Press Releases

Kite Reports Second Quarter 2017 Financial Results


  •         Filed Industry's First CAR-T Marketing Authorization Application in        Europe for Axicabtagene Ciloleucel for Potential EU Approval and        Launch in 2018     
  •         Submitted Investigational New Drug Application for KITE-585, a CAR-T        Candidate that Targets BCMA in Multiple Myeloma     
  •         Conference Call Today at 5:30 AM PDT / 8:30 AM EDT     

    SANTA MONICA, Calif.--(BUSINESS WIRE)--      Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today      reported second quarter 2017 financial results and provided a corporate      update for the period ended June 30, 2017.   


      "We've continued to make significant progress on key clinical and      commercial milestones in the last six months alone," said Arie      Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer      of Kite. "With the anticipated events on the horizon for the remainder      of 2017, the potential for CAR-T to become one of the most powerful      anti-cancer agents for certain patients may finally be realized."   


      Second Quarter 2017 Financial Results   

  •         Revenue was $10.1 million for the second quarter of 2017.     
  •         Research and development expenses were $70.9 million for the second        quarter of 2017, including $13.1 million of non-cash stock-based        compensation expense.     
  •         General and administrative expenses were $41.1 million for the second        quarter of 2017, including $12.1 million of non-cash stock-based        compensation expense.     
  •         Net loss was $109.8 million, or $1.94 per share, for the second        quarter of 2017.     
  •         Non-GAAP net loss for the second quarter of 2017 was $84.7 million, or        $1.50 per share, excluding non-cash stock-based compensation expense        of $25.2 million.     
  •         As of June 30, 2017, Kite had $781.1 million in cash, cash        equivalents, and marketable securities.     

      Recent Highlights   


      Axicabtagene Ciloleucel (axi-cel) Regulatory and Clinical Development   

  •         The submission of axi-cel to the U.S. Food and Drug Administration        (FDA) remains under review with a PDUFA Action Date of November 29,        2017.     
  •         Submitted a Marketing Authorization Application to the European        Medicines Agency (EMA) for axi-cel as a treatment for patients with        relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed        follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma        (PMBCL) who are ineligible for autologous stem cell transplant. This        application represents the first chimeric antigen receptor (CAR)        T-cell therapy submitted to the EMA.     
  •         Patients are now being treated in ZUMA-5, the Phase 2 trial of axi-cel        in indolent B-Cell Non-Hodgkin lymphoma.     
  •         Patients in the European Union (EU) are now being treated with        axi-cel. Kite is currently enrolling adult patients with        relapsed/refractory DLBCL, PMBCL and TFL in certain EU medical centers.     
  •         A publication from researchers at the National Cancer Institute        reported complete remissions up to 56+ months in patients with        chemorefractory aggressive non-Hodgkin's lymphoma (NHL) after        receiving anti-CD19 CAR T-cells in a clinical trial.     

      KTE-C19 Development   

  •         At the 2017 American Society of Clinical Oncology annual meeting, Kite        reported 73 percent minimum residual disease (MRD) negative complete        remission rate in an updated analysis of the Phase 1 ZUMA-3 trial of        KTE-C19 in adults with high burden relapsed/refractory acute        lymphoblastic leukemia (ALL). Adverse events included cytokine release        syndrome and neurologic events, and were generally reversible.     

      CAR-T Pipeline   

  •         Submitted an investigational new drug (IND) application for KITE-585,        a CAR-T therapy candidate that targets BCMA expressed in multiple        myeloma.     

      TCR Pipeline   

  •         Opened a Phase 1 clinical trial of KITE-718, a T-cell receptor (TCR)        cell therapy candidate that targets MAGE A3/A6 antigen expressed in        solid tumors, including non-small cell lung cancer, bladder cancer and        head and neck cancer.     

      Axi-cel Commercial Preparation   

  •         Completed recruitment and training of cell therapy account managers to        support customer service and logistical coordination.     
  •         Conducted test runs of technical operations for ordering, scheduling,        processing and shipment of cell therapy product at key major medical        institutions in preparation for potential approval and launch.     

      Intellectual Property   

  •         Favorable outcome at the United States Patent and Trademark Office        (USPTO) in an ex parte reexamination of Kite's seminal Eshhar        ‘465 CAR-T patent (U.S. Patent No. 7,741,465) that confirmed the        patentability of its amended claims. The Eshhar ‘465 patent term        continues to June 2027, not including certain potential extensions.     

