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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cardiff Oncology Inc | NASDAQ:CRDF | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.06 | -1.70% | 3.46 | 3.43 | 3.50 | 3.63 | 3.11 | 3.55 | 1,713,971 | 21:00:10 |
SAN DIEGO, Nov. 9, 2017 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a clinical-stage precision medicine biotechnology company, today announced company highlights and financial results for the third quarter ended September 30, 2017. The company is issuing this press release in lieu of conducting a conference call.
"We are excited by our continued clinical research advancement of PCM-075, our oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor," said Bill Welch, Chief Executive Officer of Trovagene, "including the FDA's authorization to proceed with our Phase 1b/2 clinical trial in acute myeloid leukemia (AML) as well as the granting of Orphan Drug Designation by the FDA for PCM-075 to treat patients with AML."
Company Highlights
Trovagene made significant progress in the third quarter to advance the clinical research of PCM-075 for solid and hematologic tumor cancers, including the publication of a Phase 1 safety study of PCM-075 in patients with advanced metastatic solid tumors, the FDA's authorization to proceed with a Phase 1b/2 trial in AML and the announcement of multiple combination preclinical studies demonstrating apparent synergy of PCM-075 in combination with ten different chemotherapeutics commonly used in solid and hematologic tumor cancers as well as targeted therapies, such as abiraterone acetate, and FLT3 inhibitors.
"We are increasingly encouraged by the synergy data observed with the combination of PCM-075 and abiraterone acetate," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. Abiraterone acetate, marketed as Zytiga® by Centocor Ortho Biotech, Inc., a member of the Johnson & Johnson family of companies, is the leading global anti-androgen therapy for metastatic Castration-Resistant Prostate Cancer (mCRPC) with 2016 sales in excess of $2.0 billion. "Even with broad adoption of Zytiga®, we believe there continues to be a large medical need to extend its benefit of response in mCRPC. We are working closely with key investigators to develop a Phase 2 clinical trial protocol with oral dosing of PCM-075 and abiraterone with a planned submission to our existing solid tumor IND," said Dr. Erlander.
Other Clinical Development Highlights of PCM-075
Third 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 September 30, |
Nine Months Ended September 30, | ||||||||||||
2017 |
2016 |
2017 |
2016 | ||||||||||
Revenues: |
|||||||||||||
Royalties |
$ |
59 |
$ |
47 |
$ |
170 |
$ |
208 | |||||
Diagnostic services |
58 |
38 |
142 |
69 | |||||||||
Clinical research services |
6 |
4 |
8 |
36 | |||||||||
Total revenues |
123 |
89 |
320 |
313 | |||||||||
Costs and expenses: |
|||||||||||||
Cost of revenues |
474 |
424 |
1,428 |
1,143 | |||||||||
Research and development |
1,414 |
3,937 |
6,676 |
||||||||||
Selling and marketing |
420 |
2,941 |
2,443 |
9,127 | |||||||||
General and administrative |
3,659 |
2,711 |
9,915 |
9,184 | |||||||||
Restructuring charges |
(46) |
- |
1,670 |
- | |||||||||
Total operating expenses |
5,921 |
10,013 |
22,132 |
30,676 | |||||||||
Loss from operations |
(5,798) |
(9,924) |
(21,812) |
(30,363) | |||||||||
Net interest expense |
(16) |
(355) |
(877) |
(968) | |||||||||
Gain on change in fair value of derivative financial instruments- warrants |
1,529 |
88 |
2,013 |
675 | |||||||||
Loss on extinguishment of debt |
- |
- |
(1,656) |
- | |||||||||
