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Sernova is a regenerative medicine company developing therapeutic technologies with multibillion-dollar market potential for each of its clinical indications. Sernova est une société de médecine régénérative développant des technologies thérapeutiques offrant un potentiel de marché de plusieurs milliards de dollars pour chacune de ses indications cliniques.

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Press Releases Communiqués de presse

Latest Press Releases Derniers communiqués de presse

May 21, 2019 21 May, 2019

Sernova Corp Announces Appointment of Deborah Brown to its Board of Directors

April 30, 2019 30 April, 2019

Sernova Announces Collaboration to Advance Therapeutic Cell Pouch Technologies for the Treatment of Hypothyroidism

April 11, 2019 11 April, 2019

Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes

February 11, 2019 11 February, 2019

Sernova Corp Announces First Patient Implanted with Sernova Cell Pouch in a Phase I/II US Clinical Trial for the Treatment of Hypoglycemia Unawareness

January 30, 2019 30 January, 2019

Sernova Announces the Appointment of Dr. David Lillicrap, M.D. to its Scientific Advisory Board

January 28, 2019 28 January, 2019

Sernova to Participate on Diabetes Panel and Present at NobleConXV, 15th Annual Investor Conference January 28th - 29th, 2019

January 17, 2019 17 January, 2019

Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I/II Cell Pouch Diabetes Clinical Trial

December 20, 2018 20 December, 2018

Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes

 

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Press Release Communiqué de presse - May 21, 2019 21 May, 2019

Sernova Corp Announces Appointment of Deborah Brown to its Board of Directors


May 21, 2019 9:00 a.m. EST

LONDON, ONTARIO – May 21, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) a clinical-stage regenerative medicine company, today announced the appointment of Ms. Deborah Brown to its Board of Directors.

Ms. Brown has extensive leadership experience with more than 20 years in senior management roles at a number of pharmaceutical companies and currently serves as a Managing Partner at Accelera Canada Ltd. She served as President of EMD Serono, a division of Merck KGaA, Executive Vice President at Serono US, General Manager, Director of Marketing, and Business Unit Director at Serono Canada and Manager, International Regulatory at Pasteur Merieux Connaught. Ms. Brown is a former Board Chair of Rx&D (now Innovative Medicines Canada) and as a Director of the Board, oversaw the 100th anniversary of the association and the launch of the Canadian Innovation Timeline promoting the contributions Canadian researchers have made to the discovery and advancement of life science research. Ms. Brown is also a former board member of BIOTECanada. Ms. Brown holds an MBA from Ivey School of Business. She sits on the board of several corporate and not-for-profit organizations, including Life Sciences Ontario and the Hamilton/Burlington SPCA.

“Deborah’s nomination comes at an important time as we expand the breadth and experience surrounding Sernova to help support our clinical development programs, regulatory affairs, R&D, and business development strategy,” said Mr. Frank Holler, Sernova’s Board Chair. “We’d also like to thank Bruce Weber, who is stepping down as a director, for his positive contributions to Sernova during his seven years as Board of Director member.”

Management resolutions at the AGM were approved by a majority of shareholders who voted, including the election of the directors, Frank Holler (chair), James Parsons, Deborah Brown, Jeffrey Bacha, and Philip Toleikis; approval of the stock option plan and amendments and approval of Davidson and Co. LLP as Sernova’s auditor. Additionally, the TSX Venture Exchange (the “Exchange”) has accepted the Plan for filing, as approved by shareholders at the AGM.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada:

Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - April 30, 2019 30 April, 2019

Sernova Announces Collaboration to Advance Therapeutic Cell Pouch Technologies for the Treatment of Hypothyroidism


Co-investigators, Dr. Sam Wiseman of the University of British Columbia and Sernova Corp awarded the prestigious Transplant Research Foundation of British Columbia Venture Grant

April 30, 2019; 9:00 a.m. EST

LONDON, ONTARIO – April 30, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company announced today a collaboration with the University of British Columbia’s, Dr. Sam Wiseman for development of a Cell Therapy-based Program for the treatment of hypothyroidism. This collaboration is funded by a Transplant Venture Grant awarded by the Transplant Research Foundation (TRF) of British Columbia.

“The only current option for treatment of patients following thyroidectomy, to ensure avoidance of hypothyroidism, is administration of life-long daily thyroid medication, with intermittent blood testing and adjustment of medication dosing,” said Dr. Sam Wiseman, thyroid surgeon and researcher, and the Director of Research in the Department of Surgery at Providence Healthcare in Vancouver. “We hypothesize that through transplantation into Sernova’s vascularized Cell Pouch, the function of the thyroid gland may be preserved, and dependence on thyroid medication avoided. This approach is exciting because it could offer patients a cell therapy option for preservation of their gland function.”

