Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (January 2016)
24 slides from Pulmatrix's investor presentation, Jan 11, 2016
Slide 1: Engineering the Future for Inhaled Therapeutics
January 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: Pulmonary Disease Market: Opportunity for Better Therapeutics
Pulmonary Disease Market: Opportunity for Better Therapeutics Drugs for Pulmonary Disease: Unmet Patient Need Lung delivery High % of drug misses target Local/systemic side effects Systemic Delivery Poor delivery of drug to lung tissue Systemic toxicity limits dose Select Products: Address millions
Slide 4: 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: Unlocking full potential of inhaled drugs $33 BB + Market by 20191 Select Products: Address millions of patients and broad range of diseases Pulmonary Disease Mark
Slide 5: iSPERSE Pipeline
iSPERSE Pipeline 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 Allergic/invasive Asp. infection Enter clinic 2016 20k patients >5M patients PUR1500 Anti-fibrotic Idiopathic pulmo
Slide 6: iSPERSE Technology Platform: Enabling High Value Product Opportunities
iSPERSE Technology Platform: Enabling High Value Product Opportunities iSPERSE Technology Platform: Small, dense, dispersible, and respirable salt-containing particles Enabling efficient lung delivery of high drug loads Flexible formulation concepts enable small molecules, anti-infectives and biolog
Slide 7: PUR1900: Inhaled Anti-Fungal for CF
PUR1900: Inhaled Anti-Fungal for CF First Inhaled Antifungal for CF Target indications: Eradication or suppression of pulmonary fungal infections in CF Steroid sparing therapy for Allergic Bronchopulmonary Aspergillosis (ABPA) Drug Product Profile Itraconazole Inhalation Powder Spray dried powder of
Slide 8: Opportunity to Develop PUR1900 for Multiple Indications
Opportunity to Develop PUR1900 for Multiple Indications Pulmonary Aspergillus infections cause allergic, chronic and invasive diseases, each with significant unmet need Early opportunities focused on rare and orphan indications with efficient development options Phase 1/2 plan centered on fungal inf
Slide 9: Existing Anti-Fungals are Limited by PK and Side Effects
Existing Anti-Fungals are Limited by PK and Side Effects Poor oral bioavailability and lung penetration in CF patients Extensive drug-drug interactions Substrate and inhibitor of CYP3A4 21 drug classes contraindicated Frequent GI side effects associated with oral dosing Sermet-Gaudelus et al AAC (20
Slide 10: PUR1900 Achieves High Lung and Low Plasma Exposure
PUR1900 Achieves High Lung and Low Plasma Exposure Repeat 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 with
Slide 11: PUR1900 CF Value Proposition
PUR1900 CF Value Proposition Aggressive market penetration in CF expected due to high patient compliance and preference with commensurate pricing (ex Tobi Podhaler, Pulmozyme) Beyond CF: Multiple other rare/orphan indications served with same inhaled drug product E.g. Chemotherapy patients, transpla
Slide 12: iSPERSE for IPF
iSPERSE for IPF Recently approved drugs energized field Nintedanib and Pirfenidone Despite efficacy, significant unmet need remains GI side effects and oral bioavailability may limit tolerability, use and efficacy Possible to evaluate inhaled PK and target specificity to assess potential for locally
Slide 13: PUR1500: Anti-Fibrotic for IPF
PUR1500: Anti-Fibrotic for IPF Idiopathic Pulmonary Fibrosis (IPF) Rare disorder afflicting approximately 130,000 patients in the US; 40,000 deaths per year and approximately 110,000 patients in Europe 1-3 Fibrotic scarring leads to reduced lung function and mortality within 2-5 years Drug Product P
Slide 14: iSPERSE Technology Platform: Enabling High Value Product Opportunities
iSPERSE Technology Platform: Enabling High Value Product Opportunities iSPERSE Technology Platform: Small, dense, dispersible, and respirable salt-containing particles Enabling efficient lung delivery of high drug loads Flexible formulation concepts enable small molecules, anti-infectives and biolog
Slide 15: PUR0200: Bronchodilator for COPD
PUR0200: Bronchodilator for COPD Low Mid High Drug Product Profile Branded generic iSPERSE version of a marketed $5B WW once daily LAMA bronchodilator Uses commercially available capsule-based passive DPI device Commercial scale capsule based device Clinical PD Data in COPD Patients Black circles sh
Slide 16: PUR0200 PK Data from COPD Patients: Cmax/AUC Bioequivalence
PUR0200 PK Data from COPD Patients: Cmax/AUC Bioequivalence Plasma levels increase with dose and with similar kinetics At lowest iSPERSE dose, matched Cmax with lower AUC Q1 2016 Trial: Evaluating slight variations in particle size and particle size distribution around the 1/6th reference dose Match
Slide 17: PUR0200 Clinical Design To Define Bioequivalent Formulation Targets
PUR0200 Clinical Design To Define Bioequivalent Formulation Targets Single dose PK study in HNV Primary outcomes: plasma PK Seven period cross-over design 42 subjects 5 PUR0200 formulations 2 periods of reference administration Formulation parameters designed to encompass reference product Study sta
Slide 18: PUR0200 Fast Follower: Significant Near-Term Market Potential
PUR0200 Fast Follower: Significant Near-Term Market Potential Drug Class Muscarinic antagonist (bronchodilator) Dosing profile Once daily, inhaled Regulatory Path EU PK Bioequivalence Development Status Clinical trial Q1 2016 Addressable Market Size (2019)* 22MM Data from next PK Bioequivalence stud
Slide 19: A Wide Range of Opportunities
NCEs for Respiratory Disease Profile: Novel compounds to address high unmet need in COPD, CF and IPF iSPERSE enables: High drug loading and targeted lung delivery to maximize efficacy Evaluating multiple existing, development stage pharma compounds Pulmatrix: Building Future Value Reformulation for
Slide 20: 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 21: Share Statistics
Share Statistics Trading Symbol PULM Total Shares Outstanding 14.5 million Financials Cash on Hand At Sep. 30, 2015 $22 million Runway based on anticipated expenses Mid-2017 Cap Structure Insider Ownership 57% Key Financial Data
Slide 22: Anticipated Near Term Milestones
Anticipated Near Term Milestones PUR0200 Jan 2016 Initiate pilot BE PK study in EU Q2 2016 Clinical data from pilot BE PK study Q4 2016 Initiate development towards pivotal BE study with partner PUR1900 Jan 2016 Initiate GLP non-clinical safety program supporting Phase 1 Q2 2016 Completion of GLP no
Slide 23: Pulmatrix Investment Opportunity
Pulmatrix Investment Opportunity High Value Pipeline Inhaled anti-fungal for Cystic Fibrosis Inhaled anti-fibrotic for Idiopathic Pulmonary Fibrosis Clinical-stage COPD candidate (R&D collaboration with Mylan) Proprietary iSPERSE Technology Engineered particles enable highly efficient delivery of dr
Slide 24: Engineering the Future for Inhaled Therapeutics
January 2016 NASDAQ: PULM Engineering the Future for Inhaled Therapeutics