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spk00: Good afternoon and welcome to the President Full Year 2023 Financial Results and Update Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Please note that this event is being recorded. I would now like to turn the conference over to Steve Harrison. Vice President of Investor Relations.
spk02: Please go ahead. Excuse me, Mr. Steve Harrison. Please go ahead. Excuse me, Steve. Please go ahead.
spk08: Thank you, and I apologize for any technical difficulty here. Again, welcome to our 2023 full-year financial call. With me is our CEO, Helen Salzaveri, CFO, Harry Tomasian, and Jim Schaefer. Please refer to our most recent filings for our forward-looking statements. With that, I'll turn the call over to Helen. Thank you.
spk03: Thank you, Steve, and thank you to everyone for joining us. And again, apologies for this little bit of technical problems. But I think we are going through a very, very transformative year. 2024 is poised to be a transformational year for PrestoGen. We are on track to present a pivotal phase two data for our lead asset, PLGN 2012, in Q2. and intend on submitting our BLA in the second half of 2024. This is due in part to the positive guidance and pathways provided by the FDA and to the tireless work done by our team over the last several years, starting from the discovery in 2020 all the way to the potential filings in 2024. For today's call, I will focus on our AgInverse platform and we are working rapidly and prudently to advance our obviously our ultra car assets and we are looking forward to the data readouts later on this year for ultra car platform as we outline in today's press release so for today let me just jump into our ad universe platform why we are Excited about this platform and our lead asset that it pays us. For those of you who might not be familiar with this platform, this is a very differentiated platform from the rest of the viral platforms. Why do I say that? It's very simple. First of all, this platform is built based on the library of the gorilla adenovactors. These adenovactors are not like other adenovactors. First of all, they have a high capacity that you can put a number of genes in them. But more importantly, they have the ability, because there is no pre-immunity in humans or very little, you can keep dosing this with these vectors. With all of the other viral vectors, when you dose one or at best twice, you're getting this neutralizing antibody, which eventually inhibited immune responses and then after a while you're just shooting a blank that's one of the major issues in the vectors other vectors and other platforms that exist here on the other hand because we don't have pre-immunity to this you can keep on giving and because of the design of these factors and the specific uh in biological nature of these vectors Now, even when there is a neutralizing antibody kept at bay and doesn't enhance it. Why do I say that? We have clinical data actually from various indications that you can be dosing the patient, and we have dosed some of the patients up to 18 times. And not only you have kept enhancing their immune responses, but you have kept the neutralizing antibodies at bay. And finally, one other aspect. of the platform, which is very important, is the specialized manufacturing process, which allows high titers. And you can imagine that becomes very important, especially in commercial manufacturing process. So let's dive into our lead asset, which is our PR Gen 2012. Our PR Gen 2012 has been designed to identify the epitopes HPV 6 and 11 and target the cells that are infected with this virus. Why is that important? In a rare disease of basically RRP or recurrent respiratory papillomatosis, the root cause of this disease is the infection, HPV 6 and 11 infection in this patient, which then causes these benign tumors on the vocal cords or in the trachea of this patient. Therefore, they can't talk or they can't breathe or book. These patients, for decades, have gone through this devastating disease with really no treatment except surgery. What does surgery do? If removing this benign tumor, it's like mowing your grass, and then they keep coming back. And as a result, the patient, first of all, it gets worse, the situation. There is a danger, and there is a continuous problem that you have not solved. In order to really address this disease, you have to get to the root, which means what? Means that you have to address the infection underlying HPV 6 and 11. And this is exactly what we designed PRG in 2012 to do to awaken the immune responses of these patients to identify these cells that are infected and cause the benign tumors to grow and then to destroy them. And based on that, what we have done is looked at the number of the patients. In the United States, there are estimated between 15,000 to 20,000 patients. Ex-US, you are looking at excess of 125,000 patients. So as we mentioned, this is truly a devastating disease with no current treatment. When we started our trials with PRGM 2012, we, first of all, designed the trial that the patient, they have the history of the patient in 12 months prior to receiving their vaccine. And then these patients, they receive a course of full vaccination within 85 days. And then after that, we have been following these patients to see for the recurrence of this benign tumor. single-arm phase one pivotal trial that we run originally, what we observed was, first of all, from a safety perspective, these patients had very favorable safety, mainly grade one, grade two, which is some rashes at the site of injection or some fever, and then it resolved within a day or two, very similar to the flu shots that you get. Secondly, one thing that was very specific about our design for this vaccine is that it's given subcutaneously in the arm or leg again similar to the flu shot we don't require any kind of a device we don't require anything it can be done in any office of any of the physicians right so now what we saw Besides the safety and the endpoints that we had put, we decided to go to the most severe patient population. What do we mean by that? We define that, and our KOLs and investigators have defined that as patients that at least require three surgeries in a prior year. Actually, the average number of surgeries that our patients had in our trial was upwards of 60. surgery per year. So you can imagine every couple of months this patient had a surgery. Some of them, they had 10 surgeries in a prior year. What we observed was after the follow-up of 12 months, 50% of these patients did not require any surgery. And we referred to them as a complete responder. If we look at overall patient population that they reduce their number of surgeries, we are looking at 83% response rate.
