CAMBRIDGE, Mass., Nov. 14, 2019 /PRNewswire/ -- Leap Therapeutics,
Inc. (NASDAQ:LPTX) today reported financial results for the third
quarter ended September 30, 2019.
"The body of clinical data we presented in the third quarter for
both DKN-01 monotherapy and combination treatment for cancer
patients continues to demonstrate impressive activity. Patients
with advanced gastroesophageal junction and gastric cancer whose
tumors expressed high levels of DKK1
(DKK1-high) achieved higher survival
and objective response outcomes to the combination of DKN-01 and
KEYTRUDA," commented Christopher K.
Mirabelli, Ph.D., President and Chief Executive Officer of
Leap. "DKN-01 also showed durable benefit in patients with
endometrial cancer with Wnt pathway alterations, including a
monotherapy complete response, highlighting the potential utility
of DKN-01 for biomarker-targeted patient populations."
Dr. Mirabelli continued: "We also completed enrollment in the
dose escalation phase of our clinical trial evaluating TRX518 in
combination with BAVENCIO and cyclophosphamide; however, we've made
the strategic decision to deprioritize further development of
TRX518 at this time in order to focus our resources on our more
advanced DKN-01 program. The safety profile observed to date was
acceptable, and patients who are benefiting from treatment in the
TRX518 program will continue to be treated."
DKN-01 Development Program Update
- DKN-01 in ESOPHAGOGASTRIC CANCER: Leap
presented data from the KEYNOTE-731 clinical study evaluating
DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients
with advanced esophagogastric cancer. Study results demonstrated
that patients with DKK1-high status
had improved outcomes, including longer progression free survival
(PFS) independent of PD-L1 Combined Positive Scores (CPS). In ten
evaluable gastroesophageal junction and gastric cancer patients who
had not received prior PD-1/PD-L1 therapy, 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). Fifteen evaluable DKK1-low patients experienced 5.9 weeks PFS and
17.4 weeks OS, with a 20% DCR. PD-L1 CPS did not predict efficacy
to the combination of DKN-01 plus KEYTRUDA.
- DKN-01 in GYNECOLOGICAL CANCERS: The Company
presented data from the ongoing clinical study of DKN-01 as a
monotherapy and in combination with paclitaxel in patients with
advanced gynecological cancers at the International Gynecologic
Cancer Society Annual Global Meeting held in September. In the
cohort of sixteen evaluable monotherapy patients with epithelial
endometrial cancer (EEC) with identified Wnt signaling mutations,
patients had higher response rates and demonstrated longer PFS as
compared to patients without Wnt signaling mutations. Specifically,
one patient had a complete response and one patient had a partial
response, representing a 12.5% single agent ORR, seven patients had
a best response of stable disease, and seven patients had
progressive disease. In the six evaluable monotherapy EEC
patients who did not have any identified Wnt signaling mutations,
none had clinical benefit. Patient follow-up is continuing in this
study, which has been expanded to include focused cohorts of
patients with carcinosarcoma.
- DKN-01 plus OPDIVO in BILIARY TRACT
CANCER: The first patients have been dosed in an
investigator-initiated clinical study to evaluate DKN-01 in
combination with Bristol-Myers Squibb's OPDIVO® (nivolumab) in
previously treated patients with advanced biliary tract cancer. The
study is being conducted by Massachusetts General Hospital and will
enroll up to 36 biliary tract cancer patients who have progressed
after one or more lines of systemic therapy for advanced biliary
tract cancer. The primary endpoint of the study will be ORR, to be
assessed in the overall population as well as in subgroups
stratified by tumor DKK1 and PD-L1
expression. Bristol-Myers Squibb is
providing OPDIVO drug supply and partial funding for the study,
with Leap providing DKN-01 drug supply as well as additional
partial funding.
TRX518 Development Program Update
- FURTHER DEVELOPMENT OF TRX518 HAS BEEN
DEPRIORITIZED: Leap has completed enrollment in dose
escalation phase of the clinical trial evaluating TRX518 in
combination with cyclophosphamide chemotherapy and BAVENCIO®
(avelumab). However, instead of pursuing additional
enrollment through the expansion cohorts in this study as initially
planned, the Company has decided to reprioritize resources on the
further development of the DKN-01 program. There were no safety or
efficacy concerns leading to this decision, and patients who are
benefitting from the combination therapy will continue to be
treated in the study.
Selected Third Quarter 2019 Financial Results
Net loss was $7.9 million for the
third quarter 2019, compared to $6.6
million for the same period in 2018. This increase was
primarily due to the recording of a $1.8
million gain in the third quarter 2018 as a result of a
change in the fair value of the warrant liability, partially offset
by a decrease in research and development expense.
Research and development expenses were $5.8 million for the third quarter 2019, compared
to $6.5 million for the same period
in 2018. This decrease was primarily due to a decrease of
$0.4 million in clinical trial costs
as a result of the timing of patient enrollment and a decrease of
$0.3 million in manufacturing costs
related to clinical trial material manufacturing campaigns.
