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): August 8, 2017

 

 

ADVERUM BIOTECHNOLOGIES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-36579   20-5258327
(State or Other Jurisdiction   (Commission   (I.R.S. Employer
of Incorporation)   File No.)   Identification No.)

1035 O’Brien Drive

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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

 

 


Item 2.02 Results of Operations and Financial Conditions

On August 8, 2017, Adverum Biotechnologies, Inc. issued a press release regarding, among other matters, its financial results for its second quarter ended June 30, 2017. A copy of the 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 August 8, 2017.

 

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: August 8, 2017   ADVERUM BIOTECHNOLOGIES, INC.
  By:  

/s/ Leone Patterson

    Leone Patterson, Chief Financial Officer

 

3


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press release dated August 8, 2017.

 

4

EX-99.1

Exhibit 99.1

 

LOGO

Adverum Biotechnologies Reports

Second Quarter 2017 Financial Results and Provides Update

MENLO PARK, CA, August 8, 2017 – Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a leading gene therapy company advancing novel medicines that have the potential to address unmet needs in serious rare and ocular diseases, today reported financial results for the second quarter ended June 30, 2017 and provided a corporate update.

“We are making important progress with our development and regulatory initiatives to transform Adverum into a clinical-stage company by the end of this year,” said Amber Salzman, Ph.D., president and chief executive officer of Adverum Biotechnologies. “Since the beginning of this year, we have held meetings with the FDA, paving the way to advancing our three lead gene therapy programs toward the clinic. We plan to begin patient enrollment in a Phase 1/2 clinical trial for alpha-1 antitrypsin deficiency in the fourth quarter of this year. We believe we have multiple options for building value with our robust pipeline, in house manufacturing process and assay development expertise, and a platform of leading AAV vector technology, including novel vector development capabilities.”

Recent Highlights

 

  In June 2017, Adverum appointed Athena Countouriotis, M.D. as senior vice president and chief medical officer. Dr. Countouriotis has significant experience leading clinical development teams and programs, from preclinical through clinical stages of development and approval. Over the course of her career, she has been involved in multiple clinical programs, with a focus on orphan oncology indications, which have supported regulatory approvals in the United States and Europe.

 

  In May 2017, Adverum presented new preclinical data on the Company’s next-generation vectors at the Association for Research in Vision and Ophthalmology (ARVO) and American Society of Gene & Cell Therapy (ASGCT) 2017 annual meetings. These presentations highlighted the work underway to leverage Adverum’s leading capabilities in novel vector development.

2017 Outlook

 

  For ADVM-043, Adverum’s gene therapy product candidate for treating alpha-1 antitrypsin (A1AT) deficiency, the Company met with the U.S. Food and Drug Association (FDA) in July 2017 and plans to begin enrolling patients in a Phase 1/2 trial in the fourth quarter of 2017.

 

  For ADVM-053, Adverum’s gene therapy product candidate for treating hereditary angioedema (HAE), the Company held a pre-investigational new drug (IND) meeting in the first quarter of 2017 and is planning to file an IND application with the FDA.


  For ADVM-022, Adverum’s intravitreal injection gene therapy product candidate for wAMD, the Company held a pre-IND meeting with the FDA in the first quarter of 2017 and is planning to file an IND application with the FDA.

 

  Adverum plans to attend the following upcoming conferences:

 

    BioCentury’s NewsMakers Conference in New York on September 8, 2017

 

    Discovery on Target in Boston, September 25 – 29, 2017

 

    Cell & Gene Therapy CEO in New York on September 25, 2017

 

  Adverum’s cash, cash equivalents and marketable securities of $197.4 million as of June 30, 2017 are expected to fund the three lead gene therapy programs through the end of 2019 and through the achievement of meaningful clinical data in patients for at least one of the Company’s lead programs.

Financial Results for the Three Months Ended June 30, 2017

 

  Cash, cash equivalents and marketable securities were $197.4 million as of June 30, 2017, compared to $209.5 million as of March 31, 2017 and $222.2 million as of December 31, 2016.

 

  Revenues, consisting of revenue from collaborative research, were $0.5 million for the three months ended June 30, 2017, compared to $0.3 million for the same period in 2016.

 

  Research and development expenses were $8.5 million for the three months ended June 30, 2017, compared to $8.0 million for the same period in 2016. This increase was due to an overall increase in research and development activities for the Company’s three lead gene therapy programs.

