Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the first quarter ended March 31,
2017. The company also announced that an investigator-sponsored
clinical trial of DKN-01 will be conducted in patients with
advanced hepatocellular carcinoma (HCC) at the University Medical
Center of the Johannes Gutenberg-University Mainz in Germany.
“The hepatocellular carcinoma study is an
important element of our plan to test DKN-01 in genetically-defined
cancer populations,” commented Christopher K. Mirabelli, Ph.D,
Chief Executive Officer of Leap Therapeutics. “We continue to
pursue an aggressive clinical development plan for both of our
programs and are highly encouraged by the positive clinical data we
presented this quarter.”
“We believe that DKN-01 could be a novel therapy
for patients with hepatocelluar carcinoma. DKN-01 has shown
activity in patients with aberrant Wnt/beta-catenin signaling, a
pathway that is frequently mutated in patients with hepatocellular
carcinoma. Alterations of this pathway are a driver of
hepatocellular carcinoma disease progression,” observed Markus
Moehler, M.D., Ph.D, Professor of Gastrointestinal Oncology and
Jens Marquardt, M.D., Lichtenberg Professor for Molecular
Hepatocarcinogenesis, Johannes-Gutenberg University in Mainz,
principal investigators of the study. “There is a lack of
effective targeted therapies to offer patients, and we look forward
to conducting this clinical study of DKN-01 as a monotherapy and in
combination with sorafenib, the only approved therapy in advanced
stages of hepatocellular carcinoma.”
Recent Progress
- Presented DKN-01 clinical biomarker data from an
esophagogastric cancer clinical study at the ASCO Gastrointestinal
Cancers Symposium 2017 detailing Wnt-pathway alterations. An arm
has been added to this study to explore a genetically-defined
population for DKN-01 development.
- Reported top-line preliminary median progression-free survival
data of 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. This data will be presented at the
upcoming American Society for Clinical Oncology (ASCO) Annual
Meeting 2017.
- Academic collaborators presented an analysis of our clinical
data at the 2017 American Association for Cancer Research Annual
Meeting demonstrating that TRX518, a GITR agonist monoclonal
antibody, has biological activity in patient tumors and can reduce
the activity of regulatory T cells, immunosuppressive cells that
prevent the immune system from attacking cancer. Leap presented
DKN-01 clinical and non-clinical data at the conference.
- Opened a 20 patient Part B expansion phase of a multi-dose
study of TRX518 monotherapy.
Selected First Quarter 2017 Financial
Results
Net loss was $9.4 million for the first quarter
of 2017, compared to $5.1 million for the same period in 2016.
Research and development expenses were $6.4
million for the first quarter 2017, compared to $4.1 million for
the same period in 2016. This increase was primarily due to
increased stock-based compensation expense and clinical development
expenses of our clinical product candidates.
General and administrative expenses were $3.8
million for the first quarter 2017, compared to $1.1 million for
the same period in 2016. This increase was primarily due to
increased stock-based compensation expense and legal, finance and
administrative expenses to support the company’s transition to
public company operations and our transaction with Macrocure
Ltd.
Net cash used in operating activities were $6.3 million for the
first quarter 2017, compared to $4.1 million for the first quarter
2016. This increase was primarily due to increased clinical
development expense for our product candidates and administrative,
finance and legal expenses associated with public company
operations and the transaction with Macrocure Ltd.
Cash, cash equivalents and marketable securities totaled $23.8
million at March 31, 2017. Research and development incentive
receivables totaled $3.6 million.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC), the
predominant form of primary liver cancer, is one of the most common
solid malignancies, and has emerged as a major cause of
cancer-related death worldwide. The National Cancer Institute
estimates there will be approximately 40,000 cases of liver and
intrahepatic biliary tract cancer in the US this year and 30,000
deaths. To date, very few effective treatment options for
hepatocellular carcinoma patients exist and the
multityrosine-kinase inhibitor sorafenib is the only available
systemic therapy for the management of advanced cases. The survival
benefit attributed to sorafenib is only three months.
Hepatocellular carcinomas are highly heterogenous and lack
actionable mutations in most patients. 20-40% of patients have
genetic alterations that lead to activation in Wnt/β-catenin
signaling.
