Leap Therapeutics Reports Second Quarter 2017 Financial Results
August 11 2017 - 6:00AM
Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the second quarter ended June 30,
2017.
“We have continued to make steady progress in
the development of both of our clinical-stage antibody programs
this quarter. Our antibody targeting the DKK1 protein, DKN-01, has
advanced to studies in biomarker-selected populations and we are
preparing to initiate the first of multiple DKN-01 immunotherapy
combination studies,” commented Christopher K. Mirabelli, Ph.D.,
President and Chief Executive Officer of Leap Therapeutics.
“Additionally, for our GITR agonist antibody, TRX518, we have fully
enrolled one of our two repeat-dose monotherapy studies and are
rapidly advancing development to begin combination studies.”
Recent Highlights
- Announced collaboration with Merck (known as MSD outside the
United States and Canada), to investigate DKN-01 in combination
with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in
patients with relapsed or refractory advanced esophagogastric
cancers.
- Reported updated response and progression-free survival data in
Leap’s clinical trial evaluating DKN-01 in combination with
standard of care chemotherapy in patients with advanced biliary
tract cancers at the American Society for Clinical Oncology (ASCO)
Annual Meeting 2017.
- Enrolled first patient in new arm of the DKN-01 P102
esophagogastric cancer clinical trial focused on genetically
defined Wnt pathway mutations.
- Completed enrollment of the expanded cohort of the DKN-01 P103
advanced biliary tract cancer study.
- Completed dose escalation phase and fully enrolled the
expansion cohort of TRX518 multi-dose study TRX518-003.
Anticipated 2H 2017 Milestones
- Enroll first patient in a combination study of DKN-01 and
KEYTRUDA® in patients with relapsed or refractory advanced
esophagogastric cancers.
- Enroll first patient in a combination study of TRX518 and
chemotherapy in patients with advanced solid tumors.
- Initiate a new clinical trial evaluating DKN-01 in patients
with endometrioid gynecological cancers, a population with an
enhanced percentage of patients with genetically defined Wnt
pathway mutations.
- Expand clinical development of DKN-01 and TRX518 in
combinations with immune checkpoint inhibtors.
Selected Second Quarter 2017 Financial
Results
Net loss was $6.9 million for the second quarter
of 2017, compared to $7.5 million for the same period in 2016.
Research and development expenses were $4.9
million for the second quarter 2017, compared to $6.1 million for
the same period in 2016. This decrease was primarily due to a
reduction in the manufacturing costs of our clinical product
candidates.
General and administrative expenses were $2.1
million for the second quarter 2017, compared to $1.1 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 $17.2 million at June 30, 2017. Research and
development incentive receivables totaled $3.2 million. The Company
believes that its current cash and cash equivalents and the
anticipated receipt of the research and development incentive
receivable will be sufficient to fund the Company’s operating
expenses into the second quarter of 2018.
About Leap Therapeutics
Leap Therapeutics’ (NASDAQ:LPTX) 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 gastroesophageal
cancer and biliary tract cancer, with an emerging focus on patients
with defined mutations of the Wnt pathway and on combinations with
immune checkpoint inhibitors, such as Merck’s KEYTRUDA®
(pembrolizumab). 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.
