Please welcome our guest… Jane Century VP Operations, Penn-Century Inc. PCCI sponsors: An all-volunteer, non-profit organization PCCI sponsorship … An all-volunteer, non-profit organization PENNCENTURY™ Expanding the reach of aerosol medicine Targeting aerosol medicine directly to the lungs and other inaccessible places in the body Penn-Century, Inc. - At a Glance Incorporated in 1997 by Ted Century PhD, President & Chief Scientific Officer, and Jane Century, VP Operations 10 patents issued; 11th filed Highly profitable, cash-flow positive, self-funded Large, growing, loyal global customer base Lean organization by design; Mostly outsourced manufacturing with final assembly in 3500 sq ft facility Seeking M&A exit, strategic partnership, or licensing agreements Penn-Century, Inc. Evolved organically to meet an unmet need for a safer, less wasteful and more precise method of developing and testing respiratory and other drugs Completely mechanical, hand-held Used in animal and in vitro models Product line includes - liquid and dry powder drug delivery devices The advantages of pulmonary drug delivery THE PLUSES Lungs offer the body’s broadest exposure to the vascular system Can treat both pulmonary and systemic diseases Far faster than pills – avoids metabolic changes Shots hurt! Avoids systemic side affects common to IV drugs Higher concentration in lungs Two major hurdles to pulmonary drug delivery ANATOMICAL : - We are not designed to have anything in our lungs but air - Particles must be 1-5ul to bypass nose and throat TECHNOLOGICAL : - To make particles of an inhalable size, most nebulizers and inhalers depend on compressed air, propellant, heat or ultrasound - This creates a lot of air and not much drug moving at high momentum The two most common methods of pulmonary drug delivery: Inhaler/Nebulizers • Slow, wasteful, inefficient • Typically for symptom management • Hard to determine how much got in •High momentum • Cannot target a lobe or lesion • Can contaminate atmosphere or expose clinicians Liquid bolus/droplet Fast - but harsh • Limited tolerance • Poor distribution in the lung • Current pulmonary drug delivery methods Nasal sprayers MDIs Nebulizers/Masks Liquid bolus (droplet) delivery via an ET tube Penn-Century MicroSprayer® offers best of both worlds Nasal sprayers MDIs Nebulizers Liquid bolus delivery via an ET tube MicroSprayer® Aerosolizer Intratracheal Aerosol Delivery Aerosol medicine that is administered - not inhaled Fast at high volumes Not dependent on breath capacity of subject Targeted, local drug delivery Low momentum, but high concentration Precisely quantifiable More uniform distribution Faster, safer delivery of larger, clinically effective volumes Highly efficient at smaller doses MicroSprayer® Aerosolizer: Key features Liquid device is purely mechanical, hand-held aerosol drug delivery platform No air No heat No vibrating mesh Works with vast array of drugs, biologics, suspensions Narrow enough to target the lungs, as well as other areas stomach, sinuses, colon, bladder, uterus ® MicroSprayer Aerosolizer Model IA-1C Narrow flexible tubing Operates at 3000 psi with patented FMJ-250 High Pressure Syringe Can be made to any length, inserted via ET tube or bronchoscope ® MicroSprayer Aerosolizer Model IA-1B Larger, less flexible tubing Larger particle sizes Operates at 700 psi with a 1 ml disposable polycarbonate syringe Can be inserted directly or via a catheter Dry Powder Insufflator™ Delivers a cloud of dry powder directly to lungs Can deliver particles of nano- to macro-scale Manually operated with air syringe or air pump Custom lengths for use in ET tube or bronchoscope Widely used and trusted for pulmonary drug development • • In wide use by 700+ leading pharmaceutical and biotech companies, medical research centers, universities, government military labs, and CROs around the world Cited in more than 800 peer-reviewed research publications and drug patents Penn-Century devices successfully deliver pharmaceutical and bioactive formulas Anesthetics Antibiotics Anti-inflammatories Bronchodilators Chemotherapy COX-2 inhibitors DNA and siRNA formulas Epinephrine Gene therapy Heparin Hormones L-dopa Liposomes Monoclonal antibodies Nanoparticles Peptides Proteins Radio-opaque imaging Surfactant Suspensions Vaccines Viral vectors Multiple clinical applications Interventional bronchoscopy Acute care, EMT settings Rapid, local high-volume delivery of chemotherapy, antibiotics, biotech drugs nanomedicine and more Diagnostic applications Imaging Targeted anesthesia Safer, faster, effective therapies for: Lung cancer Emphysema/COPD Cystic fibrosis Pneumonia Tuberculosis Infectious diseases Organ transplant 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 to Scale manufacturing - under design controls Further expand our preclinical/R&D business Develop and pursue regulatory and reimbursement pathways Attract an acquirer, strategic partner or licensee able to take the technology forward to fully commercialize the devices for a myriad of human and veterinary clinical applications Penn-Century, Inc. - Questions 1) Our production capacity is limited but demand continues to grow. How do we find time to expand our production capacity, which is largely centered in one person - without upsetting our customers? 2) We have had excellent success with an innovative technology in animal models. What will a strategic partner or acquirer be looking for from us to make the case for clinical commercialization? (How important is it to get a 510K on our own?) 3) We are a self-funded company of three people. Is there some way we can attract an investor who could bring not only additional resources, but become a part of the team with added management, financial, regulatory and med device experience? PENNCENTURY™ Expanding the reach of aerosol medicine