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 second quarter 2016 and recent business highlights.
“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 Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. “We have enrolled all 72 chemorefractory diffuse large B-cell lymphoma (DLBCL) patients in the pivotal portion of our ZUMA-1 study, and Kite remains on track to announce interim data from approximately 50 of these patients at 3-month follow-up later this quarter. Subject to these interim results and discussions with the U.S. Food and Drug Administration (FDA), we expect to submit a Biologics License Application (BLA) for KTE-C19 by the end of 2016. We look forward to sharing details about KTE-C19 commercial preparations, manufacturing readiness and new development programs at our Investor Day and webcast on October 18.”
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 2016 annual 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.
- Opened Kite’s new state-of-the-art commercial manufacturing facility in 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 Research and 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.
- Appointed Paul Jenkinson, a corporate finance executive with extensive global operations experience, as Chief Financial Officer.
Second Quarter 2016 Financial Results
- Revenue was $4.8 million for the second quarter of 2016.
- Research and development expenses were $47.4 million for the second quarter of 2016, and include $8.5 million of non-cash stock-based compensation expense.
- General and administrative expenses were $23.5 million for the second quarter of 2016, and include $11.3 million of non-cash stock-based compensation.
- Net loss was $64.3 million, or $1.31 per share, for the second quarter of 2016.
- Non-GAAP net loss for the second quarter of 2016 was $44.5 million, or $0.91 per share, which excludes non-cash stock-based compensation of $19.8 million.
- As of June 30, 2016, Kite had $531.1 million in cash, cash equivalents, and marketable securities. Kite continues to expect the full year 2016 net cash burn to be $235 million to $250 million, which includes approximately $20 million in 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 million to $310 million, which includes an estimated $80 million of non-cash stock-based compensation expense. (Original Source)
Shares of Kite Pharma closed today at $58.25, down $0.34 or -0.58%. KITE has a 1-year high of $89.84 and a 1-year low of $38.41. The stock’s 50-day moving average is $51.69 and its 200-day moving average is $48.76.
On the ratings front, KITE has been the subject of a number of recent research reports. In a report issued on August 5, Jefferies Co. analyst Biren Amin reiterated a Buy rating on KITE. Separately, on July 26, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $75.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and John Newman have a total average return of 8.2% and -12.1% respectively. Amin has a success rate of 56% and is ranked #376 out of 4102 analysts, while Newman has a success rate of 34% and is ranked #4004.
The street is mostly Bullish on KITE stock. Out of 9 analysts who cover the stock, 8 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $80.00, which implies an upside of 36.1% from current levels.
Kite Pharma, Inc. is a clinical stage biotechnology company, which engages in the development and commercialization of novel cancer immunotherapy products designed to target and kill cancer cells. It uses engineered autologous cell therapy, which involves the genetic engineering of T cells. Its lead product candidate, KTE-C19, a CAR-based therapy, which seeks treat patients with refractory diffuse large B-cell lymphoma, primary mediastinal large B-Cell lymphoma, and transformed follicular lymphoma.