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 December 31, 2022.
The 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 cancer patients.”
“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.
In 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 incentive plans.
The securities 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.
Effective 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 Richard.
DKN-01 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.
FL-301 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.
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. 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/.
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.