On May 13, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported first quarter 2026 financial results and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (the "Noncontingent Settlement Payment") and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. §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. Under the Company’s license with Genevant, the Company expects to receive in July 2026 an estimated $178.7 million of the Noncontingent Settlement Payment, which includes reimbursement of the Company’s litigation costs. In addition, the Company owns approximately 16% of the outstanding common equity of Genevant. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Quarterly Report on Form 10-Q to be filed with the SEC on May 13, 2026 and Annual Report on Form 10-K filed with the SEC on March 23, 2026.

Corporate Updates

In April 2026, the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for imdusiran for the treatment of chronic hepatitis B. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational therapies to treat serious conditions with unmet medical need. A drug granted Fast Track designation may be eligible for several benefits, including earlier and more frequent meetings and communications with the FDA and the potential for rolling review of its application. If relevant criteria are met, investigational therapies that receive Fast Track designation may also qualify for Accelerated Approval or Priority Review of a Biologics License Application or New Drug Application.

Financial Results

Cash, Cash Equivalents and Investments

As of March 31, 2026, the Company had cash, cash equivalents and investments in marketable securities of $95.2 million compared to $91.5 million as of December 31, 2025. During the three months ended March 31, 2026, the Company used $8.1 million in operating activities, which included one-time payments related to its restructuring efforts, and received $11.5 million of proceeds from the exercise of stock options.

Revenue

Total revenue was $179.1 million for the quarter ended March 31, 2026, compared to $1.8 million for the same period in 2025. The increase of $177.4 million was due to license revenue from Genevant related to the Company’s portion of the Noncontingent Settlement Payment.

Operating Expenses

Research and development expenses were $4.1 million for the quarter ended March 31, 2026, compared to $9.0 million for the same period in 2025. The decrease of $4.8 million was due primarily to cost savings from the Company’s decisions to reduce its workforce and discontinue in-house scientific research, as well as lower clinical trial costs as studies neared completion.

General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $5.8 million for the same period in 2025. This increase was due primarily to higher legal fees driven by the settlement with Moderna, partially offset by cost-cutting efforts by the Company, which drove reductions in employee compensation-related expenses.

There were no restructuring costs in the quarter ended March 31, 2026, compared to $12.4 million for the same period in 2025.

Net Income/Loss

For the quarter ended March 31, 2026, the Company’s net income was $169.7 million, or income of $0.88 per basic and $0.87 per diluted common share, as compared to a net loss of $24.5 million, or a loss of $0.13 per basic and diluted common share, for the quarter ended March 31, 2025.

Outstanding Shares

As of March 31, 2026, the Company had 196.9 million common shares issued and outstanding, as well as 9.7 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)

Three Months Ended March 31,
2026 2025
Revenue
Collaborations and licenses $ 204 $ 1,316
License revenue from Genevant 178,741 —
Non-cash royalty revenue 181 448
Total revenue 179,126 1,764
Operating expenses
Research and development 4,120 8,959
General and administrative 5,889 5,832
Change in fair value of contingent consideration 209 299
Restructuring costs — 12,373
Total operating expenses 10,218 27,463
Income (loss) from operations 168,908 (25,699 )
Other income
Interest income 815 1,197
Interest expense (17 ) (28 )
Foreign exchange (loss) gain (11 ) 4
Total other income 787 1,173
Net income (loss) $ 169,695 $ (24,526 )
Net income (loss) per common share
Basic $ 0.88 $ (0.13 )
Diluted $ 0.87 $ (0.13 )
Weighted average number of common shares
Basic 193,768,641 190,707,085
Diluted 195,214,067 190,707,085

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

March 31,
2026 December 31,
2025
Cash, cash equivalents and marketable securities, current $ 95,226 $ 91,471
License receivable from Genevant 178,741 —
Accounts receivable and other current assets 3,044 2,985
Total current assets 277,011 94,456
Property and equipment, net of accumulated depreciation and impairment 22 32
Other non-current assets 131 130
Total assets $ 277,164 $ 94,618

Accounts payable and accrued liabilities $ 4,474 $ 5,459
Lease liability, current 631 547
Total current liabilities 5,105 6,006
Liability related to sale of future royalties 3,278 3,442
Contingent consideration 8,604 8,395
Lease liability, non-current — 199
Total stockholders’ equity 260,177 76,576
Total liabilities and stockholders’ equity $ 277,164 $ 94,618

