Thank you for standing by. And welcome to Salarius Pharmaceuticals Third Quarter 2021 Corporate and Financial Results Conference 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. [Operator Instructions] Thank you.

I would now like to turn the conference over to Jason Rando of Tiberend Strategic Advisors. Please go ahead..

Great. Good morning, and thank you for joining Salarius Pharmaceuticals 2021 third quarter financial and corporate results call. Earlier this afternoon, Salarius Pharmaceuticals issued a press release detailing its financial results for the three months ended September 30th, 2021, which we encourage listeners to read.

The press release can be found in the News section of salariuspharma.com. Before beginning today's call, I would like to make the following statement.

Today, we will be making certain forward-looking statements about operating metrics, future expectations, plans, events and circumstances, including statements about our strategy, future operations, and the development and effectiveness of our lead investigational drug candidate, seclidemstat, and our expectations regarding our capital allocations 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, including those detailed in the risk factor section at Salarius Pharmaceuticals' Annual Report on Form 10-K for the year ended 2020 and subsequent Quarterly Reports on Form 10-Q, which had been filed with the SEC, as well as in our other filings we make with the SEC from time-to-time.

Salarius 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 Salarius Pharmaceuticals, who will provide an update on Salarius' corporate and clinical achievements during the third quarter and its vision for the future; and Mark Rosenblum, CFO, who will review Salarius' third quarter financial results. With that, David, I turn the call to you..

Thank you, Jason, and thank you to everyone dialing in to our conference call today, particularly, all of you who are joining us for the first time.

The third quarter in recent weeks were yet another exciting period for Salarius as we continue to implement our strategy to build a multi-pronged approach to investigating seclidemstat in cancers were LSD1 is known to be effective.

In summary, during the third quarter in recent weeks, Salarius increased the number of sarcoma clinical trial sites, completed enrolment in the Initial Ewing Sarcoma Combination Therapy Safety Lead-in Cohort, enrolled additional patients in the myxoid liposarcoma and FET-rearranged sarcoma cohort and established a research partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center.

In addition, Nationwide Children's Hospital presented data at an important medical conference demonstrating seclidemstat's differentiated mechanism of action resulting in unique anti-cancer activity. And finally, we received $2.7 million from the Cancer Prevention Research Institute of Texas and Selarius was added to the FTSE Global Microcap Index.

Now. It was a busy quarter and has been a busy past few weeks, so there's a lot to review today. But before we get into details, I would like to take a moment to provide some background to those of you on today's call who are new to the Selarius story.

For those of you who are not new to Selarius, please indulge me where I have some perspective to our newest listeners. Our lead asset called Seclidemstat is an oral drug a tablet actually that inhibits a widely validated cancer target LSD1. Targeting the LSD1 enzyme has been an area of interest in Cancer Research for over a decade.

The LSD1 plays a key role in the development of progression of numerous cancers. Seclidemstat is a novel reversible LSD1 inhibitor with a differentiated mechanism of action that granted broad activity across several cancer types compared to other LSD1 inhibitors being researched in clinical trials.

LSD1 carries out its cancer promoting effects by causing dysregulated gene expression which results from the misreading of genetic code in the nucleus of the cells. A good analogy for appreciating dysregulated gene expression and on an analogy I've used before is baking.

If we follow a recipe precisely and then mix the correct ingredients in the right amounts, the result is a successful birthday cake. This regulated gene expression is essentially the misreading of our genetic recipe. All the right ingredients are there, however, they are in the incorrect quantities.

And that occurs in the context of living cells, meaning our genetic code is misread, it can meet the development and progression of cancer. Seclidemstat is designed to correct this dysregulation and we believe the research presented during the third quarter affirms and confirms this capability.

As we've discussed our recent accomplishments and future plans, you'll hear me describe a two-pronged development strategy; speed to market represented by our sarcoma program and expand the market represented by our hematologic or blood cancer program; and our continuing research into other large market opportunities.

With that as the back drop, let's discuss the accomplishments in third quarter in recent weeks. Seclidemstat is currently in two clinical programs spanning five different patient groups and is being studied as a single agent therapy and in two different combination therapies.

Our lead clinical program which we refer to as our Sarcoma Program, is a Phase ½ clinical trial with three patient arms. The first arm is investigating seclidemstat in combination with chemotherapies, topotecan and cyclophosphamide to the treatment of Ewing sarcoma.

