Annexon (Nasdaq: ANNX) deepens pipeline, adds $200M credit facility and new endpoints
Rhea-AI Filing Summary
Annexon, Inc. reported second quarter 2026 results while advancing its late-stage neuroinflammatory pipeline. For the quarter ended June 30, 2026, the company recorded a net loss of $55,348 thousand, compared with $49,156 thousand a year earlier, driven by higher research and development and general and administrative expenses. For the first six months of 2026, net loss was $99,490 thousand, modestly improved from $103,512 thousand in 2025.
Cash and cash equivalents were $199,270 thousand and short-term investments were $9,973 thousand as of June 30, 2026, with total assets of $246,068 thousand and stockholders’ equity of $186,061 thousand. Management highlighted a new $200 million credit facility, stating it strengthens the balance sheet and extends the anticipated cash runway into 2028.
Clinically, Annexon expanded its Phase 3 ARCHER II trial of vonaprument in geographic atrophy to add a Month 24 dual primary endpoint alongside the Month 15 endpoint and launched an open-label extension study. The company expects Month 15 primary endpoint assessment in the fourth quarter of 2026 and completion of ARCHER II, including Month 24 analyses, in the third quarter of 2027. A BLA submission for tanruprubart in Guillain-Barré syndrome is expected in the fourth quarter of 2026, and proof-of-concept data for ANX1502 are anticipated in fall 2026.
Positive
- $200 million credit facility is expected to strengthen liquidity and extend the company’s cash runway into 2028, supporting completion of multiple late-stage clinical milestones.
- Vonaprument’s Phase 3 ARCHER II program is strengthened by a dual Month 15 / 24 primary endpoint strategy and an open-label extension study, with a global registration path established with U.S. and European regulators.
- Multiple near-term catalysts are outlined, including a BLA submission for tanruprubart in Q4 2026, Month 15 ARCHER II data in Q4 2026, and proof-of-concept data for ANX1502 in fall 2026.
Negative
- The company remains highly loss-making, with a second quarter net loss of $55,348 thousand and a six-month net loss of $99,490 thousand.
- Accumulated deficit increased to $1,016,879 thousand as of June 30, 2026, reflecting a long history of operating losses ahead of potential product approvals.
Filing Explained
ARCHER II now has two efficacy checkpoints, but its next state change depends on the Month 15 DMC review in Q4 2026.
The August 12, 2026 Form 8-K reports a material company event and furnishes press releases describing financial, business, and clinical updates. In the ongoing ARCHER II trial, Annexon added a Month 24 dual primary endpoint alongside Month 15 and launched an open-label extension; the disclosed structure allows the trial to seek success at either independent efficacy timepoint.
The two primary endpoints measure the proportion of patients with confirmed best-corrected visual-acuity loss of at least 15 letters at two consecutive visits, assessed through months 15 and 24. After Month 24, eligible patients may receive monthly vonaprument in the open-label extension, which is designed to evaluate longer-term safety and benefit.
The next decision point is the independent Data Monitoring Committee's Month 15 assessment, expected in the
8-K Event Classification
Key Figures
Key Terms
geographic atrophy medical
open-label extension medical
Fast Track designation regulatory
Priority Medicine (PRIME) designation regulatory
best corrected visual acuity medical
Data Monitoring Committee regulatory
Earnings Snapshot
Management stated that the $200 million credit facility is expected to extend the anticipated cash runway into 2028.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Annexon (ANNX)’s net losses for Q2 2026 and the first half of 2026?
How much liquidity does Annexon (ANNX) report as of June 30, 2026?
What is the size and impact of Annexon (ANNX)’s new credit facility?
What are the key timelines for Annexon (ANNX)’s vonaprument Phase 3 ARCHER II trial?
When does Annexon (ANNX) expect to file a BLA for tanruprubart in GBS?
What proof-of-concept data timeline did Annexon (ANNX) provide for ANX1502?
UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On August 12, 2026, Annexon, Inc. (the “Company”) announced certain financial results for the second quarter ended June 30, 2026. A copy of the Company’s press release, titled “Annexon Reports Second 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 8.01. | Other Events. |
On August 12, 2026, the Company issued a press release titled “Annexon Expands Vonaprument Phase 3 Program in Geographic Atrophy to Add Month 24 Dual Primary Endpoint Complementing Month 15 Primary Endpoint and Launch Open-Label Extension Study.” A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and, other than the quotes contained therein, is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press release, dated August 12, 2026, titled “Annexon Reports Second Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones”. | |
| 99.2 | Press release, dated August 12, 2026, titled “Annexon Expands Vonaprument Phase 3 Program in Geographic Atrophy to Add Month 24 Dual Primary Endpoint Complementing Month 15 Primary Endpoint and Launch Open-Label Extension Study”. | |
| 104.1 | Cover Page Interactive Data File, formatted in inline XBRL. | |
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: August 12, 2026 | Annexon, Inc. | |||||
| By: | /s/ Jennifer Lew | |||||
| Jennifer Lew | ||||||
| Executive Vice President and Chief Financial Officer | ||||||
Exhibit 99.1
Annexon Reports Second Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones
Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026
Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary Endpoint Strategy and Launch of Open-Label Extension Study; Month 15 Primary Endpoint on Track for Q4 2026
POC Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in Fall 2026
$200 Million Credit Facility Strengthens Balance Sheet and Capabilities; Anticipated Runway Extended into 2028
Company to Host Business Update Call Today at 8:00 a.m. ET
BRISBANE, Calif., August 12, 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 second quarter 2026 financial results. The Company will host a business update call today at 8:00 a.m. ET to discuss corporate and clinical developments across its C1q-focused neuroinflammatory pipeline. Please register for the event here.
“2026 is a defining year for our company, with meaningful progress across both our Guillain-Barré syndrome (GBS) and geographic atrophy (GA) programs that position us to potentially deliver two transformative therapies for millions of patients in need. The quality and consistency of the data generated to date reinforce our confidence in the differentiated potential of our C1q-targeted approaches to address neuroinflammatory diseases at their source, and we are encouraged by the growing enthusiasm from patients and physicians,” said Douglas Love, president and chief executive officer of Annexon. “With our leadership capabilities and financial position strengthened, we are entering an exciting period of execution, with multiple important clinical and regulatory milestones expected over the next 6 to 12 months and a significant opportunity to create value for patients and stakeholders.”
2026 Strategic Priorities and Key Milestones
Tanruprubart: Potential to be the first targeted, fast-acting therapy for GBS, an indiscriminate life-threatening neuromuscular emergency affecting 150,000 people annually worldwide and driving an estimated $20+ billion annual healthcare burden in the U.S.
| • | Early improvement in strength and clinically meaningful reduction in disability shown with tanruprubart in the first ten U.S. and European patients with GBS from the ongoing, open-label FORWARD study. Early outcomes reinforce the consistency and reproducibility of tanruprubart treatment effect previously demonstrated in Phase 3 and real-world evidence studies. |
| • | EU Marketing Authorisation Application under review with the European Medicines Agency supported by robust data package demonstrating rapid benefit on function and disability in placebo-controlled studies and Real-World Evidence study demonstrating favorable outcomes versus current treatments, intravenous immunoglobulin and plasma exchange. |
| • | Next Milestone: Biologics License Application (BLA) submission with U.S./European data from FORWARD trial expected in fourth quarter of 2026. |
Vonaprument: Potential to be the first targeted vision-preserving therapy for GA, a leading cause of blindness affecting more than 8 million patients worldwide.
| • | The ongoing, global, double masked Phase 3 ARCHER II trial remains on track, and all eligible patients have received at least 12 months of treatment, with masked event accrual consistent with projected timelines. Vonaprument continues to be generally well-tolerated with a low discontinuation rate (<10%) and high compliance (>95%), reinforcing significant enthusiasm by physicians/patients. |
| • | To maximize the best-in-class potential of vonaprument, a Month 24 dual primary endpoint was added while maintaining the Month 15 primary endpoint. This strategic enhancement was enabled by the strong power and execution of the Phase 3 ARCHER II trial. With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or 24, which are independent efficacy timepoints. |
| • | Annexon also launched an open-label extension (OLE) study to evaluate the the long-term safety and benefit of vonaprument in patients with GA. Following completion of the 2-year ARCHER II study, all patients have the option to receive monthly vonaprument treatment in the OLE study. |
| • | Next Milestones: Month 15 primary endpoint on track for the fourth quarter of 2026, with final trial completion, including the Month 24 primary endpoint expected in the third quarter of 2027. |
ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing.