According to the American Thyroid Association (ATA), 20 million Americans currently live with thyroid disease, and 12% of Americans will develop a thyroid condition during their lifetime. The thyroid gland produces and secretes thyroid hormone that is essential for life because it serves to regulate the entire body’s metabolism. The thyroid gland affects all critical body functions including heart rate, energy levels, and the rate at which energy is produced from nutrients. Loss of thyroid function, or hypothyroidism, may occur spontaneously, or due to partial or complete removal of the thyroid gland by operation (thyroidectomy).

“The cell-based treatment of hypothyroid disease following thyroidectomy represents a third significant clinical application including type-1 diabetes and hemophilia further validating Sernova’s Cell Pouch platform technologies in significant potential markets,” said Dr. Philip Toleikis, President and CEO of Sernova. “The development of a regenerative medicine approach for these chronic diseases is becoming a reality. In this case of thyroid disease, successful transplantation of thyroid tissue into Sernova’s cell pouch would represent a major advance in treatment of this very common problem.”

Thyroidectomy is commonly performed for cancer diagnosis or treatment, as well as for treatment of benign (non-cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the US yearly, and the majority of individuals undergoing a thyroid operation will be diagnosed with benign disease after their operation. Patients with Grave’s disease and thyroid nodules undergoing total thyroidectomy, and many patients undergoing partial thyroidectomy require life-long thyroid hormone medication. Post-surgical thyroid hormone replacement therapy, if monitored carefully, can be effective; however, patients often suffer from side effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative impact on quality of life, and costs to the healthcare system.

Sernova’s approach in the treatment of hypothyroid disease is to transplant healthy thyroid cells of patients undergoing thyroidectomy into the pre-implanted vascularized Cell Pouch. Currently, pre-clinical proof-of- concept work is underway. The collaboration will accelerate Sernova’s research efforts and set the stage for the preparation of a regulatory submission for future clinical assessment of people suffering from hypothyroid disease with the aim to preserve thyroid function and improve patient quality of life.

In other news, Sernova has been invited to present at the 2019 Bloom Burton & Co. Healthcare Investment Conference, being held at the Metro Toronto Convention Centre, in Toronto on April 30 and May 1st. Sernova President and CEO, Dr. Philip Toleikis will speak to its latest corporate presentation and US Phase I/II Human Clinical Trial at 4:00 PM EDT, on Wednesday, May 1st.

About Sernova Corp.

Sernova, Corp., (TSX-V: SVA) is a clinical stage (US FDA; Health Canada) company, developing disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-dependent (TI) diabetes, hemophilia A and thyroid disease. Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases such as hypothyroid disease treated through replacement of proteins or hormones missing or in short supply within the body.

For further information contact:

United States Danny Matthews, Senior Associate, Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada:

Dominic Gray Corporate Communications Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of pre-clinical results and clinical trials. 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.

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Press Release Communiqué de presse - April 11, 2019 11 April, 2019

Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes


April 11, 2019, 9:00 a.m. EDT

LONDON, ONTARIO – April 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the first Cell Pouch™ transplant of insulin-producing cells in its U.S. Phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for Clinical Islet Transplantation in type 1 diabetes.

“Sernova’s Cell Pouch technologies are positioned to provide the most severe patients with improved, long term options to manage their diabetes,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the Pancreatic Islet Transplant Program at the University of Chicago. “The current standard of care, involves islet transplants into the portal vein which has significant limitations including the development of an immediate blood-mediated inflammatory reaction (IBMIR), limited supply of donor organs and the challenges in isolating and obtaining a consistent quality of islet preparations.”

In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This procedure enables the development of vascularized tissue chambers and provides an interval for patient stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In accordance with the protocol the Sentinel Pouch will be removed approximately 90 days post-transplant to assess islet survival as an interim indicator of efficacy.

“Sernova’s Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic cells, to enhance the curative potential of islet transplantation and other cell therapies,” said Dr. Philip Toleikis, President and CEO of Sernova. “We are thrilled with Dr. Witkowski’s progress as well as his decision to move forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch.”

“This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for cell therapies across a range of indications including type 1 diabetes, hemophilia and thyroid disease,” added Dr. Toleikis.

The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.

About the Study

The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.

A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.

About Hypoglycemia Unawareness and Diabetes

Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.

About the Cell Pouch

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States:

Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

Canada:

Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - February 11, 2019 11 February, 2019

Sernova Corp Announces First Patient Implanted with Sernova Cell Pouch in a Phase I/II US Clinical Trial for the Treatment of Hypoglycemia Unawareness in Subjects with Type 1 Diabetes


February 11, 2019; 9:00 a.m. EST

LONDON, ONTARIO – February 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the first patient implanted with Sernova’s Cell Pouch™ in the Phase I/II clinical trial evaluating the safety and efficacy of Sernova’s Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes.

