UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of
the Securities Exchange Act of 1934
Filed by the Registrant x Filed by a Party other than the Registrant ¨
Check the appropriate box:
| ¨ | Preliminary Proxy Statement |
| ¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
| ¨ | Definitive Proxy Statement |
| ¨ | Definitive Additional Materials |
| x | Soliciting Material Pursuant to § 240.14a-12 |
AVALANCHE BIOTECHNOLOGIES, INC.
(Name of Registrant as Specified In Its Charter)
N/A
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
| ¨ | Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. |
| | (1) | Title of each class of securities to which transaction applies: |
| | (2) | Aggregate number of securities to which transaction applies: |
| | (3) | Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined). |
| | (4) | Proposed maximum aggregate value of transaction: |
| ¨ | Fee paid previously with preliminary materials. |
| ¨ | Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the form or schedule and the date of its filing. |
| | (1) | Amount Previously Paid: |
| | (2) | Form, Schedule or Registration Statement No.: |
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): March 3, 2016
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 No.) | | (I.R.S. Employer Identification No.) |
1035 O’Brien Drive, Suite A
Menlo Park, CA 94025
(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 communication 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 March 3, 2016, Avalanche Biotechnologies, Inc. issued a press release regarding, among other matters, its financial results for its fourth quarter and year ended December 31, 2015. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information in 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 March 3, 2016. |
Additional Information and Where to Find It
This Current Report on Form 8-K does not constitute a solicitation of any vote or approval. In connection with its previously announced proposed acquisition of Annapurna Therapeutics SAS, Avalanche Biotechnologies, Inc. (the “Company”) intends to file with the Securities and Exchange Commission (the “SEC”) a proxy statement of the Company, as well as other relevant documents concerning the proposed transaction. INVESTORS AND SECURITYHOLDERS OF THE COMPANY ARE URGED TO READ THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. A free copy of the proxy statement and other filings containing information about the Company may be obtained at the SEC website at www.sec.gov. You will also be able to obtain these documents, free of charge, from the Company by directing a written request to: Avalanche Biotechnologies, Inc., 1035 O’Brien Drive, Suite A, Menlo Park, CA 94025, Attention: Investor Relations. Investors and securityholders are urged to read the proxy statement and the other relevant materials when they become available before making any voting decision with respect to the issuance of the Company’s common stock or any other matters relating to the proposed transaction.
Certain Information Regarding Participants
The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the proposed transaction and the issuance of the Company’s common stock. Information regarding the special interests of these directors and executive officers in the proposed transaction will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of the Company is also included in Avalanche’s Annual Report on Form 10-K for the year ended December 31, 2014 and the proxy statement for the Company’s 2015 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site at www.sec.gov and from Investor Relations at the Company at the address set forth above.
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | | | | | |
| Date: March 3, 2016 | | | | AVALANCHE BIOTECHNOLOGIES, INC. |
| | | |
| | | | By: | | /s/ Paul B. Cleveland |
| | | | | | Paul B. Cleveland, Chief Executive Officer |
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EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| |
| 99.1 | | Press release dated March 3, 2016. |
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Exhibit 99.1
AVALANCHE BIOTECHNOLOGIES REPORTS FOURTH QUARTER AND FISCAL 2015 FINANCIAL RESULTS
MENLO PARK, CA, March 3, 2016 – Avalanche Biotechnologies, Inc. (Nasdaq: AAVL), a gene therapy company committed to discovering and developing novel medicines for patients suffering from chronic or debilitating disease, today reported financial results for the fourth quarter and year ended December 31, 2015.
“2015 was a year of reorientation for Avalanche following our Phase 2a trial results for AVA-101, our lead program for wet AMD. The team has been focusing on preclinical work designed to inform our decision on the best path forward in wet-AMD, enhancing and then applying our next-generation vector discovery platform to fuel an R&D pipeline, and continuing work under our collaboration with Regeneron. We were also looking for opportunities to leverage our expertise and resources by identifying additional assets to bring into the company,” said Paul B. Cleveland, president and chief executive officer of Avalanche. “On February 1 we announced a proposed combination with Annapurna Therapeutics, a gene therapy company with four product candidates in development, including a program for the potential treatment of alpha 1 antitrypsin deficiency which is expected to be in the clinic by the end of this year and a candidate for the potential treatment of hereditary angioedema which is expected to be in the clinic in 2017. We believe that this transaction will transform Avalanche into a leading gene therapy company with an extensive pipeline.”
