Good afternoon, everyone. I'm Sam Semenkow, one of the biotech analysts here at Citi, and it's my pleasure to host 2seventy for the last session of Citi's Virtual Oncology Leadership Summit. Just as a reminder, if you have a question during the session, please email it directly to me at samantha.semenkow@citi.com, and I'll ask them on your behalf. And with that, welcome, Chip, Anna, and Vicki. It's a pleasure to have you here. Thanks, Sam. Thanks for hosting us, and thanks to Citi for putting this on. We appreciate it. Yeah, absolutely. And it's great to have you back on a fireside chat with us. So maybe we can just start off. Recently, you announced a shift in 2seventy' s strategy. You're going to focus solely on the development and commercialization of ABECMA and the sale of the company's pipeline to Regeneron. That is in the progress of being completed right now. So can you just walk through the rationale behind this decision, what it means for 2seventy going forward? Sure. Yeah, thanks, Sam. Happy to do that. I guess just before getting going, we'll refer you to our Safe Harbor provision. We would likely be making forward-looking statements, and we encourage people to do their homework on the company. So yeah, this is something that was several months in the making, and I think was driven by a couple of different things we were trying to solve for. We started 2seventy back in the fall of 2021, and that was based on a heritage and a big belief in the transformative power of cell therapy. And unlike a lot of other oncology cell therapy companies, we were starting from a great position with an approved first-in-class product with ABECMA and then a deep and diversified pipeline behind that. But what we found over the subsequent two years, a couple of different things happened. One was, quite frankly, the cost of capital and the availability of capital for early-stage cell therapy research. That cost just went up, and the availability just got a lot tighter. And ABECMA, which had been delivering cash flow to the business to offset that need for capital, as is well documented now, ran into headwinds in the second half of last year. Our fundamental belief in ABECMA is unchanged, but we needed time to prove that out. And at the same time, our ability to continue to fund cell therapy early-stage research was just getting harder and harder to do. And fortunately, we had a very committed partner in Regeneron, partnered with them dating back to 2018, who also have a belief in the transformative power of cell therapy, but they also have a very different cost of capital. They have a 10-year horizon. So this deal is a huge win for that side of our business, approximately 160 people moving over to Regeneron, taking over all of those programs, taking over a meaningful part of a real estate footprint, and with a big commitment in terms of capital, timeframe, just leadership commitment to that platform. So they've been incredibly successful 35 years now in just R&D platforms, and this, we believe, could be the next one for them. So very exciting. We're going to close that in the first half of this year. And what that does then is leaves 2seventy as much more of a pure play. It unlocks the value of ABECMA. It's clear to see. And that is our singular focus. So you see Vicki, Anna, and about 60 other employees will remain, all of us with the single goal of getting ABECMA back on track, delivering more for patients, expanding into the third line, moving the business towards cash flow break-even and profitability, and no need for new financings or dilution of any kind. So that's a great place to be, and we've got some work in front of us to deliver on that, but we're super excited about kind of where we stand now with the business and with ABECMA. Yeah, great. Thank you for that. And so the first next catalyst coming up is, of course, the ODAC meeting on March 15th to discuss the overall survival data for KarMMa-3. It's really only a few weeks away. So I think it would just be helpful to lay out some context around the overall survival data first. You presented it at the ASH meeting. You showed that the hazard ratio was 1.01 in the intent-to-treat population. And this incorporated the 56% of patients that crossed over to the standard of care arm. Can you just remind us, just high level, what the rationale for that crossover design was and whether FDA actually recommended that study to be designed this way? Yeah. I'll turn it over to Anna here, who's our CMO or CMO to be here at 2seventy and has been with the ABECMA development since the very early days. So tremendous resource to have with us here today. The study, in reference to KarMMa-3, was the first randomized controlled study of a BCMA-targeted CAR-T. The primary endpoint was progression-free survival with overall survival as a secondary endpoint. As a reminder, we hit a statistically significant result during a pre-specified interim analysis. So very strong efficacy on the median PFS analysis versus standard of care. The FDA, later in the