Nurix Therapeutics Announces Multiple Presentations Showcasing Depth of Research Pipeline and Scientific Leadership at the American Association for Cancer Research (AACR) 2026 Annual Meeting

On March 23, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that two oral presentations and three poster presentations highlighting the breadth of its research pipeline and scientific leadership will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, to be held April 17-22, 2026, in San Diego, California.

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The presentations will provide additional mechanistic validation of CBL-B, Aurora kinase A (AURKA) and mutant BRAF as therapeutic targets across multiple cancer indications and will highlight the potential of Nurix’s orally bioavailable degraders to effectively suppress the oncogenic activity of these proteins in preclinical models.

Additionally, Gwenn Hansen, Ph.D., chief scientific officer of Nurix Therapeutics, has been selected to speak in an AACR (Free AACR Whitepaper) Advances session on induced proximity pharmacology, including targeted protein degradation. AACR (Free AACR Whitepaper) Advances sessions bring together leading scientific perspectives to provide a comprehensive view of recent developments, the current state of research, and emerging challenges in the field.

Oral Presentation Details:

Title: Designing Effective Degrader Therapeutics: What Early Clinical Experience Has Taught Us
Speaker: Gwenn Hansen, Ph.D., chief scientific officer, Nurix Therapeutics
Session type: Advances in Diagnostics and Therapeutics
Session title: Induced Proximity Pharmacology: Degraders and Beyond
Session date and time: Wednesday, April 22, 2026, 10:15 a.m. – 11:45 a.m. PT

Title: Discovery and characterization of CBL-B intramolecular glue inhibitors that increase T cell activation and suppress tumor growth
Presenter: Fred Cohen, Ph.D.
Session type: Minisymposium
Session category: Chemistry
Session title: Targeted Therapies
Session date and time: Tuesday, April 21, 2026, 4:30 p.m. PT
Abstract presentation #: 6733

Poster Presentation Details:

Title: NRX-4972, a selective, oral, Aurora kinase A degrader, demonstrates increased efficacy in an SCLC tumor model, and greater in vitro synergy than an AURKA inhibitor
Presenting author: Ryan Rountree, Ph.D.
Session category: Targeted Protein Degradation and Induced Proximity
Session title: Targeted Protein Degradation and Induced Proximity
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 5166

Title: NRX-0305, an orally bioavailable, CNS penetrant pan-mutant BRAF degrader demonstrates robust efficacy in intracranial models of melanoma brain metastasis and primary glioma
Presenting author: Sasha Borodovsky, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 1
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 4617

Title: NRX-0305 is an orally bioavailable, pan-mutant BRAF degrader that exhibits single-agent and combination efficacy with MEKi or anti-EGFR across Class 1/2/3 BRAF-mutant cancers
Presenting author: Ya-Wen Lu, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 2
Session date and time: Tuesday, April 21, 2026, 2:00 p.m. – 5:00 p.m. PT
Poster #: 5801

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

About NRX-0305
NRX-0305 is a potent, selective, and orally bioavailable CNS-penetrant pan-mutant BRAF degrader that Nurix is exploring for use in oncology. Nurix has reported preclinical data demonstrating potent anti-tumor activity in multiple cell line-derived and patient-derived xenograft disease models representing Class I, Class II, and Class III B-RAF mutations. Anti-tumor activity was also observed in the setting of CNS disease and treatment-resistance, suggesting the potential for utility across a broad range of solid tumor types.

About NRX-4972
NRX-4972 is a CNS-penetrant, orally bioavailable and highly selective degrader of Aurora A kinase (AURKA). AURKA is an oncogene frequently overexpressed in adult solid tumors, hematologic malignancies, and pediatric cancers. Several AURKA inhibitors are effective in preclinical tumor models, but this activity has failed to translate into clinical efficacy. To address the limitations of inhibitors, Nurix has designed bifunctional targeted protein degraders of AURKA that enable removal of both enzymatic and scaffolding functions.

