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Sernova Corp Sernova Corporate Presentation Q1, 2013 P.M. Toleikis, Ph.D., President and CEO Founded 2006, London Ontario; TSX(v); SVA.V

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Page 1: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova Corp

Sernova Corporate Presentation Q1, 2013

P.M. Toleikis, Ph.D., President and CEO

Founded 2006, London Ontario; TSX(v); SVA.V

Page 2: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova Corp

Cautionary and Forward-Looking Information

This presentation may contain forward looking statements. Forward looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. The information does not constitute any advice, promise or obligation of Sernova Corp. and does not necessarily represent the most current source of company information. Sernova Corp. cannot, and does not, guarantee or ensure either the accuracy, completeness, or authenticity of this presentation’s contents and may make changes and revisions to the information on this presentation at any time and without notice. The information is presented and stored on an "as is" basis and the use of the presentation to collect information is completely at your own risk. This presentation contains information about third-parties merely as a convenience. The inclusion of such information does not imply that Sernova Corp. endorses or accepts any responsibility for the content or use of such information. For more information on Sernova Corp, investors should review filings available at www.sedar.com.

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Page 3: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova Company Overview A Clinical Stage Company in Regenerative Medicine/Cell Therapy:

Technologies Cell Pouch ™ - Implantable medical device for therapeutic cells;

Therapeutic cells - Donor, stem cells, xenogeneic cells

Sertolin ™ - Local immune protection;

First Product Focus: Insulin-Dependent Diabetes Patient population - 9M NA

Current Products: insulin injections, insulin pumps

Sernova’s Goal: eliminate insulin injections; reduce diabetes side effects Improved patient QOL, reduction in disease side effects, efficacy

Sernova’s Proof and Development Status Cell Pouch™ Proven safe environment for cells

Sertolin™ Proven Local immune protection Therapeutic Cells Proven safety/efficacy for diabetes Status: Phase I/II Ongoing Clinical study – interim results: 2013

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Page 4: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova’s Patent Portfolio

Over 20 issued and pending patents in 5 families:

Composition and use of medical devices for delivery and cell transplantation

Methods for predicting long-term therapeutic cell function

Use of sertoli and genetically modified sertoli cells for treatment of disease

Use of combinations of sertoli cells and other cell types for treatment of disease

In vitro co-culture of mammalian cells with sertoli cells

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Page 5: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

DIABETES Sernova’s Cell Pouch™ First Clinical Indication

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9M

14.6M

US Market 23.6M Patients

10%

63%

27%

Diabetes Market Diabetes Epidemiology*

Type 1 Insulin-dependent (10%)

Type 2 Insulin-resistant (63%)

Type 2 Insulin-dependent; (27%)

Insulin therapy: 37% (9M US/34M Asia)

Diabetes side effects: heart, kidney, nerve

disease, stroke, amputations, blindness

*American Diabetes Association, 2007

Diabetes Healthcare Costs $174 billion: US cost of diagnosed diabetes in 2007 $116 billion for direct medical costs $58 billion for indirect costs (disability, work loss, premature mortality)

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Diabetes Treatments Are Inadequate

Artificial management of blood glucose

Insulin injections, pumps, etc.

Often painful leading to poor compliance (side effects)

Insulin levels spike and decay

Low patient QOL

“Natural” management of blood glucose

Portal vein transplant of islets (Edmonton Protocol)

No compliance issues; normal glucose control

Expensive; Limited in application

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The Current Approach to Islet Transplantation:

The Edmonton Protocol

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Portal vein islet transplantation for patients with hypoglycemia unawareness A study of 36 patients using the Edmonton Protocol: 44% were insulin independent at 1 year 15% insulin independent at 5 years (Shapiro et al. NEJM 355:13, 2006)

Edmonton Protocol - Gap

73%

0 12 24 36 48 60 72 84 96 108

0

20

40

60

80

100

C-peptide positive

Insulin Independence

Corrected HbA1C and absence of hypoglycemia

15%

% S

urv

iva

l

Time (Months)

