BLRX

- 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. (NASDAQ: 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. 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. 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). 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. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and by Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC) and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn. Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the expectations with regard to the Phase 1/2a GLIX1 clinical trial, expected timing of a clinical dosing, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third.-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx's is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx's business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United StatesChuck PadalaLifeSci Advisors, [email protected] IsraelMoran MeirLifeSci Advisors, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2026-financial-results-and-provides-corporate-update-302864836.html

This article first appeared on GuruFocus. Revenue: $0.3 million for Q2 2026, consistent with Q2 2025, primarily from royalties on APHEXDA product sales. R&D Expenses: $2.9 million in Q2 2026, up from $2.3 million in Q2 2025, driven by GLIX1 project costs. G&A Expenses: $0.9 million in Q2 2026, compared to $0.2 million in Q2 2025, reflecting a prior-year reversal of a provision for doubtful accounts. Nonoperating Expenses: $0.7 million in Q2 2026, down from $1.9 million in Q2 2025, related to fair value adjustments of warrant liabilities. Net Loss: $4.3 million for Q2 2026, versus a net loss of $3.9 million in Q2 2025. Cash Position: $13.1 million in cash and equivalents as of June 30, 2026, sufficient to fund operations into the first half of 2027. Royalty Revenue: $0.3 million in Q2 2026 from Ayrmid's APHEXDA sales. Subsequent Offering: Raised $3.75 million in a registered direct offering announced after the quarter. Warning! GuruFocus has detected 5 Warning Signs with BLRX. Is BLRX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. GLIX1 shows promising preclinical efficacy in GBM, including temozolomide-resistant models, and has a clean safety profile with excellent blood-brain barrier penetration. Phase 1/2a trial of GLIX1 is progressing well, with dosing in the second cohort underway and the third expected in September, ahead of schedule. Strong synergy between GLIX1 and PARP inhibitors in HR-proficient ovarian cancer models, supporting expansion into additional cancer types. Enrollment in the Phase 2b pancreatic cancer trial (chemo for MedPac) is tracking well, with an interim futility analysis expected later this year. Company has sufficient cash runway into the first half of 2027, supplemented by a recent $3.75 million offering and non-dilutive royalty revenue from APHEXDA sales. Net loss increased to $4.3 million in Q2 2026 from $3.9 million in Q2 2025, driven by higher R&D expenses for GLIX1. Cash position remains tight at $13.1 million, requiring additional financing to extend runway beyond early 2027. APHEXDA sales remain modest at $1.6 million in Q2 2026, with royalty revenue flat year-over-year, indicating slow market adoption. The pancreatic cancer program faces potential competitive pressure from new treatments like Revolution Medicines' thyroxin, which could impact motixafortide's future role. GLIX1 is still in early-stage development, with Phase 1 data not expected until the first half of 2027, leaving significant clinical and regulatory risks. Q: Based on the GLIX1 and PARP inhibitor synergies announced, how would this be positioned in ovarian cancer, and what line of therapy is appropriate based on what you're seeing so far?A: Ella Sorani, VP of Development, explained that the combination of GLIX1 with a PARP inhibitor at suboptimal concentrations showed substantially better efficacy than control, better than either monotherapy at higher doses, and was similar to the effect of cisplatin in an HR-proficient patient-derived xenograft model. Since PARP inhibitors are currently approved as maintenance therapy following standard of care (resection and chemotherapy), this provides various options for the clinical development plan. However, it is premature to finalize the strategy, and discussions are ongoing with ovarian cancer key opinion leaders to tailor the best path forward. Q: Did the recent approval of Revolution Medicines' drug change your approach to the chemoprevention objectives in pancreatic cancer?A: CEO Philip Serlin acknowledged that the approval could potentially change the treatment landscape in pancreatic cancer. However, he believes there is still a role for motixafortide and CXCR4 inhibition. The company is looking forward to the upcoming interim futility analysis and will make decisions on the study's direction based on those results. He emphasized that there remains significant unmet medical need in PDAC, leaving room for other treatments and combinations. Q: Has Aremis continued to