CAMBRIDGE, Mass., March 16, 2020 /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, 2019.
Leap Highlights:
- Entered into an exclusive option and licence agreement with
BeiGene, Ltd. for the clinical development and commercialization of
DKN-01, Leap's anti-Dickkopf-1 (DKK1)
antibody, in Asia (excluding
Japan), Australia, and New
Zealand
- Completed a $27 million equity
financing with BeiGene, Perceptive Advisors, and a lead
institutional investor
- Presented final data from its Phase 1/2 clinical trial of
DKN-01 plus Keytruda® (pembrolizumab) in patients with advanced or
recurrent esophagogastric cancer at the American Society of
Clinical Oncology 2020 Gastrointestinal Cancers Symposium
- Presented updated data from its Phase 2 clinical trial of
DKN-01 as monotherapy and in combination with paclitaxel
chemotherapy in patients with advanced gynecological malignancies
at the 2019 International Gynecologic Cancer Society Annual Global
Meeting and at the Society of Gynecologic Oncology 50th
Annual Meeting on Women's Cancer
- Announced investigator-initiated study of DKN-01 in patients
with DKK1+ advanced prostate cancer
- Announced investigator-initiated study of DKN-01 plus Opdivo®
(nivolumab) in patients with advanced biliary tract cancer that is
partially supported by Bristol-Myers Squibb
- Announced investigator-initiated study of DKN-01 plus
Tecentriq® (atezolizumab) in patients with advanced esophagogastric
cancer that is funded by Roche
"We ended 2019 having made significant progress in the clinical
development of DKN-01 as both a monotherapy and in combination with
other therapies as a treatment for cancer. We've generated an
abundance of data that continues to demonstrate DKN-01's activity
against multiple difficult-to-treat tumor types," said Christopher K. Mirabelli, Ph.D., President and
Chief Executive Officer of Leap. "We've carried this momentum into
the new year, having achieved our top corporate goal of securing a
strategic partner for development of DKN-01 in the Asia-Pacific region. We look forward to
working with BeiGene to bring DKN-01 to patients in this geographic
area where the incidence of esophagogastric cancer is highly
prevalent and to develop DKN-01 in combination with tizlelizumab,
their anti-PD-1 antibody."
Business Update
- Leap and BeiGene Sign Exclusive Option and License
Agreement for DKN-01 - Leap and BeiGene announced an
exclusive option and license agreement for the clinical development
and commercialization of DKN-01. Under the terms of the agreement,
Leap will receive an upfront cash payment of $3 million from BeiGene in exchange for granting
BeiGene an option to an exclusive license to develop and
commercialize DKN-01 in Asia
(excluding Japan), Australia, and New
Zealand, and will be eligible to receive an additional
payment from BeiGene upon BeiGene's exercise of the option
following initial proof-of-concept studies. Leap will retain
exclusive rights for the development, manufacturing, and
commercialization of DKN-01 for the rest of the world.
Additionally, Leap is eligible to receive payments from BeiGene
based upon the achievement of certain development, regulatory, and
sales milestones for a total deal value of up to $132 million, together with tiered royalties on
any product sales of DKN-01 in the licensed territory.
- Leap Completes $27 Million
Equity Financing with BeiGene, Perceptive Advisors and
another institutional investor - In connection with
the licensing agreement with BeiGene, Leap has also entered into a
securities purchase agreement to issue and sell in a private
placement 1,421,801 shares of Series A mandatorily convertible
preferred stock to a lead institutional investor and 1,137,442
shares of Series B mandatorily convertible preferred stock to
BeiGene and Perceptive Advisors. On March 5, 2020, the Leap stockholders approved the
conversion of the Series A preferred stock into a pre-funded
warrant to purchase 14,413,902 shares of common stock and the
conversion of the Series B preferred stock into 11,531,133 shares
of common stock. Each investor also received a warrant to
purchase an equal number of shares at an exercise price of
$2.11 per share.
DKN-01 Clinical Update
DKN-01 is a humanized monoclonal antibody targeting the
DKK1 protein, a Wnt pathway
modulator. DKN-01, as a single agent, has achieved partial
responses in three different cancer indications. In combination
with immune checkpoint inhibitors and with chemotherapy, DKN-01 has
achieved overall response rates and survival data that is greater
than the historical benchmarks, particularly in biomarker targeted
patient populations.
