ADC Therapeutics SA

Thank you for holding. Good morning and welcome to Therapeutics Third Quarter 2020 Financial and Operating Results Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Amanda Hamilton, Investor Relations Manager at ABC Therapeutics. Please proceed.

Thank you, operator. This morning, we issued a press release announcing our third quarter 2020 financial results and business updates. This release is available on the ADCT website at ir.adttherapeutics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jay Feingold, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our third quarter 2020 financial results. In addition, Jennifer Herron, our Chief Commercial Officer, will be available for questions. As a reminder, this conference call may contain statements that constitute forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors. We refer you to the section titled Cautionary Statements Regarding Forward-Looking Statements in Exhibit 99.2 of our report on Form 6-K filed with the U.S. Securities and Exchange Commission earlier today for further information on forward-looking statements. Such statements speak only as of the date of this conference call. We expressly disclaim any obligation or undertaking to update these forward-looking statements unless required to do so by applicable law. In addition, during today's call, we will be presenting certain non-IFRS financial information that management uses when monitoring and evaluating operational performance, generating future operating plans, and making strategic decisions regarding the allocation of capital. These non-IFRS measures have limitations with financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. We refer you to the section titled Use of Non-IFRS Financial Measures in Exhibit 99.3 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today for further information on non-IFRS financial measures, including reconciliation of IFRS to non-IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin. Chris?

Thanks, Amanda, and thank you all for joining us this morning. I'm pleased to be here today to share our recent corporate and clinical accomplishments. Our team has made tremendous progress over the past quarter as we prepare for the launch of our first drug and continue to build out and advance our deep pipeline of highly potent and targeted antibody drug conjugates. I would like to thank our teams for their resilience and dedication over the past month. In September, we reached a major milestone for our organization, announcing the submission of our BLA to the FDA for our lead program, Longo. for the treatment of relapsed and refractory diffuse large B-cell involvement. As we have previously discussed, this submission is based on data from our pivotal Phase II LOCUS II trial, which evaluated the efficacy and safety of MONCA in patients with relapsed or refractory DLVTL following two or more lines of prior systemic therapy, and demonstrated important anti-tumor activity and durability, as well as manageable toxicity across patients with difficult-to-treat disease. We are expecting to receive FDA feedback on this submission later this month, and in anticipation of our pending PDUFA date, we are currently preparing to launch Longer in 2021. In order to prepare for launch, we have recruited highly experienced and focused oncology, commercial, and medical affairs teams based out of our New Jersey office. Despite COVID restrictions, this team is collaborating seamlessly and engaging key PLBCL stakeholders. As we anticipate the FDA acceptance of our PLA later this month, we have continued our efforts to ensure a quick sales team build in 2021, comprising predominantly of haematology oncologist specialists with knowledge and network to effectively communicate the long-term value proposition to key stakeholders. The Salesforce will cover more than 90% of the DLBCL opportunity, and we anticipate a hybrid approach at launch due to COVID-19. Therefore, we are staffing and training all members of our commercial and medical organizations to be prepared to pivot between face-to-face and virtual launch activities. We have developed a multi-channel engagement plan to ensure that all key audiences – physicians, nurses, office managers, payers, and patients – receive the necessary information and support to ensure rapid and easy access to, and safe administration of, Longer. As part of our Longer preparations, we have had the opportunity to engage with healthcare professionals in advisory boards and market research regarding Longer's maturing profile. And I'm pleased to report that the profile resonates really well. Hematologists and oncologists have shared with us their challenges to find an agent in the third line in relapsed refractory DLBCL that can potentially address the majority of their patients, be they transplant eligible or ineligible, high-risk disease, heavily pretreated, or refractory populations. Based on feedback from physicians on long-term efficacy, tolerability profile, and needs of administrations, We believe Lonco had the opportunity to become the standard of care in the third line based on our competitive profile versus other available options. In addition to our Lonco commercial preparations, we have continued to progress and expand our pipeline. I'm pleased to hand the call over to Chief Medical Officer Jay Feingold, who will now discuss those programs with you in more detail. Jay.