Gt Biopharma, Inc. · NASDAQ:GTBP
Gt Biopharma — Investor Presentation (November 2021)
33 slides from Gt Biopharma's investor presentation, Nov 1, 2021
Slide 1: GT Biopharma: Tri-specific NK cell engagers (TriKE)
GT BIOPHARMA Tri-specific NK cell engagers (TriKE®) Utilizing novel camelid nanobody platform technology with target-directed immunotherapy for cancer November 1, 2021
Slide 2: Forward Looking Statement
Forward Looking 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,” “estimates,” “expects,” “intends,” “may
Slide 3: GT Biopharma Snapshot
GT Biopharma Snapshot Corporate Profile Stock Information GT Biopharma is a clinical stage immuno-oncology company 2 focused on its proprietary Tri-Specific Natural Killer Cell Stock Price (as of October 29, 2021) Engager or TriKE® platform technology. Shares Outstanding (as of June 30, 2021) TriKE’
Slide 4: Investment Opportunity - Next Generation of NK Cell Engagers for Cancer
Investment Opportunity —- Next Generation of NK Cell Engagers for Cancer Proprietary TriKE® Platform — Camelid Nanobodies NK Cell Engagers — Safer than T Cells* POC Established and Broad Applicability Multiple Catalysts Well-funded Experienced Leadership TriKE® platform creates tri-specific NK cells
Slide 5: Natural Killer Cell Engagers to Fight Cancer
Natural Killer Cell Engagers to Fight Cancer Natural Killer Cells * Cytotoxic lymphocytes in the innate immune system + Recognize and kill cancer cells + Mediate antibody-dependent cellular cytotoxicity (ADCC) via the highly potent CD16 activating receptor NK Cell Engagers * TriKE® nanobody platform
Slide 6: TriKE: Tri-Specific NK Cell Engagers - Modular Platform
TriKE®: Tri-Specific Natural Killer (NK) Cell Engagers — Modular Platform Proprietary platform utilizing camelid nanobody technology designed to bridge NK cells to tumor cells while inducing NK cell activation and expansion at the site of the tumor to enhance killing Tri-specific Modular Platform wi
Slide 7: TriKE Modular Platform Allows for Multiple Tumor-Associated Antigen Targeting
TriKE® Modular Platform Allows for Multiple Tumor-Associated Antigen Targeting scFv Nanobody Anti-Tumor Associated Antigen + Binds to well-known tumor-specific antigens * Defines the specificity of each TriKE® + Localizes NK cells at the site of the malignancy * Utilizes scFv fragments for most TriK
Slide 8: TriKE - NK Cell-Driven Serial Killing of AML Tumor Cells
TriKE® — NK Cell-Driven Serial Killing of AML Tumor Cells + First-in-class modular immune oncology protein therapeutic platform technology — not a cell therapy + Target-directed antibody-dependent cellular cytotoxicity (ADCC) killing + Integrated CD16 and IL-15 driven activation of NK cells: + ADCC
Slide 9: TriKE Nanobody Pipeline
TriKE® Nanobody Pipeline Candidates Approach Target Indication Pre-Clinical GMP Manufacturing Phase 1 Phase2 ELL. caer PC —_ ee eae 7 — wort sera sacra eames == ones menoy® at sentra
Slide 10: GTB-3550 for AML and MDS
Gar BIOPHARMA GTB-3550 for AML and MDS First generation TriKE® provides POC for platform
Slide 11: GTB-3550 TriKE Has Established Initial Proof of Concept in Phase 1 AML Trial
GTB-3550 TriKE® — Has Now Established Initial Proof of Concept in Phase 1 AML Trial a-CD16 1L-15 a-CD33 First-in-class immune oncology therapy Target-directed NK cell ADCC killing of CD33+ hematological cancers Incorporates IL-15 within the TriKE® for enhanced NK cell proliferation and persistence C
