EPURINES, Inc

Raising $500k seed fund for a Innovative Drug Development startup in Utah

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 The Company: ePurines, Inc is a drug development company focused on innovative purinergic-based therapies for obesity, metabolic syndrome renal and liver diseases. ePurines has been founded by internationally recognized experts in purinergic signaling. The core technologies of the ePurines were developed in the VA labs and are patented by the US Department of Veterans Affairs. ePurines is physically located in the University of Utah Research Park in Salt Lake City, Utah, which is an ideal and strategic place for the growth and development of startups (http://vp.admin.utah.edu/research/history/).  Visit https://www.epurines.com/

Vision, Strategy and Values:  ePurines created a unique technological platform in developing novel drugs that target purinergic signaling. The central strategy is to combine the state-of-the-art technology, innovation and skills of its scientists leading to patented drug for the treatment of obesity, metabolic syndrome, renal and liver diseases. The first value proposition of ePurines is: “To Promote the Health of Those Who Served Our Country”.

Intellectual Property:  The founding members of the ePurines have developed substantial intellectual property encompassing diseases of the kidney and gastrointestinal system, obesity, organ rejection following transplantation, ischemic-reperfusion injury. Many of these technologies were patented and managed by the US Department of Veterans Affairs, as they were developed in the VA laboratories. In May 2020, the US Department of Veterans Affairs has offered ePurines an Exclusive License Option for two intellectual properties to develop P2Y2 receptor antagonists for the treatment of lithium-induced nephrogenic diabetes insipidus (US Patent # 9,901,624) and for the prevention and/or treatment of diet-induced obesity (US Patents # 10,024,846; and 10,107,795). ePurines exercised the Exclusive Licensing Option offered to it.

Business Goals: The first business goal of the ePurines is be to develop P2Y2 receptor antagonists for the treatment of lithium-induced nephrogenic diabetes insipidus (NDI) and diet-induced obesity.  NDI is a common kidney condition seen in the bipolar Veterans treated with lithium salts. It is a debilitating condition for which there is no safe therapy.  About 39% of the world population is obese or overweight. Diet-induced obesity or consumption of excessive calories is the most common cause of obesity in the world.

Technology Platform:  ePurines’ technology platform operates by designing, developing and evaluating small molecules that selectively antagonize the P2Y2 receptor. Multiple approaches, such as rational drug designing and testing, screening of libraries, and the use of AI and deep-learning assisted drug selection will be used. The required in vitro and in vivo models for evaluation of molecules are already available in the laboratories of the ePurine scientists. It is anticipated that within three to four years one or two potential molecules will be identified and INDs will be filed with the FDA.

Market Size: The prevalence of bipolar disorder among general population is 2%, whereas its prevalence among Veterans is 4%. Bipolar disorder affects 5.7 million adults in the United States and it is the sixth leading cause of disability in the world.  Lithium is the only effective drug available to counter the suicidal ideation in patients with bipolar disorder. However, chronic administration of lithium causes nephrogenic diabetes insipidus, a debilitating kidney condition, for which there is no safe therapy. According to the World Health Organization 39% or both men and women aged 18 years of above are overweight or obese. In the United States, about 40% of adults are obese, and another 32% overweight. The prevalence of obesity and overweight among Veterans is even higher. Overweight and obesity are the prime contributors for the development of type-2 diabetes mellitus (T2DM) and hypertension in addition to several other diseases, including cancers. In June 2013, the American Medical Association has officially designated obesity as a “disease”, thus paving the way for treatment strategies, coding and billing for prescription drugs to treat obesity and for reimbursement by insurance companies. These in turn stimulate R&D for new anti-obesity drugs. 