General and administrative expenses were $2.2 million for the third quarter 2019, compared
to $2.1 million for the same period
in 2018. The increase was primarily due to a $0.1 million increase in stock based compensation
as a result of new stock options granted to employees and directors
in 2019.
Cash, cash equivalents and marketable securities totaled
$10.1 million at September 30, 2019. Research and development
incentive receivables, short term, totaled approximately
$752,000 at September 30, 2019.
About Leap Therapeutics
Leap Therapeutics (NASDAQ:LPTX) is focused on developing novel
cancer 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.
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, New York, NY,
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.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
5,772
|
|
$
6,457
|
|
$
18,698
|
|
$
14,922
|
|
General and
administrative
|
|
2,151
|
|
2,142
|
|
6,481
|
|
6,858
|
|
|
Total operating
expenses
|
|
7,923
|
|
8,599
|
|
25,179
|
|
21,780
|
Loss from
operations
|
|
(7,923)
|
|
(8,599)
|
|
(25,179)
|
|
(21,780)
|
Interest
income
|
|
80
|
|
128
|
|
281
|
|
327
|
Interest
expense
|
|
(5)
|
|
(4)
|
|
(21)
|
|
(18)
|
Australian research
and development incentives
|
|
(7)
|
|
299
|
|
129
|
|
1,188
|
Foreign currency
loss
|
|
(80)
|
|
(249)
|
|
(114)
|
|
(615)
|
Change in fair value
of warrant liability
|
|
-
|
|
1,793
|
|
-
|
|
(3,720)
|
Net
loss
|
|
|
|
(7,935)
|
|
(6,632)
|
|
(24,904)
|
|
(24,618)
|
Dividend attributable
to down round feature of warrants
|
|
-
|
|
-
|
|
(359)
|
|
-
|
Net loss attributable
to common stockholders
|
|
$
(7,935)
|
|
$
(6,632)
|
|
$
(25,263)
|
|
$
(24,618)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
(0.33)
|
|
$
(0.45)
|
|
$
(1.15)
|
|
$
(1.76)
|
|
Diluted
|
|
|
$
(0.33)
|
|
$
(0.55)
|
|
$
(1.15)
|
|
$
(1.76)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
23,923,196
|
|
14,701,785
|
|
22,039,386
|
|
13,955,949
|
|
Diluted
|
|
|
23,923,196
|
|
15,211,716
|
|
22,039,386
|
|
13,955,949
|
|
|
Leap Therapeutics,
Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
10,058
|
|
$
16,284
|
Research and
development incentive receivable
|
|
752
|
|
836
|
Prepaid expenses and
other current assets
|
|
210
|
|
202
|
Total
current assets
|
|
11,020
|
|
17,322
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
149
|
|
86
|
Right of use asset,
net
|
|
1,214
|
|
-
|
Research and
development incentive receivable, net of current portion
|
|
177
|
|
-
|
Deferred tax
assets
|
|
120
|
|
124
|
Other assets
|
|
|
1,461
|
|
1,542
|
Total
assets
|
|
$
14,141
|
|
$
19,074
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
4,889
|
|
$
3,579
|
Accrued
expenses
|
|
2,317
|
|
2,872
|
Restricted stock
liability
|
|
159
|
|
-
|
Lease liability -
current portion
|
|
566
|
|
-
|
Total
current liabilities
|
|
7,931
|
|
6,451
|
|
|
|
|
|
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
Warrant
liability
|
|
-
|
|
3,448
|
Lease liability, net of
current portion
|
|
648
|
|
-
|
Total
liabilities
|
|
8,579
|
|
9,899
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized; 24,194,877 and
14,703,159 shares issued and
outstanding as of September 30, 2019 and December 31,
2018, respectively
|
|
24
|
|
15
|
Additional paid-in
capital
|
|
192,383
|
|
162,393
|
Accumulated other
comprehensive income
|
|
327
|
|
302
|
Accumulated
deficit
|
|
(187,172)
|
|
(153,535)
|
Total
stockholders' equity
|
|
5,562
|
|
9,175
|
Total
liabilities and stockholders' equity
|
|
$
14,141
|
|
$
19,074
|
|
|
Leap Therapeutics,
Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended September 30,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
$
(21,008)
|
|
$
(18,983)
|
Cash used in
investing activities
|
|
(100)
|
|
-
|
Cash
provided by financing activities
|
|
14,836
|
|
15,946
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
46
|
|
549
|
Net decrease
in cash and cash equivalents
|
|
(6,226)
|
|
(2,488)
|
Cash and cash
equivalents at beginning of period
|
|
16,284
|
|
25,737
|
Cash and cash
equivalents at end of period
|
|
$
10,058
|
|
$
23,249
|
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SOURCE Leap Therapeutics, Inc.