Full Year 2023 Moleculin Biotech Inc Earnings Call
Operator: Greetings. Welcome to the Molecular in Biotech 2003, year-end conference call and web site. At this time, all participants are in a listen-only mode.
Greetings and welcome to the molecular and biotech 2023 year end conference call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please note that.
Operator: The question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press Star Zero on the telephone keypad. Please note that this conference is being recorded. I would now turn the conference over to Genean Thomas and Best Relations. Thank you. You may begin.
Speaker Change: This conference is being recorded I will now turn the conference over to Ginny and Thomas Investor Relations. Thank you you may begin.
Jenene D. Thomas: Thank you, Darrell, and 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, or future projections. 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 laws and are based on assumptions, while 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 those contemplated by such forward-looking statements are discussed in the periodic reports and molecular files with the Securities and Exchange Commission. These documents are available in the investor section of the company's website and on the Securities and Exchange Commission's website.
Speaker Change: Thank you Daryl and 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 projections. 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 Law.
Speaker Change: And are based on molecular on its 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 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 <unk> files with.
Speaker Change: 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 this webcast released to or is based on studies publications surveys and other data obtained from.
Jenene D. Thomas: Additionally, certain information contained in this webcast release is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it does not independently verify and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or that any independent source of verification has verified any information obtained from third-party sources. Any data discussed regarding clinical trials and progress are considered preliminary and subject to change. Joining us on the call from Moleculine's leadership team are Walter Kemp, Chairman and Chief Executive Officer, Dr. John Paul Waymack, Senior Chief Medical Officer, and Jonathan Foster, Executive Vice President and Chief Financial Officer. I'd now like to turn the call over to Walter Kemp, Chairman and CEO. Wally, please proceed.
Speaker Change: Third party sources and the company's own estimates from research while the company believes these third party sources to be reliable as of the date of this presentation. It 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 information.
Speaker Change: And obtain from third party sourced.
Speaker Change: Any day to discuss regarding clinical trials in progress are considered preliminary and subject to change joining us on the call from molecular and his leadership team are Walter Club, Chairman and Chief Executive Officer, Dr. John Paule, Waymark, Senior Chief Medical Officer, and Jonathan Foster Executive Vice President and Chief Financial Officer, I would now like to turn the call.
Walter V. Klemp: Paul over to Walter Clements, Chairman and CEO Walid. Please proceed.
Walter V. Klemp: Thanks, Danine, and welcome everyone to our year-end recap and pipeline update. We have some very exciting progress to talk about today, and because of that, we will primarily focus on our AML second line strategy and the significant opportunity we believe this represents. As we review the activities of 2023 and the data that we have just now announced, it becomes increasingly clear that animicin, anthracyclines, that is, remain perhaps the most critical component of treatment for AML and STS. For too long, though, the limitations of anthracyclines have prevented a majority of patients from benefiting. Anomycin has changed that, and for the first time ever, we're showing a viable pathway to enable that underserved majority to benefit from answer cycles. It's for this reason that we won't be focusing on the rest of our development pipeline today, other than to say that preclinical work continues to position both our stat three inhibitors and our metabolic inhibitors for continued outside investment that only helps molecular investment. The primary focus of this call and the updates we expect to provide over the coming months is squarely on animicin, and even more specifically, on the treatment of relapse or refractory AML. And for good reasons.
Walter V. Klemp: Thanks, Tony and welcome everyone to our year end recap and pipeline update.
Walter V. Klemp: We have some very exciting progress to talk about today and because of that we will primarily focus on our AML second line strategy.
Walter V. Klemp: And the significant opportunity we believe this represents.
Walter V. Klemp: As we review the activities of 2023 and the data that we are just now announcing.
Walter V. Klemp: It becomes increasingly clear that Ana Meissen anthracycline that has.
Walter V. Klemp: Remained perhaps the most critical component of treatment for AML and STS.
For too long, though the limitations of Anthracycline have prevented a majority of patients from benefiting.
Walter V. Klemp: And then my son has changed that and for the first time ever.
Walter V. Klemp: We're showing a viable pathway to enable that underserved majority.
Walter V. Klemp: To benefit from Anthracycline.
Walter V. Klemp: For this reason that we won't be focusing on the rest of our development pipeline today other than to say that preclinical work continues to position both our statutory inhibitors and our metabolic inhibitors for continued outside investments that only helps molecular and investors.
Walter V. Klemp: The primary focus of this call and the updates we expect to provide over the coming months are squarely on animation.
Walter V. Klemp: And even more specifically on the treatment of relapsed or refractory AML.
And for good reason.
Walter V. Klemp: A lot of small biotechs would give anything to have the data we just announced. Anomycin was able to generate a 60% CRC rate in second-line patients, and that includes a 50% CR rate in combination with another 10% CRI. A conservative estimate says that anamicin should be able to more than double the number of patients achieving complete remission as compared with all of the approved targeted therapies combined. Now, this is possible in part because of anamicin's complete lack of cardio toxicity.
Walter V. Klemp: A lot of small biotech frankly would give anything to have the data we just announced.
Walter V. Klemp: <unk> was able to generate a 60% CRC rate in second line patients and that includes a 50% CR rate in combination with another 10% Cri.
Walter V. Klemp: Our conservative estimate says that <unk> should be able to more than double the number of patients achieving complete remission.
Walter V. Klemp: As compared with all of the approved targeted therapies combined.
Walter V. Klemp: This was possible in part because of animations complete lack of cardio toxicity, we've treated 82 subjects, so far across multiple studies and have yet to see any indication of cardio toxicity.
Walter V. Klemp: We've treated 82 subjects so far across multiple studies and have yet to see any indication of cardiotoxicity. What is important here is that all of this puts us on course to begin a pivotal registration study this year with the potential for securing an accelerated approval pathway from regulation. Look, this is a fundamentally different company than most of you on this call invested in, candidly even compared with just a few short months ago.
Walter V. Klemp: And what's what is important here is it all of this puts us on course to begin a pivotal registration study this year with the potential for securing an accelerated approval pathway from regulators.
Walter V. Klemp: Look this is a fundamentally different company than most of you on this call invested in candidly, even compared with just a few short months ago.
We are now phase III ready.
