Globeimmune Inc · OTC:GBIM
Globeimmune — IPO Roadshow (June 2014)
28 slides from Globeimmune's IPO roadshow presentation, Jun 12, 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 12, 2014
Slide 2: Free Writing Prospectus Statement
3 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 prosp
Slide 3: Initial Public Offering Summary
4 Initial Public Offering Summary Over-Allotment 15% or 234,375 shares (100% primary) Offering Size 1,562,500 shares (100% primary) Price Range $15.00 - $17.00 Potential Current Investor Participation Up to $10 million Celgene, HealthCare Ventures, Lilly Ventures, Morgenthaler Ventures, others Excha
Slide 4: GlobeImmune
5 GlobeImmune Differentiated immunotherapeutic platform Proof of concept in infectious disease & oncology Major alliances with Gilead and Celgene Multiple additional proprietary programs – 4 ongoing phase 2 studies with multiple upcoming readouts – Over $60 million in partnership revenue to date – U
Slide 5: Experienced Management and Strong Investors
6 Experienced Management and Strong Investors Exec. Director Clinical Res. Allen Cohn, MD Rocky Mountain Cancer Center US Oncology CEO & President, Board of Dir. Timothy C. Rodell, MD RxKinetix, OXIS International, Cortech, Univ. of Colorado VP Corporate Development Kirk Christoffersen, MBA OSI, Gil
Slide 6: Pipeline
Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights Product Candidate Indication Phase 2 Phase 2b Phase 2 Phase 2 Phase 1 7 GS-4774 GILD WW License GI-19000 GI-2010 GI-18000 GI-6207 CELG Option GI-6301 CELG WW License GI-4000 GI-4000 GlobeImmune Chordoma Resected pancreas Non-small cell lung cance
Slide 7: Tarmogen Immunotherapy: Heat-inactivated Recombinant Yeast
9 Tarmogen ® Immunotherapy: Heat-inactivated Recombinant Yeast • Potent helper and killer T cell responses • Target antigen(s) expressed internally • Safe and well tolerated to date Down-regulates regulatory T cells >500 patients and healthy volunteers >5 years safety data in pancreas cancer
Slide 8: Mechanism of action
Mechanism of action 10 Generating a Targeted Cellular Immune Response
Slide 9: Infectious Disease Pipeline
11 Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights Product Candidate Indication Phase 2 Infectious Disease Pipeline GS-4774 GILD WW License GI-19000 GI-2010 GI-18000 GlobeImmune HIV Delta virus Hepatitis B virus (HBV) Tuberculosis
Slide 10: GS-4774 in Chronic Hepatitis B
GS-4774 12 HBV fusion protein GS-4774 in Chronic Hepatitis B M
Slide 11: Phase 2 in Chronic HBV Infected Subjects
GS-4774 14 OAV GS-4774 (low) + OAV OAV GS-4774 (med) + OAV OAV GS-4774 (high) + OAV Oral antiviral (OAV) Oral antiviral alone Chronic HBV under control with an oral antiviral n=175 25 50 50 50 Phase 2 in Chronic HBV Infected Subjects Randomized open label dose ranging trial Wk 0 Wk 24 Wk 48 Primary
Slide 12: Oncology Pipeline
15 Phase 2b Phase 2 Phase 2 Phase 1 Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights Product Candidate Indication Oncology Pipeline GI-6207 CELG Option GI-6301 CELG WW License GI-4000 GI-4000 GlobeImmune Medullary thyroid cancer Chordoma Resected pancreas Non-small cell lung cancer
Slide 13: GI-6207 Targets Carcinoembryonic Antigen
GI-6207 16 CEA GI-6207 Targets Carcinoembryonic Antigen • 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 sub
Slide 14: GI-6207 Medullary Thyroid Cancer
GI-6207 17 Medullary Thyroid Cancer • 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 approved
Slide 15: GI-6207-02 – Phase 2 in MTC
GI-6207 18 Minimally or asymptomatic MTC n=34 17 17 GI-6207 for 12 months Observation GI-6207 for 12 months GI-6207-02 – Phase 2 in MTC • Randomized, open label, cross-over trial • Primary endpoint - calcitonin kinetics 6 months 18 months Primary Endpoint 12 months
Slide 16: GI-6301 Targets Brachyury Expressing Cancers
GI-6301 19 GI-6301 Targets Brachyury Expressing Cancers • Brachyury – Lung, breast, colon, bladder, kidney, ovary, pancreas, chordoma – Transcription factor involved in normal embryogenesis – Important driver of metastasis Brachyury
Slide 17: GI-6301 Chordoma
GI-6301 20 Chordoma • Ultra-orphan indication • Clinical presentation • Treatment * C2/C3 chordoma – 100% of chordoma cells express brachyury – 250-300 new US cases annually; prevalence 2,400 – 400 new EU cases annually; prevalence 3,600 – Indolent and clinically silent until later stages – Aggressi
Slide 18: GI-6301 Clinical Summary
GI-6301 21 GI-6301 Clinical Summary • NCI sponsored phase 1 34 subject, open label dose escalation trial 4 dose groups Fully enrolled • Ten chordoma patients enrolled in Phase 1 Initial chordoma results presented at ASCO 2014 • Phase 2 trial being designed
Slide 19: GI-6301 Tumor Growth Kinetics – First Chordoma Patients
22 GI-6301 Tumor Growth Kinetics – First 7 Chordoma Patients 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 20: GI-4000 16.6 Month mOS – BDX-001 + GI-4000 vs Placebo
GI-4000 24 16.6 Month mOS – BDX-001 + GI-4000 vs Placebo *42 month mOS (GI-4000/gem) vs 25 month mOS (gem alone) *Retrospective analysis of survival based on proteomic test results
Slide 21: 43% Reduction in Risk of Death vs Case-matched Controls
25 43% Reduction in Risk of Death vs Case-matched Controls Hazard ratio = 0.567 p = 0.240
Slide 22: Key strategic collaborations
Key strategic collaborations
Slide 23: Gilead Alliance
GI-13020 27 Gilead Alliance • Exclusive license to all HBV Tarmogens – Signed in October 2011 • 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 digits to mid tee
Slide 24: Celgene Collaboration & Option Agreement
28 Celgene Collaboration & Option Agreement • Exclusive option to oncology products • Option agreement economics • Option structure • GI-6301 license Program-by-program basis GI-6301 licensed by Celgene in 2013 $40 million upfront Clinical, regulatory and commercial milestones for each product Celge
Slide 25: Operations and financial
Operations and financial
Slide 26: Summary Financials and Capitalization
31 Summary P&L Capitalization Summary Financials 2011 2012 2013 1Q2013 1Q2014 Revenue 5,108 14,642 22,518 2,132 1,418 Net income (loss) (13,725) (2,015) 9,476 (1,552) (2,445) Year Ended December 31, Three months ended Common stock outstanding as of March 31, 2014 (1) 3,573,900 Common stock offered 1
Slide 27: Efficient and Scalable Manufacturing
32 Efficient and Scalable Manufacturing • Established manufacturing – Scaleable efficient process • 250L commercial scale projected • Low capital cost • Portable equipment – Facilitates technology transfer
Slide 28: GBIM Value Drivers
34 • GS-4774 Phase 2 data • Potential additional Gilead M/S payments • One or more infectious disease INDs • Full GI-6301 phase 1 data • GI-6301 chordoma phase 2 study • Continued phase 2 development of GI-4000 in pancreas & NSCLC – Subject to collaboration or additional financing other than IPO • C