CAMBRIDGE, Mass., Nov. 12, 2020 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial
results for the third quarter ended September 30, 2020.
Leap Third Quarter Highlights:
- First patient dosed in Phase 2a study of Leap's anti-Dickkopf-1
(DKK1) antibody DKN-01 in combination
with tislezumab, BeiGene's anti-PD-1 antibody, for the treatment of
metastatic gastric or gastroesophageal junction (G/GEJ) cancer
- Presented updated data from DKN-01 in esophagogastric (EGC)
cancer demonstrating positive outcomes in DKK1-high patients
- Presented updated data for DKN-01 in endometrial cancer
demonstrating single agent activity in biomarker-selected
patients
- U.S. Food and Drug Administration (FDA) Fast Track designation
granted to DKN-01 for the treatment of G/GEJ cancer
"Data from our ongoing studies continue to demonstrate the
potential of DKN-01 as both a single-agent or combination treatment
with chemotherapy or anti-PD1 therapies for the treatment of
biomarker-defined cancer patients," said Douglas E. Onsi, President and Chief Executive
Officer of Leap. "We are also excited by the progress we've made
with BeiGene this quarter, having dosed the first patient 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."
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
signaling. 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 G/GEJ Cancer – Leap and BeiGene, Ltd. 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
expected to enroll up to 72 patients.
Part A will enroll up to 24 patients with G/GEJ adenocarcinoma who
have received no prior systemic treatment in the locally
advanced/metastatic setting (first-line treatment), and Part B will
enroll up to 48 patients with previously treated, inoperable,
locally advanced or metastatic DKK1-high G/GEJ adenocarcinoma (second-line
treatment). The study is designed to evaluate safety, tolerability,
and efficacy of the combination therapy of intravenous DKN-01 and
tislelizumab ± CAPOX (capecitabine + oxaliplatin) in G/GEJ
adenocarcinoma patients. Treatment will be conducted in repeating
21-day cycles until the patient meets pre-established criteria for
discontinuation or is no longer deriving clinical benefit. Part A
and Part B of the study will be conducted concurrently.
- 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. Important patient subgroups in this study
demonstrated consistent benefit in DKK1-high patients, including:
-
- Anti-PD-1/PD-L1 refractory patients (all): The
four DKK1-high patients had a
significantly longer median progression-free survival (PFS) of 12.8
weeks and median overall survival (OS) of 46 weeks as compared to
the five DKK1-low patients who
experienced PFS of 6 weeks and OS of 16 weeks.
- Anti-PD1/PD-L1 refractory GEJ/GC patients: The
three DKK1-high patients had a best
response of stable disease (SD) and a longer PFS of 13.4 weeks and
OS of 37.4 weeks, as compared to the two DKK1-low patients who both had progressive
disease (PD) with a PFS of 3.6 weeks and OS of 11.7 weeks.
- Anti-PD-1/PD-L1 naïve GEJ/GC patients: As
previously reported, DKK1-high
patients experienced over 22 weeks PFS and nearly 32 weeks 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 PFS
and over 17 weeks OS, with a 20% DCR in fifteen evaluable patients.
PD-L1 Combined Positive Scores (CPS) did not predict efficacy on
the combination of DKN-01 plus pembrolizumab. In multi-variate
analysis, DKK1-high status correlated
with longer PFS independent of PD-L1 CPS scores.
- 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 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. Twenty-nine EEC 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. Three important biomarker-selected subgroups were the
focus of the data presentation:
-
- Patients with Wnt Signaling Alterations: Patients
with a Wnt signaling alteration had a higher response rate, greater
clinical benefit, and longer PFS and OS compared to patients
without a Wnt signaling alteration. In the group of 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 SD, and 10 patients (50%) had
PD, representing an ORR of 10% and a DCR of 50%. In the group of
six patients without any Wnt signaling alterations, one patient
(16.6%) had a best response of SD and five patients (83.3%) had PD.
