MEI Pharma Reports Fiscal Third-Quarter 2020 Results and Recent Corporate Highlights

SAN DIEGO, May 7, 2020 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its third quarter ended March 31, 2020 and highlighted recent corporate progress.

"Entering our fiscal fourth quarter, MEI is well positioned as we continue progress across our business, as highlighted by the recent grant of Fast Track designation by FDA for ME-401 and our newly announced global alliance with Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These key achievements advance our efforts to optimize ME-401 to benefit patients across multiple B-cell malignancies inside and outside the U.S. and, importantly, the $100 million upfront payment from Kyowa Kirin helps extend our cash runway through at least 2023, including the ramp-up of MEI's commercial activities and the potential launch of ME-401 in the U.S."

Dr. Gold continued: "With respect to the COVID-19 pandemic, all companies conducting clinical trials are facing a unique and challenging situation, and I'd like to thank all health care workers and other essential workers on the frontlines that are caring for the sick and keeping our society functioning. MEI will continue to be proactive in order to minimize the impact to our business, particularly the ongoing ME-401 TIDAL study. While the situation remains fluid, we will continue to focus on keeping the impact on TIDAL modest as we remain in close contact with all our sites to maintain patients on study and keep enrollment ongoing, even if at a somewhat reduced rate."

Recent Highlights

    --  In April 2020, the Company entered a global license, development and
        commercialization agreement to further develop and commercialize MEI's
        --  MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the
            --  MEI to book U.S. sales on 50-50 profit and cost sharing.
        --  $100 million in an upfront cash payment to MEI.
        --  $582.5 million in potential development, regulatory and commercial
        --  Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
            --  MEI to receive escalating tiered royalty payments from mid-teens
                on ex-U.S. sales.
    --  In April 2020, Cheryl L. Cohen, former chief commercial officer of
        Medivation, Inc. and a product launch and commercialization veteran with
        over 25 years of service in the pharmaceutical and biotechnology
        industry, joined the Board of Directors.
    --  In March 2020, the Company was granted Fast Track designation by the
        U.S. FDA for ME-401 for the treatment of adult patients with relapsed or
        refractory follicular lymphoma.

Fiscal Third-Quarter Fiscal Year 2020 Financial Results

    --  As of March 31, 2020, MEI had $92.8 million in cash, cash equivalents
        and short-term investments, with no outstanding debt. Giving effect to
        the KKC Agreement, our cash, cash equivalents and short-term investments
        would have been $192.8 million.
    --  For the three months ended March 31, 2020, cash used in operations was
        $10.3 million, compared to $11.3 million for the same period in 2019. 
        For the nine months ending March 31, 2020, cash used in operations was
        $34.9 million, compared to $31.4 million for 2019.  The increase
        primarily relates to costs associated with our clinical development
    --  Research and development expenses were $9.0 million for the quarter
        ended March 31, 2020, compared to $9.1 million for 2019. The decrease
        was primarily related to decreased drug manufacturing costs associated
        with ME-401, offset by increased clinical trial costs for the ME-401
        TIDAL study and increased personnel and legal patent costs.
    --  General and administrative expenses were $3.9 million for the quarter
        ended March 31, 2020, compared to $3.6 million for 2019. The increase
        primarily relates to increased headcount to support our activities.
    --  Revenue was $1.2 million for the quarter ended March 31, 2020, compared
        to revenue of $1.2 million for the same period in 2019. Revenue resulted
        from the recognition of fees allocated to research and development
        activities related to the Helsinn and Kyowa Kirin Japan License
    --  Net loss was $4.3 million, or $0.04 per share, for the quarter ended
        March 31, 2020, compared to net loss of $17.4 million, or $0.24 per
        share for the same period in 2019. Net loss decreased primarily as a
        result of a non-cash gain in the current quarter and a non-cash expense
        in the prior quarter related to changes in the fair value of the warrant
        liability associated with the May 2018 financing. The Company had
        105,998,677 shares of common stock outstanding as of March 31, 2020,
        compared with 71,280,660 shares as of March 31, 2019.
    --  The adjusted net loss for the quarter ended March 31, 2020, excluding a
        non-cash gain related to changes in the fair value of the warrants (a
        non-GAAP measure), was $12.1 million, compared to an adjusted net loss
        of $12.2 million for 2019.

