Roche 3 - LSW - Life Sciences & Pharmaceutical News

Basel, 13 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held 17-21 October 2025 in Berlin, Germany. The data underscore Roche’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers.

Key presentations include:

Giredestrant: Primary results from the phase III evERA Breast Cancer study, the first positive head-to-head phase III trial investigating a selective oestrogen receptor (ER) degrader-containing regimen versus a standard of care combination in the post-cyclin-dependent kinase inhibitor setting for people with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.^1,2 The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations.³ Data will be presented as a late-breaking oral abstract.
Tecentriq: Results from the IMvigor011 trial, the first global phase III study pioneering a circulating tumour DNA (ctDNA)-guided approach to post-surgery treatment in muscle-invasive bladder cancer (MIBC).⁴ Topline results show that people who had detectable ctDNA and were treated with Tecentriq® (atezolizumab) had statistically significant and clinically meaningful improvements in disease-free survival (DFS) and overall survival (OS).⁵ Data will be presented as part of the Presidential Symposium.
Alecensa: Final OS data from the pivotal ALEX study of Alecensa® (alectinib).⁶ Alecensa is an established first-line treatment and a standard of care for people with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).^7-9 Data will be presented as a late-breaking oral abstract and published simultaneously in the Annals of Oncology.
Alecensa: Updated results from the phase III ALINA study, reinforcing the role of adjuvant Alecensa as the standard of care for patients with resected ALK-positive NSCLC.¹⁰After a median follow-up of approximately four years, Alecensa DFS data compared with chemotherapy will be presented.¹⁰

Overview of key presentations featuring Roche medicines:

Medicine	Abstract title	Abstract number/presentation details
Breast cancer
Giredestrant	Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial	#LBA16 late-breaking oralProffered paper session 1: Breast cancer, metastaticSaturday 18 October 202510:15-10:25 CEST
Giredestrant	Preoperative window-of-opportunity study with giredestrant or tamoxifen (tam) in premenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) and Ki67≥10% early breast cancer (EBC): the EMPRESS study (IIS: MEDSIR)*	#294MO mini oralMini oral session: Breast cancer, early stageSunday 19 October 202510:50-10:55 CEST
Giredestrant plus Itovebi™ (inavolisib)	Interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS breast cancer (BC): A phase Ib/II study of GIRE treatment (rx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC)	#508P posterPoster session: Breast cancer, metastaticMonday 20 October 202512:00-17:30 CEST
Itovebi™	phase I/Ib trial of inavolisib (INAVO) + pertuzumab (P) + trastuzumab (H) forPIK3CA-mutated (mut), HER2-positive advanced breast cancer (HER2+ aBC)	#548P posterPoster session: Breast cancer, metastaticMonday 20 October 202512:00-17:30 CEST
Genitourinary cancer
Tecentriq® (atezolizumab)	IMvigor011: a phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer	#LBA8 late-breaking oralPresidential Symposium IIIMonday 20 October 202516:30-16:42 CEST
Lung cancer
Alecensa® (alectinib)	Final overall survival (OS) and safety analysis of the phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC)	#LBA73 late-breaking oralProffered paper session: NSCLC metastaticFriday 17 October 202517:06-17:16 CEST
Alecensa® (alectinib)	Updated results from the phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC)	#1787MO mini oralMini oral session 2: Non-metastatic NSCLCMonday 20 October 202514:50-14:55 CEST
Tecentriq	Patterns of disease progression (PD) and efficacy associated with tumour burden from the phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in ES-SCLC	#2762MO mini oralMini Oral session 1: Non-metastatic NSCLCSaturday 18 October 202517:15-17:20 CEST
Gastrointestinal cancer
Tecentriq (IIS: NCI, Alliance)**	Clinical outcome of patients (pts) with sporadic vs Lynch syndrome-related stage III colon carcinoma (CC) with deficient mismatch repair (dMMR) treated in a randomized trial of adjuvant FOLFOX alone or combined with atezolizumab (atezo; anti-PD-L1)	#752P posterPoster session: Colorectal cancerSunday 19 October 2025
Divarasib	Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors	#927MO mini oralMini oral session: Developmental therapeuticsFriday 17 October 202517:00-17:05 CEST

* Investigator Initiated Study (IIS). The study is sponsored by MEDSIR and supported by Genentech, a member of the Roche Group.
** Investigator Initiated Study (IIS). The study is sponsored by the National Cancer Institute (NCI), conducted by the Alliance for Clinical Trials in Oncology and supported by Genentech, a member of the Roche Group.

About Roche in oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA16.
[2] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT05306340.
[3] Roche. Positive phase III results show Roche’s giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer [Internet; cited 2025 October]. Available from: https://www.roche.com/media/releases/med-cor-2025-09-22.
[4] Powles T, et al. IMvigor011: a phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA8.
[5] Natera. IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit [Internet; cited 2025 October]. Available from: https://www.natera.com/company/news/imvigor011-bladder-cancer-trial-achieves-positive-results-with-signatera-strongly-predicting-adjuvant-immunotherapy-benefit/https://www.natera.com/company/news/imvigor011-bladder-cancer-trial-achieves-positive-results-with-signatera-strongly-predicting-adjuvant-immunotherapy-benefit/.
[6] Mok T, et al. Final overall survival (OS) and safety analysis of the phase 3 ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA73.
[7] Peters S, et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(9); 829-838.
[8] Mok T, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31(8):1056-1064.
[9] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.5.2024.
[10] Dziadziuszko R, et al. Updated results from the phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC). To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #1787MO.

