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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 and Rose Pharma Inc Enter Licensing and Collaboration Agreement to Develop an Inhaled Rapid-Acting, Short-Duration GLP-1 for Weight Management

09/09/26
PDF Version
  • Collaboration combines Rose Pharma investigational rapid-acting GLP-1 receptor agonist with MannKind’s Technosphere® inhalation technology
  • MannKind to receive an equity interest and potential royalties while providing pharmaceutical development and manufacturing support through completion of a Phase 1b clinical study

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, and Rose Pharma Inc. (Rose Pharma) today announced that they have entered into a worldwide licensing and collaboration agreement to develop ROSE-010 Technosphere for weight management. ROSE-010 is an investigational, rapid-acting glucagon-like peptide-1 (GLP-1) receptor agonist that will be formulated using MannKind’s proprietary Technosphere dry-powder inhalation technology. The companies intend to evaluate whether a rapid-acting, short-duration inhaled GLP-1 may offer a flexible approach to weight management.

Under the agreement, Rose Pharma received an exclusive, worldwide license to use MannKind’s Technosphere technology to develop and commercialize ROSE-010 Technosphere. MannKind will support formulation development and advancement of the program through pharmaceutical development services to completion of Phase 1b in weight management.

As part of the transaction, MannKind will receive an equity interest in Rose Pharma and the right to receive royalties on potential future net sales of ROSE-010 Technosphere. The agreement also provides MannKind with representation on Rose Pharma’s board of directors to support continued strategic alignment as the program advances. Rose Pharma will retain responsibility for the program’s clinical development, regulatory strategy and commercialization. Specific financial terms of the agreement were not disclosed.

“ROSE-010 represents a compelling opportunity to apply Technosphere technology in weight management, one of the most dynamic areas of healthcare,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind. “We believe our integrated capabilities across inhaled formulation, product development, manufacturing and regulatory execution can help reduce technical and execution risk, providing a more efficient path to advance this differentiated program and further demonstrate the versatility of the Technosphere platform.”

“There remains a significant unmet need not only to help patients maintain weight loss, but also to reach treatment-naïve individuals who may be hesitant to begin currently available GLP-1 therapies,” said Enda Kenny, PhD, Chief Executive Officer of Rose Pharma. “An inhaled therapy with a rapid-acting, short-duration profile could provide patients with greater flexibility and a new way to approach weight management. ROSE-010 Technosphere also has potential application in irritable bowel syndrome, where there is significant unmet medical need for pain relief. MannKind’s extensive expertise in pulmonary drug delivery, formulation development and manufacturing makes the company an ideal partner to advance this differentiated program.”  

The potential appeal of a more flexible approach is supported by a recent patient preference survey of more than 1,300 adults with obesity, led by Angela Fitch, MD, FACP, MFOMA, Dipl. ABOM. Respondents expressed strong interest in a rapid-acting, short-duration GLP-1 profile offering greater flexibility and patient control. An abstract reporting findings from the research has been accepted for presentation at ObesityWeek® 2026.

The collaboration builds upon prior feasibility and formulation work involving ROSE-010 and Technosphere technology. Initial activities will focus on formulation re-establishment and optimization, followed by nonclinical and regulatory-enabling development. MannKind will provide development and manufacturing support as the program advances through completion of a Phase 1b clinical study.

About ROSE-010
ROSE-010 is a rapid-acting, short-duration GLP-1 analogue designed for rapid onset and short duration of effect, enabling flexible, patient-controlled timing of when therapy is active in the body. ROSE-010 is supported by four completed human clinical trials. In a Phase 2a clinical trial in weight management, ROSE-010 demonstrated reductions in mealtime caloric intake and weight loss with a favorable GI tolerability profile consistent with its limited exposure window. In a Phase 2a study of patients with irritable bowel syndrome (IBS), ROSE-010 showed clinically meaningful, statistically significant pain relief, supporting its potential as the first targeted, on-demand therapy for acute IBS pain.

About Rose Pharma
Rose Pharma is a clinical-stage biopharmaceutical company advancing ROSE-010 in weight management and IBS pain relief, areas of high unmet need. In weight management, ROSE-010 is designed to offer a differentiated, flexible treatment approach that may broaden the GLP-1 market by addressing treatment-naïve patients who have not initiated currently available therapies, while also potentially serving patients seeking options for weight-loss maintenance. The company’s strategy is to pursue Phase 2b clinical studies in weight management and IBS pain relief to support strategic partnerships for late-stage development and commercialization. Rose Pharma is incorporated in Delaware with operations in the United States. For more information, visit rosepharmainc.com.

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. These statements include, without limitation, statements regarding the potential of a rapid-acting, short-duration inhaled GLP-1 to offer a flexible approach to weight management and the receipt of future royalties. 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 testing of an investigational drug product 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.

TECHNOSPHERE and MANNKIND are registered trademarks of MannKind Corporation.


MannKind Contacts:

Media Relations:
Christie Iacangelo
media@mnkd.com

Investor Relations:
Kate Miranda
ir@mnkd.com

Rose Pharma Contact:

Lynn Sullivan
Chief Business Officer
info@rosepharmainc.com

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