(Press release, Nurix Therapeutics, MAR 23, 2026, View Source [SID1234663825])

Moleculin Hits 45 Subject Enrollment Milestone, Triggering Final Countdown to Mid-2026 MIRACLE Trial Data Readout

On March 23, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the final phase of preparation for the trial’s interim 45 subject data unblinding, which remains on track for mid-2026 and represents a potentially defining inflection point for the Company.

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"We believe this upcoming data readout represents the most important milestone in our history to date," said Walter Klemp, Chairman and CEO of Moleculin. "This is a critical achievement for Moleculin and, more importantly, for patients facing relapsed or refractory AML. Reaching the 45 subject mark brings us to the threshold of our first meaningful look at MIRACLE data. Based on what we believe to be encouraging blinded results announced in February, we believe we are building real momentum toward what could be a transformative outcome. Our Phase 2 AML MB-106 clinical trial generated greater efficacy than any drug ever approved for relapsed or refractory AML, and it contributed to the more than 100 patients treated to date without any associated cardiotoxicity. What remains now is to demonstrate that a larger Phase 3 trial can produce results that will support new drug approval. The upcoming unblinding of the first 45 subjects should be a strong indicator of that potential. A true next-generation anthracycline has long been sought by medical science and would rightly be considered a gamechanger, not just for AML but for a wide range of cancers. We now appear to be on the threshold of finding out whether this can become a reality."

Moleculin Biotech continues to advance toward a defining milestone with its ongoing MIRACLE trial, a global, adaptive Phase 2B/3 study designed to evaluate AnnAraC across eight countries to date. The trial protocol provides for early unblinding of data after the first 45 subjects complete treatment, which is expected to yield an initial dataset of approximately 30 patients treated with AnnAraC (at two different dose levels) and 15 patients in the control arm receiving cytarabine plus placebo. This upcoming interim readout is anticipated to provide critical insights into efficacy, safety, and dose optimization as the study progresses toward its Phase 3 portion. Enrollment continues in parallel with the 45th subject unblinding as the Company advances to 90 total subjects thereby concluding Part A of MIRACLE, expected in Q3 2026, with the complete unblinding of Part A thereafter.

Encouraging early signals have already emerged from this difficult-to-treat patient population. In February 2026, Moleculin reported a preliminary blinded composite complete remission rate of 40% among the first 30 patients enrolled in the MIRACLE trial, consisting of 30% complete remission and 10% complete remission with partial hematologic recovery. These findings are particularly notable given that approximately 35% of subjects had previously failed venetoclax-based therapies, and many exhibited adverse genetic markers typically associated with poor outcomes. Additionally, the multinational nature of the trial underscores consistent activity across diverse clinical settings. Even with the inclusion of the control arm, these preliminary blinded aggregate outcomes compare favorably to historical remission rates associated with cytarabine alone in relapsed or refractory acute myeloid leukemia.

The MIRACLE trial’s adaptive design is intended to support a streamlined global registration pathway by integrating data from its Phase 2B portion into the planned Phase 3 portion, in alignment with regulatory guidance, including FDA Project Optimus principles. Following the interim readout, enrollment is expected to continue toward 90 patients to enable a second unblinding, with the Phase 3 portion of the study commencing once the optimum dose is determined. The program remains on track toward a potential accelerated approval pathway based solely on the Complete Remission primary endpoint.

Progress in the MIRACLE trial also reflects broader momentum across Moleculin’s oncology pipeline, which includes ongoing and planned studies targeting pancreatic cancer, brain tumors, and soft tissue sarcoma. With dosing of the 45th subject now complete, the Company is entering a catalyst-rich period leading up to the anticipated mid-2026 interim data readout, a milestone that could significantly influence the future development of Annamycin in the treatment of acute myeloid leukemia.

For additional information on the MIRACLE trial, please visit ClinicalTrials.gov and reference Identifier: NCT06788756.

