Slide 1: 12-Month Results from Ongoing Open-Label Extension Study of TPIP in PAH Patients
12-Month Results from Ongoing Open-Label Extension Study of TPIP in PAH Patients July 16, 2026 We’re in. For science. TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension
Slide 2: Forward Looking Statements
Forward Looking Statements The forward-looking statements in this presentation are based upon the Company's efficacy concerns related to TPIP; failure of third parties on which the Company is current expectations and beliefs, and involve known and unknown risks, uncertainties dependent to manufactur
Slide 3: Speakers and Agenda
Speakers Agenda Slides Will Lewis Chair & CEO 1 Opening Remarks 5-7 Gene Sullivan Chief Product 2 Study Results 9-18 Strategy Officer 3 KOL Reflection 19 Dr. Raymond Benza George M. and Linda H. Kaufman Academic Chair of Cardiology, Sentara Health 4 Closing Remarks 20-21 KOL: key opinion leader 3
Slide 4: Opening Remarks
Opening Remarks Will Lewis | Chair & CEO 4
Slide 5: TPIP: Investigational Once-Daily Prostanoid with Potential for Best-in-Class Efficacy
TPIP: Investigational Once-Daily Prostanoid with the Potential to Deliver Best-in-Class† Efficacy with Enhanced Tolerability Potential Advantages of TPIP Efficacy* Safety* Convenience** • Inhaled therapy delivered • Potential for reduced systemic • Administered once daily vs. directly to the lung ti
Slide 6: Phase 2b Study Illustrated TPIP's Competitive Efficacy and Safety Profile
Phase 2b Study Illustrated TPIP’s Competitive Efficacy and Safety Profile Pulmonary Vascular 6-Minute Walk NT-proBNP Safety & Resistance (PVR) Distance (6MWD) Concentration Tolerability Placebo-Adjusted Reduction1 Placebo-Adjusted Improvement2 Placebo-Adjusted Reduction3 at Week 16 at Week 16 at Wee
Slide 7: 12-Month OLE Results: Sustained Improvement Across All Efficacy Measures
12-Month OLE Results: Sustained Improvement Across All Efficacy Measures Including Reduction in Mortality Risk Status2 Patients who continued TPIP showed: Sustained improvement Sustained improvement Further improvement in Clinically meaningful in 6MWD1 in NT-proBNP1 WHO Functional Class improvement
Slide 8: Study Results
Study Results Gene Sullivan | Chief Product Strategy Officer 8
Slide 9: Open-Label Extension Intended to Evaluate TPIP's Long-Term Safety & Tolerability
Open-Label Extension Intended to Evaluate TPIP’s Long-Term Safety & Tolerability Over 24 Months Key OLE Study Endpoints Open-Label Treatment Period *** Primary Endpoint 16 weeks 24 months 4 weeks • Safety and tolerability (frequency & severity of TEAEs) 3-week titration Secondary Endpoints period***
Slide 10: Baseline Characteristics Were Comparable Across Groups
Baseline† Characteristics Were Comparable Across Groups Continued TPIP1 Placebo Crossed2 Total N=60 N=31 N=91 Age: Mean, years 47.9 47.6 47.8 Sex: Male, % (n) 13.3% (8) 19.4% (6) 15.4% (14) Geographic Region: % (n) United States 10.0% (6) 9.7% (3) 9.9% (9) Europe 36.7% (22) 35.5% (11) 36.3% (33) Res
Slide 11: 91% of OLE Patients Remained on TPIP at Month 12
91% of OLE Patients Remained on TPIP at Month 12 Phase 2b Study 24-Hour of TPIP in PAH PVR Study Lead-in Studies: N=62 (TPIP) and N=33 (placebo) N=1 (TPIP)* completed 95% of completers enrolled in OLE 24-Month OLE Study (N=90) of TPIP in PAH N=91 Continued TPIP 1 Placebo Crossed2 Treatment Groups: N
Slide 12: TPIP Generally Safe and Well-Tolerated; No Newly Identified Safety Signals Through Month 12
TPIP was Generally Safe and Well-Tolerated; No Newly Identified Safety Signals Through Month 12 Total (N=91) SAFETY % n Any TEAE 89.0% 81 ≤640 µg Max Dose Achieved 86.1% 62 All TEAEs of cough were >640 µg Max Dose Achieved** 89.5% 17** classified as mild or moderate, Serious 18.7% 17 with >85% being
Slide 13: Sustained Improvement in 6MWD Over 12 Months
Patients that Continued on TPIP Showed Sustained Improvement in 6MWD Over 12 Months Continued T PIP Mean-Continued T PIP Median-Continued T PIP Placebo-crossed Continued TPIP Placebo Crossed Mean-Placebo-crossed Median-Placebo-crossed Mean Improvement from Mean - Continued TPIP Mean - Placebo Crosse
Slide 14: Sustained Reduction in NT-proBNP Over 12 Months
