Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (June 2020)
32 slides from Pulmatrix's investor presentation, Jun 17, 2020
Slide 1: Pulmatrix
PULMATRIixX 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: Leadership Team
Leadership Team Management e CEO & Director Dr. Rusty Clayton Head of Clinical Development Michelle Siegert VP Finance Michael Lipp, PhD Chemistry Manufacturing & Controls Strategy eat | PULMATRixX Board of Directors rbd ‘ Amit Munshi Director ve, Director Mark Iwicki Director Nocion DRA Kalas!
Slide 4: Pulmatrix mission and iSPERSE technology
PULMAT RIX PULMATRIiX is committed to the development and commercialization of novel and transformational medicines for patients all over the world, using our proprietary iSPERSE™ technology to optimally deliver both respiratory and non-respiratory therapies via the respiratory system. Our initial f
Slide 5: Investment Highlights
Proprietary iSPERSE platform technology to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory therapeutics Ascalable platform with application across drug classes and dry-powder delivery devices creates broad potential for pipeline development and strategic partnership 50-
Slide 6: Cipla Partnership (2019): Expanding Global Opportunities for Pulmazole
Cipla Partnership (2019): Expanding Global Opportunities for Pulmazole Partnership Validates Pulmazole Development Plan and Potential of iSPERSE Technology Platform Cipla is India’s 2" largest pharmaceutical company with global presence in over 130 countries, over 35 manufacturing facilities and a v
Slide 7: J&J Partnership (2019): Global Lung Cancer Partnership Opportunity
J&J Partnership (2019): Global Lung Cancer Partnership Opportunity Partnership Further Validates iSPERSE Technology and Opens Global Opportunity in Lung Cancer Johnson & Johnson is the world’s largest healthcare company with over 130,000 employees and 130 years of existence $7.2M up-front payment pl
Slide 8: Robust Pipeline with Projected Significant Value Catalysts
Robust Pipeline with Projected Significant Value Catalysts a Pulmazole* Allergic Bronchopulmonary (Cipla 50-50) with Asthma PUR1800** en (J&J License Option) e) Anticipated PUR3000 Neurology eck we . Pre-Clinical PUR4000 Respiratory One Ph1 Ready Asset Anticipated in 2021 Two clinical readouts antic
Slide 9: Sensory Cloud Partnership (2020): Collaboration to Combat COVID-19
Sensory Cloud Partnership (2020): Collaboration to Combat COVID-19 Enables Potential Use of PURO03 & PUROOG as an Over-The-Counter Anti-Contagion Product S Partnership Sensory Cloud Worldwide, royalty bearing license to proprietary salt formulations (PUR003 & PUR006) for OTC nasal delivery to potent
Slide 10: iSPERSE
iSPERSE Small Dense and Dispersible
Slide 11: iSPERSE Platform
iSPERSE Platform Small, Dense & Dispersible Particles Designed for Highly Efficient Respiratory Delivery Potential iSPERSE Advantages Evolution of Engineered Dry Powder Drug Delivery e Can be used with a broad range of drugs, small molecule to biologic Large Porous Particle e Can be used with almost
Slide 12: iSPERSE Enables Product Development
iSPERSE Enables Product Development Not Possible with Conventional Technologies Small Molecule APIs with Challenging Physical/Chemical Attributes Amorphous or Crystalline API ae PULMATRiX APIs Limited by Predicted Efficacious Dose Inhaled Antibiotics > 30mg; Small Molecules > 1mg Control of Pulmonar
Slide 13: Pulmazole
Pulmazole Inhaled Antifungal Cipla 50-50 Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Slide 14: Worldwide 50-50 co-development and revenue share
Worldwide 50-50 co-development and revenue share Pulmazole partnership with Cipla Technologies represents ~$1.5B peak net revenue opportunity in U.S. alone * iSPERSE enables itraconazole delivery to the lung, resulting in Pulmazole potential to address the underlying cause of disease while avoiding
Slide 15: Allergic Bronchopulmonary Aspergillosis
Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma Exaggerated Response of the Immune System to the Fungus Aspergillus in Patients with Asthma and Cystic Fibrosis Treatment focus e Control of asthma symptoms e Prevention and treatment of pulmonary exacerbations e Reduction of pul
Slide 16: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA col Shenae e ~50% of ABPA patients have inadequate response to oral steroids alone e ~20% of ABPA patients become steroid dependent . e Long-term steroid use associated with development of Gastro Intestinal licati includi rs . illosi lnteloranicé complications i
