Full Press Release Details
Trovagene Announces Fourth Quarter and Full-Year 2017 Results
SAN DIEGO, CA February 26, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage precision medicine biotechnology company, developing
targeted therapeutics to treat hematologic and solid tumor cancers, today announced company highlights and financial results for the fourth quarter and full-year ended December 31, 2017. The company is issuing this press release in lieu of
conducting a conference call.
I m very proud of our transformation and accomplishments in 2017 and excited as we begin 2018 executing on
strong clinical development programs for our lead drug candidate, PCM-075, with two active clinical studies underway, said Bill Welch, Chief Executive Officer of Trovagene. The first study is TROV-052 (ClinicalTrials.gov Identifier NCT03303339), a Phase 1b/2 open-label clinical trial of PCM-075 in patients with Acute Myeloid Leukemia (AML) in combination with standard-of-care. The second study is our UNITE (TROV-053), Phase 2 open-label clinical trial of
PCM-075 in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) in combination with abiraterone acetate (Zytiga ) and prednisone
(ClinicalTrials.gov Identifier: NCT03414034).
Trovagene reported a net loss of $2.6 million, or $0.06 per diluted share in the fourth quarter
of 2017, as compared to a net loss of $8.5 million, or $0.34 per diluted share, for the same quarter of 2016. Net cash used in operating activities in the fourth quarter of 2017 was $3.3 million, compared to $9.0 million in the fourth
quarter of 2016. These quarter-over-quarter reductions are attributed primarily to the reductions of sales, marketing and research expenses associated with diagnostic programs in order to focus on PCM-075
We are also excited about the positive preclinical data demonstrating significant synergy of
PCM-075 in combination with chemotherapies and targeted therapeutics, including cytarabine and abiraterone acetate, which are used in AML and mCRPC, respectively, said Mark Erlander, PhD, Chief
Scientific Officer of Trovagene. We believe the selective nature of PCM-075 to PLK1 may allow for enhanced combination treatments over
standard-of-care in a variety of hematologic and solid tumor cancers where there are high medical needs.
During the year ended December 31, 2017, the Company advanced its business with the following activities:
Fourth Quarter 2017 Financial Results
Year-End 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, 2017, 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.
VP, Corporate Communications
Condensed Consolidated Statements of Operations
(in thousands, except for per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 116 | $ | 50 | $ | 286 | $ | 258 | ||||||||
| Diagnostic services | 54 | 17 | 196 | 86 | ||||||||||||
| Clinical research services | 15 | 1 | 23 | 37 | ||||||||||||
| Total revenues | 185 | 68 | 505 | 381 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of revenues | 383 | 587 | 1,811 | 1,730 | ||||||||||||
| Research and development | 1,207 | 3,785 | 7,883 | 15,007 | ||||||||||||
| Selling and marketing | 292 | 2,396 | 2,735 | 11,523 | ||||||||||||
| General and administrative | 1,582 | 2,292 | 11,497 | 11,476 | ||||||||||||
| Restructuring charges | 505 | 790 | 2,175 | 790 | ||||||||||||
| Total operating expenses | 3,969 | 9,850 | 26,101 | 40,526 | ||||||||||||
| Loss from operations | (3,784 | ) | (9,782 | ) | (25,596 | ) | (40,145 | ) | ||||||||
| Net interest expense | (9 | ) | (408 | ) | (886 | ) | (1,376 | ) | ||||||||
| Gain on change in fair value of derivative financial instruments - warrants | 1,388 | 1,787 | 3,401 | 2,462 | ||||||||||||
| Loss on extinguishment of debt | (1,656 | ) | ||||||||||||||
| Other loss, net | (165 | ) | (145 | ) | (170 | ) | (145 | ) | ||||||||
| Net loss | $ | (2,570 | ) | $ | (8,548 | ) | $ | (24,907 | ) | $ | (39,204 | ) | ||||
| Preferred stock dividend | (6 | ) | (6 | ) | (24 | ) | (24 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (2,576 | ) | $ | (8,554 | ) | $ | (24,931 | ) | $ | (39,228 | ) | ||||
| Net loss per common share - basic | $ | (0.06 | ) | $ | (0.28 | ) | $ | (0.72 | ) | $ | (1.30 | ) | ||||
| Net loss per common share - diluted | $ | (0.06 | ) | $ | (0.34 | ) | $ | (0.72 | ) | $ | (1.37 | ) | ||||
| Weighted average shares outstanding - basic | 40,182 | 30,639 | 34,680 | 30,175 | ||||||||||||
| Weighted average shares outstanding - diluted | 40,182 | 30,712 | 34,680 | 30,281 |
Condensed Consolidated Balance Sheets
| December 31, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 8,226 | $ | 37,893 | ||||
| Accounts receivable | 77 | 100 | ||||||
| Prepaid expense and other current assets | 1,166 | 957 | ||||||
| Total current assets | 9,469 | 38,950 | ||||||
| Property and equipment, net | 2,426 | 3,827 | ||||||
| Other assets | 390 | 1,173 | ||||||
| Total Assets | $ | 12,285 | $ | 43,950 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 825 | 1,131 | |||||
| Accrued expenses | 1,455 | 4,021 | ||||||
| Deferred rent | 334 | 285 | ||||||
| Current portion of long-term debt | 1,332 | 2,360 | ||||||
| Total current liabilities | 3,946 | 7,797 | ||||||
| Long-term debt, less current portion | 14,176 | |||||||
| Derivative financial instruments - warrants | 649 | 835 | ||||||
| Deferred rent, net of current portion | 1,184 | 1,374 | ||||||
| Total Liabilities | 5,779 | 24,182 | ||||||
| Stockholders equity | 6,506 | 19,768 | ||||||
| Total liabilities and stockholders equity | $ | 12,285 | $ | 43,950 |
Condensed Consolidated Statements of Cash Flows
| Year Ended | ||||||||
| December 31, | ||||||||
| 2017 | 2016 | |||||||
| Operating activities | ||||||||
| Net loss | $ | (24,907 | ) | $ | (39,204 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,248 | 1,070 | ||||||
| Stock based compensation expense | 4,013 | 7,504 | ||||||
| Change in fair value of derivative financial instruments - warrants | (3,401 | ) | (2,462 | ) | ||||
| Loss on extinguishment of debt | 1,656 | |||||||
| Other non-cash items | 1,236 | 964 | ||||||
| Changes in operating assets and liabilities | (3,126 | ) | 1,088 | |||||
| Net cash used in operating activities | (23,281 | ) | (31,040 | ) | ||||
| Investing activities: | ||||||||
| Capital expenditures, net | (100 | ) | (823 | ) | ||||
| Net sales and maturities (purchase) of short-term investments | 24,062 | (24,010 | ) | |||||
| Net cash provided by (used in) investing activities | 23,962 | (24,833 | ) | |||||
| Financing activities: | ||||||||
| Proceeds from sales of common stock, net of expenses | 10,861 | 2,285 | ||||||
| Proceeds from exercise of options | 367 | |||||||
| Net repayment of debt | (17,239 | ) | (351 | ) | ||||
| Net cash used in (provided by) financing activities | (6,378 | ) | 2,301 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 8 | (6 | ) | |||||
| Net change in cash and equivalents | (5,689 | ) | (53,578 | ) | ||||
| Cash and cash equivalents Beginning of period | 13,915 | 67,493 | ||||||
| Cash and cash equivalents End of period | $ | 8,226 | $ | 13,915 |