On May 11, 2018 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2018 (Press release, Leap Therapeutics, MAY 11, 2018, View Source;p=RssLanding&cat=news&id=2348662 [SID1234526528]).
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"We had a strong first quarter, as we presented data from our study of DKN-01 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) in patients with esophagogastric cancer, and dosed the first patients in new trials for both of our programs," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We also successfully completed a public offering, strengthening our balance sheet and enabling further growth of the company."
Recent Pipeline Highlights:
DKN-01:
Completed enrollment of the dose escalation phase and presented interim data of a clinical trial evaluating DKN-01 and KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. Data from the dose escalation phase indicated that the combination was well tolerated with early signals of clinical activity. In the high-dose DKN-01 cohort, one of four evaluable patients naïve to anti-PD-1/PD-L1 therapy had a partial response with a 66% reduction in target tumor volume. This patient has a tumor phenotype which is typically less responsive to anti-PD-1 therapy. The study is now enrolling two expansion cohorts in patients with esophagogastric cancer who are naïve to anti-PD-1/PD-L1 therapy (n=40) and patients who are refractory to anti-PD-1/PD-L1 therapy (n=15).
Presented data on the monotherapy activity of DKN-01 in patients with advanced esophagogastric cancer. Of 16 patients evaluable by central imaging analysis, two patients had a partial response and five patients had stable disease, representing a total disease control rate of 43.8%. One patient who had failed prior investigational immunotherapies had a partial response on DKN-01 monotherapy and remained on study for over a year.
Enrolled the first patients in a clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with endometrioid gynecologic cancers, a population of cancers with frequent alterations of the Wnt signaling pathway resulting in increased expression of DKK1.
TRX518:
Enrolled the first patients in a clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or Opdivo (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively.
Business Highlights
Completed a public offering for $16.1 million in gross proceeds, which supports further growth of the company and extends the cash runway into the fourth quarter 2019.
DKN-01 Program Update Call:
On Friday, May 18, 2018 at 12:00PM ET Leap will be hosting a conference call and webcast for the investment community with DKN-01 clinical investigators where the Company will provide a program update. To access the conference call, please dial (866) 589-0108 (US/Canada Toll-Free) or (409) 231-2048 (international) and refer to conference ID 7196723. The presentation will also be webcast live and will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be available on the Company’s website approximately two hours after the event and will be available for a limited time.
Selected First Quarter 2018 Financial Results
Net loss was $10.6 million for the first quarter 2018, compared to $9.4 million for the same period in 2017. This increase was primarily due to a non-cash change in the fair value of the warrant liability offset by a decrease in stock-based compensation expense.
Research and development expenses were $4.2 million for the first quarter 2018, compared to $6.4 million for the same period in 2017. This decrease was primarily due to a decrease in stock-based compensation expense and a decrease in manufacturing costs related to clinical trial material.
General and administrative expenses were $2.1 million for the first quarter 2018, compared to $3.8 million for the same period in 2017. This decrease was primarily due to a decrease in stock-based compensation expense and a decrease in legal, audit and consulting fees.
Cash, cash equivalents and marketable securities totaled $35.4 million at March 31, 2018. Research and development incentive receivables, current and long term, totaled approximately $1.6 million at March 31, 2018.