Medicilon Delivers One Stop Preclinical Support as Yizhong Pharma Secures NMPA Clinical Approval for YXC‑001 Tri‑functional Antibody Fusion Protein and YXC‑002 4th‑Generation EGFR Kinase Inhibitor

On August 24, 2026 Yizhong Pharma, a STAR-Market-listed biotech company, reported it has obtained Clinical Trial Approval Notices from the National Medical Products Administration (NMPA) for two proprietary innovative drug candidates: YXC-001, a tri functional antibody fusion protein, and YXC-002, a 4th-generation EGFR kinase inhibitor.

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!

As Yizhong Pharma’s CRO partner, Medicilon executed full-scope preclinical studies (PD, PK, Tox) for YXC -001 under GLP requirements supporting China-US dual filings. For YXC-002, Medicilon completed full CMC deliverables (API, DP) alongside its complete preclinical package(PD, PK, Tox). High-quality datasets and on-time project delivery underpinned the successful IND approvals.

Scientific Progress: Two Novel Candidates Address Unmet Oncology Needs
Discovery landscape is advancing toward refined, differentiated and original innovation. Multi modal fusion antibodies and next-generation targeted small molecules represent key strategies to overcome clinical drug resistance and improve patient outcomes.

YXC-001 targets advanced solid tumors while YXC-002 is developed for non-small-cell lung cancer (NSCLC). Powered by novel mechanisms and compelling preclinical activity, both candidates may expand therapeutic options for difficult-to-treat patient populations.

YXC-001: First-in-Class Tri-functional Antibody Fusion Protein for Advanced Solid Tumors
YXC-001 is a first-in-class tri-functional antibody fusion protein designed to resolve the long standing efficacy toxicity trade off in advanced solid tumor therapy via structural engineering and tumor targeted delivery, representing a shift from single target blockade toward multi mechanism, spatially controlled immunomodulation.
The molecule integrates functional domains derived from a PD-1 antibody, anti-VEGF antibody and an optimized low-toxicity IL- 2 moiety. Engineered conformational changes to IL-2 eliminate systemic toxicity; antibody mediated targeting concentrates IL-2 within the tumor microenvironment for local activation.
This mechanism relieves immune suppression, remodels tumor vasculature to enhance T-cell infiltration, and expands intratumoral effector cells, amplifying anti tumor immunity while limiting systemic exposure-related risks. In mouse lung cancer models, YXC-001 demonstrated superior tumor growth inhibition compared with a PD-1 monoclonal antibody (Keytruda) and a PD-1/VEGF bispecific antibody at equivalent doses, with a clear dose response profile.
YXC- 002: 4th-Generation High Brain-Penetrant EGFR-TKI for NSCLC with Drug Resistance and CNS Metastases
YXC-002 in tablet formulation is Yizhong Pharma’s proprietary Class 1 small-molecule EGFR-TKI. It covers canonical and non-canonical EGFR driver and resistance mutations in NSCLC and is intended for patients with central nervous system (CNS) metastases.
Its unique structural design yields three core advantages
It confers activity against the C797S resistance mutation with high selectivity for mutant over wild type EGFR to minimize off target effects; it shows stronger anti tumor activity than BDTX 1535 (a Phase II stage 4th generation EGFR TKI), particularly against 19del sensitizing mutation and L858R T790M C797S triple mutation; and its molecular architecture enables robust blood brain barrier penetration.
The dual IND clearances mark a key transition from concept to clinical stage for Yizhong Pharma’s multifunctional antibody and small molecule targeted drug platforms, validating its original innovation capacity and differentiated pipeline strategy.
Medicilon’s One Stop Preclinical CRO Accelerates IND Progress
Medicilon deployed dedicated cross functional project teams for both programs, delivering end to end services covering CMC, PD, PK, Tox and regulatory support. Customized development strategies were implemented through close inter department collaboration.
The Medicilon’s pharmacodynamics team built bespoke in-vivo models for trispecific antibodies and EGFR- resistant tumors to match the projects’ cutting-edge requirements. Medicilon maintains a portfolio of more than 800 oncology pharmacology models, enabling comprehensive evaluation of small-molecule agents, monoclonal/bispecific antibodies, ADC/AOC modalities and CAR-T/CAR- NK cell therapeutics.

