Q4 2020 Salarius Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the Solaris Pharmaceuticals, Q4, and year end 2020 financial results call. At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference maybe recorded should you require any further assistance. Please press star zero.
I would now like to hand, the conference over to your host Jason.
Jason Rando with cheaper and strategic advisors. Sir Please go ahead.
Good afternoon, everyone and thank you for joining hilarious pharmaceuticals, 2024th quarter, and full year financial and corporate results call.
Earlier this afternoon, Soliris Pharmaceuticals issued a press release detailing its financial results for the free months full year ended December 31 2020.
We encourage listeners to read.
The press release can be found in the news section of Soliris farmer Dot com.
There is also file a 10-K this afternoon, which is available on Soliris pharma dot com and SEC Gov.
Before beginning todays call I would like to make the following statement.
Today, we will be making certain forward looking statements about future expectations plans events and circumstances, including statements about our strategy future operations and the development of our lead investigational drug candidate <unk> debt.
And our expectations regarding our capital allocation and cash resources.
These statements are based on our current expectations and you should not place undue reliance on these statements.
Actual results may differ materially due to our risks and uncertainties.
Clothing, those detailed in the risk factors section that's hilarious pharmaceuticals, 10-K filed with the SEC and other filings, we make with the SEC from time to time.
Soliris pharmaceuticals disclaims any obligation to update information contained in these forward looking statements.
Whether as a result of new information future events or otherwise.
With us on today's call is David Arthur Director and CEO of Soliris Pharmaceuticals, who will provide an update on comparisons corporate and clinical achievements during the fourth quarter and its business in the future.
And Mark Rosenblum, CFO, who will review <unk> fourth quarter and full year 2020 financial results.
David Please go ahead.
Thank you, Jason and thank you to everyone joining our conference call today, including all of you who are joining for the first time.
Today's call highlights an exciting time in the growth of Soliris in just the past few weeks, we have achieved important clinical milestones in the development of our lead drug candidate <unk>.
And we have achieved significant milestones in financing so areas. We've completed the dose escalation portion of the Ewing sarcoma clinical trial and secondly, <unk> is now being investigated at the recommended phase two dose in three distinct patient populations made up of Ewing sarcoma and Ewing relay.
Sarcomas, which in the case of viewing related Sarcomas include two patient populations made up of Myxoid LIFO sarcoma and other <unk> translocated sarcomas.
Each of these three patient groups.
<unk> sarcoma Myxoid LIFO sarcoma in S. E T transport cadence sarcoma is potentially represents a separate regulatory path to approval and the related commercial opportunity.
These recent clinical milestones and the expansion of the human clinical trial to include unions related sarcomas per.
Further underpins and supports the first prong of our development strategy speed to market.
Soliris is now investigating three patient populations each of which is supported by future clinical results. We believe has the potential for accelerated regulatory approval.
And supports our strategy of speed to market.
In parallel I am very pleased to report that as a result of a series of financial transactions Soliris now has the capital resources approximately $37 million in the available cash to fund our current clinical trials, while providing the ability to develop <unk>.
In larger market indications, including solid tumors and hematologic cancers.
These larger market indications represent the second prong of our development strategy expand the market.
In addition to these clinical and financial achievements. We have also amended the human clinical trial to expand the addressable Ewing sarcoma patient population and improve patient access to <unk> earlier in the patient's treatment paradigm by.
By combining <unk> with the common second or third line chemotherapy treatment tope of T can and cyclophosphamide, we hope to open the door to second them stacked potential use much earlier in our ewing patients treatment continuum.
As a second or third line therapy.
While improving patient outcomes.
Let me make sure I clearly communicated the importance of these developments. We believe we have integrated <unk> into the Ewing sarcoma standard of care and circlet them stack can now be easily administered as a second or third line therapy in our ongoing clinical trial.
In addition to increasing the number of patients who can receive <unk> treatment. We believe that this also makes it easier for physicians to utilize <unk> early in the Ewing sarcoma continuum of care, while potentially improving patient outcomes.
Fine.
In a small subset of viewing related sarcoma patients with relapsed or refractory disease that enrolled in the advanced solid tumor trial.
All patients in the subset showed indications of circlet them stat drug activity as evidenced by a medium time to progression that was greater or longer than a benchmark commonly used for single agent activity in there.
This advanced relapsed soft tissue sarcoma setting.
