An all-volunteer,An all-volunteer,non-profit organizationnon-profit organization

Please welcome our guest…Please welcome our guest…

Jane CenturyJane CenturyVP Operations, Penn-Century Inc.VP Operations, Penn-Century Inc.

PCCI sponsors:PCCI sponsors:

An all-volunteer,An all-volunteer,non-profit organizationnon-profit organization

PCCI sponsorship …PCCI sponsorship …

Expanding the reach of aerosol medicine

PENNCENTURY™

Targeting aerosol medicine directly to the Targeting aerosol medicine directly to the lungs and other inaccessible places in the lungs and other inaccessible places in the

bodybody

Penn-Century, Inc. - At a GlancePenn-Century, Inc. - At a Glance

Incorporated in 1997 by Ted Century PhD, President & Incorporated in 1997 by Ted Century PhD, President &

Chief Scientific Officer, and Jane Century, VP OperationsChief Scientific Officer, and Jane Century, VP Operations

10 patents issued; 1110 patents issued; 11thth filed filed

Highly profitable, cash-flow positive, self-fundedHighly profitable, cash-flow positive, self-funded

Large, growing, loyal global customer baseLarge, growing, loyal global customer base

Lean organization by design; Mostly outsourced Lean organization by design; Mostly outsourced

manufacturing with final assembly in 3500 sq ft facilitymanufacturing with final assembly in 3500 sq ft facility

Seeking M&A exit, strategic partnership, or licensing Seeking M&A exit, strategic partnership, or licensing

agreementsagreements

Penn-Century, Inc.Penn-Century, Inc.

Evolved organically to meet an unmet need for a Evolved organically to meet an unmet need for a

safer, less wasteful and more precise method of safer, less wasteful and more precise method of

developing and testing respiratory and other drugsdeveloping and testing respiratory and other drugs

Completely mechanical, hand-heldCompletely mechanical, hand-held

Used in animal and Used in animal and in vitro in vitro modelsmodels

Product line includes - liquid and dry powder drug Product line includes - liquid and dry powder drug

delivery devicesdelivery devices

The advantages of pulmonary The advantages of pulmonary drug deliverydrug delivery

THE PLUSESTHE PLUSES Lungs offer the body’s broadest Lungs offer the body’s broadest

exposure to the vascular systemexposure to the vascular system Can treat both pulmonary and Can treat both pulmonary and

systemic diseasessystemic diseases Far faster than pills – avoids Far faster than pills – avoids

metabolic changesmetabolic changes Shots hurt!Shots hurt! Avoids systemic side affects Avoids systemic side affects

common to IV drugs common to IV drugs Higher concentration in lungsHigher concentration in lungs

Two major hurdles to pulmonary Two major hurdles to pulmonary drug deliverydrug delivery

ANATOMICAL ANATOMICAL ::

- We are not designed to have anything in our - We are not designed to have anything in our lungs but air lungs but air

- Particles must be 1-5ul to bypass nose and throat - Particles must be 1-5ul to bypass nose and throat

TECHNOLOGICAL TECHNOLOGICAL ::

- To make particles of an inhalable size, most - To make particles of an inhalable size, most nebulizers and inhalers depend on compressed air, nebulizers and inhalers depend on compressed air, propellant, heat or ultrasound propellant, heat or ultrasound

- This creates a lot of air and not much drug - This creates a lot of air and not much drug moving at high momentummoving at high momentum

The two most common methods ofThe two most common methods ofpulmonary drug delivery:pulmonary drug delivery:

Inhaler/Inhaler/NebulizersNebulizers

Liquid bolus/dropletLiquid bolus/droplet

• Slow, wasteful, inefficientSlow, wasteful, inefficient• Typically for symptom Typically for symptom managementmanagement• Hard to determine how Hard to determine how much got inmuch got in•High momentumHigh momentum• Cannot target a lobe or Cannot target a lobe or lesionlesion• Can contaminate Can contaminate atmosphere or expose atmosphere or expose cliniciansclinicians

• Fast - but harshFast - but harsh• Limited tolerance Limited tolerance • Poor distribution in the Poor distribution in the lunglung

Current pulmonary Current pulmonary drug delivery methodsdrug delivery methods

Nasal sprayersNasal sprayers

MDIsMDIs

Nebulizers/MasksNebulizers/Masks

Liquid bolus (droplet) Liquid bolus (droplet) delivery via an ET delivery via an ET tubetube

Penn-Century MicroSprayerPenn-Century MicroSprayer®® offers offers best of both worldsbest of both worlds

Nasal sprayersNasal sprayers

MDIsMDIs

NebulizersNebulizers

Liquid bolus delivery Liquid bolus delivery via an ET tubevia an ET tube

MicroSprayerMicroSprayer®® AerosolizerAerosolizer

Intratracheal Aerosol Intratracheal Aerosol DeliveryDelivery

Aerosol medicine that is Aerosol medicine that is administeredadministered - not inhaled - not inhaled

Fast at high volumesFast at high volumes Not dependent on breath Not dependent on breath

capacity of subjectcapacity of subject Targeted, local drug Targeted, local drug

deliverydelivery Low momentum, but high Low momentum, but high

concentrationconcentration Precisely quantifiablePrecisely quantifiable More uniform distributionMore uniform distribution Faster, safer delivery of Faster, safer delivery of

larger, clinically effective larger, clinically effective volumesvolumes

Highly efficient at smaller Highly efficient at smaller dosesdoses

MicroSprayerMicroSprayer®® Aerosolizer: Key Aerosolizer: Key featuresfeatures

Liquid device is purely Liquid device is purely mechanical, hand-held mechanical, hand-held aerosol drug delivery aerosol drug delivery platform platform

