Q1 2021 Marker Therapeutics Inc Earnings Call
Hello, and welcome to the marker Therapeutics first quarter 2021 operating and financial results conference call and webcast. At this time all participants are in a listen only mode.
Once you require operator assistance. Please press star zero on your telephone keypad, Oh question and answer session will follow the formal presentation.
As a reminder, this conference is being recorded it's now my pleasure to turn the call over to CFO Tony Kim. Please go ahead Sir.
And welcome everyone. The press release reporting our financial results is available in the news section of our corporate website at Www Dot marker therapeutics Dot com and.
As a reminder, we will be making forward looking statements regarding our financial outlook. In addition to regulatory product development and commercialization plans and research activities.
These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted a day.
Description of these risks can be found in our most recent form 10-Q and 10-K on file with the SEC.
I would now like to turn the call over to Peter.
Thanks, Tony Good afternoon, and thank you for joining us today I'm pleased to say that we're off to a productive start to the year. During the first quarter, we completed a 56 and a half million dollars public offering of common stock that will support the continued growth of our pipeline and we're making steady progress on both the clinical on the manufacturing fronts in March.
We treated the first patient with empty for one in the safety lead in portion of our phase II trial in post transplant acute myeloid leukemia or AML. This is a significant milestone for us as it is our first company sponsored trial with multi theory therapy, but also a critical first step towards developing what we believe could be a potentially transformed.
Therapy for these patients who are present have only a 25% chance of surviving five years.
We currently have several sites open and enrolling and our clinical team is hard at work getting additional clinical sites online our chief Medical Officer, Dr. Michael We can hear you will provide further details surrounding our email trial on just a moment and we look forward to taking your questions at the end of today's call.
In parallel with the clinical developments, we continue to optimize the empty for one cell therapy manufacturing process as we prepare to operationalize our new in house manufacturing facility in the first half of this year in.
In brief we're excited to explore how these modifications can be applied across on multi ta therapies.
Potentially result in an increase in the number of T cells available per patient administration amongst other benefits, our chief Development Officer, Dr. Juan Vera.
Just a day to day a lot of details about the important process improvements that we've implemented we look forward to completing the technology transfer from Baylor College of Medicine and manufacturing in house all of the study drug for our AML trial and future trials.
This year, our primary focus is on completing treatment of the patient from the safety lead in portion of our study with <unk> hundred one Andrew moving patients in the phase two portion of the trial.
As you May recall, our cell therapy was designed to address this work coming to current treatments, while maintaining patient safety. Many cell therapies in development today are pursuing single or even dual targets. However, this approach has demonstrated little limited improvement in patient outcomes. By contrast, we believe that our multi antigen approach.
Has the potential to induce a lasting anti tumor effect by allowing the patient's own T cells to expand and kill cancer cells alongside our therapy.
By targeting multiple antigens in epitopes present within the tumor we believe that our multi TAA T cell therapy can effectively address the tumor heterogeneity well recruiting endogenous immunity to amplify the immune response to epitopes spreading at this time I'd like to hand over the call to Dr. Michael <unk>, Our Chief Medical Officer.
To review details of our phase two trial on our progress to date nicely.
Thank you Peter and you just heard this has been an important quarter for us as we dose the first patient within the safety lead in portion of our phase two trial in post transplant AML.
Just as a reminder, we plan to enroll approximately six patients in this portion of the trial.
Patients will be dosed with empty for a line our lead product candidate manufactured with a legacy reagent, which was used in the phase one trial conducted by our partners at the Baylor College of Medicine.
The remaining three patients will be dosed with study drug manufactured using a new reagent criminal alternative supply.
Our clinical operations team has made considerable progress on getting sites open and are currently nine sites activated.
Definitely we plan on opening approximately 20 sites in total for the phase two portion of the study and anticipate being able to treat the first patient in the main portion of the protocol in Q3 on this year.
