Leap Therapeutics Reports Second Quarter 2020 Financial Results
CAMBRIDGE, Mass., Aug. 13, 2020 /PRNewswire/ -- 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:
-- Completed a $51.75 million public offering of common stock and
pre-funded warrants to purchase common stock
-- Presented updated data for DKN-01 monotherapy that showed a complete
response and partial response in endometrial cancer patients with
additional responses observed for the DKN-01 plus paclitaxel combination
in carcinosarcoma patients
-- Announced Orphan Drug Designation of DKN-01 for the treatment of gastric
and gastroesophageal junction cancer
"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."
Business Update
-- Leap Completed $51.75 Million Public Offering of Common Stock and
Pre-Funded Warrants to Purchase Common Stock - In June 2020, Leap
announced the closing of an underwritten public offering yielding
aggregate gross proceeds of $51.75 million, before deducting
underwriting discounts and commissions and other offering expenses
payable by Leap.
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.
-- Leap Presented Updated Data for DKN-01 Monotherapy and Paclitaxel
Combination in Gynecologic Cancers - Leap announced updated clinical
data from its ongoing Phase 2 clinical trial of DKN-01, as both a
monotherapy and in combination with paclitaxel chemotherapy, in patients
with advanced gynecological malignancies. Leap hosted a conference call
with Rebecca Arend, M.D., Assistant Professor and Associate Scientist,
Gynecologic Oncology Clinic, The University of Alabama at Birmingham
School of Medicine Comprehensive Cancer Center Experimental Therapeutics
Program, on April 23, 2020, to discuss the data. Key findings from the
P204 study include the following:
-- 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.
-- Leap Announced Orphan Drug Designation of DKN-01 for the Treatment of
Gastric and Gastroesophageal Junction Cancer - Leap announced that the
U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug
Designation for DKN-01 for the treatment of gastric and gastroesophageal
junction cancer. The FDA's Office of Orphan Drug Products grants orphan
status to support development of medicines for underserved patient
populations, or rare disorders, that affect fewer than 200,000 people in
the U.S. Orphan Drug Designation provides to Leap certain benefits,
including market exclusivity upon regulatory approval if received,
exemption of FDA application fees, and tax credits for qualified
clinical trials.
Selected Second Quarter 2020 Financial Results
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 activities.
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.
CONTACT:
Douglas E. Onsi
President & Chief Executive 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.
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:
5,350 6,136 9,953 12,926
Research and development
2,521 2,325 4,674 4,330
General and administrative
7,871 8,461 14,627 17,256
Total operating expenses
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
$(0.12) $(0.37) $(0.57) $(0.82)
Basic
$(0.12) $(0.37) $(0.57) $(0.82)
Diluted
Weighted average common shares outstanding
52,442,597 22,906,025 42,037,405 21,081,869
Basic
52,442,597 22,906,025 42,037,405 21,081,869
Diluted
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
65,280 4,241
Total current assets
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
$67,673 $7,448
Total assets
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
6,836 8,486
Total current liabilities
Non current liabilities:
Restricted stock liability 159
Deferred revenue, net of current portion 750
Lease liability, net of current portion 354 552
7,940 9,197
Total liabilities
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)
59,733 (1,749)
Total stockholders' equity (deficiency)
$67,673 $7,448
Total liabilities and stockholders' equity (deficiency)
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
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SOURCE Leap Therapeutics, Inc.
