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spk01: Good day and thank you for standing by. Welcome to the Agenis Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker 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. If you require any further assistance, please press star 0. I would now like to hand the conference over to Divya Vasudevan. Thank you. Please go ahead.
spk02: Thank you, Tamiya, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As another reminder, this call is being recorded for audio broadcast. Joining me today are Dr. Gerald Armand, Chairman and Chief Executive Officer, Dr. Jennifer Buell, Chief Executive Officer of Ming Therapeutics, Dr. Stephen O'Day, Chief Medical Officer of Agenis, and Christine Klaskin, Vice President of Finance. Now, I'll turn the call over to Gero to highlight the progress we have made to date this year. Gero?
spk06: Thank you very much, Divya, and thank you all for your participation and your interest in Agenis as well as Mink Therapeutics. As we have shared previously, our business model is comprised of four pillars. Now, for today's discussion, I will redefine what those four pillars are, and we will primarily talk about pillar number one, two, and three, and I'll make some broad comments about pillar number four. The first pillar is what we describe as our significant value creators. We believe these compounds and opportunities could be significant. And they represent certainly our next generation compounds. And one primary example of that, which we will talk about in some detail today, is our next generation CTLA-4 inhibitor, HN1181. The second pillar is represented by our partner programs and recently launched affiliated businesses, including Mink Therapeutics and Saponix. The third pillar we describe as supportive programs, such as Bostilumab and Zoliferilumab, and I will define what we mean by supportive programs in just a bit. And our fourth pillar, which is a silent component of our business, we don't talk very much about it, but a very important component because without it, we wouldn't be able to accomplish the kind of things, innovations and advancements as we have. And that is represented by our vertically integrated structures comprised of key operational capabilities for the company, including our commercial manufacturing, including our vision technology, which is our response prediction platform designed to facilitate the development of our pipeline by targeting patients who are likely to respond to therapy. Now, I would like to begin the call by addressing the first pillar, which is driven by our flagship program, AGEN 1181. Now, as you know, we have a CITC presentation coming up. This morning, we announced the CITC publication of an abstract summarizing data from a dose escalation study of over 100 patients treated with our next-generation CTLA-4 inhibitor, AGEN1181, as both monotherapy and in combination with our PD-1 inhibitor, Bostelamab. More details will be presented this Friday. I will provide a top-line summary here. AGEN 1181 is the first reported CTLA-4 inhibitor to demonstrate clinical activity in nine cold or treatment-resistant tumors as monotherapy and in combination with bostilumab. Secondly, AGN1181 monotherapy and in combination with falcilumab has shown compelling clinical activity and durable responses across a number of cold tumors such as colorectal, endometrial, pancreatic cancer, and they have been, as I said, in treatment-resistant settings such as PD-1 relapsed and refractory melanoma, non-small cell lung cancer, and cervical cancer. Importantly, we are seeing evidence of more favorable safety profile relative to first-generation CTLA-4 molecules. Also, AGEN 1181 is performing as designed. We designed this model for a specific performance. And so far in the clinic, it is indicating that it's delivering that performance. And that is to expend the benefit of immune therapies to a broader patient population with deeper, more durable responses than what is available to them today. Dr. Steven Roday will share additional comments along with our plans to accelerate development of 1181 alone and in combination with Maltulamab. As I mentioned earlier, full details of this will not be released until the poster is released this Friday at the CITC conference. That's Friday, November 12th. Next, I would like to address our second pillar of our business model, which include our recently launched affiliates and partner programs. As you know, amongst our accomplishments with regard to our second pillar is the launch of these businesses. To start with, on October 15th, we announced the successful IPO of Ming Therapeutics, which has raised over $40 million and a valuation of $400 million. We are pleased that Mink has been one of the best performing IPOs recently, having appreciated 58% as of the closing price race yesterday. Dr. Jennifer Buell, the newly appointed CEO of Mink Therapeutics, will tell you more about Mink programs and share a preview of the three abstracts where we announced recently, which will be presented at CITC this week. Now separately, in September, we also announced the launching of Saponix. Saponix is our subsidiary working on building an integrated vaccine platform based on scalable and secure manufacturing of saponin-based adjuvant. This premise behind Saponix business model is captured in the following, and I'll outline this in four different categories. Firstly, the need for vaccines offering long-lasting efficacy and efficient production has become amplified because of the needs as described by the current reality, which is the pandemic. The durability offered by QS21 Stimulant, which is our flagship adjuvant, has been validated by Shingrix, which offers protection exceeding nine years. And this is particularly important in the current climate where we know the current vaccines are waning in activity after three, six months. and whereas POS21 Stivalan is largely responsible in