(Press release, Moleculin, MAR 23, 2026, View Source [SID1234663824])

GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan, granted Orphan Drug Designation for small-cell lung cancer in Japan

On March 23, 2026 GSK plc (LSE/NYSE: GSK) reported that risvutatug rezetecan (or Ris-Rez, for short), a B7-H3-targeted antibody-drug conjugate (ADC), has received Orphan Drug Designation (ODD) from Japan’s Ministry of Health, Labour and Welfare for the treatment of small-cell lung cancer (SCLC). The ODD was supported by preliminary clinical data showing durable responses in patients with extensive-stage SCLC (ES-SCLC) who were treated with Ris-Rez in the phase I ARTEMIS-001 clinical trial.1 This is the sixth regulatory designation for Ris-Rez, which is being developed in a range of solid tumours, including lung, prostate and colorectal cancers.

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Lung cancer is the second most common cancer in Japan, and SCLC makes up 10-15% of cases.2,3 Of patients with SCLC, 70% have ES-SCLC, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.4 ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options and poor long-term survival. Most patients with ES-SCLC relapse after initial treatment and the median overall survival with standard-of-care for these patients is approximately 8 months.5

About Ris-Rez
Ris-Rez is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez. GSK’s global phase III trial (NCT07099898) for Ris-Rez in relapsed ES-SCLC began in August 2025.

Regulatory designations received for Ris-Rez to date include ODDs from the US Food and Drug Administration (FDA) in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.

(Press release, GlaxoSmithKline, MAR 23, 2026, View Source [SID1234663823])

Chugai Obtains Regulatory Approval for Lunsumio and Polivy Combination Therapy for Additional Indication of Relapsed or Refractory Large B-cell Lymphoma

On March 23, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of the combination therapy of anti-cancer agent / anti-CD20/CD3 humanized bispecific monoclonal antibody Lunsumio subcutaneous injection 5mg and 45mg [generic name: mosunetuzumab (genetical recombination)] (hereafter, Lunsumio) and anti-cancer agent/antimicrotubule-binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] (hereafter, Polivy) for the treatment of relapsed or refractory large B-cell lymphoma. This marks the first approval in the world for the combination therapy of Lunsumio and Polivy for this indication.

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"For patients with relapsed or refractory large B-cell lymphoma, treatment options remain limited and unmet medical needs persist. The Lunsumio and Polivy combination therapy achieved responses in approximately 70% of patients and showed a 59% reduction in the risk of disease progression or death compared to the chemotherapy control arm. We are committed to delivering this treatment to patients as quickly as possible by providing timely information to healthcare professionals and promoting appropriate use," said Dr. Osamu Okuda, Chugai’s President and CEO.

This approval is based on the results of the global, multi-center, randomized Phase III SUNMO study evaluating the efficacy and safety of the combination therapy compared to the regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx; not approved in Japan) in patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.

In the interim analysis of the study, the objective response rate (ORR), a primary endpoint assessed by an independent review committee, was 69.7% (95% CI: 60.7-77.8) in the Lunsumio and Polivy combination therapy group and 44.1% (95% CI: 31.2-57.6) in the R-GemOx group, with a between-group difference of 25.7% (97.5% CI: 7.4-43.9). At the time of the primary analysis, the progression-free survival (PFS), also a primary endpoint assessed by an independent review committee, was 11.5 months (95% CI: 5.6-18) in the Lunsumio and Polivy combination therapy group and 3.8 months (95% CI: 2.9-4.1) in the R-GemOx group, demonstrating a 59% reduction in the risk of disease progression or death.

The safety profile of the combination therapy of Lunsumio and Polivy was consistent with the known profiles of each agent in their respective individual studies. Adverse events were observed in 131 of 135 patients (97.0%) in the Lunsumio and Polivy combination therapy group and in 61 of 64 patients (95.3%) in the R-GemOx group. The main adverse events in the Lunsumio and Polivy combination therapy group included injection site reactions in 71 patients (52.6%), neutropenia in 62 patients (45.9%), anemia in 41 patients (30.4%), and cytokine release syndrome in 35 patients (25.9%), among others.1

Approval Information (Lunsumio) *Relevant sections only, with modifications underlined

Product name: "LUNSUMIO subcutaneous injection 5mg" and "LUNSUMIO subcutaneous injection 45mg"

