Salarius Pharmaceuticals, Inc.

Q2 2021 Earnings Conference Call

8/5/2021

spk02: Good day, ladies and gentlemen, and welcome to the second quarter 2021 Solaris Pharmaceuticals earnings webcast and conference call. At this time, our participants are in a listen-only mode. Later, we will conduct the question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchtone telephone. I will now turn the conference over to your host, Mr. Jason Rando, with Tiberin's Strategic Advisors, please go ahead.
spk10: Good morning, everyone, and thank you for joining Solaris Pharmaceuticals' 2021 second quarter and full year financial and corporate results call. Earlier this morning, Solaris Pharmaceuticals issued a press release detailing its financial results for the three months and the full year ended June 30th, 2021, which we encourage listeners to read. The press release can be found in the news section of solarisfarma.com. Solaris also filed a 10-Q this morning, which is available on solarisfarmer.com and sec.gov. Before beginning the call, I would like to make the following statement. Today, we'll 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, Sekla Demstat, 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 Solaris Pharmaceuticals' annual report on Form 10-K for the year ended 2021, and subsequent quarterly reports on Form 10-Q, which have been filed with the SEC, as well as in our other filings 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 Solaris Pharmaceuticals, who will provide an update on Solaris' corporate and clinical achievements during the second quarter and its vision for the future. And Mark Rosenblum, CFO, will review Solaris' second quarter financial results. With that, David, please go ahead.
spk07: Thank you, Jason, and thank you to everyone for joining our conference call today, particularly those of you dialing in for the first time. These continue to be exciting times for Solaris. The events of the second quarter and recent weeks have continued a period of substantial growth highlighted by significant progress in our clinical programs, including completing dose escalation in our advanced solid tumor trial, initiating our enlarged dose expansion program, Phase II sarcoma trial, and initiating a trial in hematologic or blood cancers. Solaris also sustained its balance sheet strength, ending the quarter with more than $33 million in cash and cash equivalents. Ongoing trials are actively recruiting and treating patients with secludemstat across five patient groups, three in high unmet need sarcomas, and two in high unmet need hematologic cancers. and we are expecting potential data readouts later this year and into 2022. It is a long list of accomplishments for just one quarter, but with the first half of 2021 now closed, we are pleased at how well Solaris is positioned for the second half of 2021 and beyond. Before I review our recent accomplishments in more detail and future plans, I would like to take a moment to provide some background to those of you on today's call who are new to the Solaris story. A lead asset called secludemstat is an oral drug, a tablet actually, that inhibits the 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. Secludemstat is a novel, reversible inhibitor of the LSD1 enzyme with a differentiated mechanism of action that grants it broad activity across several cancer types compared to other LSD1 inhibitors in the clinic. 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 cake. This regulated gene expression is essentially the misreading of our genetic recipe. All the right ingredients are there, however, they're in the incorrect quantities. When that occurs in the context of living cells, the recipe or our genetic code is misread, it can lead to the development and progression of cancer. Seclademstat is designed to correct this dysregulation, and we believe the research presented during the second quarter affirms this capability. As we discuss our recent accomplishments and future plans, you will hear me describe a two-pronged development strategy. Speed the market, represented by our sarcoma program, and expand the market, represented by our hematologic or blood cancer program, and speed our continuing research into other large market opportunities. Let's now talk about the second quarter. Back in the first quarter, we reported top line data and key observations from our dose escalation clinical trials of ceclodemstat in relapsed or refractory Ewing sarcoma and advanced solid tumors. In the second quarter, we provided further detailed results in three poster sessions and a poster discussion session at the 2021 American Society of Clinical Oncology Annual Meeting, also referred as ASCO. ASCO is the world's largest gathering of oncologists and cancer researchers. These two trials were successful in achieving their intended goals, including establishing that seclidemstat has a manageable safety profile, a pharmacokinetic profile that supports twice-daily oral dosing at a range of tolerable dose levels, and that the recommended phase 2 dose is 900 milligrams administered twice daily. This dose was not only tolerable, but provides drug exposure in patients above levels in which preclinical studies showed drug activity. The ASCO