Leap Therapeutics Reports Third Quarter 2024 Financial Results
Rhea-AI Summary
Leap Therapeutics (LPTX) reported Q3 2024 financial results with a net loss of $18.2 million, compared to $13.7 million in Q3 2023. Research and development expenses increased to $14.9 million from $11.5 million year-over-year. The company completed enrollment in Part B of the Phase 2 DeFianCe study for DKN-01 in colorectal cancer with 188 patients, with data expected mid-2025. Patient follow-up continues in Part C of the DisTinGuish study with 170 patients, with data expected late 2024 or early 2025. Cash position stands at $62.8 million, expected to fund operations into Q2 2026.
Positive
- Strong cash position of $62.8 million, funding operations into Q2 2026
- Completed enrollment of 188 patients in Phase 2 DeFianCe study
- Successful enrollment of 170 patients in DisTinGuish study
Negative
- Net loss increased 32.8% to $18.2 million in Q3 2024
- R&D expenses increased by $3.4 million to $14.9 million
News Market Reaction 1 Alert
On the day this news was published, LPTX declined 7.69%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Leap Highlights:
- Completed enrollment in the expanded randomized controlled Part B of the Phase 2 DeFianCe study evaluating DKN-01, Leap's anti-DKK1 monoclonal antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC); data expected in mid-2025
- Patient follow-up continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in late 2024 or early 2025
- Initiated development of FL-501, Leap's anti-GDF-15 monoclonal antibody
"We have made significant progress advancing our pipeline this quarter, including the completion of enrollment in the expanded Part B of the Phase 2 DeFianCe study of DKN-01 in patients with advanced colorectal cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to sharing initial randomized controlled data from the DisTinGuish study and the DeFianCe study in the coming months. In addition, based on positive preclinical data, we are enthusiastically moving FL-501 into development. With a strong cash position that is expected to fund operations into Q2 2026, Leap is well positioned for continued success and long-term growth to deliver personalized medicines to patients fighting against cancer."
DKN-01 Development Update
- Enrollment completed in the expanded randomized controlled Part B of the DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC. Part B of the DeFianCe study (NCT05480306) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. Part B of the study enrolled 188 patients. The Company expects to report initial data in mid-2025.
- Patient follow-up continuing in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with GEJ and gastric cancer, with initial data expected in late 2024 or early 2025. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with tislelizumab and chemotherapy in first-line, HER-2 negative patients with GEJ and gastric cancer. Part C of the study enrolled 170 patients. The Company expects to report initial data in late 2024 or early 2025.
Pipeline Update:
- Advancing FL-501 into development as a potential best-in-class anti-GDF-15 antibody with promising preclinical data. FL-501 is a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases. FL-501 may also enhance the activity of the immune system in the tumor micro-environment. FL-501 was engineered for higher target affinity and a longer plasma half-life compared to competing therapies. In preclinical cachexia models, FL-501 increased body weight and restored muscle mass.
Selected Third Quarter 2024 Financial Results
Net Loss was
Research and development expenses were
General and administrative expenses were
Cash and cash equivalents totaled
About Leap Therapeutics
Leap 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 (
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 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) 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 and Adimab; (iv) whether any Leap clinical trials and products will receive approval from the
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 14,915 | $ 11,503 | $ 44,099 | $ 61,549 | ||||||||||
General and administrative | 2,940 | 3,330 | 9,833 | 10,672 | ||||||||||
Total operating expenses | 17,855 | 14,833 | 53,932 | 72,221 | ||||||||||
Loss from operations | (17,855) | (14,833) | (53,932) | (72,221) | ||||||||||
Interest income | 894 | 1,084 | 2,534 | 3,089 | ||||||||||
Australian research and development incentives | (499) | 554 | - | 1,124 | ||||||||||
Foreign currency loss | (8) | (501) | (18) | (953) | ||||||||||
Change in fair value of Series X preferred stock warrant liability | - | - | - | 12 | ||||||||||
Loss before income taxes | (17,468) | (13,696) | (51,416) | (68,949) | ||||||||||
Provision for income taxes | (708) | - | (708) | - | ||||||||||
Net loss | (18,176) | (13,696) | (52,124) | (68,949) | ||||||||||
Dividend attributable to down round feature of warrants | - | - | (234) | - | ||||||||||
Net loss attributable to common stockholders | $ (18,176) | $ (13,696) | $ (52,358) | $ (68,949) | ||||||||||
Net loss per share | ||||||||||||||
Basic & diluted | $ (0.44) | $ (0.51) | $ (1.44) | $ (3.78) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic & diluted | 41,209,639 | 26,987,182 | 36,307,890 | 18,240,455 | ||||||||||
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
September 30, | December 31, | |||||||||
2024 | 2023 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 62,823 | $ 70,643 | ||||||||
Research and development incentive receivable | 780 | 771 | ||||||||
Prepaid expenses and other current assets | 209 | 183 | ||||||||
Total current assets | 63,812 | 71,597 | ||||||||
Property and equipment, net | - | 5 | ||||||||
Right of use assets, net | 370 | 257 | ||||||||
Deposits | 865 | 966 | ||||||||
Total assets | $ 65,047 | $ 72,825 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 5,946 | $ 6,465 | ||||||||
Accrued expenses | 9,049 | 5,957 | ||||||||
Income tax payable | 722 | - | ||||||||
Lease liability - current portion | 376 | 262 | ||||||||
Total current liabilities | 16,093 | 12,684 | ||||||||
Total liabilities | 16,093 | 12,684 | ||||||||
Stockholders' equity: | ||||||||||
Preferred stock, | - | - | ||||||||
Common stock, | 38 | 26 | ||||||||
Additional paid-in capital | 500,850 | 459,591 | ||||||||
Accumulated other comprehensive income | 6 | 106 | ||||||||
Accumulated deficit | (451,940) | (399,582) | ||||||||
Total stockholders' equity | 48,954 | 60,141 | ||||||||
Total liabilities and stockholders' equity | $ 65,047 | $ 72,825 | ||||||||
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||
Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||
Cash used in operating activities | $ (15,600) | $ (10,488) | $ (44,787) | $ (33,373) | ||||||||||
Cash provided by investing activities | - | - | - | 48,969 | ||||||||||
Cash provided by (used in) financing activities | (66) | (1) | 37,080 | (30) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | 10 | (183) | (113) | (323) | ||||||||||
Net increase (decrease) in cash and cash equivalents | (15,656) | (10,672) | (7,820) | 15,243 | ||||||||||
Cash and cash equivalents at beginning of period | 78,479 | 91,415 | 70,643 | 65,500 | ||||||||||
Cash and cash equivalents at end of period | $ 62,823 | $ 80,743 | $ 62,823 | $ 80,743 | ||||||||||
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SOURCE Leap Therapeutics, Inc.
FAQ
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