Tag: GlobeNewswire

Perth, Australia – November 2, 2026 – Atos, a global leader of AI-powered digital transformation, today announces the appointment of Judith Stewart as Head of Healthcare & Life Sciences for Asia Pacific, reinforcing the company’s commitment to accelerating growth and innovation across the sector and helping organizations harness the potential of artificial intelligence, sovereign technologies and cybersecurity.

Judith brings more than 18 years of international healthcare leadership experience, with a strong track record delivering healthcare reforms and transformations for public and private sector organizations across Australia and the UK. Prior to joining Atos, she held Executive roles for several years within WA Health, most recently as Executive Director for Child and Adolescent Community Health Services in Perth, Western Australia.  

In her new role, Judith will lead Atos’ Healthcare & Life Sciences business across Asia Pacific, with a focus on accelerating growth, strengthening customer relationships, fostering innovation and supporting clients as they navigate an increasingly complex technology landscape.

Daniele Principato, EVP and Head of International Markets at Atos, said:
“Judith brings extensive healthcare leadership experience and a deep understanding of the challenges facing the sector. Her appointment strengthens our Healthcare & Life Sciences capabilities in Asia Pacific and our ability to help clients accelerate transformation while addressing critical priorities around AI, cybersecurity and digital sovereignty.”

Judith Stewart, Head of Healthcare & Life Sciences, Asia Pacific at Atos, said:
“I am delighted to join Atos and look forward to working with our talented teams, customers and partners across Asia Pacific. Healthcare and Life Sciences organizations are navigating significant change, and technology and AI have an important role to play in helping them transform and innovate. I look forward to helping our clients unlock that potential and deliver meaningful outcomes for the communities they serve.”

The appointment reflects Atos’ continued investment in Asia Pacific and its commitment to supporting Healthcare & Life Sciences organizations as they harness advanced technologies to transform healthcare delivery, strengthen resilience and drive sustainable innovation.

***

About Atos

Atos is the Atos Group brand dedicated to AI-powered, secure, end-to-end digital services. Atos designs, develops, and operates critical digital environments that drive performance, resilience and sovereignty, helping public and private organizations worldwide retain control over their data and infrastructures, while meeting regulatory requirements.

With more than 51,000 employees serving over 4,500 clients across 54 countries, Atos helps modernize core IT systems, accelerate cloud and data transformation, strengthen cybersecurity, and deliver secure digital workplace environments to support its clients, its employees and society. Atos also provides consulting and advisory services through its Atos Amplify brand.

A trusted partner in operating complex and mission-critical environments, Atos supports organizations across highly regulated and sovereign contexts.

About Atos Group

Atos Group is a global leader in digital transformation with c. 53,000 employees and annual revenue of c. €7.2 billion, operating in 54 countries under two brands – Atos for services and Eviden for products and systems. European number one in cybersecurity and a leader in cloud, Atos Group is committed to a secure and decarbonized future and provides tailored AI-powered, end-to-end solutions for all industries. Atos Group is listed on Euronext Paris.

Press contact

lucie.leonardi@atos.ai

Attachment

• Judith Stewart

— Follows US FDA new drug application submission in September 2026, marking important global regulatory progress —

— Filings supported by positive SAFFRON global Phase III data demonstrating statistically significant and clinically meaningful PFS and OS improvements —

— Data selected for ESMO 2026 Presidential Symposium and simultaneously published in The New England Journal of Medicine —

HONG KONG and FLORHAM PARK, N.J., Nov. 01, 2026 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) today announces that regulatory filings for ORPATHYS^® (savolitinib) in combination with TAGRISSO^® (osimertinib) have been accepted for review in Europe and Japan.

In Europe, the European Medicines Agency (EMA) has validated and accepted for regulatory review the Marketing Authorization Application (MAA) submitted by AstraZeneca, seeking approval for the combination for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) whose tumors have MET overexpression or amplification, and who had disease progression on or after an epidermal growth factor receptor (“EGFR”) tyrosine kinase inhibitor (“TKI”) therapy.

