Salarius Pharmaceuticals, Inc.

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.

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.

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.