Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (August 2017)
27 slides from Pulmatrix's investor presentation, Aug 3, 2017
Slide 1: Engineering Respiratory Products for Major Unmet Pulmonary Diseases
Engineering Respiratory Products for Major Unmet Pulmonary Diseases August 2017 NASDAQ: PULM 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: Executive Summary: Pulmatrix and iSPERSE Technology
Executive Summary Pulmatrix and iSPERSE™ Technology De-risked portfolio targeting large markets with high unmet need: PUR1800 (Phase 2): Narrow spectrum kinase inhibitor (NSKI) for Acute Exacerbations of COPD (AECOPD) PUR1900 (Phase 1): Inhaled reformulation of oral anti-fungal for Allergic Bronchop
Slide 4: Experienced Leadership Team with Record of Success
Experienced Leadership Team with Record of Success Management Team Proven fundraising and capital management ability Experienced R&D team focused on pulmonary drug delivery and the role of inhaled particles Commercialization and partnership experience Board of Directors Diverse Collective Experience
Slide 5: iSPERSE Significantly Improves Patient Care Compared to Conventional Inhalation Technology
Large Porous Particle (LPP; AIR®/ARCUS™) iSPERSE™ Significantly Improves Patient Care Compared to Conventional Inhalation Technology 1µm iSPERSE™ enables the sickest patient to receive the same dose of medication as a healthy patient iSPERSE™ Differentiation iSPERSE™ Advantages Small, dense, dispers
Slide 6: Product Pipeline and 2017-2018 Development Focus
Product Indication PreClin Ph1 Ph2 Ph3 Milestone PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) Phase 2 (2H2018) PUR1900 Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Severe Asthma Phase 1B (1H2018) PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Phase 1 (2019) PUR0200-US LAMA Ch
Slide 7: PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI) for AECOPD
PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI) Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Slide 8: NSKIs Block Steroid Resistant Inflammation & Lung Remodeling Processes
Narrow Spectrum Kinase Inhibitors (NSKI) Block Steroid Resistant Inflammation & Lung Remodeling Processes Source: Barnes PJ. Pharmacol Rev 2016; 68:788–815 Source: Barnes PJ. J Allergy Clin Immunol 2013; 131:636-45 Source: Geraghty P et al. Am J Respir Cell Mol Biol. 2014; 50(3):559-70 Source: Angat
Slide 9: PUR1800 (NSKI): $1B+ Potential Given Large Market in AECOPD
PUR1800 (NSKI): $1B+ Potential Given Large Market and Broad Efficacy Potential in AECOPD Meaningful AECOPD Disease Burden Unlike Steroids, PUR1800 Has Anticipated Efficacy Across Different AECOPD Phenotypes COPD is the 3rd leading cause of death in the U.S. Diagnosed prevalence of COPD is ~16 M in t
Slide 10: PUR1800 is a Novel Product with Demonstrated Target Engagement and Tolerability
PUR1800 (NSKI) is a Novel Product with Clinically Demonstrated Target Engagement and Tolerability MOA Narrow spectrum triple kinase inhibitor of p38 mitogen activated protein (MAP) kinase (α/γ), Src family kinases, and Syk kinases Lead Indication Acute exacerbations of COPD Development Status Comple
Slide 11: PUR1800 Decreases Markers of Inflammation in Patients with Moderate-to-Severe COPD
PUR1800 (NSKI) Decreases Markers of Inflammation in Patients with Moderate-to-Severe COPD (EST001) p38MAPK Phosphorylation Levels in Sputum Cells Recovered From COPD Subjects Concentration of Sputum Neutrophils Recovered From COPD Subjects After 12 days of treatment, PUR1800 (500 µg dose) significan
Slide 12: PUR1800 Exhibits Favorable Pharmacokinetics with Repeat Dosing
PUR1800 (NSKI) Exhibits Favorable Pharmacokinetics with Repeat Dosing (EST001) Pharmacokinetic Data for Repeat Dose in COPD Patients In COPD patients, PUR1800 showed dose proportional pharmacokinetics and increased plasma concentration with repeat dosing, indicating clinical utility over an extended
Slide 13: PUR1800 Phase 2 Clinical Study
Moderate-to-Severe COPD Patients 30% ≤ FEV1 < 80% (n=40) Randomization (2:2:1) 14-28 days Phase 2 Endpoints Safety and tolerability Single dose PK profile Multiple dose PK profile over 14-28 days Analysis of sputum inflammation and target engagement Patient specific biomarkers through Functional Res
