Annexon Reports Third Quarter 2022 Financial Results and Plans to Provide Updates on Complement Therapeutic Portfolio in January 2023 - Annexon Biosciences



clinical pipeline
for diseases of the body, brain & eye

Annexon Reports Third Quarter 2022 Financial Results and Plans to Provide Updates on Complement Therapeutic Portfolio in January 2023

November 03, 2022

Company to provide portfolio updates across autoimmune, neurodegeneration and ophthalmology therapeutic franchises in early January

Presentations at upcoming scientific conferences highlight company’s novel approach to treating complement-mediated diseases of the body, brain and eye

Company well-funded with operating runway into the second half of 2025

BRISBANE, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today reported third quarter 2022 financial results. Additionally, Annexon announced plans to provide updates and outline anticipated milestones across its business and portfolio of complement-targeted therapies in January 2023.

“2022 has been a year of marked progress. With compelling clinical and biomarker data from ANX005 in both Guillain-Barré Syndrome (GBS) and Huntington’s disease (HD), we are enthusiastic about its future as we advance a late-stage GBS trial and prepare to initiate a late-stage HD trial. Further, we are on-track to evaluate data in December from multiple signal-finding studies in our autoimmune franchise, as well as safety and target engagement data with our first-in-class oral, small molecule, ANX1502, which is progressing well through Phase 1 dose-escalation,” said Douglas Love, president and chief executive officer of Annexon. “We are also excited about ANX007, which has demonstrated target engagement and tissue penetration preclinically and in patients. Our optimally designed Phase 2 ARCHER trial of ANX007 for geographic atrophy (GA) is underway, which enrolled patients with baseline characteristics consistent with those who have benefited from other complement therapies. Distinct from those agents, ANX007 is uniquely designed to block both upstream and downstream complement activity, and we look forward to reviewing data from the ARCHER trial in the first half of 2023.”

Love continued, “We remain sharply focused on building on our insights and execution through the remainder of this year and in the year ahead. This is an exciting time for Annexon as we execute a purposeful strategy to efficiently evaluate a wide array of diseases for which the classical pathway drives disease burden. With the most comprehensive classical complement pipeline in development, we’re rigorously pursuing multiple paths to drive value across our portfolio for patients, employees and our supporters.”

Upcoming Medical Meeting Presentations

Third Quarter 2022 Financial Results

About Annexon

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical readouts anticipated throughout 2023 and beyond.

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,” “suggest,” “target,” “on track,” “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: anticipated milestones; cash operating runway; engagement with regulators; upcoming medical meeting presentations; the potential benefits from treatment with anti-C1q therapy; timing of data reports; and continuing advancement of the company’s innovative portfolio and progression of clinical studies. 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 early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other 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:

Chelcie Lister
THRUST Strategic Communications

Media Contact:

Sheryl Seapy
Real Chemistry

Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
    Three Months Ended
September 30,
    Nine Months Ended
September 30,
    2022     2021     2022     2021  
Operating expenses:                        
Research and development (1)   $ 27,862     $ 27,581     $ 83,966     $ 72,849  
General and administrative (1)     8,207       8,099       24,938       20,406  
Total operating expenses     36,069       35,680       108,904       93,255  
Loss from operations     (36,069 )     (35,680 )     (108,904 )     (93,255 )
Interest and other income (expense), net     1,015       82       1,340       303  
Net loss     (35,054 )     (35,598 )     (107,564 )     (92,952 )
Net loss attributable to common stockholders   $ (35,054 )   $ (35,598 )   $ (107,564 )   $ (92,952 )
Net loss per share attributable to common stockholders, basic and diluted   $ (0.51 )   $ (0.93 )   $ (2.21 )   $ (2.43 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted     68,652,859       38,341,110       48,710,433       38,261,359  
(1) Includes the following stock-based compensation expense:                                
Research and development   $ 2,433     $ 2,382     $ 6,509     $ 6,330  
General and administrative   $ 2,478     $ 2,046     $ 7,174     $ 5,577  

Condensed Consolidated Balance Sheets
(in thousands)
    September 30,     December 31,  
    2022     2021  
Current assets:            
Cash and cash equivalents   $ 210,658     $ 74,843  
Short-term investments     58,861       167,872  
Prepaid expenses and other current assets     5,258       4,978  
Total current assets     274,777       247,693  
Restricted cash     1,032       1,166  
Property and equipment, net     17,093       17,848  
Operating lease right-of-use assets     19,616       20,333  
Other non-current assets     204        
Total assets   $ 312,722     $ 287,040  
Liabilities and Stockholders' Equity            
Current liabilities:            
Accounts payable   $ 6,921     $ 11,153  
Accrued liabilities     11,323       9,250  
Operating lease liabilities, current     1,806       1,202  
Other current liabilities     170       139  
Total current liabilities     20,220       21,744  
Operating lease liabilities, non-current     31,900       33,387  
Total liabilities     52,120       55,131  
Stockholders’ equity:            
Common stock     48       39  
Additional paid-in capital     664,839       528,365  
Accumulated other comprehensive loss     (406 )     (180 )
Accumulated deficit     (403,879 )     (296,315 )
Total stockholders' equity     260,602       231,909  
Total liabilities and stockholders’ equity   $ 312,722     $ 287,040  

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