Full Press Release Details
Trovagene Announces Second Quarter 2018 Highlights and Financial Results
SAN DIEGO, CA August 3, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics
for the treatment of leukemias, lymphomas and solid tumor cancers, today announced company highlights and financial results for the second quarter ended June 30, 2018. The company is issuing this press release in lieu of conducting a conference
We are continuing to advance our clinical development of PCM-075 in Acute Myeloid Leukemia (AML) and metastatic
Castration-Resistant Prostate Cancer (mCRPC), achieving several key milestones during the second quarter, said Tom Adams, Executive Chairman of Trovagene. In our AML trial, we have successfully completed treatment of 10 patients with PCM-075, 6 at the first dose level of 12 mg/m2 and 4 at the second dose level of 18 mg/m2, in combination
with either low-dose cytarabine (LDAC) or decitabine. I m also pleased to report that we received Investigational Review Board (IRB) approval for our Phase 2 trial of
PCM-075 in combination with abiraterone acetate (Zytiga ) in patients with mCRPC from the Harvard Medical Cancer Centers and patient recruitment is
During the second quarter of 2018 the Company has advanced its business with the following activities:
On June 27, 2018, Trovagene announced preliminary clinical data from the first dosing cohort
showing a treatment effect with PCM-075 in combination with low-dose cytarabine (LDAC) or decitabine, as measured by decreases in leukemic cells in both peripheral blood
and bone marrow in patients in its ongoing Phase 1b/2 trial in relapsed or refractory Acute Myeloid Leukemia (AML). Both blood and bone marrow samples were obtained from patients with relapsed or refractory AML enrolled in the Phase 1b/2 trial prior
to, and at timepoints following administration of PCM-075, in combination with cytarabine or decitabine. Among the 6 patients evaluated, no dose-limiting toxicities (DLTs) were observed that would prohibit
further escalation of the PCM-075 dosing. Three patients exhibited substantial reductions in the percentage of both circulating leukemic cells within the blood and leukemic cells within the bone marrow. Two of
these three patients continued on treatment in the second cycle and further decreases in circulating leukemic cells in the blood and within the bone marrow were observed. One patient had a decrease in his bone marrow blasts from 96% to 40% at the
end of cycle 2 and has continued on treatment in cycle 3.
On June 21, 2018, Trovagene announced it has received Institutional Review Board (IRB) approval from Dana-Farber/Harvard Cancer Center and its Phase
2 clinical trial of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone in mCRPC is officially activated and recruiting patients.
The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the
principal investigator for the trial.
On June 15, 2018, Trovagene announced completion of the first
dose cohort of PCM-075 in combination with decitabine, in its Phase 1b/2 clinical trial in patients with AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine. The combination of
PCM-075 and decitabine was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at 18 mg/m2 of PCM-075 (approximately a 50% increase) in combination with decitabine.
On May 17, 2018, Trovagene announced the completion
of the first dose cohort in its Phase 1b/2 clinical trial of PCM-075 in combination with LDAC, in AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with LDAC. Patients eligible for Phase 1b have relapsed or refractory
disease and may have received as many as three prior regimens for treatment of their AML. The combination of PCM-075 and LDAC was well tolerated in all patients. The independent Safety Review Committee (SRC)
has recommended escalating to the second dose cohort of three patients at PCM-075 at 18 mg/m2 (approximately a 50% increase) in combination with LDAC.
2018, Trovagene announced the presentation of pharmacodynamic and biomarker data from the first patient to complete a safety treatment cycle in its Phase 1b/2 clinical trial of PCM-075 in AML at the American
Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. The poster entitled Pharmacodynamic and Tumor Biomarker Analysis of a PLK1 Inhibitor, PCM-075, in a Phase 1b/2 Trial for Acute Myeloid
Leukemia presents the methodology developed to track dynamic changes in blood leukemic cells, genomic alterations and PLK1 inhibition in AML patients treated with PCM-075 in combination with LDAC.
On April 16, 2018, Trovagene announced the
presentation of data showing that PCM-075 exhibits synergistic activity when combined with FLT3 inhibitors in a human xenograft AML model, at the AACR Annual Meeting in Chicago, IL. The poster entitled
Selective Polo-like Kinase 1 (PLK1) Inhibitor PCM-075 is Highly Active Alone and Shows Synergy When Combined with FLT3 Inhibitors in Models of Acute Myeloid Leukemia (AML) presents data demonstrating
that PCM-075 in combination with quizartinib (Daiichi-Sankyo) resulted in 97.3% tumor growth inhibition (TGI), compared to 77.9% with quizartinib and 80.2% with PCM-075
Second Quarter 2018 Financial Results
About Trovagene, Inc.
