Abbisko Cayman Limited · HKEX:2256
Abbisko Cayman — Abbisko Therapeutics — H1 2023 Earnings Presentation
32 slides from Abbisko Cayman's earnings presentation, August 2023
Slide 1: Abbisko Therapeutics 1H23 Interim Results and Business Updates
Abbisko Therapeutics 1H23 INTERIM RESULTS and BUSINESS UPDATES August 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements The accuracy of Abbisko’s estimates regarding expenses, future revenue, future expenditures and needs for and ability to obtain additional financing, Abbisko’s ability to obtain and maintain intellectual property protection for its product candidates and approved products,
Slide 3: Agenda
Agenda Opening Remarks & Strategy Dr. Yao-Chang Xu Clinical Update Dr. Jing Ji Preclinical Update Dr. Zhui Chen Financial Update Dr. Zidong Zhang Closing Remarks & Outlook Dr. Yao-Chang Xu Q&A 2
Slide 4: Opening Remarks & Strategy
OPENING REMARKS & STRATEGY Dr. Yao-Chang Xu 3
Slide 5: Clinical, R&D, and BD Steadily Advancing in 1H23, with a Strong Financial Position
Abbisko: Clinical, R&D, and BD Steadily Advancing in 1H23, with a Strong Financial Position Mid & Late Clinical Pipeline Pimicotinib (ABSK021) ꟷ Achieved Breakthrough Therapy Designation recognitions (BTD/PRIME) in China, US, and Europe ꟷ Conducted a global Phase III clinical trial of TGCT and com
Slide 6: Transitioning from Late Clinical Stage to Commercial Stage
Abbisko: Transitioning from Late Clinical Stage to Commercial Stage Commercial Stage Commercialization: enter overseas Mid & Late Clinical Stage markets through partnership, develop Entered into mid & late clinical stage: domestic market through Early Research Stage ‒ Pimicotinib (ABSK021) TGCT
Slide 7: Oncology-Focused Pipeline of BIC & FIC Assets
Our Oncology-Focused Pipeline Consists of BIC & FIC Assets, CSF-1R Near Commercialization, FGFR Franchise in POC, and Early-Stage Assets for BD and Clinics CSF-1R (ABSK021) Early-Stage Assets FGFR Franchise In POC Near Commercialization For BD and Clinics 1. First TGCT indication in Phase III: 1. Hu
Slide 8: Out-licensing Deal with Allist for ABK3376 (EGFR-TKI)
We Entered into an Out-licensing Deal with Allist for ABK3376 (EGFR-TKI) in Mar’23, Exploring Discovery-Driven Out-licensing Partnership for Preclinical Compounds EGFRm NSCLC Treatment Landscape Allist C797S 1L/2L Drug- Osimertinib ABK3376 resistant Almonertinib Mutation Mainland China Furmone
Slide 9: Our Pipeline (Clinical)
Our Pipeline (Clinical) Mono/Combo Commercial Programs Targets Indications IND Phase I/Ia Phase Ib/II Phase III/NDA Partner Therapy Rights TGCT Mono Global cGvHD Mono Global Pimicotinib CSF-1R (ABSK021) Solid Tumors Mono/Combo Global ALS Mono Ex-Mainland China Partner HK and Macau Mono Irpagratinib
Slide 10: Our Pipeline (Preclinical)
Our Pipeline (Preclinical) Mono/Combo Lead Commercial Programs Targets Indications IND-Enabling IND Partner Therapy Optimization/PCC Rights ABSK051 CD73 Multiple Tumors Combo Global RMS and Other ABSK012 FGFR4 mut. Mono Global Solid Tumors Mono/Combo with Allist Furmonertinib ABK3376 EGFR-C797S EGFR
Slide 11: Clinical Update
CLINICAL UPDATE Dr. Jing Ji 10
Slide 12: Expanding Pimicotinib into Multiple CSF-1R-Dependent Therapeutic Areas
We Aim to Expand Pimicotinib (ABSK021) into Multiple CSF-1R-Dependent Therapeutic Areas with Multi-Billion Dollars Market Potential 1 Accelerated 2 3 Combo in broad Expansion into other indications (many Strategy development with potential orphan drug status) oncology in TGCT indications TGCT cGvHD
Slide 13: We Advance Clinical Development of Pimicotinib Rapidly
We Advance Clinical Development of Pimicotinib (ABSK021) Rapidly 2021 2022 2023 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Application for EOP2 meeting TGCT Ph3 TGCT Ph3 First TGCT Completed Breakthrough with FDA and FPI CHN FPI US patient enrollment of Therapy Submit pre- FDA agreed with dosed with 30+ TGCT Designati
Slide 14: Pimicotinib Improved ORR at 77.4% with a Clean Safety Profile
At ASCO 2023, We Reported Pimicotinib (ABSK021) ’s Improved ORR at 77.4% with a Clean Safety Profile Efficacy Safety The preliminary ORR: 77.4% (24/31, QD 50 mg) (by IRC, Favorable safety profile at both cohorts with no apparent including 2 CR), 100% DCR hepatotoxicity Dose dependency: ORR 40%
Slide 15: Global Phase III Trial for TGCT Approved by FDA and CDE
The Global Multicenter Phase III Trial for TGCT Is Approved by the FDA and CDE, and Patient Enrollment Has Started in US and China A randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Pimicotinib (ABSK021) at the dose of 50mg QD in patients
Slide 16: Global Phase II Trial for cGvHD Approved by the CDE
The Global Multicenter Phase II Trial for cGvHD Is Approved by the CDE, and Patient Enrollment Has Started in China A multicenter, single-arm, open-label Phase II clinical study designed to evaluate the efficacy and safety of Pimicotinib (ABSK021) in the treatment of patients with chronic graft-ve
Slide 17: Pimicotinib Clinical Progress and Future Development Plan
Pimicotinib (ABSK021) Clinical Progress and Future Development Plan 2022 2023 2024 Phase III MRCT TGCT TLR(3) Phase II cGvHD TLR(3) Solid Tumor Explore multiple malignant solid tumors including glioblastoma, pancreatic and Other cancer, osteosarcoma, and others Indications 1. FPI: first patient in.
