Non-Confidential www.sementis.com.au September 2019 Version: 190822XH Sementis: Revolutionizing the Global Vaccine Industry
Disclaimer August 2018 This presentation is issued by Sementis Limited ACN 138 550 811 (“Sementis”) in order to provide a summary about Sementis and its current and proposed research and development activities. The information contained in this presentation is general in nature and does not purport to be complete. This presentation has been prepared by Sementis in good faith and with due care but none of Sementis or any of its officers, employees, related bodies corporate, affiliates, agents or advisers guarantees or makes any representations or warranties, express or implied, as to, or takes responsibility for, the accuracy or reliability of the information contained in it. All information contained within this presentation including, but not limited to, references to projections, platforms, outcomes, current and future product pipelines are best estimates only and may be subject to change without notice. There is no guarantee that Sementis’ technology or any of its vaccines will prove effective. Therefore, nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee, whether as to the past, present or the future. To the maximum extent permitted by law, Sementis and its related bodies corporate and each of their respective directors, employees, officers, affiliates, agents and advisers expressly disclaim any and all liability (including without limitation for negligence) for representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions or matters, express or implied, contained in, arising out of or derived from, or for omissions from, this presentation. In particular, this presentation does not constitute, and shall not be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of Sementis or its technology and vaccines. 2
Executive Summary Sementis has revolutionary vaccine “platform” technology that has the potential to create totally safe 1 and highly effective 2 vaccines to any number of diseases and conditions. Sementis also has revolutionary manufacturing technology that allows for the rapid production of huge volumes of vaccines 3 . Sementis is initially focusing on vaccines for allergies, universal influenza and mosquito borne diseases, namely: • A cure for peanut allergy addressing a market estimated to be worth well over $U.S.10 billion • A world first combined vaccine for Zika and Chikungunya • A universal influenza vaccine would address a market potentially bigger than a peanut vaccine Sementis has entered into a technology evaluation collaboration with a major pharma. Sementis’ revolutionary vaccine and manufacturing technology together make the world’s best 4 and maybe only effective solution to pandemic and bio-terror threats. Successful proof of concept work has been completed and published in peer reviewed journals that reports on the effectiveness and safety 1 of the platform technology and for a number of the vaccines. The next step is to complete the manufacturing processes in conjunction with the Australian CSIRO in order to proceed to human trials within the first half of 2020 5 . After an extensive review process, the American National Institute of Allergies and Infectious Diseases (NIAID) has funded a successful monkey study for the chick/zika vaccine. It has also funded the manufacture of a Master Cell Bank. Peered reviewed publications that describes our SCV platform technology and the proof-of-concept studies carried out with our single vectored chikungunya+Zika virus candidate vaccine: • Eldi P et al (2017) Production of a Chikungunya Vaccine Using a CHO Cell and Attenuated Viral-Based Platform Technology. Mol. Ther.; 25 (10): 2332-2344 (http://www.cell.com/molecular-therapy-family/molecular-therapy/abstract/S1525-0016(17)30280-0) • Prow NA et al (2018) A vaccinia-based single vector construct multi-pathogen vaccine protects against both Zika and chikungunya viruses. Nat Comms. DOI: 10.1038/s41467-018-03662-6 (https://www.nature.com/articles/s41467-018-03662-6) • Prow NA, Jimenez Martinez R, Hayball JD, Howley PM, Suhrbier A.(2018) Poxvirus-based vector systems and the potential for multi-valent and multi-pathogen vaccines. Expert Rev Vaccines. Oct 9:1-10. doi: 10.1080/14760584.2018.1522255 (https://www.tandfonline.com/doi/full/10.1080/14760584.2018.1522255?needAccess=true) For 1, 2, 3, 4 & 5: see footnotes on page 56 3
Contents The Evolution of the Vaccine Market 01 Enter Sementis: The Revolutionary Platform 02 Sementis manufacturing 03 Vaccines in development 04 Sementis Allergies 05 Sementis Infectious Diseases 06 Sementis Tactical Response 07 Looking ahead 08 Sementis people 09 Glossary/appendices 10 Footnotes 11 4
