Slide 1: Engineering the Future for Inhaled Therapeutics
September 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 specialty 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
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) Michael Higgins BOD-Audit Chair (Genzyme) Scott Rocklage, PhD BOD Investor (Cubist, Pearl) Board of Di
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 $7.9B WW by 20191 PUR1900 Anti-fungal Cystic Fibrosis 20k patients ABPA Asthma >5MM patients PUR1500 Not Disclosed IPF 140k patients P
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: Pulmatrix R&D Expertise
iSPERSE Technology Platform: Pulmatrix R&D 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 development
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 Product Overview Branded generic iSPERSE version of a once daily Long Acting Muscarinic Antagonist (LAMA) bronchodilator Marketed reference product generates annual worldwide sales $5B ($2B EU) Multiple clinical studies completed in both healthy volunteers and COPD p
Slide 11: European Development of Bioequivalent Orally Inhaled Drugs
European Development of 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 --> No
Slide 12: PUR0200 Clinical Design To Define Bioequivalent Formulation Targets
PUR0200 Clinical Design To Define Bioequivalent Formulation 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
Slide 13: PUR0200: Established Improved Product Profile for US
PUR0200: Established Improved Product Profile for US Low Mid High Shows a matching patient benefit of iSPERSE PUR0200 vs marked product at 80% lower dose of inhaled drug Clinical PD Data in COPD Patients
Slide 14: 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 15: PUR1900: Targeting Fungal Infections
PUR1900: Targeting Fungal Infections Product Overview Inhaled formulation of Itraconazole to treat pulmonary fungal infections Superior PK profile when delivered by inhalation API is commonly used to treat Aspergillus infection Enabled by iSPERSE dry powder delivery technology PUR1900 offers possibl
Slide 16: 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. PUR1900: Fungal Infections in Cystic Fibrosis A combination of the host’s underlying immune state as well as pathogen-driven factors ultimately det
Slide 17: PUR1900: Inhaled Itraconazole in Cystic Fibrosis
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 18: 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 19: 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 20: 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 21: 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 22: 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 Lower Development Costs Lower Clinical Risk Moderate Development Costs Moderate Clinical Risk Higher Development Costs Higher Cli
Slide 23: iSPERSE NCE Opportunities
iSPERSE NCE Opportunities Idiopathic Pulmonary Fibrosis Current oral drug (Esbriet, Ofev) profiles offset by GI side effects and poor oral bioavailability which limit tolerability, use, and efficacy Critical need for inhaled options to overcome side effects and enable drugs against new targets SBIR-
Slide 24: PULM Development Timeline and Milestones
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 CMC
Slide 25: Share Statistics
Share Statistics Trading Symbol 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 26: Engineering the Future for Inhaled Therapeutics
September 2016 NASDAQ: PULM Engineering the Future for Inhaled Therapeutics