Full Press Release Details
Leap Therapeutics Reports Second Quarter 2022
Mass., August 12, 2022 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial results for the second quarter ended June 30, 2022.
"The Company has made important steps during
the second quarter to expand the development of DKN-01 with the initiation of a randomized controlled clinical trial in combination with
BeiGene's tislelizumab and chemotherapy in first-line G/GEJ cancer patients. The results to date from Part A and B of our DisTinGuish
study have been compelling, and we look forward to further data readouts in the second half of the year," said Douglas E. Onsi,
President and Chief Executive Officer of Leap. "We are also excited to initiate a company-sponsored study in second-line colorectal
cancer patients and to support an investigator-initiated study with Merck's anti-PD-1 antibody pembrolizumab in endometrial cancer
patients, as part of a broad strategy for the global development of DKN-01."
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
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 NK cell ligands on tumor cells.
Selected Second Quarter 2022 Financial Results
Net Loss was $17.0 million for the second quarter
2022, compared to $9.5 million for the same period in 2021. The increase was primarily due to an increase in manufacturing costs related
to clinical trial material, an increase in clinical trial costs due to patient enrollment and the duration of patients on study in the
DisTinGuish trial and an increase in the number of research and development employees to support the development of DKN-01.
Research and development expenses were $14.0 million
for the three months ended June 30, 2022, compared to $7.2 million for the three months ended June 30, 2021. The increase in
research and development expenses was due to an increase of $5.2 million in manufacturing costs related to clinical trial material and
manufacturing campaigns, an increase of $1.2 million in clinical trial costs due to patient enrollment and duration of patients on study,
an increase of $0.4 million in payroll and other related expenses due to an increase in headcount of our research and development full
time employees, and an increase of $0.2 million in stock based compensation expense due to new stock options and restricted stock units
granted to research and development full time employees, offset by a decrease of $0.2 million in consulting fees.
General and administrative expenses were $2.9
million for the three months ended June 30, 2022, compared to $2.8 million for the three months ended June 30, 2021. The increase
in general and administrative expenses was due to an increase of $0.1 million in stock based compensation expense due to new stock options
and restricted stock units granted to general and administrative full time employees.
Cash and cash equivalents totaled $90.9 million
at June 30, 2022. Additionally, short-term research and development incentive receivable totaled $1.1 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. 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 COVID-19, 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;
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
President & Chief Executive Officer
Leap Therapeutics, Inc.
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Operations |
| (in thousands, except share and per share amounts) |
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| License revenue | $ | - | $ | 375 | $ | - | $ | 750 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 14,045 | 7,206 | 21,829 | 14,013 | ||||||||||||
| General and administrative | 2,855 | 2,795 | 5,703 | 5,535 | ||||||||||||
| Total operating expenses | 16,900 | 10,001 | 27,532 | 19,548 | ||||||||||||
| Loss from operations | (16,900 | ) | (9,626 | ) | (27,532 | ) | (18,798 | ) | ||||||||
| Interest income | 39 | 1 | 44 | 3 | ||||||||||||
| Interest expense | (17 | ) | (16 | ) | (38 | ) | (30 | ) | ||||||||
| Australian research and development incentives | 587 | 244 | 624 | 315 | ||||||||||||
| Foreign currency loss | (733 | ) | (129 | ) | (498 | ) | (150 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (17,024 | ) | $ | (9,526 | ) | $ | (27,400 | ) | $ | (18,660 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic & diluted | $ | (0.15 | ) | $ | (0.12 | ) | $ | (0.24 | ) | $ | (0.24 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic & diluted | 113,248,937 | 76,389,525 | 113,248,937 | 76,384,077 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 90,883 | $ | 114,916 | ||||
| Research and development incentive receivable | 1,130 | 1,189 | ||||||
| Prepaid expenses and other current assets | 428 | 769 | ||||||
| Total current assets | 92,441 | 116,874 | ||||||
| Property and equipment, net | 28 | 36 | ||||||
| Right of use assets, net | 863 | 459 | ||||||
| Research and development incentive receivable, net of current portion | 610 | - | ||||||
| Deferred tax assets | 150 | 159 | ||||||
| Other long term assets | 60 | 90 | ||||||
| Deposits | 51 | 293 | ||||||
| Total assets | $ | 94,203 | $ | 117,911 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,553 | $ | 4,189 | ||||
| Accrued expenses | 2,463 | 5,366 | ||||||
| Lease liability - current portion | 395 | 432 | ||||||
| Total current liabilities | 10,411 | 9,987 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 474 | 37 | ||||||
| Total liabilities | 10,885 | 10,024 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 88,318,454 shares issued and outstanding | 88 | 88 | ||||||
| Additional paid-in capital | 374,108 | 371,638 | ||||||
| Accumulated other comprehensive income (loss) | 94 | (267 | ) | |||||
| Accumulated deficit | (290,972 | ) | (263,572 | ) | ||||
| Total stockholders' equity | 83,318 | 107,887 | ||||||
| Total liabilities and stockholders' equity | $ | 94,203 | $ | 117,911 |
Leap Therapeutics, Inc.
Consolidated Statements of Cash Flows
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cash used in operating activities | $ | (12,259 | ) | $ | (7,752 | ) | $ | (23,777 | ) | $ | (16,339 | ) | ||||
| Cash provided by (used in) financing activities | - | 4 | (210 | ) | 18 | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (78 | ) | (9 | ) | (46 | ) | (16 | ) | ||||||||
| Net decrease in cash and cash equivalents | (12,337 | ) | (7,757 | ) | (24,033 | ) | (16,337 | ) | ||||||||
| Cash and cash equivalents at beginning of period | 103,220 | 43,491 | 114,916 | 52,071 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 90,883 | $ | 35,734 | $ | 90,883 | $ | 35,734 |