Slide 1: Corporate Overview
PULMATRIX Corporate Overview 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 Overview
Pulmatrix Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Clinical Programs for Partnership or Monetization 3
Slide 4: Pursuing Strategic Alternatives Leveraging Pipeline, iSPERSE Technology and Cash
PULM (NASDAQ) Pursuing Strategic Alternatives that Leverage the Company’s Pipeline, iSPERSE Technology and Cash on Hand ● Proprietary iSPERSETM platform technology that seeks to optimize pharmacokinetics and Enabling pharmacology in respiratory and non-respiratory therapeutics iSPERSETM ● A scalable
Slide 5: 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 ● 15 years of experience developing ● Develo
Slide 6: 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 Ted Raad – CEO & Director ● Entrepreneur-in-residence at Polaris Partners and Board Member ● Previously Chief Business Officer of Pulmatrix of Voya
Slide 7: iSPERSE Enabled Pipeline
iSPERSE Enabled Pipeline Product Pipeline Indication Phase 1 Phase 2 Status PUR3100 Ph2 Ready Acute Migraine (IND Accepted) DHE PUR1800 Acute Exacerbations in Chronic Kinase Inhibitor Obstructive Pulmonary Disease Pursuing Partnership (NSKI) (AECOPD) PUR1900 Allergic Bronchopulmonary • Closing Ph2b
Slide 8: PUR3100 Overview
Pulmatrix Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Clinical Programs for Partnership or Monetization 8
Slide 9: Strategic Rationale for PUR3100
Strategic Rationale for PUR3100 MAP0004 – Basis for Optimization The Solution – PUR3100 ● Oral Inhaled formulation of DHE to treat acute migraines Product Result ● Developed by MAP Pharma and subsequently acquired by Allergan ü Content uniformity achieved DHE through iSPERSE particle ● Tmax = 12 min
Slide 10: PUR3100 Highlights
PUR3100 Highlights ● Inhaled Dihydroergotamine (DHE) for the Treatment of Acute Migraine ● Utilizes Pulmatrix’s proprietary iSPERSE™ drug delivery technology Product ● Commercially available off the shelf dry powder inhaler (RS01) used for patient dosing ● Optimal exposure and PK profile, ease of us
Slide 11: iSPERSE Technology
iSPERSE™ Technology Small, dense and dispersible particles designed for highly efficient respiratory delivery iSPERSE Enables Sick Patients to Get More Effective Doses Potential iSPERSE Advantages Evolution of Engineered Dry Powder Drug Delivery ● Can be used with a broad range of drugs, small molec
Slide 12: RS01 Inhaler Overview
RS01 Inhaler Overview Commercially available inhaler from PlastiapeTM ● Pulmatrix uses the RS01 inhaler platform for delivery of all iSPERSE products currently in pipeline § Device uses pre-metered capsules and inspiratory effort of patient to deliver dose § Robust across various formulations and th
Slide 13: Available Published <2-Hour Pain Freedom Data (non-Sub Q)
Available Published < 2-Hour Pain Freedom Data (non-Sub Q) MAP0004 (PUR3100 proof of concept) compared to available CGRP and triptan data Pain Freedom Above Placebo (%) Drug/Route Class Dose 24h Rescue%8 0.5 hour 1 hour 2 hour 24 hour 5mg 0 7 22 13 604 Risatriptan Tablet/Wafer1, 2 10mg 1 9 31 18 554
Slide 14: PUR3100: Potential Novel DHE Therapy
PUR3100: Potential Novel DHE Therapy PUR3100 displays potential advantages among other DHE products (approved & not approved) Features/ Characteristics PUR3100 MAP00041 STS1012 TrudhesaTM Migranal® IV DHE IND Accepted – Ph2 Ready No FDA Approval No FDA Approval FDA Approved FDA Approved FDA Approved
Slide 15: Clinical Data
Pulmatrix Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Clinical Programs for Partnership or Monetization 15
Slide 16: PUR3100 Phase 1 Clinical Study
PUR3100 Phase 1 Clinical Study ● Evaluate Safety, Tolerability, and Pharmacokinetics Objectives ● Demonstrate comparative bioavailability of PUR3100 to IV DHE Randomized Double-blind, Double-dummy Single Dose Study in 24 Healthy Volunteers Inhaled Placebo + 1mg IV DHE (n=6) Initial Phase 1 Study ● I
Slide 17: PUR3100 Achieved All Phase 1 Study Objectives
PUR3100 Achieved All Phase 1 Study Objectives Desired Target Product PUR3100 Phase 1 Result Profile Characteristic Tmax < 15 Minutes ü Tmax = 5 min ü ~2.5- to 4-fold lower mean AUC0-inf relative to Overall AUC ≤ IV DHE While IV DHE Maintaining a Lower Cmax than IV DHE ü 9- to 12-fold lower mean Cmax
