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AMGEN TO PRESENT AT THE BANK OF AMERICA MERRILL LYNCH GLOBAL HEALTHCARE CONFERENCE

On May 7, 2026 Amgen (NASDAQ:AMGN) reported it will present at the Bank of America Merrill Lynch Global Healthcare Conference at 10:00 a.m. PT on Wednesday, May 13, 2026. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, MAY 7, 2026, View Source [SID1234665307])

ALX Oncology’s Evorpacept in Combination with Zanidatamab Generates Promising, Durable Response in Patients with Advanced HER2-Positive Breast Cancer and High CD47 Expression

On May 7, 2026 ALX Oncology Holdings Inc. ("ALX Oncology" Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA) in patients with heavily pre-treated HER2-positive metastatic breast cancer (mBC) were presented for the first time today in a poster session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 congress. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced a promising, durable response.

Specifically, patients in the trial with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) had a confirmed objective response rate (cORR) of 100% (n=5/5), while the cORR was 25% (n=1/4) among those with lower CD47 expression (<20%). Those patients whose tumors expressed higher levels of CD47 also had longer median progression-free survival (mPFS): 22.1 months as compared to 3.4 months in the low-CD47 expression group. The median duration of response (mDOR) among patients whose tumors expressed high levels of CD47 was also notable at 20.2 months.

"There is a large and growing population of patients with advanced breast cancer who need novel treatment options once their disease has progressed following treatment with currently available therapies, including trastuzumab deruxtecan," said Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, who presented the findings today. "Our data suggest that adding evorpacept to HER2-targeted agents may provide one such option, and we may be able to optimize patient selection for these regimens by using a biomarker-driven approach that incorporates CD47."

The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluating evorpacept plus zanidatamab included patients with heavily pre-treated HER2-positive mBC (median of five prior HER2-targeted therapies), all of whom had received prior ENHERTU therapy. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile.

The exploratory analyses comprised 24 patients, including 10 with ccHER2-positive disease. Seventeen of 24 samples were evaluable for CD47 expression, including samples from nine of the 10 ccHER2-positive patients. Patients received zanidatamab plus evorpacept at dosages of 20 mg/kg (n=3) or 30 mg/kg (n=21). As of the August 1, 2024 data cut-off, key findings from the analyses include:

The cORR among all 24 patients was 33% and the mPFS was 3.6 months.
Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months.
All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with an mDOR of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of <20%), cORR was 25% (n=1/4) and mPFS was 3.4 months.
"The findings from these exploratory analyses provide additional evidence that adding evorpacept to HER2-targeted therapies may generate durable responses in heavily pretreated HER2-positive breast cancers, including in patients in the post-ENHERTU setting," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "They also further support the use of a biomarker-driven approach to predict treatment response, as we previously observed in the HER2-positive gastric cancer setting. We designed the ongoing ASPEN-09-Breast Phase 2 trial of evorpacept plus trastuzumab and chemotherapy to provide additional insight into this approach and, we hope, move closer to delivering a new therapeutic option for this group of patients."

Q1 2026 Results Conference Call and Webcast Details

ALX Oncology management will host a webcast tomorrow (Friday, May 8), to provide an overview of Q1 2026 financial results. Sara Hurvitz, M.D., will join the call to discuss and provide perspective on the Phase 1b/2 trial data shared at the ESMO (Free ESMO Whitepaper) Breast Cancer congress.

Date & Time: Friday, May 8, 2026, 8:30 a.m. ET
Guest Speaker: Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center; Professor and Head, Division of Hematology and Oncology, Department of Medicine, University of Washington
Webcast Access: View Source;tp_key=2800839c82
Participant Listening Options by Phone: To access the conference call, please dial 1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology First Quarter 2026 Financial Results Conference Call.

Another option for instant telephone access to the event is to use the Call Me link below:
View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

(Press release, ALX Oncology, MAY 7, 2026, https://ir.alxoncology.com/news-releases/news-release-details/alx-oncologys-evorpacept-combination-zanidatamab-generates [SID1234665301])

Alpha Tau Successfully Treats First Pancreatic Cancer Patient in Italy with Alpha DaRT® at the University of Verona’s Pancreas Institute

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.

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])

Aligos Therapeutics Reports Recent Business Progress and First Quarter 2026 Financial Results

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.

"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])

Alector Reports First Quarter 2026 Financial Results and Provides Business Update

On May 7, 2026 Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies to counteract the devasting progression of neurodegeneration, reported first quarter 2026 financial results and recent portfolio and business updates. As of March 31, 2026, Alector’s cash, cash equivalents, and investments totaled $206.5 million.

