CAMBRIDGE, Mass., May 14, 2021 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused
on developing targeted and immuno-oncology therapeutics, today
reported financial results for the first quarter ended March 31, 2021.
Leap First Quarter Highlights:
- Completed enrollment for first-line patient cohort in the
DisTinGuish study, a clinical trial evaluating Leap's
anti-Dickkopf-1 (DKK1) antibody,
DKN-01, in combination with tislelizumab, BeiGene Ltd.'s anti-PD-1
antibody, with or without chemotherapy, in patients with gastric or
gastroesophageal junction cancer (G/GEJ)
- Presented updated clinical data from the Phase 2 study of
DKN-01 as a monotherapy and in combination with paclitaxel in
patients with advanced gynecological malignancies at the Society of
Gynecologic Oncology (SGO) 2021 Virtual Annual Meeting on Women's
Cancer
- Announced partnership to use a clinically validated tumor
expression assay utilizing RNAscope® and image analysis with
Flagship Biosciences for patient enrollment
"We're off to a strong start this year as we've continued to
advance our understanding of DKN-01 and the potential role it can
play as both a monotherapy or in combination with existing
treatments in multiple DKK1 biomarker
defined cancer indications," said Douglas
E. Onsi, President and Chief Executive Officer of Leap. "The
completion of enrollment of the first-line patient cohort in the
DisTinGuish study brings us one step closer to an important
milestone for us with our partner BeiGene, anticipated later this
year."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the DKK1
protein. DKK1 modulates the
Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which have
an important role in tumor cell signaling and in mediating an
immuno-suppressive tumor microenvironment through enhancing the
activity of myeloid-derived suppressor cells and downregulating NK
cell ligands on tumor cells.
- Leap Announced Completion of Enrollment in First-Line
Cohort in the DisTinGuish Study of DKN-01 plus Tislelizumab and
Chemotherapy in Gastric Cancer – In April 2021, Leap announced the completion of
enrollment for the first-line patient cohort in the DisTinGuish
study (NCT04363801), a clinical trial evaluating DKN-01 in
combination with tislelizumab, BeiGene Ltd.'s anti-PD-1 antibody,
with or without chemotherapy, in patients with G/GEJ. The study,
which is being conducted in two parts in the United States and the Republic of Korea,
enrolled 25 patients with first-line G/GEJ cancer and will enroll
up to 48 patients with second-line G/GEJ cancer whose tumors
express high levels of DKK1. Initial
data is expected in the second half of 2021. Leap is conducting
this combination study as part of an exclusive option and license
agreement with BeiGene for the development of DKN-01 in
Asia (excluding Japan), Australia, and New
Zealand.
- Leap Presented Final Data for DKN-01 in Gynecologic
Cancers – At the SGO 2021 Virtual Annual Meeting on Women's
Cancer, Leap presented the final data from the study of DKN-01 as a
monotherapy or in combination with paclitaxel in groups composed of
epithelial endometrial cancer (EEC), epithelial ovarian cancer
(EOC), or carcinosarcoma (MMMT) patients. The key findings from the
study were:
-
- EEC patients and patients with Wnt activating mutations
express higher levels of DKK1: EEC patients expressed higher
levels of DKK1 and had a higher
frequency of Wnt activating mutations than patients with EOC.
Within EEC, patients with endometrioid histology had higher
DKK1 expression than those with
non-endometrioid histology. Patients whose tumors had Wnt
activating mutations expressed 14.4 times higher levels of
DKK1.
- DKN-01 has enhanced activity in patients whose tumors
express high levels of DKK1:
In the group of 22 EEC patients treated with DKN-01 monotherapy for
whom DKK1 expression data was
available, patients with DKK1-high
tumors (n=7) had greater ORR (14% vs. 0%), DCR (57% vs. 7%), and
median PFS (3.0 months vs. 1.8 months [HR 0.39; 95% CI: 0.14, 1.1])
compared to patients with DKK1-low
tumors (n=15). Additionally, seven patients did not have
DKK1 expression results available, of
whom one had a complete response (14%) and five (72%) had a best
response of stable disease, including three patients with Wnt
activating mutations. In the group of 24 EEC patients treated with
DKN-01 plus paclitaxel, 72% of whom had received three or more
prior systemic therapies, DKK1-high
patients (n=11) had improved median PFS (5.4 months vs. 1.8 months
[HR 0.34; 95% CI: 0.12, 0.97]) compared to DKK1-low patients (n=9). Four patients did not
have DKK1 expression data
available.
