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Gracell Biotechnologies Inc. Stock Price: Quote, Forecast, Splits & News (GRCL)

Perplexity Finance

Company Profile

Gracell Biotechnologies Inc. Price & Performance (GRCL)

Stock Performance

Updated Feb 21, 2024, 9:00 PM UTC

Gracell Biotechnologies Inc.

$10.25USD

-$14.81 (-59.1%)

Open

$10.26

Market Cap

$989.87M

Year High

$10.44

High

$10.28

P/E Ratio

-10.6

Year Low

$1.40

Low

$10.17

Dividend Yield

0.00%

Volume

6.37M

Latest News

AstraZeneca Expands Cell Therapy Pipeline with EsoBiotec Acquisition
Jan 1, 2025
AstraZeneca has announced plans to acquire Belgian biotech EsoBiotec for up to £1 billion, reinforcing its commitment to next-generation cancer therapies. This deal follows AstraZeneca’s earlier purchase of Gracell Biotechnologies, signaling a strategic push into innovative CAR-T treatments that could reshape the oncology landscape and talent market.12
Alcon Secures Control of Aurion Biotech Amid Corporate Dispute
Jan 1, 2025
Alcon has gained a majority stake in Aurion Biotech, ousting its CEO and ending a months-long power struggle. The move allows Alcon to steer Aurion’s clinical-stage cell therapy, AURN001, toward phase 3 trials. The dispute had previously involved legal battles over IPO plans and boardroom influence.13
Biotech Markets See Diverging Fortunes as Large Caps Outperform
Last week, the Nasdaq Biotech Index slipped 1.4%, while the Arca XBI ETF dropped 3.1%. Large-cap biotech stocks have gained 13% year-to-date, contrasting with a 6% decline for smaller peers. Market volatility remains high, but leading companies continue to attract investor confidence despite broader uncertainty.34

What's Happening

Peers

Earnings

Report Date

Nov 13, 2023

Rev Estimate

—

Avg 1d Change

4.47%

Report Period

Q3 2023

Reported EPS

-0.1

Beat +61.54%

Implied Move 1d

17.21%

Transcript

2m 28s

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 these risk and factors. This conference call contains time sensitive information that is accurate only as of the date of this live broadcast November 13, 2023. Risa 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 Grintao's CEO, Doctor. William Tong. William? Thank you, Kevin. And, again, I will begin with the key pipeline and corporate updates. I will then turn the call over to our CMO, doctor Wendy Lee. To provide insights into GC012F clinical data, that were recently presented at the 20th International Myeloma Society [indiscernible] annual meeting. Next, our CFO, doctor Kevin Shen, will discuss our Q3 20 23 financial results. After our prepared remarks, we will open the call to questions. The past few months has been exciting. Both for Grayscale and the Kashi field at the large. [indiscernible] have achieved several important milestones.

4m 9s

Including the initiation of patient dosing in our first company sponsored U. S. Trial, The presentation of the latest update of Fast Cart T GC012F at the recent IMS meeting. And upcoming American Society of Hematology annual meeting. The advancement of the investigator initiated clinical study lupus [indiscernible] s l e.

4m 39s

And also the release of quickly good data from our solid tumor program at the Society of Immunotherapy of Cancer. S I t c.

4m 48s

Annual meeting.

4m 50s

This period marks a crucial juncture for the country field. Some of the most significant hurdles faced by CAR T in the treatment of blood cancers are being addressed by innovative next generation conti candidates. Aspirations such as rapid manufacturing, achieving a cleaner safety profile and enabling deeper more durable responses were shared by all copy researchers and were also personal motivators for myself that led to the funding of Grayscale. It was a journey with a vision to push the boundaries of what possible in cancer treatment. The progress we have made is an [indiscernible] To the entire GreyCell teams relentless pursuit of innovation.

5m 46s

We are also finding ourselves at the forefront of pivotal era in medical science. Where the application of CAR T therapy is expanding beyond hematological cancers. [indiscernible] in autoimmune diseases and solid tumors are massive. [indiscernible] our approach is encouraged 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 CC0 12 F for the treatment of SLE, I look forward to sharing our ongoing progress and I remain confident that our journey will lead to meaningful advancement in the field.

6m 46s

Now I hope to provide a more detailed overview of what we have achieved in the Q3, In September, we announced dosing of 1st patient in the U. S. Phase Ibtwo investigational new drug IND study. Evaluating our lead candidate BCMA CD19 due targeting FADCAR 12F in the treatment of relapsed refractory multiple myeloma.

7m 16s

RRMM. And we look forward to activating a handful additional sites in the U. S. In the coming months. As a reminder, Phase 1b portion is designed to evaluate safety and the tolerability of GC012. [indiscernible] determined the recommended phase 2 dose.

7m 41s

We anticipate enrolling approximately 12 patients across 2 dose levels in the Phase Ib portion. We estimate that it will likely take a to complete patient enrollment. In China, we expect to commence patient enrollment this quarter.

8m 1s

In the Phase onetwo IND study in The guidelines for clinical research on hematologic cells trial Newly enacted in August has impacted our timeline we are happy to report that we have now received all the required approvals and are ready to launch the study in China.

8m 24s

In late September, at IMS annual meeting, The updated clinical data were presented from the ongoing Phase one IIT [indiscernible] as a frontline treatment for patients with transplant eligible high risk, newly diagnosed multiple myeloma, [indiscernible] In this 19 patient dataset, with a median follow-up of 15 months, [indiscernible] percent of patients achieved minimum residual disease Negative. Singent complete response. MRD negative SCR. Doctor Van Dhillie will elaborate on the key findings In a few minutes. Longer term follow-up data from the study including additional patients, Annual Meeting in December.

9m 21s

We are continuing to see compelling efficacy data and the safety profile I look forward to sharing more details in San Diego next month. To this date, have reported clinical data of GC012F on 60 oncology patients in 3 IITs. Including 51 patients with multiple myeloma, and a 9 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 5 CAR T cells, [indiscernible] Also, the very favorable safety profile demonstrated in these studies including known neurotoxicity observed in any of the 60 patients could potentially provide critical differentiation early line settings.

10m 17s

And additional indications.

