Leap Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results
Leap Therapeutics (Nasdaq:LPTX) reported its financial results for 2020, revealing a net loss of $27.5 million, down from $32.9 million in 2019, primarily due to reduced R&D expenses. The company secured a $51.75 million public offering and signed a licensing agreement with BeiGene for DKN-01 in key Asia-Pacific regions. Key advancements include positive outcomes in EGC cancer for DKN-01 and receiving both Orphan Drug and Fast Track Designations from the FDA. Cash and equivalents stood at $52.1 million as of December 31, 2020, signaling a stable financial position for ongoing projects.
- Reduced net loss from $32.9 million in 2019 to $27.5 million in 2020.
- Completion of $51.75 million public offering to bolster financial resources.
- Signed strategic agreement with BeiGene for DKN-01, expanding market presence.
- Positive clinical data for DKN-01 in EGC cancer and endometrial cancer, demonstrating potential treatment efficacy.
- Received Orphan Drug and Fast Track Designations from FDA for DKN-01, enhancing its development pipeline.
- None.
CAMBRIDGE, Mass., March 12, 2021 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2020.
2020 Leap Highlights:
- Signed agreement with BeiGene, Ltd. for rights to Leap's anti-DKK1 antibody, DKN-01, in Asia (excluding Japan), Australia and New Zealand
- Completed a
$51.75 million public offering of common stock and pre-funded warrants to purchase common stock - Presented updated data from study of DKN-01 plus pembrolizumab in esophagogastric (EGC) cancer demonstrating positive outcomes in DKK1-high patients
- Data for DKN-01 in endometrial cancer demonstrates single agent activity in biomarker-selected patients
- First patient dosed in Phase 2a study of DKN-01 in combination with tislelizumab, BeiGene's anti-PD-1 antibody, for the treatment of metastatic gastric or gastroesophageal junction (G/GEJ) cancer
- Received Orphan Drug Designation and Fast Track Designation for DKN-01 from FDA
"2020 was a transformative year for Leap as we executed our first strategic alliance with BeiGene and advanced our DKN-01 development program, initiating our Phase 2a combination study with BeiGene's tislelizumab in gastric cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The data for DKN-01 to date, both as a monotherapy and in combination approaches, provide evidence of the potential utility of DKN-01 as an attractive treatment option for multiple biomarker-focused cancer indications."
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 and PI3K/AKT signaling pathways. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.
- Leap and BeiGene Announced First Patient Dosed in Study of DKN-01 in Combination with Tislelizumab for the Treatment of Metastatic Gastric/Gastroesophageal Junction (G/GEJ) Cancer – In September 2020, Leap and BeiGene announced that the first patient was dosed in the DisTinGuish trial (NCT04363801), a Phase 2a, nonrandomized, open-label, multicenter study of Leap's DKN-01 in combination with BeiGene's tislelizumab with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced G/GEJ adenocarcinoma. The study, which will be conducted in two parts, is currently evaluating approximately forty patients with second-line G/GEJ cancer whose tumors are DKK1-high per perspective analysis. In addition, the study is evaluating the combination of DKN-01 with tislelizumab and capecitabine and oxaliplatin in approximately twenty patients with first-line G/GEJ cancer. Initial data is expected in the second half of 2021.
- Leap Presented Updated Data from DKN-01 in EGC Demonstrating Positive Outcomes in DKK1-high Patients – At the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting, Leap presented clinical data from the Phase 1b/2a clinical trial of DKN-01 in patients with advanced EGC. In the study, high levels of tumoral DKK1 expression correlated with improved clinical outcomes in heterogeneous EGC patients treated with DKN-01 monotherapy or in combination with paclitaxel or the anti-PD-1 antibody, pembrolizumab.
- Leap Presented Updated Data for DKN-01 in Endometrial Cancer Demonstrating Single Agent Activity in Biomarker-selected Patients – At the American Association for Cancer Research (AACR) Virtual Special Conference on Endometrial Cancer: New Biology Driving Research and Treatment, Leap presented additional clinical data from the epithelial endometrial cancer (EEC) patients treated with DKN-01 monotherapy as part of its ongoing Phase 2 clinical trial for DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. In the study, DKN-01 demonstrated single agent activity in biomarker-selected EEC patients, including an ongoing complete response that is over 2.5 years in duration and prolonged progression-free survival. Additional data from this study will be presented at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer.
- Leap Receives Orphan Drug Designation and Fast Track Designation – On June 11, 2020, the FDA granted Orphan Drug Designation to DKN-01 for the treatment of gastroesophageal junction and gastric cancer. On September 24, 2020, the FDA granted Fast Track Designation to DKN-01 in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1, following disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.
