Announcement • Jul 08
Biolinerx and Hemispherian Announce New Preclinical Data Demonstrating Strong Synergistic Effect Between Glix1 and Parp Inhibitor in A Patient-Derived Ovarian Cancer Xenograft Model BioLineRx Ltd. and Hemispherian AS announced highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer. Synergy was demonstrated in a combination arm of GLIX1 and the PARP inhibitor olaparib at low doses, with substantially better efficacy compared to the control arm and compared to each drug individually at its optimal dose. GLIX1 in combination with olaparib also showed comparable efficacy to that seen with the chemotherapy drug cisplatin. Results reinforce synthetic lethality between GLIX1 and PARP inhibitors, indicating that GLIX1 can broaden the use of PARPi in ovarian cancer. Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy, as well as for patients with platinum-resistance. GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors' requirement for HR-deficiency, enabling synergistic activity in HR-proficient cancers. This effect was first observed in vitro, where GLIX1 showed reproducible synergy across different PARP inhibitors and multiple HR-proficient ovarian cancer cell lines, with very high ZIP synergy scores. Today's results represent a compelling in vivo confirmation of GLIX1 and PARPi synergy from an HR-proficient ovarian cancer PDX model. The study included six arms: cisplatin, GLIX1 monotherapy and olaparib monotherapy (all at doses expected to be optimal), low-dose GLIX1, a low-dose GLIX1/olaparib combination arm, and a control arm. Results show substantially better efficacy in the combination arm versus the control arm and versus the monotherapy arms, despite using lower doses in the combination arm. The low-dose GLIX1/olaparib combination tumor reduction was similar to cisplatin, the current chemotherapy benchmark. BioLineRx and Hemispherian plan to present the data from this study at one or more future medical conferences. GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death. The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during Second Half 2026, with full results on the dose escalation part expected in 2027. The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.8m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Revenue is less than US$5m (US$1.4m revenue). Market cap is less than US$100m (₪39.3m market cap, or US$13.2m). Reported Earnings • May 29
First quarter 2026 earnings released: US$0.001 loss per share (vs US$0.002 profit in 1Q 2025) First quarter 2026 results: US$0.001 loss per share (down from US$0.002 profit in 1Q 2025). Net loss: US$1.60m (down 131% from profit in 1Q 2025). Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Asia. 
