Q3 2023 Gracell Biotechnologies Inc Earnings Call
Speaker 1: 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 Shea, Chief Financial Officer. Please go ahead.
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 Shea Chief Financial Officer, Sir. Please go ahead.
Good morning, and welcome to <unk> third quarter 2023, corporate update conference call and webcast with me today.
Speaker 2: Good morning, and welcome to Group Resell's third quarter 2023 corporate update conference call and webcast.
Speaker 2: With me today are Crystal's founder and Chief Executive Officer, Dr. William Thao, and our Chief Medical Officer, Dr. Wendy Lee.
As founder and achieved exactly office there.
And our Chief Medical Officer, Dr. Lindsey.
Speaker 2: We're excited to discuss the advancement of the trials underway with our CAR-T candidates on today's call.
David This is Scott.
Of the trials underway with our car T candidate on today's call.
Speaker 2: We're looking forward to sharing with you our recent business development and upcoming objectives as we have six weeks remaining in 2023 and are looking forward to 2024.
We're looking forward to share with you our recent business developments and upcoming objective as we have six weeks remaining in 2023 and are looking forward to 2024.
Speaker 2: As a reminder, we'll conduct a question and answer session following our formal remarks.
As a reminder, we will conduct a question and answer.
Following our formal remarks.
Speaker 2: This morning, Grisel issued a press release announcing unaudited financial results for the third quarter ended September 30, 2023. We encourage everyone to read this press release, and would like to remind you that this call is being recorded for review.
This morning, <unk> issued a press release announcing unaudited financial results for the third quarter ended September 32023.
We encourage everyone to read the press release I would like to remind you that this call is being recorded for replay.
Speaker 2: Please know 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 filing with SEC for a full disclosure of this risk and the factors.
Please note that certain information discussed on the call today, including financial data clinical data.
One of our core what we felt 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 I'm pleased.
Please refer to the risk factors section of our latest 20-F filing.
For a full disclosure of the suite and the factors.
Speaker 2: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 13, 2023. RESA 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 security law.
This conference call content I'm, starting the information that is accurate only as of the date of this live broadcast November 13, 2023, Greenfield undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances.
The date of this conference call except as.
May be required by applicable securities law.
Speaker 2: I will now turn the call over to GreenStone CEO , Dr. William Thao. William.
I will now turn the call over to Greece, Our CEO Dr. William.
Yeah.
Speaker 3: Thank you, Kevin. And again, welcome everyone to today's call. I will begin with the key pipeline and corporate update.
Thank you, Kevin and again welcome everyone to today's call.
I will begin with a pipeline and a corporate update.
Speaker 3: I will then turn the call over to our CMO, Dr. Wendy Lee, to provide insights into GC012F clinical data that were recently presented at the 20th International Myeloma Society, IMS, annual meeting.
Turn the call over to our CMO, Dr. Wendy Lee to provide insights into <unk> clinical data.
Recently presented at the International Myeloma Society.
Annual meeting.
Speaker 3: Next, our CFO , Dr. Kevin Shea, will discuss our third quarter 2023 financial results.
Next our CFO and Kevin.
We'll discuss our third quarter 2023 financial results.
Speaker 3: After our prepared remarks, we will open the call to questions.
After our prepared remarks, we will open the call to questions.
The past few months have been exciting both for Grace, So and the car T field.
Speaker 3: The past few months has been exciting, both for Grayscale and the cloudy fields at the line.
At the launch.
Speaker 3: At Graysilve, we have achieved several important milestones.
Okay, great. So we have achieved several important milestones.
Speaker 3: including the initiation of patient dosing in our first company-sponsored U.S. trial.
Including the initiation of patient dosing in our first company sponsored a U S trial.
Speaker 3: The presentation of the latest update of FAST CAR-T GC012F at the recent IMS meeting.
The presentation of the latest update of thoughts.
<unk> zero trough out at the recent IMF meeting.
Speaker 3: and upcoming American Society of Hematology Annual Meeting.
The upcoming American Society of Hematology annual meeting.
Speaker 3: the advancement of the investigator-initiated clinical study in systemic lupus erythematosus SLE, and also release of preclinical data from our solid tumor program at the Society of Immunotherapy of Cancer, SITC, annual meeting.
And advancement of the investigator initiated clinical study in systemic lupus erythematosus.
E.
And also believe preclinical data from our solid tumor program and our society.
Therapy of <unk>.
Hey, Andrew.
King.
Speaker 3: This period marked a crucial juncture for the country field.
This period Mark sure Jonathan.
Speaker 3: Some of the most significant hurdles faced by CAR-T in the treatment of blood cancers are being addressed by innovative, next-generation CAR-T candidates.
Some of the most significant hurdles faced by car T in the treatment of blood cancers.
<unk> addressed by innovative next generation car T candidate.
Aspirations such as.
Speaker 3: Rapid manufacturing, achieving a cleaner safety profile, and enabling deeper, more durable responses were shared by all company research.
Rapid manufacturing, achieving a clean safety profile and enabling deeper more durable responses with <unk>.
Good bye all comp researchers Andrew.
Speaker 3: and were also personal motivators for myself that led to the founding of Grace.
<unk> also personal motivator for myself.
The funding.
Speaker 3: It was a journey with a vision to push the boundaries of what's possible in cancer treatment.
It was a journey with.
With a vision to push the boundaries of what Costco in cancer treatment.
Speaker 3: The progress we have made is a testament to the entire Grayscale team's relentless pursuit of innovation.
The progress we have made is a testament to the entire great. So team's relentless pursuit of innovation.
Speaker 3: We are also finding ourselves at the forefront of a pivotal era in medical science.
We're also finding ourselves at the forefront of pivotal era and medical science.
Speaker 3: where the application of Kashi therapy is expanding beyond hematological cancer.
Whereas the application with car T therapy.
Pending beyond Hematological cancers.
Speaker 3: The unmet need in autoimmune diseases and solid tumors are massive.
I met need in auto immune diseases and solid tumors massive.
Speaker 3: At Grayscale, our approach is anchored in rigorous scientific research and commitment to innovation.
Had a great sell.
Our approach is anchored in rigor scientific research and commitment to innovation.
I am pleased to see right. We have made in these disease areas.
Speaker 3: 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.
Electing our dedication to addressing areas of high.
<unk> needs with cutting edge solutions.
Speaker 3: Today, we'll share some initial findings in our translational research on GC012F for the treatment of SLE.
Today, we will share some initial findings in our translational research.
<unk> for the treatment of Soe.
I look forward to sharing our ongoing progress and remain confident that our journey will lead to meaningful advancement in the field.
Speaker 3: I look forward to sharing our ongoing progress and to remain confident that our journey will lead to meaningful advancement in the field.
No I hope.
Speaker 3: Now I hope to provide a more detailed overview of what we have achieved in the third quarter.
To provide a more detailed overview of what we have achieved in the third quarter.
Speaker 3: In September , we announced dosing of first patient in the US phase 1b slash 2 investigational new drug IND study, evaluating our lead candidate BCMA CD19 dual-targeting VASCAR GC012F in the treatment of relapse refractory multiple myeloma, RRMM.
In September.
We announced dosing our first patients in the U S based <unk> slash two investigational new drug IND study evaluating our lead candidate BC MAA CD 19, dual targeting car T. As you'll recall back in the treatment of relapse refractory multiple myeloma.
And then.
Speaker 3: One clinical site is currently recruiting patients, and we look forward to activating a handful of additional sites in the U.S. in the coming months.
One clinical site is currently recruiting patients and we look forward to activating a handful of additional sites in the U S in the coming months.
