Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (November 2017)
35 slides from Pulmatrix's investor presentation, Nov 14, 2017
Slide 1: Pulmatrix Corporate Overview November 2017
PULMATRIX Corporate Overview November 2017 NASDAQ: PULM Exhibit 99.1
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,” “pla
Slide 3: Three Study Readouts in 2018-2019 with Products Exceeding $6B in Estimated Revenue Potential
Three Study Readouts in 2018-2019 with Products Exceeding $6B in Estimated Revenue Potential ABPA = Allergic Bronchopulmonary Aspergillosis CF = Cystic Fibrosis NOTE - PUR1800 is iSPERSE re-formulation of in-licensed NSKI RV1162 from Janssen LEAD PROGRAM iSPERSE™ Pulmazole Anti-Fungal PUR1800 is an
Slide 4: Robust Pipeline with Projected Near-Term Value Catalysts
Product Indication 2018* 2019* Milestone Pulmazole Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Severe Asthma Phase 1 Mid-2018 Phase 1b Mid-2019 PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) Phase 2a 4Q 2018 PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Phase 1 (2019) PUR0200
Slide 5: iSPERSE Best-in-Class Engineered Particles Enable Development and Patient Care Advantages
iSPERSE™ Best-in-Class Engineered Particles Enable Development and Patient Care Advantages PK = Pharmacokinetic iSPERSE™ enables the sickest patient to get the right dose every time iSPERSE™ Differentiation iSPERSE™ Advantages Small, dense, dispersible, respirable particles Flow rate independent per
Slide 6: Pulmazole – Inhaled Antifungal
Pulmazole – Inhaled Antifungal Inhaled itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Asthmatics
Slide 7: Pulmazole Targets ABPA Patients' Unmet Need for an Efficacious and Well Tolerated Antifungal
Pulmazole Targets ABPA Patients’ Unmet Need for an Efficacious and Well Tolerated Antifungal Meaningful ABPA Disease Burden ABPA is caused by hypersensitivity to Aspergillus fumigatus and untreated may result in pulmonary fibrosis, respiratory failure and potentially death ~1.5% of adult asthma pati
Slide 8: ABPA-Asthma Overview and Treatment Shortcomings
3rd Line 2nd Line ABPA-Asthma Overview Treatment Flow Treatment Shortcomings Increase Disease Burden for ~300K U.S. ABPA- Asthma Patients Source: Shah. Allergy Asthma Immunol Res. 2016;8(4):282; Agarwal. Clinical & Experimental Allergy. 2013;43:850; Patterson. Proc Am Thorac Soc. 2010;7:237; Tracy.
Slide 9: Reducing Fungal Burden Plays an Important Role in ABPA Treatment
Reducing Fungal Burden Plays an Important Role in ABPA Treatment Pulmazole expected to reduce fungal burden and attenuate inflammatory response DC = dendritic cell; AM = alveolar macrophage Moss (2014) Eur Resp J 43:1487-1500 Antifungals Steroids Omalizumab Oral antifungals, including itraconazole,
Slide 10: Literature Indicates Antifungals Improve Exacerbations
Literature Indicates Antifungals Improve Exacerbations Literature and Physicians Confirm the Importance of Antifungals in ABPA Treatment Physicians View Antifungals as Clinically Effective* Experts interviewed indicated antifungal agents reduce exacerbations and chronic steroid use Physicians attrib
Slide 11: Lower Plasma Concentration and Greater Lung Concentration of Pulmazole vs Oral Sporanox
Lower Plasma Concentration of Pulmazole at ~1/10 Oral Sporanox Dose >5X Greater Lung Concentration of Pulmazole at ~1/10 Oral Sporanox Dose Pulmazole: Anticipated Efficacy & Safety Benefits vs Oral itraconazole (Sporanox) In preclinical dog studies, Pulmazole reverses the systemic to lung exposure r