presentations also revealed the secludemstat demonstrated drug activity in both FET-rearranged sarcoma patients and Ewing sarcoma patients. Three patients with FET-rearranged sarcomas treated with secludemstat reported time to progression greater than a benchmark commonly used to assess single-agent activity in patients with these types of advanced soft tissue sarcomas. Let me take a moment to put this in perspective. Three FET-rearranged sarcoma patients treated with secludemstat demonstrated a time to progression which we believe indicates single-agent drug activity in these types of advanced soft tissue sarcomas, meaning that while the data is from a small subset of patients, seclidemstat appears to have single-agent activity and can extend time to progression for patients with FET-rearranged sarcomas. This is important given that progression-free survival which is related to time to progression, is a well-accepted clinical endpoint for sarcoma registration trials. Based upon this data, we expanded the sarcoma trial to investigate seclidemstat in two additional patient groups, patients with myxoid liposarcoma and patients with FET-rearranged sarcomas, where we are researching seclidemstat as single-agent therapies. When we consider that there are three to four times the number of patients with FET-rearranged sarcomas as there are patients with Ewing sarcoma, you can begin to understand why we are excited about this preliminary drug activity data, that we have tripled the number of sarcoma types in our trial, and that we have tripled the number of sarcoma patients in our dose expansion trial. We are very excited about seclidemstat's potential to help patients with FET-rearranged sarcomas, but we are equally excited about seclidemstat's potential to help patients with Ewing sarcoma. In preclinical research, seclidemstat demonstrated synergy when combined with topotecan and cyclophosphamide for TC, a common second- and third-line treatment for Ewing sarcoma. These synergistic results tell us that when seclidemstat is combined with TC in treating a Ewing sarcoma cell line, one plus one does not equal just two. It means that one plus one equals more than two when it comes to anti-cancer activity. This is important because we are now treating Ewing sarcoma patients with combination seclidemstat and TC therapy, where drug activity, as I mentioned, one plus one is greater than two. and because we have already seen single-agent, seclidemstat-only drug activity in a patient with refractory Ewing sarcoma. As we have previously discussed, a patient with refractory Ewing sarcoma treated with just seclidemstat alone showed a dramatic 76% reduction in the size of their prospectively defined target lesions after six cycles of treatment with seclidemstat. Remember, Target lesions are generally the patient's largest measurable tumors. So we are now building on this single-agent activity by now attacking Ewing sarcoma with the combined synergistic effect of secludemstat and TC therapy that we believe will potentially improve patient outcomes and achieve objective responses. Again, you can begin to understand why we at Solaris are excited about our overall sarcoma program and the positive impact we could have on patients. With the recent addition of the Fox Chase Cancer Center as a sarcoma clinical trial site, we now have nine trial sites actively recruiting and enrolling patients in our sarcoma trial. And I'm happy to report that we have already enrolled patients in each of the three patient groups. And given that our sarcoma trial is open label, we are in a position to provide updates as the trial progresses later this year and into 2022. As I mentioned, the Advanced Solid Tumor Trial, or AST, trial a few times. I'm also happy to report that during the second quarter, we completed dose escalation in this trial, which, as we have discussed, provided additional safety, pharmacokinetic data, and allowed us to pinpoint myxoid liposarcoma and FET-rearranged sarcomas as new target indications for our sarcoma development pipelines. The AST trial also generated additional clinical data that is informing our development planning in additional larger market opportunities. In short, we've leveraged the strong results from the dose escalation stages of our two clinical trials to direct, one, direct our research into three high unmet need sarcoma indications, and two, expand our the addressable Ewing patient population for seclidemstat by introducing seclidemstat earlier in the treatment cycle, potentially as a second or third line therapy with a seclidemstat combination therapy that has demonstrated synergistic anti-cancer activities. Further, and just as exciting as the sarcoma clinical trial accomplishments, is the fact that the potential of seclidemstat was further amplified during our key opinion leader and investor event which highlighted important properties of secludemstat that we believe set it apart from other LSD1 inhibitors. But before I discuss our key opinion leader or KOL event and the recent announcement of the newest clinical trial, I would like to ask Mark Rosenblum, Chief Financial Officer, to discuss our strong financial foundation, which is enabling all of this growth. Mark, please proceed.
