Mannkind Corporation · NASDAQ:MNKD
Mannkind — Technical Presentation (July 2026)
34 slides from Mannkind's technical presentation, Jul 29, 2026
Slide 1: INFLO-1 Data Readout: Strengthening the Nintedanib DPI Opportunity in IPF
INFLO-1 Data Readout: Strengthening the Nintedanib DPI Opportunity in IPF July 29, 2026 © Copyright 2026. All rights reserved. Mannkind Corporation.
Slide 2: Cautionary Statement
Cautionary Statement Statements in this presentation that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended
Slide 3: Agenda
Agenda 1 The IPF Opportunity 2 Clinical Overview 3 Closing Remarks Michael Castagna, Dr. Wassim Fares 4 Q&A PharmD Senior Vice President, Therapeutic Area Head, Chief Executive Officer Respiratory 3 © Copyright 2026. All rights reserved. MannKind Corporation.
Slide 4: Major Catalysts Driving 2026 & Beyond
Major Catalysts Driving 2026 & Beyond Afrezza® Pediatrics Furoscix ReadyFlow Nintedanib DPI Autoinjector • Population expansion; • Reduces administration from • Urgent need for new, INHALE-1ST hours to seconds effective therapies in IPF • Unique value proposition • Supports broader adoption • Lung t
Slide 5: The IPF Opportunity
The IPF Opportunity 5 © Copyright 2026. All rights reserved. MannKind Corporation.
Slide 6: Highlights
Highlights ✓ Phase 1b study demonstrated safety and tolerability in patients with IPF • No serious adverse events • No GI burden • No discontinuations • No difference in spirometry parameters between placebo (empty cartridge) and Nintedanib DPI ✓ Phase 2 global study underway • First patient dosed;
Slide 7: A Validated Category + Persistent Unmet Need Creates an Opportunity for Targeted Inhaled Approaches
A Validated Category + Persistent Unmet Need Creates an Opportunity for Targeted Inhaled Approaches U.S. MARKET LANDSCAPE ~650,000 patients with ILDs >$150K >200 ILD subtypes can progress to fibrosis annual brand pricing / patient >$40B ~100,000+ ~180,000 implied U.S. total addressable market patien
Slide 8: IPF: A Progressive and Fatal Disease with Problematic Therapies
IPF: A Progressive and Fatal Disease with Problematic Therapies 3 • Current therapies exhibit major safety and tolerability issues • Discontinuation rates out of 4 are as high as 50%1 patients with IPF are not on an approved • A minority of patients even start IPF therapy antifibrotic therapy1 • 80%
Slide 9: Local Delivery, Systemic Advantage: A Potentially Better Path Forward
Local Delivery, Systemic Advantage: A Potentially Better Path Forward Target the lungs directly Bypass the GI tract Improve efficacy and tolerability Efficient, targeted Lower systemic exposure May support long-term deep-lung delivery adherence 9 © Copyright 2026. All rights reserved. MannKind Corpo
Slide 10: Our Technology is Differentiated
Our Technology is Differentiated Versatile Platform with Competitive Advantages • Technosphere® technology provides highly efficient delivery – Dry powder administered via portable inhalers – Rapid, uniform distribution deep into the lung • FDKP (fumaryl diketopiperazine) microparticles drive extens
Slide 11: Technosphere Particles Driven Predominantly by FDKP
Technosphere Particles Driven Predominantly by FDKP Afrezza Tyvaso DPI 90% FDKP 99% FDKP 10% active API 1% active API Pipeline Target powder is 10mg max per dose and is 80-99% Nintedanib DPI Technosphere 80% FDKP FDKP and 1-20% drug load Powder 20% active API Used in >50,000 patients 11 © Copyright
Slide 12: Case Study: Patient Preference in Rare Lung Disease
Case Study: Patient Preference in Rare Lung Disease $600M Treprostinil Revenue ($M) $500M $400M 78% 73% 77% 65% 67% $300M 63% 66% 61% 65% 61% 24% 61% 63% $200M 38% 50% $100M 100% 100% 99% 76% 100% 100% 62% 39% 37% 35% 33% 100% 39% 39% 35% 34% 27% 23% 22% 50% 37% $0M Nebulized DPI The inhaled trepros
Slide 13: Clinical Overview
Clinical Overview 13 © Copyright 2026. All rights reserved. MannKind Corporation.
