Leap Therapeutics Reports Full Year 2016 Financial Results and Progression-Free Survival Data in Advanced Biliary Tract Cance...
March 31 2017 - 4:36PM
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the year ended December 31, 2016 and
top-line progression-free survival (PFS) data.
Preliminary median progression-free survival was
9.4 months in Leap’s clinical trial evaluating DKN-01 in
combination with standard of care chemotherapy in patients with
advanced biliary tract cancers. The median PFS for standard of care
chemotherapy has been reported to be six to eight months. Data from
the study has been submitted for presentation at an upcoming
medical conference.
“2016 was an important year for Leap. We became
a public company and we generated exciting clinical data from our
multiple ongoing clinical studies of two innovative cancer
therapeutics,” said Christopher K. Mirabelli, Ph.D, Chief Executive
Officer of Leap. “We are especially pleased with the PFS observed
in patients with biliary cancers and the clinical data from our
industry-leading GITR agonist program.”
About the DKN-01 P103 Clinical Trial
The open-label, dose-escalation study enrolled
27 patients with treatment-naïve advanced biliary tract cancer.
Patients received two dose levels of DKN-01 in combination with
gemcitabine and cisplatin. The primary objective of this study is
to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in
combination with gemcitabine and cisplatin. The study has recently
been expanded to enroll an additional 20 patients to enhance
biomarker collection and analysis.
2016 Accomplishments
- Presented proof of concept clinical data of DKN-01 in advanced
biliary tract and esophagogastric cancers with encouraging overall
response and disease control rates at meetings of the European
Society for Medical Oncology (ESMO), American Society for Clinical
Oncology (ASCO), and the Cholangiocarcinoma Foundation.
- Identified Wnt-pathway alterations as a potential
genetically-defined population for DKN-01 development
- Developed and presented first observed cases of human
pharmacodynamic activity of GITR agonist TRX518 on
immunosuppressive T cells.
- Initiated two repeat-dose TRX518 studies in patients with
refractory solid tumors.
- Commenced trading on the Nasdaq Global Market in January
2017.
Selected Year-End 2016 Financial Results
Net loss was $25.6 million for the year ended
December 31, 2016, compared to $12.1 million for the year ended
December 31, 2015.
Research and development expenses were $23.3
million for the full year 2016, compared to $10.4 million for the
same period in 2015. This increase was primarily due to clinical
development expenses and manufacturing costs of our clinical
product candidates.
General and administrative expenses were $4.2
million for the full year 2016, compared to $1.5 million for the
same period in 2015. This increase was primarily due to increased
personnel and legal expenses to support the company’s expanding
operations, including our acquisition of Macrocure Ltd.
The financial results presented for 2016
represent Leap Therapeutics as a private company, as the merger
with Macrocure was completed on January 23, 2017. The
financial results presented also include an unaudited pro-forma
calculation of Leap Therapeutics’ balance sheet to present the
merger with Macrocure and the related transactions as if they had
closed on December 31, 2016. The financial statements for the first
quarter 2017 will reflect the actual transaction closing date and
subsequent financial results as a public company.
2017 Objectives and Upcoming Presentations
DKN-01 Program Objectives
- Extend biomarker clinical studies to include
genetically-identified populations in gastric, liver, ovarian, and
uterine cancers
- Initiate immunotherapy combination study with PD-1
inhibitor
- Present DKN-01 non-clinical and clinical biomarker data at the
2017 American Association for Cancer Research Annual Meeting
- Present clinical data of DKN-01 in advanced biliary tract and
esophagogastric cancers
TRX518 Program Objectives
- Complete enrollment of TRX518-003 repeat-dose monotherapy study
in patients with refractory solid tumors
- Present TRX518 clinical biomarker data at the 2017 American
Association for Cancer Research Annual Meeting
About Leap
Therapeutics Leap Therapeutics’ (NASDAQ:LPTX) 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 gastroesophageal cancer in
combination with paclitaxel and in patients with biliary tract
cancers in combination with gemcitabine and cisplatin. DKN-01 has
demonstrated single agent activity in non-small cell lung cancer
patients. Leap’s second clinical candidate, TRX518, is a novel,
humanized GITR agonist monoclonal antibody designed to enhance the
immune system’s anti-tumor response. For more information
about Leap Therapeutics, visit http://www.leaptx.com or our public
filings with the SEC that are available via EDGAR at
http://www.sec.gov or via http://www.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 statements
relating to Leap’s expectations with respect to the development and
advancement of DKN-01, TRX518, and other programs, including the
initiation, timing and design of future studies, enrollment in
future studies, business development, and other future
expectations, plans and prospects. Leap has attempted to identify
forward looking statements by such terminology as ‘‘believes,’’
‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’
‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’
‘‘should,’’ or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements. 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 risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not
limited to: 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; our plans to research, develop, and
commercialize our drug product candidates; our ability to achieve
market acceptance of our drug product candidates; unanticipated
costs or delays in research, development, and commercialization
efforts; the applicability of clinical study results to actual
outcomes; the size and growth potential of the markets for our drug
product candidates; the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for
financing; 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 Securities and
Exchange Commission (the "SEC"), including Leap Therapeutics’
Form 10-K that Leap filed with the SEC on March 31, 2017. These
statements are only predictions and involve known and unknown
risks, uncertainties, and other factors. 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.
