Abbisko Cayman Limited · HKEX:2256
Abbisko Cayman — Abbisko Therapeutics — FY2022 Earnings Presentation
31 slides from Abbisko Cayman's earnings presentation, Mar 16, 2023
Slide 1: Abbisko Therapeutics 2022 Full Year Results and Business Updates
Abbisko Therapeutics 2022 FULL YEAR RESULTS AND BUSINESS UPDATES March 16, 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 Dr. Yao-Chang Xu Business Update Dr. Jing Ji Dr. Zhui Chen Financial Update Dr. Zidong Zhang Closing Remarks Dr. Yao-Chang Xu Q&A 2
Slide 4: Opening Remarks
OPENING REMARKS Dr. Yao-Chang Xu 3
Slide 5: Major Achievements Were Accomplished in Various Aspects Since 2022
Major Achievements Were Accomplished in Various Aspects Since 2022 Clinical Development Business Development +3 Proof of Concept data readouts Eli Lilly and Company ▬ Pimicotinib (ABSK021) ORR 68% Global co-discovery collaboration ▬ Irpagratinib (ABSK011) ORR 33.3% in FGF19 IHC+ HCC with FGF19 o
Slide 6: Expanding Pimicotinib into Many CSF-1R-Dependent Diseases
We Aim to Expand Pimicotinib (ABSK021) into Many CSF-1R- Dependent Diseases with Multi-Billion Dollars of Market Potential 1 2 3 4 Indications TGCT cGvHD ALS Solid Tumors Addressable ~60k ~6k ~43k >400k patient no. (1) ~14k ~14k (2) ~19k Commercial >US$1.5bn >US$0.5bn >US$1.5bn >US$6bn potential (1)
Slide 7: Internal Discovery Powers New & Broad Business Development Opportunities
Our Internal Innovative Discovery Powers New & Broad Business Development Opportunities Discovery R&D Global Clinical Commercialization Platform/Expertise Development Capability New & Broad Business Development Model Partners Constant & Sustainable Outputs ▬ Internal Discovery Engine to generate pro
Slide 8: Business Update
BUSINESS UPDATE C9) Dr. Jing Ji
Slide 9: We Continue to Grow and Advance Our Pipeline
We Continue to Grow and Advance Our Pipeline Assets Target Indication Mono/Combo Discovery IND Enabling Phase I/Ia POC (i) Pivotal Partner Rights TGCT Monotherapy Monotherapy/ ABSK021 Solid tumors Combination therapy Global Pimicotinib CSF-1R cGvHD Monotherapy ALS Monotherapy Ex-China Partner and Ta
Slide 10: Pimicotinib Has Demonstrated Potentially Best-in-Class Efficacy
Pimicotinib (ABSK021) Has Demonstrated Potentially Best-in-Class Efficacy The preliminary ORR: 68.0% (17/25, 95%CI: 46.50%-85.05%) (by IRC based on RECIST1.1) 1 CR and 16 PR within 6 months in patients receiving 50mg QD treatment (out of 25 patients) 100% preliminary disease control rate (“DCR
Slide 11: Pimicotinib Potentially Best-in-Class Safety Profile
Pimicotinib (ABSK021) Has Also Demonstrated Potentially Best-in-Class Safety Profile Pimicotinib Pexidartinib(1) Vimseltinib(1) Abbisko Daiichi Sankyo Deciphera Phase Ib ENLIVEN study-Part 1 Phase II, Cohort A Trial Trial Trial (NCT04192344) (NCT02371369) (NCT03069469) Patient no. 32 Patient no. 61
Slide 12: First Global Multicenter Phase III Trial for TGCT Approved by FDA and CDE
The First Global Multicenter Phase III Trial for TGCT Is Approved by both US FDA and China CDE A randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Pimicotinib (ABSK021) at the dose of 50 mg QD in patients with Tenosynovial Giant Cell Tumor
Slide 13: Productive Communication with FDA on Pimicotinib in TGCT
Productive Communication with FDA on Pimicotinib (ABSK021) in TGCT Resulted in Favorable Pivotal Design and Clear Regulatory Path in the US Rapid development of Pimicotinib (ABSK021) in TGCT Leverage in-depth analysis of existing data to negotiate 13 months from FPI(1) to FDA’s greenlight on piv
Slide 14: We Engaged Top KOLs for the Global Phase III Registration Study
We Engaged Top KOLs for the Global Phase III Registration Study Advancing the Phase III study globally Multiple sites in North America 1st investigator meeting of ABSK021-301 ▬ Feb 2023, Shanghai ▬ Over 100 attendees from ~30 sites Prof. Xiaohui Niu ~30 sites ▬ Beijing Jishuitan hospital in China
Slide 15: Future Development Plan of Pimicotinib
Future Development Plan of Pimicotinib (ABSK021) 2022 2023 2024 Phase III MRCT TGCT TLR(3) Phase II cGvHD TLR(3) Solid Tumor Explore multiple malignant solid tumors including glioblastoma, pancreatic cancer, and Other osteosarcoma, and others. Indications 1. FPI: first patient in. 2. LPI: last patie
