Full Press Release Details
Leap Therapeutics Reports Second Quarter 2024
MA - August 12, 2024 - 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, 2024.
| Overall response rate (ORR) increases to 33% across all evaluable patients and 38% across evaluable patients with left-sided CRC in updated data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC) | ||
| Expanded the randomized controlled Part B of the DeFianCe study to 180 patients; enrollment expected to be completed by end of September 2024 with data expected in mid-2025 | ||
| Patient follow-up continues in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in Q4 2024 or early 2025 | ||
| Completed $40 million private placement with new and existing investors, including Gilead Sciences, Inc. |
"With the momentum provided by our $40 million
private placement, we are positioned to achieve our critical company milestones," said Douglas E. Onsi, President and Chief Executive
Officer of Leap. "We have executed well on our two DKN-01 randomized controlled trials and on preparatory activities for registrational
studies. We look forward to sharing initial data from both randomized controlled studies over the next 12 months as we strive to deliver
new treatments for patients fighting against cancer."
DKN-01 Development Update
| ORR among response-evaluable patients (n=27) was 33% and disease control rate (DCR) was 93%, including 9 PRs and 16 patients with a best response of SD | ||
| Median progression-free survival (PFS) was unchanged at 6.3 months |
| 38% ORR and 100% DCR in response-evaluable population (8 PRs, 13 SDs) | ||
| Median PFS was unchanged at 8.6 months |
Selected Second Quarter 2024 Financial Results
Loss was $20.4 million for the second quarter 2024, compared to $13.4 million for the same period in 2023. The
increase was primarily due to an increase in research and development expenses.
and development expenses were $17.9 million for the second quarter 2024, compared to $11.1 million for the same period
in 2023. The increase of $6.8 million was primarily due to an increase of $5.7 million in clinical trial costs due to patient enrollment,
the duration of patients on study, the enhancement of correlative studies, increase in site activity associated with Part C of the
DisTinGuish study, and the expansion of the size of Part B of the DeFianCe study. There was also an increase of $0.6 million in manufacturing
costs related to clinical trial material and manufacturing campaigns 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.
and administrative expenses were $3.4 million for the second quarter 2024, compared to $3.6 million for the same period
in 2023. The decrease was due to a decrease of $0.3 million in professional fees associated with our business development activities,
partially offset by a $0.1 million increase in payroll and other related expenses.
Cash and cash equivalents totaled $78.5 million at June 30,
About Leap Therapeutics
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
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;
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; and (v) exposure
to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. 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 a 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
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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 17,885 | $ | 11,104 | $ | 29,184 | $ | 50,046 | ||||||||
| General and administrative | 3,367 | 3,558 | 6,893 | 7,342 | ||||||||||||
| Total operating expenses | 21,252 | 14,662 | 36,077 | 57,388 | ||||||||||||
| Loss from operations | (21,252 | ) | (14,662 | ) | (36,077 | ) | (57,388 | ) | ||||||||
| Interest income | 865 | 1,157 | 1,640 | 2,005 | ||||||||||||
| Australian research and development incentives | 253 | 298 | 499 | 570 | ||||||||||||
| Foreign currency gain (loss) | 6 | (145 | ) | (10 | ) | (452 | ) | |||||||||
| Change in fair value of Series X preferred stock warrant liability | - | (38 | ) | - | 12 | |||||||||||
| Net loss | (20,128 | ) | (13,390 | ) | (33,948 | ) | (55,253 | ) | ||||||||
| Dividend attributable to down round feature of warrants | (234 | ) | - | (234 | ) | - | ||||||||||
| Net loss attributable to common stockholders | $ | (20,362 | ) | $ | (13,390 | ) | $ | (34,182 | ) | $ | (55,253 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic & diluted | $ | (0.52 | ) | $ | (0.91 | ) | $ | (1.01 | ) | $ | (4.01 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic & diluted | 39,122,662 | 14,710,375 | 33,830,083 | 13,794,605 |
Consolidated Balance
(in thousands, except
share and per share amounts)
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 78,479 | $ | 70,643 | ||||
| Research and development incentive receivable | 754 | 771 | ||||||
| Prepaid expenses and other current assets | 354 | 183 | ||||||
| Total current assets | 79,587 | 71,597 | ||||||
| Property and equipment, net | - | 5 | ||||||
| Right of use assets, net | 475 | 257 | ||||||
| Research and development incentive receivable, net of current portion | 505 | - | ||||||
| Deposits | 859 | 966 | ||||||
| Total assets | $ | 81,426 | $ | 72,825 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,809 | $ | 6,465 | ||||
| Accrued expenses | 7,347 | 5,957 | ||||||
| Lease liability - current portion | 443 | 262 | ||||||
| Total current liabilities | 15,599 | 12,684 | ||||||
| Non current liabilities: | ||||||||
| Lease liability, net of current portion | 39 | - | ||||||
| Total liabilities | 15,638 | 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; 38,264,464 and 25,565,414 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 38 | 26 | ||||||
| Additional paid-in capital | 499,511 | 459,591 | ||||||
| Accumulated other comprehensive income | 3 | 106 | ||||||
| Accumulated deficit | (433,764 | ) | (399,582 | ) | ||||
| Total stockholders' equity | 65,788 | 60,141 | ||||||
| Total liabilities and stockholders' equity | $ | 81,426 | $ | 72,825 |
Leap Therapeutics, Inc.
Condensed Consolidated
Statements of Cash Flows
| (Unaudited) | (Unaudited) | |||||||||||||||
| Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Cash used in operating activities | $ | (13,671 | ) | $ | (10,185 | ) | $ | (29,187 | ) | $ | (22,885 | ) | ||||
| Cash provided by (used in) investing activities | - | (348 | ) | - | 48,969 | |||||||||||
| Cash provided by (used in) financing activities | 37,117 | - | 37,146 | (29 | ) | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 112 | (90 | ) | (123 | ) | (140 | ) | |||||||||
| Net increase (decrease) in cash and cash equivalents | 23,558 | (10,623 | ) | 7,836 | 25,915 | |||||||||||
| Cash and cash equivalents at beginning of period | 54,921 | 102,038 | 70,643 | 65,500 | ||||||||||||
| Cash and cash equivalents at end of period | $ | 78,479 | $ | 91,415 | $ | 78,479 | $ | 91,415 |