|
Leap Therapeutics, Inc. |
Condensed Statement of Operations |
|
|
|
|
|
|
|
|
|
(Amount in thousands) |
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
$ |
23,292 |
|
|
$ |
10,411 |
|
|
General and administrative |
|
|
4,229 |
|
|
|
1,511 |
|
|
|
|
Total operating expenses |
|
|
27,521 |
|
|
|
11,922 |
|
Loss from
operations |
|
|
(27,521 |
) |
|
|
(11,922 |
) |
Interest
income |
|
|
2 |
|
|
|
1 |
|
Interest
expense - related party |
|
|
(1,233 |
) |
|
|
(129 |
) |
Other
income (expense), net |
|
|
3,120 |
|
|
|
- |
|
Net
loss |
|
|
(25,632 |
) |
|
|
(12,050 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss: |
|
|
|
|
Foreign currency translation adjustments |
|
|
295 |
|
|
|
(1 |
) |
Comprehensive loss |
|
$ |
(25,337 |
) |
|
$ |
(12,051 |
) |
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc. |
Condensed Balance Sheet |
|
|
|
|
|
|
|
|
|
(Amount in thousands) |
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
793 |
|
|
$ |
405 |
|
|
Research and development incentive receivable |
|
|
3,053 |
|
|
|
- |
|
|
Prepaid expenses and other current assets |
|
|
183 |
|
|
|
89 |
|
|
|
|
|
|
Total current assets |
|
|
4,029 |
|
|
|
494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
119 |
|
|
|
- |
|
|
Deferred offering costs |
|
|
1,402 |
|
|
|
- |
|
|
Other assets |
|
|
907 |
|
|
|
766 |
|
|
|
|
|
|
Total assets |
|
$ |
6,457 |
|
|
$ |
1,260 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Deficiency |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
3,225 |
|
|
$ |
2,048 |
|
|
Accrued expenses |
|
|
2,658 |
|
|
|
479 |
|
|
Notes payable and accrued interest - related party |
|
|
30,274 |
|
|
|
3,141 |
|
|
|
|
|
|
Total current liabilities |
|
|
36,157 |
|
|
|
5,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
(29,700 |
) |
|
|
(4,408 |
) |
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
6,457 |
|
|
$ |
1,260 |
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc. |
Condensed Statement of Cash Flows |
|
|
|
|
|
|
|
|
|
(Amount in thousands) |
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
(25,337 |
) |
|
|
(8,102 |
) |
Cash flows from investing activities: |
|
|
(144 |
) |
|
|
- |
|
Cash flows from financing activities: |
|
|
25,618 |
|
|
|
8,270 |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
|
251 |
|
|
|
(1 |
) |
Net
increase (decrease) in cash and cash equivalents |
|
|
388 |
|
|
|
167 |
|
Cash and
cash equivalents at beginning of period |
|
|
405 |
|
|
|
238 |
|
Cash and
cash equivalents at end of period |
|
$ |
793 |
|
|
$ |
405 |
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360
Argot Partners
Susan Kim
212-203-4433
susan@argotpartners.com
or
Heather Savelle
617-663-4863
heather@argotpartners.com
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