Q2 2022 Gracell Biotechnologies Inc Earnings Call
of managing strategic alliances and collaborations at both large pharmaceutical and small biotech companies. Dr. Wendy Lee joined GrayCell as the Chief Medical Officer on August 1st, and she is based in the US. Dr. Lee will oversee GrayCell's clinical development activities, including advancement of our rich pipeline of autologists and the allogeneic product candidates across the fast car and the true-use car technology platforms. Before she joined us, she was a CMO at Exuma Biotech, where she provided strategic medical and clinical leadership for the advancement of its cell therapy pipeline in the US and Asia. Dr. Lee brings in significant expertise on both clinical development and medical affairs, and will be invaluable as we are on track to file the US R&D application for GC012F in Relapse Refractory Multiple Myeloma, or RRMM, later this year. I will now turn the line over to Wendy. Thank you, William. It is a tremendous honor to join GrayCell as its Chief Medical Officer, as the company continues to advance its pipeline on multiple fronts. I have several years of experience in the CAR T field, and also held oncology clinical development roles with increasing responsibilities over the past two decades.
including leading early and late stage clinical trials for several therapeutic candidates for the treatment of hematological malignancy and solid tumors.
and overseeing more than 30 successful IND findings, new drug applications, and biologics lessons applications in both the U.S. and China.
I believe a successful oncology therapy needs to bring substantial clinical benefits to patients, especially those with high on that medical needs.
I recognize the significant differentiation and the vast potential of our pipeline based on the fast car and true u-car platforms to fulfill those unmet medical needs.
In past two weeks, I have been impressed by the caliber of the passionate Griselle team, both in China and in the U.S. I look forward to working closely with the entire clinical team as Griselle is on track to commence company-sponsored trials in relapse, refractory multiple myeloma, or RRMM.
for GC012F in both the US and China pending the outcomes of the regulatory processes that are underway. With that, I will turn the line back over to William. Thanks. Thank you, Wendy. Thanks,project members.
We had a successful quarter with multiple readouts from three clinical programs at AACR, ESCO, and EHOP, which give us additional confidence in the differentiation and the value of our fast car and true u-car platforms.
Just a refresher, the FAST Car platform aims to revolutionize the car team manufacturing and enables the next day manufacturing.
which also important to preserve the youth and the fitness of T-cells.
The allogeneic True UCA platform leverages a novel, proprietary design to optimize the persistence of allogeneic CAR T cells in patient body, making possible a delicate balance of therapeutic effects and safety.
Currently, under these two platforms, we continue to advance multiple clinical trials, including two company-sponsored trials under China INDs and several investigator-initiated trials, or IIT for short.
First, let's focus on our lead candidate, the BCMA CD19 dual targeting car cheese therapy, GC012F, based on our FSCAR next day manufacturing platform.
We continue to advance the three RITs on two indications for this candidate.
We have completed enrollment in the RIT study for RRMM.
We present it updated clinical update.
that showcase the deep response favorable safety profile.
and differentiate next-day manufacturing in tune at both ESCO and IHA.
Specifically, the data underscored deep responses achieved, including a 100% MID negativity rate in all patients treated.
Based on a June 8, 2022, cutoff date following enrollment completion of 29 patients,
of which 90% were classified as high risk.
It also demonstrated consistency, favorable safety profile, and a promising median duration response of 15.7 months in mostly high-risk, heavily pre-treated patients.
We are continuing to follow patients with deepening responses.
Encouraged by consistently positive data.
We are on track to complete R&D submissions of 12F and RRMM in both the U.S. and China before year-end. We submitted a pre-R&D meeting request to U.S. FDA in June 2022 and received confirmation that FDA intends to provide a written response in October 2022.
The tech transfer process with LONZA has been completed, and we are continuing to collaborate closely with LONZA, as we anticipate commencing in the U.S. trials next year.
In parallel, we submit the pre-ID meeting request to China NMPA in July and anticipate the NMPA will provide a response in October .
We are pleased to report enrollment has been well underway in an IIT evaluating GC012F in newly diagnosed multiple myeloma patients.
We anticipate that data from the single site open label study will demonstrate the potential of 12F to move into frontline given its favorable safety profile.
Combined with potential for faster turnaround time leveraging our next day manufacturing and attractive efficacy profile given the younger T cells with enhanced fitness.
