ANNX Annexon Inc.

13.7
-0.92  -6%
Previous Close 14.62
Open 14.25
52 Week Low 13.03
52 Week High 38.01
Market Cap $525,735,390
Shares 38,374,846
Float 36,377,596
Enterprise Value $323,496,248
Volume 143,134
Av. Daily Volume 224,127
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ANX005
Warm autoimmune hemolytic anemia (WAIHA)
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
ANX005
Huntington’s disease
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ANX005
Amyotrophic lateral sclerosis (ALS)
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ANX007 - ARCHER
Geographic atrophy
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ANX005
Guillain-Barré Syndrome
Phase 2/3
Phase 2/3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

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.
ANX005
Multifocal Motor Neuropathy (MMN)
Phase 2
Phase 2
Phase 2 trial to be initiated early 2022.
ANX009
Lupus Nephritis (LN)
Phase 1b
Phase 1b
Phase 1b trial to be initiated early 2022.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced recent highlights and reported third quarter 2021 financial results.

    "The third quarter marks another quarter of meaningful progress with our portfolio, including effectively advancing three clinical-stage product candidates in five clinical trials," said Douglas Love, Esq., president and chief executive officer of Annexon. "We're also pleased to have been granted Orphan Drug designation by the FDA for ANX005, underscoring the Agency's recognition…

    SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced recent highlights and reported third quarter 2021 financial results.

    "The third quarter marks another quarter of meaningful progress with our portfolio, including effectively advancing three clinical-stage product candidates in five clinical trials," said Douglas Love, Esq., president and chief executive officer of Annexon. "We're also pleased to have been granted Orphan Drug designation by the FDA for ANX005, underscoring the Agency's recognition of ANX005's potential as a novel therapy for the treatment of Huntington's disease. Additionally, in collaboration with multiple academic and physician key opinion leaders, we conducted two C1q Series R&D Events that highlighted the applicability of our platform and differentiated scientific approach targeting the classical complement cascade in a range of autoimmune and neurodegenerative diseases. The combination of a rich set of milestones, a strong balance sheet, and a talented team, lays the foundation for a transformational year ahead. We look forward to sharing the continued progress across our portfolio, including initial data from our Huntington's disease clinical trial, as we work to bring treatments to patients suffering from serious complement-mediated diseases."

    Program Highlights

    • Second C1q Series R&D Event Highlights Neurodegeneration Franchise: Annexon hosted its second C1q Series event, which spotlighted the company's neurodegeneration franchise and approach to treating complement-mediated neurodegenerative diseases. During the event, Annexon's leadership team and participating key opinion leaders shared their perspectives on:
      • The role of C1q and the classical complement pathway in neurodegenerative diseases, including Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS);
      • Research on neurofilament light chain (NfL) and natural history data showing the association of a rise in NfL with clinical progression in both HD and ALS; and
      • Internal data demonstrating the ability to reduce NfL with ANX005, both clinically in Guillain-Barré syndrome (GBS), and preclinically in HD and ALS.
    • Initial Data from Phase 2 trial of ANX005 in HD Expected in the Fourth Quarter of 2021: Annexon is studying its lead compound, ANX005, a clinical-stage investigational monoclonal antibody intended to treat patients with complement-mediated disorders, in a Phase 2 trial in patients with HD. The company anticipates initial data from the trial in the fourth quarter of 2021, which is expected to include data from a subset of 16 patients who have completed the six-month treatment period, including safety and tolerability, C1q target engagement in cerebral spinal fluid and serum, and impact on NfL levels. The full dataset from all patients who complete both the six-month on-treatment and three-month off-treatment periods are expected to be reported in the first half of 2022.
    • ANX005 Granted Orphan Drug Designation for the Treatment of HD: The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for ANX005 for the treatment of patients with HD. Orphan Drug designation provides orphan status to drugs or biologics that are intended to treat rare diseases or disorders affecting fewer than 200,000 people in the United States, and certain incentives to the product sponsor, including tax credits for qualified clinical trials and fee waivers. The designation confers eligibility for seven years of market exclusivity following FDA product approval.

