Slide 1: Engineering the Future for Inhaled Therapeutics
June 2016 NASDAQ: PULM Engineering the Future for Inhaled Therapeutics Exhibit 99.1
Slide 2: Disclaimers & Forward Looking Statements
Disclaimers & Forward Looking Statements This presentation contains forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is
Slide 3: Pulmatrix Investment Highlights
Pulmatrix Investment Highlights Company Overview Lexington, MA-based pharma company Focused on developing novel inhaled therapies for unmet needs in respiratory disease (NASDAQ:PULM) Fully integrated capabilities - from concept to clinical development High Value Pipeline Product candidates target CO
Slide 4: Pulmatrix Team: A History of Biotech Success
Pulmatrix Team: A History of Biotech Success Terry McGuire BOD Investor (AIR, Cubist, Ironwood) Robert Clarke, PhD CEO (12+ years) (AIR, Alkermes) Steve Gillis, PhD BOD Investor (Immunex, Bluebird) Kurt Graves BOD Independent (Vertex) Michael Higgins BOD-Audit Chair (Genzyme) Scott Rocklage, PhD BOD
Slide 5: Enhanced lung delivery via iSPERSE engineered particle platform
Enhanced lung delivery via iSPERSE engineered particle platform High percent of drugs to the lung Reduced systemic toxicities Pulmatrix: Seeking to unlock the full potential of inhaled drugs $33 BB + Market by 20191 Select Products: Address millions of patients and broad range of diseases Pulmonary
Slide 6: Pulmatrix Pipeline: iSPERSE Pulmonary Therapeutics
Pulmatrix Pipeline: iSPERSE Pulmonary Therapeutics Product Class Indication Formulation/Feasibility Non-Clinical Phase 1 Phase 2 Addressable Market PUR0200 LAMA COPD $7.9 BB by 20191 PUR1900 Anti-fungal Cystic Fibrosis 20k patients Immuno- compromised 200k patients Allergic/invasive Asp. infection >
Slide 7: iSPERSE Technology Platform: Engineered for Exceptional Performance
iSPERSE Platform: Small, dense, dispersible, and respirable salt-containing particles Variegated formulation concepts to achieve product advantages (particle size, formulation, etc.) Clinically validated advantages over conventional technologies Broad novel IP portfolio into 2030s Particle Engineeri
Slide 8: iSPERSE Technology Platform: In House Engineering Expertise
iSPERSE Technology Platform: In House Engineering Expertise Pulmatrix iSPERSE Expertise: Fully integrated R&D team Formulation/aerosol science In house spray drying capability from bench top to Size 1 scale (non-GMP) Scale product concepts from early feasibility to kg scale (Size 1) CMC method devel
Slide 9: iSPERSE Technology Platform: Enabling High Value Product Opportunities
iSPERSE Technology Platform: Enabling High Value Product Opportunities Branded Generics of Inhaled Drugs 505(b)2 Reformulation for Inhalation NCEs for Respiratory Disease PUR0200 LAMA for COPD 22 MM – EU addressable market 35 MM – US addressable market EU Mylan partnership Lower Development Costs Lo
Slide 10: PUR0200: Bronchodilator for COPD
PUR0200: Bronchodilator for COPD Low Mid High Drug Product Profile Branded generic iSPERSE version of a once daily Long Acting Muscarinic Antagonist (LAMA) bronchodilator Currently market version annual worldwide sales $5B ($2B EU) Clinical PD Data in COPD Patients Shows a matching patient benefit o
Slide 11: PUR0200: Clinical Design To Define Bioequivalent Formulation Targets
PUR0200: Clinical Design To Define Bioequivalent Formulation Targets Single dose PK study in healthy volunteers Primary outcomes: safety/tolerability; plasma PK Seven period cross-over design 42 subjects 5 PUR0200 formulations 2 periods of reference product administration Formulation parameters desi
Slide 12: PUR0200: Significant Market Potential
PUR0200: Significant Market Potential Drug Class Muscarinic antagonist (bronchodilator) Dosing profile Once daily, inhaled Regulatory Path EU PK Bioequivalence Development Status Clinical trial completed Q2 2016 Addressable Market Size (2019)* 22MM in the EU Data from current Pharmacokinetic/Bioequi
