Q2 2021 GT Biopharma Inc Earnings Call

[music].

Greetings and welcome to the G T Biopharma second quarter 2021 conference call.

All participants are currently in a listen only mode.

Following the formal presentation, we will open the call up for a question and answer session.

At this time I'd like to turn the conference call over to David Castaneda Investor Relations for the company.

Thank you you May proceed.

Thank you operator, good morning, everyone and welcome to G. T. Biopharma second quarter 2021 conference call earlier. This morning, we issued a press release summarizing the company's second quarter 2021, corporate updates the management will discuss on the call. Today you can access the press release by going to the news and media section and then the press releases page on our website at G T Biopharma Dot com.

<unk> Biopharma is following presentation and ensuing question and answer session will include statements that are or may be deemed forward looking statements.

Some cases, you can identify forward looking statements by terminology, including anticipates believes can continue could estimate expect intend may plan potential predict should will would or the negative thereof.

Other variations thereon or other comparable terminology, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time as a result, it is not possible for management to predict all risks nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially.

From those contained in any forward looking statements we may make.

In light of these risks uncertainties and assumptions the forward looking events and circumstances discussed in this presentation may not occur and actual results could differ.

Yeah.

[noise] could differ materially and adversely from those anticipated or implied in the forward looking statements.

Cautioned not to place undue reliance upon such forward looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward looking statements are reasonable we cannot guarantee that the future results levels of activity performance or events and circumstances reflected in the forward looking statements will be achieved or occur.

We direct you to our annual report on Form 10-K for the year ended December 31, 2020. Our subsequent current reports on form 8-K, our quarterly report on Form 10-Q for the quarter ended March 31, 2021, and our other filings with the Securities and Exchange Commission.

Any forward looking statement included in this presentation speaks only as of the date hereof.

Except as required by law, we do not undertake any obligation to update or revise or to publicly announce any update or revisions to any of the forward looking statements whether as a result of new information future events or any other reason after the date of this presentation for all forward looking statements. We claim the protection of the Safe Harbor for forward looking statements contained in the private Securities Litigation Reform Act.

Of 1995, nothing in this presentation or discussion shall be deemed an offer to purchase or sell the company securities.

Now I'd like to turn the call over to Tony Cataldo, Chairman and CEO G T Biopharma Tony.

Thank you David Good morning, everyone and thank you for joining us and this is G. T biopharma for a scheduled conference call.

Want to thank the investment community for paying attention to the progress at G. T. Biopharma as demonstrated in the first half of this year. Additionally, I want to thank my entire staff for their due diligence hard work and the contribution they have made for an amazing person.

The year. The last this fiscal quarter has been marked with numerous events and milestones reflecting tremendous success for the company.

We were added into the Russell 2000, the Chicago options exchange and now have enough money to execute the Companys business plans for the next couple of years approximately $40 million.

We also completed our new sponsored research agreement with the University of Minnesota headed by the Tri creator Dr. Jeffrey Miller and his team at the University of Minnesota.

This will further enhance our advancement of the trial platform, adding more value to GTS expanded portfolio. Our G. D. G. T. B 35, 50 trial clinical trial continues to show safety and clinical results and remains well tolerated with patients who have for all intents and purposes has been written off the trial clinical data.

As shown that it is a remarkably effective at activating patients own NK cells, creating persistence of the NK cells proliferation of NK cells, and making NK cell and serial killers of cancer cells.

Unlike our competitors, we don't need ex vivo outside manufacturing of NK cells or a combination drug therapies to supplement our product everything that <unk> does is inside the body. They tried stands alone in the field of NK cell technology companies as a true monotherapy. Additionally, the strike is a toolkit for other NK cell therapies, we have.

Data that shows that G. T will continue to update the investment community as events unfold as well as significant corporate development milestones.

I often indicate to existing and prospective investors and analysts that I believe that it is the data and not the CEO that speaks most meaningfully to the merit and potential of <unk> biopharma.

Such I will now turn the call over to Martin Schroeder, our Chief Technical and Technology Officer and Dr. Greg Burke, Our Chief Medical Officer, who will recap the impressive and encouraging data we observed and reported in recent months, we will close out the call with a Q&A session to reiterate I am exceedingly pleased with our advancement over the last.

Quarter is clearly evidenced by our concern share price appreciation.

