Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported financial results for the fourth quarter and year ended
December 31, 2017. Leap additionally announced that its Annual
Meeting of Stockholders will be held on Thursday, May 3, 2018, at
11:00 a.m., Eastern Time, at the offices of Morgan, Lewis &
Bockius LLP, One Federal Street, Boston, Massachusetts 02110.
“We had a very successful 2017 at Leap, our first year as a
public company. We have advanced clinical development of both of
our innovative cancer programs to explore novel combinations with
immunotherapies and chemotherapies and have laid the foundation for
a data-rich 2018,” said Christopher K. Mirabelli, Ph.D., Chief
Executive Officer of Leap. “We additionally strengthened our
balance sheet to continue to grow the company and further advance
our pipeline.”
2017 Accomplishments
DKN-01
- Announced parallel development strategy to evaluate DKN-01 in
patients with documented alterations of the Wnt signaling pathway
and to evaluate DKN-01 as a combination immunotherapy.
- Wnt Signaling Studies
- Initiated a Phase 2 clinical trial evaluating DKN-01 as a
monotherapy and in combination with paclitaxel in patients with
advanced endometrioid gynecologic malignancies. The study will
enroll approximately 50% of patients with Wnt signaling
abnormalities.
- Announced an investigator-sponsored clinical trial, DIAL-1, in
patients with advanced hepatocellular carcinoma (HCC) with
activated Wnt signaling at the University Medical Center of the
Johannes Gutenberg-University Mainz in Germany.
- Immunotherapy Studies:
- Enrolled first patient in combination study evaluating DKN-01
with anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with
esophagogastric cancer.
- Announced an immunotherapy collaboration, DINAMIC, with the
European Organisation for Research and Treatment of Cancer (EORTC).
The cooperative group sponsored clinical trial will evaluate DKN-01
in combination with atezolizumab (TECENTRIQ®) +/- paclitaxel in
advanced esophagogastric malignancies and DKN-01 + atezolizumab in
advanced biliary tract cancers at EORTC centers across Europe.
- Presented proof of concept clinical data of DKN-01 in
combination with chemotherapy in patients with advanced biliary
tract or esophagogastric cancers at major medical conferences
including the American Society for Clinical Oncology (ASCO) annual
meeting and the ASCO Gastrointestinal Cancer Symposium. The data
included encouraging overall response and disease control rates,
progression-free survival data, and biomarker data.
TRX518:
- Fully enrolled the monotherapy cohorts of the 003 repeat-dose
clinical trial evaluating TRX518 in patients with advanced solid
tumors.
- Presented interim data from the repeat-dose monotherapy study,
including robust disease control and signs of pharmacodynamic
activity including CD8+ T cell activation.
- Initiated combination cohorts of study 003 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:
- Completed $18M private-placement financing with participation
from Eli Lilly and Company and other existing and new
investors.
- Completed a clinical collaboration agreement with Merck for the
study of the combination of DKN-01 and KEYTRUDA®
(pembrolizumab).
2018 Objectives
DKN-01 Program Objectives
- Present interim data from clinical trial evaluating DKN-01 and
KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric
cancer.
- Present interim data from the Phase 2 clinical trial evaluating
DKN-01 ± paclitaxel in patients with advanced gynecologic cancers
enriched for patients with Wnt pathway alterations.
- Present final data from the combination study of DKN-01 with
gemcitabine and cisplatin in advanced biliary tract cancers.
- Enroll first patient in the DIAL-1 clinical trial.
- Enroll first patient in the DINAMIC clinical trial.
TRX518 Program Objectives
- Present interim data from study of TRX518 in combination with
gemcitabine chemotherapy, KEYTRUDA® (pembrolizumab), or Opdivo®
(nivolumab).
- Present TRX518 clinical biomarker data from monotherapy
studies.
Selected Year-End and Fourth Quarter 2017 Financial Results
Net loss was $29.7 million for the year ended December 31, 2017,
compared to $25.6 million for the year ended December 31, 2016. Net
loss was $6.6 million for the fourth quarter of 2017, compared to
$5.7 million for the same period in 2016.
Research and development expenses were $22.5 million for the
full year 2017, compared to $23.3 million for the same period in
2016. This decrease was primarily due to reduced manufacturing
expenses of our clinical product candidates. Research and
development expenses were $4.4 million for the fourth quarter of
2017, compared to $7.4 million for the same period in 2016.
General and administrative expenses were $9.8 million for the
full year 2017, compared to $4.0 million for the same period in
2016. This increase was primarily due to increased personnel,
stock-based compensation, and expenses related to operating as a
public company. General and administrative expenses were $2.1
million for the fourth quarter of 2017, compared to $0.5 million
for the same period in 2016.
Cash, cash equivalents and marketable securities totaled $25.7
million at December 31, 2017. Research and development incentive
receivables totaled $1.7
million.
