Q4 2021 Tyme Technologies Inc Earnings Call

Hello, and welcome to the time Technologies, Inc fiscal year.

Our 2021 financial results and business update conference call as a brief reminder, all participants are currently in a listen only mode. If anyone requires operator assistance during the conference. Please press star zero on your telephone keypad. Following the presentation. There will be a question and answer session note that this.

This call is being recorded at the company's request and will be made available on the company's website. Following the end of the call at this time I'd like to remind our listeners that remarks made during this call may state men and 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 time and 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 fact, there's the good.

The conference actual results to differ materially from these contemplated by such forward looking statements are discussed and the periodically.

Time flies with the Securities and Exchange Commission. These documents are available and the investors section of the company's website and on the Securities and exchange Commission's website. We encourage you to review of these documents.

Call carefully I would now like to turn the call over to Mr. Ritchie Cunningham CEO of time Mr. Cunningham. Please proceed.

Thank you operator, and welcome everyone to our presentation. This evening I'm Ritchie Cunningham CEO of time, and it's my pleasure to meet with you share of the findings of our strategic review and the path forward.

Forward.

As you will learn today every aspect of the company was contemplated our pipeline strategic vision personnel clinical process and data.

I would say it was quite an ex significant and undertaking and it took several months to complete.

And my prior work experience, which spans across the lifecycle of the pharmaceutical.

Humans business.

Came in handy throughout the review process.

From leading on early drug discovery biotech with having the understanding and knowing the importance of early translational data.

And the launch and commercialization of several drugs throughout my career.

Now with that being said the clear outlier on the slide is my time and the NFL.

And I get it.

Really doesn't apply much the biotech.

Except for the fact that performing at a high level of success requires focus and discipline.

Now personally.

I always had a passion for finding opportunities that could positively impact the lives of people and.

And working and health care offered me a wonderful opportunity to do just that.

When look.

And the transition from the NFL I was fortunate to meet the CEO of Premier.

As many of you know premier is 1 of the largest buying groups for health care providers missed.

And Mr. O'leary at the time digging my first opportunity and I will always be grateful to him for sharing with me his wealth of experience and knowledge.

Now during that time I also got a chance to meet with the Ceos.

OS from the largest and most successful hospital systems and learned about the delivery of healthcare and.

And then followed that same leadership team from Premier 2 of turn on opportunity, which was Valeant pharmaceuticals, and our boss shelf.

Where I led and built commercial teams and sales and marketing.

From there I was recruited the behringer Ingelheim, where I had a great run.

On launching a couple of blockbuster drugs and addition to the the tyrosine kinase inhibitor by the name of <unk>.

Now after my time, and a large pharmaceutical organization and then ventured out to biotech where I became the CEO of and early stage biotech company.

And there I made 2 acquisitions on my first 2 years, including a spin out from.

By the name of Ikea gin and the familiar acquiring of Sanofi Genzyme R&D unit and rare disease.

From those acquisitions, we've built and early stage pipeline that led to multiple licensing deals with companies such as Roche Sanofi GSK and others before exiting via cell of the company.

Following the sale of <unk>.

Pfizer I became aware of the opportunity of time after my due diligence I was very intrigued.

And I believe it was a great fit and the SM 88 novel approach towards helping people without sacrifice.

Coupled with the initial data and my view was and is completely compelling.

I've been here now for about 6 months and I can share with you that my level.

<unk> statement for time, and our future has only increased.

As you all know our company is only as good as the people that comprises.

That was the top of mind when I came on board I am fortunate to have the support of an accomplished team of individuals who have done it before and other organizations and no.

Level of ply their experience towards making time a success.

Those of you who know time may be more familiar with the team on the left side of the slide we have our founder Chairman and Chief Scientific Officer, Steve Hoffman, Our Chief Business Officer, Dr. Jonathan Eckard, and James Bill, Our Chief Legal officer.

I also need.

How to organize the team who are not on the slide note that we are of very strong committed and competent group that make up this company and I'm proud to be part of it.

I also want to take a minute to introduce the 2 recent team additions that we're pleased to have on board.

And we will greatly benefit from the wealth of experience of the each bring to us and theyre given fields.