The Evolution of the Vaccine Market 5
Past, Present and Future Scourges Past Scourges Present Scourges Present Scourges Future Scourges under control in the • Smallpox epidemic with a • HIV been with us since to • The ever looming fear of kill rate of 1 in 3, Polio, 1980 and yet still no developed world but Pandemic flu, Zika, Nipah, Pandemic Flu effective vaccine available Ebola, Lassa, SARS, MERS, not eradicated • Seasonal flu that is difficult ?????? to control with current • Vaccines for measles, vaccines mumps, rubella, polio, • No effective vaccines for Hepatitis A and B, etc. food allergies, hepatitis C, • Many of these diseases are and new emerging not under control in the diseases such as Zika, underdeveloped world chikungunya, and MERS • Many vaccines have limited effectiveness 6
The Vaccine Market Today Historically, the vaccine market was a small part of the Pharmaceutical Industry, however in the past decade, its growth has outstripped the rest of the industry. The global vaccine market is expected to reach $US48 billion by 2021 (from $US 32 billion in 2016) – a CAGR of 8.3 % (a) . Other studies expect double-digit growth (b) . (a) Vaccines by Technology, Disease Indicator, End User and Type – Forecasts to 2021. Markets and Markets, August 2016 (b) Global Human Vaccine Market 2016-2020. Research and Markets, January 2016 7
Growth Drivers in the Vaccine Market Growth in the global vaccine market has been driven by: 01 02 03 04 The high prevalence of Rising government funding for Advances in technology, which Advances in manufacturing infectious diseases vaccine development and are dramatically expanding the technology, which will change increased focus on possibilities of vaccine the economics of vaccinations. immunization programs treatments (e.g. cancer) 8
A Potted History of Vaccines In the late 1700s, it was observed It was eventually discovered they that milkmaids were immune had the cowpox virus, which gave from smallpox. them immunity to smallpox. The smallpox vaccine was the The smallpox vaccine (the The vaccine industry was born, first and is the only vaccine that vaccinia virus) is a derivative of with the Latin word ‘vaccine’ has been used to eradicate a the cowpox virus and has been meaning “from Cows”. human disease! successfully used for over two hundred years. 9
Evolution of Sementis’ Vectored Vaccine Technology In the 1980s, gene for rabies surface antigen was inserted into the vaccinia virus (Copenhagen Version), then injected into fox bait and fed to animals in Northern Europe. The question, therefore, remained: The theory was that this new vaccine would not only give "If this version of the vaccinia the animals immunity to smallpox but, importantly, also to virus could be made non- rabies. It worked , and its effectiveness as a rabies vaccine replicating, i.e. totally safe , why has been proven in multiple studies over the past twenty not use it as a platform for all years. sorts of diseases in humans?” However, because the vaccine replicates (multiplies) it can cause harm in a small proportion of recipients. This was acceptable during the smallpox era, as this disease had a kill rate of 1-in-3. However, now that smallpox has been eradicated it is no longer acceptable. 10
Enter Sementis: The Platform Revolutionizing the Global Vaccine Industry 11
Sementis Sementis’ revolutionary SCV vaccine platform A working vaccine for Peanut Allergy, Universal technology and groundbreaking manufacturing Influenza and the world's first dual vaccine for technology are both poised to revolutionize the the Zika and Chikungunya mosquito borne vaccine industry and make a significant medical diseases are just three of the multiple vaccine contribution to the world. applications made possible by Sementis’ SCV platform technology 12
The Revolutionary SCV Platform The Sementis vaccine platform is called Sementis Copenhagen Vector (SCV). The SCV platform is essentially the old smallpox vaccine (the original vaccinia virus ), which was effectively used to eradiate rabies in Northern Europe and smallpox worldwide. However, Sementis has genetically manipulated the vaccine that is expected to make it: Totally safe 1 Powerfully immunogenic It does not replicate (multiply) to make it It is more visible to the immune system, thereby harmful 1 . making it more active, resulting in a highly potent immune response 6 . 13 For 1 & 6: see footnotes on page 56
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