penetrate transplant centers with APHEXDA, and has the competitive environment materially changed with generics?A: CEO Philip Serlin noted that the company cannot provide much guidance on sales execution since Aremis handles it. He pointed out that generics were already on the market when BioLineRx launched the product in 2024, and price was not necessarily the main impediment. He compared the situation to plerixafor, which took several years to accelerate sales due to the effort required to change standard operating procedures at transplant centers. He remains optimistic about the long-term outlook. Q: What is the current status of the GLIX1 Phase 1/2a clinical trial in glioblastoma?A: CEO Philip Serlin reported that the trial initiated in March, with the first patient dosed in April at NYU Langone Health. Two additional academic centers (Northwestern University and Moffitt Cancer Center) have enrolled patients. Recruitment is going extremely well, with dosing commenced in the second of five planned cohorts in Phase 1, and the third cohort expected to begin in September. The drug has shown a very good safety and tolerability profile to date. Phase 1 data is anticipated in the first half of 2027. Q: What were the key financial results for the second quarter of 2026?A: CFO Mali Zeevi reported revenues of $0.3 million, primarily from royalties on APHEXDA sales. R&D expenses were $2.9 million, up from $2.3 million due to GLIX1 project costs. G&A expenses were $0.9 million, compared to $0.2 million in the prior year, which included a reversal of a provision for doubtful accounts. Nonoperating expenses were $0.7 million, down from $1.9 million. The net loss for the quarter was $4.3 million, compared to $3.9 million in the same period of 2025. Cash and equivalents stood at $13.1 million as of June 30, 2026. Q: What is the company's cash runway and how does the recent capital raise factor in?A: CEO Philip Serlin stated that the company ended the quarter with $13.1 million in cash, sufficient to fund operations into the first half of 2027. Additionally, the company announced a $3.75 million registered direct offering expected to close shortly after the call. The company also benefits from nondilutive funding through royalties and milestone-driven revenue from license agreements with Aremis and Gloria Biosciences. Q: What new preclinical data was presented for GLIX1 in GBM?A: CEO Philip Serlin highlighted new preclinical data demonstrating potent antitumor activity of GLIX1 in GBM across multiple in vivo studies, including a temozolomide-resistant patient-derived xenograft model and three orthotopic CDX GBM models. GLIX1 produced significant tumor growth inhibition and survival benefit across all doses tested. Notably, in a subcutaneous temozolomide-resistant PDX model, GLIX1 showed robust antitumor effect while temozolomide showed no effect, supporting its potential to treat patients who do not respond to the current standard of care. Q: What is the status of the pancreatic cancer (PDAC) program with motixafortide?A: CEO Philip Serlin reported that Columbia University, supported by Regeneron and BioLineRx, is executing a randomized Phase 2b clinical trial (chemo for MedPac) evaluating motixafortide in combination with cemiplimab and standard chemotherapy. Enrollment continues to track well. A prespecified interim futility analysis is planned when 40% of progression-free survival events are observed, expected later this year. Q: What is the market opportunity for GLIX1 in glioblastoma?A: CEO Philip Serlin emphasized the significant unmet need in GBM, noting that the current standard of care was established more than 20 years ago with no meaningful improvement since. Median survival following diagnosis remains approximately 12 to 18 months. By 2030, annual GBM incidence is expected to reach over 18,000 patients in the US and over 13,000 across the EU, representing a combined total addressable market of more than $3.7 billion in the US and Europe alone. Q: What are the next steps for the GLIX1 program in terms of clinical development and presentations?A: CEO Philip Serlin stated that the Phase 2a expansion part of the trial is planned to include additional cohorts, including GBM (newly diagnosed and/or recurrent) as well as additional cancers with or without standard of care, such as PARP inhibitors. The study was accepted for presentation at the European Association of Neuro-Oncology (ENO) 2026 Conference and the Society for Neuro-Oncology (SNO) 2026 Annual Meeting. Additionally, data on GLIX1 and PARP inhibitor synergy will be presented at the ESMO Annual Conference in October, where the abstract has been accepted. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Management to Hold Conference Call at 8:30 a.m. EDT TEL AVIV, Israel, Aug. 25, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it will release its unaudited financial results for the second quarter ended June 30, 2026 on Monday, August 31, 2026, before the U.S. markets open. The Company will host a conference call at 8:30 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. 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 has been initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn. CONTACTS:United StatesChuck PadalaLifeSci Advisors, [email protected] IsraelMoran MeirLifeSci Advisors, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/biolinerx-to-report-second-quarter-2026-results-on-august-31-2026-302859223.html

