Annexon Biosciences Highlights Business and Portfolio Progress and Key Anticipated Milestones and Reports Second Quarter 2022 Financial Results - Annexon Biosciences



clinical pipeline
for diseases of the body, brain & eye

Annexon Biosciences Highlights Business and Portfolio Progress and Key Anticipated Milestones and Reports Second Quarter 2022 Financial Results

August 08, 2022

Advancing Robust Pipeline of Five Clinical-Stage Product Candidates Following ANX105 and ANX1502 Phase 1 Trial Initiations

Multiple Clinical Readouts Anticipated throughout 2022 and 2023

Operating Runway into the Second Half of 2025 Following $130 Million Private Placement

BRISBANE, Calif., Aug. 08, 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 outlined progress across its broad pipeline of fit-for-purpose product candidates and anticipated clinical milestones, and reported second quarter 2022 financial results.

“Annexon was founded with an ambitious goal: deliver game-changing treatments to patients suffering from complement-mediated diseases by stopping the classical complement cascade at its start. I’m encouraged by the progress made in the first half of this year toward turning our vision into a reality,” said Douglas Love, Esq., president and chief executive officer of Annexon. “We’re rigorously advancing our pipeline of five clinical-stage drug candidates, each with a substantial and unique value proposition across autoimmune, ophthalmic and neurodegenerative indications. We are planning for initial clinical data on ANX005 and ANX009 in multiple autoimmune diseases later this year, made important regulatory progress in our ophthalmic program with the granting of Fast Track Designation to ANX007 for the treatment of geographic atrophy, and initiated clinical dosing with ANX1502, an oral small molecule complement agent, as well as with ANX105, a next-generation monoclonal antibody. With the proceeds from our recent financing, we are well-positioned to execute our milestones with a multi-year runway into the second half of 2025. Overall, we’re invigorated by the promise of our platform and pipeline to make a meaningful difference in the treatment landscape for patients.”

Portfolio Highlights

Business Highlights

Key Anticipated Milestones

Annexon is rigorously advancing five clinical-stage drug candidates, each with distinct routes of administration, anticipated dosing schedules, and a fit-for-purpose design to selectively inhibit the classical complement pathway in specific compartments of the body, brain or eye. The company anticipates several potential catalysts across its pipeline throughout 2022 and 2023.

ANX005: intravenously administered mAb

ANX007: intravitreally administered Fab

ANX009: subcutaneously administered Fab

ANX1502: orally administered small molecule

ANX105: intravenously administered mAb

Second Quarter 2022 Financial Results

About Annexon

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that aims 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 data anticipated throughout 2022 and 2023. For more information, visit

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; the potential benefits from treatment with anti-C1q therapy; timing of data reports and trial initiation and design; and continuing advancement of the company’s innovative 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 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
June 30,
    Six Months Ended
June 30,
  2022     2021     2022     2021  
Operating expenses:                      
Research and development (1) $ 29,106     $ 24,572     $ 56,104     $ 45,268  
General and administrative (1)   8,303       6,801       16,731       12,307  
Total operating expenses   37,409       31,373       72,835       57,575  
Loss from operations   (37,409 )     (31,373 )     (72,835 )     (57,575 )
Interest and other income (expense), net   272       79       325       221  
Net loss   (37,137 )     (31,294 )     (72,510 )     (57,354 )
Net loss attributable to common stockholders $ (37,137 )   $ (31,294 )   $ (72,510 )   $ (57,354 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.96 )   $ (0.82 )   $ (1.88 )   $ (1.50 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted   38,584,400       38,277,950       38,573,950       38,219,143  

(1) Includes the following stock-based compensation expense:                      
Research and development $ 2,117     $ 2,402     $ 4,076     $ 3,948  
General and administrative $ 2,403     $ 2,115     $ 4,696     $ 3,531  

Condensed Consolidated Balance Sheets
(in thousands)

  June 30,     December 31,  
  2022     2021  
Current assets:          
Cash and cash equivalents $ 104,614     $ 74,843  
Short-term investments   72,980       167,872  
Prepaid expenses and other current assets   3,778       4,978  
Total current assets   181,372       247,693  
Restricted cash   1,032       1,166  
Property and equipment, net   17,418       17,848  
Operating lease right-of-use assets   19,864       20,333  
Other non-current assets   1,018        
Total assets $ 220,704     $ 287,040  
Liabilities and Stockholders' Equity          
Current liabilities:          
Accounts payable $ 10,301     $ 11,153  
Accrued liabilities   8,060       9,250  
Operating lease liabilities, current   1,729       1,202  
Other current liabilities   164       139  
Total current liabilities   20,254       21,744  
Operating lease liabilities, non-current   32,406       33,387  
Total liabilities   52,660       55,131  
Stockholders’ equity:          
Common stock   39       39  
Additional paid-in capital   537,269       528,365  
Accumulated other comprehensive loss   (439 )     (180 )
Accumulated deficit   (368,825 )     (296,315 )
Total stockholders' equity   168,044       231,909  
Total liabilities and stockholders’ equity $ 220,704     $ 287,040  

« back to news page