Salarius Pharmaceuticals Inc (SLRX) 2021 Q3 法說會逐字稿

Thank you for standing by, and welcome to the Salarius Pharmaceuticals' Third Quarter 2021 Corporate and Financial Results Conference Call. (Operator Instructions)

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

Good afternoon, 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 30, 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 allocation and cash resources. These statements are based on 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 Factors section of Salarius Pharmaceuticals annual report on Form 10-K for the year ended 2020 and subsequent quarterly reports on Form 10-Q, which have been filed with the SEC as well as our other filings, which we make with the SEC from time to time. Solaris 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, will review Salarius' third quarter financial results.

With that, David, I'll 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 we got another exciting period for Salarius as we continue to implement our strategy to build a multi-pronged approach to investigating seclidemstat in cancers where LSD1 is known to be a factor.

In summary, during the third quarter and recent weeks, Salarius increased the number of sarcoma clinical trial sites completed enrollment 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 anticancer activity. And finally, we received $2.7 million from the Cancer Prevention Research Institute of Texas and Salarius was added to the FTSE Global Micro Cap Index. Wow, 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 Salarius story. For those of you who are not new to Salarius, please indulge me while I add 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 as LSD1 plays a key role in the development and 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 an analogy I've used before is baking. If you follow a recipe precisely and mix the correct ingredients in the right amounts, the result is a successful birthday cake.

Dysregulated gene expression is essentially the misreading of our genetic recipe. All the right ingredients are there. However, they are in the incorrect quantities. When that occurs in the context of living cells, meaning our genetic code is misread, it can lead to the development and progression of cancer.

Seclidemstat designed to correct this dysregulation, and we believe the research presented during the third quarter affirms and confirms this capability. As we discuss our recent accomplishments and future plans, you will 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 backdrop, let's discuss the accomplishments in the 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 1/2 clinical trial with three patient arms. The first arm is investigating seclidemstat in combination with chemotherapies, topotecan and cyclophosphamide for 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, salaries added five new clinical trial sites to our sarcoma trial, increasing the number of active sites 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 are also actively completing the contracting process with several additional cancer centers, which we anticipate bringing online its clinical trial sites by year-end. Patient enrollment in the sarcoma clinical trial is 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 relapse or refractory Ewing sarcoma.

As we have mentioned previously, 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 a patient's treatment paradigm. In addition, as we have 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 anticancer activity.

In summary, we have added more clinical trial sites able to add seclidemstat to a commonly used second and third-line therapy, where the addition of seclidemstat to this therapy is shown to be synergistic, meaning one plus one equals more than two in anti-cancer activity in preclinical experiments. We believe these factors are all positively influencing enrollment across the sarcoma trial.

We are also pleased to report that the initial combination therapy safety lead-in cohort for the Ewing sarcoma trial arm has completed enrollment, 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. Jonathan Wettstein, the institute's director and will 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 unique ability to inhibit LSD1's nonenzymatic functions, leading to anticancer activity in FET-rearrange sarcomas. And the MD Anderson Cancer Center, which activated an investigator-initiated clinical trial to study seclidemstat in hematologic blood cancers, myelodysplastic syndrome, MDS, and chronic myelomonocytic leukemia, or CMML.

We believe this widespread interest in seclidemstat staff is due to the drug's 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 that 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. The 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. Data presented at a cancer research conference last month indicates that seclidemstat robust scaffolding inhibition is essential to its anti-cancer activity in FET-rearranged sarcomas. In fact, seclidemstat demonstrated potent activity across cell lines, while an inactive control agent and an irreversible LSD1 inhibitor demonstrated minimal or no activity against the same cell lines.

This means that in FET-rearranged sarcoma cell lines, seclidemstat worked where an irreversible LSD1 inhibitor did not work. Based upon all this 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 30, 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 30, 2021, increased by $2 million compared to the loss from operations of $1.8 million for the same time span last year, which was primarily due to the absence of grant income and increased overall spending.

CPRIT grant revenue was zero for the three-month period ended September 30, 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 costs increased approximately $200 thousand, resulting from higher clinical trial costs and increased personnel costs, more than offsetting lower chemical manufacturing costs when compared to the same period a year ago. General and administrative costs increased $0.4 million during the current quarter compared to the year ago period, resulting from higher overall personnel costs and increased professional fees. As of September 30, 2021, total cash, cash equivalents totaled $31.9 million compared to just $9.6 million at September 30, 2020.