      Second Half 2017 Milestones   



  •         Commercial launch of axi-cel in the United States, if approved.     
  •         One year follow-up data from ZUMA-1 study of axi-cel in patients with        aggressive NHL.     
  •         Preliminary data from ZUMA-6 combination study of axi-cel and        atezolizumab (PD-L1 checkpoint inhibitor) in refractory DLBCL.     


  •         Preliminary follow-up Phase 1 data from ZUMA-3 and ZUMA-4 studies of        pediatric and adult ALL, respectively.     
  •         Advance ZUMA-3 and ZUMA-4 studies into Phase 2.     


  •         Initiate Phase 1 KITE-585 trial in multiple myeloma.     

      About Kite   


      Kite is a biopharmaceutical company engaged in the development of      innovative cancer immunotherapies with a goal of providing rapid,      long-term durable response and eliminating the burden of chronic care.      The company is focused on chimeric antigen receptor (CAR) and T cell      receptor (TCR) engineered cell therapies designed to empower the immune      system's ability to recognize and kill tumors. Kite is based in Santa      Monica, CA. For more information on Kite, please visit      Sign up to follow @KitePharma on Twitter at   


      Cautionary Note on Forward-Looking Statements   


      This press release contains forward-looking statements for purposes of      the safe harbor provisions of the Private Securities Litigation Reform      Act of 1995. The press release may, in some cases, use terms such as      "predicts," "believes," "potential," "proposed," "continue,"      "estimates," "anticipates," "expects," "expected," "plans," "intends,"      "may," "could," "might," "will," "should" or other words that convey      uncertainty of future events or outcomes to identify these      forward-looking statements. Forward-looking statements include      statements regarding intentions, beliefs, projections, outlook, analyses      or current expectations concerning, among other things: the ability and      timing of obtaining regulatory approval based on the studies of      axicabtagene ciloleucel, commercially launching axicabtagene ciloleucel,      advancing additional product candidates, including KTE-C19, KITE-718 and      KITE-585, and meeting the second half 2017 milestones, and Kite's      ability to maintain intellectual property protection. Various factors      may cause differences between Kite's expectations and actual results as      discussed in greater detail in Kite's filings with the Securities and      Exchange Commission, including without limitation in its Form 10-Q for      the quarter ended June 30, 2017. Any forward-looking statements that are      made in this press release speak only as of the date of this press      release. Kite assumes no obligation to update the forward-looking      statements whether as a result of new information, future events or      otherwise, after the date of this press release.   


      Conference Call and Webcast Details   


      Kite will host a live conference call and webcast today at 5:30 AM      Pacific Time (8:30 AM Eastern Time) to discuss financial results and      provide a business update. To access the live conference call by      telephone, please dial 888-771-4371 (U.S.) or 847-585-4405      (International). The conference ID number for the live call is 45253546.      The webcast will be made available on the Company's website at      under the Investors tab in the Events and Presentations section.      Following the live audio webcast, a replay will be available on the      Company's website for approximately 30 days.   

          KITE PHARMA, INC.       
          (In thousands)       

            JUNE 30, 2017


            DECEMBER 31,

          Current assets                                                       
          Cash, cash equivalents, and marketable securities                                  $                  781,111                                  $                  414,422       
          Prepaid expenses and other current assets                                                     17,169                                                     12,974       
          Total current assets                                          798,280                                          427,396       
          Property and equipment, net                                          49,722                                          44,409       
          Intangibles assets and goodwill, net                                          31,921                                          31,398       
          Other assets                                                     27,190                                                     21,101       
          Total assets                                  $                  907,113                                  $                  524,304       
          LIABILITIES AND STOCKHOLDERS' EQUITY                                                       
          Current liabilities                                                       
          Accounts payable                                  $                  15,803                                  $                  10,660       
          Deferred revenue                                          30,570                                          29,482       
          Accrued expenses and other current liabilities                                                     42,191                                                     15,000       
          Total current liabilities                                          88,564                                          55,142       
          Deferred revenue, less current portion                                          78,354                                          19,779       
          Contingent consideration                                          15,450                                          14,218       
          Other non-current liabilities                                                     15,491                                                     7,195       
          Total liabilities                                                     197,859                                                     96,334       
          Total stockholders' equity                                                     709,254                                                     427,970       

