taxes paid
$
28
The deferred income tax assets have been offset by a valuation allowance, as realization is dependent on future earnings, if any, the timing and amount of which are uncertain. The net valuatio n allowance increased by $ 16.6 million from December 31, 2024 to December 31, 2025 . The net valuation allowance increased by $ 15.6 million from December 31, 2023 to December 31, 2024.
The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood, and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At present, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a valuation allowance has been established.
As of December 31, 2025 and 2024 , the Company had federal net operating loss carryforwards of approximately $ 117.5 million and $ 88.7 million , respectively, available to reduce future taxable income. As of December 31, 2025 and 2024 , the Company also had state net operating loss carryforwards of $ 49.1 million and $ 37.7 million , respectively. Both the federal and state net operating loss carryforwards incurred before 2018 begin expiring in 2035 , if not utilized. The federal net operating losses incurred since 2018 of $ 116.7 million do not expire. The state net operating losses begin to expire in 2035 . As of December 31, 2025 and 2024 , the Company had Israel net operating losses of $ 7.9 million, respectively, which carryforward indefinitely.
As of December 31, 2025 and 2024 , the Company had federal research and development tax credit carryforwards of approximately $ 11.5 million and $ 8.0 million, respectively. If not utilized, the carryforwards will begin expiring in 2035 . As of December 31, 2025 and 2024 , the Company had state research and development credit carryforwards of approximately $ 3.4 million and $ 2.6 million , respectively, which will begin expiring in 2030 if not utilized .
Pursuant to the Internal Revenue Code of 1986, as amended (“IRC” ) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50 % occurs within a three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate.
The Company’s ability to use its remaining net operating loss and tax credit carryforwards may be further limited if the Company experiences an IRC Section 382 ownership change in connection with future changes in our stock ownership.
In the United States, the Company files income tax returns in the U.S. Federal jurisdiction, California and Massachusetts. The Company’s tax years for 2019 and forward are subject to examination by the Federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits.
The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. There was no accrued interest and penalties associated with uncertain tax positions as of December 31, 2025 and 2024 . The Company has no t recorded any interest or penalties as of December 31, 2025 or 2024.
On July 4, 2025, the OBBBA was signed into law. The legislation includes several changes to federal tax law that generally allow for more favorable deductibility of certain business expenses beginning in 2025, including the restoration of immediate expensing of domestic research and development expenditures, reinstatement of 100 % bonus depreciation, and
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more favorable rules for determining the limitation on business interest expense. OBBBA changes effective for 2025 were determined to have no impact to the income tax provision for year ended December 31, 2025 .
Note 9. Preferred Stock and Stockholders’ Equity
Convertible Preferred Stock
The Company has 5,000,000 authorized shares of preferred stock with a par value of $ 0.001 per share:
• Series X 1 non-voting convertible preferred stock, 515,000 shares designated; 110,086 shares issued and outstand ing at December 31, 2025 and 2024, and
• Series X non-voting convertible preferred stock, 10,000 shares designated; 4,422 shares issued and outstanding at December 31, 2025 and 2024.
Each share of Preferred Stock is convertible into 55.5556 shares of common stock, at the option of the holder at any time, subject to certain limitations, including, that the holder will be prohibited from converting the Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above a conversion blocker, which is initially set at 9.99 % or 9.9 % of the total common stock then issued and outstanding immediately following the conversion of such shares of Series X Preferred Stock or Series X 1 Preferred Stock, respectively. The holder of the Preferred Stock is entitled to receive dividends on shares of the Preferred Stock equal (on an as-if-converted-to-common-stock basis and without regard to any beneficial ownership limitations) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Preferred Stock. In the event of any liquidation, dissolution or winding up, the holder of the Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu with all holders of common stock. Shares of the Preferred Stock will generally have no voting rights, except as required by law and except that the consent of a majority of the holders of either series of outstanding Preferred Stock will be required to amend the terms of such series.
