Good morning everyone, and welcome to the Rafael Holdings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Barbara Ryan, Rafael Holdings Investor Relations. Please begin. Thank you, Lawrence. Welcome and thank you all for joining us this morning. The purpose of today's call is to provide you with an update on the two phase III clinical trials for devimistat or CPI-613, AVENGER 500 for the treatment of patients with metastatic pancreatic cancer and ARMADA 2000 for the treatment of patients with relapsed or refractory acute myeloid leukemia. Joining me this morning is Ameet Mallik, our Chief Executive Officer of Rafael Holdings. Before we begin, I would like to remind you that any statements made during this call that are not historical are considered to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the Risk Factors section in our most recent annual report on Form 10-K, which was filed with the Securities and Exchange Commission on October 18th, 2021, as well as our other reports filed with the SEC. Any forward-looking statements represent our views as of today, October 28th, 2021, only. A replay will be available on the company's website, www.rafaelholdings.com. It is now my pleasure to turn the call over to Ameet Mallik, Chief Executive Officer of Rafael Holdings. Thank you, Barbara, and welcome to today's conference call. First, let's start with top-line results from the AVENGER 500 phase III clinical trial evaluating Rafael Pharmaceuticals' lead investigational compound, devimistat or CPI-613, in combination with modified FOLFIRINOX versus FOLFIRINOX alone in patients with first-line metastatic adenocarcinoma of the pancreas. We're disappointed to announce the study did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival. In this multinational phase III clinical trial, 528 patients with metastatic adenocarcinoma of the pancreas who had no prior therapy were randomized to receive either devimistat in combination with modified FOLFIRINOX in the test arm or FOLFIRINOX alone in the control arm. Devimistat given with modified FOLFIRINOX did not significantly improve overall survival compared to FOLFIRINOX alone. The hazard ratio was 0.95 with a P -value of 0.66 in the intent to treat population. The median overall survival in the devimistat plus modified FOLFIRINOX treatment arm was 11.1 months, compared to 11.7 months in the FOLFIRINOX control arm. In the safety population treatment-emergent adverse events of grade 3 or higher occurred in 88.8% of patients in the devimistat plus modified FOLFIRINOX treatment arm and 80.9% of patients in the FOLFIRINOX control arm. 3.5% of the patients in the devimistat plus modified FOLFIRINOX treatment arm and 1.3% of the patients in the FOLFIRINOX control arm experienced related treatment-emergent adverse events leading to death. In addition to the AVENGER 500 trial, devimistat is also being evaluated in a phase III study called ARMADA 2000 in patients with relapsed or refractory acute myeloid leukemia. As a result of a planned interim analysis, the independent data monitoring committee has recommended the trial be stopped due to a determination that it was unlikely to achieve the primary endpoint. We are disappointed by the results of the two phase III clinical trials with devimistat, and we're committed to working in collaboration with Rafael Pharmaceuticals to further evaluate the data. We would like to thank the patients, families, and investigators for their participation in both the AVENGER 500 and ARMADA 2000 trials. Operator, you may now open the call for questions. Thank you, sir. At this time, if you would like to ask a question, please press star one on your telephone keypad. Again, that is star one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Thank you. Your first question comes from the line of Arieh Coll from Coll Capital. Your line is open. Good morning. Thank you for hosting this call this morning. I understand everyone is disappointed today, but just wanted to ask a couple questions. Number one, just wanted to know what your next steps are here in terms of doing extra analysis of the data from this trial. Number two, what your thoughts are about next steps regarding some of the earlier trials that you have ongoing. Yeah, no, thanks for your question. As you can imagine, this data is all received, you know, very recently this week. We wanted to make sure that we were providing the information in a very timely manner to the market, given how relevant this is. We do need to further analyze the data and go through it all to better understand implications. We're also gonna work with Rafael Pharmaceuticals as they evaluate alternatives regarding the ongoing and planned clinical activities. As you may be aware, you know, beyond pancreatic cancer and relapsed refractory AML, there is recruitment ongoing for trials in Burkitt's lymphoma, clear cell sarcoma, and biliary tract cancer. I can't specifically talk to you about future plans other than to say we're gonna evaluate everything together with Rafael Pharmaceuticals. Okay, got it. As you know, from the phase II studies that were done in pancreatic cancer several years ago, there were a couple patients who've been very fortunate and remain healthy to this day. How long might it take to try and look through the data more clearly to try and better understand why it is you have this outlier group of patients whose health remains good? 