Full Press Release Details
Leap Therapeutics Reports Second Quarter
2020 Financial Results
Cambridge, MA - August 13, 2020
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today reported financial results for the second quarter ended June 30, 2020.
Leap Second Quarter Highlights:
"Our partnership with BeiGene for
the clinical development and commercialization of DKN-01 is progressing extremely well, and we look forward to dosing the first
patient this quarter in the combination study of DKN-01 plus tislelizumab, BeiGene's anti-PD-1 antibody, for the treatment
of gastric or gastroesophageal junction cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of
Leap. "DKN-01 continues to show potential to treat multiple biomarker-defined cancers, as both a single agent and in combination
with chemotherapy or anti-PD-1 therapies. We are excited about the promise of this program and, with the proceeds from our recent
public offering, are well funded to drive development forward."
DKN-01 Clinical Update
DKN-01 is a humanized monoclonal antibody
that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 has an
important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.
| DKN-01 Monotherapy in Endometrial Cancer: Twenty-nine endometrial cancer patients were enrolled in the DKN-01 monotherapy arm, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. In the 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of stable disease, and 10 patients (50%) had progressive disease, representing an overall response rate (ORR) of 10% and a disease control rate (DCR) of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of stable disease and five patients (83.3%) had progressive disease. | ||
| DKN-01 plus Paclitaxel in Carcinosarcoma: Fifteen patients with carcinosarcoma were enrolled in the DKN-01 plus paclitaxel arm, six of whom were evaluable for response as of the data-cutoff date. Two patients (33%) have had a partial response, one patient (17%) has had a best response of stable disease, and three patients (50%) had progressive disease, representing an ORR of 33% and a DCR of 50%. Nine patients had not reached their first tumor assessment. |
Selected Second Quarter 2020 Financial
Net loss was $6.5 million for the second
quarter 2020, compared to $8.4 million for the same period in 2019. This decrease was primarily due to revenue recognized from
the BeiGene agreement, a decrease in clinical development expenses and non-cash foreign currency gains associated with changes
in the Australian dollar exchange rate related to certain manufacturing activities.
Research and development expenses were
$5.4 million for the second quarter 2020, compared to $6.1 million for the same period in 2019. The decrease was primarily due
to lower clinical trial costs due to timing of patient enrollment and lower consulting fees associated with research and development
General and administrative expenses were
$2.5 million for the second quarter 2020, compared to $2.3 million for the same period in 2019. The increase was primarily due
to higher legal, audit and consulting fees associated with corporate and business development activities.
Cash, cash equivalents and marketable securities
totaled $64.9 million at June 30, 2020. Research and development incentive receivables, current and long term, totaled approximately
$0.3 million at June 30, 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 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 view 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 Leap's 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: that the initiation, conduct, and
completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely
affected, or impacted by COVID-19 related issues, 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 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the
SEC. 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.
President & Chief Executive Officer
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| June 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 64,887 | $ | 3,891 | ||||
| Research and development incentive receivable | 181 | 185 | ||||||
| Prepaid expenses and other current assets | 212 | 165 | ||||||
| Total current assets | 65,280 | 4,241 | ||||||
| Property and equipment, net | 81 | 124 | ||||||
| Right of use assets | 711 | 1,026 | ||||||
| Research and development incentive receivable, net of current portion | 124 | - | ||||||
| Deferred tax assets | 125 | 127 | ||||||
| Deferred costs | 413 | 831 | ||||||
| Deposits | 939 | 1,099 | ||||||
| Total assets | $ | 67,673 | $ | 7,448 | ||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,716 | $ | 4,571 | ||||
| Accrued expenses | 2,232 | 3,441 | ||||||
| Deferred revenue - current portion | 1,500 | - | ||||||
| Lease liability - current portion | 388 | 474 | ||||||
| Total current liabilities | 6,836 | 8,486 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | - | 159 | ||||||
| Deferred revenue, net of current portion | 750 | - | ||||||
| Lease liability, net of current portion | 354 | 552 | ||||||
| Total liabilities | 7,940 | 9,197 | ||||||
| Stockholders' equity (deficiency): | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 59,657,742 and 24,194,877 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 60 | 24 | ||||||
| Additional paid-in capital | 268,770 | 193,319 | ||||||
| Accumulated other comprehensive income | 121 | 76 | ||||||
| Accumulated deficit | (209,218 | ) | (195,168 | ) | ||||
| Total stockholders' equity (deficiency) | 59,733 | (1,749 | ) | |||||
| Total liabilities and stockholders' equity (deficiency) | $ | 67,673 | $ | 7,448 |
| Leap Therapeutics, Inc. | |
| Condensed Consolidated Statements of Operations | |
| (in thousands, except share and per share amounts) |
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| License revenue | $ | 375 | $ | - | $ | 750 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,350 | 6,136 | 9,953 | 12,926 | ||||||||||||
| General and administrative | 2,521 | 2,325 | 4,674 | 4,330 | ||||||||||||
| Total operating expenses | 7,871 | 8,461 | 14,627 | 17,256 | ||||||||||||
| Loss from operations | (7,496 | ) | (8,461 | ) | (13,877 | ) | (17,256 | ) | ||||||||
| Interest income | 20 | 119 | 88 | 201 | ||||||||||||
| Interest expense | (13 | ) | (9 | ) | (25 | ) | (16 | ) | ||||||||
| Australian research and development incentives | 30 | 61 | 115 | 136 | ||||||||||||
| Foreign currency gains (loss) | 943 | (76 | ) | (48 | ) | (34 | ) | |||||||||
| Net loss | (6,516 | ) | (8,366 | ) | (13,747 | ) | (16,969 | ) | ||||||||
| Dividend attributable to down round feature of warrants | - | - | (303 | ) | (359 | ) | ||||||||||
| Dividend attributable to Series A & B convertible preferred stock | - | - | (372 | ) | - | |||||||||||
| Series A & B convertible preferred stock - beneficial conversion feature | - | - | (9,399 | ) | - | |||||||||||
| Net loss attributable to common stockholders | $ | (6,516 | ) | $ | (8,366 | ) | $ | (23,821 | ) | $ | (17,328 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.12 | ) | $ | (0.37 | ) | $ | (0.57 | ) | $ | (0.82 | ) | ||||
| Diluted | $ | (0.12 | ) | $ | (0.37 | ) | $ | (0.57 | ) | $ | (0.82 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 52,442,597 | 22,906,025 | 42,037,405 | 21,081,869 | ||||||||||||
| Diluted | 52,442,597 | 22,906,025 | 42,037,405 | 21,081,869 |
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Cash Flows |
| (in thousands) |
| (Unaudited) | ||||||||
| Six Months Ended June 30 | ||||||||
| 2020 | 2019 | |||||||
| Cash used in operating activities | $ | (13,377 | ) | $ | (14,051 | ) | ||
| Cash provided by (used in) investing activities | 25 | (100 | ) | |||||
| Cash provided by financing activities | 74,382 | 13,582 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (34 | ) | 32 | |||||
| Net increase in cash and cash equivalents | 60,996 | (537 | ) | |||||
| Cash and cash equivalents at beginning of period | 3,891 | 16,284 | ||||||
| Cash and cash equivalents at end of period | $ | 64,887 | $ | 15,747 |