On March 11, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Leap Therapeutics, MAR 11, 2022, View Source [SID1234609977]).
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Leap Highlights:
Presented positive new data from the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the ESMO (Free ESMO Whitepaper) Annual Congress and ASCO (Free ASCO Whitepaper) GI Cancers Symposium
Completed a $103.6 million public offering of common stock and pre-funded warrants to purchase common stock, resulting in net proceeds of $96.8 million
Entered partnership on companion diagnostic with Leica Biosystems to advance care for cancer patients
Presented clinical data from its Phase 2 clinical trial of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer
"2021 was year of substantial clinical accomplishments for Leap as we presented positive data from our DisTinGuish clinical trial, which demonstrated compelling efficacy driven by enhanced clinical responses and survival benefit associated with high tumoral DKK1 expression that is independent of PD-L1 expression in patients with first-line gastroesophageal junction (G/GEJ) cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Following our public offering, we are well funded to advance DKN-01 into the next stages of development in G/GEJ and other cancers, and we look forward to presenting updated data from the DisTinGuish Study in the second half of 2022."
Business Update
Leap Completed a $103.6 Million Public Offering of Common Stock and Pre-Funded Warrants to Purchase Common Stock. In September 2021, Leap announced the commencement and closing of an underwritten public offering of 27,568,072 shares of its common stock, including the sale of an additional 4,740,000 shares of its common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares, and of pre-funded warrants to purchase 8,771,928 shares of its common stock. Aggregate gross proceeds to Leap from the offering were $103.6 million, including $7.25 million invested by its collaborator and existing investor BeiGene, Ltd., resulting in net proceeds after underwriting discounts and commissions and offering expenses of $96.8 million.
Entered Partnership on Companion Diagnostic with Leica Biosystems to Advance Care for Cancer Patients. In January 2022, Leap and Leica Biosystems, a cancer diagnostics company, entered into an agreement to develop a companion diagnostic to detect DKK1. The assay developed by Leica will utilize RNAscope technology on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity to help identify patients most likely to benefit from DKN-01 treatment.
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.
Positive New Data from the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy Presented at the ASCO (Free ASCO Whitepaper) GI Cancer Symposium. The Company presented positive updated new data from the first-line cohort of the Phase 2a study in patients with gastric or gastroesophageal junction cancer (G/GEJ) and initial findings from the still-enrolling Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced G/GEJ patients with high tumoral DKK1 expression.
First-Line Part A Key Findings:
Overall preliminary median progression-free survival (PFS) was 10.7 months
PFS was longer in DKK1-high patients at 11.9 months, compared to 10.7 months in DKK1-low patients
Preliminary median duration of response (DoR) was 10.7 months in DKK1-high patients, compared to 7.9 months in DKK1-low patients
Median overall survival has not been reached
Among patients who received a full first cycle of DKN-01 (modified intent to treat, n=22), the objective response rate (ORR) was 68%, including one complete response (CR) and 14 partial responses (PR)
90% ORR in DKK1-high patients (n=10)
56% ORR in DKK1-low patients (n=9)
Activity was independent of PD-L1 expression
79% ORR in PD-L1-low (vCPS < 5) and 67% ORR in PD-L1-high (vCPS > 5) patients
100% ORR in DKK1-high, PD-L1-low patients (n=6)
Combination was well tolerated, safety profile consistent with previous update and reflecting the underlying patient population
Second-Line Part B Key Findings:
DKN-01 and tislelizumab administered in DKK1-high, PD-1 naïve patients was well tolerated at both 300mg and 600mg DKN-01 doses
Among evaluable patients who received a full first cycle of DKN-01 (response evaluable modified intent to treat, n=20), the objective response rate (ORR) was 25%, including 5 PRs and 4 stable disease (SD). One additional patient has had an irPR by iRECIST criteria
PD-L1 expression is low overall in the study population and not correlated with DKK1 expression
The study is ongoing and enrolling in the 600mg DKN-01 cohort. Twelve patients were on study at the time of the data cut, four of whom had not yet had their first imaging assessment
Final Data for DKN-01 as a Monotherapy or in Combination with Paclitaxel in Groups Composed of Epithelial Endometrial Cancer (EEC), Epithelial Ovarian Cancer (EOC), or Carcinosarcoma (MMMT) Patients Presented at the SGO 2021 Virtual Meeting on Women’s Cancer. The key findings from the study were:
DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 23 EEC patients treated with DKN-01 monotherapy for whom DKK1 expression data was available, patients with DKK1-high tumors (n=8) achieved 1 CR and 1 PR, along with greater ORR (25% vs. 0%), DCR (63% vs. 7%), and median PFS (4.3 months vs. 1.8 months [HR 0.26; 95 CI: 0.09, 0.75]) compared to patients with DKK1-low tumors (n=15). In the group of 24 EEC patients treated with DKN-01 plus paclitaxel, 72% of whom had received three or more prior systemic therapies, DKK1-high patients (n=11) had improved median PFS (5.4 months vs. 1.8 months [HR 0.34; 95% CI: 0.12, 0.97]) compared to DKK1-low patients (n=9).
Selected Year-End and Fourth Quarter 2021 Financial Results
Net Loss was $40.6 million for the year ended December 31, 2021, compared to $27.5 million for the year ended December 31, 2020. The increase was primarily due to increased research and development expenses and general and administrative expenses.
License revenues were $1.5 million for each of the full years 2021 and 2020, and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. License revenues were $0.4 million for each of the fourth quarters 2021 and 2020.
Research and development expenses were $32.2 million for the full year 2021, compared to $20.4 million for the same period in 2020. Research and development expenses were $8.1 million for the fourth quarter ended 2021, compared to $5.1 million for the same period in 2020. The increases were primarily due to an increase in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns, an increase in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, and an increase in payroll and other related expenses due to an increase in headcount of research and development full time employees.
General and administrative expenses were $10.8 million for the full year 2021, compared to $9.6 million for the same period in 2020. General and administrative expenses were $2.8 million for the fourth quarter ended 2021, compared to $2.4 million for the same period in 2020. The increases were primarily due to an increase in payroll and other related expenses due to an increase in headcount of general and administrative full time employees and an increase in compensation expense.
Cash and cash equivalents totaled $114.9 million at December 31, 2021. Research and development incentive receivables totaled $1.2 million at December 31, 2021.