- Presented DKK1 Biomarker
Assay Validation Data – At the American Association for
Cancer Research Annual Meeting 2021, Leap and its clinical
laboratory partner, Flagship Biosciences, presented data on the
validation of a DKK1 RNAscope
chromogenic in situ hybridization (CISH) assay and digital image
analysis solution. Leap and Flagship have demonstrated that the
DKK1 RNAscope assay and accompanying
digital image analysis solution is specific, sensitive, accurate
and reproducible according to Clinical Laboratory Improvements
Amendments (CLIA) guidelines. The assay is currently being used to
prospectively identify G/GEJ patients with elevated tumoral
expression of DKK1 in the ongoing
DisTinGuish clinical trial.
Selected First Quarter 2021 Financial Results
Net Loss was $9.1 million for the
first quarter 2021, compared to $7.2
million for the same period in 2020. This increase was
primarily due to increased development activity for the DKN-01
program and an increase in headcount and compensation expense as
the Company has grown throughout the year.
License revenues for each of the first quarter 2021 and 2020
were $0.4 million, and relate to the
BeiGene Agreement for the development and commercialization of
DKN-01 in Asia (excluding
Japan), Australia, and New
Zealand. The BeiGene Agreement became effective on
January 3, 2020.
Research and development expenses were $6.8 million for the first quarter 2021, compared
to $4.6 million for the same period
in 2020. The increase of $2.2 million
in research and development expenses was primarily due to an
increase of $0.8 million in payroll
and other related expenses due to an increase in headcount of our
research and development full time employees, an increase of
$0.6 million in manufacturing costs
related to clinical trial material and an increase of $0.8 million in clinical trial costs due to
timing of patient enrollment.
General and administrative expenses were $2.7 million for the first quarter 2021, compared
to $2.2 million for the same period
in 2020. The increase of $0.5
million in general and administrative expenses was due to a
$0.3 million increase in payroll and
other related expenses during the three months ended March 31, 2021 as compared to the same period in
2020 and a $0.2 million increase in
professional fees primarily due to increased recruiting and
information technology costs.
Cash and cash equivalents totaled $43.5
million at March 31, 2021.
Research and development incentive receivables totaled $0.02 million at March 31,
2021.
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. DKN-01 is in clinical trials in patients with
esophagogastric, hepatobiliary, gynecologic, and prostate cancers.
Leap has entered into a strategic partnership with BeiGene, Ltd.
for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New
Zealand. For more information about Leap Therapeutics, visit
http://www.leaptx.com or view our public filings with the SEC that
are available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
RNAscope® is a registered trademark of Advanced Cell
Diagnostics, Inc., Newark, CA,
USA.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, Section 21E of the Securities Exchange Act of 1934, as
amended, and the Private Securities Litigation Reform Act of 1995,
which involve risks and uncertainties. These statements include
Leap's expectations with respect to the development and advancement
of DKN-01, including the initiation, timing and design of future
studies, enrollment in future studies, potential for the receipt of
future option exercise, milestone, or royalty payments from
BeiGene, and other future expectations, plans and prospects.
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: that the initiation,
conduct, and completion of clinical trials, laboratory operations,
manufacturing campaigns, and other studies may be delayed,
adversely affected, or impacted by COVID-19 related issues; the
accuracy of our estimates regarding expenses, future revenues,
capital requirements and needs for financing; 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; 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's Annual Report on
Form 10-K for the fiscal year ended December
31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap's
Quarterly Reports on Form 10-Q and the other reports Leap files
from time to time with the SEC. Any forward-looking statement
contained in this release speaks only as of its date. Leap
undertakes no obligation to update any forward-looking statement
contained in this release to reflect events or circumstances
occurring after its date or to reflect the occurrence of
unanticipated events.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
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Leap Therapeutics,
Inc.
