Q3 2022 Aptose Biosciences Inc Earnings Call

Okay.

Okay.

Good afternoon. My name is Angela and I will be your conference operator today I would like to welcome everyone to the App tolls Biosciences conference call third quarter ending September 30th 2022 at this time all participants are in listen mode.

Speakers remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star one on your telephone keypad. If you would like to withdraw your question. Please press the pound key. Thank you as a reminder, this conference call is being <unk>.

Recorded and I would like to take this time to introduce this is Susan.

Pietro Paolo Sousa.

Thank you Sandra and good afternoon, and welcome to the <unk> Biosciences conference call to discuss financial and operational results for the third quarter ended September 32022 earlier today, absolutely issued a press release relating to these financial results news release as well as related SEC filings are acceptable.

This website joining me on today's call are Dr. William G Rice, Chairman, President and CEO , Dr. Raphael de Hart Senior Vice President.

Officer and Mr. Fletcher Payne senior Vice President and Chief Financial Officer.

Before we proceed I would like to remind everyone that certain statements made during this call will include forward looking statements within the meaning of U S and Canadian Securities laws forward looking statements reflect apoptosis current expectations regarding future events. They are not guarantees of performance and it is possible that actual results and performance could differ materially from these stated.

Vacations.

Bob known and unknown risks uncertainties and assumptions that may cause actual results performance and achievement to differ materially from those expressed to learn more about these risks and uncertainties. Please read the risk factors set forth in apoptosis. Most recent annual report on Form 10-K, a D C and SEDAR filings.

All forward looking statements made during this call speak only as of the date, they're made up toast undertakes no obligation to revise or update the statements to reflect events or circumstances. After the date of this call except as required by law I will now turn the call over to Dr. Rice, Chairman, President and CEO of <unk> Biosciences, Dr right.

Thank you Susan I want to welcome everyone to our call for the third quarter ended September 30th 2022.

Let's begin the call by addressing an issue that's on the minds of all of our shareholders.

We're acutely aware that the biotech market has experienced a significant year to date downward trend and similarly, the companys stock has fallen with the tied to trading it shouldn't expect cigna.

Significant lows.

Positive news releases buying about post stockpile management, and other insiders investor presentations and positive meetings with many quality investors have not yielded improved share prices to date.

Ironically, as we presented to fundamental health care investors with domain knowledge. The common viewpoint emerged that our lead clinical candidate ATM four three to three nine are just two or three nine it looks like a real drug that gives complete remissions as a single agent and.

And very challenging AML patients.

And they were surprised that they had been unaware of 239 and its strong clinical activity.

From a drug development perspective, apoptosis by far in the best position and which as its ever been.

Most employee share our sense of purpose to develop safe and potent drugs for patients whose lives are being threatened by acute myeloid leukemia or AML.

We now wrapping up a very successful phase one trial with two or three nine in patients with relapsed or refractory AML.

Performed extensive dose exploration that demonstrated a highly favorable safety profile and that has allowed us to assemble a superior safety package.

We also explored extensive mutational diversity among a male patient populations and this approach revealed a breath of formal responses across a diverse group of very ill and difficult to treat AML patients, including many who already had been treated with and had been filled by the best available therapies.

We continued to see rapid blast reductions and impressive response rates and mutation defined subgroups across three dose levels up to three nine and we look forward to providing the full scope of data from the phase one trial during December at the Ash Conference.

While we continue our outreach to investors to broaden the awareness around the growing to three nine data package.

This trial has delivered everything we had hoped it now is complete and we are moving on to our dose expansion program to explore single agent and combination therapy and enriched AML populations and positioned to three nine for single arm phase two registrational studies with an eye toward accelerated approval.

With regard to the market, we take a calm and long term perspective.

According to Mckinsey article earlier this year biotech stops stocks have taken a major hit and companies without commercial stage assets have been affected most severely the.

The cycle is a familiar one for the sector and with history as our guide. It is a question of when not whether the biotech public market will turn more favorable.

In the meantime, emerging companies like App dose might better whether such headwinds by scrutinizing cash management and financing by continuing recruitment of exceptional talent.

By identifying the best options to achieve planned milestones.

