Full Press Release Details
Leap Therapeutics Reports Fourth Quarter
and Full Year 2019 Financial Results
Cambridge, MA - March 16, 2020
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today reported financial results for the fourth quarter and year ended December 31, 2019.
"We ended 2019 having made significant
progress in the clinical development of DKN-01 as both a monotherapy and in combination with other therapies as a treatment for
cancer. We've generated an abundance of data that continues to demonstrate DKN-01's activity against multiple difficult-to-treat
tumor types," said Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "We've carried
this momentum into the new year, having achieved our top corporate goal of securing a strategic partner for development of DKN-01
in the Asia-Pacific region. We look forward to working with BeiGene to bring DKN-01 to patients in this geographic area where the
incidence of esophagogastric cancer is highly prevalent and to develop DKN-01 in combination with tizlelizumab, their anti-PD-1
DKN-01 Clinical Update
DKN-01 is a humanized monoclonal antibody
targeting the DKK1 protein, a Wnt pathway modulator. DKN-01, as a single agent, has achieved partial responses in three different
cancer indications. In combination with immune checkpoint inhibitors and with chemotherapy, DKN-01 has achieved overall response
rates and survival data that is greater than the historical benchmarks, particularly in biomarker targeted patient populations.
As part of the collaboration
with BeiGene, Leap plans to study the combination of DKN-01 and BeiGene's anti-PD-1 antibody, tislelizumab and will evaluate
approximately 40 DKK1-high patients with second-line GC or GEJ. In addition, Leap plans to evaluate the combination of DKN-01 with
tislelizumab and chemotherapy in approximately 20 patients with first-line GC/GEJ. These clinical trials are expected to initiate
in the first half of 2020.
In light of the global emergency
of the new coronavirus, COVID-19, the Society of Gynecologic Oncology will not conduct its 2020 Annual Meeting on Women's
Cancer, previously scheduled for March 28-31, 2020, in Toronto, Canada. Leap is currently awaiting additional information about
the oral presentation that was to be made at the conference and evaluating other data presentation opportunities for the study
in gynecologic cancers.
Selected Year-End and Fourth Quarter
2019 Financial Results
Net loss was $32.9 million for the year
ended December 31, 2019, compared to $23.1 million for the year ended December 31, 2018. This increase was primarily due to increased
research and development expenses and a change in warrant liability accounting.
Research and development expenses were
$24.4 million for the full year 2019, compared to $21.8 million for the same period in 2018. This increase was primarily due to
increased full-year clinical trial costs due to increased patient enrollment, payroll and stock-based compensation expense, offset
by reduced manufacturing expenses of our clinical product candidates and consulting expenses. Research and development expenses
were $5.7 million for the fourth quarter of 2019, compared to $6.9 million for the same period in 2018. This decrease was primarily
due to reduced clinical trial costs in the fourth quarter of 2019 resulting from the maturing of our clinical trials and from lower
manufacturing and consulting expenses.
General and administrative expenses were
$9.1 million for the full year 2019, compared to $8.9 million for the same period in 2018. General and administrative expenses
were $2.6 million for the fourth quarter of 2019, compared to $2.1 million for the same period in 2018. These increases were due
to increases in performance-based and stock-based compensation expense.
Cash, cash equivalents and marketable securities
totaled $3.9 million at December 31, 2019. Research and development incentive receivables totaled $0.2 million. Subsequent to the
financial year end, Leap completed a $27.0 million private placement and received $3.0 million from the agreement with BeiGene.
About Leap Therapeutics
Leap Therapeutics (Nasdaq:LPTX) is focused
on 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,
hepatobiliary, gynecologic, and prostate cancers. Leap has formed a partnership with BeiGene, Ltd. for the rights to develop DKN-01
in Asia (excluding Japan), Australia, and New Zealand. 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 https://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
regarding expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of
future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments
from BeiGene, and other future expectations, plans and prospects. 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 known and unknown risks,
uncertainties and other factors that could cause actual results to differ materially from our expectations. Such 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 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; 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 SEC, including Leap's Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, as filed with the SEC on March 16, 2020. 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.
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, New York, NY, USA. TECENTRIQ
is a registered trademark of Genentech, Inc., South San Francisco, CA.
Chief Financial Officer
Leap Therapeutics, Inc.
