ANNX Annexon Inc.

24.99
-0.02  -0%
Previous Close 25.01
Open 25.26
52 Week Low 15.33
52 Week High 31.84
Market Cap $953,558,874
Shares 38,157,618
Float 34,156,009
Enterprise Value $581,346,569
Volume 85,177
Av. Daily Volume 195,932
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Drug Stage Catalyst Date
ANX005
Amyotrophic lateral sclerosis (ALS)
Phase 2
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Warm autoimmune hemolytic anemia (WAIHA)
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ANX005
Huntington’s disease
Phase 2
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ANX007
Geographic atrophy
Phase 2
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ANX005
Guillain-Barré Syndrome
Phase 2/3
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Latest News

  1. – Cash balance of $370.7 million as of September 30, 2020 bolstered by July IPO –
    – Recently expanded ANX005 clinical program into neurodegeneration, with initiation of Phase 2 in Huntington's Disease –
    – Fully enrolled Phase 1b DDI trial in Guillain-Barré Syndrome –

    SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (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 brain, body and eye, today announced third quarter 2020 financial results and recent business highlights.

    "We continue to make strong progress across our classical complement platform, including expanded development of ANX005…

    – Cash balance of $370.7 million as of September 30, 2020 bolstered by July IPO –

    – Recently expanded ANX005 clinical program into neurodegeneration, with initiation of Phase 2 in Huntington's Disease –

    – Fully enrolled Phase 1b DDI trial in Guillain-Barré Syndrome –

    SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (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 brain, body and eye, today announced third quarter 2020 financial results and recent business highlights.

    "We continue to make strong progress across our classical complement platform, including expanded development of ANX005 in Huntington's Disease, and advancement of our subcutaneous formulation, ANX009, into the clinic," said Douglas Love, Esq., president and chief executive officer of Annexon. "Our unique focus on C1q allows us to address a diverse set of classical complement-mediated autoimmune and neurodegenerative diseases, and we're well capitalized to conduct several promising near- and mid-term Phase 2 clinical trials in these devastating diseases."

    Program Highlights

    • Initiated Phase 2 trial evaluating ANX005 in Huntington's Disease (HD) Initiated patient dosing in a Phase 2 trial designed to assess safety, tolerability, and biomarkers of target engagement and impact on neurodegeneration
    • Initiated Phase 1 first-in-human trial of ANX009. Initiated subcutaneous dosing of healthy volunteers with Annexon's third clinical-stage drug candidate in a Phase 1 trial designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses
    • Completed enrollment of Guillain-Barré Syndrome (GBS) Drug-Drug Interaction (DDI) trial. Fully enrolled global Phase 1b DDI trial assessing safety and potential pharmacokinetic effect of ANX005 co-administered with IVIg in GBS patients. Data are anticipated in early 2021

    Anticipated Upcoming Milestones

    • ANX005, a clinical-stage investigational monoclonal antibody intended to treat patients with complement-mediated disorders

      -- Phase 2 trial in patients with HD is ongoing with initial data anticipated in 2H 2021

      -- Phase 2/3 trial in patients with GBS is planned to initiate in early 2021 with data anticipated in 2023

      -- Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS) is planned to initiate in early 2021 with initial data anticipated in 2H 2021

      -- Phase 2 trial in patients with warm autoimmune hemolytic anemia (wAIHA) is planned to initiate in early 2021 with initial data anticipated in 1H 2022

    • ANX007, a clinical-stage investigational monoclonal antibody Fab for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases

      -- Phase 2 trial in patients with geographic atrophy (GA) is planned to initiate in early 2021 with data anticipated in 2023 
    • ANX009, a clinical-stage investigational, subcutaneous formulation of an antigen-binding fragment (Fab) intended to treat systemic antibody-mediated autoimmune diseases 

