Investor Presentation
Improving the Quality of Life
for Patients with Chronic
Disease
TSX-V:
SVA
2015
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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Sernova is a Canadian based, clinical stage,
regenerative medicine therapeutics company
Sernova has developed a scalable, implantable
medical device, The Cell Pouch, for the survival and
function of therapeutic, immune protected cells
Our platform addresses the unmet needs of patients
suffering severe chronic diseases, focused on
Dr. Philip Toleikis
, PRESIDENT AND CEOPrevious Angiotech Head of R&D (reached $2.0B market cap; drug/device combinations)
Frank Holler
, CHAIRMANCo-Founder Angiotech & ID Biomedical ($1.6BM Exit to GSK), Xenon Pharma
Ralph Deiterding
, CFO20 years financial bknd; MKS, Workbrain - $40M IPO; TSX and Nasdaq exp.
Delfina Siroen
, SR. DIRECTOR RESEARCH & DEV.>20 years academic and corporate experience; Product development, Clincal, management. U. Western Ontario, Sernova Corp
Nick Borrelly
, BUSINESS DEVELOPMENT25 years sales & marketing and corporate/business development at Ciba-Geigy/Novartis & Sanofi-Aventis
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Key Management
Board of Directors
Frank Holler
Jeffrey Bacha
James Parsons
Bruce Weber
Our Therapeutic System
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Therapeutic
Cells
Immune
Protection
Cell
Pouch™
The Total Regenerative Medicine
Solution
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Cell Pouch™
An implantable medical device for therapeutic
cells placed under the skin
Proven safety in humans
Therapeutic Cells
Cells that produce and release missing (or
needed) proteins or hormones into the
bloodstream (human donor cells, xenogeneic
cells, stem cell derived cells)
Proven safety & initial efficacy in humans
Immune Protection
Providing local immune protection of the
therapeutic cells within the Cell Pouch
eliminating the need for antirejection drugs
The Cell Pouch delivery system offers a potential for treatments across
multiple chronic diseases, primarily Diabetes (Type 1 and 2) and
Haemophlia
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10%63%
27%
Diabetes
Epidemiology
Type 1:
Insulin Dependent (10%)
Type 2
: Insulin Dependent (27%)
Type 3:
Insulin Resistant (63%)
Insulin therapy:
37% (9M US/34M Asia)
Sernova patented countries:
25M patients)
Diabetes side effects:
heart, kidney, nerve disease,
stroke, amputations, blindness
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)
Diabetes Market
& Opportunity
Sernova Product #1: Diabetes
➺
Patient population: Insulin injections, insulin pumps,
Edmonton Protocol
➺
9M North America, 35-40M Worldwide
➺
Sernova product goals: Reduce hypoglycemia
unawareness; reduce exogenous insulin; improve
patient QOL, improve glucose control; improve
long-term efficacy
➺
Development status: Phase I/II clinical POC: Interim
device and cell safety results released
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Sernova Product #2: Haemophilia
➺
Patient population: Haemophilia
A ≈20,000 NA/EU
➺
Current products: 3X weekly infusions of Factor VIII
($200k/yr)
➺
Sernova’s Product: Therapeutic cells within the Cell
Pouch which release Factor VIII on a constant basis
➺
Sernova product goals: Improved efficacy with
prophylactic treatment; reduced cost; improved patient
QOL; reduction of disease side effects
➺
Development status: Preclinical
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$5B/yr Orphan indication for patients whose blood is missing a critical
clotting agent
Current State of the Art
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Components, clockwise
include:
➺
Insulin
➺
Insulin pump reservoir
➺
AAA battery
➺
Insulin pump infusion set
➺
Emergency glucagon kit
➺
Insulin pump
➺
Test strips
➺
Lancets
Insulin Pumps – a huge unmet medical need
Typical Approximate Annual Cost (US):
with
insurance
$4,000
without
insurance
$26,000
Diabetes Treatment Overview
➺
Main Problem: Outdated Treatment
Methods
➺
What people are using is inadequate
•
Insulin injections, pumps, medications, etc.,
or
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Transplant of donor islets into the portal vein
➺
Numerous limitations
•
Inconvenient (Insulin injections 4-6x day)
•
Constant monitoring lowers patient’s quality of life
•
Painful needles & infection prone
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Poor compliance
serious side effects
•
Expensive
➺
No new significant developments or
permanent alternatives to treat diabetes
for the last 70+ years
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Sernova’s Goal is
for the Cell Pouch
to be transplanted
with advanced
cells such as
insulin responsive
stem cells, locally
protected from the
immune system
without the need
for anti-rejection
drugs.
Preclinical Proof of Concept
(A)
Severely diabetic animal. Cell Pouch™ &
therapeutic cells transplanted. Achieve normal
glucose level for 100 days and then device
removed and animals return to diabetic state.
(B)
Positive glucose tolerance test. Meaning:
Sugar injected into the bloodstream is able to
be removed. The insulin released from the Cell
Pouch™ brings sugar levels back to the normal
state.
