Leap Therapeutics Reports First Quarter 2019 Financial Results
"In the first quarter, we presented important new data for both of our programs. DKN-01's activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented
Recent Developments
- DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher
DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete. - DKN-01 in GYNECOLOGICAL CANCERS: At the
Society for Gynecologic Oncology 50th Annual Meeting on Women's Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing. - DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in
DKK1 -positive metastatic prostate cancer patients. - TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.
- TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO® (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First 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. |
||||||||||
Condensed Consolidated Statements of Operations |
||||||||||
(in thousands, except share and per share amounts) |
||||||||||
Three Months Ended March 31, |
||||||||||
2019 |
2018 |
|||||||||
(Unaudited) |
||||||||||
Operating expenses: |
||||||||||
Research and development |
$ 6,790 |
$ 4,231 |
||||||||
General and administrative |
2,005 |
2,113 |
||||||||
Total operating expenses |
8,795 |
6,344 |
||||||||
Loss from operations |
(8,795) |
(6,344) |
||||||||
Interest income |
82 |
77 |
||||||||
Interest expense |
(7) |
(6) |
||||||||
Australian research and development incentives |
75 |
646 |
||||||||
Foreign currency gains (loss) |
42 |
(144) |
||||||||
Change in fair value of warrant liability |
- |
(4,851) |
||||||||
Net loss |
(8,603) |
(10,622) |
||||||||
Dividend attributable to down round feature of warrants |
(359) |
- |
||||||||
Net loss attributable to common stockholders |
$ (8,962) |
$ (10,622) |
||||||||
Net loss per share - basic and diluted |
$ (0.47) |
$ (0.85) |
||||||||
Weighted average common shares outstanding - basic and diluted |
19,237,444 |
12,449,421 |
Leap Therapeutics, Inc. |
||||||||||
Condensed Consolidated Balance Sheets |
||||||||||
(in thousands, except share and per share amounts) |
||||||||||
March 31, |
December 31, |
|||||||||
2019 |
2018 |
|||||||||
(Unaudited) |
||||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ 21,709 |
$ 16,284 |
||||||||
Research and development incentive receivable |
844 |
836 |
||||||||
Prepaid expenses and other current assets |
159 |
202 |
||||||||
Total current assets |
22,712 |
17,322 |
||||||||
Property and equipment, net |
74 |
86 |
||||||||
Right of use asset, net |
1,578 |
- |
||||||||
Research and development incentive receivable, net of current portion |
74 |
- |
||||||||
Deferred tax assets |
126 |
124 |
||||||||
Other assets |
1,519 |
1,542 |
||||||||
Total assets |
$ 26,083 |
$ 19,074 |
||||||||
Liabilities and Stockholders' Equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ 3,298 |
$ 3,579 |
||||||||
Accrued expenses |
4,150 |
2,872 |
||||||||
Lease liability - current portion |
738 |
- |
||||||||
Total current liabilities |
8,186 |
6,451 |
||||||||
Non current liabilities: |
||||||||||
Warrant liability |
- |
3,448 |
||||||||
Lease liability, net of current portion |
833 |
- |
||||||||
Total liabilities |
9,019 |
9,899 |
||||||||
Commitments and contingencies |
||||||||||
Stockholders' equity: |
||||||||||
Common stock, $0.001 par value; 100,000,000 shares authorized as of |
22 |
15 |
||||||||
Additional paid-in capital |
187,635 |
162,393 |
||||||||
Accumulated other comprehensive income |
278 |
302 |
||||||||
Accumulated deficit |
(170,871) |
(153,535) |
||||||||
Total stockholders' equity |
17,064 |
9,175 |
||||||||
Total liabilities and stockholders' equity |
$ 26,083 |
$ 19,074 |
Leap Therapeutics, Inc. |
||||||||||
Condensed Consolidated Statements of Cash Flows |
||||||||||
(in thousands) |
||||||||||
Three Months Ended March 31, |
||||||||||
2019 |
2018 |
|||||||||
(Unaudited) |
||||||||||
Cash used in operating activities |
$ (6,868) |
$ (5,478) |
||||||||
Cash provided by financing activities |
12,322 |
15,005 |
||||||||
Effect of exchange rate changes on cash and cash equivalents |
(29) |
112 |
||||||||
Net increase in cash and cash equivalents |
5,425 |
9,639 |
||||||||
Cash and cash equivalents at beginning of period |
16,284 |
25,737 |
||||||||
Cash and cash equivalents at end of period |
$ 21,709 |
$ 35,376 |
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