Slide 12: GTB-3550 Phase 1 Study Design
GTB-3550 Phase 1 Study Design anwar 2) (EES eee ad = (=) mp a wn { Opa 2 —. | | | Block | sanyer [ wlock? | scoyen [Blocks vest | ge tour etvaan ‘360m sen "96 Pour fon swiyoey Soeene 3 : : ee 2 te Y C18 do) Phase 1 (safety and dose finding) + Six dose levels + Escalation based on continual reassessm
Slide 13: GTB-3550 First in Human Phase 1 Trial - Individual Results
GTB-3550 First in Human Phase 1 Clinical Trial — Individual Results 180 180 Disease and Prior Tr t History "ir AML. Triple Hit Lymphoma ~6 therapies: 1. EPOCH, 2. RICE x3, 2. XRT to abdominal lymphadenopathy 4. NAMNK Cincal Tl §. CART, 6.and-CD20 and Ant-C03 manocional antbody cial ial Tle AML. AML
Slide 14: GTB-3550 Safety Profile: Well-Tolerated & Minimal CRS
GTB-3550 Safety Profile: Well-Tolerated & Minimal Cytokine Release Syndrome (CRS) Panel A: Dose equivalent of GTB-3550 compared to Panel B: Systolic Blood Pressure recombinant human IL-15 oh PER MOLE BASIS sb Dose of GTB-3550 (tig/kg) Fold Higher than MTD rhiL-15 ef 5 0.54 zx 10 1.08 al 25 2.69 eof
Slide 15: NK Cell Activation Upon Administration of GTB-3550
NK Cell Activation Upon Administration of GTB-3550 VARS LILLIE ge Facaaé eEEEEED 8
Slide 16: GTB-3550 - Sustained Proliferation of NK Cells Without Sustained T Cell Stimulation
GTB-3550 — Sustained Proliferation of NK Cells Without Sustained Stimulation of T Cells (CD4, CD8) Proliferating Cells Proliferating Cells Day 15 Day 22 wo = co oy teens 2 ome = 00 4 A ee 2 at ~ «© D.0h0 ae © Ska + wowots S00. ewe + owt KI67+ KI67+ NK CD8 CD4 16
Slide 17: GTB-3550 - No Loss of CD16 During Treatment
GTB-3550 — No Loss of CD16 During Treatment GTB-3550 Therapy Ends Day 19 Data from Patient #11 treated with 150 ug/kg/day 17
Slide 18: GTB-3550 Rescues NK Cells and Increases Cancer Cell Killing
GTB-3550 Rescues NK Cells and Increases Cancer Cell Killing K562 AML Cancer Cells + Patient’s NK Cells GTB-3550 Therapy tttt From patient #7 treated at 50 mcg/kg patient Lysis Measured in Standard 4 hr Chromium Release Top panels: No added cytokines or TriKE Bottom Right: Same as Top Right but GTB-3
Slide 19: GTB-3550 Phase 1 Demonstrates Proof of Concept for CD33 TriKE in AML/MDS
GTB-3550 Phase 1 Demonstrates Proof of Concept for CD33 TriKE® in AML/MDS + GTB-3550 induces reproducible NK cell proliferation, activation and persistence in all patients at all dose levels with minimal clinically significant toxicity. + Minimal CRS resulting from hyperactivation of patient’s T-cel
Slide 20: 2nd Generation TriKEs
Ger BIOPHARMA 2°4 Generation TriKE’s Utilize camelid nanobody technology
Slide 21: Advantages of Camelid Antibodies - Nanobodies in 2nd Generation TriKEs
Advantages of Camelid Antibodies — Nanobodies in 2"4 Generation TriKE’s® ' Light Chai Heavy Chai * Camelidae family of mammals include llamas, camels, va f oo ae and alpacas vi * Camelid antibody is made up of only 2 heavy chains as Vall — Heavy chain IgG (helgG) ii — Do not contain the CH1 region c
Slide 22: Second Generation TriKE (Camelid) Improves NK Function
Second Generation TriKE® (Camelid) Improves NK Function CD 33+ HL60 Targets 2 S =e soFV16-m 15-33 (GTB-3550) 2 Ss =e cam 16-115-33 (GTB-3650) ES S$ %CD107a+ NK Cells NS °° 2 01 1 10 100 Concentration (nM) e S O= scFV16-m 15-33 (GTB- 3550) = 20 cam 16-wt15-33 (GTB- 3650) %IFNg+ NK Cells 0.01 0.41 1 1