Market Capture: Currently, there are no safe drugs to prevent or treat diet-induced obesity and the use of available drugs is limited to extremely obese people. In fact, some of the anti-obesity drugs have been withdrawn by the FDA due to serious adverse effects. Thus, there is a large unmet need for safe and efficacious anti-obesity drugs that are suitable in all types of subjects.  Purinergic signaling mediated by extracellular nucleotides, nucleosides and nucleobases is an emerging field with a vast potential for the development of novel therapies for a variety of disease conditions. Currently there are only a handful of purinergic drugs in the market or in pipeline, such as the blood thinners, and so the market is widely open, especially for anti-obesity drugs and anti-NDI drugs. There are no estimates or projections available for the future market capitalization by purinergic-based drugs, but considering the fact that Plavix® and Brilinta®, both target purinergic receptors, became blockbuster drugs, one can expect substantial market cap for future purinergic-based drugs as well. Development of a potent and safe antagonist of P2Y2 receptor will find immediate use in the Veterans Affairs Healthcare System for the treatment of lithium-induced nephrogenic diabetes insipidus. The Global Anti-Obesity Drugs Market Forecast 2020-2030 estimated that the market reached $1.9 billion in 2019 and is expected to grow at a CAGR of 32% in the first half of the forecast period. In 2019, the innovator drugs submarket held 75% of the global anti-obesity drugs market. The on-going COVID-19 pandemic is expected to increase the demand for drugs to promote weight loss, given that obesity is a significant risk factor for case-fatality rates in COVID-19 (Dietz and Santos-Burgoa, 2020). The US Centers Disease Control and Prevention notes that severe obesity (BMI ≥ 40) is associated with higher risk levels for complications due to COVID-19. Obesity could also drive severe complications of COVID-19 disease at younger ages (Kass et al, 2020; Busetto et al, 2020). Similar negative impacts of obesity have been observed in patient outcomes during the H1N1 pandemic of 2009 (Honce and SchultzCherry, 2019). Obesity will likely have major impacts on both non-communicable and communicable diseases and may affect global evolutionary trends of influenza other viral diseases. Hence, it is expected that the anti-obesity market will increase substantially over the next several years.

Competition:  Currently very few purinergic-based drugs are developed and/or marketed by the major pharmaceutical companies, which also develop and market drugs that interact with a variety of non-purinergic targets. The market is not saturated and so, the entry into market is not difficult.  By having a startup biotech company that exclusively focuses on purine-based drugs for a variety of diseases and conditions itself is a competitive advantage. Because the core technology is consolidated and developed further with accumulation of tacit knowledge. In due course these will constitute the core competitive advantages for ePurines. Thus, the potential competition can be overcome by increasing the value of ePurines. The key players in the market are Rhythm Pharmaceuticals, Pfizer, Arena Pharmaceuticals, Vivus, Alizyme, Norgine, Shionogi, GlaxoSmithKline, Orexigen Therapeutics, Merck, Eisai, F. Hoffmann-La Roche, Novo Nordisk, Boehringer Ingelheim, AstraZeneca, Zafgan.

Management: The Founding Members, Board of Directors and Scientific Advisors of ePurines are experienced individuals with expertise in clinical medicine and/or biomedical research and business administration. They have been collaborating for years and decades, and thus form a very cohesive, complementary and synergistic team with drive to lead the ePurines. They are competent to lead the company, define its strategy, and maintain a competitive advantage. They are assisted by a a Strategic Advisor specialized in startups, a Developmental and Regulatory Advisor with more than 10 years of industry experience and a Legal Counsel specialized in corporate and intellectual property laws.

Investment Requirements & Options: The total investment required to successfully file one or two IND applications in 3 to 4 years is about $4 million. It is expected that ePurines will raise some of this amount through federal grants. Upon successful IND approval by the FDA, the options are to either exit by selling the ePurines for a substantial profit and thus generously compensate the investors or to go public and raise funds through IPO. The founding members prefer the latter option in view of the long-term opportunities in developing purinergic-based drugs and growth. The immediate requirement of ePurines is seed funding to the tune of $500k. 

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