Month: September 2026

• In the phase III IMAgINATION study, sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential
• Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage¹
• IgAN is a progressive kidney disease that is typically diagnosed in young adults and up to 50% of people progress to kidney failure within 20 years, requiring dialysis or transplantation^2-4
• Interim data will be presented at an upcoming medical meeting and shared with health authorities

Basel, 23 September 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today positive prespecified interim results from the ongoing phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN). The study met its primary endpoint with sefaxersen achieving statistically significant and clinically meaningful improvements in proteinuria reduction, compared to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR). Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.^5,6 Sefaxersen is a once-monthly subcutaneous injection designed to enable self-administration for people with IgAN. The safety and tolerability profile of sefaxersen was consistent with previously reported data, with no new safety signals identified.

“These interim phase III results show the clinical potential of sefaxersen to modify a key surrogate endpoint of kidney function in people with IgA nephropathy’’ said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Sefaxersen may therefore offer a new treatment option to help slow disease progression and potentially reduce the long-term need for dialysis or kidney transplantation.”

“For patients and families navigating IgAN, the prospect of kidney failure, dialysis, or transplantation creates overwhelming uncertainty,” said Bonnie Schneider, Director and Co-Founder of the IgA Nephropathy Foundation. “As someone who has advocated for this community for over two decades, positive results from the IMAgINATION study give us hope that emerging therapies could help preserve kidney function and transform the treatment landscape.”

The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105. Interim analysis data will be presented at an upcoming medical congress and shared with health authorities, with the goal of bringing this treatment to patients as soon as possible.

IgAN, also known as Berger’s disease, is a chronic and progressive autoimmune disease that leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis.^3,4 Typically diagnosed before the age of 40 years, it affects at least 25 adults per million worldwide each year.^7,8 It is the most common form of primary glomerulonephritis (inflammation of the tiny filters, glomeruli, in the kidneys) and is a major cause of chronic kidney disease as well as kidney failure.⁷

About sefaxersen
Sefaxersen, an investigational highly specific liver-directed antisense oligonucleotide that inhibits factor B production, is the first mRNA-targeted therapy for IgA nephropathy (IgAN).¹ Serum complement factor B levels are elevated in people with IgAN. When we reduce these levels, it in turn reduces the level of protein in urine, which is a key indicator of improved kidney function.^9,10

Sefaxersen is designed to provide sustained control of the alternative complement pathway, an important pathway in IgAN, enabling once-monthly subcutaneous dosing and is intended for self-administration in people with IgAN.¹¹ In phase I and II trials, sefaxersen was shown to be generally well tolerated in healthy volunteers and people with IgAN who were at high risk of progression, and reduced proteinuria and plasma complement factor B.^1,12

Roche licensed sefaxersen from Ionis for the treatment of complement mediated diseases.

About the IMAgINATION study
IMAgINATION [NCT05797610] is a phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous sefaxersen, an investigational antisense inhibitor of complement factor B, in patients with primary IgA nephropathy at high risk of progression.^11,13 The study enrolled 459 people, who are randomised 1:1 to receive sefaxersen or placebo for 105 weeks.^11,13 Participants may switch to open-label treatment after week 105 at the investigator’s discretion or after the common-close timepoint, whichever occurs first.^11,13 The primary endpoint of the study is the change from baseline in the urine protein-to-creatinine ratio at 37 weeks.^11,13

About primary immunoglobulin A nephropathy (IgAN)
IgAN, also known as Berger’s disease, is a serious, chronic and progressive autoimmune kidney disease affecting at least 25 adults per million worldwide each year and is typically diagnosed before the age of 40 years.^4,7,8 In IgAN, immune complexes deposit in the kidneys, which activates the complement system’s alternative pathway, leading to inflammation and subsequent kidney damage.¹⁴ It is the most common form of primary glomerulonephritis (inflammation of kidney glomeruli) and remains a leading cause of kidney failure, with up to 50% of patients experiencing end-stage kidney disease within 20 years of diagnosis.^3,7 Many current therapies aim to reduce protein levels in the urine and control blood pressure to slow progression of the disease.¹⁵

Updated KDIGO 2025 guidelines* highlight the need to address both the underlying immune-mediated causes of IgAN and the downstream consequences of kidney damage.¹⁶ While new therapies have expanded treatment options, important unmet needs remain, including improved long-term preservation of kidney function and more targeted approaches that address key drivers of disease progression.^15,16

About Roche in Immunology
For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus, autoimmune kidney diseases and severe skin conditions (atopic dermatitis). Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

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

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

*KDIGO guidelines serve as the foundational framework for healthcare organisations, policymakers, and clinicians worldwide to standardise kidney disease diagnosis, staging, and treatment.