| • | Dosing is complete. The ongoing proof-of-concept (POC) study is evaluating pharmacokinetics (PK) and pharmacodynamics (PD) in relation to food intake, and reduction in complement and bilirubin markers as a measure of hemolysis in patients with cold agglutinin disease (CAD). |
| • | Next Milestone: Update on POC trial in CAD anticipated in the Fall of 2026. |
Corporate Updates
| • | Entered into a strategic credit facility of up to $200 million with Oxford Finance LLC, with an initial $50 million drawn at closing, bolstering Annexon’s financial position, and diversifying its capital structure. |
| • | 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 Annexon’s board of directors as the Company prepares for potential commercialization. |
Second Quarter 2026 Financial Results
| • | Cash and operating runway: Cash, cash equivalents and short-term investments were $209.2 million as of June 30, 2026. Annexon’s current cash, cash equivalents and short-term investments and funds from the credit facility are expected to fund operations and anticipated milestones into 2028. |
| • | Research and development (R&D) expenses: R&D expenses were $46.6 million for the quarter ended June 30, 2026, compared to $44.2 million for the quarter ended June 30, 2025. The change in R&D expenses is primarily associated with the Phase 3 ARCHER II trial of vonaprument in GA and contract manufacturing expenses of our product candidates. |
| • | General and administrative (G&A) expenses: G&A expenses were $10.6 million for the quarter ended June 30, 2026, compared to $7.6 million for the quarter ended June 30, 2025. The change in G&A expenses reflects ongoing corporate consulting and professional services costs for the advancement of our registrational programs. |
| • | Net loss: Net loss attributable to common stockholders was $55.3 million or $0.28 per share for the quarter ended June 30, 2026, compared to $49.2 million or $0.34 per share for the quarter ended June 30, 2025. |
Corporate Webcast Details
Annexon will host a webcast at 8:00 a.m. ET today, August 12, 2026. Please register for the webcast here. The live webcast and replay may be also accessed by visiting Annexon’s website at https://ir.annexonbio.com/events-and-presentations/events.
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 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 improve the lives of millions of patients; timing of and topline data from the Month 15 primary endpoint and Month 24 primary endpoint in the pivotal Phase 3 ARCHER II trial; the potential of vonaprument to be the first targeted vision-preserving therapy for GA; the potential of tanruprubart to be the first targeted and fast-acting therapy for GBS; expectation of multiple important clinical and regulatory milestones over the next 6 to 12 months; timing of a BLA submission with supportive initial U.S./European data from FORWARD trial; timing of POC trial data for ANX1502 in CAD; 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 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:
Beth Keshishian
917-912-7195
beth@bethkeshishian.com
ANNEXON, INC.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended June 30, |
Six Months Ended June 30, |
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| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: |
||||||||||||||||
| Research and development (1) |
$ | 46,590 | $ | 44,160 | $ | 82,376 | $ | 92,339 | ||||||||
| General and administrative (1) |
10,637 | 7,566 | 20,904 | 16,792 | ||||||||||||
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| Total operating expenses |
57,227 | 51,726 | 103,280 | 109,131 | ||||||||||||
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| Loss from operations |
(57,227 | ) | (51,726 | ) | (103,280 | ) | (109,131 | ) | ||||||||
| Interest and other income, net |
1,879 | 2,570 | 3,790 | 5,619 | ||||||||||||
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| Net loss |
(55,348 | ) | (49,156 | ) | (99,490 | ) | (103,512 | ) | ||||||||
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| Deemed dividend on modification of common stock warrants |
— | (1,857 | ) | — | (1,857 | ) | ||||||||||
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| Net loss attributable to common stockholders |
$ | (55,348 | ) | $ | (51,013 | ) | $ | (99,490 | ) | $ | (105,369 | ) | ||||
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| Net loss per share, basic and diluted |
$ | (0.28 | ) | $ | (0.34 | ) | $ | (0.50 | ) | $ | (0.71 | ) | ||||
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| Weighted-average shares used in computing net loss per share, basic and diluted |
201,003,269 | 148,320,803 | 197,620,477 | 148,215,392 | ||||||||||||
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| (1) | Includes the following stock-based compensation expense: |
| Research and development |
$ 2,663 | $ 2,688 | $ 5,031 | $ 5,517 | ||||
| General and administrative |
