CAMBRIDGE, Mass., May 14, 2020 /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, 2020.
Leap First Quarter Highlights:
- Entered into an exclusive option and license agreement with
BeiGene, Ltd. for the clinical development and commercialization of
DKN-01 in Asia (excluding
Japan), Australia, and New
Zealand
- Completed a $27 million equity
financing with BeiGene, Perceptive Advisors, and a lead
institutional investor
- Presented updated data for DKN-01 monotherapy that showed a
complete response and partial response in endometrial cancer
patients with additional responses observed for the DKN-01 plus
paclitaxel combination in carcinosarcoma patients
- 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
- Announced Executive Leadership Team and Board of Directors
changes
"We've made great strides in the first quarter, as we continue
to generate compelling data demonstrating DKN-01's potential as a
single agent or in combination with PD-1 antibody therapy or
chemotherapy in treating multiple biomarker-defined cancer
indications," said Douglas E. Onsi,
President and Chief Executive Officer of Leap. "Our partnership
with BeiGene for the clinical development and commercialization of
DKN-01 is off to a strong start. Site initiation activities are now
underway for our combination study of DKN-01 plus tislelizumab,
BeiGene's anti-PD-1 antibody, in patients with gastric or
gastroesophageal junction cancer, and we look forward to dosing the
first patients in the second half of this year."
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 in Asia (excluding Japan), Australia, and New
Zealand. Under the terms of the agreement, Leap received an
upfront cash payment of $3 million
from BeiGene. Leap will be eligible to receive an additional
payment from BeiGene upon BeiGene's exercise of the option and
payments based upon the achievement of certain development,
regulatory, and sales milestones, for a total deal value of up to
$132 million. In addition, Leap is
entitled to receive tiered royalties on any product sales of DKN-01
in the licensed territory. Leap will retain exclusive rights for
the development, manufacturing, and commercialization of DKN-01 for
the United States, Europe, Japan, and the rest of the world.
- Leap Completes $27 Million
Equity Financing with BeiGene, Perceptive Advisors and Another
Institutional Investor - Simultaneous with the BeiGene
Agreement, Leap also entered into a securities purchase agreement
and issued and sold 1,421,801 shares of Series A mandatorily
convertible preferred stock to a lead investor and an aggregate of
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. In addition, the lead investor
has the right to appoint a member to Leap's Board of
Directors.
- Leap Makes Executive Leadership Changes – Leap
announced the following changes to the Company's Executive
Leadership Team and Board of Directors:
-
- Christopher K. Mirabelli, Ph.D.,
stepped down from his role as President and Chief Executive Officer
and will continue to serve as the Chairman of Leap's Board of
Directors and an employee, providing ongoing leadership around the
Company's research and development efforts.
- Douglas E. Onsi was named
President and Chief Executive Officer, while maintaining his
previous role as Chief Financial Officer. Mr. Onsi will also serve
as a member of the Board of Directors.
- John Littlechild stepped down
from Leap's Board of Directors.
- Cynthia Sirard, M.D., was
promoted to Chief Medical Officer from Vice President, Clinical
Research and Development.
- Mark O'Mahony was promoted to
Chief Manufacturing Officer from Vice President of Chemistry,
Manufacturing, and Controls.
DKN-01 Clinical 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
signaling. DKK1 has an important role
in tumor cell signaling and in mediating an immuno-suppressive
tumor microenvironment.
- Leap Presented Updated Data for DKN-01 Monotherapy and
Paclitaxel Combination in Gynecologic Cancers – Leap
announced updated clinical data from its ongoing Phase 2 clinical
trial of DKN-01, as both a monotherapy and in combination with
paclitaxel chemotherapy, in patients with advanced gynecological
malignancies. Leap hosted a conference call with Rebecca Arend, M.D., Assistant Professor and
Associate Scientist, Gynecologic Oncology Clinic, The University of Alabama at Birmingham School of
Medicine Comprehensive Cancer Center Experimental Therapeutics
Program, on April 23, 2020, to
discuss the data. Key findings from the P204 Study include the
following:
DKN-01 Single Agent
Activity
- Endometrial Cancer: Twenty-nine endometrial cancer
patients were enrolled in the DKN-01 monotherapy arm, over 75% of
whom had experienced three or more prior lines of therapy. Of those
patients, 26 were evaluable for response. In the 20 patients with a
Wnt signaling alteration, one patient (5%) has an ongoing complete
response, one patient (5%) had a partial response, eight patients
(40%) had a best response of stable disease, and 10 patients (50%)
had progressive disease, representing an overall response rate
(ORR) of 10% and a disease control rate (DCR) of 50%. In the group
of six patients without any Wnt signaling alterations, one patient
(16.6%) had a best response of stable disease and five patients
(83.3%) had progressive disease.
