CAMBRIDGE, Mass., Aug. 9, 2019 /PRNewswire/ -- Leap
Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the second quarter ended
June 30, 2019.
"We recently presented positive data from our clinical study of
DKN-01 plus KEYTRUDA which demonstrated higher survival and
objective response outcomes in patients with advanced
gastroesophageal junction and gastric cancer whose tumors expressed
high levels of DKK1 (DKK1-high). As we have seen with the single
agent partial responses in patients with endometrial cancer,
DKN-01's activity continues to be impressive in biomarker-targeted
patient populations," commented Christopher
K. Mirabelli, Ph.D, President and Chief Executive Officer of
Leap Therapeutics. "In addition, we have enrolled our first
patients in the triple chemoimmunotherapy study of TRX518 in
combination with BAVENCIO and cyclophosphamide."
Recent Developments
- DKN-01 CLINICAL INVESTIGATOR WEBCAST: On
August 6, 2019, Leap hosted a DKN-01
program update webcast with Samuel J.
Klempner, MD, Assistant Professor, Massachusetts General
Hospital Cancer Center and Harvard Medical
School, and Rebecca C. Arend,
MD, Assistant Professor and Associate Scientist, Gynecologic
Oncology Clinic, UAB Comprehensive Cancer Center Experimental
Therapeutics Program. A replay of the webcast and the presentation
slides are available under "Events & Presentations" in the
Investor section of Leap's website,
https://www.leaptx.com/program-webcasts.
- DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented
data from the KEYNOTE-731 clinical study evaluating DKN-01 in
combination with KEYTRUDA in patients with advanced esophagogastric
cancer. In gastroesophageal junction and gastric cancer patients
who had not received prior PD-1/PD-L1 therapy, the combination of
DKN-01 plus KEYTRUDA demonstrated improved outcomes in patients
whose tumors are DKK1-high.
DKK1-high patients experienced 22.1
weeks median progression free survival (PFS) and 31.6 weeks median
overall survival (OS), with a 50% overall response rate (ORR) and
80% disease control rate (DCR) in ten evaluable patients.
DKK1-low patients experienced 5.9
weeks PFS and 17.4 weeks OS, with a 20% DCR in fifteen evaluable
patients. PD-L1 Combined Positive Scores (CPS) did not predict
efficacy to the combination of DKN-01 plus KEYTRUDA. In
multi-variate analysis, DKK1-high
status correlated with longer PFS independent of PD-L1 CPS.
- DKN-01 in GYNECOLOGICAL CANCERS: The clinical
study of DKN-01 as a monotherapy and in combination with paclitaxel
in patients with advanced gynecological cancers has been expanded
to include focused cohorts of patients with carcinosarcoma.
Overall, ninety-six patients have been enrolled in the study, and
enrollment is ongoing. Additional response and biomarker data will
be available in September at the International Gynecologic Cancer
Society Annual Global Meeting.
- TRX518 TRIPLE COMBINATION THERAPY: Leap enrolled
the first patients in the clinical trial evaluating TRX518 in
combination with cyclophosphamide chemotherapy and BAVENCIO. Dose
escalation in the study is ongoing.
- $21 MILLION EQUITY
COMMITMENT FACILITY: Leap entered into purchase agreements
with Lincoln Park Capital Fund, LLC (LPC) pursuant to which Leap
sold $1 million in common stock and
has the option, but not the obligation, to sell to LPC up to an
additional $20 million in shares of
common stock in tranches over a twenty-four month period. The price
of shares sold will be based on the market prices prevailing at the
time of each sale to LPC. There is no upper limit as to the price
per share that LPC may pay for future stock issuances under the
agreement, and Leap will control the timing and amount of any
future sales.
Selected Second Quarter 2019 Financial Results
Net loss was $8.4 million for the
second quarter 2019, compared to $7.4
million for the same period in 2018. This increase was
primarily due to an increase in clinical development expense and
the recording of a loss in the second quarter 2018 as a result of a
decrease in the fair value of the warrant liability.
Research and development expenses were $6.1 million for the second 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 $2.3 million for the second quarter 2019,
compared to $2.6 million for the same
period in 2018. This decrease was primarily due to a decrease in
legal, audit and consulting fees.
Cash, cash equivalents and marketable securities totaled
$15.7 million at June 30, 2019. Research and development incentive
receivables, current and long term, totaled approximately
$1.0 million at June 30, 2019. Subsequent to the end of the
quarter, Leap announced the commitment facility with LPC and sold
$1.0 million in common stock.
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.
BAVENCIO® is a registered trademark of Merck KGaA,
Darmstadt, Germany, and is
marketed under a global strategic alliance between Merck KGaA,
Darmstadt, Germany, and Pfizer
Inc., New York, USA.
