Leap Therapeutics Reports First Quarter 2021 Financial Results
Leap First Quarter Highlights:
- Completed enrollment for first-line patient cohort in the DisTinGuish study, a clinical trial evaluating Leap's anti-Dickkopf-1 (
DKK1 ) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.'s anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ) - Presented updated clinical data from the Phase 2 study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the
Society of Gynecologic Oncology (SGO) 2021 Virtual Annual Meeting on Women's Cancer - Announced partnership to use a clinically validated tumor expression assay utilizing RNAscope® and image analysis with Flagship Biosciences for patient enrollment
"We're off to a strong start this year as we've continued to advance our understanding of DKN-01 and the potential role it can play as both a monotherapy or in combination with existing treatments in multiple
DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the
- Leap Announced Completion of Enrollment in First-Line Cohort in the DisTinGuish Study of DKN-01 plus Tislelizumab and Chemotherapy in Gastric Cancer – In
April 2021 , Leap announced the completion of enrollment for the first-line patient cohort in the DisTinGuish study (NCT04363801), a clinical trial evaluating DKN-01 in combination with tislelizumab, BeiGene Ltd.'s anti-PD-1 antibody, with or without chemotherapy, in patients with G/GEJ. The study, which is being conducted in two parts inthe United States and theRepublic of Korea , enrolled 25 patients with first-line G/GEJ cancer and will enroll up to 48 patients with second-line G/GEJ cancer whose tumors express high levels ofDKK1 . Initial data is expected in the second half of 2021. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 inAsia (excludingJapan ),Australia, and New Zealand .
- Leap Presented Final Data for DKN-01 in Gynecologic Cancers – At the SGO 2021 Virtual Annual Meeting on Women's Cancer, Leap presented the final data from the study of 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. The key findings from the study were:
- EEC patients and patients with Wnt activating mutations express higher levels of DKK1: EEC patients expressed higher levels of
DKK1 and had a higher frequency of Wnt activating mutations than patients with EOC. Within EEC, patients with endometrioid histology had higherDKK1 expression than those with non-endometrioid histology. Patients whose tumors had Wnt activating mutations expressed 14.4 times higher levels ofDKK1 .
- DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 22 EEC patients treated with DKN-01 monotherapy for whom
DKK1 expression data was available, patients withDKK1 -high tumors (n=7) had greater ORR (14% vs. 0%), DCR (57% vs. 7%), and median PFS (3.0 months vs. 1.8 months [HR 0.39; 95% CI: 0.14, 1.1]) compared to patients withDKK1 -low tumors (n=15). Additionally, seven patients did not haveDKK1 expression results available, of whom one had a complete response (14%) and five (72%) had a best response of stable disease, including three patients with Wnt activating mutations. 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 toDKK1 -low patients (n=9). Four patients did not haveDKK1 expression data available.
- Presented
DKK1 Biomarker Assay Validation Data – At theAmerican Association for Cancer Research Annual Meeting 2021, Leap and its clinical laboratory partner, Flagship Biosciences, presented data on the validation of aDKK1 RNAscope chromogenic in situ hybridization (CISH) assay and digital image analysis solution. Leap and Flagship have demonstrated that theDKK1 RNAscope assay and accompanying digital image analysis solution is specific, sensitive, accurate and reproducible according to Clinical Laboratory Improvements Amendments (CLIA) guidelines. The assay is currently being used to prospectively identify G/GEJ patients with elevated tumoral expression ofDKK1 in the ongoing DisTinGuish clinical trial.
