sernova corporate presentation
TRANSCRIPT
THE PATH TO A REGENERATIVE MEDICINE CURE
SernovaCorp
CORPORATE
INVESTOR DECK
CURRENT VERSIONOctober, 2021
2021
This presentation contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward- looking statements in this
presentation 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. Forward-looking statements include statements about subsequent clinical activity, including enrolment of patients and continuing results therefrom,
and the potential benefits, safety and efficacy of the Cell Pouch for various indications, including type 1 diabetes (T1D).
While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to significant scientific, business, economic,
competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors that could cause Sernova’s actual
results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-
looking statements contained in this presentation. Results in early-stage clinical trials may not be indicative of full results or results from later stage or
larger scale clinical trials and do not ensure regulatory approval. Readers should not place undue reliance on these statements, or the scientific data
presented and should refer to the risk factors identified in the company’s continuous disclosure filed on SEDAR.com. 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.
FORWARD-LOOKING
STATEMENTS
THE PATH TO A REGENERATIVE MEDICINE CURE
SernovaCorp
Sernova Corp is a clinical-stage company developing products for the treatment of chronic debilitating diseases. The company is engaged in the research and development of its proprietary Cell Pouch System consisting of an implantable device and immune-protected therapeutic cells
Sernova develops a commercially-viable treatment insulin-dependent human diabetes (T1D) and other metabolic, blood and rare diseases with therapeutic cells placed into its implanted vascularized and scalable medical device.
SernovaIntegratedRegenerativeMedicinetherapeuticsolution
Immuneprotectedtherapeuticcellsproducingmissingproteinsor hormones within the organ-like environment of the implanted cell Pouch Device
INVESTMENT HIGHLIGHTS
Cell therapy therapeutics platform treating chronic diseases such as T1D
Active US Phase I/II diabetes clinical trial
Pre-Clinical proof-of-concept demonstrated using human cells in Hemophilia A & Thyroid Disease
Multiple global markets with significant revenue potential for Sernova’splatform application technology
Multiple collaborations with Pharmaceutical Industry Leaders
REGENERATIVE MEDICINE
THE FUTURE IS NOW
Regenerative Medicine (RM) is a rapidly evolving field of medicine that is a paradigm shift in chronic disease treatment & outcomes
It is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues
Regenerative Medicine also includes the generation and use of therapeutic stem cells, tissue engineering and the production & regeneration of artificial organs
Sernova Regenerative Medicine therapeutics approach is focused on the potential of a functional cure vs. masking disease & long-term treatment of symptoms with prescription medication
Sernova’s Platform ApproachIntegrated RM Therapeutic Solution for Treatment of Chronic Diseases
Immune ProtectionTechnologies to protect therapeutic cells from immune system attack
Cell Pouch Immune Protection
Therapeutic Cells
Therapeutic CellsHuman cells (donor / stem) & tissuesthat produce & release missing proteins or hormones into thebloodstream
Cell PouchImplantable proprietary medical device that provides vascularized environment for therapeutic cells
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Sernova’sCommercializationApproach
MostCriticalUnmetNeed BroaderPopulation
Pote
ntia
lRev
enue
s
TherapeuticCells
⚫ Self Cells (autograft)
⚫ Donor cells (allograft)
⚫ Stem cell-derived cells
Cell Pouch Technologies
⚫ Organ like environment
Immune Protection
⚫ Medications
⚫ Conformal coating approach
⚫ Gene editing approach
Natural cell
environment
Cell engraftment
Biocompatible
Versatility: Stem cell-derived islet
cells
Versatility:
tissue
Versatility:
Human cells
Scalable
No Fibrosis
Vascularizes
SOLUTIONS
CELL POUCH SUPERIORITYThe challenging device issues and hurdles conquered by Sernova
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CELL POUCH cGMP MANUFACTURINGManufacture of the Cell Pouch in multiple sizes is conducted GMP by a
US contract manufacturer in a Class VII Clean Room
Product and process development is conducted in accordance withmanufacturer’s Quality System
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ISO 13485
EU Medical Devices regular MDR 2017/745
US FDA Quality System Regulations (QSR) 32 CFR 820
Canadian Medical Device Regulation (CMDR)
Two-year real time Cell Pouch product stability and package integrity
CELL POUCH CELLULAR IMMUNE PROTECTIONCONFORMAL COATING
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Sernova’s proprietary cellular conformal coating technology – developed and optimized with over 12 years of research at the University of Miami
• It consists of a thin biocompatible porous polymer hydrogel coating surrounding therapeutic cells (islets, stem cells)