At this time I will turn it over to Dr. Van turnout and then Frank per veto to introduce themselves Jan.

Thank you.

Good afternoon, and good evening.

My name is Doug young on total notes from a pediatric hematologist oncologist and genetic epidemiologists.

On the license.

License and our position both in the U S and Europe.

University of Southern California.

And as a physician scientists and.

From the research program and genetic EPPY and.

And then it'll network and pediatric cancer.

Total.

The way my academic work I joined Amgen is the safety officer.

And oncology and was part of of team.

The successfully filed.

NDA for Kipp events.

Subsequently I joined Bristol Myers Squibb, and the late stage development program.

And was part of the team that successfully.

And we filed the sat and the CML.

Subsequently and moves into the early stage drug development of the senior director of BMS.

Several of the submissions of their pre <unk> the assets.

As well as leading the team that brought the <unk> map and.

The monoclonal antibody.

But against C of Swan and to BMS.

And let the early development phase of the compound that was later successfully approved and multiple myeloma.

And then join US <unk> pharma as executive director of where I led the development of the anti Egfr IR.

The dual <unk> inhibitor and effect of inhibitor.

Subsequently I move to <unk> as VP clinical development for oncology what are the led several of these and develop their DNA vaccine program and oncology.

In all your Natera, a senior VP and head of oncology the develop their cell free DNA technique that.

It's optimized and the need on the premium and it'll space and apply it to oncology with the use of liquid biopsies and pre and post treatment diagnosis and oncology.

I subsequently worked as a consult and I recently joined the time after having the introduce.

Hi, Richard kind of him.

And after having seen the very impressive first in human data and other elements of the pipeline I accepted the position of acting CMO.

I'm very thrilled to join time at this time and the developments.

And.

I've been impressed by the experience of the management team as well as the opportunities that lay ahead of us to meet the unmet medical needs and patients with the the assets at that time.

I'm now going to pass the mic to Frank Burrito, Chief Financial Officer.

Thank you Dan and good afternoon to everyone on.

And I am Frank poor phaedo.

We'll be starting next week as the new CFO at time.

I've spent over 25 years at Novartis spin.

Specifically in the oncology Bu.

And various leadership positions, including UFC.

So head of global finance for their oncology translational Medicine unit and global head of finance.

Most recently I was VP of finance the European pharma.

And was part of the team that brought our first product through FDA approval and commercialization.

I've spent a number of years.

C of clinical trial spend launching products, along with strategic planning and.

And I am very excited to join time of such a pivotal point in their history and look forward to doing my part as we endeavor to find ways to develop compounds that help patients.

Now I'm going to turn it back to Ritchie.

<unk> excellent. Thanks, John Thanks, Frank for those introductions.

As I mentioned in my opening comments.

We kicked off of strategic review that started in January.

We need to to answers.

To several of following questions that youll see on the slide.

What is times drug.

The development process.

What's our product profile and what's the differentiation.

Do we have the right data needed to make informed decisions.

What do external experts think of our current data and development programs.

And our capabilities strategic strategic vision, and how are we communicating that vision.

And whats our IP position.

What are we spending our precious capital on.

In addition, do we have the right people in place and we're pursuing the right programs and what other opportunities should we pursuing the pursuing or should we not pursue it.

It was a robust effort.

And as you will learn as part of that process, we had the benefit of seasoned professionals and are giving fields.

To help us reach the answers to these questions.

Today, I will share with you those findings and how the process was conducted and the conclusions that we reached putting us on a path forward of path that we believe will unlock the full potential of time.

I want to take a minute to share with you the cross section of industry professionals.

<unk> and thought leaders that helped us.

And with this processing to head down this path.

We believed it was important to bring in and external and independent objective viewpoint.

As you can see we saw perspectives from multiple relevant disciplines that worked with internal teammates as well as getting internal and I understand.

Of the data and information and reaching the ultimate conclusions that we'll share with you today.

So 1 common theme.

Amongst all involved.

And I think the match that let the fire at time.

Was the early dynamic results that we've seen with estimates.

Understanding that's the reason I'm here and I I.

I believe that's the reason why the team is here.

A few points here to make that excites me.

Broad activity across 15 cancer types with some intriguing responses, including complete responses.

