BioLineRx Ltd.

BioLineRx Ltd. is a biopharmaceutical company focused on life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA (motixafortide), a novel peptide for stem-cell mobilization and solid tumors, specifically indicated in the United States for stem cell mobilization for autologous transplantation in multiple myeloma ¹. APHEXDA is developed and commercialized by Ayrmid Pharma Ltd. globally (excluding Asia) and by Auspex Bioscience (Guangzhou) Co., Ltd. (Gloria) in Asia ². BioLineRx is also advancing motixafortide for pancreatic cancer and other solid tumors outside of Asia ³. In September 2025, the company entered into a collaboration with Hemispherian AS for the development, clinical evaluation, and commercialization of GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma (GBM) and other cancers ⁴.

The core business model of BioLineRx involves generating revenue primarily through strategic licensing and collaboration arrangements, including upfront and milestone payments, and royalties on product sales ⁵. Following the out-licensing of motixafortide to Ayrmid in November 2024, the company shut down its independent commercialization activities in the United States and refocused its operations on development activities in Israel in oncology and rare diseases, aiming for a significantly reduced annual cash burn rate ⁶. The company's strategy emphasizes in-licensing additional assets in oncology and rare diseases, structured with back-ended, success-based consideration to secure assets with modest upfront payments and align incentives with partners ⁷.

APHEXDA (motixafortide) is a novel, short peptide that acts as a high-affinity antagonist for CXCR4, a receptor overexpressed in various human cancers and involved in hematopoietic stem cell homing ⁸. Its FDA approval in September 2023 is for stem cell mobilization for autologous transplantation in multiple myeloma ⁹. Clinical data has shown motixafortide's ability to mobilize higher numbers of long-term engrafting HSCs compared to G-CSF ¹⁰. The company retains rights to develop motixafortide in solid tumor indications outside of Asia, including pancreatic ductal adenocarcinoma (PDAC), where an investigator-initiated Phase 2b trial is ongoing ¹¹. Motixafortide has also been granted three Orphan Drug Designations by the FDA for HSC mobilization, AML, and pancreatic cancer, and two by the EMA for pancreatic cancer and HSC transplantation ¹².

GLIX1, Hemispherian's lead drug candidate, is a first-in-class, oral, small molecule targeting DNA damage response ¹³. It is initially being developed for newly diagnosed and recurrent GBM, a highly aggressive form of brain cancer with limited treatment advancements since 2005 ¹⁴. GLIX1's mechanism involves restoring TET2 activity, leading to DNA damage and cell death in cancer cells ¹⁵. Preclinical studies have shown its efficacy in orthotopic GBM xenograft models and synergy with PARP inhibitors ¹⁶. An IND application was cleared by the FDA in August 2025, and a Phase 1/2 study is expected to initiate in Q1 2026 ¹⁷. GLIX1 has also received Orphan Drug Designation from both the FDA and EMA ¹⁸.

BL-5010 is a commercialized, legacy therapeutic product, a customized pen-like applicator containing an acidic aqueous solution for the non-surgical removal of skin lesions ¹⁹. It offers an alternative to invasive treatments and minimizes infection risk ²⁰. In December 2014, BioLineRx out-licensed the rights to Perrigo Company plc for over-the-counter (OTC) indications in Europe, Australia, and other selected countries ²¹. Perrigo received CE Mark approval for BL-5010 for wart removal in March 2016 and launched an improved version in 2019 ²². In March 2020, Perrigo relinquished license rights for certain countries, and BioLineRx returned those rights to IPC, its licensor, in exchange for royalties on sublicense receipts ²³.

For the year ended December 31, 2025, BioLineRx reported revenues of $1.2 million ²⁴, a significant decrease of $27.7 million compared to $28.9 million in 2024 ²⁵. Cost of revenues for 2025 was $0.2 million, a decrease of $9.1 million from $9.3 million in 2024 ²⁶. Research and development expenses decreased by $1.1 million, or 11.5%, to $8.1 million in 2025 from $9.2 million in 2024 ²⁷. Sales and marketing expenses were $0 in 2025, down from $23.6 million in 2024 ²⁸. General and administrative expenses decreased by $3.2 million, or 50.3%, to $3.1 million in 2025 from $6.3 million in 2024 ²⁹. The company recorded net non-operating income of $8.1 million in 2025, compared to $18.4 million in 2024 ³⁰. Net financial income was $0.2 million in 2025, a change from net financial expenses of $7.3 million in 2024 ³¹. The company reported a net loss of $2.0 million in 2025, compared to $9.2 million in 2024 and $60.6 million in 2023 ³². As of December 31, 2025, the accumulated deficit was $401 million ³³, and cash, cash equivalents, and short-term bank deposits totaled $20.9 million ³⁴.

