speaker
Operator

Good day, and thank you for standing by. Welcome to the Arbutus Borough Pharma Corporation's fourth quarter and year-end 2021 financial results and corporate update call. At this time, all participants are 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'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lisa Capparelli, Vice President of Investor Relations. Please go ahead.

speaker
Lisa Capparelli

Thank you, Catherine. Good morning, everyone, and thank you for joining Arbutus' fourth quarter and year-end financial and business update call. Joining me today from the Arbutus executive team are Bill Collier, President and Chief Executive Officer, David Hastings, Chief Financial Officer, Dr. Gaston Piccio, Chief Development Officer, and Dr. Mike Sophia, Chief Scientific Officer. Bill will begin with a review of recent accomplishments and clinical developments, followed by Dave Hastings, who will provide a review of the company's fourth quarter and year-end financial results. After opening remarks, we will open the call up for Q&A. Distan Pichio and Mike Sophia will be available to address clinical and scientific-related questions. Before we begin, we'd like to remind you that some of the statements made during the call today are forward-looking statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our annual report on 10-K being filed later today. With that, I'll turn the call over to Bill. Bill?

speaker
Catherine

Thank you, Lisa. Good morning, everyone. Thank you for joining us. We appreciate your interest and your support of Arbutus Biopharma. This morning, we issued our fourth quarter and year-end financial and business update press release, which provides updates on our clinical and preclinical programs directed at finding a functional cure for patients with hepatitis B and a treatment for coronavirus infections, including SARS-CoV-2. If I had to sum up this past year in one word, it would be transformative. And I'll explain why. In 2021, the Arbutus team did a fantastic job of advancing our proprietary early research compounds into IND enabling studies. Specifically, our oral RNA destabilizer that we now refer to as AB161, and also our oral PD-L1 inhibitor, which we're calling AB101. The potential addition of the PD-L1 inhibitor, AB101, in a proprietary combination with our RNAi therapeutic, 729, and our capsid inhibitor, 836, would allow us to explore our three-pronged strategy to provide a functional cure for chronic HPV infection. As you know, this three-pronged approach consists of suppressing surface antigen, reducing HPV DNA, and boosting the immune system. Now, the potential role for the RNA destabilizer 161 in our approach is the opportunity to provide a proprietary oral treatment regimen for HPV. We're excited about this progress and look forward to completing the IND enabling studies for both these compounds in the second half of this year. Now, in addition, we secured both strategic and clinical partnerships that, in line with our strategic initiatives, allowed us, first of all, to initiate multiple combination clinical trials to evaluate 729 as a cornerstone therapy with other compounds in patients with HPV. Secondly, we expanded the geographic reach of 729 to China to address the largest HPV patient population. And thirdly, we've been able to broaden our pipeline to include development programs against coronavirus infections. And I'd like to elaborate on these strategic accomplishments starting with our combination trials with our lead HPV compound, 729. With the compelling safety and efficacy data from our Phase 1A, 1B clinical trial, in 2021, we moved 729 into three Phase 2A clinical trials to evaluate 729 as a cornerstone therapy in combination with one or more approved investigational compounds. As enrollment continues or is near completion in these trials, data is expected in the second half of this year from our clinical trial evaluating 729, a nucleotide analog, and interferon, as well as data from our partnered trial evaluating 729 with assembly's core inhibitor. Now, with respect to our partnered program with ANTIOS's liver-targeted NUKE, As we mentioned in our press release today, enrollment is complete in this cohort. However, the majority of patients were enrolled in Ukraine, which obviously is currently in a state of war. And these patients may be lost to follow-up before completing the study. Therefore, Arbutus and Antios may report limited data on a reduced number of patients from this clinical trial. Also, as a reminder, we do have a fourth phase 2A combination trial that we expect to initiate in the first half of this year to evaluate 729 combined with VTP300, that's the Vaxitec therapeutic vaccine, and a nuke. And our goal is to utilize the learnings from all of these trials to provide insights with the potential to de-risk the use of our proprietary compounds in combination with 729 to develop a functional cure for HPV, as well as to support our go-forward clinical and regulatory strategy for Phase IIb development. Now, let's move on to expanding the geographic reach of AB729. At the end of last year, we executed an important strategic partnership with Qilu Pharmaceutical, one of the leading pharmaceutical companies in China. For us to reach the largest HPV patient population in need of a functional cure for chronic HPV infection, it was