Analyst Conference Summary

biotechnology

conference date: November 9, 2021 (press release only)
for quarter ending: September 30, 2020 (third quarter, Q3 2021)

Forward-looking statements

Overview: Began first clinical trial.

Basic data (GAAP):

Revenue was $2.2 million, up sequentially from $na million, and up from $1.7 million year-earlier. All revenue was from collaborations.

Net loss was $29 million, down sequentially from loss of $na million, and from loss of $11 million year-earlier.

EPS loss $0.68, down sequentially from loss of $na, and from loss of $0.31 year-earlier.

Guidance:

none

Conference Highlights:

Sarah Boyce, CEO said "This past quarter we initiated our Phase 1/2 Marina trial for AOC 1001, which transitions us into a clinical stage company. This trial is important for both AOC 1001 and our platform as it is expected to generate the first proof of concept data on the AOC platform's potential to deliver RNA therapy outside of the liver – a first for the field of RNA conjugates and for Avidity. This is also an important milestone for the myotonic dystrophy community who currently have no therapeutic options. We look forward to sharing preliminary data on AOC 1001 in the second half of next year as we work to achieve our ambitious agenda of having AOCs for DM1, DMD and FSHD in the clinic by the end of 2022." 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. The company plans to initiate a Phase 1/2 clinical study of AOC 1001 in adults with DM1 in the second half of 2021.

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.

Avidity also has potential therapies for other muscle diseases in development, with a possible IND planned for 2022 for AOC 1044 for DMD and for the FSHD (facioscapulohumeral muscular dystrophy) program.

Cash and equivalents ended at $413 million, down sequentially from $na million. No debt.

Operating expense of $ million consisted of $25 million for R&D and $7 million for G&A.

Q&A:

none

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