Fourth Quarter and Fiscal 2015 Financial Results
| | • | | Cash, cash equivalents and marketable securities as of December 31, 2015 were $259.1 million, compared to $159.4 million as of December 31, 2014. |
| | • | | Revenues, consisting of revenue from collaborative research, were $1.0 million for the quarter ended December 31, 2015, compared to $0.2 million for the quarter ended December 31, 2014. Full year 2015 collaboration revenue was $2.3 million compared to $0.6 million in 2014. |
| | • | | Research and development expenses were $7.2 million for both the quarters ended December 31, 2015 and December 31, 2014. Full year 2015 R&D expenses were $25.5 million compared to $17.0 million in 2014. |
| | • | | General and administrative expenseswere $5.4 million for the quarter ended December 31, 2015, compared to $3.4 million for the quarter ended December 31, 2014. Full year 2015 G&A expenses were $22.1 million compared to $8 million in 2014. |
| | • | | Restructuring chargesincurred in connection with our implementation of a restructuring plan in December 2015 were $2.6 million recorded in the quarter ended December 31, 2015, related to one-time termination severance payments and other employee-related benefits, including approximately $1 million of stock-based compensation expense related to the acceleration of restricted stock units in December 2015. |
| | • | | Net loss attributable to common stockholders was $14.1 million, or $0.55 per basic and diluted share, for the quarter ended December 31, 2015, compared to a net loss attributable to common stockholders of $10.4 million, or $0.46 per basic and diluted share, for the quarter ended December 31, 2014. Full year 2015 net loss attributable to common stockholders was $47.5 million, or $1.86 per basic and diluted share compared to a net loss attributable to common stockholders of $28.6 million, or $2.46 per basic and diluted share for the full year 2014. |
About Avalanche Biotechnologies, Inc.
Avalanche is a gene therapy company committed to discovering and developing novel medicines that can offer potentially life-changing therapeutic benefit to patients suffering from chronic or debilitating disease. Avalanche is leveraging its next generation adeno-associated virus (AAV)-based directed evolution platform to generate product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. With significant capabilities and expertise in vector optimization, process development and manufacturing, Avalanche seeks to discover and develop targets in ophthalmology and beyond.
Safe Harbor Statements
Additional Information about the Proposed Transaction with Annapurna and Where to Find It
This announcement does not constitute a solicitation of any vote or approval. In connection with the proposed transaction with Annapurna, Avalanche intends to file relevant materials with the Securities and Exchange Commission, or the SEC, including a proxy statement. INVESTORS AND SECURITY HOLDERS OF AVALANCHE ARE URGED TO READ THESE MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AVALANCHE, ANNAPURNA AND THE PROPOSED TRANSACTION AND ISSUANCE OF AVALANCHE COMMON STOCK. The proxy statement and other relevant materials (when they become available), and any other documents filed by Avalanche with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Avalanche by directing a written request to: Avalanche Biotechnologies, Inc., 1035 O’Brien Drive, Suite A, Menlo Park, CA 94025, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement and the other relevant materials when they become available before making any voting decision with respect to the issuance of Avalanche common stock and other matters relating to the proposed transaction.
