Gracell Biotechnologies - Q2 2023
August 14, 2023
Transcript
Operator (participant)
Ladies and gentlemen, thank you for standing by. My name is Bhavesh, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Gracell 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 Xie. You may begin your conference.
Kevin Xie (CFO)
Welcome to Gracell's second quarter 2023 corporate update conference call and the webcast. With me today are Gracell Founder and the Chief Executive Officer, Dr. William Cao, and our Chief Medical Officer, Dr. Wendy Li. We're excited to discuss the advancements 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. We'd 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 programs, Gracell's 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 Factors section of our latest 20 S filing with SEC for a full disclosure of these risks and factors.
This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 14th, 2023. Gracell 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 Gracell CEO, Dr. William Cao. William?
William Cao (Founder, Chairman and CEO)
Thank you, Kevin. 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 transactions. I will return the call over to our CMO, Dr. Wendy Li, to provide insights into data presentations from 3 studies presented at American Society of Clinical Oncology, ASCO, and the European Hematology Association, EHA, in June.
Next, our CFO, Dr. Kevin Xie, 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 BiCAR, GC012F, received significant recognition at the ASCO and EHA annual meetings, where our investigators presented a 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 median progression-free survival, mPFS, of 38 months in an investigator-initiated trial or IIT, with 29 relapsed refractory multiple myeloma RRMM patients.
As a reminder, the IIT data shared at ASCO had a cutoff date of April 12, 2023. We believe GC012F represents a next generation of CAR T therapy candidate. It leverages multiple special features and a proprietary BiCAR 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 the 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, GC012F has demonstrated the benefits of dual targeting in late and early line multiple myeloma, as well as in BNHL, and achieved a deep and a durable response.
Most recently, we are generating the data from preclinical studies supporting the strong rationale for utilizing dual targeting GC012F to treat refractory systemic lupus erythematosus, or rSLE. Moreover, GC012F is produced utilizing our FasTCAR overnight manufacturing process, that facilitates shortened patient wait times and enhance cell fitness, thereby giving clinicians more predictability and flexibility in managing the treatment.
Currently, GC012F is being evaluated in company-sponsored clinical trial in relapsed refractory multiple myeloma in the U.S., and in three IITs, 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.-based 1b/2 trial evaluating GC012F for RRMM. Patient screening is underway at the first activate site. As a reminder, the phase 1b portion primarily aims to evaluate the safety and tolerability, 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 9-10 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 EHA Congress, the updated data from the BNHL China IIT showed 100% ORR at 3 months and 67% CR at 6 months among 9 patients, all with a challenging diffuse large B-cell lymphoma, or DLBCL subtype.
The IIT evaluating GC012F 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 IIT for GC012F in refractory SLE has been successfully launched in China during the second quarter. Multiple patients have been dosed. We expect to share the clinical data in the first half of 2024. Simultaneously, we are amassing compelling pre-clinical data that strongly support the rationale for CD19 BCMA dual targeting in the treatment of SLE.
First of all, in our clinical studies, our candidates have demonstrated the effective elimination of CD19 positive B cells, which is, of course, crucial to facilitate an immune reset and combat 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 should also address 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 GC012F's dual targeting design, has the potential to provide a more effective and long-lasting therapeutic approach for refractory SLE.
In our preclinical studies, GC012F CAR T has shown a more effective elimination of ASCs compared to CD19 CAR T alone. Last but not 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, IND, filing to the U.S. FDA in 2023 for the planned phase I 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 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 reprioritized pipeline chart in the Gracell corporate presentation deck, available on our website. The decisions made during this strategic review reflect our determination to be at the 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 Evo Capital and joined by RA Capital, TCGX, Janus 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 Gracell 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 essential part of our success story. Now, I'll hand the call over to our CMO, Dr. Wendy Li, to highlight the three data sets that were presented in June at ASCO and EHA. Wendy, please go ahead.
Wendy Li (CMO)
Thank you, William. We're continuing to generate clinical data from the ongoing trials for GC012F, our FasTCAR-enabled BCMA and CD19 dual targeting autologous CAR T cell therapy. This candidate aims to transform cancer and autoimmune disease treatment by driving fast, deep, and durable responses with an improved safety profile and fast overnight manufacturing.
