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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Leap Therapeutics Inc | NASDAQ:LPTX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.10 | -3.06% | 3.17 | 3.06 | 3.30 | 3.35 | 3.05 | 3.31 | 137,458 | 21:30:00 |
CAMBRIDGE, Mass., March 16, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2019.
Leap Highlights:
"We ended 2019 having made significant progress in the clinical development of DKN-01 as both a monotherapy and in combination with other therapies as a treatment for cancer. We've generated an abundance of data that continues to demonstrate DKN-01's activity against multiple difficult-to-treat tumor types," said Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "We've carried this momentum into the new year, having achieved our top corporate goal of securing a strategic partner for development of DKN-01 in the Asia-Pacific region. We look forward to working with BeiGene to bring DKN-01 to patients in this geographic area where the incidence of esophagogastric cancer is highly prevalent and to develop DKN-01 in combination with tizlelizumab, their anti-PD-1 antibody."
Business Update
DKN-01 Clinical Update
DKN-01 is a humanized monoclonal antibody targeting the DKK1 protein, a Wnt pathway modulator. DKN-01, as a single agent, has achieved partial responses in three different cancer indications. In combination with immune checkpoint inhibitors and with chemotherapy, DKN-01 has achieved overall response rates and survival data that is greater than the historical benchmarks, particularly in biomarker targeted patient populations.
Selected Year-End and Fourth Quarter 2019 Financial Results
Net loss was $32.9 million for the year ended December 31, 2019, compared to $23.1 million for the year ended December 31, 2018. This increase was primarily due to increased research and development expenses and a change in warrant liability accounting.
Research and development expenses were $24.4 million for the full year 2019, compared to $21.8 million for the same period in 2018. This increase was primarily due to increased full-year clinical trial costs due to increased patient enrollment, payroll and stock-based compensation expense, offset by reduced manufacturing expenses of our clinical product candidates and consulting expenses. Research and development expenses were $5.7 million for the fourth quarter of 2019, compared to $6.9 million for the same period in 2018. This decrease was primarily due to reduced clinical trial costs in the fourth quarter of 2019 resulting from the maturing of our clinical trials and from lower manufacturing and consulting expenses.
General and administrative expenses were $9.1 million for the full year 2019, compared to $8.9 million for the same period in 2018. General and administrative expenses were $2.6 million for the fourth quarter of 2019, compared to $2.1 million for the same period in 2018. These increases were due to increases in performance-based and stock-based compensation expense.
Cash, cash equivalents and marketable securities totaled $3.9 million at December 31, 2019. Research and development incentive receivables totaled $0.2 million. Subsequent to the financial year end, Leap completed a $27.0 million private placement and received $3.0 million from the agreement with BeiGene.
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has formed a partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.
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 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, milestones 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: 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 Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. OPDIVO® is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA. TECENTRIQ® is a registered trademark of Genentech, Inc., South San Francisco, CA.
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
Leap Therapeutics, Inc. | ||||||||||||||
Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31 | Three Months Ended December 31 | |||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 24,366 | $ 21,830 | $ 5,668 | $ 6,908 | ||||||||||
General and administrative | 9,085 | 8,921 | 2,604 | 2,063 | ||||||||||
Total operating expenses | 33,451 | 30,751 | 8,272 | 8,971 | ||||||||||
Loss from operations | (33,451) | (30,751) | (8,272) | (8,971) | ||||||||||
Interest income | 313 | 447 | 32 | 120 | ||||||||||
Interest expense | (23) | (19) | (2) | (1) | ||||||||||
Australian research and development incentives | 132 | 756 | 3 | (432) | ||||||||||
Foreign currency gains (loss) | 126 | (835) | 240 | (220) | ||||||||||
Change in fair value of warrant liability | - | 7,284 | - | 11,004 | ||||||||||
Income (loss) before income taxes | (32,903) | (23,118) | (7,999) | 1,500 | ||||||||||
Income taxes | 3 | (20) | 3 | (20) | ||||||||||
Net income (loss) | (32,900) | (23,138) | (7,996) | 1,480 | ||||||||||
Dividend attributable to down round feature of warrants | (359) | - | - | - | ||||||||||
Net income (loss) attributable to common stockholders | $ (33,259) | $ (23,138) | $ (7,996) | $ 1,480 | ||||||||||
Net income (loss) per share | ||||||||||||||
Basic | $ (1.47) | $ (1.64) | $ (0.33) | $ 0.10 | ||||||||||
Diluted | $ (1.47) | $ (2.11) | $ (0.33) | $ 0.10 | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic | 22,582,687 | 14,144,287 | 24,194,877 | 14,703,159 | ||||||||||
Diluted | 22,582,687 | 14,412,695 | 24,194,877 | 14,764,282 |
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
December 31, | ||||||||||
2019 | 2018 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 3,891 | $ 16,284 | ||||||||
Research and development incentive receivable | 185 | 836 | ||||||||
Prepaid expenses and other current assets | 165 | 202 | ||||||||
Total current assets | 4,241 | 17,322 | ||||||||
Property and equipment, net | 124 | 86 | ||||||||
Right of use assets | 1,026 | - | ||||||||
Deferred tax assets | 127 | 124 | ||||||||
Deferred offering costs | 831 | 162 | ||||||||
Deposits | 1,099 | 1,380 | ||||||||
Total assets | $ 7,448 | $ 19,074 | ||||||||
Liabilities and Stockholders' Equity (Deficiency) | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 4,571 | $ 3,579 | ||||||||
Accrued expenses | 3,441 | 2,872 | ||||||||
Lease liability - current portion | 474 | - | ||||||||
Total current liabilities | 8,486 | 6,451 | ||||||||
Non current liabilities: | ||||||||||
Warrant liability | - | 3,448 | ||||||||
Restricted stock liability | 159 | - | ||||||||
Lease liability, net of current portion | 552 | - | ||||||||
Total liabilities | 9,197 | 9,899 | ||||||||
Stockholders' equity (deficiency): | ||||||||||
Common stock, $0.001 par value; 100,000,000 shares authorized, 24,194,877 | 24 | 15 | ||||||||
Additional paid-in capital | 193,319 | 162,393 | ||||||||
Accumulated other comprehensive income | 76 | 302 | ||||||||
Accumulated deficit | (195,168) | (153,535) | ||||||||
Total stockholders' equity (deficiency) | (1,749) | 9,175 | ||||||||
Total liabilities and stockholders' equity (deficiency) | $ 7,448 | $ 19,074 |
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31, | Three Months Ended December 31, | |||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||
Cash used in operating activities | $ (26,902) | $ (26,033) | $ (5,894) | $ (7,050) | ||||||||||
Cash provided by (used in) investing activities | (85) | - | 15 | - | ||||||||||
Cash provided by (used in) financing activities | 14,817 | 15,906 | (19) | (40) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (223) | 674 | (269) | 125 | ||||||||||
Net decrease in cash and cash equivalents | (12,393) | (9,453) | (6,167) | (6,965) | ||||||||||
Cash and cash equivalents at beginning of period | 16,284 | 25,737 | 10,058 | 23,249 | ||||||||||
Cash and cash equivalents at end of period | $ 3,891 | $ 16,284 | $ 3,891 | $ 16,284 |
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SOURCE Leap Therapeutics, Inc.
Copyright 2020 PR Newswire
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