In Japan, AstraZeneca has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare (MHLW), which has also been accepted for review, seeking approval in patients with unresectable, advanced or recurrent NSCLC whose tumors have MET overexpression or amplification, and who had disease progression following EGFR-TKI therapy.

These filings in Europe and Japan follow the submission of an NDA for the same combination to the US Food and Drug Administration (FDA) in September 2026, marking further progress in expanding global access to this innovative targeted combination therapy.

The regulatory filings are supported by positive results from the SAFFRON global Phase III trial. These results have been presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in The New England Journal of Medicine.  

ORPATHYS^® plus TAGRISSO^® demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (“PFS”) and overall survival (“OS”) versus doublet platinum-based chemotherapy in patients who progressed on treatment with TAGRISSO^®. ORPATHYS^® plus TAGRISSO^® reduced the risk of disease progression or death by 45% compared to chemotherapy (based on a PFS hazard ratio [“HR”] of 0.55; 95% confidence interval [“CI”] 0.42-0.72; p<0.001). Median PFS as assessed by blinded independent central review (BICR) was 7.6 months for ORPATHYS^® plus TAGRISSO^® versus 5.4 months for the comparator arm. Results for the key secondary endpoint of OS showed ORPATHYS^® plus TAGRISSO^® reduced the risk of death by 32% versus chemotherapy (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). ORPATHYS^® plus TAGRISSO^® extended median OS by 4.9 months versus the comparator arm (17.8 versus 12.9 months). The safety profile was consistent with the known profiles of each medicine, and there were no new safety concerns.

Third-generation EGFR-TKIs have significantly improved outcomes for patients with EGFRm NSCLC. However, MET overexpression or amplification is one of the most common mechanisms of resistance on third-generation EGFR-TKI treatment. MET-driven progression is associated with poor prognosis, and there remains a significant unmet need for effective and well-tolerated treatment options in this setting.

ORPATHYS^® is being jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.^1,2 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.³ Approximately 75% of NSCLC patients are diagnosed with advanced disease.⁴ Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.^​5

MET is a tyrosine kinase receptor that has an essential role in normal cell development.⁶ MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.^6,7 Approximately one in three patients’ tumors will develop high levels of MET overexpression or amplification (IHC3+>90% and FISH10+) after progression on a third-generation EGFR-TKI.⁸

About SAFFRON

SAFFRON is a randomized, open-label, multi-center, global Phase III trial studying the efficacy of ORPATHYS^® (300 mg twice daily) added to TAGRISSO^® (80 mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO^®. The trial enrolled patients in 230 centers across 29 countries in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoint includes OS.

Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial. ​In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridization (FISH), which detects a specific DNA sequence from cancer cells.

About ORPATHYS^®

ORPATHYS^® (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS^® is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS^® also received a conditional approval in China for the treatment of adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS^® in combination with TAGRISSO^® is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO^®. This was based on results from the global SAVANNAH Phase II trial. The global, randomized, SAFFRON Phase III trial in the same treatment setting comparing the combination with doublet platinum-based chemotherapy reported positive high-level results, demonstrating a statistically significant and clinically meaningful improvement in PFS and OS in August 2026.

About TAGRISSO^®

TAGRISSO^® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases.

TAGRISSO^® is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO^® is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first four medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS^®, the further clinical development for ORPATHYS^®, its expectations as to whether any studies on ORPATHYS^® would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of ORPATHYS^®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS^® for a targeted indication; the sufficiency of funding; HUTCHMED’s and AstraZeneca’s ability to successfully develop and commercialize ORPATHYS^®. In addition, as certain studies rely on the use of other drug products such as TAGRISSO^® as combination therapeutics with ORPATHYS^®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

Investor Enquiries	+852 2121 8200 / ir@hutch-med.com
Media Enquiries
FTI Consulting –	+44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Tim Stamper	+44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)
Brunswick – Zhou Yi	+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Panmure Liberum	Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden	+44 20 7886 2500
Cavendish	Joint Broker
Geoff Nash / Nigel Birks	+44 20 7220 0500
Deutsche Numis	Joint Broker
Duncan Monteith / Ramin Naji	+44 20 7545 8000