Schengrix for this long-lasting efficacy. But, on the other hand, the supply is limited due to the reliance on a complicated and expensive extraction process from the Chilean soapbark tree. So, to this end, we're working with two companies, Phytan Biotech and Ginkgo Bioworks, to optimize the plant cell culture process, which we have developed for the purposes of manufacturing QS21 stimulant and next-generation saponin-based adjuvants. This is very important because some of our next-generation saponin-based adjuvants are particularly relevant to respiratory viral infections. Among our objectives is to also establish a platform for developing next-generation adjuvants, effective and scalable vaccine formulations with optimized antigen and adjuvant pairing. And in the future, we'll talk about what we mean by that. Now, in addition to this, also part of our second pillar is the driver of our certainly past and also, importantly, future partnerships. In October, we announced the first patient dose with agent 1-777, our FC-enhanced TIGIT by specific antibody license to BMS recently. This achievement triggered a $20 million milestone payment from BMS and BMS intends to advance AGEN-1777 in high priority indications such as non-small cell lung cancer. We are very excited about the prospects of AGEN-1777. Our clinical stage, AGEN-2373, is a differentiated CD137 molecule. It's a CD137 agonist. Otherwise, in the past it was known as 4-1-BB as well. It is designed to selectively enhance tumor immunity while avoiding toxicity associated with systemic CD137 activation. We presented clinical data at ASCO this year showing that Agen 2373 led to prolonged disease stabilization in heavily pretreated cancer patients with good tolerability, no evidence of liver toxicity, which has been one of the issues with other CD137s. Associated, of course, with this is the fact that this has been done in a monotherapy setting. And we are, of course, starting combination trials with this. AGEN 2377, with our AGEN 1181, which is our next-generation CTLA-4, in PD-1 relapsed and refractory melanoma this year. Another program involves our clinical collaboration partner, NELIM, which has recently dosed the first patient in a combination study of our first-generation CTLA-4 with Nelum's hedgehog inhibitor and chemotherapy in first-line pancreatic cancer patients. Now, next is our third pillar, which is our supportive programs, and they constitute the third pillar of our business model and our strategy. Now, what do we mean by this? Our supportive programs include Boxolimab, our PD-1 anybody, and Zolifrolimab, our first-generation CTLA-4 anybody. These are programs which, on their own, do not represent blockbuster opportunities for us. However, in combination with other novel agents in our portfolio or in combination with agents in other companies' portfolio, they represent important opportunities. So when people ask us, why does the world need another PD-1 antibody, it isn't that the world needs another PD-1 antibody, but we need it because we have an extensive portfolio of agents, and in the context of developing combinations, our PD-1 antibody will make that job a lot easier, a lot more efficient, and at the end, deliver much more prudent economics to the healthcare system and to patients. Among important achievements of our supportive programs was this year, we reported at ESMO back in August that the combination of bostilumab and zolotrilumab resulted in near doubling of responses, that is 33% responses versus what has been reported for pembrolizumab, in PD-L1-positive cervical cancer patients. Now let me touch upon some of the recent announcements that we made and the potential implications of those developments for our company, for our portfolio going forward. As you may have noted, we recently withdrew the BLA for Bostelumab monotherapy due to a technicality associated with the accelerated approval window closing for us, following, of course, the technicality associated of the accelerated window closing, followed the full approval of pembrolizumab in second-line cervical cancer, which the FDA granted the approval of four months ahead of the FDA goal date. Now of note is the fact that this BLA withdrawal was not related to Balsillimab's performance. In fact, our agent met and exceeded predefined clinical milestones for this indication, for this trial. Our agent achieved trial endpoints with 20% response rates in PD-L1 positive patients versus 14% reported in Pembrolizumab labeled. And of course, in single arm trials, it's very difficult to compare these types of numbers to each other, but we are still heartened very much that we showed 20% responses versus 14% responses, as opposed to the other way around, for example. Now, we also completed successfully three FDA-approved inspections for our PDUFA date of October 16th, 2021, with no 483 cited, which is a very big achievement for our company, our organization, and we're very proud of that. Given the clinical benefit demonstrated by Bacillamab, we are planning to launch expanded access programs to give patients and doctors access to both Bacillamab in several countries, perhaps including the U.S., pending the regulatory process associated with expanded access. As a result of our BLA withdrawal, we also announced this continuation of our phosphilimab confirmatory trial, BRAVA, which is expected to reduce our R&D expenses by over $100 million over the next couple of years. Now, with these developments, we expect to end the year with approximately $250 million in cash to execute on our combination development programs for Asia and 1181 and beyond. Now, let me pause here and address two frequently asked questions that have been put to us. One is the fact that we withdrew the BLA for Does that impact our development programs going forward that involve Bostilumab? For example, Bostilumab plus 1181. Does it impact it? Now, before I answer that question, let me address the fact that