“Islet transplantation has shown success as a therapeutic option for treating patients with hypoglycemia unawareness; the most unstable, high-risk form of type 1 diabetes. Given the limited supply of donor islet cells, it is imperative to develop approaches that capitalize on a more efficient use of donor islet cells,” said Dr. Piotr Witkowski principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “We believe Sernova’s Cell Pouch creates a vascularized environment, rich in microvessels that will allow robust engraftment and extended survival of the transplanted islet cells. We hope this will result in the need for fewer transplants per patient and, ultimately, create a long-term treatment option for patients suffering from hypoglycemic unawareness.”

Cell Pouches, including, small sentinel pouches were implanted. Following development of the vascularized tissue chambers, and stabilization on immune protection medications, the Cell Pouch will be transplanted with donor islet cells. Approximately 90-days after transplant, small sentinel devices are removed to evaluate islet survival as an initial efficacy endpoint.

“This important clinical milestone represents an exciting time at Sernova as we pursue safe, effective, and innovative regenerative medicine treatments for patients with hypoglycemia unawareness in type 1 diabetes,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “We are confident this US clinical trial will support and add important data to the positive pre-clinical results of our small and large diabetes animal models, and our first-in-human trial with Health Canada. It will also contribute to the development of broader applications for the Cell Pouch including our diabetes stem cell technologies and additional indications.”

The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.

About the Study

The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.

A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939 . For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact (773) 702-2504.

About Hypoglycemia Unawareness and Diabetes

Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.

About the Cell Pouch

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - January 30, 2019 30 January, 2019

Sernova Announces the Appointment of Dr. David Lillicrap, M.D. to its Scientific Advisory Board


Sernova Adds Scientific Advisory Board Expertise as it Broadens its Therapeutic Cell Therapy Applications for Rare Blood Diseases

January 30, 2019 9:00 a.m. EST

LONDON, ONTARIO – January 30, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) a clinical-stage regenerative medicine company, today announced the appointment of Dr. David Lillicrap, M.D., FRCPC to its Scientific Advisory Board (SAB).

Dr. David Lillicrap is Associate Head, Research, and Professor in the Department of Pathology and Molecular Medicine at Queen's University at Kingston, Ontario, Canada. He holds a Tier 1 Canada Research Chair (CRC) in Molecular Hemostasis and is a past Career Investigator of the Heart and Stroke Foundation of Ontario. In 2013, he was elected to the Fellowship of the Royal Society of Canada. Dr. Lillicrap serves as a member of the Medical Advisory Board of the World Federation of Hemophilia. He is a member of the Council of the International Society on Thrombosis and Haemostasis (ISTH), is a past Chair of ISTH’s Scientific and Standardization Committee and is Co-Editor-in-Chief of the Society’s journal, the Journal of Thrombosis and Haemostasis. Dr. Lillicrap has also been a SAB member of the Horizon 2020 HemAcure program developing a personalized medicine approach for treatment of hemophilia of which Sernova is partner. He is an internationally recognized expert on the molecular basis of common inherited bleeding disorders.

“We are pleased to welcome David to Sernova’s Scientific Advisory Board,” said Dr. Philip Toleikis President and CEO Sernova Corp. “Dr. Lillicrap’s internationally recognized leadership in hematology and novel cell and gene therapy-based applications will be instrumental as we expand the breadth and experience of our Scientific Advisory Board in support of Sernova’s hemophilia and other rare disease programs.”

As a Canada Research Chair in Molecular Hemostasis, his program of research focuses on the molecular basis of the hemostatic system (coagulation), with a particular emphasis on the commonest inherited bleeding disorders, hemophilia, and von Willebrand disease. During his tenure as a Canada Research Chair, Dr. Lillicrap’s group has achieved several research accomplishments including the establishment of a national reference laboratory for the genetic diagnosis of inherited bleeding disorders. His research interests focus on three key areas including von Willebrand factor pathobiology, factor VIII immunology and the evaluation of novel gene, and cell-based strategies for the treatment of hemophilia.

About the Cell Pouch System

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of immune protected therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans. Within the Horizon 2020 HemAcure program corrected human cells from subjects with Hemophilia A have been shown to engraft within the Cell Pouch, produce Factor VIII and improve blood clotting in a preclinical model of hemophilia A.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - January 28, 2019 28 January, 2019

Sernova to Participate on Diabetes Panel and Present at NobleConXV, 15th Annual Investor Conference January 28th - 29th, 2019


January 28, 2019 6:00 a.m. EST

LONDON, ONTARIO – January 28, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical- stage regenerative medicine company announced today that Dr. Philip Toleikis, President and CEO will present the latest company overview and is invited to participate on the Diabetes Panel at NobleConXV — Noble Capital Markets’ Fifteenth Annual Investor Conference at the W Hotel in Fort Lauderdale, Fla., on Monday January 28th at 11:00 a.m. Eastern Time.

