- Company Announces Plans to Initiate a
Rolling Submission of the Biologics License Application for KTE-C19
with the U.S. Food and Drug Administration for an Expanded
Indication of Aggressive Non-Hodgkin Lymphoma in December 2016 with
a Targeted Completion in Q1 2017
- Potential Approval and Commercial
Launch of KTE-C19 Expected in 2017
- Conference Call to Be Held Today at
8:30 a.m. Pacific Time/11:30 a.m. Eastern Time
Kite Pharma, Inc. (Nasdaq: KITE), a clinical-stage
biopharmaceutical company focused on developing engineered
autologous cell therapy (eACT™) products for the treatment of
cancer, today reported financial results for the third quarter 2016
and recent business highlights.
Kite also announced that it has met with the U.S. Food and Drug
Administration (FDA) to discuss the company’s plans to submit the
Biologics License Application (BLA) for KTE-C19. Kite currently
intends to file for the broader label of aggressive non-Hodgkin
lymphoma, which includes chemorefractory diffuse large B-cell
lymphoma (DLBCL), transformed follicular lymphoma (TFL), and
primary mediastinal B-cell lymphoma (PMBCL). The BLA submission
will be based on the primary analysis of the ZUMA-1 pivotal trial.
Kite plans to initiate the rolling submission of the BLA for
accelerated approval of KTE-C19 by the end of December 2016 with a
targeted completion by the end of the first quarter 2017 and a
potential approval and commercial launch of KTE-C19 in 2017.
“We are making history with each step we take toward bringing
engineered T-cell therapy to patients. We are very pleased with the
outcome from our productive discussions with the FDA and their
willingness to partner with us to advance this innovative therapy,”
said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief
Executive Officer. “We will focus on initiating and finalizing the
submission based on the FDA feedback and look ahead to the
potential approval of KTE-C19 in 2017.”
Third Quarter 2016 and Recent Highlights
- Reported positive topline results from
the pre-planned interim analysis in the KTE-C19 ZUMA-1 pivotal
trial in patients with aggressive non-Hodgkin lymphoma, which
includes chemorefractory DLBCL (n=51), and TFL and PMBCL (n=11).
The study met the pre-specified response endpoint with an objective
response rate of 76 percent in DLBCL (Cohort 1). Thirty nine
percent of patients maintained complete response at three-month
follow up. Grade 3 or higher cytokine release syndrome (CRS) and
neurological toxicity was observed in 18 percent and 34 percent of
patients, respectively. Treatment emergent Grade 5 events were
observed in 3 percent of patients.
- Reported ongoing complete responses in
three of seven patients at the 12-month follow-up in the Phase 1
portion of the ZUMA-1 study of KTE-C19 in chemorefractory DLBCL at
the European Society for Medical Oncology (ESMO).
- Announced planned oral and poster
presentations of KTE-C19 clinical and manufacturing data at the
2016 annual meeting of the American Society of Hematology. The
presentations will include additional clinical data from the
interim analysis of the ZUMA-1 pivotal trial as well as clinical
and manufacturing data from the ZUMA-3 and ZUMA-4 clinical studies
in adult acute lymphoblastic leukemia (ALL) and pediatric ALL,
respectively. Preliminary results from a clinical study of a fully
human anti-CD19 chimeric antigen receptor (CAR) conducted at the
National Cancer Institute will also be shared in an oral
presentation.
- Initiated patient enrollment in a Phase
1b/2 combination study of KTE-C19 and atezolizumab, Genentech’s
anti-PD-L1 monoclonal antibody. This is the first combination study
of an anti-CD19 engineered CAR T-cell and a checkpoint
inhibitor.
- At the Kite investor day on October 18,
2016:
- Detailed manufacturing and commercial
preparations for potential KTE-C19 commercial launch;
- Outlined KTE-C19 expansion studies with
the potential to deliver six additional indications in B-cell
malignancies;
- Announced the expansion of Kite’s
T-cell receptor (TCR) and CAR T development pipeline with four new
INDs planned in the 2016-2018 timeframe; and
- Presented “T cells 2.0” next-generation
cell programming technologies to realize the full potential of
engineered T-cell therapy.
- Licensed multiple neoantigen directed
TCR product candidates to treat solid tumors expressing mutated
KRAS antigens from the National Institutes of Health.
Third Quarter 2016 Financial Results
- Revenue was $7.3 million for the third
quarter of 2016.
