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BioLineRx Issues Letter to Shareholders

On January 21, 2025, BioLineRx Ltd., a biopharmaceutical company focused on developing transformative therapies in oncology and rare diseases, published a letter addressed to its shareholders. This communication comes about two months after a significant strategic pivot marked by the exclusive licensing agreement with Ayrmid Ltd. for their innovative therapy, APHEXDA (motixafortide). This agent represents a new generation in stem cell mobilization, which is pivotal in treating conditions like multiple myeloma. With its successful transition from early clinical trials to FDA approval and subsequent commercial launch in September 2023, the company looks to solidify its long-term vision.

Key Highlights of the Licensing Agreements

To comprehend the future trajectory of BioLineRx, it is crucial to revisit the essentials of its licensing agreements. The recent negotiation with Ayrmid was strategically aimed at expanding the reach of APHEXDA. Under this agreement, Ayrmid will develop and market APHEXDA across various indications, excluding solid tumors, in territories outside of Asia. In return for this exclusive license, BioLineRx has received a substantial upfront payment of $10 million, with the potential for earning an additional $87 million based on commercial milestones and royalties that could reach up to 23% on net sales.

In tandem, the agreement established with Guangzhou Gloria Biosciences Co., Ltd. allows for APHEXDA's commercialization in Asia, starting with its application in stem cell mobilization. BioLineRx attracted an additional $15 million here, along with the opportunity to earn up to ~$200 million in commercial milestones, plus tiered royalties on net sales.

BioLineRx 2.0 Initiative

With recent transformations, the company embraces a new identity, dubbed 'BioLineRx 2.0'. The objective is to refine its operations into a lean drug development firm that effectively leverages its team’s significant expertise and proven success, particularly highlighted by the development of motixafortide. They still hold rights to develop motixafortide for all solid tumor indications worldwide, save for Asia, which could bring significant profit avenues as trials continue without high costs on their part. One investigator-initiated Phase 2b trial is already underway at Columbia University.

Looking forward, BioLineRx aims to in-license additional therapies in oncology and rare diseases over the next two years, enabling the advancement of promising assets through clinical trials. With a strategy focused on low-cost transactions and success-based payment terms, the company is well-positioned to invest in innovative solutions while maintaining financial health.

Financial Outlook

Looking ahead, BioLineRx expects the revenue from its license agreements to substantially enhance its cash flow over time. The proceeds accrued from these initiatives, combined with a planned operating expense of around $12 million per year, are anticipated to sustain the company’s ambitions well into the latter half of 2026.

Moreover, BioLineRx is taking steps to regain Nasdaq compliance—essential for maintaining its listing status. This includes a strategic alteration to the ratio of its American Depositary Shares. The impending reverse stock split reflects the company’s commitment to fulfilling Nasdaq’s minimum bid price requirement, crucial for ongoing market participation.

Conclusion

As BioLineRx embarks on 2025 with renewed momentum, it remains focused on developing pioneering therapies in its key sectors. With a polished financial framework featuring a $29.5 million cash position and a streamlined operational model, the company is poised to create profound shareholder value. Management looks forward to sharing additional advancements, with updates expected at the release of fourth-quarter results in March.

Thank you for your continued support.

Sincerely,

Phil Serlin
Chief Executive Officer

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is committed to delivering life-altering therapies focused on oncology and rare diseases. The company’s flagship product is APHEXDA (motixafortide), approved in the U.S. for stem cell mobilization in multiple myeloma treatment. With a robust pipeline and extensive development experience, BioLineRx is determined to translate innovative discoveries into effective patient therapies.