M P for one which was granted orphan drug designation in post transplant AML has been well tolerated in an ongoing phase one clinical trial conducted by our academic collaborators at Baylor College of medicine in this setting.
Overall results showed that and keep our one was well tolerated with no incidence of cytokine release syndrome, neurotoxicity low grade three four gvhd and a post allogeneic setting and demonstrated an anti tumor effect with significant in vivo expansion of T cells.
As reported in a recent publication by Lula at all from December 2000, 2011 of the 17 patients from the adjuvant disease setting.
First with multi day specific T cell therapy, after receiving an allogeneic stem cell transplant never relaxed medium leukemia free survival R. L. S. S. Not reached at a median follow up on 1.9 years.
With 11 of the 15 patients remaining alive estimated two years overall survival of 77% at a median follow up of one nine years post infusion, which compares favorably with transplant outcomes for risk mash and all on D. S patients post transplant additions.
Additionally, eight patients were treated for activities that was resistant to salvage therapy post transplant with a median of five prior lines of therapy.
As for the 10.
Two of the eight patients achieved objective responses with one complete response and one partial response with six patients continuing with cable vs. Some of which had reduction in tumor burden.
Now based on these results we are optimistic about empty for one's potential in this patient population to briefly recap. This multi center animal study will be evaluating clinical efficacy of our product in patients with AML and those adjuvant and active disease settings. Following an allogeneic stem cell transplant in the adjuvant setting approximately 120 patients will be randomized.
On one to one day.
Either M. P for one at 90 day post transplant versus standard of care observation, while about 40 patients with active disease will receive and tea for one as part of the same on growth.
Primary objectives of the trial are to evaluate relapse free survival and the Ashland group and determined the complete remission rate and duration of complete remission enacted to these patients.
Additional objectives include for the Adjuvant group overall survival and graft versus host disease relapse free survival, while additional objectives for the actives. Each group include overall response rate duration of response progression free survival and overall survival and with that I'd like to hand, the call over to Dr. One there our chief development Officer.
Sure.
Thank you Mike Kelly in parallel to the progress we have made on the clinical front, we continue to work on simplifying and streamline our manufacturing process, while improving the T cell phenotype and 90 on the specificity of the final drug product. We believe these improvements may have on impact on the clinical performance.
Much of the drug product in our phase II clinical study.
He's manufacturer optimization fault on the two major categories technical on biological improvements.
Present, we have incorporated several technical improvements, including first 50 per cent reduction into manufacturing time, resulting in a 16 day manufacturing process.
In this manner, the vein to vein time, while improving manufacturing throughput.
On a decrease in the number of technical interventions by approximately 95% producing in this way there'll be subsequent terminations third and improved manufacturing process, which will reduce the risk of manufacturing failures and poor on final. Despite the reduction in the manufacturing time, we're able to produce sufficient numbers.
The patients in the current clinical study.
In addition to this technical improvements, we're now capable of producing a final drug product with a more favorable cell phenotype, a greater magnitude of antigen specificity on that.
Broader docket that recognition profile, we believe the combination of these technical and biological improvements May result in a clinical benefit in the upcoming study in AML Importantly, these CNC changes have already been approved by the FDA and are currently implemented in the safety lead in portion of.
And until they start with.
With that I will turn the call back to Tony Our Chief Financial Officer to review the financials Tony.
Thanks Juan.
We ended the first quarter was $64 5 million in cash and cash equivalents, we expect that our current cash balance will support operations into the first quarter of 2023.
Net loss for the quarter ended March 31, 2021 was $8 8 million compared to a net loss of $6 5 million for the quarter ended March 31 2020.
Our research and development costs. During the three months ended March 31, 2021 was $5 6 million compared to $3 8 million. During the three months ended March 31 2020 the.
The increase of $1 8 million was primarily attributable to increases in head count related expenses and infrastructure expenses due to growth of research and development operations.
