Connect Biopharma Holdings Limited · NASDAQ:CNTB
Connect Biopharma — Investor Presentation (June 2023)
40 slides from Connect Biopharma's investor presentation, Jun 5, 2023
Slide 1: Corporate Presentation June 2023
Corporate Presentation June 2023 | NASDAQ: CNTB Developing next-generation therapeutics for T cell-driven inflammatory diseases
Slide 2: Forward-looking statements
Forward-looking statements This presentation regarding Connect Biopharma Holdings Limited ("Connect," "we," "us" or "our") has been prepared solely for informational purposes. Certain information contained in this presentation relates to, or is based on, studies, publications, surveys and other data
Slide 3: Company Highlights
Company Highlights AD=atopic dermatitis; CD=Crohn’s disease; H3R=histamine-3 receptor ; IL-4Rα =interleukin-4-receptor alpha; SIP1=sphingosine 1-phosphate receptor 1; UC=ulcerative colitis. aUnaudited cash, cash equivalents and investments as of March 31, 2023. Targeting inflammatory diseases with h
Slide 4: A Robust Pipeline of Potentially Differentiated Therapies
A Robust Pipeline of Potentially Differentiated Therapies Connect Biopharma has global development & commercialization rights to all product candidates aThe Company’s clinical trial in China of CBP-201 in patients with AD is included as the Company intends to submit a New Drug Application (NDA) in C
Slide 5: CBP-201: A Next Generation Anti-IL-4Rα Antibody
CBP-201: A Next Generation Anti-interleukin-4-receptor alpha (IL-4Rα) Antibody In Development For Type 2 Inflammatory Diseases
Slide 6: CBP-201: Next Gen IL-4Rα Blocker Shows Potential for Less Frequent Dosing
CBP-201: Next Gen IL-4Rα Blocker Shows Potential For Less Frequent Dosing, Greater Sustained Efficacy, and Faster Onset CBP-201 is a novel, human monoclonal IgG4 antibody directed against IL-4Rα, a common subunit for IL-4 and IL-13 receptors. Blockade of IL-4 and IL-13 binding to IL-4Rα results in i
Slide 7: CBP-201 Demonstrated Higher Potency Than Dupilumab In Vitro
CBP-201 Demonstrated Higher Potency Than Dupilumab in Head-to-Head In Vitro Comparison1 CBP-201 demonstrated higher potency than dupilumab in inhibiting STAT6 signaling and cytokine-induced TF-1 cell proliferation. Stimulation CBP-201c Dupilumabc STAT6 Signaling (Activity on HEK-Blue IL-4 / IL-13 ce
Slide 8: Atopic Dermatitis (AD): Large Opportunity Despite Advent of Biologics
Atopic Dermatitis (AD): Large Opportunity Despite Advent of Biologics A chronic inflammatory disorder characterized by eczematous skin lesions, itch, localized pain, and sleep disturbances. Adults have moderate-to-severe disease4 6.6 M People in the United States have AD4 26.1 M AD prevalence in Chi
Slide 9: CBP-201: Global Phase 2b Trial in AD
CBP-201: Global Phase 2b Trial in AD
Slide 10: Treatment with CBP-201 Led to Rapid and Sustained Improvements in EASI
Treatment with CBP-201 Led to Rapid and Sustained Improvements in EASI Total Score at Weeks 2 and 16 Head and neck Upper limbs Trunk Lower limbs Week 2 Week 16 Week 2 Week 16 Week 2 Week 16 Week 2 Week 16 * * ** * * ** * * *** *** AD=atopic dermatitis; ANCOVA,=analysis of covariance; BSA=body surfac
Slide 11: CBP-201: Phase-3 Ready After Achieving Global Phase 2b Endpoints
