Annexon secures up to $200M credit facility
Annexon drew $50 million at closing; another $100 million is tied to program milestones, and $50 million is subject to lender approval.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Annexon, Inc. reported third-quarter 2026 financial results and program updates. Cash, cash equivalents and short-term investments were $213.4 million as of September 30, 2026, and are expected to fund operations and anticipated milestones into 2028. Net loss attributable to common stockholders was $51.2 million, or $0.25 per share, versus $54.9 million, or $0.37 per share a year earlier.
Tanruprubart’s EU MAA is under EMA review, and a U.S. BLA submission supported by U.S./European FORWARD data is anticipated in Q4 2026; 18 patients had been treated in the open-label study. Vonaprument’s ARCHER II Month 15 single-study primary endpoint assessment is expected in Q4 2026. If the independent Data Monitoring Committee recommends that the endpoint was met, it will assess two prespecified sub-studies, with results anticipated in Q1 2027. Alternatively, the DMC may recommend continuing through the Month 24 primary endpoint analysis; trial completion is expected in Q3 2027.
ANX1502’s enteric-coated tablet proof-of-concept study involved nine patients with cold agglutinin disease; no significant safety signals were observed, and formulation optimization is underway. Annexon entered an up-to-$200 million credit facility with Oxford Finance LLC, drawing $50 million at closing; $100 million is available upon milestones related to vonaprument and tanruprubart registrational programs, while the remaining $50 million is subject to lender approval.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointQuarterly net loss narrowed to $51.2 million from $54.9 million.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
Biologics License Application (BLA) regulatory
Marketing Authorisation Application (MAA) regulatory
Data Monitoring Committee (DMC) regulatory
proof-of-concept (POC) medical
BCVA medical
Earnings Snapshot
Cash, cash equivalents and short-term investments of $213.4 million as of September 30, 2026, are expected to fund operations and anticipated milestones into 2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What patient-retention data did Annexon report for ANNX’s ARCHER II trial?
What biomarker changes were seen in ANNX’s ANX1502 study?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code:
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 9, 2026, Annexon, Inc. (the “Company”) announced certain financial results for the third quarter ended September 30, 2026. A copy of the Company’s press release, titled “Annexon Reports Third Quarter 2026 Financial Results, Business Updates 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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Press Release, dated November 9, 2026, titled “Annexon Reports Third Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones” |
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 9, 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 Third Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones
Differentiated C1q Platform Advances Two Registrational Programs with Blockbuster Potential, Driving Near-Term Value Catalysts
Tanruprubart U.S./EU FORWARD Data in GBS Strengthens BLA Submission Package Anticipated in Q4 2026; Tanruprubart EU MAA Currently Under Review
Vonaprument ARCHER II Phase 3 Well-Designed to Demonstrate Clinically Meaningful Vision Protection in GA; Month 15 Primary Endpoint Assessment on Track for Q4 2026
ANX1502 Data Support Continued Development of Potential First Oral C1s Inhibitor for Autoimmune Diseases, including gMG; Tablet Formulation Optimization Underway
Cash, Cash Equivalents and Short-Term Investments of $213 Million as of September 30, 2026, Provide Anticipated Runway into 2028
BRISBANE, Calif., November 9, 2026 – Annexon, Inc. (Nasdaq: ANNX) a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact approximately 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported third quarter 2026 financial results.
“Annexon is well-positioned for a transformative next 12 months, with multiple value-creating milestones expected across our differentiated upstream C1q platform,” said Douglas Love, President and Chief Executive Officer of Annexon. “By targeting C1q tanruprubart and vonaprument have each demonstrated first-in-kind benefits in clinical trials to date, with tanruprubart accelerating functional recovery in Guillain-Barré syndrome (GBS) and vonaprument protecting vision in geographic atrophy (GA). Together, they have the potential to become groundbreaking therapies for millions of patients worldwide. In the third quarter, we advanced both programs, strengthened our balance sheet and added experienced leaders to our Board of Directors, advisory board, and team. We enter the final months of the year with significant focus and momentum to deliver on our mission to help millions live their best lives.”
2026 Strategic Priorities and Key Milestones
Tanruprubart in GBS: Potential first targeted, fast-acting therapy for GBS, a life-threatening neuromuscular emergency affecting 150,000 people annually worldwide, with an estimated annual U.S. healthcare burden of approximately $20 billion.
Vonaprument in GA: Potential first targeted vision-preserving therapy for GA, a leading cause of blindness affecting more than 8 million people worldwide.
ANX1502 for Autoimmune Diseases: Potential first-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing.
