Avidity Biosciences Q1 2024 Earnings Report
Key Takeaways
Avidity Biosciences reported a cash position of $915.9 million at the end of Q1 2024, following a $400 million private placement. They are advancing their AOC platform and plan to initiate the global Phase 3 HARBORâ„¢ study for del-desiran this quarter. Collaboration revenue was $3.5 million, and research and development expenses were $66.8 million.
Initiation of global Phase 3 HARBORâ„¢ trial for del-desiran (AOC 1001) in DM1 is on track for this quarter.
Avidity to report FSHD data from FORTITUDEâ„¢ trial this quarter and DMD data from EXPLORE44â„¢ trial in 2H24.
Presented positive long-term del-desiran data from MARINA-OLEâ„¢ showing reversal of disease progression in people living with myotonic dystrophy type 1 across multiple endpoints.
Cash position of $915 million at the end of Q124 following successful private placement.
Avidity Biosciences
Avidity Biosciences
Avidity Biosciences Revenue by Segment
Forward Guidance
Avidity anticipates several milestones including the initiation of the global Phase 3 HARBORâ„¢ trial of del-desiran for adults living with DM1 in the second quarter of 2024, sharing preliminary data in approximately half of participants in the Phase 1/2 FORTITUDEâ„¢ trial of AOC 1020 in people living with FSHD in the second quarter of 2024, and sharing 5 mg/kg cohort data from the Phase 1/2 EXPLORE44â„¢ trial of AOC 1044 in people living with DMD44 in the second half of 2024.
Positive Outlook
- Initiate global Phase 3 HARBORâ„¢ trial of del-desiran for adults living with DM1 in Q2 2024.
- Share preliminary data in approximately half of participants in the Phase 1/2 FORTITUDEâ„¢ trial of AOC 1020 in people living with FSHD in Q2 2024.
- Share 5 mg/kg cohort data from the Phase 1/2 EXPLORE44â„¢ trial of AOC 1044 in people living with DMD44 in 2H 2024.
- Advance programs in cardiology and immunology through internal discovery efforts and key partnerships.
- AOCs have the potential to target a range of different cells and tissues beyond the liver, and to treat cardiac and immunological diseases.
Challenges Ahead
- Avidity may not be able to resolve the partial clinical hold related to the serious adverse event which occurred in the Phase 1/2 MARINA® trial.
- Additional data related to Avidity’s current clinical programs that continues to become available may be inconsistent with the data produced as of the respective data cutoff dates.
- Unexpected adverse side effects to, or inadequate efficacy of, Avidity's product candidates that may delay or limit their development, regulatory approval and/or commercialization.
- Later developments with the FDA and other global regulators that could be inconsistent with the feedback received to date regarding the proposed design and protocol for the Phase 3 HARBOR trial.
- Avidity could exhaust its available capital resources sooner than it currently expects.