At EHEI in June 2022, we also unveiled first data of VC0-QF in relapse refractory non-Hodgkin Membership that evening at the evening of the Ayatollah Kh
NHL from the ongoing IIT
This initial data
that that would be a potent and fast activity with 100% CR rate at one month observed in all three patients treated.
I saw the cutoff date of February 22nd, 2022.
To put this into perspective, all three patients have DL-DCL, a fast-growing, aggressive form of NHL.
This is yet another demonstration of our unwavering commitment in developing innovative cell therapies to patients.
Enrollment is continuing in its ongoing study.
Turning to the off-the-shelf 2U-card platform, GC502 is our 2U-card based software.
CD19, CD7 dual-directed allogeneic cut three cell therapy candidate.
For the treatment of relapse, refractory B-cell acute lymphoblastic leukemia, R-R-DLL.
At IHA 2022, we presented updated data from a single-arm open-label RIT with longer follow-up compared to the data shared in April at AACR.
As of a cutoff date of February 22, 2022, three out of four patients achieved MID-negative COVID-19.
CI at their one month assessment.
The eHAN data demonstrates a very promising response rate, manageable, and reversible adverse event.
and a robust expansion of GC502 cells.
We are very encouraged by these early results, which show the potential of TC502 and warrant further evaluation.
Being the second product candidate from our allogeneic TruYuCal platform, GC502 further validates TruYuCal platform approach and potential wide applicability.
Last but not least, I'd hope to provide updates on our donor-derived allogeneic candidate.
The CE19 targeted car T cell therapy,
This is a unique product candidate for the treatment of RRBLL patients.
who failed transplant and may not be eligible for autologous CAR T therapy.
We are pleased to announce that we have recently completed the Phase 1 portion of the registration of Phase 1-2 clinical trial underway under China R&D for the treatment of RRBLL.
We are on track to commence Phase II portion in the third quarter 2022.
We are very proud of the work we have done to advance our pipeline, and we think we have an even more exciting second half ahead of us.
We are on track to file RMD in the US and China for 12F for the treatment of relapse refractory multiple myeloma during the second half of 2022.
Currently, we have two R&D trials and three IIT studies ongoing.
and also recently completed enrollment in two IIT studies.
We expect to present clinical data.
updates
from a few of IITs at major medical conferences in the second half of 2022.
Simultaneously, we are advancing our early pipeline candidates.
and are on track to bring our first SmartCar candidate for Solid Humans into the community stage this year.
These clinical and operational developments in Venice were itself objective to deliver accessible and highly efficacious treatments to patients across a wide range of malignancies.
Now, I will hand it over to our CFO , Dr. Carolyn Shear, to discuss the second quarter of 2022 financial results. As CFO , I will hand it over to our CFO , Dr. Carolyn Shear, to discuss the second quarter of 2022 financial results.
Kevin, please go ahead.
Thank you, William. Turning to our financials, I'd like to touch on a few trends.
as of June 30, 2022.
The company had RMB 1 billion, 700 and 7.3 million or US dollar 254.9 million in cash and the cash equivalents and short term investment.
In addition, the company had short-term borrowing.
and the current portion of long-term borrowings of RMB 102.3 million or USD 15.3 million and long-term borrowings of RMB 53 million or USD 7.9 million.
We are very well funded with cash runway into 2024.
We expect the cash usage for this year to be approximately US$100 million.
primarily to fund our R&D and clinical programs in the US and China and to support expansion of our GMP manufacturer facilities in Suzhou.
Net loss attributable to ordinary shareholders for this quarter was RMB 146.3 million or US dollar 21.8 million.
compared to RMB 96.2 million for the corresponding per year period.
Research and development expenses for RMB $117.1 million.
for USD 17.5 million compared to RMB 65.3 million in the corresponding prior year period.
The increase was primarily due to the increased spending on R&D as well as higher payroll and personnel expenses.
and higher facility related costs.
With that, I'd like to turn it back to the operator to open the session for your questions.
I'd like to turn it back to the operator to open the session for your questions. Operator.
Thank you all speakers.
If you would like to ask a question at this time, please press star followed by the number one on your telephone keypad. Again to ask a question at this time, please press star followed by the number one on your telephone keypad.
And the first question today comes from the line of Joe Catanzaro from Piper Sandler, your line is open.
Great. Thanks so much for taking my questions. Maybe the first one, great to hear that you filed a meeting, a pre-ID meeting request with the FDA. Just wondering at this point whether you have any comments or updated thoughts on where potentially the U.S. study for GC012 could initiate in terms of dose level relative to the dose you've explored in the China IIT and if not, whether this was a sort of main focus or expected focus of your pre-IND.
our pre-MD package in a few weeks.
