Full Press Release Details
Leap Therapeutics Reports Fourth Quarter and
Full Year 2021 Financial Results
MA - March 11, 2022 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2021.
| Presented positive new data from the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the ESMO Annual Congress and ASCO GI Cancers Symposium | ||
| Completed a $103.6 million public offering of common stock and pre-funded warrants to purchase common stock, resulting in net proceeds of $96.8 million | ||
| Entered partnership on companion diagnostic with Leica Biosystems to advance care for cancer patients | ||
| Presented clinical data from its Phase 2 clinical trial of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer |
"2021 was year of substantial clinical accomplishments
for Leap as we presented positive data from our DisTinGuish clinical trial, which demonstrated compelling efficacy driven by enhanced
clinical responses and survival benefit associated with high tumoral DKK1 expression that is independent of PD-L1 expression in patients
with first-line gastroesophageal junction (G/GEJ) cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap.
"Following our public offering, we are well funded to advance DKN-01 into the next stages of development in G/GEJ and other cancers,
and we look forward to presenting updated data from the DisTinGuish Study in the second half of 2022."
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 Year-End and Fourth Quarter 2021
Net Loss was $40.6 million for the year ended
December 31, 2021, compared to $27.5 million for the year ended December 31, 2020. The increase was primarily due to increased
research and development expenses and general and administrative expenses.
License revenues were $1.5 million for each of
the full years 2021 and 2020, and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding
Japan), Australia, and New Zealand. License revenues were $0.4 million for each of the fourth quarters 2021 and 2020.
and development expenses were $32.2 million for the full year 2021, compared to $20.4 million for the same period in 2020. Research and
development expenses were $8.1 million for the fourth quarter ended 2021, compared to $5.1 million for the same period in 2020. The
increases were primarily due to an increase in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns,
an increase in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, and an increase in payroll and other
related expenses due to an increase in headcount of research and development full time employees.
and administrative expenses were $10.8 million for the full year 2021, compared to $9.6 million for the same period in 2020. General and
administrative expenses were $2.8 million for the fourth quarter ended 2021, compared to $2.4 million for the same period in 2020. The
increases were primarily due to an increase in payroll and other related expenses due to an increase in headcount of general and administrative
full time employees and an increase in compensation expense.
Cash and cash equivalents totaled $114.9 million
at December 31, 2021. Research and development incentive receivables totaled $1.2 million at December 31, 2021.
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,
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) | ||||||||||||||||
| Year Ended December 31 | Three Months Ended December 31 | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| License revenue | $ | 1,500 | $ | 1,500 | $ | 375 | $ | 375 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 32,160 | 20,423 | 8,070 | 5,101 | ||||||||||||
| General and administrative | 10,766 | 9,616 | 2,793 | 2,428 | ||||||||||||
| Total operating expenses | 42,926 | 30,039 | 10,863 | 7,529 | ||||||||||||
| Loss from operations | (41,426 | ) | (28,539 | ) | (10,488 | ) | (7,154 | ) | ||||||||
| Interest income | 9 | 93 | 5 | 2 | ||||||||||||
| Interest expense | (41 | ) | (39 | ) | (2 | ) | 3 | |||||||||
| Australian research and development incentives | 1,226 | 231 | (358 | ) | (112 | ) | ||||||||||
| Foreign currency gains (losses) | (379 | ) | 738 | 31 | 549 | |||||||||||
| Loss before income taxes | (40,611 | ) | (27,516 | ) | (10,812 | ) | (6,712 | ) | ||||||||
| Income taxes | 24 | 2 | 24 | 2 | ||||||||||||
| Net loss | (40,587 | ) | (27,514 | ) | (10,788 | ) | (6,710 | ) | ||||||||
| Dividend attributable to down round feature of warrants | - | (303 | ) | - | - | |||||||||||
| 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 | $ | (40,587 | ) | $ | (37,588 | ) | $ | (10,788 | ) | $ | (6,710 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.47 | ) | $ | (0.63 | ) | $ | (0.10 | ) | $ | (0.09 | ) | ||||
| Diluted | $ | (0.47 | ) | $ | (0.63 | ) | $ | (0.10 | ) | $ | (0.09 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 85,825,283 | 59,327,713 | 113,107,809 | 76,376,160 | ||||||||||||
| Diluted | 85,825,283 | 59,327,713 | 113,107,809 | 76,376,160 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 114,916 | $ | 52,071 | ||||
| Research and development incentive receivable | 1,189 | 73 | ||||||
| Prepaid expenses and other current assets | 769 | 130 | ||||||
| Total current assets | 116,874 | 52,274 | ||||||
| Property and equipment, net | 36 | 65 | ||||||
| Right of use assets, net | 459 | 528 | ||||||
| Deferred tax assets | 159 | 179 | ||||||
| Deferred costs | - | 345 | ||||||
| Other long term assets | 90 | - | ||||||
| Deposits | 293 | 980 | ||||||
| Total assets | $ | 117,911 | $ | 54,371 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,189 | $ | 2,717 | ||||
| Accrued expenses | 5,366 | 2,747 | ||||||
| Deferred revenue - current portion | - | 1,500 | ||||||
| Lease liability - current portion | 432 | 408 | ||||||
| Total current liabilities | 9,987 | 7,372 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | - | 204 | ||||||
| Lease liability, net of current portion | 37 | 144 | ||||||
| Total liabilities | 10,024 | 7,720 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 88,318,454 and 59,657,742 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 88 | 60 | ||||||
| Additional paid-in capital | 371,638 | 270,155 | ||||||
| Accumulated other comprehensive loss | (267 | ) | (579 | ) | ||||
| Accumulated deficit | (263,572 | ) | (222,985 | ) | ||||
| Total stockholders' equity | 107,887 | 46,651 | ||||||
| Total liabilities and stockholders' equity | $ | 117,911 | $ | 54,371 |
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Cash used in operating activities | $ | (35,157 | ) | $ | (25,957 | ) | $ | (10,716 | ) | $ | (5,988 | ) | ||||
| Cash provided by investing activities | - | 25 | - | - | ||||||||||||
| Cash provided by financing activities | 98,035 | 73,997 | 755 | - | ||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (33 | ) | 115 | 106 | 84 | |||||||||||
| Net increase (decrease) in cash and cash equivalents | $ | 62,845 | $ | 48,180 | (9,855 | ) | (5,904 | ) | ||||||||
| Cash and cash equivalents at beginning of period | 52,071 | 3,891 | 124,771 | 57,975 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 114,916 | $ | 52,071 | $ | 114,916 | $ | 52,071 |