Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (April 2021)
33 slides from Pulmatrix's investor presentation, Apr 12, 2021
Slide 1: Pulmatrix
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: Board of Directors, Management & Advisors
Board of Directors Michael Higgins Chairman Rick Batycky, PhD Todd Bazemore Director Director NOCcion THERAPEUTICS. an Chris Cabell, MD Mark Iwicki Director Director ZX 4 emergent alae. PULMATRiX Management & Advisors Ted Raad CEO & Director Rusty Clayton, MD Medical Director & Advisor Michelle Sieg
Slide 4: PULM (NASDAQ) Investment Highlights
PULM (NASDAQ) Investment Highlights e Proprietary iSPERSE platform technology that seeks to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory therapeutics e Ascalable platform with applicability across drug classes and dry-powder delivery devices to support pipeline devel
Slide 5: Pipeline Presents Multiple Potential Value Inflection Points
Pipeline Presents Multiple Potential Value Inflection Points iSPERSE™ enabled products span across multiple therapeutic categories ee peactrotne | or [a2 [as [as [at [a2] as | os Tat [az] as] Acute Exacerbations in }Phib = PUR1800 Chronic Obstructive | | Ph1b Data Anticipated NSKI Pulmonary Disease
Slide 6: iSPERSE
ISPERSE Small Dense and Dispersible Engineered Dry Powder Proprietary Technology
Slide 7: iSPERSE Platform
iSPERSE Platform iSPERSE Enables Sick Patients to Get More Effective Doses tz (e.g., metered: dose, reservoir, heaaun or blister-based inhalers) w for penetration deep into lung, based j Large Small Fae pharmacokinetics profile compared to oral delivery ae pean eter: P portfolio into 2030s Small Mol
Slide 8: Pulmazole
Pulmazole Inhaled Antifungal Cipla Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma ©) © 1 Source: Physician Interviews and Payer Interviews; ClearView Health Partners Analysis Pulmazole worldwide co-d
Slide 9: 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 approximately 1.5% of adult asthma patients (~300,000 U.S.)' and patients with cystic fibrosis Treatment focus e Control of asthma symptoms e Prevention and t
Slide 10: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA Visual Changes @) ee e ~50% of ABPA patients have inadequate response to oral steroids alone e ~20% of ABPA patients become steroid dependent , e Long-term steroid use associated with development of Gastro Intestinal Intolerance complications including invasive
Slide 11: Pulmazole: Potential to Change Standard of Care for ABPA
Pulmazole: Potential to Change Standard of Care for ABPA Phase 1/1b study successfully set all endpoints Demonstrated safety and tolerability of Pulmazole administered up to 14 days 4 ~100—400 fold lower plasma exposure over 24 hours than expected with oral Sporanox ~50 Cincespesue =~B5 Plasmatsposu
Slide 12: Pulmazole Development Plan Builds Upon Clinical Precedent
Pulmazole Development Plan Builds Upon Clinical Precedent of Oral Itraconazole Improvement of FEV, in ABPA Oral itraconazole outcomes demonstrated in clinical literature Tw NEW ENGLAND JOURNAL of MEDICINE i Journal of Clinical Immunology i Expert Review of Respiratory Medicine 2000, Stevens et al. i
Slide 13: Phase 2b Study Intended to Demonstrate Proof of Concept
Phase 2b Study Intended to Demonstrate Proof of Concept in Patients with Asthma and ABPA Successful FDA Type C meeting enables Ph2b study potential start in Q1 2022, assuming COVID-19 pandemic risk to patient safety and study operations has abated" Patient Profile “a Patients (M/F, ages 18-80) with
Slide 14: 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 concomitant use with oral steroids drives the revenue forecast 65% ~1.3B Net ~200M 30% U.S. ABPA Asthma Revenue U.S. Other Indications Current Use of Antifungal 1st Line Future Use of Antifungal 1st Line Clair Xo
Slide 15: PUR3100
PUR3100 Inhaled Dihydroergotamine (DHE) for Treatment of Acute Migraine ® Significant unmet need in a large market K=—4 represents ~$575M U.S. peak net revenue opportunity" Lung delivery offers many potential advantages including fast acting pain relief and symptom control with a favorable tolerabil
Slide 16: Acute Treatment of Migraine: Large underserved market
Acute Treatment of Migraine: Large underserved market Large Market >1 billion worldwide >38 million U.S. Affects 3x’s more women than men Pa PULMATRixX 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 rch Fou
Slide 17: Migraine Market is Expanding
Migraine Market is Expanding $3.4B Sales in 2017 to $5.1B Projected Sales in 2021 CGRP have expanded the market but predominant use is for chronic not acute migraine ~3% CGRP y ~12% CGRP i ©) Set account for (only branded) (only branded) ©) “sx of all migraine cour prescriptions, mostly generic trip
Slide 18: Migraine — Inhaled DHE Therapy Potential Advantages
Migraine — Inhaled DHE Therapy Potential Advantages What Do Patients Want? Absence of: nausea, lethargy, medication overuse, dysgeusia* 24+ hour headache relief through sustained target engagement! Fast onset of action through early Tyax and sustained target engagement! Migraine upon awakening, quic
Slide 19: Inhaled DHE (MAP0004) Can Achieve Pain Freedom in < Minutes
Inhaled DHE (MAP0004) Can Achieve Pain Freedom in < 30 Minutes Other acute migraine therapies have slower efficacy: triptan at ~1 hour and CGRP at ~2 hours % Patients @ Mean DHE Concentration (pg/mL) Plasma DHE (ng/mL) 80 100000 100.0 mMAPO004 ‘—*=MAP0004 250 ug/kg Placebo a =e 1 Actuation (N=6) =®=
Slide 20: PUR3100 Two-Part Ph1/Ph2 Study Intended to Demonstrate Proof of Concept
PUR3100 Two-Part Ph1/Ph2 Study Intended to Demonstrate Proof of Concept and Enable Pivotal Study PUR3100 Effectiveness Evaluated in Both Part 1 and Part 2 Phase 1 (Part 1) Phase 2 (Part 2) Safety & PK Dose Confirmation Part 1-Safety/PK e Initial assessment of 32 patients of PK and acute safety in cl
Slide 21: PUR3100: $575M Peak Net Revenue Potential at LOE in the U.S.
