On May 14, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a new initiative with Bristol Myers Squibb (NYSE: BMY). This collaboration aims to leverage AI, multimodal real-world data and data science techniques to optimize clinical trial designs and enhance the Probability of Technical & Regulatory Success (PTRS) across five initial clinical trial programs.

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!

With Lens, Tempus’ AI-enabled analytical platform, BMS and Tempus are applying insights from a vast library of de-identified multimodal records to optimize clinical research and strengthen PTRS across BMS’ development portfolio. This collaboration combines unprecedented scale of real-world data with emerging AI-techniques to pressure test assumptions, characterize complex patient populations, validate control group assumptions, and pinpoint the optimal patient segments most likely to benefit from investigational therapies.

This new initiative is supporting key assets in solid tumor oncology, including lung, colon, and prostate cancers. Beyond oncology, the collaboration extends into neuroscience to accelerate drug development in Alzheimer’s Disease, demonstrating the versatility of the Tempus multimodal database across multiple therapeutic areas.

"Our collaboration with BMS aims to optimize clinical development by peering deeper into patient biology than ever before," said Ryan Fukushima, CEO of Data and Apps at Tempus. "Our multimodal data library allows us to connect the dots between clinical records and molecular subtypes. Together, we are doing more than just generating insights. We are uncovering the hidden biological signals of unmet patient need, which allows us to assess trial assumptions and stratify patient groups with unprecedented precision. We are moving past traditional approaches and creating a new level of data-driven confidence in the drug development process."

"This collaboration is about improving the quality of decisions we make in development, where the impact is greatest," said Bryan Campbell, Senior Vice President, Drug Development Strategy & Innovation at Bristol Myers Squibb. "By combining Tempus’ multimodal real-world data capabilities with our development expertise, we can rigorously pressure-test trial assumptions, better understand patient heterogeneity, and design studies with a higher probability of technical and regulatory success. This is a critical step toward more disciplined, data-driven development with the goal of bringing life-changing medicines to patients faster."

This initiative builds upon the existing work between Tempus and BMS, which includes the deployment of the Next Pathways program across 13 community-based health systems to address care gaps for patients with advanced non-small cell lung cancer (aNSCLC).

(Press release, Tempus, MAY 14, 2026, View Source [SID1234665737])

On May 14, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that Professor Casper H.J. van Eijck, MD, PhD, Professor and Pancreato-biliary Surgeon at Erasmus Medical Center ("Erasmus MC") and a consultant for AIM, and AIM Chief Executive Officer Thomas K. Equels, MS, JD, participated in a Virtual Investor KOL Connect segment.

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!

The on-demand segment provides investors with an in-depth discussion on AIM’s substantial progress and strategic focus to advance Ampligen (rintatolimod) for the treatment of late-stage pancreatic cancer, a lethal malignancy with a significant unmet medical need.

The Virtual Investor KOL Connect Segment can be accessed here.

Through these insights from Prof. Dr. van Eijck, a globally recognized pancreatic cancer clinical expert and the foremost expert in the use of Ampligen in pancreatic cancer, the segment examines Ampligen’s mechanism of action, its potential to provide a positive immunotherapeutic approach, existing clinical data, development strategy, and anticipated regulatory milestones, supporting AIM’s focused commitment to advancing a potential new treatment option for patients with late-stage pancreatic cancer.

Developing Ampligen in the Treatment of Pancreatic Cancer

The Company has previously reported positive interim progress in both Mid-Year 2025 and Year-End 2025 reports on the ongoing Phase 2 clinical study evaluating Ampligen in collaboration with AstraZeneca and its anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients post-FOLFIRINOX standard of care (the "DURIPANC" study). A Mid-Year 2026 report, completion of enrollment and milestones are expected this June, 2026.

See more information about DURIPANC at ClinicalTrials.gov NCT05927142.

DURIPANC is a follow-up to the AIM/Erasmus MC Named Patient Program ("NPP") utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival data:

Progression-Free Survival ("PFS") of 12.6 months compared to 8.6 months for historical controls, for an improvement of 4 months in PFS
Overall Survival ("OS") of 19.7 months compared to 12.5 months for historical controls, for an improvement of 7.2 months in OS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, PFS of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, OS of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in OS
Based upon stratification for immune marker CA 19-9 less than 1000, PFS of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in PFS
Based upon stratification for immune marker CA 19-9 less than 1000, OS of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in OS
Clinical experience to date in both the NPP and DURIPANC suggest consistent improvement in Quality of Life
See more information in slides 12-14 in Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer

Ampligen’s progress in late-stage pancreatic cancer at Erasmus MC has been published in peer-reviewed oncology journals:

Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses (2024)
Rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3 (2023)
Rintatolimod (Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program (2022)
Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients? (2021)

(Press release, AIM ImmunoTech, MAY 14, 2026, View Source [SID1234665695])

On May 14, 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 its financial results for the first quarter ended March 31, 2026, and is providing shareholders with 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!