$ 2,150 | $ 1,517 | $ 3,938 | $ 3,766 |
ANNEXON, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands)
| June 30, 2026 |
December 31, 2025 |
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| (Unaudited) | ||||||||
| Assets |
||||||||
| Current assets: |
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| Cash and cash equivalents |
$ | 199,270 | $ | 162,051 | ||||
| Short-term investments |
9,973 | 76,294 | ||||||
| Prepaid expenses and other current assets |
3,514 | 3,846 | ||||||
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| Total current assets |
212,757 | 242,191 | ||||||
| Restricted cash |
1,032 | 1,032 | ||||||
| Property and equipment, net |
9,675 | 10,617 | ||||||
| Operating lease right-of-use assets |
14,333 | 15,185 | ||||||
| Other non-current assets |
8,271 | 8,546 | ||||||
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| Total assets |
$ | 246,068 | $ | 277,571 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 15,731 | $ | 14,931 | ||||
| Accrued and other current liabilities |
19,625 | 24,791 | ||||||
| Operating lease liabilities, current |
3,126 | 2,908 | ||||||
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| Total current liabilities |
38,482 | 42,630 | ||||||
| Operating lease liabilities, non-current |
21,525 | 23,293 | ||||||
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| Total liabilities |
60,007 | 65,923 | ||||||
| Stockholders’ equity: |
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| Common stock |
175 | 149 | ||||||
| Additional paid-in capital |
1,202,847 | 1,128,917 | ||||||
| Accumulated other comprehensive loss |
(82 | ) | (29 | ) | ||||
| Accumulated deficit |
(1,016,879 | ) | (917,389 | ) | ||||
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| Total stockholders’ equity |
186,061 | 211,648 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 246,068 | $ | 277,571 | ||||
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Exhibit 99.2
Annexon Expands Vonaprument Phase 3 Program in Geographic Atrophy with Addition of Month 24 Dual Primary Endpoint Complementing Month 15 Primary Endpoint and Launch of Open-Label Extension Study
Strong Execution of Well-Powered ARCHER II Trial Reaffirms Month 15 Primary Endpoint on Track for Q4 2026
Strategic Expansion Underscores Vonaprument’s Best-in-Class Potential as the First and Only Treatment for Vision Preservation in GA
BRISBANE, Calif., August 12, 2026 – Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies for multiple neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced the addition of a Month 24 dual primary endpoint to complement the current Month 15 primary endpoint in its Phase 3 ARCHER II trial, and launch of an open-label extension (OLE) study of vonaprument for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or 24, which are independent efficacy timepoints.
“Our objective is to maximize the best-in-class potential of vonaprument to preserve visual acuity for millions of patients at risk of irreversible vision loss. The strong power and execution of our Phase 3 ARCHER II trial provide a clear opportunity to seamlessly incorporate a Month 24 dual primary endpoint while maintaining the Month 15 primary endpoint,” said Douglas Love, president and chief executive officer of Annexon. “As ARCHER II was already designed to remain masked through Month 24, this strategic addition allows us to also evaluate the longer-term profile of vonaprument for inclusion into the label without change to the study operation. We look forward to delivering the Month 15 data milestone on schedule in the fourth quarter of this year and delivering Month 24 data thereafter as a separate and additional assessment.”
In the ongoing global, double-masked Phase 3 ARCHER II trial, all eligible patients have received at least 12 months of treatment, with masked event accrual in line with projections. The study retains strong statistical power and continues to be well-executed with a low discontinuation rate (<10%) and high compliance (>95%), reinforcing significant enthusiasm by physicians and patients. Upon completion of Month 24, all patients have the option to receive monthly vonaprument treatment in the OLE study. The OLE study is designed to evaluate the long-term safety and benefit of vonaprument in patients with GA.
An independent Data Monitoring Committee (DMC) will assess the primary endpoint of the overall study at Month 15, and the Company expects to report the DMC’s assessment in the fourth quarter of 2026. Following this assessment, the DMC may recommend that the ARCHER II overall study has met its Month 15 primary endpoint, enabling the planned analysis of the trial’s two sub-studies, with results anticipated in the first quarter of 2027; or it may recommend that the study continues until the Month 24 primary endpoint analysis. Completion of ARCHER II, including the Month 24 analyses, is expected in the third quarter of 2027.