At both ASCO and EHA in June, long-term follow-up data from the multiple center IIT in RRMM was presented. Based on a data cut-off date of April 12, 2023, the data showed deep responses with 100% MRD negativity, and 82.8% MRD negative stringent CR in 29 RRMM patients. The median PFS was 38 months at this data cut-off date, suggesting the durable responses achieved by GC012F among this hard-treated, predominantly high-risk patient population.
The safety profile was consistently favorable, with no neurotoxicity of any grade, and then no second primary malignancy reported with this longer-term follow-up. We are very encouraged by this clinical data, and have commenced patient enrollment in the phase Ib trial in the US. Data evaluating GC012F for treatment of BNHL was also presented at ASCO and EHA, including as an oral session at the later meeting.
Based on a data cut-off date of April 12, 2023, the updated data from the ongoing IIT showed an ORR of 100% in all 9 patients treated. Notably, all 9 enrolled patients are diffuse large B-cell lymphoma patients, which is the most challenging subtype of BNHL. GC012F demonstrated impressive, deep, and durable responses, and the complete response rate was 77.8% at month 3, and 66.7% at month 6, respectively.
5 of my patients experienced grade 1 CRS, and 1 patient had grade 3 CRS, which resolved within 2 days after standard of care treatment. No neurotoxicity or ICANS of any grade were observed. This data further supports the clinical potential and wide applicability of GC012F.
Additionally, we presented the 1st data from the company's sponsored phase 1 study in China of GC007G at the EHA Congress. GC007G is a donor-derived allogeneic anti-CD19 CAR-T candidate that has been designed to treat relapsed refractory B-cell acute lymphoblastic leukemia patients, who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, or other unsuitable conditions.Among the 9 patients enrolled and treated between March 2021 and May 2022, 100% of patients achieved MRD negative CR or CRI at day 28 after infusion of GC007G.
At a median follow-up of 415 days, 7 of 9 patients remained in CR or CRI, where two patients had a CD19 negative relapse. The 1-year PFS and OS were 76.2% and 85.7% respectively. Grade 1-3 CRS were reported and all resolved after treatment. No neurotoxicity or ICANS was observed. No chronic GVHD occurred.
In closing, I would like to highlight that several clinical studies have initiated over the past few months, including the company-sponsored phase 1B study of GC012F in RRMM in the US, the IIT of GC012F in refractory SLE in China, and the IIT of SMART CAR-T GC506, targeting claudin 18.2 in solid tumors. Overall, we are very pleased with the progress of our clinical pipeline, and we're eagerly looking forward to building on this momentum. I will now hand the call over to our CFO, Dr. Kevin Xie. Kevin?
Kevin Xie (CFO)
Thank you, Wendy. Turning to our financial results for the second quarter ended June 30, 2023, I'd like to touch on a few financial trends. As of June 30, 2023, the company had RMB 1,188 million, or $163.8 million in cash and the cash equivalents and short-term investments.
We expect the cash use this year to be approximately $100 million, primarily to fund our R&D and clinical programs in the US and China. As announced in early August, we completed a private placement financing with $100 million with upfront and up to additional $50 million in the event that the warrants are fully exercised within 24 months after the closing of the upfront purchase.
With this, we have extended our cash runway by one and a half years, are now expected our current cash position to be sufficient to cover our operational plans and R&D activities into the second half of 2026, if the warrants are fully exercised.
For the three months ended June 30, 2023, net loss attributable to ordinary shareholders were RMB 146.9 million, or $2,023 million, compared to RMB 146.3 million for the corresponding prior year period. Research and development expenses for the second quarter 2023 were RMB 103.8 million, or $14.3 million, compared to RMB 117.1 million in the corresponding prior year period.
The decrease was primarily due to the slightly decrease of spending on research, development, clinical trials, and payroll. With that, I'd like to turn back to the operator to open the session for your questions. Operator?
Operator (participant)
Thank you. If any participant would like to ask a question, please press the star followed by the one on your telephone keypad. Our first question comes from the line of Kelly Shi from Jefferies. Please go ahead with your question.