Slide 17: 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 Ee JS sieescuannennme neon Fold Higher ~50 Lung Exposure Demonstrated safety and tolerability of Pulmazole administered up to 14 days | seenssesseevseeeseeusecnnecneeuseennecnnecnnensernnecnneennennn
Slide 18: Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox
Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox Improvement of FEV, in ABPA Pulmazole is Anticipated to Improve Upon Sporanox Outcomes Demonstrated in Clinical Literature 1 NEW ENGLAND JOURNAL of MEDICINE : Journal of Clinical Immunology : Expert Review of Respiratory Medicine
Slide 19: Phase 2 Study Underway to Support Proof of Mechanism
Phase 2 Study Underway is Expected to Support Proof of Mechanism in Patients with Asthma-ABPA 28-day Safety, Tolerability, Pulmonary Function and Biomarker Study in Patients with Asthma and ABPA Primary Endpoint Randomized, Double-blind, Placebo Controlled Study (1:1 Randomization; N=16 Per Arm) End
Slide 20: Phase 3 Trial Powered to Show FEV1 Improvement
Phase 3 Trial Powered to Show FEV, Improvement Potential Ph3 Study Design Pending Ph2 Results and FDA Feedback Randomized, Double-blind, Placebo Controlled Study Primary Endpoint (N=120 Per Arm). 16 Weeks Dosing with 16 Weeks Follow-up Patient Profile Secondary Endpoints Patients (M/F, ages 18-79) w
Slide 21: 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 65% ~1.3B Net ~200M 30% U.S. ABPA Asthma Revenue U.S. Other Indications Current Use of Antifungal 1st Line Future Use of Antifungal 1st Line Xolair Annual Price:
Slide 22: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for Lung Cancer Reformulation of Janssen’s RV1162 : y Narrow Spectrum Kinase Inhibitor (NSKI) =
Slide 23: PUR1800 Highlights
PUR1800 Highlights (iSPERSE Enabled RV1162) IND Ready with Potential to Address Significant Unmet Need in Lung Cancer In pre-clinical studies, RV1162 demonstrated multifactorial efficacy in steroid-resistant inflammation In clinical studies, RV1162 lactose blend demonstrated target engagement, anti-
Slide 24: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Block Steroid Resistant Inflammation & Lung Remodeling Processes Treat Steroid-Resistant Inflammation e Inhibit p38 MAP kinases (p38MAPk) to restore steroid sensitivity and reduce inflammation e Block inflammatory action of Src, which promotes cytokine produc
Slide 25: PUR1800 iSPERSE Formulation Overcame Limitations of RV1162
PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend Formulation iSPERSE Particle Engineering Be 1800 — Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend formulation Janssen ex
Slide 26: First in Human Study of RV1162 (NSKI)
First in Human Study of RV1162 (NSKI) Positive Study Results and Opportunity for iSPERSE Enablement of Further Clinical Development Resulted in Pulmatrix License of RV1162 and NSKI Portfolio Clinical Data Summary RV1162 Reduced RV1162 Reduced p38 MAPK Phosphorylation Sputum Neutrophils p38 phosphory
Slide 27: 28-Day GLP Toxicology Study Resulted in PUR1800
28-Day GLP Toxicology Study* Resulted in PUR1800 Improved Safety Margins Relative to RV1162 iSPERSE Enabled Higher LUNG Dosing and Potentially Longer-Term Dosing with PUR1800 500 pg > ~300 ug Nominal Dose Lung Dose Dose proportional systemic exposure Reduced potential for lung drug accumulation No n
Slide 28: PUR1800 Phase 1b Trial in Stable COPD
PUR1800 Phase 1b Trial in Stable COPD Phase 1b: Safety Study Bridging from Lactose to iSPERSE Formulation Randomized, Double-blind, 3-way Crossover Study; 3 Dose Groups (2 active, 1 placebo) Endpoints with 15 pts. 14 Days of Daily Dosing, with 28-day Crossover and 28-day Follow-up PUR1800 PUR1800 (2
Slide 29: New Therapies Under Evaluation
New Therapies Under Evaluation
Slide 30: Pulmatrix Prioritized Two 505(b)(2) Opportunities for Pre-Clinical Development
Pulmatrix Prioritized Two 505(b)(2) Opportunities for Pre-Clinical Development with Goal of Delivering One Ph1 Ready Asset in 2021 iSPERSE Enabled Development Opportunities Prioritized in Neurology and Respiratory Disease iSPERSE Opportunities Strengthen Inhaled Pulmonary Administration Pulmonary De
Slide 31: Appendix
Appendix
Slide 32: Glossary of Terms
Glossary of Terms 505(b)(2) | FDA Regulatory Pathway for Drug Approval IgG Immunoglobulin G Antibodies ABPA Allergic Bronchopulmonary Aspergillosis IND Investigational New Drug ACQ-6 Asthma Control Questionnaire 6 IP Intellectual Property BAL Bronchoalveolar Lavage LPS Lipopolysaccharide cmc Chemist