LianBio · OTC:LIANY
LianBio — Corporate Update (May 2023)
32 slides from LianBio's corporate update, May 1, 2023
Slide 1: EXPLORER-CN Topline Data Results and Mavacamten China Commercial Opportunity Call
EXPLORER-CN Topline Data Results and Mavacamten China Commercial Opportunity Call May 1, 2023
Slide 2: Disclaimer
2 Disclaimer The information herein contains statements about future expectations, plans and prospects for LianBio. The words “expect,” “believe,” “continue,” “estimate,” “potential,” “will,” “plan,” “anticipate” and similar expressions are intended to identify forward-looking statements, although n
Slide 3: Yizhe Wang, Ph.D., Chief Executive Officer, LianBio
3 Yizhe Wang, Ph.D. Chief Executive Officer, LianBio
Slide 4: Today's Agenda
4 Today’s Agenda Obstructive Hypertrophic Cardiomyopathy (oHCM) Treatment and diagnosis in China today Zhuang Tian, M.D., Professor of Cardiology, Peking Union Medical College Hospital; EXPLORER-CN Investigator Phase 3 EXPLORER-CN Topline Data Review Clinical and regulatory update Michael Humphries,
Slide 5: Inflection Point for Continued Growth
5 Inflection Point for Continued Growth • Vision to accelerate patient access to innovative medicines • Decrease the time it has historically taken to bring new medicines into China • Leverage newly available regulatory paths that shorten timeline to approval • Design and execute bespoke development
Slide 6: HCM Diagnosis and Treatment in China Today
HCM Diagnosis and Treatment in China Today 6 Zhuang Tian, M.D. • Professor of Cardiology, and Deputy Director of the Internal Medical Department, Peking Union Medical College Hospital • Member of Chinese Society of Rare Diseases • Member and Secretary of the Heart Failure Group of Chinese Society of
Slide 7: HCM Clinical Definition and Diagnosis
1. Circulation 2020;142:e558-e631 2. Clin J Heart Fail & Cardiomyopathy 2022;6:80-105 3. Chinese Circulation Journal 2023;38:1-33 4. Circulation 2006;114:2232-9 HCM Clinical Definition1-3 HCM is a disease state in which morphologic expression is confined solely to the heart. It is characterized pr
Slide 8: Clinical Course of HCM: More than 50% of Patients Experience Adverse Outcomes
Clinical Course of HCM: More than 50% HCM Patients will Experience Adverse Clinical Outcomes Chinese Patients Experience Same Adverse Clinical Pathways J Am Coll Cardiol 2022;79:372-389 Percentage of HCM patients experiencing adverse clinical pathways Clinical profiles and prognostic pathways 8
Slide 9: Prognosis in oHCM Patients: Higher Risks of Severe Heart Failure and Death
Annual rate of progression to severe heart failure in oHCM is 3.2-7.4%1 The risk of HCM-related death is twice that in non- obstructive HCM patients2 Prognosis in oHCM Patients: Significantly Higher Risks of Severe Heart Failure and Death Compared with Nonobstructive Patients 9 LVOT obstruction is a
Slide 10: Treatment of HCM: Significant Unmet Needs in China
10 Treatment of HCM: Significant Unmet Needs in China Treatment goals: relieving clinical symptoms, improving cardiac function, delaying disease progression, and reducing disease death1 1. Clin J Heart Fail & Cardiomyopathy 2022;6:80-105 2. Circulation 2020;142:e558-e631
Slide 11: Chinese Physician and Patient Enthusiasm for New Treatment Options
11 Chinese Physician and Patient Enthusiasm for New Treatment Options Treatment flow chart of oHCM* Clin J Heart Fail & Cardiomyopathy 2022;6:80-105 * Mavacamtent not approved in China at time of publication Mavacamten is recommended in the latest China HCM guidelines HCM patient advocacy group (肥厚型
Slide 12: EXPLORER-CN Topline Data & Regulatory Update
EXPLORER-CN Topline Data & Regulatory Update 12 Michael Humphries, FRCP Chief Scientific Advisor, LianBio
Slide 13: Mavacamten: Precision Medicine Approach to Diseases of Diastolic Dysfunction
13 Mavacamten: Precision Medicine Approach to Treating Diseases of Diastolic Dysfunction Mechanism of Action Mavacamten is a first-in-class myosin inhibitor that targets the excessive contractility and impaired relaxation, myocardial energetics and compliance, with the intent of correcting the abn
Slide 14: EXPLORER-CN Study Design
14 EXPLORER-CN Study Design A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study EOS, end of study; EOT, end of treatment; LVOT, left ventricular outflow tract; NYHA, New York Heart Association; oHCM, obstructive hypertrophic cardiomyopathy; QD, once daily Key inclusion criteria: • Aged
Slide 15: EXPLORER-CN Subject Disposition
15 EXPLORER-CN Subject Disposition Randomized n=81 Mavacamten n=54 Placebo n=27 Completed 30-week treatment n=54 Completed 30-week treatment n=25 Entered LTE period n=54 Entered LTE period n=25 Discontinued (n=2) • n=1 withdrawal by subject • n=1 other (COVID-19) Participants Signed ICF n=152 12 Cli
Slide 16: EXPLORER-CN Baseline Demographics and Characteristics
16 EXPLORER-CN Baseline Demographics and Characteristics Mavacamten (n=54) Placebo (n=27) Age, years, mean (SD) 52.4 (12.1) 51.0 (11.8) Sex, n (%) Male Female 41 (75.9) 13 (24.1) 17 (63.0) 10 (37.0) BMI, mean (SD) 25.17 (3.46) 26.11 (3.58) NYHA Class, n (%) Class II Class III 44 (81.5) 10 (18.5) 18