Speaker 3: As a reminder, the phase 1b portion is designed to evaluate safety and the tolerability of GC012F, as well as determine the recommended phase 2 dose.
As a reminder, the phase <unk> portion is designed to evaluate safety and Tolerability of <unk> <unk>.
Well, Ed good timing the recommended phase II dose.
Speaker 3: We anticipate enrolling approximately 12 patients across two dose levels in the phase 1b portion.
We anticipate enrolling approximately 12 patients across two dose levels in the phase <unk> portion.
Speaker 3: We estimate that it will likely take approximately 9 to 10 months to complete patient enrollment.
We estimate that it will likely take approximately nine to 10 months to complete patient enrollment.
Speaker 3: In China, we expect to commence patient enrollment this quarter in the phase 1 slash 2 R&D study in RRMM.
In China, we expect to commence patient enrollment this quarter in the phase one two study.
And then.
Speaker 3: the guidelines for clinical research on somatic cells trials.
The guidelines for clinical research.
So <unk> trial.
Speaker 3: newly enacted 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.
Newly elected in August has impacted our timeline.
We are happy to report that we have now received all the required approvals.
Ready to launch the study in China.
Speaker 3: In late September , at the IMS annual meeting, the updated clinical data was presented from the ongoing phase I IIT evaluating GC012F as a frontline treatment for patients with transplant eligible high-risk newly diagnosed multiple myeloma, NDMM.
In late September.
IMS annual meeting the updated clinical data was presented.
The ongoing phase one.
<unk> evaluating <unk>.
Frontline treatment for patients with.
With transplant eligible high risk newly diagnosed multiple myeloma Andy in them.
Speaker 3: In this 19 patient data set with a median follow-up of 15 months.
In this 19 patient dataset with a median follow up 15 months.
Speaker 3: 100% of patients achieved minimum residue disease, negative, tangent, complete response, MRD negative, SCR.
Percent of patients achieved minimal residual disease negative stringent complete response.
The negative SCR.
Speaker 3: Dr. Vandily will elaborate on the key findings in a few minutes.
Dr. <unk> will elaborate on our key findings.
Units.
Speaker 3: Longer-term follow-up data from this study, including additional patients, will be presented at the 65th ASH annual meeting in December .
Longer term follow up data from this study, including additional patients will be presented at <unk>.
65 Ash annual meeting in December.
Speaker 3: We are continuing to see compelling efficacy data and a safety profile, and look forward to sharing more details in San Diego next month.
We are continuing to see compelling efficacy data and the safety profile.
And look forward to sharing more details in San Diego next month.
Speaker 3: To this date, we have reported clinical data of GC012F on 60 oncology patients in three IITs.
To this date, we have reported clinical data <unk> 60 oncology patients.
Alright.
Speaker 3: including 51 patients with multiple myeloma and nine with diffuse large B-cell lymphoma.
Including 51 patients with multiple myeloma, and Eni with diffuse large b cell lymphoma.
Speaker 3: The consistent findings provide good evidence supporting our strong scientific rationale in leveraging the power of dual targeting and validating the superior qualities of Fast CAR T-cell.
The consistent findings provided good evidence supporting a strong scientific rationale in leveraging the power of dual targeting and validating the superior quality of car T cells.
Speaker 3: Also, the very favorable safety profile demonstrated in these studies, including no neurotoxicity observed in any of the 60 patients,
Also the very favorable safety profile demonstrated in these studies, including low neurotoxicity observed in any of the 60 patients.
Speaker 3: could potentially provide a critical differentiation, early line settings. And.
Potentially provide a critical differentiation early <unk>.
And additional indications.
Speaker 3: We are very encouraged by the profile of GC012F and have high confidence that this therapy could bring profound benefits to the patients worldwide.
We are very encouraged by the profile of <unk>.
And have high confidence that this therapy.
Brink's profound benefit to patients worldwide.
In the second quarter of this year.
Speaker 3: We were thrilled to launch a new RIT-evaluating B19 B-semi-duotargeting GC012F in refractory SLE, or RSLE. This new direction is inspired by the groundbreaking clinical discovery shared by Professor George Shet's group.
We were thrilled to launch a new <unk> evaluating <unk>.
King.
<unk> targeting <unk> in refractory.
Paul.
Sorry.
This new direction is inspired by the groundbreaking clinical discovery shared by Professor George shipped.
Speaker 3: We see immense opportunity here and believe 12F is ideally positioned as a potential treatment for many autoimmune conditions, including SLE, combining its safety track record, CT19-BCMA dual targeting capability, and faster and consistent product delivery.
We see immense opportunity here and I believe <unk> is ideally positioned as a potential treatment for many autoimmune conditions, including SLE.
Combining safety track record.
<unk> dual targeting capability.
And faster and consistent product delivery.
Speaker 3: In the field of autoimmune disease treatment, safety stands as a critical factor for defining success.
In the field of autoimmune disease treatment safety stand.
Critical factor for defining success.
Speaker 3: As oncologists learn ways to better manage adverse events, the safety of CAR-T has become less of a concern in cancer applications.
As oncologists to learn ways to better manage the adverse events. The safety of Ekati has it become less of a concern in cancer applications.
Speaker 3: However, we believe the focus on safety will be renewed when the industry seeks to potentially adopt CAR-T as a treatment for auto
However, we believe the focus on safety will be renewed when the industry seeks to potentially adopt katja.
<unk> as a treatment for autoimmune conditions.
Speaker 3: Any successful therapy must demonstrate exceptional tolerability and safety profile.
Any successful therapy must demonstrate exceptional tolerability and safety profile.
Speaker 3: So far, GC012F has been used to treat 60 cancer patients, including those who are frail and vacillating advanced cancer.
So far <unk> has been used to treat 16 cancer patients, including those who are frail and gasoline advanced cancer.
Speaker 3: We have observed a consistent safety profile characterized by mostly low-grade cytokine release syndrome, CRS, and notably, no incidences of neurotoxicity to date.
We have observed a consistent safety profile characterized by mostly low grade.
Cytokine release syndrome, Crs and notably note incidents system neurotoxicity today.
Speaker 3: 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.
It is important to point out these encouraging results being derived from the same compound currently being investigated in.
Underway for SME.
This consistent track record of safety gives us confidence as we expand our studies to a new field, where the standards for safety.
<unk> hi.
Speaker 3: On the efficacy side, the promise of CAR-T is to induce a complete immune reset, where all the autoreactive cells are eliminated and newly generated cells are expected to be open.
On the efficacy side the promise of car T is to induce a complete re.
<unk>.
Order auto reactive cells eliminated and newly generated sales expected to be.
Okay.
Speaker 3: For B-cell-mediated diseases, such as SLE, some were hoping to complete depletion of B-cells could reset immune system.
For B cell mediated diseases, such as SME.
So we're hoping to complete depletion of b cells could reset immune system.
Speaker 3: Based on this theory, CD19 is considered a valid target for CAR-T, as it is expressed throughout the early and the mature stage of.
Based on this theory CD 19 is considered a valid target for car T. As it is expressed throughout the early and the mature stage of T cells.
Speaker 3: However, we think it's important to remember that SLE is a disease in which autoantibodies attack a patient's own tissue.
However, we think it's important to remember <unk> is a disease in which auto antibodies attack a patients own tissue.
Speaker 3: So in addition to resetting B cells, our view is that.
So in addition to resetting b cells.
Our view is that.
Speaker 3: And effective therapy should also address the disease-causing autoantibody-secreting cells, or AST.
An effective therapy should also address that disease, causing auto antibody secreting cells or a SP.
