Earnings release
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Exhibit 99.1 AVROBIO Reports Second Quarter 2021 Financial Results and Provides Business Update U.S. Food and Drug Administration granted Fast Track Designation to AVR - RD - 04 for cystinosis Company is planning to initiate multiple registration trials in 2022 Multiple data and regulatory updates anticipated over next 12 months CAMBRIDGE , Mass . , Aug. 5 , 2021 — AVROBIO , Inc. ( Nasdaq : AVRO ) , a leading clinical - stage gene therapy company with a mission to free people from a lifetime of genetic disease , today reported financial results for the quarter ended June 30 , 2021 , and provided a business update . “ Data from the patients dosed to date across three indications continue to support our first - in - class , one - time investigational gene therapies as potentially transformative treatments for the more than 50,000 people worldwide living with the life - limiting lysosomal disorders we are researching , " said Geoff MacKay , president and CEO of AVROBIO . “ In the second half of this year , we plan to share updated safety data from our ongoing clinical trials and plan to meet with regulatory agencies to discuss initiating potential registration trials in 2022 for Fabry disease , cystinosis and Gaucher disease type 3 . With our Pompe disease and Hunter syndrome programs anticipated to enter the clinic in 2022 , we remain fiercely committed to our purpose : to free people living with genetic disease from a lifetime of symptoms , chronic treatment and inevitable disease progression . " Multiple program milestones anticipated over the next 12 months AVR - RD - 01 in Fabry disease : Two additional patients have been dosed in the FAB - GT trial since June 2021 . AVROBIO intends to amend the FAB - GT Phase 2 trial protocol in August 2021 to include female participants and eliminate the antibody status exclusion as well as collect additional central nervous system ( CNS ) and cardiovascular data . Company plans to engage the U.S. Food and Drug Administration ( FDA ) to discuss a revised regulatory approach with the goal of initiating a registration trial in mid - 2022 . AVROBIO expects to present updated safety and tolerability data on all nine FAB - GT Phase 2 patients dosed to date in the fourth quarter of 2021 and updated efficacy and durability data for all dosed patients at the 18th Annual WORLDSymposium in February 2022 .