Avidity Biosciences
RNA
conference date: May 10, 2022 (press release only)
for quarter ending: March 31, 2022 (first quarter, Q1 2022)
Forward-looking
statements
Overview: Planning to have 3 clinical trials underway by end of 2022.
Basic data (GAAP):
Revenue was $2 million, flat sequentially from $2 million, and flat from $2 million year-earlier. All revenue was from collaborations.
Net loss was $34 million, up sequentially from loss of $39 million, and down from loss of $24 million year-earlier.
EPS loss $0.71, up sequentially from loss of $0.82, and down from loss of $0.64 year-earlier.
Guidance:
none
Conference Highlights:
Sarah Boyce, CEO said "This year will prove to be significant for Avidity as we look forward to sharing a mid-point update from the AOC 1001 Marina trial in adults with myotonic dystrophy type 1 in Q4 and advancing two additional programs, AOC 1020 and AOC 1044, into the clinic. We continue to build our infrastructure to support our goal of having three programs addressing three distinct rare diseases in clinical development by the end of this year. With our AOC platform technology, we aim to revolutionize the delivery of RNA therapeutics as we fulfill our mission of profoundly improving people's lives affected by serious diseases." AOCs are Antibody Oligonucleotide Conjugates, a method of delivering RNA to target cells.
In Q3 2021 initiated a Phase 1/2 trial for AOC 1001 for DM1 (myotonic dystrophy type 1). It is in a collaboration with Myotonic Dystrophy Clinical Research Network supporting END-DM1, a natural history study to advance the understanding of disease progression in patients with DM1. Trial enrollment is on track. Early safety data should be available in Q4 2022.
AOC 1044 for DMD (Duchenne Muscular Dystrophy) could enter the clinic by the end of 2022.
AOC 1020 for the FSHD (facioscapulohumeral muscular dystrophy) could enter the clinic by the end of 2022. Avidity entered a collaboration with the FSHD Clinical Trial Research Network (FSHD CTRN) to support a natural history study called the Motor Outcomes to Validate Evaluations Plus (MOVE+) Study to enhance the understanding of how to utilize whole-body MRI and other tools to identify specific biomarkers for FSHD that can potentially accelerate and support future clinical trial design.
Cash and equivalents ended at $397 million, down sequentially from $406 million. No debt.
Operating expense of $36 million consisted of $28 million for R&D and $9 million for G&A.
Q&A:
none
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