    Business Highlights

    • Leadership Team Strengthened by Appointment of Ted Yednock, Ph.D., as Chief Innovation Officer and Larry Mattheakis, Ph.D., as Chief Scientific Officer: In the third quarter, Annexon appointed Ted Yednock, Ph.D., as chief innovation officer (CIO), and Larry Mattheakis, Ph.D., as chief scientific officer (CSO). Dr. Ted Yednock served as Annexon's CSO since 2013. As CIO, he will serve as chairman of the Scientific Advisory Board and continue to enhance and integrate Annexon's key scientific findings and collaborations. Dr. Larry Mattheakis brings decades of drug discovery and development expertise to the CSO role, supporting the advancement of Annexon's current and future pipeline.

    Third Quarter 2021 Financial Results

    • Cash and Operating Runway: Cash and cash equivalents and short-term investments were $271.4 million as of September 30, 2021. Annexon expects that its current cash position is sufficient to fund its operating plans into 2024.
    • Research and development (R&D) expenses: R&D expenses were $27.6 million for the quarter ended September 30, 2021, compared to $11.8 million for the quarter ended September 30, 2020.
    • General and administrative (G&A) expenses: G&A expenses were $8.1 million for the quarter ended September 30, 2021, compared to $3.8 million for the quarter ended September 30, 2020.
    • Net loss: Net loss was $35.6 million or $0.93 per share for the quarter ended September 30, 2021, compared to $15.6 million or $0.77 per share for the quarter ended September 30, 2020.

    About Annexon

    Annexon (NASDAQ:ANNX) is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company's pipeline is based on its platform technology addressing 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 advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. 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: continuing advancement of the company's innovative portfolio; timing of data from clinical trials; timing of completion of clinical studies and clinical development milestones; the company's ability to deliver on its objectives and the potential for a transformational year ahead; 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; cash position sufficient to fund its operating plans into 2024; the benefits of Orphan Drug designation; and leadership team service. 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.

    Contact:

    Chelcie Lister

    THRUST Strategic Communications

    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,
     
      2021  2020  2021  2020 
    Operating expenses:                
    Research and development (1) $27,581  $11,775  $72,849  $31,279 
    General and administrative (1)  8,099   3,810   20,406   8,999 
    Total operating expenses  35,680   15,585   93,255   40,278 
    Loss from operations  (35,680)  (15,585)  (93,255)  (40,278)
    Other income (expense), net  82   (52)  303   64 
    Net loss before taxes  (35,598)  (15,637)  (92,952)  (40,214)
    Provision for income taxes     1      5 
    Net loss  (35,598)  (15,638)  (92,952)  (40,219)
    Accretion on redeemable convertible preferred stock     (145)     (705)
    Deemed dividend – beneficial conversion feature on redeemable

    convertible preferred stock
         (6,219)     (6,219)
    Net loss attributable to common stockholders $(35,598) $(22,002) $(92,952) $(47,143)
    Net loss per share attributable to common stockholders,

    basic and diluted
     $(0.93) $(0.77) $(2.43) $(4.79)
    Weighted-average shares used in computing net loss per

    share attributable to common stockholders, basic and diluted
      38,341,110   28,465,156   38,261,359   9,845,754 
                     
                     
    (1) Includes the following stock-based compensation expense:                
    Research and development $2,382  $624  $6,330  $1,284 
    General and administrative $2,046  $847  $5,577  $1,613 
                     

    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

      September 30,

    2021
      December 31,

    2020
     
      (Unaudited)     
    Assets        
    Current assets:        
    Cash and cash equivalents $68,519  $268,565 
    Short-term investments  202,848   82,641 
    Prepaid expenses and other current assets  4,131   2,805 
    Total current assets  275,498   354,011 
    Restricted cash  1,166    
    Property and equipment, net  12,219   1,935 
    Operating lease right-of-use assets  20,680    
    Other assets  593    
    Total assets $310,156  $355,946 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $4,797  $3,734 
    Accrued liabilities  7,059   6,497 
    Deferred rent, current     391 
    Operating lease liabilities, current  63    
    Total current liabilities  11,919   10,622 
    Deferred rent     1,046 
    Operating lease liabilities, non-current  33,760    
    Total liabilities  45,679   11,668 
    Commitments and contingencies        
    Stockholders' equity:        
    Common stock  38   38 
    Additional paid-in capital  523,458   510,309 
    Accumulated other comprehensive loss  (75)  (77)
    Accumulated deficit  (258,944)  (165,992)
    Total stockholders' equity  264,477   344,278 
    Total liabilities and stockholders' equity $310,156  $355,946 



    Primary Logo

    View Full Article Hide Full Article
  2. – Dr. Ted Yednock's appointment enhances Annexon's commitment to scientific innovation and pursuit of future programs –

    – Dr. Larry Mattheakis brings decades of drug discovery and development expertise to support advancement of Annexon's current and future pipeline –

    SOUTH SAN FRANCISCO, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage company developing a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the appointment of Ted Yednock, Ph.D., as chief innovation officer (CIO), and the appointment of Larry Mattheakis, Ph.D., as chief scientific officer (CSO).

