CAMBRIDGE, Mass., May 15, 2023
/PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a
biotechnology company focused on developing targeted and
immuno-oncology therapeutics, today reported financial results for
first quarter ended March 31,
2023.
Leap Highlights:
- Presenting new long-term follow-up data from Part A of the
Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and
chemotherapy in first-line patients with advanced gastroesophageal
adenocarcinoma (GEA) at the upcoming 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting
- Enrollment completed in Part A of the Phase 2 DeFianCe study of
DKN-01 in combination with standard of care bevaiczimab and
chemotherapy as a second-line treatment for patients with advanced
colorectal cancer (CRC)
- Acquired Flame Biosciences, adding FL-301, a clinical stage
anti-Claudin18.2 antibody, and preclinical antibody programs
targeting Claudin18.2/CD137 and GDF15 to Leap's pipeline, along
with approximately $50 million in
cash.
"We continued to execute extremely well on our DKN-01 program
during the first quarter of 2023 with the completion of enrollment
in Part A of the DeFianCe second-line CRC study and excellent
progress in enrolling our randomized, controlled Part C of the
DisTinGuish first-line GEA study," said Douglas E. Onsi, President and Chief Executive
Officer of Leap. "We look forward to presenting long-term follow-up
data from Part A of the DisTinGuish study at ASCO in June,
including updated response and overall survival data. With the
acquisition of Flame Biosciences at the beginning of the year, we
are in a strong financial position to develop our pipeline of
personalized medicines for cancer patients."
DKN-01 Development Update
- Updated data from Part A of the DisTinGuish Study of
DKN-01 plus tislelizumab and chemotherapy in gastric cancer
patients to be presented at the 2023 ASCO Annual Meeting.
The Company will be presenting new long-term follow-up data in
first-line patients with advanced GEA from Part A of the
DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating
Leap's anti-Dickkopf-1 (DKK1)
antibody, DKN-01, in combination with tislelizumab and chemotherapy
at the 2023 ASCO Annual Meeting, being held in Chicago, IL on June
2-6, 2023. Details of the presentation are below:
-
- Title: A phase 2 study (DisTinGuish) of DKN-01 in
combination with tislelizumab + chemotherapy as first-line (1L)
therapy in patients with advanced gastric or GEJ adenocarcinoma
(GEA).
- Presenter: Samuel J. Klempner, Harvard Medical School
- Session Type: Poster Discussion Session
- Session Title: Gastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
- Date and Time: Monday, June 5, 2023, at
11:30 a.m. ET
- Abstract Number: 4027
- Poster Number: 335
- Announced completion of enrollment in Part A of the
DeFiance Study of DKN-01 for the treatment of colorectal cancer
patients. The DeFianCe study (NCT05480306) is a Phase 2,
randomized, open-label, multicenter study of DKN-01 in combination
with standard of care bevacizumab and chemotherapy in patients with
advanced CRC who have received one prior systemic therapy for
advanced disease. The study began with an initial Part A cohort
that has enrolled 33 patients and is designed to expand into a
130-patient Part B randomized controlled trial. The primary
objective is progression free survival. Secondary objectives
include overall response rate, duration of response, and overall
survival. Leap expects to report initial data from Part A of the
study in mid-2023.
Selected First Quarter 2023 Financial Results
Net Loss was $41.9 million for the
first quarter 2023, compared to $10.4
million for the same period in 2022. The increase was
primarily due to in-process research & development (IPR&D)
expense of $29.6 million associated
with the acquisition of Flame Biosciences.
Research and development expenses were $38.9 million for the first quarter 2023,
compared to $7.8 million for the same
period in 2022. The increase in research and development expenses
was due to IPR&D expense associated with the Flame acquisition
of $29.6 million, increased headcount
and compensation expense of $0.8
million, increased manufacturing costs of $0.8 million, increased stock based compensation
expense of $0.1 million, partially
offset by decreased clinical trial costs of $0.2 million.
General and administrative expenses were $3.8 million for the first quarter 2023, compared
to $2.8 million for the same period
in 2022. The increase in general and administrative expenses was
due to increased finance and legal fees, primarily associated with
the Flame acquisition, of $0.7
million and increased headcount and compensation expense of
$0.3 million.
Cash and cash equivalents totaled $102.0
million at March 31, 2023.
