Full Press Release Details
Leap Therapeutics Reports First Quarter 2023
Cambridge, MA - May 15, 2023 - Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial
results for first quarter ended March 31, 2023.
"We continued to execute extremely well
on our DKN-01 program during the first quarter of 2023 with the completion of enrollment in Part A of the DeFianCe second-line CRC study
and excellent progress in enrolling our randomized, controlled Part C of the DisTinGuish first-line GEA study," said Douglas E.
Onsi, President and Chief Executive Officer of Leap. "We look forward to presenting long-term follow-up data from Part A of the
DisTinGuish study at ASCO in June, including updated response and overall survival data. With the acquisition of Flame Biosciences at
the beginning of the year, we are in a strong financial position to develop our pipeline of personalized medicines for cancer patients."
DKN-01 Development Update
Title: A phase 2 study (DisTinGuish)
of DKN-01 in combination with tislelizumab + chemotherapy as first-line (1L) therapy in patients with advanced gastric or GEJ adenocarcinoma
Presenter: Samuel J. Klempner,
Harvard Medical School
Session Type: Poster Discussion
Session Title: Gastrointestinal
Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: Monday, June 5,
2023, at 11:30 a.m. ET
Abstract Number: 4027
Selected First Quarter 2023 Financial Results
Net Loss was $41.9 million for the first quarter
2023, compared to $10.4 million for the same period in 2022. The increase was primarily due to in-process research & development (IPR&D)
expense of $29.6 million associated with the acquisition of Flame Biosciences.
Research and development expenses were $38.9 million
for the first quarter 2023, compared to $7.8 million for the same period in 2022. The increase in research and development expenses was
due to IPR&D expense associated with the Flame acquisition of $29.6 million, increased headcount and compensation expense of $0.8
million, increased manufacturing costs of $0.8 million, increased stock based compensation expense of $0.1 million, partially offset by
decreased clinical trial costs of $0.2 million.
General and administrative expenses were $3.8
million for the first quarter 2023, compared to $2.8 million for the same period in 2022. The increase in general and administrative expenses
was due to increased finance and legal fees, primarily associated with the Flame acquisition, of $0.7 million and increased headcount
and compensation expense of $0.3 million.
Cash and cash equivalents totaled $102.0 million
at March 31, 2023. Research and development incentive receivables totaled $2.3 million at March 31, 2023.
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 being developed in patients with esophagogastric, gynecologic, and colorectal
cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer.
Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. 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
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements
within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management
of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements.
The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will
be achieved. Words such as "anticipate," "expect," "project," "intend," "believe,"
"may," "will," "should," "plan," "could," "continue," "target,"
"contemplate," "estimate," "forecast," "guidance," "predict," "possible,"
"potential," "pursue," "likely," and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify forward-looking statements.
All statements, other than historical facts,
including statements regarding the continuation over time of the clinical collaboration with BeiGene on the ongoing Part C of the
DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the expected benefits of the merger with Flame Biosciences; the
cash runway into mid-2025 and the sufficiency of Leap's cash, cash equivalents and short-term investments to fund operations;
stockholder approval of the conversion rights of the Series X Non-Voting Convertible Preferred Stock; the anticipated timing for
initiation of or success of enrollment in clinical trials and release of clinical data, and any outcomes of such trials; the
potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future preclinical and
clinical development plans in connection with our programs; the ability to enter into a new strategic partnership for DKN-01 or any
of Leap's other programs; the ability of NovaRock Biotherapeutics to conduct the FL-301 clinical trial in China; and any
assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to
differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability
to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of
Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic
partnerships for DKN-01 or any of its other programs; (iv) whether any Leap clinical trials and products will receive approval from
the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; (v) exposure to inflation, currency rate and
interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities; (vi) 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, global conflict, or supply chain related issues; (vii) Leap's
ability to successfully integrate the Flame operations and realize the anticipated benefits of the acquisition of Flame; (viii)
whether Leap's stockholders approve the conversion of the Series X Non-Voting Convertible Preferred Stock; (ix) whether
Leap's cash resources will be sufficient to fund Leap's continuing operations and the newly acquired Flame operations,
including the liabilities of Flame incurred in connection with the completion of the merger; and (x) Leap's ability to comply
with the continued listing requirements of the Nasdaq Capital Market. New risks and uncertainties may emerge from time to time, and
it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or Implied) are made about
the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking
statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject
to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk
Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of
the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to
publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as
required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date
subsequent to the date hereof.
