CAMBRIDGE, Mass., Nov. 9, 2018 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported a business update and financial results for the third
quarter ended September 30, 2018.
"Our team has executed extremely well over the past quarter,
rapidly enrolling multiple clinical trials and presenting
impressive clinical and preclinical data for both of our
programs. We are excited about the potential for our DKN-01
antibody in patients with esophagogastric cancer, both in
combination with KEYTRUDA® (pembrolizumab) and with
paclitaxel. We believe that the emerging response and disease
control rates, and now the progression-free survival and overall
survival data, reflect outcomes that are clinically meaningful to
patients with very difficult to treat cancer and are greater than
what has previously been demonstrated with approved single agents,"
commented Christopher K. Mirabelli,
Ph.D, President and Chief Executive Officer of Leap Therapeutics.
"In addition, we look forward to presenting data from the
studies of our TRX518 antibody in combination with KEYTRUDA,
OPDIVO® (nivolumab) or gemcitabine at the European Society for
Molecular Oncology 2018 Immuno-Oncology Congress in December."
Recent Developments
Since the end of the second quarter, the Company has continued
to make strong progress with the development of their product
candidates.
- DKN-01/KEYTRUDA: At the European Society for
Molecular Oncology (ESMO) 2018 Annual Congress, Leap presented
clinical data from a study evaluating DKN-01 in combination with
KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric
cancer. As of the cut-off date for the poster, DKN-01 and
pembrolizumab had a 23.5% overall response rate and 58.8% disease
control rate in evaluable gastric or gastroesophageal junction
cancer patients who have been heavily pre-treated and not received
any prior anti-PD-1/PD-L1 therapy. All four of the responding
patients had tumors that were microsatellite stable, which is a
subgroup of patients who have historically experienced a less than
ten percent response rate to KEYTRUDA monotherapy.
- DKN-01/PACLITAXEL: At the Society for
Immunotherapy of Cancer 33rd Annual Meeting, Leap presented an
update on a clinical study evaluating DKN-01 in combination with
paclitaxel in patients with advanced esophagogastric cancer. The
combination of DKN-01 and paclitaxel generated a 46.7% overall
response rate, 19.6 weeks median progression free survival, and
61.1 weeks median overall survival in fifteen evaluable patients as
a second line therapy. In the benchmark RAINBOW study, paclitaxel
monotherapy in second line gastroesophageal junction or gastric
cancer patients generated a 16.1% overall response rate, 2.9 months
median progression free survival, and 7.4 months median overall
survival. Additionally, in our study in the subgroup of twelve
evaluable patients with heavily pre-treated esophageal squamous
cell carcinoma, the combination of DKN-01 and paclitaxel produced a
33.3% overall response rate, 13.7 weeks median progression free
survival, and 31.0 weeks median overall survival.
- DKN-01 in HCC: The first patient has been
enrolled in Leap's investigator-initiated study of DKN-01 as a
monotherapy and in combination with NEXAVAR® (sorafenib) in
hepatocellular carcinoma patients with Wnt pathway activation.
- TRX518/BAVENCIO: In July, Leap announced a
collaboration agreement with Pfizer and Merck KGaA, Darmstadt,
Germany to evaluate TRX518 in
combination with BAVENCIO® (avelumab) and cyclophosphamide
chemotherapy. Under the terms of the collaboration, Leap will be
conducting a Phase I/II clinical trial in advanced solid tumors
including expansion populations in patients with
relapsed/refractory ovarian, breast, and prostate cancers.
- TRX518/KEYTRUDA or OPDIVO or GEMCITABINE: During
the third quarter, Leap presented initial data from a clinical
trial evaluating TRX518 in combination with gemcitabine
chemotherapy or in combination with KEYTRUDA® (pembrolizumab) or
OPDIVO® (nivolumab). Three patients treated with TRX518 in
combination with anti-PD1 antibodies have experienced clinical
benefit. An esophageal squamous cell carcinoma patient treated with
TRX518 and KEYTRUDA demonstrated a partial response with a 77%
reduction in tumor volume, and an ocular melanoma patient
experienced stable disease with a 23% reduction in tumor volume. An
urothelial carcinoma patient who had progressed while on KEYTRUDA
has had a partial response with TRX518 and OPDIVO with a 39%
reduction in tumor volume. We have also fully enrolled the TRX518
and gemcitabine expansion cohort. We plan to present additional
data from this trial at the ESMO Immuno-Oncology Congress in
December 2018.
Selected Third Quarter 2018 Financial Results
Net loss was $6.6 million for the
third quarter of 2018, compared to $6.8
million for the same period in 2017.
Research and development expenses were $6.5 million for the third quarter 2018,
compared to $6.8 million for the
same period in 2017. The decrease of $0.3 million was primarily due to a decrease
of $1.3 million in manufacturing
costs related to clinical trial material. This decrease was
partially offset by an increase of $0.7
million in clinical trial costs, an increase of $0.2 million in payroll and other related costs
and an increase of $0.1 million in
stock based compensation expense.
General and administrative expenses were $2.1 million for the third quarter 2018, compared
to $1.8 million for the same
period in 2017. The increase of $0.3
million in general and administrative expenses was primarily
due to a $0.2 million increase in
stock based compensation expense and an increase of $0.1 million in legal, audit and consulting fees
associated with corporate and business development activities.