CBP-201: Phase-3 Ready After Achieving its Global Phase 2b Trial Endpoints in Adults with Moderate-to-Severe AD Strober, B et al. Maui Derm 2022 Abstract and Poster (and reflects additional data analyses conducted by the Company subsequently). Silverberg, J et al. Maui Derm 2022 Abstract and Poster
Slide 12: CBP-201: China Pivotal Trial in AD
CBP-201: China Pivotal Trial in AD
Slide 13: China Pivotal Trial in Moderate-to-Severe AD: Trial Design
Randomization China Pivotal Trial in Moderate-to-Severe AD: Trial Design Responders or not STAGE 1 Placebo n=85 Screen Randomize (n=255 2:1)a CBP-201 600 mg LD D1 + 300 mg Q2W, n=170 STAGE 2 (Ongoing) CBP-201 300 mg Q4Wb CBP-201 300 mg Q2W CBP-201 300 mg Q2W Key Inclusion Criteria: 18 to 75 years of
Slide 14: China Pivotal Trial in AD: Baseline Demographic and Disease Characteristics
China Pivotal Trial in AD: Baseline Demographic and Disease Characteristics Characteristics* CBP-201 N=170 Placebo N=85 Total N=255 Age (years) Mean (SD) Median (min, max) 39.3 (16.1) 36.0 (18, 74) 40.7 (17.5) 36.0 (18, 74) 39.7 (16.5) 36.0 (18, 74) Female, n (%) 57 (34%) 33 (39%) 90 (35%) BMI (kg/m
Slide 15: Significantly More Patients Achieved IGA 0/1 With CBP-201 than Placebo
Significantly More Patients Achieved IGA 0/1 and ≥2 point Reduction With CBP-201 Treatment than Placebo FAS=full analysis set; IGA=investigator global assessment; Q2W=every 2 weeks. ***, **, * for P<0.001, <0.01, <0.05, respectively, vs placebo. aMissing data in CBP-201 group is imputed by jump to r
Slide 16: Significantly More Patients Achieved EASI-75 With CBP-201 than Placebo
Significantly More Patients Achieved EASI-75 With CBP-201 Treatment than Placeboa FAS=full analysis set; IGA=investigator global assessment; Q2W=every 2 weeks. ***, **, * for P<0.001, <0.01, <0.05, respectively, vs placebo. aMissing data in CBP-201 group is imputed by jump to reference imputation (J
Slide 17: Significant Changes in EASI Score and EASI-50, -75, -90
Significant Changes Were Observed With CBP-201 Treatment in Change in EASI Score and Patients Achieving EASI-50, -75, -90 EASI-50, -75, and -90 at Week 16 Secondary Endpoint: Significant improvement in EASI at week 2 are observed with all response categories at Week 16. EASI-50/-75/-90=at least 50%/
Slide 18: Significant and Sustained Improvements in Pruritus/Itch With CBP-201
Significant and Sustained Improvements in Pruritus/Itch Were Observed With CBP-201 Treatment PP-NRS=peak pruritus numerical rating scale; FAS=full analysis set; Q2W=every 2 weeks. ***, **, * for P<0.001, <0.01, <0.05, respectively, vs placebo. Missing data in CBP-201 group is imputed by jump to refe
Slide 19: Safety Results from Stage 1
Safety Results from Stage 1 CBP-201 was generally well tolerated with no new safety signals aRepresents the primary analysis population. bOther herpes TEAEs were: ‘herpes simplex’ (n=1 per treatment arm); ‘herpes simplex reactivation’ and ‘oral herpes’ (both n=1 in the CBP-201 arm); ‘herpes zoster’
Slide 20: CBP-201 China Pivotal Trial Stage 1 Met its Endpoints and Supports NDA Submission
CBP-201 China Pivotal Trial Stage 1 in Adults With Moderate- to-Severe AD Met its Endpoints and Supports NDA submission AD=atopic dermatitis; CDE=Center for Drug Evaluation; EASI=eczema area and severity index; Q2W=every 2 weeks; Q4W=every 4 weeks. Ongoing stage 2 maintenance period could potentiall
Slide 21: CBP-201: Global Phase 2b in Asthma
