1. 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

    jlew@annexonbio.com

    Media:

    Miriam Mason

    Annexon Biosciences

    mmason@annexonbio.com



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  2. – 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
    jlew@annexonbio.com
    
    Sara Michelmore
    MacDougall Advisors
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com

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

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

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

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

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

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

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

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

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

    Annexon's Approach to Autoimmune Disease

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

    Advancing ANX009 into Phase 1b Study in Lupus Nephritis

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

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

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

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

    Advancing ANX005 into Phase 2 Program in Multifocal Motor Neuropathy

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

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

    Annexon C1q Series: Autoimmune Portfolio Expansion

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

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

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a class of next-generation complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline of differentiated product candidates addresses a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is currently conducting clinical trials in multiple serious autoimmune, neurodegenerative and ophthalmic diseases, including Guillain-Barré Syndrome, warm autoimmune hemolytic anemia, Huntington's Disease, amyotrophic lateral sclerosis and geographic atrophy. Annexon is deploying a disciplined, biomarker-driven development strategy designed to improve the probability of technical success of its portfolio. For more information, visit www.annexonbio.com.

    About Lupus Nephritis

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

    About Multifocal Motor Neuropathy

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

    References:

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

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

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

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

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

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

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

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "on track," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: broadening of the company's autoimmune franchise through advancement and initial indication selection of its third clinical-stage product candidate ANX009 into Lupus Nephritis and expansion of the ANX005 clinical program into MMN; broad potential of the company's complement approach to deliver multiple, differentiated, first-in-class therapies for patients suffering across a spectrum of autoantibody-driven diseases; extended reach of the company's growing portfolio of C1q inhibitors into new and expanded autoimmune indications; timing of and patient selection for the company's clinical trials; the company's precision medicine approach and potential delivery of transformative therapies to patients; ANX005 as a potential treatment for GBS; the company's ability to deliver on its objectives; and the implementation of the company's business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of COVID-19 or other public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.



    Investor Contacts: 
    Jennifer Lew
    Chief Financial Officer, Annexon Biosciences 
    jlew@annexonbio.com
    
    Sara Michelmore 
    smichelmore@macbiocom.com
    
    Media Contact: 
    Miriam Mason 
    Senior Vice President, Annexon Biosciences 
    mmason@annexonbio.com

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  4. SOUTH SAN FRANCISCO, Calif., June 16, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, announced that Douglas Love, Esq., President & Chief Executive Officer, will present at the virtual Raymond James Human Health Innovation Conference on June 23rd, 2021 at 1:20 pm EDT.

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

    About Annexon,

    SOUTH SAN FRANCISCO, Calif., June 16, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. ("Annexon") (NASDAQ:ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, announced that Douglas Love, Esq., President & Chief Executive Officer, will present at the virtual Raymond James Human Health Innovation Conference on June 23rd, 2021 at 1:20 pm EDT.

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

    About Annexon, Inc.

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



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer, Annexon Biosciences, jlew@annexonbio.com
    Sara Michelmore smichelmore@macbiocom.com
    
    Media Contact:
    Miriam Mason, Annexon Biosciences, mmason@annexonbio.com

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

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

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

    Current cash position sufficient to fund operations through 2023

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

    Recent Business Highlights

    Annexon is advancing a…

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

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

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

    Current cash position sufficient to fund operations through 2023

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

    Recent Business Highlights

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

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

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

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

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

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

    First Quarter 2021 Financial Results

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

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

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

    About Annexon, Inc.

    Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a rigorous, biomarker-driven development strategy designed to improve the probability of technical success over shorter development timelines. For more information, visit www.annexonbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "on track," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: sufficiency of the company's cash to fund operations; continuing advancement of the company's innovative portfolio; timing of data from clinical trials and regulatory submissions; timing of completion of clinical studies and clinical development milestones; the company's ability to deliver on its objectives; and the implementation of the company's business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of COVID-19 or other public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. 



    ANNEXON, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

      Three Months Ended

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

    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

      March 31,

    2021
      December 31,

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

     



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com

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

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

    About

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

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

    About Annexon, Inc.

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



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contact:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com

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

    Recent Business Highlights

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

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

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

    Recent Business Highlights

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

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



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

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

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

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



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

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

    Fourth Quarter and Full-Year 2020 Financial Results

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



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



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



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

    About Annexon, Inc.

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

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: advancement of the company's clinical and preclinical programs; timing of data from clinical trials and submission of data to peer-reviewed forums; confidence in the company's product candidates; the company's ability to drive value in 2021 and beyond; and the implementation of the company's business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of COVID-19 or other public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC.  Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.



    ANNEXON, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

      Three Months Ended

    December 31,
      Year Ended

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



    ANNEXON, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

      December 31,

    2020
      December 31,

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

     



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

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

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

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

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

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

    About the Phase 2 ARCHER Clinical Trial and ANX007

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

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

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

    About Annexon, Inc.



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

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: advancement of the company's clinical and preclinical programs; timing of data from clinical trials; and the implementation of the company's business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications which the company may pursue. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of COVID-19 or other public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the company's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.



    Investor Contacts:
    Jennifer Lew, Chief Financial Officer
    Annexon Biosciences
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

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  9. 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
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    SVP, Corporate Communications
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

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  10. 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
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

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  11. 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
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

    Primary Logo

    View Full Article Hide Full Article
  12. 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
    jlew@annexonbio.com
    
    Sara Michelmore
    smichelmore@macbiocom.com
    
    Media Contacts:
    Miriam Mason
    Annexon Biosciences
    mmason@annexonbio.com
    
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

    Primary Logo

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  13. – 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
    swheeler@wheelhouselsa.com
    
    Alexandra Santos
    asantos@wheelhouselsa.com
    
    Media Contact:
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com

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  14. – 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
    swheeler@wheelhouselsa.com
    
    Alexandra Santos
    asantos@wheelhouselsa.com
    
    Media Contact:
    Caroline Rufo, Ph.D.
    crufo@macbiocom.com
    

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  15. – 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
    swheeler@wheelhouselsa.com
    
    Alexandra Santos
    asantos@wheelhouselsa.com
    
    Media Contact:
    Caroline Rufo
    crufo@macbiocom.com

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  16. 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

    swheeler@wheelhouselsa.com

    Alexandra Santos

    asantos@wheelhouselsa.com

    Media Contact:

    Sara Michelmore

    smichelmore@macbiocom.com 

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  17. 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 prospectus-eq_fi@jpmorgan.com 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 dg.prospectus_requests@bofa.com; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by email at PostSaleManualRequests@broadridge.com 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

    swheeler@wheelhouselsa.com

    Alexandra Santos

    asantos@wheelhouselsa.com

    Media Contact:

    Sara Michelmore

    smichelmore@macbiocom.com

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