The Medicilon’s toxicology group tailored preclinical strategies according to each molecule’s structure and mechanism‑of‑action to generate robust safety data. The regulatory team provided full‑cycle support including dossier preparation, regulatory submission and CDE query responses, removing roadblocks throughout the IND review process.

Medicilon congratulates Yizhong Pharma on the clinical approval of YXC‑001 and YXC‑002. We look forward to positive clinical outcomes that will benefit patients. Moving forward, Medicilon will continue to enhance its integrated platform. With robust technical capabilities, reliable delivery and rigorous compliance frameworks, we will support more original‑innovation programs and accelerate the translation of novel drug concepts into clinical candidates.

(Press release, Shanghai Medicilon, AUG 24, 2026, View Source [SID1234670296])

European Commission Expands Role of Gilead’s Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer Across PD-L1 Status

On August 24, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the European Commission (EC) has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).

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!

Trodelvy plus Keytruda is the first and only antibody-drug conjugate (ADC) plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

This decision follows the recent EC approval of Trodelvy as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Together, these approvals establish Trodelvy as the backbone therapy for patients with first-line metastatic TNBC across PD-L1 status in Europe. This decision provides a new treatment option for the most aggressive form of breast cancer at the first sign of metastatic disease.

"The approval of Trodelvy plus Keytruda represents a meaningful advance in the treatment of patients with PD-L1-positive metastatic TNBC," said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and investigator of the ASCENT-04 study. "This regimen helps redefine a standard of care by offering a novel first-line treatment option for a metastatic patient population with a particularly aggressive form of breast cancer."

The approval is based on data from the Phase 3 ASCENT-04 /KEYNOTE-D19 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment. In ASCENT-04/KEYNOTE-D19, Trodelvy demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1-positive metastatic TNBC.

"Today’s approval transforms the treatment landscape for all patients with first-line metastatic TNBC," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "With Trodelvy-based options now approved in the EU for all eligible first-line metastatic TNBC patients across PD-L1 status, we have established a new, much-needed backbone therapy. This is an important milestone for patients who need new options earlier in their treatment journey."

Metastatic TNBC has historically been difficult to treat, with a poor prognosis and an urgent need for more effective first-line options. With today’s approval, Trodelvy is now positioned to address this need across the full spectrum of the disease, building on its extensive clinical legacy in later lines of therapy and its established safety and efficacy profile in more than 75,000 patients treated globally.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About Triple-Negative Breast Cancer

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

The U.S. FDA and the European Commission have approved the use of Trodelvy alone or in combination with pembrolizumab in first-line metastatic TNBC, across PD-L1 status. It is also globally approved for second-line and later metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer.

Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression, including in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. INDICATIONS FOR TRODELVY

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:

Locally Advanced or Metastatic Triple-Negative Breast Cancer

First Line

A s a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later

For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: : Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and, if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to ≤Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).

In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).

In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38.

UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.

(Press release, Gilead Sciences, AUG 24, 2026, View Source [SID1234670298])

Elicio Therapeutics to Participate at the Wells Fargo 21st Annual Healthcare Conference

On August 24, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported that management will participate in one-on-one meetings at the upcoming Wells Fargo 21st Annual Healthcare Conference, taking place September 8-10, 2026, in Boston, MA.

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!

Wells Fargo 21st Annual Healthcare Conference
Format: One-on-one Meetings
Date: Thursday, September 10, 2026

If you are interested in arranging a 1×1 meeting with management at the conference, please contact your Wells Fargo representative.