About Leap TherapeuticsLeap
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, alone and in combination with paclitaxel,
and in patients with biliary tract cancer, in combination with
gemcitabine and cisplatin. An investigator-initiated study of
DKN-01 will be conducted in hepatocellular carcinoma patients, in
combination with sorafenib. 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 that is in two monotherapy studies. 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
(in thousands) |
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
$ |
6,404 |
|
|
$ |
4,087 |
|
|
General and
administrative |
|
|
3,804 |
|
|
|
1,056 |
|
|
|
|
Total operating expenses |
|
|
10,208 |
|
|
|
5,143 |
|
Loss from
operations |
|
|
(10,208 |
) |
|
|
(5,143 |
) |
Interest
income |
|
|
50 |
|
|
|
- |
|
Interest
expense - related party |
|
|
(121 |
) |
|
|
(113 |
) |
Australian
research and development incentives |
|
|
397 |
|
|
|
- |
|
Foreign
currency gains |
|
|
468 |
|
|
|
109 |
|
Net
loss |
|
|
(9,414 |
) |
|
$ |
(5,147 |
) |
Accretion
of preferred stock to redemption value |
|
|
(244 |
) |
|
|
Net loss
attributable to common stockholders |
|
$ |
(9,658 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share - basic and diluted |
|
$ |
(1.39 |
) |
|
|
Weighted
average common shares outstanding - basic and diluted |
|
|
6,945,623 |
|
|
|
|
Leap Therapeutics, Inc.Condensed Balance Sheet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
(in
thousands) |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
23,800 |
|
|
$ |
793 |
|
|
Research
and development incentive receivable |
|
|
3,167 |
|
|
|
3,053 |
|
|
Prepaid
expenses and other current assets |
|
|
319 |
|
|
|
183 |
|
|
|
|
|
|
Total
current assets |
|
|
27,286 |
|
|
|
4,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
159 |
|
|
|
119 |
|
|
Research
and development incentive receivable, net of current portion |
|
|
397 |
|
|
|
- |
|
|
Deferred
offering costs |
|
|
- |
|
|
|
1,402 |
|
|
Other
assets |
|
|
937 |
|
|
|
907 |
|
|
|
|
|
|
Total
assets |
|
$ |
28,779 |
|
|
$ |
6,457 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficiency) |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
2,793 |
|
|
$ |
3,225 |
|
|
Accrued
expenses |
|
|
1,819 |
|
|
|
2,658 |
|
|
Notes
payable and accrued interest - related party |
|
|
- |
|
|
|
30,274 |
|
|
|
|
|
|
Total
current liabilities |
|
|
4,612 |
|
|
|
36,157 |
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
preferred stock, 0 and 42,500,000 shares authorized as of March 31,
2017 and December 31, 2016 |
|
|
|
|
|
Series A redeemable convertible preferred stock, $0.001 par
value; 0 and 9,000,000 shares designated as of March 31, 2017 and
December 31, 2016, respectively; 0 and 9,000,000 shares issued
and outstanding as of March 31, 2017 and December 31, 2016,
respectively; liquidation preference of $0 and $11,800 as of March
31, 2017 and December 31, 2016, respectively |
|
|
- |
|
|
|
11,800 |
|
|
Series B convertible preferred stock, $0.001 par value; 0 and
21,500,000 shares designated as of March 31, 2017 and December 31,
2016, respectively; 0 and 21,500,000 shares issued and outstanding
as of March 31, 2017 and December 31, 2016, respectively;
liquidation preference of $0 and $28,189 as of March 31, 2017 and
December 31, 2016, respectively |
|
|
- |
|
|
|
28,189 |
|
|
Series C convertible preferred stock, $0.001 par value; 0 and
12,000,000 shares designated as of March 31, 2017 and December 31,
2017, respectively; 0 and 11,781,984 shares issued and
outstanding as of March 31, 2017 and December 31, 2016,
respectively; liquidation preference of $0 and $30,542 as of March
31, 2017 and December 31, 2016, respectively |
|
|
- |
|
|
|
30,542 |
|
Stockholders' equity (deficiency): |
|
|
|
|
|
Common stock, $0.001 par value; 100,000,000 and 58,500,000
shares authorized as of March 31, 2017 and December 31, 2016,
respectively; 9,392,414 and 0 shares outstanding as of March 31,
2017 and December 31, 2016, respectively |
|
|
9 |
|
|
|
- |
|
|
Additional
paid-in capital |
|
|
134,347 |
|
|
|
145 |
|
|
Accumulated
other comprehensive income (loss) |
|
|
(105 |
) |
|
|
294 |
|
|
Accumulated
deficit |
|
|
(110,084 |
) |
|
|
(100,670 |
) |
|
|
|
|
|
Total
stockholders’ equity (deficiency) |
|
|
24,167 |
|
|
|
(100,231 |
) |
|
|
|
|
|
Total
liabilities, convertible preferred stock and stockholders' equity
(deficiency) |
|
$ |
28,779 |
|
|
$ |
6,457 |
|
|
|
Leap Therapeutics, Inc.Condensed Statement of Cash
Flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
|
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
(in
thousands) |
|
Cash used in operating
activities |
|
|
$ |
(6,349 |
) |
|
$ |
(4,133 |
) |
|
Cash used in investing
activities |
|
|
|
(65 |
) |
|
|
(30 |
) |
|
Cash provided by financing
activities |
|
|
|
29,848 |
|
|
|
6,900 |
|
|
Effect of exchange rate changes on
cash and cash equivalents |
|
|
|
(427 |
) |
|
|
(11 |
) |
|
Net increase in cash and cash
equivalents |
|
|
|
23,007 |
|
|
|
2,726 |
|
|
Cash and
cash equivalents at beginning of period |
|
|
|
793 |
|
|
|
405 |
|
|
Cash and
cash equivalents at end of period |
|
|
$ |
23,800 |
|
|
$ |
3,131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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