It is important to note that these indications of drug activity occurred at doses below below the recommended phase II dose that we're currently using in our ongoing viewing and viewing related sarcoma trials again to be clear line of.
Small subset of patients with relapsed or refractory Ewing related sarcoma, we observed a median increase in the patient's time to progression when compared to a benchmark commonly used for single agent activity.
Advanced <unk>.
<unk> soft tissue sarcomas setting.
We believe this is exciting preliminary data circlet them stats activity in viewing related sarcomas.
I cannot understate, our view regarding the importance of these developments to the ongoing growth of <unk> and hilarious, nor can I understate, how well, we believe dispositions hilarious for the future.
Mark and I look forward to speaking in detail about each of these accomplishments later in the call.
However.
Before that I would like to take a moment and provide my thoughts on the past 12 months.
If you had asked me a year ago. This is hilarious would be in the position of strength that we are now in I.
I would have responded with a resounding absolutely.
Why would I have said that because we had a well defined strategy and we executed on a plan that I fully expected would yield positive results.
Of course this plan did not factor in the COVID-19 pandemic.
And just a matter of days last March the world was impacted by a once in a generation situation soliris was not immune but in spite of the many uncertainties. We were able to quickly make adjustments that enabled us to persevere and certain ways become stronger as a company.
This type of thing.
This type of Fortitude was especially evident in those who led and participated in our clinical trials, including our clinical development team the investigators and staff at our cancer centers that are implementing our clinical trials and most importantly, the trial participants and their families who selflessly volunteered their time.
<unk> and energy despite these many challenges.
For the patients with advanced cancers participating in our clinical trials every day activities suddenly became an even greater or deal. If these patients were willing to participate in our trials. So that we could continue developing several of them staff to all the past and current participants in our trial. We thank you.
Later in today's discussion I will talk more about the positive impact of our recent clinical and financial milestone achievements and our plans to continuing developing sexual them staff for a larger market indications, including solid tumors and hematological cancers, but now I would like to hand, the call over to our Chief Financial Officer, Mark Rosenblum.
<unk>, who will speak to our fourth quarter full year 2020 financial results Mark. Please go ahead. Thank.
Thank you David for the three months period ended December 31, 2020, Soliris reported a net loss of $1 8 million or 10 per basic and diluted share compared to a net loss of $1 $9 million.
And 46 cents per share in the fourth quarter of 2009.
For the full year Soliris reported a net loss of $7 $4 million and 50 per.
Per basic and diluted share versus a loss of $6 9 million were $2 12 per basic and diluted share for the prior year.
The loss from operations before other income for the three months ended December 31, 2020 decreased by $3 million compared to the loss from operations of overall $2 1 million for the same time spend last year, which was primarily due to an increase of <unk> 4 million.
And grant revenue.
And lower general and administrative costs more than offsetting higher research and development expenses expenditures.
Increased research and development costs resulted from increased drug manufacturing costs.
The decrease in general and administrative costs, resulting resulted from the absence of expenses related to soliris as onetime transformation into a public company during 2000, and 2019, which did not reoccur in the current period.
This offset higher personnel costs in the current period.
Our December 31 balance sheet States, the company had $11 $1 million in cash and cash equivalents.
The balance sheet was strengthened in early 2021 as the company raised over $30 million from both the sale of our common stock an underwritten public offering and warrants exercises. We also received $9 million in non dilutive secret financing during Q1 2020.
<unk>.
Soliris has an additional $4 $8 million under the secret Grant and we expect to receive a portion of that amount in 2021.
The results of these funding activities is that Soliris is currently available cash of approximately $37 million.
Our strongest financial position to date.
We believe Solaris has the financial resources available to advance our ongoing clinical trials through completion and beyond.
With that I'd like to return the call to David.
Thank you Mark.
As we've discussed our goal as a company is to maximize the potential of <unk> and by doing so bring hope to patients and their families facing limited treatment options, while creating and building shareholder value.
To that end I would like to state that by mid year 2021. This year, we hope to have active clinical trials across five separate patient populations evaluating secular <unk> as single agent therapy and in up to three different combination therapies.
As discussed earlier.
Cleaning the dose escalation stage of our Ewing sarcoma clinical trial was a major achievement.
The primary purpose of the study was to determine the safety and Tolerability of cycling that staff with secondary endpoints to assess the maximum tolerated dose determined the recommended phase two dose.
And measure any tumor activity pharmacokinetics and pharmacodynamics.
I am pleased to report that the dose escalation stage succeeded.