"We made important strides in the first quarter of 2026 with strong commercial adoption of the TAMP platform enabled by RenovoCath, resulting in record quarterly revenue exceeding 50% of the revenue we generated in all of 2025," said Shaun Bagai, Chief Executive Officer of RenovoRx. "We generated Q1 revenue of $563,000, an increase of 136% compared to the fourth quarter of 2025, mainly driven by the growing number of active cancer centers and rising procedural utilization across our existing customer base. Additionally, we ended the quarter with $12.4 million in cash, which, we believe, is sufficient to fund our operations into at least the second half of 2027. With a solid sales pipeline, we are confident in sustaining growth as our business scales."

"Our commercial momentum is being driven by our focused and scalable expansion strategy into cancer centers," continued Mr. Bagai. "We have grown from 5 active commercial cancer center customers at the beginning of 2025 to 16 today, with 32 additional centers progressing through stages of evaluation, approval, and onboarding. Notably, we are seeing meaningful repeat utilization across our existing centers, which we believe reflects growing physician confidence and clinical utility. As we expand our footprint and deepen utilization, we believe that RenovoRx is building a durable commercial foundation with the potential for predictable, recurring revenue growth."

"Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives," added Mr. Bagai. "We expect continued revenue growth throughout 2026, supported by ongoing cancer center activations and continued transition of Phase III TIGeR-PaC trial sites into commercial centers after full enrollment is complete. At the same time, TIGeR-PaC remains on track for complete enrollment in June 2026, reinforcing the strength of our dual-track strategy. With a strengthened balance sheet and growing commercial traction, we believe RenovoRx is well positioned to deliver meaningful value creation in the quarters ahead and continue to expand access to life-changing care for patients battling difficult-to-treat cancers."

RenovoCath Commercialization Update

RenovoRx saw further acceleration in the commercial rollout of RenovoCath during the first quarter of 2026, achieving its strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase compared to the fourth quarter of 2025 and totaling more than 50% of the Company’s total revenue generated in 2025. This significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across the Company’s installed base. The Company defines "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

RenovoRx’s commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. RenovoRx began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026 we had 16 active centers. RenovoRx is also advancing a robust pipeline of 32 additional centers in various stages of evaluation, approval, and onboarding, representing a significant expansion of its near-term commercial footprint. In total, these 48 centers have approximately quadrupled the Company’s near-term commercial sales pipeline compared to the first quarter of 2025, reflecting the rapid expansion of RenovoRx’s commercial footprint year-over-year. Up to 15 TIGeR-PaC Phase III clinical trial sites that have previously utilized RenovoCath are expected to continue transitioning to commercial clinical use following completion of trial enrollment. These anticipated conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026. The Company continues to target 36 active commercial cancer centers by year-end 2026.

RenovoRx continues to observe organic repeat ordering behavior from existing customers, which the Company views as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs
Advancement of the ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC) continued in the first quarter of 2026. Based on current projections, RenovoRx expects to send notification of closure of enrollment in the trial in the beginning of June, completing the Company’s milestone of finishing trial enrollment by the end of June 2026. As of May 14, 2026, 106 patients had been randomized in the trial, representing approximately 93% of the required 114 patients, and currently there are 12 enrolled patients in induction, which gives rise to the expectation that enrollment will be closed by the end of June. Seventy-four events (i.e., patient deaths) have been observed of the 86 events required to trigger the final analysis. The Company continues to anticipate final data in mid to late 2027.

During the first quarter of 2026, RenovoRx continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across its clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, the Company has elected to defer publication of interim data until study completion.

RenovoRx expects that TIGeR-PaC trial sites will continue transitioning to commercial use following completion of enrollment, representing a meaningful potential driver of revenue growth in the second half of 2026. RenovoRx continues to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline.

RenovoRx continues to advance broader clinical programs by generating new data through the Company’s continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath.

In terms of scientific data, in January 2026, a pharmacokinetic subset study of the TIGeR-PaC trial was presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium by a TIGeR-PaC Investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of the TAMP therapy platform in LAPC. The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. A full paper is submitted for publication later this year.

