Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (August 2019)
33 slides from Pulmatrix's investor presentation, Aug 22, 2019
Slide 1: Pulmatrix Corporate Overview
PULMATRIX Corporate Overview I 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: Transforming Therapies Through iSPERSE Enabled Drug Delivery
Pulmatrix’s proprietary iSPERSE platform, with an initial focus on respiratory disease, optimizes pharmacokinetics and pharmacology to develop, commercialize and deliver transformational medicines to patients globally Transforming Therapies Through iSPERSETM Enabled Drug Delivery Source: D Singh et
Slide 4: Investment Highlights
Phase 2 ABPA and Phase 1b AECOPD programs with potential combined peak U.S. revenue potential exceeding $3.5B* Expanding global opportunity with Cipla partnership on Pulmazole lead program Proprietary iSPERSE technology to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory
Slide 5: Experienced Leadership Team
Experienced Leadership Team With Experience to Execute and Deliver Value Mark Iwicki Chairman Terry McGuire Director Strong Background in Product Development & Commercialization Management Bill Duke CFO Ted Raad CEO & Director Dr. Rusty Clayton Head of Clinical Development Michael Lipp, PhD Chemistr
Slide 6: Product Pipeline
Product Pipeline Indication 2019 2020 Pulmazole Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Robust Pipeline with Projected Significant Value Catalysts* * Estimate
Slide 7: iSPERSE Small Dense and Dispersible
iSPERSE Small Dense and Dispersible
Slide 8: iSPERSE Enables Product Development Not Possible With Conventional Technologies
iSPERSE Enables Product Development Not Possible With Conventional Technologies Small molecules, biologics and macromolecules with challenging physical and chemical attributes Targeted delivery to provide efficacious doses Control of pulmonary and systemic exposure IMPROVING DELIVERY IMPROVING DOSIN
Slide 9: Potential iSPERSE Advantages
Potential iSPERSE Advantages Evolution of Engineered Dry Powder Drug Delivery iSPERSE Platform Can be used with a broad range of drugs, small molecule to biologic Can be used with any device (e.g. metered-dose, reservoir, capsule or blister-based inhalers) Requires low inspiratory flow for penetrati
Slide 10: Pulmazole Inhaled Antifungal
Pulmazole Inhaled Antifungal Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Slide 11: Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Shah. Allergy Asthma Immunol Res. 2016;8(4):282; Tracy, J Fungi 2016;2:17; Agarwal, Clinical & Experimental Allergy. 2013;43, 850-873; Patterson. Proc Am Thorac Soc. 2010;7:237; Physician Research: Clearview Analysis; Estimate of
Slide 12: Dose Limiting Side Effects of Oral Antifungal Therapy Reduce Clinical Utility
Dose Limiting Side Effects of Oral Antifungal Therapy Reduce Clinical Utility Significant Unmet Need Exists in ABPA Wang. AMAC. 2010;54:2409. Denning. Clinical Infectious Diseases. 2002;34:563; Lestner. Clinical Infectious Diseases 2009; 49:928–30; Denning. Clinical and Experimental Dermatology. 200
Slide 13: Ph1/1b Data Highlights Potential to Improve Upon Oral Sporanox
Ph1/1b Data Highlights Potential to Improve Upon Oral Sporanox Known FEV1, Safety and Tolerability Profile Phase 1/1b : Safety, Tolerability & PK Study in Healthy Normal Volunteers and Patients with Asthma Part 1: Single Ascending Dose (SAD) Healthy Normal Volunteers (n=6/cohort): Optional 4th cohor
Slide 14: Pulmazole: Potential to Change Standard of Care for ABPA
Pulmazole: Potential to Change Standard of Care for ABPA Ph1/1b study successfully met all endpoints Source: ACAAI – 2018 – A Phase 1/1B Study of an Inhaled Formulation of Itraconazole in Healthy Volunteers and Asthmatics; Study Poster Presented at ACAAI in 2018, www.pulmatrix.com Phase 1/1b Part 1
Slide 15: Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox
Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox Improvement of FEV1 in ABPA 2018, Agarwal et al. In acute stage treatment naive ABPA patients, monotherapy itraconazole is effective in considerable number of patients, including improved FEV1 within 6 weeks, with less side-effect
Slide 16: Phase 2 Study Underway in Patients with Asthma-ABPA
1/10th of dose 28-day safety, tolerability, pulmonary function and biomarker study in patients with asthma and ABPA Phase 2 Study Underway is Expected to Support Proof of Mechanism in Patients with Asthma-ABPA Randomized, double-blind, placebo controlled study (1:1 randomization; n = 16 per arm) Pri
Slide 17: Potential Phase 3 Study Design
1/10th of dose Potential Ph3 study design pending Ph2 results and FDA feedback Phase 3 Trial Powered to Show FEV1 Improvement Randomized, double-blind, placebo controlled study (n=120 per arm). 16 weeks dosing with 16 weeks follow-up. Primary Endpoint FEV1 Secondary Endpoints Disease control (ACQ-6)
Slide 18: Pulmazole: $1.5B Peak Net Revenue Potential in the U.S.
