Leap Therapeutics Reports Second Quarter 2023 Financial Results
- Positive data from Phase 2 studies of DKN-01 in treating colorectal and gastric cancer
- Initiation of randomized controlled trials based on positive data
- Promising long-term follow-up data presented at the 2023 ASCO Annual Meeting
- Decrease in net loss to $13.4 million in the second quarter of 2023
- None.
Leap Highlights:
- Announced that initial data from Part A of the Phase 2 DeFianCe study of DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC) exceeded a twenty percent (
20% ) overall response rate (ORR) with a high disease control rate, leading to the initiation of the 130-patient randomized controlled Part B of the study - Presented new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and chemotherapy demonstrating 19.5 months median overall survival (OS) in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
"The Company made important progress on our DKN-01 program during the second quarter. Based on Part A of the DeFianCe study exceeding our threshold of a
DKN-01 Development Update
- Announced initial results from Part A of the DeFianCe Study of DKN-01 for the treatment of colorectal cancer patients and initiation of the randomized controlled Part B of the study. The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter 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 for advanced disease. The study began with an initial Part A cohort that enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. Initial results indicated an ORR above twenty percent (
20% ) with a high disease control rate, which exceeds the benchmarks expected for this population. The study has expanded into a 130-patient Part B randomized controlled trial. The primary endpoint of the randomized study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to be able to enroll Part B in approximately 12 months. - Presented updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the 2023 ASCO Annual Meeting. The Company presented new long-term follow-up data in first-line patients with advanced GEA from Part A of the DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating Leap's anti-Dickkopf-1 (
DKK1 ) antibody, DKN-01, in combination with tislelizumab and chemotherapy. Highlights from the data include: - At two years follow up, DKN-01 plus tislelizumab and chemotherapy demonstrated an ORR of
73% in the modified intent-to-treat (mITT) population and86% in the PD-L1 low-subgroup - Median OS of 19.5 months and median progression-free survival (PFS) of 11.3 months exceeds benchmark results in the overall population
- Combination was well tolerated with manageable toxicity, with most adverse events related to DKN-01 being low-grade
Selected Second Quarter 2023 Financial Results
Net Loss was
Research and development expenses were
General and administrative expenses were
Interest income was
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 outcomes of patients in Part A of the DeFianCe study, the anticipated timing for initiation of or success of enrollment in Part B of the DeFianCe study, Part C of the DisTinGuish study, and other 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 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 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 June 30, | Six Months Ended June 30, | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 11,104 | $ 14,045 | $ 50,046 | $ 21,829 | ||||||||||
General and administrative | 3,558 | 2,855 | 7,342 | 5,703 | ||||||||||
Total operating expenses | 14,662 | 16,900 | 57,388 | 27,532 | ||||||||||
Loss from operations | (14,662) | (16,900) | (57,388) | (27,532) | ||||||||||
Interest income | 1,157 | 39 | 2,005 | 44 | ||||||||||
Interest expense | - | (17) | - | (38) | ||||||||||
Australian research and development incentives | 298 | 587 | 570 | 624 | ||||||||||
Foreign currency loss | (145) | (733) | (452) | (498) | ||||||||||
Change in fair value of Series X preferred stock warrant liability | (38) | - | 12 | - | ||||||||||
Net loss attributable to common stockholders | $ (13,390) | $ (17,024) | $ (55,253) | $ (27,400) | ||||||||||
Net loss per share | ||||||||||||||
Basic & diluted | $ (0.91) | $ (1.50) | $ (4.01) | $ (2.42) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic & diluted | 14,710,375 | 11,324,893 | 13,794,605 | 11,324,893 | ||||||||||
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
June 30, | December 31, | |||||||||
2023 | 2022 | |||||||||
(Unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 91,415 | $ 65,500 | ||||||||
Research and development incentive receivable | 2,046 | 2,099 | ||||||||
Prepaid expenses and other current assets | 419 | 351 | ||||||||
Total current assets | 93,880 | 67,950 | ||||||||
Property and equipment, net | Property and equipment, net | 13 | 20 | |||||||
Property and equipment, net | Right of use assets, net | 467 | 669 | |||||||
Research and development incentive receivable, net of current portion | 563 | - | ||||||||
Deferred costs | - | 576 | ||||||||
Other long term assets | - | 30 | ||||||||
Property and equipment, net | Deposits | 934 | 1,108 | |||||||
Total assets | $ 95,857 | $ 70,353 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 6,500 | $ 5,657 | ||||||||
Accrued expenses | 4,826 | 5,152 | ||||||||
Lease liability - current portion | 436 | 416 | ||||||||
Total current liabilities | 11,762 | 11,225 | ||||||||
Non current liabilities: | ||||||||||
Lease liability, net of current portion | 38 | 262 | ||||||||
Total liabilities | 11,800 | 11,487 | ||||||||
Stockholders' equity: | ||||||||||
Common stock, | 26 | 10 | ||||||||
Additional paid-in capital | 457,038 | 376,896 | ||||||||
Accumulated other comprehensive income | 414 | 128 | ||||||||
Accumulated deficit | (373,421) | (318,168) | ||||||||
Total stockholders' equity | 84,057 | 58,866 | ||||||||
Total liabilities and stockholders' equity | $ 95,857 | $ 70,353 | ||||||||
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||
Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Cash used in operating activities | $ (10,185) | $ (12,259) | $ (22,885) | $ (23,777) | ||||||||||
Cash provided by (used in) investing activities | (348) | - | 48,969 | - | ||||||||||
Cash used in financing activities | - | - | (29) | (210) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (90) | (78) | (140) | (46) | ||||||||||
Net increase (decrease) in cash and cash equivalents | (10,623) | (12,337) | 25,915 | (24,033) | ||||||||||
Cash and cash equivalents at beginning of period | 102,038 | 103,220 | 65,500 | 114,916 | ||||||||||
Cash and cash equivalents at end of period | $ 91,415 | $ 90,883 | $ 91,415 | $ 90,883 | ||||||||||
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SOURCE Leap Therapeutics, Inc.
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