Xynomic Pharmaceuticals Holdings Inc
Xynomic Pharmaceuticals — Bison Capital Acquisition — SPAC Merger (September 2018)
34 slides from Xynomic Pharmaceuticals's SPAC merger presentation, Sep 19, 2018
Slide 1: Bison Capital Acquisition Corp. & Xynomic Pharmaceuticals, Inc. Investor Presentation
Bison Capital Acquisition Corp. & Xynomic Pharmaceuticals, Inc. Investor Presentation September 2018
Slide 2: Disclosure Disclaimer
Disclosure Disclaimer This investor presentation is not a proxy statement or a solicitation of a proxy, consent or authorization with respect to an y s ecurities or in respect of the proposed transaction. This investor presentation shall also not constitute an offer to sell or the solicitation of an
Slide 3: Transaction Overview - 1
Transaction Overview - 1 3 • On September 12, 2018, Bison Capital Acquisition Corp. (“BCAC”) signed a definitive merger agreement with Xynomic Pharmaceuticals, Inc. (“Xynomic”) • The merger consideration, entirely payable in BCAC shares at $10.15 per share, consists of » $350 million, subject to cer
Slide 4: Transaction Overview - 2
• BCAC will re - domesticate as a Delaware corporation prior to closing • Upon closing, BCAC will change its name to “Xynomic Pharmaceuticals Holdings, Inc.” • The board of BCAC will consist of nine directors » 4 current directors of BCAC including 3 current independent directors » 3 current directo
Slide 5: Why Healthcare? Why Oncology Biotech?
Why Healthcare? » Strong, persistent and growing global market demand bolstered by aging population, technological advancement and scientific breakthroughs Why Oncology Biotech? » Cancer remains one of the leading causes of natural deaths worldwide » There are a high degree of unmet medical need
Slide 6: Why Xynomic?
Why Xynomic? 6 A pipeline of late stage and early stage innovative small molecule programs Focusing on potentially best - in - class or first - in - class oncology therapeutics Abexinostat (Abex), the lead program, in - licensed from Pharmacyclics/AbbVie » A Phase 3 HDAC inhibitor being invest
Slide 7: Transaction Valuation, Sources and Uses, Ownership at Close
Value At Close 1,2 Total Shares Outstanding 43.1 $ per Share (estimate based on cash per share) $10.42 Equity Value $449.3 Net Cash $58.0 Enterprise Value $391.3 Transaction Valuation Sources and Uses 1 Sources $ % Bison Trust Capital $62.9 3 100% Total Sources $ 62.9 100 % Uses $ % Bison Trust Capi
Slide 8: Experienced Management Team
Experienced Management Team 8 Y. Mark Xu, Chairman, CEO & President Successful serial entrepreneur Pharmacyclics (General Manager, Greater China), Schering (research & development), McKesson (marketing), Bridge Lab (cofounder, China CFO) W. Jason Wu, PhD, COO More than 20 years drug developmen
Slide 9: World Class Scientific Advisory Board
World Class Scientific Advisory Board (SAB) Dr. Pamela Munster • Professor of Medicine and Director of the Early Phase Clinical Trials Unit, University of California San Francisco • Renowned expert in solid tumor • Led cancer clinical trials for numerous big pharma and emerging biotech companies Dr.
