Annexon, Inc 8-K, filed Nov 10, 2025
Annexon, Inc. (ANNX)
About this 8-K
Annexon, Inc filed this 8-K on November 10, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition.
On November 10, 2025, Annexon, Inc. (the “Company”) announced certain financial results for the third quarter ended September 30, 2025. A copy of the Company’s press release, titled “Annexon Reports Third Quarter 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: November 10, 2025 |
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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 Third Quarter 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones
Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA)
Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing
Topline ARCHER II Pivotal Data for Vonaprument in Dry AMD with GA on Track for Second Half of 2026; Potential to Be the First Approved Vision Sparing Therapy for the Treatment of Eight Million GA Patients Worldwide
ANX1502 Cold Agglutinin Disease (CAD) Proof of Concept Study Ongoing with Expected 2026 Completion; Potential to Be the Only Oral C1s Inhibitor for the Treatment of Multiple Neuroinflammatory Autoimmune Diseases
Strong Financial Position and Execution Extends Operations into 2027, Through Several Important Milestones, Including Tanruprubart Global GBS Filings, Vonaprument Topline GA Phase 3 Data, and ANX1502 Autoimmune Proof of Concept Data
BRISBANE, Calif., November 10, 2025 – Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress, announced key anticipated milestones and reported third quarter 2025 financial results.
“We’re pleased with the focused execution of our business strategy across our late-stage neuroinflammation platform, and the strong momentum we’ve built over 2025 heading into a meaningful 2026. Our next-generation complement inhibitor candidates continue to demonstrate the power of stopping neuroinflammation at its source, enabling multiple programs advancing toward key near-term milestones,” said Douglas Love, president and chief executive officer of Annexon. “Our registrational Guillain-Barré Syndrome program is on track for EU Marketing Authorisation Application (MAA) submission in January 2026, positioning it to become the first targeted therapy for GBS, a disease that annually affects 150,000 people worldwide. Dialogue with the FDA is also ongoing regarding the generalizability package supporting the U.S. Biologics License Application (BLA) submission. Furthermore, our registrational Phase 3 trial for vonaprument in GA is on track to deliver topline data in the second half of 2026. The study is designed to confirm the significant vision preservation observed in our Phase 2 trial and benefit the eight million people affected by GA worldwide.”
Mr. Love continued, “Finally, we are building on the early learnings from our ANX1502 program, the first and only clinical stage oral inhibitor of C1s. We’ve observed targeted drug levels in fasted CAD patients, and we continue to dose to deepen our understanding of ANX1502’s profile, anticipating study completion in 2026. With a prioritized capital plan, our runway is extended into 2027 through each of the above anticipated milestones. Overall, Annexon is uniquely positioned to drive near-term value while pursuing additional opportunities to achieve our mission of helping millions of patients suffering from devastating neuroinflammatory diseases.”
Recent Corporate and Clinical Program Updates
Tanruprubart (ANX005) in GBS: Targeted neuroinflammatory inhibitor of C1q and the classical pathway delivered in a single infusion to rapidly halt aggressive neuroinflammation and damage in GBS, an acute, rare, neuromuscular emergency that affects ~150,000 people worldwide each year. There are no FDA-approved therapies for GBS and limited evidence of effectiveness from the current standards of care (SOC) therapy used in GBS.
Vonaprument (ANX007) in Dry AMD Patients with GA: Neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for dry AMD with GA, a leading cause of blindness affecting more than eight million people worldwide. There are no approved therapies for GA targeting the preservation of vision.
ANX1502 for Autoimmune Conditions: First-in-kind oral C1s inhibitor, has the potential to offer disruptive advantages of clinically validated upstream classical complement inhibition with the convenience and flexibility of oral administration.
Third Quarter 2025 Financial Results
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is developing the next generation of complement inhibitors to stop neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can 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 therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing and results of regulatory interactions related to ANX005; 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 make an MAA submission for European registration in January 2026 and to achieve regulatory approval for ANX005; the potential therapeutic benefit of ANX007; timing of and results from the Phase 3 ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for ANX007 to be the first drug 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 commercialize its product candidates, if approved; continued development of ANX007 and ANX1502; anticipated cash runway into late first quarter 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 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
jallaire@lifesciadvisors.com
Media Contact:
Beth Keshishian
917-912-7195
beth@bethkeshishian.com
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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Nine Months 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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$ |
49,700 |
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$ |
30,105 |
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$ |
142,039 |
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$ |
76,094 |
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General and administrative (1) |
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7,318 |
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9,337 |
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24,110 |
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25,500 |
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Total operating expenses |
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57,018 |
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39,442 |
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166,149 |
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101,594 |
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Loss from operations |
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(57,018 |
) |
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(39,442 |
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(166,149 |
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(101,594 |
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Interest and other income, net |
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2,096 |
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4,618 |
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7,715 |
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11,984 |
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Net loss |
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(54,922 |
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(34,824 |
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(158,434 |
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(89,610 |
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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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$ |
(54,922 |
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$ |
(34,824 |
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$ |
(160,291 |
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$ |
(89,610 |
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Net loss per share, basic and diluted |
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$ |
(0.37 |
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$ |
(0.25 |
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$ |
(1.08 |
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$ |
(0.68 |
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Weighted-average shares used in computing net loss per share, |
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149,123,701 |
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139,933,019 |
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148,521,489 |
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130,945,980 |
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(1) Includes the following stock-based compensation expense: |
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Research and development |
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$ |
2,380 |
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$ |
2,325 |
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$ |
7,897 |
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$ |
6,918 |
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General and administrative |
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$ |
1,455 |
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$ |
2,284 |
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$ |
5,221 |
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$ |
7,293 |
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ANNEXON, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands)
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September 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
139,419 |
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$ |
49,498 |
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Short-term investments |
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49,302 |
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262,519 |
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Prepaid expenses and other current assets |
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4,101 |
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4,444 |
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Total current assets |
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192,822 |
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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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11,152 |
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12,638 |
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Operating lease right-of-use assets |
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15,587 |
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16,705 |
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Other non-current assets |
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8,549 |
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3,235 |
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Total assets |
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$ |
229,142 |
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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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$ |
18,219 |
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$ |
10,426 |
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Accrued and other current liabilities |
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22,543 |
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17,568 |
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Operating lease liabilities, current |
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2,818 |
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2,518 |
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Total current liabilities |
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43,580 |
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30,512 |
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Operating lease liabilities, non-current |
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24,120 |
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26,454 |
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Total liabilities |
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67,700 |
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56,966 |
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Stockholders’ equity: |
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Common stock |
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115 |
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109 |
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Additional paid-in capital |
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1,030,536 |
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1,003,685 |
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Accumulated other comprehensive (loss) income |
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(76 |
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10 |
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Accumulated deficit |
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(869,133 |
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(710,699 |
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Total stockholders' equity |
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161,442 |
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293,105 |
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Total liabilities and stockholders’ equity |
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$ |
229,142 |
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$ |
350,071 |
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