Slide 18: Irpagratinib Demonstrated Favorable Efficacy and Safety Profile in 2L+ HCC
Irpagratinib (ABSK011) Demonstrated Favorable Efficacy and Safety Profile in 2L+ HCC Promising preliminary efficacy in HCC with FGF19 Excellent clinical safety profile with low high-grade overexpression TEAE rate All FGF19 High FGF19 160mg BID FGF19 TEAEs 1 by Preferred Number (%) of Patients (N
Slide 19: Future Development Plan for Irpagratinib
Future Development Plan for Irpagratinib (ABSK011) 2022 2023 2024 and beyond Phase Ib Phase II/III 2L+ HCC High Dose QD Escalation BID Dose RP2D (mono) Expansion (moderate, high) BID Escalation 1/2L HCC Phase II Phase II/III (combo with BID Dose RP2D Dose Escalation Expansion atezolizumab) Other Com
Slide 20: ABSK121: A Next-gen Pan-FGFR Inhibitor Overcoming Resistant Mutations
ABSK121: A Next-gen Pan-FGFR Inhibitor Overcoming FGFR Resistant Mutations ~7% of all human cancer have Superior activities against all evaluable FGFR2/3 resistant mutations with broader FGFR gene alterations; More coverage than competitors than 1 million patients Fold change in cellular IC50 vers
Slide 21: ABSK121: First Patient Enrolled in US and China
ABSK121: First Patient Enrolled, as The First Human Study is Ongoing in both US and China Escalation Part Expansion Part Screening Treatment Safety follow up Screening Treatment Safety follow up 28 days 28 days per cycle 30 days post EOT 28 days 28 days per cycle 30 days post EOT Boin Design UC: FGF
Slide 22: Preclinical Update
PRECLINICAL UPDATE Dr. Zhui Chen 21
Slide 23: Comprehensive Portfolio Covering Major Types of Solid Tumors
Establishing a Comprehensive Portfolio Covering Major Types of Solid Tumors Multiple Solid Tumors Franchise Lung CNS Cancer Tumor ABSK043 Pimicotinib (ABSK021) ABSK061/121 ABSK112 ABSK112 ABSK044 P131/141 P131 Gastrointestinal Gynecological Tumor Cancer Irpagratinib (ABSK011) ABS
Slide 24: Great Potential Beyond Oncology
Great Potential Beyond Oncology cGvHD (chronic graft- HBV / HIV versus-host disease) Oral Advantages Pimicotinib ABSK043 ALS (amyotrophic (ABSK021) PD-L1 lateral sclerosis) CSF-1R IPF (idiopathic pulmonary fibrosis) Cardiovascular & ACH (achondroplasia) Metabolic Diseases ABSK061 P151 ~ $3B(1) G
Slide 25: IND Approval of ABSK112: Next-gen EGFR Exon20ins Inhibitor
IND Approval of ABSK112: A Next-gen EGFR Exon20ins Inhibitor with Improved Activity, Selectivity, and Brain Penetrating Ability Current Exon20ins inhibitors face significant ABSK112 has excellent selectivity, broad spectrum mutation coverage, and brain challenges in efficacy and safety penetrati
Slide 26: ABSK044: A Brain-penetrating Oral PD-L1 Inhibitor
ABSK044: A Brain-penetrating Oral PD-L1 SMW Inhibitor Building up an Oral PD-L1 Franchise with ABSK043 Superior Efficacy in Humanized Tumor Model Strong market potential of oral PD-L1 small molecules ꟷ Better access and safety management 3000 Vehicle Tumor Volume (mm3) INC086550 20mpk po BID ꟷ Enh
Slide 27: P131: Next-gen MTA-Cooperative PRMT5 Inhibitors
P131: Discovery of Next-gen MTA-Cooperative PRMT5 Inhibitors – High Selectivity Reduce Hematologic Toxicity and Side Effect Robust Activity in MTAP-null Cancer Cell Lines Large patient population and commercial potential as and Non-lethal High Selectivity over MTAP WT Cell 10-15% of all human canc
Slide 28: Financial Update
FINANCIAL UPDATE Dr. Zidong Zhang 27
Slide 29: 1H23 Loss Narrowed; A Strong Cash Position for Multiple Years' Operations
1H23 Loss Narrowed due to Increase in Revenue and Reduction in SG&A, Offsetting Increase in R&D Expense; A Strong Cash Position for Multiple Years’ Operations PnL Net Loss Narrows Strong Cash Position to Fund Multiple Years (1H23 - 209M vs 1H22 - 222M) (1H23 2,102M) 1H23 Revenue of 57M vs 12M 1H22
Slide 30: Closing Remarks & Outlook
CLOSING REMARKS & OUTLOOK Dr. Yao-Chang Xu 29
Slide 31: Milestones Achieved in 1H23; Data to be Published at ESMO
We Have Achieved Several Milestones in 1H23 as Planned; FGFR4 2L HCC/Oral PD-L1 Efficacy Data will be Published at ESMO Pipeline Target Clinical Trial Stage Event 2023 Clinical candidates Target Action US Pivotal Trial Design Approval 1H Mar’23 Apr’23 CHN FPI Pimicotinib TGCT Phase III Global MR
Slide 32: Q&A
Q&A 9