SAN DIEGO, Nov. 7, 2018 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a clinical-stage oncology therapeutics
company, using a precision medicine approach to develop drugs that
target cell division (mitosis) for the treatment of leukemias,
lymphomas and solid tumor cancers, today announced company
highlights and financial results for the third quarter ended
September 30, 2018. The Company is
issuing this press release in lieu of conducting a conference
call.
"We are pleased with the progress we are making in the clinical
development of onvansertib in the cancers and indications where
there is a significant need to bring new treatment options to
physicians and their patients - Acute Myeloid Leukemia (AML),
metastatic Castration-Resistant Prostate Cancer (mCRPC) and
metastatic Colorectal Cancer (mCRC)," said Dr. Thomas Adams, Executive Chairman of Trovagene.
"Our Phase 1b dose-escalation segment
of our AML trial is on track to reach our maximum tolerated dose
and identify our recommended Phase 2 dose within the next couple of
months and our Phase 2 trial in mCRPC is moving forward as planned
with active enrollment and treatment of patients. We have also
begun preparing for the initiation of a Phase 1b/2 trial in mCRC and plan to file our
Investigational New Drug (IND) application and protocol to the FDA
before the end of this year."
Dr. Adams added, "We anticipate the following key milestones
over the next twelve months: the first formal presentation of data
from our AML trial at the American Society of Hematology (ASH)
conference in December of 2018; reaching the maximum tolerated dose
and identifying the Phase 2 dose in our AML trial in the first
quarter or 2019; completing enrollment of patients in our AML and
mCRPC trials by the end of the second quarter in 2019; initiating
our Phase 1b/2 trial in mCRC in the
first half of 2019; and reporting additional data from our AML
trial and mCRPC trial throughout 2019."
The Company has advanced its business with the following
recent activities:
- Announced New Patent Claim Allowances Affirming Broad Patent
Portfolio Coverage of NPM1 Mutations by U.S. Patent and Trademark
Office
On October 24, 2018, Trovagene
announced that the U.S. Patent and Trademark Office (USPTO) has
allowed claims that affirms broad coverage of NPM1 mutation
testing; Patent Application 14/750331, entitled "Nucleophosmin
Protein (NPM) Mutants, Corresponding Gene Sequences and Uses
Thereof." This patent encompasses broad claims around the
assessment of NPM1 mutational status in any cancer type, including
acute myeloid leukemia (AML). This not only aligns with the
Company's current biomarker strategy and clinical development of
onvansertib in AML, but also strengthens the revenue generating
potential for Trovagene.
- Announced Exclusive License Agreement with MIT for Combination Therapy of Anti-Androgens and
Polo-like Kinase Inhibitors in Prostate Cancer
On October 3, 2018, Trovagene
announced that it has entered into an exclusive patent license
agreement with the Massachusetts Institute of
Technology (MIT). Under the
agreement, Trovagene has exclusive rights to develop combination
therapies that include anti-androgen or androgen antagonist and a
Polo-like Kinase (PLK) inhibitor for the treatment of cancer. The
exclusive license agreement is part of the Company's strategy to
explore the efficacy of Onvansertib, its first-in-class, 3rd
generation, highly-selective, oral PLK1 inhibitor, in combination
with anti-androgen drugs in cancers including prostate, breast,
pancreatic, lung and gastrointestinal. There is a need for
new therapies that effectively treat cancers that depend on
internal androgen signaling, such as castration-resistant prostate
cancer, as well as cancers which over-express androgen receptor
(AR), or are otherwise dependent on the synthesis of steroid
hormones for their growth, such as some breast cancers. In-vitro
and in-vivo preclinical research demonstrates a unique synergistic
effect with the combination of PLK inhibitors and anti-androgens,
which was the precursor that led to the current Phase 2 trial of
onvansertib in combination with Zytiga® (abiraterone
acetate)/prednisone that is being conducted at the three Harvard
Medical Cancer Centers.
