Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (January 2020)
31 slides from Pulmatrix's investor presentation, Jan 13, 2020
Slide 1: Pulmatrix Corporate Overview
PULMATRIX Corporate Overview Exhibit 99.1
Slide 2: Forward-Looking Statements
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 or anticipat
Slide 3: Investment Highlights
PULM (NASDAQ) Investment Highlights * Source: Physician Interviews and Payer Interviews; ClearView Health Partners Analysis Proprietary iSPERSE platform technology to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory therapeutics A scalable platform with application acros
Slide 4: Cipla Partnership: Expanding Global Opportunities for Pulmazole
Partnership Validates Pulmazole Development Plan and Potential of iSPERSE Technology Platform Cipla Partnership: Expanding Global Opportunities for Pulmazole Partnership Cipla Technologies $22M up-front payment, combined with funds raised by Pulmatrix should fully fund the company beyond the Pulmazo
Slide 5: J&J Partnership: Global Lung Cancer Partnership Opportunity
Partnership Further Validates iSPERSE Technology and Opens Global Opportunity in Lung Cancer J&J Partnership: Global Lung Cancer Partnership Opportunity Partnership Johnson & Johnson $7.2M up-front payment plus a $2M milestone payment upon completion of Ph1b clinical study Johnson & Johnson is the w
Slide 6: Pulmatrix Growth Strategy is Based on Five Core Value Drivers
Pulmatrix Growth Strategy is Based on FIVE Core Value Drivers Robust Pipeline with Projected Significant Value Catalysts Product Pipeline Indication 2019 2020 2021 Pulmazole* Anti-fungal (Cipla 50-50) Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma PUR1800** NSKI (J&J License
Slide 7: Leadership Team
Leadership Team Management Board of Directors Ted Raad CEO & Director Michael Lipp, PhD Chemistry Manufacturing & Controls Strategy Michelle Siegert VP Finance Dr. Rusty Clayton Head of Clinical Development Mark Iwicki Chairman Amit Munshi Director Matthew Sherman Director Rick Batycky Director Mich
Slide 8: iSPERSE Small Dense and Dispersible
iSPERSE Small Dense and Dispersible
Slide 9: iSPERSE Platform: Small, Dense & Dispersible Particles
Small, Dense & Dispersible Particles Designed for Highly Efficient Respiratory Delivery iSPERSE Platform Sources: D Singh et al., Br J Clin Pharmacol. 2018, 84(9):2097-2105; Perry, J, et al., Br J Clin Pharmacol. 2019, 85(3):580-589; ACAAI – 2018 – A Phase 1/1B Study of an Inhaled Formulation of Itr
Slide 10: iSPERSE Enables Product Development Not Possible with Conventional Technologies
iSPERSE Enables Product Development Not Possible with Conventional Technologies Dry Powder Formulation of Biologics and Macromolecules Proteins, Peptides and Nucleic Acids for Lung Delivery Small Molecule APIs with Challenging Physical/Chemical Attributes Amorphous or Crystalline API APIs Limited by
Slide 11: Pulmazole Inhaled Antifungal
Pulmazole Inhaled Antifungal Cipla 50-50 Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Slide 12: Pulmazole Highlights
Pulmazole Highlights * Research: Clearview Analysis 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 * iSPER
Slide 13: 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 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.
