SAN DIEGO, Feb. 27, 2020 /PRNewswire/ -- Trovagene,
Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer
Medicine™ oncology therapeutics company developing drugs that
target cell division (mitosis) for the treatment of various cancers
including prostate, colorectal and leukemia, today announced
company highlights and financial results for the fourth quarter and
full-year ended December 31, 2019.
The company is issuing this press release in lieu of conducting a
conference call.
"We continue to advance the clinical development of onvansertib,
our first-in-class, third-generation, oral and highly selective
Polo-like Kinase 1 (PLK1) inhibitor, including very encouraging
to-date results from our Phase 1b/2
trial in KRAS-mutated metastatic colorectal cancer (mCRC)," said
Dr. Thomas Adams, Chief Executive
Officer and Chairman of Trovagene. "Regardless of the specific KRAS
mutation, we are seeing quantitative decreases in the mutational
burden of this once considered 'undruggable' mutation and
confirmation of the activity of onvansertib by radiographic scans
showing tumor regression in all treated patients.
Additionally, in our Phase 2 study in metastatic
castration-resistant prostate cancer (mCRPC), onvansertib is
demonstrating its ability to overcome resistance in patients
treated first-line with androgen-receptor signaling inhibitor,
Zytiga®. Data presented earlier this month at ASCO-GU show both
efficacy and durability of response to treatment when onvansertib
is added to daily Zytiga® therapy. Notably, several patients
currently on treatment have had progression-free survival of
greater than seven months. Enrollment is also on track in our Phase
2 study of onvansertib in patients with acute myeloid leukemia
(AML). We continue to see efficacy in this difficult-to-treat,
relapsed/refractory patient population, including in patients who
have relapsed following initial treatment with venetoclax, a
scenario with limited treatment options and a great need for new
targeted therapeutics."
The Company has advanced its business in the fourth quarter
of 2019, and to-date in 2020, with the following activities and
milestone achievements:
- Announced presentation of Phase 2 data demonstrating the
ability of onvansertib to overcome Zytiga®-resistance and provide
clinical benefit for mCRPC patients
On February 13, 2020, we announced
the presentation of positive data from our ongoing Phase 2 trial of
onvansertib in combination with Zytiga® for the treatment of
patients with Zytiga®-resistant mCRPC. The data demonstrates the
efficacy of onvansertib in Zytiga®-resistant mCRPC across known
androgen receptor resistance mechanisms. Additionally,
onvansertib-induced decreases in circulating tumor cells (CTCs) is
a surrogate for efficacy and associated with greater
progression-free survival in mCRPC patients.
- Announced data demonstrating the effectiveness of
onvansertib as a pan-KRAS inhibitor with confirmed tumor regression
and clinical benefit achieved in KRAS-mutated mCRC
patients
On January 27, 2020, we announced
the presentation of data from our ongoing Phase 1b/2 trial of onvansertib in combination with
FOLFIRI/Avastin in patients with KRAS-muted mCRC. All patients
treated showed tumor regression by radiographic scan at 8 weeks and
confirmation by further tumor shrinkage at 16 weeks, with clinical
benefit achieved in 100% of patients. Tumor regression occurred
across all major KRAS mutations associated with mCRC, an indication
of onvansertib's pan-KRAS inhibitory effect; three patients had
greater than 25% tumor shrinkage. One patient is proceeding to
curative surgery, which is considered to be unprecedented in this
patient population, in which there has been only a 5% response rate
to standard-of-care therapy.
- Announced positive data presented in an oral session at the
American Society of Hematology ("ASH") conference demonstrating
efficacy, durability of response and safety of onvansertib in
completed Phase 1b trial in
AML
On December 9, 2019, we announced
the presentation of data demonstrating efficacy, durability of
response and safety of onvansertib from the completed Phase
1b segment of the ongoing trial in
AML, in an oral session at ASH. Efficacy was observed in patients
treated at onvansertib doses ranging from 27 to 90
mg/m2, with a complete response (CR) and CR with
incomplete count recovery (Cri) rate of 31% (5 out of 16) of
patients. Treatment was well tolerated; adverse events related to
onvansertib were primarily on-target hematological (based on
mechanism of action) and were easily managed and reversible.
Biomarker positive patients showed a higher response to treatment;
67% (4 out of 6) of patients had marked decreases in bone marrow
blast cells vs only 18% (1 out of 11) biomarker negative
patients.
- Announced data showing the ability of onvanserib to rescue
patients previously treated with, and resistant to, venetoclax in
AML
On December 4, 2019, we announced
data showing the ability of onvansertib to rescue
venetoclax-resistant AML patients. Patients develop resistance to
venetoclax in approximately 11 months following the start of
treatment with no viable therapeutic options and a median survival
of only 1.7 to 2.3 months and a poor prognosis. Onvansertib as a
single agent inhibits tumor growth in both venetoclax-resistant
in-vitro and in-vivo AML models. The combination of onvansertib and
venetoclax is synergistic, which supports the addition of
onvansertib to venetoclax in venetoclax-resistant AML patients.