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Three Months Ended March 31,
2026 2025
Net income (loss) $ 169,695 $ (24,526 )
Non-cash items 1,061 5,866
License receivable from Genevant (178,741 ) —
Other changes in working capital (125 ) 5,269
Net cash used in operating activities (8,110 ) (13,391 )
Net cash provided by investing activities 2,199 11,349
Net cash provided by financing activities 11,619 2,784
Effect of foreign exchange rate changes on cash and cash equivalents (10 ) 4
Increase in cash and cash equivalents 5,698 746
Cash and cash equivalents, beginning of period 18,008 36,330
Cash and cash equivalents, end of period 23,706 37,076
Investments in marketable securities 71,520 75,631
Cash, cash equivalents and marketable securities, end of period $ 95,226 $ 112,707

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 delivery technology enabling subcutaneous delivery. In Arbutus’ Phase 2a clinical trials, eight patients with chronic hepatitis B ("cHBV") achieved functional cure following treatment with imdusiran and nucleos(t)ide analogue ("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, MAY 13, 2026, View Source [SID1234665623])

On May 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the quarter ended March 31, 2026 and provided a corporate update on the advancement of its innovative DNase oncology platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Highlights

Generated robust translational data supporting the DNase I platform across multiple oncology settings

Completed process improvement and analytical development activities supporting future clinical manufacturing readiness

Established translational and biomarker insights intended to help inform and de-risk future clinical trial design

Collaboration partner received approval from Israeli Ministry of Health to conduct investigator-initiated exploratory study of DNase I in combination with anti-CD19 CAR T cells in large B-cell lymphoma

"We entered 2026 with a clear focus on advancing the translational, manufacturing and clinical foundation of our DNase I platform while maintaining financial discipline," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "During the quarter, we achieved important progress across investigator-initiated studies, translational research and manufacturing readiness activities. We believe the growing body of translational evidence supporting NET-targeting approaches, combined with the expanding understanding of NETs as drivers of tumor progression, immune suppression and therapy resistance, continues to strengthen the potential opportunity for DNase I as a differentiated adjunctive immuno-oncology therapy across multiple cancer settings."

Xenetic’s proprietary DNase technology is being developed as a potential adjunctive therapeutic approach designed to improve the effectiveness of existing cancer treatments, including immunotherapies, through the targeting of NETs, which are increasingly recognized as key drivers of immune suppression and therapeutic resistance within the tumor microenvironment.

Summary of Financial Results for First Quarter 2026

Royalty revenue for the three months ended March 31, 2026 increased approximately 36% to approximately $0.8 million, compared to approximately $0.6 million for the comparable prior year period, primarily driven by increased royalty payments recognized under the Company’s sublicense agreement with Takeda Pharmaceuticals Co. Ltd.

Research and development expenses for the three months ended March 31, 2026 decreased approximately 25% to approximately $0.7 million from approximately $0.9 million for the comparable prior year period, primarily due to lower preclinical and exploratory study costs, partially offset by increased manufacturing development efforts supporting the Company’s DNase I program.

General and administrative expenses for the three months ended March 31, 2026 decreased by approximately 1.4%, to approximately $0.6 million from approximately $0.7 million in the comparable quarter in 2025. The decrease was primarily due to a decrease in personnel costs and share-based expenses related to our interim Chief Executive Officer substantially offset by an increase in legal expenses related to our strategic review process during the first quarter of 2026 compared to the same period in 2025.

Net loss for the quarter ended March 31, 2026 decreased approximately 49% to approximately $0.5 million, compared to approximately $0.9 million for the same period in 2025.

The Company ended the first quarter of 2026 with approximately $7.3 million in cash and cash equivalents, compared to approximately $7.9 million as of December 31, 2025.

(Press release, Xenetic Biosciences, MAY 13, 2026, View Source [SID1234665642])

On May 13, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported financial results for the first quarter ended March 31, 2026 and reviewed recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected into the third quarter of 2027, we believe we are well positioned to execute through multiple potential value-inflection milestones."

Recent Highlights

ACR-368: CHK1 / CHK2 Inhibitor

Recently presented interim analysis of the ongoing, multi-arm, registrational intent Phase 2b study across both OncoSignature-positive (BM+) and BM- endometrial cancer (EC) subjects showed a confirmed overall response rate (cORR) of 52% (N = 23) in serous EC subjects versus an ORR of 22% (N = 37) in non-serous EC subjects, with all subjects having received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1. This is consistent with the higher BM positivity rate and elevated biomarker levels in subjects with serous versus non-serous EC.
Arm 1 is ongoing and is stratifying for treatment of EC based on BM+ predicted sensitivity to ACR-368
Arm 2 was successfully completed, showing that ultra-low dose gemcitabine (ULDG) may contribute to ACR-368 efficacy, while maintaining a favorable tolerability profile, in BM- subjects
Arm 3 is investigating ACR-368 with ULDG sensitization in serous EC subjects with up to two prior LoT without the need for pre-treatment tumor biopsy or biomarker stratification ("serous all comer")
Arm 4 enrollment and dosing was recently initiated, investigating single agent ACR-368 without ULDG, in the same "serous all comer" subject population as Arm 3
Clinical data from the Phase 2b trial was featured in a late-breaking oral presentation by Professor Panagiotis Konstantinopoulos of the Dana-Farber Cancer Institute at the European Society of Gynecological Oncology (ESGO) Annual Congress, followed by a company-hosted KOL panel, during which renowned experts expressed strong enthusiasm for the data on ACR-368 and reiterated the high unmet need for patients suffering from serous EC
Two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting uncovered the underlying molecular mechanisms for potent synergies between ACR-368 and anti-PD-L1 checkpoint inhibitors or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support potential clinical combination studies with antibody-drug conjugates (ADCs) or immune checkpoint inhibitors (ICIs), including a planned Phase 3 confirmatory study of ACR-368 with ICIs.

