Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — Non-Deal Roadshow (March 2022)
37 slides from Ascentage Pharma Group International's roadshow presentation, March 2022
Slide 1: Ascentage Pharma Group: Advancing Therapies That Restore Apoptosis
Ascentage Pharma Group Advancing Therapies That Restore Apoptosis March, 2022
Slide 2: Disclaimer
Disclaimer PROPRIETARY AND CONFIDENTIAL 1 1
Slide 3: Innovative and Proprietary Platform Delivering Potentially First and/or Best-in-Class Drugs
Innovative and Proprietary Platform Delivering Potentially First and/or Best-in-Class Drugs Breakthrough Strong pipeline science 1 10+ 178 600+ 100+ NDA Approval indications issued patents pending applications publications 12 50+ novel clinical trials compounds Dedicated team 30+ INDs 1 Global devel
Slide 4: Major Achievements in 2021
Major Achievements in 2021 NDA approval of v Clinical breakthrough for (HQP1351) apoptosis asset APG-2575 n The first and the only approved third generation BCR-ABL inhibitor in China n Registrational pivotal study of APG-2575 for treatment of patients with CLL/SLL n Received support from National M
Slide 5: Expected Milestones in 2022
Expected Milestones in 2022 Key asset clinical development and data release expectation NDA submission： We expect to HQP1351 submit a full-approval NDA • A phase Ib study for treatment of patients with CML and Ph + ALL is application of Olverembatinib for ongoing in the US. We will continue to consu
Slide 6: Olverembatinib: the only approved and commercialized third generation BCR-ABL inhibitor in China
Olverembatinib: the only approved and commercialized third generation BCR-ABL inhibitor in China • The first commercialized product of Ascentage Pharma Co-promote with Innovent Biologics Accelerate the market coverage • The only approved and in China Received commercialized third NDA Approval genera
Slide 7: Commercialization Market potential - Maximize market value of Olverembatinib
Commercialization Market potential - Maximize market value of Olverembatinib CML ~ 40% received 2nd+ line therapy • Annual Sale of Global CML patients in China Along with the increase of 2nd Market is $6 Bn 100,000 generation TKI treatment, • Annual sale of 2 2nd generation + the number of T315I mut
Slide 8: Multiple Ongoing Strategic Alliances
Multiple Ongoing Strategic Alliances BCL-xL BCR-ABL & BCL-2 BCL-2 MDM2-p53 BCL-2 IAP 7
Slide 9: Constant Improvement in Cash Flow
Constant Improvement in Cash Flow The first 1.3Bn Issuance and commercialized placement of product and realized additional shares rmb revenue and raised 1.74Bn 70.3 Cash& Year-on-year rmb % Cash Equivalent Increase 27.91M 123.2 Year-on-year Revenue rmb Increase % 8
Slide 10: Key Financial Highlights
Key Financial Highlights Revenue¹ R&D Expense Total Assets (RMB mm) (RMB mm) (RMB mm) 27.9 2940.1 766.5 564.6 14.5 463.9 1731.0 12.5 1229.4 1205.1 6.3 6.8 249.6 118.8 581.7 2017 2018 2019 2020 2021 2017 2018 2019 2020 2021 Dec-17 Dec-18 Dec-19 Dec-20 Dec-21 EBIT² OPEX Cash & Equivalents³ (RMB mm) (R
Slide 11: Our Experienced Executives Team
Our Experienced Executives Team Dajun Yang, M.D., Ph.D. Yifan Zhai, M.D., Ph.D. Gang Zhu. Yiqing Chen CO-FOUNDER CHIEF MEDICAL OFFICER CHIEF COMMERCIAL OFFICER CHIEF FINANCIAL OFFICER CHAIRMAN & CHIEF EXECUTIVE OFFICER Shaomeng Wang Ph.D. Thomas Knapp Jeff Kmetz Chongdong Fu, Ph.D. Co-Founder Profes
Slide 12: Rich Pipeline With Significant Global Opportunities
Rich Pipeline With Significant Global Opportunities Product Target Indications Preclinical Ph I Ph II Registration Trial NDA Approval Trial Region Rights Regions Rights Product Target Indications Preclinical Ph I Ph II NDA NDA Approval Trials Regions Regions Resistant CML Resistant CML Resistant CML
Slide 13: HQP1351 Olverembatinib Overview