Slide 16: Irpagratinib 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 TEAE rate overexpression All FGF19 High FGF19 160mg BID TEAEs（1） by Preferred Number (%) of Patients (N=48)（
Slide 17: Complete Response Observed in Patient Treated with Irpagratinib
Complete Response was Observed Later from a Patient Treated with Irpagratinib at 160mg BID (Partial Response by An Earlier Cutoff Date) Baseline Week 40, complete response (CR) 52-year-old female with HCC ▬ Child-Pugh score: 5 ▬ BCLC stage: C Chronic Hepatitis B Baseline ▬ ▬ Prior surgery ▬ Prior
Slide 18: Future Development Plan of Irpagratinib
Future Development Plan of Irpagratinib (ABSK011) 2022 2023 2024 and beyond Phase Ib Phase II/III 2L+ HCC High Dose QD Escalation 2nd Dose RP2D (mono) Expansion BID Escalation 1/2L HCC Phase II Phase II/III (combo with RP2D Dose Confirmation Dose Expansion atezolizumab) Other Combine with oral agent
Slide 19: Fexagratinib Positive PoC Confirmed in mUC Patients with FGFR3 Alterations
Fexagratinib (ABSK091) Positive PoC Has Been Confirmed in mUC Patients with FGFR3 Alterations Most of the mUC patients with FGFR3 alterations (including mutations and/or fusions) had tumor shrinkage and approximately 30.7% (4/13) of the patients achieved partial response confirmed by Independent R
Slide 20: Future Development Plan of Fexagratinib
Future Development Plan of Fexagratinib (ABSK091) 2022 2023 2024 and beyond Phase II 2L UC (mono) 1/2L UC Phase II (combo with tislelizumab) 19
Slide 21: Business Update
BUSINESS UPDATE Dr. Zhui Chen 20
Slide 22: Proprietary Discovery Engine with Global Quality and Efficiency
Proprietary Discovery Engine with Global Quality and Efficiency Drives Long Term Growth High efficiency with global quality and Fully integrated end-to-end discovery engine standard Target identification Drug discovery Translational & High efficiency in delivering ~2 PCCs per year & validation &
Slide 23: Next Wave of Programs from Discovery to Clinic
Next Wave of Programs from Discovery to Clinic to Generate Sustainable Returns ABSK112 ABSK051 ABSK012 Next-Generation Target CD73 (Small Molecule) FGFR4 Mutant EGFR Exon20 Lung, Breast, Liver etc. Indications Lung RMS, liver, breast etc. (Broad PD-1 combination) Best-in-class wild type Best-in-
Slide 24: Discovery-Driven Out-licensing Partnership in Preclinical Stage
We Value Discovery-Driven Out-licensing Partnership in Preclinical Stage 4th-Generation EGFR-TKI ABK3376 with Allist EGFRm NSCLC Treatment Landscape Allist C797S 1L/2L Drug- Osimertinib ABK3376 resistant Almonertinib Mutation Furmonertinib Mainland China Hong Kong Taiwan Strong and balanced
Slide 25: Collaboration with Multi-National Pharma for Global Co-Discovery
We Collaborate with Multi-National Pharma for Global Co-Discovery INNOVATION GLOBOLIZATION A new collaboration model Potential financial benefits A worldwide co-discovery collaboration on a novel and challenging drug target Abbisko eligible to receive up to US$258m in potential milestone payment
Slide 26: Financial Update
FINANCIAL UPDATE Dr. Zidong Zhang 25
Slide 27: Robust Financial Position to Support Future Business Growth
We Maintain in Robust Financial Position to Support Future Business Growth Strong cash position RMB2,258.8m (~US$324m) cash and bank balances to fund multiple years Sufficient for multiple years of operations based on current burn of operation rate Cash burn for operations(1) ~US$55m in 2022 D
Slide 28: Closing Remarks and 2023 Outlook
CLOSING REMARKS AND 2023 OUTLOOK Dr. Yao-Chang Xu 27
Slide 29: 2022: A Year Full of Data Verifications amid Challenges
2022: A Year Full of Data Verifications amid Challenges, as We Successfully Delivered Most of Our 2022 Goals Despite COVID Lockdowns Pipeline Target Clinical trial Stage Event 2022 goals 2L HCC, mono Phase Ib Preliminary PoC readout Irpagratinib FGFR4 1L/2L HCC, (ABSK011) Phase II Preliminary data
Slide 30: 2023: Continuous Clinical and IND Progresses Are Well Underway
2023: Continuous Clinical and IND Progresses Are Well Underway Pipeline Target Clinical trial Stage Event 2023 Clinical candidates Target US Pivotal Trial design approval 1H Pimicotinib TGCT Phase III Global MRCT Pivotal Trial to start 1H CSF-1R (ABSK021) Extended Efficacy/Safety Results from
Slide 31: Thank You
= ; he “Thank You a 2 Abbisko