Full Press Release Details
Leap Therapeutics Reports First Quarter 2022
CAMBRIDGE, Mass., May 13, 2022 -
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, 2022.
"We are making consistent progress in advancing
DKN-01 across multiple tumor types and look forward to Dr. David Wise of New York University presenting initial prostate cancer data at
the upcoming ASCO conference," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "With compelling response
and survival data for DKN-01 in combination with BeiGene's tislelizumab in gastric cancer patients presented in January, and the
recent completion of enrollment in our second-line cohort, we are preparing for updated data readouts from our DisTinGuish study in the
second half of the year. We are also looking forward to hosting an R&D Day in late June to outline the next phase in the clinical
development strategy for 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 First Quarter 2022 Financial Results
Net Loss was $10.4 million for the first
quarter 2022, compared to $9.1 million for the same period in 2021. The increase was primarily due to an increase in clinical
trial costs due to the timing of 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.
License revenues were $0.4 million for the first
quarter 2021 and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia,
and New Zealand. There were no license revenues recognized in the first quarter 2022, as the upfront payment was fully recognized
as of December 31, 2021.
Research and development expenses were $7.8 million for
the first quarter 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses
was due to an increase of $0.6 million in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, an increase
of $0.6 million in payroll and other related expenses, and an increase of $0.2 million in stock based compensation expense during the
three months ended March 31, 2022. These increases were partially offset by a $0.4 million decrease in manufacturing costs related to
clinical trial material due to timing of manufacturing campaigns.
General and administrative expenses were $2.8
million for the first quarter 2022, compared to $2.7 million for the same period in 2021. The increase in general and administrative
expenses was due an increase of a $0.2 million in stock based compensation expense and an increase of $0.1 million in payroll and other
related expenses during the three months ended March 31, 2022. These increases were partially offset by a $0.2 million decrease in professional
Cash and cash equivalents totaled $103.2
million at March 31, 2022. Research and development incentive receivables totaled $1.3 million at March 31, 2022.
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 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, 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; 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 events.
President & Chief Executive Officer
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| (Unaudited) | ||||||||
| Three Months Ended March 31 | ||||||||
| 2022 | 2021 | |||||||
| License revenue | $ | - | $ | 375 | ||||
| Operating expenses: | ||||||||
| Research and development | 7,784 | 6,807 | ||||||
| General and administrative | 2,848 | 2,740 | ||||||
| Total operating expenses | 10,632 | 9,547 | ||||||
| Loss from operations | (10,632 | ) | (9,172 | ) | ||||
| Interest income | 5 | 2 | ||||||
| Interest expense | (21 | ) | (14 | ) | ||||
| Australian research and development incentives | 37 | 71 | ||||||
| Foreign currency gain (loss) | 235 | (21 | ) | |||||
| Net loss attributable to common stockholders | (10,376 | ) | (9,134 | ) | ||||
| Net loss per share | ||||||||
| Basic | $ | (0.09 | ) | $ | (0.12 | ) | ||
| Diluted | $ | (0.09 | ) | $ | (0.12 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic | 113,248,937 | 76,378,569 | ||||||
| Diluted | 113,248,937 | 76,378,569 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 103,220 | $ | 114,916 | ||||
| Research and development incentive receivable | 1,233 | 1,189 | ||||||
| Prepaid expenses and other current assets | 491 | 769 | ||||||
| Total current assets | 104,944 | 116,874 | ||||||
| Property and equipment, net | 32 | 36 | ||||||
| Right of use assets, net | 355 | 459 | ||||||
| Research and development incentive receivable, net of current portion | 38 | - | ||||||
| Deferred tax assets | 164 | 159 | ||||||
| Other long term assets | 75 | 90 | ||||||
| Deposits | 293 | 293 | ||||||
| Total assets | $ | 105,901 | $ | 117,911 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,287 | $ | 4,189 | ||||
| Accrued expenses | 2,694 | 5,366 | ||||||
| Lease liability - current portion | 363 | 432 | ||||||
| Total current liabilities | 7,344 | 9,987 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | - | 37 | ||||||
| Total liabilities | 7,344 | 10,024 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 88,318,454 shares issued and outstanding as of March 31, 2022 and December 31, 2021 | 88 | 88 | ||||||
| Additional paid-in capital | 372,842 | 371,638 | ||||||
| Accumulated other comprehensive loss | (425 | ) | (267 | ) | ||||
| Accumulated deficit | (273,948 | ) | (263,572 | ) | ||||
| Total stockholders' equity | 98,557 | 107,887 | ||||||
| Total liabilities and stockholders' equity | $ | 105,901 | $ | 117,911 |
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash used in operating activities | $ | (11,518 | ) | $ | (8,587 | ) | ||
| Cash provided by (used in) financing activities | (210 | ) | 14 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 32 | (7 | ) | |||||
| Net decrease in cash and cash equivalents | (11,696 | ) | (8,580 | ) | ||||
| Cash and cash equivalents at beginning of period | 114,916 | 52,071 | ||||||
| Cash and cash equivalents at end of period | $ | 103,220 | $ | 43,491 |