On May 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 first quarter 2020 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 5, 2020, View Source [SID1234557031]).
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"We continue making strong progress toward commercializing Iovance TIL for melanoma and cervical cancer indications," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "While COVID-19 has impacted healthcare systems globally, we have been able to continue our key business operations due to dedication from our employees and through close collaboration with our clinical sites and other business partners. Cancer patients are still in critical need of access to therapy and a one-time treatment may offer an attractive therapeutic option to patients and treating physicians. With the first potential cell therapy in solid tumors and a broad TIL platform, Iovance remains well-positioned to become the leader in development, manufacturing, and commercialization of TIL cell therapy for cancer."
First Quarter 2020 Updates
Clinical:
·Melanoma: the last patient in the pivotal Cohort 4 of C-144-01 melanoma study was dosed in January 2020. The enrollment of this cohort was completed approximately three months ahead of schedule with over-enrollment due to increased demand for participation.
·Cervical: enrollment in the cervical study C-145-04 continues and completion of enrollment in the pivotal program is on track for approximately mid-2020.
Regulatory:
·Iovance continues preparing for submission of a Biologics License Application (BLA) in late 2020 through data compilation as well as internal readiness activities.
Manufacturing:
·Manufacturing at all manufacturing organizations continues as planned for ongoing clinical studies.
·Construction of the Iovance manufacturing facility at the Navy Yard in Philadelphia continues with initiation of the build of clean rooms in April 2020, ahead of schedule.
Corporate:
·Iovance continues to build a strong team with approximately 190 employees across multiple locations and an experienced commercial team in place preparing for launch of lifileucel.
·Iovance has been granted or allowed a total of 12 patents for compositions and methods of treatment in using Iovance TIL in a board range of cancers related to its 22-day second generation (Gen 2) manufacturing process.
Clinical Data Presentations:
·Oral presentation of updated data from Cohort 2 in the C-144-01 trial in metastatic melanoma at upcoming ASCO (Free ASCO Whitepaper) 2020: the abstract #10006 is titled "Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies." The virtual scientific program of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) will be held May 29-31, 2020.
·H. Lee Moffit Cancer Center’s TIL data from Phase 1 lung cancer study presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I: Moffit’s presentation demonstrated the potential clinical benefit for TIL in non-small cell lung cancer (NSCLC), including two durable complete responses lasting beyond 12 months, in a Phase 1 study supported by Iovance Biotherapeutics, a Stand Up To Cancer Catalyst grant, and other partners.
First Quarter 2020 Financial Results
Net loss for the first quarter ended March 31, 2020, was $69.6 million, or $0.55 per share, compared to a net loss of $37.0 million, or $0.30 per share, for the first quarter ended March 31, 2019.
Research and development expenses were $57.0 million for the first quarter ended March 31, 2020, an increase of $26.1 million compared to $30.9 million for the first quarter ended March 31, 2019. The increase in first quarter 2020 over the prior year period was primarily attributable to an increase in costs associated with the license to the IOV-3001 IL-2 analog from Novartis, clinical trials due to higher enrollment, growth of the internal research and development team, and increased manufacturing activities.
General and administrative expenses were $13.9 million for the first quarter 2020, an increase of $4.8 million compared to $9.1 million for the first quarter 2019. The increase in first quarter 2020 over the prior year period was primarily attributable to growth of the internal general and administrative team, higher stock-based compensation expenses, as well as higher legal costs.
At March 31, 2020, the company held $251.2 million in cash, cash equivalents, short-term investments and restricted cash compared to $312.5 million at December 31, 2019. The first quarter 2020 spend included upfront license payments and the purchase of clinical materials.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss the first quarter 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 4564469. 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.