Full Press Release Details
Leap Therapeutics Reports Fourth Quarter and
Full Year 2022 Financial Results
MA - March 24, 2023 - 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, 2022.
"Over the past year, we advanced DKN-01,
our anti-DKK1 antibody, into its first randomized controlled clinical trial in gastric cancer, entered into the new indication of colorectal
cancer, and facilitated an endometrial cancer investigator-sponsored trial. We enhanced Leap's pipeline and financial strength
through the acquisition of Flame Biosciences, which included FL-301, a clinical stage anti-Claudin18.2 antibody, preclinical programs
targeting Claudin18.2/CD137 and GDF15, as well as approximately $50 million in cash," said Douglas E. Onsi, President and Chief
Executive Officer of Leap. "In 2023, we are focused on executing our development plan for DKN-01 by completing enrollment in Part
C of the DisTinGuish study and Part A of the DeFianCe study, with the objective of presenting new data over the course of the year and
identifying a new strategic partner as data is generated. Our plan for our Claudin18.2 and GDF15 programs is to generate additional preclinical
data to differentiate these antibodies from their competitors and to prepare for future clinical trials, while our collaborator continues
a monotherapy study of FL-301 in China. We are looking forward and fully committed to our mission to acquire and develop a pipeline of
biomarker-focused antibody therapies for cancer patients."
DKN-01 Development Update
Selected Year-End and Fourth Quarter 2022 Financial Results
Net Loss was $54.6 million for the year ended
December 31, 2022, compared to $40.6 million for the year ended December 31, 2021. The increase was primarily due to increased research
and development expenses and general and administrative expenses, partially offset by an increase in interest income and increase in
research and development incentive income.
There were no license revenues for the year ended
December 31, 2022, compared to $1.5 million for the year ended December 31, 2021. The upfront payment was recognized in full as of December
31, 2021 for the agreement with BeiGene.
Research and development expenses were $45.0
million for the full year 2022, compared to $32.2 million for the same period in 2021. Research and development expenses were $11.0 million
for the fourth quarter ended 2022, compared to $8.1 million for the same period in 2021. 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 and duration of patients on study, an increase in payroll and other related expenses due to an increase
in headcount of research and development full time employees, and an increase in stock based compensation expense.
General and administrative expenses were $11.8
million for the full year 2021, compared to $10.8 million for the same period in 2021. General and administrative expenses were $2.9
million for the fourth quarter ended 2022, compared to $2.8 million for the same period in 2021. 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 stock based compensation expense.
Cash and cash equivalents totaled $65.5 million
at December 31, 2022, which excludes the approximately $50 million cash received from the Flame Biosciences acquisition. Research and
development incentive receivables totaled $2.1 million at December 31, 2022.
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 being developed in patients with esophagogastric,
gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with
gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. 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 the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management
of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements.
The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will
be achieved. Words such as "anticipate," "expect," "project," "intend," "believe,"
"may," "will," "should," "plan," "could," "continue," "target,"
"contemplate," "estimate," "forecast," "guidance," "predict," "possible,"
"potential," "pursue," "likely," and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify forward-looking statements.
statements, other than historical facts, including statements regarding the continuation over time of the clinical collaboration with
BeiGene on the ongoing Part C of the DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the expected benefits
of the merger with Flame Biosciences; the cash runway into mid-2025 and the sufficiency of Leap's cash, cash equivalents and
short-term investments to fund operations; stockholder approval of the conversion rights of the Series X Non-Voting Convertible Preferred
Stock; the anticipated timing for initiation of or success of enrollment in clinical trials and release of clinical data, and any outcomes
of such trials; the potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future
preclinical and clinical development plans in connection with our programs; the ability to enter into a new strategic partnership for
DKN-01 or any of Leap's other programs; the ability of NovaRock Biotherapeutics to conduct the FL-301 clinical trial in China;
and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results
to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability
to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's
clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01
or any of its other programs; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration
or equivalent foreign regulatory agencies; (v) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations
in the market price of Leap's traded securities; (vi) 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; (vii) Leap's ability to successfully integrate the Flame operations and realize the anticipated
benefits of the acquisition of Flame; (viii) whether Leap's stockholders approve the conversion of the Series X Non-Voting Convertible
Preferred Stock; (ix) whether Leap's cash resources will be sufficient to fund Leap's continuing operations and the newly
acquired Flame operations, including the liabilities of Flame incurred in connection with the completion of the merger; and (x) Leap's
ability to comply with the continued listing requirements of the Nasdaq Global Market. New risks and uncertainties may emerge from time
to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or Implied) are made
about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking
statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to
a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors"
in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties,
and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which
it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise
any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof.