10m 20s

We are very encouraged by the profile of GC012F and have high confidence that this therapy Cliff brings profound benefits to the patients worldwide.

10m 33s

In the Q2 of this year, we were thrilled to launch a new IT evaluation [indiscernible] in refractory SLE. Or RSOE, This new direction is inspired by the groundbreaking clinical discovery shared by Professor George Sheps group [indiscernible] We see immense opportunity here.

11m

And believe Telfer is ideally positioned as a potential treatment for many autoimmune conditions. Including SLE, [indiscernible] CD19 BCMA dual targeting capability and faster and consistent product delivery.

11m 20s

In the field of autoimmune disease treatment, safety stands as a critical factor for defining success. As oncologists learn ways to better manage it, adverse events, the safety of CAR T has become less of concern in cancer applications.

11m 37s

However, we believe the focus on safety will be renewed when the industry seeks to potentially adopt CAR T as a treatment for autoimmune conditions. Any successful therapy must demonstrate exceptional tolerability, and safety profile.

11m 56s

So far, t c 0 12 f has been used to treat 60 cancer patients. Including those who are frail and vastly advanced cancer. We have observed a consistent safety profile characterized by mostly low grade cytokine release income, CRS. And notably, No. [indiscernible] 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 SW. 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.

12m 48s

On the efficacy side, the promise of CAR T is to induce a complete immune reset.

12m 55s

Where all autoreactive cells are eliminated and newly generated cells are expected Okay. For these rare diseases such as SOE, 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 the mature stage of B cell. However, we think it's important to remember that SLE is a disease in which autoantibodies 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 ASP.

13m 50s

ASP populations could be CD19 positive, or CD19 negative. And are BCMA positive.

13m 57s

So the use of CD19 single targeting CAR T therapy alone may not be sufficient to eliminate all autoantibody 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 SOE. In recent months, have been working on preclinical and translational studies to support this rationale.

14m 37s

Today, we are delighted to share some preliminary findings first, we analyze the samples from 4 initial patients. Treated with g c012 f at one time 10 to 5th kilos per kilo. [indiscernible] And after the 3 months follow-up, we can see B cells have been restored to naive phenotype in these 4 patients.

15m 4s

This provides very encouraging early evidence that t c012 f is inducing immune reset. Secondary, we run studies with bone marrow samples collected from our SLE RIT patients.

15m 20s

And demonstrate that the CD19 can be semi 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 B cell CAR T got both B cell and ASC. And is designed to achieve a deeper and wider elimination of disease causing B cells. As well as plasma cells. You can find the details of these findings our latest corporate presentation deck. [indiscernible] Upcoming cell therapy [indiscernible] Later this month.

16m 4s

Lastly, on the manufacturer side, we believe that GC012 is positioned favorably with its overnight manufacturing. And enhanced self fitness. Combined with our team's significant experience accumulated over the years, Although SLE is a chronic disease, fast acting delivery is still highly meaningful for better clinical outcomes To ensure optimal CAR T expansion, in the patient body, Patients typically need to stop therapy treatment. [indiscernible] [indiscernible] and also during the wait for CAR T production. Except for the use of low dose steroids, fast and a consistent delivery of CAR T therapy. Would help to shorten this period of suboptimal disease control and greatly reduce the risk of disease flare and additional oven damage during the wait. In short, we believe 12F is a highly differentiated candidate backed by outstanding safety record. Novel, and strong scientific rationale and fast copy technology.

17m 17s

SOS supported by our team's extensive experience in manufacturing and optimizing the process. We eagerly anticipate advancing the clinical development innate autoimmune disease Currently, the IT evaluating TC12F in SLE continues to enroll patients more than a handful of patients have been treated.

17m 42s

And the goal is for patient enrollment to progress into double digit range. We expect to release the 1st public readout from this ongoing IIT in the first half of twenty twenty four.

17m 58s

We are currently on track to submit R and D filings in the U. S. And China in 2023. For the planned Phase one clinical trial.

18m 7s

The U. S. Submission will be the 2nd time the [indiscernible] to be reviewed by the US FDA and will be an important milestone we continue to advance our efforts to provide innovative and effective treatment options, to patients with autoimmune disease.

18m 27s

Beyond the 5 card platform, are also continuing to advance our smart car technology for the treatment of solid tumors. At the City Annual Meeting in early November, we presented a preclinical data evaluating Smart CAR T cell in solid tumor models. [indiscernible] stands for suppressive molecule activated and rejuvenated T cell. In our novel Smart CAR T technology, includes proprietary switch receptor targeting the suppressive tumor microenvironment. In which the inhibitory CDL beta signal is blocked and it converted into a pro T cell signal in CAR T cells. Our studies have shown that smart CAR T cells are younger and are more resistant to TGF beta mediated apoptosis and exhaustion. Upon repeated challenges of tumor cells, MRCA 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. Especially in mouse models, smart car team exhibit better killing activities in tumor rechallenge studies and higher tumor burden studies. Compared with conventional CAR T.

19m 55s

Earlier in Q4, we initiated our IT in China to evaluate our smart car key candidates GC five zero six, In patients with clotting 18.2 positive solid tumors.

20m 10s

We decided to further streamline our pipeline during the Q1. 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. We suspended China Phase II trial evaluate [indiscernible] for the treatment of B cell acute lymphoblastic [indiscernible] Or BALL. Considering the limited commercial opportunity for this niche candidate, As a reminder, we have seen compelling data in the Phase one study with GC007G. Including a 100% MIND negative CR CRCRI among 9 BLL patients. TC-07G is HLA matched donor derived allogeneic CAR T. And does not leverage our fast CAR and TrueuCAR T technology platform or Smart CAR T module.

21m 14s

The updated pipeline chart will be found in the corporate presentation posted to Grayscale's IR [indiscernible] [indiscernible] our financial position in August 2023 as we completed a private placement transaction raising $100,000,000 upfront and up to $50,000,000 in additional If the warrants are fully exercised within 24 months, With the support from the top tier roster of institutional investors, This capital raise extend our cash runway into the second half of twenty twenty six assuming the full exercise of warrants.