About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global Phase 3 registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit

Forward-Looking Statements
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

              MEI PHARMA, INC.


           (In thousands, except per share amounts)

              March 31,            
     June 30,

                                                                  2020                    2019



     Current assets:

      Cash and
       equivalents                                              $7,438                  $9,590

       investments                                              85,360                  64,899

      Total cash,
       and short-
       investments                                              92,798                  74,489

      Common stock
       receivable                                                    -                  5,274

       and other
       assets                                                    2,604                   2,435

       assets                                                   95,402                  82,198

       assets, net                                                 235                     261

      Property and
       net                                                         986                     204

      Total assets                                             $96,623                 $82,663



     Current liabilities:

       payable                                                  $2,492                  $4,787

       liabilities                                               5,287                   4,559

       revenue                                                   2,478                   4,955

       liabilities                                              10,257                  14,301

       long-term                                                 2,817                   2,819

       liability                                                 9,051                  17,613

       liabilities                                              22,125                  34,733

     Stockholders' equity:

       $0.01 par
       value; 100

       outstanding                                                   -

       stock,                                 issued and
       $0.00000002                            outstanding
       par value;                             
       226,000                                        March 31,
       shares                                 2020 and
                                              June 30,
           authorized;                        2019,
       105,999 and                            respectively
       shares                                                        -

       capital                                                 333,256                 279,148

       deficit                                               (258,758)              (231,218)

       equity                                                   74,498                  47,930

       equity                                                  $96,623                 $82,663


                MEI PHARMA, INC.


                (In thousands, except per share amounts)


                                                                              Three Months Ended                   Nine Months Ended
                                                          March 31,                           March 31,


                                                            2020                     2019                     2020                 2019


     Revenue                                             $1,244                   $1,249                   $3,409               $3,785

     Operating expenses:

      Cost of revenue                                        860                    1,163                    2,189                3,161

      Research and development                             8,963                    9,071                   26,206               24,268

      General and
       administrative                                      3,864                    3,631                   12,189               10,853

      Total operating expenses                            13,687                   13,865                   40,584               38,282


      Loss from operations                              (12,443)                (12,616)                (37,175)            (34,497)

     Other income (expense):

      Change in fair value of
       warrant liability                                   7,732                  (5,201)                   8,562               13,274

      Interest and dividend
       income                                                382                      462                    1,074                1,352

      Other income (expense)                                                                                 (1)                 (1)

     Net loss                                          $(4,329)               $(17,355)               $(27,540)           $(19,872)

     Net loss:

     Basic                                             $(4,329)               $(17,355)               $(27,540)           $(19,872)

     Diluted                                           $(4,329)               $(17,355)               $(27,540)           $(43,309)

     Net loss per share:

     Basic                                              $(0.04)                 $(0.24)                 $(0.32)             $(0.28)

     Diluted                                            $(0.04)                 $(0.24)                 $(0.32)             $(0.60)

      Shares used in computing net loss per share:

     Basic                                              105,999                   71,200                   85,995               71,069


     Diluted                                            105,999                   71,200                   85,995               72,011


                MEI PHARMA, INC.

           Reconciliation of GAAP Net Loss to Adjusted Net Loss

                (In thousands)


                                                    Three Months Ended March 31,                          Nine Months Ended March 31,

                                    2020                         2019                        2020         2019

     Net loss                  $(4,329)                   $(17,355)                  $(27,540)   $(19,872)

      Add: Change in fair
       value of warrant
       liability                 (7,732)                       5,201                     (8,562)    (13,274)

      Adjusted net loss        $(12,061)                   $(12,154)                  $(36,102)   $(33,146)

View original content to download multimedia:

SOURCE MEI Pharma, Inc.