Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (July 2023)
37 slides from Pulmatrix's investor presentation, Jul 11, 2023
Slide 1: Pulmatrix
PULMATRixX 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: Pulmatrix mission and iSPERSE technology
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 4: Management Team
Management Team Deep expertise in respiratory diseases & drug delivery technology across all stages of development Margaret Wasilewski, MD ~ Chief Medical Officer Jason Perry - CMC & Pharmaceutical Development © 25 years in pharmaceutical drug development 218 years of experience developing © Develop
Slide 5: Credentialed Board of Directors
Credentialed Board of Directors Board of directors with extensive experience in public and private life sciences companies Michael J. Higgins ~ Chairman ‘© Entrepreneur-in-residence at Polaris Partners and Board Member of Genocea, Voyager, Kindex, Madauder and Sea Pharmaceuticals ‘© Former SVP, COO,
Slide 6: PULM (NASDAQ) Investment Highlights
PULM (NASDAQ) 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 to support pipeline devel
Slide 7: iSPERSE Enabled Pipeline
iSPERSE Enabled Pipeline PUR1900 Allergic Bronchopulmonary Anti-fungal Aspergillosis (ABPA) (Cipla Partnership) _ in Patients with Asthma Ph2 Ready (IND Submitted) PURS 00 Acute Migraine | = Pursuing Perhorsip to Aavance Ph2b (POC) Study Underway PUR1800 Acute Exacerbations in Chronic Kinase Inhibit
Slide 8: iSPERSE
iSPERSE ‘Small Dense and Dispersible Engineered Dry Powder Proprietary Technology
Slide 9: iSPERSE Platform
iSPERSE Platform Small, dense and dispersible particles designed for highly efficient respiratory delivery iSPERSE Enables Sick Patients to Get More Effective Doses Poten Can be used with a broad range of drugs, small molecule to biologic © Can be used with almost any device (eg., metered-dose, rese
Slide 10: PUR1900
PUR1900 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 PUR1900 potential to address the underlying cause of disea
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 Treatment focus e Control of asthma symptoms Healthy Lung Disea
Slide 12: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA e ~50% of ABPA patients have inadequate response to oral steroids alone Cutaneous Reactions ~20% of ABPA patients become steroid dependent e Long-term steroid use associated with development of Hepatic Abnormality = complications including invasive aspergillosis
Slide 13: PUR1900 Development Plan Builds Upon Clinical Precedent
PUR1900 Development Plan Builds Upon Clinical Precedent of Oral Itraconazole Improvement of FEV, in ABPA Oral itraconazole outcomes demonstrated in clinical literature Expert Review of Respiratory Medicine ‘te NEW ENGLAND. i Journal of Clinical Immunology JOURNAL gf MEDICINE 2003, Wark et al. 2000,
Slide 14: PUR1900: Potential to Change the Standard of Care for ABPA
PUR1900: Potential to Change the Standard of Care for ABPA Phase 1/1b study successfully met all endpoints Demonstrated safety and tolerability of PUR1900 administered up to 14 days 4 ~100-400 fold lower plasma exposure over 24 hours than expected with oral Sporanox v v v Fold Higher Fold Lower ~5 L
Slide 15: PUR1900: Phase 2b Study Design
PUR1900: Phase 2b Study Intended to Demonstrate Proof of Concept in Patients with Asthma and ABPA Patient Profile (A Patients (WF, ages 18-80) with confirmed asthma and ABPA douso-bing Pracebo (n=6) PUR1900 20mg, Open Label asthma therapies, oral steroids) —— - Ee Ee- eeled <4 weeks > <8 weeks > PUR
Slide 16: PUR1900: Up to $1.5B Peak Net Revenue Potential in the U.S.
PUR1900: Up to $1.5B Peak Net Revenue Potential in the U.S. Anticipated increase of first-line concomitant use with oral steroids drives the revenue forecast 65% ~1.3B Net ~200M U.S. ABPA Asthma Revenue U.S. Other Indications 30% Current Use of Antifungal 1st Line Future Use of Antifungal ‘st Line x
Slide 17: PUR3100
PUR3100 Inhaled Dihydroergotamine (DHE) for Treatment of Acute Migraine ~$575M U.S. peak net revenue, a 1% total Rx share, is a conservative forecast! iSPERSE mitigates the manufacturing / device issues resulting in the MAP0004 FDA complete response Ph1 results: Safe, well tolerated, 5-minute T,,.,
Slide 18: PUR3100: Acute Treatment of Migraine
PUR3100: Acute Treatment of Migraine Large underserved market Large Market >1 billion worldwide >38 million U.S. Affects 3x’s more women than men aq 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
Slide 19: Inhaled DHE Therapy Potential Advantages
ry Inhaled DHE Therapy Potential Advantages Migraine — Puln Fast onset of action Migraine upon 24+ hour headache Inhaled preferred Absence of: through early Trax. awakening, quick to relief through over intranasal, nausea, lethargy, and sustained peak intensity, rescue sustained target convenient de
Slide 20: PUR3100 Phase 1 Clinical Study Design
