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
- Announced results of preclinical research on August 16, 2017, indicating potential synergy
(interaction of discrete drugs such that the total effect is
greater than the sum of the individual effects) of PCM-075 with
Quizartinib, an investigational FLT3 Inhibitor, by Daiichi Sankyo,
in FLT3 mutant xenograft mouse models. The FDA recently approved
Rydapt® (midostaurin) by Novartis for the treatment of newly
diagnosed adult patients with AML that are FLT3 mutation-positive
in combination with cytarabine and daunorubicin induction and
cytarabine consolidation chemotherapy. There are two additional
FLT3 inhibitors in ongoing phase 3 trials, including Quizartinib.
Trovagene believes that a combination of PCM-075 with a FLT3
inhibitor for AML patients with a FLT3 mutation could extend
treatment response and possibly slow or reduce resistance to FLT3
activity.
- Announced results of preclinical research on August 21, 2017, indicating potential synergy of
PCM-075 with a histone deacetylase, or HDAC, inhibitor in NHL cell
lines. This synergy assessment study was conducted by Dr.
Steven Grant, Associate Director for
Translational Research and co-Leader, Developmental Therapeutics
Program, Massey Cancer Center.
- Announced that the FDA granted Orphan Drug Designation to
PCM-075 on September 28, 2017, for
the treatment of patients with AML.
- Announced receiving FDA authorization to proceed with its Phase
1b/2 trial of PCM-075 in patients with AML on July 26, 2017. This trial is designed to
determine the safety, tolerability, dosing and scheduling of
PCM-075 for patients with AML, while providing a preliminary
assessment of anti-leukemic activity, and exploring the use of
correlative biomarker analysis to select patients most likely to
respond.
- Announced expansion and strengthening of its Board of Directors
with the appointment of Athena Countouriotis, M.D. Dr.
Countouriotis brings significant experience in oncology clinical
development and orphan indications.
- Entered into an agreement with Novogene Co. Ltd., a leading
global provider of genomic services and solutions and one of the
largest sequencing capacities in the world, whereby Novogene will
purchase NextCollect™, reagents and methods to extract cell-free
DNA (cfDNA) for validation of urine DNA extraction methods in the
Chinese market.
Third Quarter 2017 Financial Results
- Trovagene received gross proceeds of approximately $7.1 million from the sale of 6,191,500 shares of
its common stock and 4,643,626 share of warrants through a
registered direct offering and private placement in July 2017.
- Trovagene reported a net loss of $4.3
million, or $0.12 per diluted
share in the third quarter of 2017, as compared to a net loss of
$10.2 million, or $0.34 per diluted share, for the same quarter of
2016.
- Total operating expenses were approximately $5.9 million for the three months ended
September 30, 2017, a reduction of
$4.1 million from $10.0 million for the same period in 2016.
- Research and development expenses decreased by $2.5 million to $1.4
million for the three months ended September 30, 2017, from $3.9 million for the same period in 2016.
- Selling and Marketing expenses decreased by $2.5 million to $0.4
million for the three months ended September 30, 2017, from $2.9 for the same period in 2016.
- General and administrative expenses increased by $1.0 million to $3.7
million for the three months ended September 30, 2017, from $2.7 million for the same period in 2016. The
increase was primarily due to the expenses related to the
immediately vested restricted stock awards granted to the CEO.
- Net cash used in operating activities in the third quarter of
2017 was $6.6 million, compared to
$7.0 million in the third quarter of
2016. The quarter-over-quarter reduction can be attributed
primarily to a decrease in research and development expenses as a
result of a shift in business focus and lower selling and marketing
expenses as a result of reduction in force.
- Net cash provided by financing activities in the third quarter
of 2017 was $6.4 million, compared to
$3.7 million in the second quarter of
2016. The increase is primarily due to the sale of our securities
during July fundraising activity.
- The weighted average diluted shares of common stock outstanding
used to calculate per share results was 36.5 million.
- As of September 30, 2017,
Trovagene had approximately $7.4
million of cash and cash equivalents.
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,
2016
|
|
|
|
|
|
|
|
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
|
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SOURCE Trovagene, Inc.