spk10: Okay.
spk03: Now, when we look at the immunological responses of these patients, the patients that they had the complete response, they have a significant increase in their immune responses to HPV 6 and 11. And this is exactly what the mechanism of this vaccine is all about at the same token one thing that we have to say we have been following now these patients for more than 12 months actually these patients are in full response and they are upwards of 24 months this is two years after vaccination and again i'm going to stress severe patient population with the average number of surgeries six mean average right so when we look at also we have based on the data the safety the efficacy the fda last year for the first time in the history of any company has given us a breakthrough designation as well as accelerated tasks and agreed that our single arm pivotal phase one data plus a single-arm Phase II, which we had started, can act as pivotal, and based on that, we can submit a BLA. So as we have mentioned, last year we finished the enrollment to our Phase II, and we are really excited that we will be presenting the full data set of our Phase II by the end of Q2. We already have published in the science translation our complete phase one data and the mechanism of action of that. And we are supposed to submit our BLA in the second half of this year. And we have received an agreement from the FDA that we have enrolling BLA. So as you can imagine, this is quite exciting and also a proof of concept for this platform. Simultaneously, we have been advancing another molecule, PRGN-2009, and that has been already positioned in HPV 16 and 18 cancers, head and neck cancers, cervical cancers, and the phase two studies in head and neck has been initiated last year And we are currently enrolling and recruiting patients to this arm of head and neck with the early onset of the disease. And this is quite exciting. Why? Because when you look at the head and neck, the response rate of the patient, even to the checkpoint inhibitor, has been 18%. So there is a wide gap here for the improvement. Last year at ASCO, we showed that when we treated HPV-related cancer patients, these are the stage four patients, these patients had, basically, we had 30% objective responses, partial responses, complete responses, and the complete responses, they were durable. We had over a year, for instance. response in some of these patients. This is in a patient population that I stress again. Checkpoint inhibitors in cervical cancers are 15%, and then they fail for in head and neck, 18%. So now positioning PRD in 2009 in a head and neck in combination with the PEMBRO in an early onset is quite exciting, and this trial is recruiting, and we have enrolled patients to get on. Simultaneously, we moved this asset towards the cervical cancer. Last year, we received an IND approval from FDA to open the phase two study in combination with PEMBRO in a relapsed metastatic cervical cancer patient. And currently, as we speak, we are recruiting to this trial, and this is quite exciting. So as you can imagine, this platform, with the differentiation that it has from all the other platforms, with the efficacy that has shown, and in our lead PRGN 2012, based on its safety, clinical efficacy, and also in discussions with the KOL and investigators Their high excitement about this molecule for this rare disease because of ease of administration, because of efficacy of clinical response, and the durability of response has generated a lot of excitement and really has positioned us to become a leader in treatment for this rare disease. So with that as a highlight, I would like to now actually transfer to Harry Tomasian to give us our CFO an update on our financial. Harry?
