Full Press Release Details
Trovagene Announces First Quarter 2018 Highlights and Financial Results
SAN DIEGO, CA May 8, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapies
to treat hematologic and solid tumor cancers, today announced company highlights and financial results for the first quarter ended March 31, 2018. The company is issuing this press release in lieu of conducting a conference call.
We are pleased with the rapid progress we are making in executing our clinical development programs in both hematologic and solid tumor cancers as well
as the support from investigators for our lead drug candidate, PCM-075, said Bill Welch, Chief Executive Officer of Trovagene. The first dosing cohort of
PCM-075 in combination with low-dose cytarabine (LDAC) in our Phase 1b/2 Acute Myeloid Leukemia (AML) study is fully enrolled, and we anticipate opening the next dosing
cohort to enrollment this quarter. Our second study, a Phase 2 trial of PCM-075 in combination with abiraterone acetate (Zytiga ) in patients with
metastatic Castration-Resistant Prostate Cancer (mCRPC), is on track to begin enrolling patients later this year with the Harvard Medical Cancer Centers.
Trovagene reported a net loss of $4.8 million, or $0.09 per diluted share in the first quarter of 2018, as compared to a net loss of $10.0 million,
or $0.32 per diluted share, for the same quarter of 2017. Net cash used in operating activities in the first quarter of 2018 was $2.9 million, compared to $8.8 million in the first quarter of 2017. These year-over year, and
quarter-over-quarter, reductions are attributed primarily to the elimination of expenses associated with diagnostic programs and transition of the Company to focus on therapeutics and the clinical development of its lead drug candidate, PCM-075.
During 2018 the Company has advanced its business with the following activities:
First Quarter 2018 Financial Results
About Trovagene, Inc.
Trovagene is a clinical-stage, oncology therapeutics company. The Company s primary focus is to develop oncology therapeutics for the treatment of
hematologic and solid tumor cancers for improved cancer care, utilizing its technology in tumor genomics. Trovagene has intellectual property and proprietary technology that enables the Company to analyze circulating tumor DNA (ctDNA) and clinically
actionable markers to identify patients most likely to respond to specific cancer therapies. Trovagene plans to continue to vertically integrate its tumor genomics technology with the development of targeted 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.
Condensed Consolidated Statements of Operations
(in thousands, except for per share amounts)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenues: | ||||||||
| Royalties | $ | 49 | $ | 66 | ||||
| Diagnostic services | 40 | 29 | ||||||
| Clinical research services | 11 | |||||||
| Total revenues | 100 | 95 | ||||||
| Costs and expenses: | ||||||||
| Cost of revenues | 366 | 616 | ||||||
| Research and development | 1,884 | 4,280 | ||||||
| Selling, general and administrative | 2,505 | 3,605 | ||||||
| Restructuring charges | 1,720 | |||||||
| Total operating expenses | 4,755 | 10,221 | ||||||
| Loss from operations | (4,655 | ) | (10,126 | ) | ||||
| Net interest expense | (2 | ) | (429 | ) | ||||
| Loss (gain) from change in fair value of derivative financial instruments- warrants | (130 | ) | 556 | |||||
| Other income | 1 | |||||||
| Net loss | (4,786 | ) | (9,999 | ) | ||||
| Preferred stock dividend | (6 | ) | (6 | ) | ||||
| Net loss attributable to common stockholders | $ | (4,792 | ) | $ | (10,005 | ) | ||
| Net loss per common share - basic | $ | (0.09 | ) | $ | (0.32 | ) | ||
| Net loss per common share - diluted | $ | (0.09 | ) | $ | (0.32 | ) | ||
| Weighted average shares outstanding - basic | 55,364 | 30,961 | ||||||
| Weighted average shares outstanding - diluted | 55,364 | 30,961 |
Condensed Consolidated Balance Sheets
| March 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,657 | $ | 8,226 | ||||
| Accounts receivable and unbilled receivable | 114 | 77 | ||||||
| Prepaid expense and other current assets | 1,068 | 1,166 | ||||||
| Total current assets | 7,834 | 9,469 | ||||||
| Property and equipment, net | 2,224 | 2,426 | ||||||
| Other assets | 345 | 390 | ||||||
| Total Assets | $ | 10,408 | $ | 12,285 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 652 | $ | 825 | ||||
| Accrued expenses | 1,685 | 1,455 | ||||||
| Deferred rent | 342 | 334 | ||||||
| Current portion of long-term debt | 1,175 | 1,332 | ||||||
| Total current liabilities | 3,854 | 3,946 | ||||||
| Derivative financial instruments - warrants | 779 | 649 | ||||||
| Deferred rent, net of current portion | 1,096 | 1,184 | ||||||
| Total Liabilities | 5,729 | 5,779 | ||||||
| Stockholders equity | 4,679 | 6,506 | ||||||
| Total Liabilities and Stockholders Equity | $ | 10,408 | $ | 12,285 |
Condensed Consolidated Statements of Cash Flows
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Operating activities | ||||||||
| Net loss | $ | (4,786 | ) | $ | (9,999 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 252 | 331 | ||||||
| Stock based compensation expense | 1,406 | 921 | ||||||
| Change in fair value of derivative financial instruments - warrants | 130 | (556 | ) | |||||
| Other non-cash items | (79 | ) | 775 | |||||
| Changes in operating assets and liabilities | 221 | (230 | ) | |||||
| Net cash used in operating activities | (2,856 | ) | (8,758 | ) | ||||
| Investing activities: | ||||||||
| Capital expenditures, net | (5 | ) | (11 | ) | ||||
| Net maturities of short-term investments | 5,195 | |||||||
| Net cash (used in) provided by investing activities | (5 | ) | 5,184 | |||||
| Financing activities: | ||||||||
| Proceeds from exercise of warrants | 1,449 | |||||||
| Repayment of debt | (157 | ) | (157 | ) | ||||
| Net cash provided by (used in) financing activities | 1,292 | (157 | ) | |||||
| Effect of exchange rate changes on cash and cash equivalents | (1 | ) | ||||||
| Net change in cash and equivalents | (1,569 | ) | (3,732 | ) | ||||
| Cash and cash equivalents Beginning of period | 8,226 | 13,915 | ||||||
| Cash and cash equivalents End of period | $ | 6,657 | $ | 10,183 |