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Durable Treatment Effect of KTE-C19 Supported by Updated Patient Follow-up in ZUMA-1 Trial Presented at Annual Meeting of the
Interim Results from Pivotal Phase 2 Portion of KTE-C19 ZUMA-1 Trial Expected in Second Half of 2016, to Support Planned BLA Filing in Late 2016 and Product Launch in 2017
"Our ZUMA-1 update at AACR last month highlighted the potential of KTE-C19, our breakthrough immunotherapy candidate, to put patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL), a patient population burdened with a short life expectancy and limited treatment options, into a durable complete remission," noted
"Our commitment to delivering a breakthrough personalized cell therapy to cancer patients now extends fully to our manufacturing and market planning areas. Validation and qualification activities at our state-of-the-art commercial manufacturing facility are underway. The commercial team is actively evaluating a broad range of market and payor strategies for making KTE-C19 available to patients with a significant unmet need."
First Quarter 2016 and Recent Highlights
- At AACR, reported rapid and durable responses in patients with chemorefractory diffuse large B cell lymphoma treated with KTE-C19 in the phase 1 portion of ZUMA-1.
- Ongoing complete responses were observed in 3 of 7 patients at 9-month study follow-up (1 patient) and 6-month study follow-up (2 patients).
- KTE-C19-related adverse events consisted predominantly of cytokine release syndrome and neurotoxicity, which were generally reversible.
- Partnered with
Genentech to study KTE-C19 in combination with the checkpoint inhibitor atezolizumab. Kite expects to initiate a Phase 1b/2 combination study in patients with chemorefractory diffuse large B cell lymphoma in the second half of 2016. - Expanded our clinical and research partnership with the
National Cancer Institute (NCI) by entering into a newCooperative Research and Development Agreement (CRADA) withJames (Jim) N. Kochenderfer , M.D., and the NCI's Experimental Transplantation and Immunology Branch.- Phase 1 study of human anti-CD19 chimeric antigen receptor for treating B-cell malignancies currently ongoing.
- Also at AACR,
William Lu , Ph.D., a collaborator of Kite's at the NCI, reported data from a Phase 1 study of a T cell receptor (TCR) product candidate targeting MAGE-A3 that was advanced under Kite's CRADA with the Surgery Branch at the NCI.- Data reported at AACR support Kite's plan to file later this year an investigational new drug (IND) application for a TCR product candidate that targets a MAGE-A3 antigen expressed on solid tumors.
- Entered into a research and license agreement with
Leiden University Medical Center inthe Netherlands to identify and develop additional TCR product candidates targeting solid tumors that are associated with the human papillomavirus (HPV) type 16 infection. - Appointed
Tim Moore , a biopharma executive with more than 30 years of global operations experience, as Executive Vice President, Technical Operations, to lead product development, manufacturing, supply chain, quality assurance, and end-to-end process optimization for all aspects of Kite's engineered T cell product candidates. - Augmented Kite's commercial function, under the leadership of Chief Commercial Officer
Shawn Tomasello , with the appointment of an integrated executive team responsible for all aspects of commercial and medical affairs strategy, planning, and analysis for the potential launch of KTE-C19.
First Quarter 2016 Financial Results
- Revenue was
$5.1 million for the first quarter of 2016. - Research and development expenses were
$34.4 million for the first quarter of 2016, and include$8.5 million of non-cash stock-based compensation expense. - General and administrative expenses were
$16.5 million for the first quarter of 2016, and include$6.4 million of non-cash stock-based compensation expense. - Net loss was
$43.9 million , or$0.90 per share, for the first quarter of 2016. - Non-GAAP net loss for the first quarter of 2016 was
$29.1 million , or$0.60 per share, which excludes non-cash stock-based compensation of$14.9 million . - As of
March 31, 2016 , Kite had$577.4 million in cash, cash equivalents, and marketable securities. - Kite continues to expect the full year 2016 net cash burn to be
$235 to$250 million dollars , which includes approximately$20 million in capital expenditures, but excludes any inflows or outflows from business development activities. The estimated full year 2016 net cash burn is primarily driven by an estimated net loss of$295 to$310 million , which includes an estimated$80 million of non-cash stock-based compensation expense.
