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What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Release Details

MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF

07/29/26
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  • Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations
  • 90% of patients had no [60%] or mild [30%] cough
  • ~450 total inhalations administered in patients with IPF
  • Global Phase 2 INFLO-2 trial actively enrolling patients
  • Conference call and webcast scheduled for July 29 at 4:30 p.m. ET

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, today announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF).

The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days.

INFLO-1 Topline Results
Key findings from the study included:

  • No serious adverse events
  • No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting)
  • No bronchospasm events
  • No treatment discontinuations or dose reductions
  • No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges)
  • Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved

Additional data will be presented at a future conference.

"The INFLO-1 results represent an important milestone for our nintedanib DPI program and further validates the potential of our Technosphere® platform in pulmonary fibrosis," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Across our Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 inhalations administered to people living with IPF. Importantly, cough was not a meaningful barrier to treatment. When observed, cough events were generally mild, transient and resolved, with no cough-related discontinuations or dose reductions. These findings provide growing confidence as we continue to advance Phase 2 development."

Phase 1a Program Established Foundation for Clinical Development
The INFLO-1 findings build upon previously reported results from MannKind's completed Phase 1a first-in-human study in healthy volunteers. In that study, nintedanib DPI demonstrated favorable safety and tolerability with no serious adverse events, no discontinuations, and no safety signals identified. Pharmacokinetic analyses demonstrated rapid absorption and dose-proportional increases in plasma concentrations consistent with deep-lung delivery following inhalation.

Across the completed Phase 1a and Phase 1b studies, a total of 48 individuals have received nintedanib DPI, 18 of whom were patients with IPF, providing the largest reported clinical dataset with an inhaled nintedanib therapy in patients with IPF to date.

Global Phase 2 INFLO-2 Study Underway
MannKind's global Phase 2 INFLO-2 study is actively enrolling patients with IPF. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 210 participants across approximately 85 sites worldwide and is designed to further evaluate the safety, tolerability and efficacy of nintedanib DPI.

Participants are being randomized to receive either nintedanib DPI (2mg four times daily or 4mg twice daily) or placebo for 12 weeks, followed by a 24-week open-label extension in which all participants will receive active treatment. The primary objective of the study is to assess safety and tolerability of nintedanib DPI. Secondary objectives include evaluating a potential efficacy signal, including the annualized rate of decline in forced vital capacity (FVC), a key measure of lung function in IPF. Additional endpoints will assess disease progression, pulmonary exacerbations, exercise capacity, patient-reported outcomes, and pharmacokinetics.

About INFLO-1
INFLO-1 was a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib DPI in patients with IPF. The U.S. trial consisted of multiple ascending doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics of nintedanib DPI compared to placebo in patients with IPF. More information on INFLO-1 is available at: ClinicalTrials.gov (NCT07344558).

Differentiated Approach to a Significant Unmet Need
IPF is a chronic, progressive lung disease characterized by irreversible fibrosis and declining lung function. Despite available therapies, the disease remains associated with substantial morbidity and mortality.

Nintedanib, currently approved as an oral therapy for IPF, has demonstrated the ability to slow disease progression but can be associated with systemic side effects that may limit tolerability, treatment persistence, and the ability to use combination therapies. Nintedanib DPI (MNKD-201) leverages MannKind’s Technosphere® dry powder inhalation technology to deliver nintedanib directly to the deep lung, with the goal of achieving therapeutic concentrations at the site of disease while reducing systemic exposure.

MannKind has developed two FDA-approved dry powder inhalation therapies utilizing its proven Technosphere formulation technology, with clinical data demonstrating less than 3% discontinuation due to cough in adult patients.

About IPF
Idiopathic pulmonary fibrosis is a chronic, progressive lung disease characterized by irreversible scarring of lung tissue that leads to worsening lung function over time. Despite available therapies, IPF remains associated with significant morbidity and mortality. According to the American Lung Association and GlobalData, there are an estimated 100,000 IPF patients in the U.S. with a 20% rise in the last decade. IPF affects an estimated 1-1.5 million people worldwide, based on global prevalence analyses reporting approximately 13-20 patients per 100,000 population.1

Investor Call
Management of the Company will host a conference call to discuss results at 4:30 p.m. ET on July 29, 2026. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD, and Wassim Fares, M.D., MSc, FCCP, Senior Vice President, Therapeutic Area Head – Respiratory.

To view and listen to the webcast, visit MannKind's website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available on MannKind's website for approximately 90 days.

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. Forward-looking statements include statements regarding the continuing development of MNKD-201 and the potential of our platform in pulmonary fibrosis. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of a drug may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

MANNKIND and TECHNOSPHERE are registered trademarks of MannKind Corporation.

1 National Library of Medicine (U.S.). Idiopathic pulmonary fibrosis. MedlinePlus Genetics. Available at: https://medlineplus.gov/genetics/condition/idiopathic-pulmonary-fibrosis/.


MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com

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