¹  World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2026.
²  World Health Organization. International Agency for Research on Cancer. All Cancers Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed October 2026.
³  American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026.
⁴  Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688.
⁵  Gao X, et al. The safety and efficacy of osimertinib for the treatment of EGFR T790M mutation positive non-small-cell lung cancer. Expert Rev Anticancer Ther. 2016;16(4):383-390.
⁶  Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074)
⁷  Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. J Hematol Oncol. 2019;63.
⁸  De Marinis F, et al. Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study. Ann Oncol. 2025;36(8):920-933.

NEW YORK, Nov. 01, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced rotational changes and retirement of certain members of its Board, and reiterated its intention to add new members with the requisite global commercial experience in the biopharmaceutical sector in line with its next phase of commercial delivery and growth.

After 12 years of serving on the Board since 2014, Mr William Burns will retire from the Board at the Company’s 2026 Annual General Meeting. Ms Jane Bell AM will take over as Chair of the Nomination and Remuneration Committee, having been co-Chair with Mr Burns since April 2026. The Board recognizes the contribution by Mr Burns to the Company’s strategic direction and corporate governance.

Dr Philip Krause will also retire from the Board, after having been a director since 2022. Dr Krause has provided regulatory and clinical development expertise as a Board member and consultant to Mesoblast after a long career at the U.S. Food and Drug Administration (FDA). The Board recognizes his significant contribution to activities by the Mesoblast team which advanced Ryoncil^® (remestemcel-L-rknd) to FDA approval.

Chair Mr Philip Facchina said, “On behalf of the Board, I wish to thank Mr Burns for his broad contributions spanning more than a decade and Dr Krause for his significant contribution to Mesoblast as a director. The Company is now a revenue-generating commercial enterprise following the successful launch of RYONCIL in the United States. In line with this, we plan to recruit and appoint new directors with U.S. and global commercial expertise in the biotechnology and pharmaceutical sectors.”

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors
Paul Hughes
T: +61 3 9639 6036
Media – Global	Media – Australia
Rubenstein	BlueDot Media
Caroline Nelson	Steve Dabkowski
T: +1 703 489 3037	T: +61 419 880 486
E: cnelson@rubenstein.com	E: steve@bluedot.net.au

MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR^® Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 ± 38 mm²). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch^* (PPM) in a cohort of medium annuli patients from the EMBARK Study.

The 30-day Medium-size DurAVR THV results were presented by Azeem Latib, MD during the Emerging Concepts and Innovations in TAVR session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California.

30-day Results Highlights

• DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.64 ± 0.19 cm² (baseline 0.8 ± 0.2 cm²) and a single digit mean pressure gradient (MPG) of 6.17 ± 1.40 mmHg (baseline 45.5 ± 11.7 mmHg). 
• At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).
• No moderate or severe prosthesis–patient mismatch was observed at 30 days.

“These are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak. That matters because prosthesis-patient mismatch is not just a small-annulus problem. A recent study in younger, lower-risk TAVR patients found PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.¹ As TAVR moves to patients who will live with their valve for decades, this is the hemodynamic profile we designed DurAVR to deliver, and we look forward to PARADIGM confirming it in a randomized setting,” said Chris Meduri, M.D., Anteris Chief Medical Officer.

The DurAVR THV is being evaluated in the ongoing global PARADIGM pivotal trial (ClinicalTrials.gov ID NCT07194265), which is actively enrolling patients and will include use of the Medium-size DurAVR THV. This prospective, randomized controlled trial (RCT) is designed to evaluate the safety and effectiveness of DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis.

^{¹Suruga K, et al. Prosthesis-Patient Mismatch in Young and Low-Risk Patients After Newer Generation Balloon-Expandable Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025;18(12).}

^{*Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn’t have a large enough opening (EOA) to accommodate the patient’s blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR).}

^{**As defined in VARC-3}

About the PARADIGM Trial

The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs).

