Annexon Biosciences Announces Business and Program Highlights and Reports Third Quarter 2021 Financial Results - Annexon Biosciences
	
	
	
	
	
	
	
	
	
	
	
	
	
	




	











		
		

 



	
clinical pipeline
for diseases of the body, brain & eye

Annexon Biosciences Announces Business and Program Highlights and Reports Third Quarter 2021 Financial Results


November 09, 2021

$271 Million Cash and Investments at End of Third Quarter 2021 Supports Operating Runway into 2024, Including Several Key Clinical Milestones across the Portfolio

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (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 announced recent highlights and reported third quarter 2021 financial results.

“The third quarter marks another quarter of meaningful progress with our portfolio, including effectively advancing three clinical-stage product candidates in five clinical trials,” said Douglas Love, Esq., president and chief executive officer of Annexon. “We’re also pleased to have been granted Orphan Drug designation by the FDA for ANX005, underscoring the Agency’s recognition of ANX005’s potential as a novel therapy for the treatment of Huntington’s disease. Additionally, in collaboration with multiple academic and physician key opinion leaders, we conducted two C1q Series R&D Events that highlighted the applicability of our platform and differentiated scientific approach targeting the classical complement cascade in a range of autoimmune and neurodegenerative diseases. The combination of a rich set of milestones, a strong balance sheet, and a talented team, lays the foundation for a transformational year ahead. We look forward to sharing the continued progress across our portfolio, including initial data from our Huntington’s disease clinical trial, as we work to bring treatments to patients suffering from serious complement-mediated diseases.”

Program Highlights

Business Highlights

Third Quarter 2021 Financial Results

About Annexon

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.

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,” “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: continuing advancement of the company’s innovative portfolio; timing of data from clinical trials; timing of completion of clinical studies and clinical development milestones; the company’s ability to deliver on its objectives and the potential for a transformational year ahead; the implementation of the company’s business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue; cash position sufficient to fund its operating plans into 2024; the benefits of Orphan Drug designation; and leadership team service. 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.

Contact:

Chelcie Lister
THRUST Strategic Communications
chelcie@thrustsc.com

ANNEXON, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2021     2020     2021     2020  
Operating expenses:                                
Research and development (1)   $ 27,581     $ 11,775     $ 72,849     $ 31,279  
General and administrative (1)     8,099       3,810       20,406       8,999  
Total operating expenses     35,680       15,585       93,255       40,278  
Loss from operations     (35,680 )     (15,585 )     (93,255 )     (40,278 )
Other income (expense), net     82       (52 )     303       64  
Net loss before taxes     (35,598 )     (15,637 )     (92,952 )     (40,214 )
Provision for income taxes           1             5  
Net loss     (35,598 )     (15,638 )     (92,952 )     (40,219 )
Accretion on redeemable convertible preferred stock           (145 )           (705 )
Deemed dividend – beneficial conversion feature on redeemable
convertible preferred stock
          (6,219 )           (6,219 )
Net loss attributable to common stockholders   $ (35,598 )   $ (22,002 )   $ (92,952 )   $ (47,143 )
Net loss per share attributable to common stockholders,
basic and diluted
  $ (0.93 )   $ (0.77 )   $ (2.43 )   $ (4.79 )
Weighted-average shares used in computing net loss per
share attributable to common stockholders, basic and diluted
    38,341,110       28,465,156       38,261,359       9,845,754  
                                 
                                 
(1) Includes the following stock-based compensation expense:                                
Research and development   $ 2,382     $ 624     $ 6,330     $ 1,284  
General and administrative   $ 2,046     $ 847     $ 5,577     $ 1,613  
                                 

ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)

    September 30,
2021
    December 31,
2020
 
    (Unaudited)          
Assets                
Current assets:                
Cash and cash equivalents   $ 68,519     $ 268,565  
Short-term investments     202,848       82,641  
Prepaid expenses and other current assets     4,131       2,805  
Total current assets     275,498       354,011  
Restricted cash     1,166        
Property and equipment, net     12,219       1,935  
Operating lease right-of-use assets     20,680        
Other assets     593        
Total assets   $ 310,156     $ 355,946  
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable   $ 4,797     $ 3,734  
Accrued liabilities     7,059       6,497  
Deferred rent, current           391  
Operating lease liabilities, current     63        
Total current liabilities     11,919       10,622  
Deferred rent           1,046  
Operating lease liabilities, non-current     33,760        
Total liabilities     45,679       11,668  
Commitments and contingencies                
Stockholders’ equity:                
Common stock     38       38  
Additional paid-in capital     523,458       510,309  
Accumulated other comprehensive loss     (75 )     (77 )
Accumulated deficit     (258,944 )     (165,992 )
Total stockholders’ equity     264,477       344,278  
Total liabilities and stockholders’ equity   $ 310,156     $ 355,946  



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