First Quarter 2026 and Subsequent Key Highlights
RenovoRx continued to execute on its dual clinical and commercial strategy during the first quarter of 2026, leveraging the operational foundation established in 2025 to drive measurable commercial progress. The Company’s lean commercial infrastructure is now actively supporting cancer center expansion and revenue growth, while physician-to-physician advocacy and real-world clinical experience continue to drive adoption.

Since receiving FDA 510(k) clearance in 2014, RenovoCath has been used in 750 successful procedures, underscoring the device’s growing clinical utility and physician acceptance. The Company was also bestowed with external recognition for its innovation, being named one of Fast Company’s "World’s Most Innovative Companies of 2026," in the Medical Devices category.

During the first quarter of 2026, RenovoRx strengthened its balance sheet through the successful completion of an oversubscribed private placement, generating approximately $10 million in gross proceeds. The financing reflects strong institutional investor demand and supports the Company’s ongoing clinical development and commercial expansion initiatives. Proceeds are expected to be used for working capital and general corporate purposes, providing additional flexibility as RenovoRx continues to scale its operations and advance its growth strategy.

Financial Highlights for the First Quarter Ended March 31, 2026

●
Revenue for the three months ended March 31, 2026 was $563,000, compared to $197,000, year-over-year. The increase was driven by acceleration in the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.
●
Research and development expenses were approximately $1.2 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year. The decrease was primarily driven by higher receipts received from the TIGeR-PaC clinical trial.
●
Selling, general and administrative expenses were approximately $2.7 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year, a reflection of the Company’s continued execution on its commercial infrastructure strategy.
●
Net loss for the quarter ended March 31, 2026 was approximately $3.5 million, compared to approximately $2.4 million for the quarter ended March 31, 2025.
●
Cash and cash equivalents were approximately $12.4 million as of March 31, 2026. During the first quarter, the Company strengthened its balance sheet with approximately $10 million in gross proceeds from a March 2026 private placement financing. The Company believes its current cash resources are sufficient to fund operations into at least the second half of 2027.
●
Shares Outstanding: As of March 31, 2026, common shares outstanding totaled 45.05 million.
●
Guidance: Reiterating full year 2026 revenue guidance of $3 to $4 million.

Conference Call Details
Event: RenovoRx First Quarter 2026 Financial Results and Business Highlights Call

Date: Thursday, May 14, 2026

Time: 4:30 P.M. ET

Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)

Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until May 28, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13760238.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAY 14, 2026, View Source [SID1234665712])

On May 14, 2026 Ontada, a McKesson business dedicated to real-world oncology data and insights, reported that it will present new real‑world research and introduce ON.Journey, a new oncology data solution, at ISPOR 2026.

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!

To continue advancing impactful real-world oncology research, Ontada is launching ON.Journey, a new portfolio of off-the-shelf, longitudinal oncology datasets. Built using oncology-specific artificial intelligence and natural language processing applied to structured and unstructured clinical data from Ontada’s proprietary dataset of electronic medical records from community oncology practices, ON.Journey enables medical affairs, health economics and outcomes research (HEOR), epidemiology, and real-world evidence teams to generate rich clinical insights with speed. With claims data natively integrated, ON.Journey allows teams to analyze treatment utilization alongside clinical outcomes—without the need for custom integration or third-party linkage.

"ON.Journey reflects our focus on delivering data solutions that help life sciences teams generate evidence with greater speed and consistency," said Christine Davis, president of Ontada. "It enables access to research-grade oncology data, supporting evolving needs across the lifecycle."

Ontada will present 12 posters at ISPOR 2026, including four that examine real-world treatment adoption, outcomes and patterns of care across community oncology populations.

"Real‑world evidence provides important insight into how cancer care is delivered," said Jessica K. Paulus, ScD, vice president, Real-World Research for Ontada. "The studies presented at ISPOR reflect our commitment to using high‑quality community oncology data to inform evidence generation and deepen understanding of care delivered in real world clinical practice settings."

