Dynavax Technologies Corporation
DYNAVAX TECHNOLOGIES CORP (Form: 8-K, Received: 03/13/2017 16:34:09)

 

 

 

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 13, 2017

 

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 13, 2017, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the quarter and year ended December 31, 2016. 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 13, 2017, titled "Dynavax Reports Fourth Quarter and Year End 2016 Financial Results and Company Update"

 

 

 

 


 

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 13, 2017

 

 

 

By:

 

/s/  DAVID JOHNSON

 

 

 

 

 

David Johnson

 

 

 

 

 

Vice President

 

 

 

 


 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

 

 

 

EX-99.1

 

 

Press Release, dated March 13, 2017, titled “Dynavax Reports Fourth Quarter and Year End 2016 Financial Results and Company Update”

 

 

Exhibit 99.1

 

DYN ΛV AX

        INNOVATING IMMUNOLOGY

 

 

DYNAVAX REPORTS FOURTH QUARTER AND YEAR END 2016 FINANCIAL RESULTS AND COMPANY UPDATE

--Key outcomes for multiple programs in 2017—

 

BERKELEY, CA – March 13, 2017 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2016.  The net loss for the year ended December 31, 2016 was $112.4 million, or $2.92 per share, compared to $106.8 million, or $3.25 per share, for the year ended December 31, 2015.

The Company had $81.4 million in cash, cash equivalents and marketable securities as of December 31, 2016, compared to $196.1 million at December 31, 2015. In addition, in the first quarter of 2017 the Company received proceeds of $23.3 million from sales of common stock under an at-the-market sales agreement.

“We are pleased with the continued progress of our immuno-oncology portfolio during 2016 and the recent promising clinical results from our combination trial in melanoma,” said Eddie Gray, chief executive officer for Dynavax. “With the expansion of SD-101 into Phase 2 in both melanoma and head and neck cancer this quarter, our marketing application for HEPLISAV-B under review by the FDA and our strong cash balance, we are in position to deliver key outcomes for several programs during 2017.”

Overview

During the last few years, the company has steadily advanced on its objective to evolve into an immuno-oncology company as it prepared for an anticipated launch of HEPLISAV-B™.  Following receipt of the HEPLISAV-B Complete Response Letter (CRL) from the FDA in November 2016, the company was restructured to focus resources on the immuno-oncology portfolio and to enable HEPLISAV-B to advance through the FDA review process to an approval decision. 

Recent Progress

SD-101

In early March, Dynavax presented promising clinical data from the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101 in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada, in patients with metastatic melanoma. Encouraging overall response rates and complete response rates in patients naïve to anti-PD-1 therapy were observed.

Based on the results of the initial dose escalation phase this trial is being expanded into Phase 2 studies in both melanoma and head and neck cancer. Patients will be enrolled in two cohorts, those naïve to anti-PD-1 treatment and patients who have progressive disease on anti-PD-1 therapy. The trial is designed to build on the encouraging results seen in the anti-PD-1 naïve patient group while allowing for continued dose escalation in patients who have progressive disease on anti-PD-1 therapies.

 


 

HEPLISAV-B

In February, Dynavax filed its responses to the November 2016 CRL issued by the FDA for HEPLISAV‐B, the company’s vaccine candidate intended for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established August 10, 2017 as the Prescription Drug User Fee Act (PDUFA) action date.

As part of the January restructuring, the company suspended manufacturing activities, commercial preparations and other longer term investment related to HEPLISAV-B during the regulatory review period and reduced its global workforce by approximately 40%.  If the product is approved, Dynavax plans to satisfy anticipated initial demand from existing stockpiled inventory and to scale up commercial activities based on market demand and investment priorities.

Financials

Total revenues were $7.3 million for the fourth quarter of 2016 and $11.0 million for the full year of 2016 compared to $0.7 million and $4.1 million for the same periods in 2015.  The increase was primarily due to recognition of $7.2 million under the research collaboration and license agreement with AstraZeneca related to the initiation of a Phase 2a clinical trial by AstraZeneca.

