August 08, 2016
Kite Pharma Reports Second Quarter 2016 Financial Results
Interim Results from Pivotal Phase 2 Portion of ZUMA-1 Clinical Trial of KTE-C19 Expected in Late Third Quarter of 2016
KTE-C19 Biologics License Application Filing Planned in Late 2016; Commercial Launch of KTE-C19 Expected in 2017
Kite Investor Day Scheduled for
Conference Call to Be Held Today at
"During the second quarter we continued to expand our pipeline, broaden
our engineered cell therapy capabilities through access to key enabling
technologies, and advance the development of KTE-C19 as a potential
first-to-market breakthrough immunotherapy for patients with advanced
non-Hodgkin lymphoma (NHL)," noted
Second Quarter 2016 and Recent Highlights
- Completed enrollment of all targeted chemorefractory DLBCL patients (n=72) in the Phase 2 portion of ZUMA-1, the first multi-center pivotal study of engineered T-cell therapy in chemorefractory DLBCL patients.
Obtained access for KTE-C19 to the recently initiated Priority
Medicines (PRIME) regulatory initiative from the
European Medicines Agency(EMA). PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need.
Reported at the
June 2016annual meeting of the American Society of Clinical Oncology(ASCO):
Results from a study conducted at the
National Cancer Institute(NCI) of low-dose chemotherapy conditioning followed by anti-CD19 chimeric antigen receptor (CAR) T-cell therapy showing that CAR T-cell therapy was effective in inducing a high response rate in patients with advanced non-Hodgkin lymphoma (NHL). Kite is using a similar conditioning regimen in its ZUMA-1 Study of KTE-C19.
- Ongoing complete responses in 3 of 7 patients at 9-month study follow-up in the Phase 1 portion of the ZUMA-1 study of KTE-C19 in chemorefractory DLBCL. Grade 3 or higher cytokine release syndrome was observed in 14% and neurotoxicity in 57% of the Phase 1 patients; all were reversible except in one patient with dose-limiting toxicity.
- Findings from a multi-institutional, retrospective meta-analysis of outcomes from 635 patients with chemorefractory DLBCL (SCHOLAR-1). The results document the consistently poor outcomes in this patient population, with an overall response rate of 26%, complete response rate of 8% and median overall survival of 6.6 months.
- Results from a study conducted at the
Opened Kite's new state-of-the-art commercial manufacturing facility
El Segundo, California, which is expected to be operational for commercial launch in 2017.
Expanded the Company's development of T-cell receptor (TCR) therapies
targeting HPV-associated cancers by entering into a new
Cooperative Researchand Development Agreement (CRADA) with the Experimental Transplantation and Immunology Branch of the NCI and lead investigator Christian S. Hinrichs, M.D.
Entered a research collaboration with
Cell Design Labs, Inc.to develop a molecular "switch" technology that provides dynamic control and precise regulation of engineered CAR-T cells after therapeutic administration.
Accessed technology for the development of allogeneic cell therapies
through a license agreement and research collaboration with the
Regents of the
University of California. The technology platform supports the differentiation of engineered T-cells from pluripotent stem cells.
Paul Jenkinson, a corporate finance executive with extensive global operations experience, as Chief Financial Officer.
Second Quarter 2016 Financial Results
$4.8 millionfor the second quarter of 2016.
Research and development expenses were
$47.4 millionfor the second quarter of 2016, and include $8.5 millionof non-cash stock-based compensation expense.
General and administrative expenses were
$23.5 millionfor the second quarter of 2016, and include $11.3 millionof non-cash stock-based compensation.
Net loss was
$64.3 million, or $1.31per share, for the second quarter of 2016.
Non-GAAP net loss for the second quarter of 2016 was
$44.5 million, or $0.91per share, which excludes non-cash stock-based compensation of $19.8 million.
June 30, 2016, Kite had $531.1 millionin cash, cash equivalents, and marketable securities. Kite continues to expect the full year 2016 net cash burn to be $235 millionto $250 million, which includes approximately $20 millionin capital expenditures, but excludes any inflows or outflows from future business development activities, if any. The estimated full year 2016 net cash burn is primarily driven by an estimated net loss of $295 millionto $310 million, which includes an estimated $80 millionof non-cash stock-based compensation expense.
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. The press release may, in some cases, use terms such as
"predicts," "believes," "potential," "proposed," "continue,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements include
statements regarding intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the ability and
timing of obtaining interim KTE-C19 data, filing a Biologics License
Application with the
Conference Call and Webcast Details
Kite will host a live conference call and webcast today at 4:30PM
Eastern Time (
|KITE PHARMA, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, and marketable securities||$||531,126||$||614,722|
|Prepaid expenses and other current assets||10,472||16,371|
|Total current assets||541,598||631,093|
|Property and equipment, net||42,466||30,116|
|Intangible assets and goodwill, net||35,280||36,740|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||20,050||11,787|
|Total current liabilities||43,019||36,169|
|Deferred revenue, less current portion||25,139||32,176|
|Other non-current liabilities||5,376||7,778|
|Total stockholders' equity||545,456||615,760|
|Total liabilities and stockholders' equity||$||635,675||$||707,963|
|KITE PHARMA, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|THREE MONTHS ENDED||SIX MONTHS ENDED|
|Research and development||47,356||16,588||81,771||25,849|
|General and administrative||23,520||9,774||40,013||18,945|
|Total operating expenses||70,876||26,362||121,784||44,794|
|Loss from operations||(66,081||)||(21,959||)||(111,862||)||(37,510||)|
|Other income (expense):|
|Other income (expense)||(30||)||570||(63||)||571|
|Total other income||727||1,067||1,384||1,531|
|Benefit from income taxes||1,080||-||2,289||-|
|Net loss per share, basic and diluted||$||(1.31||)||$||(0.48||)||$||(2.21||)||$||(0.84||)|
|Weighted-average shares outstanding, basic and diluted||49,157||43,249||48,877||42,860|
Note Regarding Use of Non-GAAP Financial Measures
Kite provides non-GAAP net loss and non-GAAP net loss per share that include adjustments to GAAP figures. These adjustments to GAAP net loss exclude non-cash stock-based compensation expense. Kite believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Kite's financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Kite's operating results. In addition, these non-GAAP financial measures are among the indicators Kite's management uses for planning purposes and measuring Kite's performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Kite may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
|KITE PHARMA, INC.|
|Reconciliation of GAAP to Non-GAAP Net Loss|
|(In thousands, except per share amounts)|
|THREE MONTHS ENDED|
|Net loss - GAAP||$||(64,274||)||$||(20,892||)|
|Non-cash stock-based compensation expense||19,758||9,381|
|Net loss - Non-GAAP||$||(44,516||)||$||(11,511||)|
|Net loss per share, basic and diluted - GAAP||$||(1.31||)||$||(0.48||)|
|Non-cash stock-based compensation expense per share||0.40||0.22|
|Net loss per share, basic and diluted - Non-GAAP||$||(0.91||)||$||(0.26||)|
|Weighted average common shares outstanding, basic and diluted||49,157||43,249|
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