ANNX 8-K
Annexon, Inc. (ANNX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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Item 2.02. Results of Operations and Financial Condition.
On March 30, 2026, Annexon, Inc. (the “Company”) announced certain financial results for the fourth quarter and the year ended December 31, 2025. A copy of the Company’s press release, titled “Annexon Reports Fourth Quarter and Year-End 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
Exhibit |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: March 30, 2026 |
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Annexon, Inc. |
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By: |
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/s/ Jennifer Lew |
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Jennifer Lew |
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Executive Vice President and Chief Financial Officer |
Exhibit 99.1
Annexon Reports Fourth Quarter and Year-End 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones
ARCHER II Topline Pivotal Phase 3 Data in Geographic Atrophy (GA) Expected Q4 2026; Vonaprument has Potential to Be the First Vision-Preserving Therapy for GA
Tanruprubart MAA Filed in Europe with Potential to Be the First Targeted Fast-Acting Therapy for Guillain-Barré Syndrome (GBS); U.S./European FORWARD Study Data Expected to Support Planned BLA Submission in 2026
ANX1502 Advancing as First Oral C1 Inhibitor for Autoimmune Disease; Proof-of-Concept (POC) Data Anticipated in 2026
Strong Balance Sheet with Cash, Cash Equivalents and Short-Term Investments of Approximately $238.3 Million as of December 31, 2025, and Anticipated Runway into Second Half 2027
BRISBANE, Calif., March 30, 2026 – Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported fourth quarter and full year 2025 financial results.
“We’re energized by this defining period for Annexon. Two decades of C1q and classical complement pathway research have enabled our bold mission of pioneering a new class of targeted immunotherapies that reshape how neuroinflammation is treated. Today, our scientific platform has translated into two late stage registrational programs with the potential to improve the lives of millions in large, underserved markets worldwide,” said Douglas Love, president and chief executive officer of Annexon. “Leveraging one mechanism to stop neuroinflammation at its source, vonaprument is designed to protect photoreceptor neurons to preserve vision in GA, while tanruprubart is designed to protect peripheral nerves to support faster, more complete and durable recovery in GBS.”
Mr. Love continued, “Grounded in robust vonaprument Phase 2 ARCHER data and strong execution of the ongoing Phase 3 ARCHER II trial, we are on track to report topline pivotal data in the fourth quarter of this year. ARCHER II is the first study to evaluate visual preservation as the primary endpoint in patients with GA and the first pivotal study with an aligned global regulatory path. Additionally, we have filed for Marketing Authorization Application (MAA) in the EU for tanruprubart and are preparing for potential approval of the first targeted therapy for GBS. We’re also focused on the ongoing US/EU FORWARD study which is designed to broaden experience across western geographies to support a planned U.S. Biologics License Application (BLA) submission in 2026. Lastly, we anticipate POC data for our first-in-kind classical complement oral inhibitor, ANX1502, in autoimmune disease this year. Overall, with a strengthened balance sheet and continued focus on our core priorities, we are well-positioned to deliver multiple near-term value driving catalysts in the year ahead.”
2026 Strategic Priorities and Key Milestones
Vonaprument– Potential to be the first targeted vision-preserving therapy for dry age-related macular degeneration (AMD) with GA, a leading cause of blindness affecting more than 8 million patients worldwide.
Tanruprubart – Potential to be the first targeted fast-acting therapy for GBS, a leading cause of neuromuscular paralysis impacting approximately 150,000 people annually worldwide.
ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing.