      -- Phase 1 first-in-human trial is ongoing with data anticipated in 1H 2021 

    Third Quarter 2020 Financial Results

    • Cash and cash equivalents:  Cash and cash equivalents were $370.7 million as of September 30, 2020 compared to $43.9 million as of December 31, 2019. In July 2020, Annexon completed an upsized IPO of 14,750,000 shares of its common stock, including the exercise of the underwriters' option to purchase an additional 2,139,403 shares of common stock, resulting in net proceeds of $262.4 million, after deducting underwriting commissions and offering expenses
    • Research and development (R&D) expenses: R&D expenses were $11.8 million for the quarter ended September 30, 2020 compared to $7.1 million for the quarter ended September 30, 2019
    • General and administrative (G&A) expenses:  G&A expenses were $3.8 million for the quarter ended September 30, 2020 compared to $2.0 million for the quarter ended September 30, 2019
    • Net loss:  Net loss was $15.6 million for the quarter ended September 30, 2020 compared to $10.2 million for the quarter ended September 30, 2019. Net loss attributable to common stockholders was $22.0 million or $0.77 per share for the quarter ended September 30, 2020 compared to $10.5 million or $24.14 per share for the quarter ended September 30, 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 brain, body 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 establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended tissue compartments. 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; the company's capital position and ability to conduct promising near- and mid-term Phase 2 clinical trials; timing and commencement of future nonclinical studies and clinical trials and research and development programs; and the implementation of the company's business model and strategic plans for its business and product candidates, including 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 pursuant to Rule 424(b) under the Securities Act 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)

    (Unaudited)

      Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2020  2019  2020  2019 
    Operating expenses:                
    Research and development (1) $11,775  $7,089  $31,279  $17,729 
    General and administrative (1)  3,810   1,981   8,999   5,660 
    Total operating expenses  15,585   9,070   40,278   23,389 
    Loss from operations  (15,585)  (9,070)  (40,278)  (23,389)
    Loss on remeasurement of redeemable convertible preferred stock liability     (1,340)     (5,670)
    Other (expense) income, net  (52)  224   64   821 
    Net loss before taxes  (15,637)  (10,186)  (40,214)  (28,238)
    Provision for income taxes  1   2   5   3 
    Net loss  (15,638)  (10,188)  (40,219)  (28,241)
    Accretion on redeemable convertible preferred stock  (145)  (281)  (705)  (815)
    Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock  (6,219)     (6,219)   
    Net loss attributable to common stockholders $(22,002) $(10,469) $(47,143) $(29,056)
    Net loss per share attributable to common stockholders, basic and diluted $(0.77) $(24.14) $(4.79) $(67.04)
    Weighted-average shares used in computing net loss per share

    attributable to common stockholders, basic and diluted
      28,465,156   433,749   9,845,754   433,406 
                     
    (1) Includes the following stock-based compensation expense:                
    Research and development  624   159   1,284   391 
    General and administrative  847   451   1,613   1,122 
                     

    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (Unaudited)

      September 30,

    2020
      December 31,

    2019
     
    Assets        
    Current assets:        
    Cash and cash equivalents $370,686  $43,931 
    Prepaid expenses and other current assets  2,889   1,475 
    Total current assets  373,575   45,406 
    Property and equipment, net  2,039   2,138 
    Other long-term assets     2,354 
    Total assets $375,614  $49,898 
    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities:        
    Accounts payable $3,954  $2,371 
    Accrued liabilities  4,649   2,194 
    Deferred rent, current  385   366 
    Total current liabilities  8,988   4,931 
    Deferred rent  1,147   1,437 
    Total liabilities  10,135   6,368 
    Redeemable convertible preferred stock     143,984 
    Stockholders' Equity (Deficit):        
    Preferred stock      
    Common stock  38   4 
    Additional paid-in capital  508,318   2,202 
    Accumulated other comprehensive loss  (78)  (80)
    Accumulated deficit  (142,799)  (102,580)
    Total stockholders' equity (deficit)  365,479   (100,454)
    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $375,614  $49,898 


    Investor Contact:
    Sylvia Wheeler
    
    
    Alexandra Santos
    
    
    Media Contact:
    Caroline Rufo, Ph.D.
    

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  2. – First patient dosed in Phase 2 study of ANX005 C1q targeted mAb –

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (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 brain, body and eye, today announced that it has initiated a Phase 2 study, dosing the first patient with its full-length monoclonal antibody ANX005 in Huntington's Disease (HD). The Phase 2 trial in HD expands Annexon's classical complement platform into neurodegenerative diseases of the brain and highlights the pioneering research of the company's co-founder, the late Dr. Ben Barres, former member of the National Academy…

    – First patient dosed in Phase 2 study of ANX005 C1q targeted mAb –

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (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 brain, body and eye, today announced that it has initiated a Phase 2 study, dosing the first patient with its full-length monoclonal antibody ANX005 in Huntington's Disease (HD). The Phase 2 trial in HD expands Annexon's classical complement platform into neurodegenerative diseases of the brain and highlights the pioneering research of the company's co-founder, the late Dr. Ben Barres, former member of the National Academy of Sciences and Chair of Neurobiology, Stanford University. Aberrant activation of C1q plays a significant role in the neurodegenerative process by causing synapse loss, chronic neuroinflammation and eventual neuronal death.

