Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (September 2017)
30 slides from Pulmatrix's investor presentation, Sep 11, 2017
Slide 1: Engineering Respiratory Products for Major Unmet Pulmonary Diseases
Engineering Respiratory Products for Major Unmet Pulmonary Diseases September 2017 NASDAQ: PULM Exhibit 99.1
Slide 2: Disclaimers & Forward Looking Statements
Disclaimers & Forward Looking Statements This presentation contains forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is
Slide 3: Clear Corporate Strategy with Value Creation Milestones in 2018
Clear Corporate Strategy with Value Creation Milestones in 2018 Target iSPERSE™ technology toward major respiratory diseases PUR1800 novel narrow spectrum kinase inhibitor (NSKI) for AECOPD Phase 2 data expected in 4Q 2018 $2.5B U.S. potential revenue opportunity Significantly reduced development ri
Slide 4: Experienced Leadership Team with Record of Success
Experienced Leadership Team with Record of Success Management Team Proven fundraising and capital management ability Experienced R&D team focused on pulmonary drug delivery and the role of inhaled particles Commercialization and partnership experience Board of Directors Diverse Collective Experience
Slide 5: iSPERSE Significantly Improves Patient Care Compared to Conventional Inhalation Technology
iSPERSE™ Significantly Improves Patient Care Compared to Conventional Inhalation Technology 1µm iSPERSE™ enables the sickest patient to receive the same dose of medication as a healthy patient iSPERSE™ Differentiation iSPERSE™ Advantages Small, dense, dispersible, respirable particles Flow rate inde
Slide 6: Product pipeline and milestones
Product Indication PreClin Ph1 Ph2 Ph3 Milestone PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) Phase 2 (2H2018) PUR1900 Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Severe Asthma Phase 1B (1H2018) PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Phase 1 (2019) PUR0200-US LAMA Ch
Slide 7: PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI) Acute Exacerbations of COPD
PUR1800 — Narrow Spectrum Kinase Inhibitor (NSKI) Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Slide 8: NSKIs Block Steroid Resistant Inflammation & Lung Remodeling Processes
Narrow Spectrum Kinase Inhibitors (NSKI) Block Steroid Resistant Inflammation & Lung Remodeling Processes Source: Barnes PJ. Pharmacol Rev 2016; 68:788–815 Source: Barnes PJ. J Allergy Clin Immunol 2013; 131:636-45 Source: Geraghty P et al. Am J Respir Cell Mol Biol. 2014; 50(3):559-70 Source: Angat
Slide 9: PUR1800 is a Novel Product with Clinically Demonstrated Target Engagement and Tolerability
PUR1800 (NSKI) is a Novel Product with Clinically Demonstrated Target Engagement and Tolerability MOA Narrow spectrum triple kinase inhibitor of p38 mitogen activated protein (MAP) kinase (α/γ), Src family kinases, and Syk kinases Lead Indication Acute exacerbations of COPD Development Status Comple
Slide 10: PUR1800: Broad Efficacy Potential and Significant Unmet Need in AECOPD
PUR1800 (NSKI): Broad Efficacy Potential and Significant Unmet Need in AECOPD Meaningful AECOPD Disease Burden Unlike Steroids, PUR1800 Has Anticipated Efficacy Across Different AECOPD Phenotypes COPD is the 3rd leading cause of death in the U.S. Diagnosed prevalence of COPD is ~16 M in the U.S. 77%
Slide 11: PUR1800 Decreases Markers of Inflammation in Patients with Moderate-to-Severe COPD
PUR1800 (NSKI) Decreases Markers of Inflammation in 30 Patients with Moderate-to-Severe COPD (EST001) p38MAPK Phosphorylation Levels in Sputum Cells Recovered From COPD Subjects Concentration of Sputum Neutrophils Recovered From COPD Subjects After 12 days of treatment, PUR1800 (500 µg dose) signifi
Slide 12: PUR1800 Exhibits Favorable Pharmacokinetics with Repeat Dosing
PUR1800 (NSKI) Exhibits Favorable Pharmacokinetics with Repeat Dosing (EST001) Pharmacokinetic Data for Repeat Dose in COPD Patients In COPD patients, PUR1800 showed dose proportional pharmacokinetics and increased plasma concentration with repeat dosing, indicating clinical utility over an extended
Slide 13: PUR1800 Phase 2 Clinical Study
Moderate-to-Severe COPD Patients 30% ≤ FEV1 < 80% (n=40) Randomization (2:2:1) 14-28 days Phase 2 Endpoints Safety and tolerability Single dose PK profile Multiple dose PK profile over 14-28 days Analysis of sputum inflammation and target engagement Patient specific biomarkers through Functional Res
Slide 14: Lack of Options in AECOPD and PUR1800 Efficacy Profile Drive Commercial Valuation
Lack of Options in AECOPD and PUR1800 Efficacy Profile Drive Commercial Valuation Source: Physician Interviews; Payer Interviews; ClearView Analysis. With ~30% of patients failing corticosteroids and antibiotics, clinicians are seeking options that reduce the burden of exacerbations High Unmet Need
