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- 2. Disclaimer • The views presented in this document are for discussion purposes only. Globavir Biosciences (the “Company”) is not advocating any of the courses of action presented in it, which are being presented solely to illustrate a range of available options. This analysis is presented on the understanding that, apart from showing this document to those of your officers, employees or advisers who are engaged in reviewing it on your behalf, its contents will not be reproduced, redistributed or passed on, directly or indirectly, by you to any other person or published, in whole or in part, for any purpose without our written permission. This document does not constitute or form part of any offer for purchase, sale or subscription of, or solicitation or invitation of any offer to buy, sell or to subscribe for, any securities nor may it or any part of it be relied on in connection with any contract or commitment whatsoever. If you do not have professional experience in matters relating to investments you should not act or rely on it, and you should return this document. The distribution of this document in other jurisdictions may be restricted by law, and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. By accepting this document you agree to be bound by the terms of this notice. • This document has been prepared from information which is believed at the date of this document to be reliable. Phrases like "expects", " believes", "anticipates" and similar phrases do not constitute warranties or guarantees of any kind, express or implied. The information in this document is subject to change without notice. We undertake no responsibility or obligation to provide you with any additional information or to update the document or to correct any inaccuracies in it that may become apparent. The information in this document must not be used as the basis for any prescribing decisions and may not represent the approved label in all territories. Our affiliate and subsidiary companies retain the right to request the return of this document at any time. The Company’s affiliate and subsidiary companies expressly disclaim any and all liability for representations or warranties, express or implied, contained in, or for omissions from, this document or any written or oral communication concerning it or its subject matter transmitted or made available to any person. 2
- 3. Table of Contents Slides q Executive Summary 4 q GBV 006 Background 5 q GBV 006 in dengue fever treatment alone is $400MM market 6 q How Calthrin Mediated Endocytosis (CME) Works 7 q GBV 006 data in Ebola 8 q Additional data in other vial infections 9 q Other pathogens that can be treated with CME 10-12 q GBV 006 in treatment of C. diff colitis 13 q Our product strategy 14 q Appendix 15 3
- 4. Ø GBV 006 is a drug that works on various pathogens – affecting host based mechanism (i.e. human cells) Ø Various pathogens deploy Clathrin Mediated Endocytosis (CME) – that helps these pathogens enter into human cells – a mechanism that is utmost necessary for pathogens to cause infections Ø Since GBV 006 works on CME – it is not susceptible to normal defense mechanisms of these viruses – including mutations and resistance Ø Globavir’s plan is to develop the drug for dengue first, which in itself is nearly ~$400MM market. • Then focus on developing this drug for other high commercial value indications like C. diff toxin. • To the best of our knowledge, currently none of the existing developmental drugs for C. diff utilize this mechanism Executive Summary
- 5. Glycoproteins Capsid Envelope Viral Genome 5 GBV006: A Potent, Broad-Spectrum Anti-Infective GBV006: Anti-Viral Program Ø Exclusive worldwide development rights licensed from Stanford University Ø Combination of two FDA approved drugs Ø 100% survival in Ebola and Dengue infected mice when treated with GBV006 Ø Targets host biological process, conferring broad spectrum anti-infective activity
- 6. Dengue Treatment – International Markets and US/ Western Europe Traveler’s Market Ø Currently there is no approved treatment for dengue fever Ø With nearly 390 million patients with dengue and growing international travel and transportation – it is a matter of time before this disease becomes important to the US and other Western Countries Ø Even today, as dengue affects many countries in South East Asia and Latin America – many consider getting a treatment or vaccination while traveling to these countries § However, the best available option, which is a vaccine developed by Sanofi-Aventis, and approved in some countries (not approved in the US) offers protection against serotype 2, a particular type of dengue virus, of only 32% Ø GBV 006 provides an alternative to these travelers with a potential drug if they get infected with dengue while traveling abroad. • Sanofi’s vaccine is estimated to have market potential of ~$1.4BN – and with its efficacy and current market potential, we estimate, GBV 006 to have nearly $400MM peak market potential in treatment of dengue alone Dengue is $400MM Market for GBV006
- 9. 9 GBV001 and GBV002 Exhibits potent In Vitro Antiviral Activity in Chikungunya and other viruses GBV006 Activity in Various Virus Infections Virus Family GBV001 EC50 μM GBV002 EC50 μM CHIKV Togaviridae 4.7 0.7 Virus Family GBV001 EC50 μM GBV002 EC50 μM EBOV Flioviridae 2.2 4.2 RSV Paramyxoviridae <0.12 <0.12 SARS-CoV Coronaviridae 7.8 NE TACV Arenaviridae 3.2 7.2 HIV Retroviridae 0.8 2 WNV Flaviviridae 0.5 NE Junin Arenaviridae 4.8 1.7
- 10. 10 1 - Inoue, Y., Tanaka, N., Tanaka, Y., et al. (2007) J. Virology 2 - Lakadamyali, M. et al. (2004) Microbes Infect. CHC siRNA and block SARS infection 1 Knock-down of CME genes inhibits CHIK infection 3,4 3 - Sourisseau, M., Schilte, C., Casartelli, N., et al. (2007) PLoS Pathogens 4 - Bernard, E., Solignat, M., Gay, B., et al. (2010) PLoS One Influenza virions associated with CCP during internalization 2 GBV006: Broad Spectrum Anti-Infective Additional Pathogens Reliant on Host Vesicle Trafficking -Clathrin Mediated Endocytosis (CME)
- 14. Development Timeline CommercialOpportunity Viral Target DENV CHIK EBOV Near-terms Low High Mid-long term C. difficile Bacterial Target (toxin) 14 Priority Pipeline Indication Phase II in 2018 GBV006: Product Strategy GBV006 Development Priorities
- 15. Appendix
- 16. 16 RSV infection relies on pinocytosis/endocytosis, golgi processing, and secretory pathways. EGFR activity required for infection 2 AP1 and AP2 modulate RSV infection 1 1 - Kolokolstov, A, Deniger, D., Fleming, E. et al. (2007) J. Virology 2 - Krzyzniak, M, Zumstein, M, Gerez, J., et al. (2013) PLoS ONE GBV006: Broad Spectrum Anti-Infective Multiple Targets of GBV006 are Crucial to RSV Infection
- 18. 18 1 - Abrami, L., et al., (2010) PLoS Pathogens CHC and AP-1 in toxin uptake regulate Anthrax toxin uptake 1 2 - Olofsson, A., Skalman, L., Obi, I., et al (2014) mBio Disrupting CME reduces H. pylori vesicle uptake 2 Further Bacterial Infections Relying on CME GBV006: Broad Spectrum Anti-Infective
- 19. 192 - Veiga, E., et. al. (2007) Cell Host Microbe 3 - Bonazzi, M., et. al. (2011) J Cell Bio Adhered bacteria colocalize with endocytotic machinery 2 Knock-down of endocytotic machinery decreases infection and adhesion2,3 1 - Raymond, B. et al. (2013) Cell These bacteria, such as enteropathogenic E. coli, adhere to cell walls by hijacking host endocytotic machinery.1 GBV006: Broad Spectrum Anti-Infective Enterobacteriacae Deliver Toxins Using CME