Q1 2022 Alaunos Therapeutics Inc Earnings Call
Good day, and thank you for standing by and welcome to the Atlanta Therapeutics first quarter 2022.
This conference call.
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Your speaker today, Mr. Alex Lobo.
Relation.
The floor is yours.
Okay.
Good morning, and welcome to the Alon US Therapeutics first quarter 2022 financial results conference call and audio webcast.
With me today is Kevin Boyle Senior Chief Executive Officer Drew Denninger, Vice President of research and development and Mike Wang Vice President of Finance.
Earlier this morning, a lot of issued a press release announcing financial results for the three months ended March 31 2022.
We encourage everyone to read today's press release as well as the Ilana's quarterly report on Form 10-Q for the quarter ended March 31, 2022, which was filed this morning with the SEC.
The company's press release and quarterly report will also be available on the <unk> web site at a lot of dotcom.
Yeah.
In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.
Please note that certain information discussed on today's call is covered under the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
Participants are cautioned that this conference call contains time sensitive information that is accurate only as of the date of this live broadcast May 16 2022.
Actual results could differ materially from those stated or implied by forward looking statements made made today due to risks and uncertainties associated with the company's business.
Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Gov.
The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this live webcast, except as maybe required by applicable securities law.
With that said I would like to turn the call over to Kevin Boyle Kevin.
Thank you Alex and welcome everyone to the <unk> Therapeutics first quarter 2022 earnings call.
Our team has been working diligently to advance our strategy of generating meaningful clinical progress and delivering shareholder value.
I am proud of our team and the significant progress made since we last spoke.
We recently announced the successful dosing of the first patient in our phase one two TCR T Library trial.
We expect to continue to enroll and treat patients in this trial in accordance with our manufacturing capabilities.
We also have two posters that had been accepted at upcoming scientific conferences.
Namely a S. GCT later today and ESCO in early June .
Drew will provide additional details on both posters and just a couple of minutes.
I would like to focus today's call on our TCR T Library trial.
As you May recall this phase one two study is a basket trial targeting hotspot mutations across six solid tumor indications.
Non small cell lung colorectal and dmitry them, pancreas, ovary and bile duct cancers.
We are enrolling patients at MD Anderson cancer Center with one of these six cancers based on matching neo antigen HLA pairings that are available in our TCR T Library.
Our library consist of 10, Tcr's four K Ras five T P 53, and one egfr.
Two weeks ago, we reported that we dosed the first patient in the trial.
The patient has non small cell lung cancer and has now cleared the 28 day safety window.
The patient was treated with TT TCR T cells targeting a K Ras G 12 D mutation.
The trial design calls for the first imaging at six weeks post infusion.
With the Beijing trial design it is possible that the second patient in this study will be dosed at the second dose level.
That decision will be made at a later point in consultation with the investigators.
As excited as we are to have treated the first patient we are actively working to consent and enroll additional patients in this trial.
In collaboration with MD Anderson, we have screened approximately 500 long or colorectal patients for both tumor mutation and H L. A.
We have found greater than 5% of the patients match one of the Tcr's in our library.
We expect to report initial data from the TCR T Library trial at a medical meeting in the second half of this year potentially ESMO or the sixth annual Cri E. N C. I E. A C R International cancer Immunotherapy conference.
We do not intend to provide a patient by patient update or provide readouts before the chosen conference.
With regards to manufacturing the dose received by the first patient represents the first clinical product that has been fully manufactured using our in house Cgmp suite.
This is a great accomplishment and a testament to our team's dedication over the last year and building out our in house capabilities.
As we noted on our previous quarterly call. Our current anticipated capacity in the cgmp suite allows for the manufacturer of approximately one product per month.
We believe this will be sufficient to support our clinical efforts throughout the rest of this year.
However, we recognize that as we expand the program we will require additional capacity.
To do this we are implementing a three pronged strategy to expand our manufacturing capabilities of which we are already working on the first two.
First we are working to implement S. O piece that will allow for simultaneous production of multiple products.
This includes further optimizing our manufacturing process by introducing cryo preserved cell product.
