Iovance Biotherapeutics, Inc.

Good afternoon and welcome to the IOBAN's fourth quarter and full year 2020 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that portion of the call, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would like to turn the call over to your speaker, Sara Pellegrino, Vice President, Investor and Public Relations at Iovant. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Maria Fardis, our President and Chief Executive Officer, Frederick Finckenstein, our Chief Medical Officer, and John Mark Bellamine, our Chief Financial Officer. We are also joined by Jim Ziegler, Senior Vice President Commercial. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three and 12 months ended on December 31st, 2020, as well as corporate updates. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals business focus, business plan, pre-commercial activities, clinical trials and regulatory plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, collaborations, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that introduction, I will hand the call over to Maria.

Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight our 2020 progress as well as our 2021 priorities at Iovance during today's conference call. During 2020, we continue to advance and broaden our tumor infiltrating lymphocytes or TIL platform across multiple indications, including metastatic melanoma, cervical, head and neck, and non-small cell lung cancers. For our lead TIL product candidate, lifelucel and metastatic melanoma, we reported new and updated data from our ongoing C14401 clinical study, demonstrating durable responses in our cohort two for one-time treatment with lifelucel. We initiated a dialogue with FDA and learned that we need to continue refining the information from our potency assays. We continue our work to refine existing assays as well as to develop new assays in pursuit of our biologics license application, or BLA, which is our top priority for 2021. In additional indications, we completed enrollment in two cohorts for lifelucel and advanced cervical cancer. We reported the initial clinical data for TIL in combination with pembrolizumab in head and neck cancer, and we activated sites for our registration-directed study of LN145 in non-small cell lung cancer. We believe that the growing body of TIL clinical data across multiple late-stage cancers, coupled with combination of TIL and checkpoint inhibitors in earlier stages of disease, validate the significance and broad potential for TIL. We also continue to execute toward all manufacturing and pre-commercial activities in furthering our commitment to address the critical needs of cancer patients. I am very confident in the strength of our employees to deliver on this mission. We have an impressive 76% of our nearly 250 employees who have at least a year of cell therapy experience. On the call today, I would like to spend a few minutes highlighting the lead indications. Then I would let Frederick highlight our recent clinical study updates. I will begin with our first pivotal program, Life Elusive in Advanced Melanoma. Metastatic melanoma is a common skin cancer accounting for approximately 96,000 patients diagnosed and 7,000 deaths each year in the United States alone. We are focused on metastatic melanoma patients that have exhausted their most commonly used available care options and need alternative therapies. In early January of 2021, we provided a corporate update that median duration of response still has not been reached at 28.1 months of median study follow-up for cohort 2 from our C14401 clinical study. We, as well as KOLs, continue to be very enthusiastic about the durability of response following one-time treatment midlife in useful. For the post-anti-PD-1 patient population similar to cohort 2, chemotherapy is only currently available option and offering a 4% to 10% response rate and overall survival of only 7 to 8 months. We intend to present the long-term follow-up data from cohort 2 at an upcoming medical conference. As previously mentioned, reaching agreement with FDA on the potency assay is a top priority for IOVAN. Following a type B meeting with the U.S. FDA during fourth quarter of last year, we reached agreement on the duration of clinical data follow-up for our pivotal cohort four to support the BLA. We did not reach an agreement with the agency on the potency assays to define till and continue our work to define existing potency assays while developing new assays. While the length of time until BLA submission depends on future dialogue with the agency, we continue staying prepared for a BLA submission in 2021. We plan to provide updates when available. Our second pivotal program is investigating LN145, now also known as ripenucel, in the C14504 study to support a BLA submission in metastatic cervical cancer. Enrollment in both cohorts one and two of this study have been completed. Patients in our pivotal cohort one are post-chemotherapy, whereas cohort two includes post-anti-PD-1 patients. We believe that inclusion of both cohorts in the BLA may strengthen the potential label and reflects the expected upcoming treatment landscape in cervical cancer. The resolution of the potency assay for lifelucel and melanoma is a key step toward our BLA submission plan in the cervical cancer indication. As a reminder, the FDA has previously granted both breakthrough therapy and fast-track designations for lifelucel in cervical cancer. Turning to our manufacturing facility, Iovance Cell Therapy Center, or ICTC, The construction of clean rooms was completed in late 2020. Process equipment are now in place in the available clean rooms and activities in support of clinical manufacturing are expected to initiate in the coming months. Commercial manufacturing remains on track for 2022 with capacity to meet the demand for up to thousands of patients. Iovance has transformed pill manufacturing from a lengthy academic process to a shorter, scalable, centralized GMP process yielding a cryopreserved product. Our Gen 2 process is 22 days. To date, more than 400 patients have received Iovans TIL with a continuing success rate above 90%. We have also built and continue to augment our intellectual property, which is covered by more than 20 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process. Our Iovance IP portfolio includes patent applications and granted patents directed toward Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, cryopreservation, and combination of TIL with checkpoint inhibitors. Turning to our commercial launch preparation, the Iovance team is currently focused on KOL engagement, site activation and training, TIL education and awareness, patient access, and other readiness activities. Our priority is to ensure launch success while taking a gated approach to commercial readiness expenses and a headcount prior to BLA submission. Our medical affairs team works with a network of treating healthcare professionals, or HCPs, and patient advocacy groups to ensure that the information about TIL is available to interested organizations. A core commercial team continues to partner with the leading U.S. cancer centers to build their TIL service line capabilities and the intent to scale our training and onboarding upon BLE submission. Our market access team continues to meet with the private payers and the Centers for Medicare and Medicaid Services, or CMS, to ensure patients have appropriate and timely access to Lifelucel. We believe that CMS and payers recognize the unmet need and clinical value of Lifelucel, as well as the potential benefits for patients with metastatic melanoma. We are also pleased with the development and progress of our Iovance CARES program. Our goal is to deliver a best-in-class cell ordering and patient support system that assists the patients at every step of the process. I will now pass the call to Friedrich to outline our clinical study updates, including the enrollment status, as well as introduction of new cohorts and treatment regimens into our existing studies. Friedrich?