process, has asked us about overall survival. We've seen an FDA focus on overall survival, not unique to us, but kind of across the space. Our sense is that they want to make sure that there's no detriment on overall survival and that that curve is not going to shift in the future as they're considering an approval or an expansion of the label. But in terms of the study design and kind of what we did and why we did it, I'd ask Anna to answer that one. Yes. Thank you, Samantha. Thank you, Chip. So overall, I need to reemphasize that we have chosen a very patient-centric study design. As you've seen from the standard of care outcome of 4.4-month median PFS, the kind of available therapies at the time of study initiation and during enrollment and also as of today is quite poor. Therefore, we have chosen to really provide patients the opportunity to receive ide-cel upon progression in the standard of care arm. This was discussed very, very thoroughly with KOLs, investigators, and they were incredibly pushing forward on this part because it is an important aspect to be considered in such a phase III randomized study. We have also, of course, always been in constant interactions with FDA prior to initiating the study, but also during the study, and have also taken into account the FDA recommendations along the way. Yeah. That's how it came to this crossover design. It's mainly due to the very poor outcomes of the patients that are triple-class exposed and refractory myeloma patients. Got it. Okay. And then also with the ASH data, you shared a sensitivity analysis on KarMMa-3, which I think is something that we've seen FDA also perform in some of the recent ODACs, like LUMAKRAS comes to mind. The method you used was called, I think, a two-stage Weibull model. FDA used something similar. So I guess, could you just walk through what makes this a robust sensitivity analysis and how convincing you expect this to be for FDA? Yes. Thank you again for that question. So I'm not a biostatistician. That's important to say while answering the question. Neither am I. The Weibull model is a very well-known and used biostatistical analysis to adjust for situations such as crossover. It is important to adjust for such a crossover because there is a bias introduced. If you are kind of allowing patients to crossover, you also introduce the bias of prognosis of the patient. You do not know what the prognosis is and why patients actually crossover. Maybe they have a better prognosis and therefore crossover versus others who are not crossing only have reverse prognosis, potentially. That's kind of to that is a bias introduced that none of the statistical analysis can account for. Therefore, this Weibull model is one of the commonly used models to adjust for this introduced bias into a study by a crossover design. So since it is used in many other kind of situations where similar designs have been used, this is the standard that we are kind of providing. In addition to that, we, of course, have done multiple more analyses that I cannot share, and it also has not been disclosed. Also, prospectively defined, I think that's another important thing. These adjustments for crossover analysis were all prospectively defined, part of our statistical analysis plan, and always also shared with FDA. So it was a clearly prospectively assessed analysis. In these additional analyses, this is something that we could potentially see in terms of the briefing documents from Bristol and yourselves during the ODAC. Is that the implication that we should take from that? I cannot share anything what you will see in the documents that will be released. But I just wanted to mention that we did, of course, thoroughly look at overall survival analysis from different angles. Got it. Okay. Understood. And then so I think you were kind of getting at this. For the adjusted standard of care arm and the sensitivity analysis, the median OS was 23.4, which is quite different than what we saw at 41.4 months for the ABECMA arm. I wonder, have you done any benchmarking work from the literature to sort of sense-check the median survival of that standard of care group? In other words, are the results from the sensitivity analysis, are they within the range of expectations that we would expect for a standard of care therapy in terms of overall survival? Yes. So there are multiple real-world evidence studies available and published. So just the LocoMMotion is one of the key studies, but there are more. And talking and starting with PFS data, these PFS data that we've seen in KarMMa-3 are completely in line with what they've seen in real-world evidence. The overall survival is a bit more difficult, but also in line with what we are seeing. It is, if anything, a little bit better than and it is adjusted than what we've seen in the real-world evidence. But again, it is important to note that real-world evidence data are not having the same rigor of follow-up, etc. But overall, the key message is, yes, we have looked at other real-world evidence