Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (December 2021)
33 slides from Pulmatrix's investor presentation, Dec 7, 2021
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: Management Team
Management Team Deep expertise in respiratory diseases & drug delivery technology across all stages of development Rusty Clayton, MD — Medical Director & Strategic Advisor © 15+ years of executive experience in pharmaceutical, biologics and medical device development © Former Chief Medical Officer a
Slide 4: Credentialed Board of Directors
Credentialed Board of Directors Board of directors with extensive experience in public and private life sciences companies PULMATR Michael J. Higgins — Chairman © Entrepreneur-in-residence at Polaris Partners and Board Member of Genocea, Voyager, Kindex, Madauder and Sea Pharmaceuticals © Former SVP
Slide 5: PULM (NASDAQ) Investment Highlights
PULM (NASDAQ) Investment Highlights e Proprietary iSPERSE platform technology that seeks to optimize pharmacokinetics and pharmacology in respiratory and non-respiratory therapeutics e Ascalable platform with applicability across drug classes and dry-powder delivery devices to support pipeline devel
Slide 6: iSPERSE Enabled Pipeline With Multiple Potential Milestones
confidential iSPERSE Enabled Pipeline With Multiple Potential Milestones PUR1800 is positioned as an ’asset to partner” following with Ph1b and chronic tox in hand =, ror [or [oof oo] of oa] cm [oe or [aa] ofan Acute Exacerbations in Chronic PUR1800 7 Ph1b Top Line Obstructive Pulmonary Disease Dita
Slide 7: iSPERSE
iSPERSE Small Dense and Dispersible Engineered Dry Powder Proprietary Technology
Slide 8: iSPERSE Platform
iSPERSE Platform Sn = d ea and dicner a) Small, dense and dispersible iSPERSE Enables Si e Can be Can be A’ ns) with high je doses into lun: se Large = e cts with improved ‘ 4um pharmacokinetics profile compared to oral delivery roRRCUES Paleeschos™3 pense e Broad IP portfolio into 2030s ‘Small Mole
Slide 9: Pulmazole
Pulmazole Inhaled Antifungal Cipla Worldwide Development & Commercial Partnership Inhaled Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma iSPERSE enables itraconazole delivery to the lung, providing Pulmazole potential to address the underlying cause of d
Slide 10: Pulmazole: Potential to Change Standard of Care for ABPA
Pulmazole: Potential to Change Standard of Care for ABPA Phase 1/1b study successfully met all endpoints Demonstrated safety and tolerability of Pulmazole administered up to 14 days JS ~100—400 fold lower plasma exposure over 24 hours than expected with oral Sporanox ~5 ace esure ~85 Scag eepoeua 1/
Slide 11: Pulmazole Development Plan Builds Upon Clinical Precedent
Pulmazole Development Plan Builds Upon Clinical Precedent of Oral Itraconazole Improvement of FEV, in ABPA Oral itraconazole outcomes demonstrated in clinical literature we NEW ENGLAND Journal of Clinical Immunology : Expert Review of Respiratory Medicine JOURNAL of MEDICINE 2003, Wark et al. 2018,
Slide 12: Phase 2b Study Intended to Demonstrate Proof of Concept
Phase 2b Study Intended to Demonstrate Proof of Concept in Patients with Asthma and ABPA Successful FDA Type C meeting enables Ph2b study anticipated start in Q1 2023 Patient Profile : O'R Patients (WF, ages 18-80) with confirmed asthma and ABPA ae placebo-controlled study (N=30 patients) Patients a
Slide 13: Pulmazole: $1.5B Peak Net Revenue Potential in the U.S.
Pulmazole: $1.5B Peak Net Revenue Potential in the U.S. Anticipated increase of 1 line concomitant use with oral steroids drives the 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 Clair Xol
Slide 14: PUR3100
PUR3100 Inhaled Dihydroergotamine (DHE) for Treatment of Acute Migraine Significant unmet need in a large market represents ~$575M U.S. peak net revenue opportunity! Lung delivery offers many potential advantages including fast acting pain relief and symptom control with a favorable tolerability pro
Slide 15: Acute Treatment of Migraine
Acute Treatment of Migraine: Large underserved market Large Market >1 billion worldwide >38 million U.S. Affects 3x’s more women than men Pa PULMATRixX Large Unmet Medical Need 75% of patients not actively treated with Rx’s due to poor efficacy 80% of patients on Rx’s would try new therapies ‘oundat
Slide 16: Migraine Inhaled DHE Therapy Potential Advantages
Migraine — ry Inhaled DHE Therapy Potential Advantages What Do Patients Wa Absence of: nausea, lethargy, medication overuse, dysgeusia‘ 24+ hour headache relief through sustained target engagement! Inhaled preferred over intranasal, convenient device and administration Fast onset of action through e
Slide 17: PUR3100 Pharmacokinetics Compare Favorably With MAP0004
PUR3100 Pharmacokinetics Compare Favorably With MAP0004 Dog inhaled kinetics predicts human inhaled kinetics AUC ine jose Normalized gimLyim ymL)/mg MAP0004 dog PUR3100 pharmacokinetics achieves similar EM Br0008 Bay — = soo 10.23 accurately pharmacokinetics " MAP0004 Human? 4.15 9.22 predicts MAP00
Slide 18: All PUR3100 Doses are Anticipated to Be in Therapeutic Window
All PUR3100 Doses are Anticipated to Be in Therapeutic Window Orally inhaled DHE (MAP0004) has a superior profile to other DHE DHE pg/mL -O=IV 1: mg (MAP) 100,000 9 >50% Emesis —C—MAP0004 0.44 mg =O=MAP0004 0.88 mg 10,000 Therapeutic Window = ==~STS1015.4 mg == INP104 1.45mg 1,000 100 Sub Therapeuti
Slide 19: PUR3100 Initial Phase Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics
PUR3100 Initial Phase 1 Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics 2 bioavailability of PUR3100 (pulmonary inhaled) relative to IV DHE To demc ate safety and comparativ Randomized Double-blind, Double-dummy Single Dose Study in 32 Healthy Volunteers ‘ Intravenous DHE _ ‘ (n
Slide 20: PUR3100 Ph2 Dose Confirmation Study Intended to Demonstrate Proof of Concept
PUR3100 Ph2 Dose Confirmation Study Intended to Demonstrate Proet of mel and Enable Pivotal lard to evalu: Randomized Double-blind Placebo-Controlled Study in Otherwise Healthy Patients with Migraine Phase 2-Dose Confirmation © Patients provided with dose to q Placebo : (n=30) administer at home dur
Slide 21: PUR3100: $575M Peak Net Revenue Potential at LOE in the U.S.
