Annexon Reports Third Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones
Further credit availability depends on clinical-program milestones and lender approval, while two registrational programs approach assessments.
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 Summary
Annexon (Nasdaq: ANNX) reported a narrower third-quarter net loss and advanced its investigational programs for neurological and retinal diseases. 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. Cash, cash equivalents and short-term investments totaled $213.4 million at September 30; the company expects funding to last into 2028.
Annexon expects a Q4 2026 U.S. tanruprubart application for Guillain-Barré syndrome; its European application is under review. Vonaprument’s ARCHER II Phase 3 trial in geographic atrophy remains on track for a Q4 2026 Month 15 primary endpoint assessment, with completion expected in Q3 2027. ANX1502 completed a nine-patient study, with tablet optimization underway. Annexon also secured an up to $200 million credit facility and drew $50 million at closing.
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.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointQ3 2026 net loss attributable to common stockholders narrowed to $51.2 million from $54.9 million a year earlier.
- Moderate point. Forward-looking: it has not happened yet and may not happen.$213.4 million in cash, cash equivalents and short-term investments is expected to fund operations and anticipated milestones into 2028.
- Moderate pointUp to $200 million Oxford Finance credit facility secured; $50 million drawn at closing. 25% of market cap
- Moderate point. Forward-looking: it has not happened yet and may not happen.Tanruprubart U.S. application expected in Q4 2026, incorporating U.S. and European FORWARD data.
- Moderate point. Forward-looking: it has not happened yet and may not happen.ARCHER II Month 15 primary endpoint assessment expected in Q4 2026; trial completion expected in Q3 2027.
- Moderate pointQ3 2026 R&D expenses decreased to $41.4 million from $49.7 million a year earlier.
8 minor points
- Minor pointQ3 2026 loss per share narrowed to $0.25 from $0.37 a year earlier.
- Minor pointTanruprubart FORWARD study treated 18 patients, with functional outcomes and generally well-tolerated safety consistent with earlier studies.
- Minor pointARCHER II retention reached 90%; all eligible patients received at least 15 months of treatment.
- Minor pointANX1502 nine-patient proof-of-concept study completed, with no significant safety signals and reductions in disease biomarkers.
- Minor pointANX1502 tablet optimization underway to improve absorption before studies in diseases including generalized myasthenia gravis.
- Minor pointNine-month R&D expenses decreased to $123.744 million from $142.039 million in the comparable 2025 period.
- Minor pointNine-month net loss attributable to common stockholders narrowed to $150.708 million from $160.291 million a year earlier.
- Minor pointNine-month loss per share narrowed to $0.75 from $1.08 a year earlier.
Negative
- Moderate pointCredit facility borrowing adds debt; non-current term loan carrying value was $49.340 million at September 30, 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.ARCHER II may continue through the Month 24 primary endpoint analysis instead of proceeding to early sub-study assessment.
- Minor point. Forward-looking: it has not happened yet and may not happen.Additional credit requires program milestones for $100 million and lender approval for the remaining $50 million.
- Minor pointTanruprubart European application remains under review by the European Medicines Agency.
- Minor point. Forward-looking: it has not happened yet and may not happen.ARCHER II sub-study assessment depends on the monitoring committee recommending that the Month 15 endpoint was met.
5 minor points
- Minor pointQ3 2026 G&A expenses increased to $10.9 million from $7.3 million a year earlier.
- Minor pointNine-month G&A expenses increased to $31.774 million from $24.110 million in the comparable 2025 period.
- Minor pointQ3 2026 interest expense was $833,000 versus none a year earlier.
- Minor pointQ3 2026 interest and other income, net declined to $1.853 million from $2.096 million a year earlier.
- Minor pointNine-month interest and other income, net declined to $5.643 million from $7.715 million a year earlier.
News Explained
Beyond the
Key Figures
- Cash and short-term investments
- $213.4 million
- As of September 30, 2026; expected to fund operations and anticipated milestones into 2028
- Strategic credit facility
- Up to $200 million
- Facility with Oxford Finance LLC
- Initial facility draw
- $50 million
- Drawn at closing
- Additional facility availability
- $100 million milestone-based; remaining $50 million subject to lender approval
- Strategic credit facility
- Patients treated
- 18 patients
- Ongoing open-label U.S. and European FORWARD study of tanruprubart
- Patient retention
- 90%
- ARCHER II; eligible patients had received at least 15 months of treatment
- Research and development expenses
- $41.4 million vs. $49.7 million
- Three months ended September 30, 2026 vs. 2025
- Net loss attributable to common stockholders
- $51.2 million vs. $54.9 million
- Quarter ended September 30, 2026 vs. 2025
Previous Earnings Reports
-
Q3 2025 reported higher R&D expenses and net loss versus the prior-year quarter.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
biologics license application regulatory
marketing authorisation application regulatory
data monitoring committee medical
bcva medical
proof-of-concept medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
BRISBANE, Calif., Nov. 09, 2026 (GLOBE NEWSWIRE) -- 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
- In the ongoing open-label U.S. and European FORWARD study, 18 patients have been treated with tanruprubart to date, representing a broad spectrum of disease from moderate to severe in both male and female patients ranging in age from 12 to 78 years old. Functional outcomes, complete target engagement, and a generally well-tolerated safety profile were observed in FORWARD, consistent with Phase 3 and real-world evidence studies. Patient-level data from the first six patients in FORWARD were presented at medical conferences and are available on Annexon’s website here.
