On May 7, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT Hepatic Delivery System was presented today at the ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026.

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Presentation details

Congress: ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026
Date: May 7, 2026
Session: 13:15 (local congress time)
Format: E-poster
Title: Safety and Feasibility of Percutaneous Hepatic Perfusion with Melphalan in Patients with Liver-Dominant Metastatic Breast Cancer
Presenter: Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School)
Abstract number: 574eP
Background

Liver-dominant metastatic breast cancer remains a significant clinical challenge, as progression in the liver can be a major driver of morbidity and may limit the effectiveness of systemic therapies. M-PHP is a liver-directed procedure designed to deliver high-dose melphalan to the liver while reducing systemic exposure through extracorporeal hemofiltration.

About the analysis

Independent investigators at three European centers retrospectively identified 15 patients with liver-dominant metastatic breast cancer treated with M-PHP (CHEMOSAT) at three European centers. The analysis evaluated feasibility, safety, and tumor response per RECIST v1.1.

Key findings (retrospective cohort; N=15)

Patient population: Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1–6).
Treatment delivery: Patients received a median of 1 M-PHP cycle (range 1–7), typically followed by ICU admission of 1–2 days.
Safety: 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3–4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days.
Liver response: Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response.
Overall survival: Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9–NR; range 0.1–76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7–NR).
"These data from independent European investigators represent real-world evidence supporting the use of HEPZATO KIT and CHEMOSAT in liver-dominant metastatic breast cancer and underscore the need for further evaluation in this heavily pretreated population," said Gerard Michel, Chief Executive Officer of Delcath Systems.

HEPZATO KIT is currently being evaluated in a randomized Phase 2 trial in metastatic breast cancer patients with liver dominant disease (PHP-MBC-202; ClinicalTrials.gov identifier NCT06875128).

(Press release, Delcath Systems, MAY 7, 2026, View Source [SID1234665320])

On May 7, 2026 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2026.

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Cash and investments in marketable securities on March 31, 2026, were $731.6 million as compared to $245.8 million on December 31, 2025. Nektar’s cash and marketable securities at March 31, 2026, exclude net proceeds of approximately $351 million from the secondary offering completed by the Company on April 23, 2026.

"2026 is shaping up to be a defining year for Nektar and for our lead biologic candidate rezpegaldesleukin," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We have now shown that longer-term treatment with rezpegaldesleukin continues to deepen clinical responses in two distinct immune-mediated diseases, reinforcing our belief that this novel Treg mechanism can transform the treatment paradigm for autoimmune disease. The Phase 3 ZENITH-AD program in atopic dermatitis will initiate by July, and we will have our End-of-Phase 2 meeting for alopecia areata this quarter. With a substantially strengthened balance sheet and over one billion dollars in cash and investments, we are well positioned to advance rezpegaldesleukin into late-stage development with strong scientific and clinical conviction."

Revenue in the first quarter of 2026 was $10.9 million as compared to $10.5 million in the first quarter of 2025.

Total operating costs and expenses in the first quarter of 2026 were $49.9 million as compared to $55.0 million in the first quarter of 2025. Operating expenses decreased due to a decrease in G&A expenses, partially offset by an increase in R&D expenses.

R&D expense in the first quarter of 2026 was $35.7 million as compared to $30.5 million for the first quarter of 2025. R&D expense increased primarily due to increased expenses for the development of rezpegaldesleukin as we commenced activities to support a Phase 3 program in atopic dermatitis.

G&A expense was $13.4 million in the first quarter of 2026 as compared to $24.3 million in the first quarter of 2025. G&A expense decreased primarily due to a decrease in legal expenses.

Our non-cash loss from our equity method investment in Gannet BioChem was $1.8 million in the first quarter of 2026, as compared to $4.5 million in the first quarter of 2025.

Net loss for the first quarter of 2026 was $44.9 million or $1.82 basic and diluted net loss per share as compared to net loss of $50.9 million or $3.621 basic and diluted loss per share in the first quarter of 2025.

Recent Business Highlights

● In April, Nektar closed a successful underwritten public offering of $373.8 million of shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of common stock.

● In April, Nektar announced topline results from the 16-week blinded treatment extension of REZOLVE-AA, demonstrating deepening of responses in severe-to-very-severe alopecia areata at 52 weeks.

● In March, Nektar presented data from the Phase 2b REZOLVE-AD and REZOLVE-AA studies of rezpegaldesleukin at the 2026 American Academy of Dermatology Annual Meeting.

● In February, Nektar established a Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a tumor necrosis factor receptor 2 (TNFR2) antibody, in multiple sclerosis.

● In February, Nektar closed a successful public offering of its common stock, including the full exercise of underwriters’ option to purchase additional shares, raising $460 million in gross proceeds.

● In February, Nektar presented new maintenance data from the REZOLVE-AD Phase 2b Study in atopic dermatitis, demonstrating durable and new responses with rezpegaldesleukin across key disease measurements with both monthly and quarterly dosing.