    "This is an exciting time at Annexon…

    – Dr. Ted Yednock's appointment enhances Annexon's commitment to scientific innovation and pursuit of future programs –

    – Dr. Larry Mattheakis brings decades of drug discovery and development expertise to support advancement of Annexon's current and future pipeline –

    SOUTH SAN FRANCISCO, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage company developing a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the appointment of Ted Yednock, Ph.D., as chief innovation officer (CIO), and the appointment of Larry Mattheakis, Ph.D., as chief scientific officer (CSO).

    "This is an exciting time at Annexon, with three clinical-stage drug candidates advancing in seven clinical trials across our portfolio. Ted and Larry's deep and complimentary expertise is invaluable at this stage of our company's growth and will further our pursuit to bring anti-C1q therapies to millions of people suffering from complement-mediated diseases," said Doug Love, Esq., president and chief executive officer of Annexon. "In his new role as CIO, Ted brings his deep knowledge and passion for the therapeutic potential of C1q and the classical complement pathway to further expand the unique promise of our novel platform. As our new CSO, Larry brings a proven track record in drug development and driving innovative solutions from early discovery to product approvals that can lift our current and future portfolio to new heights. We are thrilled by the opportunities that this strategic expansion of our team brings to the progression of our autoimmune, neurodegenerative and ophthalmic therapeutic areas."

    Dr. Yednock has served as Annexon's CSO since 2013. Under his leadership, Annexon has continued to progress and add to the scientific body of knowledge of C1q and its ability to block all downstream components of the classical complement pathway that lead to excess inflammation, tissue damage and patient disability in many complement-mediated diseases. As CIO, he will remain a member of the executive committee, serve as chairman of the Scientific Advisory Board and continue to strengthen and integrate Annexon's key scientific findings and collaborations.

    "Our understanding of the role of the complement pathway in different disease processes is exploding," said Dr. Yednock. "In just the past few months, significant findings have been published regarding the classical complement cascade in the areas of traumatic brain injury, progressive multiple sclerosis and schizophrenia. As CIO, I am excited to focus on our science, working with Larry and the Annexon scientific and clinical teams, to increase the depth and impact of our programs."

    Dr. Mattheakis was previously the senior vice president of discovery biology and translational research at Protagonist Therapeutics, where he led teams from discovery to Phase 1 or Phase 2 clinical development for six different investigational new drug (IND) candidates in autoimmune and hematological conditions and developed the key biomarkers showing clinical target engagement and pharmacodynamics. Prior to Protagonist, Dr. Mattheakis was at Exelixis leading preclinical development for XL499 – a small molecule inhibitor of PI3K delta for treating autoimmune and oncology diseases that was licensed to Merck. Prior to Exelixis, he held positions of increasing responsibility at Cytokinetics and the Affymax Research Institute, where he pioneered the development of novel assay technologies including ribosome display to identify agonists of the thrombopoietin receptor. Dr. Mattheakis received a Ph.D. in biochemistry from the University of Wisconsin-Madison and trained as a post-doctoral research fellow in the Department of Microbiology and Molecular Genetics at Harvard Medical School.

    "I am delighted to join the leadership team and to expand on the work that Annexon has pioneered in the complement space," said Dr. Mattheakis. "I look forward to helping the company continue to move the science forward in order to deliver new therapies that benefit patients with devastating complement-mediated autoimmune, neurodegenerative and ophthalmic diseases."

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing 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 advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration) and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. For more information, visit https://annexonbio.com/.

