ANNX Annexon Inc.

20.38
-0.59  -3%
Previous Close 20.97
Open 20.69
52 Week Low 17.27
52 Week High 38.01
Market Cap $779,712,041
Shares 38,258,687
Float 36,261,437
Enterprise Value $479,073,948
Volume 30,618
Av. Daily Volume 167,326
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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. Advancing subcutaneous ANX009 candidate into Phase 1b program in Lupus Nephritis 

    Deepening ANX005 neuromuscular autoimmune pipeline with new Phase 2 program in Multifocal Motor Neuropathy      

    Annexon to host virtual autoimmune R&D event with leading experts on Wednesday, July 28, at 10:30 a.m. ET 

    SOUTH SAN FRANCISCO, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a class of next generation complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced the broadening of its autoimmune franchise through advancement of its third clinical-stage product candidate…

    Advancing subcutaneous ANX009 candidate into Phase 1b program in Lupus Nephritis 

    Deepening ANX005 neuromuscular autoimmune pipeline with new Phase 2 program in Multifocal Motor Neuropathy      

    Annexon to host virtual autoimmune R&D event with leading experts on Wednesday, July 28, at 10:30 a.m. ET 

    SOUTH SAN FRANCISCO, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a class of next generation complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced the broadening of its autoimmune franchise through advancement of its third clinical-stage product candidate, ANX009, into Lupus Nephritis and expansion of the ANX005 clinical program into a second neuromuscular condition, Multifocal Motor Neuropathy (MMN).

    "Nearly 24 million Americans suffer from antibody-mediated autoimmune diseases, many of which are orphan or rare diseases with no or limited treatment options," said Douglas Love, Esq., president and chief executive officer of Annexon.1 "Annexon is focused on developing therapeutics that stop classical complement-mediated disease at the start by targeting C1q, the initiating molecule of the classical pathway. Our upstream complement approach has broad potential to deliver multiple, differentiated, first-in-class therapies for patients across a spectrum of autoantibody-driven autoimmune diseases. We are excited to expand our portfolio of C1q inhibitors into additional autoimmune indications with high unmet need."

    Annexon's Approach to Autoimmune Disease

    Annexon is pioneering a targeted approach to tackling an array of antibody-mediated autoimmune diseases by inhibiting C1q and the early classical complement pathway. Using a rigorous precision medicine approach to measure aberrant complement activity, Annexon is sharply focused on enhancing the probability of success by identifying the indications and patients most likely to respond to anti-C1q therapy and developing a class of next generation complement medicines with improved efficacy and safety characteristics. Annexon's autoimmune franchise, spanning neuromuscular, hematologic and nephritic indications, is well-supported by C1q's unique mechanism of action, a comprehensive and growing scientific and clinical dataset and Annexon's deep experience in the classical complement pathway.

    Advancing ANX009 into Phase 1b Study in Lupus Nephritis

    Annexon's third clinical-stage product candidate, ANX009, is a subcutaneous C1q inhibitor developed for antibody-mediated autoimmune diseases of blood and vascular tissues. In a recently completed Phase 1 first-in-human (FIH) study of ANX009 in healthy volunteers, the dose-escalation study demonstrated:

    • ANX009 was well-tolerated at all dose levels and no drug-related safety signals were observed
    • A clear dose response in single ascending dose cohorts, with robust C1q inhibition at higher doses
    • Sustained C1q inhibition with multiple doses, supporting the potential for twice weekly subcutaneous administration with the current formulation
    • No serious adverse events, discontinuations related to treatment or dose limiting toxicity were observed. Some participants reported mild, transient localized subcutaneous injection site reactions

    The company now plans to advance ANX009 into a Phase 1b study in Lupus Nephritis patients in early 2022. Annexon has identified biomarkers in a subset of Lupus Nephritis patients indicating high levels of aberrant classical complement activation that will be used to select patients for the initial study. Lupus Nephritis is an orphan disease that affects up to 50-60% of people with systemic lupus erythematous during the first 10 years of the disease.2

    "C1q is a key driver of pathology in Lupus Nephritis. By focusing on biomarkers related to C1q activation and disease pathology, our Phase 1b study will identify Lupus Nephritis patients most likely to respond to anti-C1q therapy," said Ted Yednock, PhD, executive vice president and chief scientific officer of Annexon. "We believe our subcutaneous ANX009 candidate has broad utility in antibody-mediated diseases of the blood and vascular tissues, and combined with our precision medicine approach, has the potential to deliver transformative therapeutic impact for Lupus Nephritis patients."

    Advancing ANX005 into Phase 2 Program in Multifocal Motor Neuropathy

    Annexon also plans to advance ANX005 into a Phase 2 trial in MMN patients in early 2022. MMN is a chronic, slowly progressive disorder in which multiple motor nerves are attacked by one's own immune system resulting in asymmetrical weakness and muscle wasting in primarily the arms and legs due to the presence of nerve-reactive, anti-GM1 IgM autoantibodies.3 These IgM autoantibodies target peripheral nerve axons and myelin sheaths, where classical complement activation facilitates nerve damage and impaired conduction.4 In a preclinical model of MMN, C1q inhibition blocks nerve damage induced by IgM autoantibodies from patient sera.5 Moreover, MMN is mechanistically related to Guillain-Barré Syndrome (GBS), an antibody-mediated autoimmune disorder that causes acute neuromuscular paralysis driven also by IgM (as well as IgG) autoantibodies targeting peripheral nerve axons and myelin sheaths that spur nerve destruction and impaired conduction. ANX005 demonstrated proof-of-concept in a placebo-controlled Phase 1b trial in GBS, and Annexon is leveraging those learnings and the prominent overlap in pathology between GBS and MMN in the upcoming MMN Phase 2 trial.

