Leap Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results
Leap Therapeutics, Inc. (Nasdaq:LPTX) reported its financial results for Q4 and the year ending December 31, 2022. The net loss grew to $54.6 million, up from $40.6 million in 2021, driven by increased research and development and administrative expenses. The acquisition of Flame Biosciences added $50 million in cash and expanded Leap's pipeline with clinical and preclinical antibody programs. Leap initiated clinical trials for DKN-01 in gastroesophageal and colorectal cancers and promoted Jason Baum to Chief Scientific Officer. Comprehensive financial metrics include $45 million in R&D expenses for 2022, a significant rise from $32.2 million in 2021.
- Acquisition of Flame Biosciences added FL-301 and $50 million in cash.
- Initiated two significant clinical trials for DKN-01.
- Promoted Jason Baum to Chief Scientific Officer.
- Net loss increased to $54.6 million in 2022, compared to $40.6 million in 2021.
- Research and development expenses rose to $45 million, up from $32.2 million in 2021.
- No license revenues in 2022 compared to $1.5 million in 2021.
Leap Highlights:
- 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
- Presented clinical data from Part B of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab in gastroesophageal (GEA) cancer patients whose tumors express high levels of
DKK1 (DKK1 -high) and preclinical data supporting the activity of DKN-01 in colorectal cancer (CRC) at theSociety for Immunotherapy of Cancer (SITC) Annual Meeting - Enrolled the first patient into Part C of the DisTinGuish study, the randomized controlled trial of DKN-01 plus tislelizumab and chemotherapy in first-line GEA cancer patients
- Enrolled the first patient into the Phase 2 DeFianCe study of DKN-01 in second-line CRC patients
- Promotion of
Jason Baum , Ph.D. to Chief Scientific Officer, effectiveApril 1, 2023
"Over the past year, we advanced DKN-01, our anti-DKK1 antibody, into its first randomized controlled clinical trial in gastric cancer, entered into the new indication of colorectal cancer, and facilitated an endometrial cancer investigator-sponsored trial. We enhanced Leap's pipeline and financial strength through the acquisition of Flame Biosciences, which included FL-301, a clinical stage anti-Claudin18.2 antibody, preclinical programs targeting Claudin18.2/CD137 and GDF15, as well as approximately
Business Update
- Leap completed the acquisition of Flame Biosciences and added FL-301 and two preclinical antibody programs to Leap's pipeline. In
January 2023 , Leap acquired Flame and its assets, including FL-301, its clinical stage anti-Claudin18.2 monoclonal antibody, FL-302, its preclinical anti-Claudin18.2/CD137 bispecific monoclonal antibody, FL-501, its preclinical anti-GDF15 monoclonal antibody, and cash of approximately as of$50 million December 31, 2022 . In the merger, Leap issued approximately 19,794,373 shares of its common stock and approximately 136,833 shares of a newly designated Series X non-voting convertible preferred stock to Flame stockholders. Leap will seek stockholder approval for the conversion of the preferred stock into common stock, pursuant to the terms of the Certificate of Designation and Nasdaq rules, at the 2023 Annual Meeting of Stockholders, which is expected to be held in June. Subject to and upon receipt of stockholder approval for such conversion, the 136,833 shares of Series X non-voting convertible preferred stock will convert into 136,833,000 shares of common stock of Leap. - Leap provided an update on the agreement with BeiGene. In
March 2023 , Leap announced that BeiGene's option under the Exclusive Option and License Agreement between Leap and BeiGene granting rights in certain Asian territories to DKN-01 has expired in accordance with the terms of the agreement. Leap and BeiGene will continue to collaborate on the ongoing Part C of the DisTinGuish trial, a randomized controlled trial of DKN-01 in combination with tislelizumab and chemotherapy in first-line gastric cancer patients, as a clinical collaboration with BeiGene supplying tislelizumab. - Promotion of
Jason Baum , Ph.D. to Chief Scientific Officer.Dr. Baum has served as our Vice President and Head ofTranslational Research sinceAugust 2020 and is being promoted to Chief Scientific Officer effectiveApril 1, 2023 .
DKN-01 Development Update
- Updated data from Part B of the DisTinGuish Study of DKN-01 plus tislelizumab in second-line patients with advanced GEA cancer whose tumors express high levels of
DKK1 , presented at the SITC Annual Meeting. - DKN-01 and tislelizumab were well tolerated at both 300mg and 600mg DKN-01 doses with no Grade 5 treatment-emergent AEs (TEAE) and no TEAEs leading to study drug discontinuation or dose reduction
- In evaluable anti-PD-1/PD-L1 naïve mITT population (n=43),
27% overall response rate (ORR) and43% disease control rate (DCR), exceeding the benchmark studies for anti-PD-1 monotherapy - In
DKK1 -high/PD-L1-high CPS ≥ 10 patients:55% ORR,73% DCR, 7.7 months median progression-free survival (PFS), median overall survival (OS) not reached - In
DKK1 -high/PD-L1 CPS > 1 and < 10 patients:8% ORR, 1.4 months PFS, 5.2 months OS - In
DKK1 -high/PD-L1-negative CPS < 1 patients:27% ORR, 1.4 months PFS, 3.9 months OS - New preclinical data in CRC models, presented at the SITC Annual Meeting.