No airNo air No heatNo heat No vibrating meshNo vibrating mesh Works with vast array of Works with vast array of

drugs, biologics, drugs, biologics, suspensionssuspensions

Narrow enough to target Narrow enough to target the lungs, as well as other the lungs, as well as other areas - stomach, sinuses, areas - stomach, sinuses, colon, bladder, uteruscolon, bladder, uterus

MicroSprayerMicroSprayer®® Aerosolizer Aerosolizer

Model IA-1CModel IA-1C Narrow flexible tubing Narrow flexible tubing Operates at 3000 psi Operates at 3000 psi

with patented FMJ-250 with patented FMJ-250 High Pressure SyringeHigh Pressure Syringe

Can be made to any Can be made to any length, inserted via ET length, inserted via ET tube or bronchoscopetube or bronchoscope

MicroSprayerMicroSprayer®® Aerosolizer Aerosolizer

Model IA-1BModel IA-1B Larger, less flexible Larger, less flexible

tubing tubing Larger particle sizesLarger particle sizes Operates at 700 psi Operates at 700 psi

with a 1 ml disposable with a 1 ml disposable polycarbonate syringepolycarbonate syringe

Can be inserted directly Can be inserted directly or via a catheteror via a catheter

Dry Powder InsufflatorDry Powder Insufflator™™

Delivers a cloud of Delivers a cloud of dry powder directly dry powder directly to lungsto lungs

Can deliver particles Can deliver particles of nano- to macro-of nano- to macro-scalescale

Manually operated Manually operated with air syringe or air with air syringe or air pumppump

Custom lengths for Custom lengths for use in ET tube or use in ET tube or bronchoscopebronchoscope

Widely used and trusted for Widely used and trusted for pulmonary drug developmentpulmonary drug development

• In wide use by 700+ In wide use by 700+ leading pharmaceutical leading pharmaceutical and biotech companies, and biotech companies, medical research medical research centers, universities, centers, universities, government military government military labs, and CROs around labs, and CROs around the worldthe world

• Cited in more than 800 Cited in more than 800 peer-reviewed research peer-reviewed research publications and drug publications and drug patentspatents

Penn-Century devices successfully deliver Penn-Century devices successfully deliver pharmaceutical pharmaceutical andand bioactive formulas bioactive formulas

AnestheticsAnesthetics AntibioticsAntibiotics Anti-inflammatoriesAnti-inflammatories BronchodilatorsBronchodilators ChemotherapyChemotherapy COX-2 inhibitorsCOX-2 inhibitors DNA and siRNA DNA and siRNA

formulasformulas EpinephrineEpinephrine Gene therapy Gene therapy HeparinHeparin HormonesHormones

L-dopaL-dopa LiposomesLiposomes Monoclonal antibodiesMonoclonal antibodies NanoparticlesNanoparticles PeptidesPeptides ProteinsProteins Radio-opaque imaging Radio-opaque imaging SurfactantSurfactant SuspensionsSuspensions VaccinesVaccines Viral vectorsViral vectors

Multiple clinical applications Multiple clinical applications

Interventional Interventional bronchoscopybronchoscopy

Acute care, EMT settingsAcute care, EMT settings Rapid, local high-volume Rapid, local high-volume

delivery of delivery of chemotherapy, chemotherapy, antibiotics, biotech drugs antibiotics, biotech drugs nanomedicine and morenanomedicine and more

Diagnostic applicationsDiagnostic applications ImagingImaging Targeted anesthesiaTargeted anesthesia

Safer, faster, effective Safer, faster, effective therapies for: therapies for: Lung cancerLung cancerEmphysema/COPDEmphysema/COPDCystic fibrosisCystic fibrosisPneumoniaPneumoniaTuberculosisTuberculosisInfectious diseasesInfectious diseasesOrgan transplant Organ transplant

Delivering a cure for lung cancer?Delivering a cure for lung cancer?

Pulmonary administration of chemotherapy by MicroSprayer®® could:•Dramatically shrinks tumors•Far greater drug efficacy at half the dose of IV delivery•Spare patients painful and debilitating side effects •Reduce hospital costs•Avoid contamination and toxic exposure of “inhaled chemotherapy”

Penn-Century, Inc. seeks toPenn-Century, Inc. seeks to

Scale manufacturing - under design controlsScale manufacturing - under design controls Further expand our preclinical/R&D businessFurther expand our preclinical/R&D business Develop and pursue regulatory and Develop and pursue regulatory and

reimbursement pathwaysreimbursement pathways Attract an acquirer, strategic partner or Attract an acquirer, strategic partner or

licensee able to take the technology forward licensee able to take the technology forward to fully commercialize the devices for a to fully commercialize the devices for a myriad of human and veterinary clinical myriad of human and veterinary clinical applicationsapplications

Penn-Century, Inc. - Penn-Century, Inc. - QuestionsQuestions

1)1) Our production capacity is limited but demand continues to Our production capacity is limited but demand continues to grow. How do we find time to expand our production capacity, grow. How do we find time to expand our production capacity, which is largely centered in one person - without upsetting our which is largely centered in one person - without upsetting our customers? customers?

2)2) We have had excellent success with an innovative technology We have had excellent success with an innovative technology in animal models. What will a strategic partner or acquirer be in animal models. What will a strategic partner or acquirer be looking for from us to make the case for clinical looking for from us to make the case for clinical commercialization? (How important is it to get a 510K on our commercialization? (How important is it to get a 510K on our own?)own?)

3)3) We are a self-funded company of three people. Is there some We are a self-funded company of three people. Is there some way we can attract an investor who could bring not only way we can attract an investor who could bring not only additional resources, but become a part of the team - with additional resources, but become a part of the team - with added management, financial, regulatory and med device added management, financial, regulatory and med device experience?experience?

Expanding the reach of aerosol medicine

PENNCENTURY™