-- Phase 1 OPTIC trial: 24-week data from first cohort to be presented at Retina Society in September; 52-week data to be presented in 1H20 --
-- Dosing of second cohort completed; 24-week data to be presented in 1H20 --
-- IND submission for ADVM-022 in diabetic retinopathy planned in 1H20 --
-- Company to host conference call today at 1:30 pm PT / 4:30 pm ET --
MENLO PARK, Calif., Aug. 08, 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 second quarter ended June 30, 2019 and provided a corporate update.
“We are extremely pleased with the clinical and regulatory progress made with our lead clinical candidate, ADVM-022, including acceptance of OPTIC data in wet AMD for oral presentation at the Retina Society meeting, completion of patient dosing of the second cohort of the OPTIC trial, and plans to submit an IND for ADVM-022 in diabetic retinopathy in the first half of 2020,” said Leone Patterson, chief executive officer, Adverum Biotechnologies. “We have also made important strides in building our team, adding senior professionals with deep functional expertise as we prepare for future growth. We are dedicated to the development of ADVM-022 and our mission to make an impact in the lives of patients with ocular and rare diseases.”
Recent Program Updates and Future Outlook
Recent Corporate Updates and Future Outlook
Financial Results for the Three Months Ended June 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 Second Quarter 2019 Conference 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 is a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control. For more information, please visit www.adverum.com.
Forward-looking Statements
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 occupying Adverum’s new facility; and Adverum’s expectations that its current cash position will fund its operations into 2021, all of which 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 May 8, 2019, and August 8, 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.
| ADVERUM BIOTECHNOLOGIES, INC. | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (In thousands) | ||||||
| (Unaudited) | ||||||
| June 30, | December 31, | |||||
| 2019 | 2018 | |||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 97,808 | $ | 154,949 | ||
| Short-term investments | 79,834 | 50,130 | ||||
| Prepaid expenses and other current assets | 2,919 | 3,675 | ||||
| Total current assets | 180,561 | 208,754 | ||||
| Operating lease right-of-use asset | 22,053 | — | ||||
| Property and equipment, net | 6,097 | 3,586 | ||||
| Restricted cash | 999 | 999 | ||||
| Deposits and other long-term assets | 174 | 156 | ||||
| Total assets | $ | 209,884 | $ | 213,495 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 740 | $ | 1,707 | ||
| Accrued expenses and other current liabilities | 5,467 | 8,784 | ||||
| Lease liability, current portion | 3,942 | — | ||||
| Deferred rent, current portion | — | 228 | ||||
| Total current liabilities | 10,149 | 10,719 | ||||
| Deferred rent, less current portion | — | 1,366 | ||||
| Lease liability, less current portion | 21,804 | — | ||||
| Other non-current liabilities | 191 | 243 | ||||
| Total liabilities | 32,144 | 12,328 | ||||
| Stockholders’ equity | 177,740 | 201,167 | ||||
| Total liabilities and stockholders’ equity | $ | 209,884 | $ | 213,495 | ||
| ADVERUM BIOTECHNOLOGIES, INC. | |||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (In thousands, except per share amounts) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Collaboration and license revenue | $ | — | $ | 493 | $ | — | $ | 709 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 8,970 | 11,217 | 19,101 | 24,011 | |||||||||||
| General and administrative | 7,132 | 9,179 | 12,708 | 14,547 | |||||||||||
| Total operating expenses | 16,102 | 20,396 | 31,809 | 38,558 | |||||||||||
| Operating loss | (16,102 | ) | (19,903 | ) | (31,809 | ) | (37,849 | ) | |||||||
| Other income (expense), net | 1,148 | 1,093 | 2,366 | 1,839 | |||||||||||
| Net loss | $ | (14,954 | ) | $ | (18,810 | ) | $ | (29,443 | ) | $ | (36,010 | ) | |||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.30 | ) | $ | (0.46 | ) | $ | (0.60 | ) | |||
| Weighted-average common shares outstanding, | |||||||||||||||
| basic and diluted | 63,740 | 62,366 | 63,429 | 59,907 | |||||||||||
Investor and Media Inquiries: Investors: Myesha Lacy Investor Relations and Corporate Communications 650-304-3892 Lee M. Stern, CFA Solebury Trout 646-378-2922 Media: Joshua R. Mansbach Solebury Trout 646-378-2964