Speaker 3: ASC populations could be CD19 positive or CD19 negative and are BCMA positive.
ASC populations could be CD, 19 clauses or to 19 negative.
And semi positive.
Speaker 3: So the use of CD19 single-targeting clonking therapy alone may not be sufficient to eliminate all the autoantibody-producing cells in all patients.
So the use of CD 19 single targeting car T therapy alone may not be sufficient to eliminate all our debt.
Antibody producing cells in all patients.
Speaker 3: Therefore, we feel there is a strong scientific rationale to support targeting both BCMA and CD9.
Therefore, we feel there is a strong scientific rationale to support targeting both <unk> and 2019.
Speaker 3: which aligns with GC012F design in order to provide a more effective and a long-lasting therapeutic approach for refractory SLE.
Which aligns with <unk> 12 F design in order to provide a more effective and long lasting therapeutic approach for refractory sorry.
Speaker 3: In recent months, we have been working on preclinical and translational studies to support this rationale.
In recent months, we have been working on preclinical and translational studies to support the rationale.
Speaker 3: Today, we are delighted to share some preliminary findings.
Today, we are delighted to share some preliminary findings.
Speaker 3: First, we analyze the samples from four initial patients treated with GC012F at 1 times 10 to 5 cells per kilo dose.
First we analyzed the samples from.
<unk> initial patients treated with <unk> zero compare at onetime tend to fit a kilo dose.
Speaker 3: And after the three months follow-up, we can see B cells have been restored to naive phenotypes in these four patients.
And at the three months follow up.
We can see b cells have been restored to naive phenotype.
These core patients.
Speaker 3: This provides very encouraging early evidence that GC012F is inducing an immune reset.
This provides some very encouraging early evidence that <unk> copper is inducing.
Reset.
Speaker 3: Secondly, we run studies with bone marrow samples collected from our SLE-IIT patients.
Secondly, we run studies with bone marrow samples collected from our SMA patients and demonstrated that the CD 19, bcm, a dual targeting car T showed a more efficient elimination of AFC compared to <unk> 19 single targeting car T.
Speaker 3: and demonstrate that the CD19b semi-dual targeting CAR-T showed a more efficient elimination of ASC compared to CD19 single targeting CAR-T.
Speaker 3: Taken together, we believe that our CD90b-CMA 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 plasmas.
Taken together, we believe that our CD 19, <unk> crunchy asbestos, both DSO and <unk>.
And isn't designed to achieve a deeper and wider elimination of disease, causing peso as well as plasma Michelle.
Speaker 3: You can find the details of these findings in our latest corporate presentation deck.
You can find the details of these findings in our latest corporate presentation deck.
Speaker 3: And we look forward to sharing more at the upcoming Cell Therapy for Autoimmune Disease Summit later this month.
And we look forward to sharing more and upcoming cell therapy for autoimmune disease Summit later this month.
Lastly on the manufacturer side, we believe that <unk> is positioned favorably.
Speaker 3: Lastly, on the manufacture side, we believe that GC012F is positioned favorably with overnight manufacturing and enhanced cell fitness.
Overnight manufacturing and enhance sales fitness.
Speaker 3: combined with our team's significant experience accumulated over the years.
Combined with our team's significant experienced accumulated over the years.
Speaker 3: Although SLE is a chronic disease, faster CAR-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 the aphresis, and also during the wait for CAR-T production. Except for the use of low-dose SLE.
Although <unk> is a chronic disease faster coffee delivery is still highly meaningful for better clinical outcomes.
Ensure optimal Karachi expansion in the patient body patients typically need to stop early treatment before three CIS and also during the wait for kind of keep production.
Except for the use of low dose steroids.
Speaker 3: Fast and consistent delivery of cardiotherapy would help to shorten this period of suboptimal disease control and greatly reduce the risk of disease flare and additional organ damage during the wait.
Fast and consistent delivery of car T therapy.
It would help to shorten the period of sub optimal disease control and greatly reduce the risk of disease flare up and additional organ damage during the wage.
Speaker 3: In short, we believe 12F is a highly differentiated candidate, backed by outstanding safety records, novel and strong scientific rationale, and fast car keys technology, as well as supported by our team's extensive experience in manufacturing and optimizing the plot.
In short we believe <unk> is a highly differentiated candidate backed by outstanding safety record novel, and a strong scientific rationale and key technology <unk>.
Supported by our team's extensive experience in manufacturing and optimizing the process.
Speaker 3: We eagerly anticipate advancing the clinical development of in-part immune disease.
We eagerly anticipate advancing the clinical development of ink auto immune disease.
Speaker 3: Currently, the IIT evaluating DC012F in SLE 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.
Currently.
Evaluating <unk> in <unk> continues to enroll patients more than a handful of patients has been treated and the goal is.
Patient enrollment to progress into double digit range.
Speaker 3: We expect to release the first public readout from this ongoing IIT in the first half of 2024.
We expect to release, our first public Readouts from this ongoing.
In the first half of 'twenty 'twenty four.
Speaker 3: We are currently on track to submit R&D filings in the U.S. and China in 2023 for the plan phase one clinical trial. The U.S. submission will be the second R&D for GC012F to be reviewed by the U.S. FDA and will be in an important milestone as we continue to advance our efforts to provide innovative and effective treatment options to patients with autoimmune disease.
We're currently on track to submit an IND filing in the U S and China in 2023 for the planned phase one clinical trial.
<unk> submission will be the second RMB <unk> 12 to be reviewed by the U S. FDA.
And we will be an important milestone as we continue to advance our efforts to provide innovative and effective treatment options to patients with autoimmune disease.
Speaker 3: Beyond the fast car platform, we also continue to advance our smart car technology for the treatment of a solid tumor.
Beyond the <unk> Com platform. We have also continued to advance our smartcard technology for the treatment of solid tumors.
Speaker 3: At the CITI annual meeting in early November , we presented the preclinical data evaluating smart CAR T-cells in solid tumor model.
At the <unk> annual meeting in early November we presented preclinical data evaluating smart car T cells in solid tumor models.
Speaker 3: SMAP stands for Suppressive Molecule Activated and Resuminated T-cells.
<unk> stands for suppressive molecule activated and the rejuvenated T cells an.
Speaker 3: And our novel smart CAR-T technology includes a proprietary switch receptor targeting the suppressive tumor microenvironment, in which the inhibitory TGL beta signal is blocked and converted into a pro-T cell signal in CAR-T cells.
And our novel small car T technology includes a proprietary switch receptor targeting the suppressive tumor microenvironment.
The inhibitory TGF beta signaling is blocked and converted into a pro T cell signal in car T cells.
Speaker 3: Our studies have shown that smart CAR T-cells are younger and more resistant to TGF-beta-mediated apoptosis and exhaustion.
Our studies have shown that smart car T cells are younger and more resistant to TGF beta media to a pub ptosis and exhaustion.
Speaker 3: Upon repeated challenges of tumor cells, smart CAR-T cells showed more potent and durable tumor-specific lysis than the conventional CAR-T, both in vitro and in vivo, in the presence of TGF-beta.
<unk> repeat and the challenges of tumor cells car T cells showed more potent and durable tumor specific licenses than the conventional car T. Both in vitro and in vivo in the presence of TGF beta.
Speaker 3: Especially in mouse models, smart CAR-T exhibits better killing activities in tumor re-challenge studies and higher tumor burden studies compared with conventional CAR-T.
Especially in mouse models Smartcards exhibit better killings activities in tumor re challenge studies.
And higher tumor burden studies compared with conventional car T.
Speaker 3: Earlier in fourth quarter, we initiated an IIT in China to evaluate our smart car T candidate, GC506, in patients with collagen 18.2 positive solid tumors.
