ANNX Annexon Inc.

20.76
+0.23  (+1%)
Previous Close 20.53
Open 20.21
52 Week Low 15.33
52 Week High 38.01
Market Cap $793,865,514
Shares 38,240,150
Float 36,242,900
Enterprise Value $433,864,279
Volume 733,629
Av. Daily Volume 186,132
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Upcoming Catalysts

Drug Stage Catalyst Date
ANX009
Healthy Volunteers
Phase 1
Phase 1
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ANX005
Huntington’s disease
Phase 2
Phase 2
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ANX005
Amyotrophic lateral sclerosis (ALS)
Phase 2
Phase 2
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ANX005
Warm autoimmune hemolytic anemia (WAIHA)
Phase 2
Phase 2
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ANX007 - ARCHER
Geographic atrophy
Phase 2
Phase 2
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ANX005
Guillain-Barré Syndrome
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
ANX005 and IVIG
Guillain Barré Syndrome (GBS)
Phase 1/2
Phase 1/2
Phase 1/2 DDI data noted trial was well tolerated.

Latest News

  1. ANX005 Huntington's Disease Phase 2 trial fully enrolled with data anticipated 2H 2021 –

    – ANX009 First-in-Human dose-ranging trial completed with data expected summer 2021 –

    – Next generation drug candidates, ANX105 and ANX1502, on track to submit INDs by end of 2021 –

    Current cash position sufficient to fund operations through 2023

    SOUTH SAN FRANCISCO, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, today announced first quarter 2021 financial results and business highlights.

    Recent Business Highlights

    Annexon is advancing a…

    ANX005 Huntington's Disease Phase 2 trial fully enrolled with data anticipated 2H 2021 –

    – ANX009 First-in-Human dose-ranging trial completed with data expected summer 2021 –

    – Next generation drug candidates, ANX105 and ANX1502, on track to submit INDs by end of 2021 –

    Current cash position sufficient to fund operations through 2023

    SOUTH SAN FRANCISCO, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, today announced first quarter 2021 financial results and business highlights.

    Recent Business Highlights

    Annexon is advancing a portfolio of innovative C1q inhibitors to stop classical complement-mediated autoimmune and neurodegenerative disease processes at the start in several indications. Recent portfolio highlights include:

    • Completed enrollment in Phase 2 trial of ANX005 in Huntington's Disease (HD). The company successfully completed enrollment in a Phase 2 trial evaluating ANX005 in HD patients. ANX005 is an intravenously administered C1q inhibitor in development for autoimmune and neurodegenerative indications. Initial data from this trial is anticipated in the second half of 2021.

    • Completed dose escalation in first-in-human study of ANX009 subcutaneous formulation. The company successfully completed dosing of ANX009 in a Phase 1 dose-ranging study in healthy volunteers. ANX009 is a subcutaneously administered C1q inhibitor in development for autoimmune indications. Data from this study is anticipated in the summer of 2021.

    • Continued clinical trial progress for lead ANX005 and ANX007 C1q inhibitors. The company's Phase 2/3 trial in Guillain-Barré Syndrome and Phase 2 trial in geographic atrophy continue to progress as planned, as well as initiation activities for the company's Phase 2 trials in warm autoimmune hemolytic anemia and amyotrophic lateral sclerosis.

    • Pipeline expansion. The company continues to advance two novel classical pathway inhibitors, ANX105 (IV) and ANX1502 (oral small molecule), toward IND submission by the end of 2021 and plans to initiate clinical development in 2022.

    "We are pleased with the strong progress on our mission to deliver transformative therapies for patients suffering from complement-driven autoimmune and neurodegenerative diseases," said Douglas Love, Esq., president and chief executive officer of Annexon. "Annexon remains on track for another exciting year, and looking ahead, is sharply focused on effectively executing our several clinical programs while advancing multiple next generation drug candidates and driving our beachhead strategy to rapidly expand our platform into mechanistically related indications."

    First Quarter 2021 Financial Results

    • Cash and cash equivalents and short-term investments: Cash and cash equivalents and short-term investments were $326.7 million as of March 31, 2021.

    • Research and development (R&D) expenses: R&D expenses were $20.7 million for the quarter ended March 31, 2021 compared to $10.2 million for the quarter ended March 31, 2020.

    • General and administrative (G&A) expenses: G&A expenses were $5.5 million for the quarter ended March 31, 2021 compared to $2.2 million for the quarter ended March 31, 2020.
    • Net loss: Net loss was $26.0 million for the quarter ended March 31, 2021 compared to $12.3 million for the quarter ended March 31, 2020.