Slide 13: iSPERSE Technology Platform: Enabling High Value Product Opportunities
iSPERSE Technology Platform: Enabling High Value Product Opportunities Branded Generics of Inhaled Drugs 505(b)2 Reformulation for Inhalation NCEs for Respiratory Disease PUR1900 Anti-fungal 5.0 MM - addressable market Lower Development Costs Lower Clinical Risk Moderate Development Costs Moderate C
Slide 14: Pulmonary Fungal Infections: High Incidence and Impact
Source: Chotirmall. Int J Biochem Cell Biol. 2014;1(52):161; Moss. Semin Respir Crit Care Med. 2015;36(2):207; Physician Interviews; ClearView Analysis. CF: Cystic Fibrosis. Pulmonary Fungal Infections: High Incidence and Impact A combination of the host’s underlying immune state as well as pathogen
Slide 15: PUR1900: Inhaled Itraconazole
Relieves high treatment burden of oral antifungal therapy and improve outcomes Inhalation delivery provides improved safety and (likely superior) efficacy at a much lower total dose of drug Targeted delivery achieves high therapeutic dose directly to the site of infection avoiding GI/systemic exposu
Slide 16: PUR1900: Multiple Potential Indications
PUR1900: Multiple Potential Indications Source: Physician Interviews; ClerView Analysis. SAFS: Severe Asthma with Fungal Sensitization. Potential PUR1900 LCM Opportunities Potential LCM Opportunities for PUR1900 Chronic Pulmonary Aspergillus SAFS Other Organ Transplant* Asthma ABPA Lung Transplant I
Slide 17: PUR1900: Product Profile Feedback
PUR1900: Product Profile Feedback Source: Physician Interviews; ClearView Analysis. DPI: Dry Powder Inhaler; SOC: Standard of Care; QOL: Quality of Life; CFQ-R: CF Respiratory Questionnaire. Profile Element Safety and Tolerability Dosing and ROA “If anything, I would anticipate that itraconazole del
Slide 18: PUR1900: Product Profile Feedback
PUR1900: Product Profile Feedback Physicians highlighted that ~85% of treated AB patients would likely be prescribed an inhaled antifungal, largely due to current dissatisfaction with available agents Source: Physician Interviews; ClearView Analysis. ABPA: Allergic Bronchopulmonary Aspergillosis. AB
Slide 19: PUR1900: U.S. Payer Reaction
PUR1900: U.S. Payer Reaction Payers expressed enthusiasm for PUR1900, highlighting that an inhaled antifungal addresses a key unmet medical need in cystic fibrosis. Source: Payer Interviews; ClearView Analysis. ROA: Route of Administration; CF: Cystic Fibrosis. “I like the product. Seems like a TOBI
Slide 20: PUR1900: Significant Commercial Opportunity
PUR1900: Significant Commercial Opportunity Source: Physician Interviews; ClerView Analysis. SAFS: Severe Asthma with Fungal Sensitization. Potential LCM Opportunities for PUR1900 Physicians identified a spectrum of potential opportunities for PUR1900 commercial footprint. Potential PUR1900 LCM Oppo
Slide 21: iSPERSE Technology Platform: Enabling High Value Product Opportunities
iSPERSE Technology Platform: Enabling High Value Product Opportunities Branded Generics of Inhaled Drugs 505(b)2 Reformulation for Inhalation NCEs for Respiratory Disease CM-YJH01 Idiopathic pulmonary fibrosis 240,000 - addressable market Lower Development Costs Lower Clinical Risk Moderate Developm
Slide 22: iSPERSE for Idiopathic Pulmonary Fibrosis
iSPERSE for Idiopathic Pulmonary Fibrosis Need for improvements on approved drugs Nintedanib and Pirfenidone Despite efficacy, significant unmet need remains GI side effects and oral bioavailability limit tolerability, use and efficacy Critical need for inhaled options to overcome side effects and e
Slide 23: Share Statistics
Share Statistics Trading Symbol PULM Total Shares Outstanding 14.5 million Financials Cash on Hand At March 31, 2016 $14.8 million Runway based on anticipated expenses mid 2017 Cap Structure Insider Ownership 55% Key Financial Data
Slide 24: Engineering the Future for Inhaled Therapeutics
June 2016 NASDAQ: PULM Engineering the Future for Inhaled Therapeutics