Cellectis Inc.

Good morning, everyone, and welcome to the Selectus' fourth quarter and full year 2019 results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. Please be aware that today's conference call is being recorded. I'd now like to introduce the first speaker, Simon Harness, Selectus Vice President of Corporate Strategy and Finance. You may begin, sir.

Thank you and welcome everyone to Selecta's fiscal year and fourth quarter 2019 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, Eric Dutton, our chief financial officer, and Dr. Francisco Esteva, vice president, clinical development. Yesterday evening, Selectus filed its annual reports and issued a press release reporting our financial results for the fourth quarter and year ended December 31, 2019. The reports and press release are available on our website at selectus.com. As a 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. I would now like to turn the call over to Andre.

Thank you, Simon. Good morning, and thank you, everyone, for joining us today. 2019 has been a year of strong execution for Selectives. I am proud to say that we are on track with the clinical development of the three wholly controlled allogenic CAR T cell product candidates, as well as three partner product candidates. UCAR TCS1 in relapsed refractory multiple myeloma, UCAR 22 in relapsed refractory BALL, and UCAR 123 in relapsed refractory AML are all wholly controlled product candidates and concurrently in phase one dose escalation trials called respectively, Melody01, Bally01, and Amily01. These studies are designed to assess the safety and optimal dose for each product candidate in three to four different dose cohorts, and when available, We're planning to share an interim data set on these programs in the second half of this year. An additional near-term value driver for Selectis is the two licensing agreements we have in place with our allogenic CAR T-cell platform with two world-class partners. We announced yesterday with Servier the execution of the amendment confirming the terms of the term sheet signed on February the 18th, 2020. Under this amendment, Selectis grants to survey an expanded exclusive worldwide license to develop and commercialize an allogenic CAR T-cell product targeting CD19, including Allo 501 and Allo 501A product candidates. We're excited about the increased focus by our partner survey and its U.S. sublicense, Allogene Therapeutics, on the pioneering UCAR T19 program in ALL and the expansion into DL-BCL patients. As part of the amendment, Selectis is entitled to receive an additional $27 million upfront payment, up to $410 million in pre-commercial and commercial milestones, as well as a flat, low double-digit royalty on sales of the licensed product. While providing Selectis an attractive economic upside, to the prologue candidates targeting CD19, this amendment significantly enriches our proprietary portfolio of targets with five additional differentiated CAR-T cell targets in both solid and liquid tumors. Our proprietary gene editing platform provides us with a vast amount of new opportunities in the ever-expanding cell therapy arena. We have recently made the selective decision to partner with iOvents Biotherapeutics to use our talent technology to develop gene-edited tumor infiltrating lymphocytes for cancer therapeutics, an area where we see tremendous promises and opportunity. We're looking forward to sharing more of this exciting new development program in the future. Hand in hand with our increased clinical development, we are seeing strong expansion in the manufacturing effort in the cell therapy space. Here, there are two main trends. First, know-how is the key proprietary asset in this industry. And second, we have seen a strong trend for consolidation. As a result, Selectis has taken the forward-looking decision to fully integrate its manufacturing expertise as a key strategic asset for the company. In March 2019, we announced our lease agreement for an 82,000 square foot commercial scale manufacturing facility in Raleigh, North Carolina. This new site being designed to develop GMP manufacturing for clinical supplies and commercial manufacturing upon regulatory approval. We are on track with the build-out process and the facility is planned to be operational next year. In addition to Raleigh, we have built a 14,000 square foot manufacturing facility in Paris, which is designed to produce critical wrote and starting material supplies for the ongoing CAR-T clinical studies and our future commercial products. This facility is designed to help us save significant amount of time and money in the manufacturing process currently done at our CMO partners, MolMed and Lonza. We believe this strategy will enable a smooth transition toward a full manufacturing independence. With that, I would like to hand the call over to Dr. Francisco Esteva, Vice President of Clinical Development, who will give you a quick overview of our wholly controlled clinical CAR T-cell program. As a brief introduction, Francisco is a medical oncologist with an outstanding track record of peer-reviewed publications with more than 20 years of experience in drug development. Francisco spent 16 years at MD Anderson Cancer Center and six years at NYU leading clinical research programs in breast cancer and solid tumors. Francisco joined Selectus in October 2019 as the head of clinical development. We are honored to have Francisco as part of our team and I'm excited about the positive impact he will have on our clinical development. Francisco, please go ahead.