21m 58s

And is intended to support us through critical upcoming milestones planned for the clinical development GC012F in multiple myeloma and SOE. Now will hand the call over to our CMO, Doctor. Wendy Lee, to highlight updated data from the ongoing IIT in NDMM Wendy? Please go ahead.

22m 24s

Thank you, William.

22m 26s

As highlighted, are continuing to amass clinical evidence [indiscernible] [indiscernible] of our lead candidates BCMA CD19, [indiscernible] In late September at the IMS Annual Meeting, we presented long term follow-up [indiscernible] From an ongoing Phase one IIT [indiscernible] in newly diagnosed monoclonaloma.

22m 59s

This patient's have not received any anti biologics therapy. [indiscernible] they are inroad to our study. And all patients in this study at 1 or more high risk features of which 89% were classified as a Stage two or 3.

23m 21s

Based on the reverse international staging system. And 63% after Madalary [indiscernible] Demonstrated a 100% ORR. And 100%, MRV negative [indiscernible] A month. The 19 transplant eligible high risk [indiscernible] As of the date of August 1st [indiscernible] [indiscernible] Also continued to show a favorable safety profile with around 78% patients Not 0 S of any grade and no patients reporting neurotoxicity or iCance. We think this data are highly compelling suggesting a potentially ideal profile for the frontline application of CAR T therapy.

24m 29s

Combining both deep response and high tolerability.

24m 34s

In December, updated results will be presented the 65th ASH Annual Meeting. I've 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 [indiscernible] [indiscernible] 3 additional patients that were not in the IMS dataset. Because those patients were not dosed or assessed when we first The obstruct to IMS. [indiscernible] [indiscernible] Kevin?

25m 36s

Thank you, Whitney. Turning to our financial results for the Q3 ended September 30, 2023.

25m 43s

I'd like to touch on a few financial trend.

25m 45s

As of September 30, 2023, the company had RMB1 1,000,000,000,000 [indiscernible] or $234,100,000 in cash and the cash equivalent and short term investments, We expect the cash used this year be approximately US100 $1,000,000 primarily to fund our R and D and the clinical programs in the U. S. And China. I've announced in early August we completed a private placement financing [indiscernible] 100,000,000 upfront and up to additional $50,000,000 in the event that the warrants are fully exercised within 24 months after closing of the upfront purchase.

26m 34s

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 and D activities into the second half of twenty twenty six. If the warrants are fully exercised, For the 3 months ended September 30, 2023, Net loss attributable to ordinary shareholders were RMB67.6 million or US9.3 million compared to RMB 171,900,000 for the corresponding prior year period. The decline in net loss is primarily a result of decrease in the fair value of warrant liabilities. The warrants issued in August private placement are meager and recorded at fair value at the time of issuance the fair value of the warrants decreased by RMB 39,900,000 dollars or US5.5 million as of September 30, 2023, and was recorded as again in the income statement. Research and development expenses for the 3 months ended September 30, 2023 were RMB90.1 million or $12,300,000 compared to RMB [indiscernible] in the corresponding prior year period, the decrease was primarily due to the decreased spending on research, development, the clinical trial as a result of timing of project spending and our strategic pipeline alignment, With that, like to turn it back to the operator to open the session for your questions.

28m 33s

Operator, Your first question comes from the line of Yigal Nowchomovitz From Citi. Please go ahead.

28m 55s

Yeah.

28m 55s

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.

29m 6s

Could you provide a little more color on the percent of antibody secreting cells that may be CD19 negative?

29m 16s

Yeah. It's it's a why did they report it? But the percentage of c nineteen negative ASH in human know, we haven't found a very, rounded reports.

29m 33s

But it is effect.

29m 36s

That that there are antibody circulating cells that are CD19 negative for sure. And BCMA positive. If you need, I can send you a reference What Okay. That that would be great. And then with the translational research you mentioned with the 4 patients, could you provide a little more quantification as to much more BISO antibody suppression you saw with the dual construct versus the CD19 CAR T alone?

30m 8s

The assay is adiSPOT. So, basically, what it does is you we take the the, PBMC bone marrow cells from the patient. Prior to the treatment after treatment, And we we put these cells [indiscernible] [indiscernible] I mean, CAR T is a treatment with the CAR T ex vivo. And see how many antibody secreting spots that are formed based on that, the difference is [indiscernible] single car and the [indiscernible] It's 10 fold.

30m 57s

More than 10fold.

31m 1s

Okay. Okay. Got it. Treated, I think 60 myeloma patients so far with Were there were there any 51 plus 9. 51 myeloma patient, 9 DLBC [indiscernible] Oh, okay.

31m 20s

Okay. Yes. Thank you. So amongst those amongst those 60 in total, did any of those patients have an underlying autoimmune condition that that may have improved with the treatment.

31m 35s

We have not.

31m 38s

Paid attention and then it would be, you know, discovered the, yeah, we we don't notice that there are certain percentage of autoimmune patients.

31m 48s

No. [indiscernible] For, liquidium. Okay.

31m 58s

Your next question comes from the line of Ben Burnett from Stifel. Please go ahead.

32m 6s

Hey.

32m 6s

Thank you very much. I also wanted to ask about the SLE study, some of the early signals you're seeing from the IIT [indiscernible] Encouraging to hear that b cells are recovering by 3 months. I guess, can you talk about the degree of B cell aplasia that you're saying? Is this is this comparable to what you've seen in the apology studies?

32m 29s

Compare with George Shepp. Studies. [indiscernible] Comparable to what what you've seen with with 12 f in your myeloma studies. In terms of amount of B cell depletion? Yes.

32m 42s

Without the depletion is similar.

32m 45s

Are those you know, the I am the SLE study is is still need to be further followed and, evaluated. But what we're seeing is [indiscernible] Declining.

33m 1s

Any curve is a similar And the recovery time or persistent, if you saw depletion [indiscernible] We need to we need to have more time to make a conclusion. Visa naive Visa recovery. So far from these 4 patient, [indiscernible] very similar to other SLE studies.

33m 28s

Does that answer your question?