essential to find a strategic partner with significant experience in developing, manufacturing, and commercializing products in mainland China, Hong Kong, Macau, and Taiwan. As part of our discussions, Qilu conducted extensive diligence before completion of the agreement. Based on their belief in the potential of 729 to be a safe and effective treatment option for HPV, Qilu paid us $40 million upfront and made a $15 million equity investment in Arbutus. along with potential additional payments of up to $245 million consisting of certain development, regulatory, and sales milestones. Finally, as part of this transaction, we're also entitled to receive double-digit tiered royalties up to the low 20% on annual net sales of 729 in their territories. This is one of the largest early clinical deals conducted with a Chinese company. As important, this partnership also allows us and Qilu to maximize the potential clinical value that 729 can bring to the millions of underserved patients in China. As we collaborate with Qilu on a clinical development strategy for 729 in China, we plan to provide updates on our progress. Now, finding a functional cure for patients with HPV remains a key initiative for Arbutus. But we also recognize the urgent need to identify new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks. We've expanded our pipeline to include preclinical programs targeting coronaviruses. We're focusing our research efforts on two essential targets critical for replication across all coronaviruses, those being the NSP5 protease, and the NSP12 polymerase. In December, through our partnership with Exchem and Proteris Biostructures, we identified unique and differentiated pan-coronavirus assets that inhibit the SARS-CoV-2 NSP5 main protease, or MPRO, which is a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks. We recognize the importance of rapidly developing oral small molecules in addition to vaccines to address this pandemic as it transitions to an endemic phase. To that end, we intend to advance an MPRO clinical candidate into IND-enabling studies this year. We are also continuing lead optimization activities for an NSP12 viral polymerase candidate. Now, aside from our progress in our research efforts and partnerships to achieve our strategic initiatives, in 2021, we continue to build convincing safety and efficacy data with AB729 and AB836. Both of these compounds are undergoing rigorous evaluation at various dose levels and dosing intervals in cohorts of patients with various baseline characteristics. This comprehensive body of evidence that we're building gives us the confidence that the dose and dosing interval we intend to advance into later stage clinical trials will be best suited to be safe and effective. This year, we anticipate reporting key data for AB729 that will include new on-treatment data on multiple cohorts of patients included in the Phase 1A, 1B clinical trials. as well as long-term follow-up data for patients who completed treatment and have discontinued AB729 and nuke therapy. We also expect to report additional AB836 data from Part 3 of the Phase 1A, 1B clinical trial that will inform potential future clinical trial development. I'm proud of the enormous progress the Arbutus team has made this last year to position the company for multiple key clinical milestones and significant growth in 2022. And I look forward to keeping all of our shareholders informed of our progress and planned continued success. Now, lastly, as you saw in our press release on Monday, Along with Genovant Sciences, we filed a lawsuit in the United States District Court for the District of Delaware against Moderna and an affiliate of Moderna seeking damages for infringement of certain U.S. patents in the manufacture and sale of mRNA-1273. That's Moderna's vaccine for COVID-19. The patents relate to nucleic acid lipid particles and lipid vesicles as well as compositions and methods for their use. As you may recall, in December 2021, the United States Court of Appeals for the Federal Circuit rejected Moderna's appeal of a prior decision of the U.S. Patent Trial and Appeals Board holding all claims of the asserted 069 patent to be patentable and dismissed Moderna's appeal challenging a similar finding of patentability with respect to certain claims of the asserted 435 patent. Moderna had initiated inter-parties review IPR challenges against these patents in 2018 and 2019. Now Arbutus and our licensee Genevent do not seek an injunction or otherwise seek to impede the sale, manufacture or distribution of mRNA-1273. However, we do seek fair compensation for Moderna's use of our patented technology that was developed with great effort and at great expense without which Moderna's COVID-19 vaccine would not have been successful. Now I do recognize that this litigation is of great interest to our shareholders and that many of you will have questions. We believe that the lawsuit we have filed is the appropriate way to resolve our claims. I ask that you be patient with us as we will not be able to provide any additional commentary on our allegations or our litigation strategy aside from what is in the publicly filed complaint other than to say we intend to pursue all appropriate avenues to defend our intellectual property rights. With that, I'll now turn the call over to Dave Hastings for a brief financial update.