Slide 14: Wassim Fares, MD, MSc, FCCP
Wassim Fares, MD, MSc, FCCP Senior Vice President, Therapeutic Area Head, Respiratory Board-certified pulmonologist with 18+ years leading respiratory clinical development—from early-stage studies through Phase 3 and post-approval • Deep experience spanning academic medicine, clinical research, and
Slide 15: Strong Preclinical Safety and Lung-Targeted PK Established the Foundation for Clinical Development
Strong Preclinical Safety and Lung-Targeted PK Established the Foundation for Clinical Development PK signal: lung concentrations were ≥100-fold higher than plasma with minimal systemic exposure Initial Tox Long-term Chronic Tox PK & Exposure Two 28-day repeat-dose studies in 6-month repeat-dose stu
Slide 16: Nintedanib DPI Clinical Development
Nintedanib DPI Clinical Development Rapidly de-risking program scaling from first-in-human to a 210-patient global study Phase 1 Phase 1b Phase 2 First-in-Human INFLO-1 INFLO-2 Healthy Volunteers in the US U.S. Patients with IPF Global Patients with IPF 1 40 10 27 ~85 210 SITE ADULTS (n) SITES PATIE
Slide 17: Phase 1a: Study Designed to Evaluate Pharmacokinetics and Safety
Phase 1a: Study Designed to Evaluate Pharmacokinetics and Safety Part A: Single-Ascending Dose (n = 24; 3:1 randomization) Safety Data Safety Data COHORT A1 Review COHORT A2 Review COHORT A3 2 mg once 4 mg once 8 mg once Part B: Multiple-Ascending Dose (7 Days) (n = 16; 3:1 randomization) Safety Dat
Slide 18: Phase 1a: Proven Molecule, Now Proven Tolerability in First-in-Human
Phase 1a: Proven Molecule, Now Proven Tolerability in First-in-Human Safe and well-tolerated over 7 days in healthy adult volunteers — no safety signals 0 0 0 Safety Signals Serious AEs Discontinuations Adverse Events Pharmacokinetics • Mild, reversible cough, typically after the first dose • Immedi
Slide 19: Cmax Drives Efficacy in Pulmonary Fibrosis
Cmax Drives Efficacy in Pulmonary Fibrosis • Cmax, not AUC, drives nintedanib efficacy — hitting a threshold peak concentration matters more than total lung exposure. • Beyond that peak, more exposure adds little — large oral-derived tissue levels contribute minimal extra anti-fibrotic benefit. • Br
Slide 20: Phase 1a: PK Data for Nintedanib DPI
Phase 1a: PK Data for Nintedanib DPI Day 7 MAD Plasma Cmax 35 30 29.4 * Nintedanib DPI 25 delivers more drug to the deep lung — 20 15 12.2 6x to 8x higher 10 8.64 plasma Cmax than 5 1.94 3.11 nebulized nintedanib 1.08 0 at every comparable Nintedanib DPI Nebulized Nintedanib dose 2mg 4mg 8mg *Result
Slide 21: Nintedanib DPI Phase-1b Study (U.S.)