Pulmazole: $1.5B Peak Net Revenue Potential in the U.S. Anticipated 1st line use drives Pulmazole’s ~$1.5B U.S. peak net revenue forecast Source: Physician Interviews; Payer Interviews; ClearView Analysis. *Also includes discount for patient compliance, patient persistence, and gross-to-net adjustme
Slide 19: Cipla Partnership: Expanding Global Opportunities
Cipla Partnership: Expanding Global Opportunities Partnership validates Pulmazole development plan and potential of iSPERSE technology platform Partnership $22M up-front payment, combined with funds raised by Pulmatrix, fully funds the company beyond the Pulmazole Ph2 study data Cipla Technologies,
Slide 20: Pulmazole Highlights
Clinical precedent supports oral Sporanox efficacy in asthma-ABPA, including FEV1 and exacerbation improvement Ph1/1b data demonstrated potential for Pulmazole to improve upon the known efficacy, safety and tolerability of oral Sporanox Improved efficacy, safety and tolerability has the potential to
Slide 21: 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) Reformulation of Janssen’s RV1162
Slide 22: Limited Efficacy in Standard of Care for AECOPD
Limited Efficacy in Standard of Care for AECOPD Moderate-to-Severe Exacerbations . Bacterial & Viral AECOPD Incidence and Etiology Steroids are standard of care for moderate-to-severe acute exacerbations, which occur across all patient severity types ~90% of the 18M annual U.S. moderate-to-severe ex
Slide 23: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Source: Barnes PJ. Pharmacol Rev 2016; 68:788–815, Barnes PJ. J Allergy Clin Immunol 2013; 131:636-45, Geraghty P et al. Am J Respir Cell Mol Biol. 2014; 50(3):559-70, Angata T et al. Cell Mol Life Sci. 2013; 70(17):3199-210 PUR1800 (p38/Src/Syk) Block steroi
Slide 24: Inhibition of Tobacco Smoke-Induced Lung Inflammation
Inhibition of Tobacco Smoke-Induced Lung Inflammation # RV1162 (NSKI) Reduces Steroid Resistant Inflammation in Preclinical Models Source: Data on File; Pulmatrix Internal Documents; ### Significant difference between each other at p<0.001; *** Significant difference from tobacco smoke control at p<
Slide 25: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 (NSKI) Decreases markers of inflammation in moderate-to-severe COPD patients RV1162 shows clinical target engagement and positive biomarker efficacy in Janssen Trial Source: EST001 Study with 35 healthy subjects and 30 subjects with moderate-to-severe COPD Clinical Dat
Slide 26: PUR1800 iSPERSE Formulation Overcame Limitations of RV1162 in Lactose Blend
Micronized RV1162 PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend PUR1800 - GLP tox formulation Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend formulation Janssen exite
Slide 27: 28-Day GLP Toxicology Study Resulted in Improved Safety Margins
28-Day GLP Toxicology Study Resulted in Improved Safety Margins Relative to RV1162 Janssen’s EST001 study of RV1162 lactose blend demonstrated efficacy biomarkers at 500 µg nominal dose (~125 µg lung dose) PUR1800 achieves same lung dose with ~ 200 µg Data supports maximum PUR1800 nominal clinical d
Slide 28: Phase 1b: Safety Study Bridging from Lactose to iSPERSE Formulation
1/10th of dose Phase 1b: safety study bridging from lactose to iSPERSE formulation PUR1800 Phase 1b Proof of Concept Trial in Stable COPD Randomized, double-blind, 3-way crossover study; 3 dose groups (2 active, 1 placebo) with 15 pts. 7 Days of daily dosing, with 28-day crossover and 7-day follow-u
Slide 29: Proposed Future Phase 2 Study Design
1/10th of dose Design to be informed by Ph1b results, FDA feedback and potential partner interest Proposed Future Phase 2 Study Design Randomized, double-blind, placebo controlled study (n=120 per arm). 16 weeks dosing with 16 weeks follow-up. Primary Endpoint Pulmonary function (FEV1) days 7, 14, 3
Slide 30: PUR1800: $2.4B in U.S. Peak Revenue Potential
PUR1800: $2.4B in U.S. Peak Revenue Potential Source: * Peak revenues expected at loss of market exclusivity, ~14 years post launch and also includes discount for patient compliance, patient persistence, and gross-to-net adjustment; ** Estimate based on ClearView Analysis, which included qualitative
Slide 31: PUR1800 Highlights
* Research: Clearview Analysis IND Ready with potential to Address Significant Unmet Needs in AECOPD PUR1800 Highlights 18M moderate-severe AECOPD yearly incidence in U.S., 80% of which is due to infection induced inflammation where standard of care (steroids) has limited efficacy In pre-clinical st
Slide 32: Glossary of Terms
Glossary of Terms ABPA Allergic Bronchopulmonary Aspergillosis ACQ-6 Asthma Control Questionnaire 6 AECOPD Acute Exacerbations of Chronic Obstructive Pulmonary BAL Bronchoalveolar Lavage CMC Chemistry Manufacturing and Controls COPD Chronic Obstructive Pulmonary Disease FeNO Fractional Exhaled Nitri
Slide 33: Appendix
pul Appendix