Exhibit 99.1

Annexon Biosciences Reports Third Quarter 2020 Financial Results and Recent Business Highlights

 

– 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., November 16, 2020Annexon, 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

 


The following information was filed by Annexon, Inc. (ANNX) on Monday, November 16, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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