spk04: Thank you, David. For the three-month period ended June 30th, 2021, Solaris reported a net loss of $3.1 million, or $0.07 per basic and diluted share, compared to a net loss of $1.8 million, or $0.13 per share, in the first quarter of 2020. The loss from operations before other income for the three months ended June 30, 2021, increased by $1.2 million, compared to the loss from operations of $1.9 million for the same time span last year, which was primarily due to lower grant revenue and higher overall operating costs. Higher research and development costs resulted from increases in personnel, clinical trial activities, and higher laboratory expenses. The decrease in general and administrative costs resulted from lower legal expenses and overall lower personnel costs, more than offsetting certain higher professional fees when compared with the same period a year ago. As of June 30th, 2021, total cash and cash equivalents totaled $33.1 million, compared to $7.2 million on June 30th in the prior year. Our working capital position in the current period was $36.8 million compared to just $7.8 million a year ago, a much healthier look. The company's overall cash position and its access to additional cash is the best in the company's history. In addition to our available cash, we have a receivable from the Cancer Prevention and Research Institute of Texas, also known as CPRET, plus the availability to draw from the ATM facility established in February 2021, and potential warrant exercises that could all add to our currently strong cash position. During the quarter, we expended all remaining available funds from the secret grant, and $4.8 million is listed as a current receivable on our balance sheet. We believe that our current cash position will be sufficient to fund our activities through the completion of our current clinical trials in 2022 and beyond. With that, I'd like to return the call to David.
spk07: Thank you, Mark. Let's return to our recent key opinion leader event and the recent announcement of our newest clinical trial, which launched our hematologic or blood cancer development program. During their key opinion leader event presentations, Dr. Jonathan Wettstein, Dr. Santchala and Dr. Kapil Bala each discussed unique aspects of seclodemstat that make it well-suited to potentially address a host of cancer indications. During his remarks, Dr. Wettstein spoke to LSD1 inhibition and the broader field of epigenetics, which are the scientific underpinnings of seclodemstat. Dr. Wettstein noted that in context of cancer, LSD1 overexpression is associated with poor prognosis across a variety of cancer types. And seclidemstat has a distinct advantage compared to other LSD1 inhibitors, as it can not only inhibit the enzymatic activity of LSD1, but also inhibit more of LSD1's scaffolding properties. The scaffolding property has high relevance in several cancer types, including solid tumors in large commercial markets. and so inhibiting this function may result in a more potent LSD1 inhibitor with advantageous therapeutic properties. Dr. Chawla spoke directly to seclidemstat's potential in a range of sarcoma indications, including observations from the clinical trials of seclidemstat in Ewing sarcoma and FET-rearranged sarcomas. Notably, Dr. Chawla highlighted that extending progression-free survival by even four to six months would show a significant improvement in treating these difficult-to-treat advanced sarcomas. As previously mentioned, seclidemstat has already shown it can achieve that progression-free survival in certain FET-rearranged patients. Dr. Chawla also addressed the potential of seclidemstat in combination with chemotherapy as a potential advancement in the treatment of these sarcomas, given the synergistic effects of each therapy. Concluding the event was Dr. Bala, who discussed the potential of LSD1 inhibition in the treatment of hematologic cancers, noting that LSD1 overexpression and dysregulation of LSD function can lead to hematologic cancer development and progression. Based on this, Dr. Bala highlighted LSD1 as an attractive therapeutic target in treating hematologic or blood cancers, with preclinical evidence suggesting seclidemsat inhibits the growth of leukemia cells, as well as cells associated with myelodysplastic syndromes and chronomyelomoncytic leukemia, both precursors to acute myeloid leukemia, or AML. In fact, Dr. Bala's research and additional observations form the basis of a recently initiated clinical trial by MD Anderson Cancer Center to investigate seclidemstat as a potential treatment for hematologic or blood cancers. As announced in June, this investigator-initiated, open-label Phase I-II trial will be conducted at the Department of Leukemia at the University of Texas MD Anderson Cancer Center in patients with myelodysplastic syndromes, or MDS, and chronic myelomonocytic leukemia, or CMML. The trial will determine safety, tolerability, maximum tolerated dose, and overall response rate of seclidemstat when used in combination with azacitidine. Like other seclidemstat drug combinations, the combination of seclidemstat and azacitidine demonstrated synergy in preclinical research. Again, one plus one equals more than two. As with our other clinical trials, we look forward to providing updates in the second half of 2021 and into 2022. We're very excited to begin to expand seclidemstat into new, larger indications, or as I mentioned earlier, expand the market. As mentioned earlier, we are also pursuing speed-to-market and expand-to-market strategies. This trial in hematologic cancers should provide proof-of-concept data demonstrating seclidemstat inhibits the growth of MDS and CMML, precursors to acute myeloid leukemia or AML. offering the potential to introduce seclidemstat into a significantly larger market opportunity. According to the American Cancer Society, AML accounted for almost 20,000 newly diagnosed cases of cancer in the US in 2020 alone. Not only does this represent an expansion of the seclidemstat development pipeline, but it also introduces seclidemstat as a potential treatment for hematologic or blood cancers and expand the market indication. I want to take a moment and highlight or restate an important piece of information. This trial in hematologic cancers was initiated because of compelling preclinical data in which secludemstat demonstrated antiproliferative activity across hematologic cancers and synergy when used in combination with adesididine. a chemotherapy drug believed to work by helping bone marrow grow normal blood cells. As I mentioned earlier, synergy means one plus one equals more than two when it comes to anti-cancer activity. This certainly furthers our belief that seclidemstat can be paired with other drugs and address high unmet need indications. This is just one example of potential new markets for seclidemstat. In coming months, we plan to initiate additional seclidemstat clinical programs in cancer indications where LSD1 overexpression is known to be the factor, including certain gynecological cancers. Our ultimate goal as a company is to maximize the potential of seclidemstat, and by doing so, make a difference in the lives of patients and their families fighting cancer. As I said earlier today, these are exciting times for Solaris, and we are looking forward to building on our current momentum throughout the second half of this year and into 2022. I would now like to take questions. Joining me at 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 Santi-Esteban, Director of Corporate Development. With that, I will now open the call to your questions.
