Pulmatrix, Inc. · NASDAQ:PULM
Pulmatrix — Investor Presentation (January 2023)
36 slides from Pulmatrix's investor presentation, Jan 11, 2023
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: Pulmatrix mission and iSPERSE technology
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 4: Management Team
Management Team Deep expertise in respiratory diseases & drug delivery technology across all stages of development Ted Raad — CEO & Director Previously Chief Business Officer of Pulmatrix e 20 years of commercial healthcare and life sciences leadership experience e Former Chief Commercial Officer at
Slide 5: Credentialed Board of Directors
Credentialed Board of Directors Board of directors with extensive experience in public and private life sciences companies Michael J. Higgins — Chairman e Entrepreneur-in-residence at Polaris Partners and Board Member of Genocea, Voyager, Kindex, Madauder and Sea Pharmaceuticals e Former SVP, COO, a
Slide 6: 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 7: iSPERSE Enabled Pipeline
iSPERSE Enabled Pipeline PUR1900 Allergic Bronchopulmonary Anti-fungal Aspergillosis (ABPA) a prey tr a (Cipla Partnership) in Patients with Asthma \\ gy PotentialPh2 PUR3100 a [Potentiapr2 =} ies Top Line Data DHE Acute Migraine Acute Exacerbations in Chronic F F , ' ‘ her eam Obstructive Pulmonary
Slide 8: iSPERSE
iSPERSE Small Dense and Dispersible Engineered Dry Powder Proprietary Technology
Slide 9: iSPERSE Platform
iSPERSE Platform iSPE loses small molecule to biologic (e.g., metered-dose, reservoir, capsule or blister-based inhalers) i low i w for penetration deep into lung, based e y on high dispersibility | | d (tens o e ) with high delivery efficiency _ i ‘ Bact Large Small = e Ss ef with improved A ‘ 4 we
Slide 10: PUR3100
PUR3100 Inhaled Dihydroergotamine (DHE) for Treatment of Acute Migraine (9) ~$575M U.S. peak net revenue, a 1% total Rx share, is a EL conservative forecast' iSPERSE mitigates the manufacturing / device issues resulting in the MAP0004 FDA complete response Ph1 results: Safe, well tolerated, 5-minute
Slide 11: PUR3100: Acute Treatment of Migraine
PUR3100: Acute Treatment of Migraine Large underserved market Large Market Large Unmet High Pharmacoeconomic Acute Treatment >1 billion worldwide Medical Need Burden New preventative treatment >38 million U.S. 75% of patients not actively $38 billion annual cost — U.S. options do not fully address A
Slide 12: Inhaled DHE Therapy Potential Advantages
Migraine — ry Inhaled DHE Therapy Potential Advantages What Do Patients Want? :: Gq Fast onset of action : Migraine upon : 24+hourheadache : Inhaled preferred : Absence of: through early T,,,, : awakening, quick to : relief through 3 over intranasal, nausea, lethargy, and sustained : peak intensity,
Slide 13: PUR3100 Phase 1 Clinical Study Design
PUR3100 Phase 1 Clinical Study to Evaluate Safety, Tolerability nonary inn ary Volunteers Inhaled Placebo + 1mg IV DHE een (n=6) Initial Phase 1 Study e IV DHE or 1 of 3 doses of PUR3100 with matching placebo | Inhaled PUR3100 ig + IV Placebo (n=6) : e Assessment of safety, tolerability, and PK afte
Slide 14: PUR3100 Achieved All Phase 1 Study Objectives and Goals
PUR3100 Achieved All Phase 1 Study Objectives and Goals Related to the Target Product Profile (TPP) Objective: To determine the safety and tolerability of single doses of inhaled PUR3100 in healthy adult subjects Objective: To characterize the systemic pharmacokinetics (PK) of single doses of inhale
Slide 15: PUR3100 Four Hour Exposure Profile Similar to IV DHE
PUR3100 Four Hour Exposure Profile is Similar to |1V DHE Equivalent T,,,., with C,,,, below the range typically associated with elevated nausea risk -® IVDHE 1.0mg © Tmax iS at the first time point (5 min) for sa FUR31000:5ing all subjects at all PUR3100 doses Tinax oe PURS100 1.0 mg . . 105 - —* PU
Slide 16: Published Pain Freedom Data Earlier Than Two Hours
Published Pain Freedom Data Earlier Than Two Hours Pain Freedom above Placebo (%) Drug/Route Class Dose peters 0.5hour 1 hour 2hour 24 hour " Risatriptan smg 0 u 22 13 - Tablet/Wafer" 2 Omg 4 9 31 18 = Sumatriptan 4 z . 4 Nasal Spray? Triptan 20mg 10 21 62 Sumatriptan 50mg = 3 17 9 50" tablet® 00mg
Slide 17: PUR3100 Kinetics Compared to MAP0004
PUR3100 Kinetics Compared to MAP0004 “+ MAP0004 1 mg -»- MAP0004 2 mg —— PUR3100 0.5 mg — PUR3100 1.0 mg © Tmax at 5 min for all PUR3100 doses Tmax Tmax — PUR3100 1.5 mg versus 12 minutes in MAP Phase 1 ot > 50% Nausea study’ 15000 4........ ee e Ahigher C,,,,, Was achieved with PUR3100 ‘Therapeutic
Slide 18: PUR3100 Kinetics vs. Marketed DHE Therapies
PUR3100 Kinetics vs. Marketed DHE Therapies © Tmax at 5 min for all PUR3100 doses versus 30 minutes for in INP1041 and 47 minutes for Migranal' e Higher C,,.,, than published intranasal (IN) formulations’ C,,,,, © Tmax ANd Cra, data could improve receptor binding kinetics and potentially translate i