(Press release, Elicio Therapeutics, AUG 24, 2026, View Source [SID1234670299])

Arbutus Commences US$230 Million Modified “Dutch Auction” Tender Offer of its Common Shares at a Price Not Greater Than US$5.75 Nor Less Than US$5.00 Per Share

On August 24, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported the commencement of a modified "Dutch Auction" tender offer to purchase for cancellation up to US$230 million in value of its common shares (the "Shares") at a price of not less than US$5.00 and not more than US $5.75 per Share, less any applicable withholding taxes and without interest, on the terms and subject to the conditions described in the offer to purchase and accompanying issuer bid circular, dated August 24, 2026 (the "Offer to Purchase and Bid Circular"), the Letter of Transmittal (the "Letter of Transmittal") and Notice of Guaranteed Delivery (the "Notice of Guaranteed Delivery") (which together, as they may be amended and supplemented from time to time, constitute the "Offer"). The Offer begins today, August 24, 2026, and will expire at 5:00 p.m., New York City time, on September 29, 2026 (the "Expiration Date"), unless extended or terminated by the Company. The Offer to Purchase and Bid Circular, the Letter of Transmittal, the Notice of Guaranteed Delivery and other tender offer materials are being filed with the Securities and Exchange Commission (the "SEC") and the applicable Canadian securities regulatory authorities which may be accessed at www.sec.gov and www.sedarplus.ca, and will also be available at investor.arbutusbio.com.

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!

Arbutus also announced today that on August 21, 2026, it obtained exemptive relief from the applicable Canadian securities regulatory authorities with respect to the proportionate take-up and extension requirements of the Offer, the details of which can be found in the Offer to Purchase and Bid Circular. Arbutus also obtained exemptive relief from the SEC with respect to the Proportionate Tender (as defined below) feature included in the Offer.

Shareholders wishing to tender to the Offer will be entitled to do so by making: (i) an auction tender for a specified price (the "Auction Price") of not less than US$5.00 and not more than US$5.75 per Share in increments of US$0.05 per Share (the "Auction Tenders"), (ii) a purchase price tender without specifying a price per Share, but rather agreeing to have a specified number of Shares purchased at the Purchase Price (as defined below) to be determined pursuant to the Offer to Purchase and Bid Circular (the "Purchase Price Tenders"), or (iii) a proportionate tender in which they will agree to sell, at the Purchase Price to be determined pursuant to the Offer to Purchase and Bid Circular, that number of Shares that will result in them maintaining their respective proportionate Share ownership in the Company (the "Proportionate Tenders"), in each case on the terms and subject to the conditions described in the Offer to Purchase and Bid Circular, the Letter of Transmittal and other tender offer materials.

The Company intends to pay for the Share repurchase with available cash on hand. The Offer is not conditioned upon the receipt of any financing or any minimum number of Shares being tendered. The Offer is, however, subject to a number of other terms and conditions described in the Offer to Purchase and Bid Circular, the Letter of Transmittal, the Notice of Guaranteed Delivery and other tender offer materials, which will be sent to shareholders promptly after commencement of the Offer.

Upon the terms and subject to the conditions of the Offer and promptly following the Expiration Date, the Company will determine a single price per Share (the "Purchase Price"), not less than US$5.00 and not more than US$5.75 per Share (in increments of US$0.05 per Share), that the Company will pay for Shares properly tendered to and not properly withdrawn from the Offer, taking into account the Auction Prices and the number of Shares deposited pursuant to Auction Tenders and Purchase Price Tenders. The Purchase Price will be the lowest price that enables the Company to purchase Shares pursuant to valid Auction Tenders and Purchase Price Tenders having an aggregate purchase price not to exceed an amount (the "Auction Tender Limit Amount") equal to (i) US$230 million less (ii) the product of (A) US$230 million and (B) a fraction, the numerator of which is the aggregate number of Shares owned by shareholders making valid Proportionate Tenders, and the denominator of which is the aggregate number of Shares outstanding at the time of the Expiration Date. All Shares purchased in the Offer will be acquired at the same Purchase Price regardless of whether any shareholder tenders at a lower price. For the purpose of determining the Purchase Price, Shares tendered pursuant to a Purchase Price Tender will be considered to have been tendered at the minimum price per Share under the Offer. Shares tendered pursuant to a Proportionate Tender will be considered to have been tendered at a price per Share equal to the Purchase Price. Shares tendered by a shareholder pursuant to an Auction Tender will not be purchased by the Company pursuant to the Offer if the price per Share specified by the shareholder is greater than the Purchase Price. However, because of the preferential acceptance of Shares validly tendered at or below the Purchase Price by Odd Lot Holders (as defined below) and proration described in the Offer to Purchase and Bid Circular, the Company may not purchase all of the Shares tendered at or below the Purchase Price if the aggregate purchase price for Shares validly tendered and not validly withdrawn pursuant to Auction Tenders at Auction Prices at or below the Purchase Price and Purchase Price Tenders (the "Auction Tender Purchase Amount") is greater than the Auction Tender Limit Amount. Shares not purchased in the Offer will be returned to depositing shareholders promptly after the Expiration Date. The Company reserves the right, in its sole discretion, to change the per Share purchase price range and to increase or decrease the value of Shares sought under the Offer, subject to applicable law.