Fourth Quarter and Full Year 2025 Financial Results
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to millions of patients to help them live their best lives. To learn more visit annexonbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential for the company’s two late stage registrational programs to improve the lives of millions in large, underserved markets; the potential for tanruprubart to be the first targeted therapy for GBS approved in the EU; the potential therapeutic benefit of tanruprubart, if approved, compared to existing therapies; anticipated timing and results of regulatory interactions related to tanruprubart; the design, objectives and timing of the open-label tanruprubart FORWARD study; the company’s ability to gain clarity from the FDA on the generalizability package to support a BLA submission; the company’s ability to achieve regulatory approval for tanruprubart; the potential therapeutic benefit of vonaprument; timing of and results from the Phase 3 ARCHER II trial; vonaprument’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for vonaprument to be the first targeted vision-preserving therapy to be approved in Europe and the U.S. for dry AMD with GA; timing of proof-of-concept trial for ANX1502 in cold agglutinin disease and the company’s ability to provide an update upon study completion in 2026; the potential for ANX1502 to disrupt the current treatment antibody-mediated autoimmune diseases; the company’s ability to potentially reformulate enteric-coated tablets to potentially improve drug release profile that is more resistant to food effect for use in late-stage clinical development in autoimmune diseases; the company’s ability to commercialize its product candidates, if approved; continued development of vonaprument and ANX1502; anticipated cash runway into the second half of 2027; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
Media Contact:
Beth Keshishian
917-912-7195
[email protected]
ANNEXON, INC.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Year Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development (1) |
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$ |
42,659 |
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$ |
43,354 |
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$ |
184,698 |
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$ |
119,448 |
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General and administrative (1) |
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7,599 |
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9,125 |
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31,709 |
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34,625 |
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Total operating expenses |
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50,258 |
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52,479 |
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216,407 |
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154,073 |
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Loss from operations |
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(50,258 |
) |
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(52,479 |
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(216,407 |
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(154,073 |
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Interest and other income, net |
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2,002 |
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3,889 |
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9,717 |
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15,873 |
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Net loss |
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(48,256 |
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(48,590 |
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(206,690 |
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(138,200 |
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Deemed dividend on modification of common stock warrants |
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— |
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— |
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(1,857 |
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— |
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Net loss attributable to common stockholders |
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$ |
(48,256 |
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$ |
(48,590 |
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$ |
(208,547 |
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$ |
(138,200 |
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Net loss per share, basic and diluted |
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$ |
(0.28 |
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$ |
(0.33 |
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$ |
(1.34 |
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$ |
(1.01 |
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Weighted-average shares used in computing net loss per share, |
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174,644,156 |
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147,812,160 |
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155,105,832 |
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137,404,145 |
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_______________________
(1) Includes the following stock-based compensation expense: |
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Research and development |
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$ |
2,110 |
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$ |
2,752 |
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$ |
10,007 |
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$ |
9,670 |
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General and administrative |
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$ |
1,195 |
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$ |
2,470 |
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$ |
6,416 |
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$ |
9,763 |
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ANNEXON, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands)
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December 31 |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
162,051 |
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$ |
49,498 |
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Short-term investments |
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76,294 |
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262,519 |
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Prepaid expenses and other current assets |
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3,846 |
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4,444 |
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Total current assets |
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242,191 |
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316,461 |
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Restricted cash |
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1,032 |
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1,032 |
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Property and equipment, net |
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10,617 |
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12,638 |
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Operating lease right-of-use assets |
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15,185 |
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16,705 |
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Other non-current assets |
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8,546 |
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3,235 |
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Total assets |
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$ |
277,571 |
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$ |
350,071 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
14,931 |
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$ |
10,426 |
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Accrued and other current liabilities |
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24,791 |
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17,568 |
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Operating lease liabilities, current |
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2,908 |
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2,518 |
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Total current liabilities |
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42,630 |
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30,512 |
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Operating lease liabilities, non-current |
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23,293 |
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26,454 |
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Total liabilities |
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65,923 |
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56,966 |
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Stockholders’ equity: |
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Common stock |
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149 |
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109 |
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Additional paid-in capital |
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1,128,917 |
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1,003,685 |
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Accumulated other comprehensive (loss) income |
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(29 |
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10 |
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Accumulated deficit |
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(917,389 |
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(710,699 |
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Total stockholders' equity |
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211,648 |
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293,105 |
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Total liabilities and stockholders’ equity |
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$ |
277,571 |
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$ |
350,071 |
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