The second and third arms are exploring seclidemstat as single agent therapy for the treatment of myxoid liposarcoma and other FET-rearranged sarcomas. During the third quarter, Selarius added five new clinical trial sites to our sarcoma trial increasing the number of active sites to that are now supporting sarcoma enrollment to 13 total sites.

These new sites include the Cleveland Clinic, Fox Chase Cancer Center, Oncology Consultants of Houston, Virginia Cancer Specialists, and Washington University in St. Louis. These 13 sites provide a good mix of both pediatric and adult sarcoma centers of excellence.

We're also actively completing the contracting process with several additional cancer centers which we anticipate bringing online it's clinical trial sites by year end.

Patient enrollment in the sarcoma clinical trials accelerating, we believe due to the increased number of active clinical trial sites that I just discussed and the positioning of seclidemstat for use in combination with topotecan and cyclophosphamide or TC for the treatment of relapsed/refractory Ewing sarcoma.

As we have mentioned previously, the TC therapy is a common second and third line treatment for Ewing sarcoma. And adding seclidemstat to TC therapy presents an easy integration into a common treatment regimen used earlier in the patient's treatment paradigm.

In addition, as we've previously reported, in a common Ewing cell line, seclidemstat and TC demonstrated anti-cancer synergy. Meaning, that one plus one equals more than two in anti-cancer activity.

In summary, we've added more clinical trial sites able to add seclidemstat to a commonly used second and third line therapy or the addition of seclidemstat to this therapy shown to be synergistic. I mean, one plus one equals more than two in any cancer activity in treatment or experiments.

We believe these factors are all positively influencing enrollment across the sarcoma trail. We are also pleased to report that the initial Combination Therapy Safety Lead-in Cohort for reviewing sarcoma trial arm has completed enrolment and we expect the seclidemstat recommended Phase 2 dose and TC combination to be underway by early 2022.

We look forward to providing potential clinical data readouts later this year and throughout next year. All-in-all, we are very pleased with our clinical process and our clinical progress. During the quarter, we were also pleased to report the establishment of a research partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center.

The research is to be conducted in the Laboratory of Dr. Johnathan Whetstine, the institute's director, and would help identify additional indications and potential biomarkers for seclidemstat.

Other ongoing prestigious research partnerships include Nationwide Children's Hospital, which recently presented research showcasing seclidemstat's unique ability to inhibit LSD1's non-enzymatic functions leading to anti-cancer activity in FET-rearranged sarcomas.

And the MD Anderson Cancer Center which activated an investigator initiated clinical trial to study seclidemstat in hematologic blood cancers in myelodysplastic syndrome MDS and chronic myelomonocytic leukemia or CMML. We believe this widespread interest in seclidemstat is due to the drugs unique and potentially advantageous properties.

Seclidemstat employs a differentiated dual mechanism of action that appears to granted activity across several cancer types compared to other LSD1 inhibitors. We believe the seclidemstat has the ability to not only inhibit the enzymatic activity of LSD1 but to more robustly inhibit the scaffolding properties of LSD1 compared to other LSD1 inhibitors.

This scaffolding properties of LSD1 have high relevance in several cancer types including solid tumors in large commercial markets. This ability to inhibit the scaffolding properties of LSD1 was recently underscored by research conducted by Dr. Emily Theisen at Nationwide Children's Hospital.

They represented at a Cancer Research Conference last month, indicates that seclidemstat's robust scaffolding inhibition is essential towards any cancer activity in FET-rearranged sarcoma.

In fact, seclidemstat demonstrated potent activity across cell lines, while in inactive control agent and in irreversible LSD1 inhibitor demonstrated minimal or no activity against the same cell lines. This means, that in FET-rearranged sarcoma cell lines, seclidemstat worked, wherein irreversible LSD1 inhibitor did not work.

Based upon all these news, you can continue to understand why we at Salarius are extremely excited by seclidemstat's overall progress and potential. Before I shift topics and discuss the near-term future, I would like to ask Mark Rosenblum, Chief Financial Officer, to discuss our strong financial foundation which is enabling all of this progress.

Mark, over to you..

Thank you, David. For the three month period ended September 30th, 2021, Salarius reported a net loss of $3.7 million or $0.08 per basic and diluted share, compared to a net loss of $1.7 million or $0.10 per share in the third quarter of 2020.

