Annexon Releases Q2 2024 Portfolio and Financial Results, Key Milestones

Annexon, Inc., a biopharmaceutical company, reported significant strides in its portfolio and financial performance for the second quarter of 2024, focusing on therapies for neuroinflammatory diseases. The company is advancing several key clinical programs, including treatments for Guillain-Barré syndrome (GBS) and geographic atrophy (GA), as well as developing a novel oral inhibitor for autoimmune conditions.

ANX005, a monoclonal antibody targeting the classical complement pathway, has shown promising results in treating GBS. In a pivotal Phase 3 trial, a single infusion of ANX005 significantly improved recovery times compared to a placebo. Patients experienced expedited recovery, with many walking and off ventilation nearly a month sooner. The treatment was well-tolerated, with adverse events comparable to the placebo group. To further validate these results, Annexon has initiated a real-world evidence (RWE) comparability study involving 2,000 patients globally.

Meanwhile, ANX007, designed to block the classical complement pathway in the eye, is being tested for its efficacy in treating GA. The Phase 3 ARCHER II trial, which began patient dosing, aims to enroll around 630 participants. The trial is notable for its rigorous design, including measures to assess vision protection and retinal structure preservation, a critical aspect that current GA treatments have not adequately addressed. Early Phase 2 data presented at the American Society of Retina Specialists (ASRS) meeting highlighted its potential to significantly protect vision in both normal and low light conditions.

In the realm of autoimmune diseases, Annexon’s ANX1502, an oral C1s inhibitor, successfully completed a bridging study to a twice-daily tablet form. This formulation showed a safety and pharmacokinetic profile in line with previous studies. The ongoing proof-of-concept trial for ANX1502 in Cold Agglutinin Disease (CAD) aims to demonstrate its effectiveness and enable its application in other autoimmune conditions. The convenience of oral administration could offer a significant advantage over existing treatments that require frequent infusions.

Financially, Annexon reported a robust balance sheet, with cash, cash equivalents, and short-term investments totaling approximately $368.7 million as of June 30, 2024. This financial position is expected to support the company’s operations into the second half of 2026. Research and development expenses for the quarter were $25.0 million, down from $30.3 million in the same period in 2023. General and administrative expenses increased slightly to $8.6 million from $7.4 million. The net loss for the quarter was $29.6 million, reduced from $35.2 million in the previous year.

Annexon’s CEO, Douglas Love, emphasized the strategic importance of the recent data and the company’s commitment to advancing its clinical programs. The company anticipates releasing topline data for the ANX005 RWE study by the end of 2024, with a Biologics License Application (BLA) submission planned for the first half of 2025. For ANX007, Phase 3 data from the ARCHER II trial is expected in the second half of 2026. The proof-of-concept data for ANX1502 in CAD is anticipated by the fourth quarter of 2024.

Annexon’s clinical trials and strong financial health position it to deliver innovative therapies for patients with neuroinflammatory diseases. The company remains focused on leveraging its pioneering research to bring new treatments to market, aiming to address significant unmet medical needs and improve patient outcomes.