This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

For further information, please refer to ClinicalTrials.gov NCT07194265.

About Anteris

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT^® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR^® Delivery System.

DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.

Forward-Looking Statements

This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.   

For more information:
Global Investor Relations	Investor Relations (US)
investors@anteristech.com	mchatterjee@bplifescience.com
Debbie Ormsby	Malini Chatterjee, Ph.D.
Anteris Technologies Global Corp.	Blueprint Life Science Group
+61 1300 550 310 | +61 7 3152 3200	+1 917 330 4269

Website	www.anteristech.com
X	@AnterisTech
LinkedIn	https://www.linkedin.com/company/anteristech

Late-Breaking P4 study, simultaneously published in NEJM, shows CT guidance delivers matched one-year clinical outcomes with shorter procedures, demonstrating pre-procedural CCTA can guide key PCI planning decisions

NAVIGATE-PCI shows Heartflow PCI Navigator drove modifications to stent length and lesion prep compared to angiography alone

SAN FRANCISCO, Nov. 01, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced new landmark randomized clinical data presented at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, demonstrating computed tomography (CT)-guided percutaneous coronary intervention (PCI) matches gold-standard imaging outcomes with greater efficiency. These data are supported by registry insights on the procedural impact of Heartflow PCI Navigator.

In a late-breaking presentation simultaneously published in the New England Journal of Medicine (NEJM), the 1,105-patient P4 randomized clinical trial met its primary endpoint, demonstrating that CT-guided PCI planning was non-inferior to gold-standard intravascular ultrasound (IVUS) for one-year clinical outcomes. In the largest randomized trial of its kind, CT guidance achieved these matched results compared to IVUS while significantly improving procedural efficiency, delivering faster procedure times and utilizing lower contrast volume. Data from the NAVIGATE-PCI registry showed that interventional cardiologists altered their procedural strategy in approximately 70% of cases after incorporating 3D anatomic, plaque, and physiologic insights from Heartflow PCI Navigator compared to standard invasive coronary angiography alone.

“CT has already become routine for planning structural procedures like TAVR. The data presented at TCT show coronary intervention is ready to follow the same path with advanced pre-procedural imaging and Heartflow’s AI-powered analysis to deliver precision and efficiency,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “What we learned planning P4 cases across six separate tools shaped Heartflow PCI Navigator, which brings anatomy, plaque and physiology together in the first and only PCI planning tool backed by prospectively validated accuracy and randomized clinical trial data. Together, P4 and NAVIGATE-PCI support a paradigm shift in coronary intervention, bringing non-invasive CT-guided PCI planning into routine cath lab practice.”

P4 Trial: Validating CT-guided PCI Against IVUS with Greater Efficiency
Main Arena 4, November 1

The Heartflow-supported, investigator-initiated P4 trial directly evaluated the clinical efficacy of non-invasive CT-guided PCI planning against invasive IVUS guidance.

Enrolling 1,105 patients across 23 centers in the U.S., Europe, and Japan, P4 randomized stable CAD patients to either CT-guided PCI planning, including Heartflow FFR_CT Analysis and Heartflow Planner (an earlier version of Heartflow PCI Navigator), or intra-procedural IVUS guidance.

Key P4 trial one-year findings showed CT-guided PCI matched IVUS on outcomes while enabling a faster procedure and lower contrast use, including:

• CT-guided PCI matched IVUS for the primary endpoint of 12-month target-vessel failure (4.1% vs. 4.6%).
• CT-guided PCI had a 17-minute shorter median procedure time than IVUS (46 minutes vs. 63 minutes, a 27% reduction).
• Contrast volume was reduced by approximately 12% in the CT-guided arm (median 150 mL vs. 170 mL).
• CT-guided PCI more than doubled the use of advanced calcium modification (9.2% vs. 3.8%).