Slide 14: PUR1900 – Inhaled Antifungal for ABPA in Severe Asthma
PUR1900 – Inhaled Antifungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Severe Asthma
Slide 15: ABPA Disease Overview and Treatment Flow
2nd Line Disease Overview Treatment Flow ~1.5% of Adult Asthmatics Suffer from Allergic Bronchopulmonary Aspergillosis (ABPA) Source: Shah. Allergy Asthma Immunol Res. 2016;8(4):282; Agarwal. Clinical & Experimental Allergy. 2013;43:850; Patterson. Proc Am Thorac Soc. 2010;7:237; Tracy. J. Fungi. 20
Slide 16: PUR1900 First in Class Inhaled Delivery Expected to Improve Safety & Efficacy
PUR1900 (Antifungal) First in Class Inhaled Delivery Expected to Improve Safety & Efficacy MOA Triazole that inhibits P450-dependent synthesis of ergosterol, a key component of fungal cell wall biosynthesis Lead Indication Allergic Bronchopulmonary Aspergillosis (ABPA) in Asthma Other Potential Indi
Slide 17: Use of Antifungal Agents in Treating ABPA
Use of Antifungal Agents in Treating ABPA Prescribers indicated that PUR1900 may replace ~85% of the current oral antifungal use in treatment of ABPA +115% PUR1900 (Antifungal) Expected to Become Gold Standard Antifungal for ABPA in Severe Asthma Source: Physician Interviews; ClearView Analysis Futu
Slide 18: PUR1900 Global Forecast
PUR1900 Global Forecast 2033 Peak PUR1900 U.S. ABPA-Asthma Forecast and Overall Global Forecast Source: Physician Interviews; Payer Interviews; ClearView Analysis. * Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment. U.S. Other Indications U.S. ABPA Asth
Slide 19: PUR1900 Offers Potential Safety & Efficacy Benefits vs Oral Itraconazole
Plasma Concentration of PUR1900 vs. Oral Sporanox Lung Concentration of PUR1900 vs. Oral Sporanox PUR1900 (Antifungal) Offers Potential Safety & Efficacy Benefits vs Oral Itraconazole (Sporanox) In preclinical studies, inhaled PUR1900 achieves 5x better lung exposure than oral Sporanox with signific
Slide 20: Overall Survival with PUR1900 Compared to Oral Sporanox and Placebo
Overall Survival with PUR1900 Compared to Oral Sporanox and Placebo PUR1900 (Antifungal) Inhaled Itraconazole Improved Survival in an Immunosuppressed Guinea Pig Model In preclinical studies with immunocompromised guinea pigs, inhaled PUR1900 achieved ~90% overall survival compared to 30% with oral
Slide 21: PUR1900 Phase 1/1b Clinical Plan
Part 1: Single Ascending Dose (SAD) Healthy volunteers (n=6/cohort) Single dose 96h PK profile Safety and tolerability Part 2: Multiple Ascending Dose (MAD) Healthy volunteers (n=6/cohort) PK profile over 14d of dosing Safety and tolerability Part 3: Single Dose (SD) Asthmatics (n=12; cross-over) Si
Slide 22: PUR0200 – iSPERSE Reformulation of Spiriva
PUR0200 – iSPERSE™ Reformulation of Spiriva® Chronic Obstructive Pulmonary Disease
Slide 23: PUR0200: Immediate Out-Licensing Opportunity
PUR0200: iSPERSE™ Represents an Immediate Out-Licensing Opportunity PUR0200 is an Improved Version of the Spiriva® Handihaler® (Equivalent Lung Exposure at 80% Nominal Dose) Spiriva® is a commonly used bronchodilator for ~20M COPD patients Spiriva lacks a dry-powder multi-dose inhaler in the U.S. In
Slide 24: Summary & Development Plan
pulmatrix Summary & Development Plan
Slide 25: Significant Value Inflection Points Anticipated in 2018
2017 2018 2019 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Pulmatrix plans to advance both PUR1800 and PUR1900 to major clinical milestones Significant Value Inflection Points Anticipated in 2018 PUR1800 (NSKI) PUR1800 Phase 2b Start PUR1800 Phase 2 Data PUR1800 Phase 2b CMC PUR1800 GLP Tox Non-clinical CMC
Slide 26: Clear Corporate Strategy with Value Creation Milestones
Clear Corporate Strategy with Value Creation Milestones in 2018 Target iSPERSE™ technology toward major respiratory diseases PUR1800 novel narrow spectrum kinase inhibitor (NSKI) for AECOPD Phase 2 data expected in 4Q 2018 >$1B U.S. potential revenue opportunity Significantly reduced development ris
Slide 27: Engineering Respiratory Products for Major Unmet Needs
Engineering Respiratory Products for Major Unmet Needs August 2017