As of August 19, 2026, there were 198,105,743 Shares issued and outstanding. If the Offer is fully subscribed, then US$230 million in value of Shares will be purchased, representing between 20.2% and 23.2% of the Company’s currently issued and outstanding Shares as of August 19, 2026, depending on the Purchase Price. Arbutus’s Shares are currently listed on the Nasdaq Stock Market under the symbol "ABUS". On August 21, 2026, the last full trading day prior to the commencement of the Offer, the reported closing price of Arbutus’s Shares on the Nasdaq Stock Market was US$5.21 per Share, which is above the US$5.00 per Share lower end of the price range for the Offer. Accordingly, an election to accept the Purchase Price determined in the Offer may lower the Purchase Price to a price below such closing price and could be below the reported closing price on the Expiration Date. Shareholders are urged to obtain current market quotations for the Shares before deciding whether and at what purchase price or purchase prices to tender their Shares.

Subject to applicable law, the Company expressly reserves the right, in its sole discretion, at any time and from time to time, to extend the period of time during which the Offer is open or to vary the terms and conditions of the Offer by giving written notice or oral notice to be confirmed in writing of such extension or variation to TSX Trust Company, the depositary for the Offer (the "Depositary"), and by causing the Depositary to provide to all shareholders, where required by law, as soon as practicable thereafter, a copy of a notice in the manner set forth in the Offer to Purchase and Bid Circular. Promptly after giving notice of an extension or variation to the Depositary, but, in the case of an extension, no later than 9:00 a.m., New York City time, on the next business day after the previously scheduled or announced Expiration Date of the Offer, the Company will make a public announcement of the extension or variation and provide or cause to be provided notice of such extension or variation to Nasdaq (if required), the SEC (if required) and the applicable Canadian securities regulatory authorities. Any notice of extension or variation will be deemed to have been given and be effective on the day on which it is delivered or otherwise communicated to the Depositary at its principal office in Toronto, Ontario.

The Offer will expire at 5:00 p.m., New York City time, on September 29, 2026, unless the Company exercises its right to terminate the Offer or to extend the period of time during which the Offer will remain open. Beneficial owners should be aware that their broker, dealer, commercial bank, trust company or other nominee may establish its own earlier deadlines for participation in the Offer. Accordingly, beneficial owners wishing to participate in the Offer should contact their broker, dealer, commercial bank, trust company or other nominee as soon as possible in order to determine the times by which such owner must take action in order to participate in the Offer.

In accordance with the instructions to the Letter of Transmittal, shareholders desiring to tender Shares may do so pursuant to an Auction Tender, a Purchase Price Tender or a Proportionate Tender. Shareholders making an Auction Tender must specify the price or prices, not greater than US$5.75 nor less than US$5.00 per Share, at which they are willing to sell their Shares to the Company in the Offer, in increments of US$0.05 per Share.