Those of sponsors, including unexpected positive results and advanced breast cancer pancreatic cancers and.

<unk> e-commerce.

That's the most important because it gives us multiple shots on goal.

The safety profile and the lack of toxicity and offers us an opportunity to potentially go and combination with the potential of not further and further compromising patients.

We believe.

This is a huge.

<unk> and for SM 88.

Add to this SME date can be delivered orally.

These are the significant attributes that give us great optimism about its potential.

So what were the key findings.

What do we derived from the strategic review.

Differentiate is backed by compelling early data that lends itself to multiple downstream opportunities.

Next week.

We concluded having 2 separate pancreatic cancer trials and both second line and third line.

That appear to be completing enrollment at the same time was not optimal.

Estimate there are more efficient uses for capital.

Therefore for that reason, we decided to focus on second line.

And precision promise and wind down third line more to discuss on the business rationale as to why we're doing this and what we see as the potential positive impact to that.

Another major decision with the to diversify.

And of reallocate third line pancreatic cancer resources to pursue a breast cancer program.

This is significant for time and SM 88.

And 1 that we're incredibly excited about we have high hopes.

And the potential based on the data the market dynamics.

And it offers us and entry into a significantly large therapeutic category that we'll share with you.

Now with the broad activity observed and early preclinical programs early clinical programs.

And the estimate a profile there is a potential to go after multitude of indications.

If we were able to do this we need to be smart about how we do it.

We need to be strategic and capital efficient.

We believe 1 way to do that is by better understanding SMA. The eight's mechanism of action and identification of potential biomarkers that allow us the opportunity to select patients and have a greater probability of that.

Of a greater probability of responding to SM 88.

We are rethinking the role of time 19 the.

The rapidly changing COVID-19 landscape has changed and the direct trajectory of time 19, and how we strategically approach that opportunity and we'll talk about debt and further detail.

Now given our recent capital raise.

<unk> capital position is strongest.

And the strongest.

And his position it's ever been.

And is giving us significant runway to execute on the development goals that we put forth and that we will be putting forth.

We're building the right team and.

That is critical to our success.

And as you've just heard we didn't wait around to act on this finding.

With the addition of yarn and Frank we've rounded out of very.

On an experienced leadership team.

Now.

This particular.

Slide indication selection for a deep dive analysis is the.

The graphical depiction of the whittling down and filtering process, we went through to determine our development path forward now.

And now this was a very.

Extensive process and it was a data driven decision process focused on these 5 identify criteria.

The strength of the data.

The unmet need.

Cash the validation market opportunity and competitive landscape.

Our clinical lead programs from the review that came out of this or.

Strong out of cancer second line.

Breast cancer that will discuss further as well as sarcomas.

The clinical path forward.

Although we concluded.

We have multiple avenues to pursue we determined that the need to prioritize these opportunities the ones that.

And pick the best opportunity for commercialization attributes and the shortest period of time, where.

And we're the ones that we went with Theres a balance to this.

Now.

Here's our view on the current primary areas of clinical focus.

And the coming slides.

We will address each category and more detail.

Precision promise.

It gave us is the phase II III study and second line pancreatic cancer.

Oasis so.

The phase III breast cancer study and HR positive <unk> negative patients.

Designed to confirm confirmed the strong single agent activity that was observed and the earlier studies.

The hopes trial.

The phase II metastatic sarcoma study with 2 arms looking at Ewing sarcoma, and 1 arm and all other sarcomas and the second arm.

Pre clinically and oncology. We also have SM 88, injectable, so preclinical program, where our or SM 88 therapy is not an option.

And time 18.

This is an intra tumoral select surgically injected bile acid that is believed to have anti cancer activity.

While developing time 18, and researching bile acid, Steve Hoffman identified of ball assets that he believed.

Had the potential for anti viral activity and was identified as the potential.

Treatment for COVID-19, and.

And this was brought this was this brought US this viral antiviral program called time 19.

And I will discuss that further in the coming slides as well.

In addition to our preclinical.

And our clinical.

Programs here will have preclinical mechanism of action work and buyer market issue.

<unk> should be doing the support the current and future development path.

So the Oasis breast cancer program.