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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(Unaudited)
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2019
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2018
|
|
2019
|
|
2018
|
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|
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|
Operating
expenses:
|
|
|
|
|
|
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|
|
|
Research and
development
|
|
$
6,136
|
|
$
4,234
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|
$
12,926
|
|
$
8,465
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|
General and
administrative
|
|
2,325
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|
2,603
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|
4,330
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|
4,716
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|
|
Total operating
expenses
|
|
8,461
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|
6,837
|
|
17,256
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|
13,181
|
Loss from
operations
|
|
(8,461)
|
|
(6,837)
|
|
(17,256)
|
|
(13,181)
|
Interest
income
|
|
119
|
|
122
|
|
201
|
|
199
|
Interest
expense
|
|
(9)
|
|
(8)
|
|
(16)
|
|
(14)
|
Australian research
and development incentives
|
|
61
|
|
243
|
|
136
|
|
889
|
Foreign currency
losses
|
|
(76)
|
|
(222)
|
|
(34)
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|
(366)
|
Change in fair value
of warrant liability
|
|
-
|
|
(662)
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|
-
|
|
(5,513)
|
Net
loss
|
|
|
|
(8,366)
|
|
(7,364)
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|
(16,969)
|
|
(17,986)
|
Dividend attributable
to down round feature of warrants
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|
0
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|
-
|
|
(359)
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|
-
|
Net loss attributable
to common stockholders
|
|
$
(8,366)
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|
$
(7,364)
|
|
$
(17,328)
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|
$
(17,986)
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Net loss per share -
basic and diluted
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|
$
(0.37)
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|
$
(0.50)
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|
$
(0.82)
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|
$
(1.32)
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|
|
|
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|
Weighted average
common shares outstanding - basic and diluted
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22,906,025
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|
14,691,890
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|
21,081,869
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|
13,576,850
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Leap Therapeutics,
Inc.
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Condensed
Consolidated Balance Sheets
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(in thousands,
except share and per share amounts)
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June
30,
|
|
December
31,
|
|
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|
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|
2019
|
|
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
|
|
|
$
15,747
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|
$
16,284
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Research and
development incentive receivable
|
|
836
|
|
836
|
Prepaid expenses and
other current assets
|
|
211
|
|
202
|
Total
current assets
|
|
16,794
|
|
17,322
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
161
|
|
86
|
Right of use asset,
net
|
|
1,398
|
|
-
|
Research and
development incentive receivable, net of current portion
|
|
135
|
|
-
|
Deferred tax
assets
|
|
124
|
|
124
|
Other
assets
|
|
1,525
|
|
1,542
|
Total
assets
|
|
$
20,137
|
|
$
19,074
|
Liabilities and
Stockholders' Equity
|
|
|
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Current
liabilities:
|
|
|
|
|
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Accounts
payable
|
|
$
5,325
|
|
$
3,579
|
|
Accrued
expenses
|
|
2,474
|
|
2,872
|
|
Lease liability -
current portion
|
|
657
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|
-
|
|
|
Total current
liabilities
|
|
8,456
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|
6,451
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|
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|
|
|
|
|
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|
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Non current
liabilities:
|
|
|
|
|
|
Warrant
liability
|
|
-
|
|
3,448
|
|
Lease liability, net
of current portion
|
|
742
|
|
-
|
|
|
Total
liabilities
|
|
9,198
|
|
9,899
|
|
|
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|
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Stockholders'
equity:
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|
Common stock, $0.001
par value; 100,000,000 shares authorized as
of June 30, 2019
and December 31, 2018, 22,949,064 and 14,703,159 shares
issued and
outstanding as of March 31, 2019 and December 31, 2018,
respectively
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|
23
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|
15
|
|
Additional paid-in
capital
|
|
189,831
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|
162,393
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|
Accumulated other
comprehensive income
|
|
322
|
|
302
|
|
Accumulated
deficit
|
|
(179,237)
|
|
(153,535)
|
|
|
Total stockholders'
equity
|
|
10,939
|
|
9,175
|
|
|
Total liabilities and
stockholders' equity
|
|
$
20,137
|
|
$
19,074
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Leap
Therapeutics, Inc.
|
|
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Condensed
Consolidated Statements of Cash Flows
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|
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(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
Ended June 30,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
$
(14,051)
|
|
$
(11,531)
|
Cash used in
investing activities
|
|
(100)
|
|
-
|
Cash
provided by financing activities
|
|
13,582
|
|
16,013
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
32
|
|
262
|
Net increase
(decrease) in cash and cash equivalents
|
|
(537)
|
|
4,744
|
Cash and cash
equivalents at beginning of period
|
|
16,284
|
|
25,737
|
Cash and cash
equivalents at end of period
|
|
$
15,747
|
|
$
30,481
|
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SOURCE Leap Therapeutics, Inc.