Gracell Biotechnologies Inc. (NASDAQ:GRCL) Q3 2023 Earnings Conference Call November 13, 2023 8:00 AM ET
William Cao – Chairman and CEO
Wendy Li – Chief Medical Officer
Kevin Xie – CFO
Conference Call Participants
Yigal Nochomovitz – Citi
Benjamin Burnett – Stifel
Dev Prasad – Jefferies
Eric Schmidt – Cantor
Emily Bodnar – H.C. Wainwright
Yanan Zhu – Wells Fargo Securities
Joseph Catanzaro – Piper Sandler
Justin Zelin – BTIG
Ladies and gentlemen, thank you for standing by. Welcome to Gracell Biotechnologies Third Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After opening remarks, we will open the call for questions. Instructions for queuing up will be given at that time.
I will now turn the conference call over to Dr. Kevin Xie, Chief Financial Officer. Please go ahead.
Good morning, and welcome to Gracell third quarter 2023 corporate update conference call and webcast. With me today are Gracell Founder and Chief Executive Officer, Dr. William Cao; and our Chief Medical Officer, Dr. Wendy Li. We’re excited to discuss the advancement of the trials underway with our CAR-T candidate on today’s call.
We’re looking forward to share with you our recent business developments and upcoming objectives as we have six weeks remaining in 2023 and are looking forward to 2024. As a reminder, we’ll conduct a question-and-answer session following our formal remarks.
This morning, Gracell issued a press release announcing unaudited financial results for the third quarter ended September 30, 2023. We encourage everyone to read this press release, I would 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, future plans of our program, resource 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, and please refer to the Risk Factors section of our latest 20-F filings 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 the live forecast, November 13, 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?
Thank you, Kevin. And again, welcome, everyone, to today’s call.
I will begin with the key pipeline and corporate updates. I will then turn the call over to our CMO, Dr. Wendy Li, to provide insights into GC012F clinical data that, were recently presented at the 20th International Myeloma Society, IMS Annual Meeting. Next, our CFO, Dr. Kevin Xie, will discuss our third quarter 2023 financial results. After our prepared remarks, we will open the call to questions.
The past few months have been exciting, both for Gracell and the CAR-T field at large. At Gracell, we have achieved several important milestones, including the initiation of patient dosing in our first company-sponsored the U.S. trial, the presentation of the latest update of FasTCAR-T GC012F at the recent IMS meeting and upcoming American Society of Hematology Annual Meeting.
The advancement of the investigator initiative clinical study in systemic lupus, erythematosus, SLE and also release of preclinical data from our solid tumor program at a Society of Immunotherapy of Cancer, SITC Annual Meeting This period marked a crucial juncture for the CAR-T field. Some of the most significant hurdles based by CAR-T in the treatment of blood cancers, are being addressed by innovative next-generation CAR-T candidates.
Aspirations such as rapid manufacturing, achieving a cleaner safety profile and enabling deeper, more durable responses, were shared by all company researchers and were also personal motivators for myself that led to the funding of Gracell. It was a journey with a vision to push the boundaries of what’s possible in cancer treatment. The progress we have made, is a testament to the entire Gracell team’s relentless pursuit of innovation.
We are also finding ourselves at the forefront of our pivotal era in medical science, where the application of CAR-T therapy, is expanding beyond hematological cancers, down met needs in other immune diseases and solid tumors are massive. At Gracell, our approach is anchored in rigorous scientific research and commitment to innovation. I am pleased to see strides, we have made in these disease areas, reflecting our dedication to addressing areas of high unmet need with cutting-edge solutions.
Today, we will share some initial findings in our translational research on GC012F for the treatment of SLE. I look forward to sharing our ongoing progress and remain confident that our journey will lead to meaningful advancement in the field. Now I hope to provide a more detailed overview of what we have achieved in the third quarter.
In September, we announced dosing our first patient in the U.S. Phase 1b/2 investigation on new drug IND study, evaluating our lead candidate, BCMA-CD19 dual targeting FasTCAR GC012F in the treatment of relapsed refractory multiple myeloma, RRMM. One clinical site is currently recruiting patients, and we look forward to activating a handful additional sites in the U.S. in the coming months.
As a reminder, the Phase 1b portion is designed to evaluate safety and tolerability of GC012F as well as determine the recommended Phase 2 dose. We anticipate enrolling approximately 12 patients across two dose levels in the Phase 1b portion. We estimate that it will likely take approximately nine to 10 months to complete patient enrollment.