Both early day.

Data and key opinion leader feedback strongly supported HR positive and her 2 negative breast cancer patients.

Is that who failed of CDK 4.6 inhibitor as the priority setting for SM 88.

The second bullet here is a very important 1 and.

And we believe this represents a significant opportunity for SM 88.

The CDK 4.6 class has been successful and due to that success of migrating up the treatment.

<unk>.

And it's leaving a significant GAAP to be fueled before patients go on to chemotherapy.

Lastly, we are looking to confirm strong data that we've seen and early trials.

Which will be of significant signal signal and validation for SM 88.

So when you look at breast cancer and HR positive her 2 negative and the opportunity that we're pursuing.

And we all know breast cancer is.

As a large market.

And particular the category that we're pursuing with HR positive her 2 negative subtype represent 73% of those diagnosed.

As such we are.

Looking to target the failing of the CDK 4.6 inhibitors that are there the.

And the bottom line is this is of significant market opportunity for SM 88 of successful.

I want to take the time.

So now and talk a little bit about the landscape.

Great market opportunity.

Significant unmet need.

And an area of our SM 88 early clinical results were impressive.

Our understanding is that these breast cancer patients, they're wanting to exhaust all alternatives before going on to chemotherapy.

Theyre looking for a well tolerated oral option.

This is very important to our.

Our strategy.

As it fits the SM 88, oral and safety profile with low toxicities.

Now you'll notice on the slide.

We have the chemotherapy path towards the bottom of the treatment paradigm and red.

With the CDK 4.6 class highlighted in Blue Moon.

Moving up the first.

First line.

It leaves behind the treatment gap for better tolerated oral treatment options.

For us after CDK, 4.6 failure and before chemotherapy.

Now if I can get your attention to the upper right hand chart.

This was the SM 88 results and our first in human early studies.

We.

And had 25 breast cancer patients.

12 of our HR positive <unk> negative.

And this group 3 were complete responses to a partial responses and 4 with stable disease.

The key metric here that we're designing around is the overall response rate we're estimating it achieved 40.

Sent and these early trials.

Yes.

Now that being said success in this trial as measured by beating <unk>, plus aromatase inhibitors and had an overall response rate at 10%.

And as we achieve greater results moving upwards towards the 19, 5% observed.

By the CDK 4.6 inhibitors.

And as a single agent.

The greater confidence that will provide us that estimate and this setting.

Has real potential now.

We're focusing once again on.

On going after the failure of CDK 4 and <unk>.

When you look at this in totality and this is why.

Why were excited about the setting following the original development path of the CDK 4.6 class.

A multibillion dollar opportunity.

Where we observed positive results with SM 88.

And our early first in human studies.

So let's shift gears to.

And to pancreatic cancer.

I want to first be clear pancreatic cancer is of high priority indication for us.

A couple of observations during the review to share.

As the company last year greater than 90% of our clinical spin.

And pancreatic cancer.

With 2 separate studies.

When compared to the third line. The second line setting is clearly preferred.

The time and SM 88.

It gives us greater cost benefit and ROI.

The third line setting brings with it of much smaller.

And with a somewhat similar investment costs over time.

Now with that being said the initial position the company had.

Was third line could be a faster path to approval.

However, as we did our initial assessment that didn't appear to be the case any longer.

This was due to a couple of factors.

First.

And <unk> and enrollment impacted by the pandemic.

And second the fact that there is a limited number of patients and the third line setting.

Ultimately the enrollment and timing with second and third line, we're lining up to be the same and highlighted the real need to prioritize.

First the delay.

So knowing the importance of making such a decision.

And we took a deeper dive and.

And we discovered there was of high dropout rate, where patients were randomized into the the chemotherapy arm and they were dropping out.

It didn't appear they wanted to go back on the chemotherapy treatment.

This also.

And on our timing and recruitment of the study.

The conclusions as the whole.

Treatment of patients earlier and second line offers the best opportunity for patients and SM 88.

Second line is a more viable commercial opportunity.

There is a better way.

To utilize our capital.

And impair diversify rather than continued investment and 2 concurrent pancreatic studies with similar timelines.

The cost benefit didn't support continuing third line.

