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EX - 99.1 2 exhibit991_5621pressrelease.htm EX - 99.1 ADVERUM Exhibit 99.1 Adverum Reports First Quarter 2021 Results REDWOOD CITY , Calif . , May 6 , 2021 – Adverum Biotechnologies , Inc. ( Nasdaq : ADVM ) , a clinical- stage gene therapy company targeting unmet medical needs in ocular and rare diseases , today reported financial results for the first quarter ended March 31 , 2021 . “ Our management team and Board are focused on conducting a thorough review of patient safety data from the ADVM - 022 program to inform our next steps , " said Laurent Fischer , M.D. , chief executive officer at Adverum Biotechnologies . “ At ARVO last weekend , long - term data from the OPTIC trial were presented , demonstrating ADVM - 022's durability in patients with treatment - experienced neovascular or wet age - related macular degeneration . As part of our broader mission to advance the field of gene therapy , we are committed to the work our team is doing on behalf of patients who need new treatment options for ocular diseases . " Recent Progress • • • On April 28 , 2021 , Adverum announced a Suspected Unexpected Serious Adverse Reaction ( SUSAR ) of hypotony ( clinically - relevant decrease in ocular pressure ) , with panuveitis and loss of vision in the treated eye , in its INFINITY clinical trial evaluating ADVM - 022 for the treatment of diabetic patients with macular edema . The company has unmasked the study and is assessing and monitoring this patient and all patients treated with ADVM - 022 and is working closely with investigators , the data monitoring committee ( DMC ) , the scientific advisory board , and healthcare authorities . The patient impacted by the SUSAR event is undergoing in - person assessments with leading retina specialists across the U.S. who are working with Adverum to gain an understanding of the causes of the SUSAR and to develop a treatment plan for the patient . In addition , all patients who have received ADVM - 022 have been requested to see their treating physician for an evaluation , including ophthalmic and advanced imaging assessments to collect additional data . Adverum , working with its expert advisors , is conducting a thorough review of data from the ADVM - 022 program , taking into account learnings from the SUSAR , and plans to report its findings as the analysis progresses . At ARVO in May 2021 , long - term OPTIC clinical data were presented ( March 10 , 2021 cutoff date , n = 30 ) that continue to demonstrate the potential of ADVM - 022 to greatly reduce the anti - VEGF injection burden for patients with wet AMD . All ADVM - 022 - related ocular adverse events ( AE ) were mild ( 80 % ) to moderate ( 20 % ) in OPTIC patients with wet AMD . No clinical or fluorescein evidence of posterior inflammation and no vasculitis , retinitis , choroiditis , vascular occlusions , or endophthalmitis were observed . The OPTIC data presentation is available on the Publications section of Adverum's website . In light of the announced SUSAR , the company is evaluating its timelines and capital allocation priorities with an aim to extend its cash runway beyond prior guidance . 1