Pharmaengine, Inc. · TPEX:4162
Pharmaengine — 2022 QIC Healthcare Forum
25 slides from Pharmaengine's conference presentation, 2022
Slide 1: 2022 QIC Healthcare Forum
2022 QIC Healthcare Forum Hong-Ren Wang, Ph.D. President and CEO
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: Mission and Vision
Mission Unlock value for promising therapeutic candidates & Extend patients’ lives Vision Top tier innovative oncology drug development company in Asia
Slide 4: 2022 Marks PharmaEngine's 20th Year Committing to Oncology New Drug Development
2022 Marks PharmaEngine’s 20th Year Committing to Oncology New Drug Development 2003- 2010 • Founded the Company • Licensed-in PEP02 for Asia territory in 2003 • Expanded PEP02 license to the EU territory in 2005 2003-2010 • Completed PEP02 Phase 2 study for 2nd-line PDAC in the US and TW in 2010 20
Slide 5: Management Team with International Experience
Management Team with International Experience 15+ years of pharmaceutical industry experience. In addition to new drug President & CEO development, worked on novel drug delivery/device combination through drug Dr. Hong-Ren Wang evaluation, PK/device combination modeling, and novel formulation design
Slide 6: International Drug Development Consultants
International Drug Development Consultants Hagop Youssoufian, MSC, MD Former Chief Medical Officer at BIND Therapeutics Chia-Chi Lin, MD Alex Vo, Ph.D. Professor, Graduate Institute of Clinical Medicine, Executive Director, DMPK, Preclinical NTUCM ; Attending Physician, NTUH Science, Atea Pharmaceut
Slide 7: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model 7
Slide 8: Profitable R&D Biotech
Profitable R&D Biotech 40,000 1. Profitable since 2014 35,000 2. Strong cash flow 30,000 Revenue USD$ (000) 3. Stable Dividend payout 25,000 20,000 15,000 10,000 5,000 0 2017 2018 2019 2020 2021E EU/Asia Royalties TW Sales Milestone Taiwan Sales belongs to PharmaEngine, Inc. 8 Tiered royalties (high
Slide 9: Vision 2025
Vision 2025
Slide 10: Vision 2025 to Deliver Sustainable Growth and Enhanced Value
Vision 2025 to Deliver Sustainable Growth and Enhanced Value Commercial Pipeline Operation Pipeline delivering +20% non-GAAP revenue as ONIVYDE® life cycle management 1 Mid stage projects for out-license RD expenses (LCM) through new indications and 2 Early stage projects at Phase I/II Long-last
Slide 11: Commercial: ONIVYE Life Cycle Management
Commercial ONIVYDE® Life Cycle Management
Slide 12: ONIVYDE as Global 2L PDAC Standard of Care
ONIVYDE® as Global 2L PDAC (post-Gemcitabine) Standard of Care First FDA-approved drug in post-gemcitabine pancreatic cancer Category 1 evidence in NCCN and ESMO clinical practice guideline • ONIVYDE® is a liposome formulation of irinotecan • Sustained release profile • Preferential tumor accumu
Slide 13: ONIVYDE Has Strong Growth Momentum in Global at 2L PDAC
ONIVYDE® Has Strong Growth Momentum in Global at 2L PDAC EU 30,000Pts. US Asia 11,000 Pts. 27,000Pts. FY21 US Sales 3Q21 Sales & Royalties US$ 145M, +7% YoY US$ 16.2M, +67% YoY Approved Yet approved 13 Patients are prescribed 3-4 vials of Onivyde every two weeks, with an average four-month regimen.
Slide 14: ONIVYDE LCM: Expansion into New Tumor Types Globally
ONIVYDE® LCM: Expansion into New Tumor Types Globally LCM: Life cycle management; PDAC: Pancreatic ductal adenocarcinoma; SCLC: Small cell lung cancer; DoT: Duration of treatment; 1L: First line; 2L: Second line; 1. 14 IQVIA APLD claims, September 2020 ; 2. Expected submission dates ; 3. Risk adjust
Slide 15: ONIVYDE: Potential to Establish Standard of Care in Hard to Treat Cancers
ONIVYDE® : Potential to Establish Standard of Care in Hard to Treat Cancers 1L PDAC 2L SCLC 5Y survival rate only 7% 5Y survival rate only 6% Significant need for more effective Very few FDA approved therapies, therapies with reduced toxicity highlighting need for new options Ability to build on suc
Slide 16: R&D Portfolio
R&D Portfolio
Slide 17: Pipeline Portfolio
Pipeline Portfolio 17 1. DDR: DNA Damage Response (BRCA1/2, CHK1/2, WEE1, etc…)
Slide 18: International Collaboration
International Collaboration 18
Slide 19: PEP07 (SOL-578) – Best in Class CHK1 Inhibitor
PEP07 (SOL-578) – Best in Class CHK1 Inhibitor PEP07 (SOL-578) is a brain penetrating oral inhibitor which is more potent, selective and specific. 19
Slide 20: PEP07 (SOL-578): Significant Efficacy in Hematologic Malignancies
PEP07 (SOL-578) : Significant Efficacy in Hematologic Malignancies as Monotherapy and Combination therapy Acute Myeloid Leukemic (AML) Ara-C Sensitive Ara-C Resistant THP-1 tumor size 1500 Vehicle 2-on/5-off x 4 cycles Vehicle 2500 10 ml/kg BID (3on/4off)x4 PO (mm^3) Tumor Volume (mm3) Vehicle 150 m
Slide 21: PEP07 (SOL-578) for Potential Combination Therapies
PEP07 (SOL-578) for Potential Combination Therapies In vitro Combo treatment SoC agents Indication Cell line Ara-C AML MV4-11 / THP-1 Gemcitabine NSCLC NCI-H1703 5-Fu Esophagus KYSE-270 5-Fu Stomach MKN-45, SNU-16, SNU-5, 5-Fu CRC DLD-1, HT-29, SW480 TMZ Brain IMR-32 Sorafenib RCC A498 Green: Synerg
Slide 22: PEP07 (SOL-578) Early Clinical Development Plan
PEP07 (SOL-578) Early Clinical Development Plan 22
Slide 23: PEP07 (SOL-578) IND Development Plan
PEP07 (SOL-578) IND Development Plan Preclinical CMC Anti-tumor efficacy in two AML models and MCL model Identified novel salts Synergistic with Ara-C including Ara-C resistance model Kg-scale ready for GMP production Efficacy study for solid tumors ongoing Biomarker evaluation ongoing Toxicology IN
Slide 24: 2022: Year of Revitalization and Marching Forward
2022: Year of Revitalization and Marching Forward Growth through ONIVYDE® life cycle management 1. 2L PDAC get China (NMPA) approval 2. Reimbursement in additional EU countries for 2L PDAC indication 3. 2L SCLC Phase III data readout 4. 1L PDAC Phase III data readout (2022/2023) Advancement and grow
Slide 25: PharmaEngine
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