Abbisko Cayman Limited · HKEX:2256
Abbisko Cayman — Abbisko Therapeutics — FY2023 Earnings Presentation
38 slides from Abbisko Cayman's earnings presentation, Mar 13, 2024
Slide 1: FY2023 Full Year Results and Business Updates
Abbisko Therapeutics FY2023 FULL YEAR RESULTS AND BUSINESS UPDATES March 13 2024
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 Key Mid-Late Stage Clinical Dr. Jing Ji Update Key Early Development 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: We Achieved Many Milestones in 2023 and Built a Solid Foundation
We Achieved Many Milestones in 2023 and Built a Solid Foundation for the Next Stage Key Late Stage Clinical Programs Pimicotinib (ABSK021) ꟷ ORR: 25-week 68% (1yr follow-up ORR 87.5%), BTD in US/CHN/EU, FTD in US, ODD in EU, potential BIC; ꟷ FPI CHN/US/EU for Phase III MRCT, enrollment completion
Slide 6: We Have Built a Robust Pipeline Covering Many Diseases
We Have Built a Robust Pipeline Covering Many Diseases Discovery – IND Phase I Phase Ib / II Phase III / Pivotal ABSK043 Pimicotinib Pimicotinib ABSK012 Oral PD-L1 CSF-1R CSF-1R FGFR4 mutations Solid tumors, China, Australia cGvHD, Phase II, China, w/ Merck KGaA TGCT, Phase III,CN/US/EU, w/ Merck KG
Slide 7: In 2024, We are Advancing into a Stage with Rich Data
In 2024, We are Advancing into a Stage with Rich Data to Support Best/First-in-Class Assets with Significant Commercial Potential 2023 2024 Pimicotinib Pimicotinib (CSF-1R) TGCT Phase Ib TGCT Phase III Irpagratinib cGvHD Phase II 87.5% ORR (FGFR4) Irpagratinib HCC 2L+ Phase Ib HCC 2L+ Phase Ib ABSK0
Slide 8: Our Broad Partnership Brings in Sustainable Financial Income
Our Broad Partnership Brings in Sustainable Financial Income and Continuous Cash Inflow Partner Disease Area Geography Status Financials Upfront $70M (Greater China), total milestones TGCT Phase III of $605.5M Pimicotinib TGCT Greater China cGVHD Phase II Option fee for global PDAC Phase I
Slide 9: Abbisko is Advancing From Revenue Generation Stage to Sustained Revenue and Growth
Abbisko is Advancing From Revenue Generation Stage in 2023-24 to the Sustained Revenue and Growth Stage 2025 + Sustained Revenue and Growth 2023-2024 through commercialization and partnership Revenue Generation from clinical development and Become a fully-fledged 2016-2022 partnership commercial s
Slide 10: Key Mid-Late Stage Clinical Update
KEY MID-LATE STAGE CLINICAL UPDATE Dr. Jing Ji FGFR4 – Irpagratinib CSF-1R – Pimicotinib 9
Slide 11: FGFRs Are Pan-Cancer Targets with Large Unmet Medical Needs
FGFRs Are Pan-Cancer Targets with Large Unmet Medical Needs Large therapeutic opportunities remain after 1st-gen FGFR aberrations occur across major cancer types(11) inhibitors due to their toxicity, limited efficacy, and acquired with ~1.9mn annual incidence globally resistance Cholangiocarcinoma L
Slide 12: FGFR Franchise: Focusing on High Impact Irpagratinib and ABSK061
FGFR Franchise: Focusing on High Impact Irpagratinib and ABSK061 Selectivity over FGFR1 to improve Overcome resistant Pan- safety and efficacy Selective mutations FGFR FGFR FGFR Mutant Inhibitor Inhibitor Inhibitor Indication coverage ABSK091 (pan-FGFR) z ABSK061 (FGFR2/3) ABSK121 (pan-FGFR mutant)
Slide 13: High Unmet Medical Needs for Late-Stage HCC
High Unmet Medical Needs for Late-Stage HCC HCC: 1 M new patients New Globally, ~50% in China HCC Cases FGF19+ HCC: ~30% of all HCC Endocrine FGF19 Autocrine All HCC FGF19+ HCC Plasma Membrane Millions Cytoplasm FGFR4 KLB (klotho beta) 1.5 1.0 0.5 0.8 FRS2 0.4 Irpagratinib 1.0 p ERK SHP p 0.5 Ch
Slide 14: FGFR4 Target Therapy May Change Global HCC Treatment Landscape
