Abbisko Cayman Limited · HKEX:2256
Abbisko Cayman — Abbisko Therapeutics — H1 2024 Earnings Presentation
32 slides from Abbisko Cayman's earnings presentation, Aug 13, 2024
Slide 1: 1H2024 Interim Results and Business Updates
Abbisko Therapeutics 1H2024 INTERIM RESULTS AND BUSINESS UPDATES August 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 Business Review Dr. Yao-Chang Xu Key Clinical Update Dr. Jing Ji Financial Summary Dr. Zidong Zhang Closing Remarks Dr. Yao-Chang Xu & Outlook Q&A 2
Slide 4: Business Review
BUSINESS REVIEW Dr. Yao-Chang Xu 3
Slide 5: Significant Pipeline Milestones in 1H24 and First Profitability
We Accomplished Significant Milestones for Our Pipeline Programs in 1H24 and Achieved Profitability for the First Time Key Clinical Pipeline Update Pimicotinib ꟷ Global Phase III MRCT patient enrollment completed at the end of Mar 2024, data readout expected in 4Q24 ꟷ cGvHD Phase II ongoing, data
Slide 6: Robust Pipeline Covering Major Disease Areas
We Have Built a Robust Pipeline Covering Major Disease Areas Discovery – IND Phase I Phase Ib / II Phase III / Pivotal ABK3376 ABSK112 ABSK043 Pimicotinib Pimicotinib CSF-1R CSF-1R 4th-Gen EGFR (C797S) Next-Gen EGFR-Exon20 Oral PD-L1 cGvHD, Phase II, China, w/ Merck TGCT, Phase III,CN/US/EU, w/ Merc
Slide 7: Transforming From Revenue Generation to Sustained Revenue and Growth
Abbisko is Transforming From Revenue Generation Stage to Sustained Revenue and Growth Stage 2025 + Sustained Revenue and Growth 2020-2024 through commercialization and partnership Revenue Generation from clinical development and Become a fully-fledged 2016-2024 partnership Experienced clinical d
Slide 8: Key Clinical Updates
KEY CLINICAL UPDATES Dr. Jing Ji FGFR4 – Irpagratinib CSF-1R – Pimicotinib FGFR2/3 – ABSK061 7
Slide 9: Irpagratinib Clinical Trials in HCC Across 2L, 1L, Mono and Combo
Irpagratinib—A Potential FIC Novel Mechanism HCC Therapy Covered Various Clinical Trials in 2L,1L, Mono and Combo Treatments 2023 2024 2025 and beyond FGF19+ 2L+ Phase Ib Phase II/III Pivotal Trial ( post- ICI ) HCC (mono) FGF19+ 1/2L Atezolizumab combo Phase II ( 2L 1L ) Combo with Standard of Care
Slide 10: HCC Patients Are in Urgent Need of More Effective Therapies
HCC Patients Are in Urgent Need of More Effective Therapies 1L 2L* The therapeutic response to mTKI and ICI is limited after the progression from immunotherapy Multi-TKIs Lenvatinib or Regorafenib + Sorafenib, Lenvatinib Regorafenib, Cabozantinib approved mTKI Pembrolizumab 2-19% ORR 4-7% ORR Pr
Slide 11: FGF19+ HCC Patients Have Poor Responses to Current Therapies
FGF19+ HCC Patients Have Poor Reponses to Current Therapies FGF19+ Patients Have Poorer Responses FGF19+ Patients Have Significantly Shorter PFS upon Treatment vs FGF19- Patients When Treated with 1L mTKI with ICI as 1L Therapy Compared to FGF19- Patients FGF19- FGF19+ Median PFS (mo) 11.4 6.1 P-val
Slide 12: Irpagratinib Monotherapy 40.7% ORR in 2L+ HCC
Irpagratinib Monotherapy 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 (BI
Slide 13: Irpagratinib + Atezolizumab Combination in 1L+ HCC
Irpagratinib + Atezolizumab Combination Demonstrated Promising Efficacy in 1L+ HCC — Preliminary ORR of 50% for the 220mg BID Irpagratinib Cohort Irpagratinib+Atezo Demonstrated Percentage of Tumor Change in Patients from the Promising Efficacy in Phase II Trial Irpagratinib 220mg BID Cohort 100% Al
Slide 14: Irpagratinib Broad Potential for Treating HCC at Multiple Stages
Irpagratinib Has Broad Potential for Treating HCC Patients at Multiple Stages Therapeutic approaches under development Potential clinical benefits Significantly improved prognosis 1L Irpagratinib for the FGF19+ population Combo Treatment Higher response rate Longer survival period Good safety pr
Slide 15: Key Clinical Updates