Annual Meeting of Stockholders
The Annual Meeting of Stockholders will be held on Thursday, May
3, 2018, at 11:00 a.m., Eastern Time, at the offices of Morgan,
Lewis & Bockius LLP, One Federal Street, Boston, Massachusetts
02110. The record date for the Annual Meeting of Stockholders is
March 28, 2018. Leap expects to mail its definitive proxy statement
to all stockholders of record in the first week of April.
Rule 14a-8 Stockholder Proposal Deadline
The 2018 Annual Meeting date represents Leap’s first Annual
Meeting of Stockholders. As a result, pursuant to Rule 14a-8 under
the Securities Exchange Act of 1934, as amended, the deadline for
the receipt of any stockholder proposals submitted pursuant to Rule
14a-8 for inclusion in Leap’s proxy materials for the 2018 Annual
Meeting, is required to be a reasonable time before the Company
begins to print and mail the proxy materials. Taking into
consideration the time and process for addressing any deficiencies
in proposals that may be submitted, the Company has determined that
close of business on March 9, 2018 should be the deadline for
receipt of proposals pursuant to Rule 14a-8. Such proposals should
be delivered to: Leap Therapeutics, 47 Thorndike Street, Suite
B1-1, Cambridge, Massachusetts 02141, Attention: Corporate
Secretary. Leap recommends that such proposals be sent by certified
mail, return receipt requested. Such proposals also will need to
comply with the rules of the Securities and Exchange Commission
regarding the inclusion of stockholder proposals in Leap’s proxy
materials and may be omitted if not in compliance with applicable
requirements.
Bylaws Advance Notice Deadline for Stockholder Proposals and
Nominations
For stockholder proposals not submitted pursuant to Rule 14a-8
and stockholder nominations of directors, the stockholder must give
timely notice thereof in writing and in accordance with the
requirements set forth in the Company's bylaws to the Company's
Secretary no later than 5:00 p.m., Eastern Time on March 9, 2018 at
the address noted above.
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.
TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
Leap Therapeutics, IncConsolidated Statement of
Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Year Ended December 31 |
|
|
Three Months Ended December 31, |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
22,503 |
|
|
$ |
23,292 |
|
|
|
$ |
4,416 |
|
|
$ |
7,422 |
|
|
General and
administrative |
|
|
9,849 |
|
|
|
4,012 |
|
|
|
|
2,130 |
|
|
|
517 |
|
|
|
|
Total operating expenses |
|
|
32,352 |
|
|
|
27,304 |
|
|
|
|
6,546 |
|
|
|
7,939 |
|
Loss from
operations |
|
|
(32,352 |
) |
|
|
(27,304 |
) |
|
|
|
(6,546 |
) |
|
|
(7,939 |
) |
Interest
income |
|
|
170 |
|
|
|
2 |
|
|
|
|
52 |
|
|
|
0 |
|
Interest
expense - related party |
|
|
(121 |
) |
|
|
(1,233 |
) |
|
|
|
- |
|
|
|
(511 |
) |
Australian
research and development incentives |
|
|
1,715 |
|
|
|
3,129 |
|
|
|
|
(137 |
) |
|
|
3,129 |
|
Foreign
currency gains (loss) |
|
|
759 |
|
|
|
(217 |
) |
|
|
|
(64 |
) |
|
|
(401 |
) |
Other
expense, net |
|
|
(55 |
) |
|
|
(9 |
) |
|
|
|
(55 |
) |
|
|
(9 |
) |
Loss before income taxes |
|
|
(29,884 |
) |
|
$ |
(25,632 |
) |
|
|
|
(6,750 |
) |
|
$ |
(5,731 |
) |
Benefit from income taxes |
|
|
157 |
|
|
|
- |
|
|
|
|
157 |
|
|
|
- |
|
Net loss |
|
|
(29,727 |
) |
|
$ |
(25,632 |
) |
|
|
|
(6,593 |
) |
|
$ |
(5,731 |
) |
Accretion
of preferred stock to redemption value |
|
|
(244 |
) |
|
|
|
|
|
- |
|
|
|
Net loss attributable to common stockholders |
|
$ |
(29,971 |
) |
|
|
|
|
$ |
(6,593 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
$ |
(3.27 |
) |
|
|
|
|
$ |
(0.61 |
) |
|
|
|
|
|
Diluted |
|
$ |
(3.31 |
) |
|
|
|
|
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
9,161,844 |
|
|
|
|
|
|
10,874,967 |
|
|
|
|
|
|
Diluted |
|
|
9,188,587 |
|
|
|
|
|
|
10,901,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, IncConsolidated Balance Sheet |
|
|
|
|
|
|
|
|
|
December
31, |
|
|
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,737 |
|