Earlier in the first quarter, we initiated it in China to evaluate our smart car T candidate <unk>.
<unk> five <unk> six in patients with clogging 18, <unk> positive solid tumors.
We decided to further streamline our pipeline during the first quarter by continuing our focus in devoting our resources on the programs that have being potential.
Speaker 3: We decided to further streamline our pipeline during the fourth quarter by continuing our focus in devoting our resources on the programs that have been potential to be the best in class and address large unmet needs.
To be the best in class and address large unmet needs.
Speaker 3: We suspended China phase 2 trial evaluating GC007G for the treatment of B-cell acute lymphoblastic leukemia, or BALL.
We suspended China phase II trial, evaluating GC zero-zero LNG for the treatment of B cell acute lymphoblastic leukemia or B L.
No.
Speaker 3: considering the limited commercial opportunity for this niche candidate.
Considering the limited commercial opportunity for this niche candidate at.
Speaker 3: As a reminder, we have seen compelling data in the phase 1 study with GC007G, including 100% MID negative CR slash CRI among nine DLL patients.
As a reminder, we haven't seen compelling data in the phase one study with GC zero zero, <unk>, including a 100% <unk> negative CR flush cri among <unk> patients.
Speaker 3: TC007G is a HLA-matched, donor-derived allogeneic clot.
<unk> zero zero 70 is HLA matched donor derived allogeneic car T and does not leverage our cash cost and <unk> car T technology platform or smart car T module.
Speaker 3: and does not leverage our fast car and 2U CAR-T technology platform or smart CAR-T module. The updated pipeline chart will be found in the corporate presentation posted to Grayscale's IR website.
The updated pipeline chart will be found in our corporate presentation posted to great sales.
The web site.
Speaker 3: We significantly strengthened our financial position in August 2023 as we completed a private placement transaction raising $100 million up front and up to $50 million in additional funds if the warrants are fully exercised within 24 months.
We significantly strengthened our financial positioning August 2023, as we completed a private placement transaction, raising $100 million upfront and up to $50 million in additional funds.
The warrants are fully exercised within 24 months.
Speaker 3: with the support from the top-tier roster of institutional investors.
With the support from the top tier roster internet institutional investors.
Speaker 3: This capital raise extends our cash runway into the second half of 2026, assuming the full exercise of warrants. And it's intended to support us through critical upcoming milestones planned for the clinical development of GC012F in multiple myeloma and SLE.
This capital raise.
And 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 <unk> in multiple myeloma and <unk>.
Speaker 4: Now, I will hand the call over to our CMO, Dr. Wendy Li, to highlight updated data from the ongoing RIT in NDMM. Wendy, please go ahead. Thank you, William. As highlighted, we are continuing to amass clinical evidence supporting the tremendous potential of our work.
Now I will hand, the call over to our CMO, Dr. Wendy Lee to highlight updated data from the ongoing.
Mmm.
Wendy please.
Please go ahead.
Thank you William highlighted will come to you.
Thank you.
Evidence supporting the tremendous.
Potential of our lead candidates.
CD 19 targeting.
Targeting car T zero cloud apps.
In late September.
Annual meeting.
Suncor long term follow up data from an ongoing phase one.
Cause app.
Hey, diagnosed multiple myeloma.
Speaker 4: These patients have not received any antibiomar therapy before they are enrolled to our study. And all patients in this.
These patients have not received any.
<unk> Lama powerful before.
In our study.
In all patients.
<unk> had one or more high risk features of which 89% were classified as stage two or three <unk>.
Speaker 4: or three based on the reverse international.
International staging system.
Speaker 4: and 63% extra-medullary plasma cytoma. This is.
And the 63% after medullary plasma sarcoma.
Thank you Klaus.
Demonstrated 100%.
Speaker 4: ORR and 100% MRD negative.
Sure.
100% on Mark the last call.
John called CR rate amongst the lighting truss plants patentable high risk.
Speaker 4: among the 19 transplant-eligible high-risk
Andy.
Speaker 4: as of the data cutoff date of August 1st.
As of the data cutoff date of August 1st plenty plenty of third.
Speaker 4: PC012F also continued to show a favorable safety profile with around 70% patients not having CRS of any.
<unk> also continued to show a favorable safety profile.
With around 70% of patients not having.
<unk> of any grade.
No patients reporting.
Toxicity or iqos.
Speaker 4: We think this data are highly compelling, suggesting a potentially ideal profile for the front line of the.
We think this data are highly.
Patty, suggesting a potentially ideal profile for the south line application of car T therapy, combining Paul steep response and the high Tolerability.
Speaker 4: combining both deep response and high tolerance.
Speaker 4: In December , updated results from this ongoing study will be presented at the 65th AASH Annual Meeting.
And December updated results from this ongoing study will be presented at <unk>.
65.
Annual meeting.
As highlighted in the abstract available.
Speaker 4: in the abstract available on the OSH website.
<unk> web site.
Speaker 4: We plan to share updated data, including 22 patients.
Plan to share updated data.
22 patients with a favorable efficacy and safety profile.
Speaker 4: and safety profile consistent with FHIR data sets. The AHRQ data set includes three additional
Ms Cheng with client data.
The ash data sets.
Three additional patients that were not in the IMS data set.
Speaker 4: Because those patients were not dosed or assessed when we first submitted the abstract.
Because those patients were not dosed for a fast when wafers from Nathan.
Abstract.
Yes.
Speaker 4: I will now hand the call over to our CFO , Dr.
I will now hand, the call over to our CFO, Dr. <unk>, Thailand, So Kevin.
Speaker 2: Thank you, Whitney. 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 RMB $1,707.9 million for US dollar $234.1 million in cash and the cash equivalents and short-term investment.
Thank you Whitney turning to our financial results for the third quarter ended September 32023.
To touch on our Seo financial trends.
As of September 32023, the company had RMB 1 billion $707 9 million or U S. Dollar $234 1 million in cash and cash equivalents and short term investments.
Speaker 2: We expect the cash use this year to be approximately $100 million U.S. Primarily to fund our R&D on the clinical programs in the U.S. and China.
We expect the cash use this year to be approximately 100 million in U S. Dollar primarily to fund our R&D and clinical programs in the U S and China.
Speaker 2: As announced in early August , we completed a private placement financing with a hundred million REITs up front 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.
As announced in early August we completed a private placement financing with a $100 million upfront and up to additional five committed in the event that the warrants are fully exercised within 24 months after closing of the upfront pressures.
Speaker 2: With this, we have extended our cash runway 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.
With this we have extended our cash runway 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 exercise.
Speaker 2: For the three months ending September 30, 2023, net loss attributable to ordinary shareholders were RMB $67.6 million or US dollar $9.3 million, compared to RMB $171.9 million for the corresponding prior year period.
For the three months ended September 30, 20th lace rate.
Net loss attributable to ordinary shareholders was <unk>.
R&D $67 6 million or U S dollar 93 million.
Compared to RMB $171 9 million for the corresponding prior year period.
Speaker 2: The decline in net loss is primarily a result of decrease in the fair value of warrant liability.
The decline in net loss is primarily a result of decrease in the fair value of warrant liabilities.
Speaker 2: The warrant issues in the August private placement are measured and recorded at fair value at the time of issuance.
The warrants issued in August.
Replacement or measure and are recorded at fair value at the time of issuance.
Speaker 2: The fair value of the world decreased by RMB 39.9 million or U.S. dollar 5.5 million as of September 30, 2023 and was recorded as a gain in the income statement.