President & Chief Executive Officer
Leap Therapeutics, Inc.
Statements of Operations
thousands, except share and per share amounts)
| (Unaudited) | ||||||||||||||||
| Year Ended December 31 | Three Months Ended December 31 | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| License revenue | $ | - | $ | 1,500 | $ | - | $ | 375 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 44,965 | 32,160 | 11,034 | 8,070 | ||||||||||||
| General and administrative | 11,798 | 10,766 | 2,909 | 2,793 | ||||||||||||
| Total operating expenses | 56,763 | 42,926 | 13,943 | 10,863 | ||||||||||||
| Loss from operations | (56,763 | ) | (41,426 | ) | (13,943 | ) | (10,488 | ) | ||||||||
| Interest income | 925 | 9 | 521 | 5 | ||||||||||||
| Interest expense | (54 | ) | (41 | ) | (5 | ) | (2 | ) | ||||||||
| Australian research and development incentives | 2,051 | 1,226 | 775 | (358 | ) | |||||||||||
| Foreign currency loss | (608 | ) | (379 | ) | 697 | 31 | ||||||||||
| Loss before income taxes | (54,449 | ) | (40,611 | ) | (11,955 | ) | (10,812 | ) | ||||||||
| Benefit from (provision for) income taxes | (147 | ) | 24 | (147 | ) | 24 | ||||||||||
| Net loss attributable to common stockholders | $ | (54,596 | ) | $ | (40,587 | ) | $ | (12,102 | ) | $ | (10,788 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.48 | ) | $ | (0.47 | ) | $ | (0.11 | ) | $ | (0.10 | ) | ||||
| Diluted | $ | (0.48 | ) | $ | (0.47 | ) | $ | (0.11 | ) | $ | (0.10 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 113,239,092 | 85,825,283 | 113,239,092 | 113,107,809 | ||||||||||||
| Diluted | 113,239,092 | 85,825,283 | 113,239,092 | 113,107,809 |
thousands, except share and per share amounts)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 65,500 | $ | 114,916 | ||||
| Research and development incentive receivable | 2,099 | 1,189 | ||||||
| Prepaid expenses and other current assets | 351 | 769 | ||||||
| Total current assets | 67,950 | 116,874 | ||||||
| Property and equipment, net | 20 | 36 | ||||||
| Right of use assets, net | 669 | 459 | ||||||
| Deferred tax assets, net | - | 159 | ||||||
| Deferred costs | 576 | - | ||||||
| Other long term assets | 30 | 90 | ||||||
| Deposits | 1,108 | 293 | ||||||
| Total assets | $ | 70,353 | $ | 117,911 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,657 | $ | 4,189 | ||||
| Accrued expenses | 5,152 | 5,366 | ||||||
| Lease liability - current portion | 416 | 432 | ||||||
| Total current liabilities | 11,225 | 9,987 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 262 | 37 | ||||||
| Total liabilities | 11,487 | 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 December 31, 2022 and 2021,respectively | 99 | 88 | ||||||
| Additional paid-in capital | 376,807 | 371,638 | ||||||
| Accumulated other comprehensive income (loss) | 128 | (267 | ) | |||||
| Accumulated deficit | (318,168 | ) | (263,572 | ) | ||||
| Total stockholders' equity | 58,866 | 107,887 | ||||||
| Total liabilities and stockholders' equity | $ | 70,353 | $ | 117,911 |
Condensed Consolidated
Statements of Cash Flows
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cash used in operating activities | $ | (49,044 | ) | $ | (35,157 | ) | $ | (13,014 | ) | $ | (10,716 | ) | ||||
| Cash provided by (used in) financing activities | (210 | ) | 98,035 | - | 755 | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (162 | ) | (33 | ) | 206 | 106 | ||||||||||
| Net increase (decrease) in cash and cash equivalents | $ | (49,416 | ) | $ | 62,845 | (12,808 | ) | (9,855 | ) | |||||||
| Cash and cash equivalents at beginning of period | 114,916 | 52,071 | 78,308 | 124,771 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 65,500 | $ | 114,916 | $ | 65,500 | $ | 114,916 |