Iovance Biotherapeutics, Inc.

Hello, and welcome to the Iowa Vance Biotherapeutics First Quarter 2021 Financial Results Conference. My name is Michelle, and I will be the operator on today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and during the question-and-answer session, if you have a question, please press star then 1 on your touch-tone phone. I will now turn the call over to Ms. Sarah Pellegrino. Ma'am, you may begin.

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 Finkenstein, our Chief Medical Officer, and Jean-Marc Bellemien, 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 months ended on March 31st, 2021, 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 plans, 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 intro, I will turn the call over to Maria.

Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight our first quarter 2021 progress at Iovance during today's conference call. During 2021, we have continued to advance and expand our Iovance Tumor Infiltrating Lymphocyte, 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, Lifenucel in metastatic melanoma, We completed the submission of additional information related to our potency assays to FDA in support of a planned biologics license application or BNA submission. Resolution of the potency assay with FDA is our top priority for 2021. We also reported new and updated data from our ongoing C14401 clinical study, demonstrating durable responses in our cohort two for one-time treatment with Lifilucil. The Cohort 2 data was presented at AACR 2021, and additional data updates will be presented at ASCO 2021. In additional indications, we completed patient dosing in Cohort 2 for Lifenucel and advanced cervical cancer. For our registration-directed study of LN145 in non-small cell lung cancer, we continued to activate sites for IOV-LUN-202 and consented multiple patients. We believe that the growing body of Iovance TIL clinical data across multiple late-stage cancers, coupled with results from combination of our TIL and anti-PD-1 therapy in earlier stages of the disease, validate the significance and broad potential for Iovance TIL therapy. We also continue to execute toward all manufacturing and pre-commercial activities in furthering our commitment to address the critical need of cancer patients. I am very confident in the quality of our internal team to deliver toward this mission. An impressive 76% of our more than 250 employees have at least a year of cell therapy experience. On the call today, I would like to spend a few minutes highlighting our lead indications and manufacturing progress. Then I will let Frederic review our recent clinical data updates. I will begin with our first pivotal program, Life in LUSO for Advanced Solidoa. As discussed in our previous calls, metastatic melanoma is a common type of skin cancer. In the U.S. alone, metastatic melanoma accounts for approximately 100,000 patients diagnosed and 7,000 deaths each year in the United States. We are focused on the growing population of metastatic melanoma patients that have exhausted their most commonly used available care options and need alternative therapies in our C14401 studies. At the American Association for Cancer Research, or AACR, annual meeting, the updated data for cohort two from C14401 clinical study was presented at a clinical trial plenary session. The long-term follow-up data showed that median duration of response was not reached at 28.1 months of median study follow-up. Furthermore, overall response rates remained at 36.4%, and we saw a continued deepening of response in 17% of the patients. We, as well as KOLs, including the physicians who highlighted the data at AACR, continue to be very enthusiastic about the durability of response following one-time treatment with lichenucel in very difficult-to-treat metastatic melanoma patients. For the post-anti-PD-1 patient population enrolled in cohort 2, chemotherapy is the only currently available option and offers a 4% to 10% response rate, and overall survival of only seven to eight months. Further updates for cohort two will be highlighted at the upcoming American Society of Clinical Oncology, or ASCO, annual meeting in June. Detailed cohort two data has also been accepted for publication in a forthcoming manuscript in a peer-reviewed high-impact oncology journal. Turning to TIL in earlier lines of therapy, at the upcoming ASCO 2021 meeting, We are excited about sharing clinical data for lifelucel in combination with pembrolizumab and anti-PD-1-naive metastatic melanoma patients. Combination of Iovance TIL with available therapies and anti-PD-1-naive patients is one of Iovance's main clinical goals toward moving TIL into earlier treatment settings. Melanoma is the second clinical setting in which such combination is tested and data are being provided. As previously mentioned, reaching agreement with FDA on the potency assays for lifinusol is a top priority for IVAN. While the length of time until BLA submission depends on feedback from 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 lifinusol, in the C14504 study to support a BLA submission in metastatic cervical cancer. During the first quarter, cohort two patient dosing the lifinusil was completed in post-anti-PD-1 