speaker
Lisa

Thanks, Bill, and good morning, everybody. As I've mentioned in the past, our key financial metric is cash and financial runway. Our cash, cash equivalents and investments was approximately $191 million as of December 31st, 2021, as compared to approximately $123 million as of December 31st, 2020. The ending cash, cash equivalents, and investments balance as of December 31st, 2021 does not include the $40 million upfront payment and a $15 million equity investment received in January 2022 from Shilu Pharmaceutical as part of the exclusive licensing agreement and strategic partnership to develop and commercialize AB729 in China. Our cash use from operations for the year end of December 31, 2021 was $67.5 million, which was offset by approximately $135 million of net proceeds from the issuance of common shares under Arbutus' ATM program. For 2022, we expect our aggregate cash use to range from $90 to $95 million. And therefore, we expect our current cash runway to be sufficient to fund operations into the second quarter of 2024. I would like to now discuss the relationship with Genovant, especially as it relates to the Moderna patent infringement lawsuit that was filed on Monday. Back in 2018, along with Roivant Sciences, we launched Genovant as a company to focus on RNA-based therapeutics. We license GenoVant rights to our LNP technology for RNA-based applications outside of HPV. And we currently have a 16% equity interest in GenoVant. Now, under this licensing agreement, if GenoVant receives proceeds from an action for infringement by any third parties of Arbutus' intellectual property licensed to GenoVant, we would be entitled to receive, after deduction of litigation costs, either 20% of the proceeds received by Genovant or, if less, tiered low single-digit royalties on net sales of the infringing product, inclusive of the proceeds from litigation or settlement, which in that case would be treated as net sales. So with that, and in closing, we have established a strong financial foundation to advance the company's mission to develop a functional cure for HPV and a treatment for COVID-19 and potential future coronavirus outbreaks. Bill?

speaker
Catherine

Thanks very much, Dave. And operator, why don't we open up the lines now for Q&A.

speaker
Operator

Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from Roy Buchanan with JMP Securities. Your line is open.

speaker
Roy Buchanan

Hey, great. Thanks for taking the questions. Appreciate the details on the litigation stuff. First question on 836, anything you can say about what to expect from the data later this half? You've shown good reductions in viral DNA at 100 milligrams already. Any early thoughts about how the program might take shape in the second half? And then looking at the slide, just to verify cohorts, I and Jay have not started, correct?

speaker
Catherine

Yes, Gaston's on the call this morning. Gaston, do you want to take that question?

speaker
Gaston

Sure. Hi, Roy. So let me start with the last part of your question. I and Jay have not started yet. Right now we have We're conducting the three first cohorts, the 50, the 100, and the 200 milligram cohorts. And the data will be reported in the first half of this year. Once we have the data, I think we'll decide on next steps. We have already some plans in mind, but we need to see the final data before making those final.

speaker
Roy Buchanan

Okay, great. And then you guys had a case of rash and an ALT elevation earlier. Not sure if you can say, but any additional observations of either of those events?

speaker
Gaston

We cannot comment on that. I think the data will be reported, you know, at the time when it's reported in the first half of the year.

speaker
Roy Buchanan

Okay, great. Just thought I'd try. And then what's gating for starting the Phase IIa with VTP300? And then you mentioned in the slide starting a Phase IIb, assuming positive results. Do you think that would be a larger triple combo trial, or do you think you might be able to work in an additional, you know, a core inhibitor or some other agent to have a quadruple combination?

speaker
Gaston

So the VTP300, it's already approved in some of the countries where we are going to be executing the study. So it's just a question of, you know, activation of clinical sites and so forth. So it will, you know, Hopefully we'll be starting very soon. I think we indicated in the first half, but already has been filed in a number of countries and we just got some approvals. Secondly, in terms of the face-to-face study, yes. So we obviously from 836 to make those final decisions as to whether 836 will be part of the mix for a larger face-to-face study. We also want to see some of our preliminary data in combination with interference as well. And also we want to see other data that's emerging in the field, for example, you know, checkpoint inhibition. So there's a number of, you know, pieces of data that we're looking forward to see in the course of this year that will help us shape our final face-to-face strategy. We cannot really define what that will be at this point in time.

speaker
Roy Buchanan

Okay, great. And one, just check the box for Dave, and then I'll jump back into the queue. The net cash burn, 90 to 95 this year, just want to double check, does that include both components of the CHILU payments in January? Thanks.

speaker
Lisa

Well, yeah, no. So the cash burn is a net cash burn. The only thing that really reduces that is the on-patro entitlement fee royalties that Roy, and in terms of revenue recognition for the CHILU agreement, that $40 million was received in January, so the accounting really starts in Q1. We would expect to defer that revenue recognition over a period of time as we transfer the technology to manufacture AB729 to CHILU, and that might take a couple years.

