Full Press Release Details
Leap Therapeutics Reports Third Quarter 2021
Cambridge, MA - November 12, 2021
- 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, 2021.
Leap Third Quarter Highlights:
| Completed a $103.6 million public offering of common stock and pre-funded warrants to purchase common stock, resulting in net proceeds of $96.8 million | ||
| Presented positive initial data from the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the European Society for Medical Oncology (ESMO) Congress 2021 |
"We presented positive new data at ESMO
of DKN-01 in combination with BeiGene's tislelizumab and chemotherapy demonstrating compelling overall response rates in patients
with first-line gastric or gastroesophageal junction (G/GEJ) cancer, particularly those patients whose tumors expressed high levels of
DKK1 or low PD-L1," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to presenting additional
data from the DisTinGuish study early next year and aggressively advancing DKN-01 into the next stages of development in G/GEJ and other
DKN-01 Clinical Milestones
DKN-01 is a humanized monoclonal antibody that
binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways,
which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the
activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.
Selected Third Quarter 2021 Financial Results
Net Loss was $11.1 million for the third
quarter 2021, compared to $7.1 million for the same period in 2020. License revenues were $0.4 million for each of the third quarter
2021 and the same period in 2020, and relate to the Agreement with BeiGene for the development and commercialization of DKN-01 in
Asia (excluding Japan), Australia, and New Zealand.
Research and development expenses were $10.1 million
for the third quarter 2021, compared to $5.4 million for the same period in 2020. The increase of $4.7 million in research and development
expenses was due to an increase of $3.3 million in manufacturing costs related to clinical trial material due to timing of manufacturing
campaigns, an increase of $0.7 million in clinical trial costs due to timing of patient enrollment, an increase of $0.6 million in payroll
and other related expenses due to an increase in headcount of our research and development full time employees, and an increase of $0.1
million in stock based compensation expense due to new stock options granted to research and development full time employees in 2021.
General and administrative expenses were $2.4
million for the third quarter 2021, compared to $2.5 million for the second quarter 2020. The decrease of $0.1 million in general and
administrative expenses was due to a $0.4 million decrease in professional fees partially offset by an increase of $0.2 million in stock
based compensation expense due to new stock options granted to general and administrative full time employees in 2021 and an increase
of $0.1 million in payroll and other related expenses.
Cash and cash equivalents totaled $124.8 million
at September 30, 2021. Research and development incentive receivables totaled $1.6 million at September 30, 2021.
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. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and
prostate cancers. Leap has entered into a strategic collaboration 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, milestone, 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 is 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 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 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.
President & Chief Executive Officer
Leap Therapeutics, Inc.
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Operations |
| (in thousands, except share and per share amounts) |
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| License revenue | $ | 375 | $ | 375 | $ | 1,125 | $ | 1,125 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,077 | 5,369 | 24,090 | 15,322 | ||||||||||||
| General and administrative | 2,438 | 2,514 | 7,973 | 7,188 | ||||||||||||
| Total operating expenses | 12,515 | 7,883 | 32,063 | 22,510 | ||||||||||||
| Loss from operations | (12,140 | ) | (7,508 | ) | (30,938 | ) | (21,385 | ) | ||||||||
| Interest income | 1 | 3 | 4 | 91 | ||||||||||||
| Interest expense | (9 | ) | (17 | ) | (39 | ) | (42 | ) | ||||||||
| Australian research and development incentives | 1,269 | 228 | 1,584 | 343 | ||||||||||||
| Foreign currency gain (loss) | (260 | ) | 237 | (410 | ) | 189 | ||||||||||
| Net loss | (11,139 | ) | (7,057 | ) | (29,799 | ) | (20,804 | ) | ||||||||
| Dividend attributable to down round feature of warrants | - | - | - | (303 | ) | |||||||||||
| 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 | $ | (11,139 | ) | $ | (7,057 | ) | $ | (29,799 | ) | $ | (30,878 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic & diluted | $ | (0.14 | ) | $ | (0.09 | ) | $ | (0.39 | ) | $ | (0.58 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic & diluted | 78,218,774 | 76,321,644 | 76,631,172 | 53,548,902 |
| Leap Therapeutics, Inc. |
| Consolidated Balance Sheets |
| (in thousands, except share and per share amounts) |
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 124,771 | $ | 52,071 | ||||
| Research and development incentive receivable | 59 | 73 | ||||||
| Prepaid expenses and other current assets | 271 | 130 | ||||||
| Total current assets | 125,101 | 52,274 | ||||||
| Property and equipment, net | 43 | 65 | ||||||
| Right of use assets, net | 311 | 528 | ||||||
| Research and development incentive receivable, net of current portion | 1,508 | - | ||||||
| Deferred tax assets | 169 | 179 | ||||||
| Deferred costs | 34 | 345 | ||||||
| Deposits | 914 | 980 | ||||||
| Total assets | $ | 128,080 | $ | 54,371 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,966 | $ | 2,717 | ||||
| Accrued expenses | 2,597 | 2,747 | ||||||
| Deferred revenue - current portion | 375 | 1,500 | ||||||
| Lease liability - current portion | 323 | 408 | ||||||
| Total current liabilities | 11,261 | 7,372 | ||||||
| Non current liabilities: | ||||||||
| Restricted stock liability | - | 204 | ||||||
| Lease liability, net of current portion | - | 144 | ||||||
| Total liabilities | 11,261 | 7,720 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 87,836,818 and 59,657,742 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 88 | 60 | ||||||
| Additional paid-in capital | 369,761 | 270,155 | ||||||
| Accumulated other comprehensive loss | (246 | ) | (579 | ) | ||||
| Accumulated deficit | (252,784 | ) | (222,985 | ) | ||||
| Total stockholders' equity | 116,819 | 46,651 | ||||||
| Total liabilities and stockholders' equity | $ | 128,080 | $ | 54,371 |
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Cash Flows |
| (in thousands) |
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Cash used in operating activities | $ | (8,102 | ) | $ | (6,592 | ) | $ | (24,441 | ) | $ | (19,969 | ) | ||||
| Cash provided by investing activities | - | - | - | 25 | ||||||||||||
| Cash provided by (used in) financing activities | 97,262 | (385 | ) | 97,280 | 73,997 | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (123 | ) | 65 | (139 | ) | 31 | ||||||||||
| Net increase (decrease) in cash and cash equivalents | 89,037 | (6,912 | ) | 72,700 | 54,084 | |||||||||||
| Cash and cash equivalents at beginning of period | 35,734 | 64,887 | 52,071 | 3,891 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 124,771 | $ | 57,975 | $ | 124,771 | $ | 57,975 |