• Proven to allow for physiological transfer of insulin and glucose unlike other encapsulation technologies
• Sernova is preparing for use within its Cell Pouch for islets, stem cell derived cells for multiple applications
• The potential to eliminate the need for anti-rejection medications significantly increases the number of treatable patients for Sernova’s clinical products
Conformal Coating
Immunoisolation Summary
Due to its ‘shrink wrap’ proximity to the cells, does not affect the volume of cells for
transplantation into Sernova Cell Pouch
Unlike other encapsulation technologies allows normal movement of
nutrients/glucose/insulin in and out of cells
Allows normal glucose-stimulated insulin response (glucose tolerance test) in vitro and in
vivo
Protects donor islets from immune attack in gold standard diabetes models without
immunosuppression
Produces insulin independence for islets and stem cell-derived islets (technology to
provide an unlimited supply of cells)
Safety demonstrated in non-human primate models
Scale-up device and software for automatic quantification of CC product ready for testing
Conformal Coating and Cell Pouch
Summary of Key Findings
Conformal Coating
Sernova Cell Pouch
Safety in non-human primates
√ √
Efficacy with donor islets in T1D preclinical models
√ √
Efficacy with T1D stem cell derived technology in T1D preclinical models
√ √
Safety in humans with T1D
TBD √
Efficacy in humans with T1D with donor islets
TBD √
U of Miami/Sernova Collaboration Plan
U of Miami/Sernova Collaboration StepsFollowing on >12 years of technology development and optimization
Polymer Characterization StudiesDiabetic rodent studies in Cell Pouch of CC isletsScale-up of CC manufacturing in preparation for clinical evaluation
Sernova Clinical Study PreparationDevelopment of cGMP manufacturing of CC isletsISO 10993 biocompatibility studies (final preclinical studies)Preparation of regulatory documentationInitiation of Phase I/II US Clinical Study for T1D subjects
CELL POUCH CELLULAR IMMUNE PROTECTION
GENE EDITING
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Sernova extended its AgeX collaboration evaluating the potential of Sernova’s pluripotent stem cell-derived pancreatic islet beta cells, and hemophilia cells engineered with AgeX’sUnverCyte technology, to evade human immune detection.
UniverCyte uses a modified form of HLA-G, a potent immunomodulatory molecule, which in nature protects an unborn child from their mother’s immune system. AgeX’smodified HLA-G has the potential to allow for long-term, stable and high expression of the immunomodulatory effect.
The complementary combination of technologies could enable the transplantation of therapeutic cell in patients with T1D in an off-the-shelf manner using Sernova’s Cell Pouch, without human leukocyte antigen (HLA) tissue matching or 12 concurrent administrations of immunosuppressive medications.
Proprietary Cell Pouch is placed deep under the skin, allowing for vascularization & creating anatural environment for long-term function of therapeutic cells
Therapeutics cells are transplanted directly into the vascularized tissue chambers ofthe proprietary Cell Pouch
Therapeutic cells release missingproteins or hormones in the bloodstream to correct biologicaldysfunction
Biologically Compatible Delivery Process
GLOBAL DIISEASE = GLOBAL MARKET
DIABETES
760 bn USDHealth Expenses related to
Diabetes
845 bn USDProjected Health Expenses related toDiabetes in 2045
34.8 bn USDGlobal human insulin market for
2019
10 %Prevalence of T1D
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Diabetes is one of the module prevalent diseases pervasive medical problems, impacting society and everyday quality of life today!
463 million people are affected worldwide with Diabetes; another estimated 179 million people have it without knowing it. By 2045, projections show this number rising to some 700 million diabetics globally!
Sernova’s application for Diabetes T1D represents a potential commercial opportunity for $30 billion annually for the company and has a real blockbuster potential. The solution would also ge the fulfillment of a dream for millions of patients worldwide!
DIABETES STATISTICS
LEAD DIABETES INDICATIONHypoglycemia Unawareness
1st study population for Sernova’s integrated RM therapeutic solution for lead indication of insulin-dependent diabetes
Most critical unmet need in diabetes
Affects 15% of T1D patients (~240k patients in the US)
Clinically defined as complication of diabetes in which patient in unaware of a deep drop in blood sugar
Patients do not experience hypoglycemia warning symptoms (palpitations, anxiety, excessive sweating, light headedness)
Harmful effects: diabetic ketoacidosis (DKA), coma and death
SAFETY, TOLERABILITY & EFFICACY STUDY
US Ph I/II STUDY DESIGN
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Study Design: Company-sponsored IND. open-label, single arm study. Human donor islets are transplanted into the Cell Pouch after implantation & stable anti-rejection medication activity has been established.
