Gt Biopharma, Inc. · NASDAQ:GTBP
Gt Biopharma — Oxis International — Merger or Acquisition (July 2017)
31 slides from Gt Biopharma's merger presentation, Jul 25, 2017
Slide 1: GT Biopharma, Inc.
§ GT Biopharma, Inc.
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation and the information contained herein does not constitute or form part of, and should not be construed as, an offer or invitation to sell or subscribe for, or a solicitation of any offer or invitation to acquire, dispose of or subscribe for, securities of
Slide 3: Pending Merger Rationale
Pending Merger Rationale Oxis International Inc. (OTCBB:OXIS)Novel immuno-oncology platforms with lead product candidate currently in Phase 2 clinical trialGeorgetown Translational Pharmaceuticals, Inc. (Private)505(b)(2)-focused CNS product candidate portfolioMore rapid development timelines antici
Slide 4: Investment Highlights
Investment Highlights Diversified drug development pipeline across two therapeutic categories – oncology and CNSPipeline offers more balanced risk/reward profile with potential for steady news flowLead immuno-oncology product candidate, OXS-1550, a novel bispecific antibody drug conjugate, currently
Slide 5: Management Team with Proven Track Record of Success
Management Team with Proven Track Record of Success Name / Title Experience Anthony J. CataldoExecutive Chairman Founder, Chairman and CEO of Lion Biotechnologies (LBIO) now know as: Iovance Biotherapeutics (IOVA) – current market cap of $400MM Kathleen Clarence-Smith, M.D., Ph.D.Chief Executive Off
Slide 6: Oncology Scientific Advisory Board
Oncology Scientific Advisory Board Stephen Chang, Ph.D. Vice President of Research & Development, New York Stem Cell Foundation Lisa Haile, Ph.D., Esq. Partner, Co-Chair, Global Life Sciences Sector, DLA PiperFocuses on intellectual property Jeffrey Miller, M.D. Professor of Medicine, Division of He
Slide 7: CNS Scientific Advisory Board
CNS Scientific Advisory Board Thomas N. Chase, M.D. Sloan Business – MIT; MD Yale; Neurology – Harvard/MGH; National Institutes of Health – NINDS Director; Founding CEO of Chase Pharmaceuticals John Davis, M.D. Professor of Psychiatry and Research Professor of Medicine, University of Illinois at Chi
Slide 8: Pipeline
Pipeline Oncology Product Candidate(Indication) Pre-clin Ph I Ph II Ph III Pre-NDA Next Anticipated Milestone Anticipated Time to Next Milestone OXS-1550 BiKE(ALL & NHL) End of Phase II 14 months OXS-3550 TriKE(Myeloid Malignancies) IND opening 3 months OXS-1615(Carcinoma) Completion of IND-enabling
Slide 9: Oncology Portfolio
Oncology Portfolio
Slide 10: Novel Immuno-Oncology Technology Platforms
Novel Immuno-Oncology Technology Platforms Antibody-Drug Conjugate (ADC) Therapeutic PlatformscFvs targeting CD19, CD22, CD33, CD133, TAG72Full-length human MAbs targeting ICAM, FZD7, CD38Payloads: Diphtheria Toxin, OXS-4235, Pseudomonas ExotoxinAntibody Directed Cell-Mediated Cytotoxic (ADCC) Thera
Slide 11: Currently Approved ADC and ADCC Therapies
Currently Approved ADC and ADCC Therapies Blincyto® (blinatumomab) from Amgen is a first-in-class FDA approved bispecific CD19-directed CD3 T-cell engager antibody directed cell-mediated cytotoxic therapeutic (ADCC). Blinctyo is approved for the treatment of childhood acute lymphoblastic leukemia. A
Slide 12: OXS-1550 BiKE
OXS-1550 BiKEDual targeting delivering diphtheria toxin payload Bispecific killer engager (BiKE) ADC targeting CD19+ and CD22+ cancers with de-immunized diphtheria toxin payload Indication: CD19+ and CD22+ B-cell malignancies:Acute lymphoblastic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL)Broader
Slide 13: OXS-1550: Phase I Results
OXS-1550: Phase I Results Vallera, D., Miller, J., et. al., Clin Cancer Res: 21(6) 2015 Panel A: Partial Response in 77 yr old patient with refractory chronic lymphocytic leukemiaPanel B: Complete Response in 53 yr old patient with refractory marginal zone lymphoma which is ongoing at 27 months post
Slide 14: OXS-1550: Phase II Trial Design
OXS-1550: Phase II Trial Design Study Design Continuation Phase I dose/schedule finding component using MTD identified during previous Phase I study, but with a higher number of dosesTwo-stage Phase II extension component to confirm safety and make a preliminary determination of activity level by di
Slide 15: OXS-3550 TriKE Mechanism of Action
Anti-CD16 Anti-CD33 VL VH VL VH CD1633 BiKE CD161533 TriKE VL VH VL VH hIL15 NK Cell CD33+ AML Cell Immune Synapse CD16 CD33 Redirected Lysis TriKE-Mediated Killing TRIKE TriKE-MediatedADCC OXS-3550Trispecific Killer Engager (TriKE) Fusion Protein Mechanism of Action
Slide 16: OXS-3550 TriKE for Myeloid Malignancies
OXS-3550TriKE for Myeloid Malignancies Trispecific ADCC NK Cell engager targeting CD16 receptor on NK cells and CD33 receptor on cancer cells Contains IL-15 as an NK cell activatorIndication CD33+ myeloid malignancies:Acute Myelogenous Leukemia (AML)Myelodysplastic syndromeUnique incorporation of IL