The fair value of the warrants decreased by RMB, $39 9 million or U S dollars $5 5 million as of September 32023, and was recorded as a gain in the income statement.
Speaker 2: Research and the development expenses for the three months ended September 30, 2023 were RMB 90.1 million or U.S. dollar 12.3 million.
Research and development expenses for the three months ended September 32023, or RMB, $90 1 million or U S dollars $12 3 million compared to RMB $133 four minute in the corresponding prior year.
Speaker 2: compared to RMB, 133.4 minutes in the corresponding prior year period. The decrease was primarily due to the decreased spending on research, development, and the clinical trial as a result of timing of project spending and our strategic pipeline alignment.
Sure.
The decrease was primarily due to the decreased spending on our research development and clinical trial as a result of timing of project spending and our strategic pipeline alignment.
Speaker 2: With that, I'd like to turn it back to the operator to open the session for your questions. Operator?
With that I'd like to turn it back to the operator to open the session for your questions operator.
Speaker 1: At this time if you would like to ask a question please press star followed by the number one on your telephone keypad and if you would like to withdraw your question again press star one.
At this time, if you would like to ask a question. Please press star followed by the number one on your telephone keypad and if you would like to withdraw your question again press Star one.
Speaker 1: Your first question comes from the line of Yigal Narchomovitz from Citi, please go ahead.
First question comes from the line of Yigal <unk> from Citi. Please go ahead.
Yes, Hi, William and team. Thank you for taking my questions you.
Speaker 5: Yeah, hi, William and team. Thank you for taking the question. You mentioned the antibody-secreting cells in a certain population may be 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?
You mentioned the antibodies to creating sales certain population, maybe CD 19 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 CD 19 negative.
Speaker 3: Yeah. It's widely reported, but the percentage of CD19 negative ASC in humans
Yes.
It's widely reported.
The percentage of CD 19 negative PSC in human.
Speaker 6: Um, you know, we haven't found a very, um,
We haven't found very.
But rounded reports.
Speaker 6: But it is a fact that there are antibody-secreting cells that are CD19 negative for sure, and BCMA positive. If you need, you can see.
But it is effect.
Uh-huh antibody <unk> CD 19 negative for sure and <unk> positive.
If you need it we can send you reference for that.
Speaker 5: 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?
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 BSO antibodies suppression you saw with the dual construct versus the CD 19 car T alone.
The assay is Alice pumps.
Speaker 3: And the assay is at a spot, so basically what it does is you would take the.
Hi.
What it does is.
We would take a year.
Speaker 3: the PVMC bone marrow cells from the patient prior to the treatment.
PMC.
Bone marrow cells from the patient.
Prior to the treatment of the treatment.
Speaker 6: And we put these cells in the Headspot device with our CAR-T.
And we put the sales initiatives going to device.
With our car T.
Speaker 6: I mean, RT is a treatment with the CAR-T ex vivo. And I see how many antibody-secreting spots that are formed.
<unk> as a treatment with the car T X vivo and to see how many.
Antibody secreting spot.
<unk>.
Speaker 6: Based on that, the difference is.
Based on that.
The difference is.
Speaker 6: CD19 single-car and BCMAC 19 dual-car GC012F is tenfold, more than tenfold.
You've seen the 19 single car.
<unk> seen that in dual card <unk> to 12.
It's painful more than tenfold.
Speaker 6: Okay. 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 the 012. Were there any? No. 51 plus 9. 51 myeloma patients, 9 DLBCL patients. Okay. Yes.
Okay. 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 the.
Zero 12.
51, plus 950.
<unk> 51, myeloma myeloma patients nine Del's bcl patients.
Okay, yes. Thank you.
Speaker 5: So, amongst those 60 in total, did any of those patients have an underlying autoimmune condition that may have improved with the treatment?
So amongst those amongst those 60 in total.
Did any of those patients have.
An underlying autoimmune condition that may have.
Proved with the treatment.
Speaker 6: We have not paid attention, you know, discovered.
We have not.
Pay attention.
Okay.
Discovered.
Speaker 6: Yeah, we don't notice that there are certain percentages of heart and ear patients.
Yes.
Yes, we don't noticed slowdown so the percentage of hard on new patients.
Speaker 6: But sometimes it could have happened for liquid human.
Sometime it could have happened.
On a liquid tumor.
Okay, Alright, thank you very much.
Sure.
Your next question. Your next question comes from the line of Ben Burnett from Stifel. Please go ahead.
Speaker 1: Your next question comes from the line of Ben Burnett from Spiefel. Please go ahead.
Speaker 7: 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?
Hey, Thank you very much I also wanted to ask about the <unk> study and some of the early signals you're seeing from the Iot.
Cohorts.
Encouraging to hear the T cells are recovering by three months.
But I guess can you talk about the degree of diesel aplasia.
That you are seeing is this comparable to what <unk> seen in the oncology studies.
Compared with George ship studies.
Speaker 3: Comparable to what you've seen with 12F in your myeloma studies, just in terms of the amount of B-cell deplasia. Yes. B-cell depletion is similar, although, you know, the.
Alright.
In parallel to what you've seen with with 12 apps and your myeloma studies just in terms of amount of BSI seek ways out yet.
Peter.
<unk> is similar although.
Hi.
Speaker 6: The SLE study is still need to be further followed and evaluated. But what we're seeing is the declining curve is similar. And the recovery time or persistence of B-cell depletion, we need to have more time to make a conclusion.
The <unk> studies.
Sure.
Need to be further followed.
Uhm.
We are seeing is.
Declining.
Any curve is similar.
And the recovery time persistent b cell depletion, we need to we need to have more time to make a conclusion.
Yeah.
Speaker 3: B-cell, naive B-cell recovery so far from these four patients.
So naive b cell recovery, so far from these four patients.
Speaker 6: looks very similar to other SLE studies.
It looks <unk>.
Similar to other.
So <unk> studies.
Does that answer your question yes.
Speaker 7: Yeah, that's great. Thank you very much. I also wanted to ask about the newly diagnosed multiple myeloma study. The data 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 newly diagnosed multiple myeloma? Like, what would constitute a pivotal study in this study?
Yes, that's great. Thank you very much.
I also wanted to just ask about the newly diagnosed multiple myeloma studies.
Data <unk> had has been staying we're looking forward to the ash update, but I guess could you maybe frame for us what the regulatory parcel or could be in the U S for this asset.
Newly diagnosed myeloma.
Constitute a pivotal study in this setting.
Speaker 6: It's too early to give you that perspective. How do we design the study for newly diagnosed and also pivotal?
It's too early to.
Give you that perspective, how do we decide design study for <unk>.
Nearly diagnosed and also pivotal studies.
Speaker 6: But I, you know, based on our understanding of what the regulatory agencies view towards
Based on our understanding of what the regulatory agencies view toward.
Speaker 6: kind of a progressive development of a CLA-T therapy to early lines, it's all about safety. And of course,
The.
Progressive.
Development of our car T therapy to early lines.
All about safety and of course efficacy and this product.
Speaker 6: And this product, so far, we're convinced it's very robustly safe.
We are convinced.
Very robustly.
Speaker 6: across different indication of late and early line of multiple myeloma and TLBCL. Now, SLE. I think, you know, given the data we collected and when we have 1B RMM study data, I think that will be the time we'll communicate it with US FDA. By the time we shall have a detailed design of how do we approach the early line.
Across different indications late and early line multiple myeloma and <unk> now SME.
I think given the data we collected and.
When we have.
<unk>.
<unk> study data I think that'll be the time, we communicated with.
The U S FDA.
By the time, we shall have.
Detailed design, how do we approach.