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Improving the Standard of Care of Islet Transplantation

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Catherization laboratory Loss of 60-75% of islets immediately-IBMIR Portal hypertension, thrombosis No possible Islet imaging Expensive procedure Life long systemic antirejection drugs No potential to use unlimited sources of cells such as stem cells/xenogeneic cells

Placed under the skin Outpatient procedure; minimally invasive No IBMIR No Portal hypertension or thrombosis Islet imaging capable Reduced cost Potential for local immune protection Ideal location for stem cell and xenogeneic technologies

Edmonton Protocol Cell Pouch System™

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Cell Pouch™ Preclinical Summary

Cell Pouch™ contract manufactured (ISO 13485) Cell Pouch™ is biocompatible (ISO 10993 studies) Safety confirmed in 4 animal models rodent, pig, non-human primate Efficacy Confirmed: isograft, autograft, allograft diabetes models Sertoli cells protect therapeutic cells

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Page 11: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Cell Pouch™: A Natural Environment for Islets

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Subcutaneous Cell Pouch™ Post-Implant

Transplant Site Islet Transplantation into Cell Pouch™

8 Wks Post Cell Pouch™Implant 9 Wks Post Islet Transplant

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Cell Pouch™: Healthy Islets 12 Weeks Post-Transplant

Micro-vessel, Insulin Stain & Glucagon Post Tx

Fluorescence images of a chamber within the Cell Pouch™ stained for micro-vessels (green) and insulin (red) post-transplant. IHC of glucagon DAB staining

Tissue and Micro-Vessel Incorporation

Cell Pouch™ infiltrated with micro-vessels and collagen

Negative Glucagon

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Cell Pouch™

Robust Allograft Efficacy Results with a

Marginal Islet Dose

Cell Pouch™ Removal

Tx Cell Pouch™

Removal

*Marginal Islet dose 2500 IEQ/kg

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Healthy Islets within the Cell Pouch™

Post-Allo Tx and Antirejection Regimen

10,000IEQ/Kg 5,000IEQ/Kg

2,500IEQ/Kg

• Insulin (red) and nuclei (blue) staining within one chamber of the Cell Pouch™ post-islet transplant at each transplant dose • Islet survival within the Cell Pouch™ for up to 6 weeks (length of study) while under immunosuppressive drug therapy

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Local Sertolin™: Prevention of Graft Rejection

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A B

C D

A B

C D

Sertoli/Islets Islets Alone

Day 7

Day 21

Natural immune-privileged

environment protecting

cells from immune

destruction

Page 16: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

A Phase I/II Study of the Safety and

Efficacy of Sernova’s Cell Pouch™ for

Therapeutic Islet Transplantation

Principal Investigator:

A.M. James Shapiro, M.D., Ph.D., FRCS (Eng), FRCSC

www.islet.ca

www.clinical trials.gov

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Ongoing Sernova Cell Pouch™ Phase I/II Study Principal Investigator: Dr. A. J. Shapiro (Developer of Edmonton Protocol; U. Alberta)

Study Design 20 patients (unstable diabetes); open-label; single-arm; non-randomized

Donor islet transplantation 2-12 wks post Cell Pouch™ Implantation

Primary endpoint

Safety post Cell Pouch™ implantation and 1month post islet transplantation

Secondary endpoint

Efficacy, proportion of patients insulin independent at 3months post final islet transplant

Follow Up and Timeline

Patient follow-up for 3 years to assess long-term safety and efficacy

Health Canada Cleared – Patient Screening and Enrolment ongoing

Interim safety and efficacy expected - 2013

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Page 18: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova Cell Pouch™ Clinical Development

Plan for international study (Canada, US, Europe, Asia)

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Product Product Strategy

Cell Pouch™, donor islets and state of the art antirejection protocol

POC Cell Pouch™; ≈$50M/yr

Cell Pouch™, donor islets and local immune protection (Sertolin™)

