Q3 2022 Gracell Biotechnologies Inc Earnings Call
Ladies and gentlemen, thank you for standing by welcome to the Gray saw Biotechnologies third quarter 2022 conference call. At this time, all participants are in a listen only mode.
For the opening remarks, we will open the call for your questions instructions for queuing up will be given at that time I will now turn the conference call over to Doctor Kevin Chang CFO . Please go ahead.
Good morning, and welcome to Greenfield third quarter 2022, corporate update conference call and webcast.
With me today are Greenfields, founder and Chief Executive Officer, Dr. Williams.
And our Chief Medical Officer, Dr. One daily.
We're excited to discuss the progress of our innovative technologies and the rich clinical pipeline of car T therapies.
Today's call.
I also look forward to sharing with you our recent business developments and upcoming objectives.
The remainder of 2022.
After our formal remarks, we'll conduct a question and answer session.
This morning, we felt issued a press release announcing unaudited financial results.
For the quarter ended September 32022.
Encourage everyone to read the press release and would like to remind you that this call is being recorded for replay.
Please know that for certain information discussed on the call today, including financial data clinical data on our future plans, our bar program, where he tells management will be making forward looking statements.
Actual results.
Could differ materially from those stated or implied by those forward looking statements as a result of various important factors. Please refer to the risk factors section of our latest 20-F filing.
The SEC for a full disclosure of these risks and the factors.
The conference call content and time sensitive information that is accurate only as of the date of this live broadcast November 14 2022.
Undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except that may be required by securities law.
I will now turn the call over to Greece, Our CEO Dr. William William.
William.
Thank you, Kevin and again welcome everyone.
2022, corporate update conference call.
I will begin today's call with our key corporate and a pipeline update.
I will then kind of.
Over to our CMO, Dr. Wendy to provide insight on our first clinical data from ongoing evaluating <unk> in newly diagnosed multiple myeloma, which was accepted for an oral session at ash.
Chip.
Yeah.
CFO , Dr. Kevin sure well discuss our third quarter 2022 financial results.
After our prepared remarks, well open the call to questions.
I am glad to open this call and announced today, great. So fast car. The next day manufacture autologous car T platform was named the winner of the 2022 life.
Life Sciences Innovation Awards.
Pascal <unk>.
With a deep understanding of the challenges faced by.
The mention of Apache and we firmly believe this technology as well as the <unk>.
CD 19 dual targeting car T zero.
012 F developed on the SaaS platform.
Present to innovation that could broaden the use and accessibility of Kochi.
<unk> life Science, and innovation would identify and showcase outstanding innovation that is driving improvements in the fall.
I mean the industry.
And an expert panel of judges reviewed all the submissions and it has determined that too fast.
Has the potential to make great Inc.
Chad and the pharma industry.
And so I hope just thanks.
The recognition by the judges and I also thank the entire <unk> team.
Especially our scientists.
That commitment and hard work.
Alright, great.
<unk> continues to advance our robust clinical pipeline developed.
Autologous car T platform.
And the true Yoga Allogeneic car T platform.
First on our lead candidate <unk> hundred 12 F. The autologous <unk> 19 dual targeting fast car T therapy.
D. C 12 F is currently being studied in three indications.
<unk> refractory multiple myeloma newly diagnosed multiple myeloma and <unk> in relapsed or refractory non hodgkin lymphoma.
We completed enrollment in the investigator initiated trial.
Study evaluating 12 as well.
Matt.
In 2022 at both ESCO and <unk> annual meeting, we presented updated clinical data.
Showcased a deep response achieved favorable safety profile and a differentiator in the next stage of manufacturing.
Specifically as of June eight 2022 data cutoff.
Date, following enrolment completion at 29 patients a single infusion of <unk> 12.
Shaved a 100% the negative rates in this group of heavily pretreated patients.
Which 90% were classified as high risk.
Bob.
Also consistently demonstrate a favorable safety profile.
We are continuing follow up these patients.
Furthermore, we are on track to complete the R&D submission of 12 five.
In both the U S and China before year end.
After having submitted a pre R&D meeting request to the U S. FDA. We received a written response in October 2022.
Our response was encouraging and we are currently preparing the R&D filing in the U S.
