Tg Therapeutics, Inc. · NASDAQ:TGTX
Tg Therapeutics — Investor Presentation (October 2020)
21 slides from Tg Therapeutics's investor presentation, October 2020
Slide 1: Corporate Presentation
Corporate Presentation October 2020
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: Fearless Pursuit
Fearless Pursuit • Founded 8 years ago with one goal in mind… to create the best possible treatment options for patients with B-Cell diseases • Focused on cancer & autoimmune disease with registration programs ongoing in: • Chronic Lymphocytic Leukemia (CLL) • Marginal Zone Lymphoma (MZL) • Follicul
Slide 4: B-Cell Focused Platform Clinical Stage Portfolio Overview
B-Cell Focused Platform Clinical Stage Portfolio Overview Drug Mechanism of Stage of Candidate Action Development Umbralisib PI3Kδ/CK1ε Phase 3 (TGR-1202) Ublituximab Anti-CD20 Phase 3 (TG-1101) Cosibelimab Anti-PD-L1 Phase 1b (TG-1501) TG-1701 BTKi Phase 1 TG-1801 Anti-CD47/CD19 Phase 1 4
Slide 5: 2020: Transformational Year w/ Multiple Pivotal Data Sets
2020: Transformational Year w/ Multiple Pivotal Data Sets UNITY-NHL UNITY-CLL ULTIMATE I & II Rel/Ref MZL and FL Front Line & Rel/Ref Relapsing MS – Umbralisib Monotherapy – – Umbralisib + Ublituximab (U2) – – Ublituximab Monotherapy – Positive Topline ORR Data Trial Conduced Under SPA Trials Conduc
Slide 6: Umbralisib
Umbralisib: Investigational dual PI3k-delta & CK1-epsilon inhibitor Once Daily • Demonstrated activity across NHL and CLL • Potentially differentiated tolerability profile over 1st generation compounds • Once daily v. twice daily for 1st generation compounds 6
Slide 7: UNITY-NHL - Umbralisib Monotherapy Cohorts
UNITY-NHL - Umbralisib Monotherapy Cohorts Relapsed/Refractory MZL & FL UNITY-NHL Ph2b Trial FL & MZL Cohorts • MZL & FL Cohort’s Met Primary End Point of Overall Response Rate (ORR) • Exceeding 40% ORR hurdle Umbralisib • Interim efficacy analysis of MZL cohort, n=42, showed 52% ORR, (TGR-1202) inc
Slide 8: MZL and FL are chronic and often incurable diseases
MZL and FL are chronic and often incurable diseases characterized by multiple recurrences and relapses1 Marginal Zone and Follicular Lymphomas Estimated # of Annually Treated Patients in US2 1L TREATMENT: 1L 18,000 – 20,000a Primarily CD20-based chemo3 2L TREATMENT: ~10,000-11,000 2L ~7,000b Variabl
Slide 9: Ublituximab
Ublituximab: Investigational Next Generation Anti-CD20 Monoclonal Antibody US REGULATORY SUBMISSION PLAN TARGETS CLL (in combo with umbralisib) YE 2020/ early 2021 Multiple Sclerosis 1H 2021 Ublituximab Glycoengineered for enhanced potency over 1st generation Activity in rituximab refractory patient
Slide 10: UNITY-CLL Phase 3 Trial of U2 in CLL
UNITY-CLL Phase 3 Trial of U2 in CLL POSITIVE TOPLINE RESULTS – MAY 2020 • UNITY-CLL met the primary endpoint of improved PFS (p<.0001) • Trial will be stopped early for superior efficacy observed at the interim analysis • PFS benefit seen across both treatment naïve & relapsed/refractory patient po
Slide 11: CLL Market Opportunity
CLL Market Opportunity One of the Fastest Growing Global Hematology Markets • ~115,000 Americans living with CLL • ~20,000 newly-diagnosed patients each year • ~20,000 previously treated patients seeking treatment each year 11 *Evaluate Pharma
Slide 12: U2 Has the Potential to Address Unmet Needs in CLL
U2 Has the Potential to Address Unmet Needs in CLL • Over 60,000 patients in the US have been treated with a BTK-inhibitor creating a large population in the post-BTK setting in need of treatment options • ~20% of treatment naïve patients will be deemed poor candidates for BTK inhibitors due to pote
Slide 13: U2-Based Triplets Currently Enrolling
U2-Based Triplets Currently Enrolling U2 + Venetoclax U2 + Ibrutinib U2 + 1701 (BTKi) Phase 1 Study Phase 1 Study in rel/ref B-cell malignances in rel/ref B-cell malignances Target Enrollment: Enrolled: ~50 patients Target Enrollment: Up to 100 patients Rel/Ref CLL ~60 patients BTK Refractory CLL ~3
Slide 14: Ublituximab in Relapsing Forms of Multiple Sclerosis
Ublituximab in Relapsing Forms of Multiple Sclerosis • ~1M Americans living with MS • Completed Phase 2, data presented at multiple conferences • Fully Enrolled Phase 3 ULTIMATE Trials • Special Protocol Assessment (SPA) ▪ Topline Data Targeted for Q4 2020 14
Slide 15: Final Ublituximab Phase 2 Data in RMS
Final Ublituximab Phase 2 Data in RMS • Ublituximab was well tolerated across all patients (n=48) • No study drug related discontinuations occurred • Median B cell depletion was >99% at the primary analysis point of Week 4 (n=48) and maintained at Week 24 and Week 48 • No T1 Gd-enhancing lesions wer
Slide 16: Significant Opportunity for Ublituximab in MS
Significant Opportunity for Ublituximab in MS Global MS Market 2018 - 2025 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 >$30Billion by 2025 • Ocr
Slide 17: Multiple Treatment Options Coexist & Account for Meaningful Market Share
Multiple Treatment Options Coexist & Account for Meaningful Market Share U.S. Approval Class Drug Date Route of Administration Dosing Global 2018 Revenues by Drug/Class ($ in millions) G Betaseron 1993 Subcutaneously 1x / 2 days $643 Avonex 1996 Intramuscularly 1x / week $1,915 Interferons Rebif 200
Slide 18: Ublituximab Potential Value Proposition in MS
Ublituximab Potential Value Proposition in MS • Significant activity and manageable safety profile in Phase 2 study • Convenience of 1 hour infusion every 6 months v. 3-4 hours for ocrelizumab • Potential to strategically price to optimize patient access • Estimate $1-2B annual market opportunity in
Slide 19: Target Milestones
Target Milestones 1H 2020 2H 2020 – Q1 2021 • Report topline UNITY-NHL FL • NDA submission for umbralisib to results treat MZL & FL accepted by US • Initiate rolling NDA submission FDA & PDUFA goal dates set for umbralisib to treat • Report topline Phase 3 ULTIMATE relapsed/refractory MZL & FL MS da
Slide 20: Corporate & Financial
Corporate & Financial Key Financial Statistics Ticker: TGTX (NASDAQ) Price: $27.56 (close on 10/5/2020) Shares: ~127M (fully-diluted as of 6/30/20) Cash: $275M (as of 6/30/20) 20
Slide 21: NASDAQ: TGTX
g O TG Therapeutics NASDAQ: TGTX TG Therapeutics
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