Full Press Release Details
Leap Therapeutics Acquires Flame Biosciences
Adds FL-301, clinical stage anti-Claudin18.2
and two preclinical antibody programs to Leap's pipeline
Combined cash balance of approximately $115
enhances runway to mid-2025, fully-funding advancement of DKN-01 and FL-301
Leap to host conference call at 9:00 a.m. ET
MA - January 17, 2023 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted
and immuno-oncology therapeutics, and Flame Biosciences, Inc., a privately-held
biotechnology company, today announced that the companies have entered into a definitive merger agreement pursuant to which Leap has acquired
Flame and its assets, including FL-301, its clinical stage anti-Claudin18.2 monoclonal antibody, FL-302, its preclinical anti-Claudin18.2/CD137
bispecific monoclonal antibody, FL-501, its preclinical anti-GDF15 monoclonal antibody, and net cash of approximately $50 million as of
combined company will continue to trade on Nasdaq under the ticker symbol "LPTX," will be led by Leap's existing management
team, and will also remain focused on advancing DKN-01, Leap's anti-DKK1 monoclonal antibody, in Phase 2 clinical trials in gastric
cancer, endometrial cancer, and colorectal cancer patients. The total cash balance of the combined company as of December 31, 2022
was approximately $115 million, expected to be sufficient to fund Leap's planned operating expenses and development plans for DKN-01,
FL-301, and the preclinical programs to mid-2025.
"This is a transformative transaction for
Leap. Acquiring FL-301 is a perfect fit with our vision of developing novel biomarker-targeted therapies for cancer patients, that is
represented by our DKN-01 program. We believe that DKK1 and Claudin18.2 will become important patient selection biomarkers in gastric
cancer, alongside HER-2 and PD-L1 expression, with the potential for delivering personalized medicines to patients who currently have
poor survival outcomes," said Douglas E. Onsi, President & CEO of Leap. "The additional pipeline strength is further enhanced
by additional financial strength. With the combined company resources, Leap will focus on executing on the randomized controlled trial
for DKN-01 in combination with BeiGene's tislelizumab and chemotherapy in first-line gastric cancer patients, the new study of DKN-01
in colorectal cancer patients, and the investigator-sponsored trial of DKN-01 in combination with Merck's pembrolizumab in endometrial
"Flame conducted an extensive strategic
process. It was clear that the Leap development team, with its expertise in developing DKN-01, was the ideal partner for FL-301, our preclinical
assets, and the Flame shareholders," said Patricia Martin, the Co-Chief Executive Officer of Flame.
"We share Leap's commitment to developing
novel, biomarker-targeted therapies in cancers where there is a significant unmet need and look forward to joining them to bring DKN-01
and FL-301 to patients around the world," said Christian Richard, Head of Public Research of Samsara BioCapital.
the merger, Leap will issue approximately 19,794,373 shares of its common stock and approximately 136,833 shares of a newly designated
Series X non-voting convertible preferred stock to Flame stockholders. Upon approval by the stockholders of Leap, each share of
the Series X non-voting convertible preferred stock will be automatically converted into 1,000 shares of common stock. Flame's
institutional shareholders include Rock Springs Capital, funds and accounts advised by T. Rowe
Price Associates, Inc., Janus Henderson Investors, Samsara BioCapital, Adage Capital Management LP, Cormorant Asset Management LP, Surveyor
Capital (a Citadel company), Terra Magnum Capital Partners, Logos Capital, and Acuta Capital Partners. In
addition, Leap will pay the Flame shareholders 80% of the after-tax net proceeds, if any, from certain post-merger transactions to out-license
or sell FL-101 or FL-103, Flame's anti-IL-1b antibodies.
Leap plans to hold a
special meeting of stockholders to approve the conversion of the Series X non-voting convertible preferred stock into shares of common
stock and related matters. The number of shares of Leap common stock issuable upon conversion of the Series
X non-voting convertible preferred stock are subject to adjustment in the event of any corporate transactions or reverse stock split that
may be effectuated by Leap. HealthCare Ventures, which holds 6,763,210 shares or 6.83% of
Leap's outstanding common stock, has signed a support agreement to vote in favor of the proposals to be presented at the shareholder
meeting. Assuming the approval by the Leap stockholders, on an as-converted basis, the Flame shareholders will in the aggregate own 58%
of the outstanding shares including pre-funded warrants of Leap, and 47.4% on a fully-diluted basis assuming the exercise of all outstanding
warrants, options and restricted stock units exercisable for Leap common stock and shares eligible for grant under Leap's equity
sold in the merger have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or
other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable
exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.
Leap has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") to register the
resale by the Flame stockholders of the shares of Leap common stock to be issued in connection with the merger.
Raymond James acted as
exclusive financial advisor to Leap on the transaction.
Management and Organization
as of the closing of the transactions, the Leap leadership team will continue to be responsible for all executive positions of the combined
company. Leap has added two members nominated by Flame to its existing eight person Board of Directors: Patricia Martin and Christian
is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates
the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis,
and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating
NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the
treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment
of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease
progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth
factor (HER2)/neu-targeted therapy.
is a fully human monoclonal antibody that binds to and blocks Claudin18.2. Claudin18.2 regulates barrier properties and contributes
to cell-to-cell adhesion. Expression of Claudin18.2 is very limited in normal tissue, as it is typically buried in the tight junction
complex of gastric mucosal cells. In the development of cancer, however, cells lose their polarity and structure. As a result, Claudin18.2
may be exposed and accessible as a target for cancer therapy and is highly expressed on gastric cancer and pancreatic cancer cells. The U.S. Food
and Drug Administration has granted FL-301 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and
for the treatment of pancreatic cancer. FL-301 is being developed through an exclusive license from NovaRock Biotherapeutics for territories
excluding China and is currently in a Phase 1 clinical trial in cancer patients in China.
Conference Call Information
management team will host a conference call today at 9:00 a.m. Eastern Time to discuss the transaction. The live presentation of the
conference call can be accessed by registering here. A replay of the event will be available for a limited time and may
be access on the Investors page of Leap's website at https://investors.leaptx.com.
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. Leap has entered into a strategic collaboration with BeiGene, Ltd. for the rights to develop DKN-01
in Asia (excluding Japan), Australia, and New Zealand. 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/.
About Flame Biosciences
Flame Biosciences is
a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics that address
major unmet needs in diseases that are linked to chronic inflammation including cancer, atherosclerotic cardiovascular disease and arthritis.
Flame has been funded by Rock Springs Capital, funds and accounts advised by T. Rowe Price Associates,
Inc., Cormorant Asset Management LP, Janus Henderson Investors, Surveyor Capital (a Citadel company), Samsara BioCapital, Adage Capital
Management LP, Terra Magnum Capital Partners, Logos Capital and Acuta Capital Partners.
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,"
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