And with that I'll gladly pass this call over to Martin Schroeter Martin take it away.

Thank you Tony.

Hello, everyone as an introduction for those who may be unfamiliar G. T. Biopharma core technology is centered around our proprietary <unk>.

<unk> form and this platform originates from the pioneer were pioneering work of Dr. Jeffrey Miller at the University of Minnesota.

<unk> is designed to harness and enhance the cancer, killing cancer, killing ability of the patients endogenous our own.

Natural killer cells without the need for the addition of supplemental NK cell therapy is administered to the patient by infusion and once the balance of the patient's NK cells try to Rex the NK cell <unk>.

Target certain tumor specific proteins or tumor antigens that are expressed present on the surface of cancer cells, leading to the death of the cancer cell.

Notably <unk>.

Distinct to track relative to other therapies shrank activated NK cells target and kill multiple cancer cells in a very powerful and serial fashion.

So what is chunk check as Nader.

We're constantly columns as recombinant fusion proteins.

These are proteins that recognize specific.

Antigens as I mentioned on the surface of the cancer cell and.

And as such we it can be designed and engineered with great flexibility, allowing us to target a variety of tumor antigens.

Hematologic malignancies Sarcomas.

Tumors.

Trike, unlike cell therapies does not require patient specific customization.

So in addition to the compelling clinical data, we are seeing with GTE $35.50.

It's being evaluated in phase one clinical trial, which my colleague that FERC will discuss momentarily.

Our pipeline consists of several additional tried products, which target solid tumor cancers.

Our clinical development pipeline includes strike product candidates, which targets PD lone positive solid tumor cancers. These seven H <unk> positive solid tumor cancers or two positive solid tumor cancers in these cancers, including lung cancers breast cancers ovarian cancers gastric.

<unk> and prostate cancers to name just a few.

Let's try product candidates are presently undergoing GMP manufacturing and scale up in preparation for filing an investigational drug application with the U S FDA for evaluation in humans.

Yes.

We are also working on several additional product attract product candidates that are in various stages of preclinical evaluation.

At this point I'd like to turn the call over to Greg Burke, Our Chief Medical Officer.

And he can proceed to discuss the details of our <unk> 35, 50 clinical program Greg.

Thanks, Martin the early preclinical and clinical evidence with our first candidate Trike GTP 35, 50 for the treatment of relapsed refractory AML and Mds that was reported in the last fiscal quarter. It is very encouraging we observed both a positive safety profile and an indication of Biologic Act.

<unk> as measured by black salary reductions at the 150 microgram dose level. We have one case of grade one Crs, which was not a dose limiting toxicity there've been no. Other clinically significant toxicity is observed and in fact next week. We are escalating to the next dose level that 200 microgram cohort.

To date 12 patients had been treated in the G. T. B 35, 50 phase one trial patients 579, and 11 experienced 33%, 61%, 63% and 50% reduction.

In the CD 33 positive blood and bone marrow blast levels, respectively, 57% of patients treated between 25, and 150 micrograms experienced a reduction in the AML or Mds Blass <unk>.

Activation proliferation and persistence of functionally active NK cells occurred without the addition of supplemental NK cells.

NK cell activation.

It has been observed to increase early early during treatment and is correlated with a proportional an overall increase of absolute number of NK cells targeted delivery of IL 15 to NK cells via the $35.50, trike showed preferential proliferation of NK cells and significantly less effect on C D.

A positive and C D four positive T cells.

We also observed no CD 16, shedding by patients NK cells and saw enhanced H F 60, AML target cell, killing ex vivo.

This data indicates that GTP 35, 50 rescues the patient's exhausted and inhibitors that endogenous NK cells, resulting in their activation proliferation and persistence.

This early data indicates.

GTP 35, 50 therapy demonstrates significant bone marrow.

A level of reductions in AML and Mds patients.

Without the need for supplemental autologous and allogeneic stem cells.

I'm, sorry, so cell therapies.

Yeah.

This phase one.

The trial is expected to conclude later this fall.

The updated safety and efficacy data will be presented in an oral scent set oral session at the ESMO conference in September with that I'd like to turn the call over to the operator to open up for Q&A. Thank you.

Ladies and gentlemen at this time, we'll begin the question answer session.

To ask a question you May press Star and then one using a touchtone telephone.

All your questions you May press star two.

