Moleculin Biotech Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 11, 2023

There are 7 speakers on the call.

Operator

And welcome to the Molecular Biotech Quarterly Update Conference Call and Webcast. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Jeanine Thomas, Investor Relations. Please go ahead, Jeanine.

Speaker 1

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 management's intentions, beliefs, expectations to the Safe Harbor provisions of the federal securities laws and are based on Molecular's current expectations 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 Such forward looking statements are discussed in the periodic reports Molekulin files with the Securities and Exchange Commission.

Speaker 1

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 this webcast relates to or is based on studies, publications, surveys And other data obtained from 3rd party sources and the company's own estimates and research. While the company believes these 3rd party sources to be reliable as of the date of this Presentation does not independently verify and makes no representation as to the adequacy, fairness, accuracy or completeness of or that Any independent source of verified any information obtained from 3rd party source. Any data discussed regarding clinical trials and Doctor.

Speaker 1

Klem, Chairman and Chief Executive Officer Doctor. John Paul Womack, 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. Klimt, Chairman and CEO. Wally, please proceed.

Speaker 2

Thanks, Janine, 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 1b portion of our MB-one hundred and six trial.

Speaker 2

That's the AML trial in Europe studying the combination of Antamycin with cytarabine or ARROC. Importantly, that means we've now established our Phase 2 dose and have commenced In the meantime, the preliminary CR rate or complete response rate for the Phase 1b portion of our AML program Looks to be 33%. And as our senior CMO, Doctor. Paul Weymouth 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, We're now seeing 73% of subjects exhibiting stable disease after 2 cycles of treatment.

Speaker 2

Again, this is above expectations at this stage of STS lung metastases 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 anamycin, We've already delivered on the first three and we have more to come. Specifically, we expect to be announcing Phase 2 data for AML And more Phase 2 data for STS, 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.

Speaker 2

But we know that the main focus for most investors is on anamycin and here to discuss that in more detail is our Senior Chief Medical Officer, Doctor. Paul Womack. Paul?

Speaker 3

Thank you, Wally. I'll get right into it. For our lead compound, L anamycin, we continue to generate favorable clinical data For our ongoing Phase 1btwo clinical trials of anamycin in patients with soft tissue sarcoma with lung metastases And in patients with acute myelogenous leukemia, that is AML, we believe we are positioned to complete both trials early next year. Our soft tissue sarcoma trial, MB-one hundred and seven, is a combined Phase 1b and Phase 2 trial. For the combined Phase 1b and 2 components, We have enrolled and treated a total of 26 patients with at least 2 cycles of therapy.

Speaker 3

I should note that completion of 2 cycles occurs every 6 weeks and is immediately followed With a CT scan to assess tumor status. Among these 26 patients, we have achieved a 73% rate of stable disease. Similar results have been seen in the 15 patients who are being treated In the Phase 2 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 top line progression free survival data and overall survival data. In our ongoing Phase 1btwo, MB-one hundred and six clinical trial, which is in patients with refractory and relapsed AML, we have had 6 patients complete the dose escalation Phase 1b portion of the study.

Speaker 3

This 1b portion of the study has identified 230 milligrams per meter square As the dose to be used in the Phase 2 portion of the study, and we are now enrolling patients in the Phase 2 portion of the study. 3 in relapsed leukemia, but also patients for whom anamycin will be the first line therapy. We were not only pleased that the Phase 1b portion of the study identified the dose of anamycin to be used in the Phase 2 part of the study, But that it also resulted in 2 of the 6 patients achieving a CR or a CRI. That is a 33% CR plus CRI success rate. Again, we want to stress that these data are Preliminary and subject to change.

Speaker 3

But I would also add for perspective that 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 monitor closely for evidence of any cardiac toxicity In all patients treated with anamycin, and yet we have still not had a single patient And any of our trials exhibit any signs, symptoms, lab results, EKG results or imaging results That have shown evidence of heart damage. During the second half of this year, we anticipate Presenting the study report from our prior successful MB105 monotherapy with anamycin in patients with AML We also anticipate presenting updates on our ongoing 106 study. I am very encouraged by what we are seeing and for the potential ranamycin for both of our lead indications. Moving on to our immune transcription modulator.

Speaker 3

We continue to make progress in creating an intravenous formulation of our 1066 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 of the brain. During the second half of this year, we hope to report topline results from an investigator initiated Phase 1 study in pediatric brain tumors. We will also continue States on our IV formulation development. Regarding our 11/22 glycosylation inhibitor, We have opened an IND to initiate a Phase 1 study for the treatment of glioblastomas, That is brain tumors, brain cancers.

Speaker 3

We have also been granted orphan drug designation from FDA for the treatment During the second half of this year, we hope to report preliminary findings The National Institute of Health, that is the NIH, funded animal testing and studies with the takaribe arena virus, And we will continue to seek external funding opportunities for an investigator initiated clinical trial. John, on to you. Thanks, Paul.

