Globeimmune Inc · OTC:GBIM
Globeimmune — IPO Roadshow (June 2014)
35 slides from Globeimmune's IPO roadshow presentation, Jun 30, 2014
Slide 1: Initial Public Offering – June 2014
Initial Public Offering – June 2014 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-194606 June 30, 2014
Slide 2: Forward Looking Statements
Forward Looking Statements Some of the matters discussed in this presentation contain forward-looking statements that involve significant risks and uncertainties, including statements relating to the prospects for the Company’s Tarmogen technology, for the timing and outcome of the Company’s clinica
Slide 3: Free Writing Prospectus Statement
Free Writing Prospectus Statement • This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing in our common stock. • We have filed a registration statement (including prospec
Slide 4: Initial Public Offering Summary
Initial Public Offering Summary Issuer GlobeImmune, Inc. Exchange / Listing NASDAQ Capital Market / GBIM Offering Size 1,000,000 shares (100% primary) Over-Allotment 15% or 150,000 shares (100% primary) Price $15.00 Potential Current Up to $6 million Investor Participation Celgene, HealthCare Ventur
Slide 5: GlobeImmune
GlobeImmune • Differentiated immunotherapeutic platform • Proof of concept in infectious disease & oncology – 4 ongoing phase 2 studies with multiple upcoming readouts • Major alliances with Gilead and Celgene – Over $60 million in partnership revenue to date – Upcoming data from randomized phase 2
Slide 6: Experienced Management and Strong Investors
Experienced Management and Strong Investors Management Timothy C. Rodell, MD RxKinetix, OXIS International, CEO & President, Board of Dir. Cortech, Univ. of Colorado Jeffrey Dekker, CPA Webroot, Requisite Technology VP Finance NxTrend, Rayonier, KPMG Kirk Christoffersen, MBA VP Corporate Development
Slide 7: Pipeline
Pipeline Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights GS-4774 Hepatitis B virus (HBV) Phase 2 GILD WW License ease s i GI-19000 Tuberculosis D s iou nfect GI-2010 HIV GlobeImmune I GI-18000 Delta virus GI-6207 Medullary thyroid cancer Phase 2 CELG Option y GI-63
Slide 8: A Year of Significant Accomplishments
A Year of Significant Accomplishments • Infectious disease – Completed phase 1 trial for GS-4774 (formerly GI-13020) – Gilead enrolling 175 patient phase 2 in chronic HBV for GS-4774 • $5 million in milestones received to date – $4 million tuberculosis grant from NIH • Oncology – Initiated GI-6207 p
Slide 9: Tarmogen® Immunotherapy: Heat-inactivated Recombinant Yeast
Tarmogen® Immunotherapy: Heat-inactivated Recombinant Yeast • Potent helper and killer T cell responses – Down-regulates regulatory T cells • Target antigen(s) expressed internally • Safe and well tolerated to date – >500 patients and healthy volunteers – >5 years safety data in pancreas cancer
Slide 10: Generating a Targeted Cellular Immune Response
Generating a Targeted Cellular Immune Response Mechanism of action
Slide 11: Infectious Disease Pipeline
Infectious Disease Pipeline Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights GS-4774 Hepatitis B virus (HBV) Phase 2 GILD WW License GI-19000 Tuberculosis Infectious Disease GI-2010 HIV GlobeImmune GI-18000 Delta virus
Slide 12: GS-4774 in Chronic Hepatitis B
GS-4774 in Chronic Hepatitis B GS-4774 HBV fusion protein M His 6
Slide 13: Hepatitis B Market
Hepatitis B Market GS-4774 • 400 million patients chronically infected with HBV worldwide – Current treatment is lifelong treatment with antivirals – Antivirals control viremia but long term cure rates are <8% • 80% of acutely infected patients clear virus spontaneously – Clearance is mediated by ce
Slide 14: Phase 2 in Chronic HBV Infected Subjects
Phase 2 in Chronic HBV Infected Subjects GS-4774 Randomized open label dose ranging trial Chronic HBV under control with an oral antiviral n=175 25 Oral antiviral alone Oral antiviral (OAV) 50 GS-4774 (low) + OAV OAV 50 GS-4774 (med) + OAV OAV 50 GS-4774 (high) + OAV OAV Wk 0 Wk 24 Wk 48 Primary end
Slide 15: Oncology Pipeline
Oncology Pipeline Medullary thyroid cancer Chordoma Resected pancreas Non-small cell lung cancer Product Candidate GI-6207 GI-6301 Indication Oncology GI-4000 GI-4000 Preclinical Phase 1 Phase 2 Phase 3 Phase 2 Phase 1 Phase 2b Phase 2 Commercial Rights CELG Option CELG WW License GlobeImmune
Slide 16: GI-6207 Targets Carcinoembryonic Antigen
GI-6207 Targets Carcinoembryonic Antigen GI-6207 • CEA over-expressed in > 500,000 cases/year in US NSCLC, colorectal, breast, gastric, pancreas, medullary thyroid cancers • Phase 1 complete at NCI n=25 Monotherapy dose escalation trial Advanced metastatic cancers Stable disease in 20% of subjects C
Slide 17: Medullary Thyroid Cancer
Medullary Thyroid Cancer GI-6207 GI-6207 • MTC represents 8% of all thyroid cancer cases annually in US • Resection is the only opportunity for cure – In less symptomatic metastatic disease SoC is observation • 25% and 10% survival at 5 and 10 years with metastases • Vandetanib and cabozantinib appr