If you are using a speaker phone, we do ask that you. Please pick up the handset before pressing the keys to ensure the best sound quality.

Once again that is star and then one.

To ask a question.

Our first question comes from Justin <unk> from B Riley Securities. Please go ahead with your question.

Hi, Thanks for taking the questions I have a couple starting off can you provide any color on what can what we can expect to see at ESMO, how many patients how long the follow up.

Any details you can get.

Yeah.

Greg.

I didn't answer that but just to remind everybody because we are speaking at a major conference. There are certain embargoes that we can't articulate until that conference.

Go ahead Greg.

Sure.

Justin.

At ESMO, which is on September 20th or around that time.

We will present updated safety data at least through 12 patients were in.

Literally.

Dosing patient number 13 next week. So we most likely won't have data for that patient at ESMO, so it'll be up through 12 patients.

Got it and maybe related to that so you had mentioned that there was the one case of Crs that didn't seem to two severe can we get any more details on that like how long after treatment was observed how long does it last what interventions where where required.

And anything else you can give on that front, yes sure. It's very simple. It was just it was just it was just fever. So a fever that persists a certain amount of time is you know if its fever, along without other sometimes it's a grade one crs so.

If infection is rolled out which it was in this case it's <unk>.

<unk> as a possible Crs.

Perfect. Thanks, and I'll just have one more.

But by the way just and that's not a dose limiting toxicity of grade one fever fever Crs.

Got it.

Alright, So I think it was the last one for me.

Maybe just some details on how Dr. Miller's involvement.

As expected to evolve following the sponsored research agreement and how that is expected to advance at GTS platform.

Yeah, Martin why don't you take that one.

Martin.

Yeah.

Pardon me likely muted.

Got that.

Forgive me, yes, so jeff's involvement with.

With the company will continue to be quite strong is one of our founders and of course pre eminent a key opinion leader in the field.

The sponsored research agreement, we have several activities planned to help them more fully understand our trikes.

Capabilities as well as tax influence on NK cell biology.

During the course of therapy.

And as you're I'm sure aware as I mentioned, we are in the profit we are developing several new trike product candidates. Some of those are quite interesting dual targeting trikes at simultaneously target two are.

Different.

Tumor antigens that could go.

To help better cutoff immune escape, particularly when we move into the solid tumor.

Setting.

So yes suggests oh.

Efforts with the company will.

We will continue to be strong and it would be quite actively engaged for the long term.

Yeah.

Got it thanks for taking our questions I'll jump back in the queue.

Yeah.

Our next question comes from Ram Silverado from H C. Wainwright. Please go ahead with your question.

Thanks, very much for taking my questions. Firstly I was wondering if you could give us some color on the timing of release of final topline data from the $35.50 trial and if you have a line of sight on which medical conference you expect to present, the final data and I understand the <unk>.

Data is being presented at ESMO, but just wanted to get a sense of timing of the presentation of final data.

Sure Hi, Ram, it's Greg I can take that one.

You know as you know am is as as we continue to be in dose escalation. It's it's always difficult to predict what your recommended phase two dose in your MTBE is going to be.

Once again, when you see such a clean safety profile. That's why we've made the decision.

To escalate from 150 to 200.

No.

When you think about it it takes a couple of months to get a cohort.

Enrolled treated and completed with with data so.

So we we we won't make a decision until on the M. T D, which is really the driver of the final data for the phase one.

Until we establish a recommended phase two dose and M. T. D. So we're a few months away from that for sure. That's why we're saying it's later in the fall.

And then within a few months of that will initiate our phase two regarding the timing of of the conference around the final data.

I don't think we will have final data in time for ash for sure. So so it would be a conference later in the winter.

Early spring for the final final data, but we may release that at the press release, even before that a pop level press release.

What I would add just to expand on that as well.

Just for those who don't really understand it is get MTV is an important milestone for the company and it's a good thing.

When you're not hitting MTV that means your products still working and he may have more effectiveness as we climb that ladder.

Great and then also wanted to ask about where in the treatment continuum, you see 35, 50 potentially being most likely to be deployed within the context of AML specifically.

Yes, that's a great question Ram.

It's something we think about every day, obviously, so our current study as monotherapy and that's still our base case plans as to.

Hopefully in phase two if we see a compelling efficacy signal and what I mean by that is a significant number of durable crs not just blasts are reductions, but durable Crs we would obviously.

