Full Press Release Details
Leap Therapeutics Reports Second Quarter 2025
Cambridge, MA - August 14, 2025 -
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today
reported financial results for the second quarter of 2025.
| Board of Directors initiated process of exploring strategic alternatives to maximize shareholder value | ||
| Strategic restructuring to prioritize corporate development resulting in a further 75% reduction in workforce | ||
| Reported updated data from the randomized, controlled Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) plus bevacizumab and chemotherapy in second-line colorectal cancer (CRC) |
"This past quarter, we undertook a strategic
realignment to focus our resources on corporate development opportunities for sirexatamab and FL-501," said Douglas E. Onsi, President
and CEO of Leap Therapeutics. "As part of this effort, we completed patient treatment in the DeFianCe trial, further reduced internal
expenses, and initiated a review of strategic alternatives to maximize value for our shareholders. We intend to provide a further update
in the coming weeks. We are grateful to all of our team members, and we thank them for their important contributions to Leap and their
commitment to developing new therapies for cancer patients."
DKN-01 Development Update
Selected Second Quarter 2025 Financial Results
Net Loss was $16.6 million for the second quarter
2025, compared to $20.4 million for the second quarter 2024. The decrease was primarily due to a decrease in research and development
and general and administrative expenses, offset in part by a restructuring charge associated with the reduction in force.
Research and development expenses were $10.5 million
for the second quarter of 2025, compared to $17.9 million for the same period in 2024. The decrease of $7.4 million was primarily due
to decreases of $3.9 million in clinical trial costs, $1.7 million in payroll and other headcount related expenses, $1.4 million in manufacturing
costs, and $0.4 million in stock-based compensation expense.
General and administrative expenses were $1.8
million for the second quarter 2025, compared to $3.4 million for the same period in 2024. The decrease of $1.6 million was primarily
due to decreases of $1.4 million in payroll and other incentive based compensation expense and a $0.2 million decrease in stock-based
compensation expense.
During the second quarter of 2025, we incurred
$4.5 million of restructuring charges associated with our workforce reduction, consisting primarily of one-time employee severance and
Cash and cash equivalents totaled $18.1 million on June 30, 2025.
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused
on developing targeted and immuno-oncology therapeutics. Leap's pipeline includes sirexatamab (DKN-01), is a humanized monoclonal antibody
targeting the Dickkopf-1 (DKK1) protein, and FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor
15 (GDF-15) protein. 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; Leap's plan to reduce clinical and operational activities, reduce spending and conserve
cash, explore strategic alternatives to preserve and maximize shareholder value, including by leveraging
its cash balance and potentially selling or partnering sirexatamab or FL-501; 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 sell or enter into partnerships for sirexatamab
or FL-501; (ii) the cost and timeline to complete the DeFianCe Study and wind-down operations; (iii) any regulatory feedback that Leap
may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency or from site institutional
review boards; and (iv) the availability of strategic alternatives that would preserve or generate any shareholder value. 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
President & Chief Executive Officer
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,537 | $ | 17,885 | $ | 23,448 | $ | 29,184 | ||||||||
| General and administrative | 1,817 | 3,367 | 4,823 | 6,893 | ||||||||||||
| Restructuring charges | 4,527 | - | 4,527 | - | ||||||||||||
| Total operating expenses | 16,881 | 21,252 | 32,798 | 36,077 | ||||||||||||
| Loss from operations | (16,881 | ) | (21,252 | ) | (32,798 | ) | (36,077 | ) | ||||||||
| Interest income | 246 | 865 | 683 | 1,640 | ||||||||||||
| Interest expense | (7 | ) | - | (13 | ) | - | ||||||||||
| Australian research and development incentives | 1 | 253 | 56 | 499 | ||||||||||||
| Foreign currency gain (loss) | (2 | ) | 6 | (6 | ) | (10 | ) | |||||||||
| Net loss | (16,643 | ) | (20,128 | ) | (32,078 | ) | (33,948 | ) | ||||||||
| Dividend attributable to down round feature of warrants | - | (234 | ) | - | (234 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (16,643 | ) | $ | (20,362 | ) | $ | (32,078 | ) | $ | (34,182 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic & diluted | $ | (0.40 | ) | $ | (0.52 | ) | $ | (0.78 | ) | $ | (1.01 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic & diluted | 41,444,979 | 39,122,662 | 41,357,423 | 33,830,083 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,130 | $ | 47,249 | ||||
| Research and development incentive receivable | 739 | 704 | ||||||
| Prepaid expenses and other current assets | 292 | 86 | ||||||
| Total current assets | 19,161 | 48,039 | ||||||
| Right of use assets, net | 38 | 262 | ||||||
| Research and development incentive receivable, net of current portion | 59 | - | ||||||
| Deposits | 784 | 823 | ||||||
| Total assets | $ | 20,042 | $ | 49,124 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,339 | $ | 4,743 | ||||
| Accrued expenses | 6,623 | 8,536 | ||||||
| Income tax payable | 324 | 531 | ||||||
| Lease liability - current portion | 39 | 266 | ||||||
| Total current liabilities | 14,325 | 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 June 30, 2025 and December 31, 2024, respectively | 41 | 38 | ||||||
| Additional paid-in capital | 505,207 | 502,501 | ||||||
| Accumulated other comprehensive loss | (82 | ) | (120 | ) | ||||
| Accumulated deficit | (499,449 | ) | (467,371 | ) | ||||
| Total stockholders' equity | 5,717 | 35,048 | ||||||
| Total liabilities and stockholders' equity | $ | 20,042 | $ | 49,124 |
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Cash used in operating activities | $ | (14,486 | ) | $ | (13,671 | ) | $ | (28,966 | ) | $ | (29,187 | ) | ||||
| Cash provided by (used in) financing activities | (119 | ) | 37,117 | (180 | ) | 37,146 | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 22 | 112 | 27 | (123 | ) | |||||||||||
| Net increase (decrease) in cash and cash equivalents | (14,583 | ) | 23,558 | (29,119 | ) | 7,836 | ||||||||||
| Cash and cash equivalents at beginning of period | 32,713 | 54,921 | 47,249 | 70,643 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 18,130 | $ | 78,479 | $ | 18,130 | $ | 78,479 |