Pharmaengine, Inc. · TPEX:4162
Pharmaengine — 4Q 2024 Investors' Conference
27 slides from Pharmaengine's conference presentation, Mar 6, 2025
Slide 1: 4Q 2024 Investors' Conference
PHARMAENGINE, INC. (TWO.4162) 4Q 2024 INVESTORS’ CONFERENCE 2025/03/06 Dr. Hong-Ren Wang, President & CEO ChiHsing Chang, Vice President/Spokesperson
Slide 2: Disclaimer
Disclaimer This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes,’ ‘expects,’ ‘anticipates,’ ‘projects,’ ‘intends,’ ‘should,’ ‘seeks,’ ‘estimates,’ ‘future,’ or similar expressions or by discussion of, among other
Slide 3: Agenda
AGENDA 1. 2024 Operational Highlights 2. 2024 Operational Overview 3. R&D Pipeline Update a. PEP07 b. PEP08 4. Vision for 2025 5. Q&A
Slide 4: 2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline
2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline COMMERCIAL PIPELINE OPERATION ONIVYDE® New project R&D progress Operation with Indication expansion accelerated sustainable growth 1. In 2024, ONIVYDE® regimen 1. PEP07 two Phase 1 clinical 1. 2024 cash and cash (NALIRIFOX) for 1L
Slide 5: 2024 Operational Overview
PharmaEngine #28 4 RB 2024 OPERATIONAL OVERVIEW
Slide 6: Sales and Royalties Drive Long-Term Growth
Sales and Royalties Drive Long-Term Growth NT$(000) 2024 Item Year 2018 2019 2020 2021 2022 2023 YOY (%) Taiwan Sales 87,384 180,389 214,828 235,469 277,594 278,547 279,990 (+1%) Royalties from 109,825 133,651 271,584 419,366 376,789 426,652 543,286 (+27%) Europe and Asia Milestone/Sub- 96,221 0 569
Slide 7: 2024 Financial Results
2024 Financial Results NT$(000) 2024 2023 Amount Change % Change Operating revenue 2,523,304 767,669 1,755,635 229% Operating costs 47,740 48,697 (957) (2%) Gross profit 2,475,564 718,972 1,756,592 244% Sales expenses 37,605 38,538 (933) (2%) G&A expenses 117,767 92,970 24,797 27% R&D expenses 267,0
Slide 8: R&D Pipeline Update
PharmaEngine #28 4 RB R&D PIPELINE UPDATE
Slide 9: Pipeline Portfolio Focuses on Precision Oncology
Pipeline Portfolio Focuses on Precision Oncology Commercial Program Indications Lead Preclinical Phase I Phase II Phase III Approval Partner Rights Milestone Royalty ONIVYDE® (EU/Asia) 1L/2L PDAC Approval (liposomal irinotecan) Taiwan Sales AML/MCL PEP07 Global (CHK1i) Solid tumors DDR & PEP08 MTAP-
Slide 10: PEP07
PharmaEngine S BE KR E PEPO7
Slide 11: PEP07: A Potential Best in Class CHK1 Inhibitor
PEP07: A Potential Best in Class CHK1 Inhibitor ACR-368 Criterion PEP07 (Prexasertib) SRA-737 BBI-355 Development Phase Phase I Phase II Phase I/II Phase I/II Potency* CHK1 vs CHK2 Selectivity Oral Bioavailability BBB-Penetrating Unknown Endometrial cancer AML/MCL Indications Ovarian cancer Solid tu
Slide 12: PEP07: Phase I/Ib Development Strategy
PEP07: Phase I/Ib Development Strategy Mono Dose Escalation Mono Dose Escalation in AML and MCL in Solid Tumors ⚫ Study design ⚫ Study design ✓ Accelerated titration plus traditional 3+3 design ✓ Accelerated titration plus traditional 3+3 design ✓ Once a DLT, or ≥ Grade 2 AE related to PEP07 ✓ Once
Slide 13: PEP07 Combined with Radiation Show Significant Efficacy in Orthotropic Brain Cancer Model
PEP07 Combined with Radiation Show Significant Efficacy in Orthotropic Brain Cancer Model Tumor Size Survival Plot (Bioluminescence vs Time) Other combination candidates including Standard of Care therapies or anti-body conjugate drugs in selective indications.