Highlights of Ontada’s presence at ISPOR include:

1. Poster #HSD11: Improving Real-World Adoption of HER2-Low Therapies Through Targeted Educational Initiatives

Monday, May 18, 10:30 a.m. – 1:30 p.m. EDT
This observational study and educational initiative evaluates the use of evidence‑based educational outreach in supporting adoption of updated treatment guidelines for HER2‑low therapies.
2. Poster #MSR66: Integrating Generative Artificial Intelligence (AI) into Biostatistical Workflows for Trial Emulation: A Framework to Accelerate Real-World Evidence Generation

Monday, May 18, 4:00 p.m. – 7:00 p.m. EDT
This research outlines a framework for applying generative AI to trial‑emulation workflows to support more scalable and reproducible real‑world evidence generation.
3. Poster # RWD54: Evolution of Homologous Recombination Repair (HRR) Genetic Testing by Race Among Patients with Metastatic Prostate Cancer (mPC) in a Large Community Oncology Setting in the US, 2015 – 2024

Monday, May 18, 4:00 p.m. – 7:00 p.m. EDT
This retrospective, observational analysis uses structured electronic health record data to describe HRR genetic testing patterns by race among patients with metastatic prostate cancer.
4. Poster # HSD112: Real-World Patterns of Homologous Recombination Repair Testing of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) in the US Community Oncology Setting

Wednesday, May 20, 9:00 a.m. – 11:30 a.m. EDT
This retrospective, observational cohort study examines real-world patterns of HRR genetic testing among patients, highlighting gaps in testing during earlier stages of advanced disease.
Visit the Ontada Booth (#410) at the Pennsylvania Convention Center from May 18-20 to learn more about ON.Journey and Ontada research and data capabilities.

(Press release, Ontada, MAY 14, 2026, View Source [SID1234665738])

On May 14, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported its operational and financial results for the first quarter ended March 31, 2026.

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!

"In the first quarter, Autolus continued to expand market share for AUCATZYL in the US based on strong physician experience in adult ALL, and supported by reliable, high-quality product delivery. Our UK launch, which began in January, is off to a strong start, and we are expanding our reach in this market as well. We are pleased to report a turn to positive gross margin in the first quarter, and we expect continued improvement as we grow sales and manage costs," said Dr. Christian Itin, Chief Executive Officer of Autolus.

Dr. Itin continued, "Beyond adult ALL, given obe-cel’s established profile, we remain focused on broadening obe-cel’s utility in additional indications. Our Phase 2 pivotal studies, CATULUS in pediatric relapsed or refractory B-cell precursor ALL and LUMINA in severe lupus nephritis patients, and our Phase 1 BOBCAT trial in progressive MS, are underway and progressing well."

Dr. Itin concluded, "With good momentum with AUCATZYL and our pipeline, we continue optimizing our operating model and driving cost efficiency. The recently announced initiative will further enhance our margins, support scalable growth and position Autolus for long-term value creation."

Product and Pipeline Updates:

AUCATZYL Launch
Autolus reported net product revenue of $26.2 million for the three months ended March 31, 2026, compared to $9.0 million for the same period the prior year.
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 covering commercial patients during the first year of launch of AUCATZYL in the US was presented at the TANDEM meeting in February 2026. This real-world data showed consistency in both safety and efficacy with the pivotal FELIX clinical trial that was the basis for regulatory approvals. The ROCCA consortium registry covered approximately 60% of US commercial patients at a data cutoff of January 2026.
Obe-cel in pediatric r/r B-ALL
The Phase 2 portion of the ongoing CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (B-ALL) patients is underway and Autolus expects to report data at the end of 2027. The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL.
Obe-cel in lupus nephritis
Data from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus supported progression of obe-cel as a treatment for lupus nephritis (LN) and selection of the recommended Phase 2 dose of 50 million cells. Following alignment with the FDA on a potential registrational path to approval, the pivotal LUMINA Phase 2 trial is enrolling and the Company expects to report data in 2028.
Obe-cel in progressive MS
Autolus has advanced obe-cel into initial clinical development to explore treatment in progressive MS. The Phase 1 trial, expected to include up to 18 adult patients, is enrolling and 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 Light-Chain Amyloidosis
The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026.
Operational Updates:

In April 2026, Autolus announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this initiative, Autolus is implementing a reduction in force affecting approximately 13% of its existing overall workforce, impacting all areas of the business. The actions are expected to reduce operating expenses by approximately $15 million on an annualized basis beginning in 2027. As a result of the reorganization, which includes employee-related actions taken beginning in the second half of 2025, the Company expects to incur total restructuring charges of approximately $8 million, consisting primarily of employee severance and related costs, the majority of which will be recognized in the first half of 2026. The implementation of the workforce reduction plan is expected to be substantially complete by the third quarter of 2026.