Slide 12: Pulmazole Improved Survival in an Immunosuppressed Guinea Pig Model
Survival Pulmazole Compared to Oral Sporanox and Placebo Pulmazole: Inhaled itraconazole Improved Survival in an Immunosuppressed Guinea Pig Model In a lethal model with aspergillus infected immunosuppressed guinea pigs, Pulmazole achieved ~90% survival vs 30% with oral Sporanox at 14 days Data re-a
Slide 13: Pulmazole: Phase 1/1b Clinical Development Plan
Part 1: Single Ascending Dose Healthy volunteers (n=6/cohort) Part 2: Multiple Ascending Dose Healthy volunteers (n=6/cohort) Part 3: Single Dose Crossover Asthmatics (n=12) Pulmazole: Phase 1/1b Clinical Development Plan Pulmazole (25 mg) Pulmazole (10 mg) Pulmazole (5 mg) Pulmazole (20 mg) Pulmazo
Slide 14: Pulmazole – Commercial Assessment
Pulmazole – Commercial Assessment
Slide 15: Pulmazole: Efficacy and Safety Advantages Drive Prescriber Preference
1st Line Antifungal Usage More than Doubles Pulmazole: Efficacy and Safety Advantages Drive Prescriber Preference The Pulmazole Advantage Pulmazole Converts Majority of Oral Azole ABPA Market Patients Receiving Pulmazole Total Antifungal Therapy Pivotal Trial Design Oral Prednisone + Placebo vs. Ora
Slide 16: Pulmazole: Payers Anticipate Biologic Pricing with Minimal Access Restrictions
Pulmazole: Payers Anticipate Biologic Pricing with Minimal Access Restrictions Source: Chishimba. Journal of Asthma. 2012;49(4):423; Stevens. NEJM. 2000;342(11):757; Payer Interviews; ClearView Analysis. Red Book; Payer Interviews; Source: Payer Interviews; ClearView Analysis. PA = Prior Authorizati
Slide 17: Pulmazole: ABPA-Asthma Peak Revenue Forecast at Loss of Exclusivity in 2033
Pulmazole: ABPA-Asthma Peak Revenue Forecast at Loss of Exclusivity in 2033 Source: Physician Interviews; Payer Interviews; ClearView Analysis. * Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment. U.S. Other Indications U.S. ABPA Asthma E.U. ABPA Asthma
Slide 18: Pulmazole Profile Meets Need for a More Effective, Well Tolerated Antifungal
Pulmazole Profile Meets Need for a More Effective / Well Tolerated Antifungal and Drives Value Source: Physician Interviews; Payer Interviews; ClearView Analysis Pulmazole Clinicians told Pulmatrix they need safe and effective treatments that reduce the burden of exacerbations and steroid-use High U
Slide 19: PUR1800 — iSPERSE Narrow Spectrum Kinase Inhibitor (NSKI)
PUR1800 — iSPERSE Narrow Spectrum Kinase Inhibitor (NSKI) Novel Anti-inflammatory to Treat Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Slide 20: PUR1800: Broad Efficacy Potential and Significant Unmet Need in AECOPD
PUR1800: Broad Efficacy Potential and Significant Unmet Need in AECOPD Source: Aaron SD et al. N Engl J Med. 2003; 348(26): 2618-25. CDC Behavioral Risk Factor Surveillance System, 2013. Celli BR et al. Eur Respir J 2007; 29: 1224–1238. Chronic obstructive pulmonary disease (COPD): Fact sheet. (2014
Slide 21: NSKI in PUR1800 Decreased Markers of Inflammation in Patients with COPD
NSKI in PUR1800 Decreased Markers of Inflammation in Patients with Moderate-to-Severe COPD (Janssen Study EST001) Source: EST001 Study with 35 healthy subjects and 30 subjects with moderate-to-severe COPD MAPK = Mitogen-Activated Protein Kinases Note: PUR1800 is iSPERSE re-formulation of in-licensed
Slide 22: PUR1800 – Clinical Development Strategy
PUR1800 – Clinical Development Strategy
Slide 23: PUR1800: Phase 2a Clinical Study
