On March 27, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the fourth quarter and full year ended December 31, 2025.

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"Autolus had a strong first year of launch of AUCATZYL in the US building a market leading position in adult patients with relapsed or refractory B-ALL and demonstrating strong commercial execution, including reliable, high-quality product delivery with consistent turn-around time. Parallel to the launch, the ROCCA consortium collected real world data from approximately 60% of the commercial patients treated with AUCATZYL. Recently reported data confirm a high level of clinical activity without inducing high grade CRS and only 3% of patients experiencing high grade ICANS. We expect this positive customer experience will be a key driver for the future growth of AUCATZYL," said Dr. Christian Itin, Chief Executive Officer of Autolus.

Dr. Itin continued, "Our focus in 2026 will be on driving adoption of AUCATZYL in the US, launching in the UK and expanding the utility of obe-cel in additional indications while leveraging our established commercial and manufacturing capabilities. Based on regulatory feedback we are executing two compact pivotal studies: CATULUS in pediatric r/r B-ALL and LUMINA in severe lupus nephritis patients. In addition, we are exploring the utility of obe-cel in progressive MS patients in the Phase 1 BOBCAT study. Clinical data updates are planned for long-term follow up of the Phase 1 CARLYSLE data in severe SLE patients, initial clinical experience in light chain amyloidosis from the ALARIC study with AUTO8 and initial data from the BOBCAT study by the end of 2026."

Product and Pipeline Updates:

AUCATZYL Launch
Autolus reported net product revenue of $23.3 million* for the three months ended December 31, 2025, and $74.3 million* for the year ended December 31, 2025, driven by U.S. sales.
Following a successful National Institute for Health and Care Excellence (NICE) evaluation, AUCATZYL launched in the UK in January 2026 and is now available under routine commissioning.
Data from the ROCCA (Real-World Outcomes Collaborative for CAR T in Adult ALL) consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 and the TANDEM meeting in February 2026. Real-world data show consistency in both safety and efficacy compared to the FELIX clinical trial that was the basis for regulatory approvals. The ROCCA Consortium registry covers approximately 60% of U.S. commercial patients at a data cutoff of January 5, 2026.
Obe-cel data in pediatric r/r B-ALL
Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%. Low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, consistent with obe-cel’s adult safety profile. The Phase 2 portion of the trial is underway and Autolus expects to report data at the end of 2027.
In October 2025, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.

Obe-cel in lupus nephritis

Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) were reported at the American College of Rheumatology (ACR) Convergence 2025 and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. All patients show deep B-cell depletion after infusion, suggesting an immune reset. No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.
Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose.
Autolus has previously aligned with the US Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling and the Company expects to report data in 2028.
Obe-cel in progressive multiple sclerosis
Autolus has advanced obe-cel into initial clinical development to explore treatment in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. The Company expects to report initial data from the trial at the end of 2026 and full data in 2027.
AUTO8 in AL-Amyloidosis
The first patient was dosed in the Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis and initial data is expected to be reported at the end of 2026.

Q4 2025 Operational Updates:

In the fourth quarter of 2025, Autolus initiated an overall manufacturing life cycle plan to facilitate additional cost reductions and gross margin improvements as the Company plans to expand obe-cel into new indications and pursue larger market opportunities. The initiatives are focused on 1) optimizing the Company’s current manufacturing operating model; 2) enhancing automation opportunities for the Company’s existing manufacturing process; and 3) developing a next-generation manufacturing platform with a step change in the cost and capacity profile. The Company plans to provide a detailed update on these plans in mid-2026.

Outlook:
For 2026, the Company continues to project AUCATZYL net product revenue of between $120 million to $135 million.

Increasing patient numbers in 2026 are expected to improve manufacturing plant utilization and together with operational efficiencies, Autolus expects a shift to positive gross margin in 2026.

Based on current operating plans, including anticipated AUCATZYL net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.

Summary of Anticipated News Flow:

Longer-term follow up data from CARLYSLE trial
Year End 2026
Initial clinical data from BOBCAT Phase 1 trial in progressive MS Year End 2026
Initial clinical data from ALARIC Phase 1 trial in AL amyloidosis
(UCL collaboration) Year End 2026
BOBCAT trial progressive MS Phase 1 full data 2027
CATULUS trial pediatric Phase 2 data Year End 2027
LUMINA trial LN Phase 2 data 2028

ALL: acute lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
MS: multiple sclerosis
ALA: light-chain amyloidosis

Virtual Investor Event: Spotlight on Acute Lymphoblastic Leukemia (ALL) Program
April 8, 2026
1:00pm EDT / 6:00pm BST
A live webcast of the event will be available on the investor relations section of the Autolus website: View Source

Financial Results for the Quarter Ended December 31, 2025

Product revenue, net for the three months ended December 31, 2025, was $23.3 million*.