we have amassed an enormous amount of safety information in over 400 patients treated with Bostilumab. And As I mentioned, we have shown clear activity of Bustelimab, certainly in cervical cancer where we've treated a substantial number of patients, but also in other indications. So we have a highly active PD-1 antibody. Now, with regard to how will this withdrawal of the BLA affect our next steps going forward with combinations, We're certainly going to use the data, both the efficacy data that shows the activity of PD-L1, I mean PD-1 anybody, as well as the safety of it. We're going to use this going forward in our justification of combinations. And given the way we have designed our trials, we do not expect at this stage, we do not expect this to be a hurdle for our expeditious development of combinations. So that's number one. The second question that gets asked is, because of what has happened with the FDA having requested us to withdraw the VLA, a question such as, are we blacklisted by the FDA now? That's going to make our lives difficult going forward. Well, we certainly don't think so, and we certainly hope that that's not the case. If we, provided that we show high activity with our compounds going forward, which we expect to do, which compounds like 1181 alone and in combination with busulinab, provided that we show profound activity, of course, anyone stopping to get in the way of an expeditious approval to bring access to patients would have to be questioned. So we do not expect that our honorable agency will blacklist us or any other company for that matter for reasons that relate to what we have experienced. But having said all of that, we plan on proceeding in a pristine fashion with data that will be generated that could justify the next steps associated with our portfolio of novel agents reaching patients. So with that, I would now like to turn the call over to our chief medical officer, Dr. Stephen O'Day, to discuss the Agile 1181 clinical update shared today in our SITC abstract. And just to remind you that on Friday, there will be more details associated with the release of our poster that will have more data. So we will hold back on some of the details today to respect the confidentiality with the CIDC rules. Steven.
spk07: Thank you, Gero, and thank you all for joining us this morning. Today, we shared the first presentation of clinical data from a dose escalation study with over 100 patients treated with AGEM 1181 as monotherapy or in combination with valstilamab. The patient population was heavily pretreated. Half of these patients received at least three prior lines of therapy, including anti-PD-1 therapies. This makes their response to AGEN 1181 even more encouraging. AGEN 1181, as monotherapy and in combination with valstilabab, was efficacious across a range of tumor types. including cold and poorly immunogenic tumors and PD-1 refractory settings. Both monotherapy and combination therapy were well tolerated with no observed cases of hypophysitis, pneumonitis, or high-grade hepatitis, which you may know are clinically meaningful toxicities of first generation CTLA-4 based therapies. We have established our recommended phase two dosing for AGEN 1181 monotherapy and in combination with Valcilumab. As of the abstract cutoff date, which was July 16th, 2021, we observed four confirmed responses to single agent, agent 1181. These include a complete response in a patient with microsatellite stable endometrial cancer, a partial response in pancreatic cancer, and a partial response in cervical cancer following failure of anti-PD-1 therapy. To our knowledge, these are the first reports of response to CTLA-4 monotherapy in these specific disease settings. A fourth response was in a patient with melanoma who had failed prior anti-PD-1 therapy. We also observed significant benefit of the combination of HCN 1181 with balsafilumab across multiple cold, poorly immunogenetic Among 17 valuable MS-stable colorectal patients treated with at least one milligram per kilo of AGEN 1181, we observed four partial responses and seven cases of stable disease for a disease control rate of 65%. Just to put this in perspective, multiple trials, have demonstrated limited to no activity of PD-1 inhibitors alone or in combination with first-generation anti-CTLA-4 in MS-stable colorectal cancer. The efficacy that we have demonstrated in this setting to date highlights that Agent 11A1 is a differentiated anti-CTLA-4 and has potential to address this high unmet need. Among six evaluable ovarian cancer patients receiving at least one milligram of AGEN 1181, we observed two partial responses and three cases of meaningful stable disease. We also observed clinical activity in other GYN tumors. with the combination, including partial responses to both of our MS stable endometrial cancer patients who were treated with combination therapy. Finally, additional combination responders, including one partial response in non-small cell lung cancer patients who had failed prior PD-1 therapy, and two partial responses in visceral angiosarcoma. a subtype of angiosarcoma historically resistant to checkpoint inhibition therapy. The majority of these responses are durable and ongoing. I want to remind you that additional patient accrual and follow-up data will be included in our poster presentation at CITSE this week, with a cutoff on September 17, 2001, for our clinical data. Based on the exciting anti-tumor activity demonstrated thus far, randomized Phase II and Phase II-III trials are in active development across colorectal, MS stable, and GYN malignancies. We anticipate the outcomes of these important trials will strengthen the efficacy and safety signal demonstrated to date and support a potential filing for full and or accelerated approval based on the magnitude of benefit demonstrated in the studies. I would now like to turn the call over to Dr. Jennifer Buell, Chief Executive Officer of Mink Therapeutics.
