Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — FY2024 Earnings Presentation
39 slides from Ascentage Pharma Group International's earnings presentation, Mar 27, 2025
Slide 1: 2024 Full Year Results and Business Updates
(AAPG.NASDAQ | 6855.HKEX) 2024 Full Year Results and Business Updates March 27, 2025 STRICTLY PRIVATE AND CONFIDENTIAL
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation has been prepared by Ascentage Pharma Group International (the “Company”) and includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of
Slide 3: Agenda
Agenda 01 Business Update & Financial Review 02 Olverembatinib Updates 03 Lisaftoclax (APG-2575) Updates 04 Other Pipeline Updates 05 Q&A 3
Slide 4: Business update & financial review
Business update & financial review 4
Slide 5: 2024 – A Transformational Year
2024 – A Transformational Year Further de-risked, going global and better capitalized Leading hematological Takeda agreement and Strong financial position oncology player equity investment 2 molecules in commercial stage or NDA Validation for olverembatinib’s Dual-listed on review with multiple Phas
Slide 6: Strong growth in total revenue and olverembatinib sales in 2024
Strong growth in total revenue and olverembatinib sales in 2024 Further growth in olverembatinib sales supported by multiple tailwinds 342% growth in revenue driven by Takeda option payment Multiple tailwinds continued to drive olverembatinib and strong growth in olverembatinib sales sales growth Re
Slide 7: Prudent expense management to drive sustainable growth
Prudent expense management to drive sustainable growth R&D expenses Selling expenses Net loss (m USD, unaudited) (m USD, unaudited) (m USD, unaudited) 2022 2023 2024 (56) 130 27 27 (121) (127) 102 97 22 2022 2023 2024 2022 2023 2024 Selling and distribution expenses remained flat Manageable increase
Slide 8: Continuing to lead global innovation
Continuing to lead global innovation 30+ DATA UPDATES AT INTERNATIONAL CONGRESSES AND PUBLICATIONS 14 presentations Oral report on olverembatinib (7th years in a row) for 2L CML and lisaftoclax for MM; Data release on olverembatinib, lisaftoclax, APG-2449, APG-5918 3 presentations Data release on ol
Slide 9: Innovative pipeline
Innovative pipeline Trial Right Compounds Target Indications Phase 1 Phase 2 Phase 3 Commercial Region4 Region5 Olverembatinib CML BCR-ABL/KIT (HQP1351) CML, Ph+ ALL, SDH-deficient GIST Lisaftoclax r/r CLL/SLL¹ Bcl-2 Selective （APG-2575） CLL/SLL, AML, MDS, MM2 FAK/ALK/ APG-2449 NSCLC/ Ovarian cancer
Slide 10: Olverembatinib updates
Olverembatinib updates >) \scentage (
Slide 11: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Execute global registrational trials for CML, Ph+ ALL and GIST Compounds Target Indications & Treatments Phase 1 Phase 2 Phase 3 Commercial Region1 Monotherapy for TKI-resistant CML-CP with T315I mutation Monotherapy for TKI-resistant CML-AP with T315I mutation CML Monothera
Slide 12: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) 3rd generation BCR-ABL TKI Included in the 2024 NCCN1 guidelines for CML management The 1st approved in China after 2G TKI failures & Efficacy results Safety results The only one covered by NRDL Safety ◼ Durable anti-leukemic effects in CML ◼ Favorable clinical benefit in CM
Slide 13: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) As 2L therapy in CML-CP patients 74% CCyR and 41% MMR in No new safety signals emerged as efficacy-evaluable patients compared with those previously reported (15/17) (23/27) (20/27) (13/32) Treatment-Related Serious Adverse Events, (n=43) 88.2% 85.2% 74.1% Serious adverse re
Slide 14: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) As 2L therapy in CML-CP patients (Cont’d) Subgroup analysis 100.0% 85.7% 78.9% 69.6% 65.0% 55.6% 50.0% 50.0% 43.5% 37.5% 34.8% 33.3% Ima (1L),n=9 2G TKI (1L),n=24 Baseline BCR-ABL IS＜ Baseline BCR-ABL IS ≥10%, no mutation, n=24 mutations(non-T315I), n=9 10%, n=8 n=25 CCyR MM
