CAMBRIDGE, Mass., Aug. 11, 2017 (GLOBE NEWSWIRE) -- 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: |
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Research and development |
$ |
4 881 |
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$ |
6 124 |
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$ |
11 285 |
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$ |
10 211 |
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General and administrative |
|
2 135 |
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|
1 070 |
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|
5 939 |
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|
2 126 |
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Total operating expenses |
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7 016 |
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|
7 194 |
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17 224 |
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|
12 337 |
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Loss from operations |
|
(7 016 |
) |
|
|
(7 194 |
) |
|
|
(17 224 |
) |
|
|
(12 337 |
) |
Interest income |
|
49 |
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|
4 |
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|
99 |
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|
4 |
|
Interest expense - related party |
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- |
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(229 |
) |
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(121 |
) |
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(342 |
) |
Australian research and development incentives |
|
494 |
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- |
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|
891 |
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- |
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Foreign currency gains (losses) |
|
(432 |
) |
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|
(58 |
) |
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|
36 |
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|
51 |
|
Net loss |
|
(6 905 |
) |
|
$ |
(7 477 |
) |
|
|
(16 319 |
) |
|
$ |
(12 624 |
) |
Accretion of preferred stock to redemption value |
|
- |
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(244 |
) |
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Net loss attributable to common stockholders |
$ |
(6 905 |
) |
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$ |
(16 563 |
) |
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Net loss per share - basic and diluted |
$ |
(0,74 |
) |
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|
$ |
(2,03 |
) |
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Weighted average common shares outstanding - basic and diluted |
|
9 392 081 |
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8 171 078 |
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Leap Therapeutics, Inc. |
Condensed Consolidated Balance Sheet |
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June 30, |
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December
31, |
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2017 |
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2016 |
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(in thousands) |
Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
17 171 |
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$ |
793 |
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Research and development incentive receivable |
|
3 170 |
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|
3 053 |
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Prepaid expenses and other current assets |
|
382 |
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|
183 |
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Total current assets |
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20 723 |
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|
4 029 |
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Property and equipment, net |
|
160 |
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|
|
119 |
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|
Research and development incentive receivable, net of current
portion |
|
906 |
|
|
|
- |
|
|
Deferred offering costs |
|
- |
|
|
|
1 402 |
|
|
Other assets |
|
937 |
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|
907 |
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Total assets |
$ |
22 726 |
|
|
$ |
6 457 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficiency) |
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Current liabilities: |
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Accounts payable |
$ |
3 088 |
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$ |
3 225 |
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Accrued expenses |
|
1 287 |
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|
2 658 |
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Notes payable and accrued interest - related party |
|
- |
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|
30 274 |
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Total current liabilities |
|
4 375 |
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|
36 157 |
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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 |
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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 |
|
- |
|
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|
11 800 |
|
|
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|
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|
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 |
|
- |
|
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|
28 189 |
|
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|
|
|
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|
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 |
|
- |
|
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|
30 542 |
|
Stockholders' equity (deficiency): |
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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 |
) |
|
|
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Total stockholders’ equity (deficiency) |
|
18 351 |
|
|
|
(100 231 |
) |
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Total liabilities, convertible preferred stock and stockholders' equity
(deficiency) |
$ |
22 726 |
|
|
$ |
6 457 |
|
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Leap Therapeutics, Inc. |
Condensed Consolidated Statement of Cash
Flows |
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Six Months Ended
June 30, |
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2017 |
|
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2016 |
|
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|
(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