This article first appeared on GuruFocus. Revenue: $0.5 million for Q1 2026, up from $0.3 million in Q1 2025. Research and Development Expenses: $2.5 million for Q1 2026, up from $1.6 million in Q1 2025. General and Administrative Expenses: $0.9 million for Q1 2026, down from $1 million in Q1 2025. Net Nonoperating Income: $0.5 million for Q1 2026, down from $7.6 million in Q1 2025. Net Loss: $2.6 million for Q1 2026, compared to net income of $5.1 million in Q1 2025. Cash and Equivalents: $17.4 million at the end of Q1 2026. APHEXDA Sales: $2.5 million in Q1 2026, up from $1.4 million in Q1 2025. Warning! GuruFocus has detected 5 Warning Signs with BLRX. Is BLRX fairly valued? Test your thesis with our free DCF calculator. Release Date: May 27, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioLine Rx Ltd (NASDAQ:BLRX) initiated a Phase 1/2a trial for GLIX1, a promising molecule for glioblastoma treatment, with the first patient dosed at NYU Langone Health. GLIX1 has shown robust tumor growth inhibition and survival benefits in preclinical models, highlighting its potential in addressing high unmet needs in glioblastoma. The company reported increased sales of APHEXDA, generating $2.5 million in Q1 2026 compared to $1.4 million in Q1 2025, indicating positive market adoption. BioLine Rx Ltd (NASDAQ:BLRX) has a strong cash position with $17.4 million, sufficient to fund operations into the first half of 2027. The company is actively engaging with the oncology community, with two abstracts featuring GLIX1 accepted for publication at the ASCO meeting, showcasing its novel mechanism of action. BioLine Rx Ltd (NASDAQ:BLRX) reported a net loss of $2.6 million for Q1 2026, compared to a net income of $5.1 million in Q1 2025. Research and development expenses increased to $2.5 million in Q1 2026 from $1.6 million in Q1 2025, primarily due to the new GLIX1 project. The company has not disclosed specific dose levels for GLIX1 in clinical trials, limiting transparency on its development progress. There is significant competition in the glioblastoma treatment landscape, although BioLine Rx Ltd (NASDAQ:BLRX) believes there is still a wide-open market. The company faces challenges in the pancreatic cancer treatment landscape due to new data from competitors, which may affect future development strategies. Q: Now that dosing is underway for the Phase 1/2a trial, could you share your thoughts on the current development landscape in GBM and the challenges or competitiveness in enrolling patients? A: Philip Serlin, CEO: The GBM area is quite open with few effective treatments currently available. We are not experiencing significant recruitment challenges. Ella Sorani, Chief Development Officer, added that for recurrent and progressive GBM patients, there is no real competition in terms of recruitment, so they do not foresee any issues. Q: Could you provide an update on the activation status at Northwestern and Moffitt? Are all three centers now open and screening and enrolling patients? Are there any initial safety observations from the first patient dosed with GLIX1? A: Philip Serlin, CEO: We have not disclosed the status of each site, but NYU is recruiting, and other sites will open shortly. We plan to provide periodic updates but cannot share specific safety observations at this time. Q: Regarding the CheMo4METPANC trial, what are the anticipated next steps if it's successful, and what is the expected timeline for its conclusion? A: Philip Serlin, CEO: An interim futility analysis is expected later this year. We are considering the impact of new data from Revolution Medicine on the PDAC landscape and will evaluate the data to decide on future steps. Q: Can you provide any metrics or insights into Ayrmid's efforts with APHEXDA, such as regions covered, sales professionals, and marketing strategies? A: Philip Serlin, CEO: While we can't provide detailed guidance on Ayrmid's activities, we noted a significant increase in APHEXDA sales from $1.4 million in Q1 2025 to $2.5 million in Q1 2026, indicating positive momentum. Q: Regarding GLIX1, what dose level do you think would be the absolute maximum in the clinical trials? A: Ella Sorani, Chief Development Officer: We haven't disclosed the doses yet, but the preclinical safety data provides a significant safety margin compared to the doses expected in the clinic. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