Cost of sales increased from $11.4 million to $25.3 million for the three months ended December 31, 2025, compared to the same period in 2024. This increase was primarily due to product sales in Q4 2025 and to the timing of commercial manufacturing activity expenses upon FDA approval of AUCATZYL in November 2024. Additionally, cost of sales in Q4 2025 includes cancelled orders in the period, patient access program product, inventory reserves and write-offs and third-party royalties for certain technology licenses.

Research and development expenses increased to $35.6 million from $30.8 million for the three months ended December 31, 2025, compared to the same period in 2024. This change was primarily due to an increase in research and development activities including clinical trial costs and a reduction in the UK R&D tax credit, partially offset by commercial manufacturing-related employee and infrastructure costs shifting to cost of sales and inventory.

Selling, general and administrative expenses increased to $35.8 million from $33.7 million for the three months ended December 31, 2025, compared to the same period in 2024. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting commercialization activities.

Loss from operations for the three months ended December 31, 2025, was $72.5 million, as compared to $75.9 million for the same period in 2024.

Net loss was $90.3 million for the three months ended December 31, 2025, compared to $27.6 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended December 31, 2025, totaled $(0.34), compared to basic and diluted net loss per ordinary share of $(0.10) for the same period in 2024.

Cash, cash equivalents and marketable securities at December 31, 2025, totaled $300.7 million, as compared to $588.0 million at December 31, 2024. The decrease was primarily driven by net cash used in operating activities and impacted by a delayed cash receipt of approximately $18.6 million in the Company’s 2023 R&D tax credit expected from the UK HMRC.

(Press release, Autolus, MAR 27, 2026, View Source [SID1234663974])

On March 27, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.

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Taletrectinib (marketed as IBTROZI in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.

Across Europe, nearly 400,000 people are diagnosed with lung cancer each year, with NSCLC accounting for 80% of cases. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.

"The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options."

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.

"Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world."

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

(Press release, Eisai, MAR 27, 2026, View Source [SID1234663939])

On March 26, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported it will host a business update conference call at 11:30 a.m. Eastern Time.

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The call will highlight new analysis from its Phase 2 SkinJect study, including an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, and outline the Company’s planning toward an agentic AI–enabled clinical development platform.

The Company believes these results position the 200µg cohort as the leading dose regimen in the study, demonstrating the highest activity observed to date with continued improvement through Day 57.

Conference Call Details

Time: 11:30 a.m. ET
Pre-registration: View Source
Dial-in. (US/Canada): 833-890-6070
Dial-in. (International): 412-504-9736
Q&A Web Link: View Source
The Key Highlights to be presented at the conference call are:

Independent Clinical Perspective — Dr. Babar Rao (Principal Investigator)

The call will feature Dr. Babar Rao, an internationally acclaimed dermatology key opinion leader and Principal Investigator of the SKNJCT-003 study, who will provide an independent clinical interpretation of the dataset.

Dr. Rao is a board-certified dermatologist and dermatopathologist, and currently serves as:

Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
Clinical Associate Professor of Dermatology, Weill Cornell Medical College
He has authored over 200 peer-reviewed publications and has served as principal investigator in multiple dermatology clinical trials.

Dr. Rao is expected to highlight:

The clinical significance of 73% clearance at Day 57 in the 200µg cohort
A clear separation versus device-only active control, supporting incremental drug effect
The role of:
Microneedle-mediated tumor disruption
Local immune activation and wound-healing pathways
Importantly, Dr. Rao is expected to place these findings in the context of the broader basal cell carcinoma (BCC) treatment landscape:

BCC is the most common cancer worldwide, with millions of new cases diagnosed annually in the United States alone
Standard treatments such as Mohs surgery, while effective, are capacity constrained.
As a result, there is a significant treatment backlog, where patients may face delays or undergo procedures that may not be immediately necessary.

Dr. Rao is expected to emphasize:

The observed ~73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual resolution, which in clinical practice could allow many patients to defer or avoid immediate surgical intervention.

