CAMBRIDGE, Mass., March 12, 2021 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused
on developing targeted and immuno-oncology therapeutics, today
reported financial results for the fourth quarter and year ended
December 31, 2020.
2020 Leap Highlights:
- Signed agreement with BeiGene, Ltd. for rights to Leap's
anti-DKK1 antibody, DKN-01, in
Asia (excluding Japan), Australia and New
Zealand
- Completed a $51.75 million public
offering of common stock and pre-funded warrants to purchase common
stock
- Presented updated data from study of DKN-01 plus pembrolizumab
in esophagogastric (EGC) cancer demonstrating positive outcomes in
DKK1-high patients
- Data for DKN-01 in endometrial cancer demonstrates single agent
activity in biomarker-selected patients
- First patient dosed in Phase 2a study of DKN-01 in combination
with tislelizumab, BeiGene's anti-PD-1 antibody, for the treatment
of metastatic gastric or gastroesophageal junction (G/GEJ)
cancer
- Received Orphan Drug Designation and Fast Track Designation for
DKN-01 from FDA
"2020 was a transformative year for Leap as we executed our
first strategic alliance with BeiGene and advanced our DKN-01
development program, initiating our Phase 2a combination study with
BeiGene's tislelizumab in gastric cancer patients," said
Douglas E. Onsi, President and Chief
Executive Officer of Leap. "The data for DKN-01 to date, both as a
monotherapy and in combination approaches, provide evidence of the
potential utility of DKN-01 as an attractive treatment option for
multiple biomarker-focused cancer indications."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin
and PI3K/AKT signaling pathways. DKK1
has an important role in tumor cell signaling and in mediating an
immuno-suppressive tumor microenvironment.
- Leap and BeiGene Announced First Patient Dosed in Study
of DKN-01 in Combination with Tislelizumab for the Treatment of
Metastatic Gastric/Gastroesophageal Junction (G/GEJ) Cancer
– In September 2020, Leap and
BeiGene announced that the first patient was dosed in the
DisTinGuish trial (NCT04363801), a Phase 2a, nonrandomized,
open-label, multicenter study of Leap's DKN-01 in combination with
BeiGene's tislelizumab with or without chemotherapy as first-line
or second-line therapy in adult patients with inoperable, locally
advanced G/GEJ adenocarcinoma. The study, which will be conducted
in two parts, is currently evaluating approximately forty patients
with second-line G/GEJ cancer whose tumors are DKK1-high per perspective analysis. In addition,
the study is evaluating the combination of DKN-01 with tislelizumab
and capecitabine and oxaliplatin in approximately twenty patients
with first-line G/GEJ cancer. Initial data is expected in the
second half of 2021.
- Leap Presented Updated Data from DKN-01 in EGC
Demonstrating Positive Outcomes in DKK1-high Patients – At the Society for
Immunotherapy of Cancer's (SITC) 35th Anniversary Annual
Meeting, Leap presented clinical data from the Phase 1b/2a clinical trial of DKN-01 in patients with
advanced EGC. In the study, high levels of tumoral DKK1 expression correlated with improved clinical
outcomes in heterogeneous EGC patients treated with DKN-01
monotherapy or in combination with paclitaxel or the anti-PD-1
antibody, pembrolizumab.
- Leap Presented Updated Data for DKN-01 in Endometrial
Cancer Demonstrating Single Agent Activity in Biomarker-selected
Patients – At the American Association for Cancer Research
(AACR) Virtual Special Conference on Endometrial Cancer: New
Biology Driving Research and Treatment, Leap presented additional
clinical data from the epithelial endometrial cancer (EEC) patients
treated with DKN-01 monotherapy as part of its ongoing Phase 2
clinical trial for DKN-01, as both a monotherapy and in combination
with paclitaxel chemotherapy, in patients with advanced
gynecological malignancies. In the study, DKN-01 demonstrated
single agent activity in biomarker-selected EEC patients, including
an ongoing complete response that is over 2.5 years in duration and
prolonged progression-free survival. Additional data from this
study will be presented at the Society of Gynecologic Oncology 2021
Annual Meeting on Women's Cancer.
