CAMBRIDGE, Mass., May 15, 2019 /PRNewswire/ -- Leap
Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the first quarter ended March 31, 2019.
"In the first quarter, we presented important new data for both
of our programs. DKN-01's activity continues to be impressive in
biomarker targeted patient populations, with single agent partial
responses in patients with endometrial cancer. In addition,
TRX518 achieved a first partial response as a monotherapy and as a
combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and
Chief Executive Officer of Leap Therapeutics. "We are looking
forward to presenting additional clinical data from both programs
in the second half of the year."
Recent Developments
- DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented
clinical data from its study evaluating DKN-01 in combination with
KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric
cancer. The overall response rate and disease control rate has been
higher in patients with higher DKK1
expression as measured by in situ hybridization RNAscope.
Enrollment in this study is complete.
- DKN-01 in GYNECOLOGICAL CANCERS: At the Society
for Gynecologic Oncology 50th Annual Meeting on Women's Cancer,
Leap presented an update on its clinical study evaluating DKN-01 as
a monotherapy and in combination with paclitaxel in patients with
advanced gynecological cancers. DKN-01 monotherapy has generated
two partial responses in patients with endometrial cancer, and
DKN-01 plus paclitaxel has generated a partial response in a
patient with carcinosarcoma. An additional DKN-01 monotherapy
patient was initially reported by the treating investigator to have
experienced a partial response; however, further follow-up
identified that the patient has a tumor reduction that does not
meet the threshold for a partial response and remains on treatment
with ongoing clinical benefit. Eighty-seven patients have been
enrolled in the study, and enrollment is ongoing.
- DKN-01 in PROSTATE CANCER: The first patient has
been enrolled in an investigator-initiated study of DKN-01 as a
monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer
patients.
- TRX518 MONOTHERAPY: A non-virally mediated
hepatocellular cancer patient, who has been treated with single
agent TRX518 for two years, achieved a partial response. With
recent disease progression, this patient now continues on treatment
for clinical benefit.
- TRX518 COMBINATION THERAPY: Leap presented data
from its clinical trial evaluating TRX518 in combination with
gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO®
(nivolumab), with patients from each combination arm experiencing
responses and durable stable disease. Eighteen patients have been
enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is
ongoing.
Selected First Quarter 2019 Financial Results
Net loss was $8.6 million for the
first quarter 2019, compared to $10.6
million for the same period in 2018. This decrease was
primarily due to a non-cash charge based on the change in the fair
value of the warrant liability in the first quarter 2018, offset by
an increase in clinical development expense.
Research and development expenses were $6.8 million for the first quarter 2019, compared
to $4.2 million for the same period
in 2018. This increase was primarily due to an increase in clinical
trial expenses associated with an increase in patient enrollment
and an increase in consulting fees and payroll expenses, partially
offset by a decrease in manufacturing costs related to clinical
trial material.
General and administrative expenses were $2.0 million for the first quarter 2019, compared
to $2.1 million for the same period
in 2018. This decrease was primarily due to a decrease in
compensation expense as a result of senior management not accepting
the cash bonus awarded to them by the compensation committee,
partially offset by an increase in stock-based compensation
expense.
Cash, cash equivalents and marketable securities totaled
$21.7 million at March 31, 2019. Research and development
incentive receivables, current and long term, totaled approximately
$0.9 million at March 31, 2019.
About Leap Therapeutics
Leap Therapeutics (NASDAQ: LPTX) is focused on developing
targeted and immuno-oncology therapeutics. Leap's most advanced
clinical candidate, DKN-01, is a humanized monoclonal antibody
targeting the Dickkopf-1 (DKK1)
protein, a Wnt pathway modulator. DKN-01 is in clinical trials in
patients with esophagogastric, hepatobiliary, gynecologic, and
prostate cancers. Leap's second clinical candidate, TRX518, is a
humanized GITR agonist monoclonal antibody designed to enhance the
immune system's anti-tumor response that is in advanced solid tumor
studies. For more information about Leap Therapeutics, visit
http://www.leaptx.com or our public filings with the SEC that are
available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements include statements regarding Leap's
expectations with respect to the development and advancement of
DKN-01, TRX518, and other programs, including the initiation,
timing and design of future studies, enrollment in future studies,
business development, and other future expectations, plans and
prospects. Leap has attempted to identify forward looking
statements by such terminology as ''believes,'' ''estimates,''
''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,''
''may,'' ''could,'' ''might,'' ''will,'' ''should,'' or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Although Leap believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, forward-looking statements are
subject to known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially from our
expectations. Such risks and uncertainties include, but are not
limited to: the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for financing; the
ability to complete a financing or form business development
relationships to fund our expenses; the outcome, cost, and timing
of our product development activities and clinical trials; the
uncertain clinical development process, including the risk that
clinical trials may not have an effective design or generate
positive results; our ability to obtain and maintain regulatory
approval of our drug product candidates; our plans to research,
develop, and commercialize our drug product candidates; our ability
to achieve market acceptance of our drug product candidates;
unanticipated costs or delays in research, development, and
commercialization efforts; the applicability of clinical study
results to actual outcomes; the size and growth potential of the
markets for our drug product candidates; our ability to continue
obtaining and maintaining intellectual property protection for our
drug product candidates; and other risks. Detailed information
regarding factors that may cause actual results to differ
materially will be included in Leap Therapeutics' periodic filings
with the SEC, including Leap Therapeutics' Annual Report on Form
10-K for the fiscal year ended December 31,
2018 that Leap filed with the SEC on April 1, 2019. These statements are only
predictions and involve known and unknown risks, uncertainties, and
other factors. Any forward looking statements contained in this
release speak only as of its date. We undertake no obligation to
update any forward-looking statements contained in this release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA. OPDIVO® is a
registered trademark of Bristol Myers-Squibb Company.
