Xynomic Pharmaceuticals Holdings Inc
Xynomic Pharmaceuticals — Investor Presentation (September 2019)
32 slides from Xynomic Pharmaceuticals's investor presentation, Sep 27, 2019
Slide 1: Xynomic Pharmaceuticals Holdings, Inc. Investor Presentation
September 2019 Xynomic Pharmaceuticals Holdings, Inc. Investor Presentation Stock Ticker: XYNO
Slide 2: Disclosure Disclaimer
Contoso Suites Disclosure Disclaimer This investor presentation is not a prospectus or a solicitation of a proxy, consent or authorization with respect to any sec ur ities or in respect of the proposed transaction. This investor presentation shall also not constitute an offer to sell or the solicita
Slide 3: Corporate Overview
Contoso Suites • Strategy: develop potentially best - in - class oncology therapeutics • Experienced leadership • Experienced multinational executive team • World - class scientific/medical advisors • Robust clinical development pipeline (all with global rights) • 2 clinical stage and 1 IND stage in
Slide 4: Investment Highlights
Contoso Suites Investment Highlights • Experienced management team and world class scientific advisory board • Late - stage pure play global oncology company developing oral formulation with proven molecular targets and best - in - class potenti al • Drug candidates originated from global Top - 20 p
Slide 5: Experienced Management Team
Contoso Suites Experienced Management Team Y. Mark Xu , Chairman and CEO • Successful serial entrepreneur • Pharmacyclics (General Manager, Greater China), Schering (Research & Development), McKesson (Marketing), Bridge Lab (Co - Founder, China CFO) W. Jason Wu, PhD, COO • More than 20 years drug de
Slide 6: World Class Scientific Advisory Board
Contoso Suites World Class Scientific Advisory Board • Professor of Medicine and Director of the Early Phase Clinical Trials Unit, University of California San Francisco • Renowned expert in solid tumors • Led cancer clinical trials for numerous big pharma and emerging biotech companies • Chief of L
Slide 7: Innovative Late-Stage Oncology Pipeline (Global Rights)
Contoso Suites Ongoing Clinical Trials Planned Clinical Trials Pre - clinical 7 Innovative Late - Stage Oncology Pipeline (Global Rights) Preclinical Phase 1 Phase 2 Phase 3 Abexinostat (Abex): HDAC i nhibitor (licensor: Pharmacyclics/AbbVie) Kidney Cancer Follicular Lymphoma Diffuse Large B - Cell
Slide 8: Pipeline Summary
Contoso Suites Pipeline Summary • Abex: currently being evaluated in three therapeutic areas • Unique pharmacokinetic profile • Only HDAC inhibitor with efficacy against both B - cell and T - cell lymphomas • First commercial launch expected in early 2021 • XP - 105 (BI 860585): breast cancer • Pote
Slide 9: Commercialization
Contoso Suites Commercialization • Xynomic is well positioned to commercialize drugs in China, US and other key markets and expects to • Launch Abexinostat in early 2021 in China for treatment of diffuse large B - cell lymphoma • Launch Abexinostat in 2023 in US and China for treatment of renal cell
Slide 10: R&D Center in Shanghai, China
Contoso Suites R&D Center in Shanghai, China • 5,600 sf custom - built, fully operational, state - of - the - art leased facility • Focused on biology, organic chemistry and analytical chemistry • Led by Dr. Niefang Yu, a renowned oncology research scientist • Will staff up to 15 MS/PhD scientists b
Slide 11: Key Features of Abexinostat
Contoso Suites • Abexinostat has been granted two Fast - Track designations by the US Food and Drug Administration (FDA) • Only drug starting pivotal trial in China against 3L diffuse large B - cell lymphoma (DLBCL), the largest lymphoma subtype in China, and 3L follicular lymphoma* • Expect to laun
