Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (May 2021)
33 slides from Pulmatrix's investor presentation, May 13, 2021
Slide 1: Pulmatrix
Py PULMATRIiX 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 and Management
POLARIS Michael Higgins Chairman Rick Batycky, PhD Director Nocion THERAPEUTICS Todd Bazemore Director «ala. Chris Cabell, MD Mark Iwicki Director Director z—~ emergent PULMATRiX Ted Raad CEO & Director Rusty Clayton, MD Medical Director & Advisor Jason Perry CMC, Pharm. Development Audrey Rossow Cl
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 Acute Exacerbations in }Phib J _ PUR1800 Chronic Obstructive CL] Ph1b Data Anticipated NSKI Pulmonary Disease nigga P _ (AECOPD) Tox Studies | 6- & 9-Month Toxicology Da
Slide 6: iSPERSE
iSPERSE Small Dense and Dispersible Engineered Dry Powder Proprietary Technology
Slide 7: iSPERSE Platform
iSPERSE Platform Small, dense and cient respiratory nables Sick Patients to Get More Effective Doses slivery G a) m om 2. Ze m m m a >} @O o a E used with alr tered a doses reservoil carts or blister-based inhalers) v for penetration deep into lung, based a 28 s into lungs (tens of milligrams) with
Slide 8: PUR3100
PUR3100 Inhaled Dihydroergotamine (DHE) for Treatment of Acute Migraine Significant unmet need in a large market represents ~$575M U.S. peak net revenue opportunity1 Lung delivery offers many potential advantages including fast acting pain relief and symptom control with a favorable tolerability pro
Slide 9: Acute Treatment of Migraine: Large underserved market
Acute Treatment of Migraine: Large underserved market Large Market Large Unmet High Pharmacoeconomic Acute Treatment >1 billion worldwide Medical Need Burden New preventative treatment >38 million U.S. 75% of patients not actively $38 billion annual cost — U.S. options do not fully address acta ow"
Slide 10: 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 ~12% CGRP » Generics account for ~98% of all migraine prescriptions, mostly generic triptan CGRP’s demonstrated significant g
Slide 11: Inhaled DHE Therapy Potential Advantages
/ Inhaled DHE Therapy Potential Advantages Fast onset of action through early Tmax and sustained target engagement'2 Migraine upon 24+ hour headache : Inhaled preferred: Absence of: awakening, quick to relief through f over intranasal, nausea, lethargy, : peek intensity, rescue : sustained target co
Slide 12: 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) @ 60 miwabood 1400000 100.0 —e—MAP0004 250 ug/kg = Placebo -e-PUR3131-1A 250 ug
Slide 13: 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) interim Analysis Phase 2 (Part 2) Part 1-Safety/PK Dose Confirmation e Initial assessment of 32 patients of PK and acute safety
Slide 14: 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 as 2 generic treatment 7 y failures required ¥y \ % of patients ranking “starts to show improvement by 30 minutes” as the | 44% #1 m
Slide 15: 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 16: 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 e Steroids are standard of care for moderate-to- severe acute exacerbations, which occur across all patient severity types Acut
Slide 17: 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 18: 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 —— 4 inhibition with similar potency across p38, ait Src and Syk kinases =" e Reduce
Slide 19: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 (NSKI) 1162 ly results nstr ment and ant-i RV1162 Reduced RV1162 Reduced Clinical Data p38 MAPK Phosphorylation Sputum Neutrophils Summary cae * RV1162 lactose blend rylation was well tolerated in =0.04 human study including stable a p=0. moderate-to-severe COPD : : su
Slide 20: Janssen Out-Licensed NSKI Portfolio to Pulmatrix for Clinical Enablement Through iSPERSE
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 21: 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 ug Data supports maximum PUR1800 i nominal clinical dose of 550 yg and ability me talateee Pang ee’ Vv to
Slide 22: PUR1800 Phase 1b Trial in Stable COPD
PUR1800 Phase 1b Trial in Stable COPD ie 4 ridging from lactose formulation to iSPERSE i) Phase 1b: Safety study b Randomized, double-blind, 3-way crossover study; 3 Dose Groups (2 active, 1 placebo) Endpoints e Safety & Tolerability with 15 pts. 14 days of daily dosing, with 28-day crossover and 28
Slide 23: PUR1800: $2.4B in U.S. Peak Revenue Potential
PUR1800: $2.4B in U.S. Peak Revenue Potential © ~16M COPD patients in the U.S. Treatment Option Expected ise se e 77% experience at least one exacerbation annually PUR1800 voion 0% ~35% e ~18M moderate-to-severe AECOPD episodes ce ee ested ener rite) annually in U.S. Oral Corticosteroids + Antibioti
Slide 24: Pulmazole
Pulmazole Inhaled Antifungal Cipla Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma iSPERSE enables itraconazole delivery to the lung, providing Pulmazole potential to address the underlying cause of d
Slide 25: 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 El : —— — Treatment is usually limited to steroid and oral anti
Slide 26: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA col Shenae 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 licati includi . . illosi lnteloranicé complications in
Slide 27: 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 cane eee ~85 Basie Eopoeure 1
Slide 28: 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 te NEW ENGLAND. JOURNAL of MEDICINE i Journal of Clinical Immunology : Expert Review of Respiratory Medicine 2000, Stevens et al.
Slide 29: 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 following the resolution of contractual dispute with Cipla’ Patient Profile Randomized 1 Patients (M/F, ages 18-80) with confirmed asthma and ABPA
Slide 30: 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 Xolair A
Slide 31: Pulmatrix is committed to the development and commercialization of novel medicines
PULMATRIiX 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: Appendix
Appendix
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