Walter V. Klemp: We are now phase three ready. We have data that outperforms every asset approved in AML in a space where lesser assets have sold for billions, and we have established what we believe is a pathway to approval. Anomycin is a remarkable next-generation treatment. Its lack of cardiotoxicity combined with its greater potency and lack of cross-resistance with currently prescribed anthracyclines truly puts it in a class by itself.
Walter V. Klemp: We have data that outperforms every asset approved in AML.
Walter V. Klemp: In a space, where lesser assets have sold for billions.
Walter V. Klemp: And we have established what we believe is a pathway to approval.
Walter V. Klemp: And then my son is a remarkable next generation treatment, it's lack of cardio toxicity combined with its greater potency and lack of cross resistance with currently prescribed anthracycline.
Walter V. Klemp: Truly puts it in a class by itself.
Walter V. Klemp: And while this is true for a wide range of potential indications, it's especially meaningful in AML. The AML treatment landscape is complicated, and it's easy to lose sight of just how big the unmet need remains. We estimate that currently, in the U.S.
Walter V. Klemp: And while this is true for a wide range of potential indications, it's especially meaningful in AML.
Walter V. Klemp: The AML treatment landscape is complicated and it's easy to lose sight of just how big the unmet need remains.
Walter V. Klemp: We estimate that currently in the U S. Almost 60% of AML patients remain without a viable treatment option that could cure their disease will provide lasting where mission and that's despite all of the recent advances.
Walter V. Klemp: Almost 60% of AML patients remain without a viable treatment option that could cure their disease or provide lasting remission. And that's despite all of the recent advances in targeted therapies. While we don't have time to explore this in detail today, it's very important for investors to understand why and how significant the unmet need still is. This is so important, in fact, that we produced a short video taking you through this analysis. The link to that video is shown here, and it's also on the landing page of our website.
Walter V. Klemp: <unk> targeted therapies.
Walter V. Klemp: While we don't have time to explore this in detail today, it's very important for investors to understand why and how significant the unmet need still is.
Walter V. Klemp: This is so in four important in fact that we produced a short video taking you through this analysis.
Walter V. Klemp: The link to that video is shown here and it's also right on the landing page of our website.
Walter V. Klemp: If you are currently in investor or considering investment.
Walter V. Klemp: If you are currently an investor or considering investment in molecular, you owe it to yourself to watch this short six-minute video. And because the Unmet Need is so great, a lot of recent new drug approvals have been allowed on the basis of some pretty low performance numbers. Of the five targeted therapies that have been approved, they've done so on the basis of an average 21% CR rate. What we just announced is more than double that number. But the difference is even greater than that. The average 21% CR rate only applies to the few patients that happen to have the required targeted gene mutation, and that leaves 53% of AML patients out in the cold. In comparison, we've been treating all comers with animaicin, regardless of gene mutation or prior therapy.
Walter V. Klemp: In molecular you owe it to yourself to watch this short six minute video.
Walter V. Klemp: And because the unmet need is so great a lot of recent new drug approvals have been allowed on the basis of some pretty low performance numbers.
Walter V. Klemp: Of the five targeted therapies that have been approved.
Walter V. Klemp: They've done so on the basis of an average 21% CR rate.
Walter V. Klemp: Well, what we just announced is more than double that number.
But the difference is even greater than that.
Walter V. Klemp: The average 21% CR rate only applies to the few patients that have that happen to have the required targeted gene mutation and that at least 53% of AML patients out in the cold.
Walter V. Klemp: In comparison, we have been treating all comers with animals, regardless of gene mutation where prior therapy.
Walter V. Klemp: And this is where animison really shines compared with all of the currently approved second-line therapy. The orange bars on this chart show the CR rates documented for each existing therapy. The blue bars weight those CR rates for the actual percentage of AML patients that can benefit because they happen to have the required gene mutation. And when you add them all together, it reveals that only 13% of all second-line patients will achieve a CR as a result of current targeted therapy. But since anamicin is an all-comers drug, there's no reduction from waiting.
Walter V. Klemp: And this is where and when.
Walter V. Klemp: Really shines compared with all of the currently approved second line therapies.
Walter V. Klemp: The Orange bars on this chart shows the CR rates documented for each existing therapy.
Walter V. Klemp: The blue bars wait those CR rates for the actual percentage of AML patients that can benefit because they happen to have the required gene mutation.
Walter V. Klemp: And when you add them altogether it.
Walter V. Klemp: It reveals that only 13% of all second line patients will achieve a CR as a result of current targeted therapies.
Walter V. Klemp: But since Ana My son is an all comers drug.
Walter V. Klemp: There is no reduction from waiting.
Walter V. Klemp: Instead, 100% of the CR rate should be expected for all second-line patients, and that means our 50% CR rate is multiple times greater than the expected benefit from all targeted therapies combined. And if you're thinking that the relatively low performance bar set by targeted therapies means they don't have much market value, well, think again. In 2021, Servier, a French midfarmac company, paid $2 billion for the combination of IDFA and Tibs
Walter V. Klemp: Instead, 100% of the CR rates should be expected for all second line patients and that means our 50% CR rate is multiple times greater than the expected benefit from all targeted therapies combined.
Walter V. Klemp: And if youre thinking that the relatively low performance bar set by targeted therapies means they don't have much market value well.
Walter V. Klemp: Again.
Walter V. Klemp: In 2021.
Walter V. Klemp: Serbia.
<unk> mid pharma company paid $2 billion for the combination of <unk> and tips solo two.
Walter V. Klemp: Two drugs that together are expected to produce complete responses in just 4% of the entire population of second-line AML patients. We are currently showing a performance from anamycin that is more than 10 times that number. And if you think that's an outlier, consider that our performance numbers in the second line are better than Venetaclax's numbers in first line patients, where you would expect higher performance. Yet, Venetac generates $2 billion a year in revenue on average.
Walter V. Klemp: Two drugs that together are expected to produce complete responses in just 4% of the entire population of second line AML patients.
Walter V. Klemp: We are currently showing our performance for minimizing that is more than 10 times that number.
Walter V. Klemp: And if you think that's an outlier consider that our performance numbers in second line are better than the Nida collapses numbers in first line patients, where you would expect higher performance.
