Conference Call Presentation July 18, 2019 - SEOVF
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SEOVF
TRADED ON
The Path To A Regenerative Cure
Conference Call Presentation
July 18, 2019
Forward Looking Statement
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.
2
Our Mission Sernova is a clinical stage regenerative medicine therapeutics company developing a Cell Pouch implantable device with therapeutic cells. Our primary focus is development of treatments for patients with insulin-dependent diabetes (T1), hemophilia A and thyroid disease Sernova is currently conducting a U.S. Phase I/II clinical trial targeting an indication of high risk type 1 diabetes with an unmet need called hypoglycemia unawareness as a first approach for our therapeutic Cell Pouch technologies
Sernova Share Structure
Sernova Corp Founded in 2006
Common Shares 172,237,348
Current Price 0.22
Market Cap 37,9 M
52 Week Range $0.145-$0.27
Transfer Agent AST Trust Company
4
Management Team
Dr. Philip Toleikis
PRESIDENT AND CEO
>20 years experience. Joined Sernova
2009. Previous Angiotech VP R&D
(achieved $2.0B market cap; Product
Revenue $200M/yr, drug/device Board of Directors
combination products).
• Frank Holler
• Jeffrey Bacha
• James Parsons
Sean Hodgins • Deborah Brown
CA-CPA, CFO
>20 years experience in biotech
industry. Joined Sernova in 2018. US
and Canada experience with both
Nasdaq and TSX experience.
5
Sernova’s Approach
Cell Pouch™
Therapeutic Cells
A Total Regenerative 28%
Medicine Solution for the 40%
Therapeutic Treatment of
Chronic Diseases 32%
Immune Protection
Cell Pouch
Top Notch Doctors Therapeutic Cells Immune Protection
An implantable
To inspire hopemedical device
and contribute to Cells that produce and release Technologies to protect
health and well-being by providing
which the
provides a vascularized
best care to every patient
missing (or needed) proteins or therapeutic cells from immune
environment for therapeutic cells hormones into the bloodstream system attack 6
Sernova Pipeline
CELL POUCH PRE- DEVELOPMENT
CANDIDATE CLINICAL PHASE I PHASE II PHASE III STAGE INDICATION
TYPE 1 DIABETES
HUMAN DONOR ISLETS, P H A S E I / I I I N I T I AT E D HYPOGLYCEMIA
SYSTEMIC IMMUNE DEC 2018 UNAWARENESS
PROTECTION
MICROENCAPSULATED A N T I C I PAT E D 2 ND
ISLETS HYPOGLYCEMIA
A P P R O VA L F O R
UNAWARENESS
DIABETES
MICROENCAPSULATED A N T I C I PAT E D 3 RD ALL INSULIN
STEM CELL DERIVED A P P R O VA L F O R DEPENDENT DIABETIC
CELLS DIABETES PATIENTS
HEMOPHILIA A
SEVERE HEMOPHILIA A
CORRECTED PATIENT PRECLINICAL
PATIENTS
CELLS
ALLOGRAFT IMMUNE EARLY BROADER HEMOPHILIA
PROTECTED CELLS DEVELOPMENT A PATIENTS
THYROID DISEASE
THYROIDECTOMY
THYROID CELLS PRE-CLINICAL
PATIENTS FOLLOWING
HYPERTHYROIDISM
7
Cell Pouch Human Clinical Evaluation
Type 1 Diabetes: 1st Clinical Indication
“Hypoglycemia unawareness” affects about 10% of Type 1 Diabetes
patients or about 125k patients in the US
• Clinically defined as a complication of diabetes in which the patient is unaware of a deep drop in
blood sugar levels
• Failure to trigger secretion of epinephrine a/k/a the symptoms of hypoglycemia (Palpitations, Anxiety,
Excessive Sweating, Light Headedness)
• Patients live in constant fear of their next diabetic episode
9Type 1 Diabetes : First-in-Human Study
Study Design
2015
• Diabetes subjects with hypoglycemia unawareness
• Open-label; single-arm
• Donor islet transplantation 2-24 weeks post Cell Pouch™ implantation
• Primary endpoint
• Safety post Cell Pouch™ implantation and 1 month post islet transplantation
Cell Pouch™ and Islet Safety Met
• Safety successfully met for the Cell Pouch™