Slide 12: Key Features of Abex: In-Licensed from Pharmacyclics/AbbVie
Contoso Suites Key Features of Abex : In - Licensed from Pharmacyclics /AbbVie Molecule Small molecule HDAC inhibitor, oral 80 or 20 mg tablet, bid (twice daily) Clinical data already collected ~600 patients (18 trials) already tested globally; no drug - related deaths and more favorable safety prof
Slide 13: Abexinostat's Mechanism of Action
Contoso Suites Abexinostat’s Mechanism of Action • Histone deacetylases (HDACs) can remove acetyl groups from lysine on histones and other proteins • Altered expression and mutations of genes that encode HDACs have been linked to tumor development Source of diagram: Xynomic Pharma 13
Slide 14: Abex – Completed Clinical Trials
Contoso Suites Abex – Completed Clinical Trials * Monotherapy In Combination Protocol # # of Patients TA Phase Protocol # # of Patients TA Phase PCYC - 0401 15 Solid tumors or hematological cancers 1 CL1 - 78454 - 005 35 Solid tumors 1 PCYC - 0405 - CA 7 Hematological tumors Extension study CL1 - 78
Slide 15: Key Advantages of Abexinostat over Approved HDAC Inhibitors
Contoso Suites Key Advantages of Abexinostat over Approved HDAC Inhibitors • Abexinostat is the only HDAC inhibitor with efficacy against both B - cell and T - cell lymphomas (approved HDAC inhibitors are efficacious against T - cell lymphomas only) • Favorable safety profile than approved HDAC inhi
Slide 16: Safety Profile Better Than First Generation HDAC Inhibitors
Contoso Suites Safety Profile Better Than First Generation HDAC Inhibitors Abex * Farydak ® ( Pa no binostat ) Beleodaq ® ( Belinostat ) Istodax ® ( Romidepsin ) Zolinza ® ( Vorinostat ) Epidaza ® ( Chidamide ) hematological Neutropenia 13.3 67 1 4 27 3.5 13.3 Anemia 3.3 18 11 3 16 2.3 0 Thrombocyto
Slide 17: Abexinostat efficacy in lymphoma
Contoso Suites * Vincent Ribrag , et al. Safety and efficacy of abexinostat , a pan - histone deacetylase inhibitor, in non - Hodgkin lymphoma and chronic lymphocytic leukemia: Results of a phase 2 study. Haematologica 2017 102 (5): 903 - 909. ** One trial is from Vincent Ribrag trial above and the
Slide 18: On-going and Planned Trials
Contoso Suites On - going and Planned Trials Drug Indications Phase # of Patients Key Partners Location FPI Date Abex/Keytruda Multiple solid tumors 1b 42 UCSF US 7/25/2018 Abex 4L FL Potentially Pivotal Ph 2 120 MSKCC US and EU7 8/ 9 /2018 Abex/Pazopanib 1L or 2L RCC (Fast - Track designation by US
Slide 19: Major Potentially Pivotal Trials
Contoso Suites Major Potentially Pivotal Trials Drug Indication Location Phase # of sites and patients Estimated Efficacy Threshold for Potential Approval Estimated Commercial Launch Year Abex (mono therapy) 3L DLBCL China Pivotal phase 2 (single arm) 25 sites, 85 patients 35% ORR (or 21% ORR for 17
Slide 20: Abex: Only 3rd Line DLBCL Innovative Drug in Potentially Pivotal Trial in China
Contoso Suites Abex : Only 3rd Line DLBCL Innovative Drug in Potentially Pivotal Trial in China 20 Source: China Center for Drug Evaluation of NMPA, a s of September 5, 2019 No Registration No Status Drug Indications Sponsor Phase Drug Category Combined with Other Drugs Pivotal China Trial Starting
Slide 21: Abex: Only 3rd Line FL Innovative Drug in Potentially Pivotal Trial in China
Contoso Suites Abex : Only 3rd Line F L Innovative Drug in Potentially Pivotal Trial in China 21 Source: China Center for Drug Evaluation of NMPA, a s of September 5, 2019 No Registration No Status Drug Indications Sponsor Phase Drug Category Combined with Other Drugs Pivotal China Trial Starting Ti
