Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results - Annexon Biosciences




Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results

November 13, 2023

Company Prioritizes Greatest Near-term Value-Driving Programs: ANX005 for Guillain-Barré Syndrome (GBS), ANX007 for Geographic Atrophy (GA) and First-in-Kind Complement Small Molecule, ANX1502

ANX005 Phase 3 Pivotal Data in GBS On Track for First Half of 2024

ANX007 Awarded First-Ever PRIME Designation for the Treatment of GA; Global Regulatory Interactions Ongoing to Advance Phase 3 Program

ANX1502 Phase 1 Data on Track for Q4 2023

Focused Operations and Resources Support Cash Runway into Q2 2025

BRISBANE, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammatory-related diseases, today highlighted portfolio progress and reported third quarter 2023 financial results.

“As the leading company focused on stopping C1q from initiating and driving harmful inflammation where it starts on diseased tissue, we’re highly encouraged by the consistency of the clinical data demonstrating rapid and meaningful functional benefit across multiple disease areas,” said Douglas Love, president and CEO of Annexon. “With increasing regulatory recognition of our data in GBS and GA in particular, and the potential of these programs to offer significant therapeutic advantages over existing treatments, we are sharply focused on bringing these classical complement therapies to patients as swiftly as possible while also intentionally advancing our first-in-kind classical complement small molecule program in an array of autoimmune conditions. As a result, we have aligned our efforts and resources on our three priority programs to drive maximum value for patients and stakeholders in the near-to-mid term.”

Recent Clinical Program Updates

Key Near-Term Anticipated Milestones

Priority Programs

Next Wave Programs

Third Quarter 2023 Financial Results

About Annexon

Annexon Biosciences (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company utilizing a distinct scientific approach to stop C1q and all inflammatory aspects of classical complement pathway activation before it starts. As the only company solely focused on shutting down C1q, Annexon is developing a fit-for-purpose pipeline of therapeutics designed to provide meaningful benefits across multiple diseases of the body, brain and eye. With proof-of concept data in both Guillain-Barré syndrome and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring their potential treatments to patients as quickly as possible. To learn more 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; timing of program updates and enrollment completion for ANX005, ANX007 and ANX1502; plans to engage with U.S. and EU regulatory agencies to determine the optimal path forward for ANX007; cash operating runway; the potential benefits from treatment with anti-C1q therapy; potential of ANX007 to support strong beneficial impact on preserving vision; timing of data reports; 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 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 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,
    2023     2022     2023     2022  
Operating expenses:                        
Research and development (1)   $ 27,893     $ 27,862     $ 90,489     $ 83,966  
General and administrative (1)     6,888       8,207       23,225       24,938  
Total operating expenses     34,781       36,069       113,714       108,904  
Loss from operations     (34,781 )     (36,069 )     (113,714 )     (108,904 )
Interest and other income, net     2,299       1,015       7,368       1,340  
Net loss   $ (32,482 )   $ (35,054 )   $ (106,346 )   $ (107,564 )
Net loss per share, basic and diluted   $ (0.43 )   $ (0.51 )   $ (1.42 )   $ (2.21 )
Weighted-average shares used in computing net loss per share,
basic and diluted
    75,342,495       68,652,859       74,815,274       48,710,433  


(1) Includes the following stock-based compensation expense:                        
Research and development   $ 2,243     $ 2,433     $ 6,801     $ 6,509  
General and administrative   $ 2,306     $ 2,478     $ 7,015     $ 7,174  

Condensed Consolidated Balance Sheets
(in thousands)

    September 30,     December 31,  
    2023     2022  
Current assets:            
Cash and cash equivalents   $ 133,159     $ 140,020  
Short-term investments     32,112       102,637  
Prepaid expenses and other current assets     3,898       5,441  
Total current assets     169,169       248,098  
Restricted cash     1,032       1,032  
Property and equipment, net     15,310       16,838  
Operating lease right-of-use assets     18,305       19,128  
Total assets   $ 203,816     $ 285,096  
Liabilities and Stockholders' Equity            
Current liabilities:            
Accounts payable   $ 4,809     $ 7,416  
Accrued liabilities     10,490       13,448  
Operating lease liabilities, current     1,701       1,316  
Other current liabilities     170       180  
Total current liabilities     17,170       22,360  
Operating lease liabilities, non-current     29,807       31,542  
Total liabilities     46,977       53,902  
Stockholders’ equity:            
Common stock     53       48  
Additional paid-in capital     701,517       669,780  
Accumulated other comprehensive loss     (123 )     (372 )
Accumulated deficit     (544,608 )     (438,262 )
Total stockholders' equity     156,839       231,194  
Total liabilities and stockholders’ equity   $ 203,816     $ 285,096  


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