President & Chief Executive Officer
Leap Therapeutics, Inc.
| Leap Therapeutics, Inc. |
| Consolidated Balance Sheets |
| (in thousands, except share and per share amounts) |
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 102,038 | $ | 65,500 | ||||
| Research and development incentive receivable | 2,071 | 2,099 | ||||||
| Prepaid expenses and other current assets | 590 | 351 | ||||||
| Total current assets | 104,699 | 67,950 | ||||||
| Property and equipment, net | 16 | 20 | ||||||
| Right of use assets, net | 569 | 669 | ||||||
| Research and development incentive receivable, net of current portion | 272 | - | ||||||
| Deferred costs | - | 576 | ||||||
| Other long term assets | 15 | 30 | ||||||
| Deposits | 976 | 1,108 | ||||||
| Total assets | $ | 106,547 | $ | 70,353 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,498 | $ | 5,657 | ||||
| Accrued expenses | 4,388 | 5,152 | ||||||
| Lease liability - current portion | 425 | 416 | ||||||
| Total current liabilities | 10,311 | 11,225 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 152 | 262 | ||||||
| Series X preferred stock warrant liability | 40 | - | ||||||
| Total liabilities | 10,503 | 11,487 | ||||||
| Mezzanine equity: | ||||||||
| Series X Convertible Preferred Stock, $0.001 par value; 10,000,000 shares authorized; 136,248 and 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 67,715 | - | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 119,410,992 and 99,021,376 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 119 | 99 | ||||||
| Additional paid-in capital | 387,886 | 376,807 | ||||||
| Accumulated other comprehensive income | 355 | 128 | ||||||
| Accumulated deficit | (360,031 | ) | (318,168 | ) | ||||
| Total stockholders' equity | 28,329 | 58,866 | ||||||
| Total liabilities, mezzanine equity and stockholders' equity | $ | 106,547 | $ | 70,353 |
| Leap Therapeutics, Inc. |
| Consolidated Statements of Operations |
| (in thousands, except share and per share amounts) |
| (Unaudited) | ||||||||
| Three Months Ended March 31 | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 38,942 | $ | 7,784 | ||||
| General and administrative | 3,784 | 2,848 | ||||||
| Total operating expenses | 42,726 | 10,632 | ||||||
| Loss from operations | (42,726 | ) | (10,632 | ) | ||||
| Interest income | 848 | 5 | ||||||
| Interest expense | - | (21 | ) | |||||
| Australian research and development incentives | 272 | 37 | ||||||
| Foreign currency gain (loss) | (307 | ) | 235 | |||||
| Change in fair value of Series X preferred stock warrant liability | 50 | - | ||||||
| Net loss attributable to common stockholders | (41,863 | ) | (10,376 | ) | ||||
| Net loss per share | ||||||||
| Basic | $ | (0.32 | ) | $ | (0.09 | ) | ||
| Diluted | $ | (0.32 | ) | $ | (0.09 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic | 129,344,272 | 113,248,937 | ||||||
| Diluted | 129,344,272 | 113,248,937 |
| Leap Therapeutics, Inc. |
| Condensed Consolidated Statements of Cash Flows |
| (in thousands) |
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Cash used in operating activities | $ | (12,700 | ) | $ | (11,518 | ) | ||
| Cash provided by investing activities | 49,317 | - | ||||||
| Cash used in financing activities | (29 | ) | (210 | ) | ||||
| Effect of exchange rate changes on cash and cash equivalents | (50 | ) | 32 | |||||
| Net increase (decrease) in cash and cash equivalents | 36,538 | (11,696 | ) | |||||
| Cash and cash equivalents at beginning of period | 65,500 | 114,916 | ||||||
| Cash and cash equivalents at end of period | $ | 102,038 | $ | 103,220 |