Rafael Holdings, Inc. (RFL) Earnings Call Transcript & Summary

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, Laurence. 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 2 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 18, 2021 as well as our other reports filed with the SEC. Any forward-looking statements represent our views as of today, October 28, 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 2 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.

[Operator Instructions] And your first question comes from the line of Arieh Coll from Coll Capital.

I understand everyone is disappointed today, but I just wanted to ask couple of questions. Number one, just wanted to know what your next steps are here in terms of doing an extra analysis of data from this trial? And then number two, what your thoughts are about next steps regarding some of the earlier trials that you have ongoing?

Yes. Thanks for your question. As you can imagine, this data is all received very recently this week. And 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 going to work with Rafael Pharmaceuticals as they evaluate alternatives regarding the ongoing and planned activities. As you may be aware, beyond pancreatic cancer and relapsed refractory AML, there is recruitment ongoing for trials in Burkitt's lymphoma, clear cell sarcoma and biliary tract cancer. So I can't specifically talk to you about future plans, although I say we're going to evaluate everything together with Rafael Pharmaceuticals.

Okay. Got it. And then as you know, there -- from the Phase II studies that were done in pancreatic cancer several years ago, there were a couple of patients who have been very fortunate and remain healthy to this day. How long might it take to try and look for the data more clearly to try and better understand why does -- you have this outlier group of patients whose health remains good, because 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.

Yes. No, we plan to, again, with Rafael Pharmaceuticals, really look through all the data and anticipate that all the additional details are going to be provided and presented in some sort of scientific form, whether it be a publication, a congress, clinical trials. It will be shared in some form. So I can't comment further, because it's such preliminary information, but...

Okay. And 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?

Yes. We still have work to do with respect to the merger. As you know, the merger requires the shareholder vote as we disclosed in the S-4.

When you say shareholder vote, this is by the public company?

Yes.

Your next question comes from the line of Timur Ivannikov from Raymond James.

Yes. Just a quick question about the treatment emergent events. I'm not sure to what extent you can answer this, but it 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?

Yes. I mean what I provided earlier today is the top line safety data that I can share at this point. We will share -- Rafael Pharmaceuticals will share additional details on all these safety data in a future scientific forum.

Okay. Okay. And then for AML, could you remind us what the efficacy threshold was? Was it a 20% difference in CR? Was it something else?

Yes. So for the full study, we had to show just over an 8% difference in CR rate. That would have 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 balance was 0.5%. Now in the second look that just happened, this was based on 194 patients evaluable, that threshold went up. And obviously, based on the data that they saw at the second time, their independent judgment was to recommend to stop the study based on lack of efficacy.

Your next question comes from the line of Mick Daly from SLJ Holdings.

I'm sorry if this is a repeat question. I got disconnected for a minute. So for the shareholders of RFL for Rafael Holdings, which is down 75% this morning on the sad news. What other assets does the company have at this point?