Also in September 2022.
<unk> received a written response.
Pre R&D submission from China and MPA.
Any submission is on track.
Turning to.
That is underway to VAT age 12, five in newly diagnosed high risk multiple myeloma patients.
I'm thrilled that this data was accepted for oral session at Ash annual meeting in December 2022.
This study over a year ago.
And this won't be the first time that a we presented clinical data.
Newly diagnosed high risk patients usually respond less favorably to standard of care and associated with a poor outcome.
Remains a high unmet medical need despite of novel agents being approved in recent years we.
We hope <unk> demonstrated the potential of providing a news safe highly efficacious first line therapy.
The data in the abstract shows an excellent safety profile.
Encouraging efficacy.
CMO Dr. Wendy Lee will provide more details later in this call.
At <unk> in June 2022, we also unveiled the first data of 12, five in relapsed or refractory NHL from ongoing.
This initiative dataset demonstrated potent.
Activity was 100% CR rate at month, one observing all three patients treated.
Cutoff date of February 22, 2020.
To put this into perspective, all three patients have <unk>, a fast growing aggressive form of NHL.
Continuing enrollment enrollment and follow up of this ongoing study.
And we plan to share updated data at a medical conference in 2023.
Moving on to the off the shelf to your platform.
<unk> is our true you enabled CD 19, CD seven dual directed allogeneic car T therapy candidates.
As we outlined previously we presented updated data last June .
From a single.
Open labeled IAG with longer follow up.
To answer the data was shared in April .
The ACR.
The data was encouraging as 75% of all treated patients achieved <unk> negative CR cri.
The study is ongoing.
Next moving to our donor derived car T in October we announced.
The dosing of the first patient in China, Registrational phase II trial, evaluating <unk> and allo genetic CD 19 targeted car T cell therapy.
This is <unk>.
Arrived from HLA matched donor or the treatment of Aha.
All patients who failed transplant and may not be eligible for autologous car T therapy.
This is an exciting milestone for <unk>.
It is our first pivotal trial.
Have a reserved highly encouraging safety and efficacy data in the phase one portion and.
And we hope to share the data in 2023.
Last but not least I'm happy to report we have dosed the first patients with our smart car T candidate <unk> 503 for the treatment of Mega feeling positive solid tumors.
Alrighty.
Car T is a second generation technology for the treatment of solid tumors and to utilize our novel construct to take advantage of suppressive tumor microenvironment.
And effectively combat soldier.
We are also preparing to bring the second smart punchy candidate <unk> five or six targeting cloud 18 point too so the clinical trials soon.
For the past 10 five months in 2022, we have delivered all promised milestones, including starting several studies opening our first phase II trials and providing clinical data updates at a major medical conferences, these clinical and operational developments.
Further emphasize <unk> commitment to delivering accessible and highly efficacious treatments to the patients across a wide range of malignancies.
Now I will hand, the call over to our CMO, Dr. Wendy Lee to discuss our participation at ash.
In December .
Wendy Please go ahead.
Thank you William.
That's the William mentioned.
Abstract for first in human data from ongoing phase one open label IP evaluating T sees the old cloud app in newly diagnosed transplant eligible high risk multiple myeloma patients.
<unk> and <unk>.
Oral session at Ash 2022.
As a reminder, G C O 12 as is.
How does this car T therapy.
Candidate tumor targeting <unk> and the C D 19.
Nevada, our fast car next day manufacturing.
Good for them.
As outlined in our aseptic abstract that is now available online.
A total of 13 newly diagnosed multiple myeloma patients were treated as after July 25, 2022 abstract data cutoff.
The preliminary data shows and excellent safety profile with only 23% of patients experiencing.
One teacher Crs no high grade Crs and no neurotoxicity of any grade was observed.
Also the data shows a 100% O R R and 100% at Marquis.
Activity in all treated patients.
I'm very encouraged by this data and look forward to share more details in December .
Kevin <unk>, there were 12 fast clean safety profile.
With this potential for faster administration time, not reaching our next day manufacturing and.
Talk to Africa.
Africa profile, given the younger T cells with enhanced fitness.
We believe that he sees the world class asset could potentially.