33m 30s

Yeah. That's great. Thank you very much. Also wanted to just ask about the newly diagnosed multi myeloma study. I think data you've had is interesting. We're looking forward to the ASH update. I guess could you maybe frame for us what the regulatory path is or could be in the US for this asset and a newly diagnosed multi myeloma would constitute a pivotal setting in this setting? [indiscernible] It's too early to, give you that perspective, you know, how do we decide design the study for newly diagnosed and also pivotal studies.

34m 9s

But I you know, based on our understanding of what the regulatory agencies view toward kind of a progressive development of a CLAR T therapy to early lines it's all about safety.

34m 25s

And, of course, the efficacy. And this product [indiscernible] It's very robustly Safe.

34m 35s

Across different indication of late and early line of multiple myeloma and DLBCL. Now SLE.

34m 44s

Think know, given the data we collected and when we have, one b I think that will be the time we'll communicate it with US FDA. By the time we we shall have a detailed design. How do we approach the early line or the first line? We are not excluding anything. We definitely will move forward. In the early lines for sure.

35m 13s

Okay. Great. Thank you.

35m 18s

Your next question comes from the line of Kelly Hsieh from Jefferies.

35m 22s

Please go ahead.

35m 24s

Hi. This is Dave on for, Calishit. Thanks for taking our question. So my question is on SLE. So maybe if you can set up a expectation what type of data company is planning to release in first half of twenty twenty four? And related to that, can it shorten the dose level that you will be studying in U. S. Trials? Similar to RRR it'll be Yeah. [indiscernible] SMO, SLE patient. So we expect it's gonna be double digits when we presented data, first half of 2024. We expect majority of patients will have at least 3 months And some of the patient will have 6 months evaluation. [indiscernible] Now the dose, we start with the dose very similar that we have treated all patients. Or newly diagnosed patients too.

36m 36s

So, You know, I can't predict what's gonna happen for those level 3.

36m 42s

But now we're dosing up.

36m 44s

See what happened. And, based on what we see today, it's it's very consistent. The PK and the CIS [indiscernible] just preliminary. It seems very similar.

37m 2s

So [indiscernible] move up to 3 times 10 to 5th. Which is still very low comp compared to others in the industry. Can I don't expect to have a dose higher than 3 times 10 to 5th? Right. We'll see.

37m 24s

Thank you. Your next question is All your question? Your next comes from the line of Eric Schmidt from Cantor. Please go ahead.

37m 38s

Thanks for taking my question and and, the added information. It Also a question around the SOE translational data.

37m 46s

William, did all 4 patients achieve deep b cell aplasia or or deep b cell lymphodepletion with no [indiscernible] B cell a aplasia after [indiscernible] That's what we can say. Your your second half of question is [indiscernible] No. And what was the duration? Both of them are not.

38m 18s

Okay. Thank you. What what flu side dose are you using?

38m 22s

It's very similar to doctor Okay.

38m 28s

And what was the duration of the [indiscernible] It's [indiscernible] Bridging. The duration of the B cell depletion was similar to what you've seen in myeloma?

38m 45s

B cell dip lymphodepletion is very similar. B cell apresia, at this moment, I mean, the the longest we have seen so far is a couple of months. [indiscernible] Aftercare's infusion. So to make a claim that how long the b cell the the com I mean, complete the recovery. I think it's a it needs more time.

39m 15s

You know, I'm [indiscernible] Right now, the declining of b cells it's very similar compared with much for my homes. But when are these patients comes back with a meaningful readout?

39m 30s

I think we need couple months. To see.

39m 34s

And then, you know, I have to remind these first are 4 patients. Are low doses.

39m 43s

It's a one time 10 to 5th.

39m 44s

Thank you.

39m 46s

And, now we're moving up to [indiscernible] 25th. Okay.

39m 52s

And so we can give them an opt in.

39m 56s

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? [indiscernible] Yeah. I mean, in vivo I mean, in human. We we certainly [indiscernible] [indiscernible] many types of autoantibody we can.

40m 17s

If those autoantibodies are high, over 5, prior to therapy.

40m 23s

Right.

40m 23s

Now what I mentioned is EdiSpa is ex vivo study. So we measure typical for example, top of strategy in the antibody. [indiscernible] [indiscernible] Or anybody to measure. And it's it's a Yeah.

40m 42s

For clinical it's doable. It's, but for preclinical, we wanna have a consistent system to compare. Sorry. I missed your second point.

40m 52s

So in the patients, the SLE patients with double stranded DNA antibodies, you did see those decline. Yes.

41m 2s

Although, I do not wanna give out any data related efficacy. Yeah, bud. Thanks, Eric. Your next question comes from the line of Emily Bogner from H. C. Wainwright. Please go ahead.

41m 24s

Hi. Good morning. Thanks for taking the question.

41m 27s

There's an ASH abstract out, also on a dual CD 19 BCMA core T for SLE I was curious if that's 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 CLADIN 18.2 positive solid tumor cell in China. And maybe if you could also talk about the design there. Thanks.

41m 55s

Thanks for the question. Mean, it's still early for us to to release or to to to share the data of special efficacy we got you know, as you know, you're gonna see safety for 28 days. It's it's unlikely The typical CIS on neuro tox will happen after 15 days. [indiscernible] Within 28 days, we are comfortable to [indiscernible] You know, to to share even though it's again, I have to warn this is early data. It's a first low dose 1 time 10 to 5th per kilo. It's, about 16 $6,000,000 total. Cartesian, 6,000,000 but it's very, very encouraging.

42m 42s

Alright. We see all the signs of, your safety and and and efficacy. Now the A a reasonable set of data readout will be the first half year 2024. By the time we'll have a double digits [indiscernible] with at least 3 months and hopefully, you know, half of them, that 6 months follow-up. So that that's what we shall expect.

43m 15s

Sorry. I think maybe you misunderstood my question.

43m 19s

I meant there there was an abstract that was released to be presented at ASH from another CD 19 VCMA CAR T therapy for SLE. I was just curious if you seen that and what your thoughts were on what state present or what they showed in the abstract.