Data demonstrated that <unk> has a manageable safety profile the.
The recommended phase two dose for the expansion stage has been established and importantly, pharmacokinetic data indicated that treatment at the recommended phase two dose achieved human plasma concentrations.
Bob levels, where secular Darmstadt demonstrated activity in preclinical or animal studies.
We believe the data from these dose escalation trial is compelling and for this reason soliris had submitted the full findings, including details on safety dosing and initial efficacy signals for presentation at an upcoming oncology conference.
Once the MB.
Embargo lifts, we will be able to provide more detailed information.
Again, please allow me to reiterate because it is important to state clearly the dose escalation stage of the trial achieved all key endpoints demonstrated circlet Nab them staff safety profile established a recommended phase two dose and we believe that provided early evidence of drug activity.
Although our dose escalation trials, primarily focused on establishing second item staff safety. We believe as we stated we observed preliminary evidence supporting circlet them stats potential to treat advanced stage cancer patients.
Notably.
These observations occurred in patients primarily treated at doses below the recommended phase II dose in patients that were heavily pretreated with multiple prior treatment failures and in patients who had relapsed or refractory disease upon enrollment.
This preliminary evidence of drug activity was observed in a refractory Ewing sarcoma patient who was treated with single agent <unk> for $6 28 day cycles and demonstrated more than a 75% tumor reduction and prospectively defined some of target lesions.
However, despite this significant tumor reduction a new non target lesion appeared at the end of cycle two resulting in a classification of progressive disease is defined by response evaluation criteria in solid tumors version, one one or resist one one.
Having said that.
Solarium believes this data demonstrates preliminary single agent drug activity in a patient with refractory Ewing sarcoma, meaning.
Disease, which had failed prior medical treatments responded to sector with them SaaS.
As single agent therapy.
This is especially encouraging given the challenge in treating refractory disease and the fact that the patient received no other cancer treatment, while taking cyclothyme staff.
Given the preliminary evidence of drug activity observed Soliris believes there is a meaningful opportunity to introduce circlet them stat earlier in the Ewing sarcoma continuum of care, which we believe will benefit patients and increase the addressable Ewing sarcoma patient population.
Internal preclinical research suggests that ewing's sarcoma cell lines.
In Ewing sarcoma cell lines circlet them stat has an additive effect and an additive effect when combined with the chemotherapy agents <unk> and cyclophosphamide.
This suggests the sexual them stack can be added to <unk> and cyclophosphamide and potentially improve upon current patient outcomes.
Additionally, because <unk> and cyclophosphamide are commonly used as second or third line treatment.
Soliris can potentially increase the addressable patient population for circlet them staffed by supporting doctors and patients who use of <unk> staff earlier in the treatment paradigm.
Based on these conditions Soliris considerations soliris amended the dose expansion trial protocol, so that ewing's sarcoma patients who have failed one or two prior lines of therapy may be treated with <unk> in combination with <unk> and socs.
Cyclophosphamide as second or third line therapy.
This is an exciting development and one that aligns perfectly with our goal to increase our use of circular them staffed by exploring its potential as a treatment for a broader patient population.
In addition to the Ewing sarcoma news, we believe we have seen encouraging clinical data from a small subset of viewing related sarcoma patients enrolled in the Soliris advanced solid tumor trials.
All patients in this subgroup had relapsed or refractory disease when enrolled in the trial and all patients in this subset demonstrated signs of drug activity.
Despite being treated with <unk> at doses below the recommended phase II dose.
Patients in this subgroup exhibited a median time to progression longer than a commonly used benchmark for assessing single agent activity in this advanced relapsed soft tissue sarcoma center.
This is exactly and I want to repeat this is exactly the type of data and we were hoping to see to support <unk> potential to treat these difficult Ewing related sarcomas and move forward with our strategy to expand into new patient populations established new potential path to regulatory approval.
And pursue the related commercial opportunities.
Soliris is now initiated.
The dose expansion stage of the Ewing Ewing related sarcoma trial, which was expanded to include up to 30 patients with relapsed or refractory Ewing sarcoma as well as up to 30 patients with Sarcomas they share a similar biology to Ewing sarcoma.
I've referred to these as UN related sarcomas or.
Translocated Sarcomas.
These viewing related sarcoma patients or patients with Myxoid LIFO sarcoma, and other <unk> translocated Sarcomas will continue to be treated with single agent <unk> staff and.
