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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
August 14, 2023
Leap Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-37990 |
|
27-4412575 |
(State or other jurisdiction of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
47 Thorndike Street, Suite B1-1
Cambridge, MA |
02141 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone
number, including area code: (617) 714-0360
N/A
(Former name or former address,
if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name
of each exchange on which
registered |
Common Stock, par value $0.001 |
LPTX |
Nasdaq Capital Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results
of Operations and Financial Condition
On August 14, 2023, Leap Therapeutics, Inc.
(the “Company”) announced its financial results for the quarter ended June 30, 2023. The full text of the press
release issued by the Company in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained herein and in the accompanying
exhibit shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information
in this Current Report on Form 8-K, including the information set forth under this Item 2.02 and the exhibit hereto, shall not be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject
to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
LEAP THERAPEUTICS, INC. |
|
|
|
Dated: August 14, 2023 |
By: |
/s/ Douglas E. Onsi |
|
Name: |
Douglas E. Onsi |
|
Title: |
Chief Executive Officer and President |
Exhibit 99.1
Leap Therapeutics
Reports Second Quarter 2023 Financial Results
Cambridge,
MA – August 14, 2023 – Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology
company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for second quarter ended June 30,
2023.
Leap Highlights:
| · | Announced
that initial data from Part A of the Phase 2 DeFianCe study of DKN-01 in combination
with standard of care bevacizumab and chemotherapy as a second-line treatment for patients
with advanced colorectal cancer (CRC) exceeded a twenty percent (20%) overall response rate
(ORR) with a high disease control rate, leading to the initiation of the 130-patient randomized
controlled Part B of the study |
| · | Presented
new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01
plus tislelizumab and chemotherapy demonstrating 19.5 months median overall survival (OS)
in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting |
“The Company
made important progress on our DKN-01 program during the second quarter. Based on Part A of the DeFianCe study exceeding our threshold
of a 20% ORR, all of which are now confirmed responses, we initiated Part B, our second randomized controlled trial,” said
Douglas E. Onsi, President and Chief Executive Officer of Leap. “We also presented new long-term follow-up data from Part A
of the DisTinGuish study at ASCO, demonstrating 19.5 months median overall survival which exceeds current benchmarks. Additionally, enrollment
continues to be strong in the 160 patient randomized controlled Part C of the DisTinGuish study, and we expect to complete enrollment
in the fourth quarter of this year.”
DKN-01 Development
Update
| · | Announced
initial results from Part A of the DeFianCe Study of DKN-01 for the treatment of colorectal
cancer patients and initiation of the randomized controlled Part B of the study. The
DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study
of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with
advanced CRC who have received one prior systemic therapy for advanced disease. The study
began with an initial Part A cohort that enrolled 33 patients, including significant
numbers of patients who had early progression on first-line therapy, previous exposure to
bevacizumab, tumors with Ras mutations, or liver metastases. Initial results indicated an
ORR above twenty percent (20%) with a high disease control rate, which exceeds the benchmarks
expected for this population. The study has expanded into a 130-patient Part B randomized
controlled trial. The primary endpoint of the randomized study is progression free survival.
Secondary objectives include overall response rate, duration of response, and overall survival.
Leap expects to be able to enroll Part B in approximately 12 months. |
| · | Presented
updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy
in gastric cancer patients at the 2023 ASCO Annual Meeting. The Company presented
new long-term follow-up data in first-line patients with advanced GEA from Part A of
the DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating Leap’s
anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy.
Highlights from the data include: |
| o | At
two years follow up, DKN-01 plus tislelizumab and chemotherapy demonstrated an ORR of 73%
in the modified intent-to-treat (mITT) population and 86% in the PD-L1 low-subgroup |
| o | Median
OS of 19.5 months and median progression-free survival (PFS) of 11.3 months exceeds benchmark
results in the overall population |
| o | Combination
was well tolerated with manageable toxicity, with most adverse events related to DKN-01 being
low-grade |
Selected Second Quarter 2023 Financial
Results
Net Loss was $13.4
million for the second quarter 2023, compared to $17.0 million for the same period in 2022. The decrease was primarily due to decreased
research and development expenses and increased interest income.
Research and development
expenses were $11.1 million for the second quarter 2023, compared to $14.0 million for the same period in 2022. The decrease in research
and development expenses was primarily due to a decrease of $4.5 million in manufacturing costs related to clinical trial material, partially
offset by an increase of $0.8 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due
to an increase in headcount of our research and development full-time employees.
General and administrative
expenses were $3.6 million for the second quarter 2023, compared to $2.9 million for the same period in 2022. The increase in general
and administrative expenses was primarily due to an increase of $0.6 million in professional fees due to higher finance and legal costs
associated with our business development activities and a $0.3 million increase in payroll and other related expenses due to an increase
in headcount of our general and administrative full-time employees, partially offset by a decrease of $0.2 million in insurance costs.
Interest income
was $1.2 million for the second quarter 2023, compared to an immaterial amount for the same period in 2022. The increase reflects the
increased interest rate environment applicable to the Company’s cash balance.