    "Huntington's Disease is a devastating, progressive movement disorder with no cure and no approved therapeutic options available to patients and their families," commented Sanjay Keswani, MBBS, BSc, FRCP, Chief Medical Officer of Annexon. "In neurodegenerative conditions like HD, our goal is to disrupt the disease course by inhibiting harmful classical complement activity, including synapse loss, that leads to neurodegeneration and cognitive impairment. We are excited to advance ANX005 and look forward to initial results from our Phase 2 trial in the second half of 2021."

    "Annexon targets the initiating protein of the classical complement pathway, C1q, which uniquely binds to synapses in the brain and appears to cause inappropriate synapse elimination during chronic neurodegenerative disease, such as HD," stated Beth Stevens, PhD, Associate Professor of Neurology, Children's Hospital Boston and former postdoctoral scholar in Dr. Barres' lab. "Inhibiting C1q and protecting functioning synapses may benefit patients with neurodegenerative conditions."

    About the Clinical Trial and ANX005

    The Phase 2 open-label trial is enrolling up to 24 patients and is designed to assess safety, tolerability and biomarkers of target engagement and impact on neurodegeneration.

    ANX005 is an IV formulated monoclonal antibody designed to inhibit C1q and the entire classical complement pathway. ANX005 is designed to treat patients with antibody-mediated autoimmune and complement-mediated neurodegenerative disorders. In addition to the HD indication, Annexon has completed a Phase 1b clinical trial of ANX005 in Guillain-Barré Syndrome (GBS) and has received fast track and orphan drug designations from the U.S. Food and Drug Administration for the treatment of GBS.

    More information can be found at www.annexonbio.com or www.clinicaltrials.gov, identifier NCT04514367, or the HD Coalition for Patient Engagement https://www.huntingtonsociety.ca/hdcope/.        

    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 brain, body 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 establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended tissue compartments. 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 and timing of clinical results; the potential benefits of inhibiting C1q; and the implementation of the company's business model and strategic plans for its business and product candidates. 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 June 30, 2020 filed with the Securities and Exchange Commission (SEC) on September 9, 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 Contact:
    Sylvia Wheeler
    
    
    Alexandra Santos
    
    
    Media Contact:
    Caroline Rufo, Ph.D.
    
    

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  3. – Completed $263M IPO in July, and private financing in late June –

    – Company plans to initiate four new clinical trials by year-end, including in three expanded indications for ANX005 and first-in-human trial of ANX009 –

    – Phase 2 trials of ANX005 in GBS and ANX007 in GA remain on track for 2021 –

    SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (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 second quarter 2020 financial results and recent highlights.

    "This is an exciting time in Annexon's history as we advance our pioneering platform to treat…

    – Completed $263M IPO in July, and private financing in late June –

    – Company plans to initiate four new clinical trials by year-end, including in three expanded indications for ANX005 and first-in-human trial of ANX009 –

    – Phase 2 trials of ANX005 in GBS and ANX007 in GA remain on track for 2021 –

    SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (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 second quarter 2020 financial results and recent highlights.

    "This is an exciting time in Annexon's history as we advance our pioneering platform to treat a wide array of classical complement-mediated diseases," said Douglas Love, Esq., president and chief executive officer of Annexon. "We continue to make notable progress advancing our deep pipeline, and remain intensely focused on the execution of our near-term strategic and development plans. In that regard, we remain on track to initiate several clinical trials in diverse diseases over the balance of 2020 and early 2021."

    Recent Highlights

    • In July 2020, Annexon completed an upsized IPO of 14,750,000 shares of its common stock, including the exercise of the underwriters' option to purchase an additional 2,139,403 shares of common stock, resulting in net proceeds of $262.7 million, after deducting underwriting commissions and offering expenses.
    • In July 2020, Michael Overdorf was appointed chief business officer to oversee corporate development and commercial strategy efforts for the company. Mr. Overdorf brings nearly 20 years of industry experience to Annexon. Prior to joining, he spent 19 years at Eli Lilly and Company in various executive leadership roles, most recently in Corporate Business Development.
    • In June 2020, prior to its IPO, Annexon successfully completed a private crossover financing, with net proceeds of $96.8 million.