Early line, where the first line.
Speaker 3: But we are not excluding anything. We definitely will move forward in the early lines for sure.
But we are not excluding anything we definitely will move toward an early lines for sure.
Okay, great. Thank you.
Okay.
Your next question comes from the line of Kelly <unk> from Jefferies. Please go ahead.
Speaker 1: Your next question comes in the line of Kelly Shee from Jefferies. Please go ahead.
Speaker 8: Hi, this is Dave on for Kailashi. Thanks for taking our question. So my question is on SL.
Hi, This is Dave on for <unk>. Thanks for taking our question. So my question is on <unk>. So maybe if you can set up expectations what type of data companies planning to release in first half of 'twenty four and related to that.
Speaker 8: If you can set up an expectation, what type of data a company is planning to release in the first half of 2024, and relate it to what cell dose level you are studying and
What cell dose level, you are studying and.
Speaker 8: Can it shorten the dose level that you will be studying in US trials similar to RRMM? Or it'll be those escalations starting?
Gannett shorten the dose level that you will be starting in U S trial, similar to auto random or it will be.
Dose escalation starting from the smaller stores. Thank you.
Yes.
Yes.
Speaker 3: We are dosing more SLE patients. So we expect it's going to be double digits when we present the data first half of 2024. We expect majority of patients will have at least three months. And some of the patients will have at least three months.
We are dosing.
Is it more <unk> patients. 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.
Three months.
And some of the patient will have six months evaluation.
Speaker 6: Now, the dose, we start with the dose very similar that we have treated our MM patients, or neurally diagnosed.
Now the dose we start with the dose very similar <unk>.
So.
And many patients are newly diagnosed patients too.
Speaker 6: So, you know, I can't predict what's going to happen with dose level three, but now we are dosing up, see what happens. And based on what we see today, it's very consistent. The PK and the CIS and the nucleotides just preliminary.
So.
I can't predict what's going to happen what dose level three.
Now we are dosing a.
See what happened.
Based on what we see today.
Very consistent.
The PK in the CNS.
Trunks.
Preliminary seems very similar.
Speaker 6: So we move up to 3 times 10 to 5, which is still very low compared to others in the industry.
So.
Yes.
We will continue to move up to.
Three times 10 to five which is still very low compared to others in the industry.
Speaker 6: And I don't expect those higher than 3 times 10 to 5. But we'll see.
And I don't expect to dose higher than three times tend to fit.
But we'll see.
Right.
Thank you.
Last question for your questions.
Alright.
Speaker 1: Your next question comes from the line of Eric Schmidt from Cantor. Please go ahead.
Your next question comes from the line of Eric Schmidt from Cantor. Please go ahead.
Speaker 9: Thanks for taking my question and the added information. Also, a question around the SOE translational data.
Thanks for taking my question and the added information.
Also a question around the necessarily translational data.
Speaker 9: William, did all four patients achieve D?
William did all four patients achieve deep.
Speaker 9: or deep B-cell lymphodepletion with no detectable B-cells.
T cell <unk> or <unk> T cell lymphoma patients with no detectable b cells.
Speaker 6: It's a pleasure after Kati therapy. That's what we can say.
DSO Aplasia after car T therapy, that's all we can say.
Your second half a question has.
Speaker 9: Did we see a pleasure after lymphodepletion? No. And what was the duration? Most of it, no. Sorry. Okay. Thank you. What Flucidose are you using? It's very.
It will be soon.
Asia not building for depletion.
Yes.
Okay, what was that.
<unk> most of it.
Alright.
Okay. Thank you what flu side dose are you using.
It's very similar to the first group.
Okay, and what was the duration of the.
Okay.
To similar.
Sure.
Speaker 6: similar to multiple money loan, which.
Similar to multiple myeloma.
Richard.
The duration of the B cell depletion was similar to what <unk> seen in myeloma.
Speaker 6: the duration of the B-cell depletion was similar to what you've seen in myeloma? B-cell lymphodepletion is very similar. B-cell aplasia, at this moment, I mean.
Sure.
Neutral depletion is very similar piece of a pleasure.
At this moment.
Speaker 6: that the longest we have seen so far is a couple months of whole apricot infusion. So
The longest we are seeing so far a couple of months.
Hello.
After context infusion so.
Speaker 6: to make a claim that how long the B-cell plasia, I think it's still too early.
To make a claim that how long the <unk> thing is still too early.
<unk>.
Speaker 6: the complete recovery, I think it needs more time. Right now, the declining of B-cells, it's very slow.
The army completed recovery.
I think it could meet all the time.
Okay.
Right now the <unk>.
Signing of B cells.
It's very similar compared with multiple myeloma.
When these patients.
Speaker 6: comes back with a meaningful readout, I think we need a couple of months.
It comes back with a meaningful readouts.
I think we need a couple of months.
To see.
Speaker 6: And then, you know, I have to remind that these first four patients are low doses. It's a one time 10 to 5.
Then.
I have to remind.
These first.
<unk> patients.
Low doses.
<unk>, 10% for Q.
Speaker 6: And now we're moving up to 2 times 10 to 5th, and 3 times 10 to 5th. Okay, so we need to give them.
And now we're moving up to 2% to 5%.
Defense.
Okay. So we may have to give them an opportunity.
Okay.
Speaker 9: Thank you. I think you mentioned that you saw elimination of antibodies greeting cells. Did you also measure autoantibodies themselves and see elimination of autoantibodies?
Thank you I think you mentioned that you saw elimination of antibody secreting cells did you also measure auto antibodies themselves and see elimination of auto antibodies.
Speaker 6: Oh, yeah, yeah. I mean, in vivo, I mean, in human, we certainly measure as many types of autoantibody we can, if those autoantibodies are high, over five, prior to therapy.
Yes.
In vivo in human and we certainly measure.
Many types of auto antibody, we can if those other antibodies that are high.
Prior to therapy right now what I mentioned is an expanded ex vivo study.
Speaker 6: Now, what I mentioned is at its spot is ex vivo study. So we measure typical, for example, tapestry on the DNA.
So we measure typical for example, double stranded DNA antibody.
And I saw that.
Speaker 6: And you saw that. There are 20 autoantibodies to measure. It's, yeah, for clinical, it's doable. But for preclinical, we want to have a consistent system to compare.
20 auto antibodies to measure.
For clinical.
It's doable.
For preclinical we want to have a consistent system to compare.
Sorry, I missed the second part.
Speaker 9: So, in the patient, the SLE patients with double-stranded DNA antibodies, you did see those.
So in the patient or the SLE patients with double stranded DNA antibodies you did see those decline.
Yes.
Speaker 10: Although, I do not want to give out any data related to efficacy. Yeah, but.
Although I do not want to give out any data related to efficacy.
Yes.
Okay. That's it thank you very much.
Thank you Eric.
Your next question comes from the line of Emily Wagner from H C. Wainwright. Please go ahead.
Speaker 1: Your next question comes from the line of Emily Bogner from HC Wainwright. Please go ahead.
Hi, Good morning, Thanks for taking my question, Arizona as episodic.
Speaker 11: Hi, good morning. Thanks for taking the questions. There is an ASH abstract out also on a dual CD19 BCMA CART for SLE. I was 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 CAUDIN 18.2-positive follow-up.
Also on a dual CD 19, CMA car T for ethylene.
Have you seen that and maybe if you can comment on from the initial thoughts from there on the efficacy and safety side.
You can provide any guidance or timing on the initial data for the quarter and 18 <unk> positive solid tumors.
Speaker 11: in China, and maybe if you could also talk about the design there.
Final.
And maybe if you could also talk about the design there.
