TG Therapeutics, Inc. · NASDAQ:TGTX
TG Therapeutics — Suntrust Life Science Summit 2019
27 slides from TG Therapeutics's conference presentation, May 2019
Slide 1: Corporate Presentation – Suntrust Life Science Summit
Corporate Presentation Suntrust Life Science Summit May 2019 TarGeting B-Cell Diseases
Slide 2: Forward Looking Safe Harbor Statement
Forward Looking Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as “anticipates”, “expects”, “plans”, “bel
Slide 3: Our Goal
Our Goal To develop the best possible treatment for B-cell diseases (Cancers: CLL, MZL, FL, and DLBCL Autoimmune: MS, RA, Lupus, etc.) Ideally, developing curative combination regimens (solutions development v. drug development) 3
Slide 4: B-Cell Focused Platform
B-Cell Focused Platform Clinical Stage Portfolio Overview Mechanism of Stage of Product Action Development Umbralisib (TGR-1202) PI3Kδ/CK1ε Phase 3 Ublituximab (TG-1101) Anti-CD20 Phase 3 TG-1501 Anti-PD-L1 Phase 1b TG-1701 BTKi Phase 1 TG-1801 Anti-CD47/CD19 Phase 1 4
Slide 5: Umbralisib and Ublituximab
Umbralisib Ublituximab Next Generation PI3K delta Next Generation anti-CD20 inhibitor monoclonal antibody Overcomes 1st generation Glycoengineered for enhanced Toxicity potency over 1st generation Activity in Rituxan refractory Activity across NHL and CLL patients Shorter infusions than all other On
Slide 6: Umbralisib: Selectivity
Umbralisib: Selectivity Umbralisib 6 DiscoverX KINOMEscan
Slide 7: Umbralisib: Selectivity
Umbralisib: Selectivity CK1e 7 DiscoverX KINOMEscan
Slide 8: Umbralisib: Activity
Umbralisib: Activity Umbralisib Single Agent Phase 1 Results (as published in Lancet Oncology) CLL FL MZL 8 Lancet Oncology, February 2018
Slide 9: Multiple Pivotal Programs… All fully enrolled
Multiple Pivotal Programs… All fully enrolled Target Data Program Release MZL – Met Primary Umbralisib Endpoint FL/SLL – Target 2H- 2019 PFS Target Readout: 2H-2019/ 1H-2020 Ublituximab Mid-2020 9
Slide 10: Umbralisib in Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Umbralisib in Relapsed/Refractory Marginal Zone Lymphoma (MZL) ▪ Approximately 7,500 new cases per year, with ~3,000 relapsed patients needing treatment each year ▪ No fully approved therapies for MZL ▪ Ibrutinib received accelerated approved with 46% ORR in 2017 ▪ No PI3K-delta inhibitors approved
Slide 11: UNITY-NHL Phase 2b Clinical Trial – Marginal Zone Lymphoma Cohort
UNITY-NHL Phase 2b Clinical Trial – Marginal Zone Lymphoma Cohort MZL Cohort Design: ▪ Feb 2019 – Trial Met • Umbralisib Primary End Point ▪ Exceeded target 40% ORR • Single Agent hurdle • 800mg 1x per day ▪ Plan to meet with FDA to discuss filing for accelerated approval • Treated 69 patients ▪ Tar
Slide 12: AACR 2019 UNITY-NHL MZL Cohort Interim Data
AACR 2019 UNITY-NHL MZL Cohort Interim Data Interim Efficacy Best Overall Response of Interim Best Percent Change in Target Lesions Efficacy Population by IRC (N=42) from Baseline for Interim Efficacy Population (N=42) 2 patients by IRC were not evaluable & are considered non-responders IRC = Indepe
Slide 13: AACR 2019 UNITY-NHL MZL Cohort Interim Data: Safety
AACR 2019 UNITY-NHL MZL Cohort Interim Data Safety Adverse Events Regardless of Causality, All Treated Patients (N=69) ▪ Umbralisib was well tolerated ▪ No events of colitis reported ▪ 10 subjects (14%) discontinued umbralisib due to an AE considered at least possibly related to treatment ▪ No death
Slide 14: Umbralisib & Ibrutinib Data in MZL
Umbralisib & Ibrutinib Data in MZL Umbralisib Interim Efficacy Ibrutinib Prescribing ▪ Umbralisib appears at Information Population (n=63) least comparable based (n=42) on ORR by IRC in the interim efficacy ORR 52% 46% population CR 19% 3% ▪ Median Time to PR 33% 43% Response for umbralisib 2.7 mont
