Analyst Conference Summary

biotechnology

conference date: March 1, 2022 (press release only)
for quarter ending: December 31, 2021 (fourth quarter, Q4 2021)

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 $39 million, down sequentially from loss of $29 million, and from loss of $16 million year-earlier.

EPS loss $0.82, down sequentially from loss of $0.68, and from loss of $0.43 year-earlier.

Guidance:

none

Conference Highlights:

Sarah Boyce, CEO said "2021 was a pivotal year for Avidity, the field of RNA therapeutics and for the DM1 community as the first patient was dosed with an AOC as part of the AOC 1001 MARINA trial. This milestone transitioned us into a clinical-stage biopharmaceutical company and we continue to make great strides with our advancing and expanding pipeline and AOC platform technology. By the end of 2022, we plan to have three programs in three different rare diseases in the clinic with AOC 1001, AOC 1020 and AOC 1044." 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. In April 2021 preclinical data for AOC1001 for DM1 was presented at the American Academy of Neurorogy 2021 meeting. This showed activity in cultured human muscle cells from DM1 patients. 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 $406 million, down sequentially from $413 million. No debt.

Operating expense of $40 million consisted of $33 million for R&D and $7 million for G&A.

Q&A:

none

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