The loss from operations before other income for the three months ended September 30th, 2021, increased by $2 million compared to the loss from operations of $1.8 million for the same time spend last year which was primarily due to the absence of grant income and increased overall spending.

CPRIT grant revenue was zero for the three months period ended September 30th, 2021, compared to $1.4 million for the year-ago period resulting from the completion of the CPRIT available funding under the grant during the second quarter of this year. Hence, we have reached the maximum amount of eligible spending that can be reimbursed from CPRIT.

Research and development cost increased approximately $0.2 million resulting from higher clinical trial costs and increased personnel costs more than offsetting lower chemical manufacturing cost when compared to the same period a year ago.

General and administrative cost increased $0.4 million during the current quarter compared to the year-ago period resulting from higher overall personnel cost and increased professional fees. As of September 30th of 2021, total cash, cash equivalence totaled $31.9 million compared to just $9.6 million in September 30th, 2020.

Our working capital position on September 30th of this year was $33.6 million compared to $12.3 million a year ago; clearly a much healthier financial position. The company's overall cash position and its access to additional cash is the best of the company's history. We have access to the capital markets using our shelf registration.

Our cash our current cash position includes the $2.7 million disbursement from CPRIT or from CPRIT as a pay down of a current receivable. The payment is part of the non-dilutive brand awarded back in 2017 to support Salarius' operations and developments of its lead drug candidate seclidemstat.

Up to $2.1 million in funding remains available and is listed as a grant receivable on the company's balance sheet. We believe that our current cash position will be sufficient to fund our operations through the completion of our current clinical trials in 2022 and beyond. With that, I'd like to return the call to David..

Thank you, Mark. As you can see from Mark's discussion that in addition to our recent accomplishments and progress, Salarius continues to maintain a strong financial position. Our primary goal as a company is to maximize the potential of seclidemstat by expanding its use to into new and larger indications.

You heard me describe a two-pronged development strategy, speed to market and expand the market, represented by hematologic cancer program and our continuing research into how seclidemstat can address other cancers. Let us take a moment to talk about the future. Which is all about clinical data across our numerous patient populations and our pipeline.

Before I comment on our pipeline, let's review potential upcoming events. As mentioned, we're actively enrolling in our sarcoma trial and expect potential data readouts as early as this year and throughout 2022.

In addition, an investigator initiated clinical trial is now underway at MD Anderson Cancer Center exploring seclidemstat in combination with a commonly used cancer drug azacytidine as a treatment for hematologic cancers.

Like other seclidemstat drug combinations, the combination of seclidemstat and azacytidine demonstrated synergy in pre-clinical research. Again, meaning one plus one equals more than two in anti-cancer activity.

Clinicaltrials.gov reports that this investigator initiated trial is recruiting and we hope the trial will provide proof-of-concept data demonstrating seclidemstat's ability to treat myelodysplastic syndrome or MDS and chronic myelomonocytic leukemia or CMML, both of which MDS and CMML are precursors to acute myeloid leukemia which we all know as AML.

AML represents a significant opportunity to help patients and also represents a sizeable market opportunity. According to the American Cancer Society, AML alone accounted for almost 20,000 new U.S. cancer diagnosis last year. We're looking forward to potential initial results from this proof-of-concept clinical trial next year.

And as I've mentioned previously, the HonorHealth Research Institute located in Scottsdale, Arizona, has listed on clinicaltrials.gov a clinical trial titled a higher trial of SP-2577 plus Pembrolizumab in Select Gynecologic Cancers.

And that trial is described as an open label study of seclidemstat plus pembrolizumab or known as Keytruda in advanced recurrent small cell ovarian cancer as well as select additional ovarian and endometrial cancers within SWI/SNF pathway.

We are very excited about this clinical trial as we believe it could provide proof-of-concept data not only in cancers with select tumor mutations or also proof-of-concept data utilizing seclidemstat in combination with the checkpoint inhibitor Keytruda also known as Pembrolizumab as we just mentioned.

Keytruda is a type of cancer drug that harnesses the immune system to kill cancer cells. We are anxiously awaiting word from the HonorHealth Research Institute, they've activated the trial in the enrollment patients.