            Total liabilities and stockholders' equity         

                          $                  907,113                                  $                  524,304       
          KITE PHARMA, INC.       
          (In thousands, except per share amounts)       
                                  THREE MONTHS ENDED                                  SIX MONTHS ENDED       
                                  JUNE 30,                                  JUNE 30,       
                                                     2017                                                                2016                                                                        2017                                                                2016                          
          Revenue                                  $                  10,052                                  $                  4,795                                          $                  19,888                                  $                  9,922               
          Operating expenses:                                                                                       
          Research and development                                          70,870                                          47,356                                                  136,777                                          81,771               
          General and administrative                                                     41,101                                                                23,713                                                                        76,466                                                                40,395                          
          Total operating expenses                                                     111,971                                                                71,069                                                                        213,243                                                                122,166                          
          Loss from operations                                          (101,919                  )                                  (66,274                  )                                          (193,355                  )                                  (112,244                  )       
          Total other income (expense)                                          (1,144                  )                                  920                                                  (170                  )                                  1,766               
          Income tax (provision) benefit                                                     (6,759                  )                                             1,080                                                                        (6,698                  )                                             2,289                          
          Net loss                                  $                  (109,822                  )                          $                  (64,274                  )                                  $                  (200,223                  )                          $                  (108,189                  )       
          Net loss per share, basic and diluted                                  $                  (1.94                  )                          $                  (1.31                  )                                  $                  (3.69                  )                          $                  (2.21                  )       
          Weighted-average shares outstanding, basic and diluted                                                     56,663                                                                49,157                                                                        54,264                                                                48,877                          

      Note Regarding Use of Non-GAAP Financial Measures   


      Kite provides non-GAAP net loss and non-GAAP net loss per share that      include adjustments to U.S. Generally Accepted Accounting Principles      (GAAP) figures. These adjustments to GAAP net loss exclude non-cash      stock-based compensation expense. Kite believes that these non-GAAP      financial measures, when considered together with the GAAP figures, can      enhance an overall understanding of Kite's financial performance. The      non-GAAP financial measures are included with the intent of providing      investors with a more complete understanding of Kite's operating      results. In addition, these non-GAAP financial measures are among the      indicators Kite's management uses for planning purposes and measuring      Kite's performance. These non-GAAP financial measures should be      considered in addition to, and not as a substitute for, or superior to,      financial measures calculated in accordance with GAAP. The non-GAAP      financial measures used by Kite may be calculated differently from, and      therefore may not be comparable to, non-GAAP financial measures used by      other companies. Please refer below for a reconciliation of these      non-GAAP financial measures to the comparable GAAP financial measures.   

          KITE PHARMA, INC.       
          Reconciliation of GAAP to Non-GAAP Net Loss       
          (In thousands, except per share amounts)       
                                  THREE MONTHS ENDED                                  SIX MONTHS ENDED       
                                  JUNE 30,                                  JUNE 30,       
                                                     2017                                                                2016                                                                        2017                                                                2016                          
          Net loss - GAAP                                  $                  (109,822                  )                          $                  (64,274                  )                                  $                  (200,223                  )                          $                  (108,189                  )       
          Non-cash stock-based compensation expense                                                     25,163                                                                19,758                                                                        49,241                                                                34,622                          
          Net loss - Non-GAAP                                  $                  (84,659                  )                          $                  (44,516                  )                                  $                  (150,982                  )                          $                  (73,567                  )       
          Net loss per share, basic and diluted - GAAP                                  $                  (1.94                  )                          $                  (1.31                  )                                  $                  (3.69                  )                          $                  (2.21                  )       
          Non-cash stock-based compensation expense per share                                                     0.44                                                                0.40                                                                        0.91                                                                0.71                          
          Net loss per share, basic and diluted - Non-GAAP                                  $                  (1.50                  )                          $                  (0.91                  )                                  $                  (2.78                  )                          $                  (1.50                  )       
          Weighted-average shares outstanding, basic and diluted                                                     56,663                                                                49,157                                                                        54,264                                                                48,877                          




Christine Cassiano
SVP, Corporate Communications      & Investor Relations
Greg      Mann
VP, Investor Relations   

Source: Kite Pharma, Inc.



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