The Preferred Stock includes a provision that, in the event of a tender or exchange offer by a third party in which more than 50 % of the common stockholders receive cash or other assets, allows holders of Preferred Stock, upon any subsequent conversion, to redeem their shares for the same form of consideration. In August 2025, the Company concluded that because this redemption right may be triggered by an event outside the Company’s control and could result in settlement in cash, the Preferred Stock is classified as temporary equity. As of the current reporting date, a tender offer is not probable, and the preferred stock is not deemed probable of becoming redeemable. Because redemption is not considered probable, the Preferred Stock is not subsequently remeasured to its redemption value.
Common Stock
On June 10, 2025, the Company held its 2025 Annual Meeting of Stockholders (the “2025 Annual Meeting”). At the 2025 Annual Meeting, the Company’s stockholders approved an amendment (the “Authorized Share Increase Amendment”) to the Company’s Restated Certificate of Incorporation (as amended, the “Certificate of Incorporation”) to increase the number of authorized shares of common stock from 200,000,000 to 300,000,000 shares.
2023 Securities Purchase Agreement
On April 28, 2023, the Company entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) (i) in an initial closing, (a) an aggregate of 15,151,518 shares (the “Shares”) of the Company’s common stock, $ 0.001 par value per share ( “common stock”) , or pre-funded warrants in lieu thereof (the “Pre-Funded Warrants”), and (b) common stock warrants exercisable into an aggregate of 15,151,518 shares of common stock (or Pre-Funded Warrants in lieu thereof) (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”); (ii) in a second closing (the “Second Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 20,202,024 shares of common stock (or Pre-Funded Warrants); and (iii) in a third closing (the “Third Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 25,252,530 shares of common stock (or Pre-Funded Warrants), in each case subject to customary adjustments as provided in the 2023 Securities Purchase Agreement, Pre-Funded Warrant or Common Warrant, as
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applicable. Each Common Warrant has an exercise price of $ 3.00 per share and expires five years after issuance. The Pre-Funded Warrants are exercisable immediately and until exercised in full, with an exercise price of $ 0.001 per share.
The Pre-Funded Warrants and Common Warrants are subject to specified beneficial ownership limitations, which are generally set at 9.99 % of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99 % unless otherwise permitted. The Shares, the Warrants, and the shares of common stock issuable upon the exercise of the Warrants, have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
On May 5, 2023, the initial closing occurred, and the Company received $ 35.0 million, or net proceeds of approximately $ 33.0 million after deducting offering costs, in exchange for 8,730,168 shares of common stock and Pre-Funded Warrants to purchase 6,421,350 shares of common stock.
On July 8, 2024, the Second Closing occurred, and the Company received gross proceeds of $ 2.1 million, or net proceeds of approximately $ 2.0 million after deducting offering costs, in exchange for 909,088 shares of common stock.
On September 30, 2024, and October 1, 2024, the Third Closing occurred, and the Company received gross proceeds of $ 4.0 million, or net proceeds of approximately $ 3.8 million after deducting offering costs, in exchange for 1,727,400 shares of common stock.
In connection with the 2023 Private Placement, the Company filed on May 18, 2023, a registration statement on Form S-3 (the “2023 Registration Statement”) with the SEC to register for resale the Shares and the shares of common stock issuable upon the exercise of the Warrants. The 2023 Registration Statement became effective on June 2, 2023.
In August 2024, the Company concluded that the Common Warrants, and the potential issuance of Pre-Funded Warrants in lieu of additional shares of common stock in the Second Closing and Third Closing (the “Subsequent Closing Warrants”) do not meet the conditions to be classified as equity instruments under ASC 815-40 and must instead be recorded as liabilities on the Company’s consolidated balance sheets at their fair value and remeasured at fair value for each subsequent reporting period. As of October 2024, the Subsequent Closing Warrants either expired or were settled in connection with the Second Closing and Third Closing. Accordingly, the Company's consolidated balance sheets no longer include any fair value associated with the Subsequent Closing Warrants.
The valuation of the Common Warrants is adjusted to fair value (Level 3) at each balance sheet date until the Common Warrants are settled or expired.
