On February 25, 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 fourth quarter and year-end 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, FEB 25, 2020, View Source [SID1234554728]).

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"During 2019 we made tremendous progress in advancing Iovance TIL and PBL products," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "We conducted two planned pivotal programs for lifileucel in melanoma and LN-145 in cervical, initiated patient dosing in earlier lines of therapy and received clearance from FDA on a new IND to proceed to dose patients with our PBL product, IOV-2001. In anticipation for commercialization of Iovance TIL, we are building our internal manufacturing capability and expanding our commercial team and infrastructure. With the first potential cell therapy in solid tumors, as well as a broad TIL platform, Iovance is poised to become the leader in development, manufacturing, and commercialization of TIL cell therapy for solid tumors."

2019 Highlights and 2020 Updates

Clinical

·Initiation and completion of patient dosing in the pivotal melanoma program, cohort 4 in the C-144-01 trial: Patient dosing in the pivotal cohort 4 of the C-144-01 study was initiated in March 2019 and completed in January 2020, three months ahead of schedule. Iovance intends to submit a biologics license application (BLA) to FDA subsequent to consultation with the agency in 2020.
·Presentation of data for lifileucel in metastatic melanoma and LN-145 for metastatic cervical cancer at major medical meetings: Several clinical data presentations continued to demonstrate efficacy and safety of lifileucel in metastatic melanoma (from C-144-01 study) and LN-145 in recurrent, metastatic, or persistent cervical cancer (from C-145-04 study).
oMelanoma update
·The data for the C-144-01 study in melanoma demonstrated a 36.4% ORR by investigator as presented at ASCO (Free ASCO Whitepaper).1
·In a recent data cut for the C-144-01 study, a median duration of response (DOR) was not reached at 15.5 months of median study follow up (Jan. 2020).2
·Expansion of TIL treatment to earlier lines of therapy for melanoma, head and neck, and non-small cell lung cancer (NSCLC) patients. Patient dosing in the IOV-COM-202 clinical study was initiated in May 2019 to evaluate TIL plus pembrolizumab in patients with immune checkpoint inhibitor naïve melanoma, squamous cell carcinoma of the head and neck (HNSCC), and NSCLC. In the fourth cohort, LN-145 alone is offered to relapsed/refractory NSCLC patients.

Regulatory

·Receipt of Breakthrough Therapy designation (BTD), Fast Track designation and holding End of Phase 2 Meeting for LN-145 in cervical cancer: LN-145 was granted Fast Track and BTD from FDA in recurrent, metastatic or persistent cervical cancer with disease progression on or after chemotherapy. Following an end of Phase 2 meeting, the ongoing C-145-04 clinical study was expanded to dose 75 patients to support registration of LN-145. Additional cohorts in earlier and later line cervical cancer patients were added to study C-145-04 in anticipation of a changing landscape in this indication, specifically, a cohort allowing patients post anti-PD-1 was added.
·Clearance of the investigational new drug (IND) application by FDA and initiation of patient dosing for PBL (IOV-2001) therapy in the first hematologic indication, CLL: An IND application for IOV-2001 was accepted by FDA in the blood cancer indication, relapsed or refractory CLL or small lymphocytic lymphoma (SLL). The first patient was dosed in a Phase 1/2 study (IOV-CLL-01 study).

Manufacturing

·Continuation of high manufacturing success rate: The Gen 2 TIL therapy manufacturing process continues to be robust with a demonstrated success rate, as measured from the receipt of the starting material to the shipment of TIL product, of well over 90 percent in approximately 300 patients.
·Clinical introduction of Gen 3 TIL therapy: A proprietary 16-day, third generation TIL therapy manufacturing process (Gen 3) entered the clinic for initial evaluation in the expanded C-145-03 clinical study in head and neck cancer patients with significant unmet need, for which shorter time to TIL infusion may offer a potential benefit.
·Clinical introduction of PD-1 selected TIL therapy (LN-145-S1): A proprietary, selected TIL product LN-145-S1, aimed at taking further advantage of TIL’s ability to recognize the tumor, is also entering the clinic for initial evaluation in the expanded C-145-03 study in head and neck cancer, and subsequently in a new cohort in the IOV-COM-202 study.

Corporate

·Iovance manufacturing facility on track for commercial production in 2022: Iovance began construction of a state-of-the-art, 136,000 square foot commercial-scale production facility in Philadelphia for its TIL therapies in June 2019. The new facility is expected to be completed by year-end 2021 to support commercial supply in 2022, with capacity to meet demand for thousands of patients in multiple cancers. Iovance expects to invest approximately $85 million over three years for equipment and construction of the facility.
·The National Cancer Institute (NCI), with support from Iovance, received an award for TIL therapy technology transfer: NCI won the Federal Laboratory Consortium’s 2020 Excellence In Technology Transfer Award for "New, First-in-class Immunotherapy, for Treatment of Recurrent, Metastatic Cervical Cancer" for its collaboration with Iovance. Iovance supported NCI’s application for the award and remains a CRADA partner for ongoing research in TIL therapy.3
·New Iovance patents issued: Iovance has been granted or allowed a total of 10 U.S. patents for compositions and methods of treatment in a broad range of cancers related to its 22-day Gen 2 manufacturing process.

Research and Development

·Licensing of novel IL-2 analog (IOV-3001): Iovance obtained a license from Novartis to develop and commercialize an expectedly better IL-2 analog, an antibody cytokine engrafted protein, referred to as IOV-3001, as a targeted and selective IL-2 analog.
·Licensing of TALEN technology to develop gene edited TIL: Under a research collaboration and exclusive worldwide license agreement with Cellectis, Iovance licensed certain Cellectis TALEN technology to develop genetically edited TIL to potentially create more potent therapeutics in several cancer indications. The worldwide exclusive license enables Iovance’s use of TALEN technology addressing multiple gene targets to modify TIL for therapeutic use.

Anticipated 2020 Milestones

·Last patient dosed in the pivotal program of LN-145 for cervical cancer
·Pre-BLA Meeting with U.S. FDA
·Melanoma top-line pivotal data
·BLA submission

Fourth Quarter and Full-Year 2019 Financial Results

Net loss for the fourth quarter ended December 31, 2019, was $63.6 million, or $0.50 per share, compared to a net loss of $32.6 million, or $0.27 per share, for the fourth quarter ended December 31, 2018. Net loss for the full-year ended December 31, 2019, was $197.6 million, or $1.59 per share, compared to a net loss of $123.6 million, or $1.27 per share, for the full-year ended December 31, 2018.

Research and development expenses were $54.2 million for the fourth quarter ended December 31, 2019, an increase of $26.8 million compared to $27.4 million for the fourth quarter ended December 31, 2018. Research and development expenses were $166.0 million for the 12 months ended December 31, 2019, an increase of $66.2 million compared to $99.8 million for the prior year period. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to an increase in costs associated with manufacturing activities and capacity, clinical trials due to higher enrollment, and growth of the internal research and development team.

General and administrative expenses were $10.9 million for the fourth quarter 2019, an increase of $3.4 million compared to $7.5 million for the fourth quarter 2018. General and administrative expenses were $40.8 million for the 12 months ended December 31, 2019, an increase of $12.4 million compared to $28.4 million for the full year ended December 31, 2018. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to growth of the internal general and administrative team, as well as higher intellectual property legal costs and market research activities in preparation for commercialization.

Cash, cash equivalents, short term investments and restricted cash

At December 31, 2019, the company held $312.5 million in cash, cash equivalents, short-term investments and restricted cash compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and full-year 2019 results and 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 4693108. 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.