General and administrative expenses were $3 1 million during the three months ended March 31, 2021 compared to $2 8 million. During the three months ended March 31 2020.
At this time, we'd like to open the call up to questions operator.
Thank you and I'll be conducting a question and answer session.
Like the place from the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he'd like to remove your question from the queue from participants using speaker equipment may be necessary to pick up your handset before pressing star one.
One moment, please while we poll for questions.
Our first question today is coming from Joe Ken Zaslow from Piper Sandler Your line is now live.
Hey, guys. Thanks, so much for taking my questions here, maybe just two from me. So so with regards to the safety lead in in those six patients just wondering if we should expect any disclosures from you once that part of the trial has been completed and if so what should we what could we expect to hear out of those six patients.
Sure Joe that's a great question, let me turn that over to Dr. Michael <unk>, who can talk about the safety lead in.
Yeah. Thank you. Thank you very question regarding the safety lead in.
Six patients. The primary objective is obviously safety so we'll be looking specifically at dose limiting toxicity.
And in terms of timing on you know and as we've mentioned we are looking on track to completing the safety lead in for the six patients mid this year and you open up the main portion of the H two we you may.
I anticipate a potential announcement for Phil on the main too.
The main portion of the phase two and it's opened up potentially.
And then they say give me Dan, but it isn't any toxicity has been cleared safely.
Okay got it that's helpful. And then maybe quickly my second question. Peter you noted that the optimized manufacturing process generates a greater quantity of T cells is there any possibility of our thinking at the main portion of the phase II could use higher doses of 401 than what's being used during the safety lead in or should we just be thinking more along.
On the lines of improved T cell phenotype, and an antigen specificity. Thanks.
Thanks, Joe that's a great question I think we are very optimistic about what effects, we might see from the improvement in the manufacturing process.
But let me turn that question over to on Who's closest to.
The CMC and process improvements that we've implemented.
Sure Yes.
We actually feel very.
I'm comfortable with day improvement that we have seen in the final product in term of day analytical comparison, right and I'm, referring specifically to the.
The comparison on in regards to the on Theon the specificity.
On the cell phenotype, both with have shown that the current the new process, he's able to yield a product of greater analytical characteristics.
So from from that I think debt.
The product that will be manufactured for day I'm going to study should feel a product of <unk>.
On a biological.
Characteristics that would be superior to it but we initially tested independent studies in.
In regards to the question on the cell dose.
These new manufacturing process open debt opportunity right I think that no being able to simplify the manufacturing process and also being able to increase the overall total numbers will give us the opportunity to explore even higher yourselves.
And with that maybe I don't know if he's myself he wants to comment in terms of the prospect of of doing a high yourself those in in the clinical setting Hey, Mike.
Thank you on the phase one.
Email on yesterday that was done at Baylor College of Medicine on has been exploring higher doses.
On an shown on.
You know, Joe and then get to be a so there is an opportunity for us to increase the dose in the main portion of the fees on two based on that data and to do so without.
Necessarily doing any additional.
Safety readings per se.
Okay got it thanks, Thanks for taking my questions.
Thanks, Jeff.
Thank you. Our next question today is coming from Kristen Klaus Kehl from Cantor Fitzgerald. Your line is now live.
Hi, good afternoon, everyone. Thanks for taking my questions and I like the new look of your website I.
Wanted to first ask with all of these manufacturing technical and biological improvements that you laid out how are you thinking about how this could impact the cost and time savings on a larger scale and then do you believe that this process could be utilized a long term or will you continue to look at other items.
On.
Thanks for the question, Chris and let me turn that over to Juan.
Thank you that's excellent question.
Although we don't necessarily highlight that aspect I think that the new simplified manufacturing process.
Should have a significant impact in terms of yield.
More economic final product.
Is that mainly results from a debt reduction.
A reduction in the overall, so culture time and day overall simplification on decreasing the number of interventions.
