Gsk Plc · LSE:GSK
Gsk — EASL 2026 investor presentation
32 slides from Gsk's conference presentation, May 28, 2026
Slide 1: EASL investor presentation
28 May 2026 EASL investor presentation Bepirovirsen – B-Well 1 & 2 pivotal phase III studies gsk.com
Slide 2: Speakers
Speakers Nina Mojas Professor Seng Kaivan Melanie Paff Pedro Zarazaga President Gee Lim Khavandi Vice President SVP Global Product Global Product Director of Hepatology, Medicine Development Strategy, Specialty SVP R&D Head of Strategy National University Lead, Hepatitis B Respiratory, Health System
Slide 3: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 4: Nina Mojas
Nina Mojas President, Global Product Strategy 4
Slide 5: Chronic Hepatitis B (CHB) is a lifelong infection, globally undertreated
Chronic Hepatitis B (CHB) is a lifelong infection, globally undertreated CHB puts people at high risk of death from cirrhosis and liver cancer Diagnostic Gap globally: Only 27% • Mostly spread from mother-to-child diagnosed, less than 5% on treatment • ~95% of these infections lead to CHB • Standard
Slide 6: Today's SoC is not sufficient to reduce HCC risk
Today’s SoC is not sufficient to reduce Hepatocellular carcinoma (HCC) risk HBsAg loss associated with significant reduction in risk of HCC Risk of HCC in CHB patients receiving NA therapy 10 No complete 8 DNA 7.8% suppression 41% HCC risk Cumulative incidence Complete DNA reduction of HCC (%) 6 sup
Slide 7: Significant diagnosed population waiting for better treatment options
Significant diagnosed population waiting for better treatment options US patient opportunity China patient opportunity Infected ~75m Infected ~1.7m Diagnosed ~44m Diagnosed ~400k ~70% of CHB patients ~70% of CHB patients On treatment ~120k On treatment ~6m have HBsAg <3000 have HBsAg <3000 • Current
Slide 8: 3 key markets represent ~80% global opportunity
3 key markets represent ~80% global opportunity US China • Priority Review and collaboration with Sino Biopharmaceutical • A market leader in hepatology • Broad commercial footprint with access to >5000 medical centres • BTD and PDUFA 26 October Japan • >50% of CHB population is concentrated • SENKU
Slide 9: B-Well 1 & 2
B-Well 1 & 2 Prof Seng Gee Lim, Director of Hepatology National University Health System Singapore 9
Slide 10: Clinically meaningful rates of functional cure in virologically suppressed patients with chronic hepatitis B
GS-001 Clinically meaningful rates of functional cure in virologically suppressed patients with chronic hepatitis B infection treated with bepirovirsen: B-Well Phase 3 Trials Professor Seng-Gee Lim, National University Health System, Singapore, on behalf of the B-Well Study Group Jinlin Hou*, Seng-G
Slide 11: Therapies targeting functional cure are needed in chronic HBV infection
Therapies targeting functional cure are needed in chronic HBV infection Functional cure is the treatment goal in chronic HBV infection5,6 • Chronic HBV infection ➢ ≥24 weeks of sustained HBV DNA <LLOQ and HBsAg loss after affects 240 million people finite therapy, with or without anti-HBs worldwide1
Slide 12: B-Well 1 and 2 objectives
B-Well 1 and 2 objectives Primary outcome at Week 72 Functional cure rate in participants with baseline HBsAg ≤3000 IU/mL • 24 weeks after discontinuing all HBV treatments: – HBsAg loss (qualitative; <0.05 IU/mL) – HBV DNA <LLOQ (<20 IU/mL or target not detected) Key secondary outcomes at Week 72 Fu
Slide 13: B-Well 1 and 2 were replicate studies, identical in design
B-Well 1 and 2 were replicate studies, identical in design Double-Blind NA Discontinuation OR Durability stage¶ Screening* Treatment stage NA-only stage Continue on NA-only stage (ongoing) W‒8 W1 W24 W48 W72 W96 Key enrolment eligibility Bepirovirsen QW (300 mg + 2 loading ✓ Stable NA therapy doses‡
Slide 14: Baseline characteristics were similar across treatment groups and studies
Baseline characteristics were similar across treatment groups and studies B-Well 1 B-Well 2 Bepirovirsen Placebo Bepirovirsen Placebo Characteristic N=653 N=328 N=571 N=286 Age, mean (SD) years 50.2 (11.8) 49.2 (10.6) 48.7 (10.4) 49.2 (11.4) Male sex, n (%) 461 (71) 227 (69) 414 (73) 202 (71) Race,
Slide 15: Functional cure was achieved in 19% of bepirovirsen recipients and no placebo recipients
Functional cure was achieved in 19% of bepirovirsen recipients and no placebo recipients Primary outcome Functional cure in participants with baseline HBsAg ≤3000 IU/mL 40 35 Functional cure at Week 72 (%) 30 p<0.001 p<0.001 25 20% 19% 19% 20 Pooled functional cure rate: 15 • Bepirovirsen 19% 10 • P
Slide 16: Functional cure was achieved in 26% of recipients with baseline HBsAg ≤1000 IU/mL
Functional cure was achieved in 26% of bepirovirsen recipients with baseline HBsAg ≤1000 IU/mL, and no placebo recipients Key secondary outcome Functional cure in participants with baseline HBsAg ≤1000 IU/mL 40 p<0.001 p<0.001 35 Functional cure at Week 72 (%) 30 28% 26% 25% 25 20 Pooled functional
Slide 17: A treatment effect favouring bepirovirsen was seen across all regions
A treatment effect favouring bepirovirsen was seen across all regions Functional cure rate at Week 72 by country group (pooled data) Favors Placebo Favors Bepirovirsen Posterior mean Baseline HBsAg ≤ 3000 IU/mL Bepirovirsen Placebo difference (95% CrI) China 67/285 (24%) 0/132 (0%) 22.6% (18.1%, 27.