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360
Argot Partners
Investor Relations
Heather Savelle
212-600-1902
heather@argotpartners.com
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Leap Therapeutics,
Inc.
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|
Condensed
Consolidated Statements of Operations
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(in thousands,
except share and per share amounts)
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Three Months Ended
March 31,
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|
2019
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|
2018
|
|
|
|
|
|
|
|
|
(Unaudited)
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
$
6,790
|
|
$
4,231
|
|
General and
administrative
|
|
2,005
|
|
2,113
|
|
|
|
Total operating expenses
|
|
8,795
|
|
6,344
|
Loss from
operations
|
|
(8,795)
|
|
(6,344)
|
Interest
income
|
|
82
|
|
77
|
Interest
expense
|
|
(7)
|
|
(6)
|
Australian research
and development incentives
|
|
75
|
|
646
|
Foreign currency
gains (loss)
|
|
42
|
|
(144)
|
Change in fair value
of warrant liability
|
|
-
|
|
(4,851)
|
Net
loss
|
|
|
|
(8,603)
|
|
(10,622)
|
Dividend attributable
to down round feature of warrants
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|
(359)
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|
-
|
Net loss attributable
to common stockholders
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|
$
(8,962)
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|
$
(10,622)
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|
Net loss per share -
basic and diluted
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|
$
(0.47)
|
|
$
(0.85)
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|
|
|
|
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|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
19,237,444
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|
12,449,421
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Leap Therapeutics,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share and per share amounts)
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March
31,
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|
December
31,
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|
2019
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|
2018
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|
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(Unaudited)
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Assets
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Current
assets:
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|
Cash and cash
equivalents
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|
$
21,709
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|
$
16,284
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|
Research and
development incentive receivable
|
|
844
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|
836
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|
Prepaid expenses and
other current assets
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|
159
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|
202
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|
|
|
|
|
Total current
assets
|
|
22,712
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|
17,322
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|
|
|
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|
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Property and
equipment, net
|
|
74
|
|
86
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|
Right of use asset,
net
|
|
1,578
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|
-
|
|
Research and
development incentive receivable, net of current portion
|
|
74
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|
-
|
|
Deferred tax
assets
|
|
126
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|
124
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|
Other
assets
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|
1,519
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|
1,542
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|
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|
Total
assets
|
|
$
26,083
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|
$
19,074
|
Liabilities and
Stockholders' Equity
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Current
liabilities:
|
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|
|
Accounts
payable
|
|
$
3,298
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|
$
3,579
|
|
Accrued
expenses
|
|
4,150
|
|
2,872
|
|
Lease liability -
current portion
|
|
738
|
|
-
|
|
|
|
|
|
Total current
liabilities
|
|
8,186
|
|
6,451
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|
|
|
|
|
|
|
|
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|
Non current
liabilities:
|
|
|
|
|
|
Warrant
liability
|
|
-
|
|
3,448
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|
Lease liability, net
of current portion
|
|
833
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|
-
|
|
|
|
|
|
Total
liabilities
|
|
9,019
|
|
9,899
|
Commitments and
contingencies
|
|
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Stockholders'
equity:
|
|
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|
|
Common stock, $0.001
par value; 100,000,000 shares authorized as of
March 31, 2019 and December 31, 2018, 22,260,301 and
14,703,159 shares
issued and outstanding as of March 31, 2019 and
December 31, 2018, respectively
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|
22
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|
15
|
|
Additional paid-in
capital
|
|
187,635
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|
162,393
|
|
Accumulated other
comprehensive income
|
|
278
|
|
302
|
|
Accumulated
deficit
|
|
(170,871)
|
|
(153,535)
|
|
|
|
|
|
Total stockholders'
equity
|
|
17,064
|
|
9,175
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
26,083
|
|
$
19,074
|
Leap
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
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|
Three Months
Ended March 31,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
(Unaudited)
|
Cash used in
operating activities
|
|
$
(6,868)
|
|
$
(5,478)
|
Cash
provided by financing activities
|
|
12,322
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|
15,005
|
Effect of
exchange rate changes on cash and cash
equivalents
|
(29)
|
|
112
|
Net increase
in cash and cash equivalents
|
|
5,425
|
|
9,639
|
Cash and cash
equivalents at beginning of period
|
|
16,284
|
|
25,737
|
Cash and cash
equivalents at end of period
|
|
$
21,709
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|
$
35,376
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SOURCE Leap Therapeutics, Inc.