Annexon Q1 2024 Financial Results and Key Milestones

Annexon, Inc., a biopharmaceutical company based in Brisbane, California, is advancing its clinical platform of novel therapies targeting classical complement-mediated neuroinflammatory diseases. The company recently provided updates on its portfolio and financial results for the first quarter of 2024.

Annexon's flagship programs include ANX005, designed to treat Guillain-Barré Syndrome (GBS), ANX007 for Geographic Atrophy (GA), and ANX1502, an oral inhibitor for chronic autoimmune conditions.

ANX005, a monoclonal antibody, aims to block C1q and the entire classical complement pathway both in the body and brain. The company has initiated an advanced Phase 3 clinical trial to evaluate the efficacy and safety of ANX005 in GBS patients. This multi-center, double-blind, placebo-controlled study involves 241 participants. In March 2024, Annexon hosted an R&D Day focused on GBS, highlighting the disease's unmet needs and ANX005's novel approach. A real-world evidence comparability study using data from the International Guillain-Barré Syndrome Outcomes Study (IGOS) has also commenced, with initial data expected by the first half of 2025 to support a planned Biologics License Application (BLA) submission.

For Geographic Atrophy, ANX007, a non-pegylated antigen-binding fragment, is formulated to be administered intravitreally. At the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, Annexon presented new Phase 2 data demonstrating ANX007's neuroprotective effects on vision and related structures. These findings showed that ANX007 provided broad-based protection against vision loss and statistically significant reductions in photoreceptor loss. The company intends to initiate the pivotal Phase 3 ARCHER II trial for ANX007 in mid-2024.

ANX1502 is a first-in-class oral small molecule inhibitor targeting chronic autoimmune diseases. Annexon is conducting a bridging trial to assess the comparability of tablet and liquid suspension formulations. The company aims to complete a proof-of-concept trial for ANX1502 in Cold Agglutinin Disease (CAD) by the second half of 2024, with plans to advance into multiple mid-to-late-stage clinical trials for antibody-mediated autoimmune diseases.

Financially, Annexon reported cash, cash equivalents, and short-term investments totaling approximately $264.9 million as of March 31, 2024. This robust financial position is expected to fund the company's operations into mid-2026. Research and development expenses for the quarter were $21.0 million, a decrease from $32.3 million in the same period in 2023. General and administrative expenses also dropped to $7.6 million from $8.9 million in the previous year. The net loss for the quarter was $25.2 million, or $0.21 per share, compared to a net loss of $38.7 million, or $0.52 per share, for the same quarter in 2023.

Annexon is making significant strides in its clinical programs, aiming to deliver innovative therapies for neuroinflammatory diseases. With its strong financial footing and ongoing research, the company is well-positioned to advance its mission of bringing first-in-kind treatments to patients affected by classical complement-mediated conditions.