Leap Therapeutics Reports Third Quarter 2019 Financial Results
"The body of clinical data we presented in the third quarter for both DKN-01 monotherapy and combination treatment for cancer patients continues to demonstrate impressive activity. Patients with advanced gastroesophageal junction and gastric cancer whose tumors expressed high levels of
Dr. Mirabelli continued: "We also completed enrollment in the dose escalation phase of our clinical trial evaluating TRX518 in combination with BAVENCIO and cyclophosphamide; however, we've made the strategic decision to deprioritize further development of TRX518 at this time in order to focus our resources on our more advanced DKN-01 program. The safety profile observed to date was acceptable, and patients who are benefiting from treatment in the TRX518 program will continue to be treated."
DKN-01 Development Program Update
- DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented data from the KEYNOTE-731 clinical study evaluating DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric cancer. Study results demonstrated that patients with
DKK1 -high status had improved outcomes, including longer progression free survival (PFS) independent of PD-L1 Combined Positive Scores (CPS). In ten evaluable gastroesophageal junction and gastric cancer patients who had not received prior PD-1/PD-L1 therapy,DKK1 -high patients experienced 22.1 weeks median progression free survival (PFS) and 31.6 weeks median overall survival (OS), with a 50% overall response rate (ORR) and 80% disease control rate (DCR). Fifteen evaluableDKK1 -low patients experienced 5.9 weeks PFS and 17.4 weeks OS, with a 20% DCR. PD-L1 CPS did not predict efficacy to the combination of DKN-01 plus KEYTRUDA. - DKN-01 in GYNECOLOGICAL CANCERS: The Company presented data from the ongoing clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers at the International Gynecologic Cancer Society Annual Global Meeting held in September. In the cohort of sixteen evaluable monotherapy patients with epithelial endometrial cancer (EEC) with identified Wnt signaling mutations, patients had higher response rates and demonstrated longer PFS as compared to patients without Wnt signaling mutations. Specifically, one patient had a complete response and one patient had a partial response, representing a 12.5% single agent ORR, seven patients had a best response of stable disease, and seven patients had progressive disease. In the six evaluable monotherapy EEC patients who did not have any identified Wnt signaling mutations, none had clinical benefit. Patient follow-up is continuing in this study, which has been expanded to include focused cohorts of patients with carcinosarcoma.
- DKN-01 plus OPDIVO in BILIARY TRACT CANCER: The first patients have been dosed in an investigator-initiated clinical study to evaluate DKN-01 in combination with
Bristol-Myers Squibb's OPDIVO® (nivolumab) in previously treated patients with advanced biliary tract cancer. The study is being conducted byMassachusetts General Hospital and will enroll up to 36 biliary tract cancer patients who have progressed after one or more lines of systemic therapy for advanced biliary tract cancer. The primary endpoint of the study will be ORR, to be assessed in the overall population as well as in subgroups stratified by tumorDKK1 and PD-L1 expression.Bristol-Myers Squibb is providing OPDIVO drug supply and partial funding for the study, with Leap providing DKN-01 drug supply as well as additional partial funding.
TRX518 Development Program Update
- FURTHER DEVELOPMENT OF TRX518 HAS BEEN DEPRIORITIZED: Leap has completed enrollment in dose escalation phase of the clinical trial evaluating TRX518 in combination with cyclophosphamide chemotherapy and BAVENCIO® (avelumab). However, instead of pursuing additional enrollment through the expansion cohorts in this study as initially planned, the Company has decided to reprioritize resources on the further development of the DKN-01 program. There were no safety or efficacy concerns leading to this decision, and patients who are benefitting from the combination therapy will continue to be treated in the study.