PUR3100: $575M Peak Net Revenue Potential at LOE in the U.S. Physician and Patient Feedback Payer Feedback % of triptan patients experiencing 40% | a suboptimal response as 2 generic treatment % of patients ranking “starts to show 7 y failures required improvement by 30 minutes” as the | 44% y oy '
Slide 22: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for AECOPD NSKI Portfolio In-Licensed from Janssen, Including RV1162 RV1162 Reformulated Into iSPERSE Enabled PUR1800 PUR1800 potentially represents up to ~$2.4B" peak net revenue opportunity in the U.S. as an inhaled non-steroidal treatm
Slide 23: Limited Efficacy in Standard of Care for AECOPD
Limited Efficacy in Standard of Care for AECOPD Moderate-to-Severe Exacerbations Significant unmet need exists in AECOPD with underlying infection and/or steroid resistance e Steroids are standard of care for moderate-to- severe acute exacerbations, which occur across all patient severity types e ~9
Slide 24: Narrow Spectrum Kinase Inhibitors (NSKI)
Narrow Spectrum Kinase Inhibitors (NSKI) Block steroid-resistant inflammation and 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 prod
Slide 25: RV1162 (NSKI) Reduces Steroid-resistant Inflammation in Preclinical Models
RV1162 (NSKI) Reduces Steroid-resistant Inflammation in Preclinical Models RV1162 reduces steroid insensitive, tobacco smoke-induced inflammation and restores steroid efficacy in human and animal cell lines with broadly similar potency (data has translational utility) e Verified kinase target engage
Slide 26: RV1162 Clinical Data Summary
flammato ammatory RV1162 Reduced RV1162 Reduced p38 MAPK Phosphorylation Sputum Neutrophils Clinical Data Summary e RV1162 lactose blend was well tolerated in human study including stable moderate-to-severe COPD 25.0 5: subjects: ClinicalTrials.gov = 3.0 NCT01970618 § 200 a a3 25 “—~_, RV1162 lactos
Slide 27: PUR1800 Phase 1b Trial in Stable COPD
PUR1800 Phase 1b Trial in Stable COPD Study is fully enrolled with Randomized, double-blind, 3-way crossover study; 3 Dose Groups (2 active, 1 placebo) with 15 pts. 14 days of daily dosing, with 28-day crossover and 28-day follow-up Supa e Safety & Tolerability e Pulmonary function ‘ PUR1800 i PUR18
Slide 28: Potential Phase 2a Exploratory Study in AECOPD
Potential Phase 2a Exploratory Study in AECOPD Pulmatrix intends to pursue partnership opportunities for PUR1800 based on positive long-term toxicology data and anticipated Phib study results ene ae Retreatment if Sti NTE Phone Visits: Symptoms Not Days 1, 7, 14, Days 4, 10 R Ived at 28, 60, 90 ays
Slide 29: PUR1800: $2.4B in U.S. Peak Revenue Potential
PUR1800: $2.4B in U.S. Peak Revenue Potential e ~16M COPD patients in the U.S. Treatment Opti rrent Expected pun Use Use e 77% experience at least one exacerbation annually PUR1800 0% ~35% e ~18M moderate-to-severe AECOPD episodes EE TEE) annually in U.S. Oral Corticosteroids + Antibiotics ~58% ~34%
Slide 30: Chronic Toxicology Pathology Results Support Potential Expansion Into Chronic Treatment
Chronic Toxicology Pathology Results Support Potential Expansion Into Chronic Treatment of Pulmonary Disease (ex. COPD, IPF, Asthma) AECOPD 18M Moderate to Severe Acute Exacerbations per year in US" ah | PULMATRixX Severe Asthma ~10M Adults in US? 10% of Adult Asthma) Rare Disease <100K in US* ~16M
Slide 31: Pulmatrix is committed to the development and commercialization of novel medicines
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.
Slide 32: Appendix
Appendix
Slide 33: 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 AECOPD Acute Exacerbations in Chronic Obstructive Pulmonary Dis