If confirmed in future studies, this approach may:

Reduce procedural burden on healthcare systems
Improve patient access to care
Allow prioritization of surgical resources for higher-risk or refractory cases
He is also expected to reinforce that:

The dataset is clinically meaningful
Supports continued development and regulatory engagement
May be impactful in Gorlin Syndrome and other high-burden populations
Phase 2 Data Deep Dive — 200µg Cohort (Day 57)

Medicus will present expanded analysis of the 15-patient 200µg cohort, which demonstrated the highest activity in the study:

73% Clinical (visual) clearance
40% Histological complete response (CR)
80% Overall Response Rate (CR + partial response) with potential to exceed this level pending final Clinical Study Report (CSR)

Previously reported Topline results of the study, along with additional preliminary dataset representing partial response (PR) and over-all response rate (ORR) for each cohort, are tabulated which demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time.

Table 1. SKNJCT-003 Phase 2 topline Data by Treatment Arm

Treatment Arm (n) Day 29 post-treatment (n) Day 57 post-treatment
47 CC CR PR* ORR* 43 CC CR PR* ORR*
200 μg D-MNA 15 40% 27% 20% 47% 15 73% 40% 40% 80%
C-MNA 15 33% 20% 20% 40% 16 38% 38% 6% 44%
100 μg D-MNA 17 47% 24% 29% 53% 12 42% 33% 42% 75%

*Preliminary -pending final CSR (Clinical Study Report)
C-MNA: Microneedle device-only control arm, D-MNA: Doxorubicin-loaded microneedle array n:number of patients, CC: Clinical Clearance, CR: Histological Clearance, PR: Partial Response, ORR: Overall Response Rate

The Company will also highlight:

Continued improvement from Day 29 to Day 57, supporting a durable and evolving treatment effect
Evidence of biological activity across responders and partial responders
CEO Strategic and Clinical Positioning — Dr. Raza Bokhari

Dr. Raza Bokhari, Chairman and Chief Executive Officer, is expected to outline:

That the Phase 2 study was a proof-of-concept study "exploratory" study primarily designed to evaluate clinical (visual) clearance, with the objective of addressing a large unmet need and helping relieve the treatment backlog in basal cell carcinoma.
That refinement of histological clearance endpoints is expected to be a focus of registrational study design discussions at the planned End-of-Phase 2 (EOP2) meeting with the FDA
The Company’s view that the dataset is decision-grade and supports regulatory and business partnership engagement
He is also expected to discuss:

Optimization strategies focused on the 200µg dose
Treatment duration and repeat dosing strategies
And position the broader opportunity:

Addressing a large and underserved BCC patient population
Positioning SkinJect as a minimally invasive alternative to surgery
Expansion into Gorlin Syndrome and additional indications
Advancing Toward Agentic AI–Enabled Drug Development

The Company is expected to highlight its planning toward an Agentic AI–driven clinical development platform

Designed to:

Optimize clinical trial design and protocol simulation
Enable dynamic site selection and enrollment forecasting
Improve patient stratification and dose optimization
Increase capital efficiency and probability of success
Financial Position and Capital Strategy — Carolyn Bonner, CFO

Carolyn Bonner, President and Chief Financial Officer, is expected to provide an update on:

Approximately $31.9 million raised during 2025
$8.7 million in cash and cash equivalents at year-end 2025
Continued disciplined investment in clinical development
She is expected to emphasize alignment of capital strategy with key upcoming value inflection points, including:

Regulatory engagement
Clinical data maturation
Strategic partnering opportunities
Position Entering a Catalyst-Rich 2026

The Company believes it is entering a catalyst-rich period, including:

End-of-Phase 2 FDA meeting (SkinJect)
Potential registrational pathway alignment
Initiation of Phase 2b Teverelix study
Expansion into women’s health (endometriosis)
Advancement of AI-enabled development platform
Ongoing strategic partnering discussions

(Press release, Skinject, MAR 26, 2026, View Source [SID1234663964])

On March 26, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, reported that it will host a virtual R&D Day Event on Tuesday, April 7, 2026 at 10:00 AM EDT.

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The virtual event will feature Richard DiPaolo, PhD (Saint Louis University) and Jonathan Kay, MD, FACP, MACR (UMass Chan Medical School, Worcester, Massachusetts), who will join company management to discuss CUE-401, the company’s lead asset designed to act mechanistically both as a regulator of proinflammatory mechanisms and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance in autoimmune and inflammatory diseases.

A live question and answer session will follow the formal presentations. In addition, a live and archived webcast of the event will be available in the News and Publications section of the Company’s website. The webcast will be archived for 30 days.