spk04: Thank you very much, Dr. O'Day, and congratulations on those results. This will be an exciting conference for us at Agenis as well as at Mink, which I'm going to highlight some of the data that's coming out now. Of course, our abstracts have been released, but the data updates will be presented more fully in the upcoming posters. So turning to Mink. I want to just remind you all of our goals. And in launching Mink Therapeutics as a separate public entity enabled us a way to create two patient-focused companies with independent financing, streamlined operations, and focused teams to accelerate the development of their collective and independent innovative pipelines. So as Carol mentioned, we launched the IPO, and to date, we actually raised $46 million at point, which includes our initial public offering of $40 million, and then the green shoe, which was also executed most recently. And with those proceeds, we'll be rapidly advancing our clinical stage portfolio. Now, we believe that invariant natural killer T cells, or INKTs, represent a potential best-in-class allogeneic cell therapy approach. INKT is naturally home to the site of the tumor or infection. And we believe that this ability to penetrate solid tumors is a critical advantage compared to T cells or NK cells. And also, the capability of the cells to naturally proliferate enables us to expand upon that benefit and the functions of these cells. What we have observed to date is that other cell therapy approaches have shown limited durable efficacy in solid tumors and And we've also, of course, observed some more recent toxicity challenges. And what I can tell you that we've publicly informed is that the IMKT cells can be dosed to a billion cells with no neurotoxicity and no cytokine release syndrome observed to date. Very important clinical benefit, safety benefit of these cells. Early data from our clinical trials confirms the rapid translocation of IMKTs from the peripheral blood to the site of interest. And this is consistent with the cell's tumor-homing properties. Our SITC posters will present evidence of IMKT cell persistence beyond the time of our measurement period, as well as anti-tumor activity, anti-tumor and disease-mitigating benefits of these cells from our ongoing clinical trials. We see similar activity in the preclinical settings. We've observed tumor infiltration and anti-tumor activity of INKTs in both solid and hematologic in vivo models. These data will be discussed in great detail in our CITSE poster presentations, which will be published on November 12th. We'll also be presenting data on our CAR discovery platform, which can further boost the tumor-killing potential of INKT cells. And at CITSE, we'll present data characterizing the anti-tumor activity of our proprietary BCMA CAR-INKT. We believe that engineering INKT cells in our own hands, as well as has been published by independent researchers, that CAR-INKTs or engineered INKTs outperform other therapeutic approaches, other T-cell approaches. So together, with the ability to advance combinations with the Genesis Pipeline agents, including Baustilumab as well as Agen 1181, were so excited to develop a powerful suite of IMKT-based therapeutic regimens. With that, I'd like to turn the call over to Christine Klaskin to discuss our financials for Agenis.