HQP1351 Olverembatinib Overview The only approved and commercialized third generation BCR-ABL inhibitor in China, targeting BCR-ABL mutants, including those with the T315I mutation Received support from National Major New Drug Discovery and Manufacturing Program Best-in-class drug potential globally
Slide 14: Development Milestone: From IND Clearance to NDA Approval in 4 Years
Development Milestone: From IND Clearance to NDA Approval in 4 Years • 2021.03: received “ Breakthrough Therapy Designation “ • 2020.04: granted Orphan Drug 2021 Designation(CML) and Fast Track 2020 • 2021.11: received NDA Approval Designation by FDA • 2021.11: granted Orphan Drug Designation (CML)
Slide 15: Phase I Study Summary: Efficacy
Phase I Study Summary: Efficacy Cumulative Incidence of Progression-free Survival & Highly Efficacious in TKI Resistant CML Patients Achieving Responses Overall Survival (≥30mg) (≥ 30mg) CP CP CP No mutation T315Imutation T315i+other mutations other mutations Response Rate % (95% CI) at 36 mo 100% 1
Slide 16: Phase I Study Summary: Safety Profile and Compound Mutation
Phase I Study Summary： Safety Profile and Compound Mutation Prevalence of Treatment-related Adverse Events over Time ( ≥30mg ), Well-Tolerated With Minimal Dose Interruptions Year 1 Year 2 Year 3 Year 4 Haematologic (Grade 3/4) (n=83) (n=75) (n=70) (n=55) Thrombocytopenia Leukopaenia Anaemia Nonhaem
Slide 17: Pivotal Phase 2 Study Summary
Pivotal Phase 2 Study Summary Highly Efficacious in T315I-Mutated CML Patients Treatment-related Hematologic Adverse Events 71% G1-2 G3-4 CP 100% CP 69% T315I + n = 41 81% 32% 49% 68% 49% 39% 56% 15% 22% 37% 34% 22% 17% CHR MCyR CCyR MMR Thrombocytopenia Anemia Leukopenia Neutropenia SAE: 7% SAE: 2%
Slide 18: APG-2575 Overview
APG-2575 Overview Novel, orally administered Bcl-2 selective inhibitor, follow to Venclexta® The second drug entered into pivotal phase II study globally Best in class potential 18
Slide 19: Clinical POC Established With Best-in-Class Safety Potential
Clinical POC Established With Best-in-Class Safety Potential 1 1 2 More than 190 patients with relapsed/refractory 2 More than 300 subjects enrolled into CLL (r/r CLL) have been treated with APG-2575 the APG-2575 studies, including r/r and POC achieved CLL, FL, MCL, MZL, DLBCL, WM, • 80% PR in Evalu
Slide 20: Phase I Study in the US: Safety + 80% ORR
Phase I Study in the US: Safety+ 80%ORR Treatment-related adverse events with APG-2575 (N = 36) CLL/SLL Swimmer Plot 80% PR in Evaluable R/R CLL/SLL Patients Any grade AE (≥ 10%) No. (%) ≥ Grade 3 AE (≥ 5%) No. (%) 200 400 001-002 50mg * Withdraw Consent Any ≥ grade 3 APG-2575- Any APG-2575-related
Slide 21: Phase I Study in China: Safety/Efficacy + 100% ORR
Phase I Study in China: Safety/Efficacy+100%ORR No DLT observed, MTD not Extremely low lab and clinical Lisaftoclax is well tolerated reached TLS Treatment-related adverse events with APG-2575 (TRAEs; >10%) TRAEs > Grade 3 and SAE 20 mg 50 mg 100 mg 200 mg 400 mg 600 mg 800 mg Total >Grade 3, n (%)
Slide 22: APG-2575-CN-001 Phase I Interim Data: Efficacy
APG-2575-CN-001 Phase I Interim Data I Efficacy Ibrutinib Resistant High Risk Patient; Rapid and Deep Response Patient 01S008: Complete Response ALC (x10^9/I) 2.5 5 CR in r/r CLL (IGVH mutation, No TP53) 2.0 4 K 1.5 3 Ca Before APG-2575 After APG-2575 1.0 2 0.5 1 P 0.0 0 C1D15 C2D15 C3D15 C4D15 C1D2
Slide 23: Strong Differentiation From Venetoclax
Strong Differentiation From Venetoclax APG-2575 Compared to Venetoclax Product, Patient, Provider Attributes Efficacious in BTK resistant WM PDX model in When Selectively Targeting BCL-2 which Venetoclax shows no effect Daily ramp-up verse weekly ramp up Dose Escalation (Daily Ramp) Extremely low la
Slide 24: APG-115
APG-115 MDM2-p53 Inhibitor Activates p53 tumor suppression via MDM2-p53 PPI Potential First-in-Class Drug 25
Slide 25: APG-115: Mechanism
APG-115 : Mechanism APG-115 Delivers Anti-tumor Activity by Multiple MOAs Tumor Cells Tumor microenvironment Apoptosis Activates innate immunity by reprograming Activates WT p53-dependent macrophages M2 to M1 to suppress tumorigenesis intrinsic apoptosis. (Fang et al. 2019). T-Cell Mediated Anti- AP