CBP-201: Global Phase 2b in Asthma
Slide 22: CBP-201 Global Phase 2b in Asthma: Trial Design
Key Inclusion Criteria Moderate to severe uncontrolled asthma Existing treatment with medium to high dose inhaled corticosteroids in combination with a second reliever/controller (e.g., LABA, LTRA, LAMA, or theophylline) for at least 3 months with a stable dose ≥1 month prior to the screening visit
Slide 23: CBP-201: Late-Stage, Differentiated IL-4Rα Inhibitor for AD and Asthma
CBP-201: Late-Stage, Differentiated IL-4Rα Inhibitor for AD and Asthma Best-in-class potential Supported by clinical efficacy and safety data Achieved primary and key secondary outcomes at Week 16 in both global Phase 2b and China pivotal/stage 1 trials with > 475 patients with moderate-to-severe AD
Slide 24: Icanbelimod (CBP-307): Next Generation S1P1 Modulator for IBD
Icanbelimod (CBP-307): A Next Generation Selective Sphingosine 1-Phosphate Receptor 1 (S1P1) Modulator in Development for Inflammatory Bowel Disease (IBD)
Slide 25: Icanbelimod: Next Generation Molecular Design Offers Potential for Differentiation
Icanbelimod: Next generation Molecular Design Offers Potential for Differentiation Blocking T cell egress from lymph nodes reduces the inflammation implicated in many T cell-mediated diseases 1 S1P mediates T cell movement from lymph nodes into circulation, and hence migration to tissues to release
Slide 26: Ulcerative Colitis: Large Market Opportunity for a Best-in-Class S1P1 Modulator
Ulcerative Colitis (UC): Large Market Opportunity for a Differentiated Best-in-Class S1P1 Modulator An autoimmune disease that causes inflammation and ulceration of the inner lining of the colon and rectum (the large bowel). UC S1P WW market by 20282 >$2.5B UC WW market CAGR 2021-20282 +9.3% UC WW m
Slide 27: Icanbelimod Global Phase 2 UC (CN002) Trial Design
Primary and Secondary Endpoints Assessed at Week 12 (induction period) and Week 48 (maintenance period). Icanbelimod Global Phase 2 UC (CN002) Trial Design Response Assessed STAGE 1 INDUCTION PERIOD (12-WEEK) Placebo (n=53) Screen Randomized (n=145 1:1:1)a Icanbelimod (n=53) 0.2 mg PO QDb Icanbelimo
Slide 28: Demographics & Characteristics
Demographics & Characteristics Icanbelimod 0.1 mg PO QD (n=39) Icanbelimod 0.2 mg PO QD (n=53) Placebo (n=53) Mean age, years (SD) 42.9 (13.4) 42.1 (10.7) 41.2 (9.9) Female, n (%) 14 ( 35.9) 20 (37.7) 20 (37.7) Race, n (%) White Asian Black/African American Not reported 0 39 (100.0) 0 0 5 (9.4) 48 (
Slide 29: Icanbelimod Showed Numerical Improvements in Adapted Mayo Score and Significant Change in Complete Mayo Score
FAS=full analysis set; MI=multiple imputation; PO=by mouth; QD=once daily. aPlacebo-adjusted data is the difference in score between icanbelimod and placebo. bChange in adapted Mayo score showed a numerical improvement but did not reach statistical significance. Icanbelimod Showed Numerical Improvem
Slide 30: Significantly More Patients Showed Clinical Response and Clinical Remission at Week 12
Proportion of patients achieving clinical remission, clinical response and endoscopic improvement in patients treated with icanbelimod 0.2 mg PO QD or placebo at Week 12. Significantly More Patients Treated with Icanbelimod Showed Clinical Response and Achieved Clinical Remission at Week 12 Δ = 20.1