All Shares tendered by a shareholder who fails to specify any Auction Price for such shareholder’s Shares, or fails to indicate that such shareholder has tendered Shares pursuant to a Purchase Price Tender or a Proportionate Tender, will be considered to have been tendered pursuant to a Purchase Price Tender. A shareholder who makes an invalid Proportionate Tender, including by tendering an insufficient number of Shares to maintain such shareholder’s proportionate ownership interest in the Company following completion of the Offer, will be deemed to have made a Purchase Price Tender. Shareholders desiring to tender Shares must follow the procedures set forth in the Offer to Purchase and Bid Circular and in the Letter of Transmittal (and, if applicable, the Notice of Guaranteed Delivery).

The Purchase Price will be payable in United States dollars; however, shareholders may elect to receive the Purchase Price in an amount of Canadian dollars determined using the applicable exchange rate as described in the Offer. The risk of any fluctuation in exchange rates, including risks relating to the particular date and time at which funds are converted, will be borne solely by the shareholder wishing to receive payment in Canadian dollars.

If the Auction Tender Purchase Amount is less than or equal to the Auction Tender Limit Amount, the Company will purchase at the Purchase Price all Shares so tendered pursuant to Auction Tenders at or below the Purchase Price and Purchase Price Tenders. If the Auction Tender Purchase Amount is greater than the Auction Tender Limit Amount, the Company will purchase a portion of the Shares so tendered pursuant to Auction Tenders at or below the Purchase Price and Purchase Price Tenders, as follows:

first, the Company will purchase all Shares validly tendered at or below the Purchase Price by shareholders who own fewer than 100 Shares (the "Odd Lot Holders") and who tender all of the Shares they own; and
second, the Company will purchase at the Purchase Price, on a pro rata basis, that portion of the Shares tendered pursuant to Auction Tenders at or below the Purchase Price and Purchase Price Tenders having an aggregate purchase price, based on the Purchase Price, equal to (A) the Auction Tender Limit Amount, less (B) the aggregate amount paid by the Company for Shares tendered by Odd Lot Holders. Regardless of proration, the Company will purchase at the Purchase Price, payable in cash (subject to applicable withholding taxes, if any), a number of Shares from shareholders making valid Proportionate Tenders that results in such tendering shareholders maintaining their respective proportionate ownership interest in the Company following completion of the Offer (subject to nominal differences due to the quantity of Shares purchased from such shareholders being rounded down to the nearest whole number of Shares to avoid the purchase of fractional Shares). Shareholders making Proportionate Tenders will be prorated in a separate proration pool from shareholders making Auction Tenders and/or Purchase Price Tenders. Such proration will be based on the number of Shares necessary for such shareholders to maintain their existing ownership percentages. For purposes of the Offer, the Company will be deemed to have accepted for payment (and therefore purchased), Shares that are properly tendered at or below the Purchase Price selected by the Company and not properly withdrawn only when, as and if the Company gives oral or written notice to the Depositary of the Company’s acceptance of the Shares for payment pursuant to the Offer.

Payment for Shares taken up pursuant to the Offer will be made only after timely receipt by the Depositary of (i) the share certificates for all Shares proposed to be taken up in proper form for transfer, together with a properly completed and duly executed Letter of Transmittal (or a manually executed photocopy thereof) or, in the case of a book-entry transfer, a Book-Entry Confirmation or an Agent’s Message (each as defined in the Offer to Purchase and Bid Circular), as applicable, in lieu thereof relating to such Shares, with signatures that are guaranteed if so required in accordance with the Letter of Transmittal, and (ii) any other documents required by the Letter of Transmittal. Subject to applicable law, the Company will take up Shares validly deposited and not validly withdrawn pursuant to the Offer as soon as reasonably practicable following the Expiration Date and, in any event, not later than ten days after the Expiration Date provided that the conditions of the Offer have been satisfied or waived, and will pay for Shares taken up pursuant to the Offer promptly thereafter and, in any event, not later than three business days after such Shares have been taken up.

