Full Press Release Details
Leap Therapeutics Reports Fourth Quarter and
Full Year 2024 Financial Results
Leap to host a conference call to present updated
CRC clinical data today, March 26, 2025, at 8:00 a.m. ET
MA - March 26, 2025 - 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, 2024.
2024, we continued to advance sirexatamab, our anti-DKK1 antibody, through Phase 2 randomized controlled clinical trials as part of our
mission to bring personalized medicines to patients fighting against cancer. In particular, the updated data from Part B of the DeFianCe
study that we announced today demonstrated significantly higher ORR and longer PFS for sirexatamab in patients who have high levels of
DKK1 or who have not had prior anti-VEGF therapy, two exploratory populations with strong scientific rationale that each represent 25-50%
of the second-line CRC market," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We believe that there
is a compelling opportunity to move forward with a registrational study for sirexatamab in patients with CRC and to advance FL-501 towards
DKN-01 Development Update
The strong signal from the DeFianCe
study supports a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC
patients with high DKK1 levels or in patients who have not received prior anti-VEGF therapy.
With approximately 30,000 second-line
treated CRC patients in the US and 160,000 in the next 7 largest markets, sirexatamab has a large market opportunity in the 25-50% of
patients who have high DKK1 levels or in the approximately 50% of patients who did not receive prior anti-VEGF therapy. In addition, the
outcomes in patients with no prior anti-VEGF therapy provides an opportunity to move into treating first-line CRC patients, where there
are an estimated 45,000 patients in the US and 265,000 in the next 7 largest markets who receive therapy for their advanced disease.
Leap has engaged a leading financial
advisor to explore business development opportunities to further the development of sirexatamab.
Selected Year-End and Fourth Quarter 2024 Financial Results
Net Loss was $67.6 million for the year ended
December 31, 2024, compared to $81.4 million for the year ended December 31, 2023. The decrease was primarily due to a decrease
in research and development expenses.
Research and development expenses were $57.2 million
for the full year 2024, compared to $73.2 million for the same period in 2023. Research and development expenses were $13.1 million for
the fourth quarter ended 2024, compared to $11.7 million for the same period in 2023. The decreases for the full year 2024 were primarily
due to in-process research and development acquired in the Flame merger which were expensed in the year ended December 31, 2023.
General and administrative expenses were $12.8
million for the full year 2024, compared to $13.8 million for the same period in 2023. General and administrative expenses were $3.0 million
for the fourth quarter ended 2024, compared to $3.1 million for the same period in 2023. The decreases for the full year 2024 were primarily
due to a decrease in professional fees due to lower finance and legal costs.
Cash and cash equivalents totaled $47.2 million at December 31,
About Leap Therapeutics
Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate,
sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients
with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation
factor 15 (GDF-15) protein, in preclinical development. 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.
All statements, other than historical facts, including
statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the size of the
potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely
to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy; the anticipated timing for initiation
or 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) the results of Leap's clinical
trials and pre-clinical studies, including whether the final data from Part B of the DeFianCe study or Part C of the DisTinGuish
study are the same as the initial data reported, (ii) the actual size of the potential addressable market for sirexatamab, including
the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are
likely not to have prior anti-VEGF therapy, may be smaller than estimated, (iii) Leap's ability to successfully finance or enter
into new strategic partnerships for sirexatamab or any of its other programs; (iv) any regulatory feedback that Leap may receive
from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the registrational
Phase III clinical trials that Leap proposes to conduct using sirexatamab for the treatment of patients with second-line CRC
or with respect to any other pre-clinical or clinical development activities that Leap will be required to conduct in order to obtain
regulatory approval of sirexatamab for the treatment of second-line CRC; (v) whether any Leap products will receive approval
from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations,
as well as fluctuations in the market price of Leap's traded securities. 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 a 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.