In China, we expect to commence patient enrollment this quarter in the Phase 1/2 IND study in RRMM. The guidelines for clinical research on thematic cells trial, newly elected in August has impacted our timeline, but we are happy to report that, we have now received all the required approvals and are ready, to launch the study in China.
In next September, at the IMS Annual Meeting, the updated clinical data was presented from the ongoing Phase 1 IIT evaluating GC012F as a frontline treatment for patients with transplant eligible, high-risk, newly diagnosed multiple myeloma, NDMM. In this 19 patient data set with a median follow-up of 15 months, 100% of patients achieved minimal residual disease, negative tangent complete response, MRD negative sCR.
Dr. Wendy Li will elaborate on the key findings in a few minutes. Longer-term follow-up data from this study, including additional patients will be presented at the 65th ASH Annual Meeting in December. We are continuing to see compelling efficacy data and safety profile and look forward to sharing more details in San Diego next month.
To this date, we have reported clinical data of GC012F on 60 oncology patients in three IITs, including 51 patients with multiple myeloma and nine with diffuse large B-cell lymphoma. The consistent findings provide good evidence supporting our strong scientific rationale in leveraging the power of dual targeting and validating the superior qualities of FasTCAR-T cells.
Also, the very favorable safety profile demonstrated in these studies, including no neurotoxicity observed in any of the 60 patients could potentially provide a critical differentiation in early line settings and additional indications. We are very encouraged by the profile of GC012F and have high confidence that this therapy could bring profound benefits, to the patients worldwide.
In the second quarter of this year, we were thrilled to launch a new IIT evaluating CD19 BCMA [ph] dual targeting GC012F in refractory SRE or rSLE. This new direction is inspired by the groundbreaking clinical discovery shared by Professor George Tsokos. We see immense opportunity here and believe 12F is ideally positioned as a potential treatment for many autoimmune conditions, including SRE, combining its safety track record, CD19 BCMA dual targeting capability and faster and consistent product delivery.
In the field of automate disease treatment, safety stands as a critical factor for defining success. As oncologists learn ways to better manage the adverse events, the safety of CAR-T has, become less of concern in cancer applications. However, we believe the focus on safety will be renewed when the industry seeks, to potentially adopt CAR-T as a treatment for other autoimmune conditions.
Any successful therapy must demonstrate exceptional tolerability and safety profile. So far, TC012F has been used to treat 60 cancer patients, including those who are frail and fastening advanced cancer. We have observed a consistent safety profile characterized by mostly low-grade cytokine release syndrome, CRS, and notably, no incidences of neurotoxicity today.
It is important to point out these encouraging results have been derived from the same compound currently being investigated in the IIT underway for SLE. This consistent track record of safety gives us confidence as we expand our studies to a new field where the standards for safety are exceptionally high.
On the efficacy side, the promise of CAR-T is to induce a complete immune reset, where other auto-reactive cells are eliminated, and newly generated cells are expected to be healthy. For autoimmune diseases such as SLE, some were hoping to complete depletion of B-cells could reset immune system. Based on this theory, CD19 is considered a valid target for CAR-T as it is expressed throughout the early and mature stage of B-cell.
However, we think it’s important to remember, SLE is a disease in, which auto antibodies attack a patient’s own tissues. So in addition to resetting B-cells, our view is that an effective therapy should also address the disease-causing autoantibody-secreting cells, or ASC. ASC populations could be CD19 positive or CD19 negative and are BCMA positive. So the use of CD19 single target in CAR-T therapy alone may not be sufficient to eliminate all auto antibody-producing cells in all patients.
Therefore, we feel there is a strong scientific rationale, to support targeting both BCMA and CD19, which aligns with GC012F design in order to provide a more effective and long-lasting therapeutic approach for refractory SRE. In recent months, we have been working on preclinical and translational studies to support this rationale. Today, we are delighted to share some preliminary findings.
First, we analyzed the samples from four initial patients treated with GC012F at one-time 10-5th [ph] cells per kilo dose. And at the three months follow-up, we can see B-cells have been restored to naive phenotype in these four patients. This provides a very encouraging early evidence that GC012F is inducing an immune reset.
Secondly, we run studies with bone marrow samples collected from our SLE IIT patients and demonstrate that the CD19 BCMA dual-targeting CAR-T showed a more efficient elimination of ASC, compared to CD19 single-targeting CAR-T. Taken together, we believe that our CD19 BCMA CAR-T addresses both B-cell and ASC and is, designed to achieve a deeper and a wider elimination of disease-causing B-cells as well as plasma cell.