Okay, got it. I guess maybe just a follow-up whether...
Again, any thoughts on sort of where dosing could initiate relative to the doses you explored in the China IIT, whether you would expect...
some degree of dose escalation or whether you could initiate right at a close to or near recommended phase 2 dose.
Well it is premature to discuss the design actually this is a study design on a planned clinical programming unit in the U.S. We're awaiting feedback from the FDA on our pre-NB submission and they're aligned after we filed the NB.
Okay, got it. Fair enough. And then maybe as a quick follow-up, I think you've guided towards some clinical updates on current and new programs.
in the back half of the year, whether at a meeting or journal publication. So, wondering if you can maybe elaborate on the specific updates you might provide and whether that might include some initial frontline myeloma data. Thanks.
Joe, I'm not sure what's the specific question. Joe, I think in the recording, all these updates were kind of described. Which specific program, is this RRMM or it's newly diagnosed that you are diving in? Yeah, yeah, I guess I'm specifically asking about the newly diagnosed frontline myeloma trial.
noted is open and enrolling and whether that's an initial data set we could potentially see sometime later this year.
Yeah, I'll leave this to Andy.
Yeah, this is a newly diagnosed MM actually is a Memphis staff forward and we're encouraged by the trust place and by the PIS and the hospital on us. The trial is on the way at a single center in Shanghai, China. Yeah. And this study is actually a study focusing on the high risk newly diagnosed patients. Yeah. And the element is well on the way.
So we expect to enter more patients and like 20 patients in total and we have enrolled and treated more than half already. Yeah we're hoping to provide the first data by the end of this year. I think that's your question asking for yeah.
Thank you.
That's helpful. Sure. Thank you. That's great. Thank you.
Thank you. Your next question comes from the line of Justin Zellin from BTIG. Your line is open.
Thanks for taking my questions and welcome to Wendy. I wanted to ask how the tech transfer and manufacturing process for GC012F is going with LONSA and just the confidence around the IND filing later this year.
The tech transfer has been completed. Successful.
and the launch that has been manufactured in TC-012F.
We'll continue to collaborate with LONSA to generate additional data and putting the IMD passage together.
Great. Okay. That's helpful.
Yeah, thank you. And Wendy, maybe for the newly diagnosed multiple myeloma, the front line study that you're running, if you could just maybe for us just highlight how the treatment is current standard of care for these patients in China and how that might differ versus the United States would be helpful.
Yeah, this study actually is on the way in China right now.
Yeah, so right, we enrollment is well on the way. I just talking about that. Yes, and we're hoping to provide the first data by the end of this year. Yeah, and also GC012F is now being studied for three indication RRMM, NDMM, and the NHL. Yeah.
So that's the current in China conducting this study.
Got it. And then maybe for these patients, I'm just curious if you have a sense of what kind of background therapies, so what prior lines they may have received before being eligible for GC012F in China.
Give me that. NDMM? Newly? They are newly diagnosed.
They're newly diagnosed and also we're focusing on a high risk also. They are naive almost, right? Correct me if I'm wrong. Yes, you're right. Naive. Yes, you're right.
This is a frontline study. Okay, that's perfect. And then that's great. Thank you so much for taking my questions.
Sure. Thanks. Good question. Thank you.
Thank you. Your next question comes from the line of Louise Chen from Cantor Fitzgerald. Your line is open.
Hi, this is Wayne. Thank you for taking our questions. Two from us. The first one is what is your latest thinking on the potential partner in the U.S. for GC012 and what type of partner would be ideal? And then second is, is the China COVID lockdown impact over now in the second half of 2022 or could there still be some headwinds here? Thank you.
Yeah, you know, this is a partnership is one of our major goals of this year. We are looking for
This is a partnership is one of our major goals of this year. We are looking for partners.
potential finance with complementary
then of course they need to be
experience in the cell therapy space.
and they're interested in multiple myeloma.
So, this is what we, you know, if you call it a criteria, that's what we're looking for.
have to, you know, to be, to have both interest in the capability in this field.
And that's critical.
As you have been seeing, we are hearing and seeing that every step, including commercial capacity is very critical for a successful product.
So you can pretty much imagine who would be suitable candidates. That's where we are.