Cash and cash equivalents
totaled $91.4 million at June 30, 2023. Research and development incentive receivables totaled $2.6 million at June 30, 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 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 outcomes of patients in Part A of the DeFianCe study,
the anticipated timing for initiation of or success of enrollment in Part B of the DeFianCe study, Part C of the DisTinGuish
study, and other 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 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 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) the effect of inflation and currency rate fluctuations
on Leap’s future expenses; (vi) fluctuations in the market price of Leap’s traded securities; (vii) 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; and (viii) whether Leap’s cash resources will be
sufficient to fund Leap’s continuing operations and planned studies. 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.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
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, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 11,104 | | |
$ | 14,045 | | |
$ | 50,046 | | |
$ | 21,829 | |
General and administrative | |
| 3,558 | | |
| 2,855 | | |
| 7,342 | | |
| 5,703 | |
Total operating expenses | |
| 14,662 | | |
| 16,900 | | |
| 57,388 | | |
| 27,532 | |
Loss from operations | |
| (14,662 | ) | |
| (16,900 | ) | |
| (57,388 | ) | |
| (27,532 | ) |
Interest income | |
| 1,157 | | |
| 39 | | |
| 2,005 | | |
| 44 | |
Interest expense | |
| - | | |
| (17 | ) | |
| - | | |
| (38 | ) |
Australian research and development incentives | |
| 298 | | |
| 587 | | |
| 570 | | |
| 624 | |
Foreign currency loss | |
| (145 | ) | |
| (733 | ) | |
| (452 | ) | |
| (498 | ) |
Change in fair value of Series X preferred stock warrant liability | |
| (38 | ) | |
| - | | |
| 12 | | |
| - | |
Net loss attributable to common stockholders | |
$ | (13,390 | ) | |
$ | (17,024 | ) | |
$ | (55,253 | ) | |
$ | (27,400 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share | |
| | | |
| | | |
| | | |
| | |
Basic & diluted | |
$ | (0.91 | ) | |
$ | (1.50 | ) | |
$ | (4.01 | ) | |
$ | (2.42 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding | |
| | | |
| | | |
| | | |
| | |
Basic & diluted | |
| 14,710,375 | | |
| 11,324,893 | | |
| 13,794,605 | | |
| 11,324,893 | |
Leap Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Assets | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 91,415 | | |
$ | 65,500 | |
Research and development incentive receivable | |
| 2,046 | | |
| 2,099 | |
Prepaid expenses and other current assets | |
| 419 | | |
| 351 | |
Total current assets | |
| 93,880 | | |
| 67,950 | |
| |
| | | |
| | |
Property and equipment, net | |
| 13 | | |
| 20 | |
Right of use assets, net | |
| 467 | | |
| 669 | |
Research and development incentive receivable, net of current portion | |
| 563 | | |
| - | |
Deferred costs | |
| - | | |
| 576 | |
Other long term assets | |
| - | | |
| 30 | |
Deposits | |
| 934 | | |
| 1,108 | |
Total assets | |
$ | 95,857 | | |
$ | 70,353 | |
Liabilities and Stockholders' Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 6,500 | | |
$ | 5,657 | |
Accrued expenses | |
| 4,826 | | |
| 5,152 | |
Lease liability - current portion | |
| 436 | | |
| 416 | |
Total current liabilities | |
| 11,762 | | |
| 11,225 | |
| |
| | | |
| | |
Non current liabilities: | |
| | | |
| | |
Lease liability, net of current portion | |
| 38 | | |
| 262 | |
Total liabilities | |
| 11,800 | | |
| 11,487 | |
| |
| | | |
| | |
| |
| | | |
| | |
Stockholders' equity: | |
| | | |
| | |
Common stock, $0.001 par value; 240,000,000 shares authorized; 25,565,414 and 9,902,137 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 26 | | |
| 10 | |
Additional paid-in capital | |
| 457,038 | | |
| 376,896 | |
Accumulated other comprehensive income | |
| 414 | | |
| 128 | |
Accumulated deficit | |
| (373,421 | ) | |
| (318,168 | ) |
Total stockholders’ equity | |
| 84,057 | | |
| 58,866 | |
Total liabilities and stockholders' equity | |
$ | 95,857 | | |
$ | 70,353 | |
Leap
Therapeutics, Inc.
Condensed
Consolidated Statements of Cash Flows
(in
thousands)
| |
(Unaudited) | | |
(Unaudited) | |
| |
Three Months Ended June 30 | | |
Six Months Ended June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cash used in operating activities | |
$ | (10,185 | ) | |
$ | (12,259 | ) | |
$ | (22,885 | ) | |
$ | (23,777 | ) |
Cash provided by (used in) investing activities | |
| (348 | ) | |
| - | | |
| 48,969 | | |
| - | |
Cash used in financing activities | |
| - | | |
| - | | |
| (29 | ) | |
| (210 | ) |
Effect of exchange rate changes on cash and cash equivalents | |
| (90 | ) | |
| (78 | ) | |
| (140 | ) | |
| (46 | ) |
Net increase (decrease) in cash and cash equivalents | |
| (10,623 | ) | |
| (12,337 | ) | |
| 25,915 | | |
| (24,033 | ) |
Cash and cash equivalents at beginning of period | |
| 102,038 | | |
| 103,220 | | |
| 65,500 | | |
| 114,916 | |
Cash and cash equivalents at end of period | |
$ | 91,415 | | |
$ | 90,883 | | |
$ | 91,415 | | |
$ | 90,883 | |
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Grafico Azioni Leap Therapeutics (NASDAQ:LPTX)
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Da Mag 2024 a Giu 2024
Grafico Azioni Leap Therapeutics (NASDAQ:LPTX)
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Da Giu 2023 a Giu 2024