Selected First Quarter 2021 Financial Results
Net Loss was
License revenues for each of the first quarter 2021 and 2020 were
Research and development expenses were
General and administrative expenses were
Cash and cash equivalents totaled
About
RNAscope® is a registered trademark of
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestone, or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in
CONTACT:
President & Chief Executive Officer
617-714-0360
donsi@leaptx.com
Investor Relations
212-600-1902
heather@argotpartners.com
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Consolidated Statements of Operations |
||||||||||
(in thousands, except share and per share amounts) |
||||||||||
(Unaudited) |
||||||||||
Three Months Ended |
||||||||||
2021 |
2020 |
|||||||||
License revenue |
$ 375 |
$ 375 |
||||||||
Operating expenses: |
||||||||||
Research and development |
6,807 |
4,603 |
||||||||
General and administrative |
2,740 |
2,153 |
||||||||
Total operating expenses |
9,547 |
6,756 |
||||||||
Loss from operations |
(9,172) |
(6,381) |
||||||||
Interest income |
2 |
68 |
||||||||
Interest expense |
(14) |
(12) |
||||||||
Australian research and development incentives |
71 |
85 |
||||||||
Foreign currency gains |
(21) |
(991) |
||||||||
Loss before income taxes |
(9,134) |
(7,231) |
||||||||
Dividend attributable to down round feature of warrants |
- |
(303) |
||||||||
Dividends attributable to Series A & B convertible preferred stock |
- |
(372) |
||||||||
Series A & B convertible preferred stock - beneficial conversion feature |
- |
(9,399) |
||||||||
Net loss attributable to common stockholders |
$ (9,134) |
$ (17,305) |
||||||||
Net loss per share |
||||||||||
Basic & diluted |
$ (0.12) |
$ (0.55) |
||||||||
Weighted average common shares outstanding |
||||||||||
Basic & diluted |
76,378,569 |
31,632,213 |
|
|||||||||
Consolidated Balance Sheets |
|||||||||
(in thousands, except share and per share amounts) |
|||||||||
|
|
||||||||
2021 |
2020 |
||||||||
(Unaudited) |
|||||||||
Cash and cash equivalents |
$ 43,491 |
$ 52,071 |
|||||||
Research and development incentive receivable |
22 |
73 |
|||||||
Prepaid expenses and other current assets |
266 |
130 |
|||||||
Total current assets |
43,779 |
52,274 |
|||||||
Property and equipment, net |
56 |
65 |
|||||||
Right of use assets, net |
433 |
528 |
|||||||
Research and development incentive receivable, net of current portion |
70 |
- |
|||||||
Deferred tax assets |
178 |
179 |
|||||||
Deferred costs |
311 |
345 |
|||||||
Deposits |
980 |
980 |
|||||||
Total assets |
$ 45,807 |
$ 54,371 |
|||||||
Accounts payable |
$ 3,514 |
$ 2,717 |
|||||||
Accrued expenses |
2,335 |
2,747 |
|||||||
Deferred revenue - current portion |
1,125 |
1,500 |
|||||||
Lease liability - current portion |
418 |
408 |
|||||||
Total current liabilities |
7,392 |
7,372 |
|||||||
Restricted stock liability |
- |
204 |
|||||||
Lease liability, net of current portion |
36 |
144 |
|||||||
Total liabilities |
7,428 |
7,720 |
|||||||
Common stock, |
60 |
60 |
|||||||
Additional paid-in capital |
271,002 |
270,155 |
|||||||
Accumulated other comprehensive loss |
(564) |
(579) |
|||||||
Accumulated deficit |
(232,119) |
(222,985) |
|||||||
Total stockholders' equity |
38,379 |
46,651 |
|||||||
Total liabilities and stockholders' equity |
$ 45,807 |
$ 54,371 |
Leap Therapeutics, Inc. |
|||||||||||
Condensed Consolidated Statements of Cash Flows |
|||||||||||
(in thousands) |
|||||||||||
(Unaudited) |
|||||||||||
Three Months Ended |
|||||||||||
2021 |
2020 |
||||||||||
Cash used in operating activities |
$ (8,587) |
$ (3,926) |
|||||||||
Cash provided by financing activities |
14 |
25,605 |
|||||||||
Effect of exchange rate changes on cash and cash equivalents |
(7) |
(105) |
|||||||||
Net increase (decrease) in cash and cash equivalents |
(8,580) |
21,574 |
|||||||||
Cash and cash equivalents at beginning of period |
52,071 |
3,891 |
|||||||||
Cash and cash equivalents at end of period |
$ 43,491 |
$ 25,465 |
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