Annexon Biosciences Highlights Portfolio Progress and Key Anticipated Milestones, and Reports First Quarter 2022 Financial Results - Annexon Biosciences
	
	
	
	
	
	
	
	
	
	
	
	
	
	
















		
		

 



	
clinical pipeline
for diseases of the body, brain & eye

Annexon Biosciences Highlights Portfolio Progress and Key Anticipated Milestones, and Reports First Quarter 2022 Financial Results


May 09, 2022

Pioneering Upstream Complement-Targeted Platform with Broad Portfolio of Five Differentiated Product Candidates

Anticipating Eight Clinical Catalysts Across Robust Pipeline throughout 2022 and 2023

BRISBANE, Calif., May 09, 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 announced progress across its broad pipeline of product candidates and reported first quarter 2022 financial results.

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’s unique platform targets C1q, the initiator of the pathway that localizes on disease tissue and triggers complement’s harmful inflammation and tissue-damaging activity. The company’s product candidates are designed to block the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways.

“I am very proud of the strong execution by the Annexon team in advancing our classical complement platform across multiple indications driven by aberrant complement activity. In doing so, we’re actively building on the learnings and momentum from the first two clinical datasets generated with our lead product candidate, ANX005, which showed rapid improvement in clinical measures in two historically challenging diseases – Guillain-Barré Syndrome and Huntington’s disease,” said Douglas Love, Esq., president and chief executive officer of Annexon. “After years of research and development across our platform, and with eight clinical datasets anticipated throughout 2022 and 2023, we’re reaching a significant inflection point in proving our founding thesis: stopping the classical complement cascade at its start has the potential to provide more complete protection against inappropriate complement activity, and thereby provide important benefit to patients. We’re excited by the promise of our pioneering upstream complement platform, and we are well-positioned to create meaningful near-term value for patients, our supporters and for the business.”

Portfolio Highlights and Key Anticipated Milestones

Annexon is rigorously advancing five drug candidates, each with distinct routes of administration and dosing schedules, and a fit-for-purpose design to selectively inhibit the classical complement pathway in specific compartments of the body, brain or eye.

First 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 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,” “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
chelcie@thrustsc.com

Media Contact:

Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com

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

    Three Months Ended
March 31,
 
    2022     2021  
          (As restated)  
Operating expenses:            
Research and development (1)   $ 26,998     $ 20,696  
General and administrative (1)     8,428       5,506  
Total operating expenses     35,426       26,202  
Loss from operations     (35,426 )     (26,202 )
Interest and other income (expense), net     53       142  
Net loss     (35,373 )     (26,060 )
Net loss attributable to common stockholders   $ (35,373 )   $ (26,060 )
Net loss per share attributable to common stockholders, basic and diluted   $ (0.92 )   $ (0.68 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted     38,563,384       38,163,062  
             
(1) Includes the following stock-based compensation expense:            
Research and development   $ 1,959     $ 1,546  
General and administrative   $ 2,293     $ 1,416  
                 

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

    March 31,     December 31,  
    2022     2021  
    (Unaudited)        
Assets            
Current assets:                      
Cash and cash equivalents   $ 112,828     $ 74,843  
Short-term investments     93,831       167,872  
Prepaid expenses and other current assets     4,595       4,978  
Total current assets     211,254       247,693  
Restricted cash     1,166       1,166  
Property and equipment, net     17,805       17,848  
Operating lease right-of-use assets     20,103       20,333  
Other non-current assets     241        
Total assets   $ 250,569     $ 287,040  
Liabilities and Stockholders' Equity            
Current liabilities:            
Accounts payable   $ 9,378     $ 11,153  
Accrued liabilities     6,211       9,250  
Operating lease liabilities, current     1,275       1,202  
Other current liabilities     189       139  
Total current liabilities     17,053       21,744  
Operating lease liabilities, non-current     32,902       33,387  
Total liabilities     49,955       55,131  
Stockholders’ equity:            
Common stock     39       39  
Additional paid-in capital     532,636       528,365  
Accumulated other comprehensive loss     (373 )     (180 )
Accumulated deficit     (331,688 )     (296,315 )
Total stockholders' equity     200,614       231,909  
Total liabilities and stockholders’ equity   $ 250,569     $ 287,040  

 



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