By John Vandermosten, CFA NASDAQ: BLRX READ THE FULL BLRX RESEARCH REPORT BioLineRx Ltd. (NASDAQ: BLRX) reported first quarter 2026 financial and operational results in a May 27th press release. For the quarter, it produced license revenues of $477,000 and a net loss of $2.6 million. The joint venture (JV) with Hemispherian, Tetragon Biosciences, has started a Phase I/IIa study evaluating GLIX1 in glioblastoma (GBM) and other cancers. The first patient has been dosed. The Phase I trial seeks to establish the safety, recommended dose, and proof-of-concept for the drug. Additionally, BioLineRx will present two abstracts at the upcoming ASCO conference that highlight preclinical data for GLIX1. Enrollment for Columbia’s CheMo4METPANC Phase 2b study continues, and management anticipates that an interim readout will occur later in 2026. 1Q:26 Operational and Financial Results BioLineRx reported first quarter sales of $477,000, producing a net loss of $2.6 million or $0.00 per share. The results were announced in a press release on May 27th, 2026, followed by a conference call with management and the filing of Form 6-K providing additional information. Below we summarize financial results for the three-month period ended March 31st, 2026, compared to the same prior year period: Total and license revenues were $477,000 from the sale of Aphexda compared to $255,000. Ayrmid’s Aphexda product sales for 1Q:26 were $2.7 million vs $0.9 million; Cost of revenues was $95,000 compared with $34,000. The amounts represent license fee and royalty pass-throughs to Biokine as a proportion of royalty on motixafortide revenues; Research and development (R&D) expenses totaled $2.5 million, rising 56% from $1.6 million. The increase is attributable to spending on the new GLIX1 development program; General and administrative (G&A) expenses were $858,000, down 13% from $989,000, primarily due to lower legal and other miscellaneous expenses; Non-operating income was $458,000 vs. $7.6 million, predominantly reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet; Net financial expense amounted to $42,000, reflecting interest expense exceeding interest income; Net loss was $2.6 million or $0.00 compared to net income of $5.1 million, or $0.00. Cash, equivalents, and short-term bank deposits as of March 31st, 2026, totaled $17.3 million, down from the year-end 2025 balance of $20.9 million. Cash burn for 1Q:26 was $2.3 million, and net cash used in financing was $1.2 million. Financing cash outflows were related to loan repayments and lease liability repayments. At the end of the first quarter, loans were carried at $7.8 million on the balance sheet. The term loan is expected to be fully repaid by the end of 2027. Management reiterated its forecast of holding sufficient cash to support operations until 1H:27. GLIX1 Phase I/IIa Clinical Trial in the Treatment of Glioblastoma BioLineRx announced the start of its Phase I/IIa clinical trial evaluating GLIX1 for the treatment of glioblastoma in a March 26th press release. As of late May, the trial has dosed the first patient at NYU Langone Health and added two additional sites at Northwestern University and Moffitt Cancer Center. The Phase I/IIa GLIX1 trial is an open-label, multicenter trial. Its first part is a dose escalation study where an anticipated 30 glioblastoma patients will receive GLIX1 daily as monotherapy. It will seek a maximum tolerated and recommended dose for the next stage of the trial. The Phase I portion will also identify pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy. Trial updates are anticipated in 2H:26 and full results in 2027. Management is optimistic on enrollment, anticipating efficient enrollment and limited competition for patients from other investigational modalities. It also has a favorable view on the space, as few other treatments are showing success. The Phase IIa portion will include additional indications beyond GBM, including newly diagnosed GBM and other select cancers. The study will evaluate GLIX1 as monotherapy and in combination with standard of care. It will also evaluate GLIX1 in combination with Poly (ADP-ribose) Polymerase (PARP) inhibitors. The Phase IIa expansion will identify preliminary efficacy, PD assessments, and dose optimization data. GLIX1 ASCO Presentation BioLineRx and partner Hemispherian AS will feature two presentations at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, which is being held May 29th to June 2nd, 2026, in Chicago, Illinois. Details of BioLineRx’s participation in the event are included in a May 2026 press release. Below we provide the titles and summaries of the two abstracts. GLIX1: A first-in-class oral molecule targeting the DNA damage response by restoring TET2[1] activity Synergistic antitumor activity of GLIX1, a small molecule TET2 activator, in combination with PARP inhibition across multiple cancers SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] TET2 (Ten-Eleven Translocation 2) is a key epigenetic enzyme that initiates active DNA demethylation by converting 5-methylcytosine (5mC) in DNA into oxidized derivatives, ultimately leading to the restoration of unmethylated cytosine. This process alters gene expression by "turning on" or activating previously silenced genes.