    Contact:

    Jennifer Lew

    Chief Financial Officer, Annexon Biosciences

    Chelcie Lister



    Primary Logo

    View Full Article Hide Full Article
  3. CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye, today announced that Douglas Love, Esq., President & Chief Executive Officer, will participate in a fireside chat during the 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30, 2021 at 12:40 p.m. 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…

    CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye, today announced that Douglas Love, Esq., President & Chief Executive Officer, will participate in a fireside chat during the 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30, 2021 at 12:40 p.m. 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

    Annexon (NASDAQ:ANNX) is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing 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 advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.

    Contacts:

    Investors:

    Jennifer Lew

    Chief Financial Officer, Annexon Biosciences

    Media:

    Miriam Mason

    Annexon Biosciences



    Primary Logo

    View Full Article Hide Full Article
  4. CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye, today announced that the company will host its second virtual C1q Series event on Monday, September 27, 2021, at 10:00 a.m. ET, to discuss its neurodegeneration franchise. Annexon's R&D event will include presentations from the executive team as well as prominent key opinion leaders.

    A live webcast and slide presentation will be available in the "Events and Presentations" page of the "Investors" section of annexonbio.com. To register…

    CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye, today announced that the company will host its second virtual C1q Series event on Monday, September 27, 2021, at 10:00 a.m. ET, to discuss its neurodegeneration franchise. Annexon's R&D event will include presentations from the executive team as well as prominent key opinion leaders.

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

    About Annexon

    Annexon (NASDAQ:ANNX) is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing 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 advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.

    Contacts:

    Investors:

    Jennifer Lew

    Chief Financial Officer, Annexon Biosciences

    Media:

    Miriam Mason

    Annexon Biosciences



    Primary Logo

    View Full Article Hide Full Article
  5. – Recently expanded Autoimmune franchise with advancement of third clinical candidate, ANX009, and strategically expanded into additional autoantibody-driven diseases –

    – Continued progress in Neurodegeneration franchise with initial Phase 2 data results from ANX005 in Huntington's disease expected in Q4 2021 and initiation of Phase 2 ANX005 trial in Amyotrophic Lateral Sclerosis –

    – Appointed William D. Waddill to the Board of Directors –

    SOUTH SAN FRANCISCO, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), Annexon, a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the…

    – Recently expanded Autoimmune franchise with advancement of third clinical candidate, ANX009, and strategically expanded into additional autoantibody-driven diseases –

    – Continued progress in Neurodegeneration franchise with initial Phase 2 data results from ANX005 in Huntington's disease expected in Q4 2021 and initiation of Phase 2 ANX005 trial in Amyotrophic Lateral Sclerosis –

    – Appointed William D. Waddill to the Board of Directors –

    SOUTH SAN FRANCISCO, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Annexon, Inc. ("Annexon") (NASDAQ:ANNX), Annexon, a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced second quarter 2021 financial results and provided a mid-year business update.

    "We continue to make strong and consistent progress on our mission to deliver transformative therapies for patients suffering from classical complement-driven autoimmune and neurodegenerative diseases. With three clinical-stage drug candidates advancing in seven clinical trials, we remain laser-focused on developing game-changing therapies for patients in need while generating significant value for our shareholders," said Douglas Love, Esq., president and chief executive officer of Annexon. "We also continue to expand our corporate capabilities and are pleased to announce the appointment of Will Waddill to our Board of Directors. Will has extensive experience in biotech and finance, and will provide an invaluable perspective as we enter our next phase of growth and value creation."

    Therapeutic Franchise Highlights and Updates

    Annexon is advancing a portfolio of innovative C1 inhibitors to stop classical complement-mediated diseases at the start of the pathway in three therapeutic franchise areas: Autoimmune, Neurodegeneration and Ophthalmology.

    Autoimmune Franchise

    Annexon is pursuing a range of carefully selected neuromuscular, hematologic and nephritic antibody-mediated autoimmune indications where excess classical complement activity is a key driver of disease. During its July 28th C1q R&D series presentation, Annexon showcased the rationale and potential of its anti-C1 approach in autoimmune disease.