About Richard DiPaolo, PhD
Richard DiPaolo, PhD currently serves as Full Professor and Chair of the Department of Molecular Microbiology & Immunology at Saint Louis University. Dr. DiPaolo leads a successful and well-funded research program focused on inflammation and immune regulation in the contexts of autoimmunity, infection, and cancer. He completed his postdoctoral fellowship with Dr. Ethan Shevach in the Cellular Immunology Section of the NIAID/NIH, where he made significant contributions to the field of regulatory T cells (Tregs). Notably, Dr. DiPaolo was among the first to define the in vivo immunosuppressive functions of Tregs in autoimmune settings. He also played a pivotal role in early studies demonstrating the induction of FOXP3⁺ Tregs in vitro through activation of naïve T cells in the presence of TGF-β and IL-2, as well as their application in cell-based immunotherapies to suppress autoimmunity. Dr. DiPaolo earned his B.A. from the University of Chicago, where he spent four years in the laboratory of Dr. Jeffrey Bluestone studying T cell activation and costimulation. He went on to receive his Ph.D. from Washington University in St. Louis under the mentorship of Dr. Emil Unanue, making key discoveries related to antigen presentation and CD4⁺ T cell responses in the context of immunization and autoimmunity.

About Jonathan Kay, MD, FACP, MACR
Jonathan Kay, MD, FACP, MACR is Professor of Medicine and Population and Quantitative Health Sciences and holds the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the UMass Chan Medical School in Worcester and is Executive Co-Director of the Medical Scientist Training Program (MSTP)-funded MD/PhD Program. His clinical appointment is as a Physician at UMass Memorial Medical Center, also in Worcester. He received his medical degree from the University of California School of Medicine in San Francisco, California. He then completed an internship and residency at the Hospital of the University of Pennsylvania in Philadelphia and fellowships in rheumatology and immunology at the Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts. Dr. Kay is a Fellow of the American College of Physicians. In 2018, he received the Distinguished Service Award from the American College of Rheumatology, and he was awarded honorary membership in EULAR. In 2023, he was awarded the distinction of Master by the American College of Rheumatology. He is an ad hoc reviewer for many journals. Dr. Kay’s clinical interests span the spectrum of rheumatic diseases, with special interest in rheumatoid arthritis, spondyloarthropathies, and other forms of inflammatory arthritis. He was a member of the group that developed the 2010 ACR/EULAR Diagnostic and Classification Criteria for Rheumatoid Arthritis. He chaired the Rheumatology Working Group and was a member of the Internal Medicine and Musculoskeletal Topic Advisory Groups for the World Health Organization in its Revision of the International Classification of Diseases (ICD)-11. Over the past three decades, his clinical research has focused on clinical aspects of inflammatory arthritis and on nephrogenic systemic fibrosis (formerly known as nephrogenic fibrosing dermopathy), β2-microglobulin amyloidosis, and other rheumatologic problems of patients with chronic kidney disease. Over the past 15 years, he also has been involved in the development of biosimilars to treat rheumatic diseases. Dr. Kay has been a principal investigator on over 70 clinical trials of novel therapies for rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, gout, and osteoarthritis. He lectures internationally and is the author of more than 220 publications and book chapters.

(Press release, Cue Biopharma, MAR 26, 2026, View Source [SID1234663963])

On March 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the Company has achieved a key milestone in its ongoing Phase III TIGeR‑PaC clinical trial by surpassing 100 randomized patients and remains on track for enrollment completion in the first half of 2026, with final data expected in 2027.

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"Reaching over 100 randomized patients marks an important milestone in our Phase III trial as we maintain strong momentum toward enrollment completion. We remain committed to completing the TIGeR-PaC trial and delivering final data in 2027," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "In parallel, select TIGeR-PaC cancer centers have begun using the TAMP therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors."

RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) is being evaluated in the TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. TIGeR-PaC is evaluating IAG in locally advanced pancreatic cancer, and its potential to minimize a therapy’s toxicities versus systemic intravenous therapy.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the end of the first half of 2026, ensuring a minimum of 114 patients will be randomized.

The first and second pre-planned interim analyses were conducted per protocol specifications and triggered upon the 26th event (2023) and the 52nd event (2025), respectively. In both the first and second interim analyses, the independent data monitoring committee (DMC) for the trial recommended that RenovoRx continue with the trial, based on its review of the data.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, MAR 26, 2026, View Source [SID1234663962])