Lately and systematically collecting clinical data and de risking our assets and by determining the appropriate timing and magnitude of data to be released and that's exactly what we've been doing to give app toast and our two assets to three nine and locks the best paths for success within these market conditions.

With that said now I will move to a discussion of our clinical assets and let's start with la accepted or Lux as we call. It.

Afterwards, I will give an overview of 239, perhaps before handing it over to Dr. Bexar for additional information on our clinical plans.

As a quick reminder, looks at the Nib, formerly called CG 806, and now referred to as Lux is our secondary program.

<unk> is a clinical stage oral flit, three and PTK kinase inhibitor that we've had in development for B cell malignancies and AML.

While we observed clear signs of drug activity and clear target engagement of BT Kay and flip III.

The original generation one formulation <unk>.

Pivoted limited absorption and only one patient administered the original formulation was able to achieve exposures of blocks to enable a complete response.

However, we have been developing a new formulation for job for Lux that G. III formulation over several years for more rapid and more efficient absorption.

And for economic reasons to reduce the amount of drug substance to manufacturer.

As we reported in September of this year, the new G. III formulation demonstrated up to an 18 fold improvement in the oral bioavailability relative to the original <unk> formulation when tested as a single dose in patients.

As of today, we've tested G III as a single dose with 10 milligrams 20 milligrams 50 milligrams.

100 milligrams or 200 milligrams and a total of 20 patients and assembled a PK package around the new formulation.

We then amend the protocol of our existing phase one clinical program and submitted it to the FDA to incorporate continuous dosing and dose escalation of G III and the ongoing trial.

And to phase out the original Q1 formulation and we expect to commence continuous dosing of G. Three very soon.

If the G. Three formulation increases steady state exposures and delivers responses. We then have the potential to pursue certain types of cancers inflammation and autoimmunity indications as well as work to identify an appropriate dose development partnership for this very unique molecule.

Now, let me turn to to three nine our lead clinical program.

First I want to note that an official generic name has been established for two or three nine and that name is test pattern nib spelled T U S. P T.

And IV.

Now, let's discuss how <unk> can be applied to the treatment of AML.

As most of you are aware AML is a highly heterogeneous disease characterized by a multitude of genetic and epigenetic alterations just makes the treatment of AML, both diverse and challenging because AML disease and each patient may present with a different set of manifestations.

May be influenced by multiple oncogenic drivers rather than a single genomic alteration.

Several companies are developing investigational drugs directed at specific targets that are operative in a particular segment of the AML population with.

With our lead clinical compound compound patent up we are pleased that it represents a broader scope drug with the potential to treat multiple new tastefully defined populations of patients and they are fought against AML.

Just patented potently does so by targeting a handful of clinically validated kinases essential for key oncogenic signaling and rescue pathways that contribute to drug resistance or recurring disease.

Yet tests patented successfully avoids other kinase often associated with toxicities indeed.

Indeed, testbed nib already has demonstrated clinical responses with compelling response rates and multiple new tastefully defined target populations are relapsed or refractory AML patients, both with and without flit three mutations and Testbed Nib has achieved these clinical responses at doses with no drug related <unk>.

No drug related deaths, no drug related Q T C signals and no differentiation syndrome.

Happy to report that we have successfully completed the dose escalation and dose exploration stages of our <unk> phase one trial and have treated approximately 60 relapsed or refractory AML patients previously treated with multiple agents, including chemotherapy Bcl two inhibitors <unk>, leading agents flit three inhibitor.

And other targeted agents.

Rather than trying to run up the score in one specific AML subpopulation, we explored the activity of <unk> and our breadth of relapsed and refractory AML patients with extensive mutational diversity and once daily oral <unk> delivered for these patients formal responses and several mute.

Mutational defined populations are difficult to treat patients some of which were entirely unanticipated and would not have been identified if we had performed a more narrowly focused clinical program <unk>.

Simply the trial yielded everything you could ask for in a phase one trial, including impressive impressive response data that guide us.

To pursue several new tastefully defined patient populations.

Anne Hardy safety package that allows us to select our doses for the next stage of development.

The proven breadth of activity and superior safety of <unk> lends itself to combination therapy potentially as the drug of choice addressing the most sizable markets in AML.