Slide 18: PUR3100 Four Hour Exposure Profile is Similar to IV DHE
PUR3100 Four Hour Exposure Profile is Similar to IV DHE 4h Equivalent Tmax with Cmax below the range typically associated with elevated nausea risk 105 IV DHE 1.0 mg Plasma DHE (ng/mL) ●Tmax is at the first time point (5 min) for 104 PUR3100 0.5 mg PUR3100 1.0 mg all subjects at all PUR3100 doses 10
Slide 19: PUR3100 Kinetics Compared to MAP0004
105 104 DHE pg/mL PUR3100 Kinetics Compared to MAP0004 103 MAP0004 1 mg MAP0004 2 mg 102 PUR3100 0.5 mg PUR3100 1.0 mg ● Tmax at 5 min for all PUR3100 doses 101 Tmax Tmax PUR3100 1.5 mg versus 12 minutes in MAP Phase 1 0.0 0.5 1.0 > 50% 1.5 Nausea 2.0 study1 15000 Time (h) ● A higher Cmax was achiev
Slide 20: PUR3100 Kinetics vs. Marketed DHE Therapies
PUR3100 Kinetics vs. Marketed DHE Therapies 105 Tmax Tmax Tmax 104 DHE pg/mL ● Tmax at 5 min for all PUR3100 > 50%10Nausea 3 IN Migranal 2mg 15000 INP104 1.45 mg doses versus 30 minutes for in 102 PUR3100 0.5 mg INP1041 and 47 minutes for 101 PUR3100 1.0 mg PUR3100 1.5 mg Migranal1 ‘Therapeutic Wind
Slide 21: PUR3100: No Vomiting and Less Nausea Than IV DHE
PUR3100: No Vomiting and Less Nausea Than IV DHE Time to Subject Duration of Nausea after number Active medication Cmax (pg/mL) Dose (min) dose (min) Nausea Incidence 120 IV D.H.E. 45 1 mg SNR 4 6 Nausea chest tightness 109 IV D.H.E. 45 1 mg 112000 3 5 Nausea suprapubic pain ● Of 16 subjects with Cm
Slide 22: Attractive Market Opportunity
Pulmatrix Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Products for Partnership or Monetization 22
Slide 23: Market Opportunity
Market Opportunity ~$575M peak US revenue with approximately 1% of market capture anticipated Physician and Patient Feedback Payer Feedback % of patients on triptan experiencing a suboptimal response 40% generic treatment % of patients ranking “starts to show 2 failures required improvement by 30 mi
Slide 24: Low Risk Profile
Pulmatrix Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Clinical Programs for Partnership or Monetization 24
Slide 25: High Confidence In Potential Efficacy
High Confidence In Potential Efficacy MAP0004 established safety and efficacy for inhaled DHE, but PUR3100 shows potential advantages Met All Four Co-primary Endpoints at the PUR3100 Potential Advantages 2-hour Time Point MAP0004 Placebo ü DHE pharmacokinetics (PK) are highly predictive of clinical
Slide 26: PUR3100 Potential Phase 2 Clinical Study
PUR3100 Potential Phase 2 Clinical Study Randomized Double-blind, Double-dummy Single Dose Study in 24 Healthy Volunteers Inhaled Placebo (n=65) Phase 2 Study Objectives ● Evaluate efficacy as measured by pain Inhaled PUR3100 0.5mg freedom and freedom from most bothersome Acute Migraine (n=65) sympt
Slide 27: Development Plan to Chronic Toxicology & Phase 2 Top Line Data
Development Plan to Chronic Toxicology & Phase 2 Top Line Data YEAR 1 YEAR 2 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Ph2 CTM & Study Initiation Phase 2 FPD Ph2 Study TLR Chronic Toxicology Study Data Plan Phase 2 Study Design Activities Through Ph2 Top-Line Data Powered Phase 2 followed by single Phase 2 randomized
Slide 28: Post Phase 2 Development Plan for Completion of Required Studies for NDA
Post Phase 2 Development Plan for Completion of Required Studies for NDA YEAR 3 YEAR 4 YEAR 5 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Ph3 CTM Readiness Ph3 CTM Post FPD Ph1 Asthma Study TLR Phase 2 FPD Ph3 Study TLR FPD OLE TLR Plan Phase 3 / OLE Study Design Activities Through Ph3 and OLE Top Line Resu
Slide 29: Other Clinical Programs for Partnership or Monetization
Opportunity Overview PUR3100 Overview Clinical Data Attractive Market Opportunity Low Risk Profile Other Clinical Programs for Partnership or Monetization 29
Slide 30: 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 represents up to ~$2.4B1 peak net revenue opportunity in the U.S. as an inhaled non-steroidal treatment
Slide 31: PUR1900
PUR1900 Inhaled Antifungal Cipla Worldwide 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 disease while avoiding side ef
Slide 32: Corporate Overview
PULMATRIX Corporate Overview NASDAQ: PULM