References
[1]  Barbour SJ, et al. A single-arm phase 2 trial of an investigational RNA therapeutic to complement factor B sefaxersen for treatment of IgA nephropathy. Kidney Int. 2026;109:592-601.
[2] Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1–S276.
[3]  Caster DJ, et al. Clinicopathological characteristics of adult IgA nephropathy in the United States. Kidney Int Rep. 2023;8:1792-1800
[4] Cleveland Clinic. IgA Nephropathy [Internet; cited 2026 Sep 16]. Available from: https://my.clevelandclinic.org/health/diseases/5990-iga-nephropathy  
[5] Longhitano E, et al. Proteinuria and Progression of Renal Damage: The Main Pathogenetic Mechanisms and Pharmacological Approach. Medicina (Kaunas). 2024 Nov 6;60(11):1821.
[6] Qin X, et al. Association Between Urinary Protein-to-Creatinine Ratio and Chronic Kidney Disease Progression: A Secondary Analysis of a Prospective Cohort Study. Front. Med. 2022; 9:854300.
[7] Pitcher D, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18:727-738.
[8] McGrogan A, Franssen CF and de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 26: 414-430.
[9] Chiu YL, et al. Alternative complement pathway is activated and associated with galactose-deficient IgA. Front Immunol 2021; 12: 638309.
[10] Marques F, et al. Impact of early proteinuria reduction in glomerular disease and decline of kidney function: a retrospective cohort. J Clin Med. 2022;11(19):5968.
[11] Barratt J, et al. IMAGINATION: a global phase 3 trial of RO7434656, an antisense oligonucleotide inhibitor of complement factor B, in IgA nephropathy. Kidney Int Rep. 2024;9 Suppl. WCN24-912.
[12] McCaleb ML, et al. Inhibiting the alternative pathway of complement by reducing systemic complement factor B: Randomized, double-blind, placebo-controlled phase 1 studies with Sefaxersen. Immunobiology. 2025 Mar;230(2):152876.
[13] ClinicalTrials.gov. A Study to Evaluate RO7434656 in Participants With Immunoglobulin A Nephropathy (IgAN) (IMAGINATION) (NCT05797610) [Internet; cited 2026 Sep 16]. Available from: https://clinicaltrials.gov/study/NCT05797610  
[14] Wu MY, et al. The emerging role of pathogenesis of IgA nephropathy. J Clin Med. 2018;7:225.
[15] Floege J, et al. Current treatment of IgA nephropathy. Semin Immunopathol. 2021;43:717-728.
[16] Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1–S71

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Attachment

• Media Investor Release sefaxersen English

Roche announced today that the Board of Directors of Roche Holding Ltd has approved to propose Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board of Directors at Roche’s Annual General Meeting on March 9, 2027.

Roche Chairman Severin Schwan: “I am pleased that we have been able to propose Christophe Weber for election to the Board of Directors. Christophe’s intimate knowledge of the healthcare industry and his broad leadership experience will further strengthen our Board.”

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

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 88 88 / e-mail: media.relations@roche.com

Tristan Schmitz Phone: +41 79 529 70 35	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: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Irène Stephan Phone:  +41 79 377 83 75	Albert Thottiyil Phone: +41 79 775 66 12

Attachment

• Media Release Change in BoD English

Press Release
23 September 2026

First-half 2026 results:
AFL Group reports solid results and achieves strategic milestones in the development of its refinancing tools

As of 30 June 2026, in a complex geopolitical and financial environment, AFL Group reports solid results and displays a robust financial structure: 

• Net interest margin increases to €15.6m (vs. €15.2m in the first half of 2025), supported by the continued growth in outstanding loans.
• Net banking income amounts to €15.1m, close to the €15.4m recorded in the first half of 2025, a historically strong period in terms of earnings.
• Gross operating income reaches €4.2m.
• The Group launched major initiatives to diversify and optimise its funding sources, generating nearly €1m in associated non-recurring costs.
• One capital increase enabled 29 new shareholder local governments to join the AFL Group, bringing the total number of shareholders to 1,300.
• Balance-sheet strength is confirmed by robust liquidity and capital ratios, with regulatory capital increasing by more than €20m over the half-year.