The Company expects to announce the preliminary results of the Offer, including price and preliminary information about any expected proration, on the business day following the Expiration Date of the Offer. Because of the difficulty in determining the number of Shares properly tendered and not properly withdrawn, including due to the guaranteed delivery procedures of the Offer, and because of the proration procedures applicable to the Offer, the Company expects that it will not be able to announce the final proration results until two business days after the Expiration Date of the Offer. The Company currently expects to accept for payment and pay for Shares validly deposited and not validly withdrawn on or about the third business day following the Expiration Date or promptly thereafter.

The accounting for the Company’s purchase of Shares in the Offer will result in a reduction of the Company’s total equity in an amount equal to the aggregate purchase price of the Shares the Company purchases, plus the fees related to the Offer, a corresponding reduction in cash and cash equivalents and a reduction in the weighted average number of outstanding Shares for the purposes of calculating earnings per share in an amount equal to the weighted average number of Shares that the Company repurchases pursuant to the Offer.

Deposits of Shares are irrevocable, except that Shares may be withdrawn by the shareholder (i) at any time if the Shares have not been taken up (i.e., accepted for purchase) by the Company before actual receipt by the Depositary of a notice of withdrawal in respect of such Shares, (ii) at any time before the expiration of ten days from the date that a notice of change or variation (unless (A) the variation consists solely of waiver of a condition of the Offer, or (B) the variation consists solely of an increase in the consideration offered for those Shares pursuant to the Offer where the time for deposit is not extended for greater than ten days) has been given in accordance with the terms of the Offer to Purchase and Bid Circular; or (iii) at any time if the Shares have been taken up but not paid for by the Company within three business days of being taken up. In addition, pursuant to Rule 13e-4(f) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), Shares may also be withdrawn after October 21, 2026, which is the 40th business day after the date of the commencement of the Offer, unless such Shares have already been accepted for payment by the Company pursuant to the Offer and not validly withdrawn.

For a withdrawal to be effective, a written or printed copy of a notice of withdrawal must be actually received by the Depositary by the applicable date specified above at the place of deposit of the relevant Shares. Any such notice of withdrawal must be signed by or on behalf of the person who signed the Letter of Transmittal or Notice of Guaranteed Delivery in respect of the Shares being withdrawn or, in the case of Shares tendered in accordance with the procedures for book-entry transfer described in the Offer to Purchase and Bid Circular, any notice of withdrawal must be signed by such participant in the same manner as the participant’s name is listed on the applicable Book-Entry Confirmation or on the applicable Agent’s Message, and must specify the name of the person who deposited the Shares to be withdrawn, the name of the registered holder, if different from that of the person who deposited such Shares, and the number of Shares to be withdrawn. If the certificates for the Shares deposited pursuant to the Offer have been delivered or otherwise identified to the Depositary, then, prior to the release of such certificates, the depositing shareholder must submit the serial numbers shown on the particular certificates evidencing the Shares to be withdrawn and the signature on the notice of withdrawal must be guaranteed by an Eligible Institution (as defined in the Offer to Purchase and Bid Circular), except in the case of Shares deposited by an Eligible Institution.

All questions as to the form and validity (including time of receipt) of notices of withdrawal will be determined by the Company, in its sole discretion, which determination shall be final and binding, subject to a challenge of such determination in a court of competent jurisdiction. None of the Company, its Board of Directors, the Depositary, J.P. Morgan Securities LLC, as dealer manager (the "Dealer Manager"), J.P. Morgan Securities Canada Inc. (which has also been retained by the Company to perform certain services in Canada in connection with the Offer), Georgeson LLC, as information agent (the "Information Agent") or any other person shall be obligated to give any notice of any defects or irregularities in any notice of withdrawal and none of them shall incur any liability for failure to give any such notice.