    Anticipated Upcoming Milestones

    • ANX005, a clinical-stage investigational monoclonal antibody intended to treat patients with complement-mediated disorders, is currently being evaluated to treat Guillain-Barre Syndrome (GBS), warm autoimmune hemolytic anemia (wAIHA), Huntington's Disease (HD) and ALS. Phase 2a trials in patients with HD and ALS and a Phase 2 trial in patients with wAIHA are planned for 2H 2020. A Phase 2/3 trial in patients with GBS is expected to begin in early 2021.
    • ANX009, an investigational, subcutaneous formulation of an antigen-binding fragment (Fab), is being evaluated to treat systemic antibody-mediated autoimmune diseases. A Phase 1 first-in-human trial is expected to begin in 2020.
    • ANX007, a clinical-stage investigational monoclonal antibody Fab for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases, is being evaluated to treat geographic atrophy. A Phase 2 trial is expected to begin in 2021.

    Second Quarter 2020 Financial Results:

    • Cash and cash equivalents:  Cash and cash equivalents were $124.8 million as of June 30, 2020 compared to $43.9 million as of December 31, 2019. 
    • Research and development (R&D) expenses:  R&D expenses were $9.3 million for the quarter ended June 30, 2020 compared to $6.0 million for the quarter ended June 30, 2019.
    • General and administrative (G&A) expenses:  G&A expenses were $2.9 million for the quarter ended June 30, 2020 compared to $2.2 million for the quarter ended June 30, 2019.
    • Net loss:  Net loss attributable to common stockholders was $12.5 million or $28.87 per share for the quarter ended June 30, 2020 compared to $9.7 million or $22.30 per share for the quarter ended June 30, 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. The company's first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The company's second product candidate, ANX007, is a monoclonal antibody Fab formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended patient tissue. 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 (Securities Act), 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 and commencement of future nonclinical studies and clinical trials and research and development programs; and the implementation of the company's business model and strategic plans for its business and product candidates, including 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 prospectus filed with the Securities and Exchange Commission (SEC) on July 24, 2020 pursuant to Rule 424(b) under the Securities Act 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)

    (Unaudited)

     Three Months Ended

    June 30,
     Six Months Ended

    June 30,  


      2020   2019   2020     2019   
    Operating expenses:    
    Research and development (1)$               9,287  $              5,987  $         19,504  $         10,640 
    General and administrative (1) 2,950   2,230   5,189   3,679 
         
    Total operating expenses 12,237   8,217   24,693   14,319 
         
    Loss from operations (12,237)  (8,217)  (24,693)  (14,319)
    Loss on remeasurement of redeemable convertible preferred

    stock liability
        (1,560)     (4,330)
    Other income, net 1   376   116   597 
         
    Net loss before taxes (12,236)  (9,401)  (24,577)  (18,052)
    Provision for income taxes 4      4   1 
         
    Net loss (12,240)  (9,401)  (24,581)  (18,053)
    Accretion on redeemable convertible preferred stock 281   272   560   534 
         
    Net loss attributable to common stockholders$          (12,521) $           (9,673) $      (25,141) $      (18,587)
         
    Net loss per share attributable to common stockholders, basic and

    diluted
    $             (28.87) $            (22.30) $         (57.96) $         (42.90)
         
    Weighted-average shares used in computing net loss per share

    attributable to common stockholders, basic and diluted
     433,749   433,749   433,749   433,232 
         



    (1)    Includes the following stock-based compensation expense:       
    Research and development335 135

     660 232
    General and administrative428 302 766 671



    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (Unaudited)

     June 30,

    2020
      December 31,

    2019
     
    Assets  
    Current assets:  
    Cash and cash equivalents$    124,761  $        43,931 
    Prepaid expenses and other current assets 907   1,475 
       
    Total current assets 125,668   45,406 
    Property and equipment, net 2,048   2,138 
    Other long-term assets 3,371   2,354 
       
    Total assets$    131,087  $        49,898 
       
    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit  
    Current liabilities:  
    Accounts payable$         3,064  $          2,371 
    Accrued liabilities 9,218   2,194 
    Deferred rent, current 378   366 
       