KEY CLINICAL UPDATES FGFR4 – Irpagratinib CSF-1R – Pimicotinib FGFR2/3 – ABSK061 14
Slide 16: 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 17: Expanding Pimicotinib into Multiple CSF-1R-Dependent Areas
We Aim to Expand Pimicotinib into Multiple CSF-1R-Dependent Therapeutic Areas with Multi-Billion Dollars Market Potential 1 2 Expansion into other 3 Accelerated development in Combo in broad oncology Strategy TGCT indications (many with indications potential orphan drug status) TGCT cGvHD Solid Tumo
Slide 18: Pivotal Global Phase III Trial for TGCT
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 19: Completed Patient Enrollment for Global Phase III Trial
We Completed Patient Enrollment for the Global Phase III Trial on Schedule in March 2024 Current Progress： Enrollment of all patients was completed in March 2024 as planned Total of 94 patients were enrolled The number of enrolled patients in North America and Europe exceeds 50% of the total F
Slide 20: Pimicotinib Phase II Trial in cGvHD
Pimiconitib Phase II trial in cGvHD Is Progressing Well Phase II trial in cGvHD Mechanism of Action A multi-center, single arm, open label study for efficacy and safety CSF-1 Circulating Blood monocyte Part A Part B vessel Circulating CSF-1R monocyte Population CSF-1 3(+3) Active cGVHD after ≥ 1 p
Slide 21: Pimicotinib Clinical Development Plan
Pimicotinib Clinical Development Plan 2023 2024 2025 Phase III MRCT TGCT TLR(3) Phase II cGvHD Phase II PDAC 1. FPI: first patient in. 2. LPI: last patient in. 3. TLR: topline result. 20
Slide 22: Key Clinical Updates
KEY CLINICAL UPDATES FGFR4 – Irpagratinib CSF-1R – Pimicotinib FGFR2/3 – ABSK061 21
Slide 23: FGFR2/3 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 24: ABSK061 Preliminary Efficacy and Safety Data (ESMO-TAT 2024)
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) ORR 37.5% 1 NSCLC 1 urothelial carcinoma 1 gastric cancer DCR 75% In the 6 pati
Slide 25: Actively Pursuing the IND Application for ACH
We Are Actively Pursuing the IND Application for ACH In vivo efficacy studies Preclinical safety studies ACH Ph2 CMC Development IND-CN In children Pro-active communication with authority for IND Safety assessment in oncology patients China IND filing expected in 4Q24 24
Slide 26: ABSK061 Clinical Development Plan
ABSK061 Clinical Development Plan 2023 2024 2025 FGFR2 Aberrations Phase II 1L Gastric cancer Phase I (Mono, Dose Exploration) (Combined with chemotherapy and (Combo) immunotherapy,1L) FGFR2/3 Phase I (Mono, Dose Exploration) Phase II Aberrations Basket Trial (Combined with immunotherapy,2L) （Mono/C
Slide 27: Financial Summary
FINANCIAL SUMMARY Dr. Zidong Zhang 26
Slide 28: 1H24 Revenue, Net Profit and First-Time Profitability
In 1H24, We Recorded a Significant Increase in Revenue to￥546M, a Net Profit of ￥207M, and Achieved Profitability for the First Time P&L Strong Cash Position Revenue￥546M, Net Profit￥207M Net Cash of ￥2,123M (~$300M) for multiple years’ of operations ￥546M ¥49M Bank interest & ￥2,259M +857% Gove
Slide 29: Shares Repurchased in 1H24 and Shares Canceled
~19M Shares (~56M HKD) were Repurchased in 1H24 and 16M Shares Canceled. Our Share Repurchase may Continue based on Market Conditions On March 13,2024 we announced As of June 30,2024, we spent On July 3, 2024, 15,833,000 that we would repurchase and an amount of 56.32M HKD to shares were canceled, a
Slide 30: Closing Remarks & Outlook
CLOSING REMARKS & OUTLOOK Dr. Yao-Chang Xu 29
Slide 31: Completed 1H24 Milestones and Expect to Achieve 2H24 Milestones
We Completed All Major Milestones in 1H24 and Expect to Achieve All 2H24 Milestones on Schedule Pipeline Target Clinical Trial Stage Event 2024 Clinical Target Status Phase III enrollment completion 1Q24 Completed TGCT Phase III Pimicotinib CSF-1R Phase III data read-out 4Q24 Ongoing (ABSK021) c
Slide 32: Thanks
Thanks