Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Virtual Investor Conference August 2015
24 slides from Pulmatrix's conference presentation, Aug 6, 2015
Slide 1: Engineering the Future for Inhaled Therapeutics
Virtual Investor Conference August 6, 2015 Robert Clarke, Ph.D. President & Chief Executive Officer NASDAQ: PULM Engineering the Future for Inhaled Therapeutics
Slide 2: Forward Looking Statements
2 Forward Looking Statements Disclaimers and 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,”
Slide 3: Pulmatrix Overview
3 Pulmatrix Overview Clinical - Stage Pipeline PUR1900 could be the 1 st inhaled anti - fungal for CF; clinical data expected 2H 2016 Mylan - partnered Phase II COPD asset PUR0200 back to clinic in Q4 2015 PUR1500 is a novel inhaled treatment for IPF advancing to clinical studies Proprietary iSPERSE
Slide 4: Efficiently Managing Market Opportunities
4 Efficiently Managing Market Opportunities Pursue via partnerships (e.g. COPD with Mylan ) Full clinical development funding De - risked strategy to generate royalties on large market potential Pursue independently or partner post - value infection In - license development stage novel compounds to
Slide 5: iSPERSE Pipeline: Significant Opportunities in Respiratory Disease
5 iSPERSE Pipeline: Significant Opportunities in Respiratory Disease Product COPD PUR1900 - Anti - fungal Cystic Fibrosis PUR0200 – LAMA PUR1500 - Anti - fibrotic Formulation Feasibility Nonclinical Development Phase 1 Phase 2 IPF
Slide 6: iSPERSE Technology Platform Enables New Possibilities for Inhaled Therapies
6 iSPERSE Technology Platform Enables New Possibilities for Inhaled Therapies iSPERSE Technology Platform: Small , dense , dispersible , and respirable salt - containing particles Novel IP portfolio and applicability to any drug class from small molecule to biologic
Slide 7: Development Pipeline
Development Pipeline
Slide 8: PUR1900: Anti-Fungal for CF
8 PUR1900: Anti - Fungal for CF Cystic Fibrosis Rare genetic disorder afflicting 100,000 patients WW Impaired mucus clearance and infection susceptibility resulting in: • Increased lung infection • P ulmonary function decline PUR1900 Drug Profile: Dry powder anti - fungal in iSPERSE matrix High loca
Slide 9: PUR1900: Anti-Fungal for CF
9 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: Anti - Fungal for CF Lead API PK profile: Anticipated Program Milestones Preclinical data Q3 2015; disclosure of API Non - clinical safety completed Q2 2016 Phase 1b clinical data in CF patients in
Slide 10: PUR1900 Addresses Multiple Unmet Needs for Patients
10 PUR1900 Addresses Multiple Unmet Needs for Patients Aggressive market penetration in CF due to high patient compliance Beyond CF: Multiple other rare/orphan indications served with same inhaled drug product – E.g. Chemotherapy patients, transplant patients in a prophylactic regimen Potential peak
Slide 11: PUR0200: Bronchodilator for COPD
11 PUR0200: Bronchodilator for COPD Chronic Obstructive Pulmonary Disease Fifth leading cause of death worldwide Chronic mucus overproduction/inflammation reduces airflow and increases morbidity/mortality $25B global market by 2024 Drug Product Profile Branded generic of a marketed $5B WW once daily
Slide 12: PUR0200: Bronchodilator for COPD
12 PUR0200: Bronchodilator for COPD Product Status Commercial scale capsule based device Low Mid High Matching PD at 1/6 th lactose blend Commercial Assessment EU Potential: $300 - $500MM peak annual sales; Register 2017 US Potential: $450 - $650MM peak annual sales; Register 2020
Slide 13: PUR0200: Development Strategy
13 PUR0200: Development Strategy Mylan Partnership Global leader in generics with established commercial infrastructure Announced European partnership June 2015 Pulmatrix to receive royalty on sales European PK Bioequivalence Pathway Venue for expedited regulatory approval Pathway precedence include
Slide 14: PUR1500: Anti-Fibrotic for IPF
14 PUR1500: Anti - Fibrotic for IPF Idiopathic Pulmonary Fibrosis (IPF) Rare disorder afflicting 130,000 patients in the US; 40,000 deaths per year Fibrotic scarring leads to reduced lung function and mortality within 2 - 5 years Drug Product Profile Dry powder anti - fibrotic in iSPERSE matrix base
Slide 15: Anticipated Near Term Milestones
15 Anticipated Near Term Milestones PUR0200 Q4 2015 Report Phase 1 data at European Respiratory Society annual meeting Q4 2015 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 Bioe
Slide 16: Pulmatrix iSPERSE Technology
Pulmatrix iSPERSE Technology
Slide 17: Current Delivery Technologies Limit Truly Innovative Therapies
17 Current Delivery Technologies Limit Truly Innovative Therapies Liquid Nebulizers Metered Dose Inhalers (MDI) Lactose Blend Dry Powder Inhalers (DPI) • Poor efficiency • Long nebulization times • Lack of portability Antibiotics, Pulmozyme, Hospital settings • Poor efficiency • Limited chemical API
Slide 18: Pulmatrix iSPERSE Technology: Next Generation Advanced Engineering for Inhalation Products
18 Pulmatrix iSPERSE Technology: Next Generation Advanced Engineering for Inhalation Products DPI Flexibility Device freedom Biologics and macromolecules Enable new classes of therapeutics Poorly behaved drugs Superior formulation chemistry Drugs limited by predicted dose Enhanced dose capability iS
Slide 19: Pulmatrix: Building Future Value
19 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 20: Business
puln re Business
Slide 21: Share Statistics
21 Share Statistics Trading Symbol PULM Total Shares Outstanding 14.5 million Financials Cash on Hand At Closing (06/26/15) $27.0 million Runway based on anticipated expenses Mid - 2017 Cap Structure Insider Ownership 57% Key Financial Data
Slide 22: Pulmatrix BOD: A History of Biotech Success
22 Pulmatrix BOD: A History of Biotech Success Terry McGuire Chairman, BOD (AIR, Cubist, Ironwood) Robert Clarke, PhD CEO (AIR, Alkermes ) Scott Rocklage , PhD BOD Investor (Cubist, Pearl) Steve Gillis, PhD BOD Investor ( Immunex , Bluebird) Kurt Graves BOD Independent (Vertex) Michael Higgins BOD -
Slide 23: Pulmatrix Investment Opportunity
23 Pulmatrix Investment Opportunity Clinical - Stage Pipeline De - risked pipeline with a partnered COPD asset and 2 proprietary rare/orphan programs with multiple inflection points in the next 6 - 18 months Proprietary iSPERSE Technology E nables efficient high dose pulmonary drug delivery with red
Slide 24: Engineering the Future for Inhaled Therapeutics
Virtual Investor Conference August 6, 2015 Robert Clarke, Ph.D. President & Chief Executive Officer NASDAQ: PULM Engineering the Future for Inhaled Therapeutics