Roche Global Media Relations
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Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
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Roche Investor Relations

Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study¹
First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC²
Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC*³

Basel, 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide (CE).⁴ This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. The U.S. National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®)* have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.³

“For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,” said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and haematology at Yale Cancer Center and Smilow Cancer Hospital. “The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven't progressed after standard induction treatment with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival.”

“The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.”

The FDA approval is based on results from the phase III IMforte study, which showed that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Following 3.2 months of induction therapy, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54; 95% CI: 0.43–0.67; p<0.0001). Safety was generally consistent with the known safety profiles of Tecentriq and lurbinectedin.¹

Today’s approval builds on Tecentriq’s established role in ES-SCLC. In 2019, the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC, based on the IMpower133 study, which at the time was the first new treatment option in two decades for this patient population.⁵

About the IMforte study
IMforte [NCT05091567] is a phase III, open-label, randomised trial evaluating the efficacy and safety of Tecentriq® (atezolizumab) plus lurbinectedin (Zepzelca®) versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomised 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomised 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS) from randomisation into the maintenance phase.¹

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals.

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

All trademarks used or mentioned in this release are protected by law.

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References

[1] Paz-Ares L, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Presented at: ASCO Annual Meeting; 2025 May 30-Jun 03; Chicago, IL, USA. Abstract #8006.

[2] Paz-Ares L, et al. Unmet Needs in Maintenance Therapy for Extensive Stage Small Cell Lung Cancer. Clinical Lung Cancer. 2025;26(3): 168-178.

[3] National Comprehensive Cancer Network (NCCN). NCCN Guidelines® small cell lung cancer version 2.2026. [Internet; cited September 2025]. Available from: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1462.

[4] TECENTRIQ Prescribing Information. Genentech, Inc.

[5] F. Hoffman-La Roche Ltd. FDA approves Roche's Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer [Internet; cited September 2025]. Available from: https://www.roche.com/media/releases/med-cor-2019-03-19.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Basel, 1 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has commenced a tender offer for all of the outstanding shares of common stock of 89bio, Inc. (89bio) (NASDAQ: ETNB) at a price of $14.50 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain milestone payments of up to an aggregate of $6.00 per share in cash. The tender offer is being made pursuant to the previously announced merger agreement dated as of September 17, 2025, among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Bluefin Merger Subsidiary, Inc., a wholly owned subsidiary of Roche Holdings, Inc., and 89bio.

The tender offer period will expire at one minute after 11:59 p.m., New York City time on October 29, 2025, unless the offer is extended.

Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (SEC). Bluefin Merger Subsidiary, Inc. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.

89bio has also filed a Solicitation/Recommendation Statement with the SEC on Schedule 14D-9, which includes the unanimous recommendation of the 89bio board of directors that 89bio stockholders tender their shares in the tender offer. The closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and there being validly tendered and not validly withdrawn a majority of the outstanding shares of 89bio common stock. The offer is not subject to any financing condition. Following successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second-step merger at the same price of $14.50 per share, plus the CVR. The closing of the transaction is expected to take place in the fourth quarter of 2025.

The complete terms and conditions are set out in the Offer to Purchase, which was filed with the SEC today, October 1, 2025. 89bio stockholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request for the Solicitation/Recommendation Statement on Schedule 14D-9 to 89bio’s website at www.89bio.com or the Offer to Purchase and the other related materials to MacKenzie Partners, Inc., the Information Agent for the offer, toll free at (800) 322-2885 (or please call (212) 929-5500 if you are located outside the U.S. or Canada) or via email at tenderoffer@mackenziepartners.com.

Before making any decision with respect to the Offer, investors are urged to read the Offer to Purchase and related documents, as well as the Solicitation/Recommendation Statement, because they contain important information about the Offer.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This communication may include statements that are not statements of historical fact, or “forward-looking statements,” within the meaning of the federal securities laws, including with respect to Roche’s proposed acquisition of 89bio. Any express or implied statements that do not relate to historical or current facts or matters are forward-looking statements. These statements are generally identified by words or phrases such as “believe”, “anticipate”, “expect”, “intend”, “plan”, “will”, “may”, “should”, “estimate”, “predict”, “project”, “strategy”, “potential”, “continue” or the negative of such terms or other similar expressions. Such statements include, but are not limited to, the ability of Roche and 89bio to complete the transactions contemplated by the merger agreement, including each party’s ability to satisfy the conditions to the consummation of the offer contemplated thereby and the other conditions set forth in the merger agreement, statements about the expected timetable for completing the transaction, the parties’ beliefs and expectations and statements about the benefits sought to be achieved in Roche’s proposed acquisition of 89bio, the potential effects of the acquisition on both Roche and 89bio and the possibility of any termination of the merger agreement. These statements are based upon the current beliefs and expectations of Roche and 89bio’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable, if at all. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements, and you should not place undue reliance on these statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the offer and the subsequent merger; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer and the merger contemplated by the merger agreement may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the tender offer or the subsequent merger; the ability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on 89bio’s business; the possibility that the milestones related to the contingent value right will never be achieved and that no milestone payments may be made; and the risk of legal proceedings being brought in relation to the transactions and the outcome of such proceedings, including the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in 89bio’s public filings with the SEC, including the “Risk Factors” section of 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q, Form 8-K and in other filings 89bio makes with the SEC from time to time as well as the tender offer materials filed by Roche and its acquisition subsidiary and the Solicitation/Recommendation Statement to be filed by 89bio, in each case as amended by any subsequent filings made with the SEC.