- Announced positive response to treatment in Phase 2 trial of
onvansertib in patients with mCRPC
On November 14, 2019, we announced
data demonstrating positive response to treatment in patients
enrolled in our Phase 2 trial of onvansertib in combination with
Zytiga® (abiraterone acetate) in patients with mCRPC. 72% of
patients had decreases in PSA levels with the addition of
onvansertib following 1 cycle of treatment. 60% of patients
completing 3 months of treatment and evaluable for efficacy
achieved the primary endpoint of disease control.
- Announced data presented at ESMO providing rationale for a
clinical trial of onvansertib in subset of patients with
Highly-Aggressive Triple Negative Breast Cancer (TNBC)
On October 2, 2019, we announced
the presentation of data in a poster at ESMO demonstrating
significant tumor regression observed with onvansertib in
combination with standard-of-care paclitaxel in models of
p53-mutated TNBC. Onvansertib's preclinical data provides rationale
for conducting a clinical trial targeting the 80% of TNBC that
harbors the p53 mutation. The combination has potential to address
critical medical needs to provide targeted treatment options to
overcome resistance to paclitaxel as a single agent therapy in
TNBC.
Fourth Quarter 2019 Financial Results
Total operating expenses were approximately $4.4 million for the three months ended
December 31, 2019, an increase of
$0.2 million from $4.2 million for the same period in 2018. The
increase in operating expenses is attributed to advancing the
onvansertib clinical development programs.
Net cash used in operating activities in the fourth quarter of
2019 was $3.3 million, compared to
$3.6 million in the fourth quarter of
2018. The quarter-over-quarter decrease of $0.3 million can be attributed primarily to a
favorable change in assets and liabilities offset by increased
expenses pertaining to the clinical development of onvansertib.
Research and development expenses increased by approximately
$0.4 million to $2.9 million for the three months ended
December 31, 2019 from $2.5 million for the same period in 2018. The
overall increase in research and development expenses was primarily
due to the increased outside service costs for advancing clinical
studies related to the development of our drug candidate,
onvansertib. We expect increases in research and development costs
to continue as we advance the onvansertib clinical development
programs in mCRC, mCRPC and AML.
Selling, general and administrative expenses decreased by
approximately $0.2 million to
$1.5 million for the three months
ended December 31, 2019 from
$1.7 million for the same period in
2018. The reduction is primarily due to a decrease in outside
services and professional fees.
The weighted average basic and diluted shares of common stock
outstanding used to calculate per share results for the three
months ended December 31, 2019 was
8.3 million.
As of December 31, 2019, Trovagene
had approximately $10.2 million of
cash and cash equivalents.
About Trovagene, Inc.
Trovagene is a clinical-stage, oncology therapeutics company,
taking 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.trovageneoncology.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. 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, 2019,
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, Clinical Development and Investor Relations
858-952-7652
vkelemen@trovagene.com
Trovagene,
Inc.
Condensed
Statements of Operations
(in thousands,
except for per share amounts)
|
|
|
|
Three Months
Ended
December 31,
|
|
Year
Ended December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
93
|
|
|
$
|
76
|
|
|
$
|
243
|
|
|
$
|
250
|
|
Services
|
|
—
|
|
|
2
|
|
|
2
|
|
|
128
|
|
Total
revenues
|
|
93
|
|
|
78
|
|
|
245
|
|
|
378
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
|
—
|
|
|
—
|
|
|
—
|
|
|
597
|
|
Research and
development
|
|
2,865
|
|
|
2,497
|
|
|
11,162
|
|
|
8,164
|
|
Selling, general and
administrative
|
|
1,517
|
|
|
1,685
|
|
|
5,761
|
|
|
8,006
|
|
Restructuring
charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
664
|
|
Total operating
expenses
|
|
4,382
|
|
|
4,182
|
|
|
16,923
|
|
|
17,431
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(4,289)
|
|
|
(4,104)
|
|
|
(16,678)
|
|
|
(17,053)
|
|
Net interest
income
|
|
46
|
|
|
75
|
|
|
234
|
|
|
194
|
|
Gain from change in
fair value of derivative financial instruments warrants
|
|
1
|
|
|
38
|
|
|
28
|
|
|
617
|
|
Gain on
extinguishment of debt
|
|
—
|
|
|
—
|
|
|
—
|
|
|
18
|
|
Other (loss) income,
net
|
|
—
|
|
|
(168)
|
|
|
2
|
|
|
(237)
|
|
Net loss
|
|
(4,242)
|
|
|
(4,159)
|
|
|
(16,414)
|
|
|
(16,461)
|
|
Preferred Stock
Dividend
|
|
(6)
|
|
|
(6)
|
|
|
(293)
|
|
|
(2,794)
|
|
Net loss attributable
to common stockholders
|
|
$
|
(4,248)
|
|
|
$
|
(4,165)
|
|
|
$
|
(16,707)
|
|
|
$
|
(19,255)
|
|
Net loss per common
share - basic and diluted
|
|
$
|
(0.51)
|
|
|
$
|
(1.09)
|
|
|
$
|
(2.80)
|
|
|
$
|
(8.26)
|
|
Weighted-average
shares outstanding - basic and diluted
|
|
8,329
|
|
|
3,832
|
|
|
5,974
|
|
|
2,330
|
|
Trovagene,
Inc.