Generic name: mosunetuzumab (genetical recombination)

Indications:
The following relapsed or refractory large B-cell lymphomas:

Diffuse large B-cell lymphoma
High-grade B-cell lymphoma

Relapsed or refractory follicular lymphoma

Dosage and administration:
〈Relapsed or refractory large B-cell lymphoma (diffuse large B-cell lymphoma, high-grade B-cell lymphoma) and relapsed or refractory follicular lymphoma (Grade 3B)〉
In combination with polatuzumab vedotin (genetical recombination), mosunetuzumab (genetical recombination) is administered subcutaneously to adults in 21-day cycles.
In the first cycle, 5 mg is administered on Day 1, followed by 45 mg on Days 8 and 15, and from the second cycle onward, 45 mg is administered on Day 1 for up to 8 cycles.

Approval Information (Polivy) *Relevant sections only, with modifications underlined

Product name: "Polivy intravenous infusion 30 mg" and "Polivy intravenous infusion 140 mg"

Generic name: polatuzumab vedotin (genetical recombination)

Indications:
The following large B-cell lymphomas:

Diffuse large B-cell lymphoma
High-grade B-cell lymphoma

Relapsed or refractory follicular lymphoma

Precautions concerning indications:

This drug should be administered to patients diagnosed with Grade 3B by a pathologist with sufficient experience.

Dosage and administration:
In combination with other anti-cancer agents, polatuzumab vedotin (genetical recombination) is usually administered to adults as an intravenous infusion at a dose of 1.8 mg/kg (body weight) once every three weeks for a total of six doses. The initial dose is infused over 90 minutes, and if tolerated well, the infusion time for subsequent doses may be shortened to 30 minutes. The dose may be reduced as appropriate depending on the patient’s condition.

[Reference]

Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma (Press release from Roche issued on June 20, 2025)
View Source

About the SUNMO study

The SUNMO [NCT05171647] study is a multinational, multicenter, randomized Phase III trial that targets patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation, and evaluates the combination therapy of subcutaneously administered Lunsumio (mosunetuzumab) and intravenously administered Polivy (polatuzumab vedotin) in comparison with the R-GemOx regimen [Rituxan (rituximab), gemcitabine, and oxaliplatin]. The primary endpoints are progression-free survival and objective response rate, and the secondary endpoints include overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes (PROs: Patient Reported Outcomes).

About Lunsumio (mosunetuzumab)

Lunsumio is a T-cell-engaging bispecific antibody designed to target CD3 on T cells and CD20 on B cells. Lunsumio is expected to activate immunity mediated by cytotoxic T cells and exert antitumor effects against tumor cells expressing CD20. Lunsumio has been approved in 65 countries worldwide. Clinical studies are currently underway in follicular lymphoma (second line and untreated settings). In December 2025, in addition to the intravenous formulation, Lunsumio obtained manufacturing and marketing approval for a new subcutaneous formulation.

About Polivy (polatuzumab vedotin)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Roche and is currently being investigated for the treatment of several types of NHL.

About Large B-cell lymphoma (LBCL)

LBCL consists primarily of diffuse large B-cell lymphoma (DLBCL), which is the most common subtype of non-Hodgkin lymphoma (NHL) affecting B-cell lymphocytes, a type of white blood cell. DLBCL is the most common form of aggressive NHL and accounts for approximately 80%2 of LBCL cases. LBCL also includes high-grade B-cell lymphoma (HGBL), which is considered to be even more aggressive and to have a poorer prognosis than DLBCL. Although patients generally respond to frontline therapy, up to 40%3 experience relapse or become refractory, and in such cases, treatment options for salvage therapy are limited.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, MAR 23, 2026, View Source [SID1234663822])

BioLineRx Reports 2025 Financial Results and Provides Corporate Update

On March 23, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its audited financial results for the year ended December 31, 2025, and provided a corporate update.

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"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) (Free ASH Whitepaper) 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 View Source and posted on the Company’s investor relations website at View Source 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.

(Press release, BioLineRx, MAR 23, 2026, View Source [SID1234663821])