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-- OPTIC phase 1 trial in wet AMD progressing well with dosing of third cohort underway--
-- Company to host conference call today at 1:30 pm PT / 4:30 pm ET --
MENLO PARK, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- 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 ended September 30, 2019 and provided a corporate update. The company will host a conference call and webcast today at 1:30 pm PT/4:30 pm ET to discuss the results and recent business progress.
“The third quarter was important for Adverum, as we reported sustained benefits from a single intravitreal injection of ADVM-022 in our first cohort of treatment-experienced patients with wet AMD,” said Leone Patterson, chief executive officer, Adverum Biotechnologies. “This is the first time that a single intravitreal injection gene therapy has provided sustained efficacy for these patients, who previously required frequent ocular anti-VEGF injections to maintain their vision. We are very encouraged by these early data, particularly that none of the six patients in the first cohort, who received ADVM-022 at a dose of 6x10^11 vg/eye, required any anti-VEGF rescue injections through a median follow-up of 34 weeks. We are now dosing patients in the third cohort of OPTIC with ADVM-022 at a dose of 2x10^11 vg/eye using prophylactic steroid eye drops instead of prophylactic oral steroids. Our goal is to provide wet AMD patients with a life-changing treatment that removes the need for frequent anti-VEGF injections.”
Financial Results for the Three Months Ended September 30, 2019
Conference Call Information
Individuals can participate in today’s conference call at 1:30 pm PT (4:30 pm ET) by dialing 1-866-420-8347 (domestic) or 1-409-217-8241 (international) and refer to the “Adverum Biotechnologies Third Quarter 2019 Earnings Call.” The webcast will be accessible under Events and Presentations in the Investors section of the company's website. The archived audio webcast will be available on the Adverum website following the call, and will be available for 30 days.
About Adverum Biotechnologies, Inc.
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs for serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of its lead indication, wet age-related macular degeneration. For more information, please visit www.adverum.com.
Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements regarding: Adverum’s plans for advancing ADVM-022; the expected timing of reporting clinical data; the expected timing of filing an IND for diabetic retinopathy; expected timing of being able to occupy Adverum’s new facility; and Adverum’s expectations that its current cash position will fund its operations into 2021. All of these statements are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not achieve any of these a timely manner, or at all, or otherwise carry out the intentions or meet the expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks inherent with conducting clinical trials which may delay or cancel the reporting of data or filing an IND; the incurrence of unexpected expenses; and the risk of a delay in the enrollment of patients in Adverum’s clinical studies or in the manufacturing of products to be used in such clinical studies. Risks and uncertainties facing Adverum are described more fully in Adverum’s Form 10-Q filed with the SEC on November 7, 2019, particularly under the heading “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor and Media Inquiries:
Vice President, Investor Relations and Corporate Communications
Cherilyn Cecchini, M.D.
|Adverum Biotechnologies, Inc.|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||73,171||$||154,949|
|Prepaid expenses and other current assets||5,617||3,675|
|Total current assets||167,602||208,754|
|Operating lease right-of-use asset||21,511||-|
|Property and equipment, net||15,249||3,586|
|Deposit and other long-term assets||164||156|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||10,320||8,784|
|Lease liability, current portion||4,044||-|
|Deferred rent, current portion||-||228|
|Total current liabilities||17,746||10,719|
|Deferred rent, net of current portion||-||1,366|
|Lease liability, net of current portion||23,380||-|
|Other noncurrent liabilities||185||243|
|Commitments and contingencies|
|Additional paid-in capital||531,056||522,503|
|Accumulated other comprehensive loss||(745||)||(799||)|
|Total stockholders' equity||164,214||201,167|
|Total liabilities and stockholders' equity||$||205,525||$||213,495|
|Adverum Biotechnologies, Inc.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands except per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Collaboration and license revenue||$||250||$||833||$||250||$||1,542|
|Research and development||9,944||14,480||29,045||38,491|
|General and administrative||7,389||4,826||20,097||19,373|
|Impairment of intangible asset||-||5,000||-||5,000|
|Total operating expenses||17,333||24,306||49,142||62,864|
|Other income, net||965||1,265||3,331||3,104|
|Net loss before income tax benefit||(16,118||)||(22,208||)||(45,561||)||(58,218||)|
|Income tax benefit||-||1,250||-||1,250|
|Other comprehensive loss:|
|Net unrealized gain on marketable securities||4||53||27||129|
|Foreign currency translation adjustment||(11||)||-||27||(21||)|
|Net loss per share — basic and diluted||$||(0.25||)||$||(0.34||)||$||(0.71||)||$||(0.94||)|
|Weighted-average common shares used to compute net loss per share - basic and diluted||64,484||62,454||63,764||60,856|