The patients with a Wnt signaling alteration experienced PFS of 1.9
months and OS of 15.1 months, compared to the patients without a
Wnt signaling alteration who experienced PFS of 1.8 months and OS
of 8.4 months.
- Patients with Wnt Activating Mutations: Patients
with Wnt activating mutations had longer PFS and OS than patients
without Wnt activating mutations. The nine patients with a Wnt
activating mutation experienced PFS of 5.5 months and had not
reached a median OS, compared to the 20 patients without a Wnt
activating mutation who experienced PFS of 1.8 months and OS of
12.2 months.
- Patients expressing high tumor levels of DKK1: DKK1 expression data was available
for 19 EEC patients treated with DKN-01 monotherapy. DKK1-high patients had a higher response rate,
greater clinical benefit, and longer PFS than patients who were
DKK1-low. In the group of seven
patients with DKK1-high tumors, one
patient (14.3%) had a partial response, three patients (42.9%) had
SD, and three patients (42.9%) had PD, representing an ORR of 14.3%
and a DCR of 57.1%. In the group of 12 patients with DKK1-low tumors, one patient (8.3%) had SD and 11
patients (91.7%) had PD. The DKK1-high patients experienced PFS of 3.0 months,
compared to the DKK1-low patients who
experienced PFS of 1.8 months.
- Leap Announced FDA Fast Track Designation Granted to DKN-01
for the Treatment of Gastric or Gastroesophageal Junction Cancer
– Leap announced that the FDA granted Fast Track
designation to DKN-01 for the treatment of patients with G/GEJ
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. The Fast Track program is intended to
facilitate the development and expedite the review of drug
candidates and vaccines that treat serious conditions and fill an
unmet medical need. The purpose of Fast Track is to get important
new drugs to the patient earlier. Programs with Fast Track
designation may benefit from early and frequent communication with
the FDA, in addition to a rolling submission of the marketing
application. DKN-01 has also received Orphan Drug Designation for
the treatment of G/GEJ cancer from the FDA.
Selected Third Quarter 2020 Financial Results
Net loss was $7.1 million for the
third quarter 2020, compared to $7.9
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 third quarter 2020, compared
to $5.8 million for the same period
in 2019. The decrease was primarily driven by reductions in
clinical trial costs due to the deprioritization of the TRX518
program in November 2019 and the
timing of patient enrollment. These decreases were partially offset
by an increase in payroll and other related expeneses for research
and development employees.
General and administrative expenses were $2.5 million for the third quarter 2020, compared
to $2.2 million for the same period
in 2019. The increase was due to higher professional fees primarily
attributable to recruiting and information technology costs.
Cash, cash equivalents and marketable securities totaled
$58.0 million at September 30, 2020. Research and development
incentive receivables, current and long term, totaled approximately
$0.2 million at September 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 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
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 Leap files
from time to time with the SEC. Any forward-looking statements
contained in this release speak only as of its date. Leap
undertakes 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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
375
|
|
$
-
|
|
$
1,125
|
|
$
-
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,369
|
|
5,772
|
|
15,322
|
|