PUR3100 Phase 1 Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics Objective to demonstrate safety and comparative bioavailability of PUR3100 (pulmonary inhaled) relative to IV DHE n 24 Healthy Volunteers mmy Single Dose St Randomized Double-blind, Double- Inhaled Placebo + 1mg IV
Slide 21: PUR3100 Achieved All Phase 1 Study Objectives and Goals
PUR3100 Achieved All Phase 1 Study Objectives and Goals Related to the Target Product Profile (TPP) Objective: To determine the safety and tolerability of single doses of + No vomiting was observed in the PUR3100 dose groups inhaled PURS100 in healthy adult subjects compared to IV DHE. + Lower incid
Slide 22: PUR3100 Four Hour Exposure Profile is Similar to IV DHE
PUR3100 Four Hour Exposure Profile is Similar to IV DHE Equivalent T,,,., with C,,q, below the range typically associated with elevated nausea risk “© IVDHE 1.0mg © Tax iS at the first time point (5 min) for “= PURS1000.5mg all subjects at all PUR3100 doses Tinax # PURS100 1.0 mg —* PUR3100 1.5 mg e
Slide 23: Published Pain Freedom Data Earlier Than Two Hours
Published Pain Freedom Data Earlier Than Two Hours Pain Freedom above Placebo (%) Drug/Route Class. Dose een 0.5hour 1hour 2hour 24 hour ° Risatriptan mg 0 7 22 13 604 Tablet/Wafert:2 10mg 4 9 34 18 55* Sumatriptan . . 4 Nasal Spray>_| TiPtan 20mg 10 2 62 Sumatriptan 50mg 2 3 17 10 Ea Tablet? 100mg
Slide 24: PUR3100 Kinetics Compared to MAP0004
PUR3100 Kinetics Compared to MAP0004 “= MAPOO04 1 mg -»+ MAP0004 2 mg — PUR3100 0.5 mg — PUR3100 1.0 mg © Tax at 5 min for all PUR3100 doses Timax Tmax — PUR3100 1.5mg versus 12 minutes in MAP Phase 1 > 50% Nausea study! 15000 e Ahigher C,,,.. was achieved with PUR3100 e Published third-party studie
Slide 25: PUR3100 Kinetics vs. Marketed DHE Therapies
PUR3100 Kinetics vs. Marketed DHE Therapies Tmax Tmax Tmax © Tmax at 5 min for all PUR3100 Nwaoe 208 doses versus 30 minutes for in 15000 mrornasny INP1041 and 47 minutes for aa vchetpiad Migranal" ‘Therapeutic Window’ e Higher C,,,, than published intranasal (IN) formulations’ C,,,., DHE pg/mL. a 8
Slide 26: PUR3100: No Vomiting and Less Nausea Than IV DHE
PUR3100: No Vomiting and Less Nausea Than IV DHE subject number Nausea Incidence IWDHE.45 11mg Nausea. chest tightness IVDHE.45 tmg Nausea “suprapubio pain © OF 16 subjects with Cra. < 14,500 IVD.HE. 451mg Nausea Vomit pg/mL, 3 experienced nausea = 19% IVDHE 451mg Nausea IVDHE.451mq Nausea © Of8 sub
Slide 27: PUR3100 Potential Development Plan Through Phase 3
PUR3100 Potential Development Plan Through Phase 2 Phase 2 data will inform the design and likelihood of a single Phase 3 study aa @ 3 aa a a i Qs au Ph3 CTM Readiness Phase 2 ? FPD TR Phase 2 Study Design Powered Phase 2 followed by single Phase 3 Phase 2 randomized (1:1:1), double-blind, placebo-c
Slide 28: 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 patients on fan experi | a suboptimal response 5o) % of patients ranking “starts to show 7 improvement by 30 minutes” as the | 44% #1 most important product attribute ' 4 generic treatment
Slide 29: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for Treating AECOPD. NSKI Portfolio In-Licensed from Janssen, Including RV1162 RV1162 Reformulated Into iSPERSE Enabled PUR1800 ® PUR1800 potentially represents up to ~$2.4B" K=4 peak net revenue opportunity in the U.S. as an inhaled non-
Slide 30: 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 Noni
Slide 31: 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 32: 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, Src and Syk kinases. e Reduces steroid-s
Slide 33: PUR1800 Phase 1b Trial in Stable COPD Preliminary Results
PUR1800 Phase 1b Trial in Stable COPD Preliminary Results Objectives of safety and pharmacokinetics were completed 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 follo Endpoints © Safety & To
Slide 34: PUR1800: $2.4B in U.S. Peak Revenue Potential
PUR1800: $2.4B in U.S. Peak Revenue Potential e ~16M COPD patients in the U.S. Treatment Option curren Expected ise ise ° ry 77% experience at least one exacerbation annually PUR1800 0% =i ~18M moderate-to-severe AECOPD episodes (choral fer ens feral ds enc sienebiotes) annually in U.S. Oral Cortico
Slide 35: Chronic Toxicology Pathology Results Support Potential Expansion
Chronic Toxicology Pathology Results Support Potential Expansion Into Chronic Treatment of Pulmonary Disease (ex. COPD, IPF, Asthma) peers Severe . n 6-mont are Disease AECOPD gles Sookin us: | | Asthma 18M Moderate ° effects RAS to Severe ‘50% of Adult Acute ° 9 Asthma) Exacerbations per year in US
Slide 36: Pulmatrix
PULMATRixX NASDAQ: PULM
Slide 37: 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 AECOPD Acute Exacerbations in Chronic Obstructive Pulmonary Disease IP Intellectual Property BAL Bronchoalveolar Lavage LPS L