The World Economic Forum (WEF) and the Harvard School of Public Health report entitled “The Global Economic Burden of Non-communicable Diseases” estimates global diseases
kill 36 million people every year and will cost upwards of US$47 trillion by 2030.
The World Health Organization's four biggest killers; cancer, heart disease, diabetes and
chronic respiratory disease are dominant in non-communicable disease (NCD) mortality
and morbidity. All four are increasing in prevalence and the cost of treatment is spiraling
out of control.
Exactly what is Diabetes?
Diabetes is a condition in which blood sugar levels are too high.
Much of the food you eat is broken down into a simple sugar called glucose. In response
to a rise in glucose levels after a meal the islets beta-cells in the pancreas read blood glucose
levels and secrete insulin into the blood. Insulin acts to open the gates of cells allowing the
glucose to move from the blood stream into the cells where it can be utilized for energy.
A Type 1 diabetes diagnosis means the pancreatic beta cells that read glucose levels and secrete
insulin have been damaged or destroyed. Thus glucose cannot move from the bloodstream into the cells.
A Type 2 (insulin resistance) diabetes diagnosis is a far more common verdict for people than
Type 1. Insulin resistance happens because of chronically elevated blood sugar and insulin levels.
These elevated levels of sugar and insulin have the effect of "numbing" the cellular processes which
move the sugar from the blood stream to the cells - the body cannot respond to the insulin "requests" to move blood sugar into the cells. Roughly 27% of the people who start out as Type 2
diabetics, will, in the future require insulin injections similar to Type 1 diabetics.
Between Type-1 and Type-2 patients with diabetes the total number of diabetics requiring insulin
in just North America, is about nine million.
Sernova Corp. TSX:V-SVA is a Canadian-based medical device development company focused on
chronic metabolic, neurological, and haematological diseases. Due to the enormous market and
potential for significantly improved patient treatment, Sernova’s first product focus is on diabetes.
Sernova’s Cell Pouch System™ is a versatile, scalable credit card-sized device, made of FDA approved
materials that provides a natural "organ-like" environment for therapeutic cells such as insulin
producing islets for diabetics. Think of the Cell Pouch System™ as a potential natural insulin producing
pump with the added benefit of fine-tuned glucose control. Placed under the skin in a simple inexpensive
procedure it develops endocrine pancreas like characteristics when islets are placed into the device taking
over normal glucose control. A key feature of the device is its ability to stimulate natural microvessel
development, thought to be essential for long-term survival and function of therapeutic cells.
The TSX Venture Exchange has accepted for filing documentation with respect to a non-brokered private placement announced June 21, 2016, June 27, 2016, and June 29, 2016.
Shares: 16.8 million
Price: 25 cents
Warrants: 16.8 million share purchase warrants to purchase 16.8 million shares
Exercise price: 35 cents for a two-year period; the warrants have an acceleration provision such that if at any time after the expiry of the four-month hold period, the 20-day volume-weighted average trading price of the common shares exceeds 50 cents per share, the company may give notice to accelerate the expiry date of the warrants to a date which is not less than 30 calendar days after such notice
Insiders: Jeffrey A. Bacha 40,000; Ralph Deiterding 20,000; Frank A. Holler 50,000; James Parsons 40,000; Philip Toleikis 57,000
Pro groups: 860,000 (nine placees)
Echelon Wealth Partners -- $19,075 and 76,300 warrants;
Gravitas Securities Inc. -- $2,800 and 11,200 warrants;
Raymond James Ltd. -- $3,500 and 14,000 warrants;
Aventine Management Group Inc. -- $4,200 and 16,800 warrants;
Richardson GMP -- $5,775 and 23,100 warrants;
Mackie Research Capital Corp. -- $14,175 and 56,700 warrants;
CRG Finance AG -- $52,937.50 and 211,750 warrants;
CMF AG -- $28,000 and 11,200 warrants;
each warrant is exercisable for one share at a price of 35 cents per share for a two-year period, subject to acceleration
Sernova and JDRF Announce Funding of Joint Research Collaboration to Advance Human Clinical Trials for the Treatment of Hypoglycemic Unawareness Patients with Severe Type 1 Diabetes
$2.45 million USD awarded to advance Sernova’s Cell Pouch System(TM) (CPS) technologies in a US FDA Clinical Trial with Initiation Scheduled for the Second Half of 2016
Source: Sernova Corp
July 12, 2016, 6:00 a.m. EDT LONDON, ONTARIO – (Marketwire – July 12, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, is pleased to announce today it has entered into a research funding agreement with JDRF, the leading global organization funding and advocating for type 1 diabetes (T1D) research. The purpose of the funding is to advance human clinical trials of Sernova’s CPS technologies for treatment of hypoglycemia unawareness patients with severe type 1 diabetes. T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose.
JDRF will provide Sernova up to $2.45 million USD to support a clinical trial at a major transplantation center in the United States. The goal of the study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s proprietary, highly vascularized, cell macroencapsulated implantable and scalable device to reduce or eliminate the need for injections of exogenous insulin.
“JDRF has previously provided funding to advance the development of Sernova’s technologies through a preclinical collaboration with Massachusetts General Hospital, and we are proud to continue our support as Sernova’s technologies progress into new safety and efficacy clinical trials,” said Derek Rapp, JDRF President and CEO. “JDRF is excited about this collaboration, which advances research in encapsulated cell therapies, and will continue to drive progress toward our mission to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications.”
“Sernova and JDRF are tightly aligned in our vision to see cell-based therapies developed to reduce disease burden and significantly increase the quality of life for people living with T1D,” remarked Dr. Philip Toleikis, Sernova’s President and CEO. “We see our work with JDRF on this important clinical trial as an exciting opportunity to more rapidly advance Sernova’s therapies to treat people with diabetes and address many of the shortcomings and challenges of current insulin therapy.”
“Sernova’s progression to human clinical trials is an incredible accomplishment in the global diabetes research agenda,” said Dave Prowten, President and CEO of JDRF Canada. “I am particularly proud of this trial being a part of the JDRF portfolio because it supports advancements of the best and brightest research minds in Canada at Sernova. Also, this is a shining example of the international collaboration fostered by projects funded by JDRF. Working together with our global partners, we can accelerate this type of transformative research and ensure it becomes available for the T1D community.” To date, there is no cure for T1D, and people living with the disease are dependent on insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such
as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
Sernova Corp is a clinical stage regenerative medicine Company developing highly disruptive medical technologies to improve the treatment and quality of life of people with chronic debilitating metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device which forms highly vascularized chambers, ideal for therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required to treat disease. For more information, please visit Sernova.com or follow us on Twitter: @SernovaCorp
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which
include our belief that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.