CAMBRIDGE, Mass., Nov. 13,
2023 /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, 2023.
"Leap continued to make great strides this quarter including
advancing into the 130 patient, randomized controlled Part B of the
DeFianCe study evaluating DKN-01 plus bevacizumab and chemotherapy
in second-line colorectal cancer, after exceeding our 20% overall
response rate threshold in Part A. We are excited by the progress
made and plan on presenting new data from Part A at a medical
conference in January 2024," said
Douglas E. Onsi, President and Chief
Executive Officer of Leap. "In addition, we're focused on executing
the DisTinGuish study evaluating DKN-01 plus tislelizumab and
chemotherapy in first-line gastric cancer, and we expect to
complete enrollment into the 160-patient, randomized controlled
Part C of the trial this quarter."
DKN-01 Development Update
- Updated data from Part A of the DeFianCe Study of DKN-01
plus bevacizumab and chemotherapy in colorectal
cancer patients to be presented at a medical conference in
January 2024.
The Company expects to present new long-term follow-up data from
Part A of the DeFiance study (NCT05480306), a Phase 2, randomized,
open-label, multicenter study of DKN-01 in combination with
standard of care bevacizumab and chemotherapy in patients with
advanced colorectal cancer who have received one prior systemic
therapy for advanced disease. Initial results from Part A indicated
an overall response rate (ORR) above 20% with a high disease
control rate, which exceeded the benchmarks expected for this
population. Subsequently, the study expanded into a 130-patient
Part B randomized controlled trial.
- Part C of the DisTinGuish Study of DKN-01 plus
tislelizumab and chemotherapy in gastric cancer patients is ongoing
and enrollment is expected to be completed by the end of
2023. The DisTinGuish study (NCT0436380) is a Phase 2,
randomized, open-label, multicenter study of DKN-01 in combination
with tislelizumab and chemotherapy in first-line patients with
advanced gastroesophageal adenocarcinoma. The Company previously
presented long-term follow-up data from Part A of the study in
June 2023, showing 73% ORR in the
modified intent-to-treat population, and 85% ORR in the PD-L1
low-subgroup. The data also demonstrated 19.5 months median overall
survival and 11.3 months median progression-free survival.
Selected Third Quarter 2023 Financial Results
Net Loss was $13.7 million for the
third quarter 2023, compared to $15.1
million for the same period in 2022. The decrease was
primarily due to decreased research and development expenses and
increased interest income.
Research and development expenses were $11.5 million for the third quarter 2023,
compared to $12.1 million for the
same period in 2022. The decrease in research and development
expenses was primarily due to a decrease of $2.5 million in manufacturing costs related to
clinical trial material and manufacturing campaigns. This decrease
was partially offset by an increase of $1.1
million in clinical trial costs and an increase of
$0.8 million in payroll and other
related expenses due to an increase in headcount of our research
and development full-time employees.
General and administrative expenses were $3.3 million for the third quarter 2023, compared
to $3.2 million for the same period
in 2022. The increase in general and administrative expenses was
primarily due to an increase of $0.1
million in payroll and other related expenses due to an
increase in headcount of our general and administrative full-time
employees.
Cash and cash equivalents totaled $80.7
million at September 30, 2023.
Research and development incentive receivables totaled $0.8 million at September
30, 2023.
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 being developed in patients with
esophagogastric, gynecologic, and colorectal cancers. FL-301, is a
humanized monoclonal antibody targeting Claudin18.2, being
developed in patients with gastric and pancreatic cancer. Leap also
has preclinical antibody programs targeting Claudin18.2/CD137 and
GDF15. 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 the federal securities laws. Such statements are
based upon current plans, estimates and expectations of the
management of Leap that are subject to various risks and
uncertainties that could cause actual results to differ materially
from such statements. The inclusion of forward-looking statements
should not be regarded as a representation that such plans,
estimates and expectations will be achieved. Words such as
"anticipate," "expect," "project," "intend," "believe," "may,"
"will," "should," "plan," "could," "continue," "target,"
"contemplate," "estimate," "forecast," "guidance," "predict,"
"possible," "potential," "pursue," "likely," and words and terms of
similar substance used in connection with any discussion of future
plans, actions or events identify forward-looking statements.
