The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY...

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Transcript of The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY...

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 ResearchLeads 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

approved by FDA, EMA, etc…

NEW mechanism of action

Superior to Salbutamol!

Perflubron

CO2

Circulaire II

S-1226TM

Faster Than Salbutamol

0 secondtreatment

2 secondstreatment

3 secondstreatment

1 secondtreatment

4 secondstreatment

Pre-MCh Post-MCh

www.SolAeroMed.com/S-1226

Tissue dye

More Potent and Longer-Lasting than Salbutamol

Immediately 10 minutes 20 minutes0

10

20

30

40

50

60

No treatment

Salbutamol

S-1226™ (12%)

Time After Treatment Cessation

% O

peni

ng o

f Air

way

s

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

MarketsEmergency 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

??

TeamManagement

Experienced in the business, and top scientists

Board of DirectorsExtremely successful at growing and selling respiratory medicine

companies

AdvisorsHighly networked, experienced

2008-2012 2013 2014 2015 2016 2017-Nonclinical ResearchDrug Screening ✓Compare vs Salbutamol ✓Find Optimal Dose ✓

ManufacturingBuild Prototype ✓Secure Suppliers ✓Minimize COGS ✓Large-Scale  

Clinical DevelopmentReceive NOL ✓Phase I Phase IIa Phase IIb Phase III

MarketingSecure Marketing Partner Marketing Clearance Launch

US VCs &Partn

ers

Corporate Development

EXIT - Acquisition

CorpOff.inUS

- July 2013 - CTA@Boston Award

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-RiskedAnimal Studies

Pre-clinical Phase I Phase IIa Phase IIb Phase III Approval

Regulatory Approval

Statistically Significant

Data

Controlled Human Efficacy

Toxicity

Proof of Concept &

Animal Studies

Risk

Manufacturing

Real World Efficacy

Manufacturing - 510(k)

Efficacy – sheep, humans

Toxicity – past studies

S-1226™

Future Partnerships

We are seeking additional strategic partnerships to help fund, develop, and commercialize S-1226™