Islet Investor Presentation Oct 2016 Global Online Growth Conference
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Transcript of Islet Investor Presentation Oct 2016 Global Online Growth Conference
Investor Presentation
May 2016
Safe Harbor
This presentation includes forward-looking statements that are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. While these statements are made to convey to the public the company’s progress, business opportunities and growth prospects, readers and listeners are cautioned that such forward-looking statements represent management's opinion. Whereas management believes such representation to be true and accurate, based on information and data available to the company at this time, actual results may differ materially from those described. The company's operations and business prospects are always subject to risk and uncertainties. Important factors that may cause actual results to differ are set forth in the company’s periodic filings with the US Securities and Exchange Commission.
To become the leading innovator, developer
and provider of therapeutics and diagnostics
for diabetes.
Islet Sciences - Our Mission
Investment Highlights
Multi-pronged strategy focused on prevention, early diagnosis and treatment of diabetes
Diabetes will have an impact on over half of Americans by 2020
Developing state of the art diagnostic system for early detection and intervention of diabetes - Based on proprietary patented technologies
Key partnerships established
Globally recognized management including former head of NIH
Experienced Management & Board John Steel
Chairman, CEO, Director
20+ years experience in healthcare services and biotechnology
Former CEO of MicroIslet, Inc.
Christian Mende, M.D.
Chief Scientific Officer
Clinical Professor of Medicine at University of California, San Diego
Fellow of the American College of Physicians, the American Society of Hypertension, Nutrition and Nephrology
Gary Wilder
COO, CFO
Finance and global corporate management in the biotech, technology and a variety of other industries
Bachelor of Science in Business Administration from the University of Southern California
Gary Blackburn
Director
Currently CEO of bioMeDx Advisors, a consulting firm he established in 2010. Previously Chief Executive Officer and Director of Claremont BioSolutions from 2010 through 2015, President and CEO of Ohmx Corporation, a protein diagnostics company, from 2005 to 2010.
B.S. degree in Chemistry, Ph.D. in Biomedical Engineering from the University of Utah, completed an NSF Postdoctoral Fellowship at Cornell University. Authored numerous publications in the fields of biosensors, immunoassay detection technologies and molecular diagnostics and is the inventor or co-inventor of more than 30 U.S. and foreign patents.
Gary Keeling
Director
Executive Vice President of Sales & Marketing & BOD Member for Eight Medical Corporation
BS in Economics from the University of Pittsburgh.
Gene Mannheimer, Director Healthcare IT & Services industry at Topeka Capital Markets
MBA in Finance from the University of Southern California and a dual BS in Economics and Systems Engineering from The Wharton School, University of Pennsylvania and Moore School of Electrical Engineering
Renowned Scientific Advisory Board Thomas J. Kindt, PhD
Chair
Dr. Kindt, has previously served as Chief Scientific Officer of Diomics Corp., of San Diego and InNexus Biotechnology.
For the past 11 years Dr. Kindt has served as an adjunct member of the Department of Biology at the University of New Mexico and authored a major textbook on immunology.
From 1995 to 2005, Dr. Kindt served as Director, Division of Intramural Research, NIAID, NIH, in Bethesda, Maryland, responsible for the management of the Division including 1,300 staff members, overseeing an annual budget of $340 Million, and 6 research facilities including Bethesda, Rockville and Frederick, Maryland.
Bachelor of Science in Chemistry (cum laude) from Thomas More College and Ph.D., in BioChemistry from the University of Illinois at Urbana–Champaign.
Kevan Herold, M.D.
Professor of Immunology and Medicine at Yale University
Jerry Nadler, M.D.