Research and development expenses were $18.4 million for the fourth quarter of 2016 and $84.5 million for the full year of 2016 compared to $20.9 million and $86.9 million for the same periods in 2015. This decrease was primarily due to a reduction in outside services expense associated with the completion of the HBV-23 clinical study in the fourth quarter of 2015, partially offset by an increase in headcount as well as regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses were $8.2 million for the fourth quarter of 2016 and $37.3 million for the full year of 2016 compared to $6.7 million and $22.2 million for the same periods in 2015. This increase was primarily due to costs related to preparation for the anticipated commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development as well as costs related to sourcing a debt financing commitment.  

About Dynavax

Dynavax is a clinical-stage immunology company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications, as a vaccine for the prevention of hepatitis B and as a disease modifying therapy for asthma. Dynavax's lead product candidates are SD-101, an investigational cancer immunotherapeutic currently in Phase 1/2 studies, and HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit  www.dynavax.com .

 


 

Forward Looking Statements

This release contains forward-looking statements, including statements regarding anticipated approval and launch of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether HEPLISAV-B will be approved by the FDA; whether or not FDA will require additional clinical trials; whether there will be a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and if so, what the outcome of the VRBPAC will be and whether it will impact the timing of FDA review or negatively impact the review and approval of the BLA; whether additional studies or manufacturing process enhancements will be required, or other issues will arise that will delay the BLA review or negatively impact the review and decision whether to approve HEPLISAV-B; if approvable, whether the issues will negatively impact the potential scope of the label claims and nature of the label content for HEPLISAV-B; whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements; and other risks detailed in the “Risk Factors” section of our most recent periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

 

Contact:

Ryan Spencer

VP, Corporate Strategy & Communications

510.665.4618

rspencer@dynavax.com

 


 

DYNAVAX TECHNOLOGIES CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

Three Months Ended

 

 

Years Ended

 

 

December 31,

 

 

December 31,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

$

7,200

 

 

$

535

 

 

$

9,778

 

 

$

2,765

 

Grant revenue

 

92

 

 

 

75

 

 

 

381

 

 

 

683

 

Service and license revenue

 

-

 

 

 

75

 

 

 

884

 

 

 

602

 

Total revenues

 

7,292

 

 

 

685

 

 

 

11,043

 

 

 

4,050

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

18,442

 

 

 

20,932

 

 

 

84,493

 

 

 

86,943

 

General and administrative

 

8,171

 

 

 

6,699

 

 

 

37,257

 

 

 

22,180

 

Total operating expenses

 

26,613

 

 

 

27,631

 

 

 

121,750

 

 

 

109,123

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(19,321

)

 

 

(26,946

)

 

 

(110,707

)

 

 

(105,073

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

140

 

 

 

127

 

 

 

755

 

 

 

205

 

Interest expense

 

-

 

 

 

-

 

 

 

-

 

 

 

(572

)

Other (expense) income, net

 

(2,560

)

 

 

(43

)

 

 

(2,492

)

 

 

317

 

Loss on extinguishment of debt

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,671

)

Net loss

$

(21,741

)

 

$

(26,862

)

 

$

(112,444

)

 

$

(106,794

)

Basic and diluted net loss per share

$

(0.56

)

 

$

(0.70

)

 

$

(2.92

)

 

$

(3.25

)

Weighted average shares used to compute basic and diluted net loss per share

 

38,544

 

 

 

38,429

 

 

 

38,506

 

 

 

32,881

 

 

 


 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)

 

 

December 31,

 

 

December 31,

 

 

2016

 

 

2015

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

$

81,415

 

 

$

196,125

 

Property and equipment, net

 

17,174

 

 

 

13,804

 

Goodwill

 

1,971

 

 

 

2,043

 

Other assets

 

9,120

 

 

 

4,661

 

Total assets

$

109,680

 

 

$

216,633

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Deferred revenues

$

-

 

 

$

2,654

 

Other liabilities

 

20,479

 

 

 

26,900

 

Total liabilities

 

20,479

 

 

 

29,554

 

Stockholders’ equity

 

89,201

 

 

 

187,079

 

Total liabilities and stockholders’ equity

$

109,680

 

 

$

216,633