Second we are working to hire additional staff to support multiple shifts.
And third as we raised additional capital we will investigate physically expanding our cgmp footprint.
I would like to turn the call over to drew now to highlight our upcoming scientific presentations drew.
Thank you Kevin.
I'm so proud of our entire team who has helped us to get to this point dosing of this first in human patients for non viral TCR T cells targeting hotspot mutations in solid tumors is just the first step for US. We continue to expect to report initial data in the second half of the year at a major medical.
<unk>, which we believe is the most incredible forum to present clinical data.
Later today, we will present preclinical data for our membrane bound IL 15 program at the <unk> annual meeting.
As you May recall IL 15 is a cytokine that has been observed to support the survival of T cells and other immune cells.
Today's poster presentation will highlight the potential ability of membrane bound IL 15, TCR T cells to specifically targeting kill tumors.
Furthermore, the study demonstrated the potential of membrane bound IL 15 to establish long lived tumor specific TCR T cells.
Overall, we believe this has the potential to augment TCR T cell therapy, and deepen clinical responses targeting hotspot mutations expressed in solid tumors.
We look forward to advancing this program towards an IND filing in the second half of 2023.
In addition to presenting at <unk>, we look forward to presenting a trial in progress poster at the 2022 <unk> annual meeting.
The presentation will provide an in depth look at our adaptive trial design dosing regimen and volatile strategy.
We are grateful to be able to share. These details at such a respected for them.
As we look to expand our pipeline our research and development team continues to make progress in TCR discovery using our proprietary hunter platform.
Before I turn the call over to Mike I want to provide an update on our scientific Advisory Board.
We have realigned and strengthened our savvy with key opinion opinion leaders in TCR T cell therapy.
Our chairman is Carl June from Ukraine, renowned physician Sciences, who has been involved in all stages of cell therapy, including commercialization of car T cells.
Matthew Porteous from Stanford and Cole <unk> from UCSF brings significant expertise in synthetic receptors gene editing technologies single cell sequencing and next generation strategies.
We have also added Steven Feldman from Stanford, who has substantial experience in neo antigen specific TCR T cells and other cell therapies, especially in regards to cgmp manufacturing and quality systems.
We are confident that our scientific advisory Board will guide of walnuts, along the cutting edge of TCR T cell therapy.
I would now like to turn the call over to Mike long to review the financial results for the first quarter Mike.
Thank you drew.
Let me review our financials for the three months ended March 31st 2022.
For the first quarter of 2022, we reported a net loss of approximately $9 $8 million or <unk> <unk> net loss per share.
Impaired to a net loss of approximately 21 $6 million.
Our 10, <unk> net loss per share for the first quarter of 2021.
Research and development expenses were approximately.
<unk> $5.6 million for the first quarter of 2022 compared to approximately 13 $3 million for the <unk>.
First quarter of 2021, a decrease of 58%.
General and administrative expenses were approximately $3 $5 million for the first quarter of 2022.
Compared to approximately $8 2 million for the same period in 2021, a decrease of 57%.
As of March 2022.
<unk> had approximately $68.3 million in cash and cash equivalents.
We anticipate our cash runway.
Sufficient to fund operations into the second quarter of 2023.
Our operating cash burn for the first quarter of 2022.
$7 8 million compared to $15 $3 million in the first quarter of 2021.
A decrease of seven $5 million or 49%.
That concludes our financial update.
I would like to hand, the call back over to Kevin for closing remarks, Kevin.
Thank you Mike.
I am honored to be a part of a dedicated and talented team their hard work has transformed our innovative scientific research into clinical progress.
Dosing of the first patient in our phase one two TCR T. A library trial is just the beginning.
As we look at the year ahead, we will continue to work closely with MD Anderson to consent and enroll patients in this trial.
We also plan to invest in a multi pronged manufacturing strategy to increase capacity.
Pre clinically we are working diligently to advance our membrane bound IL 15 program towards an IND filing in the second half of 2023 as well as identify new proprietary TCR is using our hunter discovery platform.