Selected Year-End and Fourth Quarter 2020 Financial Results
Net Loss was
License revenues were
Research and development expenses were
General and administrative expenses were
Cash and cash equivalents totaled
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 a 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, 2020, as filed with the SEC on March 12, 2021. Any forward-looking statement contained in this release speaks only as of its date. Leap undertakes no obligation to update any forward-looking statement 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. | ||||||||||||||
Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31 | Three Months Ended December 31 | |||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||
License revenue | $ 1,500 | $ - | $ 375 | $ - | ||||||||||
Operating expenses: | ||||||||||||||
Research and development | 20,423 | 24,366 | 5,101 | 5,668 | ||||||||||
General and administrative | 9,616 | 9,085 | 2,428 | 2,604 | ||||||||||
Total operating expenses | 30,039 | 33,451 | 7,529 | 8,272 | ||||||||||
Loss from operations | (28,539) | (33,451) | (7,154) | (8,272) | ||||||||||
Interest income | 93 | 313 | 2 | 32 | ||||||||||
Interest expense | (39) | (23) | 3 | (2) | ||||||||||
Australian research and development incentives | 231 | 132 | (112) | 3 | ||||||||||
Foreign currency gains | 738 | 126 | 549 | 240 | ||||||||||
Loss before income taxes | (27,516) | (32,903) | (6,712) | (7,999) | ||||||||||
Income taxes | 2 | 3 | 2 | 3 | ||||||||||
Net loss | (27,514) | (32,900) | (6,710) | (7,996) | ||||||||||
Dividend attributable to down round feature of warrants | (303) | (359) | 0 | - | ||||||||||
Dividend attributable to Series A & B convertible preferred stock | (372) | - | 0 | - | ||||||||||
Series A & B convertible preferred stock - beneficial conversion feature | (9,399) | - | - | - | ||||||||||
Net loss attributable to common stockholders | $ (37,588) | $ (33,259) | $ (6,710) | $ (7,996) | ||||||||||
Net loss per share | ||||||||||||||
Basic | $ (0.63) | $ (1.47) | $ (0.09) | $ (0.33) | ||||||||||
Diluted | $ (0.63) | $ (1.47) | $ (0.09) | $ (0.33) | ||||||||||
Weighted average common shares outstanding | ||||||||||||||
Basic | 59,327,713 | 22,582,687 | 76,376,160 | 24,194,877 | ||||||||||
Diluted | 59,327,713 | 22,582,687 | 76,376,160 | 24,194,877 | ||||||||||
Leap Therapeutics, Inc. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
December 31, | ||||||||||
2020 | 2019 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 52,071 | $ 3,891 | ||||||||
Research and development incentive receivable | 73 | 185 | ||||||||
Prepaid expenses and other current assets | 130 | 165 | ||||||||
Total current assets | 52,274 | 4,241 | ||||||||
Property and equipment, net | 65 | 124 | ||||||||
Right of use assets, net | 528 | 1,026 | ||||||||
Deferred tax assets | 179 | 127 | ||||||||
Deferred costs | 345 | 831 | ||||||||
Deposits | 980 | 1,099 | ||||||||
Total assets | $ 54,371 | $ 7,448 | ||||||||
Liabilities and Stockholders' Equity (Deficiency) | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 2,717 | $ 4,571 | ||||||||
Accrued expenses | 2,747 | 3,441 | ||||||||
Deferred revenue - current portion | 1,500 | - | ||||||||
Lease liability - current portion | 408 | 474 | ||||||||
Total current liabilities | 7,372 | 8,486 | ||||||||
Non current liabilities: | ||||||||||
Restricted stock liability | 204 | 159 | ||||||||
Lease liability, net of current portion | 144 | 552 | ||||||||
Total liabilities | 7,720 | 9,197 | ||||||||
Stockholders' equity (deficiency): | ||||||||||
Common stock, | 60 | 24 | ||||||||
Additional paid-in capital | 270,155 | 193,319 | ||||||||
Accumulated other comprehensive income (loss) | (579) | 76 | ||||||||
Accumulated deficit | (222,985) | (195,168) | ||||||||
Total stockholders' equity (deficiency) | 46,651 | (1,749) | ||||||||
Total liabilities and stockholders' equity (deficiency) | $ 54,371 | $ 7,448 | ||||||||
Leap Therapeutics, Inc. | ||||||||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||||||
(in thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Year Ended December 31, | Three Months Ended December 31, | |||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||
Cash used in operating activities | $ (25,957) | $ (26,902) | $ (5,988) | $ (5,894) | ||||||||||
Cash provided by (used in) investing activities | 25 | (85) | - | 15 | ||||||||||
Cash provided by (used in) financing activities | 73,997 | 14,817 | - | (19) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | 115 | (223) | 84 | (269) | ||||||||||
Net increase (decrease) in cash and cash equivalents | $ 48,180 | $ (12,393) | (5,904) | (6,167) | ||||||||||
Cash and cash equivalents at beginning of period | 3,891 | 16,284 | 57,975 | 10,058 | ||||||||||
Cash and cash equivalents at end of period | $ 52,071 | $ 3,891 | $ 52,071 | $ 3,891 | ||||||||||
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SOURCE Leap Therapeutics, Inc.
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