Slide 18: Sustained HBV DNA <LLOQ off all HBV treatments achieved in 23% of recipients
Sustained HBV DNA <LLOQ off all HBV treatments was achieved in 23% of bepirovirsen recipients, and no placebo recipients Key secondary outcome HBV DNA <LLOQ at Week 72 off all HBV treatments Baseline HBsAg ≤3000 IU/mL 40 Sustained HBV DNA <LLOQ 35 at Week 72 p<0.001 p<0.001 Responders at Week 72 (%)
Slide 19: Sustained HBV DNA <LLOQ achieved in 31% of recipients with baseline HBsAg ≤1000 IU/mL
Sustained HBV DNA <LLOQ off all HBV treatments was achieved in 31% of bepirovirsen recipients with baseline HBsAg ≤1000 IU/mL, and no placebo recipients Key secondary outcome HBV DNA <LLOQ at Week 72 off all HBV treatments Baseline HBsAg ≤1000 IU/mL 40 p<0.001 p<0.001 Sustained HBV DNA <LLOQ 35 33%
Slide 20: 30% of bepirovirsen recipients had qHBsAg ≤100 IU/mL ~1 year after end of treatment
In addition to 19% achieving functional cure, 30% of bepirovirsen recipients had qHBsAg ≤100 IU/mL ~1 year after end of treatment HBsAg at baseline and at Week 72 with bepirovirsen treatment Functional cure or HBsAg ≤100 IU/mL breakdown <0.05 100 1% 90 19% 3% Percentage of participants (%) <0.05 – <
Slide 21: The on-treatment safety profile was consistent across B-Well 1 and 2
The on-treatment safety profile was consistent across B-Well 1 and 2 • AEs leading to permanent treatment discontinuation were low in frequency (3% of bepirovirsen recipients) • Few participants (2%) had serious adverse events related to bepirovirsen B-Well 1 B-Well 2 Pooled data Bepirovirsen Placeb
Slide 22: On-treatment AEs were consistent with the known safety profile of bepirovirsen
On-treatment AEs were consistent with the known safety profile of bepirovirsen The most common AEs on treatment were injection site reactions; none of which were serious Laboratory monitoring On-treatment AEs reported in ≥10%* of participants • Four participants (<1%) had permanent treatment [Week 1
Slide 23: Bepirovirsen induces superior, clinically significant functional cure rates
Bepirovirsen induces superior, clinically significant functional cure rates At Week 72, B-Well 1 and 2 Phase 3 trials demonstrated: Functional cure rates of: Sustained HBV DNA <LLOQ off all HBV treatments: • 19% with bepirovirsen among those with • 23% with bepirovirsen among those with baseline HBs
Slide 24: Further reading
Further reading The New England Journal of Medicine primary publication Narrated copy of this presentation Access a narrated copy of this presentation at the QR code Access the B-Well primary paper in NEJM at the QR code
Slide 25: Kaivan Khavandi, Melanie Paff
Kaivan Khavandi SVP, R&D Head of RI&I, Head of Translational Development and Sciences Melanie Paff VP, MDL for HBV 25
Slide 26: Functional cure is the gold standard for treatment
Functional cure is the gold standard for treatment Functional cure is a regulatory defined end point Patients must be off ALL therapy for six months Required Elements HBV DNA below lower limit of Functional Cure of detection HBV Surface Antigen below limit of detection 26
Slide 27: Bepirovirsen addresses key three requirements for functional cure
Bepirovirsen addresses key three requirements for functional cure 1. Suppresses viral surface antigen (HBsAg) 2. Suppresses CHB viral replication 3. Innate stimulation of the immune system 27
Slide 28: Established SoC with low functional cure rates and/or poor tolerability
Established SoC with low functional cure rates and/or poor tolerability Functional cure (FC) will reduce risk of HCC and ACM SoC today SoC tomorrow Nucleoside analogues •Established SoC • Higher functional cure •Not a cure (FC rate •Daily oral dosing <1% annually*) • Finite duration of therapy •Vira
Slide 29: Clinical benefit of functional cure
Clinical benefit of functional cure Surface antigen loss is associated with better clinical outcomes Association of HBsAg loss and clinical outcomes Primary Compensated Loss of surface antigen associated with Cirrhosis Decompensated • 89% reduced risk of hepatocellular liver disease carcinoma Hepato
Slide 30: Ongoing development plan in HBV
Ongoing development plan in HBV Expanding further eligible population of patients who may benefit from bepi therapy 100% B-United study fully recruited % of treated with NA population by Dap-tom bepirovirsen < 3000 IU/ml Baseline HBsAg Nucleos/tide treatment Stop NA 50% B-United Functional < 1000 B-
Slide 31: Summary
Summary • Bepirovirsen induces superior, clinically significant functional cure rates • FC is achievable and durable • An additional 30% of patients had very low surface antigen (≤100 IU/ml) at week 72 (vs placebo 4%)1 • Recognition of innovation by regulators - granting review acceleration pathways
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