Mirati Therapeutics Reports Fourth Quarter And Full-Year 2017 Financial Results

Mirati Therapeutics Reports Fourth Quarter And Full-Year 2017 Financial Results

SAN DIEGO, March 8, 2018 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, today reported financial results for the fourth quarter and full-year ended December 31, 2017.

"We made significant progress in our key programs in 2017," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Promising data from the sitravatinib and KRAS programs encouraged us to pursue a more aggressive approach to accelerate development, supported by the successful financing we completed in November. In early 2018, we initiated a strategic regional partnership with BeiGene Ltd. that we anticipate will rapidly expand the development of sitravatinib in multiple tumor types. We expect to report multiple key catalysts in 2018, including a mid-year clinical update for our sitravatinib program. Our KRAS inhibitor program, an important yet elusive target, is growing and we remain on track for an IND filing in the fourth quarter of 2018."

Recent Corporate Highlights

    --  Sitravatinib clinical data presented at 2017 IASLC World Conference on
        Lung Cancer
        --  Combination of sitravatinib and nivolumab in non-small cell lung
            cancer (NSCLC) patients with documented progression following
            checkpoint inhibitor therapy demonstrated 3 confirmed Partial
            Responses in first 11 evaluable patients
        --  First evaluable NSCLC patient with CBL inactivating mutation treated
            with single agent sitravatinib demonstrated confirmed Partial
            Response with 77% tumor reduction
    --  KRAS G12C lead candidates selected and advanced into IND-enabling
        development activities
        --  Significant achievement in development of a direct inhibitor of
            KRAS, a well-known but previously undruggable cancer mutation
        --  A potentially transformational, first-in-class treatment for 14% of
            NSCLC and 5% of colorectal cancer patients
        --  Program is on track to advance to IND filing in the fourth quarter
            of 2018
    --  Exclusive license agreement initiated with BeiGene Ltd. for the
        development, manufacture and commercialization of sitravatinib in Asia
        (excluding Japan), Australia and New Zealand
        --  Expected to accelerate development of sitravatinib in NSCLC as well
            as other key indications including bladder, renal and hepatocellular
            cancer
    --  $86.7M public offering completed in November 2017; $150.8M of cash, cash
        equivalents and short-term investments as of December 31, 2017

Fourth Quarter and Full Year Financial Results

Cash, cash equivalents, and short-term investments were $150.8 million on December 31, 2017, as compared to $56.7 million on December 31, 2016.

Research and development expenses for the fourth quarter of 2017 were $15.2 million, compared to $16.0 million for the same period in 2016. Research and development expenses for the year ended December 31, 2017 were $58.1 million, compared to $68.5 million for the same period in 2016. The decrease in research and development expenses for both periods is primarily due to a reduction in glesatinib expenses and a reduction in share-based compensation expense. These decreases are partially offset by increases in expenses associated with our ongoing sitravatinib clinical trials.

General and administrative expenses for the fourth quarter of 2017 were $3.0 million, compared to $3.9 million for the same period in 2016. General and administrative expenses for the year ended December 31, 2017 were $13.5 million, compared to $15.3 million for the same period in 2016. The decrease in general and administrative expense for both periods is primarily due to a decrease in share-based compensation expense.

Net loss for the fourth quarter of 2017 was $17.9 million, or $0.67 per share basic and diluted, compared to net loss of $19.7 million, or $0.99 per share basic and diluted for the same period in 2016. Net loss for the year ended December 31, 2017 was $70.4 million, or $2.78 per share basic and diluted, compared to net loss of $83.1 million, or $4.20 per share basic and diluted for the same period in 2016.

About Mirati Therapeutics

Mirati Therapeutics, Inc. is a clinical-stage oncology company developing targeted drugs products to address the genetic, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who are most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where the ability of our drugs to improve the immune environment of tumor cells may enhance and expand the efficacy of existing immunotherapy medicines when given in combination. Our pre-clinical programs include potentially first-in-class and best-in-class drugs specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better drugs and better outcomes for patients. For more information, visit www.mirati.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of the Company that are not historical facts may be considered "forward-looking statements," including, but not limited to, statements regarding Mirati's development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati's product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology. Forward-looking statements are based on current expectations of management and on what management believes to be reasonable assumptions based on information currently available to it, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from the expectations set forth in the forward-looking statements. Such risks and uncertainties include, but are not limited to, potential delays in development timelines or negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks detailed in Mirati's recent filings on Forms 10-K and 10-Q with the United States Securities and Exchange Commission. Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.


                                                            Mirati Therapeutics, Inc.

                                                      Consolidated Condensed Balance Sheets

                                                                 (in thousands)


                                                                                            December 31,          December 31,

                                                                                                             2017                 2016
                                                                                                             ----                 ----


    Assets

    Current assets

    Cash, cash equivalents and short-term investments                                                    $150,837              $56,734

    Other current assets                                                                                    4,922                2,821
                                                                                                            -----                -----

    Total current assets                                                                                  155,759               59,555


    Property and equipment, net                                                                               525                  629

    Other assets                                                                                              962                3,260


    Total assets                                                                                         $157,246              $63,444
                                                                                                         ========              =======


    Liabilities and Stockholders' Equity

    Current liabilities

    Accounts payable and accrued liabilities                                                              $13,644              $15,002
                                                                                                          -------              -------

    Total current liabilities                                                                              13,644               15,002

    Other liabilities                                                                                         314                  133
                                                                                                              ---                  ---

    Total liabilities                                                                                      13,958               15,135


    Stockholders' equity                                                                                  143,288               48,309
                                                                                                          -------               ------


    Total liabilities and stockholders' equity                                                           $157,246              $63,444
                                                                                                         ========              =======


                                                Mirati Therapeutics, Inc.

                               Consolidated Statements of Operations and Comprehensive Loss

                                           (in thousands except per share data)


                                                  Three Months Ended                        Twelve Months Ended
                                                     December 31,                              December 31,
                                                     ------------                              ------------

                                                         2017                        2016                 2017          2016
                                                         ----                        ----                 ----          ----

                                                    (unaudited)

    Expenses

    Research and development                          $15,244                     $15,952              $58,085       $68,487

    General and administrative                          2,983                       3,901               13,450        15,292
                                                        -----                                          ------

    Total operating expenses                           18,227                      19,853               71,535        83,779


    Loss from operations                             (18,227)                   (19,853)            (71,535)     (83,779)


    Other income, net                                     332                         131                1,105           661
                                                          ---                         ---                -----           ---



    Net loss                                        $(17,895)                  $(19,722)           $(70,430)    $(83,118)
                                                     ========                    ========

    Unrealized gain (loss) on
     available-for-sale
     investments                                         (35)                       (51)                (54)         (25)
                                                          ---                         ---                  ---           ---


    Comprehensive loss                              $(17,930)                  $(19,773)           $(70,484)    $(83,143)
                                                     ========                    ========             ========      ========


    Basic and diluted net loss
     per share                                        $(0.67)                    $(0.99)             $(2.78)      $(4.20)
                                                       ======                      ======               ======        ======


    Weighted average number of
     shares used in computing
     net loss per share, basic
     and diluted                                       26,833                      19,929               25,290        19,787
                                                       ------                      ------               ------        ------

CONTACT: Temre Johnson, Mirati Therapeutics Inc., Senior Manager, Investor Relations & Corporate Communications, (858) 332-3562, ir@mirati.com

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