Slide 14: Significant Unmet Need Exists in ABPA
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. 2001;26:648; Greenberger P., B.R., Demain J, et. al., Allergic Bronchopulmonary A
Slide 15: Ph1/1b Study Successfully Met All Endpoints
Ph1/1b Study Successfully Met All Endpoints Pulmazole: Potential to Change Standard of Care for ABPA 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 16: Pulmazole is Anticipated to Improve Upon Sporanox Outcomes
Pulmazole is Anticipated to Improve Upon Sporanox Outcomes Demonstrated in Clinical Literature Pulmazole Development Plan Builds Upon Clinical Precedent of Sporanox Improvement of FEV1 in ABPA Source: Stevens. NEJM. 2000;342(11):757; Wark. J Allergy Clin Immuno. 2003;111; 952; Agarwal Chest 2018; do
Slide 17: Phase 2 Study Underway in Asthma-ABPA Patients
Patient Profile (M/F, ages 18–65) with confirmed/stable asthma and ABPA Placebo Pulmazole (10 mg) Pulmazole (20 mg) Pulmazole (35 mg) Endpoints Safety Tolerability Pulmonary Function Biomarkers 28-day Safety, Tolerability, Pulmonary Function and Biomarker Study in Patients with Asthma and ABPA Phase
Slide 18: Potential Ph3 Study Design Pending Ph2 Results and FDA Feedback
Potential Ph3 Study Design Pending Ph2 Results and FDA Feedback Phase 3 Trial Powered to Show FEV1 Improvement * Final dose selection to be determined Primary Endpoint FEV1 Secondary Endpoints Disease control (ACQ-6) Combined Asthma and ABPA exacerbations (frequency/timing) Steroid use Biomarkers Sp
Slide 19: Anticipated 1st Line Use Drives Pulmazole's ~$1.5B U.S. Peak Net Revenue Forecast
Anticipated 1st Line Use Drives Pulmazole’s ~$1.5B U.S. Peak Net Revenue Forecast Pulmazole: $1.5B Peak Net 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 adjustm
Slide 20: PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for Lung Cancer Reformulation of Janssen’s RV1162 Narrow Spectrum Kinase Inhibitor (NSKI)
Slide 21: PUR1800 Highlights: IND Ready with Potential in Lung Cancer
IND Ready with Potential to Address Significant Unmet Need in Lung Cancer PUR1800 Highlights (iSPERSE Enabled RV1162) Enabled by iSPERSE lung delivery, the PUR1800 mechanism of action has potential to address significant unmet need in lung cancer Pulmatrix PUR1800 Phase 1b study results, bridging la
Slide 22: Narrow Spectrum Kinase Inhibitors Block Steroid Resistant Inflammation
Block Steroid Resistant Inflammation & Lung Remodeling Processes 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 L
Slide 23: iSPERSE Formulation Overcame Limitations of RV1162 Lactose Blend
Janssen engaged Pulmatrix to overcome poor aerosol performance, drug accumulation in vivo and concerns with safety profile of RV1162 lactose blend formulation Janssen exited respiratory and licensed RV1162 and other NSKI to Pulmatrix given iSPERSE ability to enable further clinical development PUR18
Slide 24: RV1162 Positive Study Results and Opportunity for iSPERSE Enablement
RV1162 RV1162 Positive Study Results and Opportunity for iSPERSE Enablement of Further Clinical Development Resulted in Pulmatrix License of RV1162 and NSKI Portfolio First in Human Study of RV1162 (NSKI) Source: EST001 Study with 35 healthy subjects and 30 subjects with moderate-to-severe COPD Clin
Slide 25: iSPERSE Enabled Higher Lung Dosing with PUR1800 28-Day GLP Toxicology
iSPERSE Enabled Higher LUNG Dosing and Potentially Longer-Term Dosing with PUR1800 28-Day GLP Toxicology Study* Resulted in PUR1800 Improved Safety Margins Relative to RV1162 PUR1800 Results 500 µg Nominal Dose Resulted in ~125 µg Lung Dose Data supports maximum PUR1800 nominal clinical dose of 550
Slide 26: Upcoming Milestones: PUR1800 Phase 1b Trial in Stable COPD
Q1–2020 Q2–2020 Q3–2020 Q4–2020 Upcoming Milestones 225 µg iSPERSE PUR1800 ≈ 500 µg Janssen RV1162 lactose Blend (based on predicted lung deposition) Placebo PUR1800 (500 µg) PUR1800 (500 µg) Phase 1b: Safety Study Bridging from Lactose to iSPERSE Formulation PUR1800 Phase 1b Trial in Stable COPD En
Slide 27: New Therapies Under Evaluation
New Therapies Under Evaluation
Slide 28: Two Prioritized 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 Local delivery of poorly bioavailable orals and/or high GI toxic drugs Potenti
Slide 29: Our Mission
PULMATRiX 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 focus is on r
Slide 30: Appendix
Appendix
Slide 31: Glossary of Terms
Glossary of Terms 505(b)(2) FDA Regulatory Pathway for Drug Approval ABPA Allergic Bronchopulmonary Aspergillosis ACQ-6 Asthma Control Questionnaire 6 BAL Bronchoalveolar Lavage CMC Chemistry Manufacturing and Controls COPD Chronic Obstructive Pulmonary Disease FeNO Fractional Exhaled Nitric Oxide F