The Company is making the Offer because it believes that the Offer is in the best interests of the Company and its shareholders. On July 8, 2026, the Company received approximately US$178 million as its share of the noncontingent payment under the settlement agreement entered into with Moderna, Inc. and its affiliates ("Moderna") to resolve all global patent infringement litigation and patent revocation proceedings related to Moderna’s infringement of patents protecting Arbutus’ industry-leading lipid nanoparticle technology in Moderna’s COVID-19 vaccines and other products. In connection with the receipt of these funds, the Board of Directors believes that the Offer represents an efficient mechanism to provide all of the Company’s shareholders with the opportunity to tender all or a portion of their Shares at a premium over current market prices and thereby receive a return of some or all of their investment if they so elect, while also permitting them the opportunity to retain a continuing interest in the Company. The Offer provides a mechanism for completing a sizeable repurchase of Shares more rapidly than would be possible through open market repurchases in compliance with applicable United States and Canadian securities laws. The Offer also provides shareholders with an opportunity to obtain liquidity for all or a portion of their Shares without potential disruption to the share price. In addition, if the Company completes the Offer, shareholders who do not participate in the Offer will automatically increase their relative percentage ownership interest in the Company and its future operations. The Offer also provides shareholders with an efficient way to sell their Shares without incurring brokerage fees or commissions associated with open market sales; however, shareholders who hold Shares through nominees are urged to consult their nominees to determine whether transaction costs may apply.

The tax consequences of participating in the Offer will depend on a shareholder’s particular circumstances. Canadian resident shareholders who sell Shares pursuant to the Offer may be considered to receive a deemed dividend to the extent the amount paid for Shares exceeds the paid-up capital of such Shares for purposes of the Income Tax Act (Canada). The amount paid by the Company for the Shares less any deemed dividend received by such shareholder will generally be treated as proceeds of disposition of the Shares and such shareholder may realize a capital gain or capital loss on the sale of the Shares. Shareholders not resident in Canada may be subject to Canadian withholding tax on any deemed dividend arising as a result of participation in the Offer. U.S. Holders (as defined in the Offer to Purchase and Bid Circular) will generally be treated for U.S. federal income tax purposes as either (i) recognizing gain or loss from the sale of Shares or (ii) as receiving a distribution from the Company, depending on their particular circumstances and the application of the redemption provisions of the Internal Revenue Code. All shareholders should read carefully the Offer to Purchase and Bid Circular for information regarding the income tax consequences of participating in the Offer and should consult their own tax advisors with respect to their particular circumstances.

Our Board of Directors has authorized and approved the Offer, but neither Arbutus’ management, nor any of the members of its Board of Directors, executive officers, the Dealer Manager, the Information Agent or the Depositary makes any recommendation to shareholders as to whether to tender or refrain from tendering their Shares in the Offer. Shareholders must decide how many Shares they will tender, if any, and, if desired, the price within the stated range at which they will tender their Shares. Shareholders should consult their own financial and tax advisors and read carefully and evaluate the information in, or incorporated by reference in, the Offer to Purchase and Bid Circular, the Letter of Transmittal, the Notice of Guaranteed Delivery and other tender offer materials, including the reasons for the Offer. Certain of our directors and executive officers have indicated that they intend to tender up to an aggregate of 682,630 Shares in the Offer through Purchase Price Tenders. Roivant Sciences Ltd. ("Roivant") is the beneficial owner of 38,847,462 Shares, which represents approximately 19.6% of all issued and outstanding Shares as of August 19, 2026. Roivant has advised the Company that it intends to make a Proportionate Tender. The equity ownership of our non-tendering directors, executive officers and affiliates will increase as a percentage of our issued and outstanding Shares following the completion of the Offer.

The information required to be disclosed by Rule 13e-4(d)(1) of the Exchange Act is contained in the Offer to Purchase and Bid Circular and is incorporated herein by reference. The Company is also filing with the SEC a Tender Offer Statement on Schedule TO, which includes certain additional information relating to the Offer.

The Company is mailing the Offer to Purchase and Bid Circular, the Letter of Transmittal and Notice of Guaranteed Delivery to record holders of Shares whose names appear on the Company’s shareholder list, and will furnish the Offer to Purchase and Bid Circular and the related Letter of Transmittal to brokers, dealers, commercial banks, trust companies and similar persons whose names, or the names of whose nominees, appear on the shareholder list or, if applicable, who are listed as participants in a clearing agency’s security position listing for subsequent transmittal to beneficial owners of Shares. The Offer is explained in detail in those materials.

