Leap Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results
- Positive clinical data from Phase 2 studies on DKN-01 in colorectal and gastroesophageal cancers.
- Strong overall response rate and disease control rate in second-line colorectal cancer patients.
- Enrollment completion in the DisTinGuish study for delivering randomized controlled data in 2024.
- Financially, the company reported a net loss of $81.4 million for 2023.
- Increased net loss of $81.4 million for 2023 compared to $54.6 million in 2022.
- Higher research and development expenses of $73.2 million for 2023 compared to $45.0 million in 2022.
Insights
The recent update from Leap Therapeutics regarding their clinical trials holds significant implications for the oncology sector. The reported overall response rate (ORR) of 30% and disease control rate (DCR) of 93% in the DeFianCe study of DKN-01 for colorectal cancer patients are noteworthy metrics that may suggest the therapeutic's potential efficacy. The median progression-free survival (PFS) of 6.3 months and particularly the enhanced activity in patients with left-sided tumors and rectal/rectosigmoid carcinomas, indicates a targeted approach that could fill a niche in cancer treatment regimens. The correlation between higher baseline plasma DKK1 levels and improved responses could lead to a more personalized medicine approach, potentially improving patient outcomes. However, these results must be viewed in the context of the study's scale and the need for further data to confirm these findings.
From a financial perspective, Leap Therapeutics' increased net loss from $54.6 million in 2022 to $81.4 million in 2023 is a significant jump, largely attributed to the Flame merger and consequent in-process research and development expenses. The company's R&D spending rose substantially, reflecting its commitment to advancing its pipeline. Investors should be aware of the company's cash and cash equivalents of $70.6 million, which, in relation to the burn rate, will be important for sustaining operations until the next funding event. The anticipation of Part B and Part C study results in 2024 will be a pivotal moment for the company, potentially impacting the stock's performance. The timing of these results and the company's ability to manage expenses in the interim will be critical factors for investor consideration.
Looking at the broader market, the advancements Leap Therapeutics is making in the field of immuno-oncology are part of a larger trend towards personalized and targeted cancer treatments. The company's focus on DKK1-high patients aligns with the industry's shift towards biomarker-driven therapies. The successful development of DKN-01 could position Leap Therapeutics favorably in a competitive market, especially in the gastroesophageal junction and gastric cancer space where treatment options are still limited. However, the market will also be closely monitoring the competitive landscape, as other biotech firms are also progressing in similar areas. The impact on the stock market will depend on the company's ability to leverage these results into a viable product that meets regulatory approval and commercial success.
Leap Highlights:
- Presented new clinical data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer, at the 2024 ASCO Gastrointestinal Cancers Symposium
- Completed enrollment in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer
"As we reflect on the fourth quarter and the achievements of the past year, we are proud of the strides we've made in advancing DKN-01 and integrating our pipeline of earlier stage biomarker-targeted antibody therapies. The data from Part A of the DeFianCe study, demonstrating a
DKN-01 Development Update
- Presented initial clinical data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer (CRC) patients. The Company presented initial data from Part A of the DeFianCe study (NCT05480306), a Phase 2 study evaluating DKN-01 in combination with standard of care (SOC) bevacizumab and chemotherapy in second-line (2L) patients with advanced microsatellite stable (MSS) CRC patients at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, held in
San Francisco on January 18-20, 2024 and during the Company's conference call on January 23, 2024.
- Key Findings:
- As of the December 6, 2023 data cutoff, across all patients enrolled (n=33):
- Overall response rate (ORR) among response-evaluable patients (n=27) was
30% and disease control rate (DCR) was93% , including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD) - Median progression-free survival (PFS) was 6.3 months
- 9 patients remained on therapy and were beyond 8.5 months
- Overall response rate (ORR) among response-evaluable patients (n=27) was
- Enhanced activity in patients with left-sided tumors (n=25), a group that has more frequent activation of the Wnt pathway modulated by DKK1
33% ORR and100% DCR in response-evaluable population (7 PRs, 14 SDs)- Preliminary median PFS of 8.6 months (9 patients continuing therapy within subgroup)
- Compelling ORR, DCR and PFS in patients with rectal/rectosigmoid carcinomas (n=15), a population with increasing incidence among young people and shown to have the highest
DKK1 levels:46% ORR and100% DCR in response-evaluable population (6 PRs, 7 SDs)- Preliminary median PFS of 9.4 months (6 patients continuing therapy within subgroup)
- Higher baseline plasma
DKK1 levels correlated with improved responses
- DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2)
The Company expects the 130 patient randomized controlled Part B to complete enrollment in mid-2024. As of March 15, 2024, 80 patients have enrolled in Part B.
- Announced completion of enrollment in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene's anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer. Part C of 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. Part C enrolled 170 first-line, HER2-negative patients randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is progression-free survival (PFS) in
DKK1 -high and in all patients. Secondary objectives of Part C include overall survival and objective response rate as measured by RECIST v1.1 inDKK1 -high and in all patients. The Company expects to report initial data from Part C of the DisTinGuish study in mid-2024.