FGFR4 Target Therapy May Change Global HCC Treatment Landscape Prior Abbisko FGFR4 Multi-TkIs Immuno-Therapies FGFR4 Inhibitors Inhibitor 1st Line Atezolizumab + bevacizumab Blu554 (Blueprint/Cstone) Sorafenib, Lenvatinib Tremelimumab + durvalumab Irpagratinib 2-19% ORR 20-30% ORR 36% ORR (4/1
Slide 15: Irpagratinib Demonstrated 40.7% ORR in 2L+ HCC Patients
Irpagratinib Demonstrated 40.7% ORR in 2L+ HCC patients with Superior Clinical Safety Profile in Phase Ib Trial (ESMO 2023) Irpagratinib Showed Promising Efficacy in Phase Ib Trial Change in Lesions in Prior Treated FGF19+ HCC Pts of BID Cohorts In 2L+HCC pts with FGF19+ Irpagratinib (BID) demonstra
Slide 16: Future Development Plan for Irpagratinib
Future Development Plan for Irpagratinib 2022 2023 2024 and beyond FGF19+ 2L+ Phase Ib Phase II/III Pivotal Trial HCC High Dose QD Escalation RP2D BID Dose Expansion (mono) BID Escalation FGF19+ 1/2L Atezolizumab combo Phase II Phase II/III HCC BID Dose RP2D Dose Escalation Expansion (combo) All 1L
Slide 17: CSF-1R Is A Clinically Validated Target
CSF-1R Is A Clinically Validated Target and Plays Critical Roles in Various Macrophage-Dependent Diseases with Significant Unmet Medical Needs CSF-1R regulates many types of macrophages in Neuro-degenerative Oncology Other TAs human including: Tumor-associated macrophage (TAM), which plays a criti
Slide 18: Pimicotinib Potential in Multiple CSF-1R-Dependent Diseases
Pimicotinib Potential in Multiple CSF-1R-Dependent Diseases 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 ALS Solid Tumors Addressabl
Slide 19: Pimicotinib Demonstrated Potentially Best-in-Class Efficacy and Safety Profile
Pimicotinib Demonstrated Potentially Best-in-Class Efficacy and Safety Profile (ASCO 2023 & CTOS 2022/2023) Pimicotinib Showed Promising Efficacy in Phase Ib Trial Best Percentage Change from baseline by IRC ORR 68.0% in 25 week follow-up: 1 CR and 16 PR within 6 months in patients receiving 50mg
Slide 20: Pivotal Global Phase III Trial for TGCT Is Ongoing
Pivotal Global Phase III Trial for TGCT Is Ongoing in China, US, and Europe A randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Pimicotinib at the dose of 50mg QD in patients with Tenosynovial Giant Cell Tumor Part 1：Randomized, Double-Bli
Slide 21: Pimicotinib Clinical Development Plan
Pimicotinib Clinical 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. 2. LPI: last patient in. 3. TL
Slide 22: Partnership with Merck KGaA Maximizes Pimicotinib's Value
Partnership with Merck KGaA not only Maximizes Pimicotinib’s Value by Merck’s Commercial Capability & Geographic Reach, but also brings in Significant Financial Returns for Abbisko Up to $605.5 M Total Milestones&Upfront Aggregated upfront, option exercising payment, and development & commercializat
Slide 23: Key Early Development Update
KEY EARLY DEVELOPMENT UPDATE Dr. Zhui Chen FGFR2/3 – ABSK061 Oral PD-L1 – ABSK043 PRMT5*MTA – ABSK131 22
Slide 24: FGFR2/3 Have Multi-Billion Market Potential in Achondroplasia and Cancer
FGFR2/3 Have Multi-Billion Market Potential in Achondroplasia and Many Types of Cancer Oncology Market Size Globally ~7% Gastric Cancer: 10-30% FGFR-alteration FGFR aberrations > $8 Bn in all cancers Cholangiocarcinoma: Potential global market size 10-45% FGFR2-alteration for multiple solid tumors >
Slide 25: Competitive Landscape in Achondroplasia and Proof-of-Concept
Competitive Landscape in Achondroplasia and Proof-of-Concept Competition Proof-of-Concept 1,2 Stage Vosoritide validated the concept that targeting FGFR3 can treat ACH Company Asset Preclinic Ph 1 Ph 2 Ph 3 Marketed S.C. CNP Analog Vosoritide (BMN111) Injectable peptide Works alongside the body’s na
Slide 26: ABSK061 Clinical Development