Professor & Chairman of Internal Medicine and Director of the Strelitz Diabetes Center at Eastern Virginia Medical School
Former Chief of Endocrinology at the University of Virginia
Steven Paraskevas, M.D. Ph.D. Transplant surgeon and Director of the Pancreas and Islet Transplant Program and of the Human Islet Isolation Laboratory at McGill University at McGill University
Christian Mende, M.D. Clinical Professor of Medicine at University of California, San Diego
Fellow of the American College of Physicians, the American Society of Hypertension, Nutrition and Nephrology
Strategic Partners
Academic & Grant Partners
Medical Need
Over half of Americans will have diabetes or will be pre diabetic
by 2020 at cost to U.S. healthcare system of $3.35 trillion(1)
• ~26 million Americans currently have diabetes (2)
• 79 million Americans are estimated to have pre diabetes(2)
• >$400 B total cost of diabetes in the U.S. in 2017(2)
~40% of diabetics are insulin dependent(2)
• Insulin injections do not address major complications of
insulin dependence especially kidney, heart, nerve and eye
disease
(1) Source: Reuters, UnitedHealth Group, Inc., Nov. 23, 2010
(2) Source: American Diabetes Association
Diabetes Attacks the Body in Multiple Ways
Hyperlipidemia
Hypertension
Hyperglycemia
Insulin Resistance
Hypercoagulable State
Inflammation
The Islet Sciences Path to a Cure
Early diagnosis by detecting damaged
and dying beta cells
Prevention by protecting new insulin
producing cells from immunological attack
• Preserve insulin producing cells in
newly diagnosed patients
Treatment by providing new insulin
producing cells
• Transplantation of encapsulated porcine
islets
• Regenerate patient’s cells
Human islet
protected by Lysofylline
Protection using Islet
Sciences alginate capsule
Novel method of
maturing viable porcine
islets
Initial Target Patients
Initially targeting end-stage renal disease (ESRD)
• Diabetes is leading cause of ESRD
• Causes 44% of new ESRD cases
100,000 new cases of ESRD reported annually
20-40% of Type 1 diabetics develop ESRD by age 50
• In the absence of adequate treatment by dialysis
or transplantation, these patients die
1,000,000 people currently living with kidney
transplant and diabetes
Early Diagnosis Through Detection of
Damaged and Dying Beta Cells
“A Needle in a Haystack”- Detecting β cell
DNA in the blood of prediabetic patients
With permission from Eitan Akirav PhD
β Cells
Pancreas Blood
Blood Detection
Current methods for measuring β cell death
Current evaluations of β cell mass rely on functional
assays (glucose tolerance test, c-peptide measurements,
glucose/insulin clamps)
β cell function may not provide a direct indication
regarding active β cells loss
Imaging of β cells/islets has proven difficult owing to
pancreas location and image resolution
Circulating β cell-derived factors may offer an
opportunity for detection of early β cell loss
β cell DNA is detected in primary islets and
primary insulin positive murine cells
Akirav et al., PNAS, 2011
Non obese Diabetic mouse is a spontaneous
model of human type 1 diabetes
DAPI Insulin CD31
NOD.SCID Prediabetic NOD Diabetic NOD
Akirav el al., Diabetes, 2011
Prediabetic NOD mice show a progressive
loss of glucose tolerance – NIH Funded
0
50
100
150
200
250
300
0 15 30 60
Blo
od
glu
co
se
mg
/dL
Time (min)
7 wks 9 wks
11 wks 14 wks
Akirav et al., PNAS, 2011
Circulating β cell DNA increases prior to
development of hyperglycemia
Dem
eth
yla
tio
n in
dex
7 w
eeks
9 w
eeks
11 w
eeks
14 w
eeks
Dia
betes
0.001
0.01
0.1
1
10****
0 5000 10000 15000 200000.0
0.5
1.0
1.5
2.0
Insulin (ng/pancreas)
Dem
eth
ylat
ion
ind
exAkirav et al., PNAS, 2011
β cell death is detected in real time
Akirav and Lakey labs
0
100
200
300
400
500
600
700
0
5
10
15
20
25
30
35
Pre injection 3 h 48 h 72 h
Glu
co
se
(m
g/d
L)
Rela
tive a
bu
nd
an
ce o
f b
eta
cell
DN
A
No
ram
ali
ze to
pre
ijecti
on
Gulcose Beta cell DNA
– Novel mDNA detection of b cell death
Kevan Harold, MD, PhD
Yale University, CT
β cell DNA is detected in human islets and sera of
recent onset insulin dependent diabetic patients
Akirav et al., PNAS, 2011
Expected Milestones
Corporate partnerships in place
FDA Phase 2 trials underway
Exploring accretive acquisitions
Protect and Preserve Insulin Producing Cells
Interleukin-12 : A Promising Target for Diabetes
IL-12:
• pro-inflammatory cytokine
• important for cell mediated immune responses such as type 1
diabetes and atherosclerosis
• Uses JAK/STAT4 signaling system to induce particular genes linked
to chronic inflammatory disorders
High glucose, Obesity and Diabetes markedly increase IL-12/STAT4
expression in key tissues
LSF & new oral analogs block activation of IL-12/STAT4 and preserve
islet function and viability
IL-12 is made directly in insulin producing beta cells of the pancreas
and can directly lead to reduced insulin secretion and cell death (2012
Publication)
LSF Reverses T1DM in NOD Mice
In Combo with Exendin-4
S.C. Medication Pump removed Day 28
N=9 mice/treatment group
Yang Z BBRC 2006 (344) 1017-1022 New grant for $250,000 from Iacocca Foundation to begin
to move this into the clinic
STAT-4 deficiency reduces atherosclerosis in 34 week-
old Apoe mice – Astra Zenaca/NIH Funded
female
male
IL-12 and Type 2 Diabetes
Lysofylline (LSF) Mechanism of Action
IL-12 activates key inflammatory pathway
IL-12
STAT4 STAT4 P-STAT4
Gene
expression
IL-12 receptor
Lysofylline (LSF)
Small molecule that blocks inflammatory actions of cytokines that destroy insulin-producing beta cells
Potential lead indications include:
• Adjunct therapy for islet cell (or other cellular) transplantation to reverse Type 1 diabetes
• Reversing or arresting progression of Type 1 diabetes, Latent Autoimmune Diabetes of Adults (LADA) and insulin-using Type 2 diabetes
• Treatment of diabetic nephropathy and diabetic retinopathy
Human islet cell being attacked by
inflammatory cytokines
LSF protects human islet cells
attacked by inflammatory proteins
LSF/Piglet islet co-culture study – NIH Funded, 2014
Piglet islets isolated and cultured for 8 days in ISM media
(37oC/5%C02), then encapsulated with 2.1% sodium alginate and
placed media with and without LSF (10 or 50um).
