On August 13, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2020 (Press release, Leap Therapeutics, AUG 13, 2020, sec.gov/Archives/edgar/data/1509745/000110465920094315/tm2027468d1_ex99-1.htm [SID1234563574]).

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Leap Second Quarter Highlights:

Completed a $51.75 million public offering of common stock and pre-funded warrants to purchase common stock
Presented updated data for DKN-01 monotherapy that showed a complete response and partial response in endometrial cancer patients with additional responses observed for the DKN-01 plus paclitaxel combination in carcinosarcoma patients
Announced Orphan Drug Designation of DKN-01 for the treatment of gastric and gastroesophageal junction cancer
"Our partnership with BeiGene for the clinical development and commercialization of DKN-01 is progressing extremely well, and we look forward to dosing the first patient this quarter in the combination study of DKN-01 plus tislelizumab, BeiGene’s anti-PD-1 antibody, for the treatment of gastric or gastroesophageal junction cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "DKN-01 continues to show potential to treat multiple biomarker-defined cancers, as both a single agent and in combination with chemotherapy or anti-PD-1 therapies. We are excited about the promise of this program and, with the proceeds from our recent public offering, are well funded to drive development forward."

Business Update

Leap Completed $51.75 Million Public Offering of Common Stock and Pre-Funded Warrants to Purchase Common Stock – In June 2020, Leap announced the closing of an underwritten public offering yielding aggregate gross proceeds of $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Leap.
DKN-01 Clinical Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.

Leap Presented Updated Data for DKN-01 Monotherapy and Paclitaxel Combination in Gynecologic Cancers – Leap announced updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. Leap hosted a conference call with Rebecca Arend, M.D., Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, The University of Alabama at Birmingham School of Medicine Comprehensive Cancer Center Experimental Therapeutics Program, on April 23, 2020, to discuss the data. Key findings from the P204 study include the following:
DKN-01 Monotherapy in Endometrial Cancer: Twenty-nine endometrial cancer patients were enrolled in the DKN-01 monotherapy arm, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. In the 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of stable disease, and 10 patients (50%) had progressive disease, representing an overall response rate (ORR) of 10% and a disease control rate (DCR) of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of stable disease and five patients (83.3%) had progressive disease.
DKN-01 plus Paclitaxel in Carcinosarcoma: Fifteen patients with carcinosarcoma were enrolled in the DKN-01 plus paclitaxel arm, six of whom were evaluable for response as of the data-cutoff date. Two patients (33%) have had a partial response, one patient (17%) has had a best response of stable disease, and three patients (50%) had progressive disease, representing an ORR of 33% and a DCR of 50%. Nine patients had not reached their first tumor assessment.
Leap Announced Orphan Drug Designation of DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer – Leap announced that the U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug Designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides to Leap certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials.
Selected Second Quarter 2020 Financial Results

Net loss was $6.5 million for the second quarter 2020, compared to $8.4 million for the same period in 2019. This decrease was primarily due to revenue recognized from the BeiGene agreement, a decrease in clinical development expenses and non-cash foreign currency gains associated with changes in the Australian dollar exchange rate related to certain manufacturing activities.

Research and development expenses were $5.4 million for the second quarter 2020, compared to $6.1 million for the same period in 2019. The decrease was primarily due to lower clinical trial costs due to timing of patient enrollment and lower consulting fees associated with research and development activities.

General and administrative expenses were $2.5 million for the second quarter 2020, compared to $2.3 million for the same period in 2019. The increase was primarily due to higher legal, audit and consulting fees associated with corporate and business development activities.

Cash, cash equivalents and marketable securities totaled $64.9 million at June 30, 2020. Research and development incentive receivables, current and long term, totaled approximately $0.3 million at June 30, 2020.