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 Corporation Reports 2016 First Quarter Financial Results

05/09/16
PDF Version

VALENCIA, Calif., May 09, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today reported financial results for the first quarter ended March 31, 2016.

For the first quarter of 2016, total operating expenses were $20.0 million as compared to $21.7 million for the same quarter in 2015.  Research and development expenses were $5.1 million for the first quarter of 2016, a decline of 45%, compared to the first quarter of 2015, primarily due to the reduction in force and closure of the Paramus, New Jersey facility in 2015 and the transition from development to commercial activities. General and administrative costs were $7.4 million for the first quarter of 2016, a decline of 30%, compared to the first quarter of 2015, mainly due to the reduction in force and closure of the Paramus facility in 2015 in addition to reduced professional fees related to strategic planning activities incurred in 2015 and lower non-cash stock compensation expense. Product manufacturing costs for the first quarter of 2016 were $7.5 million, an increase of 300%, compared to the same quarter of 2015, due to underutilization of the manufacturing facility and loss from foreign currency exchange of $2.4 million related to purchase commitments.

The Company's portion of the loss sharing under the Sanofi License Agreement was $5.5 million for the first quarter of 2016.  The total amount owed to Sanofi is currently $68.8 million, including accrued interest of $2.8 million.    

The net loss for the first quarter of 2016 was $24.9 million, or $0.06 per share based on 428.9 million weighted average shares outstanding, compared to the net loss of $30.7 million, or $0.08 per share on 398.9 million weighted average shares outstanding in the first quarter of 2015. The number of common shares outstanding at March 31, 2016 was 429.1 million.

Cash and cash equivalents at March 31, 2016 were $27.7 million, compared to $59.1 million at December 31, 2015. In February 2016, an upfront fee of $250,000 was received pursuant to the previously announced collaboration and license agreement with Receptor Life Sciences.  In addition, $467,000 was received from exercises of stock options by employees.  Currently, $30.1 million remains available for borrowing under the amended loan arrangement with The Mann Group. A recently filed universal shelf registration statement became effective along with a prospectus supplement for a $50.0 million ATM facility.

Conference Call

MannKind management will host a conference call to discuss these results today at 5:00 p.m. Eastern Time.  To participate in the call please dial (888) 771-4371 or (847) 585-4405 and use the participant passcode: 41477569.  Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com. 

A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 4147 7569#.  A replay will also be available on MannKind's website for 14 days.

About MannKind Corporation

MannKind Corporation (Nasdaq and TASE: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products.  Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon the 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, the ability to generate significant product sales for MannKind, difficulties or delays in obtaining regulatory feedback or completing and analyzing the results of clinical studies, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2015 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.

(Tables to follow)

MannKind Corporation
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands)
 
 Three months ended
March 31,  		 
  2016    2015   
Revenue $— $— 
       
Operating expenses:  
Research and development  5,130  9,377 
General and administrative  7,351  10,479 
Product manufacturing 7,532  1,882 
Total operating expenses  20,013  21,738 
       
Loss from operations  (20,013) (21,738)
Other income  67  1,413 
Interest expense on note payable to principal stockholder  (721) (714)
Interest expense on notes  (4,221) (9,622)
Interest income  15  3 
       
Net loss $(24,873)$(30,658)
       
Net loss per share — basic and diluted $(0.06)$(0.08)
       
Shares used to compute basic and diluted net loss per share  428,858  398,916 
       

 

MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
 
 March 31, 
2016  		December 31, 
2015 
   
Assets  
Current assets:  
Cash and cash equivalents$    27,653 $     59,074 
Receivables from collaboration    144     23 
Deferred product costs from collaboration   13,539     13,539 
Prepaid expenses and other current assets     2,807      4,018 
Total current assets   44,143    76,654 
Property and equipment — net   48,033    48,749 
Other assets     1,096      1,009 
Total$    93,272 $    126,412 
       
Liabilities and Stockholders' Deficit      
   
Accounts payable$     582 $    15,599 
Accrued expenses and other current liabilities    8,077     7,929 
Facility financing obligation   75,010    74,582 
Deferred product sales from collaboration   17,680    17,503 
Purchase commitments liabilities - current   12,927    12,475  
Deferred payments from collaboration   134,935     140,231 
Current liabilities   249,211    268,319 
Note payable to related party   49,521    49,521 
Sanofi loan facility and loss share obligation   68,835    62,371 
Senior convertible notes   27,618    27,613 
Net purchase commitments   55,605    53,692 
Other liabilities   15,946     15,225  
Stockholders' deficit (373,464)     (350,329)
Total$     93,272 $    126,412 
       

 

Company Contact:
Rose Alinaya
SVP, Finance
661-775-5300
ralinaya@mannkindcorp.com