18,698
|
General and
administrative
|
|
2,514
|
|
2,151
|
|
7,188
|
|
6,481
|
Total
operating expenses
|
|
7,883
|
|
7,923
|
|
22,510
|
|
25,179
|
Loss from
operations
|
|
(7,508)
|
|
(7,923)
|
|
(21,385)
|
|
(25,179)
|
Interest
income
|
|
3
|
|
80
|
|
91
|
|
281
|
Interest
expense
|
|
(17)
|
|
(5)
|
|
(42)
|
|
(21)
|
Australian research
and development incentives
|
|
228
|
|
(7)
|
|
343
|
|
129
|
Foreign currency
gains (loss)
|
|
237
|
|
(80)
|
|
189
|
|
(114)
|
Loss before income
taxes
|
|
(7,057)
|
|
(7,935)
|
|
(20,804)
|
|
(24,904)
|
Income
taxes
|
|
-
|
|
-
|
|
-
|
|
-
|
Net
loss
|
|
(7,057)
|
|
(7,935)
|
|
(20,804)
|
|
(24,904)
|
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
|
|
$
(7,057)
|
|
$
(7,935)
|
|
$
(30,878)
|
|
$
(25,263)
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.09)
|
|
$
(0.33)
|
|
$
(0.58)
|
|
$
(1.15)
|
Diluted
|
|
$
(0.09)
|
|
$
(0.33)
|
|
$
(0.58)
|
|
$
(1.15)
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
|
|
Basic
|
|
76,321,644
|
|
23,923,196
|
|
53,548,902
|
|
22,039,386
|
Diluted
|
|
76,321,644
|
|
23,923,196
|
|
53,548,902
|
|
22,039,386
|
Leap Therapeutics,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share and per share amounts)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2020
|
|
2019
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
57,975
|
|
$
3,891
|
Research and
development incentive receivable
|
|
209
|
|
185
|
Prepaid expenses and
other current assets
|
|
217
|
|
165
|
Total
current assets
|
|
58,401
|
|
4,241
|
|
|
|
|
|
Property and equipment,
net
|
|
73
|
|
124
|
Right of use assets,
net
|
|
620
|
|
1,026
|
Deferred tax
assets
|
|
130
|
|
127
|
Deferred costs
|
|
379
|
|
831
|
Deposits
|
|
941
|
|
1,099
|
Total
assets
|
|
$
60,544
|
|
$
7,448
|
Liabilities and
Stockholders' Equity (Deficiency)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
2,547
|
|
$
4,571
|
Accrued
expenses
|
|
2,270
|
|
3,441
|
Deferred revenue -
current portion
|
|
1,500
|
|
-
|
Lease liability -
current portion
|
|
398
|
|
474
|
Total
current liabilities
|
|
6,715
|
|
8,486
|
|
|
|
|
|
Non current
liabilities:
|
|
|
|
|
Restricted stock
liability
|
|
66
|
|
159
|
Deferred revenue, net
of current portion
|
|
375
|
|
-
|
Lease liability, net of
current portion
|
|
250
|
|
552
|
Total
liabilities
|
|
7,406
|
|
9,197
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
|
Common stock, $0.001
par value; 240,000,000 and 100,000,000 shares authorized as of
September 30, 2020 and December 31, 2019, repectively;
59,657,742 and 24,194,877 shares
issued and outstanding as of September 30, 2020 and December
31, 2019, respectively
|
|
60
|
|
24
|
Additional paid-in
capital
|
|
269,440
|
|
193,319
|
Accumulated other
comprehensive income (loss)
|
|
(87)
|
|
76
|
Accumulated
deficit
|
|
(216,275)
|
|
(195,168)
|
Total
stockholders' equity (deficiency)
|
|
53,138
|
|
(1,749)
|
Total
liabilities and stockholders' equity (deficiency)
|
|
$
60,544
|
|
$
7,448
|
Leap
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
Nine Months
Ended September 30,
|
|
|
2020
|
|
2019
|
|
|
(Unaudited)
|
|
|
|
|
|
Cash used in
operating activities
|
|
$
(19,969)
|
|
$
(21,008)
|
Cash
provided by (used) in investing activities
|
|
25
|
|
(100)
|
Cash
provided by financing activities
|
|
73,997
|
|
14,836
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
31
|
|
46
|
Net increase
(decrease) in cash and cash equivalents
|
|
54,084
|
|
(6,226)
|
Cash and cash
equivalents at beginning of period
|
|
3,891
|
|
16,284
|
Cash and cash
equivalents at end of period
|
|
$
57,975
|
|
$
10,058
|
|
|
|
|
|
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SOURCE Leap Therapeutics, Inc.