100M people in the US suffer from a problem for which we have a strong solution. The patents are issued, we are raising funds for FDA trial...

PAXEROL™ for NOCTURIA

07.21.2014

Misery associated with nocturiaInsomnia, fatigue, depression, lower quality of life

US lost work time $60B/year

Incontinence care currently 25%of the costs of nursing home care

Heart disease, stroke, brain damage, hip fractures

NOCTURIA is the #1 urology complaint of men and women 55-84

65%of peopleages 55-84

100Msufferers in US

(2.2B worldwide)

THIS IS A SIGNIFICANT UNMET MEDICAL NEED AS NO CURRENT DRUG TREATS LOW NOCTURNAL BLADDER CAPACITY

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Paxerol is a unique 8 hour extended release formulation that provides increased nocturnal bladder capacity (NBC) through the night. (+50-100%)

HOW IT WORKS: For 76% of people suffering from nocturia, low NBC is a key issue. The cause is excess Prostaglandins (PGE2) that irritate the bladder.

For sufferers of Nocturia and Over Active Bladder, a combination of APAP & ibuprofen will inhibit PGE2 production to increase comfortable bladder capacity.

People are informally using the combination of already approved drugs. It is proving effective for 80%. Our next step is to prove efficacy in trials. Our use of these drugs for this purpose and the addition of the timed release aspect are protected by numerous broad patents.

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INTRODUCING

APAP

ibuprofen

+ time release

Paxerol has three synergistic mechanisms of action.

SCIENTIFIC ADVISORSFrank Rauscher, III, Ph.D., Chief Scientist: Dep. Director, Wistar Inst.Khurshid Iqbal, Ph.D., Pharma Chemist, J&J, Hoffmann-LaRoche

LEADING CLINICAL EXPERTSTony DelConte, MD, led Novartis Enablex FDA trialsThomas Garvey III, MD, NIH, FDA, drug safety expert

LICENSING AND LEGALJoy Barton, Ph.D., Novartis, Licensing AgentEd Allera, Buchanan Ingersoll, FDA Focused LawyerPing Wang MD IP Medical Expert Andrews Kurth, (named top 1000 patent Lawyer)

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World Class TeamDavid Dill, CEO, IBM, CFO of 7 firms, 35 years as manager

6 Patents issued in 2012-2014 (16+ year life)

• Method of use claims; broad spectrum combinations.• Covers use with Over Active Bladder (OAB)• Extended release critical: 2-3 hour half life standard• Wide range dosing of APAP with antimuscarinics, diuretics, antidiuretics,

spasmolytics, and/or NSAIDs.• PCT process for worldwide protection filed 12/2010

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Intellectual Property

8,236,857 B2 – Extended-release formulation8,236,856 B2 – Delayed release formulation8,685,453 B2 – Low dose APAP and NSAIDs8,445,015 B2 – Extended-release formulation 8,445,011 B2 – Delayed-release formulation8,703,184 B2 – Delayed-release formulation

US PATENTS ISSUED:

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Vesicare, Enablex, Myrbetriq

• Effects often take months• Large % do not respond• Severe side effects• 43–83% stop in < 30 days• 10-15% fewer bathroom trips• Treats annoying problem• Significant competition

OVERACTIVE BLADDER DRUGS

2Mpatients

(0.1%)

$2BSALES

• Effects in as little as 30 mins.• 80% positive (anecdotal)• No side effects• 20% drop out (anecdotal)• 33-100% fewer nightly trips• Treats dangerous problem• No current competition

$2-8B SALES ?

Proving effective for OAB, but focused on treatment of bladder problems related to sleep

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Actionable Market

$2-8B SALES 2018

Paxerol is a new product that is effective in ways that current OAB (over active bladder) products are not.

*source 2013 Report by Debra E. Irwin et al / Company estimates

NOT A SIGNIFICANT

PROBLEM1 x per night

1.2 Billion

423 Million

Unaffordable600 Million

130 Million No efficacy 50 Million Medical Issues

$0.30 / dose/daily = $39B annual sales potential (retail)NOTE: Forecasting a new market is highly speculative.

2.4 Billion sufferers  es'mated  by  2018    

Almost all regulatory bodies outside US permit use of unlicensed drugs (“Specials”). We have an agreement for such distribution of Paxerol.

Contract signed April 2014 (Q1 2015 launch) with Ethicor Pharma, Ltd. (UK). Plan to launch Paxerol with support of key opinion leaders, education sessions, and published articles. Partnered with UDG, UK’s largest prescription drug distributor. Ethicor exits when big pharma enters markets.

Top end price target – $5/dose controlled by EthicorGross profit estimate – 98%

Only ages 60+, EU, MENA, and SA, with no advertising

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Ethicor Short-term Revenues

2015 2016 2017 2018 2019 TOTAL

$832 $6,611 $26,949 $50,538 $73,161 $151,091

$k Ethicor Projected Income

We have protocol feedback and indications of interest from key global pharmaceutical leaders.

Licensee to complete trials, patents, and launch Paxerol. We are expecting an upfront payment after Phase 2 trial (mid-2015), milestone payments, 15% royalty.

