Gt Biopharma, Inc. · NASDAQ:GTBP
Gt Biopharma — Investor Presentation (January 2019)
28 slides from Gt Biopharma's investor presentation, Jan 7, 2019
Slide 1: Company Overview
COMPANY Py “ _ OVERVIEW 2
Slide 2: Forward Looking Statements
FORWARD LOOKING GReevins STATEMENTS Safe Harbor Statement This presentation includes statements that are, or may be deemed, “forward-looking statements.” In some cases, you can identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estima
Slide 3: Clinical-stage immuno-oncology company
Clinical-stage, immuno-oncology company focused on the development of next-generation, targeted therapies based on proprietary NK-Engager TriKE and TetraKE and Bispecific ADC platforms
Slide 4: 2019: Positioned to be a Transformational Year
2019: POSITIONED TO BE A GBeecins TRANFORMATIONAL YEAR proprietary technology platforms driving next-generation immuno-oncology pipeline NK-Engager TriKE and TetraKE Bispecific-ADC program entering lead program in Phase 1 1H‘19 Phase 2 study preclinical ine Results expected 2 sisniann0 10°19 Exclusi
Slide 5: Immuno-Oncology Pipeline Overview
IMMUNO-ONCOLOGY GReevins PIPELINE OVERVIEW product Platform Indication Preclinical | Phase1 | Phase2 | Phase3 Market Candidates = Myeloid GTB-3550 THKE Malignancies —) , Myeloid > GTB-C3550 Ue Malignancies GTB-1615 . Carcinoma & / others THENTEnEKE Cancer Stem Cells > ' A B-cell Leukemias & GTB-1550
Slide 6: Employing Strategies Similar to Some of the Industry's Top Companies
EMPLOYING STRATEGIES SIMILAR TO SOME OF THE INDUSTRY’S TOP COMPANIES Cc) en Comparison GPa. Company/Product Highlight Value Indicator Amgen’s T-cell cell engager TriKEs/TetraKEs engage NK cells YABLINCYTO approved for marketing December which may have potential $175 Million (blinatumoma) ce 2014 201
Slide 7: Tri- and Tetra-Specific Natural Killer Cell Engager Platform
TRI- AND TETRA-SPECIFIC NATURAL KILLER CELL ENGAGER PLATFORM = ¢ =y BIO & PHARMA
Slide 8: Natural Killer Cell Targeting: Next Frontier in Cancer Immunotherapy
NATURAL KILLER CELL TARGETING: POTENTIAL TO BE THE NEXT FRONTIER IN CANCER IMMUNOTHERAPY We are innovating a novel immunotherapy built upon 20+ years of NK and cytokine research NK CELL TARGETING IL-2 IL-2+ Used to simulate IL-2+ rhiL-15+ eae posttransplant cufologous Autologous Allogeneic conpenes
Slide 9: BiKEs versus BiTEs
GPa. BITE Mediated Killing BiKE Mediated Killing cp3 cpi6 BIKES VERSUS BITES: ) Tumor Cell (3) © > Tumorcel (@ Blinatumomab (Amgen) CD3 x CD19 BIKE’s engage NK cells via CD16 binding TriKE and TetraKE Platform
Slide 10: BiKE Engaging an NK Cell and Targeting CD33+ AML Tumor Cell
GPa. Schematic Representation of BiKE Engaging an NK Cell and Targeting a CD33+ AML Tumor Cell z TRIKE CONSTRUCT % “Mp STARTED WITH i NK Col RA — cots Anti-CD16 Antibody U ( Cytotoxic Lysis | i .\ aw / i {I (CD 16xCD33 BIKE Immune Synapse ep33 Anti-CD33 Antibody TriKE and TetraKE Platform
Slide 11: BiKE to TriKE Technology Platform Advancement and Comparison with CAR-T
BIKE TO TRIKE TECHNOLOGY PLATFORM GBeecins ADVANCEMENT AND ILLUSTRATIVE COMPARISON WITH CAR-T Anti-CD19 scFV_ Anti-CD16 Anti-CD33 cS «) TriKE IL-15 linker designed “6 ic ) to induce NK cell activity esd and proliferation I CAR-T utilizes 41BB-L or © +—— _ CD28 intracellular domain to i -) MLAS -@ CA
Slide 12: Structure of BiKE and TriKE
GPa. Structure of BiKE and TriKE’s Vv Vv [=] % ¥, H Ib H t 1633 BiKE SFV16sFV133.pET21d V, ef): | MAAAA 161533 TriKE Buy TriKE and TetraKE Platform
Slide 13: TetraKE Construct Dimerization
4 ° GPs. ro ‘COOH lz Ls non-functional monomer NH2 Other NK Cell + Engager u ar Construct: BZ u3 non-covalent dimerization (head-to-tail) Folding pathway Tetravalent functional homodimer (~110kDa) TriKE and TetraKE Platform
Slide 14: AML Mouse Model Has Generated Compelling Data Supporting the TriKE Concept
AML Mouse Model Has Generated Compelling Data Supporting the TriKE Concept’ TriKE and TetraKE Platform (1) Clin Cancer Res. 2096 Jul 15:22(14):2440-50 CD56+CD3-Events within § «000 | 8 | g g 2000 0 L_ see esegee—_ ¥ g F rd se SS te te ¢ Demonstration that IL-15 in the TriKE drives NK cell survival a