- Announced first patient dosed in Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) - - Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide (TMZ)-resistant patient-derived xenograft model - - Management to host conference call today, May 27, at 8:30 am EDT - TEL AVIV, Israel, May 27, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: 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 March 31, 2026, and provided a corporate update. "Since our last quarterly update, we achieved a significant milestone for our company and for the GLIX1 development program with the dosing of the first patient in our Phase 1/2a clinical trial of GLIX1 in glioblastoma," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We are also very encouraged by compelling new pre-clinical data showing that GLIX1 demonstrated robust dose-dependent tumor-growth inhibition and survival benefit in orthotopic cell-derived xenograft (CDX) GBM models. Furthermore, in a newly completed subcutaneous TMZ-resistant patient-derived xenograft (PDX) GBM model, GLIX1 demonstrated a robust anti-tumor effect while no effect was observed with TMZ, highlighting the potential to address the very high unmet need in GBM." "In the coming days, we look forward to engaging with the broader oncology community at this year's ASCO meeting with two abstracts featuring GLIX1. The abstracts highlight its novel mechanism of action and provide strong rationale for the development of GLIX1 in GBM as well as in other cancers. They also highlight that in safety studies in animals GLIX1 was safe up to the highest feasible doses tested, supporting the combination with other anti-cancer agents. Furthermore, the abstracts highlight the compelling mechanistic rationale for combining GLIX1 with PARP inhibitors supported by synergistic effect in cell lines across diverse cancers including from tumor types typically less responsive to PARP inhibition." Financial Updates With $17.4 million on its balance sheet as of March 31, 2026, BioLineRx is maintaining its cash runway guidance into the first half of 2027. Development UpdatesGLIX1 Phase 1/2a clinical trial of GLIX1 in glioblastoma and other cancers initiated in March 2026. Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide (TMZ)-resistant patient-derived xenograft model Announced two abstracts on GLIX1 that were selected for publication during the American Society of Clinical Oncology (ASCO) Annual Meeting, which is scheduled for May 29-June 2, in Chicago, IL. Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications, including in combination with PARP inhibitors, are ongoing. MotixafortidePancreatic 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). APHEXDA Performance Update APHEXDA sales for the first quarter of 2026 were $2.7 million, which provided royalty revenues to the company of $0.5 million. Financial Results for the Quarter ended March 31, 2026 Revenues for the three months ended March 31, 2026 were $0.5 million, an increase of $0.2 million, compared to revenues of $0.3 million for the three months ended March 31, 2025. The increase in revenues from 2025 to 2026 reflects an increase in royalties paid by Ayrmid from the commercialization of APHEXDA. Cost of revenues for the three months ended March 31, 2026 was $0.1 million, compared to immaterial cost of revenues for the three months ended March 31, 2025. The cost of revenues reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA. Research and development expenses for the three months ended March 31, 2026 were $2.5 million, an increase of $0.9 million, or 55.8%, compared to $1.6 million for the three months ended March 31, 2025. The increase resulted primarily from expenses related to the new GLIX1 project. General and administrative expenses for the three months ended March 31, 2026 were $0.9 million, a decrease of $0.1 million, or 13.3%, compared to $1.0 million for the three months ended March 31, 2025. The decrease resulted primarily from a decrease in legal expenses, as well as a decrease in a number of other general and administrative expenses. Net non-operating income amounted to $0.5 million for the three months ended March 31, 2026, compared to net non-operating income of $7.6 million for the three months ended March 31, 2025. Non-operating income for the periods primarily relates to non-cash fair-value adjustments of warrant liabilities, as a result of changes in the Company's share price, offset by warrant offering expenses. Net financial expenses for the three months ended March 31, 2026 were immaterial compared to net financial expenses of $0.1 million for the three months ended March 31, 2025. Net financial expenses for the periods primarily relate to interest paid on loans, partially offset by investment income earned on bank deposits. Net loss for the quarter ended March 31, 2026 was $2.6 million, compared to net income of $5.1 million for the quarter ended March 31, 2025. As of March 31, 2026, the Company had cash, cash equivalents, and short-term bank deposits of $17.4 million. Conference Call and Webcast InformationTo 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 May 28, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRxBioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a clinical-stage 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. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and developed by Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC) and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn. Forward Looking StatementVarious statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the expectations with regard to the planned Phase 1/2a GLIX1 clinical trial, expected timing of a clinical readout, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third.-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx's is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx's business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United StatesChuck PadalaLifeSci Advisors, [email protected] IsraelMoran MeirLifeSci Advisors, [email protected] Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302782918.html