Slide 26: APG-115: Clinical Development and Progress
APG-115 ：Clinical Development and Progress First-in-class potential The FDA has Granted 2 Rare Pediatric Disease Granted a Fast Track Designation Achieved Clinical POC granted six ODDs to APG-115 for the (RPD) designation for the treatment of (FTD) by the FDA for the treatment of treatment of soft t
Slide 27: APG-115 Plus Pembrolizumab: Efficacy
APG-115 Plus Pembrolizumab: Efficacy Efficacy in all Cohorts Efficacy in Patients with IO Resistant Melanoma Melanoma NSCLC STK-11 ATM Liposarcoma UC MPNST Uveal Mucosal Cutaneous Unknown primary Total Response (n = 32) (n = 19) (n = 5) (n = 11) (n = 17) (n = 12) (n = 6) Response (n = 8) (n = 5) (n
Slide 28: Safety: Treatment Emergent AEs (TEAEs)
Safety: Treatment Emergent AEs (TEAEs) Grade: Grade 1–2 Grade 3–4 All grades: ≥10% G3 above: ≥2% Nausea Thrombocytopenia Vomiting Fatigue Decreased Appetite Anaemia Neutropenia Diarrhoea Dehydration Constipation Abdominal Pain Wbc Decreased Headache Dyspnoea Malaise Sepsis Pulmonary Embolism 0 10 20
Slide 29: APG-1387 Milestones & Clinical Developments
Milestones & Clinical Developments We have already completed a phase I study for the treatment of patients with CHB. The stage 1 safety evaluation of APG-1387 in combination with CHB APG-1387 Development Entecavir (ETV) for a phase II study has completed. With well- tolerated safety data, the study
Slide 30: APG-1252
APG-1252 Bcl-2/Bcl-xL inhibitor Combination use for the treatment of solid tumors and hematologic malignancies Granted an ODD for the treatment of SCLC Potential Best-in-Class Drug
Slide 31: APG-1252 plus Osimertinib: Efficacy
APG-1252 plus Osimertinib：Efficacy Best response, n (%) Dose determination 240mg (n=6) Dose determination 160mg (n=5) Expansion Arm-1 (n=20) Expansion Arm-2 (n=22) Partial response (unconfirmed) 0 (0.0) 1 (20.0) 3 (15.0) 13 (59.1) Partial response (confirmed) 0 (0.0) 0 (0.0) 1 (5.0) 8 (36.4) Stable
Slide 32: APG-2449 Milestones & Clinical Developments
Milestones & Clinical Developments APG-2449 is a novel, orally active, small molecule FAK/ALK/ROS1 triple ligase kinase inhibitor designed and developed by us. It is the first third-generation ALK inhibitor being developed in China. APG-2449 Pre-clinical data indicated that It is a very potential no
Slide 33: Pre-Clinical Assets
Pre-Clinical Assets EED Selective MDM2-p53 Degrader APG-5918 APG-265 Focused on validated targets High unmet with clear biomarker, clinical medical needs indications and fast regulatory approval Transformative new First-in-class or technology best-in-class potential 34
Slide 34: IP Portfolio for Key Clinical Assets
IP Portfolio for Key Clinical Assets Key Clinical Assets Estimated Patent Expired Year HQP1351 2035-2041* APG-2575 2037-2041* APG-115 2035-2041* APG-1387 2033-2041* APG-1252 2034-2041* *including composition, process, formulation, combination, use, new indication etc；(issued or pending) 35 35 Source
Slide 35: Sustainable Competitive Advantage
Sustainable Competitive Advantage Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions Self-developed to restore apoptosis or programmed cell death Drug Design Professional Platform and effective Professional and effective clinical groups Clinical in China an
Slide 36: Investment Highlights
Investment Highlights To discovery and development of innovative first- and To become a fully integrated globally-focused best-in-class therapies to address unmet medical biotechnology company. needs globally Global leader in apoptosis targeting therapy with commercial stage product Product pipeline
Slide 37: Ascentage Pharma Group
Ascentage Pharma Group Advancing Therapies That Restore Apoptosis
Ascentage Pharma Group International — Non-Deal Roadshow (March 2022) on 6ix