Full Press Release Details
Leap Therapeutics Reports First Quarter 2025
MA - May 13, 2025 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today reported financial results for the first quarter of 2025.
"In the first quarter of 2025, sirexatamab,
our novel anti-DKK1 antibody, continued to demonstrate encouraging efficacy, including statistically significant higher ORR and longer
PFS in both DKK1-high and VEGF-na ve second-line CRC patients. With 42 patients currently remaining on study drug, 25 in the sirexatamab
arm and 17 in the control arm, we continue to be optimistic about the maturing dataset in the full population and look forward to upcoming
data updates this quarter," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "In this difficult market
environment, we focused our resources to position Leap to advance sirexatamab in CRC and FL-501 preclinically in order to provide the
greatest value for our shareholders. I would like to personally thank all of our colleagues who have been impacted by this decision and
express my appreciation for their contributions and dedication to provide meaningful new treatment options to cancer patients."
DKN-01 Development Update
Selected First Quarter 2025 Financial Results
Net Loss was $15.4 million for the first quarter
2025, compared to $13.8 million for the first quarter 2024. The increase was primarily due to an increase in research and development
Research and development expenses were $12.9 million
for the first quarter of 2025, compared to $11.3 million for the same period in 2024. The increase was primarily due to an increase of
$1.4 million in clinical trial costs due to the expansion of the size of Part B of the DeFianCe study and the increase in activity
associated with the end of Part C of the DisTinGuish study. There was also an increase of $0.1 million in manufacturing costs related
to clinical trial material and manufacturing campaigns and an increase of $0.1 million in consulting fees associated with research and
development activities.
General and administrative expenses were $3.0
million for the first quarter 2025, compared to $3.5 million for the same period in 2024. The decrease was primarily due to a $0.4 million
decrease in professional fees and a $0.1 million decrease in stock based compensation expense.
Cash and cash equivalents totaled $32.7 million at March 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, including sirexatamab
and FL-501; 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 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 FL-501; (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; (vi) exposure
to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities; (vii) Leap's
ability to regain compliance with the Nasdaq Capital Market listing criteria; and (viii) Leap's ability to remain a going concern.
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
President & Chief Executive Officer
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Consolidated Statements of Operations
thousands, except share and per share amounts)
| (Unaudited) | ||||||||
| Three Months Ended March 31 | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 12,911 | $ | 11,299 | ||||
| General and administrative | 3,006 | 3,526 | ||||||
| Total operating expenses | 15,917 | 14,825 | ||||||
| Loss from operations | (15,917 | ) | (14,825 | ) | ||||
| Interest income | 437 | 775 | ||||||
| Interest expense | (6 | ) | - | |||||
| Australian research and development incentives | 55 | 246 | ||||||
| Foreign currency loss | (4 | ) | (16 | ) | ||||
| Net loss | $ | (15,435 | ) | $ | (13,820 | ) | ||
| Net loss per share | ||||||||
| Basic and Diluted | $ | (0.37 | ) | $ | (0.51 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic and diluted | 41,268,894 | 27,014,100 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
thousands, except share and per share amounts)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 32,713 | $ | 47,249 | ||||
| Research and development incentive receivable | 711 | 704 | ||||||
| Prepaid expenses and other current assets | 446 | 86 | ||||||
| Total current assets | 33,870 | 48,039 | ||||||
| Right of use assets, net | 152 | 262 | ||||||
| Research and development incentive receivable, net of current portion | 55 | - | ||||||
| Deposits | 802 | 823 | ||||||
| Total assets | $ | 34,879 | $ | 49,124 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,357 | $ | 4,743 | ||||
| Accrued expenses | 6,992 | 8,536 | ||||||
| Income tax payable | 536 | 531 | ||||||
| Lease liability - current portion | 154 | 266 | ||||||
| Total current liabilities | 14,039 | 14,076 | ||||||
| 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; 41,439,529 and 38,329,894 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | 41 | 38 | ||||||
| Additional paid-in capital | 503,718 | 502,501 | ||||||
| Accumulated other comprehensive loss | (113 | ) | (120 | ) | ||||
| Accumulated deficit | (482,806 | ) | (467,371 | ) | ||||
| Total stockholders' equity | 20,840 | 35,048 | ||||||
| Total liabilities and stockholders' equity | $ | 34,879 | $ | 49,124 |
Consolidated Statements of Cash Flows
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash used in operating activities | $ | (14,480 | ) | $ | (15,516 | ) | ||
| Cash provided by (used in) financing activities | (61 | ) | 29 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 5 | (235 | ) | |||||
| Net decrease in cash and cash equivalents | (14,536 | ) | (15,722 | ) | ||||
| Cash and cash equivalents at beginning of period | 47,249 | 70,643 | ||||||
| Cash and cash equivalents at end of period | $ | 32,713 | $ | 54,921 |