43m 37s

Yeah. I saw that abstract. That has been it is good to see another dual targeting CAR T that has been applied to autoimmune disease. [indiscernible] But every constructs are different. We don't know the details of their construct. And we don't know much of [indiscernible] background, particularly, the safety of the same compound or same CAR T for other indication, for example, oncology, based on what we saw from the abstract, the data looks reasonable. Think you know, we when we compare with doctor Chet's group, the patient background is different. I think, everybody would agree that, the patient that this group tend to be younger and the time from the diagnosis is short. And this abstract seems the patient's more diversified. [indiscernible] [indiscernible] Seems [indiscernible] Fine.

44m 55s

I would say similar. Because more than I think, 10 patients. So the the mean is similar. Medium is similar.

45m 4s

The age seems to be more diversified.

45m 10s

And then 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 patient, Order.

45m 26s

And the first the time from the 1st diagnosis is much longer, and they're being treated more [indiscernible] and it was if the depends of percentage of patients have Active. Lupus nephritis, and that will you know, give you a different flavor of readouts.

45m 48s

And the last day I wanna remind you know, everyone who is interested.

45m 54s

You gotta look into the product the format of final product, whether it's a fresh, cut t cells, or it's a frozen. You know, as we all appreciate. If it's a frozen, can't you sell it?

46m 7s

It's more, it is more robust.

46m 12s

In the real world for delivery for shipping and if anything happened to the patient. Right before the dosing, [indiscernible] can be stored, in the proper conditions. If it's fresh, it's gonna be changed.

46m 31s

Okay. That's helpful. Thank you. And then if you could just comment on the 18.2 30, and when we might see initial date of Yeah. We just launched, so there is really not much to share. Yeah. Hi. Any specific questions, I would happy to share with you.

46m 56s

Okay. Got it. Thank you. [indiscernible] Your next question comes from the line of Yanan Zhu from Wells Fargo Securities. Please go ahead.

47m 8s

Great. Thanks for the questions. I also have a question on the translational study for the SLE patient bone marrow Elispot assay was wondering whether the inhibition that you saw in the assay Was due to [indiscernible] negative, BCMA positive, bone marrow cells or could it be due to greater inhibition of the CD19 positive cells. And also I was wondering, would you the percentage of CD19 negative BCMA [indiscernible] in the bone marrow in these bone marrow samples.

48m 1s

Thank you. Let me answer the first question. [indiscernible] we do have a CD nineteen with the same sequence, same binder. From the [indiscernible] So the single car, c 19 car, in comparison with [indiscernible] K. So the comparison is very clear.

48m 28s

If you know, the inhibition of CD nineteen positive cells by the Duke card you know, yeah, we can always suspect when when when a single card become a a dual car, it might change certain characteristics. But at least from [indiscernible] [indiscernible] Binding perspective. The dual targeting in theory, should hit CD19 and BCMA.

49m

So [indiscernible] the effect of what we see is more than additive. It's about 10 times. So either it's additive or synergistic need to.

49m 17s

Know, do more studies to to to to illustrate that. But the observation is very clear. The dual targeting does inhibit autoantibody secreting spots Significant What was your second question?

49m 33s

Is it possible to BCMA positive ASCs in these samples?

49m 44s

Good question. We are doing it. It's a variable a lot. Among patient to patient as you will You know? So far, we [indiscernible] Which is not easy to collect the bone marrow cells from. [indiscernible] treated patients. But we need more [indiscernible] Got it.

50m 8s

And then I I was wondering if you have, you could provide any, update on the partnership, front, both regarding the myeloma perhaps as well as the new SLE initiative.

50m 27s

Thank you.

50m 30s

Yeah. We continue to engage the conversation with potential partners there are partners Interesting. Both. Oncology and immunology. And for that particular part is only interested in immunology. That that's all. As much as I can share. But, yes, we are really engaging conversations.

50m 56s

Great. Thanks for the updates.

50m 59s

Thank you.

51m 1s

Your next question comes from the line of Joe Cantonzario from Piper Sandler.

51m 7s

Please go ahead.

51m 9s

Hey, guys. Appreciate you taking my questions. Thanks for the update.

51m 13s

Maybe 2 from me. 1st 1, 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 you expect to present there? Will there be any more additional translational work from these first 4 patients that we might see there? And then my second question, I know it sounds like you continue to expect the U. S.

51m 36s

Myeloma study to complete enrollment in about 9 to 10 months. Just wanted to know if you have updated thoughts around when you may have an initial data disclosure from that study.

51m 47s

Thanks.

51m 49s

Yeah. Regarding the translation of studies, I think the data to be presented at the the summit is gonna be similar it's it's I think it's about a 10 days. From now. For less than 10 days. So [indiscernible] I don't think you should expect them significantly more information. From our presentation. [indiscernible] We are in one b for our trial, and it's in US. We have to wait the Report.

52m 31s

Submit to FDA. And get consensus, discussion with them. To, for next phase.

52m 38s

So I don't believe that we can release no data prior to that.

52m 47s

That that's my understanding. But as far as for the study, it's ongoing.

52m 52s

No. So far so good.

52m 57s

Okay. Thank you. Thanks for taking my question.

53m

Thank you.

53m 2s

Your next question comes from the line of Justin Zellin from BTIG. Please go ahead.

53m 9s

Hi. Thanks for taking the questions. So on the SLE data for the update, can you remind what we should expect? Obviously safety and what we should expect from a clinical efficacy standpoint?

53m 22s

Expect meaning, predict. You know, so far, all I can say so far so good. And and it's time, to have a meaningful efficacy data for safety because it comes in short [indiscernible] coming, you know, within 15 days, you pretty much see them all. [indiscernible] Takes 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 what we've seen before.

53m 57s

Yeah.

53m 57s

I mean, as I answered the the on the question of the other Caller, next year, you should expect double digits of patient the readout from double digit patients will be mostly at least 3 months, and some of them will be 6 months. Which is more meaningful.

54m 19s

And and our patient are very diversified.

54m 23s

I think it's more it's actually, it's a real world. The cylinder index is Based on [indiscernible] The patients. Having more severe SLU.

54m 37s

And dot age [indiscernible] And that's you know, I can [indiscernible] Great. And maybe, William, if you could give us an idea of what you would think, an impactful durability would be for for a car t for SLA. I think that'll be helpful.

