Earnings release
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EX - 99.1 2 exhibit991_110421pressrele.htm EX - 99.1 ADVERUM Exhibit 99.1 Adverum Reports Third Quarter 2021 Results REDWOOD CITY , Calif . , November 4 , 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 third quarter ending September 30 , 2021 and provided a business update . " Last month we presented new data at scientific meetings from both our OPTIC and INFINITY studies which reinforce our plans to focus the development of ADVM - 022 in wet age - related macular degeneration ( wet AMD ) at 2 x 10 ^ 11 vg / eye and lower doses with improved steroid prophylaxis , ” said Laurent Fischer , M.D. , president , chief executive officer at Adverum Biotechnologies . " The OPTIC trial data continue to demonstrate that a single - IVT injection of ADVM - 022 provides sustained durability , promising safety profile and stable aflibercept expression levels at median follow - up of 1.7 years , resulting in a durable treatment option with over 80 % reduction in annualized anti - VEGF injections to wet AMD patients who faced up to 10 anti - VEGF injections annually . These results as well as learnings from our INFINITY trial highlight important differences in the underlying pathology and co - morbidities between wet AMD and diabetic macular edema ( DME ) that will inform our phase 2 trial design in wet AMD . " • Recent Developments • Two - year OPTIC study data demonstrating sustained durability and promising safety profile from a single intravitreal injection of ADVM - 022 in wet AMD patients previously requiring frequent anti - VEGF injections were presented at the Retina Society and American Society of Retina Specialists ( ASRS ) annual scientific meetings in October ( July 16 , 2021 cutoff date , n = 30 ) : • • • • • Over 80 % reduction in annualized anti - VEGF injection frequency demonstrated at 2 x 10 ^ 11 vg / eye More than half of patients were free of injection at median follow - up of 1.7 years at 2 x 10 ^ 11 vg / eye Robust aflibercept expression and sustained efficacy observed providing CST stabilization Low ADVM - 022 - related ocular adverse events occurred at the 2 x 10 ^ 11 vg / eye dose No clinically relevant low IOP events observed in either dose Results support further studies in wet AMD , evaluating of low doses of ADVM - 022 ( 2 x 10 ^ 11 vg / eye and lower ) and enhanced prophylaxis Data and key learnings from the INFINITY trial of ADVM - 022 in patients with DME were also presented at ASRS , indicating that dose and disease state appear to have an impact in determining the therapeutic window which balances efficacy and safety . As previously announced , Adverum is no longer developing ADVM - 022 in DME and will focus development on wet AMD at low doses . Dose - dependent inflammation observed in DME patients with dose - limiting toxicity at 6 x 10 ^ 11 vg / eye may be in part related to the study population which included patients with severe vascular and renal disease • 1