Full Press Release Details
Annexon Outlines 2024 Priorities with Late-Stage Clinical Milestones Across Upstream Complement Portfolio
for Autoimmune, Ophthalmic and Neurodegenerative Diseases
ANX005 Phase 3 Pivotal Data in Guillain-Barr Syndrome (GBS) On
Track for First Half of 2024; Potential to be First Approved Treatment for GBS Patients in the U.S.
ANX007 Global Pivotal Program
in Geographic Atrophy (GA) to Initiate Mid-2024;
First Pivotal Trial Using Vision
Preservation as Primary Outcome Measure in GA
Proof-of-Concept Study of ANX1502 First-in-Kind Oral Small Molecule Inhibitor of the
Classical Pathway to Initiate in First Half of 2024
Recent Successful $125 Million Financing Extends Operating Runway into Second
BRISBANE, Calif., Jan. 7, 2024 - Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new
class of complement-based medicines for people living with devastating inflammatory-related diseases, today outlined its strategic priorities for 2024 with late-stage clinical milestones, including ANX005 for Guillain-Barr syndrome (GBS),
ANX007 for geographic atrophy (GA) and its first-in-kind oral small molecule complement inhibitor, ANX1502, for a range of autoimmune indications.
Our distinct classical complement portfolio has been built over 10 years of research focused on stopping
C1q-driven inflammation activated on diseased tissue in complement-mediated diseases of the body, brain and eye. The robust and consistent functional outcome data generated by our flagship and next wave
programs has reinforced our founding thesis of stopping the classical complement disease process where it starts, said Douglas Love, president and CEO of Annexon.
This is a pivotal time for Annexon, with registration programs for our two lead candidates, numerous late- and
mid-stage clinical catalysts expected across our portfolio, and a strong balance sheet to fuel our priority programs to meaningful inflection points. We are proud of what we ve accomplished over our
decade-long history and are excited by the potential to achieve our goal of bringing transformative therapies to millions of patients with debilitating autoimmune, ophthalmic and neurodegenerative diseases.
2024 Strategic Priorities
Annexon is sharply focused on mid- to late-stage development of three value-driving programs:
ANX005 for GBS: Report Pivotal Data from
Phase 3 Trial in GBS in First Half of 2024
ANX007 for GA: Initiate Global Registration Program in GA, with Vision Preservation as the Primary Outcome Measure, in the
ANX1502 for Autoimmune Disease: Advance First-in-Kind Oral Small
Molecule Inhibitor into Proof-of-Concept Clinical Trial in Patients in the First Half of 2024
42nd Annual J.P. Morgan Healthcare Conference
Mr. Love will present an overview of Annexon and outline the company s pipeline updates at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2023, at 2:15 p.m. PT in San Francisco. 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.
Annexon Biosciences (Nasdaq: ANNX) is a
clinical-stage biopharmaceutical company utilizing a distinct scientific approach to stop C1q and all inflammatory aspects of classical complement pathway activation before it starts. As the only company solely focused on targeting C1q, Annexon is
developing a fit-for-purpose pipeline of therapeutics designed to provide meaningful benefits across multiple diseases of the body, brain and eye. With proof-of concept data in both Guillain-Barr syndrome and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring their
potential treatments to patients as quickly as possible. To learn more visit 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, suggest, 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: the timing of completion of Phase 3 trial of ANX005 in patients with GBS; the potential therapeutic benefit of ANX005; potential benefit of ANX005, if approved, compared to existing
therapies; timing of initiation of the ARCHER II and ARROW trials; ANX007 s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for robust, dose and time dependent
preservation of vision loss in the broad patient population; continued development of ANX007 and ANX1502; ability to advance ANX1502 into a tablet formulation; market size for the various product candidates; the potential benefits from treatment
with anti-C1q therapy; and continuing advancement of the company s portfolio. 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 ongoing off-treatment
follow-up portion of the ARCHER trial and final results from the ARCHER trial; 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 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.
THRUST Strategic Communications