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8-K - 8-K - DYNAVAX TECHNOLOGIES CORPdvax-8k_20151105.htm

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 THIRD QUARTER 2015

FINANCIAL RESULTS

 

BERKELEY, CA – November 5, 2015 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2015.

 

The Company had $220.7 million in cash, cash equivalents and marketable securities as of September 30, 2015, compared to $93.4 million at June 30, 2015. The balance at September 30, 2015 includes approximately $164 million of net proceeds from sales of common stock in the third quarter and reflects payment of all principal and accrued interest, prepayment charges and other fees totaling approximately $11 million under a loan agreement.

 

Operating expenses of $29.6 million for the quarter ended September 30, 2015 increased by $4.8 million compared to the quarter ended June 30, 2015 primarily due to production, clinical trial and commercial preparation costs.

 

We recently initiated a clinical trial to evaluate the combination of our cancer immunotherapeutic product candidate SD-101 and Merck's KEYTRUDA® (pembrolizumab) in patients with metastatic melanoma. All study visits for HBV-23, the Phase 3 clinical study of HEPLISAV-B™, were completed in October 2015. Top line results of this study are expected to be released in early 2016.  

 

The net loss allocable to common stockholders for the quarter ended September 30, 2015 was $30.1 million, or $0.82 per basic and diluted share. The net loss allocable to common stockholders for the quarter ended June 30, 2015 was $23.6 million, or $0.80 per basic and diluted share.

 

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information visit www.dynavax.com.

 


 

Forward Looking Statements

This release contains forward-looking statements, including statements regarding expected timing of results from HBV-23. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether HBV-23 can be completed as expected, whether the endpoints of the study will be achieved and the final results otherwise be satisfactory, whether successful development and approval of HEPLISAV-B and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether clinical studies for our products can be enrolled, supplied and completed in a timely manner and will be sufficient for further development or for marketing approval; the potential size and value of approved indications addressable with HEPLISAV-B and the commercial potential for HEPLISAV-B; initiation and completion of pre-clinical studies and clinical trials of our other product candidates; 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; achieving the objectives of and maintaining our collaborative and licensing agreements; our ability to execute on our commercial strategies; whether our financial resources will be adequate without the need to obtain additional financing and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this presentation. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available.

 

 

 

– tables to follow –

 


 

DYNAVAX TECHNOLOGIES CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2015

 

 

2014

 

 

2015

 

 

2014

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

$

829

 

 

$

1,795

 

 

$

2,230

 

 

$

6,199

 

Grant revenue

 

359

 

 

 

414

 

 

 

608

 

 

 

2,546

 

Service and license revenue

 

-

 

 

 

-

 

 

 

527

 

 

 

10

 

Total revenues

 

1,188

 

 

 

2,209

 

 

 

3,365

 

 

 

8,755

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

24,105

 

 

 

28,072

 

 

 

66,011

 

 

 

64,942

 

General and administrative

 

5,524

 

 

 

4,083

 

 

 

15,481

 

 

 

12,325

 

Unoccupied facility expense

 

-

 

 

 

131

 

 

 

-

 

 

 

386

 

Total operating expenses

 

29,629

 

 

 

32,286

 

 

 

81,492

 

 

 

77,653

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(28,441

)

 

 

(30,077

)

 

 

(78,127

)

 

 

(68,898

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

33

 

 

 

42

 

 

 

78

 

 

 

162

 

Interest expense

 

(62

)

 

 

-

 

 

 

(572

)

 

 

-

 

Other income, net

 

17

 

 

 

216

 

 

 

360

 

 

 

300

 

Loss on extinguishment of debt

 

(1,671

)

 

 

-

 

 

 

(1,671

)

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(30,124

)

 

$

(29,819

)

 

$

(79,932

)

 

$

(68,436

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.82

)

 

$

(1.13

)

 

$

(2.43

)

 

$

(2.60

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share

 

36,532

 

 

 

26,291

 

 

 

32,880

 

 

 

26,288

 

 

 

 


 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

 

 

September 30,

 

 

December 31,

 

 

2015

 

 

2014

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

$

220,697

 

 

$

122,652

 

Property and equipment, net

 

11,606

 

 

 

7,924

 

Goodwill

 

2,106

 

 

 

2,277

 

Other assets

 

4,498

 

 

 

5,437

 

Total assets

$

238,907

 

 

$

138,290

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Deferred revenues

$

10,546

 

 

$

12,765

 

Other liabilities

 

17,173

 

 

 

15,484

 

Long-term debt

 

-

 

 

 

9,559

 

Total liabilities

 

27,719

 

 

 

37,808

 

Stockholders’ equity

 

211,188

 

 

 

100,482

 

Total liabilities and stockholders’ equity

$

238,907

 

 

$

138,290

 

 

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