Management to Hold Conference Call at 8:30 a.m. EDT TEL AVIV, Israel, May 20, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it will release its unaudited financial results for the quarter ended March 31, 2026 on Wednesday, May 27, 2026, before the U.S. markets open. The Company will host a conference call at 8:30 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. 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 May 28, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ: BLRX) (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 has been initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn. CONTACTS: United StatesChuck PadalaLifeSci Advisors, [email protected] IsraelMoran MeirLifeSci Advisors, [email protected] Logo: https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-to-report-first-quarter-2026-results-on-may-27-2026-302777565.html

This article first appeared on GuruFocus. Revenue: $1.2 million for the year ended December 31, 2025, compared to $28.9 million in 2024. Research and Development Expenses: $8.1 million for 2025, down from $9.2 million in 2024. General and Administrative Expenses: $3.1 million for 2025, compared to $6.3 million in 2024. Net Loss: $2 million for 2025, compared to $9.2 million in 2024. Cash and Equivalents: $20.9 million as of December 31, 2025. APHEXDA Sales: $6.5 million in 2025, resulting in $1.2 million of royalty revenue to BioLineRx. Warning! GuruFocus has detected 4 Warning Signs with BLRX. Is BLRX fairly valued? Test your thesis with our free DCF calculator. Release Date: March 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioLine Rx Ltd (NASDAQ:BLRX) is advancing GLIX1, a first-in-class oral small molecule for glioblastoma, with FDA and EMA Orphan Drug Designation. The company has a strong cash position with $21 million, sufficient to fund operations into the first half of 2027. GLIX1 has shown promising preclinical results, including potent antitumor activity and excellent blood-brain barrier penetration. BioLine Rx Ltd (NASDAQ:BLRX) has secured patent protection for GLIX1 through 2040, covering a wide range of cancers. The company successfully resolved a legal dispute with Biokine Therapeutics, removing financial overhang and allowing focus on GLIX1 development. Revenues for 2025 were significantly lower at $1.2 million compared to $28.9 million in 2024, primarily due to reduced milestone payments. The company faces challenges in the glioblastoma market, which has a high unmet need but also significant competition. The Phase 1/2a trial for GLIX1 is primarily focused on safety and dose determination, with efficacy as a secondary endpoint, potentially delaying efficacy data. BioLine Rx Ltd (NASDAQ:BLRX) experienced a decrease in research and development expenses, reflecting reduced activity in some areas. There is uncertainty regarding the future sales guidance for APHEXDA, as Ayrmid, a private company, has not provided long-term projections. Q: What is the potential for interim data in the upcoming Phase 1 study in glioblastoma multiforme (GBM), given the rapid progression of the disease? A: Ella Sorani, Chief Development Officer: The Phase 1 study is primarily a dose escalation study aimed at determining safety and the recommended dose for further development. While efficacy will be assessed as a secondary endpoint, the study is not designed or powered to evaluate efficacy comprehensively. Q: What is the level of enthusiasm among principal investigators (PIs) for the GLIX1 trial, and what aspects of the drug's profile are most intriguing to them? A: Ella Sorani, Chief Development Officer: There is significant enthusiasm from investigators due to the novelty of GLIX1's mechanism of action and promising preclinical results. The investigators are highly engaged and eager to initiate the study, hoping to bring new hope to patients. Q: Can you provide an update on Gloria's Phase 3 bridging trial and their pancreatic ductal adenocarcinoma (PDAC) trial? A: Philip Serlin, Chief Executive Officer: Gloria has resolved most of their financial difficulties and has started the bridging study in stem cell mobilization, which is required for approval in China. Discussions are ongoing regarding the solid tumor indications, but positive progress is being made in stem cell mobilization. Q: Will there be any interim readouts from Gloria's bridging study this year? A: Philip Serlin, Chief Executive Officer: The study is blinded and for registration, so no interim readouts are expected. However, data should be available by the middle of next year. Q: Are the patients in the GLIX1 GBM study eligible for investigational therapies due to exhaustion of standard care options? A: Ella Sorani, Chief Development Officer: Yes, the study involves recurrent or progressed GBM patients who typically have exhausted standard care options, which is common in first-in-man studies. Q: Will the GLIX1 GBM study measure blood-brain barrier penetration? A: Ella Sorani, Chief Development Officer: While biopsies are being taken, they are not mandatory, and the study is not specifically designed to assess blood-brain barrier penetration. However, if biopsies are available, samples may be taken. Q: Will Ayrmid provide guidance on APHEXDA sales? A: Philip Serlin, Chief Executive Officer: Ayrmid, being a private company, has not provided long-term guidance on APHEXDA sales. Discussions are ongoing, but it may still be too early for them to provide such guidance. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

