Leap Therapeutics Reports Third Quarter 2023 Financial Results
- The company is making significant progress in the DeFianCe study for DKN-01 in colorectal cancer, with an overall response rate exceeding 20% in Part A and advancing into the 130-patient Part B trial.
- The DisTinGuish study for DKN-01 in gastric cancer is also ongoing, with impressive overall response rates and promising long-term survival data presented.
- The company's financial results for Q3 2023 show a decrease in net loss compared to the same period in 2022, primarily due to decreased research and development expenses and increased interest income.
- None.
"Leap continued to make great strides this quarter including advancing into the 130 patient, randomized controlled Part B of the DeFianCe study evaluating DKN-01 plus bevacizumab and chemotherapy in second-line colorectal cancer, after exceeding our
DKN-01 Development Update
- Updated data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer patients to be presented at a medical conference in January 2024. The Company expects to present new long-term follow-up data from Part A of the DeFiance study (NCT05480306), a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced colorectal cancer who have received one prior systemic therapy for advanced disease. Initial results from Part A indicated an overall response rate (ORR) above
20% with a high disease control rate, which exceeded the benchmarks expected for this population. Subsequently, the study expanded into a 130-patient Part B randomized controlled trial. - Part C of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients is ongoing and enrollment is expected to be completed by the end of 2023. The DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. The Company previously presented long-term follow-up data from Part A of the study in June 2023, showing
73% ORR in the modified intent-to-treat population, and85% ORR in the PD-L1 low-subgroup. The data also demonstrated 19.5 months median overall survival and 11.3 months median progression-free survival.
Selected Third Quarter 2023 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 continuation over time of the clinical collaboration with BeiGene on the ongoing Part C of the DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the expected benefits of the merger with Flame Biosciences; the cash runway into 2025 and the sufficiency of Leap's cash, cash equivalents and short-term investments to fund operations; the anticipated timing for completion of or success of enrollment in clinical trials and release of clinical data, and any outcomes of such trials; the potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future preclinical and clinical development plans in connection with our programs; the ability to enter into a new strategic partnership for DKN-01 or any of Leap's other programs; the ability of NovaRock Biotherapeutics to conduct the FL-301 clinical trial in
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, | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 11,503 | $ 12,102 | $ 61,549 | $ 33,931 | ||||||||||
General and administrative | 3,330 | 3,186 | 10,672 | 8,889 | ||||||||||
Total operating expenses | 14,833 | 15,288 | 72,221 | 42,820 | ||||||||||
Loss from operations | (14,833) | (15,288) | (72,221) | (42,820) | ||||||||||
Interest income | 1,084 | 360 | 3,089 | 404 | ||||||||||
Interest expense | - | (11) | - | (49) | ||||||||||
Australian research and development incentives | 554 | 652 | 1,124 | 1,276 | ||||||||||
Foreign currency loss | (501) | (807) | (953) | (1,305) | ||||||||||
Change in fair value of Series X preferred stock warrant liability | - | - | 12 | - | ||||||||||
Net loss attributable to common stockholders | $ (13,696) | $ (15,094) | $ (68,949) | $ (42,494) | ||||||||||
Net loss per share | ||||||||||||||
Basic & diluted | $ (0.51) | $ (1.33) | $ (3.78) | $ (3.75) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic & diluted | 26,987,182 | 11,323,909 | 18,240,455 | 11,323,909 |
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
September 30, | December 31, | |||||||||
2023 | 2022 | |||||||||
(Unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 80,743 | $ 65,500 | ||||||||
Research and development incentive receivable | 753 | 2,099 | ||||||||
Prepaid expenses and other current assets | 265 | 351 | ||||||||
Total current assets | 81,761 | 67,950 | ||||||||
Property and equipment, net | 9 | 20 | ||||||||
Right of use assets, net | 363 | 669 | ||||||||
Deferred costs | - | 576 | ||||||||
Other long term assets | - | 30 | ||||||||
Deposits | 913 | 1,108 | ||||||||
Total assets | $ 83,046 | $ 70,353 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 5,899 | $ 5,657 | ||||||||
Accrued expenses | 4,770 | 5,152 | ||||||||
Lease liability - current portion | 369 | 416 | ||||||||
Total current liabilities | 11,038 | 11,225 | ||||||||
Non current liabilities: | ||||||||||
Lease liability, net of current portion | - | 262 | ||||||||
Total liabilities | 11,038 | 11,487 | ||||||||
Stockholders' equity: | ||||||||||
Common stock, | 26 | 10 | ||||||||
Additional paid-in capital | 458,339 | 376,896 | ||||||||
Accumulated other comprehensive income | 760 | 128 | ||||||||
Accumulated deficit | (387,117) | (318,168) | ||||||||
Total stockholders' equity | 72,008 | 58,866 | ||||||||
Total liabilities and stockholders' equity | $ 83,046 | $ 70,353 |
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||
Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Cash used in operating activities | $ (10,488) | $ (12,253) | $ (33,373) | $ (36,030) | ||||||||||
Cash provided by investing activities | - | - | 48,969 | - | ||||||||||
Cash used in financing activities | (1) | - | (30) | (210) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (183) | (322) | (323) | (368) | ||||||||||
Net increase (decrease) in cash and cash equivalents | (10,672) | (12,575) | 15,243 | (36,608) | ||||||||||
Cash and cash equivalents at beginning of period | 91,415 | 90,883 | 65,500 | 114,916 | ||||||||||
Cash and cash equivalents at end of period | $ 80,743 | $ 78,308 | $ 80,743 | $ 78,308 |
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SOURCE Leap Therapeutics, Inc.
FAQ
What are the key developments reported by Leap Therapeutics, Inc. in the Q3 financial results?
What are the key updates for the DKN-01 development in colorectal cancer patients?
What are the updates for the DKN-01 development in gastric cancer patients?