- Leap Receives Orphan Drug Designation and Fast Track
Designation – On June 11,
2020, the FDA granted Orphan Drug Designation to DKN-01 for
the treatment of gastroesophageal junction and gastric cancer. On
September 24, 2020, the FDA granted
Fast Track Designation to DKN-01 in combination with tislelizumab
for the treatment of patients with gastric and gastroesophageal
junction adenocarcinoma whose tumors express high DKK1, following disease progression on or after
prior fluoropyrimidine- and platinum-containing chemotherapy and if
appropriate, human epidermal receptor growth factor
(HER2)/neu-targeted therapy.
Selected Year-End and Fourth Quarter 2020 Financial
Results
Net Loss was $27.5 million for the
year ended December 31, 2020,
compared to $32.9 million for the
year ended December 31, 2019. This
decrease was primarily due to decreased research and development
expenses following the deprioritization of the TRX518 program in
2019.
License revenues were $1.5 million
for the full year 2020 and relate to the BeiGene Agreement for the
development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New
Zealand. License revenues were $0.4
million for the fourth quarter 2020. The BeiGene
Agreement became effective on January 3,
2020. As the BeiGene Agreement is the first such license
agreement, no license revenues were recorded during the year ended
December 31, 2019.
Research and development expenses were $20.4 million for full year 2020, compared to
$24.4 million for same period in
2019. Research and development expenses were $5.1 million for the fourth quarter of 2020,
compared to $5.7 million for the same
period in 2019. These decreases were primarily due to
decreased clinical trial costs due to deprioritizing the continued
development of TRX518 in 2019 and timing of patient enrollment,
decreased consulting fees associated with research and development
activities, and decreased rent expense due to the closing of
our research laboratory in April of 2020. These decreases were
partially offset by increases in payroll and other related expenses
due to an increase in headcount of our research and development
full time employees and increases in stock-based compensation
expense due to new stock options granted to employees.
General and administrative expenses were $9.6 million for the full year 2020, compared to
$9.1 million for the same period in
2019. The increase was due to an increase in professional fees
primarily due to increased legal, recruiting and information
technology costs, an increase in payroll and other related expenses
due to an increase in compensation expense, and an increase in
insurance expense. These increases were partially offset by a
decrease in stock-based compensation expense. General and
administrative expenses were $2.4
million for the full year 2020 compared to $2.6 million for the same period in 2019.
This decrease was due to a decrease in stock-based compensation
expense, partially offset by increased recruiting and information
technology costs.
Cash and cash equivalents totaled $52.1
million at December 31, 2020.
Research and development incentive receivables totaled $0.1 million.
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 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/.
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
a future option exercise, milestones 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. 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
Leap Therapeutics,
Inc.
|
|
|
|
|
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Year Ended
December 31
|
|
Three Months Ended
December 31
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
1,500
|
|
$
-
|
|
$
375
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
20,423
|
|
24,366
|
|
5,101
|
|
5,668
|
|
General and
administrative
|
|
9,616
|
|
9,085
|
|
2,428
|
|
2,604
|
|
|
|
Total operating expenses
|
|
30,039
|
|
33,451
|
|
7,529
|
|
8,272
|
Loss from
operations
|
|
(28,539)
|
|
(33,451)
|
|
(7,154)
|
|
(8,272)
|
Interest
income
|
|
93
|
|
313
|
|
2
|
|
32
|
Interest
expense
|
|
(39)
|
|
(23)
|
|
3
|
|
(2)
|
Australian research
and development incentives
|
|
231
|
|
132
|
|
(112)
|
|
3
|
Foreign currency
gains
|
|
738
|
|
126
|
|
549
|
|
240
|
Loss before income
taxes
|
|
(27,516)
|
|
(32,903)
|
|
(6,712)
|
|
(7,999)
|
Income
taxes
|
|
2
|
|
3
|
|
2
|
|
3
|
Net
loss
|
|
(27,514)
|
|
(32,900)
|
|
(6,710)
|
|
(7,996)
|
Dividend attributable
to down round feature of warrants
|
|
(303)
|
|
(359)
|
|
0
|
|
-
|
Dividend attributable
to Series A & B convertible preferred stock
|
|
(372)
|
|
-
|
|
0
|
|
-
|
Series A & B
convertible preferred stock - beneficial conversion
feature
|
|
(9,399)
|
|
-
|
|
-
|
|
-
|
Net loss attributable
to common stockholders
|
|
$
(37,588)
|
|
$
(33,259)
|
|
$
(6,710)
|
|
$
(7,996)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.63)
|
|
$
(1.47)
|
|
$
(0.09)
|
|
$
(0.33)
|
|
|
|
Diluted
|
|
$
(0.63)
|
|
$
(1.47)
|
|
$
(0.09)
|
|
$
(0.33)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
59,327,713
|
|
22,582,687
|
|
76,376,160
|
|
24,194,877
|
|
|
|
Diluted
|
|
59,327,713
|
|
22,582,687
|
|
76,376,160
|
|
24,194,877
|
|
|
|
|
|
|
Leap Therapeutics,
Inc.
