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Dec 31, 2023
Annexon Q4 2023 Earnings Report
Annexon's portfolio progressed and reported fourth quarter and full year 2023 financial results.
Key Takeaways
Annexon reported a net loss of $27.9 million for the quarter ended December 31, 2023. The company's cash, cash equivalents, and short-term investments totaled approximately $260 million as of December 31, 2023, providing an anticipated runway into mid-2026. Key milestones include the expected pivotal Phase 3 data for ANX005 in Guillain-Barré Syndrome (GBS) in the second quarter of 2024 and the planned initiation of the pivotal Phase 3 ANX007 ARCHER II trial in Geographic Atrophy (GA) in mid-2024.
Completed enrollment of Phase 3 clinical trial for ANX005 in GBS and expect topline data in Q2 2024.
Initiation of pivotal Phase 3 ANX007 ARCHER II trial in GA expected in mid-2024.
Clinical proof-of-concept data with ANX1502 oral inhibitor of the classical pathway expected in the second half of 2024.
Cash, cash equivalents, and short-term investments of approximately $260 million as of December 31, 2023, and anticipated runway into mid-2026.
Annexon
Annexon
Forward Guidance
Annexon anticipates several milestones in 2024, including topline data from the pivotal Phase 3 trial of ANX005 in GBS, the initiation of Phase 3 trials for ANX007 in GA, and proof-of-concept data for ANX1502 in CAD.
Positive Outlook
- ANX005 in GBS: Topline data from pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024.
- ANX005 in GBS: Initial data from RWE comparability protocol with IGOS expected in first half 2025 to support a planned BLA submission.
- ANX007 in GA: Global pivotal Phase 3 ARCHER II trial vs. sham control expected to initiate in mid-2024.
- ANX007 in GA: Pivotal Phase 3 head-to-head ARROW trial vs. SYFOVRE® (pegcetacoplan injection) planned to initiate in the second half of 2024.
- ANX1502 in CAD: Proof-of-concept (POC) trial evaluating the pharmacodynamics and efficacy of an oral tablet formulation in CAD anticipated to provide initial data in the second half of 2024, with plans for program expansion in autoimmune indications upon completion of clinical POC.
Challenges Ahead
- Risks 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 company’s ability to obtain regulatory approval of and successfully commercialize its product candidates.