In April 2026, the Company held a virtual investor event entitled: Spotlight on Acute Lymphoblastic Leukemia (ALL) Program. The event included key opinion leaders Dr. Jae Park from Memorial Sloan Kettering Cancer Center; Dr. Lori Muffly from Stanford School of Medicine; Dr. Elias Jabbour from MD Anderson Cancer Center and Dr. Michael Pulsipher from University of Utah Huntsman Cancer Institute. A recording of the event is available in the Investor Relations section of the Company’s website, under "Events".

Outlook:

Autolus reiterates its full year 2026 outlook for AUCATZYL net product revenue of between $120 million to $135 million, up from $74 million in 2025, as well as continued 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 in patients with severe refractory systemic lupus erythematosus

By year-end 2026
Initial clinical data from BOBCAT Phase 1 trial in patients with progressive MS By year-end 2026
Initial clinical data from ALARIC Phase 1 trial in patients with light-chain amyloidosis By year-end 2026
Phase 1 full data from BOBCAT trial in patients with progressive MS In 2027
Phase 2 data from CATULUS trial in patients with pediatric r/r B-ALL By year-end 2027
Phase 2 data from LUMINA trial in patients with LN In 2028

Financial Results for the Quarter Ended March 31, 2026

Product revenue, net increased to $26.2 million for the three months ended March 31, 2026, compared to $9.0 million the same period in 2025.

Cost of sales increased to $24.6 million for the three months ended March 31, 2026, compared to $18.0 million the same period in 2025. This increase was primarily due to costs related to increased product sales of AUCATZYL in the three months ended March 31, 2026 including inventory reserves and write offs compared to the same period in the prior year. Gross profit was $1.6 million in the first quarter of 2026, compared to a loss in all prior quarters.

Research and development expenses decreased to $21.2 million for the three months ended March 31, 2026, compared to $26.7 million in the same period in 2025. This change was primarily due to a decrease in research and development activities including clinical trial and clinical manufacturing supply costs.

Selling, general and administrative expenses increased to $39.9 million for the three months ended March 31, 2026, compared to $29.5 million in the same period in 2025. This increase was primarily due to salaries, other employment-related costs and professional fees supporting commercialization activities in the US and UK. In addition, this quarter also included one-time termination-related expenses, relating to the strategic operational efficiency and cost reduction initiative announced in April 2026.

Loss from operations for the three months ended March 31, 2026, was $59.5 million, as compared to $65.2 million for the same period in 2025.

Net loss was $71.6 million for the three months ended March 31, 2026, compared to $70.2 million for the same period in 2025. Basic and diluted net loss per ordinary share for the three months ended March 31, 2026, totaled $(0.27), compared to basic and diluted net loss per ordinary share of $(0.26) for the same period in 2025.

Cash, cash equivalents and marketable securities at March 31, 2026, totaled $229.4 million, as compared to $300.7 million at December 31, 2025. The decrease was primarily driven by net cash used in operating activities.

Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three Months Ended March 31,
2026 2025
Revenue:
Product revenue, net $ 26,218 $ 8,982
Total revenue, net 26,218 8,982
Cost and operating expenses:
Cost of sales (24,568 ) (17,951 )
Research and development expenses, net (21,210 ) (26,734 )
Selling, general and administrative expenses (39,953 ) (29,537 )
Loss from operations (59,513 ) (65,240 )
Total other (expenses) income, net (11,222 ) (2,696 )
Net loss before income tax (70,735 ) (67,936 )
Income tax expense (863 ) (2,225 )
Net loss (71,598 ) (70,161 )
Other comprehensive (loss) income:
Total other comprehensive (loss) income, net of tax (1,271 ) 11,068
Total comprehensive loss $ (72,869 ) $ (59,093 )

Basic and diluted net loss per ordinary share $ (0.27 ) $ (0.26 )
Weighted-average basic and diluted ordinary shares 266,143,425 266,126,548

Financial Results for the Three Months Ended March 31, 2026
Selected Consolidated Balance Sheet Data
(In thousands)

March 31, December 31,
2026 2025
Assets
Cash and cash equivalents $ 130,925 $ 104,132
Marketable securities – Available-for-sale debt securities $ 98,509 $ 196,578
Total current assets $ 368,835 $ 435,915
Total assets $ 527,065 $ 589,068
Liabilities and shareholders’ equity
Total current liabilities $ 63,599 $ 73,440
Total liabilities $ 418,239 $ 410,939
Total shareholders’ equity $ 108,826 $ 178,129

Conference Call

Management will host a conference call and webcast today at 8:30am EDT/1:30pm BST to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source

(Press release, Autolus, MAY 14, 2026, View Source [SID1234665696])