The significant decrease in 2025 revenues reflects one-time revenues in 2024 from the Gloria out-licensing transaction and the shift in operations following the Ayrmid out-licensing in Q4 2024 ³⁵. The 2025 revenues primarily consist of royalties from Ayrmid's commercialization of APHEXDA in the U.S. ³⁶. The reduction in cost of revenues in 2025 is due to lower sub-license fees on Ayrmid royalties compared to 2024, which included amortization of intangible assets, sub-license fees on upfront payments from Ayrmid, and royalties on direct product sales of APHEXDA ³⁷. The decrease in R&D expenses is mainly due to lower motixafortide-related costs after out-licensing U.S. rights to Ayrmid and a decrease in payroll and share-based compensation from reduced headcount, partially offset by GLIX1 project initiation expenses ³⁸. The absence of sales and marketing expenses in 2025 is a direct result of shutting down U.S. commercial operations after the Ayrmid transaction ³⁹. General and administrative expenses decreased due to the reversal of a provision for doubtful accounts after receiving an overdue milestone payment from Gloria, reduced payroll and share-based compensation from lower headcount, and a general decrease in administrative costs ⁴⁰.

In September 2025, BioLineRx entered into a collaboration with Hemispherian for GLIX1 development, clinical evaluation, and commercialization ⁴¹. This collaboration led to the formation of Tetragon Biosciences, Ltd., a newly created company, with BioLineRx holding 40% of the issued share capital and Hemispherian holding 60% ⁴². BioLineRx is responsible for managing and implementing Tetragon's activities, overseeing its operations, budget, and expenses ⁴³. In June 2025, BioLineRx sold its wholly-owned subsidiary, Agalimmune, to a third party for future potential royalty consideration, following the termination of AGI-134 development ⁴⁴.

BioLineRx believes its existing cash and investment balances of $20.9 million ⁴⁵ will be sufficient to meet its capital requirements into the first half of 2027 ⁴⁶. The company expects future revenues to be derived primarily from royalties on product sales, specifically from Ayrmid's commercialization of APHEXDA in stem cell mobilization in the U.S., and potential milestone payments from the license agreements with Ayrmid and Gloria ⁴⁷. The company plans to continue funding operations through existing cash resources, potential future milestone and royalty payments, interest earned on investments, and additional capital raised through public or private equity offerings or debt financings ⁴⁸.

A major growth area for BioLineRx is the development of GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma (GBM) and other solid tumors ⁴⁹. An Investigational New Drug (IND) application for GLIX1 was cleared by the FDA in August 2025 ⁵⁰, and a Phase 1/2a study in GBM and other cancers is expected to initiate in Q1 2026 ⁵¹. The open-label dose escalation Phase 1 part of the trial is designed to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas, aiming to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD, and preliminary efficacy ⁵². Data from the Phase 1 part is anticipated in H1 2027 ⁵³. The Phase 2a expansion part is planned to include various population cohorts for GBM (newly diagnosed and/or recurrent) and additional cancers, with data planned in H1 2028 ⁵⁴. GLIX1 has been granted Orphan Drug Designation by both the FDA and EMA ⁵⁵.

Another growth area involves the continued development of motixafortide for patients with pancreatic cancer and other solid tumors outside of Asia ⁵⁶. An investigator-initiated Phase 2, single-arm study (CheMo4METPANC), led by Columbia University and supported equally by BioLineRx and Regeneron, is evaluating motixafortide in combination with cemiplimab and standard-of-care chemotherapy in first-line PDAC ⁵⁷. Preliminary data from the pilot phase, reported in September 2023, showed seven out of eleven patients (64%) experienced a partial response, with a disease control rate of 91% ⁵⁸. Updated results in May 2025 indicated four of eleven patients remained progression-free after more than one year, and two underwent definitive treatment with complete or sustained partial responses ⁵⁹. Based on these results, the study was amended to a randomized multi-center Phase 2b trial of 108 patients, with the first patient dosed in February 2024 ⁶⁰. An interim futility analysis is planned for 2026, and full enrollment is projected for 2027 ⁶¹. However, a planned Phase 2b randomized study in first-line PDAC in China under the Gloria License Agreement is currently delayed, and its initiation timeline is unclear ⁶².