Other loss, net |
(7) |
- |
(5) |
- | |||||||||
Net loss |
$ |
(4,292) |
$ |
(10,191) |
$ |
(22,337) |
$ |
(30,656) | |||||
Preferred stock dividend |
(6) |
(6) |
(18) |
(18) | |||||||||
Net loss attributable to common stockholders |
$ |
(4,298) |
$ |
(10,197) |
$ |
(22,355) |
$ |
(30,674) | |||||
Net loss per common share - basic |
$ |
(0.12) |
$ |
(0.34) |
$ |
(0.68) |
$ |
(1.02) | |||||
Net loss per common share - diluted |
$ |
(0.12) |
$ |
(0.34) |
$ |
(0.68) |
$ |
(1.04) | |||||
Weighted average shares outstanding - basic |
36,466 |
30,340 |
32,826 |
30,019 | |||||||||
Weighted average shares outstanding - diluted |
36,466 |
30,340 |
32,826 |
30,137 |
Trovagene, Inc. | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
September 30, 2017 |
December 31, |
||||||||
Assets |
|||||||||
Current assets: |
|||||||||
Cash, cash equivalents and short-term investments |
$ |
7,435 |
$ |
37,893 |
|||||
Accounts receivable |
178 |
100 |
|||||||
Prepaid expense and other current assets |
939 |
957 |
|||||||
Total current assets |
8,552 |
38,950 |
|||||||
Property and equipment, net |
3,127 |
3,827 |
|||||||
Other assets |
539 |
1,173 |
|||||||
Total Assets |
$ |
12,218 |
$ |
43,950 |
|||||
Liabilities and Stockholders' Equity |
|||||||||
Current liabilities: |
|||||||||
Accounts payable |
$ |
676 |
1,131 |
||||||
Accrued expenses |
2,620 |
4,021 |
|||||||
Deferred rent |
298 |
285 |
|||||||
Current portion of long-term debt |
1,488 |
2,360 |
|||||||
Total current liabilities |
5,082 |
7,797 |
|||||||
Long-term debt, less current portion |
- |
14,176 |
|||||||
Derivative financial instruments - warrants |
2,038 |
835 |
|||||||
Deferred rent, net of current portion |
1,153 |
1,374 |
|||||||
Total Liabilities |
8,273 |
24,182 |
|||||||
Stockholders' equity |
3,945 |
19,768 |
|||||||
Total liabilities and stockholders' equity |
$ |
12,218 |
$ |
43,950 |
Trovagene, Inc. | ||||
Condensed Consolidated Statements of Cash Flows | ||||
(in thousands) | ||||
Nine Months Ended | ||||
September 30, | ||||
2017 |
2016 | |||
Operating activities |
||||
Net loss |
$ (22,337) |
$ (30,656) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||
Depreciation and amortization |
957 |
694 | ||
Stock based compensation expense |
3,117 |
5,942 | ||
Change in fair value of derivative financial instruments - warrants |
(2,013) |
(675) | ||
Loss on extinguishment of debt |
1,656 |
- | ||
Other non-cash items |
638 |
311 | ||
Changes in operating assets and liabilities |
(1,968) |
2,349 | ||
Net cash used in operating activities |
(19,950) |
(22,035) | ||
Investing activities: |
||||
Capital expenditures, net |
(136) |
(798) | ||
Net sales and maturities (purchase) of short-term investments |
24,062 |
(24,451) | ||
Net cash provided by (used in) investing activities |
23,926 |
(25,249) | ||
Financing activities: |
||||
Proceeds from sales of common stock, net of expenses |
6,635 |
2,294 | ||
Proceeds from exercise of options |
- |
367 | ||
Net repayment of debt |
(17,083) |
(299) | ||
Net cash (used in) provided by financing activities |
(10,448) |
2,362 | ||
Effect of exchange rate changes on cash and cash equivalents |
(9) |
(2) | ||
Net change in cash and equivalents |
(6,481) |
(44,924) | ||
Cash and cash equivalents—Beginning of period |
13,915 |
67,493 | ||
Cash and cash equivalents—End of period |
$ 7,434 |
$ 22,569 |
View original content with multimedia:http://www.prnewswire.com/news-releases/trovagene-announces-third-quarter-2017-company-highlights-and-financial-results-300553000.html
SOURCE Trovagene, Inc.
Copyright 2017 PR Newswire
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