Neither Roche nor 89bio undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergencies.
The test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity.
The global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings.^1,2

Basel, 30 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the primary results from the TSIX Study Program, which evaluated the performance of its new sixth-generation high-sensitivity Troponin T test for diagnosing heart attacks. Presented at the European Society for Emergency Medicine (EUSEM) 2025² and the European Society of Cardiology (ESC) 2025¹, the study results showed that the Elecsys® Troponin T hs Gen 6 test was able to identify acute myocardial infarction (AMI), or heart attack, and identify those not having an AMI, with a high level of precision.^2,3 This supports the efficient triage of patients arriving at the emergency department, ensuring healthcare resources can be focused where they are needed most. This data announcement follows the recent CE Mark approval for the test.

As one of the top three reasons for emergency care visits,⁴ chest pain creates significant anxiety and uncertainty for patients whilst putting pressure on healthcare services. Yet only one in every ten patients who presents with symptoms will actually be experiencing a heart attack.⁵ With 49% of emergency departments in Europe reporting overcrowding on a frequent basis,⁶ the ability to quickly and reliably identify those patients who are suffering from AMI, and to rule out those who are not, is crucial in ensuring the best possible outcomes for patients.

"Coronary artery disease continues to place an immense strain on global health systems, particularly in emergency care, where cases of chest pain are among the most challenging presentations to evaluate,” said Matt Sause, CEO of Roche Diagnostics. “Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence. This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity, and emergency services can prioritise resources to deliver care effectively to those in urgent need."

About Roche Diagnostics’ commitment to heart health
With a 30-year legacy in troponin innovation, Roche was the first company in the world to introduce high-sensitivity troponin tests. And Roche's troponin test was the first to receive FDA approval. Building on this legacy, the novel test is the first in a series of anticipated approvals for Roche, reflecting the company's vision for the future of coronary artery disease (CAD) management. This includes a portfolio of innovative tests that enable consistent and precise biomarker measurements to be reliably compared across healthcare settings. It also includes future acute coronary syndrome (ACS) offerings that will combine next-generation digital algorithms, biomarkers, near-patient care devices, and laboratory analysers.

About the TSIX Study Program
Forming the basis for regulatory approval, the comprehensive TSIX study program recruited a total of over 13,000 individuals.^1,4 It is the first global clinical study program of its kind to be performed in the use of troponin testing, involving patients in the US, China, Japan and the EU, and reflects Roche’s ambition to work towards more standardised care across the world.

The REF-TSIX study was designed to establish the standard upper reference limits (URLs) for troponin levels in the blood.¹ These limits represent the highest expected concentration of troponin in a healthy population, providing the benchmarks used to diagnose myocardial infraction. The study prospectively collected plasma and serum samples from a diverse global population to ensure the assay's accuracy across different demographics and healthcare settings. Data presented at European Society of Cardiology congress 2025 showed a 99th percentile URLs of 27 ng/L for the overall population and sex-specific URLs of 18 ng/L for females and 32 ng/L for males.¹ These findings confirm the test's consistency and accuracy, meeting the highest benchmarks for clinical diagnostics as recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).⁷

To validate the clinical performance of the newly established URLs, the prospective, international, multicenter, longitudinal cohort study PERFORM-TSIX enrolled 5,631 patients across 50 sites,^2,4 presenting to emergency departments with symptoms of ACS. Up to five samples were collected at intervals after presentation at the emergency department, to provide a detailed assessment of the test's performance across time points.⁴

The study data demonstrated that the assay was highly effective at detecting heart attacks, meeting its primary endpoint using the universal 99th percentile URL at three hours post emergency department presentation.³ Moreover, the study data showed that 56.6% of patients were able to be discharged in the first hours after presentation with a negative predictive value of 99.7%, underlining its excellent clinical performance.^2,4

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Daniels LB et al. Establishing reference values in healthy participants for a next generation cardiac troponin T high-sensitivity assay – the REF-TSIX global reference study. Presented at European Society of Cardiology Congress. 2025 August
[2] Peacock WF et al. Primary results of PERFORM-TSIX, a prospective, international, observational, longitudinal cohort study evaluating clinical performance of the next generation cardiac troponin T high-sensitivity Gen 6 assay in acute coronary syndrome myocardial infarction. Presented at European Society of Emergency Medicine September 2025

[3] F. Hoffmann-La Roche Ltd. Elecsys® Troponin T hs Gen 6 Method Sheet. (v.2.0). 2025
[4] Audrey J. Weiss, Ph.D., and H. Joanna Jiang, Ph.D., Agency for Healthcare Research and Quality, Most Frequent Reasons for Emergency Department Visits, 2018. Available at: https://hcup-us.ahrq.gov/reports/statbriefs/sb286-ED-Frequent-Conditions-2018.jsp
[5] Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735. PMID: 26547467.
[6] Velt KB, Cnossen M, Rood PPM, Steyerberg EW, Polinder S, Lingsma HF; CENTER-TBI investigators. Emergency department overcrowding: a survey among European neurotrauma centres. Emerg Med J. 2018 Jul;35(7):447-448. doi: 10.1136/emermed-2017-206796. Epub 2018 Mar 21. PMID: 29563151.
[7] Aakre, K. M., Saenger, A. K., Body, R., Collinson, P., Hammarsten, O., Jaffe, A. S., ... & Apple, F. S. (2022). Analytical considerations in deriving 99th percentile upper reference limits for high-sensitivity cardiac troponin assays: educational recommendations from the IFCC committee on clinical application of cardiac bio-markers. Clinical chemistry, 68(8), 1022-1030.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in post-CDK inhibitor setting, compared with standard of care plus everolimus
The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed
evERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combination¹
Data will be presented at an upcoming medical meeting and shared with health authorities