54m 56s

Yeah. I mean, that's an interesting question, you know. Interesting. I mean, this is a very difficult to answer. It's a balance between the length or the persistence of B cell depletion in the meantime, you don't you don't wanna [indiscernible] Hello?

55m 16s

Disappear for too long.

55m 18s

You wanted to be so coming back with Neo Phenotype [indiscernible] reset. And how long is it good enough 2 I think you know, our theory is we always see in oncology side, we always see Very deep. Beta cell depletion.

55m 40s

And what's translating to readout is the MRD negativity. It's it's all always, you know, [indiscernible] [indiscernible] So [indiscernible] B cell depletion in immunology will be very deep as well. But how how deep I mean, how long, particularly? What is the persistence we want we'll see. I mean, we are doing those escalation, and we'll evaluate and then, of course, advocacy.

56m 15s

Great.

56m 15s

Thanks for taking my questions.

56m 20s

We have no further questions in our queue at this time. I will now turn the call back over to Doctor. William Kauff. Closing remarks.

56m 29s

Thank you again to everyone for joining us on the call.

56m 32s

We are focused on advancing our highly differentiated and most candidates including the FASKAR, [indiscernible] The US ONDY trial in RMM is not underway.

56m 46s

And we look forward to submitting R and D filings in the U. S. And China for the planned Phase one clinical trial in R SLE this year.

56m 56s

We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapies.

57m 10s

This concludes today's conference call. Thank you for your

Key Insights

GRCL achieved several key milestones, including the initiation of patient dosing in its first company-sponsored U.S. trial for GC012F in relapsed/refractory multiple myeloma, and presented updated clinical data at major conferences (IMS and SITC).
The company is advancing GC012F, a dual-targeting BCMA/CD19 CAR-T therapy, in both oncology (multiple myeloma, DLBCL) and autoimmune diseases (SLE), with early translational data showing promising immune reset and safety profile; first public readout from the SLE IIT is expected in 1H 2024 with double-digit patient enrollment.
Updated clinical data from a Phase 1 IIT in newly diagnosed, high-risk multiple myeloma showed 100% overall response rate and MRD-negative stringent complete response in 19 patients, with a favorable safety profile (no neurotoxicity observed).
Financially, GRCL completed a $100M private placement (with up to $50M more via warrants), extending its cash runway into 2H 2026; as of September 30, 2023, the company had $234.1M in cash and equivalents, with Q3 net loss of $9.3M and R&D expenses of $12.3M.
The company is streamlining its pipeline to focus on high-potential programs, suspending a China Phase II trial for BALL due to limited commercial opportunity, and continues to advance its Smart CAR-T technology for solid tumors, with initial clinical evaluation underway in China.

Recent Transcripts

Gracell advances dual-target CAR T trials with strong safety, $100M raise extends runway to 2026.

Nov 13

Q3 2023

Clinical Progress

Dual CAR T trials advanced

Safety Profile

No neurotoxicity in 60 pts

Gracell advanced its lead CAR-T therapy, secured $100M financing, and extended cash runway to 2026.

Aug 14

Q2 2023

Pipeline Progress

GC012F Phase 1b U.S. trial initiated

Financing

$100M raised, $50M potential

Gracell advances dual-targeting CAR T pipeline and expands into autoimmune disease with strong financial position.

May 15

Q1 2023

Pipeline Progress

GC012F Phase 1b/2 US, Phase 3 China

Expansion

Autoimmune (SLE) entry

Gracell advanced its differentiated CAR T pipeline with strong clinical data and solid financial runway.

Mar 13

Q4 2022

Clinical Pipeline

Multiple Phase 1/2 Trials

Cash Position

$211M (12/22)

Income Statement

Revenue

	2018	2019	2020	2021	2022
Revenue	CN¥0	CN¥0	CN¥0	CN¥366K	CN¥0
Cost of Revenue	CN¥0	CN¥0	CN¥0	CN¥0	CN¥0
Gross Profit	CN¥0	CN¥0	CN¥0	CN¥366K	CN¥0
Gross Profit %	0%	0%	0%	100%	0%
R&D Expenses	CN¥52M	CN¥119M	CN¥169M	CN¥327M	CN¥485M

2018

2019

2020

2021

2022

Revenue

CN¥0

CN¥366K

CN¥0

Cost of Revenue

CN¥0

Gross Profit

CN¥0

CN¥366K

CN¥0

Gross Profit %

100%

R&D Expenses

CN¥52M

CN¥119M

CN¥169M

CN¥327M

CN¥485M

Cash Flow

Net Income

	2018	2019	2020	2021	2022
Net Income	-CN¥61M	-CN¥139M	-CN¥212M	-CN¥452M	-CN¥4.2B
Dep. & Amort.	CN¥3M	CN¥5.1M	CN¥22M	CN¥60M	CN¥531M
Def. Tax	CN¥0	CN¥0	CN¥0	CN¥0	CN¥0
Stock Comp.	CN¥0	CN¥0	CN¥0	CN¥60M	CN¥165M
Chg. in WC	-CN¥4.1M	CN¥703K	-CN¥11M	CN¥25M	CN¥103M

2018

2019

2020

2021

2022

Net Income

-CN¥61M

-CN¥139M

-CN¥212M

-CN¥452M

-CN¥4.2B

Dep. & Amort.

CN¥3M

CN¥5.1M

CN¥22M

CN¥60M

CN¥531M

Def. Tax

CN¥0

Stock Comp.

CN¥0

CN¥60M

CN¥165M

Chg. in WC

-CN¥4.1M

CN¥703K

-CN¥11M

CN¥25M

CN¥103M

Balance Sheet

Cash

	2018	2019	2020	2021	2022
Cash	CN¥12M	CN¥312M	CN¥754M	CN¥1.8B	CN¥1.5B
ST Investments	CN¥102M	CN¥4.2M	CN¥19M	CN¥3.6M	CN¥3.6M
Cash & ST Inv.	CN¥114M	CN¥316M	CN¥773M	CN¥1.8B	CN¥1.5B
Receivables	CN¥0	CN¥0	CN¥0	CN¥0.00000023	CN¥0
Inventory	CN¥7.7M	CN¥9.4M	-CN¥31M	CN¥8.7M	-CN¥26M

2018

2019

2020

2021

2022

Cash

CN¥12M

CN¥312M

CN¥754M

CN¥1.8B

CN¥1.5B

ST Investments

CN¥102M

CN¥4.2M

CN¥19M

CN¥3.6M

Cash & ST Inv.

