Loading...
•
Dec 31, 2024
Avidity Biosciences Q4 2024 Earnings Report
Avidity Biosciences reported its fourth quarter and full year 2024 financial results, highlighting progress in its clinical programs and a strong financial position.
Key Takeaways
Avidity Biosciences reported a net loss of $102.257 million for Q4 2024, with collaboration revenue of $2.973 million. The company ended 2024 with approximately $1.5 billion in cash, cash equivalents, and marketable securities, positioning it for significant milestones in 2025, including preparing for its first BLA submission.
Avidity Biosciences reported a net loss of $102.257 million for the fourth quarter of 2024.
Collaboration revenue for Q4 2024 was $2.973 million, primarily from a partnership with Bristol Myers Squibb.
The company's cash, cash equivalents, and marketable securities totaled approximately $1.5 billion as of December 31, 2024.
R&D expenses increased to $95.625 million in Q4 2024, driven by the advancement of clinical programs and research capabilities.
Avidity Biosciences
Avidity Biosciences
Avidity Biosciences Revenue by Segment
Revenue by Segment
Collaboration Revenue
CapyFin.com Forward Guidance
Avidity Biosciences anticipates significant progress in 2025, including preparing for its first BLA submission for del-zota, advancing its DM1 and FSHD programs, and expanding its pipeline into precision cardiology.
Positive Outlook
- Planned BLA submission for del-zota by year-end 2025, with FDA confirming accelerated approval path.
- Completion of enrollment in the Phase 3 HARBOR™ trial for DM1 anticipated mid-2025.
- Regulatory alignment on a global Phase 3 trial design for FSHD and potential accelerated approval path for FORTITUDE™ biomarker cohort by Q2 2025.
- Initiation of a global, potentially registrational trial in FSHD in Q2 2025.
- Expansion of pipeline into precision cardiology with two wholly-owned candidates for PRKAG2 syndrome and PLN cardiomyopathy.
Challenges Ahead
- Actual results may differ from those set forth in this press release due to risks and uncertainties inherent in Avidity's business.
- Data and results from ongoing clinical trials may not be indicative of final results or support BLA submissions/accelerated approvals.
- Potential inability to execute successful product launches even if approved.
- Unexpected adverse side effects or inadequate efficacy of product candidates could delay or limit development/approval.
- Potential delays in commencement, enrollment, data readouts, and completion of preclinical studies or clinical trials.