We already have reported significant clinical activity in complete remissions across three dose levels 80 milligrams $1 20, and 160 milligrams without Dlt's and we continue to observe additional clinical activity as responses mature.

We believe <unk> is a real drug for a real disease, and we plan to disclose the full dataset around ash.

I'll remind you that the ash abstracts that will be coming out later this week will not contain the most updated data fab strikes are placeholders for a broader dataset that will be presented at the meeting in December . We also plan to host a quick and virtual Kols KOL in conjunction with the conference and we will provide additional information on the <unk>.

<unk> of that call in the coming days.

Also want to call out Dr Bexar, and our entire clinical development and clinical operations groups.

That have increased the rate of patient accrual for tests patent this year by more than 40% over any previous year. This program. There are execution truly has been remarkable.

In a few moments Dr. Bexar will talk more about our clinical plans for Testbed Nib first I'd like to highlight one additional piece of recent news.

In September we were pleased to add another <unk> member to our board of directors with the appointment of Dr. Byrd Seitzinger. Dr. <unk> is an accomplished executive leader with more than 25 years of industry experience in both U S and European biotechnology, and pharmaceutical companies and multiple financial advisory positions.

Held biotech CEO and CFO positions as well as numerous senior executive and board positions, including with Bristol Myers Squibb, where he served as senior Vice President of oncology drug discovery, and Vice President for corporate and academic alliances.

<unk> benefits from our strong board of directors and our scientific Advisory Board led by Dr. Brian Drinker and were happy to add Dr. Seitzinger to that distinguished group.

I'll now turn it over to our resident Kols, our Chief Medical Officer, Dr. Rafael Bejar to talk more about our clinical plans breath.

Thanks Bill.

We achieved all of our goals in the dose escalation and dose exploration segment of this phase one trial expected. This doses ranging from 20 milligrams to 200 milligrams just to remind you by the time these relapsed or refractory AML patients reach our trial each patient harbors an amalgam of adverse mutations.

Single mutation and each suffers with disease that is by definition resistant to therapy, having already been failed by other lines of treatment, including chemotherapy targeted therapies combination therapies investigational therapies, and even hematopoietic stem cell transplants in many cases plus.

Plus these relapsed or refractory AML patients are physically compromised by the complications of their advanced disease and the toxicity that prior failed therapies for.

For these reasons patients that need an anti cancer agent potent enough to kill the highly aggressive Lincoln sales also need when its general announced to spare normal tissues and preserved the function of the normal bone marrow. So it's actually quite remarkable.

In this trial with genetically adverse all commerce overall response rates are comparable to go through it in a phase III trial, the subject commercial dose yet to spend and it is treating and arguably much sicker patient population and it's important to remind you the number and types of often dramatic responses. We've observed do not happen by accident in AML. These are not spontaneous remissions expected.

He is an active agent.

<unk> has been impressive and its capacity to deliver complete responses.

Complete remissions in a diverse AML patient population and not just that you need in AML, the wild type and now in other counting AML types with highly at risk patients.

Additional good news is that since our last update guessing is continues no concerning drug related safety signals or trends to date and three of the 160 milligram dose level, we have not observed any drug related severe adverse events no drug related deaths and we have not observed any dose limiting effects that have affected other tyrosine kinase inhibitors in particular, we've not seen adverse events related to the elevated.

Creative tops with kinase, we've not seen adverse events related to Qt prolongation, and we have not seen any relationship between the change in UTC and deaths.

We are in the midst of completing data verification and analysis from our phase one trial and we look forward to reporting this data to you. This next month's during ash and presenting the genetically defined populations along with compelling case reports, an exceptionally challenging patients and wished to statement has demonstrated strong activity.

I'll also point out that as we're preparing for our next clinical studies, we've enrolled additional patients at the lower 40 milligram dose level. This reduces regulatory risk by addressing requirements at the Fda's project Optimists and initiatives that emphasizes dose exploration during early development of oncology products. It has nothing to do with the safety of observed thus far at higher doses of <unk>, which has been impressive.

We are trying to just coffee iced teas with our meticulous approach to withstand potential FDA scrutiny.

In addition, supplementary data at the 40 milligram desktop will provide important information as we move into combination studies with lower doses of <unk>.