Trovagene is a clinical-stage,
oncology therapeutics company, using a precision medicine approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including leukemias/lymphomas and solid tumors. 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
VP, Corporate Communications
Condensed Consolidated Statements of Operations
(in thousands, except for per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 53 | $ | 45 | $ | 102 | $ | 111 | ||||||||
| Diagnostic services | 39 | 55 | 79 | 84 | ||||||||||||
| Clinical research services | 20 | 2 | 31 | 2 | ||||||||||||
| Total revenues | 112 | 102 | 212 | 197 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of revenues | 204 | 338 | 570 | 954 | ||||||||||||
| Research and development | 1,953 | 982 | 3,837 | 5,262 | ||||||||||||
| Selling, general and administrative | 2,151 | 4,674 | 4,656 | 8,279 | ||||||||||||
| Restructuring charges (benefit) | 243 | (4) | 243 | 1,716 | ||||||||||||
| Total operating expenses | 4,551 | 5,990 | 9,306 | 16,211 | ||||||||||||
| Loss from operations | (4,439) | (5,888) | (9,094) | (16,014) | ||||||||||||
| Net interest income (expense) | 35 | (432) | 33 | (861) | ||||||||||||
| Gain (loss) on change in fair value of derivative financial instruments- warrants | 711 | (72) | 581 | 484 | ||||||||||||
| Gain (loss) on extinguishment of debt | 18 | (1,656) | 18 | (1,656) | ||||||||||||
| Other (loss) income, net | (72) | 2 | (71) | 2 | ||||||||||||
| Net loss | (3,747) | (8,046) | (8,533) | (18,045) | ||||||||||||
| Preferred stock dividend | (2,776) | (6) | (2,782) | (12) | ||||||||||||
| Net loss attributable to common stockholders | $ | (6,523) | $ | (8,052) | $ | (11,315) | $ | (18,057) | ||||||||
| Net loss per common share basic and diluted | $ | (0.88) | $ | (3.12) | $ | (1.88) | $ | (7.00) | ||||||||
| Weighted average shares outstanding basic and diluted | 7,423 | 2,583 | 6,026 | 2,581 |
Condensed Consolidated Balance Sheets
| June 30, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 18,517 | $ | 8,226 | ||||
| Accounts receivable and unbilled receivable | 124 | 77 | ||||||
| Prepaid expense and other assets | 1,002 | 1,166 | ||||||
| Total current assets | 19,643 | 9,469 | ||||||
| Property and equipment, net | 1,804 | 2,426 | ||||||
| Other assets | 321 | 390 | ||||||
| Total Assets | $ | 21,768 | $ | 12,285 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 565 | $ | 825 | ||||
| Accrued expenses | 2,303 | 1,455 | ||||||
| Deferred rent | 350 | 334 | ||||||
| Current portion of long-term debt | - | 1,332 | ||||||
| Total current liabilities | 3,218 | 3,946 | ||||||
| Derivative financial instruments - warrants | 68 | 649 | ||||||
| Deferred rent, net of current portion | 1,005 | 1,184 | ||||||
| Total Liabilities | 4,291 | 5,779 | ||||||
| Stockholders equity | 17,477 | 6,506 | ||||||
| Total liabilities and stockholders equity | $ | 21,768 | $ | 12,285 |
Condensed Consolidated Statements of Cash Flows
| Six Months Ended June 30, | ||||||||
| 2018 | 2017 | |||||||
| Operating activities | ||||||||
| Net loss | $ (8,533) | $ (18,045) | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 484 | 646 | ||||||
| Stock based compensation expense | 1,627 | 1,696 | ||||||
| Change in fair value of derivative financial instruments - warrants | (582) | (484) | ||||||
| Gain (loss) on extinguishment of debt | (18) | 1,656 | ||||||
| Other non-cash items | 222 | 709 | ||||||
| Changes in operating assets and liabilities | 693 | 467 | ||||||
| Net cash used in operating activities | (6,107) | (13,355) | ||||||
| Investing activities: | ||||||||
| Capital expenditures, net | (5) | (21) | ||||||
| Net (purchase) sales and maturities of short-term investments | (32) | 24,062 | ||||||
| Net cash (used in) provided by investing activities | (37) | 24,041 | ||||||
| Financing activities: | ||||||||
| Proceeds from sales of common stock and warrants, net of expenses | 11,779 | 107 | ||||||
| Proceeds from sales of Series B Convertible Preferred Stock, net of expenses | 4,387 | - | ||||||
| Proceeds from exercise of warrants | 1,613 | - | ||||||
| Net repayment of debt | (1,375) | (16,926) | ||||||
| Net cash provided by (used in) financing activities | 16,404 | (16,819) | ||||||
| Effect of exchange rate changes on cash and cash equivalents | - | (2) | ||||||
| Net change in cash and equivalents | (10,260) | (6,131) | ||||||
| Cash and cash equivalents Beginning of period | 8,226 | 13,915 | ||||||
| Cash and cash equivalents End of period | $ 18,486 | $ 7,784 |
Non-GAAP Financial Measures
Adjusted net loss per common share is not a measure of financial performance under accounting principles generally accepted in the United States ( GAAP ) and
should not be construed as substitutes for, or superior to, GAAP net loss per common share as a measure of financial performance. However, management may from time to time use both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the Company s operations and to better understand its business. Further, management believes the addition of
non-GAAP financial measures provides meaningful supplementary information to, and facilitates analysis by, investors in evaluating the Company s financial performance, results of operations and trends.
The Company s calculations of adjusted net loss per common share may not be comparable to similarly designated measures reported by other companies, since companies and investors may differ as to what type of events warrant adjustment.
The following table reconciles reported net loss per common share to adjusted net loss per common share:
| Three Months Ended June 30, | ||||||||
| 2018 | 2017 | |||||||
| GAAP net loss per share attributable to stockholders - diluted | $ (0.88) | $ (3.12) | ||||||
| Adjustment for preferred stock dividend recognized from beneficial conversion features of Series B Convertible Preferred Stock issuance | 0.44 | |||||||
| Non-GAAP net loss per share attributable to stockholders - diluted | $ (0.44) | $ (3.12) | ||||||
| GAAP net loss attributable to stockholders | $(6,522,548) | $(8,051,871) | ||||||
| Adjustment for preferred stock dividend recognized from beneficial conversion features of Series B Convertible Preferred Stock issuance | 2,769,533 | |||||||
| Non-GAAP net loss attributable to stockholders | $ (3,753,015) | $ (8,051,871) | ||||||
| GAAP weighted average shares outstanding - diluted | 6,026,345 | 2,581,372 | ||||||
| Adjustment for Series B Convertible Preferred Stock | 593,094 | |||||||
| Non-GAAP weighted average shares outstanding - diluted | 6,619,439 | 2,581,372 |