Walter V. Klemp: Yet the needed clacks generates $2 billion a year in revenue for Abbvie.
Walter V. Klemp: And let's not forget that Jazz Pharma paid 1.5 billion for Vixios, where again, we believe our performance numbers are much greater. Any way you look at it, we believe the efficacy numbers we are sharing with you today, support, and eventual exit for molecular shareholders will be measured in billions. And again, this is just AML. As we said before, our preclinical data suggest antimicin should also be beneficial in a wide range of other indications, potentially addressing 10 times as many patients as both AML and STS combined. Keep in mind our opening slide.
Walter V. Klemp: And let's not forget the jazz pharma paid $1 5 billion for VIX Geos, where again, we believe our performance numbers are much greater.
Walter V. Klemp: Any way you look at it we believe the efficacy numbers, we are sharing with you today.
Walter V. Klemp: Support an eventual exit for molecular and shareholders that will be measured in the billions.
Walter V. Klemp: And again this is just a M L.
Walter V. Klemp: As we said before our preclinical data suggests <unk> should also be beneficial in a wide range of other indications potentially addressing 10 times as many patients as both AML and STS combined.
Walter V. Klemp: Now keep in mind, our opening slide.
John Paul Waymack: Anthrocycling remains a cornerstone of chemotherapy in many of the worst cancers, and an anthracycling that has demonstrated a lack of cardio toxicity could be a game changer for these cancers, especially in children, where the current anthracilines may cure their disease only to limit their lives because of the damage done to their hearts. With that as an overview, let me now hand the call over to Dr. Paul Weymack, our senior chief medical officer, to dive a bit deeper into the data. Paul?
Walter V. Klemp: Anthracycline remain a cornerstone of chemotherapy in many of the worst cancers.
Walter V. Klemp: And in Anthracycline does has demonstrated a lack of cardio toxicity could be a game changer for these cancers, especially in children.
Walter V. Klemp: The current Anthracycline may cure the disease only to limit their lives because of the damage done to their hearts.
Walter V. Klemp: Yeah.
Dr. Paul: With that as an overview, let me now hand, the call over to Dr. Paul way Mac, our senior Chief Medical officer to dive a bit deeper into the data Paul.
John Paul Waymack: Thank you, Wally. The next slide summarizes three clinical trials we have conducted in patients with AML. In our MB 104 clinical study, we dosed six patients with animicin at either 100 or 120 milligrams per meter square. The reason for the low dose was FDA's concern about possible cardio toxicity. However, we identified no cardiotoxicity in the study, but we did achieve one CRA despite the extremely low dose of animis.
Paul Mac: Oh. Thank you on the next slide summarizes the three clinical trials, we have conducted in patients with AML.
Paul Mac: And our MB 104 clinical study.
Paul Mac: Those six patients with animals, some either 100 or 120 milligrams per meter square.
Dr. Paul: The reason for the low dosing was FDA is concerned about possible cardio toxicity.
Dr. Paul: However, we identified no cardio toxicity in the study.
Dr. Paul: But we did achieve one cri, despite the extremely low dose of animals.
John Paul Waymack: Our next clinical trial, MB 105, treated refractory and relapsed AML patients who had an average of four prior treatment regimen They were treated with animicin as monotherapy in the study, in cohorts with dosages ranging from 120, 240 milligrams per meter square. Of note, at the 240 milligram per meter square dosing cohort, Three of the five patients treated met the criteria for CRs or CRI, and we identified no cardio toxicity in this study, and we did not reach dose limiting toxicity However, In light of the efficacy scene with the 240 milligram per meter square dosing regimen, plus efficacy we had seen in our animal studies, when animicin was combined with cyterabine, We elected to stop dose escalation and to proceed to our current trial, which would combine anamycin with sitarabine.
Dr. Paul: Our next clinical trial M B 105.
Dr. Paul: Treated refractory relapsed AML patients, who had an average of four prior treatment regimens.
Dr. Paul: Treated with minimize them as monotherapy in the study and cohorts with dosages ranging from 120.
Dr. Paul: The 240 milligrams per meter square.
Dr. Paul: Of note.
Dr. Paul: The 240 milligram per meter square dose in cohort three.
Dr. Paul: Three of the five patients treated.
Dr. Paul: The criteria for Crs, where see our eyes.
Dr. Paul: And we identified no cardio toxicity in this study and.
Dr. Paul: And we did not reached dose limiting toxicities.
Dr. Paul: However.
Dr. Paul: In light of the efficacy seen with the 240 milligram per meter squared dosing regimen.
Dr. Paul: Plus efficacy we have seen in our animal studies and animation was combined with cytarabine.
We elected to stop dose escalation.
Dr. Paul: Proceed to our current trial.
Dr. Paul: Which would combine animals some with cytarabine.
John Paul Waymack: Our combination animicin plus Citerabine clinical trial, MB106, has now enrolled 20 patients. This includes three patients for whom this is first line therapy, 10 patients for whom it is second line therapy, and seven patients for whom it is third line or beyond. Among all patients enrolled in the study, 18 are now available for efficacy. Among these are valuable patients, the rates of CRC, that is combined CR plus CRI, are 39%. But the remaining two patients, one only began treatment last week and thus should not be undergoing bone marrow efficacy evaluations for at least two more weeks, and the other has a bone marrow with very little post-chemotherapy repopulation of the marrow to be currently available. He is currently being evaluated for possible bone marrow transplantation.
Dr. Paul: A combination of <unk> plus cytarabine clinical trial that is M. B 106.
Dr. Paul: Has now enrolled 20 patients.
Dr. Paul: This includes three patients for whom this is first one.
Dr. Paul: 10 patients for whom as a second line therapy.
Dr. Paul: And seven patients for whom it is third line or beyond.
Dr. Paul: Among all patients enrolled in the study 18 are now evaluable for efficacy among these evaluable patients.
Dr. Paul: The rigs the CR C that is combined CR plus cri is 39%.
Dr. Paul: But the remaining two patients one only began treatment last week.
Dr. Paul: This should not be undergoing bone marrow efficacy evaluations for at least two more weeks and the other has a bone marrow with too little post chemotherapy repopulation of the marrow.