By John Vandermosten, CFA NASDAQ: BLRX READ THE FULL BLRX RESEARCH REPORT BioLineRx Ltd. (NASDAQ: BLRX) reported 2025 financial and operational results in a March 23rd, 2026, press release. For the year, it produced license revenues of $1.2 million and a net operating loss of $10.3 million. The joint venture (JV) with Hemispherian, called Tetragon Biosciences, expects to begin screening patients by the end of this month for the glioblastoma trial evaluating GLIX1. The Phase I trial seeks to establish the safety, recommended dose, and proof-of-concept for the drug. In support of the GLIX1 program, BioLineRx secured a Notice of Allowance for a patent covering cancers that do not express cytidine deaminase beyond a certain threshold. Enrollment for Columbia’s CheMo4METPANC Phase 2b study continues, and management anticipates that an interim readout will occur later in 2026. Efforts to advance motixafortide in sickle cell disease (SCD) are in high gear with both a poster presentation last December and continued enrollment in a second Phase I study by St. Jude. In the Asian sphere of influence, Gloria Biosciences launched its stem cell mobilization (SCM) trial in November 2025 and is expected to report data from the study approximately 18 months later. 2025 Operational and Financial Results BioLineRx reported 2025 sales of $1.2 million, producing a net loss from operations of $2.0 million or $0.00 per share. Non-operating income offset $8.1 million of the operational loss. Absent this non-cash item, net loss would have been $10.1 million, still $0.00 per share. The results were announced in a press release on March 23rd, 2026, followed by a conference call with management and the filing of Form 20-F providing additional information. Below we summarize financial results for the twelve-month period ended December 31st, 2025, compared to the prior year period: Total and license revenues were $1.2 million from the sale of Aphexda compared to $28.9 million, with the latter related to the out-licensing transaction with Gloria and direct commercial sales. Ayrmid’s Aphexda product sales for 2025 were $6.7 million, which implies a royalty rate of about 18%; Cost of revenues was $230,000, which represents license fees and royalty pass-throughs to Biokine as a royalty on motixafortide revenues, vs. $9.3 million. Prior year cost of revenues included amounts for license fees, direct costs related to license revenues, amortization of an intangible asset, and cost of product sales; Research and development expenses totaled $8.1 million, down 12% from $9.1 million, with the decline attributable to lower expenses related to motixafortide due to the out-licensing of rights to Ayrmid and a reduction in compensation arising from lower headcount. These amounts were partially offset by an increase in expenses related to the GLIX1 program; Sales and marketing expenses were $0.0 vs. $23.6 million due to the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction; General and administrative (G&A) expenses were $3.1 million, down 50% from $6.3 million primarily due to the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation related to lower headcount and an overall reduction in a number of general and administrative expenses; Non-operating income was $8.1 million vs. $18.4 million, predominantly reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet; Net financial income amounted to $184,000, reflecting interest income exceeding interest expense; Net loss was $2.0 million compared to $9.2 million, or $0.00 and $0.01 per share, respectively. Cash, equivalents, and short-term bank deposits as of December 31st, 2025, totaled $20.9 million, up from the year end 2024 balance of $19.6 million. Cash burn for 2025 was $8.1 million, and net cash from financing was $8.9 million. $2.4 million in cash from the Gloria milestone was received in June. Financing cash contributions came from issuance of share capital and warrants, as well as net proceeds from the ATM agreement with H.C. Wainwright. The ATM raised $5.0 million in 2025. Following the end of the reporting period, an additional 825,010 ADSs were sold under the program, generating net proceeds of $9.2 million. As of year-end 2025, loans were carried at $8.9 million on the balance sheet. This was partially offset by loan repayment over the 12-month period of $4.5 million. The term loan is expected to be fully repaid by the end of 2027. Management forecasts sufficient cash to support operations until 1H:27. BioLineRx also reported a favorable outcome from the binding arbitration related to Biokine’s complaint related to compensatory damages related to the transfer of motixafortide licenses. In February 2026, the arbitrator issued a final award in favor of BioLineRx, denying the claim and awarding BioLineRx expenses, including legal fees. Given the jurisdiction of the claim in Israel, we estimate this will amount to a few hundred thousand dollars. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. 