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Mar 31, 2023
Annexon Q1 2023 Earnings Report
Reported first quarter 2023 financial results and highlighted recent progress across its portfolio of complement therapies.
Key Takeaways
Annexon reported a net loss of $38.7 million, or $0.52 per share, for the first quarter of 2023. The company's cash and cash equivalents were $228.2 million as of March 31, 2023, which is expected to fund operations into 2025.
Enrollment expected to be completed in Phase 3 Trial in Guillain-Barré Syndrome During 2H’23, with Initial Topline Results Expected in 1H’24
Initial Clinical Data Expected from the Phase 2 ARCHER Trial of ANX007 in Geographic Atrophy in Mid-2023
Initial Clinical Data Anticipated from the Phase 1b Trial of ANX009 in Lupus Nephritis in 1H’23
Strong Financial Position with Operating Runway into 2025, with Multiple Mid-Stage and Pivotal Clinical Trial Readouts Expected Across 2023 and 2024
Annexon
Annexon
Forward Guidance
Annexon anticipates multiple clinical milestones over the next 18 months, which have the potential to accelerate the company's transition into a leading late-stage biopharmaceutical company focused on the treatment of complement-mediated diseases.
Positive Outlook
- Initial clinical data from ANX007 ARCHER Phase 2 trial in GA expected to be reported mid-2023, followed by additional data after the conclusion of the six-month off-treatment period by the end of 2023.
- Data expected to be reported in the second half of 2023 for ANX1502.
- Enrollment in the Phase 3 pivotal trial of ANX005 in patients with GBS is progressing and expected to be completed in second half of 2023, with initial topline clinical results anticipated during the first half of 2024.
- Initial clinical data from Phase 1b signal-finding trial of ANX009 for LN expected during the first half of 2023.
- Additional data for ANX005 in ALS expected in the second half of 2023.
Challenges Ahead
- 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 effects of COVID-19 or other public health crises on the company’s clinical programs and business operations
- The company’s ability to obtain regulatory approval of and successfully commercialize its product candidates
- Any undesirable side effects or other properties of the company’s product candidates