- Announced Completion of Dosing Cohort of Patients Treated
with Onvansertib in Combination with Decitabine in Ongoing Phase
1b/2 AML Trial
On September 27, 2018, Trovagene
announced completion of the second dosing cohort of onvansertib,
its first-in-class, 3rd generation, highly-selective oral Polo-like
Kinase 1 (PLK1) Inhibitor, in combination with standard-of-care
decitabine, in its Phase 1b/2
clinical trial in patients with Acute Myeloid Leukemia (AML). All
three patients in the cohort successfully completed treatment with
onvansertib at 18mg/m2, administered orally, once daily, on days
1-5 of the treatment cycle, in combination with decitabine and the
combination was well tolerated. The Safety Review Committee
(SRC) has recommended escalating to the next dose level of
onvansertib at 27mg/m2 (approximately a 50% increase) in
combination with decitabine.
- Announced Predictive Clinical Biomarker Approach to Identify
Acute Myeloid Leukemia (AML) Patients Most Likely to Respond to
Onvansertib
On September 5, 2018, Trovagene
announced it has developed a method for predicting response to
treatment by measuring the ability of onvansertib, a
first-in-class, 3rd generation, oral and highly-selective Polo-like
Kinase 1 (PLK1) inhibitor, to inhibit PLK1 in patients with Acute
Myeloid Leukemia (AML). PLK1 uniquely phosphorylates translational
control tumor protein (TCTP) to form pTCTP and inhibition of this
enzymatic activity by onvansertib appears to be predictive of
patient response to treatment. In the ongoing Phase 1b/2 open label clinical trial in AML, PLK1
inhibition is being assessed 3-hours following administration, at
the approximate peak concentration (Cmax) of
onvansertib. In the first six patients treated, the greatest target
engagement, or inhibition of PLK1, was observed in the three
patients who showed a response to treatment.
- Announced European Commission Grants Orphan Drug Designation
to Onvansertib (PCM-075) for Treatment of Acute Myeloid Leukemia in
Europe
On August 29, 2018, Trovagene
announced that the European Commission (EC) has endorsed the
positive opinion of the Committee for Orphan Medicinal Products
(COMP) and has granted Orphan Drug Designation (ODD) for
onvansertib, a first-in-class, 3rd generation, oral and
highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the
treatment of patients with Acute Myeloid Leukemia (AML). Orphan
drug designation by the EC provides regulatory and financial
incentives to Trovagene, including reduced fees during the product
development phase, direct access to centralized marketing
authorization in the EU, and 10-year market exclusivity following
product approval.
- Announced Completion of Second Dosing Cohort of Patients
Treated with Onvansertib (PCM-075) in Ongoing Phase 1b/2 AML Trial
On August 16, 2018, Trovagene
announced completion of the second dosing cohort of onvansertib, a
first-in-class, 3rd generation, highly-selective oral Polo-like
Kinase 1 (PLK1) Inhibitor, in combination with standard-of-care
low-dose cytarabine (LDAC), in its Phase 1b/2 clinical trial in patients with Acute
Myeloid Leukemia (AML). All three patients in the cohort
successfully completed treatment with onvansertib at 18 mg/m2,
administered orally, once daily, on days 1-5 of the treatment
cycle, in combination with LDAC and the combination was well
tolerated. The Safety Review Committee (SRC) has recommended
escalating to the next dose level of onvansertib at 27 mg/m2
(approximately a 50% increase) in combination with LDAC.
Additionally, two patients in the three-patient cohort of
onvansertib at 18 mg/m2 in combination with decitabine have also
successfully completed at least one cycle of treatment and
recruitment of the third patient to complete this cohort is in
process. Four of the eleven patients treated to-date remain on
treatment, three are currently receiving a second cycle of
treatment and one patient is scheduled to start a fifth cycle of
treatment.
- Announced USAN Approval for "Onvansertib" as Nonproprietary
Name for First-in-Class, 3rd Generation PLK1 Inhibitor,
PCM-075
On August 15, 2018, Trovagene
announced that the United States Adopted Name (USAN) Council has
approved "onvansertib" (pronounced on-van-ser-tib) as the
nonproprietary (generic) name for its drug candidate,
PCM-075. Onvansertib is a first-in-class, 3rd generation,
highly selective, oral Polo Like Kinase 1 (PLK1) inhibitor, that is
designed to target and inhibit cancer cell division
(mitosis). Assignment of a unique generic name is a very
meaningful step forward for Trovagene's drug candidate that is
currently in clinical development in Acute Myeloid Leukemia and
metastatic Castration-Resistant Prostate Cancer.
