CAMBRIDGE, Mass., May 13, 2022
/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, 2022.
Leap Highlights:
- Presented positive new data from the DisTinGuish Study of
DKN-01 plus BeiGene's anti-PD-1 antibody tislelizumab and
chemotherapy in gastroesophageal junction/gastric (GEJ/G) cancer
patients at the 2022 American Society of Clinical Oncology (ASCO)
Gastrointestinal (GI) Cancers Symposium
- Completed enrollment in Part B of the DisTinGuish Study
evaluating DKN-01 plus tislelizumab in second-line GEJ/G cancer
patients whose tumors express high levels of DKK1 (DKK1-high)
- Entered partnership on DKK1
companion diagnostic with Leica Biosystems
- Presenting initial data from the investigator-sponsored Phase
1b/2a clinical trial of DKN-01 in
prostate cancer at the 2022 ASCO Annual Meeting
"We are making consistent progress in advancing DKN-01 across
multiple tumor types and look forward to Dr. David Wise of New York
University presenting initial prostate cancer data at the
upcoming ASCO conference," said Douglas E.
Onsi, President and Chief Executive Officer of Leap. "With
compelling response and survival data for DKN-01 in combination
with BeiGene's tislelizumab in gastric cancer patients presented in
January, and the recent completion of enrollment in our second-line
cohort, we are preparing for updated data readouts from our
DisTinGuish study in the second half of the year. We are also
looking forward to hosting an R&D Day in late June to outline
the next phase in the clinical development strategy for
DKN-01."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the DKK1
protein. DKK1 modulates the
Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play
an important role in tumor cell signaling and in mediating an
immuno-suppressive tumor microenvironment through enhancing the
activity of myeloid-derived suppressor cells and downregulating NK
cell ligands on tumor cells.
- Positive New Data from the DisTinGuish Clinical Trial
(NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy
Presented at the ASCO GI Cancer Symposium. In January 2022, the Company presented positive new
progression-free survival (PFS) and overall response data from Part
A, the first-line cohort of the Phase 2a study in patients with
gastroesophageal junction or gastric (GEJ/G) cancer, and initial
findings from Part B of the clinical trial, studying DKN-01 and
tislelizumab in second-line advanced GEJ/G cancer patients with
high tumoral DKK1 expression.
-
- Part A First-Line Patients: Of the 25 first-line
patients who received a full cycle of DKN-01 therapy, overall
response rate (ORR) was 68.2%, with 90% ORR in DKK1-high patients (9 partial responses (PR)) and
56% in DKK1-low patients (1 complete
response, 4 PR). Among those patients with low PD-L1 expression ORR
was 79% (with 100% ORR in DKK1-high
patients and 57% ORR in DKK1-low
patients), and in patients with higher PD-L1 expression ORR was 67%
(with 75% ORR in DKK1-high patients
and 50% in DKK1-low patients). The
preliminary median PFS was 10.7 months in the overall first-line
population, and median overall survival had not been reached. The
Company expects to present updated survival data from the study in
the second half of 2022.
- Part B Second-Line Patients: Of the 30 second
line DKK1-high GEJ/G cancer patients
who received a full cycle of DKN-01 therapy and were response
evaluable, ORR was 25%, with an additional patient who experienced
an irPR by iRECIST criteria.
- Completed Enrollment in the DisTinGuish Clinical Trial
(NCT04363801) of DKN-01 Plus Tislelizumab in DKK1-high Second Line GEJ/G Cancer
Patients. In May 2022, the
Company completed enrollment in Part B of the DisTinGuish clinical
trial, studying DKN-01 and tislelizumab in second-line advanced
GEJ/G cancer patients with high tumoral DKK1 expression.
- Entered Partnership on Companion Diagnostic with Leica
Biosystems to Advance Care for Cancer Patients. In
January 2022, Leap and Leica
Biosystems, a cancer diagnostics company, entered into an agreement
to develop a companion diagnostic to detect DKK1 in patient tumor biopsies. The assay
developed by Leica will utilize RNAscopeā¢ technology on the
BOND-III Automated Staining System, which allows for detection of
DKK1 with high sensitivity and
specificity to help identify patients for DKN-01 treatment.
- Abstract Accepted for Poster Presentation at the Upcoming
2022 ASCO Annual Meeting Highlighting Initial Clinical Data from
the Phase 1b/2a Clinical Trial
(NCT03837353) of DKN-01 Plus Docetaxel in Prostate Cancer.
The Company will present initial clinical data from the
investigator-sponsored Phase 1b/2a
dose escalation and dose expansion study testing DKN-01 as
monotherapy or in combination with docetaxel in metastatic
castration-resistant prostate cancer at the upcoming 2022 ASCO
Annual Meeting taking place in Chicago,
IL on June 3-7. Dr.
David Wise of NYU Langone Medical
Center is the lead investigator on the study.
Selected First Quarter 2022 Financial Results
Net Loss was $10.4 million for the first quarter 2022,
compared to $9.1 million for the same period in 2021. The
increase was primarily due to an increase in clinical trial costs
due to the timing of patient enrollment and the duration of
patients on study in the DisTinGuish trial and an increase in the
number of research and development employees to support the
development of DKN-01.