spk07: Thank you, Helen. And good afternoon to those on this call. We appreciate you participating. As Helen mentioned earlier, 2024 is shaping up to be a transformative year for Precedent. We are all well on our way to completion of our drug substance manufacturing facility here in Germantown, Maryland. And with the hiring of our head of commercial operations in September of this past year, we are continuing to build out our commercial function and plan to be ready for the expected launch of PRGN 2012 in 2025. In addition, we anticipate that there will be multiple value inflection points in 2024, starting with our data readout on PRGN 2012 in the second quarter of this year. As we approach the end of the first quarter of fiscal 24, we're continuing to exercise sound financial management, preparing for the planned launch of PRGN 2012 and 2025, and continuing to move our other programs rapidly through the clinic, all while maintaining efficient SG&A operations. With that in mind, I'd like to spend a few minutes highlighting certain aspects of our financial results from 2023. In 2023, our research and development expenses were $48.6 million, an increase of 3% or $1.4 million from the prior year. This was primarily due to additional investment in our personnel, mostly through adding additional headcount to support the growth in the company's development activities. Our continued focus on SG&A costs resulted in a decrease of 16% for $7.6 million from the prior year to $40.4 million for the full year of 2023. This was due primarily to reduced legal and insurance costs and was achieved while we began to build out our commercial group. We filed our 10-K with the SEC just prior to this call, and you can find more detailed financial information in the financial statements, which are included in the 10-K. In addition, we are continuing to evaluate various opportunities and are current and are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRGN 2012 and transitioning from a clinical to a commercial stage company. This concludes our prepared remarks for today. I'll now turn it over to the operator for any questions.
spk00: Thank you, ladies and gentlemen. Thank you, ladies and gentlemen. We will now conduct the question and answer session. If you have a question, please press star 1 on your telephone keypad. If you wish to cancel your request, please press star 2. Please ensure to lift the handset if you're using a speakerphone before pressing any keys. And as a reminder, kindly limit your question to a one initial and one follow-up question only. Thank you. Your first question comes from Jennifer Kim from Cantor Fitzgerald.
spk02: Your line is now open. Jennifer?
spk00: Your line dropped. Your next question comes from Jason Butler from Citizens JMP. Your line is now open.
spk06: Hi. Thanks for taking the questions, and congrats on all the progress. To the two for me, first of all, in terms of the PRGN 2012 Phase 2 trial, can you maybe just compare the trial design here, patient population, anything about trial conduct to the Phase 1 study that we already have the data from and note any differences? And secondly, Helen, at this point, any more color you can give us on the design of a confirmatory study that you would conduct for 2012, assuming you got accelerated approval? Thank you.
spk03: Hi, Jason. Thank you. Excellent question. So, in regards to the phase one and phase two, the study, actually, the design is exactly the same. And this is why FDA has allowed us to combine They say one single arm and say two single arms and they consider that as a pivotal. So we are really excited about that. There was no different design between these two and it will total 35 patients that the data will be reported on. In regard to the confirmatory trial, Also, we have a full agreement with the FDA already that the confirmatory trial would exactly duplicate what we have done in a single-arm phase one and phase two. So it's the exact same design. However, one interesting point here, and I think it's very, very important, that based on the safety and the efficacy that we showed um and the fda has seen that data fda has recommended that we also consider an arm this is not a requirement for a confirmatory this can be separated or done differently however or we can even add it to the confirmatory trial if we wish to but for a repeat dosing because the consideration that those 80, the other 50% of the patients that they didn't go to a complete response, however they benefited and they reduced their number of surgeries, they might be able to go towards a complete response. And we are really excited about that. We already have the design of confirmatory based on what we had designed before. And clearly upon our BLA submission, our confirmatory trials will start, is going to be initiated simultaneously.
spk02: Great. Very, very helpful. Thank you, Helen. Thank you.
spk00: Your next question comes from Jennifer Kim from Cantor Fitzgerald. Your line is now open.
spk04: Hey, can you hear me? Yes. Hi, Jennifer. Oh, perfect. Sorry about before. Maybe to start off, Have you decided on your plan in terms of the format or venue for presenting the Phase 2 data? And then my second question is just from a commercial readiness standpoint, can you give more color on the manufacturing side and how much capacity do you anticipate having at timing of a potential launch? Thanks. Awesome. Thank you.