Pursue an accelerated strategy because these are patients as you know that don't have any.

Effective or even approved options, we're talking about relapsed refractory AML and high grade Mds.

So so that's our mono therapeutic approach and by the way, we're including I think as you know.

Minimal disease overseas cohort in our phase II, because that's a popular population of patients who have a high unmet need.

You know virtually all of them will relapse and were essentially trading lower volume leukemia. So M D R.

Marty cohort is very important to us.

Ultimately.

I believe that the drug could be moved up in combination with standard of care chemotherapy.

And we will while we're while while were continuing our monotherapy expansion cohorts in phase two we will initiate a combination trial most likely would have been at a klaxon Nathan sided theme, which is the most commonly used regiment in the relapsed setting. It's also as you know used in frontline setting.

There is a lot of published data that NK cells, and hypo methylated any agents, including both <unk> and decitabine are synergistic.

And work together and AML models people Theres also a lot of evidence that venetic class as well as the hyper methylate agents are not toxic to NK cells. So it makes a lot of sense to combine.

You know the engage her.

With a standard of care chemotherapy and probably the perfect regimen would be another class eight decided it so that will be done in the future as well.

Great very helpful color I wanted to switch gears now to talk about Europe be seven H three targeted trike and ask if you can provide any additional color around the preclinical data.

Previously announced as well as give us a sense of when it might be presented at a medical conference and also if you have any thoughts on the current the 783 competitive landscape, especially in terms of how that compares to other kind of canonical targets that have emerged as being of interest in the context of oncology.

Martin do you want to handle that one.

Alright, great.

Yeah.

Greg Why don't you go ahead, and then I can time no I was just going to say Martin has done all the work on it ramps.

I'll have Martin Martin presented because it's it's really been his project.

Yes, I mean, well actually the <unk> III <unk> type that we are matriculating two preclinical studies was.

Led by Jeff Miller, and his colleagues at the University of.

Minnesota, and Jeff and colleagues published on the on this product.

Product candidate already.

<unk> history as you know is ubiquitously expressed on a number of.

Tumor targets Macrogenics has been working on the 17th Street targeted.

Compounds for a number of years, we see.

Our first preclinical data for <unk>, we see using NK cells as a viable therapeutic modality to.

Very specifically target and kill B seven H three expressing cancers to date, we've looked at the ovarian cancer and breast cancer.

Prostate cancer to name a few and we've seen good killing and.

Feature cell assays in our in our animal models.

Positioning wise.

I think that it does provide an additional therapeutic agent.

For physicians to consider as they move forward with the comprehensive treatment plan for their.

For their patients.

Okay.

Yeah.

That sums it up.

Great and then just lastly, I was wondering if you could comment at all on potential combinatorial regimen that you view as most ideal for any and all of your other.

Earlier stage investigational try candidates. Thank you.

Well in.

When you talk combination therapies, there's certainly.

Comes to mind the.

Cartoon Opdivo to protect T cells.

That being said.

We are developing dual targeting tracks.

And the idea there is to.

And cutting off immune escape. So we have two targeting trying to that target CD 138, which is present on cancer stem cells.

We have Ah ones that go after Egfr.

And that.

With that Jeff <unk> III for example, PD Lone combination trials. So the platform is now.

Very versatile and that allows us to utilize multiple targeting domains with the single trike.

We could for example.

We have for example, a CD 19 trial and we could co administer that with CD 33, with a $35.50, it could be done.

But it's I think more.

More efficient to make a dual targeting CD 19, CD 33.

So it's really the dual targeting strategy, yeah I think.

To a large extent we're focused on.

More than trying to determine which try we should pair with which other standard of care therapy.

Uh huh.

Just wanted to add to that Martin that.

You know, it's a reasonable question because generally historically in oncology, it's always been about combinations.

We're we're obviously going to pursue.

You know seeking seeking a signal as monotherapy because its a much less challenging regulatory path. If it's if it's used as a single agent.

However, you know we're going to go where the science tells us to go and there's a lot of.

Strong rationale scientifically to combine trikes with as Martin mentioned checkpoint inhibitors as well as standard of care chemotherapy.

I do think we need to initiate combination studies very early into development literally after we have a couple of cohorts of single agent safety data. So.

We're gonna start doing this work with AML with then as as I mentioned, because the science is really telling us to go there and we will look at every possible solid tumor combination as well with our solid tumor types and be guided by the science as well as making sure there's a clear registration.