A safe and effective treatment option to the newly diagnosed multiple myeloma patients.
We are very encouraged by this first clinical data and very much look forward to sharing more details at the <unk>.
And you meeting.
And.
Station in December of this year.
I would now hand, the call over to our CFO Doctor haven't yet Kevin.
Thank you Wendy.
Turning to our financial I'd like to touch on I feel financial trends.
As of September 32022.
Company had RMB 1 billion $609 6 million or U S dollar $229 1 million in cash and cash equivalents.
Short term investments.
In addition, the company had short term borrowings and the current portion of long term borrowings of RMB, $125 1 million or U S dollars $17 6 million.
And long term borrowings of RMB, 48, 1 million or U S dollars $6 eight minutes.
We're very well funded with cash runway for the next 24 months.
We expect cash use for this year to be approximately U S dollar 100 minutes.
Primarily to fund, our R&D and clinical programs in the U S and China.
Net loss attributable to ordinary shareholders for the third quarter was RMB $171 9 million.
Our U S dollar $24 2 million compared to RMB 129 points for the third quarter of 2021.
Research and development expenses for the past quarter were RMB, $133 4 million or U S. Dollar 18 seven minutes.
Compared to RMB $88 6 million in the third quarter of 2021.
The increase was primarily due to the increase in spending on research and <unk>.
<unk> and the clinical trials as well as higher payroll on the personnel expenses attributable to the increased head count.
And the higher facility related costs.
With that I'd like to turn it back to the operator to open the session for your questions.
Operator.
At this time I would like to remind everyone in order to ask a question. Please press Star then the number one on your telephone keypad well pause for just a moment to compile the Q&A roster.
And your first question comes from Yigal <unk> from Citi. Please go ahead.
Hi, This is carly on.
Thanks, so much for taking our questions we have a couple on <unk>.
Diagnosed multiple myeloma.
First are you aware of any other published data for a b C and a car T. In a similar newly diagnosed population.
And that are more general question is if you could just talk about any early feedback you've gotten from kols.
The abstract data so far.
Okay.
Randy I'm going to take this one.
Got it.
Please feel free to shipping.
This is William <unk> CEO of the company.
We I think we heard.
Yeah, a few trials ongoing for newly diagnosed patients.
I believe.
With a blind clinical trial Dot org.
Probably there are two registered but we haven't heard any data.
We haven't seen the data obviously.
So so.
This conference call will be as big.
First events, you're going to see.
No serious studies.
What was the other question please.
Yeah. The other question was just on the any early feedback you've gotten from from Kols.
And then we're also curious if you can comment on.
How much more data, we'll see at ash beyond what's included in the abstract.
Sure.
So I think when industry recovery.
No project for you to answer.
If you have talked to Kols.
Adding newly diagnosed patients.
And any feedback.
Hi, yes.
We do have Utah discussion, whereas a P is actually from the leading medical centers and the reception has been very positive and they're very interesting for our products and the clinical data right and since this study is ongoing.
So we plan to provide updated data on the ash presentation.
Thank you.
Okay, great. Thanks very much.
Your next question comes from Charlie Chan from Jefferies. Please go ahead.
Hi, This is Dave on for Caliche from Jefferies. Thank you for taking our questions and congrats on the new data. So I have to go faster.
Cluster.
I mentioned the company received a written response from FDA could you provide any colors on the steps that are needed from now till filing the IMD and what steps you are also.
You mentioned <unk> will be in a.
Alright, and then.
Since the data in newly diagnosed as of late but any color or any guidance on <unk>.
<unk> in a newly diagnosed patient.
Well, let me take this.
Good question.
The Fda's feedback is very encouraging as constructive.
So somewhat expected.
So it's good.
And then we move forwards based on their feedback.
And now being preparing for.
Package part so everything moving accordingly.
And then China as well we received a response from China CBE.
We are in the process.
For mid teen the package so.
And Thats how goes.
Everything seems smooth.
No.
And regarding the trial design I think it is fair.
Too early to tell.
Talk about details for this Andy again will.
Be focusing on.
Newly diagnosed.
It is a very interesting area and we're very encouraged by the results preliminary results.
But again this is a very new fields.