Slide 15: Ibrutinib Warnings and Precautions
Ibrutinib Warnings and Precautions* ▪ The major toxicity/tolerability concerns with ibrutinib and BTKs are generally not associated with umbralisib 15 * Imbruvica Prescribing Information
Slide 16: For the Treatment of CLL
For the Treatment of CLL ▪ There are ~115,000 Americans living with CLL and ~20,000 newly UNITY-CLL diagnosed each year Enrollment Complete Randomize ▪ 85% ORR for umbralisib at higher doses in r/r CLL in Phase 1 Gazyva + U2 (Published in Lancet Oncology February 2018) CHL ▪ UNITY-CLL trial conducte
Slide 17: U2 is Highly Active in Relapsed/Refractory CLL
U2 is Highly Active in Relapsed/Refractory CLL Progression-Free Survival ▪ Median PFS for Umbralisib Monotherapy: 24 Months ▪ Median PFS and DOR not reached for Umbralisib + Ublituximab (U2) Umbralisib + Ublituximab (U2) Umbralisib Monotherapy 17 Mato A, et. al, EHA 2016
Slide 18: CLL is One of the Fastest Growing Global Hematology Markets
CLL is One of the Fastest Growing Global Hematology Markets Global CLL Market 2018-2024* ($ in billions) 2025 Estimated Global Sales: ~$10bn+(*) 12 10 8 6 4 2 0 2018E 2019E 2020E 2021E 2022E 2023E 2024E 18 * Evaluate Pharma
Slide 19: B-Cell Platform Provides Next Gen Combo's
B-Cell Platform Provides Next Gen Combo’s Mato, et al. ASH 2018 19 Nastoupil et al, Lugano 2017 19
Slide 20: Ublituximab in Multiple Sclerosis
Ublituximab in Multiple Sclerosis ▪ ~1M Americans living with MS ▪ Completed Phase 2 ▪ Presented final Phase 2 data at ECTRIMS 2018 & ACTRIMS 2019 ▪ Fully Enrolled Phase 3 ULTIMATE Trials under Special Protocol Assessment (SPA) 20
Slide 21: Ublituximab Phase 2 in Multiple Sclerosis
Ublituximab Phase 2 in Multiple Sclerosis ▪ ECTRIMS 2018 Final Phase 2 Data ▪ 48 patients through 48 weeks of treatment ▪ ARR of .07 Ublituximab Ocrelizumab Ocrelizumab Phase 2 Phase 2 Phase 3 (N=48) (N=55) Opera I&II Endpoint (Week 24) (Week 24) (96 Weeks) Annualized 0.05 0.13 0.156 Relapse Rate %
Slide 22: Ublituximab Phase 2: MRI-Gd Enhancing Lesions
Ublituximab Phase 2: MRI-Gd Enhancing Lesions ▪ Ublituximab completely eliminated all (100%) of T1 Gd- enhancing lesions at week 24 (n=44) and maintained at week 48 (n=22) 22 Fox E et al., ECTRIMS 2018
Slide 23: Significant Opportunity for Ublituximab in MS
Significant Opportunity for Ublituximab in MS Estimated Global Sales 35 30 25 $ Billions 20 15 10 5 0 2018 2019 2020 2021 2022 2023 2024 2025 US Ex-US (Japan, France, Germany, Italy, Spain & UK) Global Prevalence = ~2.3Million Global Market Size >$30Billion by 2025 ▪ Current estimated ocrelizumab sh
Slide 24: Ublituximab Value Proposition in MS
Ublituximab Value Proposition in MS ▪ Equal to better activity with comparable safety ▪ Convenience of 1 hour infusion every 6 months v. 3-4 hours for Ocrelizumab ▪ Strategically priced to optimize patient access ▪ Estimate $1-2B annual market opportunity in the US alone for ublituximab in MS 24
Slide 25: Key Goals and Objectives for 2019
Key Goals and Objectives for 2019 • Commence Phase 1 studies for TG-1501 and TG-1801 in heme cancers ✓ • Report top-line ORR results from UNITY- 1H NHL MZL cohort and FL cohort ✓ • Present updated data at major medical meetings—AACR MZL Cohort ✓ • Potential UNITY-CLL PFS top-line results • Potential
Slide 26: Corporate & Financial
Corporate & Financial Key Financial Statistics Ticker: TGTX (NASDAQ) Price: $7.97 (close on May 7, 2019) Shares: ~88M (fully-diluted) Cash: ~$125M (proforma as of 12/31/18) 26
Slide 27: NASDAQ: TGTX
eel S O TG Therapeutics NASDA Q: TGTX