studies, and they are very much in line with the KarMMa-3 standard of care arm results. Okay. Got it. And then maybe you are not able to answer this, but I'll ask anyway. So are you able to look at post hoc at the patients that did crossover and compare their overall survival post-ABECMA treatment versus those that did not crossover? I'm just asking because I'm curious if there's meaningful differences between the subgroups. And I think that's something that you mentioned, that the statistical or the sensitivity analysis can't account for. But I'm curious if you've looked at that and if there are any differences between the subgroups, those that crossed over and those that did not. Yes. Thank you. Yes, of course, we did multiple analyses, as I mentioned before, to look at different angles from the overall survival. I can't disclose any kind of details and what we have looked at and which analysis we have performed since we haven't disclosed them. But again, I want to reemphasize the reason why we have done the Weibull model and the adjusted crossover statistical adjusted for crossover statistic analysis. And that's really because we wanted to remove the introduced bias. And therefore, an analysis looking just at the set of care arm and who has crossover versus not is not going to be a meaningful analysis to look at. Therefore, I want to draw the attention back to the adjusted analysis that we have presented. Got it. All right. Yeah. I guess I was just curious if, for whatever reason, the patients that did crossover could have either positively or negatively impacted the overall survival for the standard of care arm. But I take your point that at the end of the day, perhaps it does not really matter for the data. Okay. So maybe this is a standard thing, and I just want to confirm it for the trial design. If a patient progressed after receiving ABECMA, I assume that at least some of those patients could have gone on to receive another therapy after ABECMA. Is that accounted for in the overall survival analysis at all? And maybe you could walk us through how that is accounted for. Yes. So a patient, when signing up for a study, the patient, of course, has to sign a consent form, which is including the follow-up of the patient throughout the study. And when patients receive the investigational product or also the standard of care treatment and they progress, the progression event will be counted into the progression-free survival, which is the primary endpoint. But since overall survival is a long-term outcome and also includes anything that happens after the investigational therapy or the standard of care therapy, such as new anti-myeloma treatment, that is always taken into account. And therefore, all patients are followed throughout. And overall survival is an analysis around death or still alive. And that also takes into account anything that happens after the investigational or standard of care therapy. Got it. Okay. So that's accounted in the statistics. Yes. All right. Well, so and then there are other nuances in the KarMMa-3 data I think worth highlighting. For example, the differences in the bridging therapy that were used between the two arms. You talked about this during your ASH presentation, but maybe we can reiterate it now. How did that impact the overall survival data? And how do you think FDA could incorporate this into their analysis as they're looking at the overall survival data? Yes. Also thank you for referring back to the KarMMa-3 presentation at ASH. When looking at the bridging therapies as well as the overall survival data, it is important to take into account the study design of KarMMa-3. We have rigorously defined the KarMMa-3 bridging regimens for the investigational arm of ABECMA. Patients could, where chosen, or the physicians chose the regimen that can be used as bridging prior randomization. So this was the same regimen that patients received in the standard of care arm. The physician would choose that prior to randomization. For the investigational arm of ABECMA, there were some clear rules around bridging, meaning it was optional. So not everyone had to receive bridging, and it was up to the investigator's discretion to provide bridging. Also, the patients only were able to receive one cycle. We didn't allow for more than one cycle of bridging, which also is kind of not accounting for patients who may have an infection and not be able to get infused directly, so they couldn't get another cycle of bridging. In addition to that, we needed a washout period of 14 days prior to ABECMA infusion. Overall, all of those aspects led to a suboptimal exposure to bridging therapy in the investigational arm, like ABECMA. Patients were longer without therapy in the ABECMA arm compared to the standard of care arm. When you're looking at the time between randomization and the first 60 days, more patients or the patients in the standard of care arm were much better treated than the patients in the ABECMA arm. Also, then that led to the fact that some patients in the