Q2 2023 Moleculin Biotech Inc Earnings Call

Hello, and welcome to the molecular biotech quarterly update conference call and webcast. If anyone should require operator assistance. Please press star zero on your telephone keypad.

Question and answer session will follow the formal presentation you May press star one at any time to place in the question queue.

As a reminder, this conference is being recorded.

My pleasure to turn the call over to your host Janine Thomas Investor Relations. Please go ahead your name.

Thank you Kevin Good morning, and welcome everyone. At this time I would like to remind our listeners that remarks made during this webcast may state managements intentions beliefs expectations or future projection. These are forward looking statements and involve risks and uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions of the federal Securities.

A lot and are based on molecular on current expectation and actual results could differ materially as a result, you should not place undue reliance on any forward looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward looking statements are discussed in the periodic reports molecular and file.

With the Securities and Exchange Commission. These documents are available in the investors section of the company's website and on the Securities and exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in the webcast relates to was based on studies publication surveys and other data.

From third party sources and the companies are estimates and research while the company believes these third party sources to be reliable as of the date of this presentation does not independently verify it makes no representation as to the adequacy fairness accuracy or completeness of or that any independent source of verified any.

Formation of teams and third party source.

And he just day to discuss regarding clinical trials and process that can take a preliminary and subject to change joining us on the call today from them that Black line management team I'll Watch request, Chairman and Chief Executive Officer, Dr. John Paule Whaler Senior Chief Medical Officer, and Jonathan Foster Executive Vice President and Chief.

Financial Officer, I would now like to turn the call over to Mr. Quincey, Chairman and CEO , while he please proceed.

Thanks, Denise and thanks to everyone on today's call for your interest in molecular.

We reiterated our commitment on our last two quarterly calls the 2023 would be our year of data.

And now the data from our priority pipeline programs are coming into view.

We've now completed the phase one b portion of our N. B 106 trial, that's the AML trial in Europe studying the combination of animation with cytarabine or Ara C.

Importantly that means we've now established a phase two dose and have commenced phase two recruitment.

In the meantime, the preliminary CR rate or complete response rate for the phase <unk> portion of our AML program looks to be 33%.

And as our senior CMO, Dr. Paul Weinbach will discuss that's already well above the benchmark used for approval in the class of patients we're targeting.

In our other lead indication of soft tissue sarcoma.

Now seeing 73% of subjects exhibiting stable disease after two cycles of treatment.

Again this is above expectations at this stage it S. T S Lam catastrophes and indicative of an encouraging efficacy signal.

As always I should stress that these data are preliminary and subject to change, but so far we are very encouraged by what we're seeing.

So when we look at the milestones we've set out for this year with animation.

We've already delivered on the first three and we have more to come.

Specifically, we expect to be announcing phase two data for AML and more phase two data for S. T S.

Which we intend to do with each quarterly and year end call.

And let's not forget that there is ongoing development work in our other two technologies and that should be generating news flow yet this year.

But we know that the main focus for most investors is on animation and here to discuss that in more detail is our senior Chief Medical Officer, Dr. Paul way back Paul.

Thank you Walid I'll get right into it.

For our lead compound <unk> and we continue to generate favorable clinical data.

Our ongoing phase one b two clinical trials of animation.

Patients with soft tissue sarcoma with lung metastases.

And in patients with acute myelogenous leukemia AML.

We believe we are positioned to complete both trials early next year.

Our soft tissue sarcoma trial M B 107.

It's a combined phase one b N phase II trial.

For the combined phase one b and two components, we have enrolled and treated a total of 26 patients with at least two <unk>.

<unk> as a therapy.

I should note that.

The completion of two cycles occurs every six weeks and is immediately followed with a C T scan to assess tumor status.

Now among these 26 patients we have achieved a 73% rate of stable disease.

Similar results had been seen in the 15 patients who are being treated in the phase II component of the study wherein we have a 67% rate of stable disease. After the first two cycles.

During the remainder of the second half of this year.

We anticipate reporting additional interim data, including <unk>.

Top line progression free survival data.

And overall survival data.

In our ongoing phase one b two M B 106 clinical trial.

Which is in patients with refractory in relapsed AML.

We have had six patients complete the dose escalation phase one b portion of the study.

This one b portion of the study has identified 230 milligrams per meter square is the dose to be used in the phase II portion of the study.

And we are now enrolling patients in the phase II portion of the study.

We should note that the phase two portion of the study.

