ANNX Annexon Inc.

29.11
-0.96  -3%
Previous Close 30.07
Open 30.54
52 Week Low 15.33
52 Week High 38.01
Market Cap $1,110,768,260
Shares 38,157,618
Float 34,156,009
Enterprise Value $818,686,953
Volume 242,790
Av. Daily Volume 155,107
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Upcoming Catalysts

Drug Stage Catalyst Date
ANX005 and IVIG
Guillain Barré Syndrome (GBS)
Phase 1/2
Phase 1/2
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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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ANX005
Guillain-Barré Syndrome
Phase 2/3
Phase 2/3
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ANX007
Geographic atrophy
Phase 2
Phase 2
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Latest News

  1. 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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  2. SOUTH SAN FRANCISCO, Calif., Jan. 12, 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 highlights recent achievements and outlines expected key 2021 milestones at the J.P. Morgan 39th Annual Healthcare Conference, held virtually.

    "2020 was a foundational year for Annexon as we laid the groundwork to build a leading 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…

    SOUTH SAN FRANCISCO, Calif., Jan. 12, 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 highlights recent achievements and outlines expected key 2021 milestones at the J.P. Morgan 39th Annual Healthcare Conference, held virtually.

    "2020 was a foundational year for Annexon as we laid the groundwork to build a leading 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. "With our strong capital position, highly experienced leadership team and precision medicine approach, we are rapidly advancing our portfolio and are poised to drive value in 2021 and beyond."

    2020 Program & Corporate Highlights

    • Phase 2/3 trial of ANX005 in patients with Guillain-Barre Syndrome (GBS) was initiated in late 2020
    • Drug-drug interaction (DDI) trial of ANX005 co-administered with IVIg in GBS patients was fully enrolled in late 2020
    • Phase 2 trial of ANX005 in patients with Huntington's Disease (HD) was initiated in late 2020
    • Phase 1 first-in-human trial of ANX009 subcutaneous formulated monoclonal antibody antigen-binding fragment (Fab) was initiated in 2020
    • In July 2020, Annexon completed an upsized IPO resulting in net proceeds of $262.7 million, which followed a successful private crossover financing in June 2020 with net proceeds of $96.8 million
    • In July 2020, Michael Overdorf was appointed chief business officer to oversee corporate development and commercial strategy efforts for the company, bringing nearly 20 years of executive leadership experience from Eli Lilly in business development and commercial roles

    2021 Anticipated Upcoming Milestones

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

      ○  Data from the DDI trial assessing safety and potential pharmacokinetic effect of ANX005 and IVIg in GBS is anticipated in early 2021

      ○  Initial data from the Phase 2 trial in HD is anticipated in 2H 2021

      ○  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
    • 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 
    • ANX009, a clinical-stage investigational, subcutaneous formulation of a Fab intended to treat systemic antibody-mediated autoimmune diseases

      ○  Data from the Phase 1 first-in-human trial is anticipated in 1H 2021

    Presentation & Webcast Details

    Mr. Love will present at the J.P. Morgan 39th Annual Healthcare Conference in a virtual session on January 12th at 4:30pm ET. A live webcast of the event can be accessed under the ‘Events & Presentations' section on the Investors page at www.annexonbio.com. A replay will be available on the Annexon website for 30 days after the event.

    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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  3. SOUTH SAN FRANCISCO, Calif., Jan. 05, 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 that a corporate update will be presented at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021 at 4:30pm ET.

    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…

    SOUTH SAN FRANCISCO, Calif., Jan. 05, 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 that a corporate update will be presented at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021 at 4:30pm ET.

    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 identify patients, and to 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 Contacts:
    Miriam Mason
    Annexon Biosciences
    
    
    Caroline Rufo, Ph.D.
    

    Primary Logo

    View Full Article Hide Full Article
  4. SOUTH SAN FRANCISCO, Calif., Dec. 21, 2020 (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 brain, body, and eye, announced that patient dosing has started in a Phase 2/3 clinical study of full-length monoclonal antibody, ANX005, to treat Guillain-Barré Syndrome (GBS). GBS is a rare, acute, antibody-mediated autoimmune disease that impacts the peripheral nervous system and can lead to acute paralysis and/or permanent disability from nerve loss.

    "We are pleased to advance our GBS program into later-stage clinical development, bringing us closer to potentially delivering a much-needed treatment…

    SOUTH SAN FRANCISCO, Calif., Dec. 21, 2020 (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 brain, body, and eye, announced that patient dosing has started in a Phase 2/3 clinical study of full-length monoclonal antibody, ANX005, to treat Guillain-Barré Syndrome (GBS). GBS is a rare, acute, antibody-mediated autoimmune disease that impacts the peripheral nervous system and can lead to acute paralysis and/or permanent disability from nerve loss.

    "We are pleased to advance our GBS program into later-stage clinical development, bringing us closer to potentially delivering a much-needed treatment option to patients combatting this debilitating disease," said Douglas Love, president and chief executive officer of Annexon. "The advancement of ANX005 also continues to inform our ongoing clinical development across a host of additional complement-mediated autoimmune and neurodegenerative diseases."

    Currently there are no approved therapies in the United States for GBS.  ANX005 has received both Fast Track and Orphan Drug designations for the treatment of GBS.

    "There is strong scientific rationale that blocking initiation of the classical complement cascade through specific inhibition of C1q has potential as a therapeutic intervention for GBS," said Hugh Willison, M.D., Professor of Neurology, Head of Neuroinflammation, Glasgow Biomedical Research Centre. "This anti-C1q approach is designed to act early in the disease course to prevent nerve damage and irreversible neurological disability in GBS patients." 

    About the Clinical Trial and ANX005

    The randomized, placebo-controlled Phase 2/3 trial is designed to evaluate the efficacy of ANX005 in improving disability in GBS patients. In addition to this study, Annexon has fully enrolled a global GBS drug-drug interaction (DDI) trial assessing safety and potential pharmacokinetic effect of ANX005 co-administered with IVIg in GBS patients. Data are anticipated from the GBS DDI trial in early 2021. Annexon completed a Phase 1b trial of ANX005 in patients with GBS that demonstrated full target engagement of C1q in serum and the cerebrospinal fluid (CSF), as well as a significant reduction in neurofilament light chain (NfL), a well-accepted biomarker shown to be elevated in patients with GBS and correlated with disease severity and clinical outcomes.

    ANX005 is an IV formulated monoclonal antibody designed to inhibit C1q and the entire classical complement pathway. ANX005 is intended to treat patients with antibody-mediated autoimmune and complement-mediated neurodegenerative disorders. Annexon has completed a Phase 1b monotherapy clinical trial of ANX005 in 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.

    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 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.
    

    Primary Logo

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  5. – 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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