Slide 10: Innovative Oncology Pipeline (Global Rights)
Innovative Oncology Pipeline (Global Rights) Preclinical Phase 1 Phase 2 Phase 3 Abexinostat (Abex): HDAC i nhibitor (licensor: Pharmacyclics/AbbVie) Follicular Lymphoma (2 trials) Diffuse Large B - Cell Lymphoma & Mantel Cell Lymphoma (with Janssen’s Imbruvica) Kidney Cancer (with Novartis’ Pazopan
Slide 11: Abex: In-Licensed from Pharmacyclics/AbbVie
Abex: In - Licensed from Pharmacyclics/AbbVie 11 1. AbbVie 2015 annual report 2. Pharmacyclics December 2014 Investor Presentation 3. imbruvica.com 4. AbbVie and Johnson & Johnson 2017 annual reports Abex was previously jointly developed by Pharmacyclics’ world class, proven R&D team and its ex -
Slide 12: Abex: Overview of Clinical Development
Abex: Overview of Clinical Development 12 Already tested on approximately 600 patients worldwide Unique PK profile HDAC inhibitor Monotherapy against » Follicular lymphoma (FL): 56 - 64% ORR, 625 days medium PFS » Diffuse large B - cell lymphoma (DLBCL): 34% ORR, 2.8 months medium PFS Comb
Slide 13: Abex' Mechanism of Action
Abex’ Mechanism of Action 13 Diverse functions of HDACs and HDAC inhibitors regulating different stages of cancer through multiple different mechanisms and changing different biological processes. Far right, ↑ indicates promotion or upregulation, ↓ indicates repression or downregulation. Source: Li
Slide 14: Abex – Completed Clinical Trials
Abex – Completed Clinical Trials * Monotherapy In Combination Protocol # # of Patients TA Protocol # # of Patients TA PCYC - 0401 15 Solid tumors or hematological cancers CL1 - 005 35 Solid tumors PCYC - 0405 7 Hematological tumors CL1 - 006 32 Digestive cancer CL1 - 010 1 NHL CL1 - 008 19 Late stag
Slide 15: Convenient Oral Administration
Convenient Oral Administration 15 Source: Joseph J. et al. CRA - 024781: a novel synthetic inhibitor of histone deacetylase enzymes with antitumor activity in vitro and in vivo. Mol Cancer Ther; 2006: 1309 - 1317.
Slide 16: Safety
Safety Abex * Farydak ® ( pabinostat )** Beleodaq ® ( belinostat ) Istodax ® (romidespin) ^ Zolinza ® (vorinostat) hematological Neutropenia 14 67 1 4 27 3.5 Anemia 7 18 11 3 16 2.3 Thrombocytopenia 17 34 7 0 14 5.8 GI Diarrhea 3 † 25 2 <1 1 0 Nausea 2 † 6 1 3 6 3.5 Vomiting 0 † 7 1 <1 10 1.2 other
Slide 17: Abex: Objective Response Rate
Abex: Objective Response Rate FL DLBCL PTCL Assumption Phase 1 Phase 2 Assumption Phase 1 Phase 2 Assumption Phase 1 Phase 2 40% 60% 44% 56% (n=16) 20% 40% 25% 50% 23% 31% 22% 40% (n=24) Target ORR Actual 0% 100% Source: Andrew M. Evens, et al. A Phase I/II Multicenter, Open - Label Study of the Ora
Slide 18: Strong Preliminary ORR Data Compared to Approved HDACis
Strong Preliminary ORR Data Compared to Approved HDACis and Other Relevant Therapeutics 18 Drug Company FL DLBCL PTCL Approval Year Abex Xynomic 56%, 64% 31% 40% Pralatrexate * Spectrum 27% 2009 Romidepsin * Celgene 25.4% 2011 Belinostat * Spectrum 25.8% 2014 Chidamide * Chipscreen 28% 2014 Rituxima
Slide 19: Significantly Improved Progression-Free Survival
Significantly Improved Progression - Free Survival FL *N=25= 14 FL + 11 MCL. † Median time on study in FL is 11.9 (1.2 - 24.8) months 19 Source: Andrew M. Evens, et al. A Phase I/II Multicenter, Open - Label Study of the Oral Histone Deacetylase Inhibitor Abexinostat in Relapsed/Refractory Lymphoma.
