On May 27, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"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 (Free ASCO Whitepaper) 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 Updates
GLIX1

Phase 1/2a clinical trial of GLIX1 in glioblastoma and other cancers initiated in March 2026.
The first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center.
Two additional leading cancer centers are participating in the study: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl; and Moffit Cancer Center, led by Dr. Patrick Grogan. Additional sites may be added to the study at a later date.
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 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.
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) (Free ASCO Whitepaper) 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.
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

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 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 May 28, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

(Press release, BioLineRx, MAY 27, 2026, View Source [SID1234666089])

On May 27, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that Phase I clinical studies of FL115, an IL-15 superagonist, as monotherapy via intravenous infusion in patients with advanced solid tumors have been completed, with durable treatment effects observed in 2 patients with confirmed partial response (cPR) and 1 patient with stable disease (SD).

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Phase I clinical studies of FL115 were conducted in US and China in parallel:

FL115-101 Study was conducted in US, with 11 patients treated. One patient with advanced cervical cancer and 4 prior therapies received the 1st dose in July 2024, and achieved SD. The patient was rolled off the study in Sept 2025, and continue to receive the FL115 treatment under a Single Patient IND Protocol/Treatment Plan. Data from this study will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Poster Board: 291; Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology; Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT)

FL115-102 Study was conducted in China, with 23 patients treated. One patient with highly invasive NUT-NSCLC and 3 lines of prior therapies received the 1st dose of FL115 in Apr 2025, and achieved cPR. Another patient with lymphoepithelial carcinoma (parotid gland) and 4 lines of prior therapies received the 1st dose of FL115 in Jun 2025, and achieved cPR. Both patients have been rolled off the study respectively in March and May 2026, and continue to receive the FL115 under a Compassionate Treatment program. Data from this study was presented as a Late-breaking Abstract at 40th SITC (Free SITC Whitepaper) Annual Meeting.

FL115 (IV) is currently being investigated in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Preclinical data regarding FL115 (Subcutaneous Injection) was presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, and a Phase 1 clinical study will be initiated in 2H 2026 to evaluate FL115 (Subcutaneous Injection) in patients with advanced solid tumors. In parallel, FL115 (Intravesicale Delivery) is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial in patients with nonmuscle invasive bladder cancer (NMIBC).

"We deeply appreciate the commitment and support from the patients and their families," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "With favorable safety, preliminary efficacy and duration of response observed in Phase 1 clinical studies, FL115 continues to show its potential as Best-in-class IL-15 superagonist. We are advancing FL115 for multiple indications via different delivery routes, aiming to develop optimal treatment options for cancer patients in need."

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, MAY 27, 2026, View Source [SID1234666121])

On May 27, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.

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The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.

"These achievements represent a defining moment for Ernexa Therapeutics," said Sanjeev Luther, CEO of Ernexa Therapeutics. "Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND filing in the third quarter of 2026, Most importantly, we believe ERNA-101 has the potential to bring new hope to patients and families in need of better therapeutic options."

The advancement of ERNA-101 reflects continued momentum across the company’s development and manufacturing operations and marks an important evolution in Ernexa’s corporate trajectory toward becoming a clinical-stage biotechnology company.

"With technology transfer now in progress and manufacturing activities advancing as planned, we believe Ernexa is entering a transformational phase," added CEO, Sanjeev Luther. "These milestones will significantly strengthen our operational readiness and reinforce our confidence in the path toward clinical evaluation of ERNA-101."

ERNA-101 is being advanced as part of Ernexa Therapeutics’ broader mission to develop innovative therapies designed to address significant unmet medical needs.

Key Highlights

IND submission for ERNA-101 targeted for Q3 2026
Technology transfer activities currently in progress
Process development for ERNA-101 manufacturing successfully completed
Transition to GMP manufacturing underway in preparation for clinical studies
Company advancing toward anticipated transformation into a clinical-stage biotechnology company
Progress supports planned first-in-human clinical study following IND clearance

(Press release, Ernexa Therapeutics, MAY 27, 2026, View Source [SID1234666137])

On May 28, 2026 QSA Global, Inc., a global leader in specialized radioactive source manufacturing and medical radiochemical services, and NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, reported the execution of a multi-year strategic services agreement. This partnership is designed to solidify the supply chain for radium-226 (Ra-226) targets, the starting material for Actinium-225 (Ac-225) production, and further supports NorthStar’s commercial-scale production of no carrier added (n.c.a.) Ac-225 used in next-generation Targeted Alpha Therapies (TAT).

