Full Press Release Details
Leap Therapeutics Reports First Quarter 2021
Cambridge, MA - May 14, 2021 -
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, 2021.
Leap First Quarter Highlights:
"We're off to a strong start this
year as we've continued to advance our understanding of DKN-01 and the potential role it can play as both a monotherapy or in combination
with existing treatments in multiple DKK1 biomarker defined cancer indications," said Douglas E. Onsi, President and Chief Executive
Officer of Leap. "The completion of enrollment of the first-line patient cohort in the DisTinGuish study brings us one step closer
to an important milestone for us with our partner BeiGene, anticipated later this year."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that
binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which
have an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity
of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.
Selected First Quarter 2021 Financial Results
Net Loss was $9.1 million for the first quarter
2021, compared to $7.2 million for the same period in 2020. This increase was primarily due to increased development activity for the
DKN-01 program and an increase in headcount and compensation expense as the Company has grown throughout the year.
License revenues for each of the first quarter
2021 and 2020 were $0.4 million, and relate to the BeiGene Agreement for the development and commercialization of DKN-01 in Asia (excluding
Japan), Australia, and New Zealand. The BeiGene Agreement became effective on January 3, 2020.
Research and development expenses were $6.8 million
for the first quarter 2021, compared to $4.6 million for the same period in 2020. The increase of $2.2 million in research and development
expenses was primarily due to an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our
research and development full time employees, an increase of $0.6 million in manufacturing costs related to clinical trial material and
an increase of $0.8 million in clinical trial costs due to timing of patient enrollment.
General and administrative expenses were $2.7
million for the first quarter 2021, compared to $2.2 million for the same period in 2020. The increase of $0.5 million in general and
administrative expenses was due to a $0.3 million increase in payroll and other related expenses during the three months ended March 31,
2021 as compared to the same period in 2020 and a $0.2 million increase in professional fees primarily due to increased recruiting and
information technology costs.
Cash and cash equivalents totaled $43.5 million
at March 31, 2021. Research and development incentive receivables totaled $0.02 million at March 31, 2021.
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. 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/.
RNAscope is a registered trademark
of Advanced Cell Diagnostics, Inc., Newark, CA, USA.
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 future option exercise, milestone, 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 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports Leap files from time to
time with the SEC. 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
(in thousands, except
share and per share amounts)
| (Unaudited) | ||||||||
| Three Months Ended March 31 | ||||||||
| 2021 | 2020 | |||||||
| License revenue | $ | 375 | $ | 375 | ||||
| Operating expenses: | ||||||||
| Research and development | 6,807 | 4,603 | ||||||
| General and administrative | 2,740 | 2,153 | ||||||
| Total operating expenses | 9,547 | 6,756 | ||||||
| Loss from operations | (9,172 | ) | (6,381 | ) | ||||
| Interest income | 2 | 68 | ||||||
| Interest expense | (14 | ) | (12 | ) | ||||
| Australian research and development incentives | 71 | 85 | ||||||
| Foreign currency gains | (21 | ) | (991 | ) | ||||
| Loss before income taxes | (9,134 | ) | (7,231 | ) | ||||
| Dividend attributable to down round feature of warrants | - | (303 | ) | |||||
| Dividends 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 | $ | (9,134 | ) | $ | (17,305 | ) | ||
| Net loss per share | ||||||||
| Basic & diluted | $ | (0.12 | ) | $ | (0.55 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic & diluted | 76,378,569 | 31,632,213 |
Leap Therapeutics, Inc.
Consolidated Balance
(in thousands, except
share and per share amounts)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,491 | $ | 52,071 | ||||
| Research and development incentive receivable | 22 | 73 | ||||||
| Prepaid expenses and other current assets | 266 | 130 | ||||||
| Total current assets | 43,779 | 52,274 | ||||||
| Property and equipment, net | 56 | 65 | ||||||
| Right of use assets, net | 433 | 528 | ||||||
| Research and development incentive receivable, net of current portion | 70 | - | ||||||
| Deferred tax assets | 178 | 179 | ||||||
| Deferred costs | 311 | 345 | ||||||
| Deposits | 980 | 980 | ||||||
| Total assets | $ | 45,807 | $ | 54,371 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,514 | $ | 2,717 | ||||
| Accrued expenses | 2,335 | 2,747 | ||||||
| Deferred revenue - current portion | 1,125 | 1,500 | ||||||
| Lease liability - current portion | 418 | 408 | ||||||
| Total current liabilities | 7,392 | 7,372 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | - | 204 | ||||||
| Lease liability, net of current portion | 36 | 144 | ||||||
| Total liabilities | 7,428 | 7,720 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 59,669,722 and 59,657,742 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 60 | 60 | ||||||
| Additional paid-in capital | 271,002 | 270,155 | ||||||
| Accumulated other comprehensive loss | (564 | ) | (579 | ) | ||||
| Accumulated deficit | (232,119 | ) | (222,985 | ) | ||||
| Total stockholders' equity | 38,379 | 46,651 | ||||||
| Total liabilities and stockholders' equity | $ | 45,807 | $ | 54,371 |
Leap Therapeutics, Inc.
Condensed Consolidated
Statements of Cash Flows
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash used in operating activities | $ | (8,587 | ) | $ | (3,926 | ) | ||
| Cash provided by financing activities | 14 | 25,605 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (7 | ) | (105 | ) | ||||
| Net increase (decrease) in cash and cash equivalents | (8,580 | ) | 21,574 | |||||
| Cash and cash equivalents at beginning of period | 52,071 | 3,891 | ||||||
| Cash and cash equivalents at end of period | $ | 43,491 | $ | 25,465 |