Dr. Paul: To be currently Evaluable books.
Dr. Paul: He is currently being evaluated for possible bone marrow transplantation.
John Paul Waymack: And we also have an 11% PR rate in this population. But most importantly, among patients for whom combination therapy is used as second-line therapy, the CRC rate is 60%, and the PR rate is 10%.
Dr. Paul: And we also have an 11% CR rate in this population.
Dr. Paul: But most importantly.
Among patients for whom combination therapy is used a second line therapy.
Dr. Paul: The CRC rate is 60%.
Dr. Paul: In the PR rate was 10%.
John Paul Waymack: The next slide describes all the patients who achieved a CR or CR to date in our MB 106 study. As you can see, six of the seven patients received anomycin as second-line therapy since we don't count maintenance therapy as a second-line therapy. You will also note that we have one death from pneumonia, which occurred in the CRI patient. This unfortunate case occurred at a site where they did not follow the accepted standards of care for antimicrobial prophylactic therapy in leukemia patients.
Dr. Paul: The next slide describes all the patients who achieved a CR or cri to date and RMB 106 study.
Dr. Paul: As you can see six of the seven patients received minimize some a second line therapy.
Dr. Paul: We don't count on maintenance therapy, as a second line therapy.
Dr. Paul: You will also notice that we have wonder from pneumonia, which occurred in the cri patients.
This unfortunate case occurred at a site, where they did not probably be accepted standards of care for anti microbial prophylactic therapy and.
Dr. Paul: In leukemia patients.
John Paul Waymack: As soon as we identified this problem, the site was informed of this issue, and they are now utilizing the standard of care set by the Leukemia Medical Society. I would next like to discuss the cardio toxicity issue with anthracilings in more detail. The FDA has set limits for the total amount of anthracyclines that a patient may receive over a lifetime. This ranges from 450 to 550 milligrams per meter square, depending upon the anthracycline utilized.
Dr. Paul: As soon as we identified this problem. The site was informed of this issue and they are now utilizing the standard of care.
Dr. Paul: <unk> leukemia medical societies.
Dr. Paul: I would next like to discuss the cardio toxicity issue with Anthracycline is in more detail.
Dr. Paul: The FDA has set limits for the total amount of Anthracycline that a patient may receive over a lifetime.
Dr. Paul: This ranges from 450 to 550 milligrams per meter square.
Dr. Paul: Depending upon the Anthracycline utilized.
John Paul Waymack: As you can see from the slide, among patients who reach this level, the risk of any cardiac event is 65%, and the risk of developing heart failure, That is, the heart's pumping ability being significantly impaired, is 3.8%. Among patients who receive from 600 to 850 milligrams per meter square, the risk of any cardiac event rises to 100%, and the risk of developing heart failure is 8.3%. Because of these cardiac problems with other anticyclines, we have serially monitored multiple parameters of cardiac function in all patients, in all of our anthracycline enomycin clinical trials. This included serial EKG. Proponin concentrations
Dr. Paul: As you can see from the slide.
Dr. Paul: Patients who reached this level the risk of any cardiac event is 65%.
Dr. Paul: And the risk of developing heart failure.
Dr. Paul: That is the heart's pumping ability being significantly impaired is.
Dr. Paul: This three 8%.
Dr. Paul: Among patients who received from 600 to 850 milligrams per meter square.
Dr. Paul: The risk of any cardiac event rises to 100%.
Dr. Paul: And the risk of developing heart failure is eight 3%.
Dr. Paul: Because of these cardiac problems with other into cycling, we have serially monitored multiple parameters of cardiac function in all patients.
Dr. Paul: All of our Anthracycline <unk> clinical trials.
Dr. Paul: This has included cereal ekg's.
Dr. Paul: Broken on concentrations and trucks.
John Paul Waymack: Troponins is a blood marker for acute cardiac toxicities, and ejection fractions, which is a measure of how efficiently the heart is pumping blood. These data have been reviewed by an independent cardiologist with expertise in the field of drug-induced cardiotoxicity. To date, he has found no evidence of any cardiotoxicity in any of the patients treated with animis.
Dr. Paul: <unk> are a blood marker for acute cardiac toxicities.
Dr. Paul: And ejection fractions, which is a measure of how efficiently the hardest pumping blood.
Dr. Paul: These data have been reviewed by an independent cardiologist with expertise in the field of drug induced cardio toxicity.
Dr. Paul: To date he.
Dr. Paul: As found no evidence of any cardio toxicity.
Dr. Paul: Any of the patients treated with animation.
John Paul Waymack: Finally, I would like to move on briefly to discuss our soft tissue sarcoma data. Our MB107 study is a dose escalation study in patients with soft tissue sarcoma who have pulmonary metastases in patients who have had at least one prior therapy. We finished enrollment in this study some time ago, but we are continuing to follow these patients since most of them are still alive. As you can see in the column on the far right, among patients treated using the dosing regimen of 330 milligrams per meter square or less, which we believe will be our dosing regimen for any pivotal trial, and who had one or two prior therapies, our median progression-free survival is now over three months. We have not yet reached our median overall survival since the majority of the patients who were treated are still alive. We will continue to follow these patients until we reach our median overall survival. Thank you, and I will now turn the presentation over to John. Thanks, Paul. We ended the year with roughly $24 million in cash on hand, sufficient to take us into the fourth quarter of this year.
Dr. Paul: Finally, I would like to move on briefly to discuss our soft tissue sarcoma data.
Dr. Paul: R. M. B 107 study is a dose escalation study.
Dr. Paul: And patients with soft tissue sarcoma with pulmonary.
Dr. Paul: Metastasis in patients who have had at least one prior therapy.
Dr. Paul: We finished enrollment in this study some time ago. However.
Dr. Paul: We are continuing to follow these patients since most of them are still alive.
Dr. Paul: As you can see on the column on the far right.
Among patients treated using the dosing regimen of 330 milligrams per meter square or less which.
Dr. Paul: Which we believe will be our dosing regimen for any pivotal trial.
And you had one or two prior therapies.
Dr. Paul: Median progression free survival is now over three months.
Dr. Paul: And.
Dr. Paul: We have not yet reached our median overall survival.