ACR-2316: WEE1 / PKMYT1 Inhibitor

Initial data from the Phase 1 monotherapy dose-escalation trial demonstrated a favorable safety profile, primarily limited to only transient neutropenia and notable absence of non-hematological adverse events, and demonstrated clinical activity with both tumor shrinkage as well as prolonged clinical benefit, notably including partial responses and strong disease control in small cell lung cancer (SCLC) and squamous non-small cell lung cancer (NSCLC), tumor types predicted sensitive by AP3 not previously shown sensitive to WEE1 or PKMYT1 inhibitors in development
AP3-based data presented at the AACR (Free AACR Whitepaper) Annual Meeting demonstrated the processes driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI. ACR-2316 was found to boost immune-mediated tumor killing and overcome anti-PD-L1 resistance by modulating T-cell exhaustion, providing a mechanistic rationale for potential combinations with ICIs.

CDK11 Inhibitor Program

Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds being advanced in Investigational New Drug (IND)-enabling studies.

Anticipated Upcoming Milestones

ACR-368 Ongoing Registrational Intent Phase 2b Study

A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026
Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026
Based on interim data read-out, complete enrollment of the registrational intent all-comer (biopsy-independent) serous EC Arm 3 or Arm 4 by fourth quarter of 2026

Broader Pipeline

Additional ACR-2316 Phase 1/2 clinical data for weekly and bi-weekly dosing regimens and transition into dose expansion in AP3-identified tumor types in 2026
Submit IND filing to the FDA for ACR-6840, or alternative CDK11 inhibitor candidate, in first half of 2027
Initiate additional internal programs utilizing the AP3 platform in 2026

First Quarter 2026 Financial Results

Net loss for the quarter ended March 31, 2026 was $19.0 million compared to a net loss of $19.7 million for the same period in 2025.

Research and development expenses were $15.2 million for the quarter ended March 31, 2026 compared to $15.4 million for the same period in 2025, which is materially consistent.

General and administrative expenses were $4.7 million for the quarter ended March 31, 2026, compared to $6.2 million for the same period in 2025. The difference was primarily due to a decrease in employee-related expenses including stock-based compensation.

As of March 31, 2026, the company had cash, cash equivalents and investments of $97.7 million which, together with the net proceeds raised from subsequent equity financing, is expected to fund operating expenses and capital expenditure requirements into the third quarter of 2027.

(Press release, Acrivon Therapeutics, MAY 13, 2026, View Source [SID1234665657])

On May 13, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the quarter ended March 31, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q1 2026 and Recent Business Highlights

Announced the addition of MD Anderson Cancer Center as a clinical site for Phase 1/2 trial of ATR-04 targeting EGFRi-associated skin rash.
Launched innovative protein and peptide programs for the cosmetic and cosmeceutical markets leveraging proprietary filaggrin technologies.
Secured new U.S. patent covering ATR-12, the Company’s lead product candidate being developed for Netherton syndrome.
Announced poster presentation at American Society of Gene and Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) 2026 highlighting ATR-01 preclinical data and the broader potential of Azitra’s engineered live biotherapeutic platform.
Priced private placement financing of up to approximately $10.5 million, with up to an additional approximately $20.9 million upon exercise of warrants.
"The first quarter of 2026 marked a period of meaningful execution across our clinical and strategic priorities as we continue to advance Azitra’s leadership in precision dermatology," said Francisco Salva, CEO of Azitra. "Notably, we significantly grew the clinical footprint for our Phase 1/2 Trial of ATR-04 targeting EGFRi-associated skin rash by adding the world-renowned MD Anderson Cancer Center, which is one of the world’s premier oncology institutions. We believe the addition of MD Anderson will serve to enhance patient access and support efficient trial execution in EGFR inhibitor-associated rash—a condition impacting the majority of patients receiving these therapies."

