Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (December 2020)
30 slides from Pulmatrix's investor presentation, Dec 2, 2020
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 and Management
Board of Directors Management Q 8 ron bod \ Chairman » \ Michelle Siegert Finance Rick Batycky, PhD Director Medical Director & Advisor . <p. Aidan Curran, PhD Chris Cabell, MD ; Research : ? ARENA: wy) Nocion THERAPEUTICS Kala Director — Steve Kramer Quality Kala ] IARDACEUTI Dares Clinical Operati
Slide 4: Pulmatrix
PULMAT RIX 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. Our initial f
Slide 5: Pulmatrix 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 ae PULMATRixX * D Edwards et al.,
Slide 7: Pulmatrix Pipeline
Pulmatrix Pipeline ater 800** [Phib O phib Data Anticipated (J&J License Option) Lung Cancer Coa easit |» C) 6 & 9 Month Toxicology Data Anticipated PURSION Mpina Savas mec penierhin Zelwmnaiaicy Pulmazole* Anti-fungal Allergic Bronchopulmonary PH2b Study Protocol to Be Finalized Following (Cipla Pa
Slide 8: iSPERSE
iSPERSE Small Dense and Dispersible
Slide 9: iSPERSE Platform
iSPERSE Platform nall, dense and dispersible particles d ient re — (e. 9. etered dose, reservoi Peansuis or blister-based inhalers) Requires low inspiratory flow for penetration deep into lung, based on high dispersibility Can de ‘ge doses into lungs (tens of m ) with high ster Large Small = e i sy
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
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 e Control of asthma symptoms e Prevention and treatment of pulmonary exacerbations e Reduction of pul
Slide 12: 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 rs . illosi lnteloranicé complications i
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 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 / 1
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 1 NEW ENGLAND JOURNAL of MEDICINE : Journal of Clinical Immunology : Expert Review of Respiratory Medicine
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. ABPA Asthma Revenue U.S. Other Indications Current Use of Antifungal 1st Line Future Use of Antifungal 1st Line xGlair X
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 tolerability in a 12-day study with
Slide 18: 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 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 3.5 — 30 Clinical Data Summary © RV1162 lact
Slide 20: PUR1800 iSPERSE Formulation Overcame Limitations of RV1162
PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend Formulation iSPERSE Particle Engineering y Pu 1801 Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend formulation Janssen ex
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 dosing and potentially longer-term dosing with PUR1800 500 ug » ~300 ug Data supports maximum PUR1800 i nominal clinical dose of 550 yg and ability Nerminalbese Pang ee’ v to deliv
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 i) Endpoints ap ’ BE Serovar Stable COPD Pulmonary function (FEV1) days 1, 7 and 14 © Systemic and sputum 15 patients Placebo pharmacokinetics days 1, 7 ‘ and 14 Randomized © Target
Slide 23: PUR3100
PUR3100 Acute Migraine Product ® Large market market with significant unmet CEP 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 expanded the migraine market and demonstrated
Slide 24: Acute Treatment of Migraine
Acute Treatment of Migraine: Large underserved market Large Market >1 billion worldwide >38 million U.S. Affects 3x’s more women than men ae PULMATRiX Large Unmet High Pharmacoeconomic Acute Treatment Medical Need Burden New preventative treatment 75% of patients not actively $38 billion annual cost
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 ~12% CGRP (only branded) > (only branded) 436K Others Others > Generics not : ~97% Generic » ~98% Generic meeting (96% Tri
Slide 26: PUR3100 Estimated Development Timelines
PUR3100 Estimated Development Timelines Formulation & Process Development — BA Development & Validation — Manufacture — Stability Tecore x a * * Pre-IND IND Pht Data Phib Data PH3 READY Regulatory Regulatory e PUR3100 iSPERSE formulation is anticipated to demonstrate differentiating ease of use, ons
Slide 27: PUR3100: Phase 1 Safety Study & Phase 1b POC Study
PUR3100: Phase 1 Safety Study & Phase 1b POC Study PUR 3100: Dose 1 a PUR 3100: Dose 3 PUR 3100: Dose 4 (n=6) (n=6) (n=6) * , Endpoints Healthy Normal Safety/PK Evaluation to escalate Safety and PK assessment Volunteers < > after each dose (~2 weeks) 6 Patients/Dose 16 weeks £ Dues ae Ritaciere ons,
Slide 28: Appendix
Appendix
Slide 29: 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 Calcito
Slide 30: Pulmatrix
PULMATRIixX NASDAQ: PULM