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
52,071
|
|
$
3,891
|
|
Research and
development incentive receivable
|
|
73
|
|
185
|
|
Prepaid expenses and
other current assets
|
|
130
|
|
165
|
|
|
|
|
|
Total current
assets
|
|
52,274
|
|
4,241
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
65
|
|
124
|
|
Right of use assets,
net
|
|
528
|
|
1,026
|
|
Deferred tax
assets
|
|
179
|
|
127
|
|
Deferred
costs
|
|
345
|
|
831
|
|
Deposits
|
|
|
980
|
|
1,099
|
|
|
|
|
|
Total
assets
|
|
$
54,371
|
|
$
7,448
|
Liabilities and
Stockholders' Equity (Deficiency)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
2,717
|
|
$
4,571
|
|
Accrued
expenses
|
|
2,747
|
|
3,441
|
|
Deferred revenue -
current portion
|
|
1,500
|
|
-
|
|
Lease liability -
current portion
|
|
408
|
|
474
|
|
|
|
|
|
Total current
liabilities
|
|
7,372
|
|
8,486
|
|
|
|
|
|
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
|
Restricted stock
liability
|
|
204
|
|
159
|
|
Lease liability, net
of current portion
|
|
144
|
|
552
|
|
|
|
|
|
Total
liabilities
|
|
7,720
|
|
9,197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
|
|
Common stock, $0.001
par value; 240,000,000 shares authorized; 59,657,742
and 24,194,877 shares issued and outstanding as of December
31, 2020 and 2019, respectively
|
|
60
|
|
24
|
|
Additional paid-in
capital
|
|
270,155
|
|
193,319
|
|
Accumulated other
comprehensive income (loss)
|
|
(579)
|
|
76
|
|
Accumulated
deficit
|
|
(222,985)
|
|
(195,168)
|
|
|
|
|
|
Total stockholders'
equity (deficiency)
|
|
46,651
|
|
(1,749)
|
|
|
|
|
|
Total liabilities and
stockholders' equity (deficiency)
|
|
$
54,371
|
|
$
7,448
|
Leap
Therapeutics, Inc.
|
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
Three Months
Ended December 31,
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
$
(25,957)
|
|
$
(26,902)
|
|
$
(5,988)
|
|
$
(5,894)
|
Cash
provided by (used in) investing activities
|
|
25
|
|
(85)
|
|
-
|
|
15
|
Cash
provided by (used in) financing activities
|
|
73,997
|
|
14,817
|
|
-
|
|
(19)
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
115
|
|
(223)
|
|
84
|
|
(269)
|
Net increase
(decrease) in cash and cash equivalents
|
|
$
48,180
|
|
$
(12,393)
|
|
(5,904)
|
|
(6,167)
|
Cash and cash
equivalents at beginning of period
|
|
3,891
|
|
16,284
|
|
57,975
|
|
10,058
|
Cash and cash
equivalents at end of period
|
|
$
52,071
|
|
$
3,891
|
|
$
52,071
|
|
$
3,891
|
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SOURCE Leap Therapeutics, Inc.