“Intravascular ultrasound is an established benchmark, but performing assessments inside the cath lab adds procedural time and requires expertise,” said Carlos Collet, M.D., Ph.D., principal investigator of the P4 trial and Director of Cardiovascular Imaging, Physiology and Translational Therapeutics at the Cardiovascular Research Foundation in New York. “P4 shows that non-invasive CT-guided PCI planning achieves comparable clinical outcomes with shorter procedure times and less contrast, enabling interventionalists to anticipate challenges, tailor their strategy, and enter the cath lab better prepared.”

NAVIGATE-PCI Registry: Optimizing Strategy Before Entering the Cath Lab
TCT AI Lab 3, November 1

NAVIGATE-PCI is a prospective, multi-center registry evaluating the real-world utility of Heartflow PCI Navigator, the first and only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to streamline procedures with increased efficiency and clinical confidence. In the 203-patient cohort presented at TCT, investigators evaluated how access to integrated pre-procedural insights altered treatment strategies established immediately after invasive angiography.

Key NAVIGATE-PCI findings include:

• Treatment plans were modified in approximately 70% of patients after physicians reviewed Heartflow PCI Navigator prior to intervention, compared to angiography alone. The most frequent changes included stent length (41%) and lesion preparation technique (12%).
• Physicians rated their PCI Navigator plans with higher confidence than their angiography-based plans.

“Angiography only shows a two-dimensional silhouette, leaving critical blind spots around plaque burden, calcium and true vessel size,” said Ziad A. Ali, M.D., D.Phil., principal investigator of the NAVIGATE-PCI registry and Director of the DeMatteis Cardiovascular Institute at St. Francis Heart Center in New York. “Heartflow PCI Navigator fundamentally changes our approach, providing the comprehensive 3D and physiologic clarity needed to tailor treatment plans with greater confidence before entering the cath lab.”

The BRAVEHEART Registry: Revealing High CAD Burden in Firefighters to Accelerate Prevention
TCT 1488, November 3

Highlighting the impact of Heartflow’s technology across the entire continuum of care, investigators will also present data from the prospective BRAVEHEART registry. The study evaluated the use of AI-powered Heartflow Plaque Analysis and Heartflow FFR_CT Analysis to identify hidden coronary risk and encourage earlier preventive therapy in 96 asymptomatic firefighters with at least 10 years of occupational smoke exposure.

Key BRAVEHEART findings include:

• Subclinical coronary plaque was identified in 72% of asymptomatic firefighters (mean age 48.1 years), with 16% presenting with severe total plaque volume (>250 mm³).
• Willingness to initiate lipid-lowering medical therapy was reported by 68% of participants following review of their CCTA and Heartflow Analysis insights, while 93% committed to lifestyle modifications.

Experience Heartflow PCI Navigator at TCT 2026

TCT 2026 attendees are invited to visit Heartflow at exhibit booth #3819 for live demonstrations of Heartflow PCI Navigator. See the full schedule of other Heartflow programs, including a lunch symposium, hands-on training workshops, and more at event.heartflow.com/tct2026.

About Heartflow PCI Navigator

Heartflow expanded the Heartflow One platform with the addition of Heartflow PCI Navigator to support diagnosing, managing and guiding treatment for patients throughout the spectrum of CAD care. PCI Navigator is the only integrated, AI-driven percutaneous coronary intervention (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement. Heartflow introduced PCI Navigator to close the critical information gaps interventional cardiologists face before entering the cardiac catheterization lab.

About Heartflow Plaque Analysis with Plaque Staging

Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with 95% agreement against the gold standard, intravascular ultrasound (IVUS), in a prospective, international trial.¹ Heartflow Plaque Staging builds on this foundation, categorizing plaque burden into clinical risk stages to guide actionable risk stratification.^2,3 The framework is validated in 23,000 patients with up to 16 years of follow-up, offering the reproducibility clinicians need for serial monitoring and individualized preventive care.

About Heartflow’s Technology and Research

Heartflow’s technology is redefining precision diagnostic testing and management for coronary artery disease (CAD) through clinically proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 750,000 patients worldwide.⁴ Key benefits include:

• Unmatched proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations.
• Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.^3,5,6,7 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.
• Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
• Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001.

About Heartflow, Inc.

Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

_____________________________
¹ Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.
² Rinehart, et al. JACC Imaging. 2025.
³ Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)h
⁴ Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.
⁵ Narula, et al. EHJ CVI 2024.
⁶ Danad, et al. JAMA Cardiol 2017.
⁷ Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).

BEIJING, Nov. 01, 2026 (GLOBE NEWSWIRE) — During the 2026 Chery International User Summit, hosted by Chery Automobile (9973.HK) in Wuhu, FREELANDER presented its approach to in-car interaction and driver support to international guests, bringing together an AI Voice Assistant, digital cockpit displays and smartphone-based parking functions in FREELANDER 8. FREELANDER is a British Premium Intelligent All-Terrain Brand, jointly developed by JLR and Chery.

The FREELANDER Nightfall venue at the Hengli Hotel in Wuhu

More Natural In Car Conversations

Lucia Mao, CEO of FREELANDER International, introduced an AI Voice Assistant powered by a large language model and tailored for the brand. It is designed to support more natural conversations and a deeper understanding of the vehicle.

The assistant builds on an intelligent cockpit powered by the Qualcomm SA8295P Automotive-Grade Chip, which is standard across all trims. The interface uses immersive 3D visuals and four themes, while physical buttons remain for frequently used functions.

Lucia Mao introduces the AI Voice Assistant at FREELANDER Nightfall

Driving Information Across the Dashboard

The Surround View Gallery includes a 46.3-inch Mini LED Farside Integrated Display with 8K resolution. Spanning approximately 1.2 metres across the dashboard, it brings together seven core modules, including driving information, navigation and all-terrain status. A 15.6-inch centre display complements it, with an optional 17.3-inch ceiling-mounted entertainment display for rear passengers.

Parking and Driver Support

SIVP, or Super Intelligent Valet Parking, enables parking and vehicle recall through a smartphone app in supported scenarios. Availability is market-dependent and operation is subject to system operating conditions. The driver remains responsible at all times.

FREELANDER 8 also includes L2+ advanced driver assistance as standard, with more than 30 functions. These include Adaptive Cruise Control, Lane Centring Control, Automatic Emergency Braking and Around View Monitoring with Transparent Chassis, alongside automatic and remote parking. These systems support the driver and do not make the vehicle fully autonomous.

Technology in Focus

At FREELANDER Nightfall, guests were welcomed by Mornine, an embodied AI humanoid robot from Chery International’s AiMOGA brand. The programme paired technology presentations with driving experiences, giving international visitors an opportunity to explore the brand’s approach to vehicle interaction and everyday usability.

Media contact
Daniel Bao
freelander.international@mychery.com
https://www.cheryinternational.com/

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/d455ac27-193f-4728-82a9-f697762b63cf
https://www.globenewswire.com/NewsRoom/AttachmentNg/7d7a60d4-2277-4cdd-9c00-80f04760befc

BEIJING, Nov. 01, 2026 (GLOBE NEWSWIRE) — During the 2026 Chery International User Summit, hosted by Chery Automobile (9973.HK) in Wuhu, FREELANDER signed partnership agreements with EK Kanoo Group in Bahrain and Saud Bahwan Group in Oman, extending its Middle East network alongside its official UAE dealer partners, Al Tayer Motors and Premier Motors. FREELANDER is a British Premium Intelligent All-Terrain Brand, jointly developed by JLR and Chery.

Partnerships in Bahrain and Oman

The agreements were signed at FREELANDER Nightfall in Wuhu, where international guests also explored the five-seat version of FREELANDER 8 and heard about the brand’s design and technology direction.

Tim Zhang, General Manager of the Middle East Region at Chery International, signed on behalf of FREELANDER. Talal Fuad Ebrahim Kanoo, Managing Director of EK Kanoo Group, and Abdullah Mohammed Saud Bahwan, CEO of Saud Bahwan Group, represented the two partners. FREELANDER International CEO Lucia Mao witnessed the signing.