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a rigorous, biomarker-driven development strategy designed to improve the probability of technical success over shorter development timelines. 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: sufficiency of the company's cash to fund operations; continuing advancement of the company's innovative portfolio; timing of data from clinical trials and regulatory submissions; timing of completion of clinical studies and clinical development milestones; the company's ability to deliver on its objectives; and 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. 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. 



    ANNEXON, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

      Three Months Ended

    March 31,
      
      2021  2020  
    Operating expenses:         
    Research and development (1) $20,696  $10,217  
    General and administrative (1)  5,452   2,239  
    Total operating expenses  26,148   12,456  
    Loss from operations  (26,148)  (12,456) 
    Other income, net  142   115  
    Net loss  (26,006)  (12,341) 
    Accretion on redeemable convertible preferred stock     (279) 
    Net loss attributable to common stockholders $(26,006) $(12,620) 
    Net loss per share attributable to common stockholders, basic and diluted $(0.68) $(29.10) 
    Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted  38,163,062   433,749  
              
    (1) Includes the following stock-based compensation expense:         
    Research and development $1,546  $325  
    General and administrative $1,416  $338  

    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

      March 31,

    2021
      December 31,

    2020
     
    Assets        
    Current assets:        
    Cash and cash equivalents $206,669  $268,565 
    Short-term investments  119,985   82,641 
    Prepaid expenses and other current assets  3,868   2,805 
    Total current assets  330,522   354,011 
    Restricted cash  1,166    
    Property and equipment  1,429   1,935 
    Total assets $333,117  $355,946 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $4,518  $3,734 
    Accrued liabilities  5,779   6,497 
    Deferred rent, current  398   391 
    Total current liabilities  10,695   10,622 
    Deferred rent  946   1,046 
    Total liabilities  11,641   11,668 
    Stockholders' Equity:        
    Common stock  38   38 
    Additional paid-in capital  513,539   510,309 
    Accumulated other comprehensive loss  (103)  (77)
    Accumulated deficit  (191,998)  (165,992)
    Total stockholders' equity  321,476   344,278 
    Total liabilities and stockholders' equity $333,117  $355,946 
             

     



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    
    
    Sara Michelmore
    
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    

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  2. SOUTH SAN FRANCISCO, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- Today Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, announced that Douglas Love, Esq., President & Chief Executive Officer, will present at the Bank of America Securities 2021 Virtual Healthcare Conference on May 12, 2021 at 11:45 am EDT.

    A live webcast of the event can be accessed under the ‘Events & Presentations' section on the Investors page at www.annexonbio.com.   A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.

    About

    SOUTH SAN FRANCISCO, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- Today Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, announced that Douglas Love, Esq., President & Chief Executive Officer, will present at the Bank of America Securities 2021 Virtual Healthcare Conference on May 12, 2021 at 11:45 am EDT.

    A live webcast of the event can be accessed under the ‘Events & Presentations' section on the Investors page at www.annexonbio.com.   A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to select indications, identify patients and measure target engagement and response to treatment. For more information, visit www.annexonbio.com.



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    
    
    Sara Michelmore
    
    
    Media Contact:
    Miriam Mason
    Annexon Biosciences
    

    Primary Logo

    View Full Article Hide Full Article
  3. SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Today Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced fourth quarter and full-year 2020 financial results and business highlights.

    Recent Business Highlights

    Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a range of potential indications. Recent highlights include:

    • ANX005 in Guillain-Barré Syndrome (GBS). In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin…

    SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Today Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced fourth quarter and full-year 2020 financial results and business highlights.

    Recent Business Highlights

    Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a range of potential indications. Recent highlights include:

    • ANX005 in Guillain-Barré Syndrome (GBS). In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin (IVIg) in 14 patients with GBS. The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg. IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS. Initial results from the DDI study included:



      • Co-administration of IVIg-ANX005 was well-tolerated.

      • Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range.
      • The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures. A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score.

    Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021. A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients. Data from the Phase 2/3 trial is anticipated in 2023.

    • ANX007 in Geographic Atrophy (GA). In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007. Data from this trial is anticipated in 2023.



    • In February 2021, Annexon appointed William H. Carson, M.D. to the Board of Directors. Concurrent with Dr. Carson's appointment, Thomas G. Wiggans was appointed as Annexon's chairman.

