Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (February 2018)
36 slides from Pulmatrix's investor presentation, Feb 9, 2018
Slide 1: Pulmatrix Corporate Overview February 2018
PULMATRIX Corporate Overview February 2018 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 Revenue Potential
Three Study Readouts in 2018-2019 with Products Exceeding $6B in Estimated Revenue Potential ABPA = Allergic Bronchopulmonary Aspergillosis CF = Cystic Fibrosis LEAD PROGRAM iSPERSE™ Pulmazole Anti-Fungal PUR1800 novel narrow spectrum kinase inhibitor (NSKI) for AECOPD Acute exacerbation treatment p
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 2a Mid-2019 PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) Phase 2a 3Q 2019 PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Phase 1 (2019) PUR0200
Slide 5: iSPERSE Best-in-Class Engineered Particles
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: ABPA-Asthma Overview and Treatment Flow
3rd Line 2nd Line ABPA-Asthma Overview Treatment Flow ABPA is a Chronic Disorder, Typically Requiring Both Oral Steroid and Antifungal Treatment 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;
Slide 8: 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 9: Literature Indicates Antifungals Improve ABPA Outcomes
Literature Indicates Antifungals Improve ABPA Outcomes Literature and Physicians Both 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 a
Slide 10: Pulmazole Targets ABPA Patients' Unmet Need
Pulmazole Targets ABPA Patients’ Unmet Need for an Efficacious and Well Tolerated Antifungal Meaningful ABPA Disease Burden ~1.5% of adult asthma patients (~300K in U.S.) suffer 1-3 exacerbations annually Untreated ABPA may result in pulmonary fibrosis, respiratory failure and potentially death Seve
Slide 11: Lower Plasma Concentration of Pulmazole vs. Oral Sporanox
Lower Plasma Concentration of Pulmazole vs. Oral Sporanox 5X Greater Lung Concentration of Pulmazole vs. Oral Sporanox Pulmazole: Anticipated Efficacy & Safety Benefits vs Oral Itraconazole (Sporanox) In preclinical dog studies, Pulmazole reverses the systemic to lung exposure ratio observed with or
Slide 12: Pulmazole Improved Survival in 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: Phase 1: Safety, Tolerability and PK Study
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=16) Ph1/1b Safety-Tolerability Data plus PK Data Will Highlight PK Advantages Over Oral Sporanox Pulmazole (25 mg) Pulmazole (10 m
Slide 14: Phase 2a 28-day Safety-Tolerability Study
Ph2a 28-day Safety-Tolerability Study Also Evaluating Pulmonary Function and Biomarkers of Interest Randomized, double-blind, placebo controlled study (1:1 randomization; each cohort n = 16) Exploratory endpoints: Pulmonary Function (FEV1) Biomarker IgE plasma concentrations Sputum and plasma eosino
Slide 15: Pulmazole – Commercial Assessment
Pulmazole – Commercial Assessment
Slide 16: 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 17: 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 18: Pulmazole ABPA-Asthma Peak Revenue Forecast
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 19: Pulmazole Profile Meets Need and Drives Value
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 20: PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI)
PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI) Novel Anti-inflammatory to Treat Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Slide 21: NSKI: Broad Efficacy Potential and Unmet Need in AECOPD
NSKI: 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, M
Slide 22: RV1162 (NSKI) Decreases Markers of Inflammation in COPD
RV1162 (NSKI) Decreases Markers of Inflammation in 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 p38MAPK Phosphorylation Levels in Sputum Cells Demonstrate Target Enga
Slide 23: PUR1800 – Clinical Development Strategy
PUR1800 – Clinical Development Strategy
Slide 24: 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 Study will inform both acute and chronic dosing p
Slide 25: PUR1800 – Commercial Assessment
PUR1800 – Commercial Assessment
Slide 26: Prescribers Predict PUR1800 Will Become Integral to Standard of Care
Prescriber Reported PUR1800 Utilization PUR1800 (NSKI): 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 (
Slide 27: PUR1800 AECOPD Peak Revenue Forecast
PUR1800 U.S. & EU 2038 Forecast PUR1800 (NSKI): 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 P
Slide 28: PUR1800 Profile and Need Drive Value
PUR1800 (NSKI) 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 t
Slide 29: PUR0200 – iSPERSE Reformulation of Spiriva
PUR0200 – iSPERSE™ Reformulation of Spiriva® Chronic Obstructive Pulmonary Disease
Slide 30: PUR0200 is an Improved Version of 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 31: Summary & Development Plan
pulmatrix Summary & Development Plan
Slide 32: Three Significant Value Inflection Points Anticipated in 2018–2019
2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Three Significant Value Inflection Points Anticipated in 2018–2019 Non-clinical CMC Clinical Development Clinical Milestone Phase 1 Data Phase 2a FPFD 16 Week GLP Tox Phase 1 FPFD Phase 2a Data Phase 2 CMC 28 Day GLP Tox Phase 2a FPFD Phase 2a Data Pulmazole PUR1800
Slide 33: Reasons to Believe Pulmatrix is Positioned to Create Value
Reasons to Believe Pulmatrix is Positioned to Create Significant Value in the Near Term Multiple clinical study readouts expected in 2018-2019 with products exceeding $6B revenue potential “De-risked” programs with 505(b)(2) Pulmazole and predicate NSKI anti-inflammatory data in COPD patients iSPERS
Slide 34: 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 35: 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 36: Pulmatrix Corporate Overview February 2018
PULMATRIX Corporate Overview February 2018 NASDAQ: PULM