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])

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])

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])

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])

On March 23, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported fourth quarter and year end 2025 financial results and provided a corporate update.

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"We delivered another strong quarter, maintaining a disciplined approach to capital allocation and a continued focus on maximizing our cash runway," said Lindsay Androski, President and CEO of Arbutus. "I am thrilled to announce that two additional patients from our Phase 2a trials of imdusiran have achieved functional cure in chronic hepatitis B ("cHBV"), and am pleased with our team’s continuing progress on our cHBV programs."

LNP Litigation

On March 3, 2026, Arbutus, along with its exclusive licensee, Genevant Sciences ("Genevant"), entered into a settlement agreement to resolve all global patent infringement litigation and patent revocation proceedings involving Moderna. As part of the settlement, Moderna will pay Arbutus and Genevant $950 million upfront in July 2026 ("Noncontingent Settlement Payment") and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. §1498 ("Section 1498") does not bar Arbutus’ and Genevant’s claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. In asserting that defense, Moderna argued that Section 1498 applies such that U.S. taxpayers should assume liability for its infringement of Arbutus’ and Genevant’s patents for sales made under one of its government contracts. Moderna has also consented to entry of a judgment of infringement and of no invalidity of four Arbutus/Genevant patents. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Annual Report on Form 10-K filed with the SEC on March 20, 2026. Under the Company’s license with Genevant, the Company is entitled to receive, after deduction of litigation costs, 20% of the Noncontingent Settlement Payment. In addition, the Company owns approximately 16% of the outstanding common equity of Genevant.
Arbutus continues to consult closely with and support Genevant to protect and defend Arbutus’ intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech. The Company, together with Genevant, is seeking fair compensation for use of Arbutus’ patented lipid nanoparticle ("LNP") technology that was developed with great effort and at a great expense, and without which Pfizer/BioNTech’s COVID-19 vaccines would not have been successful. The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred in December 2024, and the court issued a claim construction ruling in September 2025, which construed the disputed claim terms in a manner the Company generally considers to be favorable. The parties are awaiting further scheduling in the litigation.
Corporate Updates

Two additional patients from the Company’s Phase 2a clinical trials of imdusiran achieved functional cure, making a total of 10 patients to date that have achieved functional cure during Phase 2a clinical trials and long-term follow-up. Two of these functionally cured patients seroreverted during long-term follow-up, but remain virally suppressed and off nucleos(t)ide analogue ("NA") therapy.
In December 2025, the Company recognized revenue of $0.5 million following the achievement of a contractual milestone related to Alnylam’s use of the Company’s proprietary LNP technology in an additional product candidate to treat hepatocellular carcinoma (HCC), underscoring the important role the Company’s LNP technology plays in the delivery of nucleic acids to the body. Payment was received in January 2026.
In connection with payments the Company expects to receive under the Moderna settlement, the Company is currently evaluating a return of capital to its shareholders in the third quarter of calendar year 2026, following the receipt of its portion of the noncontingent lump sum payment from Moderna.
Financial Results

Cash, Cash Equivalents and Investments

As of December 31, 2025, the Company had cash, cash equivalents and investments in marketable securities of $91.5 million compared to $122.6 million as of December 31, 2024. During the year ended December 31, 2025, the Company used $39.6 million in operating activities, which included one-time payments related to its restructuring efforts. This was partially offset by $5.5 million of proceeds from the exercise of stock options.

Revenue

Total revenue was $14.1 million for the year ended December 31, 2025, compared to $6.2 million for the same period in 2024. The increase of $7.9 million was due to the recognition of all previously-deferred revenue as a result of the conclusion of the Company’s strategic partnership with Qilu Pharmaceutical, partially offset by a decrease in license royalty revenues due to a decline in Alnylam’s sales of ONPATTRO.

Operating Expenses

Research and development expenses were $25.2 million for the year ended December 31, 2025, compared to $54.0 million for the same period in 2024. The decrease of $28.8 million was due primarily to cost savings from the Company’s decisions to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, which included ceasing all discovery efforts, discontinuing its IM-PROVE III clinical trial, and right-sizing the Company’s workforce.

General and administrative expenses were $15.9 million for the year ended December 31, 2025, compared to $22.1 million for the same period in 2024. This decrease was due primarily to cost-cutting efforts by the Company, which drove reductions in employee compensation-related expenses and legal fees.

Restructuring costs for the year ended December 31, 2025 were $12.9 million, and all remaining restructuring-related payments are expected to be made by the first quarter of 2026.