Research and development incentive receivables totaled $2.3 million at March 31,
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 mid-2025 and the sufficiency of Leap's cash, cash
equivalents and short-term investments to fund operations;
stockholder approval of the conversion rights of the Series X
Non-Voting Convertible Preferred Stock; the anticipated timing for
initiation 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; (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 COVID-19, global conflict, or
supply chain related issues; (vii) Leap's ability to successfully
integrate the Flame operations and realize the anticipated benefits
of the acquisition of Flame; (viii) whether Leap's stockholders
approve the conversion of the Series X Non-Voting Convertible
Preferred Stock; (ix) whether Leap's cash resources will be
sufficient to fund Leap's continuing operations and the newly
acquired Flame operations, including the liabilities of Flame
incurred in connection with the completion of the merger; and (x)
Leap's ability to comply with the continued listing requirements of
the Nasdaq Capital Market. 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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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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2023
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2022
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|
Operating
expenses:
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|
|
|
|
|
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Research and
development
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|
|
$
38,942
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|
$
7,784
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|
General and
administrative
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|
|
3,784
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|
2,848
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|
|
Total operating expenses
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|
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42,726
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|
10,632
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Loss from
operations
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|
|
(42,726)
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|
(10,632)
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Interest
income
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|
|
848
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|
5
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Interest
expense
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|
-
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|
(21)
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Australian research and
development incentives
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|
|
272
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|
37
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Foreign currency gain
(loss)
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|
(307)
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|
235
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Change in fair value of
Series X preferred stock warrant liability
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|
50
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-
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Net loss attributable
to common stockholders
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|
(41,863)
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|
(10,376)
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Net loss per
share
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Basic
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|
$
(0.32)
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|
$
(0.09)
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Diluted
|
|
|
$
(0.32)
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|
$
(0.09)
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Weighted average common
shares outstanding
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Basic
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129,344,272
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113,248,937
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Diluted
|
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|
129,344,272
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113,248,937
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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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2023
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2022
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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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$
102,038
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$
65,500
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Research and
development incentive receivable
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|
2,071
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|
2,099
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Prepaid expenses and
other current assets
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|
590
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|
351
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|
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Total current
assets
|
|
104,699
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|
67,950
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Property and equipment,
net
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|
16
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|
20
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Right of use assets,
net
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|
569
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|
669
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|
Research and
development incentive receivable, net of current portion
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|
272
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|
-
|
|
Deferred
costs
|
|
-
|
|
576
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Other long term
assets
|
|
15
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|
30
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|
Deposits
|
|
|
976
|
|
1,108
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Total assets
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|
$
106,547
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|
$
70,353
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Liabilities and Stockholders'
Equity
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Current
liabilities:
|
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Accounts
payable
|
|
$
5,498
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|
$
5,657
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|
Accrued
expenses
|
|
4,388
|
|
5,152
|
|
Lease liability -
current portion
|
|
425
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|
416
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|
|
|
|
|
Total current
liabilities
|
|
10,311
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|
11,225
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|
|
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Non current
liabilities:
|
|
|
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Lease liability, net of
current portion
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152
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|
262
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Series X preferred
stock warrant liability
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40
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-
|
|
|
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Total
liabilities
|
|
10,503
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|
11,487
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|
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Mezzanine
equity:
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Series X Convertible
Preferred Stock, $0.001 par value; 10,000,000 shares
authorized; 136,248 and 0 shares issued and outstanding as
of March 31, 2023
and December 31, 2022, respectively
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67,715
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-
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Stockholders'
equity:
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Common stock, $0.001
par value; 240,000,000 shares authorized; 119,410,992
and 99,021,376 shares issued and outstanding as of
March 31, 2023 and
December 31, 2022, respectively
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119
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99
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Additional paid-in
capital
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|
387,886
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376,807
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Accumulated other
comprehensive income
|
|
355
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|
128
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Accumulated
deficit
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|
(360,031)
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|
(318,168)
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Total stockholders'
equity
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28,329
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58,866
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Total liabilities,
mezzanine equity and stockholders' equity
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|
$
106,547
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$
70,353
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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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|
|
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|
Three Months
Ended March 31,
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|
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|
2023
|
|
2022
|
|
|
|
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|
|
|
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Cash used in
operating activities
|
|
|
$
(12,700)
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|
$
(11,518)
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Cash provided
by investing activities
|
|
|
49,317
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|
-
|
Cash used in
financing activities
|
|
|
(29)
|
|
(210)
|
Effect of
exchange rate changes on cash and cash
equivalents
|
|
|
(50)
|
|
32
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
36,538
|
|
(11,696)
|
Cash and cash
equivalents at beginning of period
|
|
|
65,500
|
|
114,916
|
Cash and cash
equivalents at end of period
|
|
|
$
102,038
|
|
$
103,220
|
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SOURCE Leap Therapeutics, Inc.