PR Newswire
SAN DIEGO, Aug. 9, 2017
SAN DIEGO, Aug. 9, 2017 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced company highlights and financial results for the second quarter ended June 30, 2017. The company does not plan to have an earnings conference call.
"We are pleased by the continued advancement of our clinical development plans for PCM-075, our novel, investigational, orally available and highly selective polo-like kinase 1 (PLK1) inhibitor, including the FDA approval of our IND and Phase 1b/2 protocol to commence our trial in patients with acute myeloid leukemia (AML)," said Bill Welch, Chief Executive Officer of Trovagene. "We are also pleased with our ongoing collaborations we recently announced with our NextCollect™ urine collections and DNA preservation device and liquid biopsy tests. These partnerships support the value of our tumor genomics and correlative biomarker technology."
Company Highlights
Updated Progress Towards the Clinical Development of PCM-075
We acquired, in March 2017, the exclusive global rights for the development and commercialization of PCM-075, an oral and highly-selective polo-like kinase 1 (PLK1) inhibitor, from Nerviano Medical Sciences, S.r.l.
Precision Medicine Programs
General and Administrative
Second Quarter 2017 Financial Results
About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit https://www.trovagene.com/.
Forward-Looking Statements
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, our need for additional financing; our ability to continue as a going concern; 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; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene's strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Trovagene Contact:
Vicki Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com
Trovagene, Inc. Condensed Consolidated Statements of Operations (in thousands, except for per share amounts) | | | ||||||||||||
| | | | | | | | | | | | |||
| | Three Months Ended | | Six Months Ended | | | ||||||||
| | 2017 | | 2016 | | 2017 | | 2016 | | | ||||
| | | | | | | | | | | | |||
Revenues: | | | | | | | | | | | | |||
Royalties | | $ | 45 | | $ | 48 | | $ | 111 | | $ | 161 | | |
Diagnostic services | | | 55 | | | 24 | | | 84 | | 31 | | | |
Clinical research services | | | 2 | | | 32 | | | 2 | | 32 | | | |
Total revenues | | | 102 | | | 104 | | | 197 | | 224 | | | |
| | | | | | | | | | | ||||
Costs and expenses: | | | | | | | | | | | ||||
Cost of revenues | | 338 | | 410 | | 954 | | 719 | | | ||||
Research and development | | 982 | | 4,076 | | 5,262 | | 7,284 | | | ||||
Selling and marketing | | 615 | | 3,129 | | 2,023 | | 6,187 | | | ||||
General and administrative | | 4,059 | | 2,469 | | 6,256 | | 6,473 | | | ||||
Restructuring charges | | (4) | | - | | 1,716 | | - | | | ||||
Total operating expenses | | 5,990 | | 10,084 | | 16,211 | | 20,663 | | | ||||
| | | | | | | | | | | ||||
Loss from operations | | (5,888) | | (9,980) | | (16,014) | | (20,439) | | | ||||
| | | | | | | | | | | ||||
Net interest expense | | (432) | | (275) | | (861) | | (613) | | | ||||
Gain (loss) on change in fair value of derivative financial instruments- warrants | | (72) | | 53 | | 484 | | 587 | | | ||||
Loss on extinguishment of debt | | (1,656) | | - Werbung Mehr Nachrichten zur Cardiff Oncology Aktie kostenlos abonnieren
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