Full Press Release Details
Leap Therapeutics Reports First Quarter 2024
Cambridge, MA - May 13, 2024
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today reported financial results for the first quarter ended March 31, 2024.
| Completed $40 million private placement financing with participation from Gilead Sciences, Inc., a life sciences-focused investor, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital | ||
| Presented clinical data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC), at the 2024 ASCO Gastrointestinal Cancers Symposium | ||
| Expanded the ongoing randomized controlled Part B of the DeFianCe study from 130 patients to 180 patients to enhance the statistical power for patients with left-sided CRC; enrollment now expected to be completed in late Q3 or early Q4 2024 | ||
| Completed enrollment in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with advanced gastroesophageal junction (GEJ) and gastric cancer; first randomized controlled data for DKN-01 expected in the second half of 2024 or early 2025 |
"We appreciate the strong support of Gilead
and the new and existing institutional investors who participated in our recent $40 million financing that will enable the expansion
and continued execution of the DKN-01 development program," said Douglas E. Onsi, President and Chief Executive Officer of Leap.
"The financing provides cash runway into the second quarter of 2026, allowing the expansion of Part B of the DeFianCe CRC
study to 180 patients, the full maturation of data in Part C of the DisTinGuish GEJ/gastric cancer study, and the manufacturing
of Phase 3 clinical trial material. We are well positioned for continued success and look forward to achieving major clinical milestones
DKN-01 Development Update
| Overall response rate (ORR) among response-evaluable patients (n=27) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD) | ||
| Median progression-free survival (PFS) was 6.3 months | ||
| 9 patients remained on therapy and were beyond 8.5 months |
| 33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs) | ||
| Preliminary median PFS of 8.6 months (9 patients continuing therapy within subgroup) |
| 46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs) | ||
| Preliminary median PFS of 9.4 months (6 patients continuing therapy within subgroup) | ||
| Higher baseline plasma DKK1 levels correlated with improved responses |
Selected First Quarter 2024 Financial Results
Net Loss was $13.8 million for the
first quarter 2024, compared to $41.9 million for the same period in 2023. The decrease was primarily due to $29.6 million
of in-process research and development ("IPR&D") expense associated with the Flame merger in January 2023.
Research and development expenses were $11.3
million for the first quarter 2024, compared to $38.9 million for the same period in 2023. The decrease of $27.6 million
was primarily due to $29.6 million of IPR&D associated with the Flame merger. In addition, there was a decrease of $0.4 million in
manufacturing costs related to clinical trial material manufacturing campaigns and a decrease of $0.1 million in consulting fees associated
with R&D activities. These decreases were partially offset by an increase of $2.0 million in clinical trial costs and an increase
of $0.5 million in payroll and other related expenses due to an increase in headcount of our R&D full-time employees.
General and administrative expenses were $3.5
million for the first quarter 2024, compared to $3.8 million for the same period in 2022. The decrease was due to a decrease
of $0.3 million in professional fees associated with our business development activities.
Cash and cash equivalents totaled $54.9
million at March 31, 2024, exclusive of the $37.2 million net proceeds of the private placement completed in April 2024.
Research and development incentive receivables, current portion, totaled $0.7 million at March 31, 2024.
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 https://investors.leaptx.com/.
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 potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the
anticipated expansion of the DeFianCe study and timing for completion of clinical trials and release of clinical trial data and the expectations
surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates;
Leap's estimations of projected cash runway; the anticipated closing date of the private placement; the amount of proceeds to be received
by Leap and Leap's intended use of proceeds from the private placement; 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 and to maintain its ongoing collaborations
with BeiGene, NovaRock and Adimab; (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; and (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
global conflict, or supply chain related issues. 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 Statements of Operations
(in thousands, except share and per share amounts)
| (Unaudited) | ||||||||
| Three Months Ended March 31 | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 11,299 | $ | 38,942 | ||||
| General and administrative | 3,526 | 3,784 | ||||||
| Total operating expenses | 14,825 | 42,726 | ||||||
| Loss from operations | (14,825 | ) | (42,726 | ) | ||||
| Interest income | 775 | 848 | ||||||
| Australian research and development incentives | 246 | 272 | ||||||
| Foreign currency loss | (16 | ) | (307 | ) | ||||
| Change in fair value of Series X preferred stock warrant liability | - | 50 | ||||||
| Net loss | $ | (13,820 | ) | $ | (41,863 | ) | ||
| Net loss per share | ||||||||
| Basic and Diluted | $ | (0.51 | ) | $ | (3.24 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic and diluted | 27,014,100 | 12,934,427 |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except
share and per share amounts)
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 54,921 | $ | 70,643 | ||||
| Research and development incentive receivable | 738 | 771 | ||||||
| Prepaid expenses and other current assets | 526 | 183 | ||||||
| Total current assets | 56,185 | 71,597 | ||||||
| Property and equipment, net | - | 5 | ||||||
| Right of use assets, net | 577 | 257 | ||||||
| Research and development incentive receivable, net of current portion | 245 | - | ||||||
| Deferred costs | 39 | - | ||||||
| Deposits | 917 | 966 | ||||||
| Total assets | $ | 57,963 | $ | 72,825 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,951 | $ | 6,465 | ||||
| Accrued expenses | 4,056 | 5,957 | ||||||
| Lease liability - current portion | 430 | 262 | ||||||
| Total current liabilities | 10,437 | 12,684 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 154 | - | ||||||
| Total liabilities | 10,591 | 12,684 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value; 240,000,000 shares authorized; 25,603,471 and 25,565,414 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 26 | 26 | ||||||
| Additional paid-in capital | 460,868 | 459,591 | ||||||
| Accumulated other comprehensive income (loss) | (120 | ) | 106 | |||||
| Accumulated deficit | (413,402 | ) | (399,582 | ) | ||||
| Total stockholders' equity | 47,372 | 60,141 | ||||||
| Total liabilities and stockholders' equity | $ | 57,963 | $ | 72,825 |
Leap Therapeutics, Inc.
Condensed Consolidated
Statements of Cash Flows
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash used in operating activities | $ | (15,516 | ) | $ | (12,700 | ) | ||
| Cash provided by investing activities | - | 49,317 | ||||||
| Cash provided by (used in) financing activities | 29 | (29 | ) | |||||
| Effect of exchange rate changes on cash and cash equivalents | (235 | ) | (50 | ) | ||||
| Net increase (decrease) in cash and cash equivalents | (15,722 | ) | 36,538 | |||||
| Cash and cash equivalents at beginning of period | 70,643 | 65,500 | ||||||
| Cash and cash equivalents at end of period | $ | 54,921 | $ | 102,038 |