spk02: And ladies and gentlemen, if you have a question over the phone at this time, please press the star, then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question comes from Aiden Husinov with Benchmark.
spk08: Hi. Thank you for taking my questions. Congratulations with the quarter. I just wanted to elaborate a little bit on sickle demostat in hematologic malignancies. trial as a citizen at MD Anderson. So what are your expectations about this trial? So we see that clinicaltrials.gov mentioned September 2022 as a readout date and its overall response rate primary endpoint. But just trying to understand what's the target rate or R that you are trying to achieve and what was the historic rate that we need to compare this to?
spk07: Aidan, thanks for the question. Good morning. Let me turn that over to Dr. Mirza to add a little more color, and then we can weigh in with some follow-up if needed.
spk01: Hi, Aidan. Thanks for the question. The trial is phase one, phase two. So the first component of the trial is to determine the recommended phase two dose of the combination. The second component of the trial is to look at efficacy in terms of overall response rate. So the trial has a primary objective of safety tolerability, maximum quality dose, and a co-primary endpoint of overall response rate. These patients that are being enrolled in this trial actually have failed all standard treatments. These are HMA failure patients. As you know, these patients have really very poor prognosis and a very low overall response rate. This is a small study. Once we determine improvement in response rate, that will be reported. The trial, as I mentioned, is a small trial. It includes around 30, 40 patients total. But this data will give us an indication to move into a larger trial.
spk07: And Nadeem, I believe also we're looking at the blast activity, which will inform and allow us to move forward into AML.
spk01: That's correct. So we will be doing some biomarker analysis in this trial. As I mentioned earlier, it's a proof of concept study, and these patients actually have a very poor survival. I mean, these I would expect that some of the patients that have received combination of azacitin and venetoclax are also eligible to be enrolled in the study. So these are late stage patients, and I believe a response rate of 20, 30% would be a reasonable response rate.
spk08: Yeah, I just wanted to ask or follow up on that. what do you think is the differentiation of ceclidam-SAT versus other LSD1 inhibitors that are being tried in the same indication, AML, MDS, and CMML?
spk07: Daniela, would you like to try and address Aiden's question?
spk03: Yes, of course. Thanks, Aiden, for the question. So there are other target agents being developed with azacitidines like venetoclax, I think the advantage that we have with ceclodemstat is that LSD1 has been established as an important player in progressing hematological malignancies. But the safety profile that we have in terms of not causing significant heme toxicity is better suited for the combination with azacitidine. And mechanistically, we're approaching heme malignancies from a different point than some of these other targeted agents, where we're causing release of that differentiation block, which works synergistically with azacitidine. It's another epigenetic agent that's also causing release of this differentiation block. And so like David mentioned before, those two working together end up being synergistic. So I think there's advantages in both the mechanism and how they're both epigenetic agents and resulting in synergy, and then also the safety profile I mentioned.
spk08: Understood. All right. Thank you very much.
spk02: And again, ladies and gentlemen, if you have a question over the phone, please press star and the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from queue, please press the pound key. Your next question comes from Hunter Diamond of Diamond Equity.
spk09: Hi, everyone. Good morning, and congratulations on the quarter. So my question is, Solaris has been discussing an immuno-oncology trial, so I just wanted to get an update. What's the status and the market opportunity from your view?