Key figures as of 30/06/2026 (IFRS) (vs. 30 June 2025)

	AFL Group1 (consolidated – IFRS)	AFL2 (consolidated – IFRS)
Net banking income	€15.1m (vs. €15.4m)	€15.0m (vs. €15.3m)
Operating expenses	€10.9m (vs. €9.1m)	€10.9m (vs. €9.0m)
Gross operating income	€4.2m (vs. €6.3m)	€4.2m (vs. €6.3m)
Pre-tax income	€3.9m (vs. €6.3m)	€3.9m (vs. €6.3m)
Net profit	€2.8m (vs. €4.7m)	€2.8m (vs. €4.6m)
Cost/income ratio3	81.7% (vs. 66.4%)	81.7% (vs. 66.3%)

“The first half of 2026 opens a new chapter in AFL Group’s development. As a new electoral cycle begins for municipalities and intermunicipal bodies, we remain fully committed to our mission of financing local public investment.
 The Group delivers solid results in the first half-year period, demonstrating the resilience of its business model. The continued growth of our business activity, the strengthening of our own funds and the quality of our financial structure allow us to approach the next stages of our development with confidence.” explains Yves Millardet, Chairman of AFL’s Executive Board.

Positive results supported by continued growth in outstanding loans, despite non-recurring items  

Core business revenues continue to grow, driven by the steady increase in loans granted to shareholder local governments. Gross operating income is affected during the half-year period by non-recurring expenses, primarily related to the ongoing acquisition project of GE SCF S.C.A.

Adjusted for these non-recurring items, gross operating income amounts to €5.1m.

As of 30 June 2026, outstanding signed loans continue their steady growth and reach €10.4bn.

Cost of risk remains inherently limited

AFL’s cost of risk remains inherently limited, reflecting its public development credit institution model, its prudent risk management framework, the very strong credit quality of French local governments⁴ and the quality of the assets held within its liquidity reserve.

As of 30 June 2026, AFL records a €234k charge relating to IFRS 9 expected credit loss provisions. Total provisions represent approximately 0.014% of assets.

These provisions primarily reflect changes in the assumptions used to build macroeconomic scenarios across asset classes, together with balance-sheet growth.

Strengthened prudential own funds

During the first half of 2026, AFL’s prudential own funds increase by more than €20m, mainly as a result of earnings retention from the previous financial year and capital contributions from shareholder local governments.

This momentum illustrates the strength of AFL’s model: business growth and the commitment of its shareholder local governments jointly contribute to strengthening its development and enhancing its capacity to support local public investment.

This translates into high capital ratios as of 30 June 2026:

• AFL Group CET1 ratio: 55.67% (vs. 59.45% as of 31 December 2025) / AFL: 54.15% (vs. 57.78%)
• AFL Group Tier 1 ratio: 57.37% (vs. 61.33%) / AFL: 63.61% (vs. 68.71%)
• AFL Group banking leverage ratio: 2.45% (vs. 2.32%) / AFL: 2.71% (vs. 2.59%)
• AFL Group leverage ratio for public development credit institutions: 11.37% (vs. 11.18%) / AFL: 12.67% (vs. 12.58%).

High liquidity levels

In line with its prudent management principles, AFL maintains very strong liquidity levels as of 30 June 2026:

• AFL’s Liquidity Coverage Ratio (LCR) stands at 250% (vs. 485% as of 31 December 2025 and a regulatory minimum of 100%)
• AFL’s internal 12-month liquidity ratio (NCRR) stands at 161% as of 30 June 2026 (vs. 101% as of 31 December 2025), corresponding to a €2.4bn liquidity reserve, enabling AFL to meet all its funding needs for more than one year without recourse to the capital markets.

The strength of AFL’s financial structure is recognised by the rating agencies, assigning it ratings equivalent to those of the French sovereign.

AFL Ratings

	Fitch Ratings	Standard & Poor’s
Long-term rating	A+	A+
Outlook	Stable	Stable
Short-term rating	F1+	A-1

Significant events during the first half of 2026

Launch of major strategic initiatives to diversify and optimise AFL’s funding costs for the benefit of local governments

Since 2024, AFL’s funding cost in the bond markets, as more broadly that of French public sector issuers, has increased significantly following the downgrade of the French sovereign rating.

Against this backdrop, AFL is pursuing two major strategic initiatives aimed at strengthening its refinancing capabilities over the long term. The first involves securing access to the covered bond market through the proposed acquisition of GE SCF S.C.A., a French specialised credit institution issuer of covered bond (“société de credit foncier”), subject to the required regulatory approvals. The second focuses on obtaining a 0% prudential risk weighting for AFL’s senior debt securities.

