Kite Pharmaceuticals, Inc.
Kite Pharma, Inc. (Form: 8-K, Received: 08/08/2017 08:17:50)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): August 8, 2017

 

 

Kite Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36508   27-1524986

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

2225 Colorado Avenue

Santa Monica, California

  90404
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (310) 824-9999

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On August 8, 2017, Kite Pharma, Inc. (“Kite”) announced its financial results for the second quarter ended June 30, 2017 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by Kite under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d)  Exhibits.

The following exhibit is filed as part of this Current Report:

 

99.1    Press Release of Kite, dated August 8, 2017.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 8, 2017    

KITE PHARMA, INC.

(Registrant)

      By:   /s/ Paul Jenkinson
      Name:   Paul Jenkinson
      Title:   Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

Number

   Description
99.1    Press Release of Kite, dated August 8, 2017.

Exhibit 99.1

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., August 8, 2017—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.

 

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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

Axi-cel

 

    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.

KTE-C19

 

    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.

KITE-585

 

    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

 

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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 www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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 www.kitepharma.com 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.

 

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KITE PHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

     JUNE 30, 2017
(UNAUDITED)
     DECEMBER
31, 2016
 

ASSETS

     

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  
  

 

 

    

 

 

 

 

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KITE PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

     THREE MONTHS ENDED
JUNE 30,
    SIX MONTHS ENDED
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.

 

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KITE PHARMA, INC.

Reconciliation of GAAP to Non-GAAP Net Loss

(In thousands, except per share amounts)

 

     THREE
MONTHS ENDED
JUNE 30,
    SIX MONTHS ENDED
JUNE 30,
 
     2017     2016     2017     2016  

Net loss—GAAP

   $ (109,822   $ (64,274   $ (200,223   $ (108,189

Adjustments:

        

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

Adjustments:

        

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  
  

 

 

   

 

 

   

 

 

   

 

 

 

KITE CONTACT:

Christine Cassiano

SVP, Corporate Communications & Investor Relations

ccassiano@kitepharma.com

Greg Mann

VP, Investor Relations

gmann@kitepharma.com

###

 

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