And we now have fully enrolled sufficient numbers of patients at the 40 milligram dose.

Having said that rigor to move over onto the next stage of clinical development.

Where are we with our next stage clinical trials Im pleased to report that we will have opened recruitment for patients of our proxy expansion trial with 120 milligrams, which is debt net as a single agent.

We've identified a safe therapeutic range with a broad therapeutic window spanning the desktop is of 81160 milligrams and have selected a 120 milligrams as a primary single agent expansion dose with 80 milligrams and 160 milligrams is bracketing doses that we can adjust to.

In order to refine our dose selection if necessary in particular patients that started 120 milligrams will have the opportunity to increase their dose to 160 milligrams should they have no better than stable disease. After one cycle of treatment.

Trial is designed to confirm activity through patient enrichment of specifically yet.

Genetically defined populations, including Flint patients, who had been <unk> prior to the three inhibitor and supported by a fast track designation and are significant response rate to date.

Flipping mutated group, we've seen complete remissions in patients that have an important gene computations, including doesn't and Ras K Ras N. P. M. One and <unk> 53, as well as adverse mutations in <unk> and MLR PDD. Some of the expectations are typically associated with resistance to tyrosine kinase inhibitors, yet appeared to be sensitive to anticipate.

These patients continue to have great unmet medical need and we believe that the ability to rescue these patients and perhaps allows us to receive a stem cell transplant because we've now done several patients in our study, but allow us a quicker path to registration.

To have these data beginning mid year 2023 around the EAA timeframe.

Having just spent net and specific genetically defined populations. Our plan then will segue into phase II Registrational studies to support accelerated approval.

We've also seen activity in patients who do not carry the <unk> mutation, so costly <unk> wild type patients.

It will include relapsed or refractory AML patients with <unk> mutated <unk> three that have other address mutations exploring safety and activity in these patients and to statin treatment both as a single agent in combination with genetic lax.

Identifying meaningful activity other adverse subgroups could lead to other options for accelerated approval.

We soon will also open our recruitment in the exploratory combination study or an 80 milligram dose to send them with kinetic lacks the paradigm for the treatment of AML is increasingly moving towards combination therapy, and we hope to position <unk> as the preferred agent for combination in use in earlier lines of treatment. Once again safety profile to date suggest to spend that could become the drug of choice for combination with <unk>.

Type of method and agents.

I'm certain you'll have questions regarding our selection of doses for the single agent and combination expansion trials. So I hope this discussion items for the Q&A session.

We've accomplished a great deal since taking the reins spectrum trials from Hanmi and I'd like to thank our top notch clinical team for their Mastercard execution of dose escalation in exploration trial date, and further efficient preparation and getting eminent expansion trial ready to go.

Now I'd like to turn the call over to our CFO <unk> <unk>.

Pain for an update on our financial status Fletcher. Thanks.

Thanks, Rob Good afternoon, Al Let's review, our third quarter financials.

As most of you know from following a disciplined approach to cash management and streamlining our organization of clinical activities for our pipeline programs.

As reported last quarter. These efforts extended our cash runway into 2024.

So let's review our cash position.

We ended September 32022, with approximately $55 $4 million in cash and cash equivalents and investments.

The decrease in our cash by $7 million for Q3 during.

During the quarter. The net loss was $9 8 million translating into a <unk> 11 per share loss and down from $11 3 million loss from the comparable period in 2021.

<unk> identified an income statement, we had no revenues during the third quarter of 2019 research and development expenses were approximately $6 6 million for the quarter down $7 $7 million during the same quarter of 2021.

Research and development expenses for the nine month period ended September 32022, or $21 3 million as compared to $25 8 million for the comparative period, a decrease of $4 5 million.

The decrease was due to lower costs at the Luxe program offset by costs for the test.

Graham.

G&A expenses were $3 4 million for the quarter compared with $2 6 million.

From the same quarter of 2021 G&A expenses for the nine month period ended September 32020 to $10 9 million as compared with $15 3 million.

Third period, a decrease of approximately $4 4 million.

The decrease was primarily due to a decrease in stock based compensation expenses offset by higher compensation expenses travel expenses and professional fees.

Perfect.

