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Cellectis Inc.
8/6/2020
Greetings and welcome to the selected second quarter learning score. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Simon Hartnett. Thank you. You may begin.
Thank you and welcome everyone to Selectus' second quarter 2020 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Dr. Andre Choulika, our chairman and chief executive officer, Dr. Carrie Brownstein, our chief medical officer, and Eric Dutton, our chief financial officer. Yesterday evening, Selectus issued a press release reporting our financial results for the second quarter ended June 30, 2020. The press release is available on our website at selectis.com. As a quick reminder, we will make forward-looking statements regarding financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20F on file with the SEC and the financial report, including the management report for the year ended December 31, 2019, and subsequent filings selected makes with the SEC from time to time. I would now like to turn the call over to Andre.
Thank you, Simon. Good morning and thank you everyone for joining us today. I will start with a quick introduction before handing the call over to our Chief Medical Officer, Kerry Brownstein, for an update on our clinical programs and our Chief Financial Officer, Eric Dutton, for review of the financials. The second quarter of 2020 has been very productive for Selectist. We continue to be amazed by the commitment and the relentlessness of every nurse and doctor who gives outstanding care to cancer patients at their critical need in these exceptional times. I would like to highlight the outstanding progress our partners, Allogene and Servi, have made in driving forward for the development of our lead license candidates, UCAR-T19 and UCAR-DCMA, which Allogene renamed into ALLO-501, ALLO-501-A, and ALLO-715, respectively. As a reminder, UCAR-T19 or ALLO-501 is exclusively licensed to survey and survey exclusively sublicensed stripe in the U.S. to Allogene. UCAR-DCMA or Allo715 is exclusive essence to AlloGene. Allo501 has made headlines at ASCO in June where our partners AlloGene and Servia presented entering phase one dose escalation data in patients with non-touching lymphoma with a complete response rate of 44% and an overall response rate of 75% in the subgroup of patients who were naive to CAR-T cell treatment. No GVHD, inadequate safety profile. This data update comes as a follow-up to the data presented at ASH 2018 where the phase one dose escalation in relapsed refractory ALL patients showed an 82% CR or CRRI rate at an optimal lymphodepletion. UCAR-T-BCMA or ALO-715 is also progressing nicely into phase one. Dose escalation trial in a relaxed refractory multiple myeloma patient. The advancement of our partner program significantly deals with the anticipated milestone and wealthy revenue for Selectis. Selectis is entitled to receive up to $410 million in outstanding milestones payments plus a low double-digit royalty on a worldwide sale from Servian Allogene for the CD19-directed allogenic CAR-T program, as well as up to $2.8 billion in milestone payment plus a high single-digit royalty on worldwide sales from Allogene Darkly for the 15 licensed allogenic CAR-T cell targets, including the CNA. On our side, were pleased to see the progress in patient enrollment for our proprietary allogenic CAR-T cell programs for UCAR-T22 for patients with relapsed refractory DLL in the BALI-01 trial, as well as UCAR-T123 for patients with relapsed refractory AML in the AMLI-01 trial. Both programs are currently at dose level two in their respective phase one dose escalation, after dosing their first patient in December and January, respectively. UCAR-TCS1 for patients with relapsed refractory multiple myeloma in the MELANIE-01 trial has been put on hold early July following the death of the patient at DL2, and we're currently working with the FDA to address the agency's request and hope to resume the trial. Our strategy is to give an early-interim data update on one of our preparatory programs in Q4 for this year. At around a relevant scientific meeting, this update will be the beginning of our preparatory clinical data readout, which we plan to give on a periodically at relevant scientific meeting and regular intervals. With that, I would like to hand the call over to Dr. Brownstein, our Chief Medical Officer, to discuss the status of Selective Sponsor Trial. Carrie, please go ahead.
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