You can find the details of these findings in our latest corporate presentation deck, and we look forward to sharing more at upcoming cell therapy for autoimmune summit later this month. Lastly, on the manufacturer side, we believe that GC012F is positioned favorably with overnight manufacturing and enhanced sales fitness combined with our team’s significant experience accumulated over the years.
Although SLE is a chronic disease, FasTCAR-T delivery is still highly meaningful for better clinical outcomes, to ensure optimal CAR-T expansion in the patient body, patients typically need to stop SLE treatment before there are three cysts [ph] and also during the weight for CAR-T production, except for the use of low-dose steroids.
Fast and consistent delivery of CAR-T therapy would help to shorten this period of suboptimal disease control and greatly reduce the risk of disease flare-up and additional organ damage during the wait.
In short, we believe 12F is a highly differentiated candidate backed by outstanding safety record, novel and a strong scientific rationale and FastCAR-T technology as well as supported by our team’s extensive experience in manufacturing and optimizing the process. We eagerly anticipate advancing the clinical development of in-autoimmune disease. Currently, the IIT evaluating GC012F in SRE continues to enroll patients.
More than a handful of patients have been treated, and the goal is for patient enrollment to progress into double-digit range. We expect to release the first public readout from this ongoing IIT in the first half of 2024. We are currently on track to submit IND filings in the U.S. and China in 2023 for the planned Phase 1 clinical trial.
The U.S. submission will be the second IND for GC012F to be reviewed by the U.S. FDA and will be an important milestone as we continue to advance our efforts to provide innovative and effective treatment options, to patients with autoimmune disease. Beyond FasTCAR platform, we are also continuing to advance our SMART CART technology for the treatment of solid tumors.
At the 60th Annual Meeting in early November, we presented the preclinical data evaluating SMART CART T cells in solid tumor models. SMART stands For Suppressive Molecule Activated and Rejuvenated T cells. And our novel SMART CART T technology includes a proprietary switch receptor targeting the suppressive tumor marker environment, in which the inhibitory TGF beta signal is blocked and converted into a pro T-cell signal in CAR-T cells.
Our studies have shown that SMART CART T cells are younger and more resistant to TGF beta-mediated apoptosis and exhaustion. Upon repeated challenges of tumor cells, SMART CART T cells show more potent and durable tumor-specific lysis than the conventional CAR-T, both in vitro and in vivo in the presence of TGF-beta, especially in most models, SMART CART-T exhibit better killing activities in tumor re-challenge studies and high tumor burden studies, compared with conventional CAR-T.
Earlier in the fourth quarter, we initiated an IIT in China to evaluate our SMART CART-T candidates, GC506 in patients with Claudin 18.2 positive solid tumors. We decided to further streamline our pipeline during the fourth quarter by continuing our focus in devoting our resources on programs that have been potential to be the best-in-class and address large unmet needs.
We suspended China Phase 2 trial evaluating GC007g for the treatment of B-cell acute lymphoblastic leukemia or BALL, considering the limited commercial opportunity for this niche candidate. As a reminder, we have seen compelling data in the Phase 1 study with GC007g, including 100% MRD-negative CR/CRI among 9BLL patients.
GC007g is HLA-matched donor-derived allogeneic CAR-T and does not leverage our FasTCAR and TruUCAR-T technology platform or SMART CAR-T module. The updated pipeline chart will be found in the corporate presentation posted to Gracell’s IR website. We significantly strengthened our financial position in August 2023 as we completed a private placement transaction, raising $100 million upfront and up to $50 million in additional funds, if the warrants are fully exercised within 24 months.
With the support from the top-tier roster in institutional investors, this capital raise extends our cash runway into the second half of 2026, assuming the full exercise of warrants and is intended, to support us through critical upcoming milestones planned for the clinical development of GC012F in multiple myeloma and SLE.
Now I will hand the call over to our CMO, Dr. Wendy Li, to highlight updated data from the ongoing IIT in MDMM. Wendy, please go ahead.
Thank you, William.
As highlighted, we are continuing to amass clinical evidence supporting the tremendous potential of our lead candidate, BCMA/CD19 dual-targeting FasTCAR-T GC012F. In late September at the IMS Annual Meeting, we presented long-term follow-up data from an ongoing Phase 1 IIT evaluating GC012F in newly diagnosed multiple myeloma.
