Annexon Highlights Recent Achievements and Outlines Expected Key Milestones in 2021 for Its Broad Portfolio of Complement Therapeutics

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 39^th 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 39^th Annual Healthcare Conference in a virtual session on January 12^th 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