All statements, other than historical facts, including
statements regarding the continuation over time of the clinical
collaboration with BeiGene on the ongoing Part C of the DisTinGuish
trial, with BeiGene continuing to supply tislelizumab; the
expected benefits of the merger with Flame Biosciences; the cash
runway into 2025 and the sufficiency of Leap's cash, cash
equivalents and short-term investments to fund operations; the
anticipated timing for completion of or success of enrollment in
clinical trials and release of clinical data, and any outcomes of
such trials; the potential, safety, efficacy, and regulatory and
clinical progress of Leap's product candidates; our future
preclinical and clinical development plans in connection with our
programs; the ability to enter into a new strategic partnership for
DKN-01 or any of Leap's other programs; the ability of NovaRock
Biotherapeutics to conduct the FL-301 clinical trial in
China; and any assumptions
underlying any of the foregoing, are forward-looking statements.
Important factors that could cause actual results to differ
materially from Leap's plans, estimates or expectations could
include, but are not limited to: (i) Leap's ability to successfully
execute its clinical trials and the timing of enrollment in and
cost of such clinical trials; (ii) the results of Leap's clinical
trials and pre-clinical studies; (iii) Leap's ability to
successfully enter into new strategic partnerships for DKN-01 or
any of its other programs; (iv) whether any Leap clinical trials
and products will receive approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies; (v)
exposure to inflation, currency rate and interest rate
fluctuations, as well as fluctuations in the market price of Leap's
traded securities; and (vi) that the initiation, conduct, and
completion of clinical trials, laboratory operations, manufacturing
campaigns, and other studies may be delayed, adversely affected, or
impacted by global conflict, or supply chain related issues. New
risks and uncertainties may emerge from time to time, and it is not
possible to predict all risks and uncertainties. No representations
or warranties (expressed or Implied) are made about the accuracy of
any such forward-looking statements. Leap may not actually achieve
the forecasts disclosed in such forward-looking statements, and you
should not place undue reliance on such forward-looking statements.
Such forward-looking statements are subject to a number of material
risks and uncertainties including but not limited to those set
forth under the caption "Risk Factors" in Leap's most recent Annual
Report on Form 10-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in its
subsequent filings with the SEC. Any forward-looking statement
speaks only as of the date on which it was made. Neither Leap, nor
any of its affiliates, advisors or representatives, undertake any
obligation to publicly update or revise any forward-looking
statement, whether as result of new information, future events or
otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing Leap's views
as of any date subsequent to the date hereof.