ABSK061 Clinical Development 2022-2023 2024-2025 Dose escalation Oncology Fast to market Completed Ongoing Mono therapy in 2L iCCA, UC or other cancer types with 75mg BID high FGFR alteration rates 150mg QD 100mg BID RDE confirmation 75mg BID 50mg BID 150mg QD Value Maximization in Achondroplasia 35
Slide 27: ABSK061 Demonstrated Promising Preliminary Efficacy and Safety Data
ABSK061 Demonstrated Promising Preliminary Efficacy and Safety Data (ESMO-TAT 2024) Promising Efficacy Profile in Phase I Clinical Trial Best Percentage Change of Target Lesions ORR ~37.5% (3 PR in 8 evaluable pts) 1 NSCLC ORR 37.5% 1 urothelial carcinoma 1 gastric cancer DCR 75% Superior Clin
Slide 28: Oral PD-L1 Small Molecules Offer Blockbuster Potential
Oral PD-L1 Small Molecules Offer Blockbuster Potential 80% of PD-(L)1 Market Can be Amenable Significant Advantage of Oral PD-L1 Small Molecule Inhibitor to Oral Small Molecule Inhibitor Ease of use, no intravascular 1 ~$58Bn1 Oral formulation/ (IV) costs 80% adjustable dosing schemes Oral-oral
Slide 29: ABSK043 Is A Global Leading Oral PD-L1 Small Molecule
ABSK043 Is A Global Leading Oral PD-L1 Small Molecule Preliminary Phase I Results (ESMO 2023) Showed 27% ORR with Superior Safety Promising Efficacy Profile in Phase I Clinical Trial Best Percentage Change in Sum of Diameters of Target Lesions ORR ~27% (3 PR in 11 evaluable BID pts) 1 PR from a br
Slide 30: ABSK131 – Next Generation PRMT5*MTA Inhibitor
ABSK131 – Next Generation PRMT5*MTA Inhibitor High Unmet Medical Needs and Significant Business Value MTAP gene deletions occur in 10-15% MRTX1719 potentially contributes more than $1Bn value of ALL human cancers in recent BMS-Mirati acquisition deal! Source: https://news.bms.com/news/corporate-fina
Slide 31: ABSK131 Demonstrated Potential Best-in-Class Preclinical Properties
ABSK131 Demonstrated Potential Best-in-Class Preclinical Properties Cellular Activity MTAP – WT Company Asset Stage (IC50, nM)* Selectivity** CNS Penetration ABSK131 PCC ~8 >80× Good Lead ABSK132 ~25 ~20× High Optimization AMG193 Ph I/II >100 ~35× Good MRTX1719 Ph I/II >30 ~60× NOa TNG908 Ph I/II >5
Slide 32: Financial Update
FINANCIAL UPDATE Dr. Zidong Zhang 31
Slide 33: In FY23, our Revenues Increased to Narrow Losses, with Robust Cash Reserve
In FY23, our Revenues Increased to Narrow Losses, with Robust Cash Reserve P&L net loss narrows Strong cash position to fund multiple years Narrowed net loss driven by increased revenue of ￥106M Net cash of ￥1,972M ($278M) to fund >3yrs operations ￥106M +130% ¥19M Lisence fee income ¥2,259M -￥28
Slide 34: For FY24, We will Continue to Grow Revenue; Initiate Buybacks
For FY24, We will Continue to Grow Revenue with Moderate Expenses (cash burn <$80M); and will Initiate Buybacks to Enhance Shareholder Return Stable or Slight increase in interest income and government grants in FY24 Continue to (vs FY23) grow revenue Sustained revenue from active BD (Allist, Me
Slide 35: Closing Remarks & Outlook
CLOSING REMARKS & OUTLOOK Dr. Yao-Chang Xu 34
Slide 36: We Have Completed Most of Our 2023 Milestones
We Have Completed Most of Our 2023 Milestones Pipeline Target Clinical Trial Stage Event 2023 Clinical candidates Target Status US Pivotal Trial Design Approval 1H Completed Completed TGCT Phase III Global MRCT Pivotal Trial to Start 1H Completed Pimicotinib CSF-1R Extended Phase Ib Efficacy/S
Slide 37: Rich Milestones Expected in 2024
Rich Milestones Expected in 2024 Pipeline Target Clinical Trial Stage Event Time Clinical Phase III enrollment completion 1Q24 TGCT Phase III Pimicotinib CSF-1R Phase III data read-out 4Q24 cGvHD Phase II Full Phase II data readout 4Q24 Phase Ib Extended BID data readout 3Q24 2L HCC, mono Ir
Slide 38: Thanks
9 Thanks