Leap Therapeutics Reports First Quarter 2023 Financial Results
Leap Highlights:
- Presenting new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
- Enrollment completed in Part A of the Phase 2 DeFianCe study of DKN-01 in combination with standard of care bevaiczimab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC)
- Acquired Flame Biosciences, adding FL-301, a clinical stage anti-Claudin18.2 antibody, and preclinical antibody programs targeting Claudin18.2/CD137 and GDF15 to Leap's pipeline, along with approximately
in cash.$50 million
"We continued to execute extremely well on our DKN-01 program during the first quarter of 2023 with the completion of enrollment in Part A of the DeFianCe second-line CRC study and excellent progress in enrolling our randomized, controlled Part C of the DisTinGuish first-line GEA study," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to presenting long-term follow-up data from Part A of the DisTinGuish study at ASCO in June, including updated response and overall survival data. With the acquisition of Flame Biosciences at the beginning of the year, we are in a strong financial position to develop our pipeline of personalized medicines for cancer patients."
DKN-01 Development Update
- Updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients to be presented at the 2023 ASCO Annual Meeting. The Company will be presenting 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 at the 2023 ASCO Annual Meeting, being held inChicago, IL on June 2-6, 2023. Details of the presentation are below: - Title: A phase 2 study (DisTinGuish) of DKN-01 in combination with tislelizumab + chemotherapy as first-line (1L) therapy in patients with advanced gastric or GEJ adenocarcinoma (GEA).
- Presenter: Samuel J. Klempner, Harvard Medical School
- Session Type: Poster Discussion Session
- Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
- Date and Time: Monday, June 5, 2023, at 11:30 a.m. ET
- Abstract Number: 4027
- Poster Number: 335
- Announced completion of enrollment in Part A of the DeFiance Study of DKN-01 for the treatment of colorectal cancer patients. 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 has enrolled 33 patients and is designed to expand into a 130-patient Part B randomized controlled trial. The primary objective is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to report initial data from Part A of the study in mid-2023.
Selected First 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 mid-2025 and the sufficiency of Leap's cash, cash equivalents and short-term investments to fund operations; stockholder approval of the conversion rights of the Series X Non-Voting Convertible Preferred Stock; the anticipated timing for initiation 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. | |||||||||||
Consolidated Statements of Operations | |||||||||||
(in thousands, except share and per share amounts) | |||||||||||
(Unaudited) | |||||||||||
Three Months Ended March 31 | |||||||||||
2023 | 2022 | ||||||||||
Operating expenses: | |||||||||||
Research and development | $ 38,942 | $ 7,784 | |||||||||
General and administrative | 3,784 | 2,848 | |||||||||
Total operating expenses | 42,726 | 10,632 | |||||||||
Loss from operations | (42,726) | (10,632) | |||||||||
Interest income | 848 | 5 | |||||||||
Interest expense | - | (21) | |||||||||
Australian research and development incentives | 272 | 37 | |||||||||
Foreign currency gain (loss) | (307) | 235 | |||||||||
Change in fair value of Series X preferred stock warrant liability | 50 | - | |||||||||
Net loss attributable to common stockholders | (41,863) | (10,376) | |||||||||
Net loss per share | |||||||||||
Basic | $ (0.32) | $ (0.09) | |||||||||
Diluted | $ (0.32) | $ (0.09) | |||||||||
Weighted average common shares outstanding | |||||||||||
Basic | 129,344,272 | 113,248,937 | |||||||||
Diluted | 129,344,272 | 113,248,937 |
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
March 31, | December 31, | |||||||||
2023 | 2022 | |||||||||
(Unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 102,038 | $ 65,500 | ||||||||
Research and development incentive receivable | 2,071 | 2,099 | ||||||||
Prepaid expenses and other current assets | 590 | 351 | ||||||||
Total current assets | 104,699 | 67,950 | ||||||||
Property and equipment, net | 16 | 20 | ||||||||
Right of use assets, net | 569 | 669 | ||||||||
Research and development incentive receivable, net of current portion | 272 | - | ||||||||
Deferred costs | - | 576 | ||||||||
Other long term assets | 15 | 30 | ||||||||
Deposits | 976 | 1,108 | ||||||||
Total assets | $ 106,547 | $ 70,353 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 5,498 | $ 5,657 | ||||||||
Accrued expenses | 4,388 | 5,152 | ||||||||
Lease liability - current portion | 425 | 416 | ||||||||
Total current liabilities | 10,311 | 11,225 | ||||||||
Non current liabilities: | ||||||||||
Lease liability, net of current portion | 152 | 262 | ||||||||
Series X preferred stock warrant liability | 40 | - | ||||||||
Total liabilities | 10,503 | 11,487 | ||||||||
Mezzanine equity: | ||||||||||
Series X Convertible Preferred Stock, | 67,715 | - | ||||||||
Stockholders' equity: | ||||||||||
Common stock, | 119 | 99 | ||||||||
Additional paid-in capital | 387,886 | 376,807 | ||||||||
Accumulated other comprehensive income | 355 | 128 | ||||||||
Accumulated deficit | (360,031) | (318,168) | ||||||||
Total stockholders' equity | 28,329 | 58,866 | ||||||||
Total liabilities, mezzanine equity and stockholders' equity | $ 106,547 | $ 70,353 |
Leap Therapeutics, Inc. | |||||||||||
Condensed Consolidated Statements of Cash Flows | |||||||||||
(in thousands) | |||||||||||
(Unaudited) | |||||||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Cash used in operating activities | $ (12,700) | $ (11,518) | |||||||||
Cash provided by investing activities | 49,317 | - | |||||||||
Cash used in financing activities | (29) | (210) | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (50) | 32 | |||||||||
Net increase (decrease) in cash and cash equivalents | 36,538 | (11,696) | |||||||||
Cash and cash equivalents at beginning of period | 65,500 | 114,916 | |||||||||
Cash and cash equivalents at end of period | $ 102,038 | $ 103,220 |
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SOURCE Leap Therapeutics, Inc.