    "Despite the current standard of care, there remains significant unmet treatment needs for people living with MMN, a chronic, life-long, progressively debilitating disease," said Hugh Willison, PhD, professor of neurology and head of neuroinflammation at Glasgow Biomedical Research Centre and a scientific advisor for Annexon. "Unlike other approaches, ANX005 has demonstrated the ability to inhibit aberrant classical complement activity induced by IgM antibodies that drive nerve injury. ANX005 has the potential to provide significant benefit for MMN patients."

    Annexon C1q Series: Autoimmune Portfolio Expansion

    Annexon will host a virtual autoimmune R&D event on Wednesday, July 28, 2021, at 10:30 a.m. ET, to discuss the expansion of its autoimmune franchise. Annexon's executive team will be joined by key opinion leaders at the event.

    A live webcast and slide presentation will also be available from the "Events and Presentations" page of the "Investors" section of annexonbio.com. To register for this event, please access this link.

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a class of next-generation complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline of differentiated product candidates addresses 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 currently conducting clinical trials in multiple serious autoimmune, neurodegenerative and ophthalmic diseases, including Guillain-Barré Syndrome, warm autoimmune hemolytic anemia, Huntington's Disease, amyotrophic lateral sclerosis and geographic atrophy. Annexon is deploying a disciplined, biomarker-driven development strategy designed to improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.

    About Lupus Nephritis

    Lupus Nephritis is a severe and life-threatening autoimmune disease that disproportionately affects young women. Up to 50-60% of lupus patients develop Lupus Nephritis during the course of their disease.6 Lupus Nephritis occurs when autoantibodies that recognize the body's own tissues deposit in the kidney and trigger complement activation leading to inflammation and tissue damage. If not adequately treated, this can result in worsening kidney function and even kidney failure. Current treatments for Lupus Nephritis include steroids and immunosuppressants, but more than half of patients are not well-controlled on these therapies, so there remains significant unmet need.

    About Multifocal Motor Neuropathy

    MMN is a rare and chronic peripheral nerve disorder in which focal areas of multiple motor nerves are attacked by one's own immune system, causing progressive and asymmetric muscle weakness, primarily of the arms and legs. MMN is characterized by a chronic progressive course without any remission. MMN has similarities to GBS pathology, as it is mediated by IgM autoantibodies that inappropriately disrupt the peripheral nervous system.7 Current standard of care with intravenous immunoglobulin (IVIg) for MMN patients requires frequent high dose treatment over 2-5 days with short duration effect and is often ineffective or not tolerated, resulting in significant unmet need. 

    References:

    1.   NIH The Autoimmune Diseases Coordinating Committee. Progress in Autoimmune Diseases Research. Auth.experianidworks.com. Published March 2005. Accessed July 20, 2021.

    2.   Hahn BH, McMahon M, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res. 2012;64(6):797-808.

    3.   Vlam L, van der Pol W-L, Cats EA, et al. Multifocal motor neuropathy: diagnosis, pathogenesis and treatment strategies. Nat Rev Neurol. 2011; 8:48–58.

    4.   Piepers S, Jansen MD, Cats EA, et al. IVIg inhibits classical pathway activity and anti-GM1 IgM-mediated complement deposition in MMN. J Neuroimmunol. 2010 Dec 15;229(1-2):256-262. doi: 10.1016/j.jneuroim.2010.08.023. PMID: 20920831.

    5.   Harschnitz O, van den Berg LH, Johansen LE, et al. Autoantibody pathogenicity in a multifocal motor neuropathy induced pluripotent stem cell-derived model. Ann Neurol. 2016;80(1);71-88.

    6.   Hahn BH, McMahon M, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res. 2012;64(6):797-808. 

    7.   GBS/CIDP Foundation International. https://www.gbs-cidp.org/variants/multifocal-motor-neuropathy/. Accessed July 20, 2021.

    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: broadening of the company's autoimmune franchise through advancement and initial indication selection of its third clinical-stage product candidate ANX009 into Lupus Nephritis and expansion of the ANX005 clinical program into MMN; broad potential of the company's complement approach to deliver multiple, differentiated, first-in-class therapies for patients suffering across a spectrum of autoantibody-driven diseases; extended reach of the company's growing portfolio of C1q inhibitors into new and expanded autoimmune indications; timing of and patient selection for the company's clinical trials; the company's precision medicine approach and potential delivery of transformative therapies to patients; ANX005 as a potential treatment for GBS; 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.



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

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  2. SOUTH SAN FRANCISCO, Calif., June 16, 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 virtual Raymond James Human Health Innovation Conference on June 23rd, 2021 at 1:20 pm 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,

    SOUTH SAN FRANCISCO, Calif., June 16, 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 virtual Raymond James Human Health Innovation Conference on June 23rd, 2021 at 1:20 pm 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 improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.



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

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  3. 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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  4. 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
  5. 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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