    Recent highlights and updates in the Autoimmune franchise include:

    • Progressed enrollment in the Phase 2/3 trial of ANX005 in Guillain-Barré Syndrome (GBS), which remains on track for completion in 2023. Data from the completed drug-drug interaction study and Phase 1b trial were recently presented at the 2021 Peripheral Nerve Society Annual Meeting, demonstrating tolerability and full C1q target engagement of ANX005 in combination with IVIg and reduction of cerebrospinal fluid (CSF) complement activity following ANX005 treatment in GBS patients.
    • Advanced precision medicine approach to treat patients with a complement signature in the Phase 2 trial of ANX005 in warm autoimmune hemolytic anemia (wAIHA). In the ongoing Phase 0 (patient selection) component of the trial, several wAIHA patients have demonstrated a classical complement signature, making them potentially eligible for enrollment into the Phase 2 component of the trial. ANX005 was shown to fully inhibit complement activation of wAIHA antibodies in these patient sera. Data from the Phase 0 portion of the Phase 2 trial is expected to be submitted to a peer-reviewed forum in 2021.
    • Strategic expansion of ANX005 into a Phase 2 program in Multifocal Motor Neuropathy (MMN), a neuromuscular disorder mechanistically related to GBS. Initiation of the Phase 2 study is anticipated in early 2022.
    • Reported Phase 1 first-in-human (FIH) data for ANX009 subcutaneous product candidate, Annexon's third clinical stage drug candidate, which is being developed for the treatment of antibody-mediated autoimmune diseases of blood and vascular tissues. ANX009 was shown to be well tolerated with complete and sustained C1q inhibition, supporting twice weekly subcutaneous administration. Data from the FIH study is expected to be submitted to a peer-reviewed forum in 2021.
    • Advanced ANX009 into a Phase 1b study in Lupus Nephritis (LN), a nephritic disease characterized by autoantibody-driven activation of C1q and the classical complement pathway. Endogenous pathogenic anti-C1q antibodies (PACAs) have been shown to correlate with classical complement activation and disease activity. Initiation of the Phase 1b study is anticipated in early 2022 and will deploy Annexon's precision medicine approach targeting patients with excess classical complement and PACA activity. Complement and PACA data in LN patient samples is expected to be submitted to a peer-reviewed forum in 2021.

    Neurodegeneration Franchise

    Annexon is pioneering an approach to stop complement-mediated neurodegeneration at the start, leveraging its original discoveries of the role of C1q as a major driver of synaptic loss and neurodegeneration. Blocking C1q potentially protects against functioning synapse loss and may provide functional benefit. Annexon is utilizing biomarkers of neuronal damage to measure impact on disease.

    Recent highlights and updates in the Neurodegeneration franchise include:

    • Completed enrollment in Phase 2 trial of ANX005 in Huntington's Disease (HD) and expects to report initial data in Q4 2021.
    • Initiated patient dosing in Phase 2 trial of ANX005 in Amyotrophic Lateral Sclerosis (ALS) and now expects to report data in 2022 due to slower initial enrollment.
    • Completed preclinical study of ANX005 in SOD1 model of ALS, which demonstrated preserved neuromuscular function and reduced neuronal damage as measured by Neurofilament Light Chain (NfL). Data from the SOD1 preclinical study represent the third instance of NfL reduction by ANX005, following the Phase 1b trial in GBS patients and R6/2 preclinical model of HD. Results from the ALS preclinical study are expected to be submitted to a peer-reviewed forum in 2021.

    Ophthalmology Franchise

    Annexon is utilizing intravitreal administration of ANX007 to inhibit C1q, which is implicated in neurodegeneration in the retina. Selectively targeting C1q at the start of the classical pathway versus downstream approaches may enhance efficacy and safety for patients in ophthalmic disorders, including Geographic Atrophy (GA).

    Recent highlights and updates in the Ophthalmology franchise include:

    • Progressed enrollment in the Phase 2 trial of ANX007 in GA, which remains on track for completion in 2023.
    • ANX007 data demonstrating full target engagement of C1q in the outer layers of the retina in preclinical models is expected to be submitted to a peer-reviewed forum in 2021.

    Corporate Update        

    • In August 2021, Annexon appointed Will Waddill to its Board of Directors. Mr. Waddill brings decades of financial and operational expertise in the biotechnology industry and a distinguished track record of leadership in industry organizations, including the Association of Bioscience Financial Officers (ABFO) and the Biotechnology Industry Organization (BIO). Mr. Waddill currently serves on the boards of Protagonist Therapeutics and Arrowhead Pharmaceuticals. Most recently, he served as Senior Vice President, CFO, of Calithera Bioscience from 2014 to 2016 and previously held senior finance leadership roles at OncoMed Pharmaceuticals and Ilypsa.