Kelly Shi (SVP, Senior Research Analyst in Biotechnology)
Thank you for taking my questions, and congrats on the progress. I have a question regarding the GC012F, its US phase one trial. Can you talk about the patient selection criteria, and does the trial allow prior BCMA, BCMA, CAR-T, and also bispecific treatment, targeting both, BCMA and the GPRC5D? Thank you. Hello?
Wendy Li (CMO)
Okay, hello? Yeah, our,
Kelly Shi (SVP, Senior Research Analyst in Biotechnology)
I just want to make sure you can hear me.
Wendy Li (CMO)
Yes, a little bit wait. Yeah. The patient screening is ongoing right now. Yes. The well response to the checking treatment last week, and hopefully a potential more patients can benefit from GC012F. We're not exclude, you know, your patient, you just mentioned about the BCMA and other treatment. Mm-hmm. We have the, you know, like, the washout time. Yeah, and between this therapy and the GC012F infusion. You have more questions?
Kelly Shi (SVP, Senior Research Analyst in Biotechnology)
Thank you. Yeah, thank you. Also, would, would you be able to estimate, 1, are you going to dose the first patients? In 2023, how many patients to be dosed on this trial? Thanks.
Wendy Li (CMO)
Yeah, we plan to have 12 patients be dosed in two doses. Yeah. The patients are still in the screening right now, and so many tests were ongoing. Everything, every patient's screening is on the track.
Kelly Shi (SVP, Senior Research Analyst in Biotechnology)
Thank you.
Operator (participant)
Thank you. Our next question comes on the line of Joe Catanzaro from Piper Sandler. Please go ahead with your question.
Joseph Catanzaro (Executive Director, Senior Biotech Equity Analyst)
Hi, everybody. Thanks for taking my questions. Maybe, maybe first one on the GC012F phase 1 in, in the U.S. here. William, I know you said that the phase 1B might take 9-10 months to complete enrollment of the 12 patients. I guess, is it your expectations to fully complete this portion of the trial before disclosing any data, or is it possible we could see some data once the first dose level clears? Thanks. I have a follow-up.
William Cao (Founder, Chairman and CEO)
Yeah. Thank you, Joe. Well, to report a full set of data, it will take, take some time. You know, if the question is whether we're going to report a portion of the data, that's not conventional. I think under circumstance, circumstances, you know, maybe under CDA, it's possible, but I don't think that it's conventional to release portion of the phase I data.
Joseph Catanzaro (Executive Director, Senior Biotech Equity Analyst)
Okay, got it. That, that's helpful. I guess my follow-up, it looks like the meso deal in SMART CAR was removed from the pipeline with the prioritization. I, I know it had dosed some patients in the China IIT, so wondering if you could speak to maybe what you saw there that maybe led to this decision, and, and whether there's any learnings there with the SMART CAR platform that you could apply to the claudin program that you continue on with. Thanks.
William Cao (Founder, Chairman and CEO)
Yes. You know, our bar, as we discussed it in the previous meetings, our bar is not just seeing some patients, may benefit from SD or partial response. I think, currently on the program for solid tumor seems there is a term called 50% OR curse.
We think, you know, for such a sort of crisisy and a complicated autologous CAR T therapy, the efficacy should be higher, or the benefits to the patient should be highly differentiated from standard of care. That can continue to be our sort of internal criteria for selecting a potential product to move forward. Now, back to the 503, mesothelin and then the corresponding tumors appears very challenging. We do see, you know, the safety.
We don't see serious side effects that we need to elaborate. The CIS and the neurotoxin horrible, but the safe, the efficacy is not striking based on our standards. In the wave of our reprioritization, we focus on the front runners, our MM, early line RM, and autoimmune disease. We decide to slow down some of the early programs.
Joseph Catanzaro (Executive Director, Senior Biotech Equity Analyst)
Okay, got it. Makes sense and helpful. Thanks so much for taking my questions.
William Cao (Founder, Chairman and CEO)
Sure.
Operator (participant)
Thank you. Our next question comes on the line of Justin Zelin for BTIG. Please go ahead with your question.
Justin Zelin (Director, Biotechnology Equity Research Analyst)
Hi, good morning. Thanks for taking my questions, and congrats on the progress. Maybe just first on GC012F phase I study. If I heard correctly, I think you're, you opened up in one U.S. clinical site, and I think previously you said you expect to open up in 5-10 U.S. clinical sites. Just wondering if that's still the case here, and just, you know, when you might expect the next clinical site to come up online here?
