Inhale-3 Study Results to be Presented During a 90-Minute Symposium on Saturday, June 22 at the American Diabetes Association’s 84th Scientific Sessions

Rhea-AI Summary

MannKind will present the 17-week endpoint results of the INHALE-3 study at the ADA's 84th Scientific Sessions on June 22, 2024. The study compares Afrezza, an inhaled insulin, with multiple daily injections and insulin pumps in adults with Type 1 diabetes. The presentation, featuring Dr. Irl B. Hirsh and moderated by Dr. Roy W. Beck, will include various insights into the efficacy, safety, and quality of life outcomes of Afrezza. This event marks the largest post-market clinical trial for Afrezza in the past decade. Full results will be available later this year.

Positive

• Largest post-market clinical trial for Afrezza in the last 10 years.
• Head-to-head comparison of Afrezza with multiple daily injections and insulin pumps.
• Presentation to be delivered at a high-profile event, ADA's 84th Scientific Sessions.
• 17-week endpoint results to be disclosed by a credible team of experts.
• Potential for increased visibility and credibility for Afrezza.
• Accessibility of the presentation via livestream broadens audience reach.

Negative

• Full 30-week results are not yet available, limiting immediate comprehensive analysis.
• Potential for negative outcomes from the study which could impact stock performance.
• Dependence on future data releases to confirm efficacy and safety claims.
• Eventual results may lead to increased scrutiny and regulatory challenges.

• 17-week endpoint results comparing Afrezza^® head-to-head with multiple daily injections (MDI) and insulin pumps
• INHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced that the 17-week endpoint results from the INHALE-3 study will be presented during a 90-minute symposium and livestream on Saturday, June 22, at the American Diabetes Association’s (ADA) 84^th Scientific Sessions. The presentation will be delivered by INHALE-3 Study Protocol Chair Dr. Irl B. Hirsh and the investigational team and will be moderated by Jaeb Center founder Dr. Roy W. Beck.

“We are excited for the first read-out of results from the largest post-market clinical trial MannKind has conducted with Afrezza in the last 10 years,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “The results will speak to the common question about Afrezza: ‘How does inhaled insulin fare when compared head-to-head with usual care?’ The full 30-week results of INHALE-3 will be available later this year.”

Title:	The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Injections in Adults with Type 1 Diabetes
Date:	Saturday, June 22, 2024
Times:	8:00-9:30 AM (ET) with topics/presenters to include:
	Inhaled Insulin’s History and Study Rationale – Dr. Halis Akturk
	Study Methods & Participant Baseline Characteristics – Dr. Yogish Kudva
	Study Results I: Comparison of Inhaled Insulin vs. Rapid Acting Analogue Insulin in Users of AID or
	MDI During Standardized In-Clinic Meal Challenge –Dr. Ruth S. Weinstock
	Study Results II: Primary Efficacy, Safety, and Quality of Life Outcomes – Dr. Carol J. Levy
	Study Results III: Effect of Inhaled Insulin-Degludec Compared with AID and in Subgroups According
	to Participant Characteristics – Dr. Grazia Aleppo
	Critique of Study Design and Results – by Dr. Irl B. Hirsch
	Use of Afrezza in Clinical Practice – by Dr. Thomas Blevins
	Question and Answer Session – Moderated by Dr. Roy W. Beck
Location:	W320 Chapin Theatre at the Orange County Convention Center (+livestream)
Livestream:	Please refer to https://professional.diabetes.org/scientific-sessions for access details

MannKind will host booth# 1307 in the Exhibit Hall throughout the Scientific Sessions as well. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.

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 the release of data from a clinical study that involve 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 continued 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, 2023 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.

FAQ

What is the focus of the INHALE-3 study results presented by MannKind ?

The INHALE-3 study results focus on comparing the efficacy, safety, and quality of life outcomes of Afrezza, an inhaled insulin, against multiple daily injections and insulin pumps in adults with Type 1 diabetes.

When will the 17-week endpoint results of the INHALE-3 study be presented?

The 17-week endpoint results of the INHALE-3 study will be presented on June 22, 2024, during the ADA's 84th Scientific Sessions.

Who will present the INHALE-3 study results?

The presentation will be delivered by Dr. Irl B. Hirsh and the investigational team, moderated by Dr. Roy W. Beck.

What is Afrezza?

Afrezza is an inhaled insulin developed by MannKind for the treatment of diabetes.

What will be discussed in the INHALE-3 study presentation?

The presentation will cover study methods, participant baseline characteristics, efficacy, safety, quality of life outcomes, and the effect of inhaled insulin-Degludec compared to automated insulin delivery and multiple daily injections.

When will the full 30-week results of the INHALE-3 study be available?

The full 30-week results of the INHALE-3 study will be available later this year.