CN¥114M

CN¥316M

CN¥773M

CN¥1.8B

CN¥1.5B

Receivables

CN¥0

CN¥0.00000023

CN¥0

Inventory

CN¥7.7M

CN¥9.4M

-CN¥31M

CN¥8.7M

-CN¥26M

Go Deeper

Financial information provided by Financial Modeling Prep. Options data provided by Unusual Whales. Live transcripts provided by Quartr. Reported revenue and EPS data from Earnings powered by FinChat.io. All data is provided for informational purposes only, and is not intended for trading purposes or financial, investment, tax, legal, accounting or other advice. · See all tickers.

Overview
Latest News
Earnings
Income Statement
Cash Flow
Balance Sheet
Related

Earnings

Report Date

Nov 13, 2023

Rev Estimate

—

Avg 1d Change

4.47%

Report Period

Q3 2023

Reported EPS

-0.1

Beat +61.54%

Implied Move 1d

17.21%

Transcript

2m 28s

4m 9s

4m 39s

And also the release of quickly good data from our solid tumor program at the Society of Immunotherapy of Cancer. S I t c.

4m 48s

Annual meeting.

4m 50s

5m 46s

6m 46s

7m 16s

7m 41s

8m 1s

8m 24s

9m 21s

10m 17s

And additional indications.

10m 20s

We are very encouraged by the profile of GC012F and have high confidence that this therapy Cliff brings profound benefits to the patients worldwide.

10m 33s

11m

11m 20s

11m 37s

11m 56s

12m 48s

On the efficacy side, the promise of CAR T is to induce a complete immune reset.

12m 55s

13m 50s

ASP populations could be CD19 positive, or CD19 negative. And are BCMA positive.

13m 57s

14m 37s

15m 4s

This provides very encouraging early evidence that t c012 f is inducing immune reset. Secondary, we run studies with bone marrow samples collected from our SLE RIT patients.

15m 20s

16m 4s

17m 17s

17m 42s

And the goal is for patient enrollment to progress into double digit range. We expect to release the 1st public readout from this ongoing IIT in the first half of twenty twenty four.

17m 58s

We are currently on track to submit R and D filings in the U. S. And China in 2023. For the planned Phase one clinical trial.

18m 7s

18m 27s

19m 55s

Earlier in Q4, we initiated our IT in China to evaluate our smart car key candidates GC five zero six, In patients with clotting 18.2 positive solid tumors.

20m 10s

21m 14s

21m 58s

22m 24s

Thank you, William.

22m 26s

22m 59s

23m 21s

24m 29s

Combining both deep response and high tolerability.

24m 34s

25m 36s

Thank you, Whitney. Turning to our financial results for the Q3 ended September 30, 2023.

25m 43s

I'd like to touch on a few financial trend.

25m 45s

26m 34s

28m 33s

Operator, Your first question comes from the line of Yigal Nowchomovitz From Citi. Please go ahead.

28m 55s

Yeah.

28m 55s

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.

29m 6s

Could you provide a little more color on the percent of antibody secreting cells that may be CD19 negative?

29m 16s

Yeah. It's it's a why did they report it? But the percentage of c nineteen negative ASH in human know, we haven't found a very, rounded reports.

29m 33s

But it is effect.

29m 36s

30m 8s

30m 57s

More than 10fold.

31m 1s

Okay. Okay. Got it. Treated, I think 60 myeloma patients so far with Were there were there any 51 plus 9. 51 myeloma patient, 9 DLBC [indiscernible] Oh, okay.

31m 20s

Okay. Yes. Thank you. So amongst those amongst those 60 in total, did any of those patients have an underlying autoimmune condition that that may have improved with the treatment.

31m 35s

We have not.

31m 38s

Paid attention and then it would be, you know, discovered the, yeah, we we don't notice that there are certain percentage of autoimmune patients.

31m 48s

No. [indiscernible] For, liquidium. Okay.

31m 58s

Your next question comes from the line of Ben Burnett from Stifel. Please go ahead.

32m 6s

Hey.

32m 6s

32m 29s

Compare with George Shepp. Studies. [indiscernible] Comparable to what what you've seen with with 12 f in your myeloma studies. In terms of amount of B cell depletion? Yes.

32m 42s

Without the depletion is similar.

32m 45s

Are those you know, the I am the SLE study is is still need to be further followed and, evaluated. But what we're seeing is [indiscernible] Declining.

33m 1s

33m 28s

Does that answer your question?

33m 30s

34m 9s

But I you know, based on our understanding of what the regulatory agencies view toward kind of a progressive development of a CLAR T therapy to early lines it's all about safety.

34m 25s

And, of course, the efficacy. And this product [indiscernible] It's very robustly Safe.

34m 35s

Across different indication of late and early line of multiple myeloma and DLBCL. Now SLE.

34m 44s

35m 13s

Okay. Great. Thank you.

35m 18s

Your next question comes from the line of Kelly Hsieh from Jefferies.

35m 22s

Please go ahead.

35m 24s

36m 36s

So, You know, I can't predict what's gonna happen for those level 3.

36m 42s

But now we're dosing up.

36m 44s

See what happened. And, based on what we see today, it's it's very consistent. The PK and the CIS [indiscernible] just preliminary. It seems very similar.

37m 2s

So [indiscernible] move up to 3 times 10 to 5th. Which is still very low comp compared to others in the industry. Can I don't expect to have a dose higher than 3 times 10 to 5th? Right. We'll see.

37m 24s

Thank you. Your next question is All your question? Your next comes from the line of Eric Schmidt from Cantor. Please go ahead.

37m 38s

Thanks for taking my question and and, the added information. It Also a question around the SOE translational data.

37m 46s

38m 18s

Okay. Thank you. What what flu side dose are you using?

38m 22s

It's very similar to doctor Okay.

38m 28s

And what was the duration of the [indiscernible] It's [indiscernible] Bridging. The duration of the B cell depletion was similar to what you've seen in myeloma?

