BioLineRx & Ayrmid Ink Exclusive License Agreement to Commercialize Aphexda Through Gamida Cell

Overview

BioLineRx Ltd., a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Ayrmid Ltd. (Ayrmid), the parent company of Gamida Cell Ltd., announced that on November 20, 2024, the companies entered into a license agreement for motixafortide (commercially sold in the US as Aphexda), BioLineRx's FDA-approved stem cell mobilization agent indicated in combination with filgrastim (G-CSF) for collection and subsequent autologous transplantation in patients with multiple myeloma.

Terms of the Agreement

• Under the terms of the agreement, BioLineRx granted Ayrmid an exclusive license to develop and commercialize Aphexda (motixafortide) across all indications, excluding solid tumour indications, and in all territories other than Asia.  
• BioLineRx previously granted an exclusive license agreement to Gloria Biosciences for Aphexda (motixafortide) in the Asia region.

Receiving Transaction

In exchange for the license, BioLineRx will receive a $10 million upfront payment and is also eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties ranging from 18% to 23% on net sales of Aphexda.

Aphexda in Ayrmid portfolio

• Ayrmid will add Aphexda to its commercial portfolio, which also includes Gamida Cell's Omisirge, the first and only FDA-approved, nicotinamide (NAM)-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. 
• As part of this transaction, Ayrmid expects to transition certain members of BioLineRx's US-based commercial organization, who will support both stem cell transplant drugs.     

Through this transaction, BioLineRx will significantly reduce its long-term debt and operational expenses, which will be reviewed in detail during the company's upcoming Q3 results conference call and webcast.

Share Purchase Agreement: BioLineRx

• BioLineRx also entered into a share purchase agreement for a $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC. 
• This investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences, as well as royalties on net sales, are expected to provide a strong foundation for BioLineRx to advance its pipeline and identify potential additional assets for development. 
• The equity investment is expected to close today, November 21, 2024, subject to the satisfaction of customary closing conditions.

Motixafortide Development for PDAC

BioLineRx will continue the development of motixafortide for pancreatic ductal adenocarcinoma (PDAC) through meaningful collaborations, including an active phase 2b PDAC study led by Columbia University, and supported equally by BioLineRx and Regeneron, as well as a planned phase 2b PDAC study in China led by Gloria Biosciences.

Words from the CEO: BioLineRx

• Since APHEXDA's launch last year, patients and transplant centres continue to see the tremendous benefits it can provide, and I could not be prouder of our commercial organization that has proven its value,"" stated Philip Serlin, chief executive officer of BioLineRx.  
• Our agreement with Ayrmid, and their vision of creating a strong commercial transplant portfolio, makes them the ideal partner to realize Aphexda's full commercial potential.  BioLineRx will now leverage its proven expertise in drug development, with a continued focus on oncology and rare diseases. This new path forward aligns with our core strengths and allows us the opportunity to create enduring value for all stakeholders.

Words from the CEO: Ayrmid Ltd

• Dr. Joe Wiley, chief executive officer of Ayrmid Ltd, added, ""Aphexda represents a significant advancement in improving the lives of multiple myeloma patients as they progress along the stem cell transplant journey. Aphexda complements our existing portfolio by supporting Omisirge's growth, doubling our tran'splant portfolio, and enhancing the capabilities Gamida Cell has already established in cell therapy.” 
• Our growing momentum positions us well for continued expansion in the US and beyond, marking a key step in our journey as we continue to build on our success, strengthen our commitment to the transplant community, and execute our long-term strategy.

The equity investment offering is being made by BioLineRx pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the SEC) and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement.

Advisor to BioLineRx

MTS Health Partners, L.P. served as the exclusive financial advisor to BioLineRx Ltd. in connection with the transaction.

Advisor to Ayrmid Ltd

Moelis & Company LLC served as the exclusive financial advisor to Ayrmid Ltd. in connection with the transaction.

About Ayrmid Ltd

• Ayrmid Ltd. is the parent company of Gamida Cell Ltd. Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. 
• The company's proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.

Highbridge Capital Management

Founded in 1992, Highbridge Capital Management, LLC (Highbridge) is a global alternative investment firm offering differentiated credit and volatility focused solutions across a range of liquidity and investment profiles, including hedge funds, drawdown vehicles, and co-investments.

About the Company: BioLineRx Ltd.

• BioLineRx Ltd. is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. 
• The company's first approved product is Aphexda (motixafortide), with an indication in the US for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia).

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