Basel, 22 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. Overall survival (OS) data were immature, but a clear positive trend was observed. Follow-up continues to the next OS analysis. The giredestrant combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were observed. This is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combination.¹

“These results show that the giredestrant combination provided a meaningful benefit for ER-positive breast cancer patients whose disease has progressed following treatment with a CDK inhibitor,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussing these results with regulatory authorities with the goal of making this giredestrant-based regimen available to many people with advanced ER-positive breast cancer.”

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.² Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.³ Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.^2,4 Combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signalling pathways, with the potential for improved patient outcomes.³ Additionally, as an all-oral combination, this regimen could help minimise the impact of treatment on people’s lives without the need for injections.⁵

Our extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Data from the evERA study will be submitted to health authorities with the view of bringing this potential treatment option to patients as soon as possible.

About the evERA Breast Cancer study
evERA Breast Cancer [NCT05306340] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.¹

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause. The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations⁴. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.¹

About giredestrant
Giredestrant is an investigational, oral, next-generation selective oestrogen receptor degrader (SERD) and full antagonist.⁶

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.^7,10-12Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)¹³
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)¹
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)¹⁴
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor versus fulvestrant plus a CDK 4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)¹⁵
Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)¹⁶

About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.¹⁷Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.¹⁸
ER-positive breast cancer accounts for approximately 70% of breast cancer cases.²A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.¹⁹Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.³ Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.^3,20There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.^3,20About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2025 September]. Available from: https://clinicaltrials.gov/study/NCT05306340.
[2] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022 Oct;6(5):pkac060.
[3] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513.
[4] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924.
[5] Wood L. A review on adherence management in patients on oral cancer therapies. Eur J Oncol Nurs. 2012 Sept; 16(4):432-38.
[6] Lloyd M, et al. Next-generation selective estrogen receptor degraders and other novel endocrine therapies for management of metastatic hormone receptor-positive breast cancer: current and emerging role. Ther Adv Med Oncol. 2022 Jul 30;14:17588359221113694.
[7] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: San Antonio Breast Cancer Symposium; 2018 December 4-8; San Antonio, Texas, USA. Abstract #P5-04-07.
[8] Liang J, et al. GDC-9545 (giredestrant): A potent and orally bioavailable selective estrogen receptor antagonist and degrader with an exceptional preclinical profile for ER+ breast cancer. J Med Chem. 2021;64(16):11841-56.
[9] Jhaveri K, et al. A first-in-human phase I study to evaluate the oral selective estrogen receptor degrader (SERD), GDC-9545, in postmenopausal women with estrogen receptor-positive (ER+) HER2-negative (HER2-) metastatic breast cancer. Presented at: San Antonio Breast Cancer Symposium; 2019 December 10-14; San Antonio, Texas, USA. Abstract #PD7-05.
[10] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: The European Society for Medical Oncology Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[11] Hurvitz SA, et al. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24:1029-41.
[12] Hershman D, et al. Effect of early discontinuation and nonadherence to adjuvant hormone therapy on mortality in women with breast cancer. J Clin Oncol. 2010 May 20;28(15).
[13] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2025 September]. Available from: https://clinicaltrials.gov/study/NCT04961996.
[14] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2025 September]. Available from: https://clinicaltrials.gov/study/NCT04546009.
[15] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2025 September]. Available from: https://clinicaltrials.gov/study/NCT06065748.
[16] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2025 September]. Available from: https://clinicaltrials.gov/study/NCT05296798.
[17] World Health Organisation. Breast Cancer [Internet; cited 2025 September]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
[18] International Agency for Research on Cancer. Breast cancer cases and deaths are projected to rise globally [Internet; cited 2025 September]. Available from: https://www.iarc.who.int/wp-content/uploads/2025/02/pr361_E.pdf.
[19] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2025 September]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet.
[20] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Lunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four years¹
Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared with 2-4 hours IV infusion
If approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously administered

Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous (SC) formulation of Lunsumio® (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. A final decision is expected from the European Commission in the near future.

"Lunsumio was the first-ever approved CD20xCD3 T-cell engaging bispecific antibody demonstrating high, durable response rates and a favourable safety profile in third-line or later follicular lymphoma," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "If approved, the subcutaneous formulation could help to expand the treatment options available, offering people a fixed-duration therapy with a faster treatment administration time."

The CHMP opinion is based on results from a primary analysis of the phase II GO29781 study. Data show subcutaneous Lunsumio had pharmacokinetic non-inferiority compared to intravenous (IV) administration, with no unexpected safety signals. Overall, the rate and severity of cytokine release syndrome was low (29.8%); events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).²

Lunsumio administered subcutaneously has the potential to reduce the treatment administration time with an approximately one minute injection, compared with 2-4 hours for IV infusion, while retaining the same dosing schedule. Lunsumio is designed to be given for a fixed duration of approximately 6-12 months, depending on a patient’s response to treatment, and can be initiated in the outpatient setting. This means people have a target end date for their course of treatment and the possibility of a treatment-free period.