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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|
|
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|
Condensed Consolidated Statements of
Operations
|
|
|
|
|
|
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|
(in thousands, except share and per share
amounts)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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(Unaudited)
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|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended September
30,
|
|
Nine Months Ended September
30,
|
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|
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|
|
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|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
11,503
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|
$
12,102
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|
$
61,549
|
|
$
33,931
|
|
General and
administrative
|
|
3,330
|
|
3,186
|
|
10,672
|
|
8,889
|
|
|
|
Total operating
expenses
|
|
14,833
|
|
15,288
|
|
72,221
|
|
42,820
|
Loss from
operations
|
|
(14,833)
|
|
(15,288)
|
|
(72,221)
|
|
(42,820)
|
Interest
income
|
|
1,084
|
|
360
|
|
3,089
|
|
404
|
Interest
expense
|
|
-
|
|
(11)
|
|
-
|
|
(49)
|
Australian research and
development incentives
|
|
554
|
|
652
|
|
1,124
|
|
1,276
|
Foreign currency
loss
|
|
(501)
|
|
(807)
|
|
(953)
|
|
(1,305)
|
Change in fair value of
Series X preferred stock warrant liability
|
|
-
|
|
-
|
|
12
|
|
-
|
Net loss attributable
to common stockholders
|
|
$
(13,696)
|
|
$
(15,094)
|
|
$
(68,949)
|
|
$
(42,494)
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
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|
|
Basic &
diluted
|
|
$
(0.51)
|
|
$
(1.33)
|
|
$
(3.78)
|
|
$
(3.75)
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Weighted average common
shares outstanding
|
|
|
|
|
|
|
|
|
|
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|
Basic &
diluted
|
|
26,987,182
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|
11,323,909
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|
18,240,455
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|
11,323,909
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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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|
September 30,
|
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December 31,
|
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|
|
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|
|
2023
|
|
2022
|
|
|
|
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|
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(Unaudited)
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|
Assets
|
|
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|
|
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|
Current
assets:
|
|
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|
Cash and
cash equivalents
|
|
$
80,743
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|
$
65,500
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Research
and development incentive receivable
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|
753
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|
2,099
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Prepaid
expenses and other current assets
|
|
265
|
|
351
|
Total current assets
|
|
81,761
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|
67,950
|
|
|
|
|
|
|
|
|
|
|
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Property
and equipment, net
|
|
9
|
|
20
|
Right of
use assets, net
|
|
363
|
|
669
|
Deferred
costs
|
|
-
|
|
576
|
Other
long term assets
|
|
-
|
|
30
|
Deposits
|
|
913
|
|
1,108
|
Total assets
|
|
$
83,046
|
|
$
70,353
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
5,899
|
|
$
5,657
|
Accrued
expenses
|
|
4,770
|
|
5,152
|
Lease
liability - current portion
|
|
369
|
|
416
|
Total current liabilities
|
|
11,038
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|
11,225
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|
|
|
|
|
|
|
|
|
|
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Non current
liabilities:
|
|
|
|
|
Lease
liability, net of current portion
|
|
-
|
|
262
|
Total liabilities
|
|
11,038
|
|
11,487
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock, $0.001 par value; 240,000,000 shares authorized; 25,565,414
and 9,902,137 shares issued and outstanding as of September 30,
2023 and December 31, 2022, respectively
|
|
26
|
|
10
|
Additional paid-in capital
|
|
458,339
|
|
376,896
|
Accumulated other comprehensive income
|
|
760
|
|
128
|
Accumulated deficit
|
|
(387,117)
|
|
(318,168)
|
Total stockholders' equity
|
|
72,008
|
|
58,866
|
Total liabilities and stockholders' equity
|
|
$
83,046
|
|
$
70,353
|
|
Leap
Therapeutics, Inc.
|
|
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Condensed
Consolidated Statements of Cash Flows
|
|
|
|
|
|
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|
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(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended September 30
|
|
|
Nine Months
Ended September 30
|
|
|
|
|
|
|
|
2023
|
|
2022
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities
|
$
(10,488)
|
|
$
(12,253)
|
|
|
$
(33,373)
|
|
$
(36,030)
|
Cash provided
by investing activities
|
-
|
|
-
|
|
|
48,969
|
|
-
|
Cash used in
financing activities
|
(1)
|
|
-
|
|
|
(30)
|
|
(210)
|
Effect of
exchange rate changes on cash and cash
equivalents
|
(183)
|
|
(322)
|
|
|
(323)
|
|
(368)
|
Net increase
(decrease) in cash and cash equivalents
|
(10,672)
|
|
(12,575)
|
|
|
15,243
|
|
(36,608)
|
Cash and cash
equivalents at beginning of period
|
91,415
|
|
90,883
|
|
|
65,500
|
|
114,916
|
Cash and cash
equivalents at end of period
|
$
80,743
|
|
$
78,308
|
|
|
$
80,743
|
|
$
78,308
|
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SOURCE Leap Therapeutics, Inc.