Full Press Release Details
Leap Therapeutics Reports Third Quarter
2020 Financial Results
Cambridge, MA - November 12, 2020
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today reported financial results for the third quarter ended September 30, 2020.
Leap Third Quarter Highlights:
"Data from our ongoing studies continue
to demonstrate the potential of DKN-01 as both a single-agent or combination treatment with chemotherapy or anti-PD1 therapies
for the treatment of biomarker-defined cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap.
"We are also excited by the progress we've made with BeiGene this quarter, having dosed the first patient 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."
DKN-01 Development 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.
Part A will enroll up to 24 patients
with G/GEJ adenocarcinoma who have received no prior systemic treatment in the locally advanced/metastatic setting (first-line
treatment), and Part B will enroll up to 48 patients with previously treated, inoperable, locally advanced or metastatic DKK1-high
G/GEJ adenocarcinoma (second-line treatment). The study is designed to evaluate safety, tolerability, and efficacy of the combination
therapy of intravenous DKN-01 and tislelizumab CAPOX (capecitabine + oxaliplatin) in G/GEJ adenocarcinoma patients. Treatment
will be conducted in repeating 21-day cycles until the patient meets pre-established criteria for discontinuation or is no longer
deriving clinical benefit. Part A and Part B of the study will be conducted concurrently.
Selected Third Quarter 2020 Financial
Net loss was $7.1 million for the third
quarter 2020, compared to $7.9 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 third quarter 2020, compared to $5.8 million for the same period in 2019. The decrease was primarily driven
by reductions in clinical trial costs due to the deprioritization of the TRX518 program in November 2019 and the timing of patient
enrollment. These decreases were partially offset by an increase in payroll and other related expeneses for research and development
General and administrative expenses were
$2.5 million for the third quarter 2020, compared to $2.2 million for the same period in 2019. The increase was due to higher professional
fees primarily attributable to recruiting and information technology costs.
Cash, cash equivalents and marketable securities
totaled $58.0 million at September 30, 2020. Research and development incentive receivables, current and long term, totaled approximately
$0.2 million at September 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 entered into a strategic 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, as amended, Section 21E of the
Securities Exchange Act of 1934, as amended, 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
Leap files from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its
date. Leap undertakes 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
Consolidated Statement of Operations
Condensed Consolidated
Statements of Operations
thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| License revenue | $ | 375 | $ | - | $ | 1,125 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,369 | 5,772 | 15,322 | 18,698 | ||||||||||||
| General and administrative | 2,514 | 2,151 | 7,188 | 6,481 | ||||||||||||
| Total operating expenses | 7,883 | 7,923 | 22,510 | 25,179 | ||||||||||||
| Loss from operations | (7,508 | ) | (7,923 | ) | (21,385 | ) | (25,179 | ) | ||||||||
| Interest income | 3 | 80 | 91 | 281 | ||||||||||||
| Interest expense | (17 | ) | (5 | ) | (42 | ) | (21 | ) | ||||||||
| Australian research and development incentives | 228 | (7 | ) | 343 | 129 | |||||||||||
| Foreign currency gains (loss) | 237 | (80 | ) | 189 | (114 | ) | ||||||||||
| Loss before income taxes | (7,057 | ) | (7,935 | ) | (20,804 | ) | (24,904 | ) | ||||||||
| Income taxes | - | - | - | - | ||||||||||||
| Net loss | (7,057 | ) | (7,935 | ) | (20,804 | ) | (24,904 | ) | ||||||||
| 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 | $ | (7,057 | ) | $ | (7,935 | ) | $ | (30,878 | ) | $ | (25,263 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.09 | ) | $ | (0.33 | ) | $ | (0.58 | ) | $ | (1.15 | ) | ||||
| Diluted | $ | (0.09 | ) | $ | (0.33 | ) | $ | (0.58 | ) | $ | (1.15 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 76,321,644 | 23,923,196 | 53,548,902 | 22,039,386 | ||||||||||||
| Diluted | 76,321,644 | 23,923,196 | 53,548,902 | 22,039,386 |
Leap Therapeutics, Inc
Consolidated Balance Sheet
Leap Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 57,975 | $ | 3,891 | ||||
| Research and development incentive receivable | 209 | 185 | ||||||
| Prepaid expenses and other current assets | 217 | 165 | ||||||
| Total current assets | 58,401 | 4,241 | ||||||
| Property and equipment, net | 73 | 124 | ||||||
| Right of use assets, net | 620 | 1,026 | ||||||
| Deferred tax assets | 130 | 127 | ||||||
| Deferred costs | 379 | 831 | ||||||
| Deposits | 941 | 1,099 | ||||||
| Total assets | $ | 60,544 | $ | 7,448 | ||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,547 | $ | 4,571 | ||||
| Accrued expenses | 2,270 | 3,441 | ||||||
| Deferred revenue - current portion | 1,500 | - | ||||||
| Lease liability - current portion | 398 | 474 | ||||||
| Total current liabilities | 6,715 | 8,486 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | 66 | 159 | ||||||
| Deferred revenue, net of current portion | 375 | - | ||||||
| Lease liability, net of current portion | 250 | 552 | ||||||
| Total liabilities | 7,406 | 9,197 | ||||||
| Stockholders' equity (deficiency): | ||||||||
| Common stock, $0.001 par value; 240,000,000 and 100,000,000 shares authorized as of September 30, 2020 and December 31, 2019, repectively; 59,657,742 and 24,194,877 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 60 | 24 | ||||||
| Additional paid-in capital | 269,440 | 193,319 | ||||||
| Accumulated other comprehensive income (loss) | (87 | ) | 76 | |||||
| Accumulated deficit | (216,275 | ) | (195,168 | ) | ||||
| Total stockholders' equity (deficiency) | 53,138 | (1,749 | ) | |||||
| Total liabilities and stockholders' equity (deficiency) | $ | 60,544 | $ | 7,448 |
Leap Therapeutics, Inc
Consolidated Statement of Cash Flows
Leap Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| Nine Months Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| Cash used in operating activities | $ | (19,969 | ) | $ | (21,008 | ) | ||
| Cash provided by (used) in investing activities | 25 | (100 | ) | |||||
| Cash provided by financing activities | 73,997 | 14,836 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | 31 | 46 | ||||||
| Net increase (decrease) in cash and cash equivalents | 54,084 | (6,226 | ) | |||||
| Cash and cash equivalents at beginning of period | 3,891 | 16,284 | ||||||
| Cash and cash equivalents at end of period | $ | 57,975 | $ | 10,058 |