It's also important to note that in addition to combining seclidemstat with azacytidine and pembrolizumab, Selarius is also conducting research to identify other promising combinations to address additional larger markets with unmet needs. Finally, and something we have not typically included in our discussion is our pipeline.

For those of you who have attended one of our recent financial conferences or have visited the Salarius website and reviewed our corporate presentation, you will have noticed our discovery stage second generation LSD1 inhibitor program targeting both solid tumors and hematologic cancers.

Given our experience in the LSD1 field, we believe that this makes a lot of sense and you can see this activity in our increased non-clinical research. In addition, our financial strength is attracting companies who are now approaching us with opportunities to review other potential pipeline assets.

The takeaway point is that with seclidemstat advancing in the clinic and given our financial strength, now it's an excellent time for us to be looking both organically and inorganically a pipeline opportunities. And I said earlier today, these are exciting times for Salarius and we're looking forward to building on our current momentum.

I would now like to take questions. Joining me for the Q&A portion of this call is Mark Rosenblum, Chief Financial Officer; Dr. Nadeem Mirza, Senior Vice President of Clinical Development; and Dr. Daniela Santiesteban, Director of Corporate Development. With that, I will now open the call to your questions..

Thank you. [Operator Instructions] And your first question comes from the line of Ahu Demir of Ladenburg. Your line is now open..

Hello, everyone. Thank you very much for taking my question. My first question is about enrollment, continually open five additional clinical sites.

Do we expect any changes in terms of completion of enrollments and data readouts for sarcoma trial?.

Ahu, good to hear from you. Thanks for joining the call today, this is David. I think the answer to your question is we are continuing to add sites and we believe that will only reinforce our current estimates and our communications that we plan to release clinical data potentially at the end of this year and throughout next year.

As I mentioned during the discussion, we're already seeing the early signs of acceleration in enrollment across all three of the cohorts.

So, we really think we're doing the right activities are to keep to advancing enrolment and we've also taken additional measures to make the awareness of the study, more prominent across the country with our work they were doing with all of the major search engines and other institutes that specialize in advertising clinical trials for their sarcoma cancers.

So, the short but I just gave you the long answer. The short answer to your question is the faster we can enroll patients the sooner we're going to be able to release meaningful clinical data and that's what we're working on day in and day out right now..

Thanks for your answer, David. And I have another question focusing on FET-rearranged sarcoma. Considering you have some compelling data reduction three patients that you enrolled.

Could you please remind us in terms of the addressable market particularly comparing it to the Ewing sarcoma? And I think the second part of my question is regarding next step for FET-rearranged sarcoma patients.

What is the thought process, are you planning to attest seclidemstat as a single agent or either any combinational studies strategies you're considering.

If so, what would make the most sense combining secli with other agents, what is the thought process in terms of strategy?.

So, let me ask Daniela Santiesteban to take the first part of that question and I'll ask Nadeem to take the second part.

Daniela, are you on line?.

Yes. Happy to answer, Ahu. Thanks for the question. So, your first question in terms of the addressable market. FET-rearranged consists of a group of different sarcoma types.

So, it's myxoid liposarcoma, clear cell sarcoma, extraskeletal chondromyxoid sarcoma, and compiling all those groups together and effectively it triples or quadruples the targetable patient population compared to just doing sarcoma.

So, if we're only expands our patient population and given the rarity of the indication, it still allows for that lead to market component because a lot of with sarcoma still suffer from high unmet need on.

Does that answer that portion of the question?.

Yes, it does. I'm a little bit curious, Daniela, if you could compare it to Ewing.

Did you mention it's three times more than Ewing, like the market positions much larger, just trying to clarify?.

Yes. So, in Ewing, the estimates are further up to 500 new patients per year here in the U.S. and about 2000 if you include other larger market country. For these other ones just in the U.S., there is about 1500 to 2000 if you compile all those sub types together.

And then within the advanced sarcoma which is the patient group we're treating, it ranges based on sub type anywhere from 20%, 30%, it's 50%, 60%. And so, as a whole it does relatively triple or quadruple, and so we're up here in sarcoma numbers..

Okay, thank you. This is all for Daniela..

Nadeem Mirza, follow-up on..

Yes. Thank you, Daniela. Yes, hi Ahu, thank you for the question. What I heard from you was that you wanted to find out what our strategy is moving forward. Look, there as you mentioned we saw some compelling signal in one of our advanced solid tumor and that data was presented at ASCO and will be presented as an update at the CTOS upcoming meeting.