Patients that Continued on TPIP Showed Sustained Reduction in NT-proBNP Over 12 Months 1. 5 Phase 2b Study Mean Reduction from Basel i ne * Continued TPIP 202 Baseline NT-proBNP Concentration† (SE) Placebo Crossed Baseline* NT-proBNP Concentration at Month 12 wi t h Geomet r i c St andar d Er r or 1
Slide 15: Meaningful Improvement in WHO Functional Class by Month 12
Both Groups Showed Meaningful Improvement in WHO Functional Class (FC) by Month 12 Continued TPIP (N=60) Placebo Crossed (N=31) Phase 2b Study Phase 2b Study Functional Class 100% by Month 12 Proportion of Patients† 75% >25% of all patients 50% achieved FC I − FC I indicates no limits on physical ac
Slide 16: REVEAL Lite 2.0 Score: Simplified, Non-invasive, Validated Mortality Risk Tool
REVEAL Lite 2.0 Score: Simplified, Non-invasive, Validated Tool to Estimate the Mortality Risk of PAH Patients Estimated Estimated Scoring1,2 Points Mortality Risk Morbidity Risk3 A 1-point improvement from High Risk ≥8 >10% at 1 year baseline REVEAL score is associated with a ~23% reduction in risk
Slide 17: Clinically Meaningful Improvement in Mean REVEAL Lite 2.0 Score by Month 12
Both Groups Showed Clinically Meaningful Improvement in Mean REVEAL Lite 2.0 Score by Month 12 Continued TPIP Placebo Crossed 6. 0 Phase 2b Study Intermediate Risk REVEAL Score (SE)† Status (>5 to <8) Improvement Mean REVEAL Li t e 2. 0 Sc or e ( LOCF) 5. 5 d Er Score by Month 12 r or 5. 0 Low Risk
Slide 18: TPIP's Profile in the Evolving PAH Treatment Landscape
TPIP’s Profile Could Represent a Compelling Option in the Evolving PAH Treatment Landscape TPIP Investigational product that has not been approved for sale or found safe or effective by the FDA or any regulatory authority OLE (SOTERIA) RCT (16 weeks) OLE (12 months) RCT (12 weeks) OLE (12 months) RC
Slide 19: KOL Reflection
KOL Reflection Dr. Raymond Benza MD, FACC, FAHA, FACP George M. and Linda H. Kaufman Academic Chair of Cardiology, Sentara Health Phase 2b PAH study Steering Committee KOL: key opinion leader | MD: Doctor of Medicine | FACC: Fellow of the American College of Cardiology | FAHA: Fellow of the American
Slide 20: Results Reinforce TPIP's Potential to Become the Prostanoid of Choice
These Results, Combined with Once-Daily Inhaled Profile, Reinforce TPIP’s Potential to Become the Prostanoid of Choice 1 Sustained improvements for patients remaining on TPIP and comparable benefits for patients who switched from placebo 2 TPIP treatment led to meaningful reductions from baseline in
Slide 21: Next Steps: Registrational Program Across Four Indications
Next Steps: Design and Conduct an Expansive Registrational Program Across Four Indications PH-ILD PAH Phase 3 patient Phase 3 first trial sites enrollment progressing actively screening TPIP PPF IPF Phase 3 initiation Phase 3 initiation expected 2H:26 expected 1H:27 PAH: pulmonary arterial hypertens
Slide 22: Q&A Session
Q&A Session Thank you to the patients and investigators participating in this study! Will Lewis Gene Sullivan Martina Flammer Sara Bonstein Dr. Raymond Benza Chair & CEO Chief Product Chief Medical Officer Chief Financial Officer George M. and Linda H. Strategy Officer Kaufman Academic Chair of Card
Slide 23: Appendix
Appendix
Slide 24: Footnotes (1 of 3)
Footnotes (1 of 3) 1. Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted Reduction from Baseline PVR at Week 16; Analysis performed using an ANCOVA model, adjusting for treatment group, baseline pulmonary vascular resistance (PVR), and randomization stratification factors. The model was applied
Slide 25: Footnotes (2 of 3)
Footnotes (2 of 3) 8. Phase 3 TRIUMPH study; Hodges-Lehmann (H-L) median treatment difference in change from baseline 6MWD at 12 weeks measured at peak drug exposure (p<0.001); McLaughlin, V, Benza, R, Rubin, L. et al. Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertens
Slide 26: Footnotes (3 of 3)
Footnotes (3 of 3) 12. SOTERIA OLE participants included eligible adults with PAH on stable background therapy who completed a prior sotatercept study (Phase 2 or Phase 3) without early discontinuation were enrolled. Participants received subcutaneous sotatercept (≤0.7 mg dose once every 21 days). T
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