Slide 18: GI-6207-02 – Phase 2 in MTC
GI-6207-02 – Phase 2 in MTC GI-6207 • Randomized, open label, cross-over trial GI-6207 for 12 months Observation GI-6207 for 12 months months 12 months 18 months Primary Endpoint • Primary endpoint—calcitonin kinetics Minimally or 17 asymptomatic MTC Randomize n=34 17
Slide 19: GI-6301 Targets Brachyury Expressing Cancers
GI-6301 Targets Brachyury Expressing Cancers GI-6301 Brachyury Lung, breast, colon, bladder, kidney, ovary, pancreas, chordoma Transcription factor involved in normal embryogenesis Important driver of metastasis Brachyury
Slide 20: Chordoma
Chordoma Ultra-orphan indication – 100% of chordoma cells express brachyury – 250-300 new US cases annually; prevalence 2,400 – 400 new EU cases annually; prevalence 3,600 Clinical presentation – Indolent and clinically silent until later stages Treatment – Aggressive resection plus adjuvant proton
Slide 21: GI-6301 Clinical Summary
GI-6301 Clinical Summary GI-6301 NCI sponsored phase 1 34 subject, open label dose escalation trial dose groups Fully enrolled Ten chordoma patients enrolled in Phase 1 Initial chordoma results presented at ASCO 2014 Phase 2 trial being designed
Slide 22: Tumor Growth Kinetics – First Chordoma Patients
Tumor Growth Kinetics – First 7 Chordoma Patients GI-6301 Percentage change in tumor volume by RECIST Heery et al. “NCI Experience Using Yeast-Brachyury Vaccine (GI-6301) in Patients with Advanced Chordoma.” ASCO 2014
Slide 23: GI-4000 Targets Mutated Ras
GI-4000 Targets Mutated Ras GI-4000 Critical molecular target in multiple cancers ~200,000 Ras mutation+ cancer cases/year in U.S. – Poor prognosis – Less responsive to chemotherapy and targeted agents 176 patient Phase 2 in resected pancreas cancer – 2.6 month improvement in OS in subjects with res
Slide 24: 16.6 Month mOS – BDX-001+ GI-4000 vs Placebo
16.6 Month mOS – BDX-001+ GI-4000 vs Placebo GI-4000 *42 month mOS (GI-4000/gem) vs 25 month mOS (gem alone) *Retrospective analysis of survival based on proteomic test results
Slide 25: 43% Reduction in Risk of Death vs Case-matched Controls
43% Reduction in Risk of Death vs Case-matched Controls
Slide 26: Key strategic collaborations
Key strategic collaborations GlobeImmune
Slide 27: Gilead Alliance
Gilead Alliance GlobeImmune GI-13020 Exclusive license to all HBV Tarmogens – Signed in October 2011 GILEAD Economics – $10 million upfront – Up to $135 million in potential clinical and regulatory milestones – Up to $40 million in potential sales milestones – Tiered royalties from high single digit
Slide 28: Celgene Collaboration & Option Agreement
Celgene Collaboration & Option Agreement GlobeImmune Exclusive option to oncology products – Program-by-program basis – GI-6301 licensed by Celgene in 2013 Celgene Option agreement economics – $40 million upfront – Clinical, regulatory and commercial milestones for each product – Celgene pays all fu
Slide 29: Operations and financial
Operations and financial GlobeImmune
Slide 30: Financial Highlights
Financial Highlights GlobeImmune 30 >$60 million partnership revenue to date from Gilead & Celgene $119 million in 5 private rounds from premier VCs $7.5 million convertible note, January 2014 – Converts to common stock at IPO ~$10 million in grants $9.2 million in cash (3/31/14) $15 million IPO pro
Slide 31: Summary Financials and Capitalization
Summary Financials GlobeImmune 31 Capitalization Common stock outstanding as of March 31, 2014 (1) 3,628,245 Common stock offered 1,000,000 Total 4,628,245 Options outstanding (2) 235,342 Warrants (3) 737,232 Total 5,600,819 (1) After giving effect to the conversion of all of our outstanding preferr
Slide 32: Efficient and Scalable Manufacturing
Efficient and Scalable Manufacturing GlobeImmune 32 Established manufacturing – Scaleable efficient process 250L commercial scale projected Low capital cost Portable equipment – Facilitates technology transfer
Slide 33: Intellectual Property
Intellectual Property GlobeImmune 33 302 patents and applications owned or licensed 108 allowed or issued Cover platform, oncology, HCV, HBV, HDV, HIV, Ad-36, influenza, fungal disease, tuberculosis, other infectious diseases, and methods of manufacture
Slide 34: GBIM Value Drivers
GBIM Value Drivers GlobeImmune Last 12 months Upcoming Milestones Infectious Disease Completed GS-4774 phase 1 trial Gilead enrolling randomized 175 patient GS-4774 phase 2 in chronic HBV – $5 million in milestones to date $4 million TB grant from NIH GS-4774 Phase 2 data Potential additional Gilead
Slide 35: Investment Overview
Investment Overview GlobeImmune Targeting major diseases including HBV and multiple cancers Alliances with Gilead and Celgene – >$60 million in partnership revenue to date Proof of concept in multiple diseases Experienced management team Multiple potential near term value drivers