Speaker 6: Yeah, 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 or neurotoxin will happen.
Yeah. Thanks for the question I mean, it's still early for us to.
To release to share that data, especially the efficacy.
Safety.
As you know youre going to see 15 to put 28 days.
It's unlikely.
Typical crs or neurotoxicity or happened after.
Speaker 6: 15 days. So, within 28 days, we are comfortable to, to, you know, to, to share.
15 days so.
Within 28 days and we are comfortable too.
Sure.
Sure.
Speaker 6: Even though it's, again, I have to warn, this is early data. It's a first low dose, one time 10 to 5th per kilo. It's about $6 million total CAR T cells, $6 million. But it's very, very encouraging. We see all the signs of safety and efficacy.
Even though again I have to warn this is early data into first low dose one times 10 to five per kilo.
About $66 million total <unk> 6 million.
But it's very very encouraging.
We see all the signs.
From a safety and efficacy.
Now the.
Speaker 3: a reasonable set of data readout will be the first half year 2024. By the time we'll have a double-digit patient and with at least three months.
A reasonable set of data readout will be the first half year 2024 by the time, we will have us double digits patients.
At least three months.
Speaker 6: and hopefully half of the next six months follow up. So that's.
And hopefully.
For the six months follow up.
We should expect.
Speaker 11: Sorry, I think maybe you misunderstood my question, um, I went there, there was an abstract that was released.
Sorry, I think maybe you misunderstood my question.
I know there was an abstract that was released to be presented at ash from another CD 19, <unk> car T therapy for ethylene I was just curious.
Speaker 11: presented at ASH from another CD19 VCMA CAR T therapy for SLE. I was just curious if you've seen that and what your thoughts were on what they present or what they showed in that.
And what your thoughts were on what states.
What they showed in the abstract.
Speaker 12: Oh, yeah, I saw that abstract. That has been.
Oh, yes, I saw that abstract.
Ben.
Speaker 12: 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.
Presented somewhere before.
It is good to see another dual targeting car T.
That is being applied to auto immune disease.
But every construct to a different we don't know the details of their construct.
Speaker 12: and we don't know much about background, particularly the safety of the same compound, the same CAR T, or other indication, for example, oncology. But based on what we saw from the abstract,
We don't know much about background, particularly.
The safety of the same comp compound the same car T for other indications for example oncology.
Based on when we saw.
From the abstract.
Speaker 6: The data looks reasonable. I think, you know, when we compare with Dr. Sheth's group, the patient background is different. I think everybody would agree that the patient that in Dr. Sheth's group tend to be younger and the time from the diagnosis is short.
Data looks reasonable.
I think we.
When we compare with Dr. <unk> group.
The patient background is different I think.
Everybody would agree that.
Patient.
This group tend to be younger and the time from the diagnosis is short.
Speaker 12: And this abstract seems to patients.
And this abstract seems to patients.
Speaker 3: more diversified. The Flandau index seems
More diversified.
The <unk> index.
<unk>.
Speaker 6: I would say similar, because there are more than
I would say similar.
More than.
I think 10 patients.
Speaker 12: So the mean is similar, the median is similar, the age seems to be more diversified.
So the timing is similar medium similar age seems to more.
Diversified.
Speaker 12: And then some patients with active locus nephritis may not be fully recovered, which is not a surprise, in our opinion. Because when in the real world, when a patient is older and the time from the first diagnosis is much longer, and they're being treated in more standard of care.
And then some patients with active lupus nephritis may not be fully recovered.
Which is not the price in our opinion.
In the real World, we are in the patients.
And the time from the first diagnosis much longer.
They are being treated at a more standard of cares.
And it was.
<unk>.
<unk> as a percentage of patients.
Speaker 3: have active lupus nephritis, and that will give you a different flavor of readouts.
Active.
Lupus nephritis and download.
Give me a different flavor of Readouts.
And the last thing I want to.
Speaker 12: I remind, you know, everyone who is interested, you got to look into the product.
I remind.
Everyone, who is interested you guys are looking to the product.
Speaker 6: format of final product, whether it's a fresh CAR T-cells or it's a frozen. As we all appreciate, if it's a frozen CAR T-cells, it is more robust in the real world for delivery, for shipping. And if anything happened to the patient right before the dosing, the cell can be stored in the proper conditions. If it's a fresh cell.
Format of final product, whether it's a fresh car T cells or it's a frozen.
As we all appreciate the frozen county.
Yes.
Sure.
It is more robust and the reward for delivery for shipping.
And if anything happens to the patient.
Why before dosing.
It can be stored.
Great conditions.
It's a fresh so this can be changed.
Speaker 11: Okay, that's helpful. Thank you. And if you could just comment on the quad in 18.2 positive study and when we might see initial data there.
Okay. That's helpful. Thank you and thank you guys.
Comment on the quarter and equal to puzzle.
And when we might see initial data there.
Speaker 10: Yeah, we just launched, so there is really not much to share. Yeah, I mean, any specific questions I would.
Yes, we just launched so there is really not much to share.
Yes.
Any specific questions.
Happy to share with you.
Okay got it thank you.
Okay.
Speaker 1: Your next question comes from the line of Yanan Zhu from Wells Fargo Securities. Please go ahead.
Your next question comes from the line of Yanan, Zhu from Wells Fargo Securities. Please go ahead.
Speaker 13: Great. Thanks for the questions. I also have a question on the translational expert study for the SLE patient bone marrow ELISBOT assay. I was wondering whether the inhibition that you saw in an assay
Great. Thanks for the questions.
I also have a question on the translational.
Excellent.
Study for the S. L E patient bone marrow early spot assay.
I'm wondering whether the ambition that you saw in the assay.
Speaker 13: was due to CD19-negative PCMA-positive bone marrow cells, or could it be due to greater inhibition of the CD19-positive cells?
It was due to.
CD CD 19 negative PMA positive bone marrow cells or could it be due to.
Greater ambition.
<unk> positive cells.
Speaker 13: And also, I was wondering, would you...
And also I was wondering would you.
Speaker 13: Is it possible to quantify the percentage of CD19 negative BCMA positive cell ASCs in these bone marrow samples? Thank you.
Is it possible to quantify the percentage of CD 19 negative the CMA positive cell.
At CES in our bone marrow bone marrow samples. Thank you.
Yes.
Let me answer the first question.
Speaker 6: The, we do have a CD19 with the same sequence, same binder from the GC012F. So the single car, CD19 car, in comparison with the dual car.
The.
We do have a CD 19 with the same sequencing binder from.
<unk>.
So the single car 19 comp in.
In comparison with.
The dealer cars.
So the comparison is very clear.
Speaker 12: If, you know, the inhibition of CD19 positive cells by the duocon.
Yes.
Inhibition of CD 19 positive cells.
By the <unk> com.
Yes, we can always suspect when when when a single copy.
Speaker 6: Yeah, we can always suspect when a single car become a dual car, it might change certain characteristics.
<unk> com it might change certain characteristics.
But at least from the.
Speaker 12: single binding perspective, the dual targeting, in theory, should hit CD19 and BCMA.
Single binding perspective.
<unk> targeting.
In theory should hit 2019 and B C.
Speaker 3: So the effect of what we see is more than additive.
So the.
Effect of what we see is more than additive.
Speaker 6: It's about 10 times. So either it's additive or synergistic due targeting. We need to do more studies to.
About 10 times.
So.
It's an.
Additive or synergistic.
It does have a dual targeting.
We need to do more studies.
Speaker 6: to illustrate that, but the observation is very clear.
To illustrate that but.
The observation is very clear.
