Leap Therapeutics Reports Third Quarter 2017 Financial Results and Announces First Patient Dosed with DKN-01 and KEYTRUDA® (...
November 13 2017 - 7:00AM
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the third quarter ended September
30, 2017. Leap additionally announced that the first patient has
been dosed in a Phase 1/2 clinical trial evaluating Leap’s DKK1
antagonist, DKN-01, in combination with Merck’s anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab), in patients with relapsed or refractory
advanced esophagogastric adenocarcinoma.
“The use of checkpoint inhibitors has generated exciting
responses in a minority of patients with advanced relapsed or
recurrent esophagogastric cancer. We are hopeful that the addition
of DKN-01 to pembrolizumab will expand the clinical benefit without
added toxicity,” commented Dr. Samuel Klempner, Director of
Precision Medicine at The Angeles Clinic and Research Institute and
an investigator on the study.
“We have continued to advance development of both of our
pipeline assets as we aim to build a world-class immuno-oncology
company. This quarter we reported promising clinical activity for
both assets and have begun the process to launch clinical studies
exploring novel therapeutic combinations in targeted patient
populations,” commented Christopher K. Mirabelli, Ph.D, President
and Chief Executive Officer of Leap Therapeutics. “The combination
study of DKN-01 with pembrolizumab in esophagogastric cancer is the
first example of this strategy. We are eager to explore the
complementary mechanism of action of DKN-01 and checkpoint
inhibitors to enhance anti-tumor immune responses.”
The P102 esophagogastric cancer study is a multipart study
evaluating DKN-01 as a monotherapy and in combination with
paclitaxel or pembrolizumab in patients with advanced relapsed or
refractory esophagogastric cancer. The combination arm evaluating
DKN-01 with pembrolizumab includes both dose escalation and dose
confirmation cohorts and is designed to evaluate the safety,
pharmacokinetics and efficacy of the combination in patients with
esophagogastric adenocarcinoma. The DKN-01+pembrolizumab study will
enroll up to approximately 67 patients. The dose confirmation
cohort (n=55) will include patients that are naïve (n=40) or
refractory (n=15) to PD-1/ PD-L1 antagonists.
Recent Highlights
DKN-01:
- Announced updated clinical efficacy data from the P102 clinical
trial evaluating DKN-01 in combination with paclitaxel in patients
with advanced relapsed or refractory esophagogastric cancer. The
recent data indicated that 26% of patients on combination therapy
had a partial response. When analyzed by prior taxane experience,
patients had a response rate of 40.9% and 12.5%, a disease control
rate of 72.7% and 45.8%, and a median progression-free survival of
17.0 and 9.7 weeks, in taxane-naïve patients and taxane-experienced
patients, respectively. A patient on DKN-01 monotherapy achieved a
partial response by central imaging analysis and has been on
therapy for over one year. Enrollment in the study continues.
- Announced a collaborative-group sponsored study with the
European Organisation for Research and Treatment of Cancer (EORTC)
and Roche to evaluate DKN-01 in combination with TECENTRIQ ®
(atezolizumab), a PD-L1 antagonist, ± paclitaxel in patients with
advanced esophagogastric cancer or biliary tract cancer.
- Filed an IND application with the FDA to initiate a clinical
trial of DKN-01 in patients with gynecological malignancies, a
population known to have a high frequency of Wnt pathway
mutations.
TRX518:
- Announced clinical data from the 003 repeat-dose clinical trial
evaluating TRX518 monotherapy in patients with advanced solid
tumors. The Part B expansion cohort has been fully enrolled and as
of August 31 2017, 50% of patients experienced a best response of
stable disease, 26% had progressive disease, and 24% were
non-evaluable for response. Patient follow-up, biopsy, and
biomarker analysis are ongoing. Signs of pharmacodynamic activity
including CD8+ T cell activation have been observed.
- Announced the first combination study evaluating TRX518 in
combination with a chemotherapy, gemcitabine, or in combination
with immune checkpoint inhibitors in patients with advanced solid
tumors.
Selected Third Quarter 2017 Financial Results
Net loss was $6.8 million for the third quarter of 2017,
compared to $7.3 million for the same period in 2016.
Research and development expenses were $6.8 million for the
third quarter 2017, compared to $5.7 million for the same period in
2016. This increase was primarily due to increased clinical trial
expenses.
General and administrative expenses were $1.8 million for the
third quarter 2017, compared to $1.4 million for the same period in
2016. This increase was primarily due to an increase in stock based
compensation expense and increased headcount needed to support
public company operations.
Cash, cash equivalents and marketable securities totaled $14.2
million at September 30, 2017. Research and development incentive
receivables totaled $1.9 million.
About Leap TherapeuticsLeap Therapeutics
(Nasdaq:LPTX) is 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, a Wnt pathway modulator. DKN-01 is in clinical trials in
patients with esophagogastric cancer and biliary tract cancer, with
an emerging focus on patients with defined mutations of the Wnt
pathway and in combinations with immune checkpoint inhibitors.