Brand executives and dealer representatives at FREELANDER Nightfall

Local Partners and Customer Trust

“For me, bringing FREELANDER to the world means more than entering new markets. It means earning the trust of our customers, every day,” said Mao. She emphasised the importance of strong local partners and dependable service.

British Design and Intelligent Technology

The international five-seat FREELANDER 8 offers a two-row alternative to the six-seat layout. Phil Simmons, EVP of the FREELANDER Design Hub and a member of the original Freelander design team, discussed the connection between the vehicle’s British design heritage and its contemporary form.

Mao also introduced an AI Voice Assistant powered by a large language model and tailored for FREELANDER. It is designed to enable more natural conversations and a deeper understanding of the vehicle.

The partnerships connect the brand’s international ambitions with local dealer networks, making regional representation and customer service central to its Middle East development.

Media contact
Daniel Bao
freelander.international@mychery.com
https://www.cheryinternational.com/

A photo accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/ddfa9486-83d9-4408-99f7-32ab62a1dac2

BEIJING, Nov. 01, 2026 (GLOBE NEWSWIRE) — International media, content creators and dealer partners shared their impressions of FREELANDER 8 after a test drive programme at the 2026 Chery International User Summit, hosted by Chery Automobile (9973.HK) in Wuhu, which combined rain-soaked tracks, challenging obstacles and paved roads. FREELANDER is a British Premium Intelligent All-Terrain Brand, jointly developed by JLR and Chery.

Driving in Changing Conditions

At Tuju Campground, participants drove through mud, S-bends, wavy roads, sand and gravel. The changing surfaces gave visitors a practical view of how the vehicle responds beyond a showroom setting.

“I think the driving experience is very good. The systems are working very well on the mud,” said a guest from Slovakia. A guest from Greece described the same course as feeling “like driving normally”.

FREELANDER 8 on the all-terrain course at Tuju Campground

Design and Driving Impressions

A guest from the Dominican Republic described the vehicle as “a combination of elegance, beauty and power for the off-road”, bringing design into a discussion otherwise centred on driving performance.

The i-ATS Intelligent All-Terrain System provides nine modes, including Smart Mode for changing surface conditions and Expert Mode for experienced drivers. The All-Terrain Dual Lock System supports traction, while dual-chamber air suspension allows additional ground clearance off road.

FREELANDER 8 negotiates a cross-axle section

From Obstacles to Open Roads

The obstacle course included steep inclines, water crossings and cross-axle sections. A separate paved course allowed participants to assess acceleration, braking, handling and ride comfort.

Together, the sessions gave overseas visitors a shared basis for assessing the vehicle across different driving environments, with their feedback addressing both its all-terrain character and its suitability for everyday use.

Media contact
Daniel Bao
freelander.international@mychery.com
https://www.cheryinternational.com/

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/f095020c-eea1-4154-baa1-539e5c63bb9d
https://www.globenewswire.com/NewsRoom/AttachmentNg/c7494f3a-4687-4406-a16a-d0b1059cd0e7

BEIJING, Nov. 01, 2026 (GLOBE NEWSWIRE) — During the 2026 Chery International User Summit, hosted by Chery Automobile (9973.HK) in Wuhu, international guests tested FREELANDER 8 across mud, steep slopes and paved roads, offering first-hand feedback on the brand’s approach to combining all-terrain capability with everyday comfort. FREELANDER is a British Premium Intelligent All-Terrain Brand, jointly developed by JLR and Chery.

Testing in Rain and Mud

The programme brought together driving experiences at Tuju Campground, an obstacle course and a paved test course. Rain added to the challenge, giving participants an opportunity to assess the vehicle on slippery surfaces as well as on the road.

On a steep descent, a guest from Spain said their heart was “still pounding a little bit”, before adding: “But I trust the car.” A guest from Egypt welcomed the wet conditions as a demanding test of the slope.

A guest drives FREELANDER 8 at Tuju Campground

Comfort on the Road

On the paved course, a guest from the United Kingdom described FREELANDER 8 as “far more comfortable than I had expected.” A guest from Qatar said experiencing the car in person felt different from hearing about its capabilities.