Data from the phase II GO29781 study have been submitted to other health authorities around the world for approval consideration, including the US Food and Drug Administration.

Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice, to suit diverse patient and healthcare system needs.

About the GO29781 study
The GO29781 study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared to the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability.

This recommendation is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with third-line or later follicular lymphoma. Results showed PK non-inferiority compared to IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were 74.5% (95% confidence interval (CI): 64.4% - 82.9%) and 58.5% (95% CI: 47.9% - 68.6%) respectively, as evaluated by the independent review facility. The median duration of CR was 20.8 months (95% CI: 18.8-not evaluable [NE]) for patients receiving Lunsumio via SC administration. The most common all-grade adverse events were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). Overall, the rate and severity of CRS was low; events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).²

About follicular lymphoma

Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.^3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.³ The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.⁴ It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.^4,6

About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and off-the-shelf allogeneic CAR-T therapies. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Shadman M, et al. Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #4407.
[2] Roche data on file.
[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited September 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited September 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[5] Casulo C et al. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study. J Clin Oncol. 2015; 33(23): 2516-2522.
[6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited September 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

89bio’s pegozafermin allows for a potentially best-in-disease treatment for moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH), one of the most prevalent comorbidities of obesity
Acquisition supports Roche’s strategy as it enhances the company’s portfolio in cardiovascular, renal, and metabolic diseases (CVRM) and offers optionality for future combination development
Roche to acquire 89bio for US$14.50 per share in cash at closing, representing a total equity value of approximately US$2.4 billion. Stockholders would also receive a non-tradeable contingent value right (CVR) for up to an aggregate of US$6.00 per share in cash, representing a total deal value of up to approximately US$3.5 billion

Basel, 18 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire 89bio, Inc. (Nasdaq: ETNB), a publicly listed clinical-stage biopharmaceutical company pioneering the development of innovative therapies for the treatment of liver and cardiometabolic diseases. 89bio’s pegozafermin is a FGF21 analog currently in late-stage development for MASH in moderate and severe fibrotic patients (F2 and F3 stages) as well as cirrhotic patients (F4 stage). The transaction is expected to close in the fourth quarter of 2025.

This acquisition underscores Roche’s dedication to advancing innovative therapies in cardiovascular, renal, and metabolic diseases (CVRM), especially for patients affected by overweight, obesity, and related health challenges such as MASH. Pegozafermin offers a distinct mechanism of action that not only holds the potential for enhanced efficacy and tolerability but also unlocks opportunities for future combination development with incretins, creating synergies with Roche’s CVRM portfolio. Acquiring 89bio, therefore, fosters Roche’s activities to build a robust and differentiated pipeline that targets additional causes of metabolic disease.

“This acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing programmes in our pipeline,” said Thomas Schinecker, Roche Group CEO. “We are highly encouraged by pegozafermin’s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease. With its combined anti-fibrotic and anti-inflammatory mechanism, pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients.”

89bio’s pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) specifically designed to address critical unmet needs in MASH. With its anti-fibrotic and anti-inflammatory mechanism of action combined with a favourable safety profile, pegozafermin is positioned to potentially deliver best-in-disease efficacy for patients suffering from moderate to severe liver fibrosis (F2/F3 stages) and cirrhotic MASH (F4 stage).

Current 89bio employees will join the Roche Group as part of Roche’s Pharmaceuticals Division.

Terms of the Agreement
Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of 89bio common stock at a price of US$14.50 per share in cash at closing, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US$6.00 per share in cash, representing a total equity value of approximately US$2.4 billion at closing and representing a total deal value of up to US$3.5 billion. The price payable at closing represents a premium of approximately 52% to 89bio’s 60-day VWAP price on 17 September 2025. The merger agreement has been unanimously approved by the boards of Roche and 89bio.

89bio will file a recommendation statement containing the unanimous recommendation of the 89bio board that 89bio’s stockholders tender their shares pursuant to the tender offer. Following the completion of the tender offer, Roche will acquire all remaining shares at the same price of US$14.50 per share in cash, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US$6.00 per share in cash, through a second-step merger.

Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain commercial milestones, within specified time periods:

US$2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030)
US$1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US$3.0 billion in any calendar year (by December 31, 2033)
US$2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US$4.0 billion in any calendar year (by December 31, 2035)

There can be no assurance that any payments will be made with respect to the CVR. Assuming all of the conditions of the CVR are met, this would represent additional cash consideration of up to approximately US$1.0 billion for 89bio’s stockholders.

The transaction is expected to close in the fourth quarter of 2025. It is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of 89bio’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Citi is acting as exclusive financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel.

About Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious and increasingly prevalent form of fatty liver disease, is strongly associated with the global rise in obesity and type 2 diabetes.¹ It is estimated that 5 - 7% of the world’s adult population is affected by MASH1, and more than 75% of those living with the condition experience comorbidities such as overweight, obesity, and type 2 diabetes.² MASH is progressive and, when left untreated, can progress to cirrhosis, liver decompensation, and even to hepatocellular carcinoma.

