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Next Milestone: Phase 3 ARCHER II trial enrollment to be completed in second half of 2025; data expected in
second half of 2026 |
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ANX1502 for Autoimmune Conditions:
First-in-kind oral C1s inhibitor with convenient and flexible dosing |
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Completed bridging study in healthy volunteers from a liquid suspension formulation to a twice-daily tablet with
safety and pharmacokinetic profile similar or better than previous studies |
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Ongoing open label single arm study in cold agglutinin disease (CAD) evaluating enteric-coated tablet formulation
with improved tolerability will inform next steps for later-stage clinical development |
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Next Milestone: Clinical proof of concept data in CAD and update on future target indications in first quarter
of 2025 |
About Annexon
Annexon
Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neurodegeneration as first-in-kind treatments for millions of people living
with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and
loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and
includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. 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,” “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: the potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing of BLA submission for ANX005; potential benefit of ANX005, if approved, compared to IVIg/plasma exchange or other existing
therapies; the company’s ability to achieve regulatory approval for ANX005; the potential therapeutic benefit of ANX007; timing of the ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to
provide protection from vision loss; timing of proof-of-concept data for ANX1502; the company’s ability to commercialize its product candidates, if approved;
continued development of ANX007 and ANX1502; 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.