Iovance Biotherapeutics(IOVA) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2021, Iovance held $602.1 million in cash, cash equivalents, investments, and restricted cash, a decrease from $635 million on December 31, 2020, indicating a strong cash position expected to last into 2024 [37] - The net loss for Q4 2021 was $99.3 million or $0.63 per share, compared to a net loss of $68.4 million or $0.47 per share in Q4 2020 [38] - For the full year 2021, the net loss was $342.3 million or $2.23 per share, compared to a net loss of $259.6 million or $1.88 per share in 2020 [39] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2021 were $75.6 million, an increase of $23.1 million from $52.5 million in Q4 2020, primarily due to growth in the internal R&D team and increasing clinical trial costs [40] - General and administrative expenses for Q4 2021 were $23.8 million, up from $16.1 million in Q4 2020, attributed to growth in the internal team and increased intellectual property filing costs [43] Market Data and Key Metrics Changes - The company is focused on onboarding at least 40 authorized treatment centers (ATCs) for the commercialization of lifileucel, informed by CAR-T market data indicating that top centers account for a significant portion of treated patients [22] Company Strategy and Development Direction - The company aims to submit its Biologics License Application (BLA) for lifileucel in metastatic melanoma in the first half of 2022 and expand TIL therapy into non-small cell lung cancer and cervical cancer [13][14] - Iovance is preparing for commercial manufacturing and launch, with a focus on owning its manufacturing capabilities to ensure success [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of Iovance's position to lead in developing TIL therapies for cancer, emphasizing the importance of their manufacturing capabilities [14] - The company is actively engaged in discussions with the FDA regarding regulatory plans and is preparing for potential BLA submission [9][10] Other Important Information - The Iovance Cell Therapy Center (ICTC) has completed commissioning activities and initiated TIL clinical supply, with the first patient receiving TIL manufactured at ICTC in September 2021 [16][17] - The company has a robust intellectual property portfolio with over 35 granted or allowed patents, providing exclusivity into 2038 [18][19] Q&A Session Summary Question: Resolution on potency assay for BLA submission - Management confirmed the need for resolution on the potency assay to proceed with BLA submission and indicated ongoing discussions with the FDA [51][52] Question: Filing and validation process - Management clarified that the BLA submission process involves ongoing interactions with the FDA, and they aim to address any concerns raised during the review period [60][62] Question: Cervical cancer filing timelines - Management acknowledged changes in the treatment landscape for cervical cancer and is planning a registrational strategy based on FDA feedback [70] Question: Cohort 4 data status - Management stated that Cohort 4 data is still being worked on and will be included in the BLA submission [58][59] Question: European filing strategy - Management indicated that the European strategy hinges on the outcome of the FDA submission, with plans to move quickly if the FDA approval is granted [124][125]