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 5, 2015

 

Dynavax Technologies Corporation

(Exact name of registrant as specified in its charter)

 

Commission File Number:  001-34207

 

Delaware

  

33-0728374

(State or other jurisdiction

of incorporation)

  

(IRS Employer

Identification No.)

2929 Seventh Street, Suite 100

Berkeley, CA 94710-2753

(Address of principal executive offices, including zip code)

(510) 848-5100

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

 

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 Condition

On March 5, 2015, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the year ended December 31, 2014. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.

The information with respect to item 2.02 in this current report and its accompanying exhibit shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01.    Financial Statements and Exhibits

(d) Exhibits. The following exhibit is furnished herewith:

99.1 Press Release, dated March 5, 2015 titled, "Dynavax Reports Fourth Quarter and Year End 2014 Financial Results"

 

 

 


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.

 

 

 

 

 

 

Dynavax Technologies Corporation

Date: March 5, 2015

 

 

 

By:

 

/s/  DAVID JOHNSON

 

 

 

 

 

David Johnson

 

 

 

 

 

Vice President

 

 

 


EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

 

 

 

EX-99.1

 

 

Press Release, dated March 5, 2015 titled, “Dynavax Reports Fourth Quarter and Year End 2014 Financial Results”

 



Exhibit 99.1

 

DYNΛVAX

INNOVATING IMMUNOLOGY

 

2929 Seventh Street, Suite 100

Berkeley, CA 94710

 

Contact:

 

 

Michael Ostrach

 

 

Chief Financial Officer

 

 

510-665-7257

 

 

mostrach@dynavax.com

 

 

 

 

DYNAVAX REPORTS FOURTH QUARTER AND YEAR END 2014

FINANCIAL RESULTS

 

BERKELEY, CA – March 5, 2015 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2014.

 

The Company had $122.7 million in cash, cash equivalents and marketable securities as of December 31, 2014. Loss from operations of $91.3 million for the year ended December 31, 2014 increased by $24.8 million compared to the year ended December 31, 2013 primarily as a result of expenses relating to conduct of clinical trials. A Phase 3 clinical trial of hepatitis B vaccine HEPLISAV-B™ (known as HBV-23) was initiated in the second quarter of 2014 and an independent Data and Safety Monitoring Board (DSMB) reviewed available data in early November 2014 and late February 2015 and recommended continuation of the trial without change. A Phase 1/2 study of SD-101 in combination with local radiation for the treatment of indolent lymphoma was initiated in the fourth quarter.

 

The net loss allocable to common stockholders for the twelve months ended December 31, 2014 was $90.7 million, or $3.45 per basic and diluted share. The net loss allocable to common stockholders for the twelve months ended December 31, 2013 was $75.2 million, or $3.83 per basic and diluted share, which includes a one-time non-cash deemed dividend of $8.5 million related to the beneficial conversion feature of the Series B Convertible Preferred Stock.

 

About HEPLISAV-B

 

HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

 

About SD-101

 

SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.


About Dynavax

 

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

 

– tables to follow –

 

 


 

DYNAVAX TECHNOLOGIES CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

 

Years Ended

 

 

December 31,

 

 

December 31,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

$

1,734

 

 

$

1,580

 

 

$

7,933

 

 

$

4,929

 

Grant revenue

 

142

 

 

 

1,283

 

 

 

2,688

 

 

 

5,138

 

Service and license revenue

 

401

 

 

 

(16

)

 

 

411

 

 

 

1,184

 

Total revenues

 

2,277

 

 

 

2,847

 

 

 

11,032

 

 

 

11,251

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

19,638

 

 

 

12,131

 

 

 

84,580

 

 

 

50,870

 

General and administrative

 

5,052

 

 

 

3,700

 

 

 

17,377

 

 

 

25,943

 

Unoccupied facility expense

 

-

 

 

 

8

 

 

 

386

 

 

 

926

 

Total operating expenses

 

24,690

 

 

 

15,839

 

 

 

102,343

 

 

 

77,739

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(22,413

)

 

 

(12,992

)

 

 

(91,311

)

 

 

(66,488

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

29

 

 

 

(47

)

 

 

191

 

 

 

116

 

Interest expense

 

(35

)

 

 

83

 

 

 

(35

)

 

 

-

 

Other income (expense), net

 

133

 

 

 

(100

)

 

 

433

 

 

 

(348

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(22,286

)

 

$

(13,056

)

 

$

(90,722

)

 

$

(66,720

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred stock deemed dividend

 

-

 

 

 

(8,469

)

 

 

-

 

 

 

(8,469

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss allocable to common stockholders

$

(22,286

)

 

$

(21,525

)

 

$

(90,722

)

 

$

(75,189

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share allocable to common stockholders

$

(0.85

)

 

$

(0.91

)

 

$

(3.45

)

 

$

(3.83

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share allocable to common stockholders

 

26,298

 

 

 

23,588

 

 

 

26,289

 

 

 

19,628

 

 

 


 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)

 

December 31,

 

 

December 31,

 

 

2014

 

 

2013

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

$

122,652

 

 

$

189,376

 

Property and equipment, net

 

7,924

 

 

 

8,706

 

Goodwill

 

2,277

 

 

 

2,579

 

Other assets

 

   5,437

 

 

 

    3,961

 

Total assets

$

138,290

 

 

$

204,622

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Deferred revenues

$

12,765

 

 

$

7,298

 

Other liabilities

 

15,484

 

 

 

11,030

 

Long-term debt

 

   9,559

 

 

 

            -

 

Total liabilities

 

37,808

 

 

 

18,328

 

Stockholders’ equity

 

100,482

 

 

 

186,294

 

Total liabilities and stockholders’ equity

$

138,290

 

 

$

204,622

 

# # #

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