spk03: Thank you, Jen. We ended the third quarter of 2021 with a cash and short-term investment balance of $262 million, as compared to $100 million at December 31st, 2020. For the third quarter ended September 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or 76 cents per share basic and 72 cents per share diluted. This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or 28 cents per share basic and diluted. Our cash provided by operations for the nine months ended September 2021 was $33 million with net income of $39 million or 19 cents per share basic and 18 cents per share diluted. This compares to cash used in operations of $104 million and a net loss for the same period last year of $145 million or 87 cents per share basic and diluted. Non-cash operating expenses for the nine months ended September 2021 were $46 million compared to $35 million for the same period of 2020. We recognized revenue of $275 million through September 2021 and $57 million for the nine months ended September 2020. Revenue includes upfront license fees received, milestones earned, non-cash royalties, and revenue recognized under our collaboration agreements. I would now like to turn the call back to Garo.
spk06: I'd like to thank my colleagues for their statements during this call, and also thank you all for your interest in Agenis and Mink Therapeutics in joining us this morning. Looking into the current quarter and beyond into 2022, we expect to achieve value-driving events with our clinical and preclinical pipeline. And when we talk about preclinical pipeline, we do expect to take a number of our own discoveries into the clinic over the next months. Firstly, accelerating the development of AGEN-1181 and Bostelamab by launching our Phase 2-3 trials in colorectal cancer, in ovarian cancer, and endometrial cancers is something that we are very much focused on. And, of course, we're very encouraged with the responses that we've seen, which we have discussed some of it this morning, and you'll see additional details this Friday at CITSEE. But even beyond that, as Dr. Stephen O'Day mentioned, these responses are of a certain cutoff rate date. We do expect responses to develop beyond that cutoff date, which will not be released at this meeting this week. Secondly, initiating a combination study of Agent 1181 with our conditionally active CD137 agonist in melanoma this year. Thirdly, Advancing our TIGIC by specific through Phase I studies in collaboration with EMS. And this is a very exciting program. As we have mentioned, first, several patients are diagnosed already. Fourthly, advancing clinical development of allogeneic INKT cell therapies, as Jan mentioned, in cancer and immune-mediated diseases through MINK therapeutics. with a data update at CITSE this week, and we will have appropriate updates beyond that. Building a sustainable supply of saponin-based adjuvants, proprietary adjuvants, that include our QS21 stimulant through saponics, Launching expanded access programs for Balsilumab and providing an update regarding the strategy for Balsilumab, Zolofilumab combination in second-line cervical cancer. Now, this is a very important program that we undertake seriously because we've had a number of requests, including from our physicians who have been engaged in our trials, and it is our moral responsibility to make sure that we provide access to products that are active on terms that are going to make the patient treatment streamlined. Continuing to advance novel programs to IND, as I just mentioned, with our next IND filing planned in early 2022. And of course, integration of our vision intelligent platform to support discovery of rational drug combinations selection of new targets, and predictive biomarkers beyond what is commonly practiced today. And lastly, progressing construction of our facility, fully integrated facility for commercial manufacturing in Amerigo, California. And this is a very important undertaking for us because it will make Agenis self-reliant in its ability to deliver products without dependence on third parties, which is particularly important in today's environment where there are significant capacity constraints and supply chain issues. And once again, thank you very much for your attention. We will open it up now for questions.
spk01: As a reminder, to ask a question, you will need to press star 1 on your telephone To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Mayak Mattamni with B. Reilly Securities.
spk05: Good morning, team. Congrats on the progress on multiple frames, and thanks for taking our questions. So maybe if I can start with the 1181 question. data abstract at CITC. Just a couple of quick questions I have. So on the 24% ORR we are seeing on MSS CRC here, could you just give an update on where we are in terms of median follow-up with these patients? Just trying to understand the durability and depth of response that you're seeing. And then also on the unconfirmed PR we have in PD-1 refractory non-small cell lung cancer just would be helpful to understand the baseline patient characteristics and also how many lung cancer patients you have already in the cohort enrolled.
spk06: Okay, so let me answer the question broadly, and then of course we're going to ask Dr. Odey to provide more color. I would caution against assigning response rates, even though we're very pleased with the responses we're seeing, In such a trial where we've gone through a dose escalation process, in the beginning, certainly, the doses used were not necessarily optimized doses. So to take the denominator and the numerator and mixing and matching this probably is not an accurate depiction of response rates in this trial. Now, in addition to that, of course, in terms of certain cohorts, Because of the high science that we are engaged in here at Agenis, we really dissect the patient profiles based on a whole bunch of predictive and other biomarkers. And so patient selection criteria is going to be much more precise going forward into our phase two and three trials. So with that, Steven, if you could address Mayan's question.