The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of the Common Warrants as of December 31, 2025 and 2024 as follows:
Year Ended
December 31,
2025
2024
Expected stock price volatility
110.5 %
96.4 %
Risk-free interest rate
3.6 %
4.4 %
Expected term (in years)
2.5
3.5
Share price
$
1.51
$
4.14
2024 Securities Purchase Agreement
On May 6, 2024, the Company entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2024 Private Placement”) an aggregate of 13,110,484 shares (the “2024 Shares”) of the Company’s common stock, at a price of $ 2.37 per share, and pre-funded warrants (the “2024 Pre-Funded Warrants”) at a price of $ 2.369 per underlying share, which are exercisable to purchase 7,989,516 shares of common stock at an exercise price of $ 0.001 per share. The 2024 Pre-Funded Warrants were issued in lieu of shares of common stock and are exercisable immediately and until exercised in full. The 2024 Pre-Funded Warrants are subject to specified beneficial ownership limitations (equal to 4.99 % or 9.99 % as determined by the holders of each such warrant) of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99 % unless otherwise permitted. The 2024 Shares, the 2024 Pre-Funded Warrants, and the
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shares of common stock issuable upon the exercise of the 2024 Pre-Funded Warrants, have not been registered under the Securities Act and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
The 2024 Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2024 Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2024 Pre-Funded Warrants do not provide any guarantee of value or return.
The 2024 Private Placement resulted in gross proceeds to the Company of $ 50.0 million, or net proceeds of approximately $ 48.1 million after deducting offering costs. The Company is using the net proceeds from the 2024 Private Placement to fund pre-commercial activities for its products and general corporate purposes.
In connection with the 2024 Private Placement, the Company filed on May 24, 2024, a registration statement on Form S-3 (the “2024 Registration Statement”) with the SEC to register for resale the 2024 Shares and the shares of common stock issuable upon the exercise of the 2024 Pre-Funded Warrants. The 2024 Registration Statement became effective on June 5, 2024.
2024 Equity Distribution Agreement
On September 20, 2024, the Company entered into an Open Market Sale Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”) to sell shares of the Company’s common stock, having aggregate sales proceeds of up to $ 75.0 million, from time to time, through an “at the market” equity offering program under which Guggenheim Securities will act as sales agent. In connection with the Sales Agreement, the Company filed on September 20, 2024 a registration statement on Form S-3 containing a prospectus and prospectus supplement (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement became effective on October 2, 2024. As of the year ended December 31, 2025, the Company has not sold any shares under the Sales Agreement.
2024 Underwritten Offering
On October 29, 2024, the Company entered into an underwriting agreement with Leerink Partners, LLC, as representative of the several underwriters named therein in connection with the underwritten offering, issuance and sale by the Company (the “2024 Underwritten Offering”) of 18,356,173 shares of the Company’s common stock, at an offering price of $ 3.65 per share, and pre-funded warrants at a price of $ 3.649 per pre-funded warrant, which are exercisable to purchase 4,931,507 shares of the Company’s common stock at an exercise price of $ 0.001 per share (the “2024 Offering Pre-Funded Warrants”).
The 2024 Offering Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2024 Offering Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2024 Offering Pre-Funded Warrants do not provide any guarantee of value or return.
The 2024 Underwritten Offering closed on October 30, 2024 and resulted in gross proceeds of $ 85 million, or net proceeds of approximately $ 79.5 million after deducting underwriting discounts and commissions and offering expenses. The 2024 Underwritten Offering was made pursuant to the Shelf Registration Statement and a prospectus supplement relating to the 2024 Underwritten Offering dated October 29, 2024.
A holder of the 2024 Offering Pre-Funded Warrants (together with its affiliates) may not exercise any portion of a 2024 Offering Pre-Funded Warrant to the extent that, after giving effect to such exercise, the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates) would beneficially own in excess of 4.99 % (or, at the holder’s option upon issuance, 9.99 %) of the number of shares of the Company's common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of such 2024 Offering Pre-Funded Warrant.