Slide 15: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Global phase 1b/2 study: Favorable clinical benefit and tolerability in heavily pretreated, particularly Published in ponatinib- or asciminib-resistant patients JAMA Oncology Heavily pre-treated CML-CP patient population (N=62) Long term treatment data 52% had received ≥4 TK
Slide 16: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Global phase 1b/2 study: Favorable clinical benefit and tolerability in heavily pretreated, particularly Published in ponatinib- or asciminib-resistant patients (cont’d) JAMA Oncology Strong antileukemic activity in heavily pretreated CML-CP patients (N=51) (N=59) (N=18) (N=
Slide 17: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Potentially a cornerstone treatment for 1L therapy for Ph+ ALL Olverembatinib + Lisaftoclax demonstrates promising clinical benefits as a chemotherapy-free regimen for children with R/R Ph+ ALL Two weeks after 3 EOM combination EOC4 Grade ≥3 SAE treatment Evaluable pts, n (%
Slide 18: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Potentially a cornerstone treatment for 1L therapy for Ph+ ALL (Cont’d) Olverembatinib combination therapies as 1L treatment for Ph+ ALL demonstrated deep response in real world data, and may potentially offer a “chemo-free” treatment option Olverembatinib + pediatric-inspir
Slide 19: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) Expected near term milestones Advance enrollment in POLARIS-2 FDA-cleared phase 3 registrational trial as monotherapy for CML Advance enrollment in POLARIS-1 Phase 3 registrational trial in combination with chemo in 1L Ph+ ALL patients Olverembatinib Advance enrollment in PO
Slide 20: Lisaftoclax (APG-2575) updates
Lisaftoclax (APG-2575) updates 20
Slide 21: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Summary of key completed and ongoing clinical trials for lisaftoclax Compounds Target Indications & Treatments Phase 1 Phase 2 Phase 3 Commercial Region2 Monotherapy for r/r CLL/SLL1 CLL/ GLORA: Combo with BTKi SLL for BTKi treated CLL/SLL GLORA-2: Combo with acalabrutinib for
Slide 22: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Strong ORR and a favorable safety profile in patients with r/r CLL/SLL NCT04215809 - Phase 1b/2 trial in newly diagnosed CLL/SLL or r/r CLL/SLL Daily Ramp-up Daily Dose Ramp-up: More convenient to 20 50 20 50 100 100 200 200 400 400 X target dose HCPs & patients, lower Lisafto
Slide 23: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Efficacy results Safety results Unique clinical profile ◼ Favorable response rates and safety ◼ Low incidence of neutropenia, ◼ Daily dose ramp-up vs weekly dose results observed in MM and AML thrombocytopenia, and less infections ramp-up required by venetoclax patients ◼ Clin
Slide 24: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Strong ORR and a favorable safety profile in patients with r/r CLL/SLL (Cont’d) No observed DDI and low risk of TLS for lisaftoclax in combinations Lisaftoclax combined with acalabrutinib in TN or R/R CLL patients: 98% ORR with rituximab and acalabrutinib and a median DOR that
Slide 25: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Clinically meaningful ORR and tolerability in patients with AML Patients with r/r AML and elderly/unfit patients with newly Favorable safety profile with low early mortality diagnosed AML dosed with lisaftoclax in combination with AZA r/r AML, n = 33 Elderly/unfit AML, n = 39
Slide 26: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Clinically meaningful ORR and tolerability in patients with MDS Lisaftoclax combined with an HMA has the potential to effect Favorable safety profile with low early mortality deeper and more durable responses in MDS TN MDS, n = 40 R/R MDS, n = 8 TRAEs (Grade ≥ 3) (>10% inciden