Slide 14: PEP07: Potential Indications and Market Value
PEP07: Potential Indications and Market Value Global 2022 Market Size CAGR Potential Indication Cancer type Market Size^ 2023 Incidence* 2024-2032^ ($ Bn) Acute Myeloid Leukemia 165,500 2.1 10.7% Gastric Cancer 968,350 4.7 13.5% High Potential Soft Tissue Sarcoma 42,500 1.4 8.5% GBM 321,476 2.9 8.6%
Slide 15: PEP08
PharmaEngine S BE KR E PEP0O8
Slide 16: Protein Arginine Methyltransferase 5 (PRMT5) – Promising Target for Cancer Treatment
Protein Arginine Methyltrasferase 5 (PRMT5) – Promising Target for Cancer Treatment ⚫ PRMT5 plays critical roles in gene expression, RNA processing, DNA damage repair, and immune response. ⚫ 1st generation PRMT5 inhibitors target PRMT5 in both cancer and normal cells. Since PRMT5 is an essential pro
Slide 17: 1st Generation PRMT5 vs 2nd Generation MTA co-operative PRMT5 Inhibitor
1st Generation PRMT5 vs 2nd Generation MTA co-operative PRMT5 Inhibitor ⚫ Unlike 1st generation PRMT5 MTA inhibitors bind PRMT5 unselectively in both cancer cells and normal tissues, 2nd 1st generation PRMT5i generation, MTA co-operative PRMT5 inhibitors only target to PRMT5 PRMT5 MTAP deletion canc
Slide 18: MTAP Deletion and Synthetic Lethality
MTAP Deletion and Synthetic Lethality Normal Cells Cancer Cells (The gene MTAP is functioning normally) (The gene MTAP is non-functional) MTA MTA MTAP PRMT5 MTA MTAP PRMT5 MTA MTA co- operative PRMT5i MTAP PRMT5 MTAP PRMT5 Survival Death MTA co-operative PRMT5 inhibitors only target to MTAP deletion
Slide 19: PEP08 Inhibits the Growth of MTAP-Deleted Tumors in Vivo
PEP08 Inhibits the Growth of MTAP-Deleted Tumors in Vivo NSCLC CDX Pancreatic cancer Pancreatic cancer CDX CDX NSCLC CDX 4000 2500 3000 2250 2000 2000 Tumor Volume (mm3) Tumor Volume (mm3) 1000 1750 Vehicle control 500 1500 AMG-193 qD 50 mpk Vehicle control 400 1250 PEP08 qD 25 mpk MRTX1719 50 mpk q
Slide 20: PEP08: A Potential Best in Class PRMT5 Inhibitor
PEP08: A Potential Best in Class PRMT5 Inhibitor BMS-986504 Criterion PEP08 AMG-193 TNG462 AZ3470 (MRTX1719) IND- Development Phase Phase 1/2 Phase 1/2 Phase 1/2 Phase 1/2 enabling Potency* MTAP selectivity BBB-penetrating MTAP-deleted cancers Indication NSCLC, PDAC NSCLC Solid tumors Solid tumors N
Slide 21: MTAP Deletion Frequency in Selected Tumors and its Market Size
MTAP Deletion Frequency in Selected Tumors and its Market Size % of MTAP Eligible Cancer type Incidence* Deletion Patients No. GBM 321,476 42% 135,020 Bladder 613,791 25% 153,448 Pancreas 510,566 22% 112,325 NSCLC 2,108,000 13% 274,040 ESCC 510,716 10% 51,072 HNSCC 795,453 10% 79,545 Stomach 968,350
Slide 22: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model Target Compound Lead Approval/ Validation Screening Optimization Preclinical Phase 1 Phase 2 Phase 3 Market PEP08 PEP07 In-house R&D In-license Partners Out-license (CRO/CDMO/Commercial ) Flexible, nimble, and science/data driven
Slide 23: Drug Development Acceleration Through PharmaEngine Core Values
Drug Development Acceleration Through PharmaEngine Core Values Conventional approach normally takes 5-8 years 2-5 years 1-2 years 2-3 years 2-3 years 6-10 years Target Identification Compound Preclinical/CMC Lead Optimization Clinical Trials and Validation Screening Development PEP08 took around 2.5
Slide 24: Vision for 2025
PharmaEngine #28 4 RB VISION FOR 2025
Slide 25: Vision for 2025
Vision for 2025 Complete dose finding for PEP07 Obtain Taiwan’s NHI reimbursement 01 phase 1 hematologic cancers and solid tumors 04 for ONIVYDE® as 1L treatment of metastatic pancreatic cancer 02 Submit IND for PEP08 (1H25) 05 Submit NDA for LIPORAXEL® in Taiwan Begin incorporating green energy as
Slide 26: PharmaEngine Core Values
PharmaEngine Core Values Teamwork Diversity Sense of Work and Life Urgency Balance Continuous Critical Learning and Thinking Growth
Slide 27: Thank You
PharmaEngine #28 4 RB THANK YOU