'Cause it certainly seems like the data that we have this morning provides a very different story from what was seen in some of these phase II patients. Yeah, no. We plan to, again, with Rafael Pharmaceuticals, really look through all the data and, you know, anticipate that all the additional details are gonna be provided and presented in some sort of scientific forum, whether it be a publication, a congress, clinicaltrials.gov. It'll be shared in some forum. I can't comment further because it's such preliminary information, but. Okay. Regarding the planned merger between the public and the private company, any update on the plans there? You had been thinking of completing a merger here sometime in the next 2 months or so. Any update on those plans? Yeah, we still have work to do with respect to the merger. As you know, the merger requires the shareholder vote, as we disclose in the S-4. When you say shareholder vote, this is by the public company? Yes. Got it. Okay. Understood. Okay. That's it for now for me. Thank you very much. All right. No, thank you very much. Your next question comes from the line of Timur Ivannikov from Raymond James. Your line is open. Yeah, yeah. Hi. Thank you for taking my question. Just a quick question about the treatment emergent events. I'm not sure, you know, to what extent you can answer this, but looks like there was an imbalance in deaths. Maybe can you talk about whether those events were related to sepsis? And also, was there a difference in discontinuations between the arms? Yeah. I mean, what I provided earlier today is the top line safety data that I can share at this point. We will share, you know, Rafael Pharmaceuticals will share additional details on all the safety data in a future scientific forum. Okay. Okay, thank you. Then, for AML, could you remind us what the efficacy threshold was? Was it a 20% difference in CR? Was it something else? Thank you. Yeah. For the full study, we had to show just over an 8% difference in CR rate. That would've been the endpoint for the full study. If you remember, there was a first interim analysis that was done in June, where the independent data committee recommended that the study continue as is. The threshold at that time, the lower bound, was 0.5%. Now in the second look that just happened, this was based on 194 patients evaluable, the threshold went up. You know, obviously based on the data that they saw the second time, their independent judgment was to recommend to stop the study, based on lack of efficacy. Okay. Thank you very much. Yeah, thank you. Your next question comes from the line of Mick Daly from SLJ Holdings. Your line is open. Hi. Good morning. I'm sorry if this is a repeat question. I got disconnected for a minute. For the shareholders of RFL, for Rafael Holdings, which is, you know, down 75% this morning on this sad news, what other assets does the company have at this point? Yeah. I mean, I'd say we're quite excited about the early stage programs also at the Barer Institute. You know, we have, I think, a very novel set of compounds at the preclinical stage, as well as a great scientific medical advisory board. You know, we plan to continue to take a very holistic approach to both cancer and immune metabolism. Okay. We're excited about where the future can be for some of those compounds. Okay. What about cash on the balance sheet at this point? Yeah. If you look at the cash on the balance sheet, we raised, as you're probably aware, approximately $98 million from a PIPE financing in August. Since that time, we provided a $25 million loan to Rafael Pharmaceuticals in September. Okay. We're not providing any additional guidance at this time, but just to give you a sense of where we're at today. As we previously disclosed, we're also actively in the process of, you know, trying to sell our real estate building. We've always said that we hope to get to do that as quickly as possible. We're actively in that process, and that will give the company additional cash as well. I mean, is the back of the envelope, you had $98 million and you spent $23 milion, so you've got somewhere around $75? Yes. We gave $25 million to pharma and then, you know, there's always a little bit for holdings too, for the employees and ongoing operations. Right. Just, of course, much smaller number. Okay. We hope to get more from the real estate. We feel like with the programs that we have going forward, you know. What is the appraised value of the real estate in the last appraisal? Yeah, we can't comment on that because we're, you know, actively engaging right now. Okay. I mean, you must have- We've always disclosed, you know, in the past that it's gonna be in that, you know, in a reasonable range. I think we're- What was that last reasonable range you provided? Yeah. We've always you know, the market has changed quite a bit and, you know, what we've always said in the past is that, you know, we think that the value is gonna be reasonable. We didn't give specific numbers, but I think it would definitely increase our cash position. As we're in an active process right now, I don't wanna comment further. I mean, you've never publicly said what you carry the real estate at, on your balance sheet for? Yeah, you can just refer to the filings just for what we've disclosed. Again, right now I don't want to speculate or comment further as we're, you know, in an active process right now. Okay. I'm just asking you know, I'm not asking you to promise anything. I'm just saying if you had the number in front of you, which you last disclosed, if you could share it since you're now a public company. Yeah. Of course, I can get back to you. Unfortunately, I don't have it in front of me right now. Okay. Sorry about that. That's all for me. Thank you. Yep, thank you. There are no more phone questions. Ameet, you may continue. Okay. Well, thank you very much for your participation in today's call. We thought this information was important to share as soon as feasible. We're gonna be just evaluating the implications and look forward to updating you on our future plans, including those for our early stage pipeline and the Barer Institute. Thank you very much. This concludes today's conference call. You may now disconnect.