Dr. Paul: The majority of the patients who were treated are still alive.
Dr. Paul: We will continue to follow these patients until we reach our median overall survival.
Thank you and I will now turn the presentation over to John.
John Paul Waymack: Thanks, Paul.
John Paul Waymack: We ended the year with roughly $24 million in cash on hand sufficient to take us into the fourth quarter of this year.
Jonathan P. Foster: Keep in mind that this takes into account significant cash outlay, specifically in Q3, NQ4, for preparation to commence our AML pivotal registration study, which Paul and Wally have just discussed. On a post-split basis, our market cap as of mid-March was roughly $20,22 million with a weekly average trading volume of 55,000 shares, with approximately 2.2 million shares outstanding, including pre-funded warrants, that number increases to 2.4 million. Regarding the reverse flip, Given our clinical and regulatory progress, it is critical that we meet the minimum $1 bid price to keep our NASDA, as we wholeheartedly. We believe all such housekeeping items need to be in order as we prepare for a transformation into a pivotal stage development. We continue to monitor the short positions by brokers, and we have reached out to one broker notifying them that with such shorting and bound, a significant portion of our daily trading volume is shorted. We believe we have the opportunity to successfully break this trading pattern with our progress in animicin as we move forward in 2024. As you can see, 2024 is set to be a very exciting year from the Lexington.
John Paul Waymack: Keep in mind that this takes into account significant cash outlay, specifically in Q3 and Q4 for preparations to commence our AML pivotal registration study, which Paul and Wally.
John Paul Waymack: As discussed.
John Paul Waymack: On a post split basis, our market cap as of mid March with roughly 2000 $22 million with a weekly average trading volume of 55000 shares with approximately $2 2 million shares outstanding.
John Paul Waymack: Including pre funded warrants that number increases to two 4 million shares.
John Paul Waymack: Regarding the reverse split.
John Paul Waymack: Given our clinical and regulatory progress it is critical we.
John Paul Waymack: Meet the minimum $1 bid price to keep our NASDAQ.
John Paul Waymack: As we are wholeheartedly.
John Paul Waymack: Believe all such housekeeping items need to be in order as we prepare for our transformation into a pivotal stage development company.
John Paul Waymack: We continue to monitor the short positions by brokers and we have reached out to one broker notifying them of shorting imbalances.
A significant portion of our daily trading volume of shorting.
We believe we have the opportunity to successfully break this trading pattern with our progress in animation as we move forward in 2024.
John Paul Waymack: As you can see 2024 and shaping up to be a very exciting year from elektron.
Jonathan P. Foster: As Wally and Paul have just discussed, we're moving forward in our clinical progress with Anamitin in 2024 with the following plan, completing the MB106 AML trial with first and third line subjects and concluding the study, taking the second line data that Paul just discussed, and holding the end of Phase II meeting with the regulatory bodies here in the U.S. and in Europe, taking next feedback and initiating a pivotal study with anemycin With FTS, we're looking to close out the current trial, as Paul just mentioned, and then moving forward with an investigator-led and funded trial. As we have concluded, 2023, our year of data, we look forward to moving molecular biology into a pivotal study during 2024. Wally?
John Paul Waymack: As Wally and Paul have just discussed we're moving forward in our clinical progress with animates and in 2024 the following plan.
Completing the <unk> 106, AML trial with first and third line subjects and concluding the study.
John Paul Waymack: Taking the second line data that Paul just discussed and holding the end of phase II meeting with the regulatory bodies here in the U S and in Europe.
John Paul Waymack: Taking that feedback and initiating a pivotal study with animation on AML.
John Paul Waymack: With Fts, we're looking to close out the current trial as Paul just mentioned and then moving forward with an investigator led and funded trial.
As we have concluded 2023, our year of data.
John Paul Waymack: We look forward to moving in molecular <unk> into a pivotal study during 2024.
John Paul Waymack: Wally.
Walter V. Klemp: Thanks, John. Well, I'd like to close with where I began today, with the observation that the most important cancer therapy for both AML and STS continues to be anthracycling. And we are now providing data showing that animicin has the potential to finally bring the benefit of anthracyclines to a majority of these patients. As a bottom line summary, we are now ready for phase three. We have data that outperforms every asset approved in AML, and we're in a space where lesser assets recently sold for $2 billion. And we have what we believe is an established pathway to approval. In our view, the gap between these realities and where our market cap is today can no longer be justified.
Wally: Thanks, John.
Wally: Well I'd like to close with where I began today's presentation.
Wally: With the observation that the most important cancer therapy for both AML and STS.
Wally: <unk> to be an anthracycline.
Wally: And we are now providing the data showing that <unk> has the potential to finally bring the benefit of Anthracycline <unk> to a majority of these patients.
As the bottom line summary.
Wally: We are now phase III ready.
Wally: We have data that outperforms every asset approved in AML.
Wally: And we're in a space, where lesser assets recently sold for $2 billion.
Wally: And we have what we believe is an established pathway to approval.
Speaker Change: In our view.
Speaker Change: The gap between these realities and where our market cap is today.
Speaker Change: Can no longer be justified.
Walter V. Klemp: We believe once the market awakens to this new reality, a more appropriate trading range will be established. And this isn't just talk. I've been investing my own after-tax dollars in molecular and stock because of my belief in what I'm saying. In fact, I've personally invested over $300,000 over the last 16 months.
Speaker Change: We believe once the market awakens to this new reality.
Speaker Change: A more appropriate trading range will be established.
Speaker Change: And this isn't just talk.
Speaker Change: I've been investing my own after tax dollars and molecular stock because of my belief in what I'm, saying.
Speaker Change: In fact, I've personally invested over $300000 over the last 16 months and the rest of our management team has been investing right alongside me.
Walter V. Klemp: And the rest of our management team has been investing right alongside. We are believers, and we are committed to making this a success. From here, you can expect several things from us in the near future. One is the formation of a larger and more focused science advisory board to help guide our pathway to new drug approval. We've now shared this data with some of the most recognized and respected key opinion leaders in the global AML community. In every case,
Speaker Change: We are believers.
Speaker Change: We are committed to making this a success.
Speaker Change: From here.
Speaker Change: You can expect several things from us in the near future.