Our working capital position on September 30, 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 in 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 as a paydown of a current receivable. The payment is part of the nondilutive grant awarded back in 2017 to support Salarius' operations and development 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 into new and larger indications. You've 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's 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 are 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 SEC seclidemstat drug combinations, the combination of seclidemstat and azacytidine demonstrated synergy in preclinical research, again, meaning one plus one equals more than two in anticancer 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 is AML. AML represents a significant opportunity to help patients and also represents a sizable market opportunity. According to the American Cancer Society, AML alone accounted for almost 20,000 new U.S. cancer diagnoses 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 Honor Health Research Institute located in Scottsdale, Arizona, has listed on clinicaltrials.gov, a clinical trial titled, pilot trial of SP2577 plus pembrolizumab in select gynecological 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 the [SWI/SNF] pathway. We're very excited about this clinical trial as we believe it could provide proof-of-concept data not only in cancers with select tumor mutations, but 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 Honor Health Research Institute. They have activated their trial and their enrolled in patients. It is also important to note that in addition to combining seclidemstat with azacytidine and pembrolizumab, Salarius is also conducting research to identify other promising combinations to address additional larger markets with unmet need.

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 nonclinical 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 is an excellent time for us to be looking both organically and inorganically at pipeline opportunities. As 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. Nadine Merza, 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.

(Operator Instructions) And your first question comes from the line of Ahu Demir of Ladenburg.

My first question is about enrollment. Considering you opened five additional clinical sites, do we expect any changes in terms of completion of enrollment and data readouts for sarcoma trial?

Ahu, good to hear from you. 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 communications that we plan to release clinical data potentially 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 to keep advancing enrollment. And we've also taken additional measures to make the awareness of the study more prominent across the country with some work that we're doing with all of the major search engines and other institutes that specialize in advertising clinical trials for rare sarcoma cancers.

So the short -- 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.

I have another question, focusing on FET-rearranged sarcoma. Considering you had some compelling data readout from three patients that you enrolled could you please remind us in terms of the addressable market, particularly comparing it to do Ewing sarcoma?

And I think the second part of my question is regarding next steps for FET-rearranged sarcoma patients, what is the thought process? Are you planning to assess seclidemstat as a single agent? Or are there any combination strategies you're considering? If so, what would make the most sense combining secli with other agents? What is the thought processes in terms of strategies?

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

Yes, yes. Happy to answer, Ahu. So your first question in terms of the addressable market, FET-rearranged consists of a group of different sarcoma type. So it's mixed oil, liposarcoma, clear cell sarcoma, extraskeletal, condro myxoid sarcoma and compiling all those groups together, effectively, it triples or quadruples the targetable patient population compared to just doing sarcoma. So it certainly expands our patient population. But given the rarity of that indication, it still allows for that speed to market component because a lot of the sarcoma still suffer from high unmet need. Does that answer that portion of the question?

Yes, it does. I was also curious, Daniela, if you could compare it to Ewing, did you mention it's three times more than Ewing, like the market potential is much larger. Just trying to clarify.

Yes. So in Ewing, the estimates are that there up to 500 new patients per year here in the U.S. and about 2,000, if you include other larger market countries. For these other ones, just in the U.S., there's about 1,500 to 2,000, if you compile all those subtypes together.

And then within the advanced sarcoma, which is the patient group we're treating, it ranges based on subtype anywhere from 20%, 30% to 50%, 60%. So as a whole, it does relatively triple or quadruple based solely of Ewing sarcoma numbers.

Nadeem, would you like to follow up --

Of course, I'll turn you over to Nadeem.

Yes. Thank you, Daniela.

Yes. What I heard from you was that you wanted to find out what our strategy is moving forward. 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 FPT 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 have 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 patients.

So short answer is, yes, we will have both data for single agent. And the next phase would be with a combination with some commonly used therapeutics.

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. But currently, we -- 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. We will follow the line of treatments approved for the other combination therapeutics.

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

Your next question from Aydin Huseynov of Benchmark.