- Carcinosarcoma: Ten patients with carcinosarcoma
have been enrolled in the DKN-01 monotherapy arm, five of whom were
evaluable for response as of the data-cut off date. Two patients
(40%) had a best response of stable disease, one of whom has
continued on monotherapy for nearly two years, and three patients
(60%) had progressive disease. Five patients had not reached their
first tumor assessment.
DKN-01 plus Paclitaxel
Combination Activity
- Carcinosarcoma: Fifteen patients with
carcinosarcoma were enrolled in the DKN-01 plus paclitaxel arm, six
of whom were evaluable for response as of the data-cut off date.
Two patients (33%) have had a partial response, one patient (17%)
has had a best response of stable disease, and three patients (50%)
had progressive disease, representing an ORR of 33% and a DCR of
50%. Nine patients had not reached their first tumor
assessment.
- Endometrial Cancer: Twenty-five patients with
heavily pretreated endometrial cancer were enrolled in the DKN-01
plus paclitaxel arm. All of these patients had previously received
paclitaxel, 44% had received hormonal therapies, 32% had received
bevacizumab, 20% had received immunotherapy, and 12% had received a
PARP inhibitor. Of those patients, 22 were evaluable for response.
A total of 12 patients (55%) have had a best response of stable
disease, and ten patients (45%) had progressive disease.
- Monotherapy Patients with Wnt activating mutations have
longer Progression-Free Survival (PFS) and Overall Survival
(OS): In a pooled analysis of all DKN-01 monotherapy
patients, patients with Wnt activating mutations have demonstrated
a longer median PFS of 168 days as compared to patients without Wnt
activating mutations with median PFS of 56 days. Median OS has not
been reached in the Wnt activating mutation group in the pooled
analysis as compared to median OS of 328 days in the non-Wnt
activating mutation group.
- Monotherapy Patients with DKK1-high tumors have longer
PFS and OS: DKK1 expression as measured by in
situ hybridization RNAscope assay is currently available
for 68 of the patients on the study, 32 of whom were treated with
DKN-01 monotherapy. Seven patients (22%) were identified as
having DKK1-high tumoral expression (DKK1-high). Consistent with the results from
Leap's study in patients with esophagogastric cancer, patients
whose tumors are DKK1-high have prolonged median PFS of 168
days as compared to patients with tumors that are DKK1-low
with median PFS of 56 days. Median OS was 450 days in
the DKK1-high group in the pooled analysis as compared to 276
days in the DKK1-low group.
- Leap Presented Final Data for DKN-01 plus KEYTRUDA®
(pembrolizumab) in Esophagogastric Cancer: Leap
completed its multi-part Phase 1/2 clinical study of DKN-01, as a
monotherapy and in combination with paclitaxel or KEYTRUDA®
(pembrolizumab), in patients with advanced esophagogastric cancer.
At the American Society of Clinical Oncology 2020 Gastrointestinal
Cancers Symposium, Leap presented final data for the combination of
DKN-01 plus pembrolizumab. The combination of DKN-01 and
pembrolizumab in gastroesophageal junction cancer (GEJ) and gastric
cancer (GC) patients demonstrated improved outcomes
in DKK1-high patients who had not previously been treated with
PD-1/PD-L1 therapy. DKK1-high patients experienced over 22
weeks median PFS and nearly 32 weeks median OS, with a 50% ORR and
80% 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.
- Site Initiation Activities Underway for DKN-01 plus
Tislelizumab Combination Study: As part of the
collaboration with BeiGene, Leap intends to study the combination
of DKN-01 and BeiGene's anti-PD-1 antibody, tislelizumab. The
Company plans to evaluate approximately 40 patients with
second-line GC or GEJ whose tumors are DKK1-high. In addition, Leap will evaluate the
combination of DKN-01 with tislelizumab and chemotherapy in
approximately 20 patients with first-line GC or GEJ. Site
initiation activities for this clinical trial are underway, and the
Company expects to dose the first patients in the second half of
2020.
Selected First Quarter 2020 Financial Results
Net loss was $7.2 million for the
first quarter 2020, compared to $8.6
million for the same period in 2019. This decrease was
primarily due to revenue recognized from the BeiGene agreement and
a decrease in clinical development expenses, offset by a non-cash
charge for foreign currency losses associated with changes in the
Australian dollar exchange rate related to activities of Leap's
Australian subsidiary.