ABECMA arm may have had disease progression or increased disease burden. And when we look at the abstract that we have published at IMS last year, what we also could see is that patients with a decreased or stable disease had much better prognosis than patients with an increased disease at baseline prior to infusion of ABECMA. Having said that overall, bridging therapy matters. We also believe that KarMMa-3 is in an early line setting, which also opens up much more opportunities for bridging since patients haven't seen all kinds of therapies, such as in the late line, fourth line plus, etc., so which also gives the opportunity for patients to be being bridged better and also more adequately. So that's kind of taken together all the bridging aspects of the KarMMa-3 design. So you're saying that commercially, a lot of those restrictions that you had put in place for bridging for the ABECMA arm, they will not be followed. So bridging will be you don't need that washout period. You can treat for more cycles if you ever want to. Okay. So potentially, that could improve real-world, I guess, outcomes if that bridging therapy. Is there an education barrier that you think you'll have to account for as you launch the product, potentially, in a third line? In terms of that understanding? Yeah. For the appropriate bridging therapy to use and how to actually go about that. I mean, I think that'll be a key part of our medical affairs and the commercial strategy is to educate on that point. I think the data are clear. Some of the analyses that Anna referenced that show that I think with better bridging and debulking, those patients are more likely to have those deep and durable responses. By all means, and we certainly plan to educate on that point. Got it. Okay. So we've talked about a lot of the specific details surrounding the overall survival data, at least what you were able to disclose at this point. As we're thinking about going into the ODAC, what else should we expect them to focus on? What are the key points that investors should take away from this talk right now as we think about what to expect from ODAC? Yes. I think we have yes, we closed the focus or we disclosed the focus of the meeting on the overall survival, but it cannot be suggested for any other aspects being the focus of the day. So we need to see on the 15th. Yeah. And I would just add, I think we've been pleased to have been through similar processes with regulatory authorities in Japan and Europe successfully. And so again, it's the same dataset. It's largely the same team prepping for this conversation. And again, based on the data that we presented at ASH and that Anna has referenced today, we feel good about the dataset and our ability to respond to questions. But we have to get to the day and get to the meeting. Yeah. I know. I appreciate you can't disclose anything else. We're all waiting for the briefing docs at this point. All right. And speaking of briefing docs, I would love your thoughts on this. There's been some discussion from FDA limiting the usage of voting questions in advisory committee meetings. Just to whatever extent you can comment, are you anticipating a voting question? Do you think that's likely, or could this be one of those situations where we move into just discussion questions? I don't think we can comment or guide on that. I think the team's been hard at work being ready for all the different analyses. And any possible question, we could anticipate many meetings have a voting question. Some don't. But I don't know that we can comment further. Yeah. No, that's fair. We'll have to wait for those briefing docs. Okay. So then following the ODAC, let's assume we have a positive outcome there. How quickly do you think FDA could provide a decision on the sBLA? Do you have any internal expectations or anything you're able to share with us? Commercially, we'll be ready to go very shortly after the ODAC meeting. In terms of a final PDUFA action, we don't have a specific date. Oftentimes, an ODAC will come a couple of weeks before a final PDUFA action. We would certainly hope for a rapid response, but beyond that, we can't say. Got it. You said that you're ready for an expansion of that third level rapidly after an approval. Would that just be you have slots ready to go, assuming you do get the okay from FDA? It's across the board. It's from a manufacturing perspective, being ready to go. Commercially, in terms of the field force being trained on new data, the MSLs, the whole broader go-to-market strategy for third-line launch, those pieces are in place or the final touches in terms of being ready to be in place for a third-line plus launch. So it's really across the board. Okay. Got it. Perfect. And so you've mentioned a few times in your recent disclosures that BMS has focused on expanding the capacity for ABECMA. How should we think about that increased capacity as it relates to ABECMA's commercial trajectory in 2024, assuming a third-line approval? Yeah. So we've had success in expanding capacity. I