Speaker Change: One is the formation of a larger and more focused science Advisory Board to help guide our pathway to new drug approval.
Speaker Change: We've now shared this data.
Speaker Change: With some of the most recognized and respected key opinion leaders in the global AML community.
Speaker Change: In every case they have agreed with our assessment that there is a significant unmet need.
Walter V. Klemp: They have agreed with our assessment that there is a significant unmet need, that our efficacy numbers, if we produce them in our pivotal trial, should support new drug approval, and that they would use animicin in their practice once approved. We'll be announcing SAB appointments in the coming weeks, and I'm confident you will be impressed with their world-class credentials. Another is a formal presentation of the final data at a prestigious conference, which we expect to be announcing soon. Also, we continue to make progress in establishing the market exclusivity of animicin, and we hope to release news on that subject as well. And finally, we are preparing to meet with FDA to discuss this data and establish a concrete approval pathway for animicin that we hope to announce this summer. Until then, I encourage everyone to dig into our data. Look, until now, there has been far too much speculation and not enough facts. That has changed with our most recent analysis. We could not be more proud of what we have accomplished, and we could not be more excited for what is about to unfold.
Speaker Change: That our efficacy numbers, if we produced in our pivotal trial should support new drug approval.
Speaker Change: And that they would use <unk> in their practice once approved.
We'll be announcing the appointments in the coming weeks and I am confident you will be impressed with their world class credentials.
Speaker Change: Another is a formal presentation of the final data at a prestigious conference, which we expect to be announcing soon.
Speaker Change: Also we continue to make progress in establishing the market exclusivity Havana mindset and hope to release news on that subject as well.
And finally, we are preparing to meet with FDA to discuss this data and establish a concrete approvals for APA.
Speaker Change: Approval pathway for animation that we hope to announce this summer.
Speaker Change: Until then I encourage everyone to dig into our data.
Speaker Change: Until now there has been far too much speculation and not enough facts.
Speaker Change: That changed.
Speaker Change: With our most recent announcement.
Speaker Change: We could not be more proud of what we've accomplished and we couldnt be more excited for what is about to unfold. Thank.
Operator: Thank you very much. Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question Q. You may press star 2 if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing start.
Speaker Change: Thank you very much.
Speaker Change: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: Press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment. Please while we poll for your questions.
Operator: One moment, please, while we poll for your questions. Our first questions come from the line of Jonathan Ashall with Roth MKM. Please proceed with your questions. Thank you, guys. Good morning, and congratulations on the progress for sure.
Speaker Change: Our first questions come from the line of Jonathan Aschoff with Roth. Please proceed with your questions.
Jonathan Matthew Aschoff: Thank you guys good morning, and congrats on the progress for sure.
Jonathan Matthew Aschoff: What's the final patient number for first-line patients in this new phase two cohort, and what do you need to see in that population to make the decision to go forward with a pivotal first-line trial? Let me clarify because we think our, let's say, our first pivotal registration trial, the trial will use for new drug approval, will be on second-line patients, not first-line patients. Oh, for sure.
Jonathan Matthew Aschoff: We know what's the final patient number for first line patients in this new phase II cohort and what do you need to see in that population to make the decision to go forward with a pivotal first line trial.
Speaker Change: Let me, let me clarify because we.
Speaker Change: We think our let's say our firm.
Speaker Change: First pivotal registration trial, the trial will use for new drug approval will be on second line patients not first line patients Oh for sure.
Walter V. Klemp: But then the phase three that you're talking about. So you're talking about the phase three concern board. So you're talking about the phase three confirmatory trial for you. Right, right, right. So Paul, let me see the phase two first line patients make that decision to go forward with that trial. Exactly. Let me, let me hand that Paul over to you.
Speaker Change: Phase three that you're talking about what you are talking about the phase III confirmed board.
Speaker Change: So youre talking about their phase III confirmatory right right right.
Speaker Change: The phase III first line patients to make that decision and go forward with that trial.
Speaker Change: Exactly that's let me, let me handle the Paul over to you.
John Paul Waymack: You're closest to all those numbers. Yes, as Wally mentioned, we anticipate we're going to the FDA with second-line therapy as their initial indication. We would, however, perform a first-line study to get an additional indication, that would come after our initial approval for second line. We would anticipate the first line would be a randomized trial compared to probably a different anthracycling to show that we are at least non-inferior and potentially superior. However, as far as they can remember those patient numbers, we would, The patient numbers would be dependent upon the data we get as our current, or 106 trial is finished. As was mentioned, 106 is completed for second line, but we have only enrolled three first-line patients to date. We're continuing to enroll them.
Speaker Change: You are close to all of those numbers.
Speaker Change: Yes.
Speaker Change: As Wally mentioned, we anticipate.
Speaker Change: Going to the FDA with.
Speaker Change: With second line therapy as their initial indication.
Speaker Change: We would however perform a first line study to get an additional indication.
Speaker Change: That would be coming after our initial approval for second line.
Speaker Change: Excuse me.
Speaker Change: We would anticipate first line would be.
Speaker Change: A randomized trial.
Speaker Change: Compared to probably a different anthracycline.
Speaker Change: So that we are at least non inferior and potentially superior.
Speaker Change: However, as far as drivers.
Speaker Change: The patient numbers would be dependent upon the data we get as our current one of those six trial is finished.
Speaker Change: As was mentioned 106 is completed for second line.
Speaker Change: Only enrolled three first line patients today, we're continuing to enroll them and when we get the numbers from all the pay first line patients and 106.
John Paul Waymack: And when we get the numbers from all the first-line patients in 106, that will be compared to the literature, and that will allow us to do power factor calculations for the number of patients required for a pivotal trial while comparing us to, say, Danna Rubin. Okay, so how many, let's break it down. How many first-line patients do you intend to enroll in 106? in the phase two portion. We are currently at three. It will be driven by data. If we get very good results quickly, there would be no need to go further. I can see us stopping at six or seven or going further. Right now, we only have two available, one of CR and one who has progressive disease. The third one was those last week.
Speaker Change: That would be compared to the literature and that would allow us to do perfect calculations for the number of patients required for a pivotal trial comparing us to say again Aruba.