The effective use of capital is a critical element of our success.
With the strategic restructuring and pipeline re prioritization completed last year, our llanos took the necessary steps to rightsize the organization well ahead of the challenging market conditions, we face today.
We will continue to be good stewards of capital as we work to maximize shareholder value.
As I mentioned on our last call we have reduced our expected operating cash flow for 2022 to between 40 and $45 million of.
A significant reduction year over year.
In addition, I believe that we now have the appropriately sized team of approximately 40 dedicated individuals that will allow us to execute on our focused pipeline.
We are selectively hiring talented employees to join our team in Houston and have open positions posted on our website.
I would like to reiterate my appreciation for our team partners. The MD Anderson collaborators and our shareholders for the unwavering support on this journey of developing cancer treatments targeting solid tumors.
Before we open the call to questions I would like to remind our shareholders of record as of April 22nd that proxy materials were distributed in connection to our annual general meeting of shareholders taking place on June 13th.
More information can be found on our website.
We will now open the call to questions Chris.
Thank you.
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Sure.
Our first question comes from plenty of Pascua Lama comps of H C. Wainwright.
Sir Your line is open thank you.
Thank you this is RK from H C Wainwright.
Good morning, Kevin.
Okay.
Couple of questions here.
Yes.
For the for complaining that TCR.
T phase one two study how many patients do you need to enroll.
Good morning in part a will determine on how many patients we enroll at a given dose levels again as this is a Bayesian design it'll depend on the number of patients that we roll out the given levels and what we find out.
Directionally I would say somewhere between 10 and 15 patients will likely be from a early.
Early phase one a perspective, the number of patients that we would likely see.
There is a lot of information also to be gained by treating patients with different indications and as a reminder, we do have a total of 10 TCR is currently targeting six different solid tumor indications and there will be a lot of value in learning by treating patients with different indications and different tcr's. So.
And that will in part determined as well how many patients we treat in this early part of this trial.
Okay. Thanks for that so.
So that the trial is designed such that you hit at least cut.
A couple of patients with each indication or since it's in it's an all comers trial.
Is that part of the goal or is that is the goal more to make sure that you can evaluate all of the 10 TCR.
Expect to go off what indication it is.
No. The goal is not necessarily to use all tenant.
T see ours, but but there is value to be gained by treating different patients in different indications and using different <unk> and so we'll just this will be a very continuous learning for us as we progressed through this trial.
And it's too early to say right now.
With exact specificity because we haven't learned.
All the data that we will need.
But again, we are focused on safety in these early stages I do want to reiterate that and.
And we also will see.
Seek with this phase one trial to determine the appropriate dose as we move that forward in the clinic as well.
Thank you.
<unk>.
Okay.
At the current time you can manufacture.
For one patient per month.
How does the logistics work, especially.
In terms of identifying a patient manufacturing and dosing since some of these patients probably are well along their disease condition.
Well, we worked very closely with our partners at M. D. Anderson to determine the timing of placing these patients on the trial.
Many of these patients are progressing at different rates or as we talked about the proto.
Protocol that is.
Looked at approximately 500 patients many of those patients that have a matching TCR.
We're not ready for treatment under this trial, they're just starting their journey.
And have not met the requirements for this clinical trial. So we have.
It had been able to <unk>.
Identify patients at the appropriate time, thus far and are working closely again with the Pis at MD Anderson to determine the appropriate patients to put on the trial at what time.
Okay. My last question is on the membrane bound IL 15 program.
What needs to be done before between now and filing of the IMD.
In the second half of 'twenty three.
Okay, I'll turn it to <unk> to answer that.
So.
We have our poster presentation at <unk> today, which will cover much of the preclinical data so.
Pension towards that and we will have it on our website.
Well we.
We need to.
To the.
Manufacturing runs and the regulatory strategy, so that will take some time.
And puts us in the second half of next year.
As you'll be able to see on our.
Poster presentation.
The lion's share of the preclinical data is completed and is very encouraging, especially with growing up these long lived.
TCR T cells, which we think can be clinically meaningful.