think manufacturing is a strength for the partnership and for the product. As a reminder, we're around 30-day turnaround time consistently and inspect greater than 90% of the time. So those in late-line setting with patients who sometimes don't have the best starting material in terms of their T-cell health, those are great numbers. And so from a manufacturing perspective, it's a strength. We have capacity today. We think that capacity supports some of the growth that we're targeting. And we have the ability to increase capacity future as the demand equation unfolds. So capacity to support the launch now and then further ability to ramp as needed based on trajectory. Okay. Got it. So you have some sort of internal expectation of if you were to hit some sort of demand that could trigger you to invest further in capacity going forward to continue to support the launch? Yeah. As we've said before, that investment is more on the people side in terms of the hiring and training and retaining of staff versus building brand new plants or giant expenditures of that kind. Just. More people, less physical space. Yeah. I would say within the existing physical footprint, we have room to grow, which is important. Okay. Got it. And when you think about the potential expanded label, what are the key considerations that you can emphasize to communicate ABECMA's value proposition to physicians? In your conversations, how are these resonating with KOLs and other key decision-makers? Yeah. I'll ask Anna to comment there. I think broadly, we think about three factors for ABECMA. We've talked about manufacturing, and that's key. On-time and in-spec matters a lot, particularly for patients with rapidly advancing disease and who've already been through several lines of therapy. Safety is also important. And I think we have been pleased with the safety profile that we've seen. It's been consistent across studies. And again, as the competitive landscape unfolds, we think there are important differences that are understood, need to be understood, need to be educated upon. And then from an efficacy perspective, again, I think this is one that's underappreciated both by treating physicians and candidly by Wall Street. But as we are able to unpack for folks the KarMMa-3 data, particularly once that data is part of the label, we think the ABECMA efficacy profile is a competitive one. When you compare like-for-like patients and kind of the profile we've seen, we think we've got a good story to tell there. But Anna, maybe you can comment more in terms of what matters most for KOLs. I think these launches are much more about scientific exchange and kind of med affairs peer-to-peer interactions in terms of getting people to think about these different treatment options. Yes. Thank you, Chip. Yes. So multiple myeloma remains a very complex treatment landscape. And every patient is an individual patient with different disease burden and different aspects of the disease that need to be considered and taken into account with different medical history, etc. So therefore, I think there is no one-size-fits-all solution here. And it's still a disease that is not cured yet, which also is great to see that there are more and more treatment options coming along the way so that there are options upon relapse, even if it's not what we want to see, that patients relapse on certain therapies. But then there are options along the way. And I think that's important when considering treatment schedules for patients. And I think their efficacy plays a role, but also safety, especially in early line. If patients cannot even go to the last line or have a non-relapse rate mortality on a certain therapy, it's going to be then the patient has no option to go to the next line of therapy that may be offered at a later time point. So that's kind of why in early line, many more aspects play not many more, but safety plays as well as the role of as efficacy. And then in addition, as Chip already mentioned, the efficacy data, we do believe, are very compelling with KarMMa-3. And I want to reiterate, our patient population, including KarMMa-3, is a triple-class exposed and refractory patient population, 2-4 prior lines, not early, but 2-4 prior lines. So these patients are already highly pretreated. As we know, daratumumab is going to be used much more and more in the first-line setting with the new data that came out at ASH, the phase III trial, with daratumumab prior to transplant. We know that patients will be triple-class exposed early on in their treatment schedule, meaning that KarMMa-3 is going to be very relevant for the multiple myeloma patient population. And with our efficacy on median PFS, which is highly significant compared to the standard of care arm across all subgroups, really looks very compelling also when looking at other options that may become available in the future. Yeah. Great. Thank you for that. I wonder if you could expand a little bit on the safety component because the two things that come to mind for me are