Annexon Q2 2023 Earnings Report
Key Takeaways
Annexon reported a net loss of $35.2 million for the second quarter of 2023. The company's cash and cash equivalents were $192.9 million as of June 30, 2023, which is expected to fund operations into 2025. The company is focused on advancing its clinical-stage portfolio of medicines.
ARCHER trial results presented at ASRS further demonstrate preservation of visual function in patients with geographic atrophy.
Company to engage regulatory agencies to determine optimal path forward.
Multiple key catalysts expected in second half 2023, including completion of enrollment in the Phase 3 pivotal trial of ANX005 in GBS and Phase 1 data from ANX1502 oral small molecule.
Strong financial position with operating runway into 2025.
Annexon
Annexon
Forward Guidance
Annexon plans to provide pipeline updates and outline key milestones across its business and portfolio of complement-targeted therapies during an R&D Day in the second half of 2023.
Positive Outlook
- Enrollment in the Phase 3 pivotal trial of ANX005 in patients with GBS is progressing and expected to be completed in the second half of 2023.
- Initial topline clinical results from ANX005 trial are anticipated during the first half of 2024.
- Enrollment is underway in the multiple-ascending dose Phase 1a trial in healthy volunteers for ANX1502 in autoimmune diseases, with data expected to be reported in the second half of 2023.
- Initial clinical data from the Phase 1b signal-finding trial of ANX009 for LN is expected in the second half of 2023.
- Additional data from ANX005 in ALS are expected in the second half of 2023.
Challenges Ahead
- A planned Phase 3 trial in HD is now expected to be initiated in 2024 as the company prioritizes near-term pivotal development activities for GA.
- There are risks and uncertainties related to the company’s history of net operating losses.
- The company's ability to obtain necessary capital to fund its clinical programs is uncertain.
- The early stages of clinical development of the company’s product candidates pose risks.
- The company's ability to obtain regulatory approval of and successfully commercialize its product candidates is not guaranteed.