Full Press Release Details
Leap Therapeutics Reports Fourth Quarter
and Full Year 2020 Financial Results
MA - March 12, 2021 - 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,
2020 Leap Highlights:
"2020 was a transformative year for
Leap as we executed our first strategic alliance with BeiGene and advanced our DKN-01 development program, initiating our Phase
2a combination study with BeiGene's tislelizumab in gastric cancer patients," said Douglas E. Onsi, President and Chief
Executive Officer of Leap. "The data for DKN-01 to date, both as a monotherapy and in combination approaches, provide evidence
of the potential utility of DKN-01 as an attractive treatment option for multiple biomarker-focused cancer indications."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody
that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin and PI3K/AKT signaling
pathways. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.
Selected Year-End and Fourth Quarter
2020 Financial Results
Net Loss was $27.5 million for the year
ended December 31, 2020, compared to $32.9 million for the year ended December 31, 2019. This decrease was primarily
due to decreased research and development expenses following the deprioritization of the TRX518 program in 2019.
License revenues were $1.5 million for
the full year 2020 and relate to the BeiGene Agreement for the development and commercialization of DKN-01 in Asia (excluding Japan),
Australia, and New Zealand. License revenues were $0.4 million for the fourth quarter 2020. The BeiGene Agreement became effective
on January 3, 2020. As the BeiGene Agreement is the first such license agreement, no license revenues were recorded during
the year ended December 31, 2019.
Research and development expenses were
$20.4 million for full year 2020, compared to $24.4 million for same period in 2019. Research and development expenses were $5.1
million for the fourth quarter of 2020, compared to $5.7 million for the same period in 2019. These decreases were primarily due
to decreased clinical trial costs due to deprioritizing the continued development of TRX518 in 2019 and timing of patient enrollment,
decreased consulting fees associated with research and development activities, and decreased rent expense due to the closing of
our research laboratory in April of 2020. These decreases were partially offset by increases in payroll and other related
expenses due to an increase in headcount of our research and development full time employees and increases in stock-based compensation
expense due to new stock options granted to employees.
General and administrative expenses were
$9.6 million for the full year 2020, compared to $9.1 million for the same period in 2019. The increase was due to an increase
in professional fees primarily due to increased legal, recruiting and information technology costs, an increase in payroll and
other related expenses due to an increase in compensation expense, and an increase in insurance expense. These increases were partially
offset by a decrease in stock-based compensation expense. General and administrative expenses were $2.4 million for the full year
2020 compared to $2.6 million for the same period in 2019. This decrease was due to a decrease in stock-based compensation expense,
partially offset by increased recruiting and information technology costs.
Cash and cash equivalents totaled $52.1
million at December 31, 2020. Research and development incentive receivables totaled $0.1 million.
About Leap Therapeutics
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 entered into
a strategic 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 view 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, as amended, Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties.
These statements include Leap's 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 a 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: that the initiation, conduct, and completion of clinical trials,
laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related
issues; 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, 2020,
as filed with the SEC on March 12, 2021. Any forward-looking statement contained in this release speaks only as of its date.
Leap undertakes no obligation to update any forward-looking statement contained in this release to reflect events or circumstances
occurring after its date or to reflect the occurrence of unanticipated events.
