Full Press Release Details
Leap Therapeutics Reports Third Quarter 2022
Mass., November 14, 2022 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial results for the third quarter ended September 30, 2022.
"This past quarter saw incredible progress
across our DKN-01 program as we continue to focus on execution in our clinical, preclinical, biomarker, and manufacturing activities,
and advance into the next stages of development," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Results
from Parts A and B of the DisTinGuish trial have been compelling with updated data presented at both ESMO and SITC. We were also delighted
to announce the enrollment of the first patients into both Part C of the DisTinGuish gastric cancer study and the newly-initiated
DeFianCe colorectal cancer trial, as we explore the broad therapeutic potential of DKN-01."
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that
binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways,
which play 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 natural killer (NK) cell ligands on tumor cells.
Selected Third Quarter 2022 Financial Results
Net Loss was $15.1 million for the third quarter
2022, compared to $11.1 million for the three months ended September 30, 2021.
Research and development expenses were $12.1
million for the three months ended September 30, 2022, compared to $10.1 million for the three months ended September 30, 2021.
The increase of $2.0 million in research and development expenses was due to an increase of $1.4 million in clinical trial costs due
to patient enrollment and the duration of patients on study, an increase of $0.4 million in payroll and other related expenses due to
increased headcount, and an increase of $0.2 million in stock-based compensation expense.
General and administrative expenses were $3.2
million for the three months ended September 30, 2022, compared to $2.4 million for the three months ended September 30, 2021.
The increase of $0.8 million in general and administrative expenses were due to an increase of $0.5 million in professional fees due
to higher recruiting costs and an increase of $0.2 million in payroll and other related expenses due to an increase in headcount.
Cash and cash equivalents totaled $78.3 million
at September 30, 2022. Additionally, short-term research and development incentive receivable totaled $1.3 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. DKN-01 is in clinical trials in patients with esophagogastric,
colorectal, and gynecologic cancers. Leap has entered into a strategic collaboration 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 clinical studies, potential for the receipt of future option exercise, milestone, or royalty payments from BeiGene,
financial runway, 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 the ongoing COVID-19 related issues, global conflict or supply chain
related issues; unstable global market and economic conditions; the accuracy of our estimates regarding expenses, future revenues, capital
requirements and needs for financing; our ability to maintain compliance with the listing requirements of the Nasdaq Global Market; 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 is 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, 2021, as filed with the SEC on March 11,
2022 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.
Consolidated Statements of Operations
thousands, except share and per share amounts)
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| License revenue | $ | - | $ | 375 | $ | - | $ | 1,125 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 12,102 | 10,077 | 33,931 | 24,090 | ||||||||||||
| General and administrative | 3,186 | 2,438 | 8,889 | 7,973 | ||||||||||||
| Total operating expenses | 15,288 | 12,515 | 42,820 | 32,063 | ||||||||||||
| Loss from operations | (15,288 | ) | (12,140 | ) | (42,820 | ) | (30,938 | ) | ||||||||
| Interest income | 360 | 1 | 404 | 4 | ||||||||||||
| Interest expense | (11 | ) | (9 | ) | (49 | ) | (39 | ) | ||||||||
| Australian research and development incentives | 652 | 1,269 | 1,276 | 1,584 | ||||||||||||
| Foreign currency loss | (807 | ) | (260 | ) | (1,305 | ) | (410 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (15,094 | ) | $ | (11,139 | ) | $ | (42,494 | ) | $ | (29,799 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic & diluted | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.38 | ) | $ | (0.39 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic & diluted | 113,239,092 | 78,218,774 | 113,239,092 | 76,631,172 |
thousands, except share and per share amounts)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 78,308 | $ | 114,916 | ||||
| Research and development incentive receivable | 1,256 | 1,189 | ||||||
| Prepaid expenses and other current assets | 374 | 769 | ||||||
| Total current assets | 79,938 | 116,874 | ||||||
| Property and equipment, net | 24 | 36 | ||||||
| Right of use assets, net | 767 | 459 | ||||||
| Deferred tax assets | 142 | 159 | ||||||
| Other long term assets | 45 | 90 | ||||||
| Deposits | 1,249 | 293 | ||||||
| Total assets | $ | 82,165 | $ | 117,911 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,276 | $ | 4,189 | ||||
| Accrued expenses | 5,042 | 5,366 | ||||||
| Lease liability - current portion | 405 | 432 | ||||||
| Total current liabilities | 11,723 | 9,987 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 369 | 37 | ||||||
| Total liabilities | 12,092 | 10,024 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 99,021,376 and 88,318,454 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 99 | 88 | ||||||
| Additional paid-in capital | 375,350 | 371,638 | ||||||
| Accumulated other comprehensive income (loss) | 690 | (267 | ) | |||||
| Accumulated deficit | (306,066 | ) | (263,572 | ) | ||||
| Total stockholders' equity | 70,073 | 107,887 | ||||||
| Total liabilities and stockholders' equity | $ | 82,165 | $ | 117,911 |
Consolidated Statements of Cash Flows
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cash used in operating activities | $ | (12,253 | ) | $ | (8,102 | ) | $ | (36,030 | ) | $ | (24,441 | ) | ||||
| Cash provided by (used in) financing activities | - | 97,262 | (210 | ) | 97,280 | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (322 | ) | (123 | ) | (368 | ) | (139 | ) | ||||||||
| Net increase (decrease) in cash and cash equivalents | (12,575 | ) | 89,037 | (36,608 | ) | 72,700 | ||||||||||
| Cash and cash equivalents at beginning of period | 90,883 | 35,734 | 114,916 | 52,071 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 78,308 | $ | 124,771 | $ | 78,308 | $ | 124,771 |