Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (April 2020)
32 slides from Pulmatrix's investor presentation, Apr 24, 2020
Slide 1: Pulmatrix
va | PULMATRixX 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: Investment Highlights
PULM (NASDAQ) 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 devel
Slide 4: Cipla Partnership: Expanding Global Opportunities for Pulmazole
Cipla Partnership: Expanding Global Opportunities for Pulmazole Partnership Validates Pulmazole Development Plan and Potential of iSPERSE Technology Platform Cipla is India’s 2"4 largest pharmaceutical company with global presence in over 130 countries, over 35 manufacturing facilities and a vast ne
Slide 5: J&J Partnership: Global Lung Cancer Partnership Opportunity
J&J Partnership: 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 plus a $2
Slide 6: Sensory Cloud Partnership: Collaboration to Combat COVID-19
Sensory Cloud Partnership: Collaboration to Combat COVID-19 Enables Potential Use of PURO03 & PUROO6 as an Over-The-Counter Anti-Contagion Product Partnership Sensory Cloud Worldwide, royalty bearing license to proprietary salt Sensory Cloud is a Boston-based technology startup formulations (PURO03
Slide 7: Robust Pipeline with Projected Significant Value Catalysts
Robust Pipeline with Projected Significant Value Catalysts A Pulmazole* Allergic Bronchopulmonary a Antifungal Asperailess(ABPA)in Patios ID Orica (Cipla 50-50) with Asthma PUR1800" sub om 1 un cae CD ED 0 2:0: (J8J License Option) © anticipates PUR3000 Neurology jn ee PURAUL ésbitatony Pre-Clinical
Slide 8: Leadership Team
Leadership Team Management , ~ 9 CEO & Director yb. Dr. Rusty Clayton Head of Clinical Development Michelle Siegert VP Finance Michael Lipp, PhD Chemistry Manufacturing & Controls Strategy Bw PULMATRIiX Board of Directors ws Ironwood Chairman Amit More Y) ARENA irector y Mark Iwicki Director xal noc
Slide 9: Small Dense
SE Small Dense
Slide 10: iSPERSE Platform
iSPERSE Platform Small, Dense & Dispersible Particles Designed for Highly Efficient Respiratory Delivery Potential iSPERSE Advantages Evolution of Engineered Dry Powder Drug Delivery Can be used with a broad range of drugs, small molecule to biologic Large Porous Particle © Can be used with almost a
Slide 11: iSPERSE Enables Product Development
iSPERSE Enables Product Development Not Possible with Conventional Technologies Small Molecule APIs APIs Limited by Predicted | Control of Pulmonary and i Dry Powder Formulation with Challenging Efficacious Dose Systemic Exposure i of Biologics and Physical/Chemical Inhaled Antibiotics > 30mg, Manip
Slide 12: Pulmazole
Pulmazole Inhaled Antifungal Cipla 50-50 Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Slide 13: Pulmazole Highlights
Pulmazole Highlights Potential to Expand and Shift Inhaled Antifungal Use to First Line Treatment in ABPA 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 deliver
Slide 14: Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
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 © Control of asthma symptoms © Prevention and treatment of pulmonary exacerbations « Reduction of pul
Slide 15: Significant Unmet Need Exists in ABPA
Significant Unmet Need Exists in ABPA Meuali Changes ~50% of ABPA patients have inadequate response to oral steroids alone Cutaneous Reactions e) > ~20% of ABPA patients become steroid dependent Hepatic Abnormality aves e Long-term steroid use associated with development of Intolerance complications
Slide 16: Pulmazole: Potential to Change Standard of Care for ABPA
Pulmazole: Potential to Change Standard of Care for ABPA Ph1/1b St fi udy Successfully Met All Endpoints Phase 1/1b Part 1 & 2: H Phase 1/1b Part 3: Single Dose Crossover SAD and MAD Key Results Pulmazole 20mg Versus Single Dose Sporanox 200mg Oral Vv : = 5 Fold Higher Lung Exposure Demonstrated saf
Slide 17: Pulmazole Development Plan Builds Upon Clinical Precedent
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 tte NEW ENGLAND JOURNAL of MEDICINE Journal of Clinical Immunology Expert Review of Respiratory Medicine 20
Slide 18: Phase 2 Study Underway is Expected 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 Randomized, Double-blind, Placebo Controlled Study Primary Endpoint (1:1 Randomization; N=16 Per Arm) End
Slide 19: 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 Patient Profile Patients (M/F, ages 18-79) with moderate-to-severe i Y oa confirmed/stable asthma and ABPA eis eee ome) Final doses to be determined following Ph2 and 6-month non-clinical t
Slide 20: Pulmazole: $1.5B Peak Net Revenue Potential in the U.S.
