On November 5, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL), reported third quarter 2020 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, NOV 5, 2020, View Source [SID1234570059]).

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"Subsequent to meeting with FDA, we have moved the BLA submission date for lifileucel to 2021 in order to reach agreement on the required potency assays to fully define TIL," said Maria Fardis, PhD, President and CEO of Iovance. "In additional indications, we look forward to starting our registration-directed study in non-small cell lung cancer, and to presenting initial clinical data of TIL in combination with anti-PD-1 therapy in head and neck cancer. Our financial strength also allows us to advance our clinical programs and continue our operating plans. Overall, I believe that Iovance is well-positioned to be the leader in development, manufacturing and commercialization of TIL cell therapy for cancer."

Third Quarter 2020 and Recent Corporate Updates

Clinical:

TIL therapy, lifileucel, in melanoma: Iovance and the U.S. Food and Drug Administration (FDA) reached agreement on duration of follow up for pivotal data for the biologics license application (BLA) for lifileucel in metastatic melanoma. Additional work is underway on current and new potency assays in support of the BLA. Dialogue with FDA about the assays is expected to continue with BLA submission anticipated to occur in 2021.
TIL therapy, lifileucel, in cervical cancer: the last patient was dosed in the pivotal Cohort 1 of the C-145-04 study of lifileucel, formerly LN-145, for metastatic cervical cancer.
TIL therapy in non-small cell lung cancer (NSCLC): the protocol was finalized for the potential registration-directed study, IOV-LUN-202, to investigate LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations, who previously received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) plus chemotherapy). Cohorts 1 and 3 have patients with TPS score of less than one percent, and Cohort 2 will enroll patients with TPS score of greater than or equal to one percent.
TIL therapy, LN-145, in head and neck squamous cell carcinoma (HNSCC): in the abstract for the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, patients with HNSCC who received LN-145 in combination with pembrolizumab showed an overall response rate (ORR) of 44% and median duration of response had not been reached at 6.9 months of median study follow up (n=9). Updated data will be presented at SITC (Free SITC Whitepaper).
Iovance development program: to date, over 400 patients have been dosed with Iovance TIL products with more than 90 percent manufacturing success rate.
Manufacturing:

Construction of the Iovance Cell Therapy Center (iCTC) is advancing as planned at the Navy Yard in Philadelphia. Clean rooms are expected to be completed in late 2020 with clinical activities to initiate in early 2021. Commercial manufacturing is on track for 2022.
Corporate:

Cash position of $719.7 million at September 30 is sufficient for Iovance to execute commercial launch and pipeline programs, including the IOV-LUN-202 study in NSCLC.
A strong organization of over 200 employees is in place across multiple locations to advance research, development, manufacturing and commercial launch preparations.
Iovance has been granted or allowed a total of 20 U.S. patents for compositions and methods of treatment in using Iovance TIL in a broad range of cancers related to its 22-day second generation (Gen 2) manufacturing process.
Upcoming Data in Head and Neck Cancer at SITC (Free SITC Whitepaper) Annual Meeting (November 9-14, 2020):

Poster Presentation (Abstract #353): Safety and efficacy of tumor infiltrating lymphocytes (TIL; LN-145) in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC
Authors: A Jimeno, et al.
Presentation Times: Wednesday, Nov. 11, from 5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m. EST.
Location: Virtual Poster Hall
Third Quarter and September Year-to-Date Financial Results

Iovance held $719.7 million in cash, cash equivalents, short-term investments and restricted cash at September 30, 2020 compared to $312.5 million at December 31, 2019. The current cash position includes net proceeds of $567.0 million from a common stock public offering in June 2020. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be over $630 million.

Net loss for the third quarter ended September 30, 2020, was $58.6 million, or $0.40 per share, compared to a net loss of $49.5 million, or $0.40 per share, for the third quarter ended September 30, 2019. Net loss for the nine months ended September 30, 2020, was $191.2 million, or $1.41 per share, compared to a net loss of $134.0 million, or $1.08 per share, for the same period ended September 30, 2019.

Research and development expenses were $43.1 million for the third quarter ended September 30, 2020, an increase of $1.5 million compared to $41.6 million for the third quarter ended September 30, 2019. Research and development expenses were $149.3 million for the nine months ended September 30, 2020, an increase of $37.5 million compared to $111.8 million for the same period ended September 30, 2019.

The increase in research and development expenses in the third quarter 2020 over the prior year period was primarily attributable to growth of the internal research and development team and higher stock-based compensation, partially offset by a decrease in manufacturing costs. The increase in research and development expenses in the first nine months of 2020 over the prior year period was primarily attributable to higher patient enrollment in clinical trials, licensing fees and growth of the internal research and development team.

General and administrative expenses were $15.9 million for the third quarter ended September 30, 2020, an increase of $5.9 million compared to $10.0 million for the third quarter ended September 30, 2019. General and administrative expenses were $44.1 million for the nine months ended September 30, 2020, an increase of $14.2 million compared to $30.0 million for the same period ended September 30, 2019.

The increases in general and administrative expenses in the third quarter and first nine months of 2020 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the third quarter and year-to-date 2020 financial results and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 1190777. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.