"Over the past seven years, we have built a highly differentiated blood-brain barrier platform with the versatility to deliver antibodies, enzymes, proteins, and siRNA to the brain," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We have a rich and growing pipeline of ABC-enabled programs, and we remain deeply committed to developing therapies that can make a meaningful difference for patients living with neurodegenerative diseases."

Recent Program Updates

Alector Brain Carrier (ABC): Preclinical and Research Pipeline

At the core of Alector’s strategy is the Alector Brain Carrier (ABC), the company’s proprietary platform designed to enhance the delivery of therapeutics to the brain. ABC is intended for peripheral dosing and is adaptable across multiple drug modalities, including antibodies, enzymes, and siRNA.

The platform is built on core design principles of versatility, optimized binding properties, and translatability, with the goal of achieving efficient and targeted brain delivery while maintaining a favorable safety profile. Across multiple ABC-enabled programs, preclinical studies have demonstrated robust brain penetration, supporting the advancement of a broad pipeline aimed at addressing the underlying drivers of neurodegenerative diseases.

AL037/AL137

Alector continues to advance AL037/AL137, its ABC-enabled anti-amyloid beta (Aβ) antibody program for the treatment of AD, through investigational new drug (IND)-enabling studies. The company is targeting an IND submission in Q1 2027.
Both of our AL037 and AL137 candidates are engineered for optimal brain uptake, potency, safety, and convenience. Both candidates comprise the same high-affinity, fully human antibody that selectively binds PyroGlu3, a validated epitope on toxic amyloid beta found in plaques and retain an active effector function intended to facilitate myeloid-mediated plaque clearance. AL037 and AL137 each incorporates Alector’s proprietary ABC technology with TfR binding domains that bind the same epitope on TfR, but with different affinities and binding kinetics, to balance brain penetration and plaque removal with minimized hematologic adverse effects.
AL050

Alector continues to progress AL050, its ABC-enabled engineered glucocerebrosidase (GCase) enzyme replacement therapy (ERT) for PD, through preclinical development.
AL050 is designed to address key challenges associated with enzyme delivery to the brain, featuring an engineered GCase with improved activity and stability and a silenced effector function to maximize safety, paired with Alector’s tunable ABC technology. Preclinical studies to date have demonstrated increased GCase activity and reduced toxic substrate accumulation, supporting its continued preclinical development as a potential therapy for PD and Lewy body dementia (LBD) associated with GBA loss-of-function mutations and subsequently for idiopathic PD and LBD. We continue to evaluate our timeline to the clinic.
ABC siRNA Platform

Alector is advancing its ABC-enabled siRNA platform with the goal of making treatment more accessible by enabling peripheral dosing as a potential alternative to traditional intrathecal delivery.
Alector continues to advance AL064/AL164, its ABC-enabled tau siRNA program for the treatment of AD and other tauopathies. AL064 demonstrated robust tau mRNA knockdown and durable reduction of phospho-Tau 217 in non-human primate studies, and it was subsequently modified to further optimize siRNA stability. This modified form is advancing into IND-enabling studies as AL164.
In addition to AL164, the company is advancing early-stage siRNA programs toward lead candidate selection, including ADP062-ABC, an alpha-synuclein siRNA for PD and ADP065-ABC, an NLRP3 siRNA for multiple neurodegenerative conditions, reflecting the broad applicability of the ABC platform across disease mechanisms.
Progranulin Program (nivisnebart (AL101/GSK4527226)

The global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of nivisnebart (AL101/GSK4527226) in early AD has been discontinued following a pre-specified interim futility analysis. An independent data monitoring committee concluded that the trial was unlikely to meet its primary endpoint of slowing disease progression at completion. As the company’s platform and pipeline have continued to evolve, Alector remains focused on the significant opportunities ahead across its ABC-enabled programs.
First Quarter 2026 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2026, was $1.0 million, compared to $3.7 million for the same period in 2025. The decrease in year-over-year collaborative revenue was primarily due to lower manufacturing-related activity to support the Nivisnebart Phase 2 study in early Alzheimer’s disease.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2026, were $17.9 million, compared to $33.6 million for the quarter ended March 31, 2025. The decrease was mainly due to a decrease in personnel-related costs as a result of the reductions in force as well as a decrease in research and development expenses for the AL002 program.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2026, were $8.1 million, compared to $14.7 million for the quarter ended March 31, 2025. The decrease was mainly driven by a decrease in personnel-related costs as a result of the reductions in force.

Net Loss. For the quarter ended March 31, 2026, Alector reported a net loss of $22.9 million, or $0.21 per share, compared to a net loss of $40.5 million, or $0.41 net loss per share, for the same period in 2025.

Cash Position. Cash, cash equivalents, and investments were $206.5 million as of March 31, 2026. Management anticipates that this will be sufficient to fund Alector’s operations at least through 2027.

(Press release, Alector, MAY 7, 2026, View Source [SID1234665298])