- EU Marketing Authorisation Application (MAA) under review with the European Medicines Agency (EMA), supported by robust data package demonstrating tanruprubart’s potential to deliver rapid benefit on function and disability in patients with GBS.
- U.S. Biologics License Application (BLA) submission anticipated this quarter is further strengthened by FORWARD findings, which provide additional evidence of the consistency and reproducibility of tanruprubart treatment effect across a broad range of GBS patients with different disease neurotypes, severities, ages and geographies.
- Next Milestone: EMA review of MAA underway; BLA submission with U.S./European data from FORWARD expected fourth quarter of 2026.
Vonaprument in GA: Potential first targeted vision-preserving therapy for GA, a leading cause of blindness affecting more than 8 million people worldwide.
- Key features of the ongoing global, double-masked ARCHER II Phase 3 trial were recently highlighted in Annexon’s virtual investor event. A replay is available here.
- ARCHER II is designed to demonstrate clinically meaningful vision protection at Months 15 and 24. Given the linear progression of vision loss in GA, we believe longer treatment provides greater potential for sustained treatment benefit and increased separation between vonaprument treatment and sham over time.
- ARCHER II enrolled a patient population similar to Phase 2, which showed consistent, dose-dependent vision protection across a broad spectrum of disease. Notably, ARCHER II is larger and longer in duration and better powered than the Phase 2 trial, and we believe is well-positioned for success on the primary endpoint of BCVA 15-letter loss.
- Study execution reflects strong physician and patient engagement. All eligible patients have received at least 15 months of treatment with patient retention at
90% , and masked vision-loss events have tracked closely with projections. - ARCHER II is a single protocol supporting a global registration path. The Phase 3 single study will be analyzed for EU filing and will be allocated into two pre-defined sub-studies for the U.S. filing and maintains strong statistical power at the sub-study level.
- An independent Data Monitoring Committee (DMC) will assess the ARCHER II single study Month 15 primary endpoint in the fourth quarter of 2026. If the DMC recommends that the endpoint has been met, the DMC will evaluate the two pre-specified sub-studies, with results anticipated in the first quarter of 2027. Alternatively, the DMC may recommend continuing the trial through the Month 24 primary endpoint analysis. ARCHER II completion, including Month 24 analyses, is expected in the third quarter of 2027.
- Next Milestones: ARCHER II Phase 3 Month 15 single study primary endpoint assessment expected in the fourth quarter of 2026; ARCHER II completion, including Month 24 analyses, expected in the third quarter of 2027.
ANX1502 for Autoimmune Diseases: Potential first-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing.
- Completed proof-of-concept (POC) study evaluating an enteric-coated tablet formulation of ANX1502 in nine patients with cold agglutinin disease (CAD). No significant safety signals were observed.
- Drug activity, including observed reductions in disease biomarkers such as bilirubin and LDH, supports ANX1502’s potential for further development.
- Formulation optimization is underway to improve absorption of the enteric-coated tablet prior to executing studies in clinically validated, potentially blockbuster diseases, including neuromuscular disorders such as generalized myasthenia gravis (gMG).
- Annexon will provide further updates on the ANX1502 program as appropriate.
Corporate Updates
- Entered into a strategic credit facility of up to
$200 million with Oxford Finance LLC, drawing an initial$50 million at closing. An additional$100 million is available upon achievement of milestones related to the vonaprument and tanruprubart registrational programs. The remaining$50 million is available subject to lender approval. - Appointed Mark S. Blumenkranz, M.D., M.M.S., a retinal surgeon and biotechnology entrepreneur with more than four decades of clinical, scientific and corporate leadership experience, to the Company’s Board of Directors.
- Continued to strengthen the ophthalmology franchise with the addition of retinal specialist Eleonora (Nora) Lad, M.D., Ph.D., to Annexon’s Scientific Advisory Board. Nora is Professor of Ophthalmology and Vice Chair for Clinical Research at Duke University. Jake Shumacher joined Annexon as S.V.P., Ophthalmology Franchise Head, and is leading global commercial strategy and execution for vonaprument. Jake was formerly V.P., Commercial Head for IZERVAY at Astellas. Dr. Donald Fong, S.V.P., Clinical Development, Ophthalmology, and is leading the vonaprument clinical program, drawing on more than 25 years of experience as a retina surgeon and as former clinical lead for the vonaprument Phase 2 ARCHER study.
