Mannkind Stock Price, News & Analysis

MannKind (Nasdaq: MNKD), a company developing inhaled therapeutic products for endocrine and orphan lung diseases, has announced its participation in three upcoming investor conferences. CEO Michael Castagna and CFO Chris Prentiss will present at:

• 2024 Wells Fargo Healthcare Conference in Boston on September 4 at 11:00 a.m. ET
• Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 6 at 7:00 a.m. ET
• H.C. Wainwright 26th Annual Global Investment Conference in New York on September 10 at 9:30 a.m. ET

Live audio webcasts will be available on MannKind's website, with recordings accessible for about 30 days after each conference.

MannKind (Nasdaq: MNKD) has announced significant changes to its Board of Directors. Kent Kresa, who has served on the board since June 2004 and was Chairman from 2016 to 2020, will retire effective September 30, 2024. He will continue as Chairman Emeritus. Steven B. Binder, the company's former Chief Financial Officer, will join the board on the same date.

Binder, who served as CFO from July 2017 to April 2024, is currently Executive Vice President of Special Projects. He will step down from this role when he joins the board. James S. Shannon, current Chairman, praised Kresa's two decades of leadership and expressed enthusiasm for Binder's appointment, citing his financial stewardship and role in diversifying MannKind's revenue streams. The board will maintain nine members following these changes.

MannKind (MNKD) reported strong financial results for Q2 2024, with total revenues of $72M, up 49% year-over-year. The company achieved its ninth consecutive quarter of revenue growth, approaching an annual revenue run rate of over $275 million. Key highlights include:

- Royalties from Tyvaso DPI increased 34% to $25.6M
- Collaborations and services revenue up 132% to $26M
- Afrezza net revenue grew 20% to $16.3M
- YTD 2024 net income of $9M; Non-GAAP net income of $29M

MannKind also made progress on its clinical pipeline, initiating Phase 3 trials for MNKD-101 and Phase 1 trials for MNKD-201. The company remains focused on its diversification strategy, allocating capital towards pipeline development, in-line growth, and debt reduction.

MannKind (Nasdaq: MNKD) has launched an educational website, LearnAboutNTM.com, to raise awareness of nontuberculous mycobacterial (NTM) lung disease. The launch coincides with World NTM Awareness Day on August 4. NTM lung disease is a rare condition caused by naturally occurring bacteria that can lead to serious lung damage in susceptible individuals.

Key points:

• NTM affects nearly 100,000 people in the U.S. and over 150,000 in Japan
• Prevalence is increasing globally, with a 7.5% annual rise in the U.S.
• The disease is more common in women over 65
• MAC (mycobacterium avium complex) accounts for 80% of NTM cases in the U.S.
• 15-20% of NTM patients are refractory to treatment

The website aims to promote early detection and provide resources for patients and caregivers.

MannKind (Nasdaq: MNKD) has announced that it will release its second quarter 2024 financial results on Wednesday, August 7, 2024, before the market opens. The company will issue a press release detailing the quarterly results approximately one hour before hosting a webcast at 9:00 a.m. Eastern Time.

The webcast, accessible to investors, media, and the general public, will feature CEO Michael Castagna and CFO Chris Prentiss. Interested parties can access the webcast through MannKind's website at https://investors.mannkindcorp.com/events-and-presentations. A replay will be available in the same location within 24 hours after the call and remain accessible for about 90 days.

MannKind (Nasdaq: MNKD) announced positive results from its INHALE-3 Phase 4 clinical trial, comparing inhaled insulin Afrezza with usual care for adults with Type 1 Diabetes (T1D). The 17-week study, presented at the American Diabetes Association's 84th Scientific Sessions, met its primary efficacy endpoint, showing non-inferior HbA1c levels with inhaled insulin. Key findings include 30% of the Afrezza group achieving HbA1c <7% versus 17% in the usual care group, and 24% reaching >70% Time-in-Range (TIR) with no increased hypoglycemia. Over 50% expressed interest in continuing Afrezza. The study supports inhaled insulin as a viable T1D treatment option.

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.

MannKind (Nasdaq: MNKD) announced a non-cash transaction with Pulmatrix, obtaining a license for Pulmatrix's iSPERSE™ technology and an upgraded Boston-area R&D facility. In exchange, Pulmatrix will receive MannKind's Cricket® inhaler for DHE delivery. The iSPERSE technology will be used for clofazimine, NTM, and insulin, and for certain endocrine and lung diseases. This move aims to strengthen MannKind's capacity for formulation and asset development, leveraging both companies' technological advancements. The transaction is expected to finalize in July 2024.

Pulmatrix announced a series of transactions with MannKind involving a cross-license agreement and transfer of laboratory assets. Pulmatrix's iSPERSE™ technology will be licensed to MannKind, while Pulmatrix gains access to MannKind's Cricket® inhalation device for its PUR3100 formulation, aimed at treating acute migraine. Additionally, MannKind will assume Pulmatrix's lease for its Bedford, Mass. R&D facility, extending Pulmatrix's cash runway into 2026. The agreement, expected to close in July 2024, also includes a master service arrangement for MannKind to provide future dry powder drug formulation services to Pulmatrix.