On Thursday, H.C. Wainwright reiterated its Neutral rating on Leap Therapeutics (NASDAQ:LPTX), which currently trades at $0.45 with a market capitalization of $17.38 million. According to InvestingPro data, the stock has shown significant volatility, gaining over 10% in the past week despite an 84% decline year-to-date. The announcement follows the company’s release of additional data from an ongoing Phase 2 study. Leap Therapeutics, a biotechnology firm, shared results from Part B of the DeFianCe study, which is evaluating the efficacy of DNK-01 in combination with bevacizumab and chemotherapy in treating metastatic colorectal cancer (MSS CRC) in second-line settings.
The study showed that patients with high levels of the protein DKK1 and those who had not previously received VEGF-targeting treatments responded more favorably to the DNK-01 combination therapy. Specifically, patients with high DKK1 levels experienced a median progression-free survival (PFS) of 9.4 months, compared to 5.9 months in the control group. The objective response rate (ORR) by blinded independent central review (BICR) was also significantly higher in the DNK-01 treated group at 40% compared to just 5% in the control arm.
At the data cutoff date, the experimental cohort had not reached a median overall survival (OS), while the control arm had a median OS of 9.5 months. Additionally, 10 patients were still on the DNK-01 treatment regimen at the time of the data cutoff, versus only one patient continuing with the control treatment. Improvements in ORR and PFS were also noted in patients with DKK1 levels above the median who were treated with the triplet therapy.
Despite these findings, H.C. Wainwright expressed caution, citing uncertainties surrounding the development of Leap Therapeutics’ pipeline and the absence of significant catalysts that could drive stock valuation. The firm has chosen not to assign a price target to Leap Therapeutics stock at this time. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 3.41, though it remains unprofitable. InvestingPro’s Fair Value analysis suggests the stock may be undervalued at current levels. Discover 8 additional exclusive ProTips and comprehensive financial metrics with an InvestingPro subscription.
In other recent news, Leap Therapeutics announced updated results from its Phase 2 DeFianCe study, which showed promising outcomes for its investigational cancer drug, sirexatamab, in treating colorectal cancer (CRC). The study revealed that patients with high levels of the protein DKK1 or those who had not previously received anti-VEGF therapy experienced improved response rates and progression-free survival when treated with sirexatamab in combination with bevacizumab and chemotherapy. Despite these promising results in CRC, Leap Therapeutics decided to discontinue its DisTinGuish study for advanced gastric cancer due to unmet primary progression-free survival endpoints. The company is now focusing its efforts on advancing sirexatamab in CRC and is exploring strategic partnerships for further development in gastric cancer and other indications.
Analysts have reacted to these developments, with H.C. Wainwright downgrading Leap Therapeutics’ stock from Buy to Neutral, expressing concerns about the drug’s market potential outside of CRC. Similarly, Baird revised its rating from Outperform to Neutral, citing ambiguous survival data and a challenging financial outlook. Despite the setbacks in gastric cancer, Leap Therapeutics remains optimistic about the CRC data and is considering a Phase 3 clinical trial to confirm sirexatamab’s efficacy and safety. The company continues to explore business development opportunities, given the significant market potential for CRC therapies.
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