About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The Company is in Phase 3 trials for its lead candidate, 89bio’s pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1 Diabetes Care 2025;48(7):1057–1082
2 Front Cell Dev Biol. 2024 Jul 16;12:1433857. Doi: 10.3389/fcell.2024.1433857

IMPORTANT ADDITIONAL INFORMATION AND WHERE TO FIND IT
The tender offer for the outstanding shares of common stock of 89bio has not yet commenced. This announcement is for informational purposes only and does not constitute a recommendation, an offer to purchase or a solicitation of an offer to sell 89bio’s securities. The solicitation and offer to purchase 89bio’s common stock will only be made pursuant to an offer to purchase and related tender offer materials. At the time the tender offer is commenced, Roche Holdings, Inc. (“Roche”) and its acquisition subsidiary, a wholly owned subsidiary of Roche, will file a Tender Offer Statement on Schedule TO with the Securities and Exchange Commission (the “SEC”) and thereafter, 89bio will file a Solicitation/Recommendation Statement on Schedule 14d-9 with the SEC with respect to the tender offer. The tender offer materials (including the Offer to Purchase, a related Letter of Transmittal, and other tender offer documents) and the Solicitation/Recommendation Statement on Schedule 14d-9 will contain important information.

INVESTORS AND STOCKHOLDERS ARE URGED TO READ THESE TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, THE RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS MAY BE AMENDED FROM TIME TO TIME, CAREFULLY WHEN THEY BECOME AVAILABLE PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES IN THE TENDER OFFER BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.

The tender offer materials and the Solicitation/Recommendation Statement will be filed with the SEC, and investors and stockholders may obtain a free copy of these materials (when available) and other documents filed by Roche and 89bio with the SEC at the website maintained by the SEC at www.sec.gov. Free copies of the offer to purchase, the related letter of transmittal, and certain other offering documents will be made available by Roche, and when available, may be obtained by directing a request to the Information Agent for the tender offer, which will be named in the Tender Offer Statement on Schedule TO. Investors and stockholders may also obtain free copies of the documents filed with the SEC by 89bio on the investor relations page of 89bio’s website at www.89bio.com.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the offer and the subsequent merger; uncertainties as to how many of 89bio ’s stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer and the merger contemplated by the merger agreement may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the tender offer or the subsequent merger; the ability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on 89bio’s business; the possibility that the milestone payments related to the contingent value right will never be achieved and that no milestone payments may be made; and the risk of legal proceedings being brought in relation to the transactions and the outcome of such proceedings, including the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in 89bio’s public filings with the SEC, including the “Risk Factors” section of 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q, Form 8-K and in other filings 89bio makes with the SEC from time to time as well as the tender offer materials to be filed by Roche and its acquisition subsidiary and the Solicitation/Recommendation Statement to be filed by 89bio, in each case as amended by any subsequent filings made with the SEC.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

In AVONELLE-X, the largest long-term extension trial in nAMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on extended dosing by study end¹
Over 60% of people with a difficult-to-treat form of nAMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed²
Vabysmo was well tolerated with a consistent long-term safety profile in nAMD in both studies

Basel, 05 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data from the AVONELLE-X and SALWEEN studies of Vabysmo^® (faricimab),^1,2 presented at the 25th Euretina Congress in Paris, France. Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss.¹ In the single-arm SALWEEN study, Vabysmo showed clinically meaningful vision gains and retinal drying over one year in polypoidal choroidal vasculopathy (PCV), a vision-threatening subtype of nAMD that is especially common in Asia.²

“The robust SALWEEN findings in PCV highlight Vabysmo’s potential to deliver clinically meaningful improvements and help mitigate vision loss,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. “Alongside the long-term AVONELLE-X results in nAMD, these findings support our mission to develop and deliver impactful medicines for people with difficult-to-treat eye diseases."

In new one-year data from the single-arm, open-label Phase IIIb/IV SALWEEN study of Vabysmo for the treatment of people with PCV in Asia, patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44 and 48.² At year 1, more than 50% of patients were assigned to extended five-month dosing. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with these lesions completely resolving in more than 60% of patients and inactivation of polypoidal lesions in the majority (86%) of eyes.² Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD.²

The AVONELLE-X study was a two-year open label extension of the two-year Phase III TENAYA and LUCERNE studies of Vabysmo in nAMD.¹ Vision remained stable throughout the two years of AVONELLE-X and anatomic improvement from the parent trials were sustained through AVONELLE-X.¹ Results showed that after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months, reinforcing the results seen in TENAYA and LUCERNE. Vabysmo was well tolerated, and safety data were consistent with its known safety profile in nAMD.¹

To date, Vabysmo is approved in more than 100 countries for nAMD and diabetic macular edema (DME), and in more than 60 countries for macular edema following retinal vein occlusion (RVO). More than eight million doses of Vabysmo have been distributed globally since its initial US approval in 2022.^3-8

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. nAMD is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.^9-11 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.¹¹ Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.^{9, 12-13}

About polypoidal choroidal vasculopathy

Polypoidal choroidal vasculopathy (PCV) is a subtype of nAMD that is more prevalent in people of Asian or African descent than European descent. It accounts for up to 60% of nAMD cases in people of Asian descent, and up to 20% in people of European descent.¹⁴

PCV is characterised by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera (the whites of the eyes) and the retina. These abnormal vessels can leak fluid or blood, leading to retinal damage and vision loss.¹⁴^-16 People with PCV often experience blurred vision or a blind spot in or near the centre of their vision in one or both eyes.^16,17 Early diagnosis and treatment are important to help restore vision and prevent further vision loss.^15,18

About AVONELLE-X¹

AVONELLE-X (NCT04777201) was an open label multicenter two-year extension study of Vabysmo in 1,029 patients with nAMD who completed one of the two Phase III studies, TENAYA(NCT03823287) or LUCERNE (NCT03823300).