Slide 15: Prescribers Indicate PUR1800 Will Become Integral to Standard of Care
PUR1800 (NSKI): Prescribers Indicate 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. Prescriber Reported PUR1800 Utilization Prescriber Feedbac
Slide 16: PUR1800 Global 2038 Forecast
PUR1800 Global 2038 Forecast PUR1800 (NSKI): U.S. AECOPD 2038 Peak Revenue Forecast and Overall Global Forecast Source: Physician Interviews; Payer Interviews; ClearView Analysis. * Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment. U.S. AECOPD E.U. AECO
Slide 17: PUR1900 – Inhaled Antifungal ABPA in Severe Asthma
PUR1900 – Inhaled Antifungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Severe Asthma
Slide 18: PUR1900: ~300K U.S. ABPA-Asthma Patients with Significant Unmet Need
2nd Line Disease Overview Treatment Flow PUR1900 (Antifungal): ~300K U.S. ABPA-Asthma Patients with Significant Unmet Need 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;
Slide 19: PUR1900: First in Class Inhaled Delivery with Improved Efficacy and Safety Profile
PUR1900 (Antifungal): First in Class Inhaled Delivery with Improved Efficacy and Safety Profile MOA Triazole that inhibits P450-dependent synthesis of ergosterol, a key component of fungal cell wall biosynthesis Lead Indication Allergic Bronchopulmonary Aspergillosis (ABPA) in Asthma Other Potential
Slide 20: PUR1900: Potential Efficacy & Safety Benefits vs Oral Itraconazole (Sporanox)
Plasma Concentration of PUR1900 vs. Oral Sporanox Lung Concentration of PUR1900 vs. Oral Sporanox PUR1900 (Antifungal): Potential Efficacy & Safety Benefits vs Oral Itraconazole (Sporanox) In preclinical studies, inhaled PUR1900 achieves 5x better lung exposure than oral Sporanox with significantly
Slide 21: Overall Survival with PUR1900 Compared to Oral Sporanox and Placebo
Overall Survival with PUR1900 Compared to Oral Sporanox and Placebo PUR1900 (Antifungal): Inhaled Itraconazole Improved Survival in an Immunosuppressed Guinea Pig Model In preclinical studies with immunocompromised guinea pigs, inhaled PUR1900 achieved ~90% overall survival compared to 30% with oral
Slide 22: PUR1900 Phase 1/1b Clinical Plan
Part 1: Single Ascending Dose (SAD) Healthy volunteers (n=6/cohort) Single dose 96h PK profile Safety and tolerability Part 2: Multiple Ascending Dose (MAD) Healthy volunteers (n=6/cohort) PK profile over 14d of dosing Safety and tolerability Part 3: Single Dose (SD) Asthmatics (n=12; cross-over) Si
Slide 23: Gaps in ABPA Standard of Care and PUR1900 Efficacy - Safety Profile Drive Commercial Value
Gaps in ABPA Standard of Care and PUR1900 Efficacy - Safety Profile Drive Commercial Value Source: Physician Interviews; Payer Interviews; ClearView Analysis. Given lack of safe and effective therapies, clinicians are seeking treatments that reduce the burden of exacerbations and steroid-use High Un
Slide 24: PUR1900: Efficacy and Safety Advantages Drive Prescriber Preference
Use of Antifungal Agents in Treating ABPA Prescribers indicated that PUR1900 may replace ~85% of the current oral antifungal use in treatment of ABPA +115% PUR1900 (Antifungal): Efficacy and Safety Advantages Drive Prescriber Preference Source: Physician Interviews; ClearView Analysis Future PUR1900
Slide 25: PUR1900 Global 2033 Forecast
PUR1900 Global 2033 Forecast PUR1900 (Antifungal): U.S. ABPA-Asthma 2033 Peak Revenue Forecast and Overall Global Forecast Source: Physician Interviews; Payer Interviews; ClearView Analysis. * Also includes discount for patient compliance, patient persistence, and gross-to-net adjustment. U.S. Other
Slide 26: PUR0200 – iSPERSE Reformulation of Spiriva
PUR0200 – iSPERSE™ Reformulation of Spiriva® Chronic Obstructive Pulmonary Disease
Slide 27: PUR0200 is an Improved Version of the Spiriva Handihaler
PUR0200 is an Improved Version of the Spiriva® Handihaler® (Equivalent Lung Exposure at 80% Nominal Dose) Spiriva® $3.5B WW revenues in 2016 Spiriva lacks a dry-powder multi-dose inhaler in the U.S. In the rest of world, there is a need for therapeutically equivalent, lower cost products Unmet Needs
Slide 28: Summary & Development Plan
pulmatrix Summary & Development Plan
Slide 29: Significant Value Inflection Points Anticipated in 2018
2017 2018 2019 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Pulmatrix plans to advance both PUR1800 and PUR1900 to major clinical milestones Significant Value Inflection Points Anticipated in 2018 PUR1800 (NSKI) PUR1800 Phase 2b Start PUR1800 Phase 2 Data PUR1800 Phase 2b CMC PUR1800 GLP Tox Non-clinical CMC
Slide 30: Engineering Respiratory Products for Major Unmet Needs
Engineering Respiratory Products for Major Unmet Needs September 2017