Statements of Operations
except share and per share amounts)
| (Unaudited) | ||||||||||||||||
| Year Ended December 31 | Three Months Ended December 31 | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 24,366 | $ | 21,830 | $ | 5,668 | $ | 6,908 | ||||||||
| General and administrative | 9,085 | 8,921 | 2,604 | 2,063 | ||||||||||||
| Total operating expenses | 33,451 | 30,751 | 8,272 | 8,971 | ||||||||||||
| Loss from operations | (33,451 | ) | (30,751 | ) | (8,272 | ) | (8,971 | ) | ||||||||
| Interest income | 313 | 447 | 32 | 120 | ||||||||||||
| Interest expense | (23 | ) | (19 | ) | (2 | ) | (1 | ) | ||||||||
| Australian research and development incentives | 132 | 756 | 3 | (432 | ) | |||||||||||
| Foreign currency gains (loss) | 126 | (835 | ) | 240 | (220 | ) | ||||||||||
| Change in fair value of warrant liability | - | 7,284 | - | 11,004 | ||||||||||||
| Income (loss) before income taxes | (32,903 | ) | (23,118 | ) | (7,999 | ) | 1,500 | |||||||||
| Income taxes | 3 | (20 | ) | 3 | (20 | ) | ||||||||||
| Net income (loss) | (32,900 | ) | (23,138 | ) | (7,996 | ) | 1,480 | |||||||||
| Dividend attributable to down round feature of warrants | (359 | ) | - | - | - | |||||||||||
| Net income (loss) attributable to common stockholders | $ | (33,259 | ) | $ | (23,138 | ) | $ | (7,996 | ) | $ | 1,480 | |||||
| Net income (loss) per share | ||||||||||||||||
| Basic | $ | (1.47 | ) | $ | (1.64 | ) | $ | (0.33 | ) | $ | 0.10 | |||||
| Diluted | $ | (1.47 | ) | $ | (2.11 | ) | $ | (0.33 | ) | $ | 0.10 | |||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 22,582,687 | 14,144,287 | 24,194,877 | 14,703,159 | ||||||||||||
| Diluted | 22,582,687 | 14,412,695 | 24,194,877 | 14,764,282 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share
and per share amounts)
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,891 | $ | 16,284 | ||||
| Research and development incentive receivable | 185 | 836 | ||||||
| Prepaid expenses and other current assets | 165 | 202 | ||||||
| Total current assets | 4,241 | 17,322 | ||||||
| Property and equipment, net | 124 | 86 | ||||||
| Right of use assets | 1,026 | - | ||||||
| Deferred tax assets | 127 | 124 | ||||||
| Deferred offering costs | 831 | 162 | ||||||
| Deposits | 1,099 | 1,380 | ||||||
| Total assets | $ | 7,448 | $ | 19,074 | ||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,571 | $ | 3,579 | ||||
| Accrued expenses | 3,441 | 2,872 | ||||||
| Lease liability - current portion | 474 | - | ||||||
| Total current liabilities | 8,486 | 6,451 | ||||||
| Non current liabilities: | ||||||||
| Warrant liability | - | 3,448 | ||||||
| Restricted stock liability | 159 | - | ||||||
| Lease liability, net of current portion | 552 | - | ||||||
| Total liabilities | 9,197 | 9,899 | ||||||
| Stockholders' equity (deficiency): | ||||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized, 24,194,877 and 14,703,159 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively | 24 | 15 | ||||||
| Additional paid-in capital | 193,319 | 162,393 | ||||||
| Accumulated other comprehensive income | 76 | 302 | ||||||
| Accumulated deficit | (195,168 | ) | (153,535 | ) | ||||
| Total stockholders' equity (deficiency) | (1,749 | ) | 9,175 | |||||
| Total liabilities and stockholders' equity (deficiency) | $ | 7,448 | $ | 19,074 |
Leap Therapeutics, Inc.
Condensed Consolidated Statements
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Cash used in operating activities | $ | (26,902 | ) | $ | (26,033 | ) | $ | (5,894 | ) | $ | (7,050 | ) | ||||
| Cash provided by (used in) investing activities | (85 | ) | - | 15 | - | |||||||||||
| Cash provided by (used in) financing activities | 14,817 | 15,906 | (19 | ) | (40 | ) | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (223 | ) | 674 | (269 | ) | 125 | ||||||||||
| Net decrease in cash and cash equivalents | (12,393 | ) | (9,453 | ) | (6,167 | ) | (6,965 | ) | ||||||||
| Cash and cash equivalents at beginning of period | 16,284 | 25,737 | 10,058 | 23,249 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 3,891 | $ | 16,284 | $ | 3,891 | $ | 16,284 |