Speaker Change: Okay. So how many let's break it down how many first line patients you intend to enroll in 106.
Speaker Change: In the phase II portion.
Speaker Change: We are currently a three it will be driven by the data if we get very good results quickly.
Speaker Change: There'll be no need to go further.
Speaker Change: Staffing is six or seven or going further.
Speaker Change: Right now we only have two evaluable, one SCR and one who had progressive disease third one was dose last week.
John Paul Waymack: But we will just have to watch the data as they come in. Okay, then what's the efficacy bogey? You know, what's the CR, the CR bogey that you're looking for to say, yes, this is a contender, worthy of running a phase three trial on just the first line page? Um, it would probably be in the 40% range, around 40%.
Speaker Change: We will just have to once the data as they come in.
Speaker Change: Okay, then whats the efficacy both you know what.
Speaker Change: We are the CR bogey that you are looking for to say, yes. This is contender worthy of running a phase III trial and just first line patients.
Speaker Change:
Speaker Change: It would probably be in the 40% range around 40%.
John Paul Waymack: Okay, and certainly, if you don't do this trial, you must do a confirmatory trial in second line, yes? It depends on how the meeting with FDA goes. If we are allowed to do a single-arm study under accelerated approval, then we would need a confirmatory trial. However, if we are required to do a randomized trial as their second-line therapy study, then a confirmatory trial might not be required. That's one reason why we plan to go and meet with the FDA sometime by the beginning of summer. Thank you. That was helpful. You know, why not just use the first line anyway?
Speaker Change: Okay and certainly if you don't do this trial you must do a confirmatory in second line yes.
Speaker Change: But it depends on how the meeting with FDA goes if we are allowed to do a single arm study.
Speaker Change: Under accelerated approval, then we would need a confirmatory trial. If we are required to do a randomized trial.
Speaker Change: Our second line therapy study than a confirmatory trial might not be required.
Speaker Change: One reason why we plan to meet with the FDA.
Sometime.
Speaker Change: By the beginning of summer.
Speaker Change: Thank you that was helpful.
Speaker Change: Why not just first line anyway, because this drug looks obviously say for it certainly it looks no less effective and it's not some novel agent that docs have to get their mind around to wonder whats out and do my patient I mean so.
Walter V. Klemp: Because, you know, this drug looks obviously safer. It certainly looks no less effective. And it's not some novel agent that docs have to get their minds around to wonder, you know, what it's going to do for my patient. I mean, so, you know, why not a push in first line now?
Speaker Change: Why not a push in first line now.
John Paul Waymack: Well, that's a good question, and the reason is regulatory time to approval. If we go to first line, there are a number of drugs approved for first line. The FDA has a different standard than for second line. Whereas, as Wally mentioned, right now, most patients needing second line therapy don't have any options that are good. They don't have any approved options.
Speaker Change: That's a good question and the reason is regulatory time to approval. If we go in first line. There are a number of drugs approved for first line. The FDA is a different standard than for second line, whereas Wally mentioned right now most patients with leading second line therapy. They don't have any options that are good they don't have any approved options.
John Paul Waymack: The five drugs approved are for a minority of patients. So there is this unmet medical need out there, which is why the FDA cuts a different standard, which is why, as Wally mentioned, FDA approval of those five drugs on will be considered limited data. And that's why we're going here first, because the amount of data that would be required and data means the number of patients in time will be far less than first-line therapy. And we're eager to get this thing to market as soon as possible, and thus take the second line of their initial indication, and then move on to the first line to broaden the market share. It's really about managing costs, time, and risk, right? If we were, look, if we were Pfizer, we probably would do exactly as you're describing, right? But we're not.
Speaker Change: The five drugs approved or for a minority of patients. So there is this unmet medical need.
Speaker Change: Out there, which is why the FDA cuts a different standard which is why it is wildly mentioned.
Speaker Change: They approve those five drugs on will be considered limited data.
Speaker Change: And that's why we're going here first because the amount of data that would be required and data means the number of patients in time will be far less in first line therapy, and we are eager to get this thing to market as soon as possible and just take the second line as our initial indication and then move on to first line to broaden the market share.
Speaker Change: This is Jonathan it's really about managing it's really about managing cost time and risk right.
Speaker Change: If we look if we were Pfizer, we probably would do exactly as you're describing right, but we're not and so this what Paul just described is is a dramatic if we get what we want with FDA is a dramatic reduction in the number of patients and therefore the time it takes.
Walter V. Klemp: And so this, what Paul's just described is a dramatic, if we get what we want with FDA, is a dramatic reduction in the number of patients and, therefore, the time it takes and the cost it takes. Okay, and so is it fair to say that the STS trial, I believe you had said, is kind of now in that basket along with the lung mets from TNBC and RCC and, you know, the liver mets from pancreatic cancer? It's upon external help, we'll carry that forward, and we're going to focus on AML. That's the message I got. That's a reasonable takeaway.
Speaker Change: And cost it takes risk out there okay.
Speaker Change: Okay, and so is it fair to say that the the STS trial I believe you had said.
Speaker Change: It's kind of now in that basket, along with the you know the lung Mets from key NBC and RCC and the liver Mets from pancreatic cancer, let's say upon external help we'll carry that forward and we're going to focus on AML that that's the message.
Speaker Change: That's a reasonable takeaway and I'll, just give you a little bit of encouragement there.
Walter V. Klemp: And I'll just give you a little bit of encouragement there. The leading sarcoma experts in Europe have looked at this data and basically indicated their strong interest in running a trial they will fund to position anomycin for first-line treatment in soft tissue sarcoma. So there's, you know, a lot of these externally funded trials take a while to get off the ground, but I'm just telling you the momentum appears to be there that they like the numbers, they think it should be positioned for first line, and they want to pay for a trial. That sounds great.
Speaker Change: The leading.
Speaker Change: Arkoma experts in Europe have looked at this data and basically have indicated their strong interest to run.
Speaker Change: A trial they will fund.
Speaker Change: Two to position <unk> for first line treatment in soft tissue sarcoma. So.
Speaker Change: There is.
Speaker Change: A lot of these externally funded trials take a while to get off top that center, but I'm just I'm just telling you the momentum appears to be there that they liked the numbers. They think it should be positioned for first line and they want to pay for a trial.
