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.
Sernova Corp. has released its financial results for the three months ending Jan. 31, 2016, and is providing an overview of recent company highlights.
"Sernova has achieved significant milestones in the first fiscal quarter of 2016 both from the capital markets perspective and in expanding our highly disruptive regenerative medicine technology development programs for diabetes and hemophilia," said Dr. Philip Toleikis, president and chief executive officer.
Selected corporate highlights through February, 2016:
- Sernova was selected as a member of the 2016 TSX Venture 50 and ranked fourth in the life sciences and clean technologies category based on a number of key measures of market performance, including market capitalization growth, share price appreciation and trading volume. The Toronto Stock Exchange ranked companies from among the 1,791 companies listed on the TSX Venture Exchange as of Dec. 31, 2015.
- The European Commission's Horizon 2020 program awarded a 5.6-million-euro (approximately $8.5-million) non-dilutive grant to the HemAcure consortium, which consists of Sernova, and five European academic and private partners. The purpose is to advance the development of a GMP clinical-grade factor VIII releasing therapeutic cell product in combination with Sernova's Cell Pouch for the treatment of severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood stream. The therapeutic goal of the product is to use the patient's own cells corrected for the factor VIII gene.
- The company received an initial financing payment related to the HemAcure grant in the amount of 566,607 euros (approximately $873,000).
- The company's clinical islet diabetes program was advanced by entering into a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to establish, optimize and validate Sernova's licensed technology for creating stem-cell-derived therapeutic cells that produce insulin and are glucose responsive. This partnership accesses CCRM's expertise in developing production processes for cellular therapies and is an important step in the company's plan to commercialize an unlimited supply of glucose-responsive, insulin-producing cells for the Cell Pouch system in order to address the broader population of patients with insulin-dependent diabetes.
Highlights of financial results for the three months ended Jan. 31, 2016
The company ended the first quarter with approximately $3.6-million of cash and marketable securities at Jan. 31, 2016, up from $2.9-million at Oct. 31, 2015. For the three months ended Jan. 31, 2016, and 2015, the company reported a net loss for the period of approximately $700,000 and $600,000, respectively, or a net loss per share of nil for each period.
The company's financial information has been prepared in accordance with international financial reporting standards, and this selected information should be read in conjunction with Sernova's financial statements and management's discussion and analysis for the three months ended Jan. 31, 2016, as filed on SEDAR and also available from the company's website.
|SELECTED STATEMENT OF LOSS AND COMPREHENSIVE LOSS DATA
ended Jan. 31,
|Research and development
|General and administrative
|Loss and comprehensive loss for the period
|Basic and diluted loss per share
Total research and development expenses for the three months ended Jan. 31, 2016, decreased by $107,998 compared with the equivalent period of the prior fiscal year, primarily due to an increase in contributions and tax credits during the three months ended Jan. 31, 2016. Excluding the impact of depreciation of property and equipment, amortization of intangible assets, and share-based compensation (all non-cash items), research and development expenses increased by $89,321 during the three months ended Jan. 31, 2016, compared with the equivalent period in the prior fiscal year.
Total general and administrative expenses for the three months ended Jan. 31, 2016, increased by $138,340, as compared with the same period in the prior year.
On March 14, 2016, and in accordance with the company's 2015 incentive plan, Sernova granted 450,000 deferred share units to its directors and 3.08 million incentive stock options to certain officers, employees and consultants of the company, each such option being excisable into a common share at a price of 22.5 cents per share on or before March 14, 2026.