These initiatives share a common objective: to diversify funding sources, enhance the resilience of AFL’s business model and preserve the best possible financing conditions for local and regional governments.

Enhanced presence in the capital markets

During the first half of 2026, AFL has raised €1bn to an average spread of 14.6 basis points over the OAT curve, despite a more challenging market environment.

AFL completed its first Australian domestic bond issuance in May 2026, for an amount equivalent to €366m. This transaction marks an important milestone in AFL’s refinancing strategy and supports the diversification of its investor base while contributing to the optimization of funding costs.

Through a new €500m benchmark bond issue launched in May 2026, AFL completed its euro yield curve with a new September 2033 reference maturity. The transaction received exceptionally strong investor demand, generating the largest order book in AFL’s history at €3.7bn.

AFL continues its commitment to sustainable finance

As part of its annual funding programme and its ongoing efforts to continuously enhance its sustainable finance framework, AFL published on 29 June 2026 an updated version of its Sustainability Bond Framework.

The revised framework is aligned with international market standards, including the Green Bond Principles, Social Bond Principles and Sustainability Bond Guidelines published by the International Capital Market Association (ICMA).

The framework also received an independent external assessment through a Second Party Opinion issued by EthiFinance:

• Framework: View the ESG issuance framework
• SPO EthiFinance: View the Second Party Opinion

Subsequent events

• On 22 September 2026, the Board of Directors of AFL-ST launched a new capital increase to enable additional local governments to join the Group as shareholders.
• Since the end of the first half of the financial year, AFL has completed a new syndicated euro-denominated sustainable bond issue, maturing in 2035, for an amount of €500 million under its updated Sustainability Bond Framework. The transaction was priced at a spread of 16 basis points over the OAT curve.
• As at the date of this press release, AFL raised a total principal amount of €1,501 million on the bond markets since the beginning of 2026, at an average spread of 15 basis points over the OAT curve and completed the execution of its 2026 funding programme.

On 9 September 2026, AFL’s Executive Board formally approved AFL’s corporate and consolidated half-year financial statements for the first half of 2026. Meeting under the chairmanship of Mr. Sacha Briand on 22 September 2026, AFL’s Supervisory Board favourably reviewed AFL’s half-year financial statements.

On 22 September 2026, the Board of Directors of AFL-ST, the Société Territoriale, meeting under the chairmanship of Mrs. Marie Ducamin, approved AFL Group’s consolidated half-year financial statements.

The Statutory Auditors have completed their limited review procedures on the corporate and consolidated half-year financial statements for the period ended 30 June 2026.

This press release contains certain forward-looking statements. Although AFL Group believes that these statements are based on reasonable assumptions as of the date of publication of this press release, they are by nature subject to risks and uncertainties, including those relating to geopolitical tensions, changes in macroeconomic forecasts and developments in monetary policy, which could cause actual results to differ from those expressed or implied in such statements.

AFL Group’s financial information for the first half of 2026 consists of this press release and the report available here.   

About AFL, the public bank by and for local governments

The only French bank to be 100% owned by local governments, AFL benefits from a unique and innovative business model; that of a bank created by and for local authorities. By becoming shareholders in AFL, local authorities access quick and personalised financing for their local investments, all while signing up to a sustainable and responsible way of working. For these authorities, it provides the freedom to invest, while maintaining a well-controlled management of their finances. Since the start of its activities in 2015, AFL has already provided more than 13 billion euros in financing and now totals 1,300 shareholders.

More information: www.agence-france-locale.fr/en/ 

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1 AFL Group comprises Agence France Locale – Société Territoriale (AFL-ST), Agence France Locale (AFL), Agence France Locale Immobilier and Agence France Locale – Participations SAS.
2 AFL’s consolidated financial statements comprise Agence France Locale, Agence France Locale Immobilier and Agence France Locale – Participations SAS.
3 Calculated by adding the Additional Tier 1 (“AT1”) interest expenses to net banking income, albeit in line with IFRS, these interest charges are directly booked as a reduction in shareholders’ equity without being recorded in the income statement.  
4 The risk weighting applicable to regions, departments, municipalities and municipality groupings with their own tax-raising powers was reduced to 0% by decision of the Supervisory College of France’s Prudential Supervision and Resolution Authority (ACPR) on 21 June 2024.

Attachments

• 2026.09.23.Press_release_AFL_2026_Half-year_results
• 2026.AFL_RAPPORT_FINAL_SEMESTRIEL_ENG_compressed
• FINAL.Rapport semestriel AFL-ST ENG S1 2026