President & Chief Executive Officer
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| (Unaudited) | ||||||||||||||||
| Year Ended December 31 | Three Months Ended December 31 | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| License revenue | $ | 1,500 | $ | - | $ | 375 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 20,423 | 24,366 | 5,101 | 5,668 | ||||||||||||
| General and administrative | 9,616 | 9,085 | 2,428 | 2,604 | ||||||||||||
| Total operating expenses | 30,039 | 33,451 | 7,529 | 8,272 | ||||||||||||
| Loss from operations | (28,539 | ) | (33,451 | ) | (7,154 | ) | (8,272 | ) | ||||||||
| Interest income | 93 | 313 | 2 | 32 | ||||||||||||
| Interest expense | (39 | ) | (23 | ) | 3 | (2 | ) | |||||||||
| Australian research and development incentives | 231 | 132 | (112 | ) | 3 | |||||||||||
| Foreign currency gains | 738 | 126 | 549 | 240 | ||||||||||||
| Loss before income taxes | (27,516 | ) | (32,903 | ) | (6,712 | ) | (7,999 | ) | ||||||||
| Income taxes | 2 | 3 | 2 | 3 | ||||||||||||
| Net loss | (27,514 | ) | (32,900 | ) | (6,710 | ) | (7,996 | ) | ||||||||
| Dividend attributable to down round feature of warrants | (303 | ) | (359 | ) | 0 | - | ||||||||||
| Dividend attributable to Series A & B convertible preferred stock | (372 | ) | - | 0 | - | |||||||||||
| Series A & B convertible preferred stock - beneficial conversion feature | (9,399 | ) | - | - | - | |||||||||||
| Net loss attributable to common stockholders | $ | (37,588 | ) | $ | (33,259 | ) | $ | (6,710 | ) | $ | (7,996 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.63 | ) | $ | (1.47 | ) | $ | (0.09 | ) | $ | (0.33 | ) | ||||
| Diluted | $ | (0.63 | ) | $ | (1.47 | ) | $ | (0.09 | ) | $ | (0.33 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 59,327,713 | 22,582,687 | 76,376,160 | 24,194,877 | ||||||||||||
| Diluted | 59,327,713 | 22,582,687 | 76,376,160 | 24,194,877 |
Consolidated Balance Sheets
except share and per share amounts)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,071 | $ | 3,891 | ||||
| Research and development incentive receivable | 73 | 185 | ||||||
| Prepaid expenses and other current assets | 130 | 165 | ||||||
| Total current assets | 52,274 | 4,241 | ||||||
| Property and equipment, net | 65 | 124 | ||||||
| Right of use assets, net | 528 | 1,026 | ||||||
| Deferred tax assets | 179 | 127 | ||||||
| Deferred costs | 345 | 831 | ||||||
| Deposits | 980 | 1,099 | ||||||
| Total assets | $ | 54,371 | $ | 7,448 | ||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,717 | $ | 4,571 | ||||
| Accrued expenses | 2,747 | 3,441 | ||||||
| Deferred revenue - current portion | 1,500 | - | ||||||
| Lease liability - current portion | 408 | 474 | ||||||
| Total current liabilities | 7,372 | 8,486 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | 204 | 159 | ||||||
| Lease liability, net of current portion | 144 | 552 | ||||||
| Total liabilities | 7,720 | 9,197 | ||||||
| Stockholders' equity (deficiency): | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized;59,657,742 and 24,194,877 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 60 | 24 | ||||||
| Additional paid-in capital | 270,155 | 193,319 | ||||||
| Accumulated other comprehensive income (loss) | (579 | ) | 76 | |||||
| Accumulated deficit | (222,985 | ) | (195,168 | ) | ||||
| Total stockholders' equity (deficiency) | 46,651 | (1,749 | ) | |||||
| Total liabilities and stockholders' equity (deficiency) | $ | 54,371 | $ | 7,448 |
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Cash used in operating activities | $ | (25,957 | ) | $ | (26,902 | ) | $ | (5,988 | ) | $ | (5,894 | ) | ||||
| Cash provided by (used in) investing activities | 25 | (85 | ) | - | 15 | |||||||||||
| Cash provided by (used in) financing activities | 73,997 | 14,817 | - | (19 | ) | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 115 | (223 | ) | 84 | (269 | ) | ||||||||||
| Net increase (decrease) in cash and cash equivalents | $ | 48,180 | $ | (12,393 | ) | (5,904 | ) | (6,167 | ) | |||||||
| Cash and cash equivalents at beginning of period | 3,891 | 16,284 | 57,975 | 10,058 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 52,071 | $ | 3,891 | $ | 52,071 | $ | 3,891 |