speaker
Roy

Okay, thank you.

speaker
Operator

Thank you. Our next question comes from Dennis Ding with Jefferies. Your line is open.

speaker
Dennis Ding

Hi, good morning, and thanks for taking the question. Two for me, if I may. First question is on your hepatitis B. Can you just talk about what you'd like to see from the various triple combo studies reading out in the second half, and what do you want to see to give you confidence that there will be a higher probability of success for functional cure, which which I would think is coming in 2023, 2024. And then my second question is around your protease inhibitor. You know, I don't really think people are really appreciating that you guys have this asset. So can you just comment on when that will go into the clinic? And can you just talk about your ideal drug profile there, specifically how has preclinical studies panned out in terms of potency and your projected human PK? Okay. Thank you very much.

speaker
Catherine

Thank you, Dennis. Gaston, do you want to take the first one, and then we'll have Mike and Sophia talk about the protease?

speaker
Gaston

Yeah, sure. Can you repeat, because you were breaking up a little bit when you were asking the HVB part of the question. Please reiterate the question.

speaker
Dennis Ding

Yeah, sure. Can you just talk about the data that's coming in the second half for your triple combo studies and what you'd like to see to give you more confidence that there will be a higher probability of success for functional cure.

speaker
Gaston

Sure. So when it comes to the, specifically when it comes, for example, to the interference study, what we would like to see, hopefully, is a deeper S-angian decline, and hopefully some of the participants in the study getting to undetectable levels on treatments. something that, you know, as we've reported, we have not seen with 7 to 9 and Anouk, and pretty much nobody has seen with an SIRNA and Anouk. So the addition of interferon, we believe, is going to contribute to a deeper, maybe faster, disantigen suppression. Obviously, then that's when it comes to that particular, you know, study with addition of interferon. Then, you know, we have another interesting, you know, piece of data that's coming out, which is what happens after stopping NUC therapy in patients who have been on 7 to 9 plus a NUC for 48 weeks. Then they stop 7 to 9 for an additional six months, and now they are eventually stopping the NUC. There, I think we would like to see two things. One is whether the S-antigen either is sustainable or reduced. at the lower levels we are requiring to be able to stop the NUC, which is below 100 IU per ml. And secondly, we would like to see what happens to HPV DNA, whether HPV DNA comes back, you know, see a relapse like pretty much everyone sees after something NUC, or is HPV DNA pulled back as a result of the addition of AB7 to 9, which also, you know, could lead to a different concept, not necessarily functional cure, which is complete loss of this antigen, but could lead to a sustained biological response, which is HPV-DNA does not come back after stopping all therapies, which potentially could be beneficial for the patients as well.

speaker
Mike

Okay.

speaker
Dennis Ding

I have a question on the protease inhibitor.

speaker
Mike

Yeah. So, yeah. Hi, Dennis. This is Mike Sophia. So, to answer a couple of your comments, Look, as far as a profile for the molecule, we are certainly clearly aware of the developments in the field. And so our molecule, we're definitely trying to target to have a profile that differentiates it from what else is out there. For example, I could say that we want a molecule that we don't need retinobir boosting like Paxlovid requires. We believe that's a disadvantage for a general patient population. We clearly want an oral once-a-day dosing regimen to be competitive in the space, and clearly a molecule with very competitive, if not exceptional, potency overall. So I think those are the general characteristics that we're looking for. Now, as far as where we are, we're in sort of lead optimization here. We fully expect to nominate a compound in the second quarter of this year, sort of the latter part of the second quarter of this year, and then obviously rapidly move into IND-enabling studies and move as quickly as possible to get that molecule into the clinic. So that's sort of the general overall profile and plan that we have, realizing that, you know, there is this sense of urgency for us and our program, but also for patients and, you know, trying to identify ways to accelerate the ID-enabling study aspects of this program.

speaker
Dennis Ding

Thank you. That's helpful.

speaker
Operator

Thank you. Our next question comes from Ed Arce with HC Wainwright. Your line is open.

speaker
Ed Arce

Hi, everyone. Thanks for taking my questions. Congrats on a very productive year. First question is on ABA36. As I'm looking across the many data readouts that you plan to have this coming or this year, it would appear this is the only one in the first half. Part three, I think you mentioned earlier, cohorts I and J have not started yet. So just wondering, the additional data, could you give us a little more detail on what you expect, any more, either additional data from previously enrolled cohorts or the initial take from cohorts I and J?