Primary Objectives: To demonstrate the safety & tolerability of islet transplantation into the Cell Pouch for the treatment of HU in T1D subjects with a history of severe hypoglycemic episodes.
Secondary Objectives: To establish islet release criteria that accurately characterize the islet product & are predictive of clinical transplant outcomes into the Cell Pouch, demonstrated through defined efficacy measures
SECONDARY OBJECTIVES
Survival of endocrine tissue in the Cell Pouch
Proportion of subjects with a reduction in severe hypoglycemic events
Proportion of subjects with a reduction in HbA1c>1mg
Over 20 additional endpoint analyses
US Ph I/II SAFETY
Incidence & severity of adverse events associated with Cell Pouch were monitored:
Cell Pouch well-tolerated & safe during the implant & the time of transplant
No incidences of SAEs determined to be probable or highly probable to the Cell Pouch
Conclusion: Safety findings continue to meet the primary endpoint of the study
US Ph I/II EFFICACYLongest Observed Patient Data Presented by Clinical Investigator*
BEFORE ISLET TRANSPLANT
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VS
2nd ISLET TRANSPLANT* 6 MONTHS
VS
3rd ISLET TRANSPLANT* 6 MONTHS*Marginal Islet Dose *Marginal Islet Dose intraportal top up
83 kg – Bodyweight
6.5 – Hemoglobin A1C
14U – Daily use of Insulin
15-16U – Short acting Insulin
4 Weekly severe
hypoglycemic events
71 kg – Bodyweight
5.6 – Hemoglobin A1C
8U – Daily use of Insulin
14-15U – Short acting Insulin
0 Weekly severe
hypoglycemic events
71 kg – Bodyweight
4.9 – Hemoglobin A1C
0U – Daily use of Insulin
0U – Short acting Insulin
0 Weekly severe
hypoglycemic events
Post-transplant Glucose Tolerance TestsThe tests consistently showed increase in blood levels of C-peptide, a biomarker for insulin presence
in the bloodstream from transplanted islets
Consistent enduring blood levels of C-peptide & ongoing evidence of islet engraftment & durable therapeutic effect detected post Cell Pouch transplant
PATIENT IMPACT STATEMENT
“After completing the safety, tolerability and efficacy study of Sernova's Cell Pouchfor clinical islet transplantation and as the first transplant candidate, I can easilystate how absolutely wonderful life is to be free of always thinking of how tomanage my diabetes. After having T1D for 47 years with approximately 21,535injections of various cow/pig, synthetic insulins, 34,310 finger sticks, 1,460 urinetests, 15 years on the pump, carbohydrate counting, blood tests, low blood sugarreactions, and doctors…doctors and more doctors’ visits, I have now been free ofthe need for injectable insulin for 15 months. My Sernova team of invaluablescientists, doctors, engineers, and Dr. Witkowski, and the University of Chicago'ssupport staff have done this truly amazing feat right in the middle of a worldwidepandemic! My only wish is that it could have been done sooner.”
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ONGOING SAFETY/EFFICACY INPATIENT POPULATION
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STATUS: 6 patients enrolled, implanted with Cell Pouches and ongoing islet transplants
SAFETY: Sernova Cell Pouch implantation continues to be well-tolerated in ongoing patients
EFFICACY: Sernova is the first regenerative medicine company to demonstrate a subcutaneous islet transplanted device (Cell Pouch) achieving persistent islet graft function in diabetic patients
Clinical benefit has been reported by the investigator in case studies, in the most advanced study subjects
Sustained blood levels of C-peptideReduction of HbA1c (indicator of long-term glucose control)Overall improvement in CGM glucose control including reduction in hypoglycemia unaware eventsReduction in the need for exogenous insulin
Investigator has reported improved islet engraftment and patient outcomes with a smaller (marginal) dose of needed islets in the Cell Pouch
SERNOVA’S DIABETES PROGRAM:COMMERCIALIZATION STRATEGY
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Current Clinical Study• Completion of study enrollment; completion of patient follow-up and study report
Expand Clinical Development• Preparation for pivotal study with islets (pending FDA clearance)• Advancement into the clinic of conformal coating technology with human islets with the goal to eliminate anti-
rejection medications
