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Annexon, Inc. (ANNX)

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Previous Close29.11
Open30.02
Bid30.74 x 1000
Ask31.45 x 800
Day's Range28.59 - 32.20
52 Week Range15.33 - 38.01
Volume54,796
Avg. Volume144,426
Market Cap1.229B
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
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1y Target Est35.33
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    • Annexon Advances Classical Complement Platform with Initiation of Global Phase 2 ARCHER Trial in Patients with Geographic Atrophy
      GlobeNewswire

      Annexon Advances Classical Complement Platform with Initiation of Global Phase 2 ARCHER Trial in Patients with Geographic Atrophy

      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. CONTACT: 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

    • Annexon Welcomes William H. Carson, M.D. to the Board of Directors
      GlobeNewswire

      Annexon Welcomes William H. Carson, M.D. to the Board of Directors

      Thomas G. Wiggans appointed ChairmanSOUTH 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 StatementsThis 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. CONTACT: 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

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

      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 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 roles2021 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 StatementsThis 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. CONTACT: 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