spk07: Yeah, thank you, Gero. Thank you for the question. I think what we can say is obviously that you know, the cutoff for this abstract that we're discussing this morning was in July, and the cutoff for the poster, which will be delivered on Friday in September. And we will be updating the follow-up and the unconfirmed to confirmed responses on the Friday poster. So I think we should wait and share with you the data, but I think you'll see both the development of the further follow up on the patients and obviously further follow up in terms of the confirmation of responses.
spk05: I understood. And then my second bucket of question was around, you know, what sort of work you're doing with Neelam and sort of thinking broadly about, you know, two aspects focused on pancreatic cancer franchise given the you know, the first-gen CDLA-4 has a signal with a hedgehog, but also you're seeing, you know, PR with the next-gen CDLA-4 here. But I'm also broadly curious to hear your thoughts, Garo, as, you know, you look at other agents targeted or IO that, you know, bigger pharma companies have, and you try to, you know, prosecute 1181 in certain indications where, you know, maybe a backbone therapy might not be within a genus portfolio. So how should we think about that?
spk06: So if you can repeat the point that you're trying to make, the last point, Mayang, because when you say how should we think about it in the context of large companies' portfolio, what do you mean by that?
spk05: Yeah, for instance, you know, if OBGYN is a big priority for you, I'm just making this up, you know, having an access to a PARP or, you know, another targeted therapy could kind of make sense to be combining with a CDLA-4, for instance. So how, you know, you might be thinking of, you know, partnering up with a bigger player here, given, you know, the bigger player will also value the importance of 1181, you know, from an IO standpoint. Right.
spk06: So very good. Now it's clear. So in terms of a couple of points here, One is in comparing what we can do to large companies, we have several advantages here. Number one, we have a very extensive armamentarium of immunooncology agents. at our disposal. These are our inventions. So mixing and matching and combining them is relatively straightforward for us. That's number one. Number two, we have a technology such as vision, which is a very important tool for us in terms of its ability to be predictive of responses and patient selections. Now, what does all that mean? It means that we could be striving, as vision advances, to identifying biomarkers or patient markers that are going to be agnostic to specific indications. Okay, that's not quite there yet now, but I think we're heading in that direction. So we can envision, for example, selecting patients and therapies matching them regardless of indication. Similar to what they have done at big companies such as Merck, but they have done it in a very crude fashion. We'd like to do that much more specifically. Having said that, to address your last question, what is our partnering strategy? How do we go about thinking about the future now? What we have said in the past, is that because of our resource constraints, and when I talk about resource constraints, we're not talking about just money. We're talking about overall capabilities and global reach. Because of that, we opted to license things such as AGN-1777 globally. Now, going forward, we've made statements about AGN-1181, saying that a logical path forward for us would be the geographic segregation of the rights. So, for example, U.S. rights, we will keep, and ex-U.S. rights, we will license out. Now, in the context of an appropriate development program, it's very, very plausible that we may do a global co-development with a prospective development collaborator or a partner with these geographies cuffed out for commercial launch or product. And then, of course, as we put into place substantial resources over the coming years, earned with the performance of our products and commercial launches, I would see us even venturing into taking a bigger share of the global reach for our future collaboration deals. Does that answer your question?
spk05: Yes, yes. Very helpful, Gary. Thank you. And if I can squeeze in another one before I pass it on to my colleagues. Remind us of the pro forma ownership in INKD and then How should we think of, you know, Saponix QX, given the, you know, experience you've had with INKT, but also, you know, the considerations that are different in terms of, you know, partnerships and scale-up and capital needs might be very different than what was with INKT? Sure.
spk06: I'll ask Dr. Buol to address the INKT question, and then I'll come back to Saponix.
spk04: Sure. So, Mayank, what you now have access to is that the agenis ownership of the mink INKT is just under 80%. It's 79%. Okay.
