TrovaGene Inc (NASDAQ:TROV), a developer of cell-free molecular diagnostics, today reported its financial results for the three months and nine months ended September 30, 2015.

“During the quarter, we made great progress introducing our liquid biopsy solution for cancer monitoring to physicians under our Clinical Experience Program,” said Antonius Schuh, Ph.D., chief executive officer of Trovagene. “In addition to our clinical study programs, we are now building a compendium of case studies in real-world settings that demonstrate the ability of our platform to improve the management of cancer patients by determining mutational status and tracking actionable mutations for response to therapy and disease progression. Our goals over the next several quarters remain clear and include increasing the number of oncologists using our assays in clinical practice, presenting and publishing additional clinical study results supporting the utility of our tests, and expanding the mutation coverage of our platform. Liquid biopsy for cancer monitoring offers tremendous potential, and our strong balance sheet positions us to execute on our business plan, improve the care of cancer patients, and increase shareholder value.”

Third Quarter 2015 Financial Results

For the third quarter ended September 30, 2015, Trovagene reported a net loss of $2.7 million, or $0.23 per fully diluted common share, as compared to a net loss of $5.4 million, or $0.28 per share, for the three months ended September 30, 2014. The decrease in net loss is primarily due to changes in the fair market value of derivative instruments during the third quarter of 2015 as compared to the prior year comparable period, partially offset by increased operating expenses.

Nine Months 2015 Financial Results

For the nine months ended September 30, 2015, Trovagene reported a net loss of $20.1 million, or $0.96 per fully diluted common share, as compared to a net loss of $9.7 million, or $0.62 per share, for the nine months ended September 30, 2014. The increase in net loss is primarily due to increased operating expenses and changes in the fair market value of derivative instruments during the first nine months of 2015 as compared to the prior year comparable period.

Cash and Cash Equivalents

Trovagene had cash and cash equivalents of approximately $74 million on September 30, 2015, as compared to approximately $27.3 million on December 31, 2014.

Review of Third Quarter Announcements Demonstrate Continued Progress in Development Programs and Commercialization

  • Formed Trovagene Research Institute subsidiary; Alberto Bardelli, Ph.D. appointed as Scientific Director
    • Core technologies and intellectual property transferred from University of Torino
  • Presented clinical data at the 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
  • Presented clinical data at the World Lung Congress on Lung Cancer
    • Urine-based liquid biopsy platform shown to detect the impact of cancer therapy within 24 hours
  • Presented clinical data at the Next Generation DX summit
    • Clinical data in lung, colorectal, and pancreatic cancer demonstrate the utility of Trovagene’s Precision Cancer Monitoring platform as an important disease management tool
  • 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
  • Released results from second large-scale clinical trial for urine based HPV-HR assay
    • Results demonstrate the ability to detect high-risk HPV from precancerous lesions with high sensitivity using a convenient and non-invasive urine sample
  • Completed offering of common stock
    • Company raises gross proceeds of approximately $40.3 million

Reiteration of 2015 Goals and Objectives

  • Introduce and gain adoption of our PCM platform among strategically selected clinicians and institutions
  • Complete and conduct additional clinical studies at major oncology centers and through collaborations with integrated healthcare networks
  • Present and publish clinical results for studies using Trovagene’s PCM platform as they become available
  • Complete CLIA development and release additional urine-based assays to expand Trovagene’s liquid biopsy platform for the detection and monitoring of multiple clinically actionable oncogene mutations in parallel
  • Enter into additional R&D and commercial collaborations with pharmaceutical companies (Original Source)

Shares of TrovaGene are up 3.48% to $4.76 in after-hours trading. TROV has a 1-year high of $13.58 and a 1-year low of $4.02. The stock’s 50-day moving average is $5.35 and its 200-day moving average is $7.99.

On the ratings front, TrovaGene has been the subject of a number of recent research reports. In a report issued on October 27, Maxim Group analyst Jason Kolbert maintained a Buy rating on TROV, with a price target of $13, which implies an upside of 171.4% from current levels. Separately, on September 15, Cantor Fitzgerald’s Bryan Brokmeier initiated coverage with a Buy rating on the stock and has a price target of $10.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Bryan Brokmeier have a total average return of -14.6% and 4.5% respectively. Kolbert has a success rate of 29.4% and is ranked #3825 out of 3829 analysts, while Brokmeier has a success rate of 53.7% and is ranked #1305.

TrovaGene Inc is a development stage molecular diagnostic company. It focuses on the development and marketing of urine-based nucleic acid tests for patient/disease screening and monitoring.