Pathway for that combination.

Thank you very much.

Our next question comes from Tony Butler from Roth Capital. Please go ahead with your question.

Yes, thanks, very much two questions.

If I may the first is maybe for Greg or Morten.

In political Charles Dot Dot org.

It actually starts to phase one two study for 30.45 50.

Is enrolling obviously Masonic cancer Center University of Minnesota.

But theres also Wisconsin that is listed as well, but not recruiting and I'm. Just curious will you open that site for 30, 35.50 or wait for the phase. Two that's question. One question two is.

You spent a little bit of time, Martin Greg talking about.

Other trikes, but I think.

At least what was new to US is this notion of sort of second generation trucks, which.

You don't have.

Demonstrated greater greater potency greater activity greater cytotoxicity and I just wondered if you would just spend a minute on those and in fact.

Hum.

I think it would be seven age through.

For example, it is.

There's one that has been created based upon you know those second generation attributes in a while.

You don't spend a lot of time on it but I just I just thought it was important that.

You mentioned it because I think these things these it's just not.

One size fits all platform it seems that there are.

The flexibility of award that you have already use but also.

The flexibility to actually leads to potentially.

Well greater cytotoxicity.

That may be target dependent I appreciate any commentary around that thanks very much.

Sure I can quickly answer the question about the sites and then hand over to Martin for the discussion on the newer generation tried regarding sites.

And what's posted on clinical trials Dot Gov is is we have.

<unk> initiated an initiated Wisconsin and we've gone through the process also with Oregon.

At the time, we started the process of initiating sites frankly, we thought we would be wrapping up phase. One now we didn't we didn't think we would get this height to this high of a dose and it made sense for us to put a hold on those sites until we initiated haven't come in at phase two there for sure coming in the phase two but they may very well come in at.

The tail end of phase one now, but they are ready to go.

And we by the way are bringing on multiple new sites.

The anticipated phase two and we will have up to eight.

Eight sites eight to 10 total sites and we've received a tremendous amount of interest from you now.

Many of the Kols in AML, who want to participate in phase two so that those initiations are starting to already.

I'll hand, it over the winter.

I'm sorry.

Yeah. So thanks, Tony for the insightful.

Insightful question. So our platform is very versatile and.

Our second generation strikes, which we're implementing across.

All of our portfolio.

What we've learned about how trike interacts with the NK cell and a target cell has led to this second generation platform.

The key thoughts are we wanted to improve the steric interaction between the various binding domains of the <unk> molecule and NK cell and the target cell.

So in that regard we've moved away from.

Single chain variable fragments to.

And antibodies and in that case, we've we have seen dramatic improvement in the potency.

The drug.

Our drug candidates out some and some.

Cases, twentyfold better improvement.

Just because of improved hysteric interaction between track molecule NK cell and we've done the same.

Investigation with respect to how the NK cell.

Binds to the targets and they're in the case of the BD 17th Street Ah trial that you mentioned, it's a double antibody construct with IL 15 in the middle.

We have been optimizing the platform to.

Essentially very partner all the positive elements of <unk> therapy, and we will continue to do so obviously as we grow and mature the platform.

Yeah.

Thanks, Greg Martin appreciate it.

And ladies and gentlemen at this time, we've exhausted the audio questions I'd like to turn the floor back over for any offline questions.

Okay.

And we're showing no offline questions. So at this point I'd like to close the question and answer session.

And I'd like to turn the floor back over to Tony.

<unk> for any closing remarks.

Alright, Thank you and thanks, everybody I know all of you are right the.

Got an update on patients 10, 11, and 12 and as Greg was articulating we actually have been selected to do an oral presentation at the ESMO conference in September and because of that we are under an embargo prohibiting US released this kind of data. This is actually good news for a G. T results presented at a major conference like this.

We see much more coverage than the typical press release I want to thank everyone for listening to our second quarter of 2021 corporate update call.

Continued support of our shareholders. We Additionally, appreciate the courageous participation of the patients in our clinical trials and the dedication of all of those trial investigators will look forward to sharing future data readouts from our preclinical and clinical activities as they progress.

And thank you everyone and have a great weekend.

Ladies and gentlemen, with that we'll conclude today's conference call. We do thank you for attending you may now disconnect your lines.

Okay.

Yeah.