These patients have not received any anti-myeloma therapy, before they are enrolled to our study. And all patients in this study had one or more high-risk features of which 89% were class 5 as Stage 2 or 3 based on the reverse international staging system and 63% extramedullary plasmacytoma.
GC012F demonstrated a 100% ORR and a 100% MRV-negative strengthened CR rate amongst the 19 transplant-eligible, high-risk NDMM patients as of the data cutoff date of August 1, 2023. GC012F also continued to show a favorable safety profile with around 78% patients not having CRS of any grade and no patients reporting neurotoxicity or icons.
We think these data are highly compelling suggesting a potentially ideal profile for the frontline application of CAR-T therapy, combining both deep response and high tolerability. In December, updated results from this ongoing study will be presented at the 65th ASH Annual Meeting.
As highlighted in the abstract available on the ASH website, we plan to share updated data, including 22 patients with the favorable efficacy and safety profile, consistent with prior data sets. The ASH data set includes three additional patients that were not in the IMS data set, because those patients were not dosed or assessed, when we first submitted the abstract to IMS.
I will now hand the call over to our CFO, Dr. Kevin Xie, Kevin?
Thank you, Wendy.
Turning to our financial results for the third quarter ended September 30, 2023, I’d like to touch on a few financial trends. As of September 30, 2023, the company had RMB1,707.9 million or US$234.1 million in cash and cash equivalents and short-term investments. We expect the cash use this year to be approximately US$100 million, primarily to fund our R&D and clinical program in the U.S. and China.
As announced in early August, we completed a private placement financing with $100 million risk upfront and up to an additional $50 million in the event that the warrants are fully exercised within 24 months after closing of the upfront purchase. With this, we have extended our cash run rate significantly and now expect our cash position to be sufficient to cover our operational plan and R&D activities into the second half of 2026, if the warrants are fully exercised.
For the three months ended September 30, 2023, net loss attributable to ordinary shareholders were RMB67.6 million or US$9.3 million, compared to RMB171.9 million for the corresponding prior year period. The decline in net loss is primarily a result of a decrease in the fair value of warrant liabilities.
The warrants issued in August private placement are measured and recorded at share value at the time of issuance. The fair value of the word decreased by RMB39.9 million or US$5.5 million as of September 30, 2023, and was recorded as a gain in the income statement.
Research and development expenses for the three months ended September 30, 2023, were RMB90.1 million or US$12.3 million, compared to RMB133.4 million in the corresponding prior year period. The decrease was primarily, due to the decrease spending on research, development and the clinical trial as a result of timing of project spending and our strategic pipeline alignment.
With that, I’d like to turn it back to the operator to open the session for your questions. Operator?
[Operator Instructions] Your first question comes from the line of Yigal Nochomovitz from Citi. Please go ahead.
Yes. Hi William and team, thank you for taking the question. You mentioned the antibody secreting cells in a certain population, maybe CD19 negative, which would be helpful with your dual construct. Could you provide a little more color on the percent of antibody secreting cells that may be CD19 negative?
Yes. It’s a widely reported, but the percentage of CD19 negative ASC in humans we haven’t found a very rounded reports, but it is a fact that there are antibodies secreting cells are CD19 negative for sure and BCMA positive. If you need I can send your reference for that?
Okay. That would be great. And then with the translational research you mentioned with the four patients, could you provide a little more quantification as to how much more B-cell antibody suppression you saw with the dual construct versus the CD19 CAR-T alone?
The assay is at a spot. So basically, what it does is we take the BMC bone marrow cells from the patient prior to the treatment, after treatment. And we put these cells in the [indiscernible] spot device with our CAR-T. CAR-T is a treatment with the CAR-T ex vivo and see how many antibodies secreting spots that are formed. Based on that, the difference is CD19 single CAR and BCMA/CD19 dual CAR GC012F is – more than 10-fold.
Okay. Got it. And then final question is, I was just curious. You mentioned William, you’ve treated, I think, 60 myeloma patients so far with 012. Were there any…?
No, 51 plus 9. 51 myeloma patients and 9 DLBCL patients.
Okay. Yes, thank you. So amongst those 60 in total, did any of those patients have an underlying autoimmune condition that, may have improved with the treatment?
We have not paid attention that we discovered. Yes, we don’t notice that there are a certain percentage of autoimmune patients no, but sometimes, it could happen for liquid tumor.