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2025 Underwritten Offering
On November 12, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners, LLC, as representative of the several underwriters named therein (the “Underwriters”), in connection with the underwritten public offering and sale by the Company (the “2025 Underwritten Offering”) of 15,152,485 shares of the Company’s common stock at a public offering price of $ 1.65 per share (the “Common Stock Purchase Price”), and pre-funded warrants (the “2025 Offering Pre-Funded Warrants”) at a public offering price of $ 1.649 per 2025 Offering Pre-Funded Warrant, which are exercisable to purchase up to 15,151,515 shares of common stock at an exercise price of $ 0.001 per share. In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriters an option (the “Option”), exercisable for 30 days, to purchase up to 4,545,600 additional shares of common stock at the Common Stock Purchase Price less the underwriting discounts and commissions, which Option had been exercised in full by the Underwriters.
The 2025 Underwritten Offering closed on November 13, 2025 and resulted in gross proceeds of $ 57.5 million or net proceeds of approximately $ 53.6 million after deducting the underwriting discounts and commissions and offering expenses. The 2025 Underwritten Offering was made pursuant to the Shelf Registration Statement and a prospectus supplement relating to the 2025 Underwritten Offering dated November 12, 2025.
The 2025 Offering Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2025 Offering Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2025 Offering Pre-Funded Warrants do not provide any guarantee of value or return.
A holder of the 2025 Offering Pre-Funded Warrants (together with its affiliates) may not exercise any portion of a 2025 Offering Pre-Funded Warrant to the extent that, after giving effect to such exercise, the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates) would beneficially own in excess of 4.99 % of the number of shares of the Company's common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of such 2025 Offering Pre-Funded Warrant. A holder may increase or decrease such beneficial ownership limitation, provided that in no event shall the limitation exceed 19.99 % of the number of shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the 2025 Offering Pre-Funded Warrant.
2025 Warrant Exchange Agreement
On December 30, 2025, the Company entered into an exchange agreement (the “Warrant Exchange Agreement”) with Coastlands Capital Partners LP, ( “Coastlands Capital”), pursuant to which Coastlands Capital agreed to exchange 4,203,764 shares of the Company's common stock for a pre-funded warrant to purchase an aggregate of 4,203,764 shares of common stock (the “Exchange Warrant”), and the Company cancelled the 4,203,764 shares of common stock delivered in the exchange.
Coastlands Capital (together with its affiliates) may not exercise any portion of the Exchange Warrant to the extent that, after giving effect to such exercise, Coastlands Capital (together with its affiliates and any other persons acting as a group together with Coastlands Capital or any of the its affiliates) would beneficially own in excess of 4.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of the Exchange Warrant. Coastlands Capital may increase or decrease such beneficial ownership limitation, provided that in no event shall the limitation exceed 19.99 % of the number of shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Exchange Warrant.
Exercise of Pre-Funded Warrants from 2023 Securities Purchase Agreement
On January 30, 2024, Armistice Capital Master Fund Ltd. (the “Exercising Stockholder”) exercised Pre-Funded Warrants to purchase 600,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On January 30, 2024, the Company issued 600,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
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On May 7, 2024, the Exercising Stockholder exercised Pre-Funded Warrants to purchase 583,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On May 9, 2024, the Company issued 583,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
On July 11, 2024, the Exercising Stockholder exercised their remaining Pre-Funded Warrants to purchase 240,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On July 11, 2024, the Company issued 240,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
Common Stock Warrants and Pre-Funded Warrants
As of December 31, 2025, 51,781,090 warrants and pre-funded warrants exercisable into common stock. The Company has issued both common stock warrants and pre-funded warrants. The pre-funded warrants are exercisable for shares of common stock at a nominal exercise price and were fully paid for at issuance, except for the nominal exercise amount. The pre-funded warrants are intended to be economically equivalent to the Company’s common stock.
