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 Third Quarter Financial Results

11/02/06
PDF Version
MannKind Corporation Reports Third Quarter Financial Results

Company to Host Conference Call at 9:00 a.m. ET

VALENCIA, Calif., Nov. 2 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter and nine months ended September 30, 2006.

For the third quarter of 2006, total operating expenses were $61.1 million, compared with $32.9 million for the third quarter of 2005. Research and development (R&D) expenses increased by $26.3 million to $50.8 million, primarily due to increased costs associated with the Company's expanded clinical trials and related support for its Technosphere® Insulin program. General and administrative (G&A) expenses increased by $2.0 million to $10.3 million primarily due to an increase in stock compensation expense and increased consulting and various other general and administrative expenses, such as legal and accounting fees.

For the nine months of 2006, operating expenses totaled $162.0 million, compared with $83.1 million in the first nine of 2005. R&D expenses were $132.1 million, up $65.3 million, again primarily related to the expansion of clinical trials of MannKind's Technosphere® Insulin program. G&A expenses increased by $13.6 million to $29.9 million for the nine months ended September 30, 2006 primarily related to increased stock compensation expense, compensation and other employee related costs and increased legal, accounting and consulting fees.

The net loss applicable to common stockholders for the third quarter of 2006 was $61.0 million, or $1.23 per share based on 49.7 million shares outstanding, compared with a net loss applicable to common stockholders of $31.7 million, or $0.73 per share based on 43.5 million shares outstanding, for the third quarter of 2005.

The net loss applicable to common stockholders for the nine months ended September 30, 2006 was $159.3 million, or $3.20 per share based on 49.7 million shares outstanding, compared with a net loss applicable to common stockholders of $81.0 million, or $2.23 per share based on 36.4 million shares outstanding for nine months ended September 30, 2005.

Cash, cash equivalents and marketable securities were $50.1 million at September 30, 2006, $50.9 million at June 30, 2006 and $145.6 million at December 31, 2005.

"In the past quarter, we achieved several significant milestones," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We announced the results of an important study: Study 014, a six-month Phase 3 trial that demonstrated no adverse effect on pulmonary function. We also announced the completion of enrollment with 2,050 patients in Study 030, our pivotal two-year safety study. We have launched all pivotal efficacy trials and remain on track to complete registration studies by September 2008. We also just last week broke ground in Danbury, Connecticut for the expansion of our commercial manufacturing facility. Finally, we filed a shelf registration statement that is intended to provide us with the flexibility to take advantage of financing opportunities, if and when we deem appropriate."

Conference Call

Management of the Company will host a conference call to discuss the third quarter financial results, clinical progress and other Company developments at 9:00 a.m. ET on Thursday, November 2, 2006. Presenting from the Company will be its Chairman and Chief Executive Officer, Alfred Mann; President and Chief Operating Officer, Hakan Edstrom; and Corporate Vice President and Chief Financial Officer, Dick Anderson.

To participate in the live call by telephone, please dial (888) 566-5775 or (210) 839-8503. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at www.mannkindcorp.com.

A telephone replay of the call will be available for 48 hours by dialing (866) 394-7039 or (203) 369-0463 and entering passcode "MNKD." A replay will be available on MannKind's website for fourteen days.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Its lead product, the Technosphere® Insulin System, is currently in phase 3 clinical trials in the U.S., Europe and Latin America to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind's clinical trials and product candidates that involve risks and uncertainties. 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 Company'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, risks related to the progress, timing and results of clinical trials, the risk that future safety and efficacy studies may not confirm our past clinical results, intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, manufacturing the Company's lead product candidate, competition from other pharmaceutical or biotechnology companies, the Company's ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company's operations, the Company's ability to meet milestones and other risks detailed in MannKind's filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2005 and periodic reports on Form 10-Q and 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 news release.

                              (Tables to follow)



                             MannKind Corporation
                    Consolidated Statements of Operations
                                 (Unaudited)

    (In thousands, except
     per share amounts)      Three Months Ended        Nine Months Ended
                       September 30, September 30, September 30, September 30,
                             2006         2005         2006         2005

    Revenue                    $--          $--         $100          $--

    Operating expenses:
    Research and
     development            50,785       24,466      132,056       66,758
    General and
     administrative         10,349        8,396       29,943       16,318
    Total operating
     expenses               61,134       32,862      161,999       83,076
    Loss from operations   (61,134)     (32,862)    (161,899)     (83,076)
    Other income (expense)      51          (29)         160           (8)
    Interest expense on
     note payable to
     principal stockholder    (689)          --         (689)          --
    Interest income
     (expense)                 802        1,161        3,153        2,038
    Loss before provision
     for income taxes      (60,970)     (31,730)    (159,275)     (81,046)
    Income taxes                --           --           (5)          (1)
    Net loss applicable
     to common
     stockholders         $(60,970)    $(31,730)   $(159,280)    $(81,047)

    Net loss per share
     applicable to
     common stockholders
     - basic and diluted    $(1.23)      $(0.73)      $(3.20)      $(2.23)

    Shares used to
     compute basic and
     diluted net loss per
     share applicable to
     common stockholders    49,731       43,460       49,718       36,373



                             MannKind Corporation
                           Condensed Balance Sheet
                                 (Unaudited)
                                (in thousands)

                                                   September 30,  December 31,
    Assets                                             2006           2005

    Current assets:
      Cash and cash equivalents                      $43,086        $56,037
      Marketable securities                            7,007         89,597
      State research and development tax
       credit exchange receivable - current              918          1,194
      Prepaid expenses and other current assets       11,702          3,044

    Total current assets                              62,713        149,872


    Property and equipment - net                      84,005         76,183

    State research and development tax credit
     exchange receivable - net of current portion      2,625          2,031
    Other assets                                         359            285

    Total                                           $149,702       $228,371

    Liabilities and Stockholders' Equity

    Current liabilities                              $87,707        $21,365

    Other liabilities                                     24             29


    Stockholders' equity                              61,971        206,977

    Total                                           $149,702       $228,371

SOURCE MannKind Corporation
11/02/2006

CONTACT: Dick Anderson, Chief Financial Officer of MannKind Corporation,
+1-661-775-5302, danderson@mannkindcorp.com; or Investors, Julie Huang, or
Media, Robert Stanislaro, both of Financial Dynamics, +1-212-850-5600,
mnkd@fd.com, for MannKind Corporation
Web site: http://www.mannkindcorp.com
(MNKD)