So without a doubt that is going to have a positive impact in the cost of the final drug product right.
And but I have to highlight that we were aware that day.
There's still a aspect that can be far Derek improve on in the manufacturing process I believe to what we have here.
It's something that is a very solid and.
On a very solid and manufacturing process that will be suitable for even future commercialization. However, it. It gives a very strong foundations from this process to be optimized and to have a closed system.
To incorporate certain elements that will allow optimization of these process too.
To simplify and speed up some of the components itself from the manufacturer and so to summarize.
I agree debt.
With your statement that this cash.
Simplification has an impact wholesale the economics no no just on the biology.
And I think that this basically now has a very strong basis for future areas of improvement that I would consider at this point would be.
A minimal.
But nevertheless significant.
Thank you and yesterday you had a poster presentation with some comments from Doctor Smith at a S. GCT with ABB evaluating the potentials of the robotics implementation. So I wanted to ask based on these early findings if you could discuss if youre.
To further expand on this collaboration and what any next steps might look like.
I think we're very excited about the collaboration with ABB I think what from what we're finding is is that with the.
With the implementation of robotic technology, we can improve the consistency of the manufacturing process, which is extraordinarily important and cell therapies, but one.
I think that your your comments here would be would be valuable.
Sure. Thank you Peter I completely agree without a doubt on area of high by ability currently in the field associated with this generation of these patient specific products. They still rely on day, operator Friday day.
Definitely on inherits about ability from the starting material.
But I think that by being able to incorporate that robotic process, you're basically removing in the future a potential unknown right, which basically is the.
The addition of variability from the operator itself.
Yeah. So I think that this is something that as Peter mentioned, we're really excited about the collaboration with ABB and we look forward to continue working towards the integration of our robotic process in the manufacture of empty for one.
We believe that this is something that could really transform our.
Process and making it more.
Suitable for future commercialization. So we were really excited about the line of work.
Thank you and then the last question I have is that while I know you're focused on and Mel could you talk about how youre thinking about any next potential indications to bring in house based on the bcm proof of concept and maybe specifically what are going to be some of the key decision criteria.
Mike Lee.
I think.
It is appropriate for you.
Thank you Peter Thanks for the question on Yeah, absolutely I mean, I think you're right and I think that we have been working very closely with Baylor.
You know follow and I understand the phase one data very closely so that we can appreciate where the opportunity lies on in terms of unmet need for a patient population on and where the data is really taking on obviously.
The pancreatic cancer data was presented last year at Ash go on and you know continues to look.
You know kind of thing.
Well you know I think this being an allogeneic <unk>.
And for the and now on where we're obviously looking at other indications.
The autologous program.
You know what was it for including pancreas and.
Potentially other indications, it's really trying to see where the data leads us on where the unmet need is.
You know.
And finding the appropriate time to do so.
Yes, Kristen obviously, we think that the lymphoma data is quite striking.
We we believe strongly that the pancreatic results R. R.
We're continuing to accrue evidence that the MTA.
Multi ta a therapy is driving a meaningful therapeutic benefit for those patients with pancreatic.
Dino carcinoma. However.
However, I would ask you to just bear with us.
Because at this point I don't think that we have we've officially.
<unk> announced.
Are there plans to be owned or AML study and that is currently where our focus is is driving enrollment in that study.
Great. Thank you.
Thank you. Our next question today is coming from Matt Taylor from Oppenheimer. Your line is a lot.
Hey, guys. Thanks for the questions.
I'll tag on to that last one Peter can you can you give us an update on where Baylor is in their own ml trial. I think my mentioned from trial was testing on a higher dose of multi T. A any idea when we might see updated data from that trial or or any of the other baylor trials for that matter.
Yeah, that's a great question, Matt and thanks for the question.
Let me turn it over to Michael Lee, who who.