Slide 17: EXPLORER-CN Baseline Echo Parameters
17 EXPLORER-CN Baseline Echo Parameters Echocardiographic parameters, mean (SD) Mavacamten (n=54) Placebo (n=27) Resting LVOT peak gradient, mmHg 74.62 (35.05) 73.41 (32.23) Valsalva LVOT peak gradient, mmHg 106.78 (43.23) 99.79 (41.10) LVEF, % 77.80 (6.89) 77.00 (6.73) Maximum LV wall thickness, mm
Slide 18: Topline Safety Data
18 Topline Safety Data • Mavacamten demonstrated a safety profile consistent with past studies, with no new safety signals observed • Incidence of treatment-emergent adverse events (TEAEs) on mavacamten arm similar to placebo arm • All treatment-emergent serious adverse events (TESAEs) considered no
Slide 19: EXPLORER-CN Primary Endpoint – Topline Analysis
19 ^ Model estimated least-square mean differences were reported for continuous variables CI, confidence interval; LSM, least squares mean; LVOT, left ventricular outflow tract; SD, standard deviation; EXPLORER-CN Primary Endpoint – Topline Analysis Mavacamten (n=54) Placebo (n=27) LSM Difference^ (
Slide 20: Secondary Endpoints – Topline Analysis
• Mavacamten demonstrated treatment benefit across all pre-specified secondary endpoints 20 *Data on all secondary endpoints to be presented at a future medical meeting Secondary Endpoints – Topline Analysis* Secondary Endpoints* Mavacamten (n=54) Placebo (n=27) Difference (95% CI)^ Nominal p-value*
Slide 21: EXPLORER-CN Summary of Topline Results
• EXPLORER-CN met the study’s primary endpoint with high statistical significance (p<0.001) • Mavacamten showed a significant and clinically important improvement in change from baseline to Week 30 in Valsalva LVOT peak gradient by a LSM difference of -70.29 mmHg compared to placebo. • Mavacamten sh
Slide 22: Regulatory Status in Asia and Key Anticipated Program Milestones
22 Regulatory Status in Asia and Key Anticipated Program Milestones *Data Included in China NDA Package Global pivotal Phase 3 EXPLORER-HCM trial data Phase 1 pharmacokinetics study of mavacamten in healthy Chinese volunteers Blinded preliminary safety data from Phase 3 EXPLORER-CN trial April 21, 2
Slide 23: Mavacamten Potential in Other Diseases of Diastolic Dysfunction
Mavacamten Potential in Other Diseases of Diastolic Dysfunction 23 Brianna Sun Cardiovascular Medical Head, LianBio
Slide 24: Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
24 Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) Disease overview nHCM has no significant LVOT obstruction (e.g., <30 mmHg) at rest or with provocation Driven by diastolic impairment due to the enlarged and stiffened heart muscle – ~1/3 of HCM patients have nHCM Mavacamten treatment rationa
Slide 25: Heart Failure with Preserved Ejection Fraction (HFpEF)
25 Heart Failure with Preserved Ejection Fraction (HFpEF) Disease overview HFpEF is a disease in which the heart’s ability to pump blood through the body is decreased due to the inability of the ventricle to fully relax and fill with blood At a cellular level, cardiac myocytes in patients with H
Slide 26: Mavacamten China Market Opportunity
Mavacamten China Market Opportunity 26 Pascal Qian Chief Commercial Officer and General Manager of China, LianBio
Slide 27: Mavacamten Opportunity in China
27 Mavacamten Opportunity in China HCM Epidemiology Diagnosis Opportunity Treatment Opportunity • There are 1.1-2.8 million potential HCM patients in China with 0.2%1 prevalence rate • oHCM contributes 67% of overall HCM patients and nHCM contributes 33% of overall HCM patients • Diagnosis rate in C
Slide 28: Reaching Diagnosed Patients
Reaching Diagnosed Patients ~400 level III hospitals: ~20% diagnosed patients Launch ~1,500 Level II/III hospitals: (2,000 prescriber ~55% diagnosed patients) Self-Pay ~3,000 Level II/III hospitals: (7,000 prescribers ~80% diagnosed patients) Post-NRDL ~13,000 Level I/II/III hospitals: ~100% diagnos
Slide 29: Physician Segmentation and Engagement Strategy
29 HCM Experts ~200 (5% Patients) Confident HCM treaters ~4,500 (40% Patients) Conservative HCM treaters ~18,000 (55% Patients) Physician segmentation There are Approximately 75,000 Cardiologists in China, 30% Currently Treat HCM INNOVATORS EARLY ADOPTERS LATE ADOPTERS • Develop guidelines/consensus
Slide 30: Positioning Mavacamten for Successful China Launch
30 Positioning Mavacamten for Successful China Launch Grow the HCM Market • Improve the disease awareness Organization and Infrastructure • Execute industry-leading commercial strategy LianBio vision: Establish myosin inhibitor class as the new standard of care for oHCM by maximizing mavacamten’s va
Slide 31: Q&A
Q&A 31 Company management available for Q&A • Yizhe Wang, Ph.D., CEO • Yi Larson, CFO • Pascal Qian, CCO and General Manager of China • Michael Humphries, FRCP, Chief Scientific Advisor
Slide 32: EXPLORER-CN Topline Data Results and Mavacamten China Commercial Opportunity Call
EXPLORER-CN Topline Data Results and Mavacamten China Commercial Opportunity Call May 1, 2023