Based on that, we have two cohorts as David mentioned in the FET patient population, we have a myxoid liposarcoma cohort and we have also FET sarcoma cohort. Currently, we are investigating single agent activity but we are also looking into the potential combination.

And we've already started working towards that both in terms of generating some preclinical data but more importantly working towards a clinical program. The plan moving forward would be to potentially combine seclidemstat with most commonly used standard therapies for these myxoid liposarcoma or FET-translocated sarcoma patient.

So, the short answer is yes we will have both data for single agent and in the next phase would be with a combination that's on commonly used therapeutics..

Great. Thank you so much, Nadeem, Daniela, David. Good to hear from everyone's voice, thank you..

And Nadeem, if we were to think of myxoid liposarcoma in combination with other therapies, wouldn’t that move it up in the treatment paradigm and make it easier, perhaps more convenient for physicians to treat patients?.

Yes, absolutely will. Currently, we have if you combine with the standard treatment, so we will be looking at either first relapse or second relapse and most likely we'll move towards first relapse which is very early line of treatment and follow the line of treatments approved for the other combination therapeutics.

So, similar to what we've done in our Ewing sarcoma where we have come with combining with topotecan and cyclophosphamide to moving it in earlier phase of Ewing sarcoma. We will follow the same strategy for myxoid liposarcoma and also FET sarcoma's..

Okay, thank you..

Your next question's from Aydin Huseynov of Benchmark. Your line is now open..

Hi, everyone. Thank you for taking my questions and congratulations with the progress in this quarter. On my first question is about new molecular a new chemical entity that you had so on the presentation and also talked a little bit about.

So, I wanted to get more color on this second generation LSD1 inhibitor and just understand how it is different from seclidemstat and where this product was discovered and what is was in License or whether it was discovered internally. Just tip more ideas in terms of these asset and how are you planning to develop this asset going forward..

Happy to talk a little bit about that Aydin, it's good to hear from you. This is an organic program, so in-house. We've given everything that we have learned about the LSD1 inhibition space, the differences between reversible and in irreversible, the different binding pockets, the scaffolding versus enzymatic activity.

We thought we were in and we believe we're in a fantastic position to focus on the next generation -- not focused but work on the next general of LSD1 inhibitors. So, we did not in license any products for this particular program. We started at ground zero.

And we have a target product profile, as you can imagine, that incorporates all of our learnings to-date. And we are building this from the ground up internally.

Now, as far as developing it, we would follow the same process that we did with Seclidemstat, which is identify a hit, focus on lead optimization, select the lead, move into Ewing in vivo studies and then move into the clinic. So very traditional development path forward..

And when would you expect this trial this asset to reach clinical trials?.

It's too early to even make predictions like that. This is a very early stage research project. And the fact that we're starting early gives us the opportunity to make sure that we can develop exactly what we think we need to truly represent what a second generation LSD1 inhibitor needs to do.

So, it's too early to predict any timing on clinical trials. But is -- now that we've introduced the topic, we can continue to talk about it as we look forward to future earnings calls..

Okay, understood. Another question I have is about the comparable assets or competition. So, we've got BMS, Horizon, Imago all of them highly valued companies or franchises.

Could you give us a little bit maybe recent updates about this competitive moments, any data updates on the competition side that would give us more ideas in terms of where Seclidemstat stand in terms of the niche indications or such as sarcomas or kind of broader indications or like hematology malignancies or gynecologic cancers?.

Happy to, Daniela, would you like this step in and fill that question..

Yes, happy to. Good to hear from Aydin. So, yes, let me go through the companies you mentioned and provide the latest updates I've seen. So, as you know, ASH is coming up next month. And the company's focused on more of the team’s department are presenting there.

So I saw abstracts from Imago and MF as well as for EPs will be having at least two presentations there and providing an update on their LSD1 inhibitors. I saw rising we'll also be providing an update on their Phase 2 clinical trial in combination with azacitidine at ASH as well. So BMS has not given an update since ASCO earlier this year.

They continue to if you look on clinicaltrials.gov, and you search for their LSD1 inhibitor, they continue to conduct new clinical trials either as a leader in collaboration with others academics. And multiple indications, we -- you and I have talked about the lung cancer trial before that's in combination with Vivo.