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The partnership combines QSA Global’s decades of specialized experience in high-activity source handling, industrial regulatory compliance, and logistics with NorthStar’s innovative approach to commercial-scale radiopharmaceutical production. It features a multi-year purification campaign where QSA Global will process legacy Ra-226 on behalf of NorthStar, transforming the material into high-purity precursors that will directly feed continuous target capsule manufacturing. Following irradiation and processing by NorthStar to produce n.c.a. Ac-225, the recovered radium will be returned to QSA Global for recycling into new targets – establishing a highly efficient, closed-loop supply chain.

"This multi-year agreement with QSA Global strengthens our supply chain with a reliable, high-quality supply of Ra-226 targets critical to our n.c.a. Ac-225 production capabilities," said Dr. Frank Scholz, President & CEO of NorthStar. "By ensuring consistent access to these vital starting materials, we can confidently meet growing demand within the industry."

"By managing the complex, highly regulated lifecycle of radium-226, QSA Global enables partners like NorthStar to focus their resources entirely on commercial Actinium-225 production," said Joe Lapinskas, Innovation Director at QSA Global, Inc. "NorthStar was a foundational partner as we developed our specialized radium services. We are proud to leverage our decades of high-activity radioactive materials expertise to help secure this critical supply chain and support NorthStar’s mission of delivering life-saving TATs to patients."

About Ac-225
NorthStar has been successfully producing n.c.a. Ac-225 using an indirect manufacturing approach that combines electron-accelerator irradiation of a Ra-226 target, followed by purified Ra-225 sources that constantly in-grow n.c.a. Ac-225. Ac-225 is an alpha-emitter, which belongs to a powerful class of radioisotopes that deliver high-energy, highly localized radiation directly to diseased cells. Ac-225 can be attached to a variety of targeting molecules, including antibodies, peptides, and small molecules, enabling precise delivery to cancer cells. This versatility makes isotopes like Ac-225 particularly valuable in supporting the development of next-generation radiopharmaceutical therapies that are highly effective and selective.

(Press release, NorthStar Medical Radiostopes, MAY 27, 2026, View Source [SID1234666185])

On May 27, 2026 Archeus Technologies, a clinical-stage company advancing a portfolio of differentiated small-molecule radiopharmaceutical therapies (RPTs) to address some of the most difficult-to-treat cancers, reported that it has dosed the first patient in a Phase 1 clinical trial of ARC-706, and companion diagnostic ARC-166, in patients with metastatic cancer receiving immune checkpoint inhibition (ICI) therapies.

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Archeus is developing ARC-706 for combination use with certain validated immunotherapies across a range of oncology indications. ARC-706 leverages the unique capabilities of Archeus’ NM600 tumor-targeting platform with the addition of the therapeutic beta-emitting isotope yttrium-90 (Y-90), as well as the PET isotope yttrium-86 (Y-86) comprising ARC-166. In this first-in-human imaging and therapy study, participants will receive intravenous ARC-166 for dosimetry and patient selection, followed by ARC-706 to evaluate its safety, biodistribution, pharmacokinetics, and potential to augment anti-tumor immune response. The study also aims to determine an optimal Phase 1b dose of ARC-706 and explore changes in relevant cancer-related biomarkers.

"This study allows us to evaluate a new therapeutic strategy designed to support patients who are continuing immunotherapy despite signs of disease progression," said Grace Blitzer, M.D., assistant professor of human oncology at the University of Wisconsin School of Medicine and Public Health, radiation oncologist at the UW Carbone Cancer Center, and a principal investigator of the study. "By combining functional imaging with targeted radiotherapy, we hope to demonstrate meaningful clinical benefit to patients without disrupting ongoing immune-based treatment—a goal that could have wide-reaching impact across multiple tumor types."

Preclinical studies have demonstrated tumor-selective uptake of ARC-706 in multiple cancers that are treated with ICI therapies, and that administering ARC-706 at specific dose ranges based on ARC-166 imaging results can significantly increase the response rate to ICI therapies and the durability of responses.

"By using imaging to guide therapy and selectively deliver radiation to tumors, this trial is designed to optimize treatment selection and potentially improve responses to immune checkpoint inhibitors in patients who currently face limited options," said Zachary Morris, M.D., Ph.D., chief medical officer of Archeus Technologies and co-chair of the study, as well as associate professor and chair of the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health. "It also reflects our broader goal of advancing radiopharmaceutical strategies that can be applied across a range of difficult-to-treat cancers."

(Press release, Archeus Technologies, MAY 27, 2026, View Source [SID1234666122])