Third Quarter 2026 Financial Results
- Cash and operating runway: Cash, cash equivalents and short-term investments were
$213.4 million as of September 30, 2026, which are expected to fund operations and anticipated milestones into 2028. - Research and development (R&D) expenses: R&D expenses were
$41.4 million for the quarter ended September 30, 2026, compared to$49.7 million for the quarter ended September 30, 2025. The change in R&D expenses is primarily associated with completed contract manufacturing expenses supporting tanruprubart regulatory filings offset by continued development of vonaprument in GA. - General and administrative (G&A) expenses: G&A expenses were
$10.9 million for the quarter ended September 30, 2026, compared to$7.3 million for the quarter ended September 30, 2025. The change in G&A expenses reflects ongoing corporate consulting and professional services costs for the advancement of our registrational programs and compensation and personnel-related expenses. - Net loss: Net loss attributable to common stockholders was
$51.2 million or$0.25 per share for the quarter ended September 30, 2026, compared to$54.9 million or$0.37 per share for the quarter ended September 30, 2025.
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) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 41,368 | $ | 49,700 | $ | 123,744 | $ | 142,039 | ||||||||
| General and administrative (1) | 10,870 | 7,318 | 31,774 | 24,110 | ||||||||||||
| Total operating expenses | 52,238 | 57,018 | 155,518 | 166,149 | ||||||||||||
| Loss from operations | (52,238 | ) | (57,018 | ) | (155,518 | ) | (166,149 | ) | ||||||||
| Interest expense | (833 | ) | — | (833 | ) | — | ||||||||||
| Interest and other income, net | 1,853 | 2,096 | 5,643 | 7,715 | ||||||||||||
| Net loss | (51,218 | ) | (54,922 | ) | (150,708 | ) | (158,434 | ) | ||||||||
| Deemed dividend on modification of common stock warrants | — | — | — | (1,857 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (51,218 | ) | $ | (54,922 | ) | $ | (150,708 | ) | $ | (160,291 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (0.37 | ) | $ | (0.75 | ) | $ | (1.08 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 204,652,743 | 149,123,701 | 199,990,325 | 148,521,489 | ||||||||||||
_______________________
| (1) Includes the following stock-based compensation expense: | ||||||||||||||||
| Research and development | $ | 2,630 | $ | 2,380 | $ | 7,661 | $ | 7,897 | ||||||||
| General and administrative | $ | 2,480 | $ | 1,455 | $ | 6,418 | $ | 5,221 | ||||||||
| ANNEXON, INC. Condensed Consolidated Balance Sheets (Unaudited) (in thousands) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 102,389 | $ | 162,051 | ||||
| Short-term investments | 110,985 | 76,294 | ||||||
| Prepaid expenses and other current assets | 4,525 | 3,846 | ||||||
| Total current assets | 217,899 | 242,191 | ||||||
| Restricted cash | 1,032 | 1,032 | ||||||
| Property and equipment, net | 9,165 | 10,617 | ||||||
| Operating lease right-of-use assets | 13,882 | 15,185 | ||||||
| Other non-current assets | 8,430 | 8,546 | ||||||
| Total assets | $ | 250,408 | $ | 277,571 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 15,910 | $ | 14,931 | ||||
| Accrued and other current liabilities | 18,512 | 24,791 | ||||||
| Operating lease liabilities, current | 3,238 | 2,908 | ||||||
| Total current liabilities | 37,660 | 42,630 | ||||||
| Term loan, non-current | 49,340 | — | ||||||
| Operating lease liabilities, non-current | 20,613 | 23,293 | ||||||
| Total liabilities | 107,613 | 65,923 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 190 | 149 | ||||||
| Additional paid-in capital | 1,210,856 | 1,128,917 | ||||||
| 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 | ||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Annexon's third-quarter 2026 financial results?
Annexon reported a $51.2 million net loss attributable to common stockholders, or $0.25 per share, compared with $54.9 million, or $0.37 per share, a year earlier. Research and development expenses were $41.4 million, while general and administrative expenses were $10.9 million.
When does Annexon expect its next tanruprubart and vonaprument milestones?
Annexon expects the tanruprubart U.S. application and vonaprument ARCHER II Month 15 primary endpoint assessment in Q4 2026. The tanruprubart European application is under review. ARCHER II completion, including Month 24 analyses, is expected in Q3 2027.
How will Annexon's ARCHER II results support U.S. and European applications?
ARCHER II will be analyzed as one study for the European filing and two pre-defined sub-studies for the U.S. filing. If the independent monitoring committee recommends that the Month 15 endpoint has been met, it will evaluate the sub-studies, with results anticipated in Q1 2027. Alternatively, it may recommend continuing through the Month 24 primary endpoint analysis.
What conditions apply to Annexon's remaining Oxford Finance credit?
An additional $100 million is available upon milestones related to the vonaprument and tanruprubart registrational programs, while the remaining $50 million requires lender approval. Annexon drew an initial $50 million at closing under the facility of up to $200 million.
What did Annexon's ANX1502 study show?
The completed study in nine patients with cold agglutinin disease found no significant safety signals and observed reductions in biomarkers including bilirubin and LDH. Annexon considers the activity supportive of further development. Optimization of the enteric-coated tablet is underway to improve absorption before further studies, including in generalized myasthenia gravis.