And represent completely new addressable patient populations, each with the potential path for regulatory approval.
And a potential commercial opportunity.
The dose expansion portion of the Ewing Ewing related trial will continue to evaluate safety and antitumor activity in all participants with preliminary data readouts expected towards the end of 2021 and 2022.
Soliris has also submitted findings from the advanced solid tumor trial, including details on safety dosing and initial safety signals for presentation at an upcoming medical conference.
Once the conference embargo lifts, we will be able to provide even more information.
In summary, we believe the clinical data collected thus far from the Ewing sarcoma trial and the ongoing advanced solid tumor trial has demonstrated that <unk> has a manageable safety profile.
It can be administered at doses that are clinically relevant and we believe has provided evidence of drug activity in patient populations with advanced disease.
We believe that the clinical progress discussed to date paints a promising picture of <unk> potential.
As both a single agent.
And combination therapy for patients with hard to treat cancers in need of better treatment options solarium and our clinical investigators are excited about the potential of <unk> to treat Ewing sarcoma patients earlier and the potential to treat these additional ewing sarcoma patient unions related sarcoma patients.
In addition.
And additionally.
We believe there is a substantial unexplored potential ahead for them staffed and we anticipate even more opportunities in 2021 to justify the use of <unk> in other underserved cancers.
In that regard.
<unk> has completed much of the necessary work to begin clinical trials in other cancer indications that align with <unk> mechanism of action and.
And we look forward.
To announcing these trials in the near future areas of interest. We have previously discussed include hematologic cancers, and the use of <unk> in combination with immuno oncology therapies, specifically checkpoint inhibitors.
Checkpoint inhibitors are a class of immunotherapy treatment designed to unleash.
At human immune system attack on cancer cells. However.
These drugs do not work in all cancer patients or in all cancer types.
In addition patients do not show an initial.
In addition patients that do show an initial response can become resistant to the checkpoint inhibitor treatment and experience a return to the disease, commonly known as disease relapse.
Interestingly day.
Data from preclinical studies conducted by the translational Genomics Research Institute in Phoenix, Arizona and.
And published in the peer reviewed journal plus one last year demonstrated the potential of using <unk> in combination with checkpoint inhibitors to overcome cancer's ability to hide from the immune system and thereby unleash the immune system to attack the cancer.
In simple terms.
All of them that may turn tumors concealed from a patient's immune system called cold tumors into hot tumors are tumors. The immune system is able to identify and infiltrate these now hot tumors could then respond to treatment with checkpoint inhibitors. This provides a significant opportunity for secular them stack because.
It could be used to treat patients with a wide variety of cancers that are currently unresponsive to checkpoint inhibitors.
As I said earlier.
Considering the data we have generated to date and the potential for additional data generation and ongoing clinical programs and soon to be announced additional clinical programs. These are exciting times for celerity again.
By mid year 2021. This year, we hope to have active clinical trials across five patient populations evaluating <unk> as single agent therapy, and evaluating several of them stacking up to three different combination therapies.
I would now like to take questions. Joining me for the Q&A portion of this call is Mark Rosenblum, Chief Financial Officer, Dr. Nadine Mirza Senior Vice President of clinical development and Dr. Daniela <unk> director of corporate development with that I will now open the call to your questions.
As a reminder to ask a question you will need to press star one on your telephone.
To withdraw your question press the pound key.
Again, Thats star one on your touched on telephone to ask a question. Please.
Please standby, while we compile the Q&A roster.
Our first question comes from the line of Wang Li of Ladenburg.
Line is open.
Hi, Thanks for taking my question and thanks for the comprehensive update and summary, congratulations on all the progress. My first question is really into the expansion cohort.
The Ewing sarcoma, you mentioned the two different patient population.
Exploit in Lipa sarcoma, and others, Oklahoma just wanted to clarify there are number of patients.
Allocation for these different.
Sarcoma or.
It's a mix.
Thanks for the question.
Yes.
Dr. MRSA would you like to take that.
Yes, Hi, David Thanks.
So yes.
We have allocated around 10% to 15 from Myxoid LIFO Stockholm line around 10 to 15 in other SCD translocated sarcoma patients.
And the reason being so that we could.
We are able to see a clear signal of activity.
Got it and the reason you think.
Next slide Liberty sarcoma based on just thinking that you saw from the dose escalation.
<unk>.
That's correct and not advanced solid tumor.
That is still.
Undergoing dose escalation we have observed.