Leap Therapeutics, Inc
Consolidated Statement of Operations
| 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 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 57,211 | $ | 73,234 | $ | 13,112 | $ | 11,685 | ||||||||
| General and administrative | 12,846 | 13,807 | 3,013 | 3,135 | ||||||||||||
| Total operating expenses | 70,057 | 87,041 | 16,125 | 14,820 | ||||||||||||
| Loss from operations | (70,057 | ) | (87,041 | ) | (16,125 | ) | (14,820 | ) | ||||||||
| Interest income | 3,129 | 4,027 | 595 | 938 | ||||||||||||
| Australian research and development incentives | - | 1,101 | - | (23 | ) | |||||||||||
| Other income | - | 500 | - | 500 | ||||||||||||
| Foreign currency gain (loss) | (42 | ) | (13 | ) | (24 | ) | 940 | |||||||||
| Change in fair value of Series X preferred stock warrant liability | - | 12 | - | - | ||||||||||||
| Loss before income taxes | (66,970 | ) | (81,414 | ) | (15,554 | ) | (12,465 | ) | ||||||||
| Provision for (benefit from) income taxes | (585 | ) | - | 123 | - | |||||||||||
| Net loss | (67,555 | ) | (81,414 | ) | (15,431 | ) | (12,465 | ) | ||||||||
| Dividend attributable to common stockholders | (234 | ) | - | - | - | |||||||||||
| Net loss attributable to common stockholders | $ | (67,789 | ) | $ | (81,414 | ) | $ | (15,431 | ) | $ | (12,465 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic and Diluted | $ | (1.81 | ) | $ | (3.98 | ) | $ | (0.37 | ) | $ | (0.46 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic and diluted | 37,550,677 | 20,445,109 | 41,252,022 | 26,987,182 |
Leap Therapeutics, Inc
Consolidated Balance Sheet
| Leap Therapeutics, Inc. |
| Consolidated Balance Sheets |
| (in thousands, except share and per share amounts) |
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,249 | $ | 70,643 | ||||
| Research and development incentive receivable | 704 | 771 | ||||||
| Prepaid expenses and other current assets | 86 | 183 | ||||||
| Total current assets | 48,039 | 71,597 | ||||||
| Property and equipment, net | - | 5 | ||||||
| Right of use assets, net | 262 | 257 | ||||||
| Deposits | 823 | 966 | ||||||
| Total assets | $ | 49,124 | $ | 72,825 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,743 | $ | 6,465 | ||||
| Accrued expenses | 8,536 | 5,957 | ||||||
| Income tax payable | 531 | - | ||||||
| Lease liability - current portion | 266 | 262 | ||||||
| Total current liabilities | 14,076 | 12,684 | ||||||
| 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; 38,329,894 and 25,565,414 shares issued and outstanding as of December 31, 2024 and 2023, respectively | 38 | 26 | ||||||
| Additional paid-in capital | 502,501 | 459,591 | ||||||
| Accumulated other comprehensive (loss) income | (120 | ) | 106 | |||||
| Accumulated deficit | (467,371 | ) | (399,582 | ) | ||||
| Total stockholders' equity | 35,048 | 60,141 | ||||||
| Total liabilities and stockholders' equity | $ | 49,124 | $ | 72,825 |
Leap Therapeutics, Inc
Consolidated Statement of Cash Flows
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Cash Flows |
| (in thousands) |
| (Unaudited) | ||||||||||||||||
| Year Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Cash used in operating activities | $ | (60,299 | ) | $ | (43,753 | ) | $ | (15,512 | ) | $ | (10,380 | ) | ||||
| Cash provided by investing activities | - | 48,969 | - | - | ||||||||||||
| Cash provided by (used in) financing activities | 37,184 | (30 | ) | 104 | - | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (279 | ) | (43 | ) | (166 | ) | 280 | |||||||||
| Net increase (decrease) in cash and cash equivalents | $ | (23,394 | ) | $ | 5,143 | (15,574 | ) | (10,100 | ) | |||||||
| Cash and cash equivalents at beginning of period | 70,643 | 65,500 | 62,823 | 80,743 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 47,249 | $ | 70,643 | $ | 47,249 | $ | 70,643 |