Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Onconova Therapeutics — IPO Roadshow (September 2019)
25 slides from Traws Pharma's IPO roadshow presentation, Sep 13, 2019
Slide 1: Forward Looking Statements and Free Writing Prospectus Statement
disclaimers Forward Looking Statements This presentation contains forward-looking statements about Onconova Therapeutics, Inc. based on management’s current expectations which are subject to known and unknown uncertainties and risks. Onconova has attempted to identify forward-looking statements by t
Slide 2: Onconova Therapeutics, Inc.
ONCONOVA THERAPEUTICS, INC. Onconova Therapeutics, Inc. is a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer. Upcoming Phase 3 top-line data in Higher-Risk Myelodysplastic Syndromes (HR-MDS) Promising survival signal
Slide 3: Management Focus
MANAGEMENT FOCUS Priorities Complete INSPIRE accrual and obtain pivotal survival data 1H20 Complete business development transactions Other Goals Finalize SPA agreement with FDA for combination pivotal trial Seeking Collaboration to Initiate Future Pivotal Ph 3 Trial Complete Rasopathy PDX and pre-c
Slide 4: What exactly is MDS?
AML PRCA AA LGL MPN PNH MDS MDS is related to other bone marrow diseases What exactly is MDS? MDS: malignant bone marrow disorder characterized by: Acquired cytogenetic and genomic abnormalities, but typically only in the marrow US prevalence is 59,000 ~13,000 have higher risk (HR) MDS ~10,000 secon
Slide 5: About MDS and MOA of Rigosertib
ABOUT MDS AND MOA OF RIGOSERTIB Temporal Order of Gene Mutations in 107 MDS Patients* RAS targeted novel mode of action** IDH2 n=5 SF3B1 n=35 n=21 n=15 n=13 n=41 n=11 ZRSR2 DNMT3A USAF1 SRSF2 CUX1 JAK2 GATA2 n=13 n=4 n=5 n=69 n=28 n=21 n=8 n=52 n=15 n=11 n=5 n=23 n=10 n=7 n=20 NF1 TET2 RUNX1 EZH2 PH
Slide 6: Revised IPSS
REVISED IPSS Confidential Greenberg et al. Blood 2012;120:2454-65 September 2019 7
Slide 7: Study 04-21: Proposed Patient Population for INSPIRE
STUDY 04-21 : PROPOSED Entire ITT population PATIENT POPULATION FOR INSPIRE Very High Risk (VHR) population September 2019 8 Age < 82 years Duration of prior HMA 9 cycles of prior HMA in 12 months Time from last dose of prior HMA to random assignment 6 months.
Slide 8: INSPIRE Study Design and Statistical Objectives
INSPIRE study DESIGN AND STATISTICAL OBJECTIVES Stratification at randomization VHR vs. non-VHR U.S. vs. EUROPE vs. Asia Post Interim Analysis ITT population = 0.04 Power = 0.80 Target HR 0.72 Reduce mortality by 28% VHR subgroup = 0.01 Power = 0.80 Target HR 0.55 Reduce mortality by 45% Post-HMA HR
Slide 9: INSPIRE: Timelines & Observations
Inspire: timelines & OBSERVATIONS High proportion of VHR subgroup on current INSPIRE Trial may have favorable implications >70% seen at interim analysis on INSPIRE Validates the trial design and strict patient eligibility criteria – failure to respond or progress within 9 cycles of AZA VHR subgroup
Slide 10: Oral Rigosertib Development Program
ORAL RIGOSERTIB DEVELOPMENT PROGRAM September 2019 11
Slide 11: Combination Therapy with Rigosertib + Azacitidine
COMBINATION THERAPY WITH RIGOSERTIB + AZACITIDINE Preclinical evidence supports synergism of rigosertib + azacitidine combination AML Mouse Model Validation of combination approach Lu et al., 2016 Cancer Cell September 2019 12
Slide 12: Combination of Oral Rigosertib and Standard Dose Azacitidine
COMBINATION OF ORAL RIGOSERTIB AND STANDARD DOSE AZACITIDINE: VARIOUS DOUBLET PATIENTS RECEIVED A MEDIAN OF 7 CYCLES RESPONSE RATES (CR/PR/MCR) 90. 79.30% 80. 70.00. 60. 50.00 35.80% 36.20% 35.80% 40. 31.20% 30. 20.00:4 10. 0. AZA N = 81 AZA+Len N = 80 AZA+VPA N = 80 AZA+Ida N = 81 AZA+Rigosertib**
Slide 13: HMA Naive 840mg/day Response Data