Slide 22: Key Features of XP-105 In-Licensed from Boehringer Ingelheim
Contoso Suites • 3rd generation mTOR inhibitor, blocking activities of both mTOR complexes • Completed one Phase 1 clinical trial for solid tumors • Phase 2 ready • Xynomic plans to design and conduct a Phase 2 clinical trial in metastatic breast cancer patients 22 Key Features of XP - 105 In - Lice
Slide 23: Continuing Strong Interest in mTOR Inhibitors
Contoso Suites Continuing Strong Interest in mTOR Inhibitors • Several 1st generation mTOR inhibitors are already marketed, including e verolimus (Novartis) and temsirolimus (Pfizer), and mainly treat kidney cancer and breast cancer • Everolimus : $1.556 billion revenue in 2018* • Strong interest in
Slide 24: XP-105 (BI 860585) Superior to Competitors
Contoso Suites XP - 105 (BI 860585) Superior to Competitors XP - 105 (BI 860585) AZD - 2014* TAK228** Trial Phase Phase 1 Phase 1 Phase 1 Dosage Combined with paclitaxel Combined with paclitaxel Combined with paclitaxel Number of Subjects 24 solid tumor subjects 65 solid tumor subjects 22 solid tumo
Slide 25: Key Features of XP-102 In-Licensed from Boehringer Ingelheim
Contoso Suites • RAF is a popular molecular target in oncology and represents a significant commercial opportunity • Pan - RAF inhibitor, unique DFG - out binding, best - in - class animal data • Xynomic plan to start Phase 1/2 in US and China by 2020/2021 25 Key Features of XP - 102 In - Licensed f
Slide 26: XP-102: A 2nd-Generation Pan-RAF Inhibitor with Best-in-Class Potential
Contoso Suites XP - 102: A 2nd - Generation Pan - RAF Inhibitor with Best - in - Class Potential • Roche and Novartis have already launched 1st generation oncology drugs that target RAF kinases (in combination with MEK inhib ito rs) • Novartis’ Tafinlar (a RAF inhibitor) - Mekinist (a MEK inhibitor)
Slide 27: XP-102: Pre-Clinical Pharmacology Summary
Contoso Suites XP - 102: Pre - Clinical Pharmacology Summary • Demonstrated potency and selectivity in cellular and Kinase assays • B - RAF V600 cell lines EC 50 <10 nM • B - RAF wild - type cell lines EC 50 >1,000 nM • High efficacy in CRC and melanoma animal models • Showed no significant sign of
Slide 28: Small Molecule Kinase Inhibitors R&D Center in Shanghai, China
Contoso Suites Small Molecule Kinase Inhibitors R&D Center in Shanghai, China 28 Research Stage Programs
Slide 29: Research Stage Programs
Contoso Suites Research Stage Programs • XP - 103 • TRK/Fra - 1 inhibitor • Recent Ph 1 data of Loxo’s TRK inhibitor, Larotrectinib , showed ORR of over 90% against multiple tumors, yet drug resistance might be an issue * • XP - 103, with dual targets (TRK and Fra - 1), has the potential to maintain
Slide 30: Advancing the Pipeline on Key Programs
Contoso Suites Advancing the Pipeline on Key Programs Estimated Timelines 2H'2019 1H'2020 2H'2020 1H'2021 Abexinostat 1L or 2L renal cell carcinoma Interim data readout 3L diffuse large B-cell lymphoma File New Drug Application (NDA) Launch 3L follicular lymphoma File NDA Launch 2L mantle cell lymph
Slide 31: Capitalization Table
Contoso Suites Capitalization Table 31 In addition, there are 3,259,780 warrants (ticker XYNPW) issued and outstanding, with average exercise price of $11.50 Share holder No. of Common Shares % Management & Directors: 34,531,030 74.6% Publi c Float & Others: 11,742,816 25.4% Total 46,273,846 100.0%
Slide 32: Thank You
Thank You Angela Feng [email protected] www.xynomicpharma.com 32
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