spk03: Jennifer? So obviously, we are looking at the various options that we have, and we will give a little bit more guidance as we get closer. But clearly, we are looking forward to presenting the full set of data on our phase two and our investigators also similarly. So we will be guiding soon. In regard to the commercial readiness, Our commercial facility is actually is exactly moving according to the plan. And we will have a capacity that at the time of launch to meet not only the number of the patients, and actually we have by then have generated in thousands of doses. that the patients can be treated with. So we are confident that we can meet the needs of the commercial basically force and our patients as we move forward.
spk04: Okay, that's helpful. And maybe to follow up on what you said before on the arm to look at repeat dosing, is there any data or feedback that you're waiting on before you sort of pulled the trigger on making that decision?
spk03: No, actually, that is the arm that the design has been up to us, because that is not a requirement for a confirmatory from FDA. Our confirmatory trial is already agreed by FDA, and it's actually in the process, as I mentioned, upon our submission of the BLA, we also have initiated that going forward. The repeat dosing is what we have designed in conjunction with our investigators, and that we will also add as part of our confirmatory as another arm. But then again, that is not a requirement by the FDA. to expand our label and as well as expand the patient population that they can benefit from repeat doses, especially with the durability that we see currently, which is more than two years. Okay, got it. That's helpful. Thanks, Helen.
spk02: Your next question comes from
spk00: from HC Wainwright. Your line is now open.
spk05: Thank you. This is RK from HC Wainwright. Good afternoon, Helen and Harry. I have one question on 2012. In terms of commercializing the drug, can you give us some of the aspects of it in terms of, like, sales folks and what sort of, you know, what is the strategy there? And it being an orphan disease, do you, I mean, do you focus on some specific centers where this is being treated? Just some of the dynamics of that, please.
spk03: I'm going to ask Jim Schaefer, head of our commercial, to actually... give colors to that.
spk09: Thank you, Helen. We have recently completed primary and secondary market research to better understand not only the patients, but also the physicians and the prescribers who currently manage the RRP patients across the U.S. And, you know, what we continue to identify is that it's a relatively small group of specialty physicians, primarily laryngologists, which are subspecialty of ENT physicians that are managing uh the large majority of patients so we will be able to you know create hire and train a specialty sales team focused in the major metropolitan areas and very efficiently be able to you know increase awareness launch and then promote our product once approved okay
spk05: Thank you for that. And then going off onto the Ultracore T cell therapies, the 3007, where you're doing the dose escalation study now and hoping to present some preliminary data. What sort of data would we see in terms of the dose ranges? And also, how soon can you
spk03: um get into phase two um based on what uh you know what what you get to see from this this portion of the um of the study yeah no thanks okay so um in this trial uh actually based on our uh prior trials uh we are though there is a two dual uh cohort uh here However, this is an umbrella trial, as we have mentioned before. That basically means we are addressing a number of indications, both hematological as well as solid tumors, especially triple negative breast cancer. This is going to be very exciting. And what we are looking at, the guidance that we have given, we will be giving some updates on the interim data by the end of 2024. And we will be moving upon the dose selection as well, obviously, finishing all of the safety. Then the trial moves to the expansion phase, phase 1B. And again, those are the discussions that, based on the data that we will see, we will have with the regulatory bodies, the similar type of things as we currently have, for instance, AML, which is in a patient population, that they really have no other option in front of them. And as you are aware, other CAR Ts and TCRs have not been able, or even the off-the-shelf, have not been able to insert into that arena. And also small molecule inhibitors, unfortunately, it addresses only certain percentage six to 7% of the patients that they have those mutations, for instance, in Sledtry. And as we have seen, based on the data, those patients, unfortunately, after a year, also, there is a mutation in their tumors, and they relapse, and they have to look for other options. So I think We are really excited about that, our and the results that have been showing. And then we will be, as we have given the guidance, by the end of 2024, we will present the data on expansion.
spk05: Perfect. Thank you. Thank you very much Helen and team for taking the questions.
spk02: Thank you.
spk00: Your next question comes from Brian Chang from JP Morgan. Your line is now open.