Participants in the Solicitation
Avalanche and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Avalanche in connection with the proposed transaction with Annapurna and common stock issuance. Information regarding the special interests of these directors and executive officers in the proposed transaction will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of Avalanche is also included in Avalanche’s Annual Report on Form 10-K for the year ended December 31, 2014 and the proxy statement for Avalanche’s 2015 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site at www.sec.gov and from Investor Relations at Avalanche at the address set forth above.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts 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 the therapeutic potential of, and development plans for, our product candidates; the structure, timing and completion of our proposed transaction with Annapurna; our expectations regarding the capitalization, resources and ownership structure of the combined company; our expectations regarding the sufficiency of the combined company’s resources to fund the advancement of any development program or the completion of any clinical trial; the nature, strategy and focus of the combined company; the safety, efficacy and projected development timeline and commercial potential of any product candidates; the executive officer and board structure of the combined company; and the expectations regarding voting by Avalanche stockholders. Avalanche may not consummate the proposed transaction, or any plans or product development goals in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations or projections disclosed in our 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 and uncertainties associated with stockholder approval of the issuance of Avalanche common stock and the ability to consummate the proposed transaction, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for combined company operations and to conduct or continue planned development programs and the ability to successfully develop any of our or Annapurna’s product candidates. Risks and uncertainties facing Avalanche are described more fully in Avalanche’s periodic reports filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Avalanche undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
###
Contacts
For Avalanche:
Lauren Glaser
(650) 656-9347
lauren@avalanchebiotech.com
AVALANCHE BIOTECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
| | | | | | | | |
| | | December 31, | | | December 31, | |
| | | 2015 | | | 2014 | |
ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash, cash equivalents and marketable securities | | $ | 259,080 | | | $ | 159,404 | |
Receivable from collaborative partner | | | 449 | | | | — | |
Prepaid expenses and other current assets | | | 1,463 | | | | 874 | |
| | | | | | | | |
Total current assets | | | 260,992 | | | | 160,278 | |
Property and equipment, net | | | 3,187 | | | | 1,085 | |
Deposits and other long-term assets | | | 140 | | | | 543 | |
| | | | | | | | |
Total assets | | $ | 264,319 | | | $ | 161,906 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable and accrued liabilities | | $ | 4,612 | | | $ | 4,658 | |
Restructuring liabilities | | | 1,013 | | | | — | |
Current portion of deferred rent | | | 66 | | | | — | |
Current portion of deferred revenue | | | 883 | | | | 813 | |
| | | | | | | | |
Total current liabilities | | | 6,574 | | | | 5,471 | |
Deferred revenue, less current portion | | | 4,706 | | | | 6,646 | |
Other liabilities | | | 447 | | | | 306 | |
| | | | | | | | |
Total liabilities | | | 11,727 | | | | 12,423 | |
| | |
Stockholders’ equity | | | 252,592 | | | | 149,483 | |
| | | | | | | | |
Total liabilities and stockholders’ equity | | $ | 264,319 | | | $ | 161,906 | |
| | | | | | | | |
AVALANCHE BIOTECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| | | | | | | | | | | | | | | | |
| | | Three Months Ended December 31, | | | Year Ended December 31, | |
| | | 2015 | | | 2014 | | | 2015 | | | 2014 | |
| | | | | | | | | | | | | | | | |
Collaboration and license revenue | | $ | 960 | | | $ | 203 | | | $ | 2,319 | | | $ | 572 | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 7,192 | | | | 7,220 | | | | 25,462 | | | | 16,976 | |
General and administrative | | | 5,374 | | | | 3,403 | | | | 22,107 | | | | 7,998 | |
Restructuring charges | | | 2,573 | | | | — | | | | 2,573 | | | | — | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 15,139 | | | | 10,623 | | | | 50,142 | | | | 24,974 | |
| | | | | | | | | | | | | | | | |
Operating loss | | | (14,179 | ) | | | (10,420 | ) | | | (47,823 | ) | | | (24,402 | ) |
Other income (expense), net | | | 85 | | | | 12 | | | | 370 | | | | (1,002 | ) |
| | | | | | | | | | | | | | | | |
Net loss | | | (14,094 | ) | | | (10,408 | ) | | | (47,453 | ) | | | (25,404 | ) |
Deemed dividend | | | — | | | | — | | | | — | | | | (3,230 | ) |
| | | | | | | | | | | | | | | | |
Net loss attributable to common stockholders | | $ | (14,094 | ) | | $ | (10,408 | ) | | $ | (47,453 | ) | | $ | (28,634 | ) |
| | | | | | | | | | | | | | | | |
Net loss per share attributable to common stockholders, basic and diluted | | $ | (0.55 | ) | | $ | (0.46 | ) | | $ | (1.86 | ) | | $ | (2.46 | ) |
| | | | | | | | | | | | | | | | |
Weighted-average common shares outstanding, basic and diluted | | | 25,777 | | | | 22,603 | | | | 25,479 | | | | 11,651 | |
| | | | | | | | | | | | | | | | |