The panel will cover a broad spectrum of interests involving diabetes including the discovery and commercialization of novel diabetes therapeutics and diagnostics, diabetes research, as well as nutrition and awareness. Included on the panel are Dr. Camillo Ricordi, Director of the Diabetes Research Institute; Dr. Michael Castagna, CEO of MannKind Corporation; Steve Perrin, Ph.D., CEO and Founder of Anelixis Therapeutics; William L. Rust, Ph.D., CEO and Founder of Seraxis; Michael Fox of DugalHealth; Martin Beland, VP Marketing and Strategic Development of Inolife Sciences; Steve Glover, CEO of Variant Pharmaceuticals; and Dr. Philip Toleikis, Ph.D., President & CEO of Sernova Corp.

A video webcast of the presentation will be available the following day on the company's website www.sernova.com and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website (http://nobleconference.com) as well as on the new investor portal created by Noble called Channelchek (http://www.channelchek.com).

About Sernova, Corp Sernova, Corp., (TSX-V: SVA) is a clinical stage (US FDA; Health Canada) company, developing disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-dependent (TI) diabetes, hemophilia A and thyroid disease. Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For further information contact:

Danny Matthews, Senior Associate Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada:

Dominic Gray, Corporate Communications Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - January 17, 2019 17 January, 2019

Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I/II Cell Pouch Diabetes Clinical Trial


January 17, 2019 9:00 a.m. EST

LONDON, ONTARIO – January 17, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova’s Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes.

“We are pleased to report we are on track with patient enrollment in the Sernova Cell Pouch study for type 1 diabetes,” stated Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “The Cell Pouch System is designed to improve the quality of life of people with diabetes and this milestone marks an important step towards building further validation of Sernova’s innovative approach to diabetes treatment.”

Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.

About the Study

The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. Study subjects will receive Sernova’s Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch.

The sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second dose of purified islets. Patients will then be further followed to assess safety and efficacy for up to one year.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact (773) 702-2504.

About Diabetes

Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.

About the Cell Pouch

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

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Press Release Communiqué de presse - December 20, 2018 20 December, 2018

Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes


Initiating Treatment Phase of the Study at the University of Chicago

December 20, 2018 9:00 a.m. EST

LONDON, ONTARIO – December 20, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical-stage regenerative medicine company announces the enrollment of the first patient in its Phase I/II trial of Sernova’s Cell Pouch for Clinical Islet Transplantation in type 1 diabetes.

“There is a real need for new treatment options in the field of type 1 diabetes,” said Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “Due to Sernova’s novel approach to demonstrate vascularization of the Cell Pouch and remarkable preclinical and first-in-human data, we are hopeful this study will provide a new functional therapeutic option in the treatment of patients with diabetes.” Dr. Witkowski added, “We expect completion of enrollment of the first patient cohort to be January 2019 and full enrollment to be completed by mid- 2019 as we continue to screen patients for the Sernova study.”

“The initiation of this Phase I/II trial is an important milestone for Sernova as our team looks to showcase our research and development efforts in diabetes on a clinical level at the University of Chicago, a world leader in regenerative medicine,” added Dr. Philip Toleikis, President and CEO of Sernova. “In our pilot first- in-human study, Sernova’s regenerative medicine approach, involving therapeutic cells within Sernova’s Cell Pouch, showed surviving vascularized islets able to produce all the hormones necessary to control blood glucose levels. Based on these positive initial results, we expect our therapeutic approach will demonstrate continued safety and therapeutic benefit to people suffering from type 1 diabetes.”

The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.

About the Study

The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.

A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939 . For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact (773) 702-2504.

About Diabetes

Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes- related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.

About the Cell Pouch

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.

About Sernova Corp

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic 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. For more information, please visit www.sernova.com

For further information contact:

United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com

For investor inquiries and media inquiries in Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com www.sernova.com

Ray Matthews & Associates Tel: (604) 818-7778 ray@raymatthews.ca www.raymatthews.ca

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 beliefs about the conduct and outcome of clinical trials. 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.

Privacy PolicyPolitique de confidentialité

Updated July 6, 2018

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Sernova Corp.
700 Collip Circle, Suite 114
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Mis à jour le 6 juillet 2018

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700 Collip Circle, Suite 114
London, ON Canada N6G 4X8