For Q2.

$92 million 294.

734 common shares outstanding.

More detailed information can be found in our filings on Edgar and SEDAR.

Let's turn it back over to Dr. Rice.

Okay.

Thank you pleasure.

As we open the call for questions. Please feel free to pose a question to any of US operator, if you could please introduce the first question.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone keypad and wait for your name to be announced please stand by while I compile the Q&A roster.

Our first question comes from the line of Mr. Gregory Windsor RBC Gregory Your line is open.

Hi, This is Neil on for Greg Thanks for taking our questions and congrats on the progress made.

Maybe first just on Q3 nine could you give some more color and help us set expectations around the data update you plan to provide at ash in December .

The patient population treatment duration and maybe the type of data you plan to present thanks.

Yes, hi, thanks ill take that one initially and then perhaps Doctor Bay Harwood jump in that.

Exactly what we tried to outline today was the types of patients that we're treating a breath of patients in AML with mutations ranging from flip three Ras <unk> <unk>, three and others. So we wanted to be able to look at all of these types of patients the mix.

Co mutations for these patients identified patients that are responding and determine if their patient populations that have heightened sensitivity as well as those who might not respond as well so we'll be presenting all of those data.

We will in particular will be highlighting the patients that have that have been placed on the trial. This year. Since we took the reins of this.

Clinical trial January 1st of this year, Dr. Bexar anything further.

I mean, that's a great summary, bill okay.

Thank you.

Our next question comes from the line of stock.

D.

What sick with Cantor Fitzgerald, please standby, while I hope and Mr. Watson.

Mrs.

Amit sorry, Jeff.

Alright, great. So thank you for taking my questions.

And I guess just one.

<unk> that you're preparing and just wondering if you have.

Got any interactions with FDA on this dilution any.

<unk> ability to move forward with that one.

Okay.

So I'll, let Dr. Bexar take that one please.

Sure. So it's a great question, so as I mentioned for our expansion phase.

Which we are just beginning to look for patients now.

Using a 120 milligrams as our planned single agent dose, but that is not set in stone and we will have interactions with the FDA in early part of next year to discuss in part, but the appropriate dose going forward should be in whether they agree with our assessment, but more importantly, we built into the protocol the ability to adjust that dose based on a very.

City of signals, including any potential safety signals efficacy signals.

<unk> exposure data that suggested that this may not be the appropriate test. So we have that flexibility built in.

So just to be clear, we have collected doses for the expansion trials. That's beginning now and then as we go through that trial, we hope to be able to select out the appropriate doses to take us into what we would hope to be a single arm Registrational studies.

Okay. Thank you Lee.

Our next question comes from the line of Sumit Roy please be patient.

Yes.

Sure.

Yes.

Thanks Bernard.

Congratulations on all the progress.

And on rapidly progressing the Testbed nib.

I don't know how much you can comment on this but curious if you have noticed any.

Yes.

A few investigators that more inclined to enroll <unk> mutant patients or do you think the patient population that continue to enroll in the phase one.

Still split between the two wild type and mutant.

Well I'll begin with that one thanks, Sumit I'll begin and then I'll turn it over to Dr. Bexar. So the intent of the original phase one was to get.

As greater diversity of patients as possible, both flip through mutated and flit three wall type and then to look at all of the code mutations associated with them and again to look down at those patients who might be have greater sensitivity or lesser sensitivity.

And we've been able to learn from this potential populations that would want to move forward with <unk> expansion trials Dr. Bejar.

Yes, so as you know the.

So with three mutated population is about a third of AML. We built the study in particular to ensure that we had about a 50 50 split. So there are some controls in there to allow for that to happen and that's roughly what we've been able to achieve and going forward. In this expansion study, we're not changing that although we arent reaching for certain subsets of population.

Okay.

Okay.

Oh, I was going to be certain that that answered <unk> questions and if you had anything else.

We've lost him. Thank you. Okay. Our next question comes from the line of John Newman with Canaccord Genuity, please be patient.

I will now turn open his line.

Your line should be open Sir.

Hey, guys can you hear me.

Yes, yes, John Yes, Josh great. So.

Bill and Rob I Wonder if you could talk more about the specific populations that you were looking to enroll.