- ESOPHAGOGASTRIC CANCER (EGC): Leap completed
a multi-part Phase 1/2 clinical study of DKN-01 as a monotherapy
and in combination with paclitaxel or KEYTRUDA® (pembrolizumab) in
advanced EGC. Two DKN-01 monotherapy patients experienced partial
responses (PRs) by central imaging assessment, one of whom had
previously been treated with prior immunotherapies, including an
anti-PD-L1 antibody, was on therapy for one year. Six additional
monotherapy patients were determined to have had a best response of
stable disease (SD). The combination of DKN-01 and pembrolizumab in
gastroesophageal junction cancer (GEJ) and gastric cancer (GC)
patients demonstrated improved outcomes in DKK1-high patients and who had not previously
been treated with PD-1/PD-L1 therapy. DKK1-high patients experienced over 22 weeks
median progression-free survival (PFS) and nearly 32 weeks overall
survival (OS), with a 50% overall response rate (ORR) and 80%
disease control rate (DCR) in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks
median PFS and over 17 weeks OS, with a 20% DCR in 15 evaluable
patients.
As part of the collaboration with BeiGene, Leap plans to study the
combination of DKN-01 and BeiGene's anti-PD-1 antibody,
tislelizumab and will evaluate approximately 40 DKK1-high patients with second-line GC or GEJ. In
addition, Leap plans to evaluate the combination of DKN-01 with
tislelizumab and chemotherapy in approximately 20 patients with
first-line GC/GEJ. These clinical trials are expected to initiate
in the first half of 2020.
- GYNECOLOGICAL CANCERS: The ongoing Phase 2
clinical study of DKN-01 as a monotherapy and in combination with
paclitaxel in patients with advanced gynecological cancers has
recently completed patient enrollment. As of September 2019, twenty-two patients who had
previously received one to ten lines of therapy have been enrolled
to receive DKN-01 monotherapy. In the cohort of sixteen monotherapy
patients with epithelial endometrial cancer with identified Wnt
signaling mutations, one patient had a complete response and one
patient had a partial response, seven patients had a best response
of SD, and seven patients had progressive disease. Patient
follow-up is continuing in this study, which has been expanded to
include focused cohorts of patients with carcinosarcoma.
In light of the global emergency of the new coronavirus, COVID-19,
the Society of Gynecologic Oncology will not conduct its 2020
Annual Meeting on Women's Cancer, previously scheduled for
March 28-31, 2020, in Toronto, Canada. Leap is currently
awaiting additional information about the oral presentation that
was to be made at the conference and evaluating other data
presentation opportunities for the study in gynecologic
cancers.
Selected Year-End and Fourth Quarter 2019 Financial
Results
Net loss was $32.9 million for the
year ended December 31, 2019,
compared to $23.1 million for the
year ended December 31, 2018. This
increase was primarily due to increased research and development
expenses and a change in warrant liability accounting.
Research and development expenses were $24.4 million for the full year 2019, compared to
$21.8 million for the same period in
2018. This increase was primarily due to increased full-year
clinical trial costs due to increased patient enrollment, payroll
and stock-based compensation expense, offset by reduced
manufacturing expenses of our clinical product candidates and
consulting expenses. Research and development expenses were
$5.7 million for the fourth quarter
of 2019, compared to $6.9 million for
the same period in 2018. This decrease was primarily due to reduced
clinical trial costs in the fourth quarter of 2019 resulting from
the maturing of our clinical trials and from lower manufacturing
and consulting expenses.
General and administrative expenses were $9.1 million for the full year 2019, compared to
$8.9 million for the same period in
2018. General and administrative expenses were $2.6 million for the fourth quarter of 2019,
compared to $2.1 million for the same
period in 2018. These increases were due to increases in
performance-based and stock-based compensation expense.
Cash, cash equivalents and marketable securities totaled
$3.9 million at December 31, 2019. Research and development
incentive receivables totaled $0.2
million. Subsequent to the financial year end, Leap
completed a $27.0 million private
placement and received $3.0 million
from the agreement with BeiGene.
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 formed a 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 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
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, 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: 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, 2019,
as filed with the SEC on March 16,
2020. 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. TECENTRIQ® is a
registered trademark of Genentech, Inc., South San Francisco, CA.