• Cell Pouch™ histology assessed by independent
pathologists blinded to the treatment
• Islets housed within a natural tissue matrix
• Islets are well-vascularized
• Islet safety successfully met
• Islets show evidence of insulin, somatostatin, & glucagon
• Cell Pouch™ and islet biocompatibility met
• Proof of islet protection from immune system attack 10Type 1 Diabetes : First-in-Human Study
11Chicago Phase I/II Study
Phase I/II U.S. FDA Cleared Study
Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch™ for Clinical Islet
Transplantation
Study design: A open-label, single-arm study of Sernova Cell Pouch implanted with islets. Islets are transplanted into
the Cell Pouch after implantation and stable antirejection medication activity
Primary Objective: To demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the
treatment of TID in subject with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
Secondary Objectives: To establish islet release criteria that accurately characterize the islet product and are
predictive of clinical transplant outcomes into the Cell Pouch, which will be demonstrated through defined efficacy
measures
• 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 will occur
Status: US IND Cleared by FDA and IRB and patient enrolment initiated; Medtronic Minimed, Northridge, CA CGM is
supplying patients in Sernova’s U.S. regenerative medicine clinical trial of its Cell Pouch ; Next step: Interim safety and
efficacy results
13Phase I/II Timeline
Secondary Endpoints:
Immuno Survival of Endocrine Tissue & Identification of Hormones
Suppression
Reduction in hypoglycemic events
Introduced
Small Reduction in HbA1c
(sentinel)
Pouches
Cell Removed
1st Islet Dose
Pouch™ Transplant
Implantation Day 0 Day180 Day365
90 Days 90 Days
3-4 weeks 3weeks
Cell Pouch Vascularization Immunosuppression
Stabilized
Additional Safety Assessments
Feb 2019 Completed Days 30, 60, 270 Apr 2020
Post-Transplant Day0 Day180 Day365
90 Days 90 Days
Primary Endpoint: 2nd Islet Nov 2020
Initial Topline Safety Readout Transplant
(increase dose)
Safety
Efficacy
14Case Report of the First Treated Patient
Primary Endpoint- Safety Measures
Patient Number 1: Interim Findings
Safety- incidence and severity of adverse events determined to be probable or
highly probable to the Cell Pouch™
1. No incidences of AEs, determined to be probable or highly probable to the
Cell Pouch™
2. Cell Pouch™ well-tolerated and safe during the implant and the time of
transplant
3. No reactions to the Cell Pouch™ implant
4. Cell Pouch™ was well-incorporated with vascularized tissue and deemed
suitable to receive the islet transplant
These interim safety data meet the first measure of the
primary endpointSecondary Objectives/ Endpoints
To establish islet release criteria that:
1. accurately characterize the islet product and
2. are predictive of clinical transplant outcomes into the Cell Pouch™, which will be
demonstrated through defined efficacy measures
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 analysesFirst Patient Initial Efficacy Results
P R E IS L ET 3 MO N T HS 90 Day Post-Transplant
TRANSPLANT POST Glucose Tolerance Test
TRANSPLANT
BO DYW EIGHT 83KG 73KG Patient is given a high sugar
drink. C-peptide and insulin
response is measured over
HEMO G L O BIN 6.5 5.6* several hours
A 1C
DA IL Y U S E O F 14 U 8 U* • Showed increase in blood
L O N G A C T IN G levels of C-Peptide
IN S U L IN T R ES IBA • Showed increase in blood
levels of Insulin and a
DA IL Y U S E O F 15-16 14-15* typical insulin response
SHO RT A C T IN G • Conclusion: Definitive
IN S U L IN proof that the Cell Pouch
islets are surviving and