Patients in TENAYA and LUCERNE were treated with either 6 mg Vabysmo or 2 mg aflibercept. During AVONELLE-X, all patients were treated with Vabysmo on a treat-and-extend regimen, where the time between Vabysmo treatments could be adjusted based on retinal fluid levels and visual acuity.

About SALWEEN²

SALWEEN was a Phase IIIb/IV multicentre, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across nine markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients received four loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every eight, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalised treatment plan with doses spaced out as far as every 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48.

About Vabysmo® (faricimab)

Vabysmo is the first bispecific antibody approved for the eye. ^3,4,19 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.^19,20 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).^3-8 Review by other health authorities is ongoing.

About Roche in Ophthalmology

Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for nAMD that continuously delivers a customised formulation of ranibizumab over a period of months.²¹ Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.³ Vabysmo is approved around the world for people living with nAMD, DME and macular edema following RVO.^3,5 Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.²²

About Roche

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Khanani et al. Four-Year Outcomes of Faricimab in nAMD: Safety and Efficacy Results From the AVONELLE-X Long-Term Extension Trial – 4-7 September, EURETINA 2025.

[2] Lai et al. Faricimab for Polypoidal Choroidal Vasculopathy: 1-Year Results from the Phase IIIb/4 SALWEEN Trial. EURETINA. September 4-7, 2025

[3] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. [Internet; cited August 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf.

[4] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited August 2025]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.

[5] European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. [Internet; cited August 2025]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.

[6] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited August 2025]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.

[7] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited August 2025]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.

[8] Roche data on file.

[9] Facts & figures - macular degeneration. BrightFocus Foundation. May 15, 2025. [Internet; cited August 2025]. Available from: https://www.brightfocus.org/macular/facts-figures/.

[10] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): Associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3(1). doi:10.1186/s40662-016-0063-5.

[11] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. eBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029.

[12] Wong WL, et al. Global prevalence of age-related macular degeneration (AMD) and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Global Health. 2014;2:106–16.

[13] Connolly E, et al. Prevalence of AMD associated genetic risk factors and four-year progression data in the Irish population. British Journal of Ophthalmology. 2018 Feb;102:1691-95

[14] Cheung CM. Macular neovascularization and polypoidal choroidal vasculopathy: Phenotypic variations, pathogenic mechanisms and implications in management. Eye. 2023;38(4):659-667. doi:10.1038/s41433-023-02764-w.

[15] Cheung CM, Lai TYY, Ruamviboonsuk P, et al. Polypoidal choroidal vasculopathy: Definition, Pathogenesis, Diagnosis, and Management.Ophthalmology. 2018;125(5):708-724. doi:10.1016/j.ophtha.2017.11.019.

[16] The Foundation of the American Society of Retina Specialists. Polypoidal choroidal vasculopathy. Polypoidal Choroidal Vasculopathy - Patients - The foundation of the American Society of Retina Specialists. [Internet; cited August 2025]. Available from: https://www.asrs.org/patients/retinal-diseases/30/polypoidal-choroidal-vasculopathy.

[17] Pautler S. Polypoidal choroidal vasculopathy. Scott E. Pautler, M.D. Tampa. December 3, 2022. [Internet; cited August 2025]. Available from: https://www.scottpautlermd.com/polypoidal-choroidal-vasculopathy/. Pautler SE. Polypoidal Choroidal Vasculopathy.

[18] Chawla H, Blair K, Vohra V. Polypoidal Choroidal Vasculopathy. In: Stat Pearls. Stat Pearls Publishing; 2025. [Internet; cited August 2025]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK567780/.

[19] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.

[20] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.

[21] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited August 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.

[22] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited August 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette PetillonPhone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release AVONELLE-X and SALWEEN studies on Vabysmo English

Susvimo is under review with the EMA and once approved will be the first continuous delivery treatment for nAMD, affecting 1,7 million in the European Union¹
New seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term²
With up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR)^2-5

Basel, 04 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue® in the EU.⁶The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, and remove the implant (if required).⁶Susvimo® (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD.⁶With immediate and predictable durability, Contivue with Susvimo provides continuous delivery of a customised formulation of ranibizumab directly to the eye.⁶

“Susvimo offers people living with nAMD the opportunity to maintain their vision with as few as two treatments per year,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Moreover, this sustained delivery brings substantial long-term clinical benefits, as demonstrated by the seven years of follow-up data from the LADDER study.”

Three clinical studies contribute to the EMA’s evaluation of efficacy and safety of Contivue with Susvimo in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal. Data from Archway showed patients treated with Contivue with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections.⁷

New long-term data from the LADDER study, presented at the 25th EURETINA Congress in Paris, France, shows that Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term.² In the 59 patients continuously treated with Contivue with Susvimo over seven years, best-corrected visual acuity (BCVA) was 70.4 letters at baseline and 63.2 letters at seven years, an average decline of only six letters approximately over that time for patients who were at or near peak levels at the time of enrolment after receiving three intravitreal injections of standard of care.² Half of all patients had approximately 20/40 vision at seven years (Snellen visual acuity test). Contivue with Susvimo durability was maintained in approximately 95% of patients.²

“The seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo,” said study investigator Carl C. Awh, MD, FASR, Tennessee Retina, Nashville, TN, USA . “For patients with nAMD, the sustained drug delivery of Contivue with Susvimo may provide superior visual outcomes compared to the well-demonstrated average decline in vision associated with long-term intravitreal injections.’’