Therefore focus on second line pancreatic cancer with precision promise.

That's our primary objective.

We ultimately.

Capital Herman It was best to also take and redirect these resources from third line setting to both the second line of precision promise and the Oasis breast cancer trial.

By doing this we believe we offer our investors a portfolio with a significantly greater addressable market opportunity and greater diversification.

No real meaningful uptick and spin, which ultimately provides a greater potential ROI.

So let's talk about hopes sarcoma.

This is an investor initiated phase II trial design studying SM 88.

Based on the data from the earlier.

With us and Kols feedback.

We determined sarcomas as of focus setting for us.

It's the high unmet need and it's an orphan indication.

Of potential accelerated path to approval and it fits SM 88 profile, whereby safety and quality of life of priorities and this later setting.

Okay.

The trial, we recently published interim data and <unk>.

The abstracts highlighted durable duration of therapy and heavily pretreated pretreated patients.

And there are several cases of anti terminal activity and other clinical benefits that were observed.

We're continuing to work on completing enrollment.

We're looking to allow that data to mature and assess the potential pathways for advancement.

We also will be looking to apply some of the future learnings that we have and doing the biomarker initiative and the potential future value of how do we drive and develop these products moving forward specific around metastatic sarcomas.

Sure.

So the use of Biomarkers.

And an MAA work on mechanism of action.

The use of Biomarkers provides the path to personalized medicine.

Having a specific treatment that fits of certain genetic marker of disease.

This approach has become more and more common.

Amongst drug developers and drug development strategies for its potential to increase the probability of success and the clinic.

Ultimately.

This is about working smarter.

Understanding how a drug might respond best and of certain patient type.

That can have significant benefits for all.

All increasing the probability of success.

Doing this by selecting patients that have a better probability of responding to a particular drug.

Knowing this earlier and the clinical development and has the potential improved regulatory success and safe development time and money.

And also by doing this.

The marker and MAA work.

It allows us to.

Why what SM 88 might combined best with ultimately offering alternative paths and better outcomes for patients.

So let me go back to the earlier discussion on productivity and potential of multiple indications.

We believe using Biomarkers provides the most efficient approach to tap into the potential.

<unk> of SM 88, and.

And the paradigm excuse me and the diagram here.

You can also see the partnerships that we've developed with credible leaders and the space to execute on our strategy. We havent weighted here we've already begun this process.

So, let's move now to COVID-19, and the landscape.

Identive happening.

We are continuing to advance the time 19 pre clinically as we evaluate the COVID-19 landscape and determine the best path.

But it's important to note.

This is a rapidly evolving space with.

With the increase and.

And success and the vaccinations, which we're all fortunate of.

You add to that the pipe the therapeutic pipeline that is now.

Getting even more crowded.

And you add to it the challenges that come with the recruitment for those trials due to the number of patients available because of the success of the vaccines.

This is the landscape that we need to be cautious about we just need to make sure that we're navigating these challenges appropriately and.

And we're seeing just that.

Let's talk about <unk> 19.

Time, and 19 as an oral synthetically produced member of the bile acid family being developed for COVID-19.

It's intriguing to us because.

We believe time, 19th mechanism could be agnostic to the screen of Corona.

And reduce therefore potentially providing options for future preparedness for the next pandemic.

So we will continue the preclinical advancement to understand its true true potential.

In addition, we.

And we'll also as we generate the appropriate data consider appropriate and alternative strategies and partnership opportunities.

1 of our so more to come on time and 19.

From a financial standpoint.

Times well capitalized.

And as we look to rollout of new clinical strategy here.

We ended March 31, 2021, the fiscal year and with the $107 million.

Cash.

We're communicating and expected cash burn for 2022.

24% to 32 million.

That leaves us with 75% to $83 million at the end of the fiscal year.

We feel like we're positioned well.

The capital and the.

And on hand, and the focus of some of the key expected upcoming milestones that will talk about now.

And positions us to get there.

First I'll just communicate the oasis breast trial.

We look and get the first patient enrolled and the third quarter of 'twenty 'twenty, 1 and so we're on our way to do that.

And that's an important milestone for us and for our company into breast cancer.

The sarcoma trial enrollment, we're looking to complete debt by the first half of 2022.