Moderate-to-Severe COPD Patients 30% ≤ FEV1 < 80% (n=40) Randomization (2:2:1) 14-28 days Phase 2a Endpoints Safety and tolerability Single dose PK profile Multiple dose PK profile over 14-28 days Analysis of sputum inflammation and target engagement Patient specific biomarkers Study will inform bot
Slide 24: PUR1800 – Commercial Assessment
PUR1800 – Commercial Assessment
Slide 25: PUR1800: Prescribers Predict PUR1800 Will Become Integral to Standard of Care
Prescriber Reported PUR1800 Utilization PUR1800: Prescribers Predict PUR1800 Will Become Integral to Standard of Care Source: Physician Interviews; Physician Quantitative Survey; ClearView Analysis. Physician Reported Utilization in Moderate-to-Severe Acute Exacerbations. * Standard of Care (SOC) is
Slide 26: PUR1800: AECOPD Peak Revenue Forecast at Loss of Exclusivity in 2038
PUR1800 U.S. & EU 2038 Forecast PUR1800: AECOPD Peak Revenue Forecast at Loss of Exclusivity in 2038 Source: Physician Interviews; Payer Interviews; ClearView Analysis. * Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment. U.S. AECOPD E.U. AECOPD PUR1800
Slide 27: PUR1800 Profile and Need for More Effective AECOPD Treatment Options Drive Value
PUR1800 Profile and Need for More Effective AECOPD Treatment Options Drive Value Source: Physician Interviews; Payer Interviews; ClearView Analysis. PUR1800 Over 20% of patients fail corticosteroids and antibiotics High Unmet Need Certain prescribers anticipate PUR1800 will penetrate 35% of the addr
Slide 28: PUR0200 – iSPERSE Reformulation of Spiriva
PUR0200 – iSPERSE™ Reformulation of Spiriva® Chronic Obstructive Pulmonary Disease
Slide 29: PUR0200 is an Improved Version of the Spiriva Handihaler
PUR0200 is an Improved Version of the Spiriva® Handihaler® (Equivalent Lung Exposure at 80% Nominal Dose) Spiriva® $3.5B WW revenues in 2016 Spiriva lacks a dry-powder multi-dose inhaler in the U.S. In the rest of world, there is a need for therapeutically equivalent, lower cost products Unmet Needs
Slide 30: Summary & Development Plan
pulmatrix Summary & Development Plan
Slide 31: Three Significant Value Inflection Points Anticipated in 2018–2019
2017 2018 2019 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Three Significant Value Inflection Points Anticipated in 2018–2019 Non-clinical CMC Clinical Development Clinical Milestone Phase 1 Data 28-day Biomarker FPFD 16 Week GLP Tox 28 Day GLP Tox Phase 1 FPFD 28-day Biomarker Data Phase 2 CMC 28 Day GLP Tox Phase 2a
Slide 32: Reasons to Believe Pulmatrix is Positioned to Create Significant Value
Reasons to Believe Pulmatrix is Positioned to Create Significant Value in the Near Term Three clinical study readouts expected in 2018-2019 with products exceeding $6B revenue potential “De-risked” programs with 505(b)(2) Pulmazole and NSKI study in COPD patients iSPERSE™ dry-powder delivery technol
Slide 33: Experienced Leadership Team with Record of Success
Experienced Leadership Team with Record of Success Proven fundraising and capital management ability Experienced R&D team focused on pulmonary drug delivery and the role of inhaled particles Commercialization and partnership experience Diverse Collective Experience at Leading Respiratory Companies S
Slide 34: Glossary of Terms
Glossary of Terms ABPA – Allergic Bronchopulmonary Aspergillosis CF – Cystic Fibrosis AECOPD – Acute Exacerbations in Chronic Obstructive Pulmonary Disease LOE – Loss of Exclusivity PK – Pharmacokinetic IgE – Immunoglobulin E QOL – Quality of Life MOA – Mechanism of Action qPCR – Quantitative Polyme
Slide 35: Pulmatrix Corporate Overview November 2017
PULMATRIX Corporate Overview November 2017 NASDAQ: PULM