Pulmazole: $1.5B Peak Net Revenue Potential in the U.S. Anticipated 15 Line Use Drives Pulmazole’s ~$1.5B U.S. Peak Net Revenue Forecast 80% ~1.3B Net ~200M U.S. ABPAAsthma Revenue U.S. Other Indications 30% Current Use of Antifungal 1st Line Current Use of Antifungal 2nd Line xOlakr. | Xolair Annua
Slide 21: Reformulation of Narrow Spectrum Kinase Inhibitors
Reformulation o Narrow Spectrut
Slide 22: PUR1800 Highlights (iSPERSE Enabled RV1162)
In pre-clinical studies, RV1162 demonstrated multifactorial efficacy in steroid-resistant inflammation In clinical studies, RV1162 lactose blend demonstrated target engagement, anti-inflammatory activity, safety and tolerability in a 12-day study with stable COPD patients PUR1800 — the iSPERSE formu
Slide 23: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Block Steroid Resistant Inflammation & Lung Remodeling Processes Treat Steroid-Resistant Inflammation Inhibit p38 MAP kinases (p38MAPK) to restore steroid sensitivity and reduce inflammation © Block inflammatory action of Src, which promotes cytokine producti
Slide 24: PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162
PUR1800 iSPERSE Formulation Overcame the Limitations of RV1162 in Lactose Blend Formulation Ps Ds 3 iSPERSE Micronized RV1162 Particle Engineering PUR1800 — GLP Tox Formulation e Janssen engaged PULMATRiX to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profil
Slide 25: 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 PULMATRIiX License of RV1162 and NSKI Portfolio e RV1162 lactose blend was well tolerated in human study including stable moderate-to-severe COPD subjects:
Slide 26: 28-Day GLP Toxicology Study Resulted in PUR1800
28-Day GLP Toxicology Study* Resulted in PUR1800 Improved Safety Margins Relative to RV1162 iSPE igher LUNG Dosing and Potentially Longer-Term Dosing with PUR1800 5E Enabled t PUR1800 Results Observations & nominal clinical dose of 550 yg and abili Nominal Dose ; 3) _ sed 500 ug > ~300 ig Data suppo
Slide 27: PUR1800 Phase 1b Trial in Stable COPD
PUR1800 Phase 1b Trial in Stable COPD Phase 1b: Safety Study Bridging from Lactose to iSPERSE Formulation e Safety & Tolerability e Pulmonary function (FEV) days 1, 7 and 14 e Systemic and sputum pharmacokinetics days 1, 7 and 14 Stable COPD ee Patients e Target engagement and efficacy . pharmacodyn
Slide 28: New Therapies Under Evaluation
New Therapies Under Evaluation
Slide 29: 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 Phi Ready Asset in 2021 iSPERSE Enabled Development Opportunities Prioritized in Neurology and Respiratory Disease iSPERSE Opportunities Strengthen Inhaled Pulmonary Administration Pulmonary De
Slide 30: Pulmatrix
PULMATRIixX PULMATRixX 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
Slide 31: Appendix
Apperam™
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 Chemi