CONTACT:
Douglas E. Onsi
Chief Financial 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
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
24,366
|
|
$
21,830
|
|
$
5,668
|
|
$
6,908
|
General and administrative
|
|
9,085
|
|
8,921
|
|
2,604
|
|
2,063
|
Total
operating expenses
|
|
33,451
|
|
30,751
|
|
8,272
|
|
8,971
|
Loss from
operations
|
|
(33,451)
|
|
(30,751)
|
|
(8,272)
|
|
(8,971)
|
Interest
income
|
|
313
|
|
447
|
|
32
|
|
120
|
Interest
expense
|
|
(23)
|
|
(19)
|
|
(2)
|
|
(1)
|
Australian research
and development incentives
|
|
132
|
|
756
|
|
3
|
|
(432)
|
Foreign currency
gains (loss)
|
|
126
|
|
(835)
|
|
240
|
|
(220)
|
Change in fair value
of warrant liability
|
|
-
|
|
7,284
|
|
-
|
|
11,004
|
Income (loss) before
income taxes
|
|
(32,903)
|
|
(23,118)
|
|
(7,999)
|
|
1,500
|
Income
taxes
|
|
3
|
|
(20)
|
|
3
|
|
(20)
|
Net income
(loss)
|
|
(32,900)
|
|
(23,138)
|
|
(7,996)
|
|
1,480
|
Dividend attributable
to down round feature of warrants
|
|
(359)
|
|
-
|
|
-
|
|
-
|
Net income (loss)
attributable to common stockholders
|
|
$
(33,259)
|
|
$
(23,138)
|
|
$
(7,996)
|
|
$
1,480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
$
(1.47)
|
|
$
(1.64)
|
|
$
(0.33)
|
|
$
0.10
|
Diluted
|
|
|
|
$
(1.47)
|
|
$
(2.11)
|
|
$
(0.33)
|
|
$
0.10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
22,582,687
|
|
14,144,287
|
|
24,194,877
|
|
14,703,159
|
Diluted
|
|
|
|
22,582,687
|
|
14,412,695
|
|
24,194,877
|
|
14,764,282
|
Leap Therapeutics,
Inc.
|
Consolidated
Balance Sheets
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
3,891
|
|
$
16,284
|
Research and development incentive receivable
|
|
185
|
|
836
|
Prepaid expenses and other current assets
|
|
165
|
|
202
|
Total
current assets
|
|
4,241
|
|
17,322
|
|
|
|
|
|
Property and equipment, net
|
|
124
|
|
86
|
Right of use assets
|
|
1,026
|
|
-
|
Deferred tax assets
|
|
127
|
|
124
|
Deferred offering costs
|
|
831
|
|
162
|
Deposits
|
|
1,099
|
|
1,380
|
Total
assets
|
|
$
7,448
|
|
$
19,074
|
Liabilities and
Stockholders' Equity (Deficiency)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
4,571
|
|
$
3,579
|
Accrued expenses
|
|
3,441
|
|
2,872
|
Lease liability - current portion
|
|
474
|
|
-
|
Total
current liabilities
|
|
8,486
|
|
6,451
|
|
|
|
|
|
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
Warrant liability
|
|
-
|
|
3,448
|
Restricted stock liability
|
|
159
|
|
-
|
Lease liability, net of current portion
|
|
552
|
|
-
|
Total
liabilities
|
|
9,197
|
|
9,899
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized,
24,194,877
and 14,703,159 shares issued and
outstanding as of December 31, 2019 and
December 31, 2018,
respectively
|
|
24
|
|
15
|
Additional paid-in capital
|
|
193,319
|
|
162,393
|
Accumulated other comprehensive income
|
|
76
|
|
302
|
Accumulated deficit
|
|
(195,168)
|
|
(153,535)
|
Total
stockholders' equity (deficiency)
|
|
(1,749)
|
|
9,175
|
Total
liabilities and stockholders' equity (deficiency)
|
|
$
7,448
|
|
$
19,074
|
Leap
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
Three Months
Ended December 31,
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
$
(26,902)
|
|
$
(26,033)
|
|
$
(5,894)
|
|
$
(7,050)
|
Cash
provided by (used in) investing activities
|
|
(85)
|
|
-
|
|
15
|
|
-
|
Cash
provided by (used in) financing activities
|
|
14,817
|
|
15,906
|
|
(19)
|
|
(40)
|
Effect of
exchange rate changes on cash and cash
equivalents
|
(223)
|
|
674
|
|
(269)
|
|
125
|
Net decrease
in cash and cash equivalents
|
|
(12,393)
|
|
(9,453)
|
|
(6,167)
|
|
(6,965)
|
Cash and cash
equivalents at beginning of period
|
|
16,284
|
|
25,737
|
|
10,058
|
|
23,249
|
Cash and cash
equivalents at end of period
|
|
$
3,891
|
|
$
16,284
|
|
$
3,891
|
|
$
16,284
|
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SOURCE Leap Therapeutics, Inc.