AVROBIO, Inc. Stock Price, News & Analysis

AVROBIO, a clinical-stage gene therapy company, reported a net loss of $26.9 million for Q1 2021, slightly higher than the $26 million loss in Q1 2020. R&D expenses rose to $18.5 million, driven by increased program activities and personnel costs. The company engaged with the FDA regarding AVR-RD-01 for Fabry disease and plans to seek feedback for a registration trial in late 2021. Recent data presented at the WORLDSymposium™ showed promising outcomes across Fabry, Gaucher, and cystinosis trials. AVROBIO holds $233 million in cash, projected to sustain operations into Q1 2023.

AVROBIO, a clinical-stage gene therapy company, announced the granting of non-statutory stock options for 163,500 shares to five new employees as inducement awards. The options, approved by the Compensation Committee, include 30,500 shares from the 2019 Inducement Plan and 133,000 from the 2020 Inducement Plan, with an exercise price of $9.48 per share as of May 3, 2021. The vesting schedule spans 10 years, with 25% on the first anniversary and the remainder monthly over three years, contingent on continued employment.

AVROBIO, Inc. (Nasdaq: AVRO) announced a strategic update regarding its investigational gene therapy AVR-RD-01 for Fabry disease. Following a recent FDA approval of Fabrazyme®, AVROBIO intends to shift from an accelerated approval pathway to a registration trial. The company plans to use kidney biopsy as a primary efficacy endpoint. AVROBIO is also modifying its ongoing FAB-GT trial to include more diverse participants. CEO Geoff MacKay expressed commitment to quicken the approval process to benefit those affected by Fabry disease.

AVROBIO, Inc. (Nasdaq: AVRO) announced presentations at the 24th Annual Meeting of the American Society of Gene & Cell Therapy, scheduled for May 11-14, 2021. New data from a Phase 1/2 trial in cystinosis and preclinical findings in Pompe disease will be highlighted. Presentations include oral discussions on AVR-RD-03 for Pompe disease and AVR-RD-01 for Fabry disease, along with poster sessions on ongoing clinical trials for cystinosis and Gaucher disease type 1. The meeting underscores the company’s commitment to advancing gene therapy for lysosomal disorders.

AVROBIO (Nasdaq: AVRO) announced the granting of non-statutory stock options for up to 140,000 shares to 10 new employees as part of its 2019 Inducement Plan. These options were approved by the Compensation Committee and were granted on April 1, 2021, with an exercise price of $12.31 per share. The options vest over four years, with 25% vesting on the first anniversary and the remainder in monthly installments. AVROBIO aims to provide personalized gene therapy to combat genetic diseases, and its pipeline includes treatments for various conditions.

AVROBIO, Inc. (Nasdaq: AVRO) announced its financial results for Q4 and the year ending December 31, 2020, reporting a net loss of $28.1 million for Q4 and $119.7 million for the year, attributed to increased R&D and administrative expenses. The company highlighted significant advancements in its gene therapy pipeline, including a 100% reduction in toxic substrate in the FAB-GT trial for Fabry disease. AVROBIO expects to achieve operational milestones, including discussions with the FDA regarding AVR-RD-01's regulatory path, and anticipates funding its operations into Q1 2023 with $259.7 million in cash.

AVROBIO, Inc. (Nasdaq: AVRO) has granted non-statutory stock options for 61,500 shares of common stock to five new employees as inducement awards under its 2019 Inducement Plan. The stock options, with an exercise price of $11.45 per share, were approved by the Compensation Committee and granted on March 1, 2021. The options have a 10-year term and vest over four years, subject to continued employment. AVROBIO focuses on personalized gene therapy, aiming to treat genetic diseases through its ex vivo lentiviral gene therapy pipeline.

AVROBIO, Inc (Nasdaq: AVRO) announces that the European Commission has granted orphan drug designation for its investigational gene therapy AVR-RD-04 aimed at treating cystinosis. This gene therapy utilizes the patient's own modified stem cells to produce cystinosin, addressing the protein deficiency caused by cystinosis. Currently evaluated in a Phase 1/2 clinical trial, AVR-RD-04 has also received U.S. orphan drug status. This designation offers benefits like reduced fees and potential market exclusivity, underscoring its therapeutic promise in a challenging treatment landscape.

AVROBIO, Inc. (Nasdaq: AVRO), a clinical-stage gene therapy company, announced that its senior management will participate in three virtual investor conferences:

• Cowen 41st Annual Health Care Conference - March 4, 2021, at 10:30 a.m. ET
• Barclays Global Healthcare Conference - March 9, 2021, at 8:35 a.m. ET
• Morgan Stanley Virtual Healthcare Corporate Access Day - March 16, 2021

Live webcasts will be available on avrobio.com, and the Barclays event will be archived for 90 days.