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Adverum Biotechnologies Reports Recent Business Progress and Third Quarter 2019 Financial Results

Nov 7 2019

-- 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.”

Recent Updates

  • Announced the appointment of Peter Soparkar as chief legal officer in October 2019
  • Began dosing patients in the third cohort (n=9, dose of 2x10^11 vg/eye) of the OPTIC phase 1 trial of ADVM-022 in October 2019
  • Presented additional data from the first cohort of patients (n=6, dose of 6x10^11 vg/eye) during a podium presentation at the American Academy of Ophthalmology (AAO) Annual Meeting in October 2019. In treatment-experienced patients previously requiring frequent anti-VEGF injections to maintain vision, data demonstrated that a single intravitreal injection of ADVM-022 was sufficient to maintain vision and improve retinal anatomy, with zero rescue injections required for any of the six patients with a median follow-up of 34 weeks
  • Presented 24-week data for the first cohort of patients in the OPTIC phase 1 trial in a podium presentation at the Retina Society Annual Meeting in September 2019

Future Plans

  • In the first quarter of 2020, begin enrollment in the fourth cohort of patients in the OPTIC trial (n=9, dose of 6x10^11 vg/eye) using prophylactic steroid eye drops instead of prophylactic oral steroids
  • Present 52-week data from the first cohort of patients (n=6, dose of 6x10^11 vg/eye) in the OPTIC trial as well as 24-week data from the second cohort of patients (n=6, dose of 2x10^11 vg/eye) in the first half of 2020
  • Submit an IND application for the treatment of ADVM-022 in diabetic retinopathy (DR), a key VEGF-driven cause of vision loss among working-age adults, in the first half of 2020
  • Expects to be able to occupy its new corporate headquarters in Redwood City, CA, by the end of this year, allowing for the expansion of in-house process development capabilities to the 1000-liter production scale

Financial Results for the Three Months Ended September 30, 2019

  • Cash, cash equivalents and short-term investments were $162.0 million as of September 30, 2019, compared to $205.1 million as of December 31, 2018.  Adverum expects this quarter-end cash position to fund operations into 2021
  • Revenue of $0.3 million for the three months ended September 30, 2019 related to a development milestone that was achieved under an existing license agreement
  • Research and development expenses were $9.9 million for the three months ended September 30, 2019, compared to $14.5 million for the same period in 2018. Research and development expenses decreased primarily due to reduced activities for the development of product candidates ADVM-043 (for A1AT deficiency) and ADVM-053 (for hereditary angioedema), lower material production costs for ADVM-022 and ADVM-053 and lower personnel expenses, partially offset primarily by increased facilities costs related to the company’s new facility
  • General and administrative expenses were $7.4 million for the three months ended September 30, 2019, compared to $4.8 million for the same period in 2018. General and administrative expenses increased primarily due to higher consultant and professional service expenses, personnel costs, and increased facilities costs related to the company’s new facility
  • Net loss was $16.1 million, or $0.25 per basic and diluted share, for the three months ended September 30, 2019, compared to $21.0 million, or $0.34 per basic and diluted share, for the same period in 2018. The 2018 period included a $5.0 million non-cash charge for the impairment of an intangible asset related to the discontinued development of ADVM-043. The in-process research and development (IPR&D) asset originated from the Annapurna acquisition in May 2016

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.

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 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:

Investors:
Myesha Lacy
Adverum Biotechnologies
Vice President, Investor Relations and Corporate Communications
mlacy@adverum.com
1-650-304-3892

Media:
Cherilyn Cecchini, M.D.
Account Supervisor
ccecchini@lifescipublicrelations.com
1-646-876-5196

 
 
Adverum Biotechnologies, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
       
  September 30,
  December 31,
  2019   2018
       
   
Assets      
Current assets:      
Cash and cash equivalents $ 73,171     $ 154,949  
Short-term investments   88,814       50,130  
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  
Restricted cash   999       999  
Deposit and other long-term assets   164       156  
Total assets $ 205,525     $ 213,495  
Liabilities and stockholders' equity      
Current liabilities:      
Accounts payable $ 3,382     $ 1,707  
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  
Total liabilities   41,311       12,328  
Commitments and contingencies      
Stockholders' equity:      
Preferred stock   -       -  
Common stock   7       6  
Additional paid-in capital   531,056       522,503  
Accumulated other comprehensive loss   (745 )     (799 )
Accumulated deficit   (366,104 )     (320,543 )
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)
(unaudited)
               
  Three Months Ended September 30,   Nine Months Ended September 30,
  2019   2018   2019   2018
               
   
Collaboration and license revenue $ 250     $ 833     $ 250     $ 1,542  
Operating expenses:              
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  
Operating loss   (17,083 )     (23,473 )     (48,892 )     (61,322 )
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  
Net loss   (16,118 )     (20,958 )     (45,561 )     (56,968 )
Other comprehensive loss:              
Net unrealized gain on marketable securities   4       53       27       129  
Foreign currency translation adjustment   (11 )     -       27       (21 )
Comprehensive loss $ (16,125 )   $ (20,905 )   $ (45,507 )   $ (56,860 )
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  
               

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Source: Adverum Biotechnologies, Inc.