|
$ |
793 |
|
|
|
Research and development incentive receivable |
|
|
1,744 |
|
|
|
3,053 |
|
|
|
Prepaid expenses and other current assets |
|
|
177 |
|
|
|
183 |
|
|
|
Total current assets |
|
|
27,658 |
|
|
|
4,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
135 |
|
|
|
119 |
|
|
|
Deferred offering costs |
|
|
- |
|
|
|
1,402 |
|
|
|
Deferred tax asset |
|
|
158 |
|
|
|
- |
|
|
|
Other assets |
|
|
1,111 |
|
|
|
907 |
|
|
|
Total assets |
|
$ |
29,062 |
|
|
$ |
6,457 |
|
|
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficiency) |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,622 |
|
|
$ |
3,225 |
|
|
|
Accrued expenses |
|
|
3,461 |
|
|
|
2,658 |
|
|
|
Notes payable and accrued interest - related
party |
|
|
- |
|
|
|
30,274 |
|
|
|
Total current liabilities |
|
|
6,083 |
|
|
|
36,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non Current
liabilities: |
|
|
|
|
|
|
Warrant liability |
|
|
11,862 |
|
|
|
- |
|
|
|
Total liabilities |
|
|
17,945 |
|
|
|
36,157 |
|
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
preferred stock, 0 and 42,500,000 shares authorized as of
December 31, 2017 and 2016 |
|
|
|
|
|
|
Series A redeemable convertible preferred stock, $0.001 par
value; 0 and 9,000,000 shares designated as of
December 31, 2017 and 2016, respectively; 0 and
9,000,000 shares issued and outstanding as of December 31,
2017 and 2016, respectively; liquidiation
preference of $0 and $11,800 as of
December 31, 2017 and 2016, respectively |
|
|
- |
|
|
|
11,800 |
|
|
|
Series B convertible preferred stock, $0.001 par value; 0 and
21,500,000 shares designated as of December 31,
2017 and 2016, respectively; 0 and 21,500,000
shares issued and outstanding as of December 31, 2017 and
2016, respectively; liquidation preference of $0 and
$28,189 as of December 31, 2017 and 2016, respectively |
|
|
- |
|
|
|
28,189 |
|
|
|
Series C convertible preferred stock, $0.001 par value; 0 and
12,000,000 shares designated as of December 31,
2017 and 2016, respectively; 0 and 11,781,984
shares issued and outstanding as of December 31, 2017 and
2016, respectively; liquidation preference of $0 and
$30,542 as of December 31, 2017 and 2016,
respectively |
|
|
- |
|
|
|
30,542 |
|
|
|
Stockholders' equity (deficiency): |
|
|
|
|
|
|
Common stock, $0.001 par value; 100,000,000 and 58,500,000
shares authorized as of December 31, 2017 and
2016, respectively; 12,354,014 and 0 shares outstanding
as of December 31, 2017 and 2016, respectively |
|
|
12 |
|
|
|
- |
|
|
|
Additional paid-in capital |
|
|
141,770 |
|
|
|
145 |
|
|
|
Accumulated other comprehensive income (loss) |
|
|
(268 |
) |
|
|
294 |
|
|
|
Accumulated deficit |
|
|
(130,397 |
) |
|
|
(100,670 |
) |
|
|
Total stockholders’ equity (deficiency) |
|
|
11,117 |
|
|
|
(100,231 |
) |
|
|
Total liabilities, convertible preferred stock and
stockholders' equity |
|
$ |
29,062 |
|
|
$ |
6,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leap Therapeutics, IncConsolidated Statement of Cash
Flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Year Ended December
31, |
|
|
Three Months Ended
December 31, |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
(in
thousands) |
|
|
(in
thousands) |
Cash used in operating
activities |
|
$ |
(22,137 |
) |
|
$ |
(25,337 |
) |
|
|
$ |
(6,369 |
) |
|
$ |
(7,297 |
) |
Cash used in investing
activities |
|
|
(64 |
) |
|
|
(144 |
) |
|
|
|
- |
|
|
|
(8 |
) |
Cash provided by financing
activities |
|
|
47,763 |
|
|
|
25,618 |
|
|
|
|
17,895 |
|
|
|
6,718 |
|
Effect of exchange rate changes on
cash and cash equivalents |
|
|
(618 |
) |
|
|
251 |
|
|
|
|
8 |
|
|
|
415 |
|
Net increase (decrease) in cash and
cash equivalents |
|
|
24,944 |
|
|
|
388 |
|
|
|
|
11,534 |
|
|
|
(172 |
) |
Cash
and cash equivalents at beginning of period |
|
|
793 |
|
|
|
405 |
|
|
|
|
14,203 |
|
|
|
965 |
|
Cash
and cash equivalents at end of period |
|
$ |
25,737 |
|
|
$ |
793 |
|
|
|
$ |
25,737 |
|
|
$ |
793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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