speaker
Gaston

So, hi, Ed Gaston here. So, I mean, as we said, I mean, the data will be reported in the first half. So, really, I can't comment on any additional, you know, results from those that we reported in December of 2021 on the 100 milligram preliminary data on the 100 milligram cohort, which looks very promising, the 3.1 log. dropping HPV DNA in places A36 as among the most competitive inhibitors with a point with a very good safety profile. So I think we have to wait until we'll report, you know, the totality of the data for the 50, 100, and 200. If, you know, as I mentioned, we haven't started INJ, but if we have any preliminary data on INJ, by the time we are ready to report, we'll report that as well. But, you know, that depends on recruitment speed. I think given what we've seen so far, you know, with the low decay, I think it's fair to say that we are very confident that 836 is going to emerge as a very strong capsid inhibitor. And, again, I mean, I just reiterate what I said before. We need to see that data and analyze it critically to decide whether, you know, 836 should move forward in combination with 729 and other agents. Given what we've seen so far, I think I would lean to say yes. But, you know, I think we have to see the totality of the data for making that final decision. But given what we've seen so far based on the 3.1 log decay in H3BDNA, it looks like a very strong contender and that contributes significantly to a combination of regimens.

speaker
Ed Arce

Right. Great. Okay. And then turning to 729, as you mentioned, three readouts. It looks like all in the second half with Peg Interferon, Bebicorvir, and the Aspen compound, all combination trials. Maybe you could give us a little more clarity on sort of the order of these, if it's possible, perhaps which is first. It would appear perhaps that the Aspen trial combo that's completed, perhaps that one's first, and then I have a follow-up.

speaker
Catherine

Yeah, so let me just comment on that, and then I'll hand over to Gaston as well. So as we mentioned this morning, the study with ANTIOS, that's the one study in our lineup where the majority of the patients were recruited in Ukraine. And although that was a study that I think was close to completion, we're just really not sure right now how we can follow up those patients, you know, in an efficient or typical manner. So that's why we have tweaked our guidance today and just indicated that for that study, you know, we may be able to report some limited data on a fewer number of patients, but that's one study where clearly the Ukraine situation has had an impact. Now, our other studies, I should point out, you know, we've got a fairly well-distributed set of sites in different countries, and that's why we're maintaining our guidance on the interferon study and the assembly applicable study. I just wanted to kind of cover that off and then hand over to Gaston.

speaker
Gaston

So I think, as we indicated, the three studies in collaboration, I think, will be reported in the second half. When it comes to the 8.7 to 9 data and 0.0.1, I think we'll span both the first half and the second half. As everyone knows, I mean, obviously there is an important lever meeting that has been shifted, but it still is within the first half. So, you know, that's always a good opportunity to present our data in a scientific form. And, you know, and then the second half, obviously, there is an important meeting where the data could be presented. We, you know, we prefer to share the data with the scientific community to, you know, to get it scrutinized in a more scientific way. So those are the two options that we have. You know, the 729 data is going to be more, you know, distributed along the year. Okay.

speaker
Ed Arce

Uh, that's helpful. It was, your audio was cutting in and out a little bit, but I think I, I got the gist of what you were saying. Um, a couple more quick followups, if I may, just on, uh, the data readouts, uh, wanted to get your take if, if possible. Uh, and this is either for Michael or Gaston. Um, On the efficacy readouts from these combo trials, obviously looking at HB-S antigen declines and looking at certain things like the proportion that is below lower limit of quantification or the HBV DNA or RNA that is not detectable. Just wondering, as you collect that data and analyze it from these trials later this year, are there, in your mind, any sort of minimum proportion of patients or any sort of specific thresholds that you're looking for? Just be helpful.

speaker
Gaston

No, I'll start. We don't have a predefined threshold. you know, a threshold of a portion of patients that need to meet a certain criteria, like, you know, at least just say this example, because 50% of the patients have undetectable HPV RNA. So we will just, you know, look at the data in its validity as it comes in, and we'll determine what those proportions are, but we don't have any predefined data. When it comes to S antigen, obviously, you know, aspirationally, we will have to see as many patients as possible losing S antigen, either on treatment or after treatment is continued. But we don't have any proportion of patients.

speaker
Ed Arce

Okay, fair enough. And one just, one quick last question. around the use of the ATM. Is this something that the company intends to continue as it did pretty extensively last year?

