Attached files

file filename
8-K - 8-K - Cardiff Oncology, Inc.a13-12430_18k.htm

Exhibit 99.1

 

GRAPHIC

 

Trovagene, Inc. Announces First Quarter 2013 Earnings

 

SAN DIEGO, CA — May 14, 2013 — Trovagene, Inc. (NASDAQ: TROV), a developer of transrenal molecular diagnostics, today reported its financial results for the three months ended March 31, 2013.

 

First Quarter 2013 Financial Results

 

For the first quarter ended March 31, 2013, Trovagene reported a net loss of $1.1 million, or $0.07 per share, as compared to a net loss of $1.2 million, or $0.11 per share, for the three months ended March 31, 2012. The decrease in net loss is primarily due to a change in the fair market value of derivative instruments — warrants which was offset by increased operating expenses the during first quarter of 2013 as compared to the prior year comparable period.

 

Cash and Cash Equivalents

 

Trovagene had cash and cash equivalents of $9.2 million at March 31, 2013, as compared to $10.8 million at December 31, 2012.

 

Review of First Quarter Announcements Demonstrate Progress in Development Programs

 

·                  Initiated a pilot launch HPV-HR assay, a urine-based molecular human papillomavirus (HPV) test.

 

·                  Extended planned offering of urine-based oncogene mutation tests to include a test for the detection of a specific p53 mutation and a specific double mutation in the hepatitis B virus.

 

·                  Expanded clinical collaboration with the University of Texas MD Anderson Cancer Center to include the detection of transrenal BRAF mutations in the urine of patients with advanced or metastatic cancers.

 

About Trovagene, Inc.

 

Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine. Trovagene has a strong patent position as it relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and

 



 

mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.

 

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2012 and other periodic reports filed with the Securities and Exchange Commission.

 

(Financial Information to Follow)

 

Contact

 

Trovagene, Inc.

 

Financial

Investor Relations

Stephen Zaniboni
Chief Financial Officer

Amy Caterina
Investor Relations

Trovagene, Inc.

Trovagene, Inc.

858-952-7594

858-952-7593

szaniboni@trovagene.com

acaterina@trovagene.com

 



 

Trovagene, Inc. and Subsidiaries

(A Development Stage Company)

Selected Financial Information

Consolidated Condensed Statements of Operations

 

(in thousands, except for per share amounts)

 

 

 

Three Months Ended
March 31,

 

 

 

2013

 

2012

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

Revenues

 

$

119

 

$

34

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

802

 

337

 

General and administrative

 

1,707

 

827

 

Total operating expenses

 

2,509

 

1,164

 

 

 

 

 

 

 

Operating loss

 

(2,390

)

(1,130

)

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

Change in fair market value of derivative instruments

 

1,279

 

(32

)

Net loss and comprehensive loss

 

(1,111

)

(1,162

)

 

 

 

 

 

 

Preferred stock dividend

 

(6

)

(10

)

Net loss and comprehensive loss attributable to common stockholders

 

$

(1,117

)

$

(1,172

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.07

)

$

(0.11

)

 

 

 

 

 

 

Weighted average shares outstanding - basic and diluted

 

15,510

 

11,002

 

 



 

Trovagene, Inc. and Subsidiaries

(A Development Stage Company)

Consolidated Condensed Balance Sheet Information

 

(in thousands)

 

 

 

March 31,
2013

 

December 31,
2012

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,164

 

$

10,820

 

Other assets

 

704

 

590

 

Property and equipment, net

 

330

 

255

 

Total assets

 

$

10,198

 

$

11,665

 

 

 

 

 

 

 

Accounts payable, accrued expenses and other liabilities

 

$

1,176

 

$

730

 

Derivative financial instruments

 

7,486

 

8,766

 

Stockholders’ equity

 

1,536

 

2,169

 

Total liabilities and stockholders’ equity

 

$

10,198

 

$

11,665

 

 

###