    Total current liabilities 12,660   4,931 
    Deferred rent 1,247   1,437 
       
    Total liabilities 13,907   6,368 
       
    Redeemable convertible preferred stock 235,054   143,984 
       
    Stockholders' Deficit:  
     Common stock 4   4 
    Additional paid-in capital 9,365   2,202 
    Accumulated other comprehensive loss (82)  (80)
    Accumulated deficit (127,161)  (102,580)
       
    Total stockholders' deficit (117,874)  (100,454)
       
    Total liabilities, redeemable convertible preferred stock and stockholders' deficit$    131,087  $        49,898 
       
    Investor Contact:
    Sylvia Wheeler
    
    
    Alexandra Santos
    
    
    Media Contact:
    Caroline Rufo
    

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  4. SOUTH SAN FRANCISCO, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Annexon, Inc. (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 the appointment of Michael Overdorf as Chief Business Officer.

    "I'm pleased to welcome Michael to our organization as we look to leverage his expertise across the organization, and in particular with regard to our corporate and commercial development efforts," said Douglas Love, Chief Executive Officer of Annexon Biosciences. "The potential for our classical complement pathway platform technology is broad and deep across a number of different therapeutic areas, and…

    SOUTH SAN FRANCISCO, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Annexon, Inc. (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 the appointment of Michael Overdorf as Chief Business Officer.

    "I'm pleased to welcome Michael to our organization as we look to leverage his expertise across the organization, and in particular with regard to our corporate and commercial development efforts," said Douglas Love, Chief Executive Officer of Annexon Biosciences. "The potential for our classical complement pathway platform technology is broad and deep across a number of different therapeutic areas, and Michael will be a key member of the team driving our business development and commercial strategies." 

    Mr. Overdorf brings nearly 20 years of industry experience to Annexon. Prior to joining he spent 19 years at Eli Lilly and Company in various executive leadership roles, most recently in Corporate Business Development, a position he held for the last two years. Prior to that role, Mr. Overdorf led Lilly's Corporate Strategy, led two Phase 3 autoimmune development programs, and spent a decade in multiple global commercial leadership roles. Mr. Overdorf has deep expertise across every stage of the pharmaceutical value chain, including research and development, clinical product development, commercial launch, pricing and access, corporate affairs, and sales and marketing. Prior to Lilly he was the Co-founder, Chairman and CEO of Innosight, a consulting firm focused on disruptive innovation. Mr. Overdorf holds an MBA from Harvard Business School and a BA in Economics from Wabash College.

    "I am delighted to join the leadership team at Annexon. With an impressive pipeline of promising C1q classical complement assets, the opportunities for Annexon are vast," said Mr. Overdorf, Chief Business Officer of Annexon. "I look forward to helping the company leverage its platform and navigate its strategic commercial and business development options to enhance the value of the organization and reach patients in need of therapeutic alternatives."

    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. The company's first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The company's second product candidate, ANX007, is a monoclonal antibody Fab formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended patient tissue. For more information, visit www.annexonbio.com.

    Investor Contact:

    Sylvia Wheeler

    Alexandra Santos

    Media Contact:

    Sara Michelmore

     

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  5. SOUTH SAN FRANCISCO, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Annexon, Inc. (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 the closing of its initial public offering of 14,750,000 shares of its common stock at a public offering price of $17.00 per share. All of the shares of common stock were offered by Annexon. Annexon's common stock began trading on The Nasdaq Global Select Market on July 24, 2020, under the ticker symbol "ANNX." The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Annexon, were approximately…

    SOUTH SAN FRANCISCO, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Annexon, Inc. (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 the closing of its initial public offering of 14,750,000 shares of its common stock at a public offering price of $17.00 per share. All of the shares of common stock were offered by Annexon. Annexon's common stock began trading on The Nasdaq Global Select Market on July 24, 2020, under the ticker symbol "ANNX." The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Annexon, were approximately $250.8 million. In addition, Annexon has granted the underwriters a 30-day option to purchase up to an additional 2,212,500 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

    J.P. Morgan, BofA Securities and Cowen are acting as joint book-running managers for the offering.

    Registration statements relating to the shares sold in this offering were filed with the Securities and Exchange Commission and became effective on July 23, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at or by telephone at (866) 803-9204; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at ; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by email at or by telephone at (833) 297-2926.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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. The company's first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The company's second product candidate, ANX007, is a monoclonal antibody Fab formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended patient tissue.

    Investor Contact:

    Sylvia Wheeler

    Alexandra Santos

    Media Contact:

    Sara Michelmore

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