We have.
We have observed.
Good signal.
And for reasons.
Of confidentiality and the fact that we have submitted this to an upcoming oncology conference I can't go into details.
But we have seen a strong signal in patients.
And in based on that.
These additional 10 to 15 patients will supplement that signal and so we should be able to get that ready.
Strong.
Signal fall further.
Further development.
<unk>.
Potential.
Discussion with health authorities on on next steps.
Got it.
I know you.
Under Basel four the conference presentation, but any color on what should we expect.
Number of patients or what kind of data and.
Timing.
Net of this year.
And that you can share.
Yes. Unfortunately, the embargo is quite broad.
We can't.
Gus disclose anything that was submitted in the abstract.
Okay.
Apologize I won't be able to got it and you don't know yet.
<unk>.
And then maybe looking at.
You are going to have multiple trials ongoing.
Later this year.
And just.
No.
Joan balance sheet, just any color on what time point, what it kind of stays at the current cash can fund all these trials through with.
Completion of this.
Or is this trial standard as of two trials that will be investigated sponsored so maybe crystallize and along.
Key cash runway relating to the completion or progress.
The trial.
David would you like to take debt.
Actually one can see thanks for the question I'm going to toss that one to to Mark because he is the master of our our recent financial transactions and is managing our $37 million in available cash Mark. Thanks, Lindsay we get the tag team with because I'm sitting right next to David So really the way we look at.
Wednesday is we're going to have some readouts probably at the end of Q4, certainly in Q1 2022.
And.
At that time, we will have substantial cash available to <unk>.
First of all we'll have substantial cash available to complete all the clinical trials that we're currently conducting.
And then.
With that information it takes us to a place that says we are we have several different trials on the boards, we won't discuss what they are but.
When we get when we make the decision to pivot to a particular trial, we will have sufficient cash.
To make great headway into whatever trial, we select to us and so we're in very good shape right through the end of 2021 really well past 2022 as well.
Recent cash raise really shut us.
In a different position.
Frequently asked question is do you guys have sufficient capital to complete the trials that you are currently conducting when we have non deal Roadshows, where we have investor Roadshows. That's a very common question you guys have sufficient cash to complete the plan you are currently on and now we can say emphatically, yes, we do.
So I hope that helps you.
Okay, that's great.
And congratulations again, thanks for taking my question.
Thank you Lindsay.
Thank you. Our next question comes from the line of Adam <unk> of Benchmark Company. Your line is open.
Hi, good afternoon.
We are taking my questions and congratulations.
Strong quarter and actually the strong year.
So I just wanted to go back to <unk>.
Sarcoma and they are interrelated sarcoma trial so.
You have the.
Combo with chemotherapy in second and third line and then you have a single agent.
All four unions related Sarcomas in third line so why.
Why did you decide not to combine.
Moving to the latest Sarcomas with chemo just like you did with telecom itself.
Dean would you like to take that one.
Yes sure.
It's a very valid question.
So far the mix side LIBOR sarcoma.
There is a.
There are two drugs that are currently.
Approved.
What we have observed in these patients as a single agent.
That those patients who have failed the standard treatment still had.
Significant.
Clinical activity.
So we want to further.
Established single agent activity for the mix of our LIFO sarcoma.
If we are able to show what we observed preliminary I think it will be.
Notably on a simple.
<unk>.
Well good path to regulatory approval as a single agent.
We do have some internal discussions have been going on so we.
We are looking at further from.
The nations as well.
But we're not ready to disclose them at this time rigor.
Regarding the FCT translocation.
Sarcoma, where it is.
No standard treatment for those patients so and these patients are treated with different chemotherapies in a different regimens. So it will be difficult to select a single or cash.
Couple of chemotherapy regimens that one would want to combine with <unk>.
And among those patients in the <unk> translocated patients who had failed multiple lines of prior treatment chemotherapy than other agents.
We have observed a significant clinical activity as a single agent and following the same logical path.
If we can show.
Similar activity.
Additional patients that would be regs.
The regulatory potential regulatory path for approval flow single agent.
Alright Christian.
Okay.
Yes.
I just wanted to pull up on debt.
So what do we see there as as a success where does can you remind us what the standard of care standards for those two kind of groups of patients.
Second and third line sarcoma, and kind of third line plus young related or is there kind of all rock specific number or is there overall survival number that you're targeting.
Yes, so I can not disclose what we are aiming toward what we observe but I can tell you what the benchmark song.
