Download SAMi_IS_2013 - updated

The AsthmaCo.
June 2013
$8.9B Problem in Asthma
 SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several
“me toos” - all act via same B-adrenergic pathway
 $1.6B sales, 4th most prescribed, 15th highest selling GENERIC worldwide
 When Salbutamol doesn’t work…
 3.9M Emergency Department visits / yr
 TREATED WITH SALBUTAMOL AGAIN! – no other options exist
 $2.1B: 85% sent home after 3 hrs
 $6.8B: 15% take up 1.8M hospital bed-days
 >10,000 deaths worldwide
 WHAT IS NEEDED:
 NEW Short-Acting Bronchodilator, with NEW mechanism of action
Canadian Asthma Research
Leads to New Drug Discovery
NEW mechanism of action
Mucous plugs
Drugs can’t get to where they
are needed
New Treatment: S-1226TM
 Perflubron mixed with CO2-enriched air
 Short-Acting Bronchodilator
 Constituents are well described, safe
 Constituents have previously been
Circulaire II
approved by FDA, EMA, etc…
CO2
 NEW mechanism of action
Perflubron
 Superior to Salbutamol!
S-1226TM
Faster Than Salbutamol
Pre-MCh
Post-MCh
Tissue dye
0 second
treatment
1 second
treatment
2 seconds
treatment
3 seconds
treatment
www.SolAeroMed.com/S-1226
4 seconds
treatment
More Potent and Longer-Lasting than Salbutamol
60
% Opening of Airways
50
No treatment
40
Salbutamol
S-1226™ (12%)
30
20
10
0
Immediately
10 minutes
20 minutes
Time After Treatment Cessation
Patented in Major Markets
 Issued in US and Europe
 Pending in other jurisdictions
 Claims:
 Composition of matter and method to treat
 Monotherapy and in combination
Markets
 Emergency Department: “preceding salbutamol for acute
asthma exacerbation”


Estimated at $190M Peak Sales
Less than 10% COGS – approximately $13/unit
 Personal rescue device

Estimated at up to $2.9B Peak Sales
 Combination drug

Estimated at $2B - $4B Peak Sales
Partners
Proprietary nebulizer
Exclusive Perflubron supply
(marketed as Perflubronc® by Origen Biomedical)
Phase I Clinical Trial
Phase IIa Clinical Trial
Development Partner Candidates
Team
 Management
 Experienced in the business, and top scientists
 Board of Directors
 Extremely successful at growing and selling respiratory medicine
companies
 Advisors
 Highly networked, experienced
Corporate Development
2008-2012
Nonclinical Research
Drug Screening
Compare vs Salbutamol
Find Optimal Dose
Manufacturing
Build Prototype
Secure Suppliers
Minimize COGS
Large-Scale
2013
2014
2015
2016
2017-
✓
✓
✓
- July 2013 - CTA@Boston Award
✓
✓
✓
Clinical Development
Receive NOL
Phase I
Phase IIa
Phase IIb
Phase III
Corp
Off.
in
US
✓
US
VCs &
Partn
ers
EXIT - Acquisition
Marketing
Secure Marketing Partner
Marketing Clearance
Launch
Prototype
Proof of Concept
Market Test
Exit
US Expansion
 Interest expressed by:
 Boston Harbor Angels, Lead: Bill McPhee
 Mass Medical Angels, Lead: Frank Bobe
 Launchpad, Lead: Eduardo Pontoriero
 Office in Cambridge, MA
 Canadian Technology Accelerator

Selected in a highly competitive application process
 Cambridge Innovation Center Office
 Other
 MIT VMS, Lead: Jerome Smith
 Keiretsu Forum, Lead: Thealzel Lee
S-1226™ is De-Risked
Proof of
Concept &
Animal Studies
Animal Studies
Toxicity
Toxicity – past studies
Controlled
Human Efficacy
Efficacy – sheep, humans
Manufacturing
Manufacturing - 510(k)
Real World
Efficacy
Statistically
Significant
Data
Regulatory
Approval
Pre-clinical Phase I Phase IIa Phase IIb Phase III Approval
S-1226™
Future Partnerships
We are seeking additional strategic partnerships to
help fund, develop, and commercialize S-1226™