HMA NAÏVE 840MG/DAY (NOT TREATMENT NAÏVE) (range, 0.1-24.2+) (range, 0.7-25.1+) * Includes 2 patients treated with non-HMA, prior chemotherapy Navada et al: Blood 2018 132:230 and EHA June 2019 September 2019 14 Evaluable for response 29* Overall response per IWG 2006 26 (90%) CR+PR 10 (34%) Complet
Slide 14: Combination Therapy Independence
COMBINATION THERAPY INDEPENDENCE Single patient case data*: Hemoglobin MAY LEAD TO TRANSFUSION Platelets Platelet transfusion independence RBC transfusion independence Neutrophils 12 cycles of AZA – stable disease RBC and platelet transfusions Blasts 7% Monosomy 7 Runx-1 AZA + RIG in 09-08 for 20+ m
Slide 15: Proposed Phase 3 Design for Treatment Naive HR MDS
PHASE 3 PROPOSED DESIGN FOR TREATMENT NAÏVE HR MDS Phase 3, multi-center, international, randomized, double-blind, placebo-controlled study of oral rigosertib + injectable azacitidine (AZA) versus injectable AZA plus oral placebo in patients who are hypomethylating agent treatment-naïve with higher-
Slide 16: Combination Therapy: Next Steps and Timelines
COMBINATION THERAPY: NEXT STEPS AND TIMELINES *Dose justification based on oral rigosertib optimal transfusion independence rate data in Lower-Risk MDS (ASH 2017) Step Start Status Remarks Phase 2 expansion Fully enrolled Q1-2017 Q2-2018 Dose and schedule of 1120 mg daily dose presented at ASH 2018*
Slide 17: Rasopathies: Rigosertib for Rare Pediatric Cancers
RASOPATHIES: RIGOSERTIB FOR RARE PEDIATRIC CANCERS RTK Grb2 SOS1 P SPRED1 SHP2 RAF1 BRAF NF1 CM-AVM syndrome CFC Noonan syndrome LEOPARD syndrome syndrome MEK2 MEK2 Transcription ERK1 ERK2 Milestones NCI CRADA signed January 2018 UCSF non-clinical program initiated Funded by LLS JMML clinical progra
Slide 18: Expanding and Extending Coverage Rigosertib Patent
EXPANDING AND EXTENDING COVERAGE RIGOSERTIB PATENT Strong existing patent estate Existing coverage of composition of matter (e.g. U.S. 7,598,232), formulations, combinations and methods in US and many countries worldwide Supplemented by Orphan Designation for MDS in US, Europe New issued US patent 1
Slide 19: Phase 1/2 Study: Rigosertib and PD-1 in Advanced Kras+ NSCLC
Phase 1 Study: Rigosertib and PD-1 in Advanced Kras+ NSCLC PI: Raj Veluswamy, MSSM September 2019 20
Slide 20: ON 123300: Next Generation CDK4/6 Inhibitor
ON 123300: NEXT GENERATION CDK4/6 INHIBITOR Also targets ARK5 (NUAK1) Differentiation for a Competitive Field Partnership with HanX Biopharmaceuticals Recently launched Ibrance®, Kisquali® and Verzenio® have been hailed as potential breakthroughs in cancer therapy First FDA approval for CDK 4/6 inhi
Slide 21: Onconova Business Development Opportunities
ONCONOVA BUSINESS DEVELOPMENT OPPORTUNITIES Patent-protected, differentiated small molecule compounds Available September 2019 22 Compound Target Stage Next Step Other Agents Patents Licensing Territories Clinical Stage Rigosertib RAS pathway MDS initial indication Phase 3 INSPIRE Pivotal Readout of
Slide 22: Company Capitalization
COMPANY CAPITALIZATION *5.13 million warrants will expire by 12/31/19 if unexercised September 2019 23 Outstanding Securities As of 9/12/19 Common Stock 5,998,524 Options outstanding (WAEP: $66.65) 404,957 Warrants (WAEP: $9.113) 5,504,722*
Slide 23: Management Team
MANAGEMENT TEAM Steven M. Fruchtman, M.D. President & CEO Mount Sinai, Novartis, Janssen, Syndax, Allos Therapeutics, Spectrum Pharmaceuticals Richard Woodman, M.D. Chief Medical Officer Univ of Calgary, Scripps Clinic & Research Institute, Novartis, Ortho Biotech Products Mark Guerin Chief Financia
Slide 24: info@onconova.us
info@onconova.us September 2019 25
Slide 25: Onconova Therapeutics
ONCONOVA THERAPEUTICS
Onconova Therapeutics — IPO Roadshow (September 2019) on 6ix