Slide 15: GTB-3550: Most Advanced TriKE
GTB-3550: MOST ADVANCED TRIKE Gf... ' CD33+ ' _— ” , aH . . Single-chain, tri-specific scFv recombinant Terao Myeloid Malignancies : fusion ore conjugate C033 Phase 1 initi , Study Expect to initiate 1H’ 19 Phase 1 Study Design ~60 Relapse/Refractory AML, High Risk MDS patients and Advanced Systemic
Slide 16: GTB-C3550: Fast Follower to GTB-3550
GBrtcinus Potential for Enhanced NK cell activity’: “fast follower” to GTB-3550 GTB-C3550 2 BT Oisessto Potentially More 8 yy Ca 2 xt 2 Eicint Fong | Ha coe a ar pa E 3 - Conceaton ol) e* \ Jv. tH | cox Designed with is humanized, x uss single-domain Vy {beer men anti-CD16 Concent (8) GTB-C3550 1: F
Slide 17: GTB-1615: Solid Tumor TetraKE Candidate
GPa. Working towards being in the clinic with a solid tumor product candidate in 2019 TetraKE Construct TetraKE-Mediated Cancer Coll Killing van Ant-CD16 Antibody vw 115 Unker A _ >» 9 “OK LL 22 (om \ mot bach Goer eed con @ ea Cay ot . ‘ ‘Anti-EpCAM Antibody ] | TetraKE-Mediated "In . ~~. Cancer SO
Slide 18: Potential Benefits of TriKE and TetraKE Therapeutics
POTENTIAL BENEFITS OF TRIKE Bian AND TETRAKE THERAPEUTICS Tumor antigen targeting without the need for genetic modifications as in certain cell therapies Potential in hematologic and solid tumors Broad potential applicability - Attractive bio-distribution; important for solid tumor potential — Non-i
Slide 19: Bispecific Antibody Drug Conjugate Platform
BISPECIFIC ANTIBODY DRUG CONJUGATE PLATFORM Cc] Fee
Slide 20: Bispecific Antibody Drug Conjugate (ADC) Platform
GPa. Bispecific Antibody Drug Conjugate (ADC) Platform BISPECIFIC-ADC Bi-specific, tumor antigen-directed single-chain fusion proteins Simultaneously targets two antigens on select cancer cells Can modify to target numerous tumor antigens Platform amenable to multiple types of payloads Most advanced
Slide 21: GTB-1550: Lead Bi-Specific ADC Program
GTB-1550: LEAD BI-SPECIFIC ADC GPeeeces PROGRAM T; ti CD19 & CD22 antigens on argeung | select cancer cells Indication: B-cell lymphomas and leukemias Catalytic domain Payload: Modified Diphtheria Toxin Positive results from 25 patient Phase 1 trial Ongoing Phase 1/2 Study Design ~18 patients ™™ NHU
Slide 22: GTB-1550: Phase 1 Highlights
GTB-1550: PHASE 1 HIGHLIGHTS’ A. Bolorothorapy ——_Aftorasinglo courso of DT2219 Of the 9 patients who had measurable drug levels; 2 had durable responses All adverse events (AEs) were grade 1-2 and transient iJ Most common were weight gain, low albumin, f elevated liver enzymes, and fever iq Panel A
Slide 23: GTB-1550: Phase 1/2 Trial Design
GTB-1550: PHASE 1/2 TRIAL DESIGN - GBeecins CURRENTLY IN PHASE 2 COMPONENT‘ -———__ 1 treatment cycl ireatment cycle | Bases 00:0 0 0 'oO 6 Disease Final FiU* Survival Status Reassessment Rx Visit a Day 1 3 5 8 15 17 19 22 29 50 tyr © 678-1550 at assigned dose IV on day 1, 3, 5, and 8 and day 15, 17,
Slide 24: GTB-1550: Preliminary Clinical Results
GTB-1550: PRELIMINARY CLINICAL RESULTS GT: 1s eman FROM PHASE 1/2 INTERIM DATA REVIEW Data snapshot included review of toxicity profile, disease reassessment at Day 29 13 patients met evaluation criteria of at least 5 doses — 4 ALL, 9 NHL >50% of patients (7 of 13) exhibited clinical benefit as defi
Slide 25: Corporate Overview
Corporate Overview
Slide 26: Financial Profile: GTBP (OTCQB)
FINANCIAL PROFILE: GTBP (OTCQB) GPs Market Cap’ Shares Outstanding Average Volume’ 1: Based on Jan. 4, 2019 closing price of $.84 per share
Slide 27: Upcoming Potential Milestones for Growth
UPCOMING POTENTIAL Geen MILESTONES FOR GROWTH Potential Uplisting business TRIKE to national development & TetraKE exchange opportunities Phase 1 study Topline data from Two programs Potential expected to initiate Phase 1/2 study entering clinic by NASDAQ 1H‘19 expected 1Q‘19 2H‘19/1H‘20 listing
Slide 28: Company Overview
COMPANY OVE RVIEW 2 5 ‘ OTCQB: GTBP www.gtbiopharma.com