Our Ewing sarcoma.
The benchmark is around five to six months median PFS.
Four makes our LIFO sarcoma.
And earlier lines of patient now remember we have patients that have failed the standard treatment, but it makes a lot of local sarcoma. The range up median PFS is around three five to four months median PFS.
Our cash located.
Sarcoma.
As I mentioned, there is no clear good bench.
Benchmark, but what we have observed when you looked at the literature. Its average is around median of two to three months.
And.
In our study we have seen much much significant prolongation of these.
Progression free.
Ireland time standpoint.
I apologize again, I'm going to I'm going to probably go a little bit different.
Do you envision Google the pathway is a single arm study in any of those few income moving.
The related sarcoma cohort so trials.
Well, yes that would be a discussion with the health authorities based on those patients have <unk>.
Exhausted all treatments.
Options.
These patients represent highly unmet need.
And I think that regulators would take a view of that from.
You present them with the data showing that these patients have failed.
Either standard treatments available.
Or the fact, though standard that people use currently.
And once they have failed those treatments and yet.
Single agent <unk> said provides additional benefit in terms of prolonging the time cooking with progression.
I would certainly hope that the regulators would take debt into account.
For a potential approval.
Okay Alright.
And.
For advanced solid tumors.
Are there indications that you see as the most promising in your opinion for cyclical.
Are you planning to apply biomarker based kind of collection growth forward in the phase two.
Daniela would you like to.
Comment on <unk>.
Biomarkers and what we're currently.
Reviewing.
Yeah happy to.
And in our advanced solid tumor trial, we did enroll.
As you know these new ink related tariff implementation and based off the signal mentioned by David and Dean is why we're now expanding the Ewing sarcoma trial to include these additional patients.
Any of the STL again solid tumor trial has given us an indication of patients that may respond better to exit out of debt.
In addition, we are conducting preclinical work to identify if there are sensitizing mutation to <unk> that that work is ongoing.
We hope to report results in <unk>.
Next few months.
Alright, I appreciate that.
Another question on half from sort of this is the last one.
About the you mentioned the additive effect of chemotherapy.
And are you planning to share that data are you planning to publish that data and.
If there is additional additive effect to chemotherapy why or why wouldn't you try all the trials with chemotherapy instead of try and costs.
As a single agent. Thank you.
So Daniela why don't you start with the internal additive data and our plans to offer that and additional work and then I'll address the second part of your question.
Yeah happy to so we have done.
In vitro experiments, combining the chemo regimen tober taken in cyclophosphamide with stuck with them is that in.
Additivity.
And the mechanism there is total of ticket and cyclophosphamide or DNA damage.
James and Alex <unk> has been implicated as well in the DNA damage response.
And they also expose more DNA through its chromatin reconfiguration.
The effects of DNA damage in HN.
So we feel quite strongly about combining with turbo taken in cyclophosphamide from a mechanistic point of view, but then also importantly.
Our safety profile does that have significant overlapping toxicity concerns with the chemo regimen.
Which means that you know moving forward in clinic.
It's a good strategy I think don't have those overlapping tox concerns.
And I'll, let David mentioned, why we're taking the strategy of continuing to pursue single agent and some of the other unrelated sarcomas before commodity with chemo.
So thanks for the question. The short answer is we have not taken anything off the table.
We're going to follow the science and always try and do what's in the best interest of achieving the most positive outcomes. So where we are now with the <unk>.
Myxoid unions related Sarcomas.
Is we're following the results that we observed in the <unk>.
The subset of patients.
And we're fortifying those results with greater patient numbers and by continuing and single agent <unk>.
Therapy as Nadeem mentioned earlier.
We see results that we're hoping to see we could have potentially both a single agent and a combination therapy approach to treating those.
Those types of viewings related Sarcomas, while this is going on our we're working here in our lab internally to identify what chemotherapy agents might be the best.
Combination choices should we decide and headed that direction. So moving back to my how I started the answer to your question.
We're keeping all options on the table, but right now we like the fact that we're pursuing single agent therapy, and see where that takes us which sets up the option of head in a number of directions in the near future.
Alright. Thank you very much appreciate taking all the questions and congratulations again with the strong quarter.
Yes, thank you and take care.
Thank you. Our next question comes from Hunter Diamond Diamond Equity Research your question. Please.
Firstly, great presentation, I think one of the best ones I have heard from David and the management team.