Upcoming Milestones

● Initiation of ZENITH-AD Phase 3 program of rezpegaldesleukin in moderate-to-severe atopic dermatitis by July 2026

● End-of-Phase 2 Meeting with FDA to align on Phase 3 program in alopecia areata in Q2 2026

● 24-week data from REZOLVE-AA off-treatment observation period in Q4 2026

● 52-week data from REZOLVE-AD off-treatment observation period in Q1 2027

● Initial data from TrialNet sponsored Phase 2 study in Type 1 Diabetes in 2027

● Preclinical data presentation from the NKTR-0165 (TNFR2 agonist antibody) program at a scientific conference in H2 2026

Conference Call to Discuss First Quarter 2026 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on May 7, 2026.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 7, 2026.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, MAY 7, 2026, View Source [SID1234665336])

On May 7, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported the Company entered into a global collaboration and license agreement with GSK. Under the collaboration, GSK has licensed Halozyme’s ENHANZE drug delivery technology for the development and potential commercialization of subcutaneous administration of multiple oncology targets, including antibody drug conjugates (ADCs), as well as an option for additional future drug targets.

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"We are excited to work with GSK to advance development of several oncology therapeutics. This agreement also marks our first collaboration on subcutaneous delivery of ADCs, where we believe subcutaneous delivery with ENHANZE may meaningfully improve the benefit–risk profile," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "This collaboration reflects the continued recognition of ENHANZE as the gold standard for rapid, large-volume subcutaneous delivery, and underscores the value it provides to a growing number of leading pharmaceutical and biotechnology companies. Extending use of ENHANZE with ADCs represents a meaningful expansion of our potential addressable market, positions us at the forefront of a rapidly growing therapeutic class and reinforces the durability of our high-margin royalty revenue business."

"Novel approaches are required to reduce treatment burden for patients with cancer and help access easier forms of treatment," said Eric Richards, SVP Head of Medicine Development Leaders Oncology, GSK. "We see significant potential for subcutaneous formulations of several promising cancer targets, including ADCs, with ENHANZE and look forward to progressing the first clinical program."

GSK will make an upfront payment to Halozyme and potential future milestone payments. Halozyme will also be entitled to royalties on net sales of products that incorporate ENHANZE.

(Press release, Halozyme, MAY 7, 2026, View Source [SID1234665354])

On May 7, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in Italy in its feasibility and safety study of intratumoral diffusing alpha-emitter radiation for locally advanced pancreatic cancer (Protocol CTP-PANC-03). The procedure was performed at the Azienda Ospedaliera Universitaria Integrata di Verona by a multidisciplinary team of the Pancreas Institute, led by Pr. Salvatore Paiella, MD, PhD, principal investigator of the trial and Associate Professor of General Surgery at the University of Verona.

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Pancreatic cancer remains one of the most lethal malignancies in Italy. The 2024 incidence is nearly evenly distributed between men (6,873 cases) and women (6,712 cases), with national five-year net survival of just 11% in men and 12% in women. Roughly one patient in five is diagnosed when the tumor is still localized and amenable to surgery, meaning approximately 80% present with already advanced disease. Pancreatic ductal adenocarcinoma is the fourth leading cause of cancer-related death in women and the sixth in men in Italy, and approximately 30% of patients present with locally advanced, inoperable disease – the population for whom this study was designed.

By enabling two complementary delivery pathways – endoscopic ultrasound (EUS) and percutaneous – within a single protocol, the study aims to bring interventional radiologists and interventional oncologists into the Alpha DaRT pancreatic treatment paradigm alongside gastroenterologists, endoscopists and surgeons, and to accommodate patients whose tumor location or anatomy is less amenable to EUS access alone.

Uzi Sofer, CEO of Alpha Tau, commented: "The Pancreas Institute in Verona is widely regarded as one of the leading pancreatic cancer centers in the world, and it has been a tremendous privilege to partner with Pr. Paiella and his brilliant team to offer the surgical, scientific, and multidisciplinary approach that this disease demands – a disease in which Italian patients face an exceptionally grim outlook. Just as significant is that this is the first Alpha DaRT protocol to incorporate the percutaneous delivery route. That choice reflects what we call our ‘Innovation in Simplicity’ philosophy at Alpha Tau: rather than asking physicians to learn fundamentally new techniques, our R&D team’s focus is on adapting Alpha DaRT to the workflows that interventional radiologists, interventional oncologists, gastroenterologists, and surgeons already perform every day. Each delivery route we open up means more alternatives for physicians, more capable centers, and ultimately more lives potentially reached."

Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated: "With this study, three complementary Alpha DaRT pancreatic cancer trials are advancing simultaneously, each designed for a distinct clinical context. Our IMPACT trial in the United States evaluates Alpha DaRT combined with chemotherapy in newly diagnosed unresectable patients, ACAPELLA in France evaluates Alpha DaRT with capecitabine in patients who have completed first-line mFOLFIRINOX, and this study is designed specifically for those who have already received chemotherapy or who are medically unfit for systemic treatment – a real-world population that often has no defined next step – and evaluates Alpha DaRT as a stand-alone local intervention. The protocol’s allowance of percutaneous source placement carries scientific weight beyond physician access: it gives us the opportunity to generate prospective safety, dosimetric, and clinical outcome data on an alternative delivery route that interventional teams already use routinely for pancreatic procedures. Doing this work with the team at the Verona Pancreas Institute, an internationally recognized reference center, gives us confidence in the rigor with which the evidence will be generated."

