On May 15, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Leap Therapeutics, MAY 15, 2019, View Source [SID1234536337]).
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"In the first quarter, we presented important new data for both of our programs. DKN-01’s activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We are looking forward to presenting additional clinical data from both programs in the second half of the year."
Recent Developments
·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete.
·DKN-01 in GYNECOLOGICAL CANCERS: At the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing.
·DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer patients.
·TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.
· TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First Quarter 2019 Financial Results
Net loss was $8.6 million for the first quarter 2019, compared to $10.6 million for the same period in 2018. This decrease was primarily due to a non-cash charge based on the change in the fair value of the warrant liability in the first quarter 2018, offset by an increase in clinical development expense.
Research and development expenses were $6.8 million for the first quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.
General and administrative expenses were $2.0 million for the first quarter 2019, compared to $2.1 million for the same period in 2018. This decrease was primarily due to a decrease in compensation expense as a result of senior management not accepting the cash bonus awarded to them by the compensation committee, partially offset by an increase in stock-based compensation expense.
Cash, cash equivalents and marketable securities totaled $21.7 million at March 31, 2019. Research and development incentive receivables, current and long term, totaled approximately $0.9 million at March 31, 2019.