Vonaprument has received FastTrack Designation from the U.S. Food and Drug Administration and is the only GA program to receive PRIME designation from the European Medicines Agency (EMA). Vonaprument was also selected by EMA for the exclusive Product Development Coordinator (PDC) pilot launched in July 2025 to assist PRIME designation holders in navigating regulatory interactions, including expedited scientific advice, Marketing Authorisation Application submission readiness activities, and ad-hoc queries throughout the development program.
About Vonaprument (formerly ANX007)
Vonaprument is a clinical-stage investigational antigen-binding fragment (Fab) designed as a first-in-kind therapeutic to selectively inhibit C1q, the initiating molecule of the classical complement pathway and a key driver of neurodegeneration. It is formulated for intravitreal (IVT) administration, with the potential to be the first targeted vision-preserving therapy for GA. Vonaprument involves a differentiated neuroprotective approach designed to protect photoreceptor cells and retinal function by blocking C1q and the entire classical pathway, while allowing for normal immune activity of the lectin and alternative complement pathways. Vonaprument has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) and is the first therapeutic candidate for the treatment of GA to receive Priority Medicine (PRIME) designation from the EMA for the treatment of GA.
About the Phase 2 ARCHER Trial
ARCHER is a successfully completed, randomized, multi-center, double-masked, sham-controlled Phase 2 trial that evaluated vonaprument in a broad population of patients with GA. Across multiple measures, vonaprument consistently preserved visual function and ellipsoid zone retinal structure, reinforcing the therapeutic potential of protecting photoreceptor health early in disease progression. Vonaprument provided significant, time and dose-dependent protection from vision loss as measured by confirmed best corrected visual acuity (BCVA) ≥15-letter loss, the widely accepted and clinically meaningful functional endpoint. Significant protection from vision loss was also shown in other prespecified measures of BCVA and visual function, including low luminance visual acuity (LLVA) and low luminance visual deficit (LLVD). Vonaprument was also shown to protect key retinal structures important for vision, including significant protection of photoreceptors as measured by optical coherence tomography (OCT). Vonaprument was generally well-tolerated through month 12, with no increase in choroidal neovascularization (CNV) rates between the treated and sham arms and no events of retinal vasculitis reported.
About the Phase 3 ARCHER II Trial
ARCHER II is an ongoing global, pivotal, Phase 3 sham-controlled, double-masked trial of vonaprument in 659 patients with GA, a disease driven by early photoreceptor degeneration leading to vision loss. Enrollment was completed in July 2025. The primary endpoints of this two-year trial are the proportion of patients with confirmed best corrected visual acuity 15-letter loss at two consecutive visits, measured through months 15 and 24. Best corrected visual acuity (BCVA) ≥15-letter loss represents three lines on the standard Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart. Proportion of patients experiencing BCVA ≥15-letter loss is a well-established functional endpoint that has served as the basis for numerous ophthalmology drug approvals by the FDA and European Medicines Agency. Secondary endpoints in ARCHER II include safety, LLVA, and photoreceptor integrity (EZ). A global registration path has been established with U.S. and European regulators for ARCHER II. ARCHER II is a single protocol that will also be analyzed as two sub-studies after meeting the primary endpoint. Topline results from the Month 15 primary analysis are expected in the fourth quarter of 2026.
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 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 the potential for vonaprument to be the first targeted vision-preserving therapy for GA; timing of and results from the Phase 3 ARCHER II trial, including expected month 15 primary endpoint in the fourth quarter of 2026 and the month 24 dual primary endpoint analyses expected in the third quarter of 2027; planned analysis of the ARCHER II trial’s two sub-studies, with results anticipated in the first quarter of 2027; opportunity for patients to receive monthly vonaprument treatment in the OLE study; the company’s ability to commercialize its product candidates, if approved; 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 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; the potential for the company’s product candidates to not receive regulatory approval, including if the FDA and comparable foreign regulatory authorities determine that the company’s submission package is not sufficient or require the company to provide additional data in patients that are not feasible to obtain; 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 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:
Beth Keshishian
917-912-7195
beth@bethkeshishian.com