There, they're also looking at AML prostate is another indication they're interested in. So things are expanding both within the heme space for companies like Imago and Horizon, but BMS with its differentiated inhibitors also reversible one, they're exploring both the liquid and solid tumor space and doing so in several different combinations.

There is also a newer companies to the parties, and they -- it's jubilant therapeutics. So they have an LSD1 HDAC dual inhibitor. And they have recently reported that they're going to be filing for their R&D hopefully by year-end. So I anticipate seeing their trial start next year.

But we continue to be differentiated in terms of what indications we can pursue. And other than insight formally going after Ewing sarcoma with their LSD1 inhibitor. We're the only ones in this space targeting both Ewing sarcoma and these FET rearranged sarcomas.

Of course, we'll have competition as we start to enroll and expand our MDS and CMML trial within the heme space. But we do think we'd bring a differentiated approach with our reversible binding mechanism and the location we're binding in. So I hope that provided good update for you, Aydin..

Yes, it does. Appreciate it. Appreciate that Daniela. One last question I have is about FET-rearranged sarcoma, I just want to go back to that question and just try to understand you got two out of three patients with stable disease more than six months. Obviously, these are heavily pretreated patients.

Well, but what would -- how would the responses look like without Seclidemstat? What is the kind of the typical responses that we see in these patients? So, if the -- if they were not treated physically themselves?.

So this is Nadeem. I can take the first part and maybe if Daniela, you want to chime in. So, these patients, as you mentioned, were heavily pretreated they’ve got multiple lines of treatment. And so they are not received Seclidemstat they would not -- you will not have seen that stable disease.

These patients typically without treatment, don't -- unfortunately, don't live that long. So, the stable disease, if you will, for these patients would have been less than a couple of months or less.

It's -- what happens with these patients is once they fail all standard treatments, and for especially for FET-translocated sarcoma, there is no specific one treatment. So they may either get back on some chemotherapy, which is usually very toxic for these patients.

Again, I think for a single agent to show stabilization for greater than -- majority of the patients rather than six months, gives us a very good early signal. If you remember, in that advanced solid tumor, they were very late stage patients.

In our current expansion phase, we have limited the number of prior lines of treatment they could receive, so they could receive up to three prior lines of treatment, which means that they could -- we could enroll a fourth line patient.

So we hope that if we -- if you enroll patients that are early lines of treatment, we would expect to see a longer stabilization of disease, which will translate into a longer progression free survival. That's the strategy we are following using the Phase 1 data to inform us on which patient population to further explore in the Phase 2.

And so based on that we have currently have this expansion phase, which has two different FET-translocator sarcomas, one for myxoid and the other one for FTE specifically..

Okay, all right. Thank you very much. Appreciate all the answers. And again, congratulations for the quarter..

Thank you..

Your next question from Mike King of HC Wainwright. Your line is now open..

Hey, good afternoon, guys. Thanks for the thorough update. Just a lot of my questions have been asked and answered.

We just wanted to get a clearer understanding, about the role that Seclidemstat would play in conjunction with pembrolizumab I think you mentioned in your comments, David that ovarian endometrial cancers were your target indications of this is going to be first line or where would you see the combination of pembrolizumab and Seclidemstat fitting in? Thanks..

Yes. This is Nadeem. The current study that we are exploring is obviously in the relapse stage, relapse refractory stage patients. As you know, these patients specifically in that trial, don't have a good therapeutics available. As we start seeing in -- so Phase 1 dose expansion trials.

So, the first thing is to determine the recommended Phase 2 dose of the combination. Once that determined then we will move into early lines of patient. This trial will also providers proof-of-concept generally of combine ability of Seclidemstat with the checkpoint inhibitor.

And as you can imagine, if this is a positive trial, if we get to the appropriate recommended Phase 2 dose we can then further explore in other tumor types where either checkpoint inhibitors are used or checkpoint inhibitors have failed to show significant responses or progression free survival.

So from our perspective, this is a proof-of-concept study that will show whether the Seclidemstat can be combined with a checkpoint inhibitor and if so, what is the recommended Phase 2 dose. So this could potentially open doors for us to explore other tumors with checkpoint inhibitors have been either being used or are currently being investigated..