spk07: Hunter, this is David Arthur. Good morning. Hope you're doing well. Great question. A couple of answers. We are continuing to work with our clinical investigator and their administrative offices to get this trial activated and hope to have an announcement very soon. This is a very important trial for us and for patients. But an equally important question would be what is this trial going to mean to patients and investors when it's activated? First, it's important to note that there is an FDA-allowed trial protocol that's been submitted And we have already packaged Ceclodemstat that's ready to ship. So we're hopefully right at the finish line. Second, we are continuing to work on finalizing a clinical trial agreement with this renowned research center and initiate the investigator-led trial. Third, according to the website clinicaltrials.gov, once investigators begin to treat patients with Ceclodemstat in combination with Catruda, which as you know is a checkpoint inhibitor, they will begin to generate clinical data which could demonstrate that seclidemstat unmasks tumors and synthesizes those tumors to checkpoint inhibitor therapy. For patients fighting these gynecological cancers, this means a new treatment option for these patients who have failed all other existing options. Now, for investors, this could mean that seclidemstat could increase the number of eligible patients who could benefit from checkpoint inhibitor treatment. And as you know, checkpoint inhibitors are roughly a $16 billion a year global market that only is able to access about 40% of the potential patients. So if a drug like seclidemstat can unmask tumors and allow the checkpoint inhibitors to access some of that 60% of the market they're unable to access, this would be a, we believe this would be a significant opportunity, not only for Solaris, but also a huge benefit to patients.
spk09: Great, no, appreciate the additional color. And that's all I have in terms of questions. It was a terrific update. Thank you.
spk07: Okay. I'd like to take a question from the web, if that's okay. Okay. David, Solaris seems undervalued. What am I missing from a retail investor? This is probably one of the most asked questions I get these days, and I don't think you're missing anything. Let's just recap. Given Solaris' stage of development, potential markets, and strong cash position, we believe the company is currently quite undervalued. Let's recap, just for a moment, recent events. We hit important clinical milestones, including completing dose escalation in both the sarcoma and advanced solid tumor trials, while demonstrating drug activity in trials primarily designed to study safety. We have initiated an expanded sarcoma trial with 3X, the patients originally planned to enroll, representing 3X, the patient groups originally planned, with trial updates coming later this year in 2022. We're now treating Ewing sarcoma patients second and third line in combination with chemotherapy where we have shown one plus one is greater than two in anti-cancer activity. MD Anderson has activated and is rolling patients in a clinical trial launching seclidemstat into hematological or blood cancers, again, where the seclidemstat combination therapy showed synergy. This potentially launches Solaris into an expand-the-market opportunity As I mentioned, according to the American Cancer Society, AML accounted for almost 20,000 new U.S. diagnosed cancer patients in 2020 alone. We're in the strongest financial position we have ever experienced and are funded to complete our ongoing clinical trials and continue into 2023. And finally, we believe that LSD-1 space received significant validation with the recent initial public offering of Imago Biosciences. Imago is one of the other companies with an LSD-1 in clinical trials and a company where their LSD program appears to be their lead asset. In their recent S-1 filing, Imago reported unaudited interim phase two data, which is where Solaris plans to be next year. I think Imago closed yesterday with a market capitalization of $800 million, but I'd ask you to confirm that number. So based on these factors, I don't think you're missing anything. I stand by my comment. I believe Solaris is undervalued both as a company and in comparison to our peers.
spk02: Okay, and you have another question over the phone.
spk05: Hello?
spk02: Yes, your next question over the phone is from Mike King with HC Wainwright.
spk11: Good morning, guys. Thanks for taking the question. David, you just mentioned Imago, and I wonder if you could comment or Daniela could comment about the fact that Imago's initial studies are in polycythemia vera and essential thrombocytemia with the current formulation of the drug, and they've stated their work in solid tumors will be dependent upon another LSD1 inhibitor, but they don't get into the details as to why. So I'm just wondering if you could care to comment about why Imago looks at solid tumor universe as, you know, non-overlapping with liquid, whereas you guys kind of see them as, you know, fungible.
spk07: Happy to, and, you know, good to hear from you, Mike. Daniela, would you like to take this question?