Slide 27: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Evaluated for further application in r/r MM and AL amyloidosis R/R MM pretreated R/R MM AL amyloidosis (N = 36) with anti-CD38 MoAb (N = 9) Safety profile of R/R MM patients (≥ Grade 3 TEAEs) (N = 32) ≥ Grade 3 TEAEs Best overall response, n (%) Neutropenia 44.0% Treatment Lis
Slide 28: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Synergistic effects on AML in combination with alrizomadlin (APG-115) or olverembatinib Lisaftoclax Alrizomadlin (APG-115) Olverembatinib Lisaftoclax + alrizomadlin has potential to Olverembatinib downregulates MCL-1 and synergizes overcome venetoclax resistance in AML with li
Slide 29: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Expected near term milestones Plan to commercial launch in China for r/r CLL in 2025 Advance enrollment in GLORA FDA-cleared phase 3 registrational trial in combination with BTKi for BTKi treated CLL/SLL Advance enrollment in GLORA-2 Phase 3 registrational trial in combination
Slide 30: Other pipeline updates
Other pipeline updates >) \scentage (
Slide 31: Multiple shots-on-goal in untapped markets
Multiple shots-on-goal in untapped markets • Phase 3 registrational trials for: APG-2449 • 1L ALK-positive non-small cell lung cancer (NSCLC) patients; and ALK/FAK/ROS1 inhibitor • ALK-positive NSCLC patients who are resistant to or intolerant of 2G ALK TKIs APG-1252 • Patients treated: NSCLC, SCLC,
Slide 32: APG-2449
Potentially the 1st ALK/FAK/ROS1 triple inhibitor globally APG-2449 ◼ Innovative drug aiming at high FAK-expressing tumors and ALK/ROS1 fusion mutant ALK/FAK/ROS1 NSCLC triple ligase kinase inhibitor ◼ Through (1) effective ALK/ROS1 inhibitor and (2) FAK inhibitor in combination with chemotherapy or
Slide 33: APG-2449
APG-2449 Preliminary clinical benefit in NSCLC patients Efficacy Safety 60 40 PR Common treatment-related AEs (TRAEs; ≥ 10%) SD PD Figure 1. Best tumor response (%) in pts Best Change (%) 20 0 with NSCLC resistant to 2G ALK inhibitors Any grade Grade ≥ 3 -20 and without targetable bypass gene Popula
Slide 34: Alrizomadlin (APG-115)
Product highlights Alrizomadlin ◼ Orally bioavailable, highly selective, small molecule inhibitor targeting MDM2-p53. (APG-115) Designed to restore the activation of p53 tumor suppressor activity by blocking the MDM2-p53 interaction PPI (protein-protein interaction) ◼ 6 orphan drug designations (ODD
Slide 35: Pelcitoclax (APG-1252)
Product highlights ◼ Restore apoptosis through dual inhibition of the Bcl-2 and Bcl-xL proteins Pelcitoclax ◼ Novel combination in solid tumors and hematologic malignancies (APG-1252) ◼ ODD received from FDA for the treatment of SCLC ◼ Entered into cooperative R&D agreement (CRADA) with NCI of NIH t
Slide 36: APG-5918
China's first EED inhibitor to enter clinical trials APG-5918 ◼ APG-5918 interferes with the recognition of H3K27me by the EED, and prevents EED from interacting with histone methyltransferase EZH2 ◼ T-Cell Lymphomas (TCL): APG-5918 inhibits tumor growth of TCL both in vitro and in vivo. Mechanistic
Slide 37: Targeted protein degrader (TPD) platform and research collaborations
Collaborations with research institutes combined with proprietary targeted protein degrader (TPD) platform strengthen our R&D capability P53-MDM2 degrader Bcl-xL degraders First nominated TPD in First pre-clinical candidate to pre-clinical development be nominated University of Michigan Next-gen tar
Slide 38: Investment highlight
Investment highlight Global, integrated biopharmaceutical company with discovery and development, manufacturing 1 and commercialization capabilities, strategically targeting the global hematological malignancies market, estimated to be US$67.2 billion in 2023 and rising to US$208.8 billion by 20351
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