Got it. And how about the COVID lockdown impact?
Yeah, it does impact
I wouldn't say there is no impact.
but the impact
is pretty much on the follow-up evaluation of certain patients.
significant number of patients who are from outside of Shanghai.
And it's difficult for them to travel to Shanghai because of lockdown.
And some of the patients.
who should have been evaluated at a certain time point.
However, due to lockdown, they couldn't travel to Shanghai.
But now they are all evaluated.
After the lift up in early June , the patients were pretty much all evaluated.
Yeah.
Got it. Thank you.
Thank you.
Just as a reminder if you would like to ask a question please press star then the number one on your telephone keypad and we will continue on with question and answer. Our next question comes from the line of Kelly Shee from Jefferies your line is open.
Thank you for taking my questions. I have a couple GC 012f and I apologize if you have already addressed these questions since I got on call late. So for the...
I just want to confirm this is all for RMM only, also including NHL, and if not, are you planning to get INB for NHL?
Secondly, Abacuma recently reported positive top line data in earlier launch settings from second line to fourth line. Does this have any impact on your trial design for the US-based one trial? Thank you.
So currently we're working on RRMM for U.S. right now for R&D submission. Right now we're in the pre-R&D submission with the meeting with the FDA and we require we have the request and then FDA confirmed that we'll provide the right hand response in early October . That's for RRMM right now and the details of the design I think that's premature to discuss.
So we're looking forward to see the follow-up that they'd has.
Thank you.
Thanks.
You know, I think, Kelly, eventually we'll come to the point to evaluate and make decisions whether we're going to file IND for both, particularly NHL. But right now, the number of patients are too small, although we are very excited by the data. We have more data now. By the end of the year, we're going to have more data.
to make decisions. Great, thanks.
Thank you.
Your next question comes from the line of James Sheen from Wells Fargo. Your line is open.
Hey, good morning guys. Can you hear me?
Yes.
Great, great. Thanks for taking the question. For GC012S, can you update us on how you're thinking about MRD negativity as an endpoint? Maybe possibly I mean, looking at, just going back to the BECMA's CARMA study, they use PFS still.......
Just any updates on MRD negativity status.
And then...
I have a second one on the alginate side.
All right.
Okay.
Wendy, do you want to take the phone?
You want me to take this one?
Yeah, go ahead. You can do that or I can do that. Yeah, you just mentioned about MRD. I think that's very interesting and critical standard for the
for those like a
Next standard, yeah. So we have the striking 100% MRD negative rate in all the patients that we treated, yeah. Most of our patients were assist with the uroflofl with a very high sensitive level, you know, the MRD negative into the 10 minus. The community all agrees that MRD will be a key future decision maker for treatment choices.
Achieving MRD negative and maintaining MRD negative will be a very critical part of success and even providing potentially functional cure in multiple myeloma.
Substanding MRD negative over 12 months and even longer is the predictor of a preferential outcome in regards to PFS and OS.
Thank you.
Okay, and then for the allogeneic side, is there going to be an update later this year for any of the allogeneic assets? Yes, there is, and I think there is an update later this year for any of the allogeneic assets.
Yes, we'll have updates.
Later this year.
Yeah.
Thank you, Wayne. That's it for my end.
You're welcome James.
Thank you.
This now concludes today's Q&A session. I would like to turn the call back over to Dr. William Cowell.
I would like to turn the call back over to Dr. William Cowell.
Thank you again to everyone for joining
Graysale has strengthened its leadership team and is committed to advancing its clinical development pipeline.
We are continuing to engage with regulatory agencies in the U.S. and China as we aim to file the R&D submissions for GC 012F in RRMM by the end of the year 2022.
Concurrently, we have submitted multiple datasets, upcoming medical conferences later this year.
We continue.
to developing the partnership for one of our programs.
In conclusion, GrayCell is well positioned to deliver breakthrough CAR T cell therapies capable of overcoming major industrial challenges by leveraging our proprietary fast CAR T and true UCAR technology platform.
We look forward to further advancing our clinical programs and will keep everyone updated along the way.
Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.
Thank you for calling. Which conference are you dialing in for? Hello. I'd like to attend Graysol Biotechnologies Earnings Complex. Thank you. May I have the spelling of your first and last name please? Sure that's David. D-A-V-I-D. Brown. B-R-O-W. Anna. Thank you. May I have your company name please? Eira. That's A-I-E-R-A. Thank you. I'll join you now. Thank you.