Slide 31: Icanbelimod Sustained Clinical Remission Through Week 48
Proportion of patients treated with icanbelimod 0.2 mg that maintained or achieved clinical remission, clinical response and endoscopic improvements at Week 48. Icanbelimod Sustained Clinical Remission Through Week 48 in Patients Who Showed Clinical Response at the End of the Induction Period Clinic
Slide 32: Icanbelimod Efficacy Was Sustained in Patients Who Completed the Maintenance Period
Proportion of patients treated with icanbelimod 0.2 mg maintaining clinical remission, clinical response and endoscopic improvements among patients who completed the maintenance period. Icanbelimod Efficacy Was Sustained in Patients Who Completed the Maintenance Perioda Clinical Remission: Rectal bl
Slide 33: Icanbelimod CN002 Trial: Safety Results from 12-Week Induction Period
Safety Parameter Subjects, n (%) Icanbelimod 0.1 mg PO QD (n=39) Icanbelimod 0.2 mg PO QD (n=53) Placebo (n=52) Any TEAE 37 (94.9%) 47 (88.7%) 40 (76.9%) Grade 3 or Higher TEAE 10 (25.6%) 4 (7.5%) 4 (7.7%) Drug-Related TEAE 23 (59.0%) 34 (64.2%) 20 (38.5%) Drug-Related Grade 3 or Higher TEAE 5 (12.8
Slide 34: Icanbelimod CN002 Trial: Safety Results from Stage 2
Safety results consistent with Stage 1 data and in line with the mechanism of action for this class of medication. Safety Parameter Subjects, n (%) Icanbelimod 0.1 mg PO QD N=12 Icanbelimod 0.2 mg PO QD N=21 Placebo PO QD N=13 Open-Label 0.2 mg PO QD n=40 Any TEAE 11 (91.7) 20 (95.2) 12 (92.3) 33 (8
Slide 35: Icanbelimod CN002 Trial – Pharmacodynamic Endpoint
Icanbelimod CN002 Trial – Pharmacodynamic Endpoint Absolute lymphocyte counts (ALC) and percentage change through Week 12 (FAS) aRepresents the primary analysis population. Icanbelimod reduced the peripheral lymphocyte counts during the 12-week period.a Mean values and Percentage changes in Absolute
Slide 36: Icanbelimod in Ulcerative Colitis: Phase 3 Ready with Best-in-Class Potential
Icanbelimod in Ulcerative Colitis: Phase 3 Ready with Best-in-Class Potential Best-in-class potential Supported by clinical efficacy and safety data including through Week 48 Based on efficacy data observed with 0.2 mg dose and PK/PD data, opportunity exists to potentially increase dose for enhanced
Slide 37: Executive Leadership
Executive Leadership Zheng Wei, PhD Wubin (Bill) Pan, PhD, MBA Chin Lee, MD, MPH Steve Chan, CPA Jiang Bian, JD CO-FOUNDER, CHIEF EXECUTIVE OFFICER CO-FOUNDER, PRESIDENT & BOARD CHAIR CHIEF MEDICAL OFFICER CHIEF FINANCIAL OFFICER GENERAL COUNSEL & CHIEF COMPLIANCE OFFICER > 25 years of experience in
Slide 38: Senior Management Team
Raul Collazo, PhD Malinda Longphre, PhD Lei Sun, PhD Qingjian (QJ) Wang, PhD VICE PRESIDENT, GLOBAL HEAD OF MEDICAL AFFAIRS VICE PRESIDENT, HEAD OF CLINICAL OPERATIONS (US) VICE PRESIDENT AND HEAD OF BIOLOGICS AND CMC EXECUTIVE DIRECTOR, PRE/NON-CLINICAL > 20 years of medical/ scientific affairs, co
Slide 39: Investment Highlights
Investment Highlights Q2’2023: UC Ph2 maintenance phase full data 2H 2023: Atopic dermatitis pivotal China 52-weeks data Asthma Ph2 topline data AD data to be presented at the World Congress of Dermatology Expert and experienced leadership team in developing biologics and small molecules with global
Slide 40: SCT
SCT BIOPHARMA ce
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