On August 9, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the second quarter ended June 30, 2022 and highlighted recent corporate progress (Press release, Avidity Biosciences, AUG 9, 2022, View Source [SID1234617906]).
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"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," said Sarah Boyce, president and chief executive officer. "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."
"Our strong cash balance of over $400 million, inclusive of additional funds raised subsequent to June 30th, positions us to be well funded through 2024. This allows us to meaningfully advance our DM1, FSHD and DMD programs, as well as other programs in skeletal muscle and expand the platform into other tissues and cell types," said Mike MacLean, chief financial and chief business officer.
Recent Highlights
Commenced enrolling patients from the MARINA study into a Phase 2 open-label extension study (MARINA-OLE) of AOC 1001 in adults with DM1. Click here for more information on the MARINA-OLE or visit www.clinicaltrials.gov and search for NCT05479981.
Presented data supporting Avidity’s approach of directly targeting DUX4 with AOC 1020 at the 29th Annual FSHD Society International Research Congress. Key highlight from the conference:
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.
Second Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $398.2 million as of June 30, 2022, compared to $405.5 million as of December 31, 2021. In addition, subsequent to June 30th, we have raised $18.7 million through our "at the market" program.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company (Lilly) and totaled $2.2 million for the second quarter of 2022 compared with $2.6 million for the second quarter of 2021, and $4.0 million for the first six months of 2022 compared with $5.3 million for the first six months of 2021. The decrease was primarily due to timing of reimbursable collaboration-related research and development expenses resulting in the recognition of lower corresponding revenue under the collaboration with Lilly.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $39.8 million for the second quarter of 2022 compared with $22.7 million for the second quarter of 2021, and $67.5 million for the first six months of 2022 compared with $43.4 million for the first six months of 2021. The increase was primarily driven by the advancement of AOC 1001, AOC 1020 and AOC 1044, as well as internal and external costs related to the expansion of the company’s overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $8.7 million for the second quarter of 2022 compared with $6.3 million for the second quarter of 2021, and $17.3 million for the first six months of 2022 compared with $12.2 million for the first six months of 2021. The increase was primarily due to higher personnel costs and professional fees as well as facilities costs to support the company’s expanded operations.