Annexon Reports Fourth Quarter and Year-End 2022 Financial Results and Reiterates Anticipated Milestones - Annexon Biosciences



clinical pipeline
for diseases of the body, brain & eye

Annexon Reports Fourth Quarter and Year-End 2022 Financial Results and Reiterates Anticipated Milestones

March 06, 2023

Initial Clinical Data from Phase 2 Trial of ANX007 in Patients with Geographic Atrophy On-track for Mid-2023

Oral Small Molecule ANX1502, for Autoimmune Indications, Advances into Multi-Ascending Dose Trial

Well-capitalized with Operating Runway into 2025, Including through Multiple Mid-stage and Pivotal Clinical Trial Readouts Anticipated in 2023 and 2024

BRISBANE, Calif., March 06, 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 outlined anticipated upcoming milestones across its portfolio of complement therapies and reported fourth quarter and full year 2022 financial results.

“2022 was a year of focused execution at Annexon, establishing a strong foundation on which to drive near- and long-term value across our deep portfolio of complement therapeutics,” said Douglas Love, president and CEO of Annexon. “We expect this year to be even stronger for Annexon, as we execute the pivotal and late-stage development of our four flagship programs across all three of our therapeutic franchises – autoimmune, ophthalmology and neurodegeneration. We’re prioritizing our focus and resources on well-supported, value creating programs, including our Phase 2 program for geographic atrophy with data anticipated mid-year, using our first-in-class up- and down-stream complement approach, and our potentially paradigm-shifting oral small molecule, ANX1502, for autoimmune indications. Overall, Annexon is well-positioned to continue executing our goals with a passionate and talented team, a strong balance sheet and multi-year runway, and a steady cadence of anticipated clinical catalysts over the next six to 18 months – all designed to deliver game-changing medicines to patients.”

Recent Pipeline Progress

Key 2023-2024 Anticipated Milestones

Flagship Programs

Additional Complement Programs

Fourth Quarter and Full Year 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 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; cash operating runway; the potential benefits from treatment with anti-C1q therapy; timing of data reports; and continuing advancement of the company’s broad 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     Year Ended  
    December 31,     December 31,  
    2022     2021     2022     2021  
    (unaudited)     (unaudited)              
Operating expenses:                        
Research and development (1)   $ 28,535     $ 27,217     $ 112,501     $ 100,066  
General and administrative (1)     8,160       10,241       33,098       30,647  
Total operating expenses     36,695       37,458       145,599       130,713  
Loss from operations     (36,695 )     (37,458 )     (145,599 )     (130,713 )
Interest and other income (expense), net     2,312       87       3,652       390  
Net loss     (34,383 )     (37,371 )     (141,947 )     (130,323 )
Net loss attributable to common stockholders   $ (34,383 )   $ (37,371 )   $ (141,947 )   $ (130,323 )
Net loss per share attributable to common stockholders, basic and
  $ (0.48 )   $ (0.97 )   $ (2.60 )   $ (3.40 )
Weighted-average shares used in computing net loss per share
  attributable to common stockholders, basic and diluted
    72,368,539       38,479,221       54,673,572       38,316,273  


(1) Includes the following stock-based compensation expense:                        
Research and development   $ 2,365     $ 2,280     $ 8,874     $ 8,610  
General and administrative   $ 2,468     $ 2,075     $ 9,642     $ 7,652  

Condensed Consolidated Balance Sheets
(in thousands)
    December 31,     December 31,  
    2022     2021  
Current assets:            
Cash and cash equivalents   $ 140,020     $ 74,843  
Short-term investments     102,637       167,872  
Prepaid expenses and other current assets     5,441       4,978  
Total current assets     248,098       247,693  
Restricted cash     1,032       1,166  
Property and equipment, net     16,838       17,848  
Operating lease right-of-use assets     19,128       20,333  
Total assets   $ 285,096     $ 287,040  
Liabilities and Stockholders' Equity            
Current liabilities:            
Accounts payable   $ 7,416     $ 11,153  
Accrued liabilities     13,448       9,250  
Operating lease liabilities, current     1,316       1,202  
Other current liabilities     180       139  
Total current liabilities     22,360       21,744  
Operating lease liabilities, non-current     31,542       33,387  
Total liabilities     53,902       55,131  
Stockholders’ equity:            
Common stock     48       39  
Additional paid-in capital     669,780       528,365  
Accumulated other comprehensive loss     (372 )     (180 )
Accumulated deficit     (438,262 )     (296,315 )
Total stockholders' equity     231,194       231,909  
Total liabilities and stockholders’ equity   $ 285,096     $ 287,040  

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