    "We continue to make progress against our vision of building a leading, multi-faceted complement therapeutics company with an innovative portfolio for a broad range of autoimmune, neurodegenerative and ophthalmic diseases," said Douglas Love, Esq., president and chief executive officer of Annexon. "The DDI data gives us further confidence in ANX005. We are rapidly advancing multiple Phase 2 clinical programs across a diverse set of potential indications, and accelerating development of a number of innovative, next generation product candidates. This clinical momentum coupled with our strong capital position positions us well to drive value in 2021 and beyond."

    Fourth Quarter and Full-Year 2020 Financial Results

    • Cash and cash equivalents and short-term investments: Cash and cash equivalents and short-term investments were $351.2 million as of December 31, 2020.



    • Research and development (R&D) expenses: R&D expenses were $18.0 million for the quarter ended December 31, 2020 compared to $6.8 million for the quarter ended December 31, 2019. R&D expenses were $49.3 million for the year ended December 31, 2020 compared to $24.5 million for the year ended December 31, 2019.



    • General and administrative (G&A) expenses: G&A expenses were $5.2 million for the quarter ended December 31, 2020 compared to $2.3 million for the quarter ended December 31, 2019. G&A expenses were $14.2 million for the year ended December 31, 2020 compared to $8.0 million for the year ended December 31, 2019.



    • Net loss: Net loss was $23.2 million for the quarter ended December 31, 2020 compared to $8.9 million for the quarter ended December 31, 2019. Net loss was $63.4 million for the year ended December 31, 2020 compared to $37.2 million for the year ended December 31, 2019.

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven strategy designed to select indications, identify patients and to measure target engagement and response to treatment with its drug candidates. 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," "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: advancement of the company's clinical and preclinical programs; timing of data from clinical trials and submission of data to peer-reviewed forums; confidence in the company's product candidates; the company's ability to drive value in 2021 and beyond; and 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. 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.



    ANNEXON, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

      Three Months Ended

    December 31,
      Year Ended

    December 31,
     
      2020  2019  2020  2019 
      (unaudited)  (unaudited)         
    Operating expenses:                
    Research and development (1) $17,992  $6,795  $49,271  $24,524 
    General and administrative (1)  5,199   2,334   14,198   7,994 
    Total operating expenses  23,191   9,129   63,469   32,518 
    Loss from operations  (23,191)  (9,129)  (63,469)  (32,518)
    Loss on remeasurement of redeemable convertible preferred stock liability           (5,670)
    Other (expense) income, net  (7)  188   57   1,009 
    Net loss before taxes  (23,198)  (8,941)  (63,412)  (37,179)
    Provision for income taxes  (5)  1      4 
    Net loss  (23,193)  (8,942)  (63,412)  (37,183)
    Accretion on redeemable convertible preferred stock     (280)  (705)  (1,095)
    Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock        (6,219)   
    Net loss attributable to common stockholders $(23,193) $(9,222) $(70,336) $(38,278)
    Net loss per share attributable to common stockholders, basic and diluted $(0.61) $(21.26) $(4.15) $(88.30)
    Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted  38,157,618   433,749   16,962,398   433,493 
                     
    (1) Includes the following stock-based compensation expense:                
    Research and development  990   230   2,274   713 
    General and administrative  1,001   294   2,614   1,324 



    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

      December 31,

    2020
      December 31,

    2019
     
    Assets        
    Current assets:        
    Cash and cash equivalents $268,565  $43,931 
    Short-term investments  82,641    
    Prepaid expenses and other current assets  2,805   1,475 
    Total current assets  354,011   45,406 
    Property and equipment  1,935   2,138 
    Other long-term assets     2,354 
    Total assets $355,946  $49,898 
    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities:        
    Accounts payable $3,734  $2,371 
    Accrued liabilities  6,497   2,194 
    Deferred rent, current  391   366 
    Total current liabilities  10,622   4,931 
    Deferred rent  1,046   1,437 
    Total liabilities  11,668   6,368 
    Redeemable convertible preferred stock     143,984 
    Stockholders' Equity (Deficit):        
    Preferred stock      
    Common stock  38   4 
    Additional paid-in capital  510,309   2,202 
    Accumulated other comprehensive loss  (77)  (80)
    Accumulated deficit  (165,992)  (102,580)
    Total stockholders' equity (deficit)  344,278   (100,454)
    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $355,946  $49,898 

     



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    
    
    Sara Michelmore
    
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    
    
    Caroline Rufo, Ph.D.
    

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  4. SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced that patient dosing has begun in its Phase 2 ARCHER study of its anti-C1q therapy, ANX007, to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. Currently, there are no approved treatment options to prevent onset or progression of GA.