Selected Third Quarter 2019 Financial Results
Net loss was
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and marketable securities totaled
About
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements regarding Leap's expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. 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: the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the ability to complete a financing or form business development relationships to fund our expenses; 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; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; 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
KEYTRUDA® is a registered trademark of
CONTACT:
Chief Financial Officer
donsi@leaptx.com
617-714-0360
Investor Relations
212-600-1902
heather@argotpartners.com
Leap Therapeutics, Inc. |
||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||
Operating expenses: |
||||||||||||||
Research and development |
$ 5,772 |
$ 6,457 |
$ 18,698 |
$ 14,922 |
||||||||||
General and administrative |
2,151 |
2,142 |
6,481 |
6,858 |
||||||||||
Total operating expenses |
7,923 |
8,599 |
25,179 |
21,780 |
||||||||||
Loss from operations |
(7,923) |
(8,599) |
(25,179) |
(21,780) |
||||||||||
Interest income |
80 |
128 |
281 |
327 |
||||||||||
Interest expense |
(5) |
(4) |
(21) |
(18) |
||||||||||
Australian research and development incentives |
(7) |
299 |
129 |
1,188 |
||||||||||
Foreign currency loss |
(80) |
(249) |
(114) |
(615) |
||||||||||
Change in fair value of warrant liability |
- |
1,793 |
- |
(3,720) |
||||||||||
Net loss |
(7,935) |
(6,632) |
(24,904) |
(24,618) |
||||||||||
Dividend attributable to down round feature of warrants |
- |
- |
(359) |
- |
||||||||||
Net loss attributable to common stockholders |
$ (7,935) |
$ (6,632) |
$ (25,263) |
$ (24,618) |
||||||||||
Net loss per share |
||||||||||||||
Basic |
$ (0.33) |
$ (0.45) |
$ (1.15) |
$ (1.76) |
||||||||||
Diluted |
$ (0.33) |
$ (0.55) |
$ (1.15) |
$ (1.76) |
||||||||||
Weighted average common shares outstanding |
||||||||||||||
Basic |
23,923,196 |
14,701,785 |
22,039,386 |
13,955,949 |
||||||||||
Diluted |
23,923,196 |
15,211,716 |
22,039,386 |
13,955,949 |
Leap Therapeutics, Inc. |
||||||||||
September 30, |
December 31, |
|||||||||
2019 |
2018 |
|||||||||
(Unaudited) |
||||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ 10,058 |
$ 16,284 |
||||||||
Research and development incentive receivable |
752 |
836 |
||||||||
Prepaid expenses and other current assets |
210 |
202 |
||||||||
Total current assets |
11,020 |
17,322 |
||||||||
Property and equipment, net |
149 |
86 |
||||||||
Right of use asset, net |
1,214 |
- |
||||||||
Research and development incentive receivable, net of current portion |
177 |
- |
||||||||
Deferred tax assets |
120 |
124 |
||||||||
Other assets |
1,461 |
1,542 |
||||||||
Total assets |
$ 14,141 |
$ 19,074 |
||||||||
Liabilities and Stockholders' Equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ 4,889 |
$ 3,579 |
||||||||
Accrued expenses |
2,317 |
2,872 |
||||||||
Restricted stock liability |
159 |
- |
||||||||
Lease liability - current portion |
566 |
- |
||||||||
Total current liabilities |
7,931 |
6,451 |
||||||||
Non current liabilities: |
||||||||||
Warrant liability |
- |
3,448 |
||||||||
Lease liability, net of current portion |
648 |
- |
||||||||
Total liabilities |
8,579 |
9,899 |
||||||||
Stockholders' equity: |
||||||||||
Common stock, $0.001 par value; 100,000,000 shares authorized; 24,194,877 and |
24 |
15 |
||||||||
Additional paid-in capital |
192,383 |
162,393 |
||||||||
Accumulated other comprehensive income |
327 |
302 |
||||||||
Accumulated deficit |
(187,172) |
(153,535) |
||||||||
Total stockholders' equity |
5,562 |
9,175 |
||||||||
Total liabilities and stockholders' equity |
$ 14,141 |
$ 19,074 |
Leap Therapeutics, Inc. |
||||||||||
Nine Months Ended September 30, |
||||||||||
2019 |
2018 |
|||||||||
(Unaudited) |
||||||||||
Cash used in operating activities |
$ (21,008) |
$ (18,983) |
||||||||
Cash used in investing activities |
(100) |
- |
||||||||
Cash provided by financing activities |
14,836 |
15,946 |
||||||||
Effect of exchange rate changes on cash and cash equivalents |
46 |
549 |
||||||||
Net decrease in cash and cash equivalents |
(6,226) |
(2,488) |
||||||||
Cash and cash equivalents at beginning of period |
16,284 |
25,737 |
||||||||
Cash and cash equivalents at end of period |
$ 10,058 |
$ 23,249 |
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