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,
2018.
“We had a strong first quarter, as we presented data from our
study of DKN-01 as a monotherapy and in combination with KEYTRUDA®
(pembrolizumab) in patients with esophagogastric cancer, and dosed
the first patients in new trials for both of our programs,”
commented Christopher K. Mirabelli, Ph.D, President and Chief
Executive Officer of Leap Therapeutics. “We also successfully
completed a public offering, strengthening our balance sheet and
enabling further growth of the company.”
Recent Pipeline Highlights:
DKN-01:
- Completed enrollment of the dose escalation phase and presented
interim data of a clinical trial evaluating DKN-01 and KEYTRUDA®
(pembrolizumab) in patients with advanced esophagogastric cancer.
Data from the dose escalation phase indicated that the combination
was well tolerated with early signals of clinical activity. In the
high-dose DKN-01 cohort, one of four evaluable patients naïve to
anti-PD-1/PD-L1 therapy had a partial response with a 66% reduction
in target tumor volume. This patient has a tumor phenotype which is
typically less responsive to anti-PD-1 therapy. The study is now
enrolling two expansion cohorts in patients with esophagogastric
cancer who are naïve to anti-PD-1/PD-L1 therapy (n=40) and patients
who are refractory to anti-PD-1/PD-L1 therapy (n=15).
- Presented data on the monotherapy activity of DKN-01 in
patients with advanced esophagogastric cancer. Of 16 patients
evaluable by central imaging analysis, two patients had a partial
response and five patients had stable disease, representing a total
disease control rate of 43.8%. One patient who had failed prior
investigational immunotherapies had a partial response on DKN-01
monotherapy and remained on study for over a year.
- Enrolled the first patients in a clinical study evaluating
DKN-01 as a monotherapy and in combination with paclitaxel in
patients with endometrioid gynecologic cancers, a population of
cancers with frequent alterations of the Wnt signaling pathway
resulting in increased expression of DKK1.
TRX518:
- Enrolled the first patients in a clinical trial evaluating
TRX518 in combination with gemcitabine chemotherapy or in
combination with KEYTRUDA® (pembrolizumab) or Opdivo® (nivolumab),
anti-PD-1 therapies marketed by Merck (known as MSD outside the
United States and Canada) or Bristol-Myers Squibb,
respectively.
Business Highlights
- Completed a public offering for $16.1 million in gross
proceeds, which supports further growth of the company and extends
the cash runway into the fourth quarter 2019.
DKN-01 Program Update Call:
On Friday, May 18, 2018 at 12:00PM ET Leap will be hosting a
conference call and webcast for the investment community with
DKN-01 clinical investigators where the Company will provide a
program update. To access the conference call, please dial (866)
589-0108 (US/Canada Toll-Free) or (409) 231-2048 (international)
and refer to conference ID 7196723. The presentation will also be
webcast live and will be available under "Events &
Presentations" in the Investor section of the Company's website,
http://www.investors.leaptx.com. A replay of the webcast will
be available on the Company's website approximately two hours after
the event and will be available for a limited time.
Selected First Quarter 2018 Financial Results
Net loss was $10.6 million for the first quarter 2018, compared
to $9.4 million for the same period in 2017. This increase was
primarily due to a non-cash change in the fair value of the warrant
liability offset by a decrease in stock-based compensation
expense.
Research and development expenses were $4.2 million for the
first quarter 2018, compared to $6.4 million for the same period in
2017. This decrease was primarily due to a decrease in stock-based
compensation expense and a decrease in manufacturing costs related
to clinical trial material.
General and administrative expenses were $2.1 million for the
first quarter 2018, compared to $3.8 million for the same period in
2017. This decrease was primarily due to a decrease in stock-based
compensation expense and a decrease in legal, audit and consulting
fees.
Cash, cash equivalents and marketable securities totaled $35.4
million at March 31, 2018. Research and development incentive
receivables, current and long term, totaled approximately $1.6
million at March 31, 2018.