Advanced successful stem cell diabetes preclinical pharmaceutical collaborations with Cell Pouch to formal partnerships• Goal: Clinical development of immune protected diabetes stem cell technology in Cell Pouch for all diabetic patients
Advancement of MedTech relationships• Development of surgical tool kit for minimally invasive laparoscopic insertion of Cell Pouch and therapeutic cells• Establish marketing and distribution partner for Cell Pouch Technologies
Sernova: Physician and Payor study• Overall conclusion Cell Pouch System would be a significant contribution to current diabetes treatment• Product potential $100,000 - $200,000 per treatment
$10BOrphan
Indication
HEMOPHILIA ACELL POUCH SYSTEM RARE DISEASE PROGRAM
THERAPEUTIC BENEFITS & ESTIMATED MARKET
Completed pre-clinical proof-of-concept➡➡
Ex vivo gene editing approach
Cell manufacturing process developed Corrected patient cells survive & produce factor VIII in pre-clinical hemophilia model
Benefits of Sernova’s Cell Pouch Technology
➡➡➡➡➡
Reduce/eliminate factor VIII infusions
Maintain constant blood levels of factor VIII Reduce joint bleedsImprove long-term efficacy Improve Quality of Life
Estimated Market Size➡➡
20 K patients across North America & EU$10 B orphan indication
$
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➡
20kPatients across
North America & EU
$2,2BMarket
Opportunity
150KThyroidectomies
performed annuallyinUS
CELL POUCH SYSTEM THYROID PROGRAM
THERAPEUTIC BENEFITS & ESTIMATED MARKET
Completed pre-clinical proof-of-concept
Clinical study regulatory submission in process
Benefits of Sernova’s Cell Pouch Technology➡➡➡➡➡
Reduce / eliminate daily life long thyroid medications Recover natural feedback loop of thyroid hormones Reduce side effects from low thyroid hormone levels Improve long-term efficacyImprove Quality of Life
Estimated Market Size➡➡
150,000 thyroidectomies performed annually just in the US$2.2 B market opportunityPotential near term revenue with patient own tissueStem cell derived technology for treatment of broad population
$
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➡
NORTH AMERICA
SOUTH AMERICA
EUROPE
ASIA
BROAD GEOGRAPHIC COVERAGE
INT. PATENT PORTFOLIO
OCEANIA
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Sernova has an international patent & patent applications portfolio in multiple patent families for broad applications and continued expansion
• Composition & use of medical devices for delivery & cell transplantation
• Glucose responsive insulin secreting stem cell technologies
• Local immune protection technologies
ACTION PLAN
SERNOVA NEXT STEPS AND UPCOMING MILESTONES
01Platform Technology
Develop licensed/acquired local immune-protection technologies for therapeutic cellsPrepare local immune-protected diabetes islets and stem cell technology in preparation for
First-in-Human (FIH) studyExpand existing strong worldwide multi-family patent portfolio
02Diabetes T1D
Enroll final study patents for T1D - complete Phase I/II T1D Study Initiate Phase I/II T1D Study with Conformal Coated human islets Initiate Phase I/II T1D Study with Conformal Coated Stem Cell
Diabetes technology
03Hemophilia A (Rare Diseases)
Establish collaboration on rare diseases Market & product positioning assessment
Clinical plan development
04Thyroid
Complete and submit regulatory package to NA regulatory authorities
Initiate Phase I/II Clinical Trial
05Corporate/Partnering
Complete Corporate deals with pharma companiesComplete corporate deal with MedTech CompanyPlanned uplisting of stock
SERNOVA CORPORATE TEAM
SernovaCorp
SERNOVA CORPORATE TEAM
Dr. Philip M. TOLEIKIS
BA, MSc, PhD
CEO, President, Director
Frank SHANNON
Vice President Clinical Development and Regulatory
Affairs
David SWETLOWCPA, CA
Chief Financial Officer
BOARD OF DIRECTORS
Frank HOLLER Chairman
Jeffrey BACHADirector
Deborah BROWNDirector
James PARSONSDirector
Dr. Philip M. TOLEIKISCEO, President
Dr. Mohammad AZAB
Director
SHARE STRUCTURE
FSE/ XETRA
PSH
OTCQB
SEOVF
Sernova Corp. 31
TSX-V
SVA
OTCQB
SEOVF
FSE/XETRA
PSH
Market Cap $334M
Share Price $1.29
Strong CashPosition $32M
SharesOutstanding
258M
Fully Diluted
≈320M
Head Office700 Collip Circle, Ste 114 London,
ON, Canada N6G 4X8
Tel: 1.877.299.4603
Tel: 1.519.858.5184
Fax: 1.519.858.5099
CorpSernova
Business Development
Dr. Philip Toleikis
1.519.858.5184
Investor RelationsCorey Davis, Ph.D.
LifeScience Advisors, LLC
1.212.915.2577