- Research and development expenses were
$57.3 million for the third quarter of 2016, and includes $8.9
million of non-cash stock-based compensation expense.
- General and administrative expenses
were $25.0 million for the third quarter of 2016, and includes
$10.3 million of non-cash stock-based compensation expense.
- Net loss attributable to common
stockholders was $73.9 million, or $1.49 per share, for the third
quarter of 2016.
- Non-GAAP net loss attributable to
common stockholders for the third quarter of 2016 was $54.7
million, or $1.10 per share, which excludes non-cash stock-based
compensation expense of $19.3 million.
- Cash burn for the third quarter was
$54.0 million. It is expected that the company’s cash, cash
equivalents, and marketable securities of $477.1 million as of
September 30, 2016 will be sufficient to fund its current
operations, including planned clinical development programs,
through the first half of 2018.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company
engaged in the development of novel cancer immunotherapy products,
with a primary focus on engineered autologous cell therapy (eACT™)
designed to restore the immune system’s ability to recognize and
eradicate tumors. Kite is based in Santa Monica, CA. For more
information on Kite Pharma, please visit www.kitepharma.com. Sign
up to follow @KitePharma on Twitter at
http://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
KTE-C19 data, initiating and completing a submission of the BLA for
KTE-C19 with the FDA, obtaining regulatory approval based on the
studies of KTE-C19, commercially launching KTE-C19, researching and
developing additional product candidates, expectations regarding
the clinical effectiveness and safety of KTE-C19 and the
sufficiency of Kite’s cash, cash equivalents and marketable
securities. 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
September 30, 2016. 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 11:30 AM Eastern Time (8:30 AM Pacific 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 43463182. 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.
KITE PHARMA, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (In thousands)
SEPTEMBER 30, 2016 (unaudited) DECEMBER 31,
2015
ASSETS Current assets Cash, cash equivalents, and
marketable securities $ 477,119 $ 614,722 Prepaid expenses and
other current assets 13,988 16,371 Total current
assets 491,107 631,093 Property and equipment, net 43,548 30,116
Intangible assets and goodwill, net 34,546 36,740 Other assets
15,316 10,014 Total assets $ 584,517 $ 707,963
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities Accounts payable $ 11,293 $ 8,049 Deferred
revenue 15,083 16,333 Accrued expenses and other current
liabilities 20,979 11,787 Total current liabilities
47,355 36,169 Deferred revenue, less current portion 22,461 32,176
Contingent consideration 14,797 16,080 Other non-current
liabilities 5,551 7,778 Total liabilities
90,164 92,203 Total stockholders' equity 494,353
615,760 Total liabilities and stockholders' equity $ 584,517
$ 707,963
KITE PHARMA, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except
per share amounts) (unaudited)
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30, 2016 2015 2016
2015
Revenue: Revenue $ 7,341 $ 5,087 $
17,263 $ 12,371
Operating expenses: Research and development
57,262 21,727 139,033 47,576 General and administrative
25,032 11,135 65,046
30,080 Total operating expenses 82,294
32,862 204,079 77,656 Loss from
operations (74,953 ) (27,775 ) (186,816 ) (65,285 ) Other income
(expense): Interest income 942 342 2,712 1,307 Interest expense
(196 ) (451 ) (519 ) (456 ) Other income (expense) (31 )
(49 ) (94 ) 521 Total other income
715 (158 ) 2,099 1,372
Benefit from income taxes 292 491
2,582 491
Net loss $
(73,946 ) $ (27,442 ) $ (182,135 ) $ (63,422 ) Net loss per share,
basic and diluted $ (1.49 ) $ (0.63 ) $ (3.72 ) $ (1.47 )
Weighted-average shares outstanding, basic and diluted
49,625 43,818 48,915
43,172
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) (unaudited) THREE
MONTHS ENDED SEPTEMBER 30, 2016 2015 Net loss
- GAAP $ (73,946 ) $ (27,442 ) Adjustments: Non-cash stock-based
compensation expense 19,262 10,845 Net
loss - Non-GAAP $ (54,684 ) $ (16,597 ) Net loss per share,
basic and diluted - GAAP $ (1.49 ) $ (0.63 ) Adjustments: Non-cash
stock-based compensation expense per share 0.39
0.25 Net loss per share, basic and diluted - Non-GAAP
$ (1.10 ) $ (0.38 ) Weighted average common shares outstanding,
basic and diluted 49,625 43,818
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161109005308/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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