Coordinates and talks to Dr. Pre mile Lula are primary investigator at Baylor on a on a fairly consistent basis for them for the latest update on the dose escalation portion of the Baylor phase one trial.
Thanks, Matt for your question.
So if you look at the recent publication of.
From that group from Doctor from all Lula <unk>.
On the phase one AML Mds study there was some.
On some data included on.
Some of the higher dose levels in that paper.
So.
I think they are nearly complete with that last dose level.
So that paper I think more or less as up to date on the current status.
On the two additional dose cohort.
And I think that's right.
Very close to completion of that last cohort on with the highest dose.
Yeah, Matt.
I'm sorry that my understanding uses that Baylor was set to complete the last dose the last patient in the dose escalation phase.
Dose level, five last year, but due to disruptions because of COVID-19.
They are still in the process of finding.
Finding.
Ah patient to replace the patient that they had originally planned.
Two to treat but were unable to because of coronavirus.
Yeah that makes sense I'll have to I'll have to check out that publication.
I had a quick follow up on manufacturing just any any plans to present side by side.
Parison drug product manufactured.
With the new approach versus the the old tailored approach.
Yeah, Let me, let me direct that question to one.
Thank you, yes, that's actually a good point that we feel really proud on the progress we have made on day manufacturer in front.
And actually we're presenting a small sneak of debt information all day.
The IAC team meeting on a C J T.
So the poster is really focus on how we can best improves the manufacture of empty for one.
We disclosed the collaboration with ABB.
In incorporating a robotic process. However.
Encourage you to look at the results, where we actually disclose some information on the first part of that work which is.
Geared towards simplifying the manufacturing process and there you would be able to see net impact from a biological standpoint.
When we compare the old and the new manufacturing process.
Alright, great. Thanks, guys.
Perfect.
Thank you. Our next question is coming from Tony Butler from Roth Capital. Your line is now live.
Yes, thanks, very much Peter or myself.
You made a reference to the first six patients and.
In which case you would look at.
And a portion of the study.
And what you would look for.
Some side effects that may occur from one.
From from from one group versus the other group one of the three patients versus the other three patients from the question is is there any other biological dad.
So that you need to feed to the FDA to actually demonstrate that there's really no difference between the two.
Particular reagents that are being utilized and effectively.
Free patients from one reagent vs. Three patients from the southern region are literally identical.
And I'm curious what the biological data might be thanks.
Sure Tony Let me turn the question over to him I believe but let me start by clarifying something which is that the patients from the safety lead in or being primarily monitored for safety that is that none of them have dose limiting toxicities.
And that is the primary endpoint for these six patients from the safety lead in but from a practical standpoint, we won't be doing anything meaningfully different with these patients and we will be for the patients that will be enrolled in the official phase II. So with respect to efficacy if we see efficacy from these patients.
We will plan to continue to monitor and report them.
The same way that we would the fees to patients but mightily.
Why don't I turn it over to you for the technical answer to Tony's question.
Yes. Thank you for your question Joanne and Peter's them exactly right on.
We're really only focused on the dose limiting toxicity and that will.
Beaver reported to you the FDA if any any issues arise on you know we don't anticipate any differences in terms of the safety profile between the two cohorts.
And beyond that there's really nothing additional that we need to report to the FDA.
So in terms of you know other biological data that's already.
Hum.
You know the reagent manufacturing and similarities all all of that has already been provided so it's really just this last piece of safety data that will be provided before opening up the main portion of the phase two.
I appreciate that clarity thank you.
Thanks, Michael.
Tony.
That's a distinction that debt.
Sometimes loss in the safety lead in is really only.
Intended.
To ensure that there are no ts.
From from the product, but the issue of comparability has already been settled with the agency.
Thank you we've reached end of our question and answer session I would like to turn the floor back over to Peter for any further closing comments.
Thank you all for joining us today here on our first quarter earnings call. We appreciate your support and we hope that you all stay safe and well during this pandemic.
Have a nice evening.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.