Leap Therapeutics Reports Second Quarter 2021 Financial Results and Upcoming Data Presentation
"In the first half of the year, we made significant clinical progress in the DisTinGuish study of DKN-01 in combination with BeiGene's tislelizumab, as we completed enrollment in the first-line patient cohort," said
Key DKN-01 2021 Clinical Milestones
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (
Leap made substantial progress with the clinical development of DKN-01 during the first half of 2021 and has an important clinical milestone ahead this quarter:
Completion of Enrollment in First-Line Cohort in the DisTinGuish Study of DKN-01 plus Tislelizumab and Chemotherapy in Gastric Cancer. The Company announced the completion of enrollment for the first-line patient cohort in the DisTinGuish study (NCT04363801), a Phase 2a, open-label, clinical trial evaluating DKN-01 in combination with tislelizumab, BeiGene Ltd.'s (BeiGene) anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ). The study, which is being conducted in two parts in
Initial Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy to be Presented at the
Selected Second Quarter 2021 Financial Results
Net loss was
License revenues 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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Condensed Consolidated Statements of Operations |
|||||||||||||||||||
(in thousands, except share and per share amounts) |
|||||||||||||||||||
(Unaudited) |
(Unaudited) |
||||||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||||||
License revenue |
$ |
375 |
$ |
375 |
$ |
750 |
$ |
750 |
|||||||||||
Operating expenses: |
|||||||||||||||||||
Research and development |
7,206 |
5,350 |
14,013 |
9,953 |
|||||||||||||||
General and administrative |
2,795 |
2,521 |
5,535 |
4,674 |
|||||||||||||||
Total operating expenses |
10,001 |
7,871 |
19,548 |
14,627 |
|||||||||||||||
Loss from operations |
(9,626) |
(7,496) |
(18,798) |
(13,877) |
|||||||||||||||
Interest income |
1 |
20 |
3 |
88 |
|||||||||||||||
Interest expense |
(16) |
(13) |
(30) |
(25) |
|||||||||||||||
Australian research and development incentives |
244 |
30 |
315 |
115 |
|||||||||||||||
Foreign currency gain (loss) |
(129) |
943 |
(150) |
(48) |
|||||||||||||||
Net loss |
(9,526) |
(6,516) |
(18,660) |
(13,747) |
|||||||||||||||
Dividend attributable to down round feature of warrants |
- |
- |
- |
(303) |
|||||||||||||||
Dividend 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 |
$ |
(9,526) |
$ |
(6,516) |
$ |
(18,660) |
$ |
(23,821) |
|||||||||||
Net loss per share |
|||||||||||||||||||
Basic & diluted |
$ |
(0.12) |
$ |
(0.12) |
$ |
(0.24) |
$ |
(0.57) |
|||||||||||
Weighted average common shares outstanding |
|||||||||||||||||||
Basic & diluted |
76,389,525 |
52,442,597 |
76,384,077 |
42,037,405 |
|
||||||||||
Consolidated Balance Sheets |
||||||||||
(in thousands, except share and per share amounts) |
||||||||||
|
|
|||||||||
2021 |
2020 |
|||||||||
(Unaudited) |
||||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ 35,734 |
$ 52,071 |
||||||||
Research and development incentive receivable |
22 |
73 |
||||||||
Prepaid expenses and other current assets |
264 |
130 |
||||||||
Total current assets |
36,020 |
52,274 |
||||||||
Property and equipment, net |
50 |
65 |
||||||||
Property and equipment, net |
337 |
528 |
||||||||
Research and development incentive receivable, net of current portion |
309 |
- |
||||||||
Deferred tax assets |
176 |
179 |
||||||||
Deferred costs |
68 |
345 |
||||||||
Deposits |
980 |
980 |
||||||||
Total assets |
$ 37,940 |
$ 54,371 |
||||||||
Liabilities and Stockholders' Equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ 4,343 |
$ 2,717 |
||||||||
Accrued expenses |
2,609 |
2,747 |
||||||||
Deferred revenue |
750 |
1,500 |
||||||||
Lease liability - current portion |
354 |
408 |
||||||||
Total current liabilities |
8,056 |
7,372 |
||||||||
Non current liabilities: |
||||||||||
Restricted stock liability |
- |
204 |
||||||||
Lease liability, net of current portion |
- |
144 |
||||||||
Total liabilities |
8,056 |
7,720 |
||||||||
Stockholders' equity: |
||||||||||
Common stock, |
60 |
60 |
||||||||
Additional paid-in capital |
271,918 |
270,155 |
||||||||
Accumulated other comprehensive loss |
(449) |
(579) |
||||||||
Accumulated deficit |
(241,645) |
(222,985) |
||||||||
Total stockholders' equity |
29,884 |
46,651 |
||||||||
Total liabilities and stockholders' equity |
$ 37,940 |
$ 54,371 |
Leap Therapeutics, Inc. |
|||||||||||||
Condensed Consolidated Statements of Cash Flows |
|||||||||||||
(in thousands) |
|||||||||||||
(Unaudited) |
|||||||||||||
Six Months Ended June 30 |
|||||||||||||
2021 |
2020 |
||||||||||||
Cash used in operating activities |
$ |
(16,339) |
$ |
(13,377) |
|||||||||
Cash provided by investing activities |
- |
25 |
|||||||||||
Cash provided by financing activities |
18 |
74,382 |
|||||||||||
Effect of exchange rate changes on cash and cash equivalents |
(16) |
(34) |
|||||||||||
Net increase (decrease) in cash and cash equivalents |
(16,337) |
60,996 |
|||||||||||
Cash and cash equivalents at beginning of period |
52,071 |
3,891 |
|||||||||||
Cash and cash equivalents at end of period |
$ |
35,734 |
$ |
64,887 |
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