- Announced Positive Opinion for Orphan Drug Designation in
the European Union for PCM-075, Trovagene's Investigational Cancer
Drug
On August 1, 2018, Trovagene
announced that the European Medicines Agency (EMA) Committee for
Orphan Medicinal Products (COMP) has adopted a positive opinion
recommending PCM-075 for designation as an orphan medicinal product
for the treatment of Acute Myeloid Leukemia (AML). PCM-075 is
a first-in-class, 3rd generation, highly selective, oral Polo Like
Kinase 1 (PLK1) inhibitor, that is designed to target cell division
(mitosis). o be considered for Orphan Drug Designation in the EU,
companies must provide data that demonstrates plausibility for use
of the investigational therapy in the treatment of the disease and
establish that the drug has the potential to provide relevant
advantages or a major contribution to patient care over existing
therapies. The opinion letter sent to Trovagene by the COMP stated
that "although satisfactory methods of treatment of the condition
have been authorized in the EU, PCM-075 will be of significant
benefit to those affected by AML." The COMP, a committee of the
EMA, adopts an opinion on the granting of orphan drug designation,
after which the opinion is submitted to the European Commission for
endorsement of the opinion. The positive opinion issued by the COMP
is anticipated to be adopted by the European Commission (EC) at the
end of August 2018.
Third Quarter 2018 Financial Results
Total operating expenses were approximately $4.0 million for the three months ended
September 30, 2018, a reduction of
$2.0 million from $6.0 million for the same period in 2017. The
decrease in operating expenses is attributed to optimizing
operations to focus primarily on advancing development of
onvansertib.
Net cash used in operating activities in the third quarter of
2018 was $3.5 million, compared to
$6.6 million in the third quarter of
2017. The year-over-year reduction of $3.1
million can be attributed primarily to the elimination of
expenses associated with (1) litigation settlement paid to our
former CEO and CFO, (2) diagnostic programs and focus on
therapeutics and the clinical development of its drug candidate,
onvansertib, and (3) severance payments as a result of reduction in
force.
Research and development expenses increased by approximately
$0.4 million to $1.8 million for the three months ended
September 30, 2018 from $1.4 million for the same period in 2017. The
overall increase in research and development expenses was primarily
due to the increased outside service costs for clinical studies
related to the development of our drug candidate, onvansertib. We
expect increases in research and development costs as we continue
to advance the development of onvansertib.
Selling, general and administrative expenses decreased by
approximately $2.4 million to
$1.7 million for the three months
ended September 30, 2018 from
$4.1 million for the same period in
2017. The significant components of the decrease were primarily due
to the decrease in salaries and staff costs and stock-based
compensation.
The weighted average diluted shares of common stock outstanding
used to calculate per share results for the three months ended
September 30, 2018 was 20.6
million.
As of September 30, 2018,
Trovagene had approximately $15.1
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.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. 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.
Trovagene Contact:
Vicki
Kelemen
VP, Clinical Development
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,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
Revenues:
|
|
|
Royalties
|
|
$
|
73
|
|
$
|
59
|
|
|
$
|
175
|
|
$
|
170
|
Diagnostic
services
|
|
4
|
|
58
|
|
|
83
|
|
142
|
Clinical research
services
|
|
11
|
|
6
|
|
|
42
|
|
8
|
Total
revenues
|
|
88
|
|
123
|
|
|
300
|
|
320