Okay, thank you very much.
Your next question comes from the line of Benjamin Burnett from Stifel. Please go ahead.
Hey, thank you very much. I also wanted to ask about the SLE study, some of the early signals you’re seeing from the IIT cohorts. Encouraging to hear that B-cells are recovering by three months. But I guess, can you talk about the degree of B-cell aplasia that you’re seeing? Is this comparable to what you’ve seen in the ecology studies?
Compared with George Tsokos [ph] study?
Comparable to what you’ve seen with 12F in your myeloma studies just in terms of the amount of B-cell aplasia?
Yes. B-cell depletion is similar, although the SLE study still needs to be further followed and evaluated. But what we’re seeing is the declining – declining curve is similar. And the recovery time or persistent of B-cell depletion, we need to have more time to make a conclusion. Naive B-cell recovery so far from these four patients looks very similar to other SLE studies. Does that answer your question?
Yes, that’s great. Thank you very much. I just wanted to just ask about the newly diagnosed multiple myeloma study. I think did you’ve had is interesting. We’re looking forward to the ASH update. But I guess could you maybe frame for us what the regulatory path is or could be in the U.S. for this asset in a newly diagnosed “multiple myeloma” what would constitute a pivotal study in this setting?
It’s too early to give you that perspective, how do we decide – design study for newly diagnosed and also pivotal studies. But based on our understanding of what the regulatory agencies view towards, kind of a progressive development of CAR-T therapy to early lines it’s all about safety and, of course, efficacy. And this product I mean so far were convinced it’s very robustly safe across different indications of late and early line of multiple myeloma and DLBCL, now SLE.
I think given the data we collected and when we have 1b RRMM study data, I think that will be the time we’ll communicate with U.S. FDA. By the time, we shall have a detailed design how we approach the early line or the first line, but we are not excluding anything. We definitely will move forward in the early lines for sure.
Okay, great, thank you.
Your next question comes from the line of Kelly Shi from Jefferies. Please go ahead.
Hi, this is Dev on for Kelly Shi. Thanks for taking our question. So my question is on SLE. So maybe if you can set up an expectation what type of data, company is planning to release in first half of ’24. And related to that, what cell-dose level you are studying. And can it shorten the dose level that you will be studying in U.S. trials similar to RRMM, or it will be those escalations starting from the smaller stores [ph]?
Yes. We are dosing SMO, SLE patient. So, we expect it’s going to be double-digits when we presented data first half of 2024. We expect majority of patients will have at least three months and some of the patients will have six months evaluation. Now the dose, we started with the dose very similar that, we have treated RRMM patients or newly diagnosed patients, too.
So I can’t predict what’s going to happen with those Level 3. But now we are dosing up to see what happened. And based on what we see today, it’s very consistent. With the PK and the CIS and [indiscernible] just preliminary, it seems very similar. So, we will move up to 3×10 to 5th, which is still very low, compared to the others in the industry. And I don’t expect to dose higher than 3×10 to 5th. But we’ll see.
Thanks for your question. Right.
Your next question comes from the line of Eric Schmidt from Cantor. Please go ahead.
Thanks for taking my question and the added information. Also a question around the SLE translational data. William, did all four patients achieve deep B-cell aplasia or deep B cell lymph cell depletion with no detectable B cells?
B-cell aplasia after CAR-T therapy. That’s what we can say. Your second half question is did we see B-cell aplasia after lymph cell depletion, no.
And what was the duration?
Most of it not, sorry.
Okay. Thank you. What flu side dose are you using?
It’s very similar to [Dr. Shez Group].
Okay. And what was the duration of the…?
It’s similar to multiple myeloma regime.
The duration of the B-cell depletion was similar to what you’ve seen in myeloma?
Lymph cell depletion is very similar. B cell aplasia, at this moment, I mean, the longest we have seen so far a couple of months of full after-CART infusion. So to make a claim that how long the B-cell aplasia, I think it’s still too early. I mean complete recovery. I think it needs more time. Right now, the declining of B-cells is very similar, compared with multiple myeloma.
But when are, these patients comes back with a meaningful readouts, I think we need a couple of months to see. And then I have to remind that these first four patients are low doses. It’s a one-time 10-5th per kilo. And now we’re moving up to two times 10 to 5th and three times 10 to 5th, so we need to give them an opportunity.
