Full Press Release Details
Leap Therapeutics Reports First Quarter
2020 Financial Results
Cambridge, MA - May 14, 2020 - Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial
results for the first quarter ended March 31, 2020.
Leap First Quarter Highlights:
"We've made great strides in
the first quarter, as we continue to generate compelling data demonstrating DKN-01's potential as a single agent or in combination
with PD-1 antibody therapy or chemotherapy in treating multiple biomarker-defined cancer indications," said Douglas E. Onsi,
President and Chief Executive Officer of Leap. "Our partnership with BeiGene for the clinical development and commercialization
of DKN-01 is off to a strong start. Site initiation activities are now underway for our combination study of DKN-01 plus tislelizumab,
BeiGene's anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer, and we look forward to dosing
the first patients in the second half of this year."
DKN-01 Clinical 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 signaling. DKK1 has an
important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.
DKN-01 Single Agent Activity
DKN-01 plus Paclitaxel
Combination Activity
Selected First Quarter 2020 Financial
Net loss was $7.2 million for the first
quarter 2020, compared to $8.6 million for the same period in 2019. This decrease was primarily due to revenue recognized from
the BeiGene agreement and a decrease in clinical development expenses, offset by a non-cash charge for foreign currency losses
associated with changes in the Australian dollar exchange rate related to activities of Leap's Australian subsidiary.
Research and development expenses was $4.6
million for the first quarter 2020, compared to $6.8 million for the same period in 2019. The decrease was primarily due to decreases
in clinical trial costs due to timing of patient enrollment and decreases in consulting fees associated with research and development
General and administrative expenses was
$2.2 million for the first quarter 2020, compared to $2.0 million for the same period in 2019. The increase was primarily due to
increases in legal, audit and consulting fees associated with corporate and business development activities.
Cash, cash equivalents and marketable securities
totaled $25.5 million at March 31, 2020. Research and development incentive receivables, current and long term, totaled approximately
$0.2 million at March 31, 2020.
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 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, 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: 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, 2019, as filed with the SEC on March 16, 2020 and as may be updated
by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the SEC. 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
President & Chief Executive Officer
Leap Therapeutics, Inc.
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Operations |
| (in thousands, except share and per share amounts) |
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| License revenue | $ | 375 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 4,603 | 6,790 | ||||||
| General and administrative | 2,153 | 2,005 | ||||||
| Total operating expenses | 6,756 | 8,795 | ||||||
| Loss from operations | (6,381 | ) | (8,795 | ) | ||||
| Interest income | 68 | 82 | ||||||
| Interest expense | (12 | ) | (7 | ) | ||||
| Australian research and development incentives | 85 | 75 | ||||||
| Foreign currency gains (loss) | (991 | ) | 42 | |||||
| Net loss | (7,231 | ) | (8,603 | ) | ||||
| Dividend attributable to down round feature of warrants | (303 | ) | (359 | ) | ||||
| Dividend attributable to Series A & B convertible preferred stock | (372 | ) | - | |||||
| Series A & B convertible preferred stock - beneficial conversion feature | (9,399 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (17,305 | ) | $ | (8,962 | ) | ||
| Net loss per share | ||||||||
| Basic | $ | (0.55 | ) | $ | (0.47 | ) | ||
| Diluted | $ | (0.55 | ) | $ | (0.47 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic | 31,632,213 | 19,237,444 | ||||||
| Diluted | 31,632,213 | 19,237,444 |
| Leap Therapeutics, Inc. |
| Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share amounts) |
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,465 | $ | 3,891 | ||||
| Research and development incentive receivable | 247 | 185 | ||||||
| Prepaid expenses and other current assets | 272 | 165 | ||||||
| Total current assets | 25,984 | 4,241 | ||||||
| Property and equipment, net | 114 | 124 | ||||||
| Right of use assets | 835 | 1,026 | ||||||
| Deferred tax assets | 112 | 127 | ||||||
| Deferred costs | 623 | 831 | ||||||
| Deposits | 1,074 | 1,099 | ||||||
| Total assets | $ | 28,742 | $ | 7,448 | ||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,933 | $ | 4,571 | ||||
| Accrued expenses | 2,387 | 3,441 | ||||||
| Deferred revenue - current portion | 1,500 | - | ||||||
| Lease liability - current portion | 379 | 474 | ||||||
| Total current liabilities | 9,199 | 8,486 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | - | 159 | ||||||
| Deferred revenue, net of current portion | 1,125 | - | ||||||
| Lease liability, net of current portion | 454 | 552 | ||||||
| Total liabilities | 10,778 | 9,197 | ||||||
| Stockholders' equity (deficiency): | ||||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized, 35,799,488 and 24,194,877 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 36 | 24 | ||||||
| Additional paid-in capital | 219,642 | 193,319 | ||||||
| Accumulated other comprehensive income | 988 | 76 | ||||||
| Accumulated deficit | (202,702 | ) | (195,168 | ) | ||||
| Total stockholders' equity (deficiency) | 17,964 | (1,749 | ) | |||||
| Total liabilities and stockholders' equity (deficiency) | $ | 28,742 | $ | 7,448 |
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Cash Flows |
| (in thousands) |
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Cash used in operating activities | $ | (3,926 | ) | $ | (6,868 | ) | ||
| Cash provided by financing activities | 25,605 | 12,322 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (105 | ) | (29 | ) | ||||
| Net increase in cash and cash equivalents | 21,574 | 5,425 | ||||||
| Cash and cash equivalents at beginning of period | 3,891 | 16,284 | ||||||
| Cash and cash equivalents at end of period | $ | 25,465 | $ | 21,709 |