Congratulations with the progress in this quarter. My first question is about new molecular new chemical entity that you had 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 whether it was in license or whether it was discovered internally, just get more ideas in terms of this 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. Given everything that we have learned about the LSD1 inhibition space, the differences between reversible and irreversible, the different binding pockets, the scaffolding versus enzymatic activity, we thought we were in a -- we believe we are in a fantastic position to focus on the next generation or not focused, but work on the next-generation 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 a lead, move into IND-enabling studies and then move into the clinic. So a 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 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 about the comparable assets or competition. So like BMS, Horizon, Imago, all of them highly valued companies or franchises. Could you give us a little bit maybe recent updates about these competitive movements? Any data updates on the competition side that would give us more ideas in terms of where seclidemstat may stand in terms of the niche indications such as sarcomas or kind of broader indications like hematology malignancies or gynecologic cancers.

Happy to. Daniela, would you like to step in and field that question?

Yes. Happy to. So yes, let me go through the companies you mentioned and provide the latest update I've seen. So as you know, ASH is coming up next month. And the company is focused on more of the team department are presenting there. So I saw abstracts from Imago on MF as well as for EP. They'll be having at least two presentations there and providing an update on their LSD1 inhibitor. I saw Horizon will also be providing an update on their Phase 2 clinical trial in combination with azacytidine 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 other academics in multiple indications.

You and I have talked about the lung cancer trial before that's in combination with Nivo. 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 inhibitor is also a reversible one. They're exploring both the liquid and solid tumor space and doing so in several different combinations.

There is also a newer company to the party. It's Jubilant Therapeutics. So they have an LSD1 HDAC dual inhibitor. They have recently reported that they're going to be filing for their IND, hopefully, by year-end. So I anticipate seeing their trials start next year. But we continue to be differentiated in terms of what indications we can pursue.

And other than Incyte 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 finding it.

So I hope that provided a good update for you, Ayden?

Oh, yes, it does. Appreciate. I appreciate that, Daniel. And last question I have is about FET-rearranged sarcoma, I just want to go back to that question and just trying to understand, you got two out of three patients with stable disease more than six months. Obviously, these are heavily pretreated patients. 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 they were not treated with seclidemstat?

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 if they had not received seclidemstat, they would not -- you would 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.

What happens with these patients is once they fail all standard treatment since -- 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 greater than six months gives us a very good early signal. If you remember in that advanced solid tumor, there 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 price lines of treatment, which means that they could -- we could enroll a fourth line patient. So we hope that if you enroll patients that are earlier lines of treatment, we would expect to see a longer stabilization of disease, which would 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 currently have this expansion phase, which has 2 different FET translocator sarcomas, one for myxoid and the other one for FET specifically.

Your next question is from Mike King of H.C. Wainwright.

A lot of my questions have been asked and answered. We just wanted to get a clear understanding about the role that seclidemstat would play in conjunction with pembrolizumab. I think you mentioned in your comments, David, that ovarian and endometrial cancers were your target indications on just -- are these going to be first line? Or where would you see the combination of pembro and seclidemstat fitting in?

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

So the first thing is to determine the recommended Phase 2 dose of the combination. Once that determined, then we'll move into early lines of patients. This trial will also provide us proof-of-concept generally of combinability of seclidemstat med with a checkpoint inhibitor.

And as you can imagine, if this is a positive trial, if we get to 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 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 where checkpoint inhibitors have either been used or currently being investigated.

Nadeem, can you elaborate a little bit on what the target patient population might look like? And the reason I'm asking is because there have been other studies where a purported active molecule, whether it's IDO or arginase glutaminase inhibitors combined with the 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 due to 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 is it's an investigator sponsor study. So this is -- the sponsor is Honor 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 populations that have had prior checkpoint inhibitors and have stopped responding to see if you could sensitize them to checkpoint inhibitors, right? And that is some of the preclinical work is ongoing to actually look at the specific question.

So again, I think if we were to -- 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, is the preclinical data support, then we will further explore it in the clinic.

Okay. I just wonder, one quick follow-up. And that is, will there be some biomarker work done in conjunction with the clinical studies?

Yes. So all our studies have biomarker component.

And for the last question from Hunter Diamond of Diamond Equity.

Congrats on the earnings. So I had a quick question related to epigenetics and expanding the pipeline. I know I've asked about that before. But any ideas you have about other epigenetic assets or expanding outside the existing pipeline would be great.

Hunter, this is David. 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'd tee 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, 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 in helping them or bringing the product outright on board into Salarius.

So your point 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 the 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 epigenetics 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 decide to take action on it.

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

As you've heard from today's discussion, Salarius is continuing to fire on all cylinders. 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 the 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've just mentioned, Salarius would not be where it is today.

So I'd 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.