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 accuracy of our
estimates regarding expenses, future revenues, capital requirements
and needs for financing; the ability to complete a financing or
form business development relationships to fund our expenses; 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; 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
CONTACT:
Douglas E. OnsiChief Financial OfficerLeap Therapeutics,
Inc.donsi@leaptx.com617-714-0360
Argot PartnersInvestor RelationsSusan Kim or Heather
Savelle212-600-1902susan@argotpartners.comheather@argotpartners.com
|
|
Leap Therapeutics, Inc |
|
Condensed Consolidated Statement of
Operations |
|
(unaudited) |
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(in
thousands) |
|
|
(in
thousands) |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,802 |
|
|
$ |
5,659 |
|
|
|
$ |
18,087 |
|
|
$ |
15,870 |
|
|
General and administrative |
|
|
1,780 |
|
|
|
1,369 |
|
|
|
|
7,719 |
|
|
|
3,495 |
|
|
Total operating expenses |
|
|
8,582 |
|
|
|
7,028 |
|
|
|
|
25,806 |
|
|
|
19,365 |
|
|
Loss from
operations |
|
|
(8,582 |
) |
|
|
(7,028 |
) |
|
|
|
(25,806 |
) |
|
|
(19,365 |
) |
|
Interest
income (expense) |
|
|
19 |
|
|
|
(2 |
) |
|
|
|
118 |
|
|
|
2 |
|
|
Interest
expense - related party |
|
|
- |
|
|
|
(380 |
) |
|
|
|
(121 |
) |
|
|
(722 |
) |
|
Australian
research and development incentives |
|
|
961 |
|
|
|
- |
|
|
|
|
1,852 |
|
|
|
- |
|
|
Foreign
currency gains |
|
|
787 |
|
|
|
133 |
|
|
|
|
823 |
|
|
|
184 |
|
|
Net loss |
|
|
(6,815 |
) |
|
$ |
(7,277 |
) |
|
|
|
(23,134 |
) |
|
$ |
(19,901 |
) |
|
Accretion
of preferred stock to redemption value |
|
|
- |
|
|
|
|
|
|
(244 |
) |
|
|
|
Net loss attributable to common stockholders |
|
$ |
(6,815 |
) |
|
|
|
|
$ |
(23,378 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share - basic and diluted |
|
$ |
(0.73 |
) |
|
|
|
|
$ |
(2.72 |
) |
|
|
|
Weighted
average common shares outstanding - basic and diluted |
|
9,395,920 |
|
|
|
|
|
|
8,584,558 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc |
|
Condensed Consolidated Balance
Sheet |
|
|
|
|
|
September
30, |
|
December 31, |
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
(in thousands) |
|
|
Assets |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,203 |
|
|
$ |
793 |
|
|
|
Research and development incentive receivable |
|
|
1,894 |
|
|
|
3,053 |
|
|
|
Prepaid expenses and other current assets |
|
|
404 |
|
|
|
183 |
|
|
|
Total current assets |
|
|
16,501 |
|
|
|
4,029 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
|
148 |
|
|
|
119 |
|
|
|
Deferred offering costs |
|
|
- |
|
|
|
1,402 |
|
|
|
Other assets |
|
|
930 |
|
|
|
907 |
|
|
|
Total assets |
|
$ |
17,579 |
|
|
$ |
6,457 |
|
|
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficiency) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,598 |
|
|
$ |
3,225 |
|
|
|
Accrued expenses |
|
|
3,396 |
|
|
|
2,658 |
|
|
|
Notes payable and accrued interest - related party |
|
|
- |
|
|
|
30,274 |
|
|
|
Total current liabilities |
|
|
5,994 |
|
|
|
36,157 |
|
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
preferred stock, 0 and 42,500,000 shares authorized as of
September 30, 2017 and December 31, 2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A redeemable convertible preferred stock, $0.001 par
value; 0 and 9,000,000 shares designated as of September 30,
2017 and December 31, 2016, respectively; 0 and 9,000,000
shares issued and outstanding as of September 30, 2017 and
December 31, 2016, respectively; liquidiation preference of $0 and
$11,800 as of September 30, 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 September 30, 2017 and
December 31, 2016, respectively; 0 and 21,500,000 shares
issued and outstanding as of September 30, 2017 and December
31, 2016, respectively; liquidation preference of $0 and $28,189 as
of September 30, 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 September 30, 2017 and
December 31, 2016, respectively; 0 and 11,781,984 shares
issued and outstanding as of September 30, 2017 and December
31, 2016, respectively; liquidation preference of $0 and $30,542
as of September 30, 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 September 30, 2017 and December 31,
2016, respectively; 9,395,920 and 0 shares outstanding as of
September 30, 2017 and December 31, 2016, respectively |
|
|
9 |
|
|
|
- |
|
|
|
Additional paid-in capital |
|
|
135,649 |
|
|
|
145 |
|
|
|
Accumulated other comprehensive income (loss) |
|
|
(269 |
) |
|
|
294 |
|
|
|
Accumulated deficit |
|
|
(123,804 |
) |
|
|
(100,670 |
) |
|
|
Total stockholders’ equity (deficiency) |
|
|
11,585 |
|
|
|
(100,231 |
) |
|
|
Total liabilities, convertible preferred stock and
stockholders' equity (deficiency) |
|
$ |
17,579 |
|
|
$ |
6,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc |
|
Condensed Consolidated Statement of Cash
Flows |
|
(unaudited) |
|
|
|
|
|
Nine Months Ended
September 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(in
thousands) |
|
Cash used in operating
activities |
|
$ |
(15,768 |
) |
|
$ |
(18,040 |
) |
|
Cash used in investing
activities |
|
|
(64 |
) |
|
|
(136 |
) |
|
Cash provided by financing
activities |
|
|
29,868 |
|
|
|
18,900 |
|
|
Effect of exchange rate changes on
cash and cash equivalents |
|
|
(626 |
) |
|
|
(164 |
) |
|
Net increase in cash and cash
equivalents |
|
|
13,410 |
|
|
|
560 |
|
|
Cash
and cash equivalents at beginning of period |
|
|
793 |
|
|
|
405 |
|
|
Cash
and cash equivalents at end of period |
|
$ |
14,203 |
|
|
$ |
965 |
|
|
|
|
|
|
|
|
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