Slide 23: Second Generation TriKE (Camelid) Superior In-Vivo
Second Generation TriKE® (Camelid) Superior In-Vivo IV NK Cells 1x10" INT, seFV16-m15-93, or camté. (P) ——_— —— seeded Gudga 0 7 14 W HL-60Iue (0.75x10 21 BLI (tumor load) Harvest (NK coll numbers) Radiance (p/s) 120-1 change g see +e asst oy 23
Slide 24: Second Generation TriKE (Camelid) Highly Effective Against HER2+ Tumors
Second Generation TriKE® (Camelid) Highly Effective Against HER2+ Tumors *_ No Treatment Antibody Control W415 CAM1615HER2 Spheroid Size , - 4 Ae: Aala ne oa Ie uate E @ e. Ereerers) — — — wc. Spheroid intensity £ " Zyn ‘** SKOV/Lue, Human NK Cells. us 2" , a i , oan : HE. : 29) oe CAMIGISHERZ 4 & 2
Slide 25: GTB-5550 - Cam1615 B7H3 TriKE Pan Solid Tumor Targeting
GTB 5550 — Cam1615 B7H3 TriKE® Pan Solid Tumor Targeting GTB 5550 — Targets B7H3 o-CD16 Nanobody 1L-15 o-B7H3 Nanobody Percent CD107a+ NK Cells Percent NK Cells Treatment Condition Percent IFN-gamma NK Cells Percent NK Cells, ‘Treatment Condition Normalized To Mode BT-12 (Atypical Teratoid/Rhabdold)
Slide 26: Cam1615 B7H3 TriKE Pan Cancer Solid Tumor Targeting
Cam1615 B7H3* TriKE® Pan Cancer Solid Tumor Targeting MA148 Day 21 After MA-148 Tumor Implant 3 %CD107a+ NK Cells = s Dosing: 5x/week (MTWThF) Schedule: 3 weeks 26
Slide 27: GTB-5550 TriKE Makes NK Cell Therapies More Effective
GTB-5550 TriKE® Makes NK Cell Therapies More Effective PC-3 Prostrate Cancer Cells 24hrs PC348 Hour Cultures Targets + Targets + NK + Targets INK +L-15 B7H3 (IL-15) TriKE® 48hrs 72hrs iPSC NK Cells +145 iPSC NK Cells + B7HS (IL-15) ar
Slide 28: Competitive Advantages
Gar BIOPHARMA Competitive Advantages Nanobody technology, IP. and management
Slide 29: Competition
Competition > Advanta * The anti-CD16 component of the TriKE binds FcRylll at high affinity compared to ADCC mediated strategies that bind at low affinity. + CD16 +/- other receptor engagement does not result in proliferation of T-cells contributing to CRS. + IL-15 provides NK cell specific prolifer
Slide 30: Multi-Layered Patent Strategy
Multi-Layered Patent Strategy TriKEG Method of Use Patent Claims TriKE® Composition of Matter Claims Trike® Platform Patent Claims + TriKE® Method of Use Patent Claims + Methods of use claims highlighting coverage for oncology and infectious disease therapeutic applications. + TriKE® Composition of
Slide 31: Experienced Management Team With Deep Immuno-Oncology Experience
Experienced Management Team With Deep Immuno-Oncology Experience Proven record in biotech, pharma, product development, financing ‘Anthony Cataldo TOVANCE AA 9S CO Pesynsrira » Universiry celularit CALYPTE_ v celulari SAIS f MINNES ful ty oo. bY OF MINNESOTA Peratomics é a Allena intellikine Celgene
Slide 32: Investment Opportunity - Next Generation of NK Cell Engagers for Cancer
Investment Opportunity —- Next Generation of NK Cell Engagers for Cancer Proprietary TriKE® Platform — Camelid Nanobodies NK Cell Engagers — Safer than T Cells* POC Established and Broad Applicability Multiple Catalysts Well-funded Experienced Leadership TriKE® platform creates tri-specific NK cells
Slide 33: GT Biopharma: Tri-specific NK cell engagers (TriKE)
GT BIOPHARMA Tri-specific NK cell engagers (TriKE®) Utilizing novel camelid nanobody platform technology with target-directed immunotherapy for cancer November 1, 2021