MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) at American Diabetes Association’s 85th Scientific Sessions in Chicago, June 20-23

Rhea-AI Summary

MannKind Corporation (MNKD) will present key data on their inhaled insulin product Afrezza at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. The presentations will feature results from multiple studies, including the INHALE-1 clinical trial for pediatric patients aged 4-17 years, presented by Dr. Michael J. Haller. Additional presentations will cover patient-reported outcomes and results from a Phase III trial in India for adult Type 2 diabetes patients. The company plans to release complete pediatric study results in Q2 2025 and submit a Supplemental Biologics License Application for pediatric indication by mid-2025.

Insights

Endocrinology Specialist

MannKind's pediatric inhaled insulin trial results could offer needle-free alternative for children with diabetes.

MannKind's upcoming presentations at the ADA Scientific Sessions represent an important milestone in potentially expanding Afrezza to pediatric populations. The INHALE-1 trial investigating inhaled insulin in children and adolescents (aged 4-17) addresses a significant unmet need in diabetes care. Needle anxiety and injection burden are substantial challenges in pediatric diabetes management, often leading to suboptimal adherence and glycemic control.

The involvement of Dr. Michael Haller, a respected figure in pediatric endocrinology as Chair of the INHALE-1 study, lends credibility to this clinical program. If the data supports safety and efficacy, inhaled insulin could revolutionize mealtime insulin delivery for children, potentially improving quality of life and treatment adherence.

The additional presentation on patient-reported outcomes with Technosphere Insulin will provide valuable insights, as real-world patient experience often determines therapeutic success beyond clinical efficacy metrics. Similarly, the adult Type 2 diabetes trial results from India could demonstrate Afrezza's performance across diverse populations.

The company's timeline for topline results in Q2 2025 and regulatory submission in mid-2025 suggests confidence in their development program. If approved, Afrezza would become the first inhaled insulin for pediatric patients, potentially transforming the treatment landscape for children with diabetes who currently rely exclusively on injectable insulins.

Pharmaceutical Industry Analyst

MannKind's pediatric Afrezza data presentation signals regulatory advancement toward market expansion.

MannKind's announcement about presenting INHALE-1 trial data at the ADA Scientific Sessions represents strategic advancement in their commercial pipeline. The pediatric diabetes market constitutes a significant untapped opportunity for Afrezza, which has faced challenges gaining market share from established injectable insulins in adults.

The company's explicit regulatory timeline—topline results expected in Q2 2025 and Supplemental Biologics License Application submission planned for mid-2025—provides concrete milestones for evaluating program progress. This regulatory clarity is positive for a small-cap biopharmaceutical company with a focused product portfolio.

MannKind's dual-pronged approach is noteworthy: while pursuing pediatric indication expansion domestically, they're simultaneously presenting data from an adult Type 2 diabetes trial conducted in India. This suggests a comprehensive strategy to diversify both patient demographics and geographic markets.

The inclusion of patient-reported outcomes data at the conference acknowledges the importance of real-world experience in diabetes care. For inhaled insulin, which offers a differentiated administration route, these metrics could prove particularly valuable in driving adoption if the product receives pediatric approval.

A successful pediatric indication would significantly expand Afrezza's addressable market and potentially strengthen MannKind's position in the competitive diabetes treatment landscape.

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase inhaled insulin at the American Diabetes Association’s (ADA) 85^th Scientific Sessions from June 20-23 in Chicago.

Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will present the results from the randomized period of the INHALE-1 clinical trial during a “Future Ready” symposium. Dr. Haller is the Chair for MannKind’s Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age).

The presentation/posters planned at ADA’s 85^th Scientific Sessions regarding the most recent advances in inhaled insulin treatment include:

Symposium – Future Ready – Breakthrough in Pediatric Type 1 Diabetes Care
Sunday, June 22 – 1:30 to 3:00 p.m. (Central) in Room W 181(A-C)
Dr. Michael J. Haller will present: From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment

Patient Reported Outcomes with Use of Inhaled Technosphere Insulin (T1) (Board 827)
Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central)
Presenter: Dr. Peter Calhoun

Efficacy and Safety of Prandial Technosphere Inhaled Insulin (Afrezza) Compared with Placebo in Adult Individuals with T2DM – Results from a Phase III Clinical Trial from India (Board No. 833)
Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central)
Presenter: Dr. K M Prasanna Kumar

Additionally, MannKind will host booth #1617 in the Exhibit Hall throughout the ADA’s Scientific Sessions. Members of MannKind’s Medical Education Team will be available for scientific exchange in the medical section of the booth.

For more information about ADA’s Scientific Sessions programming, and/or to register to attend the conference, please visit: https://professional.diabetes.org/scientific-sessions.

MannKind expects to issue the topline results from the full study pediatric data set with safety extension in 2Q 2025 and anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza.

About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.

We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.

Forward-Looking Statements
This press release contains forward-looking statements about a planned release of scientific data and a potential sBLA submission for Afrezza that involves risks and uncertainties. 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 issues that develop in the preparation of data releases and filings may subject us to unanticipated delays as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, 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.

AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.

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

Investor Relations
Ana Kapor, (818) 661-5000
Email: ir@mnkd.com

FAQ

What will MannKind (MNKD) present at the ADA Scientific Sessions 2025?

MannKind will present data from the INHALE-1 clinical trial for pediatric patients, patient-reported outcomes of Technosphere Insulin, and results from a Phase III trial of Afrezza in adult T2DM patients from India.

When will MannKind release the complete pediatric trial results for Afrezza?

MannKind expects to release the topline results from the full pediatric study data set with safety extension in Q2 2025.

What age group is included in MannKind's INHALE-1 pediatric study of Afrezza?

The INHALE-1 study includes children and adolescents aged 4-17 years.

When does MannKind plan to submit the Supplemental Biologics License Application for Afrezza's pediatric indication?

MannKind anticipates submitting the Supplemental Biologics License Application in mid-2025.

Who will present the INHALE-1 trial results at the ADA Scientific Sessions?

Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida and Chair of the INHALE-1 study, will present the results.