Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (August 2018)
30 slides from Pulmatrix's investor presentation, Aug 1, 2018
Slide 1: Pulmatrix Corporate Overview August 2018
PULMATRIX Corporate Overview August 2018 NASDAQ: PULM Exhibit 99.1
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: Building Value by Meeting Important Unmet Medical Needs in ABPA and AECOPD
Pulmatrix: Building Value by Meeting Important Unmet Medical Needs in ABPA and AECOPD ABPA = Allergic Bronchopulmonary Aspergillosis; CF = Cystic Fibrosis; AECOPD = Acute Exacerbations in Chronic Obstructive Pulmonary Disease LEAD PROGRAM: iSPERSE™ Pulmazole Anti-Fungal Pulmazole is inhaled Itracona
Slide 4: iSPERSE Best-in-Class Engineered Particles Enable Development and Patient Care Advantages
iSPERSE™ Best-in-Class Engineered Particles Enable Development and Patient Care Advantages Small, dense, dispersible, respirable particles Highly efficient inhaled delivery Flow rate independent performance (consistent delivery of high drug loads) Scalable platform Broad IP portfolio into 2030s Can
Slide 5: Robust Pipeline with Projected Significant Value Catalysts
Robust Pipeline with Projected Significant Value Catalysts* LAMA = Long-Acting Muscarinic Antagonist; * Estimated Milestones Product Pipeline Indication 2H 2018 2019 1H 2020 Milestone Pulmazole Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Phase 2 4Q 2019 PUR1800
Slide 6: Pulmazole – Inhaled Antifungal
Pulmazole – Inhaled Antifungal Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Asthmatics “I am very encouraged by the phase 1 results demonstrating that it is both feasible to administer itraconazole by inhalation and further that high levels of the drug may be achie
Slide 7: PULM: Investment Opportunity $25M Raise
PULM: Investment Opportunity $25M Raise Funds Pulmatrix Through Pulmazole Ph2 Data Expected in 4Q 2019 Clinical Stage Antifungal Pulmazole is an inhaled reformulation of itraconazole in Ph2 for airway fungal infections Ph1/1b study demonstrated safety/tolerability in healthy normal volunteers dosed
Slide 8: Pulmazole Has Potential to Transform the Standard of Care for ABPA
Pulmazole Has Potential to Transform the Standard of Care for ABPA Source: Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013;51(4):361–370 Ref: Clearview Analysis.; IDSA
Slide 9: ABPA Represents a Large Addressable Antifungal Patient Population
ABPA Represents a Large Addressable Antifungal Patient Population in Aspergillus Related Diseases 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. J. Fungi. 2016;2:17; Source: Denning DW,
Slide 10: ABPA Progression and Treatment Options
ABPA Progression and Treatment Options ABPA is Treated by Allergists and Pulmonologists Greenberger P., B.R., Demain J, et. al., Allergic Bronchopulmonary Aspergillosis. J Allergy Clin Immunol Pract., 2015. 2(6): p. 703-708.; Physician Research: Clearview Analysis ABPA-Asthma Treatment Goals Treatme
Slide 11: Literature Establishes Strong Clinical Precedent for Itraconazole Use in ABPA
Literature Establishes Strong Clinical Precedent for Itraconazole Use in ABPA Source: Denning. Chest.1991; 100:813; 116(6):1665; Stevens. NEJM.2000;342(11):757; Wark. J Allergy Clin Immuno. 2003;111; 952; Agarwal Chest 2018; doi: 10.1016/j.chest.2018.01.005; Ram. Journal of Asthma. 2016:517; Physici
Slide 12: Randomized Placebo Controlled Studies Support Efficacy of Oral Sporanox in Asthma-ABPA
Randomized Placebo Controlled Studies Support Efficacy of Oral Sporanox in Asthma-ABPA NEJM 2000; 342:756-62.; J Allergy Clin Immunol 2003; 111: 952-57; BID = 2x/Day; FVC = Forced Vital Capacity; PEF = Peak Expiratory Flow; PBO = Placebo Stevens & Wark Studies — Key Takeaways Both clinical trials su
Slide 13: Pulmazole Potentially Addresses the Significant Limitations of Oral Antifungals in ABPA
Pulmazole Potentially Addresses the Significant Limitations of Oral Antifungals in ABPA Denning. Clinical and Experimental Dermatology. 2001;26:648; Source: Wang. AMAC. 2010;54:2409. Denning. Clinical Infectious Diseases. 2002;34:563; Lestner. Clinical Infectious Diseases 2009; 49:928–30; Waljee. BM
Slide 14: Pulmazole Has Up to $1.5B Peak Revenue Potential in the U.S.
