Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (March 2021)
33 slides from Pulmatrix's investor presentation, Mar 4, 2021
Slide 1: Pulmatrix
~ 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 of Directors, Management & Advisors
Board of Directors Michael Higgins tY) Chairman Ironwood Rick Batycky, PhD Todd Bazemore Director Director NOcion THERAPEUTICS x Chris Cabell, MD Mark Iwicki Director Director ——~ emergent Amit Munshi Director PULMATRiX Management & Advisors Ted Raad Rusty Clayton, MD Medical Director & Advisor Mich
Slide 4: 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 5: 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 6: Pulmatrix Partnerships
Pulmatrix Partnerships Validation of iSPERSE technology, sharing of development cost and potential revenue expansion Cost sharing of development and commercialization costs with 50-50 share of worldwide free cash flows (profit) from commercialization Expanding Global Opportunities for Pulmazole Pote
Slide 7: Pulmatrix Pipeline
Pulmatrix Pipeline ieaijex [eres fae [ea [oo [es fenfex| a aa ls as jPnib Ph1b Data Anticipated (J&J License Option) ung Cancer | 6 & 9 Month Toxicology Data Anticipated | Potential J&J License Option Execution PUR3100 Migrai J pnt /Ph2 Ph1/Ph2 (POC) DHE IEAINE: Data Anticipated Pulmazole'’ Allergic
Slide 8: iSPERSE
iSPERSE Small Dense and Dispersible
Slide 9: iSPERSE Platform
iSPERSE Platform all, dense and dispersi sm tory delivery iSPERSE Enables Sick Patients to Get More Effective Doses | e joses into lungs (tens of milligrams) with high ‘ re Large Small oa e fect and sy E cts with improved 2 . 4um pharmacokinetics profile compared to oral delivery roReouee PuneSphos™
Slide 10: Pulmazole
Pulmazole Inhaled Antifungal Cipla Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma 3S: © 1 Source: Physician Interviews and Payer Interviews; ClearView Health Partners Analysis Pulmazole worldwide co-
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 approximately 1.5% of adult asthma patients (~300,000 U.S.)' and patients with cystic fibrosis | a A aoe, | = , _ ; 5 = : <I e Typical first line treatment is
Slide 12: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA Visual Changes Cutaneous Reactions Hepatic Abi lit rarities () Gastro Intestinal @ Intolerance 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 develo
Slide 13: 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 J ~100—400 fold lower plasma exposure over 24 hours than expected with oral Sporanox ~5 cae escomre ~85 Bee eeberine 1
Slide 14: 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 The NEW ENGLAND ree) . . eae JOURNAL of MEDICINE Journal of Clinical Immunology Expert Review of Respiratory Medicine 2000, Steven
Slide 15: 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 1} Patients (M/F, ages 18-80) with
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 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 17: PUR3100
PUR3100 Inhaled dihydroergotamine (DHE) for treatment of acute migraine (QP) Large market with significant unmet need in K==4)) treatment of acute migraine Lung delivery offers many potential advantages including fast acting pain relief and symptom control with a favorable tolerability profile Recen
Slide 18: 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 ahs | 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
Slide 19: 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 (only branded) (only branded) pOthers 6 ~97% Generic > ~98% Generic Sowe | (96% Triptans) (96% Triptan) patient n
Slide 20: Migraine Inhaled DHE Therapy Potential Advantages
Migraine — I / Inhaled DHE Therapy Potential Advantages What Do Patients Want? | 1 TL 2 T 3 4) “© Fast onset of action Migraine upon 24+ hour headache Inhaled preferred Absence of: through early Tirax awakening, quick to relief through over intranasal, nausea, lethargy, and sustained peek intensity,
Slide 21: Inhaled DHE (MAP0004) Clinically Demonstrated Pain Freedom Within 30 Minutes
Inhaled DHE (MAP0004) Clinically Demonstrated Pain Freedom Within 30 Minutes with Potential for ~15 minutes Based on Pharmacokinetic Data Other acute migraine therapies have slower efficacy: triptan at ~1 hour and CGRP at ~2 hours aan = 100000 & 4 2 . g ‘ 80 2 & 10000 \* 85 . 2 S& 5° 35 == = we — 10
Slide 22: PUR3100 Lead Formulation Dog PK
PUR3100 Lead Formulation Dog PK PK data show similar kinetics to modeling of published data from MAP0004 e PUR3100 was well tolerated apart from expected emetic response Published MAP0004 dog PK data was modeled to generate putative exposure time course! The systemic exposure (AUC, C,,,,, and T,,3,)
Slide 23: PUR3100 Estimated Development Timelines
PUR3100 Estimated Development Timelines Formulation & Process Development — BA Development & Validation — Manufacture — Stability Pre-IND IND * * * Part 1 Data Top Line Data PH3 READY Regulatory Regulator e PUR3100 iSPERSE formulation is anticipated to demonstrate differentiating ease of use, fast o
Slide 24: 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) Safety & PK Part 1-Safety/PK e Initial assessment of 32 patients of PK and acute safety in cli
Slide 25: 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 26: 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 tolerability in a 12-day study with
Slide 27: 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 28: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 2 (NSKI) RV1162 Reduced p38 MAPK Phosphorylation RV1162 Reduced Sputum Neutrophils E § 20.0 os 25 So e 22 3 x ga 20 “—_. > \ oF 15 5 15.0 Eo 2 3£ 1.0 Q £8 05 3 8. '0: 2 100 E & 00 Zz. 8 ax -0.5 a 50 = oe -10 x = o——_ 1.5 0.0 + T 7 1 -2.0 Se d1i2 Sc2 123 Sc d12 Sc2 123
Slide 29: PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend
PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend Formulation 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 respi
Slide 30: 28-Day GLP Toxicology Study Resulted in PUR1800 Improved Safety Margins
28-Day GLP Toxicology Study’ Resulted in PUR1800 Improved Safety Margins Relative to RV1162 iSPERSE Enabled Higher LUNG Dosing and Potentially Longer-term Dosing with PUR1800 500 ug > ~300 yg Data supports maximum PUR1800 Nominal Dose Lung Dose 4 nominal clinical dose of 550 yg and ability to delive
Slide 31: Phase 1b study bridging RV1162 to iSPERSE formulation
ty study bridgin ion to iSPERSE f Randomized, double-blind, 3-way crossover study; 3 Dose Groups (2 active, 1 placebo) with 15 pts. 14 days of daily dosing, with 28-day crossover and 28-day follow-up x PUR1800 . PUR1800 ‘ (500 pg) ’ PUR1800 | PUR1800 i ee i > PUR1800 ‘ PUR1800 Randomized >| WEN | 3
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 BAL | Bronchoalveolar Lavage LPS Lipopolysaccharide CGRP Calcit