0001193125-15-184900.txt : 20150513 0001193125-15-184900.hdr.sgml : 20150513 20150513073038 ACCESSION NUMBER: 0001193125-15-184900 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150513 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150513 DATE AS OF CHANGE: 20150513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Avalanche Biotechnologies, Inc. CENTRAL INDEX KEY: 0001501756 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 205258327 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36579 FILM NUMBER: 15856440 BUSINESS ADDRESS: STREET 1: 1035 O?BRIEN DRIVE, SUITE A CITY: MENLO PARK STATE: CA ZIP: 94025 BUSINESS PHONE: 650-272-6269 MAIL ADDRESS: STREET 1: 1035 O?BRIEN DRIVE, SUITE A CITY: MENLO PARK STATE: CA ZIP: 94025 8-K 1 d925333d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 13, 2015

 

 

AVALANCHE BIOTECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36579   20-5258327

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

1035 O’Brien Drive, Suite A

Menlo Park, CA 94025

(650) 272-6269

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 272-6269

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02 Results of Operations and Financial Conditions

On May 13, 2015, Avalanche Biotechnologies, Inc. issued a press release regarding its financial results for its first quarter ended March 31, 2015. A copy of this press release is furnished as Exhibit 99.1 to this Form 8-K.

This information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press release dated May 13, 2015.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 13, 2015 AVALANCHE BIOTECHNOLOGIES, INC.
By:

/s/ Thomas W. Chalberg, Jr., Ph.D.

Thomas W. Chalberg, Jr., Ph.D.
President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press release dated May 13, 2015.
EX-99.1 2 d925333dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Avalanche Biotechnologies, Inc. Reports First Quarter 2015 Financial Results

MENLO PARK, Calif., May 13, 2015 – Avalanche Biotechnologies, Inc. (Nasdaq: AAVL), a clinical-stage biopharmaceutical company committed to improving or preserving the sight of people suffering from blinding eye diseases with an unmet medical need, today reported financial results for the first quarter ended March 31, 2015.

“The start of 2015 marked important milestones for Avalanche as we continue to advance our pipeline and innovate in next-generation vector technology,” said Thomas W. Chalberg, Jr., Ph.D., founder and chief executive officer. “We’re proud to collaborate with the University of Washington and vision scientists Drs. Jay and Maureen Neitz as we develop AVA-322 and AVA-323, our gene therapy product candidates for red-green color blindness. Combined with our anticipated mid-year announcement of 12 month topline data from the Phase 2a trial and 36-month follow-up from the Phase 1 trial of AVA-101 – our lead product candidate – and initiation of a Phase 2b trial, we’re looking forward to continued progress in our work to transform the treatment landscape for patients with sight-threatening eye diseases.”

Recent Business Highlights

 

    In January 2015, Avalanche completed a public offering of 2,369,375 shares of its common stock, which included 359,918 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares. The Company received net proceeds of approximately $130.6 million, after underwriting discounts, commissions and offering expenses.

 

    On March 25, 2015, Avalanche announced an exclusive license agreement with the University of Washington in Seattle to develop products based on Avalanche’s proprietary Ocular BioFactory™ Platform for the treatment of color vision deficiency, commonly known as red-green color blindness. Currently, there are no approved treatment options.

 

    Avalanche presented updates on its clinical programs in development as well as advancements in next-generation vector technology at its Analyst and Investor Day in New York City in March 2015.

First Quarter 2015 Financial Results

 

    Cash, cash equivalents and marketable securities as of March 31, 2015 was $290.1 million, compared to $159.4 million as of December 31, 2014. In January 2015, Avalanche raised net proceeds of approximately $130.6 million in a public offering of common stock.

 

    Revenues, consisting of revenue from collaborative research, was $0.2 million for the quarter ended March 31, 2015, compared to $30,000 for the quarter ended March 31, 2014.

 

    Research and development expenses were $5.6 million for the quarter ended March 31, 2015, compared to $0.9 million for the quarter ended March 31, 2014.


    General and administrative expenses were $4.1 million for the quarter ended March 31, 2015, compared to $0.7 million for the quarter ended March 31, 2014.

 

    Net loss was $9.5 million, or $0.38 per basic and diluted share, for the quarter ended March 31, 2015, compared to a net loss of $1.7 million, or $0.45 per basic and diluted share, for the quarter ended March 31, 2014.

About Avalanche Biotechnologies, Inc.

Avalanche is a biopharmaceutical company committed to improving or preserving the sight of people suffering from blinding eye diseases with an unmet medical need. Avalanche’s proprietary Ocular BioFactory™ is a platform for discovering and developing novel medicines with the potential to offer life-changing therapeutic benefit. Avalanche’s lead product candidate, AVA-101, is in mid-stage clinical development for patients with wet age-related macular degeneration. For more information, please visit www.avalanchebiotech.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avalanche’s plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, clinical studies, collaborations, product development and the potential benefits of its products under development, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Avalanche’s expectations regarding its ability to advance its AVA-101, AVA-322 and AVA-323 product candidates, initiate its Phase 2b and Phase 3 clinical trials with respect to AVA-101, and improve outcomes for patients suffering from blinding eye diseases. Such forward-looking statements involve substantial risks and uncertainties that could cause our product development program, clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our product candidates. Avalanche undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of Avalanche, see our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 5, 2015, and our subsequent periodic reports filed with the Securities and Exchange Commission.

# # #

Contacts:

Investor Contact

Lauren Glaser

(650) 656-9347

lauren@avalanchebiotech.com

Media Contact

Carolyn Wang

(415) 946-1065

cwang@w2ogroup.com


AVALANCHE BIOTECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

     March 31,      December 31,  
     2015      2014  
     (unaudited)         

ASSETS

     

Current assets:

     

Cash, cash equivalents and marketable securities

   $ 290,125       $ 159,404   

Prepaid expenses and other current assets

     1,007         874   
  

 

 

    

 

 

 

Total current assets

  291,132      160,278   

Property and equipment, net

  1,421      1,085   

Deposits and other long-term assets

  138      543   
  

 

 

    

 

 

 

Total assets

$ 292,691    $ 161,906   
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 5,315    $ 4,658   

Current portion of deferred revenue

  2,313      813   
  

 

 

    

 

 

 

Total current liabilities

  7,628      5,471   

Deferred revenue, less current portion

  4,943      6,646   

Other liabilities

  440      306   
  

 

 

    

 

 

 

Total liabilities

  13,011      12,423   

Stockholders’ equity

  279,680      149,483   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

$ 292,691    $ 161,906   
  

 

 

    

 

 

 


AVALANCHE BIOTECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

 

     Three Months Ended March 31,  
     2015     2014  
     (unaudited)  

Collaboration and license revenue

   $ 203      $ 30   

Operating expenses:

    

Research and development

     5,621        910   

General and administrative

     4,143        726   
  

 

 

   

 

 

 

Total operating expenses

  9,764      1,636   
  

 

 

   

 

 

 

Operating loss

  (9,561   (1,606

Other income (expense), net

  52      (57
  

 

 

   

 

 

 

Net loss

$ (9,509 $ (1,663
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

$ (0.38 $ (0.45
  

 

 

   

 

 

 

Weighted-average common shares outstanding, outstanding, basic and diluted

  24,887      3,673   
  

 

 

   

 

 

 
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