speaker
Lisa

Yeah, I mean, I think, you know, we obviously, as a lifetime company, have to use all the tools in the toolbox to ensure that the company is appropriately capitalized. And while we don't lay out specific plans, that's certainly one element of of our ability to fund the company. So I'll just leave it at that.

speaker
Ed Arce

Great. Thanks so much for answering my questions. Thanks, Ed. Thank you, Ed.

speaker
Operator

Thank you. Our next question comes from Brian Scorney with Baird. Your line is open.

speaker
Brian Scorney

Hey, good morning, everyone. Thanks for taking my question. Mike, I was hoping you could give us a little bit of the background on the discovery process of AB101. I know developing small molecules to disrupt protein-protein interactions has been tough, but one successful has been pretty successful. So, you know, can you kind of walk us through how 101 interacts with PD-L1? Is it a PD-1 memetic? And maybe you could give us details on what the molecular weight is and have you shown any data on oral bioavailability from the preclinical work so far? Thanks.

speaker
Mike

Yeah, sure, sure. We did present a little bit of data at HEPDART 2021. So, look, the molecules are, you know, in the slightly larger molecular weight range, okay? I would say around 700 or so. However, you know, we had good oral bioavailability for these agents. Now, you know, the process that we have gone through You know, there have been some historical data published on some small molecules that bind to PD-L1 that we sort of jumped off on and sort of introduced some very novel aspects to it ourselves and then began to investigate how these molecules work. And the way these molecules work is not like a typical antibody, which basically binds and blocks. What they do, they bind to a specific site on PD-L1. They cause dimerization of PD-L1s on the surface of the cell. This results in an internalization of the protein and ultimate degradation of that protein. So this happens actually really quite quickly, and so you then sort of have a significant depletion of PD-L1s on the cell surface. This then translates clearly into a very similar phenotype that you would see in an antibody. In fact, we show that these PD-L1 small molecules do result in immune reactivation in HPV-specific T cells by looking at interferon, again, interferon increases. We see, in fact, an in vivo animal model given an oral once-a-day dose of this agent, and this is in a MC38 tumor model, that we see reductions in tumor size that are comparable to use of antibodies. So that would be using atezolizumab as the comparator. So these molecules do work by different mechanism, but ultimately provide the same, you know, biological outcome that one sees when using an antibody. So, you know, the process that we've gone through is clearly to identify molecules that bind to the receptor. that have this functional effect of internalization, and then obviously doing typical PK assessments to optimize the PK profile that we're interested in, and then evaluate them in an in vivo model to see if that translates to in vivo efficacy, and obviously move forward from there. So I hope that answers your question.

speaker
Brian Scorney

Yes, it did. Thank you very much, Mike.

speaker
Operator

Thank you. And we have a follow-up from Roy Buchanan with JMP Securities.

speaker
Roy Buchanan

Hey, thanks for taking the follow-up. Just really quick on the 729 Phase 1. You mentioned the patients coming off of 729 and the nuke. Just wondering if you could give us a sense of the day that we'll see how long they'll be off the nuke, maybe. Thanks.

speaker
Roy

Yes, sir?

speaker
Gaston

Yeah, it's difficult to say. Let me just point out the following. In that study that we've amended to give that option to investigator and participants, they obviously stopped seven to nine, then they're being off seven to nine for six months. And after that point, after being off seven to nine, they have the option to discontinue the NUC. And again, this is not mandated by the protocol. This was an option. that investigators and the patients have based on certain criteria that we have not disclosed. The moment that they choose to do that, you know, they're being followed up obviously very carefully for safety reasons and also to monitor whether S-antigen continues to decline, goes back up, or HPV DNA and other biomarkers such as HPV RNA and so forth. The duration of that follow-up is going to be very variable because some patients have chosen to stop a while ago. Others are doing that as we speak. So it's going to be a wide range of follow-ups. I cannot really pinpoint what the exact follow-up time will be by the time we do the data cut to present that data.

speaker
Roy

Okay. Thank you.

speaker
Operator

Thank you, and I'm showing no further questions in the queue. I'd like to turn the call back to management for any closing remarks.

speaker
Catherine

Oh, thank you very much indeed. And thanks, everyone, for joining us this morning and for your questions. We look forward to keeping you updated as we move forward with many of the clinical milestones we've mentioned today, including the announcement of additional data from our combination trials evaluating 729, the cornerstone therapy, and also our Phase 1A, 1B clinical trials with 729 and 836. So with that, thank you all again. And, Operator, that concludes our call.

speaker
Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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