Analyst Conference Summary


Avidity Biosciences

conference date: August 9, 2022 (press release only)
for quarter ending: June 30, 2022 (second quarter, Q2 2022)

Forward-looking statements

Overview: DM1 trial enrolling, planning to have 3 clinical trials underway by end of 2022.

Basic data (GAAP):

Revenue was $2 million, flat sequentially from $2 million, and down from $3 million year-earlier. All revenue was from collaborations.

Net loss was $46 million, down sequentially from loss of $39 million, and down from loss of $26 million year-earlier.

EPS loss $0.92, down sequentially from loss of $0.71, and down from loss of $0.70 year-earlier.



Conference Highlights:

Sarah Boyce, CEO said "We are very pleased with the team's execution on our ambitious goal of having three AOC programs addressing three distinct rare diseases in the clinic by the end of this year. Our AOC 1001 program for DM1 is progressing with patients from the MARINA trial now enrolling in the recently initiated MARINA-OLE trial. We remain on track to report a preliminary assessment from MARINA in the fourth quarter. We also continue to collaborate with the FSHD and DMD communities as we work to advance AOC 1020 and AOC 1044 into the clinic by the end of this year" AOCs are Antibody Oligonucleotide Conjugates, a method of delivering RNA to target cells.

Additional funds were raised after Q2 ended: $18.7 million through an at the market program for stock sales (WM: and dilution).

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. Also added a Phase 2 open label extension study of patients who completed the orignial trial.

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. Avidity presented data supporting directly targeting DUX4 with AOC 1020 at the 29th Annual FSHD Society International Research Congress. Data from a FSHD mouse model showed that a single intravenous dose with the murine version of AOC 1020 prevented development of muscle weakness demonstrated by three functional assays: treadmill running, in vivo force, and compound muscle action potential.

Cash and equivalents ended at $398 million, down sequentially from $397 million. No debt.

Operating expense of $48 million consisted of $40 million for R&D and $9 million for G&A. Other income $0.6 million.



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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2022 William P. Meyers