Slide 1: Engineering the Future for Inhaled Therapeutics
October 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 Snapshot
Pulmatrix Snapshot Proprietary iSPERSETM Technology Engineered dry powder particles enable highly efficient lung delivery independent of inhalation flow rate Strong IP provides protection into 2030s De-risked Strategy Outsourced manufacture, off-the-shelf inhalation device, 505(b)2 ANDA route to reg
Slide 4: Pulmatrix Pipeline: iSPERSE Pulmonary Therapeutics
Pulmatrix Pipeline: iSPERSETM Pulmonary Therapeutics Product Class Indication Development Phase Data Readout Next Study Start Addressable Market PUR0200 LAMA COPD (Mylan Collaboration) EU Bioequivalence/ Phase 2 Q2 2017 Pivotal Registration Study 2H 2018 $7.9B WW by 20191 PUR1900 Anti-fungal Cystic
Slide 5: 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) Michael Higgins BOD-Audit Chair (Genzyme) Scott Rocklage, PhD BOD Investor (Cubist, Pearl) Board of Di
Slide 6: Pulmatrix: Respiratory Focused Market Opportunity
Pulmatrix: Respiratory Focused Market Opportunity Global Respiratory Market = $33 BB by 20191 Cowen & Co. Therapeutic Categories Outlook, Feb 2014 GBI Research, 2013 Radiant Insights, 2016 GlobalData.com Pulmatrix: Seeking to unlock the full potential of inhaled drugs COPD $11.3B2 Cystic Fibrosis $6
Slide 7: Pulmonary Platform + Product = High Value Exit Transactions
Pulmonary Platform + Product = High Value Exit Transactions Pearl Therapeutics Civitas Therapeutics Prosonix Insmed Indication COPD Parkinson’s Disease COPD Non-tuberculous Myco-bacterium Drug PT003 (LABA/LAMA) CVT-301 (L-Dopa) PSX1001 (Fluticasone propionate) Arikayce (Antibiotic) Development Stage
Slide 8: Delivering on Company Milestones
Delivering on Company Milestones Report Positive PUR0200 data for EU PUR0200 clinical data complete towards pivotal PK match FDA Orphan Status for PUR1900 PUR1900 Phase I/IA data in hand 3Q2016 4Q2016 1Q2017 2Q2017 3Q2017 4Q2017 PUR1900 Data presented At NACFC PUR0200 first patient in PUR1900 EMA su
Slide 9: iSPERSE Platform: Engineered for Exceptional Performance
iSPERSETM Platform: Small, dense, dispersible, and respirable salt-containing particles Variable formulation concepts to achieve product advantages (particle size, formulation, etc.) Clinically validated advantages over conventional technologies Broad novel IP portfolio into 2030s iSPERSETM Technolo
Slide 10: Pulmatrix iSPERSE Strategy: Derisking the Platform
Pulmatrix iSPERSETM Strategy: Derisking the Platform Outsource GMP Manufacture: Fully integrated Pulmatrix R&D team expert in formulation/aerosol science In house spray drying capability from bench top to Size 1 scale (non-GMP) Expertly scale product concepts from early feasibility to kg scale (Size
Slide 11: PUR0200 Inhaled Long Acting Muscarinic Antagonist (LAMA)
PUR0200 Inhaled Long Acting Muscarinic Antagonist (LAMA)
Slide 12: PUR0200: Bronchodilator for COPD
PUR0200: Bronchodilator for COPD Indication Overview 64MM COPD patients WW; 3rd leading cause of death in the U.S.1 Once daily long acting muscarinic antagonist (LAMA) is the first line therapy for moderate to severe COPD patients (50%) Product Overview Branded generic iSPERSETM version of a once da
Slide 13: European Development of PK Bioequivalent Orally Inhaled Drugs
European Development of PK Bioequivalent Orally Inhaled Drugs European regulations provide guidance for the development of orally inhaled products by a step-wise equivalence approach Product approval based on matching PK of test product with reference Single dose PK studies as basis for approval -->
Slide 14: PUR0200 Clinical Data: PK Bioequivalent Targets
PUR0200 Clinical Data: PK Bioequivalent Targets PUR0200 formulations Trial Design: Single dose PK study in healthy volunteers (n=42) Seven period cross-over design 5 PUR0200 formulations 2 periods of reference product administration Trial Goals: Define relationship between PUR0200 formulation parame
Slide 15: PUR0200: Improved Product Profile for US
PUR0200: Improved Product Profile for US Low Mid High Shows a matching patient benefit of iSPERSETM PUR0200 vs marketed product at 80% lower dose of inhaled active pharmaceutical ingredient (API) Reduced API could translate to improved cost of goods and side effect profile Clinical PD Data in COPD P
Slide 16: PUR0200: Next Steps in Partnership and Development
PUR0200: Next Steps in Partnership and Development EU PK Bioequivalence Path Actively negotiating partnership rights Preferred development path identified with target of next clinical trial FPI Q2 2017 PK Bioequivalent product anticipated to be registered in EU by 2019 US 505(b)2 Path Pulmatrix acti
Slide 17: PUR1900 Addressing Pulmonary Fungal Infections in CF and Severe Asthma
PUR1900 Addressing Pulmonary Fungal Infections in Patients with Cystic Fibrosis and Severe Asthma
Slide 18: PUR1900: Inhaled Antifungal for CF
PUR1900: Inhaled Antifungal for CF Indication Overview CF is a fatal genetic disease of the lungs/GI tract that affects 70K patients WW; median survival of patients is 39.3 years1. Patient populations suffer from copious, static mucus leaving patients susceptible to fungal infections caused by funga