Corporate Updates
Third Quarter 2026 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 harmful inflammation, 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 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 for the company’s two late stage registrational programs to become groundbreaking therapies for millions of patients; the blockbuster potential of the Company’s product candidates with multiple value-creating milestones expected across a differentiated upstream C1q platform; the timing and results of the BLA submission and MAA review by the EMA of tanruprubart; the potential therapeutic benefits of the Company’s product candidates; timing of and topline data from the pivotal Phase 3 ARCHER II trial at Month 15 and Month 24 and our belief that ARCHER II is well-positioned for success on the primary endpoint; the potential of vonaprument to be the first targeted vision-preserving therapy for GA and to demonstrate clinically meaningful results; the potential of tanruprubart to be the first targeted and fast-acting therapy for GBS; the Company’s ability to meet conditions and access additional capital under the Oxford credit facility; anticipated cash runway into 2028; 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 formulation optimization for ANX1502; the ability to develop ANX1502 for gMG; 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 Securities and Exchange Commission. 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:
Christian Vaughn
annexonpr@syneoshealth.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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2026 |
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2025 |
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2026 |
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2025 |
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||||
Operating expenses: |
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|
|
|
|
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|
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||||
Research and development (1) |
|
$ |
41,368 |
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$ |
49,700 |
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$ |
123,744 |
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$ |
142,039 |
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General and administrative (1) |
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10,870 |
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7,318 |
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31,774 |
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24,110 |
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Total operating expenses |
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52,238 |
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|
57,018 |
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155,518 |
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166,149 |
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Loss from operations |
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|
(52,238 |
) |
|
|
(57,018 |
) |
|
|
(155,518 |
) |
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|
(166,149 |
) |
Interest expense |
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|
(833 |
) |
|
|
— |
|
|
|
(833 |
) |
|
|
— |
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Interest and other income, net |
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|
1,853 |
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|
|
2,096 |
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5,643 |
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7,715 |
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Net loss |
|
|
(51,218 |
) |
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(54,922 |
) |
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|
(150,708 |
) |
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(158,434 |
) |
Deemed dividend on modification of common stock warrants |
|
|
— |
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— |
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— |
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|
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(1,857 |
) |
Net loss attributable to common stockholders |
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$ |
(51,218 |
) |
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$ |
(54,922 |
) |
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$ |
(150,708 |
) |
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$ |
(160,291 |
) |
Net loss per share, basic and diluted |
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$ |
(0.25 |
) |
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$ |
(0.37 |
) |
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$ |
(0.75 |
) |
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$ |
(1.08 |
) |
Weighted-average shares used in computing net loss per share, |
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|
204,652,743 |
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149,123,701 |
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199,990,325 |
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148,521,489 |
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_______________________
(1) Includes the following stock-based compensation expense: |
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||||
Research and development |
|
$ |
2,630 |
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$ |
2,380 |
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$ |
7,661 |
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$ |
7,897 |
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General and administrative |
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$ |
2,480 |
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|
$ |
1,455 |
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$ |
6,418 |
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|
$ |
5,221 |
|
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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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
102,389 |
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$ |
162,051 |
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Short-term investments |
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110,985 |
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76,294 |
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Prepaid expenses and other current assets |
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4,525 |
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3,846 |
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Total current assets |
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|
217,899 |
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242,191 |
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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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9,165 |
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|
|
10,617 |
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Operating lease right-of-use assets |
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|
13,882 |
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|
|
15,185 |
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Other non-current assets |
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|
8,430 |
|
|
|
8,546 |
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Total assets |
|
$ |
250,408 |
|
|
$ |
277,571 |
|
Liabilities and Stockholders' Equity |
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|
|
|
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Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
15,910 |
|
|
$ |
14,931 |
|
Accrued and other current liabilities |
|
|
18,512 |
|
|
|
24,791 |
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Operating lease liabilities, current |
|
|
3,238 |
|
|
|
2,908 |
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Total current liabilities |
|
|
37,660 |
|
|
|
42,630 |
|
Term loan, non-current |
|
|
49,340 |
|
|
|
— |
|
Operating lease liabilities, non-current |
|
|
20,613 |
|
|
|
23,293 |
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Total liabilities |
|
|
107,613 |
|
|
|
65,923 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Common stock |
|
|
190 |
|
|
|
149 |
|
Additional paid-in capital |
|
|
1,210,856 |
|
|
|
1,128,917 |
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Accumulated other comprehensive loss |
|
|
(154 |
) |
|
|
(29 |
) |
Accumulated deficit |
|
|
(1,068,097 |
) |
|
|
(917,389 |
) |
Total stockholders' equity |
|
|
142,795 |
|
|
|
211,648 |
|
Total liabilities and stockholders’ equity |
|
$ |
250,408 |
|
|
$ |
277,571 |
|