The following table shows the warrants to purchase common stock activity:
Roll-Forward of Warrant Activity
Common Stock Warrants
Pre-Funded Warrants
Total
Balance as of December 31, 2024
15,778,451
17,274,293
33,052,744
Issued
—
19,355,279
19,355,279
Cancelled/Expired
( 626,933
)
—
( 626,933
)
Balance as of December 31, 2025
15,151,518
36,629,572
51,781,090
As of December 31, 2025, the Company's outstanding warrants to purchase shares of common stock consisted of the following:
Date Issued
Number of Shares of Common Stock Issuable
Exercise Price
Expiration Date
2023 Securities Purchase Agreement common warrants
15,151,518
$
3.00
May 5, 2028
January 2021 pre-funded warrants
509,117
$
0.001
December 31, 2030
2023 Securities Purchase Agreement pre-funded warrants
3,844,153
$
0.001
N/A
2024 Securities Purchase Agreement pre-funded warrants
7,989,516
$
0.001
N/A
2024 Underwritten Offering pre-funded warrants
4,931,507
$
0.001
N/A
2025 Underwritten Offering pre-funded warrants
15,151,515
$
0.001
N/A
2025 Warrant Exchange Agreement
4,203,764
$
0.001
N/A
Balance as of December 31, 2025
51,781,090
Preferred Stock Warrants
As of December 31, 2025, all warrants exercisable for shares of Series X 1 Preferred Stock expired in accordance with their original terms.
Roll-Forward of Series X 1 Convertible Preferred Warrant Activity
Total
Balance as of December 31, 2024
50,207.419
Assumed and replaced
—
Exercised
—
Cancelled/Expired
( 50,207.419
)
Balance as of December 31, 2025
—
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Note 10. Stock-Based Compensation
Stock Option Plans
The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value.
The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the Company’s board of directors (the “Board”), the Company determined the expected life assumption using the simplified method as the starting point with an average period of 12 months added to take into account the extended range of time of 12 to 18 months that vested stock options granted to Board members may be exercised upon termination. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation .
Restricted Stock Units (“RSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant.
On July 10, 2024, the Company held its 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”). At the 2024 Annual Meeting, the Company’s stockholders approved an amendment to the Company's 2020 Long Term Incentive Plan (the “2020 Plan”). The 2020 Plan, as amended, (i) reflects an increase in the limit on the aggregate number of shares of the Company’s common stock that may be delivered pursuant to all awards granted under the 2020 Incentive Plan by an additional 3,500,000 shares so that the new aggregate share limit under the 2020 Plan is 17,960,000 shares, and (ii) extends the date through which the Company may grant new awards under the 2020 Plan from November 15, 2030 to April 28, 2034.
On May 1, 2023, the Company issued stock option awards to its employees with both time-based and performance-based vesting requirements, totaling 7,381,857 stock options, with 1,476,372 of the granted stock options subject to the Company’s customary time-based vesting schedule. The remaining 5,905,485 stock options granted are subject to both customary time-based vesting requirements and performance-based vesting requirements that are based on the same clinical development milestones applicable to the Second Closing and Third Closing of the 2023 Private Placement as specified in the 2023 Securities Purchase Agreement.
In December 2023, the Company amended the performance-based vesting requirements with its named executive officers and other employees that upon the Second Closing and Third Closing, a full or prorated amount of each closing installment shall vest based on the percentage of funding received relative to the total funding opportunity represented by the investors’ Second Closing and Third Closing subscription amounts. On June 13, 2024 and November 20, 2024, the performance-based vesting requirement based on the milestones applicable to the Second Closing and Third Closing were satisfied, and 5,763,085 stock options were issued.
The Company's 2014 Stock Incentive Plan (the “2014 Plan”) was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of December 31, 2025 . The number of shares reserved for issuance under the 2020 Plan and the Company's Employee Stock Purchase Plan was 3,961,166 and 24,077 shares, respectively, as of December 31, 2025.
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The following table summarizes all option activity under the 2014 Plan, 2020 Plan and inducement grants, including 2,713,083 shares forfeited by certain Company's executive officers and directors on December 30, 2025:
Shares
Issuable
Under Options
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
(in thousands)
(In years)
Outstanding as of January 1, 2024
15,381,853
$
4.21
8.9
$
235
Granted
622,000
2.22
Exercised
( 50,000
)
2.30
Forfeited / Canceled
( 316,465
)
7.29
Outstanding as of December 31, 2024
15,637,388
$
4.02
7.5
$
20,628
Granted
2,495,025
4.01
Exercised
( 100,437
)
2.30
Forfeited / Canceled
( 2,804,477
)
8.66
Outstanding as of December 31, 2025
15,227,499
$
3.17
7.3
$
357
Options vested and expected to vest as of
December 31, 2025
15,227,499
$
3.17
7.3
$
357
Options exercisable as of December 31, 2025
9,189,825
$
3.31
6.8
$
179
Intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that had exercise prices that were lower than the fair value per share of the common stock on the date of exercise. The aggregate intrinsic value of options exercised during the year ended December 31, 2025 was $ 0.2 million.