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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
March 31
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2021
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2020
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License
revenue
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|
$
375
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$
375
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Operating
expenses:
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|
|
Research and
development
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|
6,807
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|
4,603
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|
General and
administrative
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|
2,740
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|
2,153
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|
Total operating expenses
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|
9,547
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|
6,756
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Loss from
operations
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|
(9,172)
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|
(6,381)
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Interest
income
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|
2
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|
68
|
Interest
expense
|
|
(14)
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|
(12)
|
Australian research
and development incentives
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|
71
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|
85
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Foreign currency
gains
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|
(21)
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|
(991)
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Loss before income
taxes
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|
(9,134)
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|
(7,231)
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Dividend attributable
to down round feature of warrants
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-
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|
(303)
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Dividends
attributable to Series A & B convertible preferred
stock
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-
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|
(372)
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Series A & B
convertible preferred stock - beneficial conversion
feature
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-
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|
(9,399)
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Net loss attributable
to common stockholders
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|
$
(9,134)
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|
$
(17,305)
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Net loss per
share
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Basic &
diluted
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|
$
(0.12)
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|
$
(0.55)
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Weighted average
common shares outstanding
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Basic &
diluted
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76,378,569
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31,632,213
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Leap Therapeutics,
Inc.
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Consolidated
Balance Sheets
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(in thousands,
except share and per share amounts)
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March
31,
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December
31,
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2021
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2020
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(Unaudited)
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Cash and cash
equivalents
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|
$
43,491
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|
$
52,071
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Research and
development incentive receivable
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|
22
|
|
73
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Prepaid expenses and
other current assets
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|
266
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|
130
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|
|
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Total current
assets
|
|
43,779
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|
52,274
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Property and
equipment, net
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|
56
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|
65
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Right of use assets,
net
|
|
433
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|
528
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Research and
development incentive receivable, net of current portion
|
|
70
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|
-
|
Deferred tax
assets
|
|
178
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|
179
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Deferred
costs
|
|
311
|
|
345
|
Deposits
|
|
|
980
|
|
980
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|
Total
assets
|
|
$
45,807
|
|
$
54,371
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Accounts
payable
|
|
$
3,514
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|
$
2,717
|
Accrued
expenses
|
|
2,335
|
|
2,747
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Deferred revenue -
current portion
|
|
1,125
|
|
1,500
|
Lease liability -
current portion
|
|
418
|
|
408
|
|
|
|
|
Total current
liabilities
|
|
7,392
|
|
7,372
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|
|
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|
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|
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Restricted stock
liability
|
|
-
|
|
204
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Lease liability, net
of current portion
|
|
36
|
|
144
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|
|
|
|
Total
liabilities
|
|
7,428
|
|
7,720
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|
|
|
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|
|
|
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Common stock, $0.001
par value; 240,000,000 shares authorized; 59,669,722
and 59,657,742 shares issued and outstanding as of
March 31, 2021 and
December 31, 2020, respectively
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|
60
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|
60
|
Additional paid-in
capital
|
|
271,002
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|
270,155
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Accumulated other
comprehensive loss
|
|
(564)
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|
(579)
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Accumulated
deficit
|
|
(232,119)
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|
(222,985)
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Total stockholders'
equity
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|
38,379
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|
46,651
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Total liabilities and
stockholders' equity
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|
$
45,807
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|
$
54,371
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Leap
Therapeutics, Inc.
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Condensed
Consolidated Statements of Cash Flows
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(in
thousands)
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(Unaudited)
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|
|
|
|
|
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|
Three Months
Ended March 31,
|
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|
2021
|
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2020
|
|
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|
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Cash used in
operating activities
|
|
|
$
(8,587)
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|
$
(3,926)
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Cash
provided by financing activities
|
|
|
14
|
|
25,605
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Effect of
exchange rate changes on cash and cash
equivalents
|
|
|
(7)
|
|
(105)
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
(8,580)
|
|
21,574
|
Cash and cash
equivalents at beginning of period
|
|
|
52,071
|
|
3,891
|
Cash and cash
equivalents at end of period
|
|
|
$
43,491
|
|
$
25,465
|
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SOURCE Leap Therapeutics, Inc.