Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (September 2020)
30 slides from Pulmatrix's investor presentation, Sep 22, 2020
Slide 1: Pulmatrix
ate | PULMATRIixX NASDAQ: PULM
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements. All statements other than statements of historical fact contained herein, including statements regarding our business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected
Slide 3: Leadership Team
Leadership Team Management § 9 CEO & Director Dr. Rusty Clayton Head of Clinical Development | Michelle Siegert VP Finance Michael Lipp, PhD Chemistry Manufacturing & Controls Strategy Fak PULMATRixX Board of Directors airman Rick Batycky, PhD Director nocion “om > Director Amit Munshi Director 9 AR
Slide 4: Pulmatrix mission and iSPERSE technology
PULMATRiX is committed to the development and commercialization of novel and transformational medicines for patients all over the world, using our proprietary iSPERSE™ technology to optimally deliver both respiratory and non-respiratory therapies via the respiratory system. Our initial focus is on r
Slide 5: Investment Highlights
Proprietary iSPERSE platform technology that seeks to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory therapeutics Ascalable platform with applicability across drug classes and dry-powder delivery devices, that we believe creates broad potential for pipeline development
Slide 6: Pulmatrix Partnerships
Pulmatrix Partnerships Validation of iSPERSE technology, sharing of development cost and potential revenue expansion Expanding Global Opportunities for Pulmazole J&J Global Lung Cancer Initiative Partnership Over-The-Counter Partnership to Combat COVID-19 Infection Fa, PULMATRIX _ -dedwards et at, a
Slide 7: Pulmatrix Pipeline
Pulmatrix Pipeline PUR1800** Phib Data Anticipated NSKI CoD © - (J&J License Option) Lung Cancer BET enum sst > © 6 & 9 Month Toxicology Data Anticipated @ Potential Jad License Option Execution Pulmazole* Anti-fungal Allergic Bronchopulmonary PH2b Study Protocol to Be Finalized Following (Cipla Par
Slide 8: Small Dense and Dispersible
Small Dense and Dispersible
Slide 9: iSPERSE Platform
iSPERSE Platform Small, dense and dispersible particles designed for highly efficient respiratory delivery Potential iSPERSE Advantages Evolution of Engineered Dry Powder Drug Delivery * Can be used with a broad range of drugs, small molecule to biologic © Can be used with almost any device (e.g., m
Slide 10: Pulmazole
Pulmazole Inhaled Antifungal Cipla Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Pulmazole worldwide co-development, commercialization and 50-50 profit share partnership with Cipla Technologies repr
Slide 11: Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Exaggerated response of the immune system to the fungus aspergillus in patients with asthma and cystic fibrosis Treatment focus Control of asthma symptoms e Prevention and treatment of pulmonary exacerbations Reduction of pulmona
Slide 12: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA e Visual Changes e ~50% of ABPA patients have inadequate response to ~ oral steroids alone Cutaneous Reactions e ~20% of ABPA patients become steroid dependent Hepatic Abnormality ee one e Long-term steroid use associated with development of j astro Intestinal h
Slide 13: Pulmazole: Potential to Change Standard of Care for ABPA
Pulmazole: Potential to Change Standard of Care for ABPA Ph1/1b study successfully met all endpoints Phase 1/1b Part 1 & 2: Demonstrated safety and tolerability of Pulmazole administered up to 14 days SAD and MAD Key Results ~100—400 fold lower plasma exposure over 24 hours than expected with oral S
Slide 14: Pulmazole Development Plan Builds Upon Clinical Precedent
Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox Improvement of FEV, in ABPA Pulmazole is anticipated to improve upon Sporanox outcomes demonstrated in clinical literature te NEW ENGLAND JOURNAL of MEDICINE Journal of Clinical Immunology Expert Review of Respiratory Medicine 200
Slide 15: Phase 2b Study Intended to Demonstrate Proof of Concept
Phase 2b Study* Intended to Demonstrate Proof of Concept in Patients with Asthma-ABPA Ph2b study planned to commence after COVID-19 pandemic risk to patient safety and study operations has abated. An FDA Type-C meeting is anticipated to inform the Ph2b protocol and overall development plan. Patient
Slide 16: Pulmazole: $1.5B Peak Net Revenue Potential in the U.S.