Slide 20: PET neg in FL Patient: Complete Response
PET neg in FL Patient: Complete Response FL Case History 72 yo female 5 prior tx. Response » PR – Cycle 4 » CR - Cycle 8 Baseline 8 Cycles Abex 20 Source: Xynomic and licensor
Slide 21: Kidney Cancer: Compelling Ph 1b Data with Pazopanib
Kidney Cancer: Compelling Ph 1b Data in Treating VEGFi - Refractory Solid Tumors in Combination with Pazopanib Sponsored by NCI and UCSF 51 patients (72% had received two or more lines of therapy in the locally advanced or metastatic setting), Phase 1b, open - label, dose - escalation/expansion
Slide 22: Abex' Commercial Opportunities
Abex’ Commercial Opportunities Indication Global Market Size in 2023, $ Follicular Lymphoma 4.1 billion Renal Cell Carcinoma (Kidney Cancer) 4.7 billion Breast Cancer 20 billion Solid Tumors (with K eytruda) 8 billion Diffuse Large B - Cell Lymphoma 14.4 billion Sources: Decision Resources, Evaluate
Slide 23: On-going and Planned Trials
On - going and Planned Trials Drug Indications Phase # of Patients Key Partners Location FPI Date Abex/Keytruda Multiple solid tumors 1b 42 UCSF U.S. 7/25/2018 Abex 4L FL Pivotal Ph 2 120 MSK U.S. and EU7 8/ 9 /2018 Abex/Pazopanib 1L and 2L RCC Pivotal Ph 3 390 UCSF U.S., EU 6 , China and South Kore
Slide 24: Renal Cell Carcinoma (RCC)
Renal Cell Carcinoma (RCC) Successful FDA meeting on 3/16/2018 » Authorized to start pivotal Ph 3 » Priority Review designation Ph 3 design: 1L and 2L, PFS as primary end point, Abex + Pazopanib vs. Pazopanib Well positioned to become the new SOC in 1st line RCC Sites: U.S., EU 6 , China and
Slide 25: Follicular Lymphoma
Follicular Lymphoma r/r FL: 56 - 64% ORR and 625 days of medium PFS in two Ph 1/2 trials FDA has authorized to start pivotal trial (9/21/2017 meeting) Accelerated Approval designation 4L: 120 subjects, single arm, ORR as primary end point Sites: U.S. and EU7 FPI: 8/ 9 /2018 U.S. invest
Slide 26: China
China 3L FL pivotal (independent of U.S./EU trials) » ~ 66 subjects, single arm, ORR as primary end point » FPI expected in Q1’2019 r/r DLBCL » ~ 88 subjects, single arm, ORR as primary end point » FPI expected in Q1’2019 1L RCC » ~150 patients led by Prof. Jun Guo at Beijing Cancer Hospital »
Slide 27: Updated Clinical Development Timeline
Updated Clinical Development Timeline Indication Regions 2H’2018 2019 2020 2021 2022 3L FL (Abex as monotherapy) China Enroll ~66 patients (complete recruitment) NDA submission 4L FL (Abex as monotherapy) U.S. EU7 Enroll ~30 patients Enroll ~90 patients (complete recruitment) NDA submission 1L & 2L
Slide 28: XP-102: A 2nd-Generation Pan-RAF Inhibitor with Best-in-Class Potential
XP - 102: A 2nd - Generation Pan - RAF Inhibitor with Best - in - Class Potential RAF is a popular molecular target in oncology and represents a significant commercial opportunity Two big pharma (Roche and Novartis) have already launched 1st generation oncology drugs that target RAF kinases, wit
Slide 29: XP-102: Pre-Clinical Pharmacology Summary
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 toxicity in exp
Slide 30: XP-102: Current Status
XP - 102: Current Status 30 API GLP toxicity batch completed Toxicology studies on - going, expected to be completed by 2018 Formulation work in progress and expected to be finished by January 2019 Xynomic’s goal is to submit US - IND application in Q1’2019
Slide 31: Research Stage Programs: XP-103 & XP-104
Research Stage Programs: XP - 103 & XP - 104 (Small Molecule Kinase Inhibitors) XP - 103 » TRK/Fra - 1 inhibitor » A competitor’s TRK inhibitor Larotrectinib’s recent Ph 1 data show ORR of over 90% against multiple tumors, yet drug resistance might be an issue * » Our XP - 103, with dual targets (
Slide 32: R&D Center in Shanghai, China
R&D Center in Shanghai, China 5,600 sf custom - built state - of - the - art leased facility Expected to be fully operational by December 2018 Focused on Biology, organic chemistry and analytical chemistry Led by Dr. Niefang Yu, a renowned oncology research scientist Scientific staff consi
Slide 33: Pipeline Summary
Pipeline Summary Abex: currently being evaluated in 3 therapeutic areas XP - 102 (BI 882370): CRC and melanoma » Animal data from initial studies suggest promising potential » Unique binding mode XP - 103 and XP - 104: research stage assets with newer mechanisms of action Breast & Other Solid
Slide 34: Summary – Xynomic Pharma
Summary – Xynomic Pharma A U.S. oncology company founded by industry veterans Pure play oncology company: oral, proven molecular targets Drug candidates originated from global top - 20 pharma companies: high - quality U.S./EU data integrity, exclusive global rights, strong IP estate Collabor
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