 

  General and administrative expenses were $4.1 million for the three months ended June 30, 2017, compared to $5.1 million for the same period in 2016. This decrease was primarily due to lower professional fees as the 2016 period included Annapurna acquisition-related expenses.

 

  Net loss attributable to common stockholders was $11.4 million or $0.27 per basic and diluted share, for the three months ended June 30, 2017, compared to $61.7 million, or $1.76 per basic and diluted share, for the same period in 2016. The net loss for the three months ended June 30, 2016 included a non-cash goodwill impairment charge of $49.1 million in connection with the Annapurna transaction that closed in May 2016.

About Adverum Biotechnologies, Inc.

Adverum is a gene therapy company advancing novel medicines that may offer life-changing benefits to patients living with serious rare and ocular diseases. Adverum has a robust pipeline that includes product candidates designed to treat rare diseases alpha-1 antitrypsin (A1AT) deficiency and hereditary angioedema (HAE) as well as wet age-related macular degeneration (wAMD). Leveraging a next-generation adeno-associated virus (AAV)-based directed evolution platform, the Company generates product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum has collaboration agreements with Regeneron Pharmaceuticals to research, develop, and commercialize gene therapy products for ophthalmic diseases and Editas Medicine to explore the delivery of genome editing medicines for the treatment of inherited retinal diseases. Adverum’s core capabilities include clinical development and in-house manufacturing expertise, specifically in process development and assay development. For more information please visit www.adverum.com.


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 Adverum’s plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, financial condition and results of operations, the sufficiency of its cash, cash equivalents and marketable securities, as well as the advancement of, and anticipated development and regulatory milestones and plans related to, Adverum’s product candidates and preclinical and clinical studies, and the commercial potential of its product candidates, 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 consummate any plans or product or clinical development goals in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations or projections 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, the risk that Adverum’s resources will not be sufficient for Adverum to conduct or continue planned development programs and planned clinical trials, 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, the risk that Adverum will not be able to successfully develop or commercialize any of its product candidates and the risk that Adverum will be delayed in receiving or fail to receive required regulatory approvals. Risks and uncertainties facing Adverum are described more fully in Adverum’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. 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.

###


Contacts for Adverum:

Leone Patterson

Chief Financial Officer

650-665-7222

lpatterson@adverum.com

Charles Butler

Vice President, Investor Relations &

Corporate Communications

650-272-6260

cbutler@adverum.com


ADVERUM BIOTECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands)

     June 30,
2017
     December 31,
2016
 

ASSETS

     

Current assets:

     

Cash, cash equivalents and marketable securities

   $ 197,418      $ 222,170  

Receivable from collaborative partner

     —          886  

Prepaid expenses and other current assets

     2,223        2,218  
  

 

 

    

 

 

 

Total current assets

     199,641        225,274  

Property and equipment, net

     3,798        4,169  

Deposits and other long-term assets

     140        140  

Intangible assets

     5,000        5,000  
  

 

 

    

 

 

 

Total assets

   $ 208,579      $ 234,583  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable and accrued liabilities

   $ 6,351      $ 7,925  

Restructuring liabilities

     —          25  

Current portion of deferred rent

     112        96  

Current portion of deferred revenue

     1,850        1,850  
  

 

 

    

 

 

 

Total current liabilities

     8,313        9,896  

Deferred rent, less current portion

     293        352  

Deferred revenue, less current portion

     6,174        7,099  

Deferred tax liability

     1,250        1,250  

Other liabilities

     369        386  
  

 

 

    

 

 

 

Total liabilities

     16,399        18,983  

Stockholders’ equity

     192,180        215,600  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 208,579      $ 234,583  
  

 

 

    

 

 

 


ADVERUM BIOTECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share amounts)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2017     2016     2017     2016  

Collaboration and license revenue

   $ 463     $ 307     $ 925     $ 572  

Operating expenses:

        

Research and development

     8,492       7,955       17,553       15,410  

General and administrative

     4,064       5,114       12,053       13,432  

Impairment of goodwill and intangible assets

     —         49,120       —         49,120  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     12,556       62,189       29,606       77,962  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (12,093     (61,882     (28,681     (77,390

Other income (expense), net

     663       222       1,152       338  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss before income tax benefit

     (11,430     (61,660     (27,529     (77,052

Income tax benefit

     —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (11,430   $ (61,660   $ (27,529   $ (77,052
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.27   $ (1.76   $ (0.65   $ (2.50
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding, basic and diluted

     43,009       35,044       42,579       30,825