Is enrolling not only patients with refractory in relapsed leukemia.

But also patients for whom out of my son will be the first line therapy.

We were not only pleased that the phase one b portion of the study identified the dose Savannah mice and to be used in the phase two part of the study.

But then it also resulted in two of the six patients achieving a CR or cri.

That is a 33% CR plus C. Our high success rate.

Again, we want to stress that these data are preliminary and subject to change.

I would also add for perspective.

But we have seen recent new drug approvals in AML.

Based on lower levels of complete response.

So we are very encouraged by the data so far.

Finally.

Let me note that we continue to.

We monitor closely for evidence of any cardiac toxicity.

All patients treated with animation.

And yet we have still not had a single patient.

In any of our trials.

But any signs symptoms lab results.

<unk> results are imaging results.

They've shown evidence of heart damage.

During the second half of this year.

We anticipate presenting the study report from our prior successful.

M B 105, mono therapy, with Ana mice and in patients with AML study.

We also anticipate presenting updates on our ongoing one of those six study.

I am very encouraged about what we're seeing.

And for the potential <unk>.

My son for both of our lead indications.

Moving on to our immune transcription modulator.

We continue to make progress in creating an intravenous formulation of air 10 66 drug.

Simultaneously, we are having discussions with multiple academic institutions to initiate investigator sponsored clinical trials or programs.

For the treatment of adult.

And pediatric tumors.

Brain.

During the second half of this year we.

We hope to report topline results from an investigator initiated phase one study in pediatric brain tumors.

We will also continue to seek external funding opportunities for investigator initiated clinical trials.

And we will provide updates on our IV formulation development.

Regarding our 11 22 glide constellation inhibitor.

We have opened in I N D to initiate a phase one study for the treatment of Glioblastoma and that that is brain tumors brain cancers.

We have also been granted orphan drug designation from FDA for the treatment of <unk>.

Glioblastoma type brain tumors.

During the second half of this year we.

We hope to report preliminary findings of the National Institute of Health and does the NIH funding.

Abundant animal testing and studies with the Taco rebate Arena virus.

And we will continue to seek external funding opportunities.

For an investigator initiated clinical trial.

John onto you.

Thanks, Paul.

Based on our current phase one b two activities and ramping up for future programs are $32 million of cash on hand at the end of Q2.

It would take us into the third quarter of 2024.

The plan funded activities include our current trials and also beginning phase III Tox studies and other preparations for future possible AML and STS trials with animation.

We continue with our financial focus on advancing animation and clinical studies and finding an IV formulation for W. P 10 66.

R&D expense declined slightly in the second quarter versus the prior year quarter.

As we were running three clinical trials can be 106, 107, and real one last year.

Now we are focused on N b 106 and 107.

And moving antibodies support in future clinical studies.

G&A expense decreased as a result of reduced legal expenses.

And our last shareholder meeting process, we spoke with numerous shareholders.

And they voiced their concern over potential naked short selling and stock price manipulation.

We heard you.

We are aligned and we agree that we should do everything possible to guard against those.

Recently, we engaged share intelligence services to monitor trading activity in our stock.

Stock ownership.

And significant movement of ownership to provide us with more knowledge on our trading activity.

Wally.

Thanks, John well I'm sure from our discussion today, it's clear that we are laser focused on clinical execution right now.

And the payoff should be in important data readouts over the coming quarters.

These data will play to critical roles Kantar.

Continuing to communicate efficacy in both S T S and AML as well as informing the pivotal clinical trial designs that we will begin negotiating with regulatory authorities.

As John mentioned, we are in a solid position of having sufficient capital to reach what we believe are key data and regulatory milestones along the way.

But perhaps most importantly for shareholders. We believe the data rolling in over the balance of year, we'll begin to address the disconnect. We see between our current share price and what we believe is the real potential value of molecular.

Well Jeanine that covers our prepared slides for today's call, but we'd be happy to answer any questions that people may have.

Thank you Mollie Kevin. Please proceed.

Certainly without conducting a question and answer session, if you'd like to be placed in the question queue. Please press star one on your telephone keypad you May press star two if he'd like to remove your question from the queue. A confirmation tone will indicate your line is in the question queue. One moment. Please while we poll for questions.

Our first question today is coming from Jonathan Aschoff from Roth M. Katz Your line is that life.

Thank you good morning, guys, John just a fast one one for you first is is this R&D run rate.

Or is just kind of temporarily low like last year.

It should be low.