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Conference Call and Webcast DetailsKite will host a live conference call and webcast today at 4:30PM Eastern Time (
KITE PHARMA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) | |||||||||||
| (unaudited) | 2015 | ||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash, cash equivalents, and marketable securities | $ | 577,421 | $ | 614,722 | |||||||
| Prepaid expenses and other current assets | 15,066 | 16,371 | |||||||||
| Total current assets | 592,487 | 631,093 | |||||||||
| Property and equipment, net | 40,462 | 30,116 | |||||||||
| Intangible assets and goodwill, net | 37,167 | 36,740 | |||||||||
| Other assets | 9,135 | 10,014 | |||||||||
| Total assets | $ | 679,251 | $ | 707,963 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 9,614 | $ | 8,049 | |||||||
| Deferred revenue | 16,250 | 16,333 | |||||||||
| Accrued expenses and other current liabilities | 11,272 | 11,787 | |||||||||
| Total current liabilities | 37,136 | 36,169 | |||||||||
| Deferred revenue, less current portion | 28,900 | 32,176 | |||||||||
| Contingent consideration | 16,869 | 16,080 | |||||||||
| Other non-current liabilities | 6,950 | 7,778 | |||||||||
| Total liabilities | 89,855 | 92,203 | |||||||||
| Total stockholders' equity | 589,396 | 615,760 | |||||||||
| Total liabilities and stockholders' equity | $ | 679,251 | $ | 707,963 | |||||||
KITE PHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (unaudited) | |||||||||||||
| THREE MONTHS ENDED | |||||||||||||
| 2016 | 2015 | ||||||||||||
| Revenue: | |||||||||||||
| Revenue | $ | 5,127 | $ | 2,881 | |||||||||
| Operating expenses: | |||||||||||||
| Research and development | 34,414 | 9,260 | |||||||||||
| General and administrative | 16,494 | 9,171 | |||||||||||
| Total operating expenses | 50,908 | 18,431 | |||||||||||
| Loss from operations | (45,781 | ) | (15,550 | ) | |||||||||
| Other income (expense): | |||||||||||||
| Interest income | 816 | 466 | |||||||||||
| Interest expense | (126 | ) | (4 | ) | |||||||||
| Other expense | (34 | ) | - | ||||||||||
| Total other income | 656 | 462 | |||||||||||
| Benefit from income taxes | 1,209 | - | |||||||||||
| Net loss | $ | (43,916 | ) | $ | (15,088 | ) | |||||||
| Net loss per share, basic and diluted | $ | (0.90 | ) | $ | (0.36 | ) | |||||||
| Weighted-average shares outstanding, basic and diluted | 48,832 | 42,466 | |||||||||||
Note Regarding Use of Non-GAAP Financial MeasuresKite 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) (unaudited) | |||||||||||||
| THREE MONTHS ENDED | |||||||||||||
| 2016 | 2015 | ||||||||||||
| Net loss - GAAP | $ | (43,916 | ) | $ | (15,088 | ) | |||||||
| Adjustments: | |||||||||||||
| Non-cash stock-based compensation expense | 14,864 | 6,677 | |||||||||||
| Net loss - Non-GAAP | $ | (29,052 | ) | $ | (8,411 | ) | |||||||
| Net loss per share, basic and diluted - GAAP | $ | (0.90 | ) | $ | (0.36 | ) | |||||||
| Adjustments: | |||||||||||||
| Non-cash stock-based compensation expense per share | 0.30 | 0.16 | |||||||||||
Net loss per share, basic and diluted - Non-GAAP | $ | (0.60 | ) | $ | (0.20 | ) | |||||||
| Weighted average common shares outstanding, basic and diluted | 48,832 | 42,466 | |||||||||||
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