Fantastic. Thank you. Thank you gentlemen for taking all my questions.
Thank you very much.
Thank you.
Our next question comes from Nick Abbott of Wells Fargo. Your line is open.
Okay terrific, thanks for taking our questions.
Congratulations on dosing the first patient.
So for the phase one Kevin.
So you're going to how should we think about the ability to expand the trial with the current GMP.
<unk> facility with.
With successful implementation of those closed two strategies, how many patients a month do you think you could.
Treat.
Yes, it's a good question Nick.
What I would say is we will update folks later as we.
Successfully execute upon those two initiatives, so not quite ready to to.
To share that right now, but I do think we need to look at our manufacturing capabilities multi pronged about how do we increase the throughput into our existing footprint and then what other levers do we have to <unk>.
Expand.
Either footprint ourselves or in partnership with our contract manufacturer to scale up our manufacturing capabilities. So I believe that we have many different strategies that we're looking at and we will.
Likely be in a position on the next quarterly call to provide some more color with regards to increasing throughput at our existing facility.
But I would like to.
Reiterate that when we hire somebody.
It is not an immediate plug and play that there is a.
And on ramping of that individual and a.
Learning of the process, especially our non viral approach to.
Manufacturing these TCR T cells. So there is a learning curve once we do hire individuals that is typically in the range of around three to six months' timeframe.
Alright, thank you.
And then on <unk> 15.
The abstract.
Clearly suggest that.
Including the membrane bound IL 15 also is the.
T cell phenotype.
And so you have this time central memory, which obviously is highly desirable if you want to have kind of long term production of these cells.
But just a question do you think there are situations where the.
Non membrane bound IL 15.
But it would be preferred over the membrane bound IL 15, or do you think you can move of.
Membrane bound IL 15.
Yeah.
Yeah, It's a good question.
And so.
We do see both types of TCR T cells in patients.
You have different phenotypes as you mentioned, we don't know which one's better.
So we need to try both.
Clearly in mouse models stem cell memory cells are way better than effector cells, but there's none.
Sufficient data to show that the human so we have the capability to grow diverse pools of TCR T cells in both programs with our membrane bound IL 15, we get an extra boost of the younger sells to stem cell memory cells.
And we think that that's something worth exploring.
And so the clinical data are going to have to drive that sort of decision.
Thanks, Joe and then the last one for me probably also for you and that is all.
On the Hunter, how should we think about output I can see that there is proven.
Proven and technology and technology that is building a team was but at some point there'll be diminishing returns.
And is that the point that you really begin to focus on unique neo antigens. So so how do we think about hunter in terms of shed neo antigen output and then also.
It's on unique neo antigens.
Sure.
So we have a very successful program and Hunter, we are able to find.
Tcr's targeting neo antigens from most of the patients we screen, which is in line with what.
People have seen in tills out of the NCI and other places.
So we're able to do that in house, we are increasingly focused on P. 53, K Ras in Egfr in order to grow the library, especially with highly desired HLA types as.
We find more and more TCR is there may be a plateau.
It is biologically there, but we're nowhere near close to that right now.
Also point you towards.
Creator that we've extended with Dr. Rosenberg at the NCI to look at personalized TCR T. So we have interest in the unique.
<unk>.
Neo antigens as well as the hotspot neo antigens.
So I don't think were close to the estimate diminishing returns point at this time.
Great. Thanks drew.
Thank you.
Thank you.
And next we have.
Niccolo of Cantor.
Your line is open.
Hi, good morning, and thanks for taking my questions. So my first question is I think you mentioned the first patient cleared the 28 day safety huddle any more details on what are the hurdles that you had bolton and all of that when do you destock safety panned out questions you are expectations and as a follow up to that any further details you can give on them can you ask did you want to decrease.
And lines of therapy based on that you can share and I might have missed this what the dose that accretion goes on and I had a quick follow up.
All good questions and.
For them as mentioned, we are going to provide additional data at the appropriate scientific conferences here in the second half of 2022. So at this point.
We're just reiterating <unk> was the K Ras mutation and.
It's the first dose level that we have which is.
