PR Newswire
CAMBRIDGE, Mass., April 1, 2019
CAMBRIDGE, Mass., April 1, 2019 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported an update on its clinical development programs along with financial results for the fourth quarter and year ended December 31, 2018.
Leap Highlights
DKN-01 Clinical Update
DKN-01 is a humanized monoclonal antibody targeting the Dickkopf-1 (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.
TRX518 Clinical Update
TRX518 is unique among Glucocorticoid-Induced TNF Receptor (GITR) agonist antibodies for its aglycosyl design, permitting activation of GITR signaling without depleting CD8-positive T-effector cells. TRX518 has been shown to increase CD8-positive T-effector cell infiltrate and the expression of granzyme B, as well as decrease CD4-positive T-regulatory cell infiltrate. TRX518 is the first GITR agonist antibody in the industry to have reported partial responses as a monotherapy, in combination with PD-1 antibodies, and in combination with gemcitabine chemotherapy.
Selected Year-End and Fourth Quarter 2018 Financial Results
Net loss was $23.1 million for the year ended December 31, 2018, compared to $29.7 million for the year ended December 31, 2017. This decrease was primarily due to a noncash charge to decrease the fair value of the warrant liability. Net income was $1.5 million for the fourth quarter of 2018, compared to a net loss of $6.6 million for the same period in 2017. The 2018 increase was due to the decrease in the fair value of the warrant liability in the fourth quarter, leading to a $11 million non-cash gain. The requirement to revalue the warrant liability each quarter has resulted in the Company's net income or net loss being highly variable.
Research and development expenses were $21.8 million for the full year 2018, compared to $22.5 million for the same period in 2017. This decrease was primarily due to reduced manufacturing expenses of our clinical product candidates and a decrease in stock based compensation expense offset by increased clinical trial costs due to increased patient enrollment. Research and development expenses were $6.9 million for the fourth quarter of 2018, compared to $4.4 million for the same period in 2017. This increase was due to increased clinical development expense associated with the start-up operations and enrollment of our ongoing clinical trials.
General and administrative expenses were $8.9 million for the full year 2018, compared to $9.8 million for the same period in 2017. This decrease was due to a decrease in stock based compensation expense. General and administrative expenses were $2.1 million for the fourth quarter of 2017, compared to $2.1 million for the same period in 2017.
Cash, cash equivalents and marketable securities totaled $16.3 million at December 31, 2018. Research and development incentive receivables totaled $0.8 million. Subsequent to the financial year end, Leap completed a public offering of $13.225 million of common stock and warrants, resulting in net cash proceeds of $12.1 million. Leap believes that its current cash and the expected receipt of research and development tax incentives will be sufficient to fund its operating expenses into the second quarter of 2020.
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'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 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 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 Leap Therapeutics' periodic filings with the SEC, including Leap Therapeutics' Annual Report on Form 10-K for the fiscal year ended December 31, 2018 that Leap filed with the SEC on April 1, 2019. 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., Kenilworth, NJ, USA. OPDIVO® is a registered trademark of Bristol Myers-Squibb Company.
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
[email protected]
617-714-0360
Argot Partners
Investor Relations
Heather Savelle
212-600-1902
[email protected]
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 | |||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
Operating expenses: | ||||||||||||||
Research and development | $ 21,830 | $ 22,503 | $ 6,908 | $ 4,416 | ||||||||||
General and administrative | 8,921 | 9,849 | 2,063 | 2,130 | ||||||||||
Total operating expenses | 30,751 | 32,352 | 8,971 | 6,546 | ||||||||||
Loss from operations | (30,751) | (32,352) | (8,971) | (6,546) | ||||||||||
Interest income | 447 | 170 | 120 | 40 | ||||||||||
Interest expense | (19) | (528) | (1) | (516) | ||||||||||
Interest expense - related party | - | (121) | - | - | ||||||||||
Australian research and development incentives | 756 | 1,715 | (432) | (137) | ||||||||||
Foreign currency gains (loss) | (835) | 759 | (220) | (64) | ||||||||||
Change in fair value of warrant liability | 7,284 | 473 | 11,004 | 473 | ||||||||||
Loss before income taxes | (23,118) | (29,884) | 1,500 | (6,750) | ||||||||||
Income taxes | (20) | 157 | (20) | 157 | ||||||||||
Net loss | (23,138) | (29,727) | 1,480 | (6,593) | ||||||||||
Accretion of preferred stock to redemption value | - | (244) | - | - | ||||||||||
Net loss attributable to common stockholders | $ (23,138) | $ (29,971) | $ 1,480 | $ (6,593) | ||||||||||
Net income (loss) per share | ||||||||||||||
Basic | $ (1.64) | $ (3.27) | ||||||||||||
Diluted | $ (2.11) | $ (3.31) | ||||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic | 14,144,287 | 9,161,844 | ||||||||||||
Diluted | 14,412,695 | 9,188,587 |
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
December 31, | ||||||||||
2018 | 2017 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 16,284 | $ 25,737 | ||||||||
Research and development incentive receivable | 836 | 1,744 | ||||||||
Prepaid expenses and other current assets | 202 | 177 | ||||||||
Total current assets | 17,322 | 27,658 | ||||||||
Property and equipment, net | 86 | 135 | ||||||||
Deferred tax asset | 124 | 158 | ||||||||
Other assets | 1,542 | 1,111 | ||||||||
Total assets | $ 19,074 | $ 29,062 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 3,579 | $ 2,622 | ||||||||
Accrued expenses | 2,872 | 3,461 | ||||||||
Total current liabilities | 6,451 | 6,083 | ||||||||
Non current liabilities: | ||||||||||
Warrant liability | 3,448 | 11,862 | ||||||||
Total liabilities | 9,899 | 17,945 | ||||||||
Stockholders' equity: | ||||||||||
Common stock, $0.001 par value; 100,000,000 shares authorized as | 15 | 12 | ||||||||
Additional paid-in capital | 162,393 | 141,770 | ||||||||
Accumulated other comprehensive income (loss) | 302 | (268) | ||||||||
Accumulated deficit | (153,535) | (130,397) | ||||||||
Total stockholders' equity | 9,175 | 11,117 | ||||||||
Total liabilities and stockholders' equity | $ 19,074 | $ 29,062 | ||||||||
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31, | Three Months Ended December 31, | |||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
Cash used in operating activities | $ (26,033) | $ (22,137) | $ (7,050) | $ (6,369) | ||||||||||
Cash used in investing activities | - | (64) | - | - | ||||||||||
Cash provided by (used in) financing activities | 15,906 | 47,763 | (40) | 17,895 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | 674 | (618) | 125 | 8 | ||||||||||
Net increase (decrease) in cash and cash equivalents | (9,453) | 24,944 | (6,965) | 11,534 | ||||||||||
Cash and cash equivalents at beginning of period | 25,737 | 793 | 23,249 | 14,203 | ||||||||||
Cash and cash equivalents at end of period | $ 16,284 | $ 25,737 | $ 16,284 | $ 25,737 |
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SOURCE Leap Therapeutics, Inc.
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