Thank you, I think you mentioned that you saw elimination of antibody secreting cells. Did you also measure autoantibodies themselves and see elimination of auto antibodies?
Yes. I mean in vivo, I mean in human, we certainly measure as many types of auto antibody we can if those auto-antibodies are high over five prior to the therapy, right. Now what I mentioned is ELISPOT [ph] ex vivo study. So we measure typical, for example, double stranded DNA antibody – 20 auto antibodies to measure. Yes, for clinical, it’s doable. It’s for preclinical, we want to have a consistent system to compare. Sorry, I missed your second part.
So in the – SLE patients with double-stranded DNA antibodies, you did see those decline?
Yes. Although I do not want to give out any data related to efficacy. Yes.
Okay. That’s it. Thank you very much.
Your next question comes from the line of Emily Bodnar from H.C. Wainwright. Please go ahead.
Hi, good morning, thanks for taking the question. There was an ASH abstract also on a dual CD19/BCMA CAR-T for SLE. I’m just curious if you’ve seen that and maybe if you can comment on some initial thoughts from there on the efficacy and safety side. And then if you could provide any guidance for timing on initial data for the Claudin 18.2 positive solid tumor study in China? And maybe if you could also talk about the design there?
Thanks for the question. I mean, it’s still early for us to release or to share the data especially efficacy, safety, because as you know, you’re going to see safety in the first 28 days, it’s unlikely the typical CIS and neurotox will happen after 15 days. So within 28 days, we are comfortable to share, even though it’s, again, I have to warn, this is early data. It’s the first low-dose one-time 10 to 5th per kilo. It’s about $6 million total CAR-T cell, $6 million.
But it’s very, very encouraging. We see all the signs of safety and efficacy. Now a reasonable set of data readout will be the first half year 2024. By the time, we’ll have double-digit patients with at least three months and hopefully half of the six months follow-up. So that’s what we should expect.
Sorry, I think maybe you misunderstood my question. I know there was an abstract that was released to be presented at ASH from another CD19/BCMA CAR-T therapy for SLE. I was just curious if you see that and what your thoughts were on what they present or what they showed in the abstract?
Yes. I saw that abstract that has been presented somewhere before. It is good to see another dual targeting CAR-T that is being applied to autoimmune disease. But every construct is different. We don’t know the details of their construct, and we don’t know much about background, particularly the safety of the same compound, the same CAR-T or other indications, for example, oncology.
But based on what we saw from the abstract, the data looks reasonable. I think when we compare with Dr. [indiscernible] group, the patient background is different. I think everybody would agree that the patients that this group tend to be younger and the time from the diagnosis is short. And this abstract seems the patients are more diversified. The SLEDAI index seems, I would say, similar because more than, I think, 10 patients.
So the mean is similar, medium and similar. The age seems is more diversified. And then some patients with active lupus nephritis may not be fully recovered, which is not the price, in our opinion, because when in the real world, when the patients are older and the first time from the first diagnosis is much longer, and they have been treated more standard of care.
And if it depends on percentage of patients have active lupus nephritis, and that will give you a different flavor of readouts. And the last thing, I want to remind everyone who is interested, you got to look into the product, the format of final product, whether it’s a fresh CAR-T cells or it’s frozen.
As we all appreciate if it’s frozen, CAR-T-cells is more, it is more robust in the real world for delivery for shipping and if anything happened, to the patient right before the dosing that can be stored in the appropriate conditions. If it’s a fresh store, it’s going to be changed.
Okay. That’s helpful. Thank you. And if you could just comment on the Claudin 18.2 positive study and when we might see initial data there?
Yes, we just launched. So, there is really not much to share. Yes, I mean, any specific questions, would be happy to share with you.
Perfect, thank you.
Your next question comes from the line of Yanan Zhu from Wells Fargo Securities. Please go ahead.
Great, thanks for the questions. I also have a question on the translational study for the SLE patient bone marrow ELISPOT assay. I was wondering whether the inhibition that you saw in assay was due to CD19 negative BCMA positive bone marrow cells? Or could it be due to greater inhibition of the CD19 positive cells. And also, I was wondering, is it possible to quantify the percentage of CD19 negative BCMA-positive cells ASCs in these bone marrow samples? Thank you.
Let me answer the first question. We do have a CD19 with the same sequence same binder from the GC012F. So the single CAR C19 CAR in comparison with the dual CAR. So the comparison is very clear. If the inhibition of CD19 positive cells by the dual CAR, yes, we can always suspect when a single CAR, become a dual CAR, it might change certain characteristics. By at least from the single binding perspective, the dual targeting, in theory should hit CD19 and BCMA. So, the effect of what we see is more than additive.