And you'll have a chance to see the data mature.

And further readout down the road.

And then the pancreatic cancer data update from part 1 and the first half of 2022, we want.

And I'll make sure that we're publishing net data.

And then the preclinical biomarker initiative data by the second half of 2022, and and precision promise of pancreatic cancer second line trial. The graduation decision from a phase III 2 of phase III trial by the second half of 2022 or earlier.

And then lastly.

The Oasis breast cancer trial update that we've targeted for first half of 2023.

These are the key milestones that we'll be looking towards.

And we're excited about the path to see those come to fruition.

Okay.

So closing remarks.

We believe we've got a robust.

Pipeline with multiple shots on goal.

A solid plan that includes building a strong foundation and understanding of the potential of SM 88.

Focus and discipline investing wisely and strategically.

And of data driven development approach.

Were all funded to advance these programs.

Programs.

We ended the year with $107 million and cash.

And we built and experienced management team with a proven track record and.

It's ready and excited about the path to move forward.

Now.

Just want to.

Share with you.

Because of the unique profile of SM 88.

Including the favor of the favorable tolerability.

That we see with it.

We believe we're delivering scientific solutions without compromise.

<unk> and novel therapeutic treatment.

That's dedicated to a better quality of life for all patients.

Now with that being said I'd.

Like to move into Q&A.

As a reminder, cask of question you will need to press star 1 on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.

Our first question comes from the line of Swire, Jamar, Pakula, Roma and <unk> from H C. Wainwright. Your line is now open.

Thank you.

Good afternoon, Richie thanks, Thanks for getting a.

Giving.

The detailed plan.

On 4 time.

And.

And so we can see that you know the.

The current per.

Portfolio of ideas.

And it up.

It is is to get a better better.

And use and better ROI and better use.

And of capital.

But at the same time.

Trying to understand.

Since.

You are not going to be owning any of these programs totally and because they are being run by third parties, how do you.

How do you plan to utilize the data the.

And that is expected to come out of these 3 studies over the next day, yet in the half to 2 years.

No. Good question RK and thanks for asking the question.

And the the programs and where I have right now is going to be the foundation of how we move forward. It's the start.

To.

The data for the development path for SM 88.

Ultimately as that progresses as an organization, we will certainly look towards the opportunity to design and execute on these trials ourselves. It is the current path forward and when you look at the Georgetown trial.

As an opportunity that was there for us and.

The build to take advantage of the timing of doing that and partnering with Georgetown and beat the timing of us having to go back and do this ourselves. So there's a timing component and balance that goes to that and that was the reason why we did that and it just so happens pan can and the way that trial was designed.

And with the Pan Ken.

And we wanted to.

Is.

Is another trial that we believe and and into phase 2.3 trial that gives us an opportunity.

To move pretty quickly and so it comes down the timing at the end of the day and and we're excited about it we think if it works the.

And the opportunity is there we're going to.

Taken of run with it so it's positioned us well and.

And for this point and time and where we're at I think it's the right strategy.

Thanks.

Regarding the.

Second line study and the third line share deals.

For the.

The part of the pancreatic cancer.

And then on as of.

Until yesterday.

So.

How much of.

The slow and us and recruiting into the phase III study.

Yeah.

As is the contribution of having actually the same molecule being tested in the phase 2 study, making not only kind of kols, but also patients.

They do understand the data from the phase 2 study before trying to think about it.

I'm sorry, the second line.

And what I'm thinking of kind of get this drug into the third line patient.

Yeah, I think RK.

And it's more than likely of minimal impact I don't see it as a major impact.

On that.

And my sense.

The third line patient.

So all of them.

And looking for you know.

Alternative treatments.

And the our second line trial of I don't think it had a real significant impact as my response to that.

Okay.

And then.

On the on the preclinical programs.

And the management have had these.

And for Awhile now.

<unk>.

So what sort of data should we expect from these over the say the next year or so because that is pretty much kind of drive the real pipeline of the.

Of the company.

Yeah, absolutely so.

We've.

We've already started down that path working with Mayo clinic is as we indicated NYU, we've worked within the past and.

And what I can tell you is that we were already at the point, where we've developed a successful organoid model.