spk06: Now, as far as saponics is concerned, saponics you can assume to follow pretty much the footsteps of INKT or mink therapeutics. So we formed Saponix recently based on the need that I articulated for an effective vaccine that has long-term, long-lasting protection. And as I said earlier, one of the limitations of current vaccines, even though they're highly efficacious, we don't know, for example... how efficacious they'll be to potential new variants. We hope that they'll be highly efficacious. But one thing we know for sure is that their efficacy wanes after three, six months. That is for sure. And of course, the prospects of a booster shot every three, six months forever is not an appropriate way of strategizing for vaccines. So having longer-lasting immunity is critically important. And the only limitation of QS21 stimulant right now is not that it cannot offer that long-lasting protection. It can, of course, but we are quantity limited. And hence, The right thing to do for us, the morally appropriate thing to do is to collaborate with governments and potential with other companies to sprint towards being able to manufacture QS21 stimulant and other adjuvants down the pipe that have very potent nasal immunity, mucosal immunity characteristics. at a high speed so that we can offer the benefit of QS21 beyond the limited number of patients that are, or I should say, healthy individuals that are benefiting in the context of Shingrix, for example. We need to get what we have shown scientifically to be possible with this process. It's an engineering challenge that could take us to billions of doses of production of QS21 stimulant.
spk05: Very helpful. Thanks again for taking our question. Thank you.
spk01: Your next question comes from the line of Kelly Shee with Jeffrey.
spk09: Hi, good morning. This is Jason Bouvier on for Kelly Shee. Thank you for taking our call, and congratulations again on the 1181 data. Just one question on the Valzal combo and cervical. You mentioned on a previous call you'd need to discuss a possible path forward with the FDA. Can you provide any, do you have any higher resolution on the timing of that conversation and maybe when we can expect to learn about the outcome of the meeting? And then what do you anticipate that path looking like going forward? Thanks a lot.
spk06: Okay. So it's not clear entirely yet, but we will have some additional data points that will inform us what the next steps will be, whether there will be next steps by the end of this year.
spk09: Okay, great. Thank you.
spk01: Your next question comes from the line of Matt Phipps with William Blair.
spk08: Good morning. Thanks for taking my questions. Congratulations on the update. Dr. O'Dea, I was wondering if you could, I realize you probably have to wait for Friday for a lot of disclosure, but any more comments on any colitis seen with this combination, 1181, one thing we've kind of been looking at based on the update last year. And then... You know, as we were thinking about these Phase II-III trials, I wondered if, I guess, one, any thoughts on the endometrial landscape? We've had two approvals this year for immunotherapy regimens, one in the DMMR setting for monotherapy and then two plus Lendvima in the MSS setting. So I'm just kind of curious if you can give us any insight on where you're thinking of going in endometrial, assuming that's one of the gynecological treatments. cancers, and then you mentioned phase two or phase two slash three, any of these potentially accelerated pathways?
spk06: Matt, thank you for this question. Let me just guide you broadly, and then, of course, Dr. Odey will answer. So we have made a strategic decision not to discuss the competitive, you know, our next moves with regard to details of our clinical trials design. because of competitive reasons, because of competitive reasons. I mean, what happened with the bowel monotherapy approval process, of course, highlights how important competitive issues are and timelines are, and, of course, how important FDA consideration is for reviewing one company's product versus another company's product. And so that's why we're going to be a little bit guarded in terms of how much detail we provide. But we have discussed this internally. And Stephen, feel free to indulge in any kind of detail that we have determined to be publicly disclosable at this point.
spk07: Thanks, Matt. You know, in terms of the development, I think Gero has spoken about it. Obviously, we're very excited about launching these trials in GYN malignancies. in ovarian and endometrial and more to come on that. We haven't disclosed further. But needless to say, we have KOLs and leadership around these trials that are very excited about the data to date and a rational plan forward. In terms of the toxicity, I think, obviously, what is really remarkable to date is the lack of hypophysitis, pneumonitis, or clinically relevant high-grade hepatitis, which, as you know, are important and potentially life-threatening and or chronic toxicities of first-generation CTLA-4. So we see this really as a difference with over 100 patients treated. In terms of colitis, I'll refer you to the abstract right now. There will be further safety follow-up on Friday with updated patients and follow-up. But certainly, we're confident that the colitis is certainly, again, it's difficult with cross-trial comparisons of first-generation agents, but we feel very good about the colitis in the sense that it appears to be comparable or in the same range as first generation, and we have strategies in our Phase II programs to mitigate that further, which we're very excited about. So more to come with the follow-up safety data, but that's what I can say about the colitis to date.
spk08: Thank you.
spk01: At this time, there are no further questions. I would like to turn the call back over to management for closing remarks.
spk06: Thank you very much for everybody. I think we've had quite an extensive call, and we look forward to your engagement, additional questions. Please feel free to connect with us. Thank you again.
spk01: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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