Leap Therapeutics, Inc. |
Condensed Consolidated Statement of
Operations |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2017 |
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2016 |
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2017 |
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2016 |
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(in thousands) |
|
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|
(in thousands) |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
4 881 |
|
|
$ |
6 124 |
|
|
$ |
11 285 |
|
|
$ |
10 211 |
|
|
General and
administrative |
|
2
135 |
|
|
|
1
070 |
|
|
|
5
939 |
|
|
|
2
126 |
|
|
|
|
Total
operating expenses |
|
7 016 |
|
|
|
7 194 |
|
|
|
17 224 |
|
|
|
12 337 |
|
Loss from
operations |
|
(7
016 |
) |
|
|
(7
194 |
) |
|
|
(17
224 |
) |
|
|
(12
337 |
) |
Interest
income |
|
49 |
|
|
|
4 |
|
|
|
99 |
|
|
|
4 |
|
Interest
expense - related party |
|
- |
|
|
|
(229 |
) |
|
|
(121 |
) |
|
|
(342 |
) |
Australian
research and development incentives |
|
494 |
|
|
|
- |
|
|
|
891 |
|
|
|
- |
|
Foreign
currency gains (losses) |
|
(432 |
) |
|
|
(58 |
) |
|
|
36 |
|
|
|
51 |
|
Net loss |
|
(6 905 |
) |
|
$ |
(7 477 |
) |
|
|
(16 319 |
) |
|
$ |
(12 624 |
) |
Accretion
of preferred stock to redemption value |
|
- |
|
|
|
|
|
|
|
(244 |
) |
|
|
|
|
Net loss attributable to common stockholders |
$ |
(6 905 |
) |
|
|
|
|
|
$ |
(16 563 |
) |
|
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|
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|
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|
|
|
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|
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|
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|
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|
Net loss
per share - basic and diluted |
$ |
(0,74 |
) |
|
|
|
|
|
$ |
(2,03 |
) |
|
|
|
|
Weighted
average common shares outstanding - basic and diluted |
|
9 392 081 |
|
|
|
|
|
|
|
8 171 078 |
|
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Leap Therapeutics, Inc. |
Condensed Consolidated Balance Sheet |
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|
June 30, |
|
December
31, |
|
|
2017 |
|
2016 |
|
|
(in thousands) |
Assets |
|
|
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|
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Current
assets: |
|
|
|
|
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|
|
|
Cash and
cash equivalents |
$ |
17
171 |
|
|
$ |
793 |
|
|
Research
and development incentive receivable |
|
3
170 |
|
|
|
3
053 |
|
|
Prepaid
expenses and other current assets |
|
382 |
|
|
|
183 |
|
|
|
|
|
|
Total
current assets |
|
20
723 |
|
|
|
4
029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
160 |
|
|
|
119 |
|
|
Research
and development incentive receivable, net of current portion |
|
906 |
|
|
|
- |
|
|
Deferred
offering costs |
|
- |
|
|
|
1
402 |
|
|
Other
assets |
|
937 |
|
|
|
907 |
|
|
|
|
|
|
Total
assets |
$ |
22 726 |
|
|
$ |
6 457 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficiency) |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
$ |
3
088 |
|
|
$ |
3
225 |
|
|
Accrued
expenses |
|
1
287 |
|
|
|
2
658 |
|
|
Notes
payable and accrued interest - related party |
|
- |
|
|
|
30
274 |
|
|
|
|
|
|
Total
current liabilities |
|
4 375 |
|
|
|
36 157 |
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
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Convertible
preferred stock, 0 and 42,500,000 shares authorized as of
June 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 June 30, 2017
and December 31, 2016, respectively; 0 and 9,000,000 shares
issued and outstanding as of June 30, 2017 and December 31,
2016, respectively; liquidiation preference of $0 and
$11,800 as of June 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 June 30, 2017 and
December 31, 2016, respectively; 0 and 21,500,000 shares
issued and outstanding as of June 30, 2017 and December 31,
2016, respectively; liquidation preference of $0 and $28,189 as
of June 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 June 30, 2017 and
December 31, 2016, respectively; 0 and 11,781,984 shares
issued and outstanding as of June 30, 2017 and December 31,
2016, respectively; liquidation preference of $0 and $30,542
as of June 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 June 30, 2017 and December 31, 2016,
respectively; 9,395,920 and 0 shares outstanding as of June
30, 2017 and December 31, 2016, respectively |
|
9 |
|
|
|
- |
|
|
Additional
paid-in capital |
|
135
000 |
|
|
|
145 |
|
|
Accumulated
other comprehensive income |
|
331 |
|
|
|
294 |
|
|
Accumulated
deficit |
|
(116
989 |
) |
|
|
(100
670 |
) |
|
|
|
|
|
Total
stockholders’ equity (deficiency) |
|
18 351 |
|
|
|
(100 231 |
) |
|
|
|
|
|
Total
liabilities, convertible preferred stock and stockholders' equity
(deficiency) |
$ |
22 726 |
|
|
$ |
6 457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, Inc. |
Condensed Consolidated Statement of Cash
Flows |
|
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|
Six Months Ended June
30, |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Cash used in operating activities |
$ |
(13 411 |
) |
|
$ |
(10 669 |
) |
Cash used in investing activities |
|
(66 |
) |
|
|
(136 |
) |
Cash provided by financing
activities |
|
29 868 |
|
|
|
12 900 |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
(13 |
) |
|
|
(4 |
) |
Net increase in cash and cash
equivalents |
|
16 378 |
|
|
|
2 091 |
|
Cash
and cash equivalents at beginning of period |
|
793 |
|
|
|
405 |
|
Cash
and cash equivalents at end of period |
$ |
17 171 |
|
|
$ |
2 496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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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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