Gracell Biotechnologies Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Grace L Biotechnology's fourth quarter and full year 2020 conference call. At this time, all participants are in a listen-only mode. After opening remarks, we will open the call for your questions. Instructions for queuing up will be given at that time. I would now like to turn the conference over to Kevin Che, CFO. Please go ahead.

Good morning, and welcome to Griselle's fourth quarter earnings conference call and webcast. This is our first earnings call as a public-traded company. Yesterday, Griselle issued a press release announcing unaudited financial results for the three months ended December 31, 2020. We encourage everyone to read this press release, as well as Griselle's Form 20F. for the year end December 31st, 2020, which will be filed with SEC by April 30th, 2021. There's a slide presentation accompanying today's call. This slide presentation and the fourth quarter earnings release can be accessed on the investor relations section of Griswold website at griswoldbio.com. I would like to remind you that this call is being recorded for replay. Please note that certain information discussed on this call today is covered under the safe harbor provision of private securities litigation reform act. We caution listeners that during this call, resource management will be making forward-looking statements. Actual results may differ materially from those stated or implied by these forward-looking statements as a result of various important factors, including the clinical trial results of our product candidates, actions of regulatory agencies, which may affect the initiation, timing, and progress of our clinical trials, and the marketing approval. Our ability to achieve commercial success if any of our product candidates is proved our ability to obtain and maintain protection of intellectual property for our product candidates and the technology platforms, and other risk factors more fully disclosed in the risk factors section of our final prospectus and any substance filing with the SEC. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 10, 2021. Grisel undertakes no obligation to revise or update any forward-looking statements to reflect events and circumstances after the date of this conference call, except as may be required by security law. With me today are Grisel's founder and chief executive officer, Dr. William Tao, our Chief Medical Officer, Dr. Martina Serge. We're excited to discuss our innovative technologies and the clinical pipeline of CAR T therapies in today's call. We also look forward to sharing with you our recent business development and upcoming targets for 2021. With that said, I'd like to turn the call over to Grace, our CEO. Dr. William Cao. William?

Thank you, Kevin. And again, welcome everyone to our fourth quarter earnings conference call. For those of you that are new to Gray Cell Story, we are a global clinical stage biopharmaceutical company dedicated to discovering and developing breakthrough CAR T-cell therapies. CAR T-cells can be classified in two groups. as either autologous, derived from T-cells of the cancer patient, or allogenetic, derived from the T-cells of a healthy donor. We have developed our proprietary technology platform in each of these areas, FASC-CAR and TRU-U-CAR, that we believe represent game-changing advances in the CAR-T industry. By leveraging these proprietary technology platforms, GraceL is developing a rich clinical stage pipeline of multiple autologous and allogenetic product candidates to overcome major industry challenges that are persistent with conventional CAR-T therapies, including lengthy manufacture times, suboptimal production quality, high therapy costs, and lack of effective CAR T therapies for solid tumors. Our pipelines of autologous and allogenetic cell therapy candidates is in ongoing studies with highly competitive data in several indications. In addition, we have assembled a highly experienced leadership team in this space with a proven track record of success. We are very excited to have completed a successful IPO that was supported by top-tier institution investors that our CFO, Dr. Kevin Shea, will discuss in greater detail shortly. We believe the support of our investors reflects confidence in our highly differentiated CAR T therapies and the pioneering technology platform. So on slide five, you'll see that Grayscale has developed two proprietary sophisticated technology platforms to improve treatment outcomes and address commercial bottlenecks. FastCard is Grayscale's autologous CAR-T platform designed to overcome challenges of conventional CAR-T therapies by significantly shortening cell manufacturing time from weeks down to next day, which importantly also contribute to enhanced T cell fitness. TruUcar is a gray cell platform of allogeneic CAR T therapies that can be administered off the shelf at a lower cost. Unlike autologous CAR T therapies, these products use T cells from non-HLA-matched healthy donors, making them readily available to treat cancer patients. We have also developed proprietary technology enhancements, dual CAR and enhanced CAR, that can be leveraged with our FastCAR and TrueU CAR platforms to further enhance and differentiate our CAR T product candidates. FastCAR-enabled dual CAR therapies are designed to control relapse in patients by reducing the likelihood of antigen escape. For allogenetic CAR T-cell therapies, dual CAR can be an effective strategy to reduce rejection of CAR T-cells by patients' immune system. Our second technology enhancement, Enhance the CAR, further strengthen CAR T-cells functionality. by overcoming the immunosuppressive tumor microenvironment and or increasing cytokine signaling. With enhanced CAR, we can also enable CAR T cells to achieve intended functions by regulating the expression of one or a combination of cytokine, cytokine receptors, or checkpoint ligands. On slide six, You'll see how our autologous fast car tea platform has distinguished itself from conventional car tea approaches by significantly shortening the manufacturing time from industry norm of two to six weeks to just 22 to 36 hours, effectively creating a next-day manufacturing system. We have developed a proprietary system of concurrent manufacturing activating and transducing resting T cells in a single step, where we have many of our proprietary elements working together to ensure high transduction efficiency while also avoiding aging the cells. Because our process greatly preserves T cell fitness, our therapies only need a small number of cells in comparison to others. eliminating the need of ex vivo expansion. This is in contrast to lengthy and costly steps in conventional CAR T manufacturing to activate transduce and expand T cells. The time saved is critical for patients with rapidly progressive disease, and it can make a difference in clinical outcome. And together with substantial cost savings, We believe FastCardT can increase accessibility of cell therapies for cancer patients. However, the benefits of our FastCard platform go beyond shortening the manufacturing time and increasing the speed in which the therapies can be delivered to patients. As we show on slide 7, the platform is designed to overcome several other key challenges, with conventional CAR T therapies. The most notable benefit is the enhanced T cell fitness. CAR T cells manufactured on this platform appear younger, less exhausted, and show enhanced proliferation, persistence, bone marrow migration, and tumor cell clearance activities, as demonstrated in our preclinical studies. Based on clinical data to date, Our lead fast car therapy has demonstrated fast, deep, and durable responses in multiple myeloma patients, which Dr. Sush will elaborate upon shortly. Moreover, we have developed a fully closed production design, meaning from leukocytes collected from the patient to the finished product in the IV bag. The entire manufacturing process is enclosed. This reduces the risk of cross-contamination and enables scalability by allowing multiple patient samples to be processed in a single clean room. On the cost side, the shortened manufacturing time reduces the direct cost of consumables, labor, and facility in a linear fashion. While also generating substantial cost savings to the health care system, since our fast the process reduces amount of time the patient is waiting for the therapy. On slide eight, we show how we are able to couple our innovative FASTCAR platform with the technology enhancement of DUCAR. DUCAR is designed to control relapse in patients in FASTCAR by reducing the likelihood of antigen escape and to reduce rejection of the CAR T-cell by patients. treated with true CAR-enabled allogeneic CAR-T therapies. Stimulated by two CARs, dual antigen-targeting CAR-T cells have the potential to maintain in vivo longer than single antigen-targeting CAR-T cells. Now, I will hand it over the call to our CMO, Dr. Martina Sersch, to discuss the pipeline and our clinical programs. Martina, please go ahead.