Gracell Biotechnologies Inc.

Ladies and gentlemen, thank you for standing by. My name is Bhavesh and I will be your conference operator today. At this time, I would like to welcome everyone to the Greshel Biotechnologies second quarter 2023 earnings conference call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press the star followed by the one on your telephone. If you'd like to withdraw your question, please press the star followed by the one once again. Thank you. I will now hand the call over to Kevin Shipp. You may begin your conference.

Good morning, and welcome to Griselle's second quarter 2023 corporate update conference call and webcast. With me today are Griselle's founder and the chief executive officer, Dr. William Chow, and our chief medical officer, Dr. Wendy Lee. We're excited to discuss the advancement of the trials underway with our CAR-T candidates on today's call. We also look forward to sharing with you our recent business developments and upcoming objectives as we progress through 2023. We will conduct a question and answer session following our formal remarks. This morning, we issued a press release Announcing unaudited financial results for the second quarter ended June 30, 2023. We encourage everyone to read this press release and would also like to remind you that this call is being recorded for replay. Please note that for certain information discussed on the call today, including financial data, clinical data, and the future plans of our program, results management will be making forward-looking statements. Actual results could differ materially from those stated or implied by those forward-looking statements as a result of various important factors. Please refer to the risk factor section of our latest 20th signing with SEC for a full disclosure of these risks and the factors. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 14, 2023. GRISA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. I will now turn the call over to Green Cell CEO, Dr. William Tsao. William.