Slide 17: OXS-1615 TetraKE for Carcinoma
OXS-1615TetraKE for Carcinoma Tetraspecific ADC targeting CD16/IL-15/EpCAM/CD133 Targets EpCAM+ present on the majority of solid tumors and CD133+, an establishe cancer stem cell markerPotential indications: carcinomas including breast, prostate, pancreatic, head and neck, colon, kidney, liver, and
Slide 18: OXS-4235 Small molecule for multiple myeloma
OXS-4235Starting development: Small molecule for multiple myeloma Small molecule P62-ZZ inhibitor targeting the treatment of multiple myeloma and associated osteolytic lesionsIn in vitro and in vivo models of multiple myeloma and osteoporosis, OXS-4235 demonstrated the ability to kill multiple myelo
Slide 19: CNS Portfolio
CNS Portfolio
Slide 20: AccuBreak Technology Platform
AccuBreak Technology PlatformInnovative Design for Maximum Dose Flexibility and Accurate Breakability Precise adjustment of dose timing and amount:Alleviates disabling peak-dose side effectsMaximizes efficacyMinimizes side effectsFormulation is particularly adapted to drugs for which:No marketed dos
Slide 21: AccuBreak Tablets Have Relatively Straightforward Path to NDA Approval
AccuBreak Tablets Have Relatively Straightforward Path to NDA Approval For the NDA to be a 505(b)(2)Total tablet strength must remain the same as initial tabletPackage insert must remain the same (except for new tablet description)Only 2 Phase I studies in healthy volunteers (N=24 to 48) are expecte
Slide 22: Chronic Neuropathic Pain: Urgent Need for Better Drugs
Chronic Neuropathic PainUrgent Need for Better Drugs – Prevalence Increasing with Aging Population Neuropathic pain reflects a chronic dysfunction of the nervous system Causes include diabetic neuropathy, postherpetic neuralgia, certain forms of chemotherapy, trauma, and multiple sclerosis ~16 MM Am
Slide 23: PainBrake for Chronic Neuropathic Pain
PainBrake for Chronic Neuropathic Pain PainBrake can achieve nearly complete pain relief but without peak dose side effectsFrequent small accurate doses of analgesic to avoid peak dose side effects and maintain constant pain controlActive component of PainBrake does not give rise to tolerance or dep
Slide 24: PainBrake: Potential Timeline to NDA Filing
PainBrake: Potential Timeline to NDA Filing Anticipate that 2 Phase I trials needed for 505(b)(2) NDA, provided that total tablet strength is within FDA-approved rangeNDA filing potentially in 15-18 months from fundingEstimated total budget to NDA filing of ~$2.6 MM PainBrake Estimated Timeline to N
Slide 25: GTP-004 for Myasthenia Gravis
GTP-004 for Myasthenia GravisAddresses Medical Need for Safer and Better Tolerated Treatment Only one drug, Pyridostigmine, currently approved for this rare muscular diseaseApproved drug restores muscle strength to pre-disease state, but GI side effects (nausea, vomiting, diarrhea) are dose limiting
Slide 26: GTP-004: Potential Timeline to NDA Filing
GTP-004: Potential Timeline to NDA Filing Anticipate 505(b)(2) NDA expected to require 1 placebo-controlled trialExpect to be able to reference all preclinical (toxicology), pharmacokinetic and clinical safety data of each approved drug componentPrimary endpoint of placebo-controlled trial will be s
Slide 27: GTP-011 for Motion Sickness
GTP-011 for Motion SicknessClear Medical Need for Better Treatments Prevalence 9-38% of population1 (depending on the study) Children 2 to 12 years old are most susceptible.Novartis’ Transderm Scop (scopolamine transdermal patch) is first-line treatmentDeleterious side effects, especially in elderly
Slide 28: GTP-011: Potential Timeline to NDA Filing
GTP-011: Potential Timeline to NDA Filing Anticipate 505(b)(2) NDA will require 1 placebo controlled trialConfirm in healthy volunteers in specialized center that GTP-011 prevents motion sickness (“go/no-go” study)If “go,” manufacture 3 commercial batches for NDAConduct multicenter study in speciali
Slide 29: Anticipated Upcoming Milestones Q4 2017 – Q1 2018
Anticipated Upcoming Milestones Q4 2017 – Q1 2018 GTP-004 File INDComplete Phase I Proof-of-Concept GTP-011 File INDComplete Phase I Proof-of-Concept OXS-1550 Phase II ongoing OXS-3550 IND Opening Start Phase I/II OXS-1615 Solid Tumor TriKE Start Phase 1/11 Fall OXS-4235 Start IND-enabling studies
Slide 30: Financials & Capitalization – Pro Forma
Financials & Capitalization – Pro Forma Closing price was $0.02 on July 5, 2017Assumed conversion price of all current debt is $0.007 Current Structure Post 1:300 Reverse Split Stock Price $0.02 $6.00 Current Common Shares Outstanding (Pre-Merger) 148,932,433 496,441 Common Shares Outstanding (Post-
Slide 31: Investment Highlights
Investment Highlights Diversified drug development pipeline across two therapeutic categories – oncology and CNSPipeline offers more balanced risk/reward profile with potential for steady news flowLead immuno-oncology product candidate, OXS-1550, a novel bispecific antibody drug conjugate, currently
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