Research and development expenses was $4.6 million for the first quarter 2020, compared
to $6.8 million for the same period
in 2019. The decrease was primarily due to decreases in
clinical trial costs due to timing of patient enrollment and
decreases in consulting fees associated with research and
development activities.
General and administrative expenses was $2.2 million for the first quarter 2020, compared
to $2.0 million for the same period
in 2019. The increase was primarily due to increases in legal,
audit and consulting fees associated with corporate and business
development activities.
Cash, cash equivalents and marketable securities totaled
$25.5 million at March 31, 2020. Research and development
incentive receivables, current and long term, totaled approximately
$0.2 million at March 31, 2020.
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 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, 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: 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, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's
Quarterly Reports on Form 10-Q and the other reports we file from
time to time with the SEC. 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.
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.
|
Condensed
Consolidated Statements of Operations
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
375
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
4,603
|
|
6,790
|
General and
administrative
|
|
2,153
|
|
2,005
|
Total operating expenses
|
|
6,756
|
|
8,795
|
Loss from
operations
|
|
(6,381)
|
|
(8,795)
|
Interest
income
|
|
68
|
|
82
|
Interest
expense
|
|
(12)
|
|
(7)
|
Australian research
and development incentives
|
|
85
|
|
75
|
Foreign currency
gains (loss)
|
|
(991)
|
|
42
|
Net loss
|
|
(7,231)
|
|
(8,603)
|
Dividend attributable
to down round feature of warrants
|
|
(303)
|
|
(359)
|
Dividend attributable
to Series A & B convertible preferred stock
|
|
(372)
|
|
-
|
Series A & B
convertible preferred stock - beneficial conversion
feature
|
|
(9,399)
|
|
-
|
Net loss attributable
to common stockholders
|
|
$
(17,305)
|
|
$
(8,962)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
Basic
|
|
$
(0.55)
|
|
$
(0.47)
|
Diluted
|
|
$
(0.55)
|
|
$
(0.47)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
Basic
|
|
31,632,213
|
|
19,237,444
|
Diluted
|
|
31,632,213
|
|
19,237,444
|
Leap Therapeutics,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
2020
|
|
2019
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
25,465
|
|
$
3,891
|
Research and
development incentive receivable
|
|
247
|
|
185
|
Prepaid expenses and
other current assets
|
|
272
|
|
165
|
Total
current assets
|
|
25,984
|
|
4,241
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
114
|
|
124
|
Right of use
assets
|
|
835
|
|
1,026
|
Deferred tax
assets
|
|
112
|
|
127
|
Deferred
costs
|
|
623
|
|
831
|
Deposits
|
|
1,074
|
|
1,099
|
Total
assets
|
|
$
28,742
|
|
$
7,448
|
Liabilities and
Stockholders' Equity (Deficiency)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
4,933
|
|
$
4,571
|
Accrued
expenses
|
|
2,387
|
|
3,441
|
Deferred revenue -
current portion
|
|
1,500
|
|
-
|
Lease liability -
current portion
|
|
379
|
|
474
|
Total
current liabilities
|
|
9,199
|
|
8,486
|
|
|
|
|
|
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
Restricted stock
liability
|
|
-
|
|
159
|
Deferred revenue, net
of current portion
|
|
1,125
|
|
-
|
Lease liability, net of
current portion
|
|
454
|
|
552
|
Total
liabilities
|
|
10,778
|
|
9,197
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized, 35,799,488
and
24,194,877 shares issued and outstanding as of March 31, 2020
and
December 31, 2019, respectively
|
|
36
|
|
24
|
Additional paid-in
capital
|
|
219,642
|
|
193,319
|
Accumulated other
comprehensive income
|
|
988
|
|
76
|
Accumulated
deficit
|
|
(202,702)
|
|
(195,168)
|
Total
stockholders' equity (deficiency)
|
|
17,964
|
|
(1,749)
|
Total
liabilities and stockholders' equity (deficiency)
|
|
$
28,742
|
|
$
7,448
|
Leap
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended March 31,
|
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
|
$
(3,926)
|
|
$
(6,868)
|
Cash
provided by financing activities
|
|
|
25,605
|
|
12,322
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
|
(105)
|
|
(29)
|
Net increase
in cash and cash equivalents
|
|
|
21,574
|
|
5,425
|
Cash and cash
equivalents at beginning of period
|
|
|
3,891
|
|
16,284
|
Cash and cash
equivalents at end of period
|
|
|
$
25,465
|
|
$
21,709
|
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SOURCE Leap Therapeutics, Inc.