Thank you, Kevin. And again, welcome everyone to our second quarter 2023 corporate update conference call. I will begin today's call with key pipeline updates and details regarding our recent financial transaction. I will then return the call over to our CMO, Dr. Wendy Lee, to provide insights into data presentations from three studies presented at American Society of Clinical Oncology, ESCO, and the European Hematology Association, EHA, in June. Next, our CFO, Dr. Kevin Shear, will discuss our second quarter 2023 financial results. After our prepared remarks, we will open the call to questions. We had a very successful second quarter with multiple data updates from our clinical programs. Notably, our lead product candidate, BCMA-CD19 dual-targeting FAST-CAR-BGC012F, received significant recognition at the ESCO and EHA annual meetings, where our investigator presented two oral sessions with updated data from our studies in multiple myeloma and BNHL. In particular, at ASCO, GC012F showed 93% overall response rate, ORR, 83% stringent complete response, SCR rate, 100% minimum residual disease negativity, and immediate progression-free survival, MPFS, of 38 months. in an investigator-initiated trial, or RIT, with 29 relapsed refractory multiple myeloma RRMM patients. As a reminder, the RIT data shared at ASCO had a cutoff date of April 12, 2023. We believe GT012F represents a next generation of CAR T therapy candidates. It leverages multiple special features, and proprietary fast car next-day manufacture technology. It is specifically designed to enhance therapeutic efficacy, safety, and product availability time. GC012F and its BCMA CD19 dual targeting design were built utilizing our team's deep knowledge in biology, immunology, and molecular biology. They went through years of development and perfection. We believe we have designed and chosen a compound that strikes an optimal balance between safety and efficacy. The dual targeting approach not only broadens GC012F's applicability in indications where either BCMA or CD19 is a primary proven target, but moreover makes GC012F a potent weapon against complex diseases where multiple antigens are involved, which is true for many hematological cancers and autoimmune disease. Based on the clinical data showcased at the medical meetings over the past year, DC012F has demonstrated the benefits of dual targeting in late and early line multiple myeloma, as well as in BNHL, and achieved deep and durable response. Most recently, We are generating data from preclinical studies supporting the strong rationale for utilizing dual-targeting GC012F to treat refractory systematic lupus erythematosus, or RSLE. Moreover, GC012F is produced utilizing our fast-card overnight manufacture process that facilitates shortened patient wait times and enhance cell fitness. thereby giving clinicians more predictability and flexibility in managing the treatment. Currently, GC0 talk-up is being evaluated in company-sponsored clinical trial in relapsed refractory multiple myeloma in the U.S. and in three RITs, in newly diagnosed multiple myeloma, NDMM, BNHL, and SLE. Recently, we have reached a significant milestone as the patient enrollment has commenced in our U.S. Phase 1b flu trial evaluation GC0-12-F4-RR-MM. Patient screening is underway at the first activated site. As a reminder, the Phase 1b portion primarily aims to evaluate the safety and colorability, as well as determine the recommended Phase 2 dose. We anticipate enrolling approximately 12 patients in the Phase 1b portion. We estimate that it might take approximately 9 to 10 months to complete patient enrollment. Thereafter, we plan to share our data with the FDA and proceed into the Phase 2 portion. We are also continuing to augment the compelling clinical data on GC012F across other indications. At an oral session at EHAR Congress, the updated data from the BNHL China IIT showed 100% ORR at three months and 67% CR at six months among nine patients, all with a challenging diffuse large B-cell lymphoma or DL-BCL subtype. The IIT evaluating 12-12 in new diagnosed multiple myeloma patients is also advancing. We plan to provide an update from this study, including data from additional patients and a longer follow-up at an upcoming medical meeting later in September. Moving on to our immunology program, we are excited to report that RIT for GC05F in refractory SLE has been successfully launched in China during the second quarter. Multiple patients have been dosed, and we expect to share the clinical data in the first half of 2024. Simultaneously, we are amassing compelling preclinical data that strongly support the rationale for CD19-BCMA dual targeting in the treatment of SLE. First of all, in our clinical studies, our candidate has demonstrated the effective elimination of CD19-positive B-cells which is, of course, crucial to facilitate an immune reset and a comeback SLE. Secondly, SLE is a B-cell autoimmune disease resulting from a range of autoantibodies attacking the patient's own system. We believe the treatment show also addressed autoantibodies creating plasma cell or ASC. ASC populations are generally BCMA-positive, and a significant portion of them are CD19 negative. So the use of CD19 single-targeting CAR T therapy alone may not be sufficient to eliminate all the disease-causing ASCs in all patients. Therefore, targeting both BCMA and CD19, which aligns with DC012F's dual-targeting design, has the potential to provide a more effective and a long-lasting therapeutic approach for refractory SLE. In our preclinical studies, 12F CAR-T has shown a more effective elimination of ASCs compared to DD19 CAR-T alone. Last but not the least, based on the preclinical data we collected so far, we found no evidence suggesting occurrence of serious adverse events in body. These preclinical data, as well as the consistently favorable safety data we have accumulated in over 50 cancer patients, give us strong level of confidence in the preclinical potential of GC012F in autoimmune disease. We are currently on track to submit investigational new drug IMG filing to the U.S. FDA in 2023 for the planned phase 1 trial. This will be an important milestone as we continue to advance our efforts to provide innovative, effective treatment options for patients with autoimmune disease. During the second quarter, we've completed a strategic review across our clinical programs and have decided to focus on our resources on our most innovative, validated product candidates, such as GC012F, which we believe have the potential to be the best in class and address large unmet medical needs. You can find our reprioritize the pipeline chart in the Grayscale corporate presentation deck available on our website. The decisions made during this strategic review reflects our determination to be at forefront of medical innovation and underscore our dedication to improving the lives of patients through transformative life-changing therapies. In early August, we were delighted to complete a private placement transaction raising $100 million upfront and up to 50 million additional funds if the warrants are fully exercised within 24 months. The financing was led by Vivo Capital and joined by RA Capital, TCGX, Janice Henderson, and other well-known healthcare investors. This additional funding greatly strengthened our financial position, extends our cash runway into the second half of 2026, and is intended to support us through critical upcoming milestones planned for the clinical development of GC012F in multiple myeloma and SLE. We thank our existing investors for their unwavering support and extend a warm welcome to our new investors who took time to thoroughly understand our technology and the pipeline. The trust and the confidence you have shown in us are truly appreciated. The Gray Cell team is committed to our mission to develop innovative and efficacious cell therapy candidates for patients with cancer and autoimmune disease. Thank you for being an essential part of our success story. Now, I'll hand the call over to our CMO, Dr. Wendy Li, to highlight the three datasets that were presented in June at ESCO and EHA.