Cash, cash equivalents and marketable securities totaled
$23.2 million at September 30, 2018. Research and
development incentive receivables totaled $2.1 million. In October 2018, we received $0.8 million of research and development tax
incentive payments from the Commonwealth of Australia. We anticipate that our
current cash resources will extend until late in the third quarter
of 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 cancer,
hepatobiliary cancer, and gynecologic cancer. 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.
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 relating to
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 risks and uncertainties that could cause actual results
to differ materially from our expectations. These risks and
uncertainties include, but are not limited to: our ability to
operate as a going concern; 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 Securities and Exchange Commission (the "SEC"),
including Leap Therapeutics' Form 10-K that Leap filed with the SEC
on February 23, 2018. 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. OPDIVO® is a
registered trademark of Bristol-Myers Squibb Company. BAVENCIO® is
a registered trademark of Pfizer, Inc. NEXAVAR® is a registered
trademark of Bayer Healthcare Pharmaceuticals, Inc.
CONTACT:
Leap Therapeutics, Inc.:
Douglas E. Onsi
Chief Financial Officer
donsi@leaptx.com
617-714-0360
Argot Partners:
Heather Savelle
Mary Jenkins
212-600-1902
heather@argotpartners.com
mary@argotpartners.com
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
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
6,457
|
|
$
6,802
|
|
$
14,922
|
|
$
18,087
|
|
General and
administrative
|
|
2,142
|
|
1,780
|
|
6,858
|
|
7,719
|
|
|
Total operating
expenses
|
|
8,599
|
|
8,582
|
|
21,780
|
|
25,806
|
Loss from
operations
|
|
(8,599)
|
|
(8,582)
|
|
(21,780)
|
|
(25,806)
|
Interest
income
|
|
128
|
|
40
|
|
327
|
|
130
|
Interest
expense
|
|
(4)
|
|
(21)
|
|
(18)
|
|
(12)
|
Interest expense -
related party
|
|
-
|
|
-
|
|
-
|
|
(121)
|
Australian research
and development incentives
|
|
299
|
|
961
|
|
1,188
|
|
1,852
|
Foreign currency
gains (loss)
|
|
(249)
|
|
787
|
|
(615)
|
|
823
|
Change in fair value
of warrant liability
|
|
1,793
|
|
-
|
|
(3,720)
|
|
-
|
Net
loss
|
|
(6,632)
|
|
(6,815)
|
|
(24,618)
|
|
(23,134)
|
Accretion of
preferred stock to redemption value
|
|
-
|
|
-
|
|
-
|
|
(244)
|
Net loss attributable
to common stockholders
|
|
$
(6,632)
|
|
$
(6,815)
|
|
$
(24,618)
|
|
$
(23,378)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
$
(0.45)
|
|
$
(0.73)
|
|
$
(1.76)
|
|
$
(2.72)
|
|
Diluted
|
|
|
|
$
(0.55)
|
|
$
(0.73)
|
|
$
(1.76)
|
|
$
(2.72)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
14,701,785
|
|
9,395,920
|
|
13,955,949
|
|
8,584,558
|
|
Diluted
|
|
|
|
15,211,716
|
|
9,395,920
|
|
13,955,949
|
|
8,584,558
|
Leap Therapeutics,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
23,249
|
|
$
25,737
|
|
Research and
development incentive receivable
|
|
937
|
|
1,744
|
|
Prepaid expenses and
other current assets
|
|
191
|
|
177
|
|
|
Total current
assets
|
|
24,377
|
|
27,658
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
98
|
|
135
|
|
Research and
development incentive receivable, net of current portion
|
|
1,131
|
|
-
|
|
Deferred tax
asset
|
|
147
|
|
158
|
|
Other
assets
|
|
1,373
|
|
1,111
|
|
|
Total
assets
|
|
$
27,126
|
|
$
29,062
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
4,149
|
|
$
2,622
|
|
Accrued
expenses
|
|
1,897
|
|
3,461
|
|
|
Total current
liabilities
|
|
6,046
|
|
6,083
|
|
|
|
|
|
|
|
Non Current
liabilities:
|
|
|
|
|
|
Warrant
liability
|
|
14,452
|
|
11,862
|
|
|
Total
liabilities
|
|
20,498
|
|
17,945
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized; 14,703,159 and
12,354,014
shares issued and outstanding as of September 30, 2018
and December 31, 2017, respectively
|
|
15
|
|
12
|
|
Additional paid-in
capital
|
|
161,468
|
|
141,770
|
|
Accumulated other
comprehensive income (loss)
|
|
160
|
|
(268)
|
|
Accumulated
deficit
|
|
(155,015)
|
|
(130,397)
|
|
|
Total stockholders'
equity
|
|
6,628
|
|
11,117
|
|
|
Total liabilities and
stockholders' equity
|
|
$
27,126
|
|
$
29,062
|
Leap Therapeutics,
Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended September 30,
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
(Unaudited)
|
Cash used in
operating activities
|
|
$
(18,983)
|
|
$
(15,768)
|
Cash used in
investing activities
|
|
-
|
|
(64)
|
Cash
provided by financing activities
|
|
15,946
|
|
29,868
|
Effect of
exchange rate changes on cash and cash
equivalents
|
549
|
|
(626)
|
Net increase
(decrease) in cash and cash equivalents
|
|
(2,488)
|
|
13,410
|
Cash and cash
equivalents at beginning of period
|
|
25,737
|
|
793
|
Cash and cash
equivalents at end of period
|
|
$
23,249
|
|
$
14,203
|
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SOURCE Leap Therapeutics, Inc.