Nintedanib DPI Phase-1b Study (U.S.) A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Nintedanib Dry Powder Inhalation (MNKD-201) in Patients with Idiopathic Pulmonary Fibrosis. 21 © Copyright 2026. All rights reserved. Mann
Slide 22: INFLO-1 Phase 1b: First-in-Patient Study to Assess Safety, Tolerability and Pharmacokinetics
INFLO-1 Phase 1b: First-in-Patient Study to Assess Safety, Tolerability and Pharmacokinetics Multiple-Ascending Dose (7 Days) (n = 27; 2:1 randomization) Safety Data Review COHORT 1 (Sponsor & External DSMB) COHORT 2 2 mg TID 4 mg BID Objectives Early Safety Data Pulmonary Tolerability Multiple-Asce
Slide 23: Phase 1b: A Clean Safety Profile in First IPF Study
Phase 1b: A Clean Safety Profile in First IPF Study 0 0 0 Safety Signals Bronchospasms Discontinuations None of the diarrhea, A known risk for inhaled Where current oral therapies nausea or vomiting that limits powders — none observed, see discontinuation rates as oral nintedanib (OFEV®) even in fib
Slide 24: Phase 1b Cough: Mild and Transient
Phase 1b Cough: Mild and Transient Most patients had no cough — and when it occurred, it was mild and led to zero discontinuations. Cough was not correlated to powder mass. ~60% of patients had NO cough ~30% of patients had a mild cough 0 discontinuations from cough (11 of 18 on active drug) No seve
Slide 25: Nintedanib DPI Delivers Deep Inhaled Exposure in Patients with IPF
Nintedanib DPI Delivers Deep Inhaled Exposure in Patients with IPF 500 448 WHY IT MATTERS # of Doses Administered 400 270 282 448 300 doses in patients with IPF with Nintedanib DPI ~75× 200 100 the IPF dosing experience vs. 6 the other inhaled nintedanib 0 formulation Healthy Volunteers Patients wit
Slide 26: Nintedanib DPI Phase-2 Study (Global)
Nintedanib DPI Phase-2 Study (Global) A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Two Different Doses of Nintedanib Dry Powder Inhalation (MNKD-201) in Patients with Idiopathic Pulmonary Fibrosis. 26 © Copyright 2026. All rights reserved. MannKin
Slide 27: INFLO-2 Phase 2: Global Enrollment Underway in IPF
. INFLO-2 Phase 2: Global Enrollment Underway in IPF STUDY DESIGN Phase 2 Controlled Study Phase 2 Open-Label Extension • Randomization 2:2:1:1 (12 weeks) (24 weeks) • Sample size 210 • Aged 40-85 Nintedanib DPI 4 mg BID Nintedanib DPI 4 mg BID • Patients with IPF without current background IPF Nint
Slide 28: Closing Remarks
Closing Remarks 28 © Copyright 2026. All rights reserved. MannKind Corporation.
Slide 29: A Layered Patent Estate Extends Protection to 2046+
A Layered Patent Estate Extends Protection to 2046+ Product-specific Patent Estate (MNKD-201) COMPOSITION Composition for treating pulmonary fibrosis To 2041 THE PLATFORM MOAT Covers FDKP-nintedanib + surfactant dry powders and the methods of making and using them. >1,400 patents in force worldwide,
Slide 30: Nintedanib DPI: Lung-Targeted Delivery Without the Nebulizer Burden or Systemic AEs
Nintedanib DPI: Lung-Targeted Delivery Without the Nebulizer Burden or Systemic AEs PROVEN PLATFORM Technosphere® particles are validated in 2 FDA-approved <3% DPI DPI products used in adult patients, including elderly individuals with compromised lung function discontinuation due to cough in approv
Slide 31: Nintedanib DPI is Positioned to Anchor the Future of IPF Therapy
Nintedanib DPI is Positioned to Anchor the Future of IPF Therapy Nintedanib is the gold standard — 1 2 oral anti-fibrotics 2014 – Today but oral GI burden caps its use. Oral nintedanib and pirfenidone Novel MOAs & delivery routes 2 JASCAYD · Next-gen agents (e.g., Tyvaso, Emerging Tyvaso DPI, Raline
Slide 32: MannKind Has Three Shots on Goal in IPF
MannKind Has Three Shots on Goal in IPF One proven platform. One large, under-served market. Nintedanib DPI Proven molecule, now with proven 1 Wholly-owned tolerability in IPF. Phase 2 underway. 2 Tyvaso DPI United Therapeutics Partnership Currently approved in PAH and PH-ILD. Future expansion into
Slide 33: Q&A
Q&A Contact: ir@mnkd.com 33 © Copyright 2025. All rights reserved. MannKind Corporation.
Slide 34: © Copyright 2026. All rights reserved. MannKind Corporation.
34 © Copyright 2026. All rights reserved. MannKind Corporation.