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Leap Therapeutics Provides Update on BeiGene Option Agreement for DKN-01 DisTinGuish Trial of DKN-01 plus tislelizumab and chemotherapy to continue as a clinical collaboration Cambridge, MA

Key Takeaway: Leap Therapeutics has provided an update regarding its collaboration with BeiGene, stating that the option for DKN-01's rights in certain Asian territories has expired. Despite this, both companies will proceed with the Part C of the DisTinGuish trial, which assesses DKN-01 in combination with tislelizumab and chemotherapy for gastric cancer. Enrollment in the trial is set to conclude by late 2023. Leap is focused on generating clinical data and exploring new partnerships while managing a cash runway extended through mid-2025 due to a recent acquisition.

Market Sentiment Analysis

POSITIVE FACTORS

  • Leap Therapeutics continues its collaboration with BeiGene on the DisTinGuish trial.
  • The upcoming study has attracted 160 participants and is expected to complete enrollment in late 2023.
  • Leap's recent acquisition of Flame Biosciences has enhanced its cash runway into mid-2025.
  • The company is focused on targeted therapies for various cancer patients, showing a commitment to innovation in oncology.

CONCERNS & RISKS

  • The expiration of the option agreement with BeiGene may raise questions about future collaboration terms.
  • There are inherent risks associated with clinical trial executions, including potential delays in results and regulatory approvals.
  • Future success depends on Leap's ability to form new strategic partnerships, which are uncertain.

Full Press Release Details

Leap Therapeutics Provides Update on BeiGene
Option Agreement for DKN-01
DisTinGuish Trial of DKN-01 plus tislelizumab and
chemotherapy to continue as a clinical collaboration
MA - March 16, 2023 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that BeiGene's option under the Exclusive Option and License Agreement
between Leap and BeiGene granting rights in certain Asian territories to DKN-01, Leap's anti-DKK1 monoclonal antibody, has expired
in accordance with the terms of the agreement. Leap and BeiGene will continue to collaborate on the ongoing Part C of the DisTinGuish
trial, a randomized controlled trial of DKN-01 in combination with BeiGene's anti-PD-1 antibody, tislelizumab, and chemotherapy
in first-line gastric cancer patients, as a clinical collaboration with BeiGene supplying tislelizumab. Enrollment in the 160-patient
study is expected to be completed in late 2023.
"We look forward to continuing to collaborate
with BeiGene to execute on our first randomized controlled trial for DKN-01 in first-line gastric cancer patients," said Douglas
E. Onsi, President and Chief Executive Officer of Leap. "With global rights to DKN-01 and a cash runway that was enhanced into mid-2025
by our recent acquisition of Flame Biosciences, we will look to identify a new strategic partner as we generate new clinical data from
our ongoing studies in first-line gastric cancer patients, second-line colorectal cancer patients, and an investigator-sponsored study
in endometrial cancer patients. We will also continue the development of the newly-acquired Claudin18.2 programs as part of our focus
on biomarker-targeted antibody therapies for cancer patients, particularly those with GI cancers."
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
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 our clinical collaboration with
BeiGene on the ongoing Part C of the DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the enhancement of
our cash runway into mid-2025; our future development plans in connection with our newly-acquired Claudin18.2 programs; the potential,
safety, efficacy, and regulatory and clinical progress of Leap's product candidates, including the anticipated timing for enrollment
of clinical trials and release of clinical trial data and outcomes of such trials; the ability to enter into a new strategic partnership
for DKN-01 or any of Leap's other programs; 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 cost of such clinical trials;
(ii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs; (iii) whether
any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory
agencies; (iii) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price
of Leap's traded securities; (iv) 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;
(v) the results of Leap's clinical trials and pre-clinical studies; and (vi) Leap's ability to comply with the continued
listing requirements of the Nasdaq Global 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.

Frequently Asked Questions

What is the status of the option agreement with BeiGene?

Leap's option agreement with BeiGene for DKN-01 has expired.

What trial is Leap continuing with BeiGene?

Leap is continuing the DisTinGuish trial, studying DKN-01 with tislelizumab.

What is DKN-01 used for?

DKN-01 targets DKK1 for treating esophagogastric, gynecologic, and colorectal cancers.

When is enrollment for the DisTinGuish trial expected to finish?

Enrollment for the trial is expected to be completed by late 2023.

What strategic plans does Leap have for DKN-01?

Leap aims to find a new strategic partner as they gather clinical data for DKN-01.

Last updated: Mar 16, 2023