The vehicle’s i-ATS Intelligent All-Terrain System offers nine terrain modes, while its All-Terrain Dual Lock System helps maintain traction. Dual-chamber air suspension with Continuously Controlled Damping supports ride comfort across changing surfaces.

Intelligent Parking

The programme also introduced SIVP, or Super Intelligent Valet Parking, for parking and vehicle recall through a smartphone app in supported scenarios. Availability is market-dependent and subject to system operating conditions; the driver remains responsible at all times.

The guests’ responses highlighted how confidence on difficult terrain and comfort on ordinary roads both shape perceptions of the brand.

Media contact
Daniel Bao
freelander.international@mychery.com
https://www.cheryinternational.com/

A photo accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/ddbb9207-a18e-4581-a6d2-7c8ccb5d35b0

• 34,246 vehicles were delivered in October 2026
• 334,547 vehicles were delivered year-to-date in 2026, increasing by 38.5% year-over-year
• Cumulative deliveries reached 1,332,139 as of October 31, 2026

SHANGHAI, Nov. 01, 2026 (GLOBE NEWSWIRE) — NIO Inc. (NYSE: NIO; HKEX: 9866; SGX: NIO) (“NIO” or the “Company”), a pioneer and a leading company in the global smart electric vehicle market, today announced its October 2026 delivery results.

The Company delivered 34,246 vehicles in October 2026. The deliveries consisted of 18,125 vehicles from NIO brand, 8,383 vehicles from ONVO brand, and 7,738 vehicles from FIREFLY brand. Cumulative deliveries reached 1,332,139 as of October 31, 2026.

On October 23, 2026, the NIO All-New ES8 reached its 160,000th delivery. From January to October 2026, the NIO All-New ES8 has ranked first in cumulative retail sales volume in both the large SUV segment and the RMB400,000-level vehicle segment in China. As the industry transitions from spec-led to brand-driven competition, sustained sales momentum for the NIO All-New ES8 further enhances recognition of the NIO brand in the premium market.

About NIO Inc.
NIO Inc. is a pioneer and a leading company in the global smart electric vehicle market. Founded in November 2014, NIO aspires to shape a sustainable and brighter future with the mission of “Blue Sky Coming”. NIO envisions itself as a user enterprise where innovative technology meets experience excellence. NIO designs, develops, manufactures and sells smart electric vehicles, driving innovations in next-generation core technologies. NIO distinguishes itself through continuous technological breakthroughs and innovations, exceptional products and services, and a community for shared growth. NIO provides premium smart electric vehicles under the NIO brand, premium smart electric vehicles for families through the ONVO brand, and high-end smart electric compact cars with the FIREFLY brand.

Safe Harbor Statement
This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. NIO may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in announcements, circulars or other publications made on the websites of each of The Stock Exchange of Hong Kong Limited (the “SEHK”) and the Singapore Exchange Securities Trading Limited (the “SGX-ST”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about NIO’s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: NIO’s strategies; NIO’s future business development, financial condition and results of operations; NIO’s ability to develop and manufacture vehicles of sufficient quality and appeal to customers on schedule and on a large scale; its ability to ensure and expand manufacturing capacities including establishing and maintaining partnerships with third parties; its ability to provide convenient and comprehensive power solutions to its customers; the viability, growth potential and prospects of the battery swapping, BaaS, and NIO Assisted and Intelligent Driving and its subscription services; its ability to improve the technologies or develop alternative technologies in meeting evolving market demand and industry development; NIO’s ability to satisfy the mandated safety standards relating to motor vehicles; its ability to secure supply of raw materials or other components used in its vehicles; its ability to secure sufficient reservations and sales of its vehicles; its ability to control costs associated with its operations; its ability to build its current and future brands; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in NIO’s filings with the SEC and the announcements and filings on the websites of each of the SEHK and SGX-ST. All information provided in this press release is as of the date of this press release, and NIO does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For more information, please visit: http://ir.nio.com

Investor Relations
ir@nio.com

Media Relations
global.press@nio.com