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spk06: Good afternoon. Thank you for standing by and welcome to CDI Biopharma's second quarter 2021 earnings call. During today's presentation, all parties will be in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. This conference is being recorded today, August 5, 2021. I'd now like to turn the conference over to Dr. Adam Craig, CEO and President of TBI Biopharma. Please go ahead.
spk02: Thank you, Laurie, and welcome to this afternoon's conference call. Joining me today are David Kersky, Chief Financial Officer, and Bruce Seeley, Chief Operating Officer. Following formal remarks, the conference call will be open for questions. Before I begin, please note that during this call, we will be making forward-looking statements based on current expectations. Such statements are within the meaning of the safe harbour provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the types of statements identified as forward-looking statements in our 2020 Annual Report on Form 10-K that was filed March 17, 2021, and our subsequent periodic reports filed with the SEC which are available on our website in the investor section. Such forward-looking statements represent our views only as of the date of this call and are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements, including many that are beyond our control. For a further description of the risks and uncertainties that would cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see our peer audit reports filed with the SEC. This quarter, we have continued to advance Procritinib towards a potential US approval and commercial launch this year. The FDA's acceptance with priority review of our NDA submission for the use of pacritinib in myelofibrosis patients with thrombocytopenia underscores the unmet medical need in this area. Our PDUFA target action date is November 30, 2021, and the FDA is not currently planning to hold an advisory committee meeting to discuss the application. As a reminder, the NDA was accepted based on data from Phase III, Persyst-2, and Persyst-1, and the Phase II to PAC-203 clinical trials, with a focus on the severely thrombocytopenic patients, that is, those with platelet counts less than 50 times 10 to the 9 per liter. Patients enrolled in these studies with severe thrombocytopenia and patients receiving pacritinib 200 milligrams twice a day were the focus of the NDA and included both frontline treatment naive patients and patients with prior exposure to JAK2 inhibitors. One-third of the existing myelofibrosis patient population have severe thrombocytopenia or approximately 7,000 patients. A population with suboptimal and limited treatment options and an urgent need for new therapies. To address this need, Our team has been working diligently on pre-commercialization activities, including market access, distribution of supply chain, disease education, and third force deployment. We are eager to commercially launch Procritinib immediately upon approval from the FDA, and given our application's priority review status, we are prepared to launch on the PDUFA date or earlier. In preparation for an early launch, we have completed the hiring of our third force leadership team and started to recruit our key account managers who will be our sales force. Moving on from myelofibrosis, last year we launched a study for creatinine in severe COVID-19 patients in response to the pandemic. This study prevent is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial comparing the use of pacritinib plus standard of care versus placebo plus standard of care in hospitalized patients with severe COVID-19. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and or extracorporeal membrane oxygenation or die by day 28. We continue to expect to report on the outcome of the interim analysis from this trial during this quarter. Finally, as we have previously discussed, we are investigating the use of Procritinib in the prevention of acute graft-versus-host disease, or GVHD. The investigators sponsored Phase II component of the ongoing Phase I-II study, investigating the addition of Procritinib to the standard prophylaxis of serolimus and low-dose tacrolimus in the treatment of GVHD continues to enroll. And we remain on track to provide an update on the progress of the phase two trial and any potential regulatory interactions around this indication later in the year. As a reminder, the American Society Hematology meeting in December 2020 data was presented from this study. that showed adding procritinib to the standard prophylaxis regime resulted in significant reduction in the expected acute graft-versus-host rates in patients within the first 100 days of therapy as compared to historical data without compromising transplantation outcomes and without any new safety concerns. I will now turn the call over to David to review our quarterly financials. David. Thank you, Adam.
spk01: As of June 30, 2021, cash and cash equivalents and short-term investments totaled $71.9 million as compared to $52.5 million as of December 31, 2020. Operating loss was $19.5 million and $10 million for the three months ended June 30, 2021 and 2020, respectively. No revenues were recognized for the three months ended June 30th, 2021 or for the three months ended December 31, 2020. Net loss for the three months ended June 30, 2021 was $19.7 million or 21 cents for basic and diluted loss per share as compared to a net loss of 14 million or 19 cents for basic and diluted loss per share for the same period in 2020. So with that, I'll hand it back to you, Adam.
spk02: Thank you, David. So with the PDUFA action target action date of November 30th, 2021, and commercial preparations well underway, we are well positioned for a potential U.S. launch later this year. We look forward to working closely with the FDA as it completes the final stages of the review of the application. This concludes our formal remarks. Lori, please open the call for questions.
spk06: And as a reminder, to ask a question, you will need to press star 1 on your telephone. Our first question is from Ben Burnett of Stifo. Please ask your question.
spk07: Mr. Burnett, your line is open. Hi. Can you hear me now? Yes.
spk00: Yes, we can.
spk07: Oh, okay. Yes. Sorry about that. So this is Carolina Ibanezon for Ben Burnett. Thank you for taking the question. I have one quick one on the data for pancreatinib in COVID-19 coming in the third quarter. Could you elaborate on the type of data we'll be getting and where the bar is set for the results also in the context of other JAG inhibitors that are already being used with emergency use authorization?
spk02: Yes, thank you, Catalina, for your question. So the analysis is a futility analysis. And we have not made public, nor will we, what the bar is. But we'll, as we said, we should be announcing the data later this quarter. And I can't comment on how, based on that, I can't comment on how we compare to other PAC inhibitors, other JAK inhibitors.
