ANNX Shareholder/Stockholder Letter Transcript:
202 Proxy Statement
202 Annual Report
Dear Fellow Stakeholders,
Building on a Decade of Therapeutic Innovation
For a decade, Annexon has pioneered the field of complement drug discovery to
develop first-in-kind therapies designed to work upstream to stop dangerous
neuroinflammation where it starts. This year marks a promising inflection point in
our 10-year journey to validate our scientific platform and make a meaningful and
positive impact on the lives of patients. With robust clinical data in hand, we believe
our therapies are strongly positioned to set a new standard of care across
complement-mediated diseases of the body, brain and eye.
Building on the discovery of our scientific Co-Founder, the late Dr. Ben Barres, and
our rigorous assessment of every node of the classical complement pathway, we
selectively focused our drug development on blocking C1 the initiating molecule of
the classical complement cascade and key driver of harmful neuroinflammation.
Unlike other approaches, our platform is uniquely focused on the upstream
components of the cascade, so that our first-in-kind therapies can have an early
and durable impact on the diseases they treat.
Douglas Love, Esq.
President and Chief Executive Officer
Our expertise in innovating C1-targeted therapies has now been clinically validated and has the potential for broad
applicability across an array of indications. Each of our product candidates is backed by winning datasets
demonstrating a differentiated profile. Importantly, our lead programs reinforce the power of our common
underlying mechanism of action blocking upstream neuroinflammation which we believe can provide a new
treatment paradigm for millions of patients with complement-mediated autoimmune, neurodegenerative and
ophthalmic diseases.
Multiple Ways to Win across Flagship Programs with Near-term Catalysts
Leading the charge is ANX005, our most advanced program in our anticipated transition to a commercial stage
company with the potential to be the first targeted therapy for Guillain-Barr Syndrome (GBS). Poised to replace
standards of care that have been used for over 40 years, ANX005 is a near-term blockbuster opportunity with
potential to address the unmet needs of thousands around the world whose lives are suddenly turned upside down by
this devastating disease.
Across multiple studies, ANX005 has consistently demonstrated early and durable functional improvements and a
differentiated safety profile. ANX005 has a robust data package that includes a placebo-controlled Phase 1b trial, a
successful Phase 3 trial, a Real-World Evidence study against current standards of care, and a drug-drug interaction
study also with standard of care. We look forward to our planned interactions with regulatory agencies in 2025.
Late-stage asset ANX007 has the potential to be the first vision-preserving treatment for dry age-related macular
degeneration (AMD) with geographic atrophy (GA) in the U.S. and Europe. As demonstrated in the Phase 2
ARCHER trial, it is the only program we are aware of to show significant vision preservation as well as significant
preservation of central retina photoreceptor neurons responsible for visual acuity. We are enthusiastic about our
positive regulatory engagements and the groundbreaking path we re on towards global registration. Affecting more
than 8 million patients globally, dry AMD with GA is a leading cause of blindness with no approved therapies
targeting the preservation of vision in these patients. Enrollment of our Phase 3 ARCHER II trial is well underway
and expected to be completed in the second half of 2025. We expect pivotal topline data in the second half of 2026
and look forward to the opportunity to bring this game-changing therapy to patients.
Finally, ANX1502, our first-in-kind oral C1s inhibitor, is in clinical evaluation for the treatment of antibodymediated autoimmune diseases. Designed to disrupt the current treatment space, this oral approach is intended to
provide robust efficacy coupled with administration convenience in a host of diseases currently managed with
infused biologics. We expect to report our next dataset in mid-2025.
Poised for a Breakthrough Year Ahead
With significant catalysts approaching, we are energized by our strong momentum and opportunities for a
breakthrough year ahead. Our flagship programs have the potential to unlock significant value and therapeutic
benefits to help millions of patients live their best lives.
This strong progress could not have been achieved without such a resilient and passionate team. The knowledge our
team has built about the role of complement and its scientific relevance across diverse diseases is truly remarkable
and is matched only by the team s relentless execution. Their efforts are a testament to the Warrior Spirit and All
For One mentality that embodies our Core Values at Annexon. There is much to accomplish this year, and I am
confident in our ability to execute our key upcoming milestones across our winning portfolio.
On behalf of the entire Annexon family, we are deeply grateful to the collaborative medical groups and the brave
patients and caregivers who serve as our inspiration to develop new treatments. And we sincerely appreciate our
talented employees, Board of Directors, Scientific Advisory Board, and our stakeholders, for their support on this
journey.
Warm regards,
Douglas Love, Esq.
President and Chief Executive Officer
Forward-Looking Statements
This letter 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, expect, goal, intend, may, objective, plan, positioned,
potential, 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 letter are forward-looking statements. These
forward-looking statements include, but are not limited to, statements regarding the company s expectations with
regard to the potential benefits from treatment targeting the classical complement pathway and the company s
portfolio; the potential therapeutic benefits of ANX005 and ANX007, if approved, compared to existing therapies;
the timing and availability of data and reports from our clinical trials for ANX007 and ANX1502; the timing of
commencement of future clinical trials; the timing of planned interactions with regulatory agencies; paths to market
and global registration; the company s commitment and ability to develop and advance product candidates into, and
successfully complete, clinical trials; and the company s ability to fully translate its pipeline into important
medicines. 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 final results from the Phase 3 ARCHER II 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 U.S. Securities and Exchange Commission. Any forward-looking statements that the company
makes in this letter are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and
speak only as of the date of this letter. 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.
4/23/2025 Letter Continued (Full PDF)