Executive Summary April 2015 “Dr.Yung-Chi Cheng’s work in pharmacology has had a profoundly positive effect on human health. He is one of Yale’s more prolific inventors, with groundbreaking therapies to treat diseases that afflict millions. Drugs he has invented are routinely used to treat cancer, HIV/AIDS and hepatitis B.” -Yale University, Office of Cooperative Research1 Yiviva is a biotechnology company, co-founded by Yale University, Yung-Chi Cheng, PhD, Peikwen Cheng, MBA, and Shwu-Huey Liu, PhD, to develop evidence-based botanical products to address aging-associated diseases. “Yi” means “medicine” in Chinese and “Viva” means “long live” in Spanish. Yiviva is bringing together the knowledge and best practices of east and west to modernize medicine and improve quality of life. Yiviva is focused on big unmet needs – starting with non-alcoholic fatty liver disease (NAFLD), a pandemic that today affects up to 1 in 3 people2 and is projected to grow 50% in the US by 20303. NAFLD is the most common chronic liver disease in the US4, Europe and Asia.5 And while it is reversible, it is now the gateway to serious chronic diseases. NAFLD increases one’s risk of getting heart disease by 5 times.6 And in the liver, it can advance to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and liver cancer. By 2020, it is projected to be the leading cause of liver transplants.7 Currently there are no approved medicines. Yiviva believes there is a huge opportunity to help millions by reversing and preventing NAFLD. Yiviva’s team has identified an herbal formulation (YIV001) historically used in Asia to protect the liver that in preclinical studies at Yale appears to significantly reduce fat and inflammation in the liver. Yiviva is now conducting in vitro and in vivo studies on YIV001’s performance and formulation, building an IP portfolio around YIV001 and its processes. Yiviva’s mission is to help people sooner and get to market quickly. Yiviva will focus on developing nutraceuticals in-house, and out-licensing drug candidates to Big Pharma. Yiviva’s plan is to launch a branded line of capsules in a year, followed by chewables and then functional drinks - selling direct-to-consumer through its ecommerce platform so that it can efficiently engage and educate the public and maximize margins. With over 68%8 of Americans using dietary supplements and 18%9 using natural supplements, it is a big and growing market – projected to reach $28.8B in the US and $20.7B in China by 2019.10 And while there are no approved treatments on the market for NAFLD or NASH, there is already a strong demand for a treatment - with $615 million in off-label sales in 201011 and a potential $5B annual market for an approved treatment12. Yiviva wants to capitalize on these growing markets. The supplements industry is reeling from a lack of science and inconsistent quality. Yiviva is well 1 2 3 4 http://ocr.yale.edu/featured-innovator/tommy-cheng ttp://www.worldgastroenterology.org/assets/export/userfiles/2012_NASH%20and%20NAFLD_Final_long.pdf http://www.diabetesincontrol.com/contact-us/10774-half-of-us-adults-could-have-non-alcoholic-fatty-liver-disease-by-2030 http://www.webmd.com/hepatitis/fatty-liver-disease http://www.ncbi.nlm.nih.gov/pubmed/23855290 http://www.galmedpharma.com/background/nafldnash/ 7 http://well.blogs.nytimes.com/2014/06/13/threat-grows-from-liver-illness-tied-to-obesity/?_r=0 8 http://www.crnusa.org/CRNPR12-ConsumerSurvey100412.html 9 https://nccih.nih.gov/research/statistics/NHIS/2012/natural-products 10 Euromonitor. Vitamins and Dietary Supplements – Global Market Size. 2015 11 Intercept S-1 Filing, p 31 12 http://seekingalpha.com/article/1968461-liver-drug-race-intercept-pharma-vs-rivals?page=2 5 6 Proprietary and Confidential positioned to set the bar for nutraceutials through its rigorous preclinical and early phase clinical studies – building evidence and consumer trust. The pharma industry is years away from approving a product. Yiviva can efficiently launch a strong pipeline of nutraceuticals to improve liver health in a year. Yiviva brings together the pioneering team from PhytoCeutica whose advances in modernizing botanical medicines have been published in Science1314 and the Wall Street Journal15. This team successfully licensed their cancer adjuvant drug PHY0906 to Kadmon Pharmaceuticals - and it is now in Phase II trials. The scientific team is lead by Dr. Yung-Chi Cheng - the Henry Bronson Professor of Pharmacology at Yale and Chairman of the Consortium for the Globalization of Chinese Medicine. Dr Cheng has discovered four approved drugs (Ganciclovir, Lamivudine, Emtricitabine, Clevudine) and is the scientific founder of successful ventures including Achillion (Nasdaq: ACHN) and PhytoCeutica. Teaming together with Dr Cheng for over 20 years, Dr. Shwu-Huey Liu is an award-winning researcher from Yale recognized by the American Association for Cancer Research with its Young Investigator Award. She is the co-inventor of PHY906 – leading the drug from preclinical to early stage clinical trials. Peikwen Cheng brings his expertise in building businesses and successfully negotiated PHY906’s license to Kadmon. He is a global entrepreneur and award-winning product designer, who helped launch MySpace in Asia and co-founded venture-backed WideRay/Qwikker and Surge Art. He is a graduate of Stanford, Tsinghua and INSEAD. Yiviva’s team is a leader in the field of botanical medicines. Over the past 15 years, Yiviva has built the STAR (Signal Transduction, Action and Response) Discovery Platform – screening over 250 herbal formulations across 25 signal transduction pathways - and gained deep insights into how different botanicals affect biological responses, including inflammation, immunomodulation and steroid hormones. Yiviva is using bioinformatics to mine this database to develop novel solutions. To ensure high quality products, Yiviva has developed Phytomics – a patented quality control platform that integrates unique biological and chemical fingerprints for complex botanical mixtures. Additionally, Yiviva has forged a strategic partnership with the leading Traditional Chinese Medicine manufacturer in Taiwan, to ensure high quality raw materials, GMP manufacturing and tight quality control using Phytomics. Through its proprietary systems, Yiviva is able to achieve +90% batch-to-batch consistency over a 10year period. Yiviva’s know-how, network and technology, gives it a clear competitive advantages in bringing ancient medicines into the future. Yiviva is poised to commercialize its powerful proprietary discovery platform into high-quality nutraceuticals to address unmet medical needs – starting with the fast growing pandemic fatty liver disease. Yiviva is seeking strategic partners and investors who share its vision and can help accelerate growth through their expertise, network and financial support. Together we can make an impact. Modern Science plus Ancient Wisdom can lead us to Health and Happiness. For more information, please contact: Peikwen Cheng, Co-founder [email protected] / +1 917.870.5000 13 14 15 http://stm.sciencemag.org/content/2/45/45ra59.abstract http://www.sciencemag.org/content/347/6219/337.3.summary http://www.wsj.com/articles/SB10001424052702304177104577313821796467932 Proprietary and Confidential