GENERAL ORGANIZATION AND BUSINESS	9 Months Ended
Sep. 30, 2019
GENERAL ORGANIZATION AND BUSINESS
GENERAL ORGANIZATION AND BUSINESS	NOTE 1. GENERAL ORGANIZATION AND BUSINESS Iovance Biotherapeutics, Inc. (the “Company”, “we”, “us” or “our”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. Tumor infiltrating lymphocyte (TIL) therapy is a platform technology that has been licensed from National Cancer Institute (NCI) primarily based on data in metastatic melanoma and advanced cervical cancer. The Company has developed its own proprietary and scalable manufacturing method which is being further investigated in multiple indications. The Company’s lead product candidates include, lifileucel for metastatic melanoma, and LN-145 for advanced cervical cancer. Both product candidates are autologous adoptive cell therapy utilizing TIL, which are T cells derived from patients’ tumors. In addition to metastatic melanoma and advanced cervical cancer, the Company is investigating the effectiveness and safety of TIL therapy for the treatment of squamous cell carcinoma of the head and neck and metastatic non-small cell lung cancer through company sponsored trials, as well as other oncology indications through collaborations. The Company is currently conducting the pivotal cohort of its C-144-01 clinical trial of lifileucel in patients with metastatic melanoma. The Company is also conducting a pivotal trial of LN-145, C-145-04, in patients with advanced cervical cancer. On June 1, 2017, the Company reincorporated to become a company governed by Delaware corporation laws. Basis of Presentation of Unaudited Condensed Consolidated Financial Information The unaudited condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2019 and 2018 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-K. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2018 was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2019. These financial statements should be read in conjunction with that report. Liquidity The Company is currently engaged in the development of therapeutics to treat cancer, specifically solid tumors. The Company currently does not have any commercial products and has not yet generated any revenues from its business. The Company currently does not anticipate that it will generate any revenues from the sale or licensing of any of its product candidates during the 12 months from the date these financial statements are issued. The Company has incurred a net loss of $134.0 million for the nine months ended September 30, 2019 and used $105.1 million of cash in its operating activities during the nine months ended September 30, 2019. As of September 30, 2019, the Company had $361.9 million in cash, cash equivalents and short-term investments ($38.9 million of cash and cash equivalents and $323.0 million in short-term investments) and $5.5 million in restricted cash. The Company expects to further increase its research and development activities and begin to prepare for commercialization, which will increase the amount of cash used during 2019 and beyond. Specifically, the Company expects continued spending on its current and planned clinical trials, continued construction of a manufacturing facility, higher payroll expenses as the Company increases its professional, scientific and commercial and medical affairs staff, increased research and development activities, initiation of pre-commercial activities and activities in anticipation of filing Biologics License Applications. However, the extent and the timing of these expenditures are under the control of the Company. Based on the funds the Company has available as of the date these financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses for at least the next twelve months from the date these financial statements are issued. Concentrations of Risk The Company is subject to credit risk from our portfolio of cash equivalents and short-term investments. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.

GENERAL ORGANIZATION AND BUSINESS

9 Months Ended

Sep. 30, 2019

NOTE 1. GENERAL ORGANIZATION AND BUSINESS

Iovance Biotherapeutics, Inc. (the “Company”, “we”, “us” or “our”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. Tumor infiltrating lymphocyte (TIL) therapy is a platform technology that has been licensed from National Cancer Institute (NCI) primarily based on data in metastatic melanoma and advanced cervical cancer. The Company has developed its own proprietary and scalable manufacturing method which is being further investigated in multiple indications. The Company’s lead product candidates include, lifileucel for metastatic melanoma, and LN-145 for advanced cervical cancer. Both product candidates are autologous adoptive cell therapy utilizing TIL, which are T cells derived from patients’ tumors. In addition to metastatic melanoma and advanced cervical cancer, the Company is investigating the effectiveness and safety of TIL therapy for the treatment of squamous cell carcinoma of the head and neck and metastatic non-small cell lung cancer through company sponsored trials, as well as other oncology indications through collaborations. The Company is currently conducting the pivotal cohort of its C-144-01 clinical trial of lifileucel in patients with metastatic melanoma. The Company is also conducting a pivotal trial of LN-145, C-145-04, in patients with advanced cervical cancer. On June 1, 2017, the Company reincorporated to become a company governed by Delaware corporation laws.

Basis of Presentation of Unaudited Condensed Consolidated Financial Information

The unaudited condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2019 and 2018 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-K. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2018 was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2019. These financial statements should be read in conjunction with that report.

Liquidity

The Company is currently engaged in the development of therapeutics to treat cancer, specifically solid tumors. The Company currently does not have any commercial products and has not yet generated any revenues from its business. The Company currently does not anticipate that it will generate any revenues from the sale or licensing of any of its product candidates during the 12 months from the date these financial statements are issued. The Company has incurred a net loss of $134.0 million for the nine months ended September 30, 2019 and used $105.1 million of cash in its operating activities during the nine months ended September 30, 2019. As of September 30, 2019, the Company had $361.9 million in cash, cash equivalents and short-term investments ($38.9 million of cash and cash equivalents and $323.0 million in short-term investments) and $5.5 million in restricted cash.

The Company expects to further increase its research and development activities and begin to prepare for commercialization, which will increase the amount of cash used during 2019 and beyond. Specifically, the Company expects continued spending on its current and planned clinical trials, continued construction of a manufacturing facility, higher payroll expenses as the Company increases its professional, scientific and commercial and medical affairs staff, increased research and development activities, initiation of pre-commercial activities and activities in anticipation of filing Biologics License Applications. However, the extent and the timing of these expenditures are under the control of the Company. Based on the funds the Company has available as of the date these financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses for at least the next twelve months from the date these financial statements are issued.

Concentrations of Risk

The Company is subject to credit risk from our portfolio of cash equivalents and short-term investments. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of

credit risk from these financial instruments. The goals of its investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.