Net Loss

For the year ended December 31, 2025, the Company’s net loss was $33.5 million, or a loss of $0.17 per basic and diluted common share, as compared to a net loss of $69.9 million, or a loss of $0.38 per basic and diluted common share, for the quarter ended December 31, 2024.

Outstanding Shares

As of December 31, 2025, the Company had 192.5 million common shares issued and outstanding, as well as 14.0 million stock options and unvested restricted stock units outstanding.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND LOSS
(in thousands, except share and per share data)

Year ended December 31,
2025 2024
Revenue
Collaborations and licenses $ 12,601 $ 3,919
Non-cash royalty revenue 1,482 2,252
Total revenue 14,083 6,171
Operating expenses
Research and development 25,241 54,037
General and administrative 15,893 22,108
Change in fair value of contingent consideration (1,830 ) 2,625
Restructuring costs 12,939 3,720
Total operating expenses 52,243 82,490
Loss from operations (38,160 ) (76,319 )
Other income
Interest income 4,068 6,585
Gain on sale of property and equipment 674 —
Interest expense (97 ) (137 )
Foreign exchange gain / (loss) 14 (49 )
Total other income 4,659 6,399
Net loss $ (33,501 ) $ (69,920 )
Net loss per common share
Basic and diluted $ (0.17 ) $ (0.38 )
Weighted average number of common shares
Basic and diluted 191,599,600 185,608,874

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

December 31, 2025 December 31, 2024
Cash, cash equivalents and marketable securities, current $ 91,471 $ 122,623
Accounts receivable and other current assets 2,985 4,693
Total current assets 94,456 127,316
Property and equipment, net of accumulated depreciation and impairment 32 3,309
Right of use asset — 1,048
Other non-current assets 130 34
Total assets $ 94,618 $ 131,707

Accounts payable and accrued liabilities $ 5,459 $ 7,564
Deferred license revenue, current — 7,571
Lease liability, current 547 483
Total current liabilities 6,006 15,618
Liability related to sale of future royalties 3,442 4,829
Deferred license revenue, non-current — 2,863
Contingent consideration 8,395 10,225
Lease liability, non-current 199 806
Total stockholders’ equity 76,576 97,366
Total liabilities and stockholders’ equity $ 94,618 $ 131,707

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Year ended December 31,
2025 2024
Net loss $ (33,501 ) $ (69,920 )
Non-cash items 3,887 7,899
Change in deferred license revenue (10,434 ) (1,357 )
Other changes in working capital 411 (1,472 )
Net cash used in operating activities (39,637 ) (64,850 )
Net cash provided by investing activities 15,580 22,948
Issuance of common shares pursuant to the Open Market Sale Agreement — 44,123
Cash provided by other financing activities 5,721 7,873
Net cash provided by financing activities 5,721 51,996
Effect of foreign exchange rate changes on cash and cash equivalents 14 (49 )
(Decrease) / increase in cash and cash equivalents (18,322 ) 10,045
Cash and cash equivalents, beginning of period 36,330 26,285
Cash and cash equivalents, end of period 18,008 36,330
Investments in marketable securities 73,463 86,293
Cash, cash equivalents and investments, end of period $ 91,471 $ 122,623

About Imdusiran (AB-729)  

Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens, including hepatitis B surface antigen ("HBsAg"), which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine ("GalNAc") delivery technology enabling subcutaneous delivery. In Arbutus’ Phase 2a clinical trials, eight patients with cHBV achieved functional cure following treatment with imdusiran and NA therapy in combination with either pegylated interferon alfa-2a or low dose nivolumab plus an immunotherapeutic, with six out of the eight patients continuing to sustain functional cure for over two years. An additional 41 patients across the Company’s Phase 2a clinical trials were able to remain off NA therapy for at least 48 weeks during their Phase 2a clinical trials following treatment with imdusiran. Two additional patients who discontinued NA therapy in their Phase 2a clinical trials have now achieved functional cure during their participation in long-term follow-up. Functional cure is defined as sustained HBsAg seroclearance and hepatitis B virus deoxyribonucleic acid ("HBV DNA") less than the lower limit of quantification after 24 weeks off treatment, with or without anti-hepatitis B surface antibodies. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and HBV DNA.

About HBV  

Hepatitis B is a potentially life-threatening liver infection caused by hepatitis B virus ("HBV"). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options.

(Press release, Arbutus Biopharma, MAR 23, 2026, View Source [SID1234663820])