On May 7, 2026 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the first quarter 2026.

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"I am pleased to continue building on our progress made so far in 2026," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Receiving Fast Track Designation is confirmation that an unmet medical need exists in chronic HBV infection and pevifoscorvir sodium has the potential to be superior to current therapies based on clinical data to date, which was evaluated by the FDA when determining the granting of this designation. In addition, we completed the first interim analysis for the B-SUPREME HBeAg- cohort with a positive outcome reflecting that the study will continue, the futility criteria were not met, and study drugs were well tolerated. The recommendation from the DSMB to increase participants has the potential to increase the probability of success of the B-SUPREME study. It is important to note, that prior to the B-SUPREME study there has not been a randomized controlled study of treatment naïve chronic HBV infection participants using tenofovir disoproxil fumarate (TDF) as the active comparator to measure HBV DNA response with the most sensitive PCR assay currently available (LLOQ <10 IU/mL). Also, we are pleased to build on our existing relationship with Amoytop with the partnership of pevifoscorvir sodium in Greater China which can potentially accelerate approval in the region. Taken together, this progress demonstrates how our team has continued to execute on our goals. As we look forward to the back half of the year, I am excited for our continued developments as we progress pevifoscorvir sodium and our other drug candidates. In particular, I look forward to providing updates on our potentially best-in-class ASO for chronic HBV infection, which is moving nicely through IND-enabling studies."

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

Pevifoscorvir sodium was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for chronic hepatitis B virus (HBV) infection.
The Phase 2 B-SUPREME study (NCT06963710) is currently ongoing. As of April 2026, there were 74 participants enrolled in the HBeAg- cohort (Part 2a), with 103 participants enrolled in the HBeAg+ cohort (Part 1a).
The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary endpoint. The first pre-specified interim analysis of the Phase 2 B-SUPREME study was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed. Findings from the first interim analysis include:
The Drug Safety Monitoring Board (DSMB) recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria were not met, per the statistical analysis plan.
The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date.
A second protocol defined interim analysis is planned when ~50% of HBeAg+ participants complete 24 weeks of the treatment period, with this enrollment threshold previously reached in January 2026. The second interim analysis is expected in the second half of 2026.
Topline data for both the HBeAg- and HBeAg+ cohorts are expected in 2027.
96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) with long-term post-treatment data expected to be presented at the upcoming European Association for the Study of the Liver (EASL) 2026 Congress.
The Company entered into an exclusive license deal with Xiamen Amoytop Biotech Co., Ltd. (Amoytop) to develop and commercialize pevifoscorvir sodium in Greater China for chronic HBV infection. Along with a $25M USD upfront, Aligos is entitled to up to $420M USD in clinical, regulatory, and sales milestones with tiered, high single-digit royalties.

ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

Along with our partner Amoytop, ALG-170675 has begun IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in Greater China.
This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg-encoding mRNA and activates the immune response through TLR-8 agonism.
ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

Additional nonclinical data demonstrating the potential synergies of ALG-055009 and incretin receptor agonists are expected to be presented at upcoming scientific conferences.
Evaluation of a variety of options to fund continued development, including potential out-licensing, is ongoing.
Financial Results for the Three Months Ended March 31, 2026

Cash, cash equivalents and investments totaled $54.9 million as of March 31, 2026, compared with $77.8 million as of December 31, 2025. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the fourth quarter of 2026, inclusive of the $25M upfront expected from the Amoytop Greater China License deal for pevifoscorvir sodium.

Net loss for the three months ended March 31, 2026 was $23.0 million or basic and diluted net loss per common share of $(2.21), compared to net income of $43.1 million or basic net income per common share of $5.12, and diluted net loss per common share of $(2.11) for the three months ended March 31, 2025.

Research and development (R&D) expenses for the three months ended March 31, 2026 were $23.4 million, compared with $14.5 million for the same period of 2025. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2026 was $0.7 million, compared with $0.5 million for the same period of 2025.

General and administrative (G&A) expenses for the three months ended March 31, 2026 were $6.4 million, compared with $5.1 million for the same period of 2025. The decrease in G&A expenses for this comparative period is primarily due to a decrease in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2026 was $0.6 million, compared with $0.4 million for the same period of 2025.

Interest and other income, net, was income of $0.8 million for the three months ended March 31, 2026 compared with income of $0.9 million for the same period in 2025.

Change in fair value of 2023 common warrants for the three months ended March 31, 2026, was income of $3.4 million compared with income of $61.5 million for the same period of 2025.

(Press release, Aligos Therapeutics, MAY 7, 2026, View Source [SID1234665299])

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])