CAMBRIDGE, Mass., Aug. 13, 2020 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial
results for the second quarter ended June
30, 2020.
Leap Second Quarter Highlights:
- Completed a $51.75 million public
offering of common stock and pre-funded warrants to purchase common
stock
- 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
- Announced Orphan Drug Designation of DKN-01 for the treatment
of gastric and gastroesophageal junction cancer
"Our partnership with BeiGene for the clinical development and
commercialization of DKN-01 is progressing extremely well, and we
look forward to dosing the first patient this quarter in the
combination study of DKN-01 plus tislelizumab, BeiGene's anti-PD-1
antibody, for the treatment of gastric or gastroesophageal junction
cancer patients," said Douglas E.
Onsi, President and Chief Executive Officer of Leap. "DKN-01
continues to show potential to treat multiple biomarker-defined
cancers, as both a single agent and in combination with
chemotherapy or anti-PD-1 therapies. We are excited about the
promise of this program and, with the proceeds from our recent
public offering, are well funded to drive development forward."
Business Update
- Leap Completed $51.75
Million Public Offering of Common Stock and Pre-Funded
Warrants to Purchase Common Stock – In June 2020, Leap announced the closing of an
underwritten public offering yielding aggregate gross proceeds of
$51.75 million, before deducting
underwriting discounts and commissions and other offering expenses
payable by Leap.
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 Monotherapy in 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.
- DKN-01 plus Paclitaxel in 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-cutoff 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.
- Leap Announced Orphan Drug Designation of DKN-01 for the
Treatment of Gastric and Gastroesophageal Junction Cancer –
Leap announced that the U.S. Food and Drug Administration (FDA)
granted the Company Orphan Drug Designation for DKN-01 for the
treatment of gastric and gastroesophageal junction cancer. The
FDA's Office of Orphan Drug Products grants orphan status to
support development of medicines for underserved patient
populations, or rare disorders, that affect fewer than 200,000
people in the U.S. Orphan Drug Designation provides to Leap certain
benefits, including market exclusivity upon regulatory approval if
received, exemption of FDA application fees, and tax credits for
qualified clinical trials.
Selected Second Quarter 2020 Financial Results
Net loss was $6.5 million for the
second quarter 2020, compared to $8.4
million for the same period in 2019. This decrease was
primarily due to revenue recognized from the BeiGene agreement, a
decrease in clinical development expenses and non-cash foreign
currency gains associated with changes in the Australian dollar
exchange rate related to certain manufacturing activities.
Research and development expenses were $5.4 million for the second quarter 2020,
compared to $6.1 million for the same
period in 2019. The decrease was primarily due to lower
clinical trial costs due to timing of patient enrollment and lower
consulting fees associated with research and development
activities.
General and administrative expenses were $2.5 million for the second quarter 2020,
compared to $2.3 million for the same
period in 2019. The increase was primarily due to higher legal,
audit and consulting fees associated with corporate and business
development activities.
Cash, cash equivalents and marketable securities totaled
$64.9 million at June 30, 2020. Research and development incentive
receivables, current and long term, totaled approximately
$0.3 million at June 30, 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 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, 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)
|
|
(Unaudited)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
375
|
|
$
-
|
|
$
750
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,350
|
|
6,136
|
|
9,953
|
|
12,926
|
General and
administrative
|
|
2,521
|
|
2,325
|
|
4,674
|
|
4,330
|
Total operating
expenses
|
|
7,871
|
|
8,461
|
|
14,627
|
|
17,256
|
Loss from
operations
|
|
(7,496)
|
|
(8,461)
|
|
(13,877)
|
|
(17,256)
|
Interest
income
|
|
20
|
|
119
|
|
88
|
|
201
|
Interest
expense
|
|
(13)
|
|
(9)
|
|
(25)
|
|
(16)
|
Australian research
and development incentives
|
|
30
|
|
61
|
|
115
|
|
136
|
Foreign currency
gains (loss)
|
|
943
|
|
(76)
|
|
(48)
|
|
(34)
|
Net loss
|
|
(6,516)
|
|
(8,366)
|
|
(13,747)
|
|
(16,969)
|
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
|
|
$
(6,516)
|
|
$
(8,366)
|
|
$
(23,821)
|
|
$
(17,328)
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.12)
|
|
$
(0.37)
|
|
$
(0.57)
|
|
$
(0.82)
|
Diluted
|
|
$
(0.12)
|
|
$
(0.37)
|
|
$
(0.57)
|
|
$
(0.82)
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
Basic
|
|
52,442,597
|
|
22,906,025
|
|
42,037,405
|
|
21,081,869
|
Diluted
|
|
52,442,597
|
|
22,906,025
|
|
42,037,405
|
|
21,081,869
|
Leap Therapeutics,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
64,887
|
|
$
3,891
|
|
Research and
development incentive receivable
|
|
181
|
|
185
|
|
Prepaid expenses and
other current assets
|
|
212
|
|
165
|
|
Total current
assets
|
|
65,280
|
|
4,241
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
81
|
|
124
|
|
Right of use
assets
|
|
711
|
|
1,026
|
|
Research and
development incentive receivable, net of current portion
|
|
124
|
|
-
|
|
Deferred tax
assets
|
|
125
|
|
127
|
|
Deferred
costs
|
|
413
|
|
831
|
|
Deposits
|
|
|
939
|
|
1,099
|
|
Total
assets
|
|
$
67,673
|
|
$
7,448
|
|
|
|
|
|
Liabilities and
Stockholders' Equity (Deficiency)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
2,716
|
|
$
4,571
|
|
Accrued
expenses
|
|
2,232
|
|
3,441
|
|
Deferred revenue -
current portion
|
|
1,500
|
|
-
|
|
Lease liability -
current portion
|
|
388
|
|
474
|
|
Total current
liabilities
|
|
6,836
|
|
8,486
|
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
|
Restricted stock
liability
|
|
-
|
|
159
|
|
Deferred revenue, net
of current portion
|
|
750
|
|
-
|
|
Lease liability, net
of current portion
|
|
354
|
|
552
|
|
Total
liabilities
|
|
7,940
|
|
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 June 30, 2020 and
|
|
|
|
|
|
December 31, 2019,
respectively
|
|
60
|
|
24
|
|
Additional paid-in
capital
|
|
268,770
|
|
193,319
|
|
Accumulated other
comprehensive income
|
|
121
|
|
76
|
|
Accumulated
deficit
|
|
(209,218)
|
|
(195,168)
|
|
Total stockholders'
equity (deficiency)
|
|
59,733
|
|
(1,749)
|
|
Total liabilities and
stockholders' equity (deficiency)
|
|
$
67,673
|
|
$
7,448
|
Leap
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Six Months
Ended June 30
|
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
|
|
$
(13,377)
|
|
$
(14,051)
|
Cash
provided by (used in) investing activities
|
|
|
25
|
|
(100)
|
Cash
provided by financing activities
|
|
|
74,382
|
|
13,582
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
|
(34)
|
|
32
|
Net increase
in cash and cash equivalents
|
|
|
60,996
|
|
(537)
|
Cash and cash
equivalents at beginning of period
|
|
|
3,891
|
|
16,284
|
Cash and cash
equivalents at end of period
|
|
|
$
64,887
|
|
$
15,747
|
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SOURCE Leap Therapeutics, Inc.