Press Release: BioLineRx Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Dow Jones
Yesterday

- Second of five planned cohorts ongoing in Phase 1/2a trial of GLIX1 in GBM; third patient cohort expected to commence dosing in September -

- Announced new data showing GLIX1 achieved potent antitumor activity in TMZ-resistant patient-derived xenograft (PDX) GBM in vivo model -

- Announced additional data demonstrating strong synergistic effect between GLIX1 and PARP inhibitor in patient-derived HR-proficient ovarian cancer xenograft model -

- Management to host conference call today, August 31, at 8:30 am EDT -

TEL AVIV, Israel, Aug. 31, 2026 /PRNewswire/ -- BioLineRx Ltd. $(BLRX)$ (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended June 30, 2026, and provided a corporate update.

"During the second quarter and subsequent period, we advanced GLIX1 across multiple fronts," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Our Phase 1/2a study in glioblastoma is advancing as planned, with the second cohort in the Phase 1 part now being dosed, and the third cohort expected to commence dosing in September. To date, a little more than four months into the study, we have been very pleased with the drug's safety and tolerability.

"Also, during the quarter, we were excited to demonstrate the potential of GLIX1 to address unmet needs for GBM as well as ovarian cancer in a number of pre-clinical models. In this regard, we announced new data in a temozolomide-resistant patient-derived xenograft (PDX) GBM in-vivo model, in which GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no effect. These results further support GLIX1's potential to treat a broad range of patients with GBM. We also generated data showing strong synergy between GLIX1 and PARP inhibitors in an HR-proficient patient-derived ovarian cancer in-vivo model, and based upon these excellent findings, we are planning to add an ovarian cancer arm to the Phase 2a expansion phase of the trial. Together, these developments keep GLIX1 on track in glioblastoma while extending its reach into additional tumor types where new treatment options are desperately needed."

Financial Updates

   -- With $13.1 million on its balance sheet as of June 30, 2026, BioLineRx is 
      maintaining its cash runway guidance into the first half of 2027. 
 
   -- On August 27, 2026, the Company entered into a definitive agreement for 
      an offering with gross proceeds of $3.75 million, expected to close on or 
      about August 31, 2026. 

Development Updates

GLIX1 in GBM

   -- In July, dosing commenced in the second of five planned cohorts in the 
      Phase 1 dose escalation part of the Phase 1/2a study. 
 
          -- Three leading cancer centers are enrolling patients in the Phase 1 
             part of the study: NYU Langone Health, led by Dr. Alexandra 
             Miller; Northwestern University, led by Dr. Roger Stupp and Dr. 
             Ditte Primdahl; and Moffit Cancer Center, led by Dr. Patrick 
             Grogan. 
 
          -- The Phase 1 part of the trial is expected to recruit up to 30 
             patients with recurrent and progressive GBM and other high-grade 
             gliomas. The objective is to establish a maximum tolerated dose 
             $(MTD)$ and/or a recommended dose based on safety, PK/PD and 
             preliminary efficacy. 
 
          -- The Phase 2a expansion part of the trial is planned to include 
             various population cohorts, including GBM (newly diagnosed and/or 
             recurrent), as well as additional cancers with/without standard of 
             care (e.g., PARP inhibitors), including an ovarian cancer arm. 
             These cohorts are expected to identify preliminary efficacy, PD 
             assessments and dose optimization data, serving as the basis for 
             rapid and effective advanced clinical development. 
 
   -- New data demonstrated potent anti-tumor effect of GLIX1 in GBM across 
      multiple in-vivo studies, including a temozolomide (TMZ)-resistant 
      patient-derived xenograft model. In the three orthotopic CDX studies, 
      significant tumor growth inhibition and survival benefit were observed 
      following treatment with GLIX1 across all doses tested, with greater 
      benefit at higher dose levels. Most notably, in the subcutaneous PDX 
      model, GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no 
      effect. 
 