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Big Pharma License

Safe Drug, low risk Huge unmet need. Tight patent barrier through 2030

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Strengths of This InvestmentThis is not a new chemical entity. Approval can be attained with a simpler, relatively inexpensive trial: Avoids Phase 1 Trial safety tests, and years of risk from unexpected side effects.

Strong Ethicor validation. International sales begin before trial completion, mitigates risk. Mid-2015 worldwide big pharma license.

Strong ROI @ up to 94% net profit.$3M to positive Cash flow 12-15 months

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5$787K raised so far primarily through pooleddue diligence of Keiretsu Forum.

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Use of FundsPrimary use of funds will be in the management of the trial process and preparations for Ethicor launch.

Ethicor GP Rev Share

Expenses

Mfg. Testing

Clinical Trials

Business Dev.

Patents/ Legal WW

G&A / other

TOTAL Expenses

Net Income

2014 Q1 Q2 Q3

$42 $125 $221

$500 – – –

$612 $425 – –

$108 $29 $33 $38

$396 $130 $130 $90

$475 $55 $50 $50

$2,095 $639 $213 $178

($2,095) ($597) ($88) $43

Figures expressed as $k

2015

Profits in Q3 2015

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Projections

Ethicor GP Rev Share

Big Pharma Milestones

Big Pharma Royalties

TOTAL Revenue

Expenses

Net Income

%

2014 2015 2016 2017 2018 2019 2020 2021

$1 $7 $27 $51 $73

– $13 $5 $5 $38

– – – – $15 $77 $307 $768

$0 $13 $12 $32 $103 $150 $307 $767

$2 $2 $1 $2 $6 $8 $16 $39

($2) $11 $11 $30 $97 $142 $291 $729

– 84% 92% 94% 95% 95% 95% 95%

Figures $Millions

Key Assumptions1. FDA approval 2018 (no accelerated approval designation)2. $0.30 retail ($0.15 wholesale) in 20183. 15% License fee (15-18% tiered structure would add $120M in 2021)4. Licensing Agent 5% fee5. A $5B big pharma drug by 2021 (no OAB or bedwetting solution)

Patents filed (issued 2012, 2013, & 2014)

FDA Confirms no Phase 1 safety tests required

EU “Special” Ethicor contract (launch Q1/2015)

Series A complete and trial contract signed

1st patient starts trial:13 week crossover design; patients with 3+ voids/night

60 patient trial completed.

Sign big pharma license (Series A cash back)

FDA approval H1- Paxerol launch 6 weeks later

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Milestones7/2010

4/2012

4/2014

Q3/2014

Q2/2015

Q3/2015

2018

Q1/2015

• 22 patients informally tested Paxerol for a Johns Hopkins physician. 17 reported good results (fewer nightly bathroom trips). (77%)

• 18 patients have since tested Paxerol, with 15 reporting good results (1-4 fewer nightly bathroom trips).

• Placebo effects are always possible, but much less likely when sleeping.

• 32 of 40 patients (80%) self-report success – without placebo controls.

• 3 articles report OAB suffers’ urine averages 700% higher PGE2 levels - Paxerol addresses PGE2 levels.

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Anecdotal Evidence

Independent clinical studies consistently report that ~70% of nocturia patients experience improvement when taking appropriate doses of certain NSAIDs

80% of patients with neurogenic bladder and 74% of patients with BPH experience improvement in nocturia when taking appropriate doses of NSAIDs (consistent with animal studies)

Johns Hopkins proves NSAIDs reduce bladder spasms

Ohio State preclinical model of bladder function showed acetaminophen equal to NSAIDs in reducing inflammation, achieved through independent mechanisms of action

Together acetaminophen and NSAIDs impact multiple independent molecular pathways to relieve nocturia symptoms

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Supporting Research

No matter how niceyour bathroom is, nobody wants to visit in the middle of the night

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OAB Market Segment

$2.1B SALES 2011

*source 2013 Report by Debra E. Irwin et al / Company estimates

AstellasVesiCare3.8M

1.6 M Enablex

In the 12 months ending January 2012, more than 17.8 million prescriptions were filled for drugs in the Over Active Bladder, accounting for almost $2.1 billion in sales.

Oxybutynin3.7M

OxybutyninER 3.6M

PfizerDetrol LA3.3 M

712 k Pfizer Toviaz

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A Serious Problem

* Results from the Third National Health and Nutrition Examination Study

12 year survival odds for women ages 65-90 based on nightly voiding episodes:

0 voids 68%1 void 60%2 voids 50%3+ voids 22%

Association of Nocturia and Mortality: Results From the Third National Health and Nutrition Examination Study

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Clinical Trial DesignInclusion Criteria

• Those who use bathroom 3+ times/night

• Those with elevated PGE2 levels

Exclusion Criteria

• Congestive heart failure, diabetes, etc.

• Those with major arthritis or muscle pains

13 week double blind crossover study

• Each patient tests all alternatives (to normalize variables)• Paxerol, APAP, ibuprofen, placebo

• Show Paxerol’s superiority in reducing nocturia

• Delay time to first awakening

• Improve quality of life

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Series A vs Series BBoth share 50% of returns until made whole for initial investment

Series A thereafter gets returns based on $1.10/shareSeries B gets 50% until 15X invested $ back (1-4 years)

Inflated returns come from Founders, not Series ASeries B thereafter get returns based on $2.20/share