Pr. Salvatore Paiella, MD, PhD, principal investigator and Associate Professor of General Surgery at the Pancreas Institute, University of Verona, added: "At the Pancreas Institute of the University of Verona, our patients benefit from a genuinely multidisciplinary model in which surgeons, gastroenterologists, endoscopists, oncologists, radiologists, and pathologists operate as a single team, supported by one of the highest pancreatic surgical volumes in Europe and a long-established research program. That clinical foundation is what allows us to undertake a study of this kind with the diligence it requires. From a procedural standpoint, the Alpha DaRT insertion proved straightforward – the sources are placed directly into the tumor through image-guided approaches, in a single session, without the burden of repeated treatments. Being the first center anywhere to evaluate the percutaneous delivery route within an Alpha DaRT protocol is something we take particular pride in. It broadens the eligible patient population beyond cases optimally suited to endoscopic access, and positions us to help define how this therapy is integrated into the wider pancreatic cancer treatment pathway. I am glad to work with Dr. Stefano Francesco Crinò and Prof. Mirko D’Onofrio, who both have extensive experience in interventional procedures in pancreatic tumors."

About the Study

CTP-PANC-03 ("A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer") is a prospective, interventional, open-label, single-arm, single-center clinical study planned to enroll up to 15 patients with locally advanced pancreatic cancer at the Azienda Ospedaliera Universitaria Integrata di Verona, with a planned safety interim analysis after the first 5 patients. Eligible patients must have histologically or cytologically confirmed locally advanced pancreatic cancer, have received at least one line of chemotherapy or be medically unfit for chemotherapy, and have an unresectable tumor of ≤ 5 cm in longest diameter. The primary objective is to evaluate the feasibility and safety of Alpha DaRT source placement; secondary objectives include local control per RECIST v1.1, changes in CA 19-9 biomarker levels, tumor coverage, and adverse event incidence. Exploratory objectives include changes in immune biomarkers (CD3, CD4, CD8, CD69, CD137) following treatment. Per protocol, Alpha DaRT sources may be delivered using either endoscopic ultrasound guidance or a percutaneous approach.

(Press release, Alpha Tau Medical, MAY 7, 2026, View Source [SID1234665300])

On May 7, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the first quarter ended March 31, 2026.

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First Quarter 2026 Financial Results

Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025
HEPZATO KIT revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025
CHEMOSAT revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025
Gross margins of 85%, compared to 86% in the first quarter of 2025
Net loss of $1.1 million, compared to a net income of $1.1 million in the first quarter of 2025
Non-GAAP adjusted EBITDA of $3.4 million, compared to $7.6 million in the first quarter of 2025
Cash provided by operations of $0.9 million in the quarter; compared to $2.2 million provided by operations in the first quarter of 2025
Repurchased 316,023 common shares for proceeds of approximately $3.0 million in the first quarter of 2026 under the approved $25 million Share Buyback Program
Cash and investments of $89.3 million as of March 31, 2026
Business Highlights

Currently 29 active centers
Approximately 36% growth in HEPZATO volume in the first quarter 2026 compared to the first quarter 2025
Announced the publication of full results from the investigator-initiated CHOPIN randomized Phase 2 trial in The Lancet Oncology, demonstrating that adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival in metastatic uveal melanoma.
Announced that CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO (Free ESMO Whitepaper)–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026)
"We delivered a strong first quarter, marked by 20% volume growth over the prior quarter and a strong increase in new patient starts," said Gerard Michel, Chief Executive Officer. "The recent publication of the full CHOPIN results in The Lancet Oncology is already having a meaningful impact on prescribing patterns, further validating HEPZATO KIT and positioning us for continued momentum and long-term value for patients and shareholders alike."

2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:

Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025
Gross margins in the range of 84% to 87%
Positive adjusted EBITDA
First Quarter 2026 Results
Total revenue for the quarter ending March 31, 2026, was $25.0 million compared to $19.8 million for the same period in the prior year. Revenue in the quarter includes sales of $23.3 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending March 31, 2026, were $9.8 million compared to $5.0 million for the same period in the prior year. The increase is primarily due to the continued costs associated with expanding the clinical team, including the share-based compensation expense related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO.

Selling, general and administrative expenses for the quarter ended March 31, 2026, were $13.1 million compared to $11.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net loss for the quarter ended March 31, 2026, was $1.1 million compared to net income of $1.1 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2026 was $3.4 million compared to adjusted EBITDA of $7.6 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2026, the Company had $89.3 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, May 7, 2026
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-800-717-1738
International: 1-646-307-1865
Webcast: View Source;tp_key=463dd4d428

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, MAY 7, 2026, View Source [SID1234665321])