   -- Clinical and pre-clinical data have been accepted for publication at 
      the European Association of Neuro-Oncology (EANO) 2026 Conference and at 
      the Society for Neuro-Oncology (SNO) 2026 Annual Meeting. 

GLIX1 in combination with PARPi

   -- New data demonstrated strong synergy between GLIX1 and PARP inhibitors, 
      reinforcing synthetic lethality between GLIX1 and PARP inhibitors. 
 
          -- Synergy was demonstrated in a patient-derived xenograft (PDX) 
             in-vivo model of HR-proficient ovarian cancer, where PARP 
             inhibitors have historically had limited efficacy. 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. Notably, the low-dose GLIX1/olaparib 
             combination tumor reduction was similar to cisplatin, the current 
             chemotherapy benchmark. 
 
   -- An abstract featuring new GLIX1 data, demonstrating synergy with PARP 
      inhibitors in HR-proficient ovarian cancer, was accepted for publication 
      at the 2026 European Society for Medical Oncology Annual Congress (ESMO 
      2026) in October. 
 
   -- BioLineRx has initiated discussions with leading PARP inhibitor companies 
      to explore potential development collaborations. 

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

   -- Enrollment is continuing in the CheMo4METPANC Phase 2b clinical trial, 
      which is being led by Columbia University, and supported by both 
      Regeneron and BioLineRx. The trial is evaluating motixafortide in 
      combination with the PD-1 inhibitor cemiplimab and standard chemotherapy 
      (gemcitabine and nab-paclitaxel). 
 
          -- A prespecified interim/futility analysis is planned when 40% of 
             progression-free survival (PFS) events are observed, which the 
             Company continues to anticipate will occur in 2026. 

APHEXDA Performance Update

   -- For the second quarter of 2026, APHEXDA sales were $1.6 million, which 
      provided royalty revenue to the Company of $0.3 million. 

Financial Results for the Quarter ended June 30, 2026

   -- Revenues for the three months ended June 30, 2026 were $0.3 million, 
      similar to the three months ended June 30, 2025. 
 
   -- Research and development expenses for the three months ended June 30, 
      2026 were $2.9 million, an increase of $0.6 million, or 26.5%, compared 
      to $2.3 million for the comparable 2025 period. The increase resulted 
      primarily from expenses related to the new GLIX1 project, offset by lower 
      expenses related to motixafortide. 
 
   -- General and administrative expenses for the three months ended June 30, 
      2026 were $0.9 million, an increase of $0.7 million, or 313.9%, compared 
      to $0.2 million for the comparable 2025 period. The increase resulted 
      from the reversal of a $0.8 million provision for doubtful accounts in 
      the 2025 period following receipt of an overdue milestone payment from 
      Gloria. 
 
   -- Non-operating expenses amounted to $0.7 million for the three months 
      ended June 30, 2026, compared to non-operating expenses of $1.9 million 
      for the three months ended June 30, 2025. Non-operating expenses for both 
      periods primarily relates to fair-value adjustments of warrant 
      liabilities on the Company's balance sheet. 
 
   -- Net financial expenses for the three months ended June 30, 2026 were $0.1 
      million compared to net financial income of $0.2 million for the three 
      months ended June 30, 2025. Net financial expenses in 2026 primarily 
      relate to interest paid on loans, partially offset by investment income 
      earned on bank deposits. Net financial income in 2025 primarily relates 
      to investment income earned on bank deposits and gains on foreign 
      currency cash balances due to the strengthening of the NIS during the 
      period, partially offset by interest paid on loans. 
 
   -- Net loss for the three months ended June 30, 2026 was $4.3 million, 
      compared to $3.9 million for the three months ended June 30, 2025. 
 
   -- As of June 30, 2026, the Company had cash, cash equivalents, and 
      short-term bank deposits of $13.1 million. 

Conference Call and Webcast Information

To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until September 1, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial was initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.

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