$4 billion.
5 billion T cells.
The first dose level.
Okay. Thank you Kevin.
For the remainder of the <unk>.
The year or should we expect further expansion of the TCR library or youre comfortable with the <unk> that you have right now.
Well, we're certainly excited to having extended it just in December from six Tcr's to 10, Tcr's, we will determine based on the progress that gets made with the hunter platform be seeking to expand our hunter.
Our TCR library continuously so certainly a internal objective of ours is to continue to grow and expand the library. The exact timing will be determined based on what we find.
Got it and just one final housekeeping question you had previously communicated an operating cash burn of 40 to 45 million trade during two Brian Jenkins.
And thank you for taking my questions.
Certainly, yes did reiterate that on the call today I do.
If you look at the burn in the first quarter and multiply it times four that doesn't get you to that range, but with the additional dosing of patients throughout the year.
Additional hiring to increase.
Manufacturing throughput, we do anticipate and reiterate that guidance of operating cash burn between 40 and $45 million here for 2022.
Thank you.
Thank you.
Thank you.
Again to ask a question. Please press star one on your telephone to withdraw.
Your question. Please press the pound key.
Our next question comes from Thomas Flaten of Lake Street Capital your.
Your line is open.
Good morning, Thanks, guys for taking the questions. Kevin I was wondering if you could characterize in a little bit more detail the patient pipeline you have.
You mentioned 500 patients screened greater than 5% matched but obviously some of those patients fallout do you have a pipeline in place now or can you just help us think through what that looks like.
Yeah.
Yes, what I would say is we do not have any concern with.
Patient accruals coming from having MD Anderson is a single side I think we are very pleased seeing the number of patients that we have going through the various.
Trials that we have opened so we have a screening trial. So after we find patients that have a match to an indication in TCR in our library. They then progressed to a screening protocol that we have open at MD Anderson and more information can be found on clinical trials Gov on that and then after the screening protocol.
Then move on to the treatment protocol again also with details available on clinical trials Dot Gov, and we have been very pleased with both the diversity of the cancer types and potential patients to be treated and mutations as well. So we're very excited.
With regards to the throughput and potential for patient treatment here, thus far in 2022.
And I know you want to hold off on sharing information about the first patient with respect to outcomes. I was wondering if you might be able to share something around.
How long the entire process took for them from screening vein to vein time and anything you can share around that.
Yes.
Well, what I will say is I'll reiterate that our manufacturing processes. Approximately 30 days every patient is a little bit different from when they get a for a for east.
How long it takes once they've been identified and consented on the trial to work through various insurance related matters and administrative matters.
So it's really quite variable in that regards.
Where you do not ever have in a perfect world and this is where I do want to set expectations, where you roll out of manufacturing and then the next day you begin manufacturing for the next patient.
That's not realistic there is quite a bit of documentation that needs to be done by the team to make sure that we're keeping good.
Good order in good conditions as part of our manufacturing.
So.
I think as we look ahead and think about the appropriate number of patients.
For 2022.
Setting expectations is it will not be rolling out and other uses of our manufacturing suite.
Whether it be for.
Implementation of cryopreservation or membrane bound IL 15 runs there will be other things.
Ace uptick process runs that need to take place there will be other things that are happening in the manufacturing suite as well. So I do want to set expectations that we're not going to have a patient a month that would be unrealistic here for 2022.
But we are very pleased with the pipeline with the patient flow and excited to present data at one of the upcoming meetings here in September .
And just a quick final question any expectations you can set around news flow for lack of a better term from NCI.
Sure.
I can't speak to NCI so.
I appreciate you're asking that question, but I do know with them kind of getting back up and running at all.
I would not anticipate too much to be shared here in 2022, I think it's but ultimately it will be up to NCI on their progress.
Great I appreciate you taking the questions. Thank you.
Thanks, Tom.
Thank you.
And again to ask a question. Please press star one on your telephone standby as we compile the Q&A roster.
And I'm seeing no further questions in the queue. This will conclude today's conference call. Thank you all for participating you may now disconnect.
Dave.
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