Full Press Release Details
Leap Therapeutics Reports Fourth Quarter and
Full Year 2023 Financial Results
MA - March 18, 2024 - 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, 2023.
"As we reflect on the fourth quarter and
the achievements of the past year, we are proud of the strides we've made in advancing DKN-01 and integrating our pipeline of earlier
stage biomarker-targeted antibody therapies. The data from Part A of the DeFianCe study, demonstrating a 30% overall response rate and
a 93% disease control rate in second-line colorectal cancer patients, showcases a strong foundation as we move into the randomized controlled
Part B of the study," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Additionally, the completion of
enrollment in Part C of the DisTinGuish study in first-line gastroesophageal junction and gastric cancer patients positions us to deliver
the first randomized controlled data for DKN-01 starting in the middle of the year. As we look ahead to a data rich 2024, we remain focused
on our mission to deliver new personalized medicines to patients fighting against cancer."
DKN-01 Development Update
The Company expects the 130 patient
randomized controlled Part B to complete enrollment in mid-2024. As of March 15, 2024, 80 patients have enrolled in Part B.
Selected Year-End and Fourth Quarter 2023 Financial Results
Net Loss was $81.4 million for the year ended
December 31, 2023, compared to $54.6 million for the year ended December 31, 2022. The increase was due to in-process research and development
acquired in the Flame merger which was expensed during the year ended December 31, 2023, costs incurred in connection with our research
and development programs, and from general and administrative costs associated with our operations.
Research and development expenses were $73.2 million
for the full year 2023, compared to $45.0 million for the same period in 2022. Research and development expenses were $11.7 million for
the fourth quarter ended 2023, compared to $11.0 million for the same period in 2022. The increases for the full year 2023 were primarily
due to in-process research and development acquired in the Flame merger, an increase in clinical trial costs, and an increase in payroll
and other related expenses due to an increase in headcount of research and development full-time employees.
General and administrative expenses were $13.8
million for the full year 2023, compared to $11.8 million for the same period in 2022. General and administrative expenses were $3.1 million
for the fourth quarter ended 2023, compared to $2.9 million for the same period in 2022. The increases for the full year 2023 were primarily
due to costs associated with our business development activities and an increase in payroll and other related expenses due to an increase
in headcount of general and administrative full-time employees.
Cash and cash equivalents totaled $70.6 million
at December 31, 2023. Research and development incentive receivables totaled $0.8 million at December 31, 2023.
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 potential safety, efficacy, and regulatory and clinical
progress of Leap's product candidates; the anticipated timing for completion of clinical trials and release of clinical trial data
and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of
Leap's product candidates; Leap's estimations of projected cash runway; 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 and to maintain its ongoing collaborations
with BeiGene, NovaRock and Adimab; (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; and (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 global conflict,
or supply chain related issues. 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.
Consolidated Statements
(in thousands, except
share and per share amounts)
| (Unaudited) | ||||||||||||||||
| Year Ended December 31 | Three Months Ended December 31 | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 73,234 | $ | 44,965 | $ | 11,685 | $ | 11,034 | ||||||||
| General and administrative | 13,807 | 11,798 | 3,135 | 2,909 | ||||||||||||
| Total operating expenses | 87,041 | 56,763 | 14,820 | 13,943 | ||||||||||||
| Loss from operations | (87,041 | ) | (56,763 | ) | (14,820 | ) | (13,943 | ) | ||||||||
| Interest income | 4,027 | 925 | 938 | 521 | ||||||||||||
| Interest expense | - | (54 | ) | - | (5 | ) | ||||||||||
| Australian research and development incentives | 1,101 | 2,051 | (23 | ) | 775 | |||||||||||
| Other income | 500 | - | 500 | - | ||||||||||||
| Foreign currency gain (loss) | (13 | ) | (608 | ) | 940 | 697 | ||||||||||
| Change in fair value of Series X preferred stock warrant liability | 12 | - | - | - | ||||||||||||
| Loss before income taxes | (81,414 | ) | (54,449 | ) | (12,465 | ) | (11,955 | ) | ||||||||
| Provision for income taxes | - | (147 | ) | - | (147 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (81,414 | ) | $ | (54,596 | ) | $ | (12,465 | ) | $ | (12,102 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic and Diluted | $ | (3.98 | ) | $ | (4.82 | ) | $ | (0.46 | ) | $ | (1.07 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic and diluted | 20,445,109 | 11,323,909 | 26,987,182 | 11,323,909 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,643 | $ | 65,500 | ||||
| Research and development incentive receivable | 771 | 2,099 | ||||||
| Prepaid expenses and other current assets | 183 | 351 | ||||||
| Total current assets | 71,597 | 67,950 | ||||||
| Property and equipment, net | 5 | 20 | ||||||
| Right of use assets, net | 257 | 669 | ||||||
| Deferred costs | - | 576 | ||||||
| Other long term assets | - | 30 | ||||||
| Deposits | 966 | 1,108 | ||||||
| Total assets | $ | 72,825 | $ | 70,353 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,465 | $ | 5,657 | ||||
| Accrued expenses | 5,957 | 5,152 | ||||||
| Lease liability - current portion | 262 | 416 | ||||||
| Total current liabilities | 12,684 | 11,225 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | - | 262 | ||||||
| Total liabilities | 12,684 | 11,487 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 25,565,414 and 9,902,137 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 26 | 10 | ||||||
| Additional paid-in capital | 459,591 | 376,896 | ||||||
| Accumulated other comprehensive income | 106 | 128 | ||||||
| Accumulated deficit | (399,582 | ) | (318,168 | ) | ||||
| Total stockholders' equity | 60,141 | 58,866 | ||||||
| Total liabilities and stockholders' equity | $ | 72,825 | $ | 70,353 |
Consolidated Statements of Cash Flows
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Cash used in operating activities | $ | (43,753 | ) | $ | (49,044 | ) | $ | (10,380 | ) | $ | (13,014 | ) | ||||
| Cash provided by investing activities | 48,969 | - | - | - | ||||||||||||
| Cash used in financing activities | (30 | ) | (210 | ) | - | - | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (43 | ) | (162 | ) | 280 | 206 | ||||||||||
| Net increase (decrease) in cash and cash equivalents | $ | 5,143 | $ | (49,416 | ) | (10,100 | ) | (12,808 | ) | |||||||
| Cash and cash equivalents at beginning of period | 65,500 | 114,916 | 80,743 | 78,308 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 70,643 | $ | 65,500 | $ | 70,643 | $ | 65,500 |