Slide 19: PUR1900: Fungal Infections in Cystic Fibrosis
PUR1900: Fungal Infections in Cystic Fibrosis 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. A combination of the host’s underlying immune state as well as pathogen-driven factors ultimately deter
Slide 20: PUR1900: Disease Prevalence of Fungal Infections in CF
PUR1900: Disease Prevalence of Fungal Infections in CF AB: Aspergillus bronchitis. ABPA: Allergic bronchopulmonary aspergillosis. % % % % % % Percent of All U.S. CF Patients Overview of Disease Prevalence by Key Patient Segment ABPA Aspergillus Bronchitis c Aspergillus Bronchitis Two recent studies
Slide 21: Patient Referral Pathway
Patient Referral Pathway Infectious Disease Specialist Pulmonologist Key Diagnostic Tools Clinical Presentation Wheezing, bloody sputum, shortness of breath, and overall deteriorating lung function are common manifestations In select instances, infectious disease specialists are consulted when clini
Slide 22: PUR1900: Inhaled Itraconazole
Relieves high treatment burden of oral antifungal therapy and improve outcomes Inhalation delivery provides improved safety and (potentially 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 e
Slide 23: PUR1900 Achieves High Lung and Low Plasma Exposure
PUR1900 Achieves High Lung and Low Plasma Exposure Once daily aerosol dosing of PUR1900 achieves 3x lung concentration over oral dosing at 25% the dose in pre-clinical evaluation Significantly lower systemic exposure with PUR1900 after both single and repeat doses Low level of systemic accumulation
Slide 24: Superior Efficacy Compared to Oral Treatment of Immunosuppressed Guinea Pigs
Superior Efficacy Compared to Oral Treatment of Immunosuppressed Guinea Pigs Treatment with PUR1900 beginning one day after infection provides greater protection than oral dosing
Slide 25: PUR1900: Cystic Fibrosis Product Profile
PUR1900: Cystic Fibrosis Product Profile 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 aspergillo
Slide 26: PUR1900: Product Profile Feedback
PUR1900: Product Profile Feedback Source: Physician Interviews ClearView Analysis. Profile Element Safety and Tolerability Dosing and ROA “If anything, I would anticipate that itraconazole delivered directly into the lungs will result in better patient outcomes compared to oral azoles.” “This ROA ma
Slide 27: 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. “I like the product. Seems like a TOBI but for fungal infections. This would be great for
Slide 28: PUR1900: Significant Commercial Opportunity
PUR1900: Significant Commercial Opportunity Source: Physician Interviews; ClerView Analysis. Potential LCM Opportunities for PUR1900 Physicians identified a spectrum of potential opportunities for PUR1900 commercial footprint. Potential PUR1900 LCM Opportunities Chronic Pulmonary Aspergillus SAFS Ot
Slide 29: PUR1900: 505(b)2 in Multiple Indications
PUR1900: 505(b)2 in Multiple Indications Formulation Development Strategy PUR1900 completing non-clinical safety testing to support Phase I clinical trials 7-day Phase I HNV/Phase IA patient trial in 2H 2017 PUR1900 next generation formulation completing CMC/scale up; targeted for Phase II POC Clini
Slide 30: PUR1500 Inhaled Antifibrotic for Idiopathic Pulmonary Fibrosis (IPF)
PUR1500 Inhaled Antifibrotic for Idiopathic Pulmonary Fibrosis (IPF)
Slide 31: PUR1500: Inhaled Antifibrotic for Idiopathic Pulmonary Fibrosis
PUR1500: Inhaled Antifibrotic for Idiopathic Pulmonary Fibrosis IPF – Extremely high unmet need IPF is fatal disease with significant unmet need that afflicts between 132,000 – 200,000 patients in the US1,2,4 and 40,000 patients in the EU3,5 40,000 deaths per year; 50,000 new diagnoses each year in
Slide 32: PUR1500 Exhibits Long Lung Half-Life
PUR1500 Exhibits Long Lung Half-Life High lung concentrations versus oral dosing at significantly lower exposure doses High lung concentrations over 48h period with corresponding low plasma exposure
Slide 33: Projected PULM Development Timeline and Milestones
Projected PULM Development Timeline and Milestones Non-clinical CMC 2016 2017 2018 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Clinical c Go / No-go Milestone PUR0200 (Mylan) CMC supporting clinic Lead-In PK PUR1900 (Anti-Fungal) Pivotal PK CMC supporting commercial CMC supporting clinic Phase 1/1b Ph 2 Phase 2 C
Slide 34: Share Statistics
Share Statistics Ticker PULM Total Shares Outstanding 14.9 million Financials Cash on Hand At June 30, 2016 $10.8 million Runway based on anticipated expenses mid 2017 Cap Structure Insider Ownership 55% Key Financial Data
Slide 35: Engineering the Future for Inhaled Therapeutics
October 2016 NASDAQ: PULM Engineering the Future for Inhaled Therapeutics
Slide 36: Glossary
Glossary 505(b)2 –US regulatory pathway for changes to previously approved drugs ABPA -Allergic Bronchopulmonary Aspergillosis ANDA – Abbreviated New Drug Application for a US generic drug approval for an existing licensed medication or approved drug FEV1 - Forced Expiratory Volume in 1 Second ICS –