It’s about 10 times. So either it’s additive or synergistic, because dual targeting, we need to do more studies to illustrate that. But the observation is very clear. The dual targeting does inhibit autoantibody secreting spots significantly. What was your second question?
Is it possible to quantify the percentage of CD19 additive BCMA-positive ASCs in these samples?
Good question. We are doing it. It’s a variable a lot among patient-to-patient, as you would so far, we collected four patients, which is not easy to collect the bone marrow cells from those treated patients, but we need more data.
Got it. And then I was wondering – if you could provide any update on the partnership front, both regarding the myeloma perhaps as well as the new SLE initiative? Thank you.
Yes. We continue to engage the conversation with potential partners. They are promised interest in both oncology and immunology and our particular partners only interested in immunology. That’s all as much as I can share. But yes, we are very engaging conversations.
Great, thanks for the update.
Your next question comes from the line of Joseph Catanzaro from Piper Sandler. Please go ahead.
Yes. Hi guys, appreciate you taking my questions Thanks for the update. Maybe two from me. First one, William, I think I heard you say that you’re going to have a presentation at the cell therapy for autoimmune disease summit later this month. Just wondering maybe if you could elaborate a little bit on what you expect to present there? Will there be any more additional translational work from these first four patients that we might see there? And then my second question, I know it sounds like you continue to expect the U.S. myeloma study to complete enrollment in about nine to 10 months. Just wanted to know if you have any updated thoughts around when you may have an initial data disclosure from that study? Thanks.
Yes. Regarding the translational studies, I think the data to be presented at the summit is going to be similar what I said. I think it’s another 10 days from now or less than 10 days. So, I don’t think you should expect a significantly more information from our presentation. We’re in 1b for RRMM trial in the U.S.
We have to wait the EOP1 and Phase 1 report submit to FDA and just consensus or discussion with them for next phase. So, I don’t believe that we can release data prior to that, but that’s my understanding. But as far as for the study, it’s ongoing, so far so good.
Okay. Thanks for taking my question.
Your next question comes from the line of Justin Zelin from BTIG. Please go ahead.
Hi, thanks for taking the questions. So on the SLE data for the update, can you remind us what we should expect, obviously, safety and what we should expect from a clinical efficacy standpoint?
Yes. expect, meaning predict, so far, all I can say so far so good and took time to have a meaningful efficacy data for safety, because it comes in short, coming within 15 days, you could much see them all. Neurotox takes a couple of more weeks, but so far, again, it’s our impression or I can say, it’s not really data. I mean impression is very consistent what we’ve seen before. Yes. I mean, as I answered the question of the other caller.
Next year, you should expect double-digits of patients. The readout on double-digit patients will be mostly at least three months and some of them will be six months, which is more meaningful. And our patients are very diversified. I think it’s actually it’s a real world. The SLEDAI index is based on SLEDAI is for patients having more severe SLE and that age order, and that’s all I can say at this moment.
Great. And maybe, William, if you could just give us an idea of what you would think an impactful durability would be for a CAR-T for SLA. I think that would be helpful?
Yes. I mean, that’s an interesting question Justin. I mean this is a very difficult to answer. It’s a balance between the length, or the persistence of B-cell depletion. But in the meantime, you don’t want to be disappear for too long, but you wanted the B-cell coming back with new phenotype, young phenotype and what we call B-cell reset. And how long is good enough to, I think our theory is we always see in oncology side.
We always see very deep B-cell depletion. And what’s translating to readout is the MRD negativity. It’s always that’s its top 100. So, we expect B-cell aplasia in immunology will be very deep as well. But how – long particularly, what is the persistence we want. We’ll see. I mean we are doing dose escalation, and we’ll evaluate in of course, the efficacy.
Great, thanks for taking my questions.
We have no further questions in our queue at this time. I will now turn the call back over to Dr. William Cao’s closing remarks.
Thank you again to everyone for joining us on the call. We are focused on advancing our highly differentiated and most competitive candidates, including the FasTCAR GC012F. The U.S. IND trial in RRMM is now underway, and we look forward to submitting the IND filings in the U.S. and China for the planned Phase 1 clinical trial in rSLE this year. We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapies.
This concludes today’s conference call. Thank you for your participation, and you may now disconnect.