<unk> expansion study.

Also wondered.

If those will be similar populations that you would look at in combination with <unk> or if that study.

Focus on different populations in terms of the meetings.

Thanks, John Thanks for the question, but I'll have Dr. Bejar address that one.

Sure. So in the single agent arm of our expansion trial. It is coming up now we're enriching for two patient populations. In particular, one is a flit three mutant patient population that has received prior <unk> three inhibitors I think thats the population of great unmet medical need and probably the group with the highest likelihood of being amenable for a single arm Registrational study.

As an accelerated approval.

We're also enriching for patients that have highly adverse mutations mutations in <unk> 53, a complex karyotype those are largely with three well type patients, although not exclusively sell now.

The combination arm, we arent enriching for any particular population there were really again just like we did for the original study accepting all comers. So we have the opportunity to see if there are any unexpected populations that respond including those that are for <unk>.

Yes, So let me just add to that a little bit we have as we've collected our most recent data we've been able to look at the various co mutations that are occurring patients and identifying subpopulations that are having impressive response rates and we hope to be able to then watched those again as we go forward in the expansion trial again, they would fall under the patient populations.

The Doctor Bexar, just described but we'll be watching for several specific co mutation profiles in patients that that may bring us other potential.

Accelerated approval pathways.

Anything else talked about here.

I think one of the rationale for doing what you just described.

Much more than just the three inhibitor right with the activity that we have against targets like <unk> and so on some of the patient populations that making more targeted by that activity are ones, who are going to look at very closely.

Thank you.

Thank you John .

And our next question will come from the line of Matthew.

Big pillar of Oppenheimer.

Okay.

I'm going to ask you about the G. III formulation have you guys announced the starting dose for the reboot.

Would that provide a similar exposure level to the highest dose tested in.

Phase, one, which I think was 900, Meg, but correct me if I'm wrong.

So you are correct.

The last dose that we've used for the original formulation is 900 milligrams PID.

And then when we went through our various studies with different at different dose levels of the new <unk> three.

We it was clear that it looked like the 50 milligrams twice a day should be able to equate with the same exposure that we had seen with the 900 milligram through the original and so our plan is to start with 50 milligrams twice a day with continuous dosing.

Dr. <unk> do you want to add anything to that.

We purposely wanted to start a little bit more conservatively consistent this is a new formulation and although we modeled what continually assessing would look like we wanted to make sure that we weren't going to exceed our prior exposures that have been cleared for safety. So 50 milligrams PID is the starting dose, but we have the ability to further dose escalate based on the data we receive at that cohort.

Have you guys do any more Tox studies on.

On either locks or the G. III formulations Tencent have you had any kind of safety.

Safety signals or DLT, then that that would be of note.

I can take that one so.

No additional Tox study since we have gone into the clinic, but before we took G. Three into the clinic, we actually did a full preclinical development to GOP talks studies to enable us to go in and clearly it was safe sufficiently safe for us to go in at these doses and even to look at continue dose escalation.

Anything you wanted to add to that we've seen no signals any stocks.

Agreed and in the clinical program, where we dose patients with a single dose we haven't seen any concerns or issues from that alright, gotcha alright, okay. So at this point no concerns, but yes. Thanks. Good question, Matt, but we haven't seen any current concerns today, but it's a new formulation. So we will watch very carefully at the exposure levels to safety and also for the hopefully.

Our responses.

Okay.

Our next question will come from Mr. Joe <unk> with H C Wainwright.

Give me just a few moments in our open so.

So that his mic is open.

Mr. Pan Janus Hey, guys can you hear me.

Hello, Joe Yes, great. Thank you.

Afternoon.

So quickly first on <unk> sorry.

You might have said this just making sure so with regard to the combination arm with <unk>.

Just a little maybe review of the mechanistic reason why youre starting at 80 versus 120 and does that dose also have bracketing doses like the mono therapy study that you can adjust to.

Yes, good question Ralph Yes.

Yes. It is a great question so.

We purposely lower the dose a little bit too just to make sure that we didn't run any early toxicity issues not that we expected any in particular, but we wanted to make sure that we were treating patients at a dose that we thought it was going to be both effective and safe I'll remind you that at 80 milligrams single agent. We saw multiple complete remissions in our study. So we think that lowering that dose isn't going.