Well this quarter and gradually increasing as you move into the fourth quarter and the first quarter of next year as we prepare for the future clinical trials as I have discussed we will have another batch of animates and being produced.

So that's where we get to the $32 million taken this into the third quarter next year.

Okay. Thank you and.

I had some more defined timing for upcoming catalysts in my last quarterly note then I see now now that we're showing if you can shine a little light on that like are you slowing down to save some money or you know what.

What might account for that.

So.

Let me John Let me, let me sort of take.

Take the front end of that but she might want to comment on that.

Specific choice of disclosures.

We don't necessarily see anything slowing down I I I do feel like Oh.

Some of this some of the.

Our progress that we.

Want to make over the balance of the year.

Involves outreach to two F D a M.

And you know as you know Jonathan.

That timing with regulatory authorities as really.

A guessing game.

And so we.

We want to be.

Well, one we want to make sure everybody understands that we're gonna start the negotiating process with regulatory authorities, but we we don't want to be too specific about the timing of when we're going to have that feedback because.

Sure sure I think we put a stake in the ground it'll will be wrong.

So we're not we're where we're seeing good recruitment in both trials. So we're not backing off the the timing there, but we we do want to try to be.

Respectful of the fact that we can't dial in regulatory dialogues with with any precision.

That's fair.

Lastly, why do you think the S. E rate was higher when you included the 31 evaluable patients at different doses. This is best Yes L. M. Then with just the 15 evaluable patients at the.

The recommended phase two dose I was just curious why that.

S D rate was kind of flipped versus what I'd expect.

So John you're you're you're you've been closest to crunching all of those numbers on a regular basis, you want to tackle that one.

Yeah, and I think Paul can can add in here as well when you look at the the time from initial diagnosis of lung metastasis, we're getting very tired patients and so youre seeing a little difference from the standpoint of the time from initial diagnosis too.

So the time when they enter in our trial the last time I looked at it. The median time from initial diagnosis of lung metastasis appeared to be around 20. So that's very tired patients from the lung metastasis standpoint, Paul you want to add some color.

I'll just add lots of color.

Statistician and say that when the numbers are 67% and 73%.

Once you've got a 10000 patient study those numbers statistically or just about the same so I would not put any great emphasis on 67 versus 73% accept those are both in our opinion really good numbers to have when you look at the literature.

That was a very fair answers thanks, guys.

Thanks, Jonathan.

Thank you next question is coming from Jeff Jones from Oppenheimer. Your line is that a lot.

Hi, guys congratulations on the quarter. Thanks for taking the question.

I guess.

You had mentioned.

Now updating on data and presenting data is there a plan to present.

At a conference or is this just going to be at the your typical quarterly updates.

So our reference here.

Was it was really focused on the quarterly updates.

Having said that.

We're definitely expecting to to have presentations at the upcoming ash and <unk> and other.

She toss in.

Other critical meetings certainly.

The data will be interesting for those conferences and we've got folks that we'll be presenting but.

Our reference in this call is really to make sure that people understand that you can count on the fact that when we do our our quarterly calls we are going to provide a very thorough clinical update.

Great appreciate that Wally.

And in terms of the M. B, one seven STS lung Mets study.

Okay.

<unk>.

In the patients.

Just hit the ERP to D. I believe you have 15 patients that valuable.

Sure.

Were there any prs or Crs or do you anticipate sharing waterfall or swimmer plot. So we can get some more visibility.

To what's going on with individual patients.

So Paul do you want to do you want to address this question.

Yes. Thank you.

First when we say the data are preliminary that that's definitely the case because at the art at the recommended phase two dose.

We still have a lot of patients who are ongoing who have not yet had progressive disease.

So are we.

We have patients who havent even had their six week initial six week follow up scans yet.

So these are very preliminary we have not yet seen a.

Patients with anything better than stable disease, but considering these are averaging about fourth line therapy are we are not surprised and we were very pleased just with such.

Late stage patients to be able to get to 67% to 73% of them you have stable disease at the time of the initial.

Valuation, especially in light of with the literature shows would be expected from this patient population.

Great. Thank you guys.

Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further closing comments.

Thank you.

Again, thanks, everybody.

Obviously as we've said in multiple conference calls before this.

The data is coming in and so it's it's it's actually a pretty exciting time for us and we're really looking forward to these especially these next two quarters just because of the timing of the additional data that's going to be coming in so please stay tuned.

We can't wait to report more data have a great day.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.

Yeah.