Nadeem, can you elaborate a little bit on what the target patient population might look like? The reason I'm asking is because there have been other studies where [prorated] active molecule, whether it's [indiscernible] or arginase glutaminase inhibitors combined with a checkpoint in a single ARM study.

And then when those studies go to randomize stage, the effect size fade.

So are you going to try to do anything in terms of study design in order to ensure that -- the real benefit above checkpoint alone is do the Seclidemstat? Maybe you can elaborate a little bit on that or is that still a work in progress?.

Yes, so this particular study that I mentioned earlier, it's an investigator sponsored study. So this is -- the sponsor is on our health, we are providing support, financial, and some, obviously, product support. What you are asking about strategy of where to explore.

So I understand, if you have the best way to approach this would be in my mind, if you want to -- if we were to explore this theoretically, we could look into patient population that have had prior checkpoint inhibitors, and have stopped responding to see if you could re sensitize them to checkpoint inhibitors, right.

And that is some of the preclinical work is ongoing we actually look at this specific question. So again, if I think if we were to start -- if we were to develop therapies in the checkpoint space, the unmet need is where checkpoint inhibitor -- patients who have received checkpoint inhibitors and they have no further therapies available.

So again, we are looking into this preclinical. If the preclinical data supports, then we will further explore it in the clinic..

Okay, thanks for the color on that. I just wonder one quick follow up. And that is will there be some biomarker work done in conjunction with the clinical studies? Thank you..

Yes. So all our studies have biomarker component..

Great, thanks..

And for the last question from Hunter Diamond of Diamond Equity. Your line is open..

Hi, everyone, congrats on the earnings. So I had a quick question related to Epigenetics and expanding the pipeline. And I've asked about that before.

But any ideas you have about, other Epigenetic assets are expanding outside the existing pipeline would be great?.

Hunter, this is David, great to hear from you. Hope you're doing well. I'm happy to comment. So we haven't really talked about pipeline activities on call previously. But, given that we are beginning to talk about it at the investor conferences, we thought we can see it up for today's discussion.

First of all, we're not limiting ourselves to just considering epigenetic programs. We do happen to have, I think some expertise in the LSD1 inhibition space. And that's why we launched our discovery phase program in a second generation LSD1 inhibitor.

Now, the other interesting thing that has happened to us over the past three to four, five months, as we've been communicating, Seclidemstat advancing in the clinic, and more importantly, are the strength of our financial position.

We've had a number of companies reach out to us proactively to talk about their assets that for whatever reason, they're unable or unwilling or they just don't want to advance and develop on their own. And they've been talking to us about possibly getting involved and helping them or bringing the product on outright on board into Salarius.

So your question about building pipeline? Yes, there's an epigenetic component. We've certainly learned a lot about epigenetics I would consider us experts or pretty close to experts on LSD1 space. But given our financial strength, we've had the opportunity to take a look at a number of opportunities that are not necessarily in the epigenetic space.

So I think the best way to answer your question in a short phrase is, yes, LSD1 we're all over that. We have a lot of people coming and talking to us right now. And we'll need to keep you informed at a later date to see whether or not something bubbles to the top and we decided to take action on it..

Great, great. Appreciate the update. That's all I have on my end. So again, congratulations on the results..

Alright, thanks for calling in. Be safe..

And there are no further questions. I would like to turn it back to David Arthur for closing the call..

As you heard from today's discussion, Salarius is continuing to fire on all cylinders. We're -- I'm really proud of the team. And I'm really proud of what we've been able to accomplish. Our clinical trials are actively enrolling patients across five different segments.

We've added to our list of clinical trial sites that is only going to enhance our ability to enroll patients and get the clinical data that everybody is looking for into your hands as soon as possible. We've reached new research agreements.

And additional preclinical research is actively underway to explore our scaffolding properties and how that can identify new cancer indications where we can further improve and add to the treatment options that are available. And underlying all this and supporting this activity is our strong financial foundation.

So you couple that with the hard work and dedication of our employees, and the support we receive from our shareholders, and we are really confident about where we're sitting right now. Without all these people I have just mentioned, Salarius would not be where it is today.

So I just like to close by thanking everyone for your time and attention today and I extend my sincerest wishes of good health to all. Be safe and thank you..

And this concludes today's conference call. Thank you everyone for participating. You may now disconnect..