Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — BIO Investor Conference 2015
20 slides from Pulmatrix's conference presentation, Oct 20, 2015
Slide 1: BIO Investor Conference: Engineering the Future for Inhaled Therapeutics
BIO Investor Conference October 20, 2015 Robert Clarke, Ph.D. President & Chief Executive Officer NASDAQ: PULM Engineering the Future for Inhaled Therapeutics
Slide 2: Disclaimers & Forward Looking Statements
2 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,” “inte
Slide 3: Pulmatrix Investment Opportunity
3 Pulmatrix Investment Opportunity High Value Pipeline Clinical - stage COPD candidate (R&D collaboration with Mylan ) Inhaled anti - fungal for Cystic Fibrosis Inhaled anti - fibrotic for Idiopathic Pulmonary Fibrosis Proprietary iSPERSE Technology Engineered particles, which enable highly efficien
Slide 4: Pulmatrix Team: A History of Biotech Success
4 Pulmatrix Team: A History of Biotech Success Terry McGuire Chairman, BOD (AIR, Cubist, Ironwood) Robert Clarke, PhD CEO (11+ years) (AIR, Alkermes ) Steve Gillis, PhD BOD Investor ( Immunex , Bluebird) Kurt Graves BOD Independent (Vertex) Dave Maki, JD BOD Investor (Juno, IDRI) Michael Higgins BOD
Slide 5: iSPERSE Technology Platform: Engineered for Exceptional Performance
5 iSPERSE Technology Platform: Engineered for Exceptional Performance Proprietary iSPERSE Technology Platform: Small , dense , dispersible , and respirable salt - containing particles Simply manufactured to reduce costs and risks, which should increase the probability of success and partner appeal
Slide 6: iSPERSE Platform: Simply Manufactured With Customizable Drug Performance
6 iSPERSE Platform: • Variegated formulation concepts to achieve product advantages (particle size, formulation etc.) • Stability, scalability, filling all demonstrated • Successfully formulated a broad class of molecules: small molecules, nucleic acids, peptides, proteins, and antibodies Particle E
Slide 7: Pulmonary Therapeutics Create Valuable Companies
7 Pulmonary Therapeutics Create Valuable Companies Indication Drug Development Stage Company Value ($MM) COPD PT003 (LABA/LAMA) Phase II Pearl (AZ 2013) Acquired : $560 MM /$1.2B total TD - 4208 (LAMA) Phase II Theravance Biopharma NASDAQ:TBPH $475MM MC Flutiform (LABA/ICS) Marketed SkyePharma Londo
Slide 8: iSPERSE Pipeline
8 iSPERSE Pipeline Product COPD PUR1900 Anti - fungal Cystic Fibrosis PUR0200 LAMA PUR1500 Anti - fibrotic Formulation Feasibility Nonclinical Development Phase 1 Phase 2 IPF Indication • Pulmatrix - Celdara Medical Fast Track SBIR to support early development of a novel biologic to treat IPF
Slide 9: PUR0200: Bronchodilator for COPD
9 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 ci
Slide 10: PK Bioequivalence: Expedited EU Regulatory Path for PUR0200
10 PK Bioequivalence: Expedited EU Regulatory Path for PUR0200 Plasma levels increase with dose and with similar kinetics Altered formulation to match PK data around the 1/6 reference dose (Evaluating slight variations in particle size and particle size distribution) Matching C max at 1/6 reference
Slide 11: PUR0200 Fast Follower: Significant Near-Term Market Potential
11 PUR0200 Fast Follower: Significant Near - Term Market Potential EU US Drug Class Muscarinic antagonist (bronchodilator) Muscarinic antagonist (bronchodilator) Dosing profile Once daily, inhaled Once daily, inhaled Regulatory Path PK Bioequivalence 505(b)2 Development Status Clinical trial Q4 2015
Slide 12: PUR1900: Inhaled Anti-Fungal for CF
12 0 24 48 72 96 120 144 168 -1 0 1 2 3 4 5 6 Time (h) [ D r u g ] Lung (ng/g) Plasma (ng/mL) PUR1900: Inhaled Anti - Fungal for CF Lead API PK profile: High lung levels Low systemic levels PUR1900 Drug Profile: • Dry powder itraconazole anti - fungal in iSPERSE matrix • High local drug concentratio
Slide 13: Opportunity to Develop a Single Anti-Fungal in Multiple Indications
13 Chronic Aspergillus Infection • Long term illness associated with Aspergillus infection • Includes patients with aspergilloma, cavitary pulmonary aspergillosis or necrotizing aspergillosis • Often with underlying disease; e.g. COPD, mycobacteria or asthma Asthma • Approximately 2.5M severe asthma
Slide 14: PUR1900 Value Proposition
14 PUR1900 Value Proposition Aggressive market penetration in CF due to high patient compliance and preference (ex Tobi Podhaler , Pulmozyme ): Beyond CF: Multiple other rare/orphan indications served with same inhaled drug product – E.g. Chemotherapy patients, transplant patients in a prophylactic
Slide 15: iSPERSE Opportunities in IPF
15 iSPERSE Opportunities in IPF • Community would embrace inhaled options to overcome side effects and enable drugs against new targets • Recently approved drugs energized field – Nintedanib and Pirfenidone – Despite efficacy, significant unmet need remains – GI side effects and oral bioavailability
Slide 16: PUR1500: Anti-Fibrotic for IPF
16 PUR1500: Anti - Fibrotic for IPF Idiopathic Pulmonary Fibrosis (IPF) Rare disorder afflicting 130,000 patients in the US; 40,000 deaths per year 1 Fibrotic scarring leads to reduced lung function and mortality within 2 - 5 years Drug Product Profile Dry powder anti - fibrotic in iSPERSE matrix ta
Slide 17: Pulmatrix: Building Future Value
17 Pulmatrix : Building Future Value • Evaluating big pharma r espiratory compounds • Focused on development stage molecules • Multiple economic structures including equity position(s) In - License Opportunities • Multiple early - stage feasibility/development partnerships • Outsourced development m
Slide 18: Share Statistics
18 Share Statistics Trading Symbol PULM Total Shares Outstanding 14.5 million Financials Cash on Hand At June 30, 2015 $25.5 million Runway based on anticipated expenses Mid - 2017 Cap Structure Insider Ownership 57% Key Financial Data
Slide 19: Anticipated Near Term Milestones
19 Anticipated Near Term Milestones PUR0200 Q1 2016 Initiate EU Phase 2 bioequivalence clinical study vs. reference product 1H 2016 Report data from EU Phase 2 bioequivalence clinical study 2H 2016 Initiate Pivotal EU PK Bioequivalence approval study with partner 2H 2016 Form U.S. development & comm
Slide 20: BIO Investor Conference
BIO Investor Conference October 20, 2015 Robert Clarke, Ph.D. President & Chief Executive Officer NASDAQ: PULM Engineering the Future for Inhaled Therapeutics