How do we.
Navigators forwards.
Or specific indications.
It remains to be studied remain to be discussed with kols.
All of those data looks really encouraging, especially the safety and the efficacy boat.
Outstanding.
I'm sure you're going to hear.
More detailed presentation.
But we're definitely not in this R&D filing that's for sure but how much.
So what is the plan.
Great to see.
Keep you updated.
Great. Thank you can I ask one more.
The last time, you mentioned you are looking for some collaboration and equal at any color on collaboration to develop.
Zero, two and less in the U S.
Yes.
It's ongoing.
It just takes longer than we.
We thought it would be.
Hey, guys to dialog is ongoing.
The interesting several products, but 12 is probably the most popular.
Alright, okay. Thank you.
Thanks.
Your next question comes from Joe Catanzaro from Piper Sandler.
Sir Please go ahead.
Hey, guys. Thanks for taking my question, maybe two quick ones from me, maybe updated thoughts around any potential.
IND filing strategy for GC 12, App as it relates to B cell lymphomas I know you said you expect it to Brian provide some updated.
Data in 2023, and maybe similarly is the strategy for the smart car solid tumor programs to generate some initial clinical data out of those <unk> in China before you think about pursuing formal <unk>.
In the in the U S and within China. Thanks.
Yeah.
Thanks, Joe.
Yes.
<unk>.
But NHL I don't think we have decide.
Decided to.
Sure.
Details of the plan was.
But certainly it's ongoing.
I think.
Okay.
When we're going to file but the direction is right.
The preliminary.
Data looks really encouraging.
Yes.
This year we.
We have been enrolling more patients and.
The data continue it looks very encouraging.
So it's probably straightforward.
We will be considered.
Our U S program.
But again I can be.
Yeah.
So.
At this moment.
And then you gave a couple of months.
To put it.
Yeah.
What was the other.
Newly diagnosed Oh no no no. The second question was around the smart car strategy and whether that's a smart guy.
Great.
Generally yes.
Data and go from there.
Correct. Thank you.
And we have dose small call it close to $5 3 million, beating positive ovarian cancer.
As you know to evaluate solid tumor it probably.
It would take a couple more months to Hanover.
<unk>.
Nation. So we are right now in the dose escalation from very low.
We have.
Enhancer embedded but we wanted to make sure.
50 is well taken care of.
The $5 six we havent start those patients yet.
We haven't decided.
Two final R&D in the United States, Illinois, China.
Because if we need to see.
More clinical evidence.
How we wanted to be at risk.
New products.
So so far.
I can say it looks good.
It's very early.
Okay, great. Thanks for taking my questions.
Sure.
Your next question comes from Justin <unk> from BTG. Please go ahead.
Hi, Thanks for taking my questions and congrats on all the progress.
My first question is with the encouraging newly diagnosed data that you have here I'm curious how you envision 12 out being used eventually in the myeloma treatment algorithm.
Could see it being used ahead of transplant or antibody based therapies.
Uh huh.
So Andy let me practice first okay.
[laughter].
Justin This is <unk>.
Newly diagnosed as neuro arena.
I'm sure everybody I understand this is a very big pie.
No.
To our understanding safety is more important than anything for newly diagnosed patients.
These patients right.
Relatively healthy.
And at the current level to safety will be much lower.
So.
We again, we are very encouraged by the confirmation of the safety profile of 12 five.
We will continue.
Generate more evidence, especially the durability of the response.
The responses deepening so we definitely it takes time to collect.
These evidence.
And I know, we need to definitely talk to.
Medical community see how they feel.
As you're aware for this study.
The design and was pretty.
I will say both encouraging.
We have enrolled.
Almost all of the patients high risk in the transplant eligible patients.
Which is which is show support.
From the.
The Hospital authority.
These transplant eligible patients.
Become a first targeted group.
<unk>.
This is this.
We're gonna.
Future expanded study how are we going to continue to target transplant eligible.
Oh in eligible.
High risk.
Normal refractory.
We just need to see more data evidence.
Further.
Bruce.
So now I think that this group.
Yes.
<unk> Goodbye in the hospital for the justification quote unquote these patients and high risk.
Whether at a transplant.