    Second Quarter 2021 Financial Results

    • Cash and cash equivalents and short-term investments: Cash and cash equivalents and short-term investments were $302.4 million as of June 30, 2021.

    • Research and development (R&D) expenses: R&D expenses were $24.6 million for the quarter ended June 30, 2021, and $45.3 million for the six months ended June 30, 2021, compared to $9.3 million for the quarter ended June 30, 2020, and $19.5 million for the six months ended June 30, 2020.

    • General and administrative (G&A) expenses: G&A expenses were $6.8 million for the quarter ended June 30, 2021, and $12.3 million for the six months ended June 30, 2021, compared to $3.0 million for the quarter ended June 30, 2020, and $5.2 million for the six months ended June 30, 2020.

    • Net loss: Net loss was $31.3 million for the quarter ended June 30, 2021, and $57.4 million for the six months ended June 30, 2021, compared to $12.2 million for the quarter ended June 31, 2020, and $24.6 million for the six months ended June 30, 2020. Net loss attributable to common stockholders was $31.3 million or $0.82 per share for the quarter ended June 30, 2021, and $57.4 million or $1.50 per share for the six months ended June 30, 2021, compared to $12.5 million or $28.87 per share for the quarter ended June 30, 2020, and $25.1 million or $57.96 per share for the six months ended June 30, 2020.

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing 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 advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. 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: continuing advancement of the company's innovative portfolio; timing of data from clinical trials and peer-reviewed forum 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)

    (unaudited)
     
      
      Three Months Ended

    June 30,
      Six Months Ended

    June 30,
     
      2021 2020  2021 2020 
    Operating expenses:                
    Research and development (1) $24,572  $9,287  $45,268  $19,504 
    General and administrative (1)  6,801   2,950   12,307   5,189 
    Total operating expenses  31,373   12,237   57,575   24,693 
    Loss from operations  (31,373)  (12,237)  (57,575)  (24,693)
    Other income, net  79   1   221   116 
    Net loss before taxes  (31,294)  (12,236)  (57,354)  (24,577)
    Provision for income taxes     4      4 
    Net loss  (31,294)  (12,240)  (57,354)  (24,581)
    Accretion on redeemable convertible preferred stock     281      560 
    Net loss attributable to common stockholders $(31,294) $(12,521) $(57,354) $(25,141)
    Net loss per share attributable to common stockholders,

      basic and diluted
     $(0.82) $(28.87) $(1.50) $(57.96)
    Weighted-average shares used in computing net loss per

      share attributable to common stockholders, basic and diluted
      38,277,950   433,749   38,219,143   433,749 
                     
                     
    (1) Includes the following stock-based compensation expense:                
    Research and development $2,402  $335  $3,948  $660 
    General and administrative  2,115   428   3,531   766 



     
    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)
     
      June 30,

    2021
      December 31,

    2020
     
      (Unaudited)     
    Assets        
    Current assets:        
    Cash and cash equivalents $99,588  $268,565 
    Short-term investments  202,798   82,641 
    Prepaid expenses and other current assets  2,007   2,805 
    Total current assets  304,393   354,011 
    Restricted cash  1,166    
    Property and equipment, less accumulated depreciation of $3,047 and $1,971

      as of June 30, 2021 and December 31, 2020, respectively
      5,129   1,935 
    Operating lease right-of-use assets  21,096    
    Total assets $331,784  $355,946 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $4,184  $3,734 
    Accrued liabilities  5,850   6,497 
    Deferred rent, current     391 
    Operating lease liabilities, current  250    
    Total current liabilities  10,284   10,622 
    Deferred rent     1,046 
    Operating lease liabilities, non-current  26,165    
    Total liabilities  36,449   11,668 
    Commitments and contingencies        
    Stockholders' equity:        
    Common stock  38   38 
    Additional paid-in capital  518,708   510,309 
    Accumulated other comprehensive loss  (65)  (77)
    Accumulated deficit  (223,346)  (165,992)
    Total stockholders' equity  295,335   344,278 
    Total liabilities and stockholders' equity $331,784  $355,946 





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

    Primary Logo

    View Full Article Hide Full Article
View All Annexon Inc. News