Encapsulated piglet islets were then culture for an additional 48
hours and evaluated for islet recovery.
400.00
450.00
500.00
550.00
600.00
650.00
700.00
0 24 48
Isle
t Eq
uiv
alen
t
Hours in Culture
Control
10um LSF
50um LSF
Single dose of LSF Significantly Reduced IFNγ
IFNgMean and Standard Error
Column
A B
2,700
2,600
2,500
2,400
2,300
2,200
2,100
2,000
1,900
1,800
1,700
1,600
1,500
1,400
1,300
1,200
1,100
1,000
900
800
700
600
500
400
300
200
100
0
* p<0.01
Legend
A = Pre LSF Dose
B = Post 24 hour LSF Dose
*
IFNγ (Interferon gamma), a key component in the cause of Type 1
diabetes, reduced by LSF in clinical trial* *Astra Zeneca, 2013
Lysofylline (LSF) Development In Process - Summary
Two open INDs
5 Phase I trials completed involving 51 healthy subjects
− LSF was well tolerated
− No subject experienced a serious adverse event
CMC package to FDA
Toxicology package for IND
Uses for athrosclerosis, diabetes and kidney disease
Combination LSF/GLP-1 (Glucagon-like peptide-1) underway
Treatment Through Transplantation of
Encapsulated Porcine Islets
Clear Benefits of Transplant Therapy
Extended kidney graft
and patient survival
Reduction of long-
term diabetes
complications
Lower long-term
healthcare costs
Quality of life
improvement 30
40
50
60
70
80
90
100
0 1 2 3 4 5 6
Pancreas & Kidney
Transplant *
Kidney Transplant
Plus Islet Therapy
Kidney Transplant
with Ongoing DM
Dialysis with
Ongoing DM
years
*1,000 performed annually
Source: CDC, 2011
Improved method of pig islet isolation and maturation
Islet Sciences
Piglet Islet Previous Porcine Islet
UC, NIH and JGRF, 2014
Diabetic C57BL/6 Mice Transplant
3,000 Encapsulated Islets (IEQ) – NIH, 2014
0
100
200
300
400
500
600
-6 7 20 33 46 60
Blo
od
Glu
co
se
(m
g/d
L)
Days Post Transplant (Days)
STZ
Txp
x x x x x
Average Insulin: Green Line, 1X = 1U Insulin
x
No Immunosuppression
2016 Expected Milestones
Develop Islet Sciences Infusion therapy for insulin
dependent patients with end stage renal disease (ESRD)
Establish infrastructure to provide scale and logistics for
clinical trials and commercialization
Develop LSF to block autoimmune damage to insulin-
producing cells
mDNA assay for detection/management of diabetes
Expand development and commercialization partnerships
Selectively acquire and develop complementary
technologies
Consolidated Balance Sheet
January 31, 2015 April 30, 2014
(Unaudited) (Audited)
ASSETS
CURRENT ASSETS
Cash $23,938 $1,141
Prepaid expenses 14,098 700
Security deposits 21,761 -
Total current assets 59,797 1,142,080
OTHER ASSETS
Fixed assets, net 5,284 -
Intangible asset (Note 3) 1,367,000 1,367,000
Goodwill (Note 3) 2,111,107 2,111,107
Total other assets 3,483,391 3,478,107
TOTAL ASSETS $3,543,188 $4,620,187
LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES
Accounts payable $3,536,284 $3,271,174
Accrued expenses 65,805 -
Accrued stock compensation expenses (Note 4) 142,177 433,346
Notes payable - related parties 53,212 91,641
Total current liabilities 3,797,478 3,796,161
Deferred income taxes 547,000 547,000
Total liabilities 4,344,478 4,343,161
Commitments and Contingencies (Note 5)
STOCKHOLDERS' EQUITY (DEFICIT)
Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding at January 31, 2015 and April 30, 2014
- -
Common stock, $0.001 par value, 100,000,000 shares authorized; 66,928,724 and 67,516,253 shares issued and outstanding at January 31, 2015 and April 30, 2014, respectively
66,929 67,517
Additional paid-in capital 21,053,550 20,598,242
Accumulated deficit (21,921,769) (20,388,733)
Total stockholders' equity (deficit) (801,290) 277,026
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)$ 3,543,188 $4,620,187
Key Takeaways
Multi-pronged strategy focused on prevention, early
diagnosis and treatment of diabetes
Diabetes will have an impact on over half of Americans
by 2020
Developing state of the art diagnostic system for early
detection and intervention of diabetes
− Based on proprietary patented technologies
Key partnerships established
Globally recognized management including former head
of NIH
Thank you for your attention!