Trovagene Announces Fourth Quarter and Year End 2015 Financial Results

SAN DIEGO, March 10, 2016 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today reported its financial results for the three months and year ended December 31, 2015.

"2015 was our coming out year, as the introduction of our liquid biopsy solution for cancer monitoring was met with great response by physicians," said Antonius Schuh, Ph.D., chief executive officer of Trovagene. "In support of our commercial efforts, we are assembling a compendium of clinical data, published manuscripts, and case studies in real-world settings that demonstrate the ability of our platform to improve the management of cancer patients by determining and tracking actionable oncogene mutations. Our goals for 2016 include increasing the number of oncologists using our assays in clinical practice, solidifying favorable health insurance reimbursement, and presenting and publishing additional clinical results from larger  data sets supporting the utility of our assay platform. Liquid biopsy for cancer monitoring offers tremendous potential, and we continue to be positioned well financially to execute on our business plan, improve the care of cancer patients, and increase stockholder value."

Fourth Quarter Financial Results

For the fourth quarter ended December 31, 2015, Trovagene reported a net loss of $7.4 million, or $0.26 per fully diluted common share, as compared to a net loss of $4.7 million, or $0.25 per fully diluted common share, for the fourth quarter ended December 31, 2014. The change in net loss is primarily due to increased operating expenses.

Year End 2015 Financial Results

For the year ended December 31, 2015, Trovagene reported a net loss of $27.5 million, or $1.21 per fully diluted common share, as compared to a net loss of $14.3 million, or $0.88 per fully diluted common share, for the year ended December 31, 2014. The increase in net loss is primarily due to increased operating expenses versus the prior year comparable period.

Cash and Cash Equivalents

Trovagene had cash and cash equivalents of approximately $67.5 million on December 31, 2015, as compared to approximately $27.3 million on December 31, 2014.

Summary of 2015 Activities

Trovagene continues to advance its Precision Cancer Monitoring^® (PCM) platform for the non-invasive monitoring of clinically actionable mutations for cancer patients. The Company currently has ongoing clinical collaborations to demonstrate the ability to determine and monitor mutational status and response to therapy in lung, colon, pancreatic, and skin cancer. Trovagene remains focused on commercializing its highly sensitive and quantitative liquid biopsy service for cancer monitoring.

In 2015, the Company's key accomplishments included the following:

Assembled commercial infrastructure and launched pilot marketing and sales program for Precision Cancer Monitoring platform

• Four sales professionals initially in the field, generated strong interest and ordering of PCM tests by practicing oncologists
• Trovagene Clinical Experience Program (CEP) deployed to enable trial use of technology by oncologists

Presented clinical study results at several medical and scientific conferences

• 2015 European Cancer Congress (ECC)
  • Quantitative detection and monitoring of circulating tumor DNA (ctDNA) and driver mutations can be used to rapidly determine treatment response
• World Lung Congress on Lung Cancer
  • Urine-based liquid biopsy platform shown to detect the impact of cancer therapy within 24 hours
• Next Generation DX summit
  • Clinical data in lung, colorectal, and pancreatic cancer demonstrate the utility of Trovagene's PCM platform as an important disease management tool
• 2015 American Association for Cancer Research Annual Meeting
  • Studies highlighted clinical utilities and advantages of Trovagene's PCM platform, including the ability to obtain significantly more ctDNA from urine samples versus plasma samples
• Association for Value-Based Cancer Care Meeting
  • Cost-benefit analysis of Trovagene's PCM platform demonstrated that the use of urinary liquid biopsy can significantly reduce costs when compared to tissue biopsy
• 2015 American Society of Clinical Oncology Annual Meeting
  • Studies addressed advantages of liquid biopsy over tissue biopsy and demonstrated ability to monitor tumor dynamics in lung, pancreatic, and colon cancers

Initiated study to monitor response to immunotherapy in melanoma patients  

• Study objective is to deliver a urinary liquid biopsy-based solution to provide faster and more accurate information for measuring response to immunotherapy

Strengthened balance sheet through two offerings of common stock

• Raised aggregate gross proceeds of approximately $63 million

Formed Trovagene Srl, also known as the Trovagene Research Institute, a European subsidiary

2016 Goals and Objectives

• Continue to build clinical evidence supporting the use of Trovagene's PCM platform
  • Submit 8 or more abstracts for presentation at key medical meetings in 2016
  • Submit up to 9 clinical and scientific manuscripts for publication that demonstrate the technical advantages and clinical utility of Trovagene's PCM platform
• Establish advantageous reimbursement relationships with third party administrators
  • Secure agreements representing more than 100 million covered lives
  • Finalize  comprehensive health-economic study plan
• Establish marketing and adoption parameters
  • Ensure high clinical interest and strong service levels
  • Expand sales and marketing presence in the oncology market
  • Conduct and document real-world case studies
• Engage in strategic partnerships for clinical trial service agreements and translational research collaborations, and to expand global presence
• Conduct  clinical studies with top academic institutions and comprehensive cancer centers

Trovagene will hold a conference call today at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific Standard Time) to review its fourth quarter and year end 2015 financial results. A live webcast of the Company's conference call will be available online at http://trovagene.investorroom.com/events. To access the conference call, please dial (888) 347-6081 (domestic), (412) 902-4285 (international), or (855) 669-9657 (Canada), conference ID# 10078930. To access a telephone replay of the call, dial (877) 344-7529 (domestic), (412) 317-0088 (international), or (855) 669-9658 (Canada), replay ID# 10078930. The replay will be available one hour after the conclusion of the call. The webcast and telephone replay will be archived on the Company's website following the conference. 

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company's technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene's precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

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 words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions. 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 need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; 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. There are no guarantees that any of our technologies or products will be utilized by oncologists or prove to be commercially successful, that Trovagene's PCM platform will ultimately be successful or result in better reimbursement outcomes or that Trovagene will meet any of its 2016 goals and objectives. 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 most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission.

(Financial Information to Follow)

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