And a lot of positive developments my question relates to what do you view as the potential of <unk> with them stat in Hematological malignancies, and what that is sort of driving that.
Hunter I hope Youre doing well thanks for the question day.
And yellow would you like to take that.
Yes happy to thanks for the question Hunter.
So LSD one as a target has been well validated <unk> malignancies.
<unk> role in blocking differentiation and then driving malignant solid growth.
And we've seen other companies with LSD one inhibitors shown.
Clinical proof of concept in hem indications specifically in AML.
Hilarious slowly embedded with studying cycle items that in a variety of heme malignancies, AML Myelodysplastic syndrome, and we've seen this cycle than it has in anti proliferative effect.
So that it shows synergistic effect when combined with a commonly used agent in the space is decided.
And then as we mentioned before one of the benefits from secondary Scott is that we have a manageable safety profile and we have not seen significant heme tox.
Some of these other LSD one inhibitors will often face in clinic, so we think that the.
A nation of our activity in the preclinical models.
Bold with our advantage in terms of.
More manageable.
50 profile we.
We will give us an advantage in pursuing circle against that within the Hematological malignancy indications and we're looking forward to formally announcing a trial in the space.
And initiating that trial in the next few months.
Great. Thank you very much Daniela for the update.
So my next question is maybe more high level. Obviously the company is in the best financial position since we've covered the company.
And in its history and it has as you stated money per existing trials I guess I'm, just trying to understand and I don't know how much you can comment on this obviously you are very positive.
David on the prospects of each subpopulation populations how.
How do you view the company is sort of how you.
Looking at and I know I may have asked this before but are you looking at sort of other assets to acquire at this point is it more stuff would come inbound or do you think theres just so many sort of prospects for a smaller public company at this point that you.
You are just trying to advance sort of these new indications that youre already have this quarter.
So hunter thanks for the question.
The answer is I am constantly looking at.
All areas that will first support the development of <unk>.
And ensure that we are maximizing its potential.
For patients and ultimately shareholders.
We want we want to do what's best for patients and create value for shareholders now having said that.
<unk>.
We are approached constantly.
Bye bye other organizations that have seen our ability to develop assets and advance them and they want to talk to us about potentially.
Assisting with their with their assets and moving them forward. So we take a lot of calls we take a lot of meetings and I can't comment or commit one way or another of what might happen in the future, but first and foremost, it's all about <unk> and <unk>, but if the right opportunity will come of it were to come along too.
Increase the pipeline.
We would we'd certainly evaluate that.
That opportunity with full force.
Absolutely Yeah, no I'm, just thinking very high level, because as you know theres only sort of a few companies where you play in epigenetics right. I mean, you can almost count them on our hands public companies that have access to funding. So I would think I guess, what I'm hearing is generally youre feeling that there are a lot of opportunities if and when.
Something arises it seems like it's a great time to be in the epigenetics market as a whole.
I think it's an outstanding time.
It's even better than greed.
Outstanding time.
Field.
There's there's there are a lot of companies that are developing other epigenetic drugs going after other targets.
I think in the LSD, one space or the LSD, one inhibitor space, we're really well positioned.
There are other companies that have recently announced preclinical programs in the <unk> space.
Many of them are pursuing reversal billety in their <unk> inhibitors. So everything we're seeing at a high level indicates that we're heading in the right direction and we just want to head down that path as quickly as we can.
Absolutely Yeah no in this in this call really affirms I've been sort of the direction and I think.
The strategies are advancing so again, thank you for taking the questions and stay safe and from.
Yeah, you as well take care.
Thank you at this time I would like to turn the call back over to Soliris CEO, David author for closing remarks, Sir.
Thank you.
Hopefully.
What you have heard me say two or three times.
Is that Soliris has never been on a stronger footing than it is right now.
Operationally clinically and financially.
We entered 2021.
With a great deal of momentum.
And now we have the resources to maintain that momentum as we advance and we hope to continue to expand our clinical programs and continue the development of several of them stat and as I mentioned earlier, hopefully what you have seen or heard as I have gone through.
Through today's review is debt.
Painted a very positive picture of what we think the future could look like.
I'd like to thank our employees.
For their dedication and loyalty and for our stakeholders for their continued support.
As we continue to work to bring hope to patients and their families. Battling these devastating cancers that we believe are well suited to treatment with <unk>.
I appreciate your time and attention today and I would like to extend my sincere swishes a good help at all thank you and I look forward to talking in the future take care.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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