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 Reduces Legacy Debt by Approximately $49.5 Million and Restructures Remaining Obligations, including Extended Maturity, Lower Interest Rates and Increased Third Tranche

04/26/21
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  • Paid Off Mann Group Non-Convertible Note of $35.1 Million in Principal plus $4.4 Million in Accrued Interest
  • Prepaid $10.0 Million Owed Under MidCap Credit Facility and Increased Borrowings Available Under Tranche 3 to $60.0 Million
  • Reduced Annual Interest Expense on Remaining Indebtedness by Approximately $5.0 Million 
  • Potential sale-leaseback of manufacturing facility to be further evaluated

WESTLAKE VILLAGE, Calif., April 26, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) announced that on April 22, 2021 it and MidCap Financial Trust, as agent, entered into an amendment of the credit and security agreement dated August 6, 2019 (the “MidCap Credit Facility”). In addition, MannKind and Mann Group, LLC entered into an amendment of the terms of the Mann Group convertible note and repaid in full outstanding amounts under the Mann Group non-convertible note on April 22, 2021. In connection with these transactions, MannKind reduced its outstanding amount of indebtedness, yet retained flexibility to borrow additional amounts under tranche 3 of the MidCap Credit Facility, which is available to borrow until June 30, 2022, subject to the satisfaction of certain milestone conditions associated with Tyvaso DPI™.

The MidCap Credit Facility was amended to modify several terms, including: (i) increasing the funds available in tranche 3, if drawn by the Company, from $25.0 million to $60.0 million; (ii) revising the conditions to drawing tranche 3, including milestone conditions associated with Tyvaso DPI™; (iii) providing for an exit fee of $1.0 million in connection with the prepayment described below in lieu of the existing prepayment penalty and exit fees; (iv) removing the requirement to issue a warrant to purchase shares of MannKind’s common stock upon the drawdown of tranche 3; (v) decreasing the interest rate on the remaining outstanding debt; (vi) extending the interest-only period and maturity of term loans under the MidCap Credit Facility; (vii) reducing the minimum cash covenant from $30.0 million to $10.0 million, effective immediately, and eliminating such covenant in the event that Tyvaso DPI™ is approved by the FDA; (viii) eliminating the requirement to test compliance with the minimum Afrezza net revenue covenant so long as the Company has $90.0 million or more of unrestricted cash; (ix) permitting the Company to make certain acquisitions subject to certain conditions; and (x) permitting the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash following such investment. In connection with the amendment of the MidCap Credit Facility, MannKind prepaid $10.0 million in cash to reduce the principal balance under the MidCap Credit Facility from $50.0 million to $40.0 million.

The Mann Group convertible note was amended to lower the interest rate to 2.5% (from 7.0%), effective April 22, 2021, and to extend the maturity to December 2025 (from November 2024). In addition, MannKind repaid the entire principal amount of $35.1 million outstanding, together with accrued and unpaid interest thereon, under the Mann Group non-convertible note and paid all accrued and unpaid interest outstanding under the Mann Group convertible note.

MannKind also announced that it is evaluating the considerations underlying a potential sale-leaseback of its manufacturing facility in Connecticut, which is being negotiated under a previously announced letter of intent. The Company will update investors regarding its plans for the facility at a future date.

MannKind’s Chief Financial Officer, Steven B. Binder commented, “Starting with the convertible debt offering in March and ending with these debt reductions and restructurings, we have positioned the Company with ample cash and a manageable debt load to fund our near-term priorities, enabling us to focus on the development of our product pipeline, investing behind growing Afrezza and supporting our collaborations.”

Further details about both transactions will be provided in a Current Report on Form 8-K filed with the Security and Exchange Commission.

TYVASO DPI is a trademark of United Therapeutics Corporation.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company’s partner Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif. with a state-of-the-art manufacturing facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements 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 these risks and uncertainties, which include, without limitation, uncertainties regarding the need to raise additional capital, MannKind’s ability to satisfy conditions required to draw additional loans under the MidCap Credit Facility, and whether MannKind will be able to make required payments under its debt obligations in the future. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2020 as well as MannKind’s other filings with the SEC. 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.

Company Contact:
Phone: (818) 661-5000
Email: ir@mannkindcorp.com


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Source: MannKind