spk07: Okay, understood. And then a quick follow-up also on the hiding curve. that you are doing to support the launch of . How should we think about the pacing and volume of additional hires for modeling purposes?
spk02: Yes. Well, obviously over the last six months, particularly since the NDA filing was accepted, we have expanded. And we have currently around 60 full-time employees. We do expect that number to approximately double. as we complete the commercial hires by the end of this year.
spk07: Okay, great. Thank you so much.
spk02: Thank you, Catalina.
spk06: Our next question is from Rene Benjamin of JMP Securities. Please ask your question.
spk05: Great. Thanks very much for taking the questions, guys, and congratulations on all the progress. Adam, I know that we've talked about, you know, how you're thinking about pricing of Procritinib when it comes out and likely to be, you know, I think as we've talked about in the past, hopefully a pretty nice premium to the JAK inhibitors that are already out there. But one of the things that we're always trying to get our hands around is the duration of therapy for Procritinib. And the phase three, you know, data that you've submitted to the FDA show us one thing, but I'm I'm trying to get a good sense as to what is the average, you know, months of duration on therapy that you've seen to date.
spk02: Yes, Ren, I'm going to defer that question to, we've actually submitted some data for ASH, and if that abstract is accepted, you'll be able to see, it will answer some of your questions. The data I'm talking about is from the expanded access With respect to the treatment on the current trials, on PASSIST-1 and PASSIST-2, we have projections on that, but unfortunately I'm unable to make that public for competitive reasons.
spk05: Okay. And then I guess just turning to the commercialization side, can you just remind me, have you guys already identified the centers or – you know, the community docs that you will be targeting right off the bat? Or, you know, how should we be thinking about the initial phases of the launch?
spk04: Bruce, you want to answer that? The initial launch, we're not surprisingly going to target the high volume accounts in the academic centers. And then we've identified also the large community accounts that treat quite a few patients, the group practice, the large group practices. And that's where the far majority of the patients are treated.
spk05: And Bruce, about how many, you know, would you be able to tell us like how many accounts are there from academic versus community?
spk04: It depends on how you look at it. Just in terms of number of physicians, the majority of physicians are going to be in the community accounts. They treat anywhere from one or two patients to five-ish patients. The large practices are the ones that we're going to be focused on and the academic centers are focused on. They can treat 20 to 50 patients per year, depending on the site.
spk05: Got it. Thanks very much, guys, and good luck. Sure. Thank you.
spk06: Our next question is from Thomas Flatton of Lake Street Capital. Please ask your question.
spk03: Hey, guys. Thanks for taking the questions. Adam, how should we think about Pacifica enrollment once you guys go live commercially? Do you see there being some cannibalization there, or do you have a strategy for segregating patients into study versus commercial product?
spk02: Thomas, thank you. It's a very important question. The It's most likely that Pacifica will continue ex-US after approval. We are no doubt towards the end of the NDA process. We'll have some discussions with the FDA around the program, but around that trial where there may be some changes to it. But big picture, I don't expect there to be cannibalization of US sales opportunities The drug is performing very well ex-U.S. at the moment, and I think we could successfully complete the trial outside the U.S. on time.
spk03: You mentioned one abstract submission to ASH. Could you qualitatively share what other types of information we might be seeing at ASH coming out on Procritinib in particular?
spk02: Yes, so one of them is duration of therapy on expanded access, which I've already alluded to, if accepted. Of course, the abstracts haven't been accepted. We're also providing a lot of, we've put together abstracts that really describe the safety profile of pacritinib in the lower platelet count patients, and with some comparison to the data we have on the safety profile of oxalitinib in that setting as well. and we've got some nice, some very favorable data that we're presenting on that. At this point, Thomas, I really prefer not to go any further than that because we have to be careful that we don't break the rules with ASH, and I'd rather let you know in November when the abstracts are hopefully accepted.
spk03: No problem. Just one final one. Any intelligence on the NCCN data a guidelines update process?
spk02: Yes. So again, a very important question. We have already started our communications with the NCCN, and we've sent a preliminary notification of where we are. And we do expect, once the drug is approved, that we'll enter into discussions with them quite quickly, and that we'll get on the NCCN guidelines as soon as possible after launch.
spk03: Excellent. Thanks, guys. Appreciate it.
spk02: Thank you, Thomas.
spk06: And our next question is from Gail Blom of Needham and Company. Please ask your question.
spk05: Hi, everyone, and thanks for taking our questions. Most of my questions have already been answered, but I think maybe a bit of a regulatory question here. With the spike in COVID and, you know, your PDUFA coming in November, Is the FDA having any issues accessing production sites and factories that are making picritinib, or is this not an issue at all?
spk02: As I've said previously, the inspection process for us started very early. I think we're coming to the end of it. We've probably nearly completed it. We've not encountered any issues with the FDA with respect to inspections. Some inspection work has been done remotely. That has been very successful without any issues, and some inspection work has been done in person. Again, we haven't encountered any issues. The resources put by the FDA into our inspections have seemed to be very good, and it's so far gone very well.
spk00: Thank you.
spk06: And there are no further questions at this time. I will now turn the call over back to Dr. Adam Craig for his closing remarks.
spk02: Thank you, Laurie, and thank you, everyone, for joining the call today. We look forward to continuing the conversation over the coming months, and we look forward to a potential approval of Procritinib later this year. Thank you.
spk06: and this concludes today's conference call thank you for participating you may now disconnect
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