Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results - Annexon Biosciences




Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results

August 07, 2023

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BRISBANE, Calif., Aug. 07, 2023 (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 highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

“This quarter, we made meaningful progress across our clinical-stage portfolio of medicines, which are squarely focused on stopping classical complement’s aggressive inflammatory cascade where it starts on diseased tissue to provide the most complete protection against this harmful inflammation and its resulting damage,” said Douglas Love, president and CEO of Annexon. “Following our recent ARCHER data, we now have clinical proof-of-concept in three difficult-to-treat diseases: Guillain-Barré Syndrome (GBS), Huntington’s disease and geographic atrophy (GA). Together, these data demonstrate the differentiated mechanism of inhibiting C1q to provide functional benefits for patients living with complement-mediated diseases. As we look ahead, we remain focused on executing toward important near-term milestones, including for our pivotal GBS program and oral small molecule program, in the second half of 2023. We look forward to providing additional updates on our progress and plans at our R&D Day later this year.”

Recent Corporate and Pipeline Updates

Key 2023-2024 Anticipated Milestones


Flagship Programs

Next Wave Programs

Second Quarter 2023 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 pathway within the immune system, when overactivated, drives inflammation in 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 the 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 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; 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; 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
June 30,
    Six Months Ended
June 30,
    2023     2022     2023     2022  
Operating expenses:                        
Research and development (1)   $ 30,251     $ 29,106     $ 62,596     $ 56,104  
General and administrative (1)     7,440       8,303       16,337       16,731  
Total operating expenses     37,691       37,409       78,933       72,835  
Loss from operations     (37,691 )     (37,409 )     (78,933 )     (72,835 )
Interest and other income, net     2,503       272       5,069       325  
Net loss   $ (35,188 )   $ (37,137 )   $ (73,864 )   $ (72,510 )
Net loss per share, basic and diluted   $ (0.47 )   $ (0.96 )   $ (0.99 )   $ (1.88 )
Weighted-average shares used in computing net loss per share,
basic and diluted
    75,230,003       38,584,400       74,546,995       38,573,950  


(1) Includes the following stock-based compensation expense:                        
Research and development   $ 2,307     $ 2,117     $ 4,558     $ 4,076  
General and administrative   $ 2,353     $ 2,403     $ 4,709     $ 4,696  

Condensed Consolidated Balance Sheets
(in thousands)
    June 30,     December 31,  
    2023     2022  
Current assets:            
Cash and cash equivalents   $ 113,614     $ 140,020  
Short-term investments     79,324       102,637  
Prepaid expenses and other current assets     4,623       5,441  
Total current assets     197,561       248,098  
Restricted cash     1,032       1,032  
Property and equipment, net     15,830       16,838  
Operating lease right-of-use assets     18,590       19,128  
Total assets   $ 233,013     $ 285,096  
Liabilities and Stockholders' Equity            
Current liabilities:            
Accounts payable   $ 7,161     $ 7,416  
Accrued liabilities     8,953       13,448  
Operating lease liabilities, current     1,616       1,316  
Other current liabilities     161       180  
Total current liabilities     17,891       22,360  
Operating lease liabilities, non-current     30,398       31,542  
Total liabilities     48,289       53,902  
Stockholders’ equity:            
Common stock     53       48  
Additional paid-in capital     696,968       669,780  
Accumulated other comprehensive loss     (171 )     (372 )
Accumulated deficit     (512,126 )     (438,262 )
Total stockholders' equity     184,724       231,194  
Total liabilities and stockholders’ equity   $ 233,013     $ 285,096  

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