spk03: Yes, yes. Thanks, Mike, for the question. So, yeah, you bring up a great point, and the answer is really it all falls back on the specific LSD1 inhibitors mechanisms of action. So Imago, like other irreversible inhibitors, does a great job of interrupting a portion of LSD1 scaffolding activities. And that portion is with LSD1 and proteins that drive hematological indications, like myelofibrosis, like ET, and PV, which are the ones you mentioned. And that's what Imago is pursuing. Our inhibitor, secludemstat, interrupts those LSD1 protein interactions But we interrupt LSD1 from interacting with other proteins where that association is important in driving other solid tumors. If you see what Imago is doing for their second generation LSD1 program that's going to focus on solid tumors, you'll see that they're approaching it more from a ProTac perspective where they're looking to degrade LSD1. And the reason for that, again, is because of LSD1's multiple properties as an enzyme, but also as a scaffolding protein. And the advantage we have, like I mentioned, is that not only are we inhibiting the portion of LSD1's scaffolding properties that drive heme malignancies, but because of where we're binding, we inhibit more of those scaffolding properties. And we actually see decreases in LSD1 protein expression with our compound already. And so that's what opens the door for Solaris to not only look in heme indications, but also these solid tumors compared to some of the other LSD1 inhibitors currently in clinical trials.
spk11: Okay. So if I could summarize, Daniela, you're saying that you guys hit the enzymatic, and David said this in his formal remarks as well, you hit the enzymatic and the scaffolding, whereas the Imago hits the current one, hits the enzymatic, and perhaps the next generation version hits the scaffolding properties. Is that a fair way to look at it?
spk03: Yeah, so they hit the enzymatic and a portion of the scaffolding. We hit the enzymatic and a bigger portion of the scaffolding. And that difference in the amount of scaffolding that we inhibit allows us to venture into solid tumors.
spk11: Gotcha. Okay, thanks for the clarification. And then I wanted just to ask a couple of quick financial questions. I'm not sure Mark can comment about the funding from National Pediatric Cancer. Foundation, but how much still remains on that grant or grants? Can you help us understand that?
spk07: Mike, this is David. Let me take the NPCF question, and then I'll turn it back over to Mark. So we did not necessarily receive a – well, let me rephrase this. We have received in the past grants from the National Pediatric Cancer Foundation. When we embarked on the Ewing sarcoma program, the National Pediatric Cancer Foundation agreed to fund a significant portion of the clinical trial costs by paying the hospitals directly for the cost of running the study. So the money didn't actually flow into Solaris. Now, the second part of your question is what's left? Well, there isn't really a grant per se, but The National Pediatric Cancer Foundation is funding a significant biomarker project that is being run with a couple of renowned researchers, and they are going to be looking at these tumor samples we've been collecting not only in the phase one portion of the study, but also the tumor samples we'll be collecting in the phase two portion to help us understand what type of biomarkers can be developed for Ewing's sarcoma.
spk04: Mike, this is Mark. When we discuss grant funding, we are always discussing CPREIT. We have received from CPREIT the full complement of their original grant, which was $18.7 million modified to $16.1 million. We have received, we have spent all that money all that funding, and we have a receivable. We've received, just to get the math easy, we've received $11.3 million from CPRET, and they still owe us $4.8 million. And that 4.8 is on our balance sheet this quarter as a receivable. Right, okay.
spk11: And then the other question is with respect to the ATM. Just remind us how much is left on that, please.
spk04: Well, the ATM was established for $25 million, well, right at the beginning of July. We have sold no shares under that. We had filed an ATM back in February 2021 for $6.3 million. The market was quite active at that point, and we sold all shares under that $6.3 million dollar ATM in early February.
spk11: Okay, great. I believe that's it. Thanks so much, guys.
spk02: All right, and I'm showing no further questions on the phone at this time, and now I want to turn the conference back to David Arthur.
spk07: Thank you. As you've heard today from today's discussion, Solaris continues to advance and expand its clinical programs. We continue to fire on all cylinders as clinical trials are now actively enrolling across five patient populations in trials investigating seclidemstat as single agent and as a component in two different combination therapies, both of which have demonstrated synergistic anti-cancer activities. Preclinical studies are underway exploring seclidemstat and several new tumor types, and we plan to announce additional clinical trials in the near future. Our strong financial position provides a firm foundation to fund our ongoing clinical trials through completion and beyond. We look forward to continuing to advance and expand the clinical program of seclidemstat and provide additional updates during the second half of 2021 and 2022. In conclusion, I would like to thank, as always, our employees for their dedication and loyalty, and our stakeholders for their continued support. I appreciate your time and attention today and would like to extend my sincerest wishes of good health to all. Thank you.
spk02: Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.
Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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