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
Expected stock price volatility
97.8 %
101.3 %
Risk-free interest rate
4.5 %
4.2 %
Expected term (in years)
6.0
6.9
Estimated dividend yield
— %
— %
The per share weighted average grant date fair value of stock options granted during the years ended December 31, 2025 and 2024 was $ 3.25 and $ 1.93 , respectively.
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Restricted Stock Units
The following table shows the RSU activity, as follows:
Shares
Issuable
Under RSUs
Weighted
Average
Grant Date Fair Value
Outstanding as of January 1, 2024
—
$
—
Granted
46,000
1.97
Exercised
—
—
Forfeited / Canceled
—
—
Outstanding as of December 31, 2024
46,000
$
1.97
Granted
336,225
4.04
RSUs Vested
( 46,000
)
1.97
Forfeited / Canceled
—
—
Outstanding as of December 31, 2025
336,225
$
4.04
Stock-based Compensation Expense
Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2025 and 2024 was comprised of the following (in thousands):
Year Ended
December 31,
2025
2024
Stock-based compensation classified as:
Research and development expense
$
4,241
$
4,277
General and administrative expense
6,210
8,845
Total stock-based compensation expense
$
10,451
$
13,122
As of December 31, 2025, total unrecognized stock-based compensation expense related to non-vested equity awards w as $ 13.8 million, which is expected to be recognized over an estimated weighted-average period of 2.1 years.
Note 11. Net Loss Per Share
Basic and diluted net loss per share are calculated using the two-class method in accordance with ASC Topic 260, Earnings Per Share. The two-class method allocates undistributed losses to the Company’s outstanding common stock, and the Preferred Stock, based on each class’s proportionate share of the total weighted-average shares outstanding. Since the Company has never declared dividends, net loss and undistributed losses are equivalent.
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. The process is used for both common stock and Preferred Stock. As the rights and preferences of the Preferred Stock are substantially identical to each other, they are considered a single class of common stock for earnings per share purposes.
For purposes of the diluted net loss per share calculation, incentive stock options, restricted stock units and common warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Basic weighted average shares outstanding for the years ended and December 31, 2025 and 2024 include 36,629,572 and 12,443,755 respectively, shares underlying pre-funded warrants to purchase common shares. As the shares underlying these pre-funded warrants can be issued for little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share.
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The calculation of basic and diluted earnings per share for our common stock and Preferred Stock is as follows:
Year Ended
December 31,
2025
2024
(In thousands, except share and per share data)
Weighted-average common shares outstanding, basic and diluted
81,836,246
48,543,787
Weighted-average shares outstanding of Series X and Series X 1 non-voting convertible preferred stock, basic and diluted
114,508
114,508
Net loss used in the calculation of basic and diluted loss per share
$
( 45,617
)
$
( 36,184
)
Net loss available to common stock
$
( 42,328
)
$
( 31,992
)
Net loss per share, common stock, basic and diluted
$
( 0.52
)
$
( 0.66
)
Net loss available to Series X and Series X 1 non-voting convertible preferred stock
$
( 3,290
)
$
( 4,192
)
Basic and diluted earnings per share of Series X and Series X 1 non-voting convertible preferred stock
$
( 28.73
)
$
( 36.61
)
The following table presents potentially dilutive securities outstanding based on the market price of the Company's common stock as of December 31, 2025 and 2024 that were excluded from the computation of diluted net loss per share because their inclusion would have been anti-dilutive. These securities consist of incentive stock options, restricted stock units and common warrants outstanding during the respective periods.
Year Ended
December 31,
2025
2024
Stock options outstanding and other equity awards
1,333,225
6,007,789
Common warrants
—
18,567,751
Total
1,333,225
24,575,540
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.