PUR3100: $575M Peak Net Revenue Potential at LOE in the U.S. Physician and Patient Feedback Payer Feedback % of triptan patients experiencing 40% a suboptimal response 2 generic treatment % of patients ranking “starts to show 7 y failures required improvement by 30 minutes” as the | 44% \ #1 most im
Slide 22: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for AECOPD NSKI Portfolio In-Licensed from Janssen, Including RV1162 RV1162 Reformulated Into iSPERSE Enabled PUR1800 PUR1800 potentially represents up to ~$2.4B" peak net revenue opportunity in the U.S. as an inhaled non-steroidal treatm
Slide 23: Limited Efficacy in Standard of Care for AECOPD
Limited Efficacy in Standard of Care for AECOPD Moderate-to-Severe Exacerbations Significant unmet need exists in AECOPD with underlying infection and/or steroid resistance Noninfectious Bacterial Acute Exacerbation in COPD (AECOPD) Etiology Bacterial & Viral Pq PULMATRIiX Steroids are standard of c
Slide 24: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Block steroid-resistant inflammation and lung remodeling processes Treat Steroid-resistant Inflammation e Inhibit p38 MAP kinases (p38MAPK) to restore steroid sensitivity and reduce inflammation e Block inflammatory action of Src, which promotes cytokine prod
Slide 25: RV1162 (NSKI) Reduces Steroid-resistant Inflammation in Preclinical Models
RV1162 (NSKI) Reduces Steroid-resistant Inflammation in Preclinical Models RV1162 reduces steroid insensitive, tobacco smoke-induced inflammation and restores steroid efficacy e Verified kinase target engagement and inhibition with similar potency across p38, Sre and Syk kinases e Reduces steroid-se
Slide 26: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 (NSKI) RV1162 Reduced p38 MAPK Phosphorylation RV1162 Reduced Sputum Neutrophils Clinical Data Summary e RV1162 lactose blend F was well tolerated in = = human study including stable p=0.68 p=0.02 moderate-to-severe COPD 3.5 subjects: ClinicalTrials.gov € 3.0 NCT019706
Slide 27: Janssen Out-Licensed NSKI Portfolio to Pulmatrix for Clinical Enablement
Janssen Out-Licensed NSKI Portfolio to Pulmatrix for Clinical Enablement Through iSPERSE iSPERSE Particle Engineering Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend formulation Janssen exited respirat
Slide 28: iSPERSE Enabled PUR1800 Provides Potential for Higher Lung Dosing
iSPERSE Enabled PUR1800 Provides Potential for Higher LUNG Dosing and Longer-Term Dosing 28-Day GLP Toxicology Study! Resulted in Improved PUR1800 Safety Margins Relative to RV1162 500 ug > ~300 yg Data supports maximum PUR1800 Nominal Dose Lung Dose 4 nominal clinical dose of 550 yg and ability to
Slide 29: PUR1800 Phase 1b Study Design
ag J - to iSPERS Randomized, double-blind, 3-way crossover study; 3 Dose Groups (2 active, 1 placebo) Endpoints e Safety & Tolerability 7 e Pulmonary function . ‘ PUR1800 ‘ PUR1800 (FEV,) (250 1g) | (500 pg) Days 1, 7 and 14 e Systemic and sputum 4 6a ==] ——_—___—_ pes | | PUR1800 . “ PUR1800 pharma
Slide 30: PUR1800: $2.4B in U.S. Peak Revenue Potential
PUR1800: $2.4B in U.S. Peak Revenue Potential se e 77% experience at least one exacerbation annually PUR1800 0% ~35% e ~18M moderate-to-severe AECOPD episodes EE TEE) annually in U.S. Oral Corticosteroids + Anti ~58% ~34% _ . : : F e > 20% corticosteroid treatment failure rate in Avitibistics’ Alone
Slide 31: Our Mission
Our Mission 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.
Slide 32: ee oO c ® a. a. = ¢
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Slide 33: Glossary of Terms
Glossary of Terms 505(b)(2) FDA Regulatory Pathway for Drug Approval IgG Immunoglobulin G Antibodies ABPA Allergic Bronchopulmonary Aspergillosis IND Investigational New Drug ACQ-6 Asthma Control Questionnaire 6 IP Intellectual Property AECOPD Acute Exacerbations in Chronic Obstructive Pulmonary Dis