Condensed Balance
Sheets
(in
thousands)
|
|
|
|
December
31, 2019
|
|
December 31,
2018
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
10,195
|
|
|
$
|
11,453
|
|
Accounts receivable
and unbilled receivable
|
|
204
|
|
|
168
|
|
Prepaid
expenses
|
|
955
|
|
|
1,144
|
|
Total current
assets
|
|
11,354
|
|
|
12,765
|
|
Property and
equipment, net
|
|
878
|
|
|
1,304
|
|
Operating lease
right-of-use assets
|
|
697
|
|
|
—
|
|
Other
assets
|
|
158
|
|
|
103
|
|
Total
Assets
|
|
$
|
13,087
|
|
|
$
|
14,172
|
|
|
|
|
|
|
Liabilities and
Stockholders Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
656
|
|
|
$
|
665
|
|
Accrued
expenses
|
|
3,260
|
|
|
1,772
|
|
Operating lease
liabilities
|
|
866
|
|
|
—
|
|
Deferred rent,
current portion
|
|
—
|
|
|
486
|
|
Total current
liabilities
|
|
4,782
|
|
|
2,923
|
|
Derivative financial
instruments warrants
|
|
4
|
|
|
32
|
|
Operating lease
liabilities, net of current portion
|
|
861
|
|
|
—
|
|
Deferred rent, net of
current portion
|
|
—
|
|
|
1,091
|
|
Other
liabilities
|
|
129
|
|
|
42
|
|
Total
Liabilities
|
|
5,776
|
|
|
4,088
|
|
|
|
|
|
|
Stockholders
equity
|
|
7,311
|
|
|
10,084
|
|
Total liabilities and
stockholders equity
|
|
$
|
13,087
|
|
|
$
|
14,172
|
|
Trovagene,
Inc.
Condensed
Statements of Cash Flows
(in
thousands)
|
|
|
|
Year
Ended December
31,
|
|
|
2019
|
|
2018
|
Operating
activities
|
|
|
|
|
Net loss
|
|
$
|
(16,414)
|
|
|
$
|
(16,461)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Depreciation and
amortization
|
|
494
|
|
|
859
|
|
Stock based
compensation expense
|
|
885
|
|
|
2,175
|
|
Change in fair value
of derivative financial instruments - warrants
|
|
(28)
|
|
|
(617)
|
|
Release of clinical
trial funding commitment
|
|
703
|
|
|
—
|
|
Gain on
extinguishment of debt
|
|
—
|
|
|
(18)
|
|
Other non-cash
items
|
|
—
|
|
|
610
|
|
Changes in operating
assets and liabilities
|
|
1,092
|
|
|
253
|
|
Net cash used in
operating activities
|
|
(13,268)
|
|
|
(13,199)
|
|
Investing
activities:
|
|
|
|
|
Net proceeds from
disposal (purchase) of capital equipment
|
|
(68)
|
|
|
23
|
|
Net cash provided
(used) in investing activities
|
|
(68)
|
|
|
23
|
|
Financing
activities:
|
|
|
|
|
Proceeds from sales
of common stock and warrants, net of expenses
|
|
8,818
|
|
|
11,779
|
|
Proceeds from sales
of Series B Convertible Preferred Stock, net of expenses
|
|
—
|
|
|
4,387
|
|
Costs related to the
clinical trial funding commitment
|
|
(40)
|
|
|
—
|
|
Proceeds from
exercise of warrants
|
|
3,300
|
|
|
1,613
|
|
Repayment of
debt
|
|
—
|
|
|
(1,376)
|
|
Net cash provided by
financing activities
|
|
12,078
|
|
|
16,403
|
|
Net change in cash
and cash equivalents
|
|
(1,258)
|
|
|
3,227
|
|
Cash and cash
equivalents Beginning of period
|
|
11,453
|
|
|
8,226
|
|
Cash and cash
equivalents End of period
|
|
$
|
10,195
|
|
|
$
|
11,453
|
|
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SOURCE Trovagene, Inc.