$LBIO Form 8-K

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Form 8-K for LION BIOTECHNOLOGIES, INC.


1-May-2015

Results of Operations and Financial Condition, Other Events

Item 2.02 Results of Operation and Financial ConditionLion Biotechnologies (“we,” “us,” “our” or the “company”) is currently in the process of finalizing its financial results for the fiscal quarter ended March 31, 2015. While complete financial information is not available, based on information currently available, we estimate that as of March 31, 2015, we had approximately $111.3 million of cash and cash equivalents. These preliminary estimates have been prepared by, and are the responsibility of, our management. Our actual cash and cash equivalents as of March 31, 2015 may differ from these estimates due to the completion of our closing procedures with respect to the fiscal quarter ended March 31, 2015, final adjustments and other developments that may arise between now and the time the financial results are finalized.

 

Item 8.01 Other EventsIn March 2015, we announced that researchers from Moffitt Cancer Center reported positive results from a pilot trial of tumor infiltrating lymphocytes (“TIL”) and ipilimumab in patients with metastatic melanoma. The Phase 1 trial was conducted at the Moffitt Cancer Center in patients with metastatic melanoma, with the objective of determining the safety and feasibility of combining TIL therapy with the CTLA-4 checkpoint inhibitor, ipilimumab. The pilot trial was partially sponsored by us. Twelve patients were treated with ipilimumab one week prior to tumor harvest for TIL expansion, a second time while their TIL were being expanded, and two more times following TIL transfer. Of the 12 patients enrolled in the trial, 11 went on to receive their autologous TIL, with five out of the 11 TIL-treated patients (46%) responding to treatment (one complete response and four partial responses), consistent with response rates from previous TIL studies in metastatic melanoma. Of the 12 enrolled patients, only one (8%) was ineligible for TIL transfer, indicating relatively high patient adherence to trial protocol.

This Current Report on Form 8-K contains forward-looking statements, including statements regarding expected financial results as of March 31, 2014. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. The company does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from the Company’s historical experience and its present expectations or projections. These risks and uncertainties include, but are not limited to, risks related to changes in estimated financial amounts based on the completion of financial closing procedures and the audit of the financial statements and market risks and uncertainties, as well as those described in “Item 1A. Risk Factors” and elsewhere in the Company’s Annual Report on Form 10-K and those described from time to time in other reports which the Company files with the Securities and Exchange Commission.

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