Wendy Li (CMO)
Yes. The first site is activity, right? Yeah, and the patients, screening is ongoing. Yes, other sites coming, so right, will be very soon. Actually some part is, working on now. Everything's on their control and on talking now.
Justin Zelin (Director, Biotechnology Equity Research Analyst)
Okay, great. Thank you. Just wanted to see, just checking. I think, as far as the prioritization goes, I mean, everything that's reflected on your, your pipeline, your new pipeline chart here, we should assume that that is still in the company's prioritization, correct?
William Cao (Founder, Chairman and CEO)
Correct.
Justin Zelin (Director, Biotechnology Equity Research Analyst)
Got it. Okay, great. Well, thanks for taking my questions.
William Cao (Founder, Chairman and CEO)
Thanks, Justin.
Operator (participant)
Thank you. As a reminder, if you'd like to ask a question, please press star followed by the number one on your telephone keypad. Our next question comes from the line of Emily Bodnar from Wainwright. Please go ahead with your question.
Emily Bodnar (Biotech Equity Research Analyst)
Hi, good morning. Thanks for taking the questions. First, can you maybe talk about how you think about the market opportunity for SLE in the US, specifically, I guess, what portion of the population you think could benefit from a CAR-T therapy? I just wanted to clarify, I think on the call, you said that the newly diagnosed data would be in the fourth quarter, but I think in the press release, it was the third quarter. Could you clarify that? Maybe comment on any next steps for that program. Thank you.
William Cao (Founder, Chairman and CEO)
Emily, I'll, I'll answer your first question first, and then I'm going to ask maybe you to repeat the second question. The market size, we are targeting refractory SLE. My impression, sorry, I can't give you, you know, exact numbers as we have been studying through IITs, based on the enrollment criteria and the endpoints we are testing and evaluating. The exact number or the size of markets, it's, you know, I can't give you exact number, but it's obvious it's a significant unmet need. The field or the KOLs are excited about this potential. What was your second question?
Emily Bodnar (Biotech Equity Research Analyst)
Could you just clarify when the newly diagnosed multiple myeloma data is coming and any next steps for that program?
William Cao (Founder, Chairman and CEO)
Yeah. Wendy, you can take that one.
Wendy Li (CMO)
Sorry, the question again?
William Cao (Founder, Chairman and CEO)
Yeah, the update, let, let me take this. The update of newly diagnosed, longer follow-up will be in-
Wendy Li (CMO)
Oh, yeah. Okay. Yes, we're looking for... Yes, we're going to share. Yeah, we're going to share.
William Cao (Founder, Chairman and CEO)
It's okay. It's okay.
Wendy Li (CMO)
Clinical data from the IIT in NDMM, later September. Yes. Right.
Emily Bodnar (Biotech Equity Research Analyst)
All right.
Wendy Li (CMO)
also we'll keep-
Emily Bodnar (Biotech Equity Research Analyst)
I guess next steps.
Wendy Li (CMO)
The next step will be, yes, the IND submission in later, 2023, this year.
Emily Bodnar (Biotech Equity Research Analyst)
Okay. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Yanan Zhu from Wells Fargo. Please go ahead with your question.
Kwan Ang (Biotech Analyst)
Hello. Hi, thanks for taking our question. This is Kwan Ang for Yanan Zhu. My first question is on RRMM. So for the base US phase 1B2 study, can you discuss the company's internal bar on, on moving the program into phase two? My second question is for SLE. So for the client, US study, what the company's plan on the dose level, is it similar to the China IIT? Thank you.
Wendy Li (CMO)
The first question, yes, we have. We're going to finish the phase 1B first, then we're going to have the meeting with FDA, and we'll be more clear for next step. The second question, you mean to compare with China, right? Yes, depends on the CDE and FDA requirements. They're slightly different from the dose level and the element frequency.
Dose level in China will be start, you know, the 2 dose, right, 1.5 and the 3 B five. Yeah. In the US will be 1 and 3, the 2 doses. Yeah, and the frequencies in China, they can, you know, come 3 patients together. In US, based on FDA requirement, have to 1 by 1 a month. That's little bit different, but the timing will be similar. Thank you.