spk01: Hey, guys. Thanks for taking our questions today. First one is on the RRP prep. So based on your market research, how should we think about the initial adoption trajectory within RRP if you were approved today? Is there a lot of pent-up demand, or do you think that this will be a small built over time type of launch? And I have a quick follow-up. Thank you.
spk03: Okay. I think, Brian, I'm going to let Jim Sheffer answer that, and I can add to that as well. Sure.
spk09: Yeah, Brian, thanks for the question. As I mentioned earlier, we recently completed a commercial market assessment for the U.S. and the rest of the world markets for RRP and for PRGN 2012. We feel like the overall uptake is going to be relatively swift because a large majority of the patients are sitting and managed by a relatively small number of laryngologists across the US. So as we educate and increase awareness about the product availability, we think that's going to be relatively quick with those physicians and patients. So whether it's a three or four year uptake curve to peak, and then with some level of retreatment that occurs for the rest of the overall sales build over time. Does that answer your question?
spk01: Yes, it does. So maybe just on expenses, how should we project sales-related expenses as you prepare for the launch? Any color on the projected cash runway, and what is the latest updates on the partnership for UltraCarty?
spk03: Okay, so I can take some of this and then definitely Harry can add to it. In regard to, as Harry mentioned, we are looking at the various strategies for basically supplementing our financial balance sheet, and we are confident that as we move forward, we have that ability. In regard to the ultracar T, actually, I'm glad you asked that question because as you can imagine, especially with the evolution and the scenarios that have happened, we saw all in the past six months the change of the label even in approved CAR T for the reason that the classical CAR T, unfortunately, some of the patients have come down with... Cancers are associated with CAR-T. And now that has to be projected in the label at the same token. Now this puts another cloud on the field of autoimmunity using this classical CAR-T. Because in a cancer patient, of course, you're dealing with indication that the patients have no option and they have no other treatments. On the other hand, when you're looking at the chronic diseases such as lupus or autoimmunity, clearly now you have to have a very, very safe life because number one, these are not patients that are stage four. These are patients that they can live for long periods of time. And secondly, most probably, they have to be redosed over their chronic disease. So in that setting, you have to have two phenomena. Number one, the safety to ensure that someone that would have had otherwise a long life, you cannot be exposing to the scenario that they might develop cancer as a result of the treatment that they received. Number two, it's the cost. It becomes very, very important, especially in chronic diseases because As we can see currently, even the cost in a cancer indication is not bearable on our system. Left alone, now you go to the chronic diseases. For those reasons, the platform that we have developed and it's moving forward. And by the way, across the indication, we have now treated more than 70 patients in this platform. And number one, the ease of the manufacturing overnight at the hospital which then does not require the costs that are associated as you can imagine with centralized manufacturing and number two the design of these cartoons that we have currently which do carry safety switches within them with under if anything goes wrong you can eliminate yourself thankfully we have enough to activate itself But obviously, we have done all of the preclinical studies. And of course, these were part of our IND packages that was given to FDA. And I think this is the advantage that currently our CAR TN, the combination of those two factors obviously have created a lot of excitement and also attention. So we will be updating as we move forward in regard to our basically partnership activities. But this is going to be a very exciting year.
spk07: Brian, I'll touch on your question around cash runway. I'll start with the historical cash burn. So last year, 2023, our cash burn was about $68.5 million, or an average of about $5.7 million per month. There'll be some increased expenditures with the build-out of commercialization and manufacturing capabilities. But through financial management, we're trying to reduce spend in other areas of the company. I will go back to my prepared remarks and reiterate that we're continuing to evaluate various opportunities, and we are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRG in 2012.
spk02: Thanks for the call. Thank you. Ladies and gentlemen, as a reminder, should you have any questions, please press star followed by the number one. I see no further questions, Lester.
spk08: Let's turn it back to Helen for concluding remarks.
spk03: Thank you, Operator, and thank you to all of those that joined us for our update call today. As you can see, 2024 is poised to be a transformative year for us at Press Agency. especially as we transition from a clinical to a commercial company. With pivotal Phase II data underway and the plans to submit a BLA in the second half of this year, we are poised to deliver health to patient population with no alternative and drive a shareholder value. We look forward to communicating further in the coming weeks and months. Thank you again for joining us.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for joining. You may now disconnect.
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