Speaker Change: That sounds great. Thank you very much guys.
Jonathan Matthew Aschoff: Thank you very much. Yeah, yep. Thank you. Our next question has come from the line of Vernon Bernardino with H.C. Wainwright. Please proceed with your questions. Hey, Vernon. Hi, Wally, hi John, and Dr. Waymack. We haven't met yet.
Speaker Change: Yep.
Speaker Change: Thank you. Our next question is come from the line of Vernon Bernardino with H C. Wainwright. Please proceed with your questions.
Vernon Bernardino: Hey, Brian.
Vernon Bernardino: Hi, Robert Hi, John.
And Dr. Wei Mac, we havent met yet, but congrats to all on the impressive results I apologize I have a cold so.
Vernon Tolentino Bernardino: Congratulations to all on the impressive results. I apologize. I have a cold, like Barry White, but anyway, I do have questions as far as the phase three doses are concerned. They are quite impressive.
Vernon Bernardino: Mike Berry away for them.
Vernon Bernardino: I.
Vernon Bernardino: If you have questions as far as.
Vernon Bernardino: The.
Vernon Bernardino: The phase III dose they are quite impressive.
Vernon Tolentino Bernardino: One thing I was wondering, you have not seen any safety issues so far, and that is fantastic. I was just wondering what, if anything, you could share with the FDA so that they can thoughts regarding that those, because conceivably, you could actually dose higher, and pardon me, I'm not an ecologist, to try to get even more efficacy out of animosity. What are your thoughts there compared to anything you could share as far as feedback from the FDA? Yeah, so Vernon, you're right to ask that question.
Speaker Change: One thing I was wondering.
Speaker Change: You have not seen any.
Speaker Change: Safety issues, so far and that is fantastic I was just wondering.
Speaker Change: What if anything you could share that that yes.
Speaker Change: Any thoughts regarding that those could conceivably you could actually at those higher and.
Speaker Change: Pardon me I'm not an oncologist to.
Speaker Change: To try to get even more efficacy out of.
Speaker Change: Adam I said what are your thoughts there.
Adam: Sure as far as feedback from FDA.
Adam: Yes, so so vernon.
Adam: Right to ask that question look generically speaking, especially as it relates to Anthracycline. The mindset for 40 years has been.
Walter V. Klemp: I mean, look, generically speaking, especially as it relates to anthracilines, the mindset for 40 years has been, you go to the maximum because you're trying to stop this cancer in its tracks, and you're willing to tolerate a lot of patient discomfort and even patient risk for the sake of beating the cancer. But Paul, you and I talk a lot about the optimum dose. And I think Vernon would love to hear what you have to say about the strategy behind it.
Adam: You go to the maximum because youre trying to youre trying to stop this cancer in its tracks and you are willing to tolerate a lot of patient discomfort and even patient risk for the sake of beating the cancer.
Speaker Change: But but Paul you and I've talked a lot about this.
Paul Mac: That's the.
Paul Mac: The optimum dose and.
Speaker Change: I think Bernard would love to hear what you have to say about the strategy behind dosing here.
Walter V. Klemp: doses. Yes, and I agree with both of you. Generally, you keep going up and up and up.
Bernard: Oh, yes.
Speaker Change: And I agree with both of you generally you keep going up and up and up.
John Paul Waymack: The reason we stopped was when we were getting CR rates of 60%, CR plus PR of 70%, and no toxicity. And when, as Wally described, the competition is in the 20% range, you reach the point where you start thinking, well, what more would I achieve at the risk of starting to get significant toxicity? So the clinical team's decision was, look, these results are far beyond what we imagined. As far as efficacy and toxicity are concerned, there is not enough data.
Speaker Change: The reason we stopped.
Speaker Change: Was when we were getting CR rates of 60% CR plus PR of 70%.
Speaker Change: <unk>.
Speaker Change: No toxicity.
Speaker Change: Emlen as wildly describe the competition is in the 20% range you've reached the point, where you start thinking well what more would I achieve at the risk of starting to get significant toxicity.
Speaker Change: Sure.
Clinical teams decision was look these results are far beyond what we imagined.
Speaker Change: As far as efficacy toxicity is not there, let's not try to improve on it or if I can quote an old Virginia thing. When you are writing Secretariat don't get off.
John Paul Waymack: Let's not try to improve on it, or if I can quote an old Virginia saying, when you're writing, secretariat, don't get off. So we got to this 230, 240. The results were really great. And I said, let's not try to go any further. This is working better than we ever imagined.
Speaker Change: So good up to this $232 40, the results were really great.
Speaker Change: And let's not let's not try to go any further this is working more than we ever imagined let's go with this.
John Paul Waymack: Let's go. Confessably, you have this dose go through a phase three trial, and it doesn't prevent you from going to hire those in post-approval. Correct. All right. But again, our number one goal is to get to an NDA as soon as possible and as cheaply as possible. We found what we thought was a safe, effective dose.
Speaker Change: So conceivably you have this dose.
And go through a phase III trial and it doesn't prevent you from going to a higher dose in a post approval trial.
Correct.
Speaker Change: Alright, but again.
Speaker Change: Our number one goal is to get to an NDA as soon as possible and as cheaply as possible. We found what we thought was the safe effective dose, we hope to get confirmation from the FDA.
John Paul Waymack: We hope to get confirmation from the FDA sometime in June or so and then proceed forward. Thank you very much. This is impressive data, and that's really the only question I had.
Speaker Change: On June or so.
Speaker Change: Uh huh.
Speaker Change: Then proceed forward.
Speaker Change: Thank you very much this is impressive data and Thats really the only one question and I. Thank you for taking it.
Vernon Tolentino Bernardino: Thank you for taking the call. There are no further questions at this time. And with that, I would like to close the call out for today. You may disconnect at this time. We appreciate your participation, and I wish you a great day. Thank you, folks. Thank you.
Speaker Change: Thanks Bernie.
Speaker Change: Thank you there are no further questions at this time and with that I would like to close the call out for today you may disconnect. At this time, we appreciate your participation and I wish you a great day.
Speaker Change: Thanks folks.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Okay.
Speaker Change: Yes.