38m 45s

39m 15s

You know, I'm [indiscernible] Right now, the declining of b cells it's very similar compared with much for my homes. But when are these patients comes back with a meaningful readout?

39m 30s

I think we need couple months. To see.

39m 34s

And then, you know, I have to remind these first are 4 patients. Are low doses.

39m 43s

It's a one time 10 to 5th.

39m 44s

Thank you.

39m 46s

And, now we're moving up to [indiscernible] 25th. Okay.

39m 52s

And so we can give them an opt in.

39m 56s

40m 17s

If those autoantibodies are high, over 5, prior to therapy.

40m 23s

Right.

40m 23s

Now what I mentioned is EdiSpa is ex vivo study. So we measure typical for example, top of strategy in the antibody. [indiscernible] [indiscernible] Or anybody to measure. And it's it's a Yeah.

40m 42s

For clinical it's doable. It's, but for preclinical, we wanna have a consistent system to compare. Sorry. I missed your second point.

40m 52s

So in the patients, the SLE patients with double stranded DNA antibodies, you did see those decline. Yes.

41m 2s

Although, I do not wanna give out any data related efficacy. Yeah, bud. Thanks, Eric. Your next question comes from the line of Emily Bogner from H. C. Wainwright. Please go ahead.

41m 24s

Hi. Good morning. Thanks for taking the question.

41m 27s

41m 55s

42m 42s

43m 15s

Sorry. I think maybe you misunderstood my question.

43m 19s

43m 37s

44m 55s

I would say similar. Because more than I think, 10 patients. So the the mean is similar. Medium is similar.

45m 4s

The age seems to be more diversified.

45m 10s

And then 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 patient, Order.

45m 26s

45m 48s

And the last day I wanna remind you know, everyone who is interested.

45m 54s

You gotta look into the product the format of final product, whether it's a fresh, cut t cells, or it's a frozen. You know, as we all appreciate. If it's a frozen, can't you sell it?

46m 7s

It's more, it is more robust.

46m 12s

46m 31s

46m 56s

Okay. Got it. Thank you. [indiscernible] Your next question comes from the line of Yanan Zhu from Wells Fargo Securities. Please go ahead.

47m 8s

48m 1s

48m 28s

49m

So [indiscernible] the effect of what we see is more than additive. It's about 10 times. So either it's additive or synergistic need to.

49m 17s

Know, do more studies to to to to illustrate that. But the observation is very clear. The dual targeting does inhibit autoantibody secreting spots Significant What was your second question?

49m 33s

Is it possible to BCMA positive ASCs in these samples?

49m 44s

50m 8s

And then I I was wondering if you have, you could provide any, update on the partnership, front, both regarding the myeloma perhaps as well as the new SLE initiative.

50m 27s

Thank you.

50m 30s

50m 56s

Great. Thanks for the updates.

50m 59s

Thank you.

51m 1s

Your next question comes from the line of Joe Cantonzario from Piper Sandler.

51m 7s

Please go ahead.

51m 9s

Hey, guys. Appreciate you taking my questions. Thanks for the update.

51m 13s

51m 36s

Myeloma study to complete enrollment in about 9 to 10 months. Just wanted to know if you have updated thoughts around when you may have an initial data disclosure from that study.

51m 47s

Thanks.

51m 49s

52m 31s

Submit to FDA. And get consensus, discussion with them. To, for next phase.

52m 38s

So I don't believe that we can release no data prior to that.

52m 47s

That that's my understanding. But as far as for the study, it's ongoing.

52m 52s

No. So far so good.

52m 57s

Okay. Thank you. Thanks for taking my question.

53m

Thank you.

53m 2s

Your next question comes from the line of Justin Zellin from BTIG. Please go ahead.

53m 9s

Hi. Thanks for taking the questions. So on the SLE data for the update, can you remind what we should expect? Obviously safety and what we should expect from a clinical efficacy standpoint?

53m 22s

53m 57s

Yeah.

53m 57s

54m 19s

And and our patient are very diversified.

54m 23s

I think it's more it's actually, it's a real world. The cylinder index is Based on [indiscernible] The patients. Having more severe SLU.

54m 37s

54m 56s

55m 16s

Disappear for too long.

55m 18s

55m 40s

56m 15s

Great.

56m 15s

Thanks for taking my questions.

56m 20s

We have no further questions in our queue at this time. I will now turn the call back over to Doctor. William Kauff. Closing remarks.

56m 29s

Thank you again to everyone for joining us on the call.

56m 32s

We are focused on advancing our highly differentiated and most candidates including the FASKAR, [indiscernible] The US ONDY trial in RMM is not underway.

56m 46s

And we look forward to submitting R and D filings in the U. S. And China for the planned Phase one clinical trial in R SLE this year.

56m 56s

We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapies.

57m 10s

This concludes today's conference call. Thank you for your

Key Insights

GRCL achieved several key milestones, including the initiation of patient dosing in its first company-sponsored U.S. trial for GC012F in relapsed/refractory multiple myeloma, and presented updated clinical data at major conferences (IMS and SITC).
The company is advancing GC012F, a dual-targeting BCMA/CD19 CAR-T therapy, in both oncology (multiple myeloma, DLBCL) and autoimmune diseases (SLE), with early translational data showing promising immune reset and safety profile; first public readout from the SLE IIT is expected in 1H 2024 with double-digit patient enrollment.
Updated clinical data from a Phase 1 IIT in newly diagnosed, high-risk multiple myeloma showed 100% overall response rate and MRD-negative stringent complete response in 19 patients, with a favorable safety profile (no neurotoxicity observed).
Financially, GRCL completed a $100M private placement (with up to $50M more via warrants), extending its cash runway into 2H 2026; as of September 30, 2023, the company had $234.1M in cash and equivalents, with Q3 net loss of $9.3M and R&D expenses of $12.3M.
The company is streamlining its pipeline to focus on high-potential programs, suspending a China Phase II trial for BALL due to limited commercial opportunity, and continues to advance its Smart CAR-T technology for solid tumors, with initial clinical evaluation underway in China.

Gracell Biotechnologies Inc. Price & Performance (GRCL)

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