Speaker 4

Based on our current Phase 1btwo activities And ramping up for future programs, our $32,000,000 of cash on hand at the end of Q2 should take us into the Q3 of 2024. The planned funded activities include our current trials and also beginning Phase III TOX studies and other preparations for future Possible AML and STS trials with anamycin. We continue with our financial focus on advancing anamycin in clinical studies and finding an IV formulation for WP1066. R and D expense declined slightly in the 2nd quarter versus the prior year quarter as we were running 3 clinical trials in B106, 107 and 301 last year. Now we are focused on MD-one hundred and six and 107 And moving Anamycin forward in future clinical studies.

Speaker 4

G and A expense decreased as a result to reduced legal expenses. In 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 this. 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?

Speaker 5

Thanks, John.

Speaker 2

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 Two critical roles, continuing to communicate efficacy in both STS and AML, As well as informing the pivotal clinical trial designs that we will begin negotiating with regulatory authorities. And as John mentioned, we are in a solid position of having sufficient capital to reach what we believe are key data and regulatory But perhaps most importantly for shareholders, we believe the data rolling in over the balance of the 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.

Speaker 1

Thank you, Wally. Kevin, please proceed.

Operator

Our first question today is coming from Jonathan Aschoff from ROTH MKM. Your line is now live.

Speaker 6

Thank you. Good morning, guys. John, just a fast one for you first. Is this R and D run rate real Or is this kind of temporarily low like last year?

Speaker 4

It should be Low this quarter and gradually increasing as we move into the Q4 and the Q1 of next year as we prepare for The future clinical trials, as I've discussed, will have another batch of NMICs being produced. So that's where we get to the $32,000,000 taking us into 3rd quarter of next year.

Speaker 6

Okay. Thank you. And I had some more defined timing for upcoming catalyst In my last quarterly note that I see now, and I was wondering if you could shine a little light on that, like are you slowing down to save some money or What might account for that?

Speaker 2

So, John, let me sort

Operator

of

Speaker 2

take the front end of that that you might want to comment on our specific choice of disclosures. We don't necessarily see anything slowing down. I do feel like

Speaker 6

some of

Speaker 2

the Progress that we want to make over the balance of the year involves outreach to FDA. And as you know, Jonathan, that timing with regulatory authorities is really A guessing game. And so we want to be we want to make sure everybody understands that we're We're going to start the negotiating process with regulatory authorities, but we don't want to be too specific about the timing of when we're going have that feedback because sure enough if we put a stake in the ground it will be wrong. So we're not We're seeing good recruitment in both trials, so we're not backing off the timing there, but we do want to try to be Respectful of the fact that we can't dial in regulatory dialogues with any precision.

Speaker 6

That's fair. And lastly, why do you think the SD rate was higher when you included the 31 evaluable patients at different doses? This is STS, LM. Then with just the 15 evaluable patients at the recommended Phase 2 dose, I was just Curious why that SD rate was kind of flipped versus what I'd expect.

Speaker 2

So John, you've been closest to Crunching all those numbers on a regular basis, you want to tackle that one?

Speaker 4

Yes. And I think Paul can add in here as well. When you look at the time from initial diagnosis of lung metastasis, we're getting very tired patients. And so you're seeing a little difference from the standpoint of the time from initial diagnosis 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 around 20 months. So that's very tired patients from a lung metastasis standpoint.

Speaker 4

Paul, you want to add some color?

Speaker 3

I'll just add lack of color and play statistician and say that when the numbers are 67% 73%, Unless you got a 10,000 patient study, those numbers statistically are just about the same. So I would not put any great emphasis on 7% versus 73% except those are both in our opinion really good numbers to have when you look at the literature.

Speaker 6

Those are very fair answers. Thanks guys.

Speaker 4

Thanks, Johnson.

Operator

Thank you. Next question is from Jeff Jones from Oppenheimer. Your line is now live.

Speaker 5

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

Speaker 6

I guess you had mentioned

Speaker 5

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?

Speaker 2

So our reference here was really focused on the quarterly updates. Having said that, We're definitely expecting to have presentations at the upcoming ASH And other CTAS and other critical meetings. Certainly, the data will be interesting for those conferences and We've got folks that will be presenting, but our reference in this call is really to make sure that people understand. You can count on the fact When we do our quarterly calls, we are going to provide a very thorough clinical update.

Speaker 5

Great. Appreciate that, Wale. And in terms of the MB-one hundred and seven STS LungMet Study, in the patients being dosed at the RP2D, I believe you have 15 patients evaluable. Were there any PRs or CRs or do you anticipate sharing waterfall or

Speaker 2

So Paul, do you want to address this question?

Speaker 3

Yes. Thank you. First, When we say the data are preliminary, that's definitely the case because at the recommended Phase 2 dose, We still have a lot of patients who are ongoing who have not yet had progressive disease. So We have patients who haven't even had their 6 week initial 6 week follow-up scans yet. So these are very preliminary.

Speaker 3

We have not yet Seeing a patient with anything better than stable disease, but considering these are Averaging about 4th line therapy, we are not surprised and we are very pleased just with such Late stage patients to be able to get 67% to 73% of them who have stable disease at the time of the initial Evaluation, especially in light of what the literature shows, would be expected from this patient population.

Speaker 5

Great. Thank you, guys.

Operator

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

Speaker 2

Full conference calls before this, the data is coming in and so 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.

Operator

Thank you. That does conclude today's teleconference and webcast.

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