RE:Sedar MD & A released today - excerpt AND SOME MORE:
Corporate Update for the years ended October 31, 2017 and 2016 and to the date of this MD&A
In October 2016, the Company entered into a collaboration with an international pharmaceutical company to study Sernova’s Cell PouchTM in a large animal diabetes model. The collaboration involves the study of safety, survival and efficacy of locally immune protected therapeutic cells in our Cell PouchTM in proof of concept studies with the goal to establish a future development and commercial partnership. The preclinical safety and efficacy studies are ongoing. This agreement included 50% cost sharing for the agreed studies. A payment in the amount of US$185,778 ($249,611) was received in December 2016.
In November 2016, we retained the services of CTI Clinical Trial and Consulting Services (“CTI”), on regulatory matters with respect to Sernova’s Cell Pouch System. CTI is supporting Sernova’s clinical trial regulatory processes including submission of Sernova’s regulatory package with the FDA to support a Phase I/II safety and efficacy human clinical trial using Sernova’s Cell Pouch technologies. The study will be conducted in the United States for treatment of hypoglycemia unawareness patients with severe type 1 diabetes. The goal of the Phase I/II safety and efficacy study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s cell macroencapsulated implantable, scalable device to reduce or eliminate the need for injections of exogenous insulin.
In May 2017, we announced we received TSX Venture Exchange acceptance, to extend the expiry date of 5,745,633 share purchase warrants that are exercisable to purchase up to 5,745,633 common shares of Sernova at an exercise price of $0.30 per share, from May 8, 2017 to November 8, 2017. The Company also obtained approval from the TSV Venture Exchange to extend the expiry date of 3,043,256 share purchase warrants that are exercisable to purchase up to 3,043,256 common shares of Sernova at an exercise price of $0.30 per share, from May 14, 2017 to November 14, 2017. All other terms of the Warrants remain unchanged, including the exercise period, as extended, being subject to abridgement on 30 days’ notice to holders in the event that the twenty-day volume weighted price of the Company’s shares exceeds $0.50.
In July 2017, Sernova announced significant scientific progress achieved in the development of a personalized regenerative medicine therapy for the treatment of Hemophilia A patients by the HemAcure Consortium and confirmation of approval of the second phase of funding of the Consortium by the European Commission. The therapy being developed by the international scientific Consortium, which includes Sernova Corp as a partner, is to treat severe Hemophilia A, a serious genetic bleeding disorder caused by missing or defective clotting factor VIII in the blood stream. This therapy consists of Sernova’s implanted Cell PouchTM device transplanted with therapeutic cells, corrected to produce Factor VIII at a level sufficient to significantly reduce the side effects of the disease and improve patient quality of life.
In summary, the following developments have been achieved by the Consortium:
A reliable procedure has been implemented to isolate and maintain required endothelial cells from a sample of the patient’s blood.
Using a novel gene correction process, the cells have been corrected and tuned to reliably produce the required Factor VIII to treat Hemophilia A.
The cells have been successfully scaled up to achieve the required therapeutic number, and cryopreserved for shipping and future transplant into the implanted Cell PouchTM.
A preliminary study confirmed survival of the Factor VIII corrected human cells injected into the hemophilia model, achieving sustained therapeutic Factor VIII levels. This preliminary work is being used to aid in dosing of these cells in the Cell PouchTM.
Safe Cell PouchTM surgical implant and cell transplant procedures have been developed in the hemophilia A model in preparation for use in hemophilia patients.
Development of Cell PouchTM vascularized tissue chambers suitable for Factor VIII producing cell transplant has been demonstrated in the hemophilia A model, expected to mimic the predicted findings in human patients.
Demonstration of survival of the Factor VIII corrected human cells transplanted into the Cell Pouch in a mouse hemophilia model as part of the study of Cell PouchTM cell engraftment.
In combination, this work is in preparation for safety and efficacy studies of the human hemophilia corrected Factor VIII producing cells in the Cell PouchTM in a preclinical model of hemophilia.
In August 2017, we announced we engaged FronTier Merchant Capital Group to provide North American investor relations (IR) and strategic marketing services to the financial community and media across North America with the goal to build our shareholder value. FronTier is assisting the company by increasing market awareness through financial market communications, including facilitating in-person introductions for the company with institutional and retail brokers in Canada and throughout the United States, and through media distribution on national television, radio and multiple on-line channels. FronTier has offices in Toronto, Montreal and Calgary. Under the terms of the engagement, FronTier has been retained for a 12-month period at $80,000 per annum plus direct expenses.
In August 2017, Sernova’s Board of Directors granted 3,735,000 stock options to certain officers, employees and consultants of the company, each such option being exercisable into a common share at a price of $0.25 per share for a period of 10 years. The Board of Directors also granted 239,778 DSU’s and approved an amendment to the Company’s Option Plan & Deferred Share Unit Plan (the “Amended Plan”) to increase the number of DSUs available by 660,222 to a maximum of 1,975,000. These additional DSUs were conditionally approved and granted subject to the Company obtaining shareholder approval and TSX Venture Exchange approval.
In November 2017, based on the successful mid-term report provided by the Horizon 2020 HemAcure consortium to the European Commission, Sernova received a second payment of non-dilutive funds from the European Commission in the amount of €
In December 2017, Sernova announced it received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch SystemTM (CPS) in the United States. Sernova plans to initiate the new clinical trial under this US IND to further investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into patients having previously received the subcutaneously implanted Cell PouchTM. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures. Patient enrolment is set to begin following institutional review board (IRB) clearance.
226,602.60 ($331,770 CDN). Sernova will use the payment to continue to fund activities related to the development of a Factor VIII releasing therapeutic cell product combined with Sernova’s Cell PouchTM to treat severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective Factor VIII in the blood stream.
In December 2017, Sernova announced it received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch SystemTM (CPS) in the United States. Sernova plans to initiate the new clinical trial under this US IND to further investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into patients having previously received the subcutaneously implanted Cell PouchTM. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures. Patient enrolment is set to begin following institutional review board (IRB) clearance.