BioLineRx expects its research and development expenses to remain a primary expense in the near future as it continues to develop GLIX1, motixafortide, and additional in-licensed assets ⁶³. The company's future R&D expenses will depend on the clinical success of these candidates and ongoing assessments of their commercial potential ⁶⁴. Sales and marketing expenses are expected to be primarily related to business development, following the shutdown of U.S. commercial operations in Q4 2024 ⁶⁵.

The company's planned capital allocation includes an investment of $5 million in Tetragon Biosciences Ltd. over 36 months (beginning September 2025) in tranches according to a development plan, which may be extended by an additional six months ⁶⁶. As of December 31, 2025, $1.2 million had been invested in Tetragon ⁶⁷. For each incremental $1 million invested beyond the threshold, BioLineRx will be entitled to an additional 1% equity interest, up to an aggregate maximum ownership of 70% ⁶⁸. The company's premises leasing obligations total approximately $1.6 million due through June 2030 ⁶⁹, and purchase order obligations amounted to $2.4 million as of December 31, 2025 ⁷⁰.

Management has concluded that there is substantial doubt about the company's ability to continue as a going concern due to significant losses and negative cash flows from operations, and an accumulated deficit of $401 million as of December 31, 2025 ⁷¹. The adequacy of available funds depends on factors such as royalty and milestone payments from license agreements, the progress and results of research and development programs, costs and timing of regulatory approvals, and intellectual property enforcement ⁷². The company cannot be certain that future liquidity sources will be available on commercially reasonable terms or at all, or that actual cash requirements will not exceed expectations ⁷³.

BioLineRx faces several material risks, including substantial doubt about its ability to continue as a going concern due to significant losses and negative cash flows from operations, with an accumulated deficit of $401 million as of December 31, 2025 ⁷⁴. The company's ability to meet future capital requirements depends on uncertain royalty and milestone payments from existing license agreements, the success of its research and development programs, and the ability to obtain additional financing ⁷⁵. A default under the secured loan agreement with BlackRock could lead to forfeiture of assets, as the company is obligated to make aggregate payments of $16.5 million as partial repayment and pay remaining amounts outstanding over a three-year period ending December 1, 2027 ⁷⁶. The company's commercial success is highly dependent on the market acceptance of GLIX1 and motixafortide, which face competition from existing therapies and generic versions, such as Mozobil's generic formulations ⁷⁷. Regulatory risks include the potential failure to obtain or maintain U.S. and foreign regulatory approvals for therapeutic candidates, which could delay or prevent commercialization ⁷⁸. The company relies on third parties for preclinical studies, clinical trials, and manufacturing, and their unsatisfactory performance or failure to meet deadlines could delay development and increase costs ⁷⁹. Dependence on out-licensing arrangements, such as those with Gloria and Ayrmid, subjects the company to risks including limited control over licensee resources and potential termination of agreements ⁸⁰. Intellectual property risks include the potential for patents to be challenged, narrowed, or found invalid, and the risk of infringing third-party rights, which could prevent commercialization ⁸¹. Operations in Israel expose the company to political, geopolitical, economic, and military instability in the region, which could adversely affect business and make capital raising more difficult ⁸². Currency fluctuations, particularly between the U.S. dollar and NIS, can harm operating results due to a significant portion of expenses being NIS-denominated ⁸³. Compliance with Israeli Innovation Authority (IIA) grant terms for motixafortide requires royalty payments and consent for technology transfer outside Israel, with potential penalties for non-compliance ⁸⁴. Provisions of Israeli law and the company's Articles of Association may delay or prevent mergers or acquisitions, even if favorable to shareholders ⁸⁵.

Management's message to shareholders emphasizes a strategic refocusing of operations on development activities in Israel in oncology and rare diseases, following the out-licensing of motixafortide to Ayrmid in November 2024, which has resulted in a significantly reduced annual cash burn rate ⁸⁶. The company's longer-term vision is to develop innovative assets with significant potential value, with development costs offset by royalties and milestones from existing motixafortide partnerships ⁸⁷. A key strategic priority is to in-license additional assets in oncology and rare diseases, targeting innovative therapeutic candidates with clear differentiation, superior efficacy, improved safety, and novel mechanisms of action ⁸⁸. Management is committed to identifying and advancing therapeutic candidates through a systematic process of asset identification, rigorous scientific and clinical validation, and disciplined in-licensing, aiming for modest upfront payments and cost-effective clinical development programs ⁸⁹. The company believes its existing cash and investment balances of $20.9 million ⁹⁰ will be sufficient to meet capital requirements into the first half of 2027 ⁹¹, with future funding expected from royalties, milestone payments, interest on investments, and additional capital raises ⁹².