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- On track to initiate Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) by end of this month - - GLIX1 is positioned to potentially address unmet needs for novel and more effective cancer treatments by targeting DNA damage response mechanisms - - Management to host conference call today, March 23, at 8:30 am EDT - TEL AVIV, Israel, March 23, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its audited financial results for the year ended December 31, 2025, and provided a corporate update. "Since our last quarterly update, we have been working diligently to move forward with a Phase 1/2a first-in-human clinical trial of GLIX1 in glioblastoma, and I am pleased to report that we expect to initiate the study by the end of this month, with the commencement of patient enrollment shortly thereafter," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1, the lead asset that we acquired through our collaboration with Hemispherian, is a unique molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models, excellent blood-brain-barrier penetration and a favorable safety profile in toxicology studies. We are eager to establish the safety, recommended dose and proof-of-concept in order to advance this promising candidate through an efficient development pathway. "In parallel, we continue to conduct pre-clinical activities in support of further development of GLIX1 in additional cancer indications with high unmet needs, and, separately, we are also conducting studies to further investigate and affirm the potential synergistic effect of GLIX1 in combination with PARP inhibitors, as we work to maximize the value of the GLIX1 opportunity. "In metastatic pancreatic cancer, enrollment has accelerated in the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide, which is being led by Columbia University and supported by both Regeneron and BioLineRx, and we continue to anticipate that a prespecified interim/futility analysis will read out in 2026. We believe PDAC represents another opportunity to introduce a much-needed new treatment option to patients suffering from a very challenging tumor type, while creating sustained value for our company," Mr. Serlin concluded. Corporate Updates Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. Financial Updates With $20.9 million on its balance sheet as of December 31, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027. Clinical Updates GLIX1 On track to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma by the end of the month. Three renowned academic centers are planned to participate in this clinical trial: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, NYU Langone Health, led by Dr. Alexandra M. Miller 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. Data from the Phase 1 part of the trial are anticipated in H1 2027. 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). 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. Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications are ongoing. Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment has accelerated 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. Sickle Cell Disease (SCD) & Gene Therapy Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in December. A second SCD study, sponsored by St. Jude Children's Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs for gene therapies for patients with SCD (NCT06442761). APHEXDA Performance Update For the full-year 2025, APHEXDA sales were $6.7 million, which provided royalty revenue to the Company of $1.2 million. Financial Results for the Year ended December 31, 2025 Revenues for the year ended December 31, 2025 were $1.2 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the up-front payment received by the Company under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid License Agreement and $6.0 million of net revenues from product sales of APHEXDA in the United States. Cost of revenues for the year ended December 31, 2025 were $0.2 million, compared to cost of revenues of $9.3 million for the year ended December 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects the amortization of intangible assets, sub-license fees on the up-front payment received for the Ayrmid License Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the year ended December 31, 2025 were $8.1 million, a decrease of $1.1 million, or 11.5%, compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX1 project. There were no sales and marketing expenses for the year ended December 31, 2025, compared to $23.6 million for the year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license agreement. General and administrative expenses for the year ended December 31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3%, compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of general and administrative expenses. Non-operating income (expenses) for the years ended December 31, 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses. Net financial income for the year ended December 31, 2025 was $0.2 million, compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income for 2025 relates to investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to loan agreement with BlackRock, partially offset by investment income earned on bank deposits. Net loss for the year ended December 31, 2025 was $2.0 million, compared to $9.2 million for the year ended December 31, 2024. As of December 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $20.9 million, sufficient to fund operations, as currently planned, into the first half of 2027. A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected]. Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 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 March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ: BLRX) (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 is expected to initiate in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS. The Company's first approved product, APHEXDAﾮ (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and developed by Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn. Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the expectations with regard to clinical trials of motixafortide and GLIX1, expected timing of clinical readouts, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx's is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx's business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United States Irina Koffler LifeSci Advisors, LLC [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-2025-financial-results-and-provides-corporate-update-302721933.html