Local immune protection of islets; ≈$150M/yr

Cell Pouch™ and insulin producing stem cells

Unlimited source of insulin-producing cells; ≈$2.3B/yr (1%)

Cell Pouch™ Diabetes Products

Page 19: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova’s Therapeutic Goal:

A Disruptive Approach to Treat Chronic Diseases

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A Natural Cell Environment:

Cell Pouch System™

Safe Prevention of Transplant Rejection Sertolin™

An Unlimited Source of Therapeutic Cells

Sernova

Page 20: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

The Cell Pouch™: Product Pipeline

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Cell Pouch™

Diabetes

Type-2 Type-1

Parathyroid

Haemophelia Parkinson’s Disease

Liver Failure

Human Donor Cells Stem Cells; Xenogeneic Cells

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2013 Goals and Value Drivers

• Interim clinical results from Phase I/II study • Preparation for a second clinical indication for the

Cell Pouch™, e.g. parathyroid gland • Development of an international regulatory strategy

for commercialization of the Cell Pouch™ for diabetes

• Development of Sertolin™ within the Cell Pouch™ for local immune protection to eliminate need for anti-rejection drugs

• Assessment of insulin producing stem cells and protected xenogeneic cells in the Cell Pouch™

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Page 22: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Management Team and BOD

Core Executive Management

President & CEO - Dr. Philip Toleikis, BA., MSc., Ph.D.

Joined 2009; Pharmaceutical/Device Consultant, V.P. R&D Pharmacology, Angiotech Pharmaceuticals (1996-2006)

Sr. Director R&D – Delfina Mazzuca-Siroen, BSc. Hon. Biochem., MSc.

20 yrs. R&D Mgmt. U. Western Ontario, Transplantation preclinical and clinical development

CFO – Bill Smethurst, CA

S.A.B. -Founding Scientist and Chair - Dr. David White, PhD., M.R.C.P., F.R.C.P., Professor Emeritus Medicine, Robarts Institute , U. of Western Ontario; S.A.B. Dr. James Shapiro, M.D., Ph.D. FRCS (ENG.)

Director of the Clinical Islet Transplantation Program at the University of Alberta and 5 additional members

Board of Directors

Dr. George Adams, MSc., Ph.D. (Chairman); CEO VentriPoint, Inc.

Jeffrey Bacha, BSc., MBA; CEO Del Mar Pharmaceuticals

James Parsons, CA ; CFO/advisory - DiaMedica, Stem Cell Therapeutics, Amorfix, Lorus Therapeutics, YM Biosciences, Astra Zeneca Canada

Bruce Weber, B.S., MBA; VP Clinical/Regulatory and QA Innovia LLC.

Dr. Philip Toleikis, BA., MSc., Ph.D.; President & CEO Sernova Corp.

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Page 23: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Sernova Company Summary A Clinical Stage Company in Regenerative Medicine/Cell Therapy:

Disruptive Technologies Cell Pouch ™ - Implantable medical device for Therapeutic Cells;

Therapeutic cells - donor, stem cells, xenogeneic cells

Sertolin ™ - Local immune protection;

First Product Focus: Insulin-Dependent Diabetes Patient population - 9M NA

Current Products: insulin injections, insulin pumps

Sernova’s Goal: eliminate insulin injections; reduce diabetes side effects Improved patient QOL, reduction in disease side effects, efficacy Clinical evaluation: Ongoing Phase I/II clinical study (Interim results: H1, 2013)

Sernova’s Depth

Experienced: management team, SAB, BOD

KOL Principal Clinical Investigator– Dr. James Shapiro Head of islet transplantation UA

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Page 24: Sernova Corp - Ahead of the Herdaheadoftheherd.com/Advertising/Sponsor_Page/SernovaCorp/...For more information on Sernova Corp, investors should review filings available at . 2 Sernova

Contact Information

Dr. Philip Toleikis, President and CEO

Tel: (604) 961-2939

email: [email protected]

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