Xynomic Pharmaceuticals Holdings Inc

Xynomic Pharmaceuticals — Investor Presentation (June 2019)

24 slides from Xynomic Pharmaceuticals's investor presentation, Jun 21, 2019

  1. Slide 1: Xynomic Pharmaceuticals Holdings, Inc. Investor Presentation June 2019

    Xynomic Pharmaceuticals Holdings, Inc. (Nasdaq: XYN) Investor Presentation June 2019

  2. Slide 2: Disclosure Disclaimer

    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 solicitation of an offe

  3. Slide 3: Why Xynomic?

    Why Xynomic? 3  Lead drug Abexinostat has been granted Fast - Track designation  Only drug starting pivotal trial in China against diffuse large B - cell lymphoma (DLBCL), the largest lymphoma subtype*  Expect to launch Abexinostat treating DLBCL in China in mid of 2020 (as a Category 1 Innovativ

  4. Slide 4: Experienced Management Team

    Experienced Management Team 4 Y. Mark Xu, Chairman and CEO  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 development experie

  5. Slide 5: World Class Scientific Advisory Board (SAB)

    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.

  6. Slide 6: 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) Kidney Cancer (1L or 2L, with Novartis’ Pazopanib, Fast - Track designation) Follicular Lymphoma (4L, US and EU) Diffuse Large B - Cell Lymphoma & Man

  7. Slide 7: Key Features of Abex: In-Licensed from Pharmacyclics/AbbVie

    Key Features of Abex : In - Licensed from Pharmacyclics/AbbVie 7 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 single drug - related death Special status US FDA Fast - Track des

  8. Slide 8: 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 - CA 7 Hematological tumors CL1 - 006 32 Digestive cancer CL1 - 010 1 NHL CL1 - 008 19 Late

  9. Slide 9: Safety Profile Better Than First Generation Abex

    Safety Profile Better Than First Generation 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

  10. Slide 10: Abex: Objective Response Rate in Lymphoma

    Abex: Objective Response Rate in Lymphoma 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% (n=16) 22% 40% (n=15) Target ORR Actual 0% 100% Source: Vincent Ribrag , et al. Safety and efficacy of abexinostat ,

  11. Slide 11: 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 11 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.

  12. Slide 12: 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 12 Source: Xynomic and licensor

  13. Slide 13: 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 Potentially Pivotal Ph 2 120 MSKCC U.S. and EU7 8/ 9 /2018 Abex/Pazopanib 1L or 2L RCC Potentially Pivotal Ph 3 390 UCSF U.S., EU

  14. Slide 14: Major Potentially Pivotal Trials

    Major Potentially Pivotal Trials 14 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 170 patients)

  15. Slide 15: Abex: Only 3L DLBCL Drug in Potentially Pivotal Trial in China

    Abex : Only 3L DLBCL Drug in Potentially Pivotal Trial in China 15 Source: China Center for Drug Evaluation, NMPA As of May 24, 2019 No Registration No Status Drug Indications Sponsor Phase Drug Category Combined with Other Drugs? Pivotal China Trial? Starting Time 1 CTR20181725 Volunt ary on hold r

  16. Slide 16: XP-105 (BI 860585)

    XP - 105 (BI 860585) 16 • Only ~2 years behind competing drug candidates being developed by major multinational pharmaceutical companies* • Xynomic plans to initiate a phase 2 trial soon • A potent and selective, 3rd generation, ATP competitive mTORC1/2 inhibitor against multiple solid tumors with p

  17. Slide 17: Continuing Strong Interest in mTORC Inhibitors

    Continuing Strong Interest in mTORC Inhibitors 17 • Several 1st generation mTORC inhibitors are already marketed, including e verolimus (Novartis) and temsirolimus (Pfizer), and mainly treat kidney cancer and breast cancer • Everolimus : $1.525 billion revenue in 2017* • Strong interest in mTORC » I

  18. Slide 18: XP-105 (BI 860585) Superior to Competitors

    XP - 105 (BI 860585) Superior to Competitors 18 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 tumor subjects E

  19. Slide 19: 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 (in

  20. Slide 20: 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

  21. Slide 21: 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 (

  22. Slide 22: R&D Center in Shanghai, China

    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  Multiple small

  23. Slide 23: Pipeline Summary

    Pipeline Summary  Abex: currently being evaluated in 3 therapeutic areas  XP - 105 (BI 860585): breast cancer » Potentially best - in - class, 3rd generation mTORC1/2 inhibitor » Only 2 years behind Takeda’s competing TAK228  XP - 102 (BI 882370): colorectal cancer and lung cancer » Animal data f

  24. Slide 24: 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 ( AbbVie and Boehringer Ingelheim ): high - quality U.S./EU data integrity, exclusive global

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