Pulmazole Has Up to $1.5B Peak Revenue Potential in the U.S. Source: Physician Interviews; Payer Interviews; ClearView Analysis. *Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment; ** Estimate based on ClearView Analysis, which included qualitative physi
Slide 15: Phase 1/1b Data Highlights Potential of Pulmazole
Phase 1/1b Data Highlights Potential of Pulmazole to Improve Upon Clinical Utility of Oral Sporanox Pulmazole (20 mg) Sporanox® (200 mg; oral) Sporanox® (200 mg; oral) Pulmazole (20 mg) Parts 1 and 2 in HNV Demonstrated safety and tolerability of Pulmazole administered up to 14 days Following inhala
Slide 16: Global Thought Leaders on the Pulmazole Clinical Advisory Board
Global Thought Leaders in ABPA and Asthma on the Pulmazole Clinical Advisory Board (CAB) Ritesh Agarwal, MD, DM – Professor of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India David Denning, FRCP, FRCPath, FIDSA, FMedSci – Professor of Infectious Diseas
Slide 17: Phase 2 Scheduled to Begin 4Q 2018 to Support Proof of Mechanism
Patient Profile Moderate-to-severe asthmatics (M/F, ages 18-65) confirmed/stable ABPA, diagnosed with ABPA Exacerbation and steroid use entry criteria Phase 2 Scheduled to Begin 4Q 2018 and Expected to Support Proof of Mechanism in Patients with Asthma-ABPA 28-day Safety, Tolerability, Pulmonary Fun
Slide 18: Phase 2b/3 Proof of Concept Trial Powered to Show Improvement in FEV1
Phase 2b/3 Proof of Concept Trial Powered to Show Improvement in FEV1 Phase 2b/3: POC Efficacy/Safety Trial in Asthmatic ABPA Patients Primary Efficacy Endpoint FEV1 Secondary Endpoint Disease control (ACQ-6) Exacerbation (frequency/timing) Steroid use Exploratory Biomarkers Sputum/plasma eosinophil
Slide 19: PUR1800 – Narrow Spectrum Kinase Inhibitor (NSKI)
PUR1800 – Narrow Spectrum Kinase Inhibitor (NSKI) Inhaled P38, Syk, Src Kinase Inhibitor to Treat Acute Exacerbations in COPD (AECOPD)
Slide 20: PUR1800: Prescribers Predict PUR1800 Will Become Integral to Standard of Care
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 (SOC) is oral corticosteroids with or wit
Slide 21: PUR1800: Inhaled NSKI Has Up to $2.4B Peak Revenue Potential in the U.S.
PUR1800: Inhaled NSKI Has Up to $2.4B Peak Revenue Potential in the U.S. 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. (20
Slide 22: PUR1800 Phase 2a Study in Stable COPD
PUR1800 Phase 2a Study in Stable COPD (RV1162 to PUR1800 Bridging Study) FEV1: Forced Expiratory Volume in 1 Second 225 mcg iSPERSE PUR1800 ≈ 500 mcg Janssen RV1162 Lactose Blend (based on predicted lung deposition) Patient Profile Moderate-to-Severe COPD Patients 30% ≤ FEV1 < 80%; n=60; 12–15 patie
Slide 23: PUR0200 – Long Acting Muscarinic Agonist (LAMA)
PUR0200 – Long Acting Muscarinic Agonist (LAMA) Inhaled Tiotropium Bromide for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Slide 24: PUR0200: Out-License Creates Revenue Stream and Further Prioritizes Pulmazole and PUR1800
PUR0200: Out-License Creates Revenue Stream and Further Prioritizes Pulmazole and PUR1800 Spiriva HH = Spiriva® HandiHaler® (18 µg dose) n = 60 COPD PATIENTS n = 60 COPD PATIENTS We Believe PUR0200 is an Improved Version of the Spiriva® HandiHaler® PUR0200 Improves Lung Function in COPD at Low Doses
Slide 25: Summary
pulmatrix Summary
Slide 26: Robust Pipeline with Projected Significant Value Catalysts
Robust Pipeline with Projected Significant Value Catalysts* LAMA = Long-Acting Muscarinic Antagonist; * Estimated Milestones Product Pipeline Indication 2H 2018 2019 1H 2020 Milestone Pulmazole Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Phase 2 4Q 2019 PUR1800
Slide 27: Experienced Leadership Team With Experience to Execute and Deliver Value
Experienced Leadership Team With Experience to Execute and Deliver Value Board of Directors Management Team Diverse Collective Experience at Leading Respiratory Companies Strong Background in Product Development and Commercialization Proven fundraising and capital management ability Experienced R&D
Slide 28: Pulmatrix is Positioned to Create Significant Value in the Near Term
Pulmatrix is Positioned to Create Significant Value in the Near Term Ph2a proof of mechanism clinical study readout in 4Q 2019 with product exceeding $1B in peak revenue potential Pulmazole is a “de-risked” 505(b)(2) program Compelling Ph1/1b data demonstrating high itraconazole lung concentration a
Slide 29: Glossary of Terms
Glossary of Terms ABPA – Allergic Bronchopulmonary Aspergillosis ACQ-6 – Asthma Control Questionnaire 6 AECOPD – Acute Exacerbations of Chronic Obstructive Pulmonary Disease CAB – Clinical Advisory Board CF – Cystic Fibrosis COPD – Chronic Obstructive Pulmonary Disease FeNO – Fractional Exhaled Nitr
Slide 30: Pulmatrix Corporate Overview August 2018
PULMATRIX Corporate Overview August 2018 NASDAQ: PULM