    "We are pleased to have commenced this important Phase 2 trial, advancing ANX007 as a potential therapy for…

    SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced that patient dosing has begun in its Phase 2 ARCHER study of its anti-C1q therapy, ANX007, to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. Currently, there are no approved treatment options to prevent onset or progression of GA.

    "We are pleased to have commenced this important Phase 2 trial, advancing ANX007 as a potential therapy for GA, a leading cause of blindness and highly burdensome disease which affects more than five million people worldwide," said Douglas Love, Esq., president and chief executive officer of Annexon. "This program harnesses our targeted anti-C1q approach, fully inhibiting the classical complement pathway with the aim of halting the damaging immune response and nerve damage that occurs in the eye."

    "Geographic atrophy can have a profound impact on patients who lose their ability to drive, read and carry out normal daily functions," said Peter K. Kaiser, M.D., Professor of Ophthalmology, Cole Eye Institute, Cleveland Clinic. "Targeting aberrant complement activity associated with the GA process has demonstrated great promise. Evaluating treatments that may reduce the rate of GA lesions growth and preserve visual function is important for these patients that have no treatment options today."

    About the Phase 2 ARCHER Clinical Trial and ANX007

    The randomized, multi-center, double-masked Phase 2 trial is designed to evaluate the efficacy and safety of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA. Monthly and every other month dosing schedules will be evaluated.

    ANX007 is an investigational monoclonal antibody antigen-binding fragment for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases. Formulated for intravitreal administration, ANX007 is designed to potently bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but not to interfere with the normal function of C3 and C5 as part of other complement pathways. In Phase 1 studies, intravitreal ANX007 demonstrated full C1q inhibition at 29 days and was well tolerated by patients.

    More information can be found at www.annexonbio.com.

    About Annexon, Inc.



    Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to identify patients, and to measure target engagement and response to treatment. 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," "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: advancement of the company's clinical and preclinical programs; timing of data from clinical trials; and the implementation of the company's business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications which the company may pursue. 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 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 Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    
    
    Sara Michelmore
    
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    
    
    Caroline Rufo, Ph.D.
    

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  5. SOUTH SAN FRANCISCO, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced the appointment of William H. Carson, M.D. to its board of directors. Concurrently with Dr. Carson's appointment, Thomas G. Wiggans has been appointed Annexon's chairman, as William Young and Carol Gallagher, PharmD, retire from the board on February 5, 2021.

    Dr. Carson brings deep expertise in pharmaceutical research, development and commercialization, with specialization in central nervous system (CNS) disorders. Most recently…

    SOUTH SAN FRANCISCO, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced the appointment of William H. Carson, M.D. to its board of directors. Concurrently with Dr. Carson's appointment, Thomas G. Wiggans has been appointed Annexon's chairman, as William Young and Carol Gallagher, PharmD, retire from the board on February 5, 2021.

    Dr. Carson brings deep expertise in pharmaceutical research, development and commercialization, with specialization in central nervous system (CNS) disorders. Most recently he was the president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc., leading the development and regulatory approvals of Otsuka's global compounds.

    "On behalf of Annexon and the board of directors, I am pleased to welcome Dr. Carson to our board," said Thomas Wiggans, newly appointed chairman of Annexon's board. "As Annexon continues to advance its portfolio of clinical-stage C1q inhibitors, Dr. Carson's medical background and distinguished experience across therapeutic research, development and commercialization will be important assets to the company. We look forward to his leadership and contributions."

    Mr. Wiggans, who succeeds William Young as chairman, has served on the Annexon board of directors since February 2017. Mr. Young retired as chairman of the Annexon board on February 5, 2021 but will continue to be engaged with the company in a consulting capacity.

    "I am deeply grateful to both Bill Young and Carol Gallagher for their invaluable service on the Annexon board of directors. Dr. Young joined the board in 2014 and has served as chairman since March 2017. He has been a strong leader and voice on our board, drawing upon his strategic and operational expertise to help guide our scientific and business priorities, and we are delighted that he will continue to provide counsel to Annexon," said Douglas Love, Esq., president and CEO of Annexon. "Dr. Gallagher joined the Annexon board in 2018 and has been instrumental in our portfolio and financing strategies over the years."

    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," "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 Mr. Young's continued engagement with the company in a consulting capacity. 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 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 Contacts:
    Jennifer Lew
    Chief Financial Officer
    Annexon Biosciences
    
    
    Sara Michelmore
    
    
    Media Contacts:
    Miriam Mason
    SVP, Corporate Communications
    Annexon Biosciences
    
    
    Caroline Rufo, Ph.D.
    

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