License revenues were $0.4 million
for the first quarter 2021 and relate to the agreement with BeiGene
for the development and commercialization of DKN-01
in Asia (excluding Japan), Australia, and New
Zealand. There were no license revenues recognized in the
first quarter 2022, as the upfront payment was fully recognized as
of December 31, 2021.
Research and development expenses were $7.8 million for the first quarter 2022,
compared to $6.8 million for the same period in 2021.
The increase in research and development expenses was due to
an increase of $0.6 million in
clinical trial costs due to timing of patient enrollment in the
DisTinGuish study, an increase of $0.6
million in payroll and other related expenses, and an
increase of $0.2 million in stock
based compensation expense during the three months ended
March 31, 2022. These increases
were partially offset by a $0.4
million decrease in manufacturing costs related to clinical
trial material due to timing of manufacturing campaigns.
General and administrative expenses were $2.8
million for the first quarter 2022, compared to $2.7
million for the same period in 2021. The increase in general
and administrative expenses was due an increase of a $0.2 million in stock based compensation expense
and an increase of $0.1 million in
payroll and other related expenses during the three months ended
March 31, 2022. These increases
were partially offset by a $0.2
million decrease in professional fees.
Cash and cash equivalents totaled $103.2
million at March 31, 2022. Research and development
incentive receivables totaled $1.3 million at March
31, 2022.
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. DKN-01 is in clinical trials in patients with
esophagogastric, hepatobiliary, gynecologic, and prostate cancers.
Leap has entered into a strategic collaboration 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 clinical studies, potential for the receipt
of future option exercise, milestone, 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;
unstable global market and economic conditions; 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 is 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, 2021, as filed
with the SEC on March 11, 2022 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 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
Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
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Leap Therapeutics,
Inc.
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Consolidated
Statements of Operations
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(in thousands,
except share and per share amounts)
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(Unaudited)
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Three Months Ended
March 31
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2022
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2021
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License
revenue
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$
-
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$
375
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Operating
expenses:
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Research and
development
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7,784
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6,807
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General and
administrative
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2,848
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2,740
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Total operating expenses
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|
10,632
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9,547
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Loss from
operations
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|
(10,632)
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(9,172)
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Interest
income
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|
|
5
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|
2
|
Interest
expense
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|
(21)
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|
(14)
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Australian research and
development incentives
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|
37
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71
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Foreign currency gain
(loss)
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235
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(21)
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Net loss attributable
to common stockholders
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(10,376)
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(9,134)
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Net loss per
share
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Basic
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$
(0.09)
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$
(0.12)
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Diluted
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|
$
(0.09)
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|
$
(0.12)
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Weighted average common
shares outstanding
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Basic
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113,248,937
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76,378,569
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Diluted
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|
113,248,937
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76,378,569
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Leap Therapeutics, Inc.
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Consolidated Balance Sheets
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(in thousands, except share and per share
amounts)
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March 31,
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December 31,
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2022
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2021
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(Unaudited)
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Assets
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Current
assets:
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Cash and cash
equivalents
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$
103,220
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$
114,916
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Research and
development incentive receivable
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|
1,233
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|
1,189
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Prepaid expenses and
other current assets
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|
491
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|
769
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Total current
assets
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|
104,944
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|
116,874
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Property and equipment,
net
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|
32
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|
36
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Right of use assets,
net
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|
355
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459
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Research and
development incentive receivable, net of current portion
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|
38
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-
|
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Deferred tax
assets
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|
164
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|
159
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Other long term
assets
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|
75
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|
90
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Deposits
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|
|
293
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|
293
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Total assets
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$
105,901
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$
117,911
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Liabilities and
Stockholders' Equity
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Current
liabilities:
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Accounts
payable
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$
4,287
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$
4,189
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Accrued
expenses
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|
2,694
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5,366
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Lease liability -
current portion
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363
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432
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Total current
liabilities
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|
7,344
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9,987
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Non current
liabilities:
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Lease liability, net of
current portion
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-
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37
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Total
liabilities
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|
7,344
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|
10,024
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Stockholders'
equity:
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Common stock, $0.001
par value; 240,000,000 shares authorized; 88,318,454
shares issued and outstanding as of March 31, 2022 and
December 31, 2021
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88
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88
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Additional paid-in
capital
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372,842
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371,638
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Accumulated other
comprehensive loss
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(425)
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|
(267)
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Accumulated
deficit
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(273,948)
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(263,572)
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Total stockholders'
equity
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98,557
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107,887
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Total liabilities and
stockholders' equity
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$
105,901
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$
117,911
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Leap
Therapeutics, Inc.
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Condensed
Consolidated Statements of Cash Flows
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(in
thousands)
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(Unaudited)
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|
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Three Months
Ended March 31,
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2022
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2021
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Cash used in
operating activities
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$
(11,518)
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$
(8,587)
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Cash provided
by (used in) financing activities
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|
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(210)
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|
14
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Effect of
exchange rate changes on cash and cash
equivalents
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|
|
32
|
|
(7)
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Net decrease
in cash and cash equivalents
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|
|
(11,696)
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|
(8,580)
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Cash and cash
equivalents at beginning of period
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|
|
114,916
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|
52,071
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Cash and cash
equivalents at end of period
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|
|
$
103,220
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|
$
43,491
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SOURCE Leap Therapeutics, Inc.