And now we're taking that to the next level and the next phase of start to do the experiments with SM 88.

So we can confirm our understanding of how it works.

And that's going to lead us to those potential biomarkers. So we expect to have a better understanding and the next I would say 12 months okay.

Okay and then the last question from me.

And I was.

Suddenly you have the.

The.

The cash.

The run these programs.

And but also you have a little bit more of them that so are you looking to.

Doing any and licensing so that you can be from the pipeline.

Outside of the molecules that you currently have.

So I would just share with.

The this.

We consider all options as we consider how we build our pipeline.

I would just start with saying, there's a lot of confidence and SM 88 and.

And its potential we think theres a multitude of shots on goal that we can take with debt with that compound that's where we're focused today we do.

And want.

Take our eye off the ball however, with that being said you always look for optionality and and as those opportunities present themselves, we'll consider them.

Okay.

Alright. Thank you thanks for taking all my questions.

Thank you.

Okay.

Thank you we received pre submitted questions.

When did you determine the third line trial did it makes sense to continue any longer what factors was that decision based on.

So as we spoke before during the review it was obvious debt the.

And the slower than expected enrollment.

It really changed.

<unk> the strategy outlook of an accelerated path for second line.

And then whereby the larger commercially viable opportunity existed and second and second line versus third.

And so.

For us when you analyze the cost benefit of continuing and further investing.

That was going to be required and accelerating.

And third line it was just really clear that.

And the more appropriate use of capital was going to be diversifying into opportunities such as breast and focusing on second line and that for US thought gave US was and is the greatest rationale and support too.

And to provide the greatest opportunity from the organization so.

And again diversification, but also ultimately the slow enrollment and timing and a lack of accelerated path focused on second line was was really the key output there.

Okay.

Thank you.

Binder to ask the question you will need to press star 1 on your telephone.

And no 1 of the draw your question press the pound key.

We have another pre submitted question.

You are highlighting your focus now on.

The preclinical and mechanism of action the U R and late stage trials isn't it a bit late for the shipping it and have been done before.

So Microsoft the sponsor that it's never too late to better understand how and where your drug works best and in fact, I see it as of continuous.

Process.

And with some commercial drugs, some still don't have and understanding of M&A, but it's definitely the preference as it creates a more efficient development strategy, especially when you look back at the profile of SM 88.

And the multiple potential shots on goal of that can be created we got to be smart.

As to how we go about that and Thats why.

And we're investing and it now.

Okay.

We have time for a couple more questions.

Our next question with the implementation of your strategic strategic review of finding what will be the new quarterly burn rate going forward for the next 24 months.

On.

So what I can tell you is that we anticipate of quarterly burn over the next 12 months to be anywhere from $6 million to $8 million.

We have this the spread and there and incorporate the wind down and third line as well as supporting the new initiatives that we're putting in place so that's where our burn.

<unk> is positioned and we're just communicating out to the next 12 months.

Our next question is how long do you anticipate the cash on hand will last before you need to raise money.

So based on the current strategy and plan we expect.

Expect to have at Liza of 3 plus your cash runway.

And enables us to get through and 2 of the key milestones.

We expect that we've shared and it gives us and our ability to generate some of the initial the data around the initiatives around MLA and biomarker.

And and get to some some key.

And events for the organization, so we feel comfortable with the cash on hand, and our current position.

At this time I am showing no further questions I would like to turn the call back over to Ritchie Cunningham for closing remarks.

Thank you I appreciate it operator and.

And I'll just close by saying.

The miles for joining us this evening really appreciate your interest.

And time.

We believe we of the right team with.

And recently with 50 years of industry experience that we recently brought on board.

It's the right time and the right strategic plan moving forward. So we look forward to providing everyone updates.

Thanks on that path as we move forward and once again, we thank you for your time.

And that's all thank you so much.

This concludes today's conference call. Thank you for participating you may now disconnect speakers, please standby assets.

Yes.

[music].

Yes.

And.

And.

Okay.

Yes.

Yes.

And.

Yeah.

Yes.

And then.

And.

Yes.

[music] net.

Okay.

Yes.

Sure.

Okay.

Good morning.

And.

[music].