Pulmazole: $1.5B Peak Net Revenue Potential in the U.S. Anticipated increase of 1° line use drives the Pulmazole ~$1.5B U.S. peak net revenue forecast 65% ~1.3B Net ~200M 30% U.S. ABPAAsthma Revenue U.S. Other Indications Current Use of Antifungal 1st Line Future Use of Antifungal 1st Line Clair Xol
Slide 17: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for Lung Cancer Reformulation of Janssen’s RV1162 Narrow Spectrum Kinase Inhibitor (NSKI) In clinical studies, RV1162 lactose blend demonstrated target engagement, anti-inflammatory activity, safety and rs tolerability in a 12-day study w
Slide 18: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Block steroid resistant inflammation and lung remodeling processes Treat Steroid-Resistant Inflammation @ © Inhibit p38 MAP kinases (p38MAPK) to restore steroid sensitivity and reduce inflammation Block inflammatory action of Src, which promotes cytokine prod
Slide 19: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 (NSKI) Positive study results and opportunity for iSPERSE enablement of further clinical development resulted in Pulmatrix license of RV1162 and NSKI portfolio p38 phosphorylation Neutrophils p=0.73 p=0.01 p=0.68 p=0.02 25.0 . Clinical Data Summary * RV1162 lactose ble
Slide 20: PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162
PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend Formulation iSPERSE Particle Engineering 800 — GLP Tox Formulation e Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend form
Slide 21: 28-Day GLP Toxicology Study Resulted in PUR1800
28-Day GLP Toxicology Study* Resulted in PUR1800 Improved Safety Margins Relative to RV1162 iSPERSE enabled higher LUNG dos' a PUR1800 Results 500 pg ~300 pg Nominal Dose Lung Dose Dose proportional systemic exposure Reduced potential for lung drug accumulation No noteworthy clinical signs Janssen R
Slide 22: PUR1800 Phase 1b Trial in Stable COPD
PUR1800 Phase 1b Trial in Stable COPD Phase 1b: Safety study bridging from lactose formulation to iSPERSE formulation Endpoints © Safety & Tolerability Stable COPD © Pulmonary function (FEV1) Patients days 1,7 and 14 * Systemic and sputum 15 patients > > Placebo pharmacokinetics days 1, 7 and 14 Ran
Slide 23: PUR3100
PUR3100 Acute Migraine Product Large market market with significant unmet need in treatment of acute migraine Lung delivery offers many potential advantages including fast acting pain relief and symptom control with a favorable tolerability profile Recent commercial success of CGRP products has aly
Slide 24: Acute Treatment of Migraine: Large Market
Acute Treatment of Migraine: Large Market >1 billion worldwide >38 million U.S. Affects 3x’s more women than men underserved market Large Unmet Medical Need 75% of patients not actively treated with Rx’s due to poor efficacy 80% of patients on Rx’s would try new therapies High Pharmacoeconomic Burde
Slide 25: Migraine Market is Expanding
Migraine Market is Expanding $3.4B Sales in 2017 to $5.1B Projected Sales in 2021 While CGRP have expanded the market, predominant use is for chronic not acute migraine 3% CGRP 13% CGRP (only branded) (only branded) 436K Others others: 97% Generic 98% Generic aactoriciy net (96% Triptans) (96% Tript
Slide 26: PUR3100 Estimated Development Timelines
PUR3100 Estimated Development Timelines Ee Pcs | ics | oa [a [ios | io | a | a [os | ow | ao | Pre-IND IND Pht Data - Phib Data PH3 READY e PUR3100 iSPERSE formulation is anticipated to demonstrate differentiating ease of use, onset of action, symptom control and tolerability e Ph1/1b study results
Slide 27: PUR3100: Phase 1 Safety Study & Phase 1b POC Study
PUR3100: Phase 1 Safety Study & Phase 1b POC Study Dose ye M PUR 3100: Dose 3 PUR 3100: Dose 4 (n=6) 4 (n=6) a (ni * . Endpoints Healthy Normal Safety/PK Evaluation to escalate © Safety and PK assessment Volunteers after each dose (~2 weeks) ¢ > © Once target PK achieved on to 6 Patients/Dose 16 wee
Slide 28: Appendix
Appendix
Slide 29: Glossary of Terms
Glossary of Terms FDA Regulatory Pathway for Drug Approval Ig¢ Immunoglobulin G Antibodies Allergic Bronchopulmonary Aspergillosis IND Investigational New Drug Asthma Control Questionnaire 6 1p Intellectual Property Bronchoalveolar Lavage LPs Lipopolysaccharide Calcitonin-Gene-Related Peptide MAD Mu
Slide 30: Pulmatrix
ate | PULMATRIixX NASDAQ: PULM