PR Newswire
CAMBRIDGE, Mass., Nov. 9, 2018
CAMBRIDGE, Mass., Nov. 9, 2018 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported a business update and financial results for the third quarter ended September 30, 2018.
"Our team has executed extremely well over the past quarter, rapidly enrolling multiple clinical trials and presenting impressive clinical and preclinical data for both of our programs. We are excited about the potential for our DKN-01 antibody in patients with esophagogastric cancer, both in combination with KEYTRUDA® (pembrolizumab) and with paclitaxel. We believe that the emerging response and disease control rates, and now the progression-free survival and overall survival data, reflect outcomes that are clinically meaningful to patients with very difficult to treat cancer and are greater than what has previously been demonstrated with approved single agents," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we look forward to presenting data from the studies of our TRX518 antibody in combination with KEYTRUDA, OPDIVO® (nivolumab) or gemcitabine at the European Society for Molecular Oncology 2018 Immuno-Oncology Congress in December."
Recent Developments
Since the end of the second quarter, the Company has continued to make strong progress with the development of their product candidates.
Selected Third Quarter 2018 Financial Results
Net loss was $6.6 million for the third quarter of 2018, compared to $6.8 million for the same period in 2017.
Research and development expenses were $6.5 million for the third quarter 2018, compared to $6.8 million for the same period in 2017. The decrease of $0.3 million was primarily due to a decrease of $1.3 million in manufacturing costs related to clinical trial material. This decrease was partially offset by an increase of $0.7 million in clinical trial costs, an increase of $0.2 million in payroll and other related costs and an increase of $0.1 million in stock based compensation expense.
General and administrative expenses were $2.1 million for the third quarter 2018, compared to $1.8 million for the same period in 2017. The increase of $0.3 million in general and administrative expenses was primarily due to a $0.2 million increase in stock based compensation expense and an increase of $0.1 million in legal, audit and consulting fees associated with corporate and business development activities.
Cash, cash equivalents and marketable securities totaled $23.2 million at September 30, 2018. Research and development incentive receivables totaled $2.1 million. In October 2018, we received $0.8 million of research and development tax incentive payments from the Commonwealth of Australia. We anticipate that our current cash resources will extend until late in the third quarter of 2019.
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 cancer, hepatobiliary cancer, and gynecologic cancer. Leap's second clinical candidate, TRX518, is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in advanced solid tumor studies. 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.
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 relating to 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 risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: our ability to operate as a going concern; 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 Leap Therapeutics' periodic filings with the Securities and Exchange Commission (the "SEC"), including Leap Therapeutics' Form 10-K that Leap filed with the SEC on February 23, 2018. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. 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. OPDIVO® is a registered trademark of Bristol-Myers Squibb Company. BAVENCIO® is a registered trademark of Pfizer, Inc. NEXAVAR® is a registered trademark of Bayer Healthcare Pharmaceuticals, Inc.
CONTACT:
Leap Therapeutics, Inc.:
Douglas E. Onsi
Chief Financial Officer
[email protected]
617-714-0360
Argot Partners:
Heather Savelle
Mary Jenkins
212-600-1902
[email protected]
[email protected]
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | ||||||||||||||
Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 6,457 | $ 6,802 | $ 14,922 | $ 18,087 | ||||||||||
General and administrative | 2,142 | 1,780 | 6,858 | 7,719 | ||||||||||
Total operating expenses | 8,599 | 8,582 | 21,780 | 25,806 | ||||||||||
Loss from operations | (8,599) | (8,582) | (21,780) | (25,806) | ||||||||||
Interest income | 128 | 40 | 327 | 130 | ||||||||||
Interest expense | (4) | (21) | (18) | (12) | ||||||||||
Interest expense - related party | - | - | - | (121) | ||||||||||
Australian research and development incentives | 299 | 961 | 1,188 | 1,852 | ||||||||||
Foreign currency gains (loss) | (249) | 787 | (615) | 823 | ||||||||||
Change in fair value of warrant liability | 1,793 | - | (3,720) | - | ||||||||||
Net loss | (6,632) | (6,815) | (24,618) | (23,134) | ||||||||||
Accretion of preferred stock to redemption value | - | - | - | (244) | ||||||||||
Net loss attributable to common stockholders | $ (6,632) | $ (6,815) | $ (24,618) | $ (23,378) | ||||||||||
Net loss per share | ||||||||||||||
Basic | $ (0.45) | $ (0.73) | $ (1.76) | $ (2.72) | ||||||||||
Diluted | $ (0.55) | $ (0.73) | $ (1.76) | $ (2.72) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic | 14,701,785 | 9,395,920 | 13,955,949 | 8,584,558 | ||||||||||
Diluted | 15,211,716 | 9,395,920 | 13,955,949 | 8,584,558 |
Leap Therapeutics, Inc. | ||||||||||
Condensed Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
September 30, | December 31, | |||||||||
2018 | 2017 | |||||||||
(Unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 23,249 | $ 25,737 | ||||||||
Research and development incentive receivable | 937 | 1,744 | ||||||||
Prepaid expenses and other current assets | 191 | 177 | ||||||||
Total current assets | 24,377 | 27,658 | ||||||||
Property and equipment, net | 98 | 135 | ||||||||
Research and development incentive receivable, net of current portion | 1,131 | - | ||||||||
Deferred tax asset | 147 | 158 | ||||||||
Other assets | 1,373 | 1,111 | ||||||||
Total assets | $ 27,126 | $ 29,062 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 4,149 | $ 2,622 | ||||||||
Accrued expenses | 1,897 | 3,461 | ||||||||
Total current liabilities | 6,046 | 6,083 | ||||||||
Non Current liabilities: | ||||||||||
Warrant liability | 14,452 | 11,862 | ||||||||
Total liabilities | 20,498 | 17,945 | ||||||||
Stockholders' equity: | ||||||||||
Common stock, $0.001 par value; 100,000,000 shares authorized; 14,703,159 and 12,354,014 | 15 | 12 | ||||||||
Additional paid-in capital | 161,468 | 141,770 | ||||||||
Accumulated other comprehensive income (loss) | 160 | (268) | ||||||||
Accumulated deficit | (155,015) | (130,397) | ||||||||
Total stockholders' equity | 6,628 | 11,117 | ||||||||
Total liabilities and stockholders' equity | $ 27,126 | $ 29,062 |
Leap Therapeutics, Inc. | ||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||
(in thousands) | ||||||||||
Nine Months Ended September 30, | ||||||||||
2018 | 2017 | |||||||||
(Unaudited) | ||||||||||
Cash used in operating activities | $ (18,983) | $ (15,768) | ||||||||
Cash used in investing activities | - | (64) | ||||||||
Cash provided by financing activities | 15,946 | 29,868 | ||||||||
Effect of exchange rate changes on cash and cash equivalents | 549 | (626) | ||||||||
Net increase (decrease) in cash and cash equivalents | (2,488) | 13,410 | ||||||||
Cash and cash equivalents at beginning of period | 25,737 | 793 | ||||||||
Cash and cash equivalents at end of period | $ 23,249 | $ 14,203 |
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SOURCE Leap Therapeutics, Inc.
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