Selected Year-End and Fourth 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 potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for 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, NovaRock 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 | ||||||||||||||
Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31 | Three Months Ended December 31 | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 73,234 | $ 44,965 | $ 11,685 | $ 11,034 | ||||||||||
General and administrative | 13,807 | 11,798 | 3,135 | 2,909 | ||||||||||
Total operating expenses | 87,041 | 56,763 | 14,820 | 13,943 | ||||||||||
Loss from operations | (87,041) | (56,763) | (14,820) | (13,943) | ||||||||||
Interest income | 4,027 | 925 | 938 | 521 | ||||||||||
Interest expense | - | (54) | - | (5) | ||||||||||
Australian research and development incentives | 1,101 | 2,051 | (23) | 775 | ||||||||||
Other income | 500 | - | 500 | - | ||||||||||
Foreign currency gain (loss) | (13) | (608) | 940 | 697 | ||||||||||
Change in fair value of Series X preferred stock warrant liability | 12 | - | - | - | ||||||||||
Loss before income taxes | (81,414) | (54,449) | (12,465) | (11,955) | ||||||||||
Provision for income taxes | - | (147) | - | (147) | ||||||||||
Net loss attributable to common stockholders | $ (81,414) | $ (54,596) | $ (12,465) | $ (12,102) | ||||||||||
Net loss per share | ||||||||||||||
Basic and Diluted | $ (3.98) | $ (4.82) | $ (0.46) | $ (1.07) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic and diluted | 20,445,109 | 11,323,909 | 26,987,182 | 11,323,909 | ||||||||||
Leap Therapeutics, Inc | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
December 31, | ||||||||||
2023 | 2022 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 70,643 | $ 65,500 | ||||||||
Research and development incentive receivable | 771 | 2,099 | ||||||||
Prepaid expenses and other current assets | 183 | 351 | ||||||||
Total current assets | 71,597 | 67,950 | ||||||||
Property and equipment, net | Property and equipment, net | 5 | 20 | |||||||
Property and equipment, net | Right of use assets, net | 257 | 669 | |||||||
Deferred costs | - | 576 | ||||||||
Other long term assets | - | 30 | ||||||||
Property and equipment, net | Deposits | 966 | 1,108 | |||||||
Total assets | $ 72,825 | $ 70,353 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 6,465 | $ 5,657 | ||||||||
Accrued expenses | 5,957 | 5,152 | ||||||||
Lease liability - current portion | 262 | 416 | ||||||||
Total current liabilities | 12,684 | 11,225 | ||||||||
Non current liabilities: | ||||||||||
Lease liability, net of current portion | - | 262 | ||||||||
Total liabilities | 12,684 | 11,487 | ||||||||
Stockholders' equity: | ||||||||||
Preferred stock, | - | - | ||||||||
Common stock, | 26 | 10 | ||||||||
Additional paid-in capital | 459,591 | 376,896 | ||||||||
Accumulated other comprehensive income | 106 | 128 | ||||||||
Accumulated deficit | (399,582) | (318,168) | ||||||||
Total stockholders' equity | 60,141 | 58,866 | ||||||||
Total liabilities and stockholders' equity | $ 72,825 | $ 70,353 | ||||||||
Leap Therapeutics, Inc | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31, | Three Months Ended December 31, | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Cash used in operating activities | $ (43,753) | $ (49,044) | $ (10,380) | $ (13,014) | ||||||||||
Cash provided by investing activities | 48,969 | - | - | - | ||||||||||
Cash used in financing activities | (30) | (210) | - | - | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (43) | (162) | 280 | 206 | ||||||||||
Net increase (decrease) in cash and cash equivalents | $ 5,143 | $ (49,416) | (10,100) | (12,808) | ||||||||||
Cash and cash equivalents at beginning of period | 65,500 | 114,916 | 80,743 | 78,308 | ||||||||||
Cash and cash equivalents at end of period | $ 70,643 | $ 65,500 | $ 70,643 | $ 65,500 | ||||||||||
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SOURCE Leap Therapeutics, Inc.
FAQ
What clinical data did Leap Therapeutics present at the 2024 ASCO Gastrointestinal Cancers Symposium?
What were the key findings from the DeFianCe study?
What is the enrollment status of Part B of the DeFianCe study?
What study did Leap Therapeutics complete enrollment in for evaluating DKN-01 in gastroesophageal junction and gastric cancer patients?
What are the primary and secondary objectives of Part C of the DisTinGuish study?
What was Leap Therapeutics' net loss for the year ended December 31, 2023?
What were the research and development expenses for the full year 2023?
How much cash and cash equivalents did Leap Therapeutics have at December 31, 2023?