Speaker 6: The dual targeting does inhibit autoantibody secreting spots significantly.
The <unk> targeting dose inhibits.
Auto antibody secreting spots significant.
What was your second question.
Speaker 13: Is it possible to quantify the percentage of CD19 negative BCMA positive ASCs in these samples?
Is it possible to quantify the percentage of CD 19 negative PMA participant positive <unk> in these samples.
Good question.
Speaker 12: Good question and we are doing it. It's a variable a lot among patient to patient as you
Doing it it's a variable a lot.
From a patient to patient su.
Speaker 6: So far, we collected four patients, which is not easy to collect the bone marrow cells from those treated patients, but we need more.
So far we.
We collected for patients.
Which is not easy to collect docomo sales from those treated patients.
We need more data.
Got it.
Speaker 13: 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.
And then I was wondering if you have if you could provide any.
Update.
The partnership.
Front.
Yeah.
Regarding the <unk>.
Myeloma, perhaps as well as the new <unk> initiative. Thank you.
Speaker 6: Yeah, we continue to engage the conversation with potential partners, they are partners.
Yes, we continue to engage.
The conversation with potential partners.
They are our partners.
Speaker 6: interested 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.
Interesting both.
Oncology and immunology.
And a particular partners only interested in immunology.
So as much as I can share.
Yes.
Busy engaging conversations.
Great Thanks for that pace.
Thank you.
Speaker 14: Your next question comes from the line of Joe Cantanzaro from Piper Sandler. Please go ahead. Yeah, hey, guys.
Your next question comes from the line of Joe Catanzaro from Piper Sandler. Please go ahead.
Yeah, Hey, guys I. Appreciate you taking my question. Thanks for the update maybe two from me first one William I think I heard you say that youre 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 be any more additional translational work from these first four pay.
Speaker 5: maybe two for 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,
<unk> that we might.
See there and then my second question.
Speaker 5: 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.
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.
Speaker 12: Yeah. Regarding the translational studies, I think the data to be presented at the summit is going to be similar, you know, what I said.
Yes.
Regarding the translational studies.
I think.
Data to be presented at the summit is it going to be similar.
What I said.
Speaker 6: It's, I think it's about 10 days from now or less than 10 days, so.
It's.
About 10 days from now or less than 10 days so.
Speaker 6: I don't think you should expect significantly more information from our presentation.
Hi.
I don't think you should expect a significantly more information from our presentation.
The.
We're in one B <unk>.
Speaker 6: We're in 1B for our MM trial in the U.S., we have to wait.
<unk> trial in the U S.
We have to wait.
Speaker 6: the EOP-1, end of phase 1 report submitted to FDA and get consensus or discussion with them for next phase.
B E.
<unk> one <unk>.
Phase one report.
To FDA.
And consensus discussion with them to go next face.
Speaker 10: So I don't believe that we can release data prior to that. That's my understanding. But as far as.
So.
I don't believe that we can.
Please.
Data prior to that.
That's my understanding.
But as far as for the study is ongoing.
So far so good.
Yeah.
Okay. Thank you thanks for taking my question.
Thank you Joe.
Speaker 1: Your next question comes from the line of Justin Zellin from BTIG. Please go ahead.
Your next question comes from the line of Justin Zelman from D. P. I G. Please go ahead.
Speaker 7: 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.
Hi, Thanks for taking the questions. So on the <unk> data for the uptake can you remind us what we should expect obviously safety and what we should expect from a clinical efficacy standpoint.
Expect meaning.
Speaker 12: um predict um you know so far all I can say so far so good um
Predict.
So far all I can say so far so good.
And it's time to have a meaningful efficacy data for safety because it becomes insured.
Speaker 3: And it's time to have a meaningful efficacy data for safety, because it comes in short. Coming, you know, within 15 days, you pretty much see them all. Neurotox takes a couple more weeks. But so far, again, it's very, our impression, or I can say it's not really data. Our impression is very consistent with what we've seen before.
Within 15 days, you could you might see them all.
Neuro Tox takes a couple of more weeks, but so far again, it's very.
Our impression all I can say, it's not really data on and pricing is very consistent to what we've seen before.
Speaker 3: Yeah, I mean, as I answered the question on the other caller, you know, next year you should expect double digits of patients. The readout on the double digit patients will be mostly at least three months. And some of them will be six months.
Yes.
As I answered the question on the other color.
Next year, you should expect.
Double digits of patients.
The readout.
Double digit patients will be mostly at least three months and some of them will be six months, which is more meaningful.
Speaker 6: And our patients are very diversified. I think it's a more, it's actually, it's a real world.
And our patients.
Very diversified I think some more.
Actions to real World.
So then the indexes based on Solander index for.
Speaker 6: Surrender index is based on surrender index is the patients having more severe SRE.
For patients.
Having more severe.
SME.
That age.
Speaker 6: older. And that's, you know, all I can say is.
Odor and Thats an origin SaaS this moment.
Speaker 7: 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.
Great and maybe William if you could just give us an idea of what you would think and impactful durability.
Would be for for car T for S holiday I think that would be helpful.
Speaker 12: Yeah, I mean, that's an interesting question, you know, it's just saying, I mean, this is a very difficult to answer, you know, it's a balance between
Yes, I mean, that's the interesting question here.
It's just saying I mean, this is very difficult to answer.
<unk>.
It's a balance between.
Speaker 12: the length or the persistence of B-cell depletion. But in the meantime, you don't want them to disappear for too long. You want the B-cell coming back with a new phenotype, young phenotype, and call it a B-cell reset. And how long is good enough?
The length or the persistence of.
B cell depletion, but in the meantime.
B.
Disappear for too long.
The peso coming back with.
New phenotype young phenotype in the corner piece a reset.
And how long it's good enough to.
Speaker 12: I think, you know, our theory is we always see in oncology side, we always see very deep B-cell depletion. And what's translated into readout is the MID negativity. It's always, you know,
<unk>.
Our theory is we always see in oncology side, we're always see very deep b cell depletion.
Transferring to readout.
<unk> negativity.
It's always.
The top 100.
Speaker 3: So we expect bisaloplasia in immunology will be very deep as well.
So we expect to be.
It's a pleasure in immunology will be very deep as well.
Speaker 3: how deep, I mean, how long particularly, what is the persistence we want?
Our deep I mean, how long, particularly what is the persistence we want.
Speaker 12: We'll see. I mean, we are doing those escalations, and we'll evaluate, you know,
We'll see I mean, we're doing dose escalation and we will evaluate.
And then of course the efficacy.
Yes.
Great. Thanks for taking my questions.
Okay.
Speaker 1: 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.
And we have no further questions in our queue. At this time I will now turn the call back over to Dr. William Kal closing remarks.
Thank you again to everyone for joining us on our call.
Speaker 3: We are focused on advancing our highly differentiated and most competitive candidates, including the fast car, GC012F.
We're focused on advancing our highly differentiated and most competitive candidates, including the Pascal <unk> CEO of <unk>.
Speaker 3: The US R&D trial in RRMM is now underway, and we look forward to submitting R&D filings in the US and China for the planned phase 1 clinical trial in RSLE this year.
The U S R&D trial.
Mmm is now underway and we look forward to submitting the R&D filings in the U S and China for the planned phase one clinical trial.
Sorry this year.
Speaker 3: We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapy.
We remain committed to pushing the boundaries of medical innovation.
And improving patient outcomes through our transformative therapies.
Speaker 1: This concludes today's conference call. Thank you for your participation and you may now disconnect.
This concludes today's conference call. Thank you for your participation and you may now disconnect.
Yes.
[music].
Yes.
[music].
Okay.