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Sep 30, 2023
Annexon Q3 2023 Earnings Report
Annexon reported third quarter 2023 financial results and highlighted portfolio progress.
Key Takeaways
Annexon reported a net loss of $32.5 million for the third quarter of 2023. The company's cash, cash equivalents, and short-term investments totaled $165.3 million as of September 30, 2023, which is expected to fund operations into the second quarter of 2025. The company is prioritizing ANX005 for GBS, ANX007 for GA and ANX1502.
ANX005 Phase 3 pivotal data in GBS is on track for the first half of 2024.
ANX007 was awarded first-ever PRIME designation for the treatment of GA, with global regulatory interactions ongoing to advance the Phase 3 program.
ANX1502 Phase 1 data is on track for Q4 2023.
Focused operations and resources support cash runway into Q2 2025.
Forward Guidance
Annexon anticipates initial topline results from the Phase 3 pivotal trial of ANX005 in patients with GBS during the first half of 2024. Interactions with U.S. and EU regulatory authorities on a global Phase 3 pivotal program for ANX007 are ongoing, with plans to provide an update by year-end 2023. Results from the single and multiple-ascending dose Phase 1 trial in healthy volunteers are expected to be reported by year-end 2023.
Positive Outlook
- ANX005 in GBS: Initial topline results from the Phase 3 pivotal trial of ANX005 in patients with GBS are anticipated during the first half of 2024.
- ANX007 in GA: Interactions with U.S. and EU regulatory authorities on a global Phase 3 pivotal program for ANX007 are ongoing, with plans to provide an update by year-end 2023.
- ANX1502 in autoimmune diseases: Results from the single and multiple-ascending dose Phase 1 trial in healthy volunteers are expected to be reported by year-end 2023.
- ANX005 in ALS: Full on-treatment data from the Phase 2a trial are expected by early 2024.
- Cash and operating runway to be sufficient to fund the company’s planned operating expenses into the second quarter of 2025.
Challenges Ahead
- Annexon will not conduct an R&D Day in 2023, and instead plans to host an event focused on the burden of disease, current treatment paradigm and market opportunity for GBS in the first half of 2024.
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