QUADRA data attributes.
Prognosis.
<unk>.
Brian .
So this is a good start.
So we're very excited about the data.
Got it that's helpful and just on the Iron D filing I was just wondering if.
If you had any thoughts on when the first patient might be dose in the U S. If I could take place sometime next year. If you get the go ahead as expected.
Yes, Randy.
Yeah for U S and the action right now and it's.
It's premature to discuss this.
And we plan to wait until we have them at St <unk>.
And we're looking forward to providing the updates along the way.
Great got it thanks, so much for taking the questions.
Yeah.
Your next question comes from Louise Chen from Cantor Fitzgerald. Please go ahead.
Hi, This is lane on for Louise Congrats on the new data and thanks for taking our question.
First question is on the GC, they're all went to us so.
I think the safety data is.
So much better on the newly diagnosed.
People myeloma patients compared to the.
Two the relapse.
Lapsed patients. So can you maybe give us more colors or why you think it will.
Much better and then the second question is.
If there is any updates you can share with us on the partnership discussion as well as the sewage L. GMP facility expansion. Thank you.
Thanks, Justin.
The safety profile appears.
Better in newly diagnosed patients.
This is not a big surprise.
We kind of expect because these patients might be healthier.
However, the response I mean do you see ice.
Rate is so low.
That's fine.
23%.
Granted two Crs and the 77% there's no crs.
It's kind of surprise.
I can.
Comment too much.
Much of the evidence.
It is new fields.
Hope that continue that way.
Hi, there.
Team studies.
When they come up data will be interesting to compare.
Yeah.
That's all I can comment.
Regarding the manufacturing capacity.
Yes.
We have.
Sort of made a justification.
We made it in.
Internal sort of a redesign adjust our space. So the capacity for the pipeline that we want to develop into clinical.
Even the first phase of commercial it's offset.
Sure Joe.
Given the circumstances, we're not aggressively expand.
As capacity for commercialization since we have.
Up to year 2025 2006.
Sufficient capacity.
Got it thank you so much.
Youre welcome.
And your next question comes from James Chen from Wells Fargo. Please go ahead.
Hi, good morning, Thanks for taking my question.
For William or Wendy can you say or how many of 12 S. Newly diagnosed patients achieved molecular remission after induction.
And then secondly, this was our first call. There are two trials the <unk> trial and the iPhone trials the gross.
That's that.
<unk> negative patients receiving fast that had improved PFS in the market.
Can you say, how many of the newly diagnosed patients have gone on to receive transplant.
The second question the second question.
Sure sure sorry.
The second question was Theres, two trials I think forte and ISR.
The data there seem to suggest that like patients with MLD negative status that go onto receive pass that the PFS and MRV negativity improves.
So do you know how many or if any of the newly diagnosed patients and 12 S trial I've gone on to receive transplant.
Hello.
Let me correct the first Wendy.
I'm not aware about these studies.
But.
We can only common how steady although the study is still on the.
Embargo for Ash, So we can't really elaborate details.
So for your second question, how many patients go home.
In our state gone too.
Transplant.
No we don't have that detail at this moment.
So hopefully in a couple of weeks, we'll have more details.
The first question.
Randy maybe you can do it.
Yeah.
I'm actually yes for all the details you know we have to I think our respect the arch embargo policy. So I think we cannot share too much details beyond the abstract at this point.
But we welcome you to join our Ash presentation.
In December and we're looking forward to discussing more at that time.
Okay.
Thanks, Helane, Hi, Wendy I appreciate it.
Okay.
There are no further questions at this time I would like to turn the call back over to Dr. William Chow.
Yeah.
Thank you again to everyone for joining us on the call.
<unk> is well positioned to deliver breakthrough Apache therapies capable of overcoming major industrial challenges by leveraging our proprietary fast car and a true your.
<unk> technology platforms.
We are proud of the progress <unk> has made over the third quarter of year 2022.
We are focused on preparing to R&D applications for the U S and China agencies and look forward to presenting the first clinical data from the newly diagnosed multiple myeloma.
And at Ash next month.
Ladies and gentlemen. This concludes today's presentation. Thank you once again for your participation you may now disconnect.
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Okay.
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Sure.
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