William Cao (Founder, Chairman and CEO)
Yanan, Yanan, the dose-
Kwan Ang (Biotech Analyst)
Thank you.
William Cao (Founder, Chairman and CEO)
For SLE is, the dose for SLE is, yes, it's going to be similar, but we haven't decided yet. We, for this IIT studies in China for SLE, we start from low dose, which is very similar to the low dose of RRMM IIT trials. It look like it's going to be the same dose for SLE, but, you know, we are excluding those.
Kwan Ang (Biotech Analyst)
Thank you. Thank you for all the color.
William Cao (Founder, Chairman and CEO)
You're welcome.
Operator (participant)
Thank you. Our final question for the day comes from Yigal Nochomovitz from Citigroup. Please go ahead with your question.
Yigal Nochomovitz (Director, Biotech Equity Research)
Yeah, hi. Thank you for taking the questions. On GC-zero-zero-seven, you indicated that you have started a registrational phase 2 in China. Can you talk about your thoughts for bringing that product to the United States for clinical development? Thanks.
William Cao (Founder, Chairman and CEO)
Wendy, I'll take this one.
Wendy Li (CMO)
Sure.
William Cao (Founder, Chairman and CEO)
The GC007g, GC007g, is a very unique product. The unmet need compared to other indications are relatively small, our plan has been limit this product development in China. We don't have intention to add on another one on our pipeline to US.
Yigal Nochomovitz (Director, Biotech Equity Research)
Okay. Then regarding the SLE trials, can you just talk a little bit more about how the design of the US SLE trial will, will be structured in terms of the patient enrollment characteristics relative to the, the IIT in China? Are they relatively similar?
William Cao (Founder, Chairman and CEO)
You-
Yigal Nochomovitz (Director, Biotech Equity Research)
In the design.
William Cao (Founder, Chairman and CEO)
It will be too early, it will be too early to elaborate the designs of SLE trial in the US. It's too early. The purpose of the IIT is exactly to test out what will be the dose, what will be the endpoints, enrollment criteria, and all these will be evaluated through the trials, IIT trials, while we are preparing for IND filing in the US.
You know, I happily, presumably, we have gained a lot of insight through the first few patients, but at this moment, it's too early to, you know, have a review. You know, we have obtained invaluable information, including the dose, the safety profile, again, preliminary, and the response.
Yigal Nochomovitz (Director, Biotech Equity Research)
Okay, then the last question I had was, you mentioned the 9-12 month timeframe for enrolling the RRMM study in the US. Can you just comment a little more in terms of the assumptions supporting that timeframe? Is it, is it a function of the competing therapies in the space, is, and the enrollment criteria? Any additional details you can provide on, on, on that timeline. Thank you.
Wendy Li (CMO)
We still keep that.
William Cao (Founder, Chairman and CEO)
Wendy?
Wendy Li (CMO)
Yeah, we still keep that. You know, like you just mentioned about, right, about 10 months that we have to finish the phase 1B. Yeah, we're going to have the EOP1 meeting with FDA. We'll be more clear with next step.
William Cao (Founder, Chairman and CEO)
Regarding the competing therapies, so far, we don't see that happening. Given the enthusiasm from all those PIs from these centers, obviously the unmet need is clear. The features of this potential product, you know, potential compound, means a lot to the patients and the doctors. The fast turnaround, the safety profile, these are still very attractive. So far, we see, see, see everything as planned.
Yigal Nochomovitz (Director, Biotech Equity Research)
Okay, thank you.
William Cao (Founder, Chairman and CEO)
You're welcome.
Operator (participant)
There are no further questions at this time. Kevin Xie, I turn the call back over to you.
Kevin Xie (CFO)
Thank you again to everyone for joining us on the call. With the strategic reprioritization of our pipeline, we are focused on advancing our highly differentiated and the most competitive candidates, including the FasTCAR, GC012F. The U.S. IND trial in RRMM is now underway. We look forward to submitting the IND filing in SLE later this year. We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapy.
Operator (participant)
Thank you. This does conclude today's conference call. Thank you for participating. You may now disconnect.