The port delivery platform devices have been specifically engineered for use with a customized formulation of ranibizumab that is gradually released over time. Roche has several molecules in the pipeline with potential for use with the port delivery platform for continued growth and expansion.

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or ‘wet’ AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.^8-10 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.¹⁰ Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.^{8, 11-12}

About Contivue with Susvimo (Port Delivery Platform with ranibizumab)

Contivue is a refillable eye implant surgically implanted into the eye during a one-time, outpatient procedure.^2-4,13 Contivue also includes four ancillary devices to initially fill, insert, refill, and remove the implant.

Contivue with Susvimo delivers a customised formulation of ranibizumab, Susvimo, over time.⁵ Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.^2-4,14The customised formulation of ranibizumab, Susvimo, delivered by Contivue with Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.¹⁵

In the US, the devices (refillable eye implant and ancillary devices) and medicine (customised formulation of ranibizumab) are approved by the Food and Drug Administration (FDA) as a single product, called Susvimo for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR).^2-4

About Roche in ophthalmology

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye conditions. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

Applying our extensive experience, we have brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first US FDA-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD), DME and DR that continuously delivers a customised formulation of ranibizumab over a period of months.^3-4Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.¹⁶Vabysmo is approved around the world for people living with nAMD, DME and macular edema following retinal vein occlusion.¹⁴Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.¹⁵

About Roche

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References

[1] Li at al. Retinal diseases in Europe.Prevalence, incidence and healthcare needs. 2017 [Internet; cited August 2025]. Available from: https://euretina.org/resource/euretina-whitebook-on-prevalence-incidence-and-healthcare-needs-for-retinal-diseases-in-europe/

[2] Khanani et al. First-Time Long-Term Efficacy and Safety Outcomes of PDS Patients Enrolled in the Ladder Phase 2 Trial of PDS for nAMD Followed for up to ~7 Years. 4-7 September, EURETINA 2025.

[3] Roche. FDA approves Roche’s Susvimo for diabetic retinopathy. 2025. [Internet;cited September 2025]. Available from: https://www.roche.com/media/releases/med-cor-2025-05-22

[4] Roche. FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness. 2025. [Internet; cited September 2025]. Available from: https://www.roche.com/media/releases/med-cor-2025-02-04

[5]: US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited September 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.

[6]. Roche data on file

[7] Khanani et al. Five Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Presented at: The American Society of Retina Specialists (ASRS) 2025 Annual Meeting; 2025 August 01; Long Beach, California, United States.

[8] Facts & figures - macular degeneration. BrightFocus Foundation. May 15, 2025. [Internet; cited September 2025]. Available from: https://www.brightfocus.org/macular/facts-figures/.

[9] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): Associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3(1). doi:10.1186/s40662-016-0063-5.

[10] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. eBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029.

[11] Wong WL, et al. Global prevalence of age-related macular degeneration (AMD) and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Global Health. 2014;2:106–16.

[12] Connolly E, et al. Prevalence of AMD associated genetic risk factors and four-year progression data in the Irish population. British Journal of Ophthalmology. 2018 Feb;102:1691-95

[13] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021

[14] Heier JS, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. The Journal of Retinal and Vitreous Diseases. 2021;41:1-19.

[15] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited September 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.

[16] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. [Internet; cited September 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Attachment

Media Release Susvimo CE mark for Contivue English

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D.
The facility will create more than 1,900 jobs and support the production of next-generation metabolic medicines, including treatments for obesity
These investments underscore Roche’s commitment to innovative manufacturing, designed to bring life-changing treatments to patients faster

Basel, 25 August 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest US manufacturing site in Holly Springs, North Carolina. This significant development marks the establishment of Genentech’s first manufacturing facility on the East Coast. The 65,000 m² facility is strategically designed to support production of the company’s future portfolio of metabolic medicines, including next-generation treatments for obesity.

Genentech’s initial investment in North Carolina is estimated at more than $700 million and is part of Roche’s $50 billion commitment to invest in US manufacturing infrastructure and R&D. The facility will create more than 1,900 jobs.

Roche Group CEO Thomas Schinecker:

“I am proud to break ground on our new state-of-the-art manufacturing facility in North Carolina, which will support the production of our next-generation obesity treatments. This $700 million project is an integral part of our broader $50 billion commitment to further expand our already significant presence in the United States, building on our 120-year legacy of driving innovation and creating jobs across America. I am excited about the impact this facility will have on delivering life-changing medicines to patients in the US and around the world.”

The company selected Holly Springs in North Carolina, a growing hub for biopharmaceutical innovation, for its highly skilled local workforce, strong academic institutions and proximity to other leading life science companies.

The new facility is expected to be completed and operational by 2029, incorporating modern biomanufacturing technologies, as well as advanced automation and digital capabilities. The 400,000 m² lot includes space for future expansion.

Designed for high-volume, efficient, and sustainable production, the new facility will increase Roche’s manufacturing capacity and enhance supply chain resilience. It complements Roche’s manufacturing sites around the world, including in Europe and Switzerland, to efficiently serve patients where they are.

About Roche

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

About neovascular age-related macular degeneration

About polypoidal choroidal vasculopathy

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About Roche in Ophthalmology

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About neovascular age-related macular degeneration

About Contivue with Susvimo (Port Delivery Platform with ranibizumab)

About Roche in ophthalmology

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About SALWEEN²