Mr. Salva continued: "In parallel, we expanded our strategic footprint with the launch of our cosmeceutical initiative, leveraging our proprietary filaggrin protein and peptide technologies to potentially address large and growing consumer markets. Based on our preliminary research, we are confident that our technologies and expertise can offer an exciting new way to address the appearance of fine lines and wrinkles as well as dry sensitive skin and eczema-like rashes. As such, this program represents a compelling opportunity to extend our platform beyond therapeutics and create additional avenues for value creation."

Mr. Salva added: "We are also highlighting our platform this week at ASGCT (Free ASGCT Whitepaper) 2026, where we are presenting ATR-01 preclinical data that underscores the potential of our engineered live biotherapeutics. With this scientific visibility occurring alongside our quarterly update, we believe it reinforces the continued progress and relevance of our platform within the broader gene and cell therapy landscape."

Mr. Salva concluded: "We are also excited to report the recent issuance of a new U.S. patent providing broad protection for our lead product, ATR-12, which we are advancing in a Phase 1b clinical trial for Netherton syndrome. With a strengthened balance sheet, expanding clinical execution, and multiple near-term catalysts, we believe Azitra is well positioned to drive continued progress across both our therapeutic pipeline and emerging cosmeceutical platform."

Pipeline Achievements and Upcoming Milestones

ATR-COSF – New Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin, expected mid-2026.
Human cosmetic application study planned for Q3 2026.
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

In June 2025, Azitra reported promising safety data with 50% of patients enrolled.
ATR12-351, a live biotherapeutic product candidate has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site to date.
Topline data from the Phase 1b trial is anticipated H2 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market Opportunity

Dosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025.
Topline data from first cohort of Phase 1/2 trial expected in H2-2026.
ATR-01 – Targeting Ichthyosis Vulgaris Which Impacts 1.3 million in the United States

Announced positive preclinical data for ATR-01 program in Q3 2025, demonstrating delivery of active, functional filaggrin through human stratum corneum and repair of damaged model skin.
IND-enabling studies continue in 2026.
Financial Results for the Quarter Ended March 31, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2026, were $1.6 million compared to $1.3 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2026, were $2.4 million compared to $1.9 million for the comparable period in 2025.
Net Loss was $3.9 million for the quarter ended March 31, 2026, compared to $3.1 million for the comparable period in 2025.
Cash and cash equivalents: As of March 31, 2026, Azitra had cash and cash equivalents of $10.1 million.

(Press release, Azitra, MAY 13, 2026, View Source [SID1234665624])

On May 13, 2026 Astrazeneca reported high-level results from a planned interim analysis of the VOLGA Phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Perioperative Imfinzi plus Imjudo (tremelimumab) in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis.

Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumour invades the muscle wall of the bladder, without distant metastases.1,2 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities.3,4 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.3-5

Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial, said: "Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments. The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared to surgery for patients in this curative-intent setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This interim analysis from the VOLGA trial highlights the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimises treatment options for patients. Together with NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this early-stage, curative-intent setting."​

The safety and tolerability of Imfinzi with or without Imjudo plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Imfinzi is approved in over 40 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. Additionally, Imfinzi added to Bacillus Calmette-Guérin therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial and is currently under review in the US, European Union (EU), Japan and several other countries. Imfinzi is also being investigated in locally advanced or metastatic disease in the NILE Phase III trial.  

Notes

Bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 cases diagnosed each year.6 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.7

In 2024, an estimated 117,500 patients were treated for MIBC with the standard of care, which included neoadjuvant cisplatin-based chemotherapy and radical cystectomy.5,8 In 2025, the NIAGARA Phase III trial established a new standard by adding perioperative Imfinzi to the regimen.9 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.3,5 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.

VOLGA
VOLGA is a Phase III, randomised, open-label, multi-centre global trial evaluating perioperative Imfinzi with or without Imjudo in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomised 1:1:1 to Arm 1 (three cycles of Imfinzi and EV, plus two cycles of Imjudo prior to surgery, followed by nine cycles of Imfinzi plus one cycle of Imjudo as adjuvant therapy), Arm 2 (three cycles of Imfinzi and EV prior to surgery, followed by nine cycles of Imfinzi adjuvant monotherapy) and Arm 3, the comparator arm.

The trial was conducted in 182 centres across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomisation to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in MIBC, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In resectable gastric and gastroesophageal junction cancers, perioperative Imfinzi added to standard-of-care chemotherapy is approved in the US and EU. Additionally, in April 2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone for patients with unresectable HCC eligible for embolisation in the EMERALD-3 Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.

Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across other tumour types including SCLC (ADRIATIC) and bladder cancer (NILE).

(Press release, AstraZeneca, MAY 13, 2026, View Source [SID1234665643])