cervical cancer patients. We believe that a BLA submission that includes both pivotal cohort one, which is evaluating lifinusil post-chemotherapy, in addition to cohort two, may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer. As we have mentioned before, the resolution of the potency assay for life-inducing melanoma and dialogue with FDA around the amount of clinical data follow-up are key steps toward our BNA submission in the cervical cancer indication. As a reminder, the FDA has previously granted both break-through therapy and fast-track designations for life and use of cervical cancer. Turning to our manufacturing facility, Iovance Cell Therapy Center, or ICTC, we have completed construction of the exterior core and shell, as well as initial clean rooms, and we have moved in. Process equipment and necessary utilities are now in place in the available clean rooms. And activities have commenced to support the start of till clinical manufacturing in late 2021. Commercial manufacturing of Iovance till remains on track for 2022 with capacity to meet the demand for up to thousands of patients in multiple indications. Iovance has transformed till manufacturing from a lengthy academic process to a shorter, scalable, centralized GMP process yielding a credit reserve product. Our Gen 2 process is 22 days. To date, more than 450 patients have received Iovans TIL with a continuing success rate above 90%. We are also looking forward to the potential to further improve the TIL manufacturing timelines and efficiencies. A shorter 16-day third-generation Iovans TIL manufacturing process, or GEN3, is being explored in two of our clinical studies. The patients receiving GEN3-TIL include a cohort of metastatic melanoma patients in the IOV-COM-202 clinical study where patient dosing has initiated, as well as a cohort of non-sponsored lung cancer patients in the IOV-LUN-202 study. We have also built and continue to augment our intellectual property, which is covered by more than 25 granted or allowed U.S. and international patents. Granted patents include composition and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process with expected exclusivity through 2038. Iovance patent applications and granted patents are also directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic modification of TIL, tumor digest and fragment composition, and methods including cryopreservation and combination of TIL with checkpoint inhibitors. In addition, as noted in this afternoon's press release, we have licensed additional patent rights from National Institutes of Health, or NIH, for cytokine tethered TIL technology, including IL-15 and IL-21, and similar technologies. We also expanded our worldwide field of use to all cancers. We believe that this expanded license and relationship with NIH may further solidify our leadership in the advancement of TIL and related intellectual property. Turning to our pre-commercial launch preparations, we remained disciplined in our gated approach to commercial readiness. Our core commercial team continues to build the foundation for site training, patient access, payer coverage, and other commercialization readiness activities. We are well positioned to rapidly scale and expand efforts across these areas pending alignment with the FDA and our potency assay. Our medical affairs team maintains clinical site engagement in preparation for commercial launch. This team continues to work with key opinion leaders and patient advocacy groups on TIL awareness and educational programs, and to ensure scientific communication at major conferences and in peer-reviewed publications. Commercial team is partnering with the leading U.S. cancer centers to build their TIL service line capabilities. Our training and onboarding program, which we will further expand upon VLA submission, is designed to ensure cross-disciplinary teams can administer the Life Eluso treatment regimen upon FDA approval. Our market access team continues to engage payers to ensure patients have access to Life Eluso. Very recently, the Centers for Medicare and Medicaid Services, or CMS, proposed two new international classification of diseases, 10th revision procedure coding system or ICD-10 codes for lifelucel. Additionally, CMS proposed to map lifelucel to existing MS-DRG-18. CMS also proposed to expand MS-DRG-18 from CAR-T cell immunotherapy to CAR-T cell and other immunotherapies including Iovans-TIL. We believe that CMS's proposal to include Lifelucel in existing MS-DRG18 is recognition of the value of Iovans pill and cell therapies for patients and the need to ensure appropriate reimbursement for providers beyond CAR T. The proposal, if finalized, has the potential to strengthen hospital reimbursement for Lifelucel therapy at the time of launch. We appreciate CMS's leadership and commitment to access to care. The Iovance team is also developing our Iovance Cares program, which remains on track. Our goal is to deliver a best-in-class chain of custody and chain of identity system, cell ordering platform, and patient support capabilities. Iovance Cares is designed to be both customer and patient-centric throughout the life and useful treatment journey. I will now pass the call to Friedrich to outline our clinical updates. Friedrich?