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Mar 31, 2024
Annexon Q1 2024 Earnings Report
Annexon reported financial results for the first quarter of 2024 and highlighted key anticipated milestones.
Key Takeaways
Annexon reported a net loss of $25.2 million for the first quarter of 2024. The company's cash, cash equivalents, and short-term investments totaled $264.9 million as of March 31, 2024, expected to fund operations into mid-2026. The company is advancing its clinical programs, including ANX005 in GBS, ANX007 in GA, and ANX1502 for autoimmune conditions.
Pivotal Phase 3 data for ANX005 in Guillain-Barré Syndrome (GBS) is expected in the second quarter of 2024.
New Phase 2 data showed neuroprotection of vision and vision-associated structures by ANX007 in Geographic Atrophy (GA); Initiation of Pivotal Phase 3 ANX007 ARCHER II Trial in GA is expected in mid-2024.
Clinical Proof of Concept (POC) data for ANX1502, an oral classical pathway inhibitor for chronic autoimmune conditions, is on track for the second half of 2024.
The company reported cash, cash equivalents, and short-term investments of approximately $264.9 million as of March 31, 2024, which is anticipated to provide runway into mid-2026.
Forward Guidance
Annexon anticipates topline data from the pivotal Phase 3 trial of ANX005 in GBS in the second quarter of 2024, initiation of the global pivotal Phase 3 ARCHER II trial for ANX007 in GA in mid-2024, and initial data from the POC trial for ANX1502 in CAD in the second half of 2024.
Positive Outlook
- Topline data from the pivotal Phase 3 trial of ANX005 in GBS expected in the second quarter of 2024.
- Initial data from RWE comparability protocol with IGOS expected in the first half of 2025 to support a planned BLA submission for ANX005.
- Global pivotal Phase 3 ARCHER II trial vs. sham control for ANX007 in GA expected to initiate in mid-2024.
- Pivotal Phase 3 head-to-head ARROW trial vs. SYFOVRE® (pegcetacoplan injection) planned to initiate in the second half of 2024.
- POC trial evaluating the pharmacodynamics and efficacy of an oral tablet formulation of ANX1502 in CAD anticipated to provide initial data in the second half of 2024.
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