I would really be sacrificing any any activity, there, but might give us a little bit more window now that we're adding another agent that is going to bring some toxicity to the table as well, but as with the single agent arm in our combination arm in this expansion, we will have the ability to adjust that dose either upward or downward and this additional data that we're gathering at 40 milligrams as a single agent now will help us understand.

And what that would look like if we needed to drop that dose.

In the combination arm down to 40.

Okay got it got it thanks, Joe anything else.

Please just a little bit on Lux. So you did mention even with earlier studies and having the new form with earlier studies and potential supply constraints, just because you're using so much drug where do you feel you are right now to be able to supply the G. III for all of your.

Current plans to start.

We don't see any limitations at this time on the G III.

This is going to be a three by three study and so we would expect that maybe fifth 12 15 patients would be able to give us a really good read on these patients. So we have we don't feel like we have any restrictions on the G. III drug supply at this point and May may everything work out so well that we need to manufacture more.

Okay got it and then when you look at yes, Bill you gave a little bit of a.

And additional teaser there that you sort of have discussed in the past about the potential for inflammatory or autoimmune disorders. So when you consider that do you have potential <unk>.

Indications are protocols.

Even in draft form and is that impacting any potential ongoing business development discussions.

Well I can't speak about any ongoing business development discussions, but what I can tell you is.

Based on the kinases that are targeted by Lux.

A number of those are involved with inflammation and autoimmunity. Some of these other diseases at that time. So at the research level, we've gone to great lengths to make sure we understand exactly what's going on inside the cells a variety of different inflammatory cells b cells T cells looking at the mechanisms and the <unk>.

Pathways that are affected and they may have been taken that into multiple animal models and we've seen activity. We've begun to publish some of those data and we will plan to continue publishing more of those as we go forward.

The big part of that is.

Trying to understand the breadth of activity up Lux and it looks like it could be taken into those other indications. If we can come up with a formulation that consistently delivers the desired levels of exposure with Lux.

Again, we might have been able to take the original formulation into these other indications where you likely have tapped lower doses lower exposures and long term dosing, but we still would prefer to be able to use the G. Three formulation.

<unk> deliver far less of the API and fewer tablets and just much more efficient dosing. So again I hope to be able to take it into those other indications into the future. Some of that we may be doing on our own and somewhat <unk>.

<unk> with other companies time will tell on that and we'll let the data drive us.

Great. Thanks, Thanks for the added color guys sure.

Brad you're taking our next callers.

Question.

May I remind you by Dallas Star one on your telephone keypad will allow you to raise your hand SD put into the queue.

For any potential additional questions.

Standby.

Mr Ed <unk>.

This question.

Mr Tang.

Thank you Ted.

I request from London.

All of my questions have been answered, but I just wanted to congratulate until the progress looking forward to more data at Ash and then also the expansion cohort data.

Starting next year. Thanks, so much okay. Thanks, a lot for being here I also wanted to reemphasize to everyone. Even though we talked about Lux a number of times here, we want to reemphasize to three nine is our lead program that is where the vast majority of our effort our cash is going to be expanded.

That drug has been derisked in so many ways with with activity clinical activity and still well tolerated. So I just want to reemphasize that the drug is going to be focused there okay.

So operator were there any other questions no. Sir we have no additional questions are persons in the question queue. So therefore at this time I would like to turn the call back over to you for any further closing comments.

Alright, so I just want to thank everyone for joining us. This afternoon 2022, thus far has been a year of truly solid execution on the clinical front I want to make sure that we thank all of our employees. Our investigators are contractors and above all the patients who continue to help US advance. This important work. We're also very <unk>.

We appreciate our shareholders and analysts all of you that are on the call. Thank you for your support we look forward to keeping you apprised of our progress and we can't wait to see at Ash a bit later this year.

Everyone. Thank you and have a great evening bye bye.

Thank you for your participation in today's conference. This concludes the <unk>.

Our brand you may now disconnect.

And we are back into pre.

Okay.

Alright, so thank you so much Chad drilling.

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

Okay.

Yeah.

Okay.

Okay.

[music].

Okay.

[music].