- DKN-01 additive activity with 5-fluorouracil (5FU) and can overcome 5FU-resistance in two xenograft models, resulting in tumor regressions. 5FU-resistant models are reflective of a second-line CRC population currently being recruited in the DeFianCe study.
- Treatment with DKN-01 as monotherapy or in combination with anti-PD-1 resulted in tumor regression in a CT26 syngeneic CRC model.
- Announced first patient enrolled in randomized, controlled Part C of the DisTinGuish Study. Part C of the DisTinGuish study will enroll approximately 160 first-line, HER2-negative patients who have had no prior therapy for unresectable locally advanced or metastatic G/GEJ adenocarcinoma and randomized on a 1:1 basis to DKN-01 in combination with tislelizumab and chemotherapy compared to tislelizumab and chemotherapy. Enrollment in Part C is currently expected to be completed in late 2023, with initial response rate data expected to be available year end 2023/early 2024 and PFS data in 2024.
- Announced first patient enrolled in DeFianCe Study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line CRC patients. The DeFianCe study (NCT05480306) is a Phase 2 study of DKN-01 in combination with bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial approximately 20 patient Part A cohort and to then expand into a 130 patient Part B randomized controlled trial. Enrollment in Part A is currently expected to be completed in the coming weeks, with initial data to be available mid-2023.
Selected Year-End and Fourth Quarter 2022 Financial Results
Net Loss was
There were no license revenues for the year ended
Research and development expenses were
General and administrative expenses were
Cash and cash equivalents totaled
About
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:
President & Chief Executive Officer
617-714-0360
donsi@leaptx.com
Investor Relations
212-600-1902
leap@argotpartners.com
Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended | Three Months Ended | |||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||
License revenue | $ - | $ 1,500 | $ - | $ 375 | ||||||||||
Operating expenses: | ||||||||||||||
Research and development | 44,965 | 32,160 | 11,034 | 8,070 | ||||||||||
General and administrative | 11,798 | 10,766 | 2,909 | 2,793 | ||||||||||
Total operating expenses | 56,763 | 42,926 | 13,943 | 10,863 | ||||||||||
Loss from operations | (56,763) | (41,426) | (13,943) | (10,488) | ||||||||||
Interest income | 925 | 9 | 521 | 5 | ||||||||||
Interest expense | (54) | (41) | (5) | (2) | ||||||||||
Australian research and development incentives | 2,051 | 1,226 | 775 | (358) | ||||||||||
Foreign currency loss | (608) | (379) | 697 | 31 | ||||||||||
Loss before income taxes | (54,449) | (40,611) | (11,955) | (10,812) | ||||||||||
Benefit from (provision for) income taxes | (147) | 24 | (147) | 24 | ||||||||||
Net loss attributable to common stockholders | $ (54,596) | $ (40,587) | $ (12,102) | $ (10,788) | ||||||||||
Net loss per share | ||||||||||||||
Basic | $ (0.48) | $ (0.47) | $ (0.11) | $ (0.10) | ||||||||||
Diluted | $ (0.48) | $ (0.47) | $ (0.11) | $ (0.10) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic | 113,239,092 | 85,825,283 | 113,239,092 | 113,107,809 | ||||||||||
Diluted | 113,239,092 | 85,825,283 | 113,239,092 | 113,107,809 |
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
2022 | 2021 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 65,500 | $ 114,916 | ||||||||
Research and development incentive receivable | 2,099 | 1,189 | ||||||||
Prepaid expenses and other current assets | 351 | 769 | ||||||||
Total current assets | 67,950 | 116,874 | ||||||||
Property and equipment, net | 20 | 36 | ||||||||
Right of use assets, net | 669 | 459 | ||||||||
Deferred tax assets, net | - | 159 | ||||||||
Deferred costs | 576 | - | ||||||||
Other long term assets | 30 | 90 | ||||||||
Deposits | 1,108 | 293 | ||||||||
Total assets | $ 70,353 | $ 117,911 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 5,657 | $ 4,189 | ||||||||
Accrued expenses | 5,152 | 5,366 | ||||||||
Lease liability - current portion | 416 | 432 | ||||||||
Total current liabilities | 11,225 | 9,987 | ||||||||
Non current liabilities: | ||||||||||
Lease liability, net of current portion | 262 | 37 | ||||||||
Total liabilities | 11,487 | 10,024 | ||||||||
Stockholders' equity: | ||||||||||
Common stock, | 99 | 88 | ||||||||
Additional paid-in capital | 376,807 | 371,638 | ||||||||
Accumulated other comprehensive income (loss) | 128 | (267) | ||||||||
Accumulated deficit | (318,168) | (263,572) | ||||||||
Total stockholders' equity | 58,866 | 107,887 | ||||||||
Total liabilities and stockholders' equity | $ 70,353 | $ 117,911 |
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended | Three Months Ended | |||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||
Cash used in operating activities | $ (49,044) | $ (35,157) | $ (13,014) | $ (10,716) | ||||||||||
Cash provided by (used in) financing activities | (210) | 98,035 | - | 755 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (162) | (33) | 206 | 106 | ||||||||||
Net increase (decrease) in cash and cash equivalents | $ (49,416) | $ 62,845 | (12,808) | (9,855) | ||||||||||
Cash and cash equivalents at beginning of period | 114,916 | 52,071 | 78,308 | 124,771 | ||||||||||
Cash and cash equivalents at end of period | $ 65,500 | $ 114,916 | $ 65,500 | $ 114,916 |
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