Slide 19: Nausea incidence by Cmax
Time to Subject Duration of | Nausea after Nausea Incidence number Active medication Dose (min) ___dose (min) 120 IV D.H.E. 45 1 mg SNR 4 6 Nausea chest tightness e Of 16 subjects with C,,,, < 14,500 109 IVDHE. 45 1 mg 412000 3 5 Nausea suprapubic Pain pg/mL, 3 experienced nausea = 19% 105 IVDHE. 45
Slide 20: PUR3100 Potential Development Plan
PUR3100 Potential Development Plan Through Phase 2 Phase 2 data will inform the design and likelinood of a single Phase 3 study FDAMtg IND Submission EoPh2 Mtg > 3/23 > 7/23 > 5/25 2023 2024 2025 Qi Qz Q3 Q4 Qi Q2 Q3 Qi Q2 2025 FPD TLR a Sat Event eS Powered Phase 2 followed by single Phase 3 Phase
Slide 21: PUR3100: $575M Peak Net Revenue Potential
PUR3100: $575M Peak Net Revenue Potential at LOE in the U.S. Physician and Patient Feedback Payer Feedback % of patients on triptan experiencing 40% | a suboptimal response 2 generic treatment % of patients ranking “starts to show 7 y failures required improvement by 30 minutes” as the | 44% #1 most
Slide 22: PUR1900
PUR1900 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 PUR1900 potential to address the underlying cause of disea
Slide 23: PUR1900: Potential to Change the Standard of Care for ABPA
PUR1900: Potential to Change the Standard of Care for ABPA Phase 1/1b study successfully met all endpoints Demonstrated safety and tolerability of PUR1900 administered up to 14 days 4 ~100—400 fold lower plasma exposure over 24 hours than expected with oral Sporanox Fold Higher Fold Lower ~5 Lung Ex
Slide 24: PUR1900 Development Plan Builds Upon Clinical Precedent
PUR1900 Development Plan Builds Upon Clinical Precedent of Oral Itraconazole Improvement of FEV, in ABPA Oral itraconazole outcomes demonstrated in clinical literature the NEW ENGLAND JOURNAL of MEDICINE ; Journal of Clinical Immunology H Expert Review of Respiratory Medicine 2000, Stevens et al. ;
Slide 25: PUR1900: Phase 2b Study Intended to Demonstrate Proof of Concept
PUR1900: 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 OR Patients (WF, ages 18-80) with confirmed asthma and ABPA fees placebo-controlled study (N=30 patients) Pa
Slide 26: PUR1900: Up to $1.5B Peak Net Revenue Potential
PUR1900: Up to $1.5B Peak Net Revenue Potential in the U.S. Anticipated increase of first-line concomitant use with oral steroids drives the revenue forecast 65% ~1.3B Net ~200M U.S. ABPA Asthma Revenue U.S. Other Indications 30% Current Use of Antifungal 1st Line Future Use of Antifungal 1st Line C
Slide 27: PUR1800
PUR1800 Inhaled p38, Syk, Src Kinase Inhibitor with Potential for Treating AECOPD NSKI Portfolio In-Licensed from Janssen, Including RV1162 RV 1162 Reformulated Into iSPERSE Enabled PUR1800 PUR1800 potentially represents up to ~$2.4B' peak net revenue opportunity in the U.S. as an inhaled non-steroi
Slide 28: 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 Acut
Slide 29: 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 30: RV1162 (NSKI) Reduces Steroid-Resistant Inflammation
RV1162 (NSKI) Reduces Steroid-Resistant Inflammation in Preclinical Models RV1162 reduces steroid insensitive, tobacco smoke-induced inflammation and restores steroid efficacy e Verified kinase target engagement and _ SO inhibition with similar potency across p38, ll 1 r 1 Src and Syk kinases . e Re
Slide 31: PUR1800 Phase 1b Trial in Stable COPD Preliminary Results
PUR1800 Phase 1b Trial in Stable COPD Preliminary Results ( 1c 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 PUR1800 ] PUR1800 Placebo (250 jg) (500 yg) ee | PUR1800 Placebo PUR180
Slide 32: Potential Phase 2 Exploratory Study in AECOPD
Potential Phase 2 Exploratory Study in AECOPD Pulmatrix intends to pursue partnership opportunities to advance a PUR1800 Phase 2 study Study objectives e ee ee Time to resolution of ri | = Ei g } Rese ere sales failure rate' , 3 EM Sate ena trey FEV. Pts. with COPD fiR¥ : eee | 3 ie . ' : Experienci
Slide 33: 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. Testnentonten Expected se e 77% experience at least one exacerbation annually PUR1800 0% ~35% e ~18M moderate-to-severe AECOPD episodes (+ oral corticosteroids and/or antibiotics) i annually in U.S. Oral Corticosteroids +
Slide 34: Chronic Toxicology Pathology Results Support Potential Expansion
Chronic Toxicology Pathology Results Support Potential Expansion Into Chronic Treatment of Pulmonary Disease (ex. COPD, IPF, Asthma) Severe Rare Disease AECOPD . <100K in US* Asthma 18M Moderate e al cM ‘es to Severe Acute Exacerbations per year in US" \\* of Adult Asthma) COPD ~16M Diagnosed & 4 le
Slide 35: Pulmatrix
Pa PULMATRIiX NASDAQ: PULM
Slide 36: 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 AECOPD Acute Exacerbations in Chronic Obstructive Pulmonary Disease IP Intellectual Property BAL Bronchoalveolar Lavage LPS L