S EVER E 6-9/ 3months 1 / 3m on t h s * able to respond to high
HYP O GL Y C EMIC
levels of sugar by
EVEN T S
releasing insulin
18
* Showed improvement with transplanted Cell PouchCONTINUOUS GLUCOSE MONITOR: IMPROVEMENT IN ALL GLUCOSE
Comparison between baseline and post transplant parameters
PARAMETERS SEEN POST TRANSPLANT
Parameter Baseline Post Transplant
Performance
Highest Sensor Glucose Value (mg/dL) 285 231
Cell Pouch™ for
Lowest Sensor Glucose Value (mg/dL) 50 66
Islet Usability
# Glucose Excursions 15 3
Transplantation
# High Excursions 7 2
# Low Excursions 8 1
Standard Deviation (Variability) 37 31
Time above 180 mg/dL
Time in Range of 70-180 mg/dL
Time below 70 mg/dL
CGM POST CELL POUCH
BASELINE CGM ISLET TRANSPLANT
More excursions, hyper/hypo events Less excursions, hyper/hypo events
Less time in range More time in rangeSummary
Transplanted Cell Pouch Showed the Following Improvements Relative to
Baseline
• 90-day improvement in Hemoglobin HbA1c
• 90-day reduction in use of daily long acting insulin
• Continuous Glucose Monitor Assessment
Improvement in all glucose control parameters measured by continuous glucose monitoring
Reduction in severe hypoglycemic events
87.5% reduction in overall hypoglycemic events
Time below 70mg/dL: 12% control versus 1% post-Cell Pouch Islets
• 90-day Glucose Tolerance Test
Showed typical insulin release curve
Showed C-Peptide blood levels
Conclusion: Cell Pouch with islets is producing blood levels of insulin and showing the ability to have blood
sugar control in initial assessments
20Future Developments / Additional Programs
Hemophilia Program
Patient Population Sernova’s Cell Pouch™ with Factor VIII
• Hemophilia A ≈ 20,000 NA/EU ($15B Orphan Indication) releasing cells:
Hemophilia Therapy • Reduce/eliminate Factor VIII infusions
• Factor VIII Gene corrected cells within Cell Pouch – produce constant
therapeutic Factor VIII levels • Maintain constant blood levels of
o Patient corrected cells (autologous) Factor VIII
o Stem cell derived technology and local immune protection (allograft)
• Reduce joint bleeds
Therapeutic Goals:
• Improved efficacy with prophylactic treatment reduced cost; improved • Improve long-term efficacy
patient QOL; reduction of disease side effects
• Improve QOL
Sernova’s Product Approach
• Corrected own patient cells into the Cell Pouch (Horizon 2020 Grant)
o Status: Corrected patient cells survive and produce Factor VIII in
hemophilia model
• Treatment for all patients
o Stem cell releasing Factor VIII product
o Status: in development
22Thyroid Disease Program
Estimated Market Sernova’s Cell Pouch™ Thyroid
$2,2 Billion releasing cells:
Thyroid Therapy (Current Standard of Care) • Reduce/eliminate daily life long thyroid
Oral – Intravenous – Others medications
Targeted Thyroid Disorders (Thyroidectomy) • Recover natural feedback loop of
• Grave’s disease thyroid hormones
• Thyroid Nodules (Hyperthyroidism)
• Hashimoto disease • Reduce side effects from low thyroid
hormone levels
Therapeutic Goals:
Improved efficacy with prophylactic treatment reduced cost; improved patient • Improve long-term efficacy
QOL; reduction of disease side effects
• Improve QOL
Sernova’s Product Approach
• Thyroidectomy patient cells transplanted into the Cell Pouch
o Status: Preclinical assessment: Corrected patient cells survive and
produce thyroid hormone
23Collaborations
24President and CEO
Dr. Philip Toleikis
1-519-858-5126
Info@Sernova.com
Investor Relations
Danny Matthews
dmatthews@soleburytrout.com
Corporate Communications
SEOVF Dominic Gray
TRADED ON 1-519-858-5126
Dominic.Gray@Sernova.comYou can also read