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, biliary tract cancer, and
gynecologic cancers, 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 advanced solid tumor 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 February 23, 2018. 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.
Opdivo® is a registered trademark of Bristol Myers-Squibb
Company.
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 Statements of
Operations |
|
|
|
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31 |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
Operating
expenses: |
|
|
|
|
Research
and development |
|
$ |
4,231 |
|
$ |
6,404 |
General
and administrative |
|
2,113 |
|
3,804 |
Total
operating expenses |
|
6,344 |
|
10,208 |
Loss from
operations |
|
(6,344) |
|
(10,208) |
Interest
income |
|
77 |
|
50 |
Interest
expense |
|
(6) |
|
- |
Interest expense -
related party |
|
- |
|
(121) |
Australian research and
development incentives |
|
646 |
|
397 |
Foreign currency gains
(loss) |
|
(144) |
|
468 |
Loss on change in fair
value of warrant liability |
|
(4,851) |
|
- |
Net
loss |
|
(10,622) |
|
(9,414) |
Accretion of preferred
stock to redemption value |
|
- |
|
(244) |
Net loss
attributable to common stockholders |
|
$ |
(10,622) |
|
$ |
(9,658) |
|
|
|
|
|
Net loss per share -
basic and diluted |
|
$ |
(0.85) |
|
$ |
(1.39) |
|
|
|
|
|
Weighted average common
shares outstanding - basic and diluted |
|
12,449,421 |
|
6,945,623 |
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc. |
|
|
|
|
Condensed Consolidated Balance Sheets |
|
|
|
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
35,376 |
|
$ |
25,737 |
Research
and development incentive receivable |
|
998 |
|
1,744 |
Prepaid
expenses and other current assets |
|
289 |
|
177 |
Total
current assets |
|
36,663 |
|
27,658 |
|
|
|
|
|
Property
and equipment, net |
|
123 |
|
135 |
Research
and development incentive receivable, net of current portion |
|
632 |
|
- |
Deferred
tax asset |
|
157 |
|
158 |
Other
assets |
|
1,111 |
|
1,111 |
Total
assets |
|
$ |
38,686 |
|
$ |
29,062 |
Liabilities and
Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
4,130 |
|
$ |
2,622 |
Accrued
expenses |
|
1,715 |
|
3,461 |
Total
current liabilities |
|
5,845 |
|
6,083 |
|
|
|
|
|
Non Current
liabilities: |
|
|
|
|
Warrant
liability |
|
16,713 |
|
11,862 |
Total
liabilities |
|
22,558 |
|
17,945 |
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
Common
stock, $0.001 par value; 100,000,000 shares authorized; 14,500,681
and 12,354,014 shares issued and outstanding as of March 31,
2018 and December 31, 2017, respectively |
|
15 |
|
12 |
Additional paid-in capital |
|
157,290 |
|
141,770 |
Accumulated other comprehensive loss |
|
(158) |
|
(268) |
Accumulated deficit |
|
(141,019) |
|
(130,397) |
Total
stockholders’ equity |
|
16,128 |
|
11,117 |
Total
liabilities and stockholders' equity |
|
$ |
38,686 |
|
$ |
29,062 |
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc. |
|
|
|
|
Condensed Consolidated Statements of Cash
Flows |
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
Cash used
in operating activities |
|
$ |
(5,478) |
|
$ |
(6,349) |
Cash used
in investing activities |
|
- |
|
(65) |
Cash
provided by financing activities |
|
15,005 |
|
29,848 |
Effect of
exchange rate changes on cash and cash
equivalents |
|
112 |
|
(427) |
Net
increase in cash and cash equivalents |
|
9,639 |
|
23,007 |
Cash and cash
equivalents at beginning of period |
|
25,737 |
|
793 |
Cash and cash
equivalents at end of period |
|
$ |
35,376 |
|
$ |
23,800 |
|
|
|
|
|
Leap Therapeutics (NASDAQ:LPTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Leap Therapeutics (NASDAQ:LPTX)
Historical Stock Chart
From Apr 2023 to Apr 2024