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
Cost of
revenues
|
|
27
|
|
474
|
|
|
597
|
|
1,428
|
Research and
development
|
|
1,830
|
|
1,414
|
|
|
5,667
|
|
6,676
|
Selling, general and
administrative
|
|
1,665
|
|
4,079
|
|
|
6,321
|
|
12,358
|
Restructuring charges
(benefit)
|
|
421
|
|
(46)
|
|
|
664
|
|
1,670
|
Total operating
expenses
|
|
3,943
|
|
5,921
|
|
|
13,249
|
|
22,132
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(3,855)
|
|
(5,798)
|
|
|
(12,949)
|
|
(21,812)
|
|
|
|
|
|
|
|
|
|
|
|
Net interest
income (expense)
|
|
86
|
|
(16)
|
|
|
119
|
|
(877)
|
(Loss)
gain on change in fair value of derivative financial instruments-
warrants
|
|
(2)
|
|
1,529
|
|
|
579
|
|
2,013
|
Gain
(loss) on extinguishment of debt
|
|
-
|
|
-
|
|
|
18
|
|
(1,656)
|
Other
income (loss), net
|
|
2
|
|
(7)
|
|
|
(69)
|
|
(5)
|
Net loss
|
|
(3,769)
|
|
(4,292)
|
|
|
(12,302)
|
|
(22,337)
|
Preferred stock
dividend
|
|
(6)
|
|
|
(6)
|
|
|
(2,788)
|
|
(18)
|
Net loss attributable
to common stockholders
|
|
$
|
(3,775)
|
|
$
|
(4,298)
|
|
|
$
|
(15,090)
|
|
$
|
(22,355)
|
Net loss per common
share – basic and diluted
|
|
$
|
(0.18)
|
|
$
|
(1.41)
|
|
|
$
|
(1.38)
|
|
$
|
(8.17)
|
Weighted average
shares outstanding – basic and diluted
|
|
20,623
|
|
3,039
|
|
|
10,945
|
|
2,736
|
Trovagene,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
September
30, 2018
|
|
December 31,
2017
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments
|
|
$
|
15,066
|
|
$
|
8,226
|
|
Accounts receivable
and unbilled receivable
|
|
129
|
|
77
|
|
Prepaid expense and
other assets
|
|
849
|
|
1,166
|
|
Total current
assets
|
|
16,044
|
|
9,469
|
|
Property and
equipment, net
|
|
|
1,627
|
|
|
2,426
|
|
Other
assets
|
|
|
250
|
|
|
390
|
|
Total
Assets
|
|
$
|
17,921
|
|
$
|
12,285
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
477
|
|
$
|
825
|
|
Accrued
expenses
|
|
|
1,718
|
|
|
1,455
|
|
Deferred
rent
|
|
|
472
|
|
|
334
|
|
Current portion of
long-term debt
|
|
|
-
|
|
|
1,332
|
|
Total current
liabilities
|
|
2,667
|
|
3,946
|
|
|
|
|
|
|
|
Derivative financial
instruments - warrants
|
|
70
|
|
649
|
|
Deferred rent, net of
current portion
|
|
1,204
|
|
1,184
|
|
Total
Liabilities
|
|
3,941
|
|
5,779
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
13,980
|
|
|
6,506
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
17,921
|
|
$
|
12,285
|
|
|
Trovagene,
Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
Nine Months
Ended
|
|
September
30,
|
|
2018
|
|
2017
|
|
|
|
|
Operating
activities
|
|
|
|
Net loss
|
$ (12,303)
|
|
$ (22,337)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and amortization
|
702
|
|
957
|
Stock based compensation expense
|
1,906
|
|
3,117
|
Change in fair value of derivative financial instruments -
warrants
|
(579)
|
|
(2,013)
|
Gain (loss) on extinguishment of debt
|
(18)
|
|
1,656
|
Other non-cash items
|
118
|
|
638
|
Changes in operating
assets and liabilities
|
587
|
|
(1,968)
|
Net cash used in
operating activities
|
(9,587)
|
|
(19,950)
|
|
|
|
|
Investing
activities:
|
|
|
|
Net proceeds from
disposal (purchase) of capital equipment
|
23
|
|
(136)
|
Net sales and
maturities of short-term investments
|
-
|
|
24,062
|
Net cash provided by
investing activities
|
23
|
|
23,926
|
|
|
|
|
Financing
activities:
|
|
|
|
Proceeds from sales
of common stock and warrants, net of expenses
|
11,779
|
|
6,635
|
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)
|
|
(17,083)
|
Net cash provided by
(used in) financing activities
|
16,404
|
|
(10,448)
|
Effect of exchange
rate changes on cash and cash equivalents
|
-
|
|
(9)
|
Net change in cash
and equivalents
|
(16,404)
|
|
(6,481)
|
Cash and cash
equivalents—Beginning of period
|
8,226
|
|
13,915
|
Cash and cash
equivalents—End of period
|
$
15,066
|
|
$
7,434
|
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SOURCE Trovagene, Inc.