Questions or requests for assistance may be directed to the Information Agent or the Dealer Manager, at their respective addresses and telephone numbers set forth below. Please direct requests for copies of the Offer to Purchase and Bid Circular, the Letter of Transmittal or the Notice of Guaranteed Delivery to the Information Agent at the telephone number and address set forth below. Copies of the Offer to Purchase and Bid Circular, the Letter of Transmittal and other related materials will be furnished promptly by the Information Agent at the Company’s expense. Shareholders may also contact their broker, dealer, commercial bank, trust company or other nominee or trust company for assistance concerning the Offer. Current and former employees of Arbutus with Shares held in a Shareworks at Morgan Stanley at Work ("Shareworks") account should contact the Company’s Finance team at [email protected] for more information about how to tender their Shares held in such Shareworks account.

Additional Information Regarding the Tender Offer

This press release is for informational purposes only and does not constitute an offer to purchase or a solicitation of an offer to sell Shares of Arbutus Biopharma Corporation. The Offer is being made only pursuant to the Offer to Purchase and Bid Circular, the Letter of Transmittal and the Notice of Guaranteed Delivery, as they may be amended or supplemented from time to time. Each of these documents is being filed with the SEC and applicable Canadian securities regulatory authorities, and shareholders may obtain a free copy of these documents from the SEC’s website at www.sec.gov, on SEDAR+ at www.sedarplus.ca and in the investors section of Arbutus’ website at investor.arbutusbio.com, or by calling Georgeson LLC, the Information Agent for the Offer, at (877) 816-4522 (toll free). We are not aware of any jurisdiction where the making of the Offer is not in compliance with applicable law. If we become aware of any jurisdiction where the making of the Offer or the acceptance of Shares pursuant to the Offer is not in compliance with any applicable law, we will make a good faith effort to comply with the applicable law. If, after a good faith effort, we cannot comply with the applicable law, the Offer will not be made to, nor will tenders be accepted from or on behalf of, holders of Shares residing in that jurisdiction, provided that we will comply with the requirements of Rule 13e-4(f)(8) promulgated under the Exchange Act. In any jurisdiction where the securities, blue sky, or other laws require the Offer to be made by a licensed broker or dealer, the Offer shall be deemed to be made on behalf of Arbutus Biopharma Corporation by the Dealer Manager or one or more brokers or dealers registered under the laws of such jurisdiction.

(Press release, Arbutus Biopharma, AUG 24, 2026, View Source [SID1234670301])

BreakBio, the Third Player in Personalized Drugs, Enters the Clinic

On August 24, 2026 BreakBio, the third player in personalized drugs after Moderna and BioNTech and the top private company in the personalized drugs space with advanced cutting-edge technology, reported that it is entering the clinic next quarter. BreakBio aims to be not first-in-class but best-in-class. It is designed for both higher efficacy than Moderna or BioNTech and it is also designed to treat more cancer indications than Moderna or BioNTech.

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!

BreakBio is designed for higher efficacy than Moderna’s individualized neoantigen therapy (INT). Higher efficacy because BreakBio is designed to find better targets per patient. It is an AI first biotech company. For every patient, its platform integrates highest quality tumor DNA sequencing, RNA sequencing, mass-spectrometry-based immunopeptidomics (of that patient) with proprietary deep AI analysis to find better targets on that patient’s cancer cells. Better targets means killing more (or all) of the cancer cells.

BreakBio is designed to extend personalized drugs to more cancer indications than Moderna. BreakBio achieves this by targeting not just neoantigens (associated with mutations as Moderna and BioNTech do) but it also searches for and finds, in each patient, some of the hundreds of cancer-associated non-mutated proteins such as cancer testis antigens, embryonic antigens, etc. – so BreakBio is designed to also work for low mutational cancers, which means it is designed to work for all solid cancers both high mutational cancers like melanoma and low mutational cancers like colorectal.

(Press release, BreakBio, AUG 24, 2026, View Source [SID1234670302])