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Cell Pouch™ Islet Transplant in Small
Animals
Photograph of islets within the Cell
Pouch™ after 100 days.
Red = insulin, Green = blood vessels,
Blue = live cells
Conclusion: Proves safety & efficacy
of islets within the Cell Pouch™ in
small animals
Cell Pouch™ Large Animal Islet Transplant Study
Implanted Cell Pouch™ chamber ready for transplant
Cell Pouch™ developed tissue chambers rich in micro-vessels for cell
transplant
Sustained large animal efficacy
Pancreatectomy Diabetes induction (STZ) 1 day Islet Transplant 4-7 days Cell Pouch™ removal
4-8 weeks 8-12 weeks 1 week
Cell Pouch™
implant
Preclinical Efficacy: Cell Pouch
™
0 1 0 2 0 3 0 4 0 0 5 1 0 1 5 2 0 2 5 3 0 N o n - d ia b e t ic D a y s P r e - T x F a s ti n g B lo o d G lu c o s e ( m m o l/ L ) 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 0 5 1 0 1 5 2 0 2 5 3 0 D a y s P o s t - T r a n s p l a n t F a s ti n g B lo o d G lu c o s e ( m m o l/ L ) C e ll P o u c h R e m o v a l H y p e r g ly c e m ic (n= 4 ) D ia b e t ic ( n = 2 ) G ly c e m ic c o n t r o l (n= 4 )
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Preclinical Efficacy: Cell Pouch
™
Healthy Islets in the Cell Pouch™ (purple); Micro-vessels (red arrows) Sernova Corp12 Weeks Post Cell Pouch™ and
Islet Transplant
Islets showing insulin (red) and supporting blood vessels (green)Sernova Corp Sernova Corp Insulin Glucagon Nuclei Insulin Somatostatin Nuclei 50um 50um Insulin vWF Insulin vWF Nuclei
Islets showing insulin (red) and other pancreas hormones (green)
50um 50um C-peptide Nuclei Insulin Nuclei
Insulinand C-peptide co-localize to the same area, therefore these images are the same section, showing co-localization of both insulin and C-peptide
Sernova Corp Sernova Corp Sernova Corp Sernova Corp Sernova Corp Sernova Corp
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Insulin Independence Proven in
Diabetic Animals
➺
Independent 3
rdparty assessment proves 95% insulin
independence in diabetic animals
➺
Proven healthy islets with strong insulin staining & microvessels
➺
Efficacy using the marginal islet mass
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200 islets/mouse
Glucose levels rise upon
Cell Pouch™ removal
Clinical Study: Proof of Concept
➺
Phase I/II Clinical Study conducted in subjects with
severe diabetes
➺
Measures of Cell Pouch™ and cell safety are
demonstrated
➻
Islets housed within a natural tissue matrix
➻
Islets are well vascularized
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Safety standards were successfully met
➻
Islets show evidence of insulin, somatostatin, & glucagon
➻
No evidence of inflammatory reaction
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No evidence of immune destruction of transplanted islets
Sernova has achieved strong preclinical confirmation of
safety and efficacy and initial clinical success with human
islets in brittle diabetic patients
Diabetes Value Drivers?
➺
Donor islets results advance proof of
concept and secures Cell Pouch as a viable
technology
➺
Unlimited supply of cells could treat the
current 35-40M diabetic population
➻
Sernova is focused on evaluating glucose responsive
stem cell technologies
➻
Sernova is evaluating immune protected xenogeneic
islets as a second source of cells
➻
Sernova is in-licensing commercial rights for appropriate
technologies and securing pharma relationships
➻
Sernova is developing local immune protection
technologies
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Why Invest in Sernova?
➺
Sernova has advanced the novel Cell Pouch technologies over the
past 6 years and has a robust international patent portfolio which
includes U.S. and foreign patents – key to pharma licensing deals
➺
Key preclinical safety and efficacy demonstrated with islet therapy
treatment with confirmatory safety human clinical data
➺
Potential for multiple licensing deals
➺
We believe Sernova is the only regenerative medicine company
with a disruptive technology with multi billion dollar market potential
for each of its clinical indications
➺
Experienced management w/ a track record of deals and buyouts
w/ large pharma companies
Sernova: Potential Upside/3-12 mth
Roadmap
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pII
pIII
sales
2009-12 Time= 6mths-1y M/C Range>$150M Immediate Potential – 3-5x Return With Efficacy (> 10X) With Partner ($1.50-2.00)
pre-clinical
Clinical
Market Authorization Diabetes – Human TrialsHemo - Pre-Clinical $0.30/share M/C>$40M
~Partnerships
Licensing
seller = bio buyer = pharmadeal zone
academic
pI/II
Contact
Investor Relations
Ray Matthews
+1-604-818-7778
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General Inquiries
1-877-299-4603
114 - 700 Collip Circle
London, ON N6G 4X8
Business
Development
Philip Toleikis
+1-604-961-2939
www.sernova.com