the less parkinsonianism and as well as some less harsh language around secondary primary malignancies for ABECMA compared to, say, CARVYKTI. When you're thinking about earlier lines of therapy for these myeloma patients, how much is that resonating, those two things, for these earlier line patients with treating physicians? And how much of a difference do you expect that to really make when you go to commercialize ABECMA? Yes. I like to start with the secondary malignancies. And that's kind of a topic that was hot last year with FDA releasing the investigation on T-cell malignancies. And I just think that we need to clearly differentiate between T-cell malignancies and other secondary prior malignancies or secondary hematological malignancies that are not of T-cell origin. And all CAR-Ts have received this letter that was publicly announced in January that a label update is warranted to adjust for the potential risk of a T-cell malignancy with the CAR-T cell therapy. And that's because we are also infusing CAR-T cells into the patients. And therefore, it is a class effect label update. There is the other label update that was coming at the same time frame that was, I think, only CARVYKTI being implicated by that. And that is secondary hematological malignancies. That is different from the class effect T-cell malignancies. In the label update, they had a 10% rate of secondary malignancies in their initial pivotal study. That's kind of a different label update and also plays a role, especially in early line, if patients experience secondary malignancies early on. That also reduces their possibility of getting treatments at a later time point or even kind of having a non-relapse mortality. Coming over to the delayed neurotoxicity, I also would like to clarify that for ABECMA, we had limited adverse events with regards to parkinsonism, etc. We have one in our label. In KarMMa-3, none of those events have occurred. Also not in the late line, but also not in the early line clinical trials. The one case we have is in one study amongst all the hundreds of clinical trial patients. So therefore, I do think it's important to iterate that ABECMA does not seem to have the same issue of delayed neurotoxicity as other therapies such as CARVYKTI. So that is another aspect that needs to be considered when it comes to patients that either have neurological disorders to start with or also to think about potential negative effects on therapies when it comes to later line when the patients come later line. So I do think it plays a role, the safety aspect, when it comes to early line of therapy. Great. Okay. Appreciate that explanation. So moving on a little bit, but sticking in the same theme, what are you hearing from physicians in terms of how they're sequencing CAR-T therapies versus bispecifics, specifically in late-line myeloma? But then maybe can we work to extrapolate on how that might look as the bispecifics and the CAR-Ts move into the third-line setting as well? Just trying to get a feel on how that dynamic could evolve over time. I think, again, it's wonderful to see that more treatment options become available with different targets, different modalities. I think it's very pleasing to see the options that are becoming available for multiple myeloma patients, which is also increasing hope. When it comes to the decision between the bispecific and the CAR-T, multiple factors need to be taken into account. There are some scientific aspects of data that have been recently released, such as, for example, being exposed to bispecifics, which is a T-cell engager. Potentially, the T-cells may be less fit and also have an implication on the drug product of a CAR-T, which probably makes a CAR-T prior bispecific more beneficial. There are other aspects such as length of therapy, toxicity, infection risk, etc., that also are a key consideration of bispecs versus CAR-T. Also, the data and real-world evidence with regards to efficacy post one or the other, I think there are also more promising data to say the CAR-T first versus the bispecifics. Nevertheless, I would like to reiterate, this is an individual patient decision. Together with the physician, there is, of course, always going to be a multiple assessment done to what treatment therapy is optimal for a certain patient. When it comes back to conferences and KOL feedback, based on the last conferences we have been and currently there is ASTCT, I do believe it's clear, the message is clear that the CAR-T is preferred prior to the bispecifics. But how this will evolve with more treatment data and also more real-world evidence data becoming available, we cannot 100% foresee. But for so far, the scientific aspects probably indicate more to give the CAR-T prior to the bispecifics. Is there a difference in where the patient is treated based on line of therapy, like between the community versus being referred to an academic center? I guess I'm asking is in earlier lines, are more patients really seen in the community? And then as they progress, they get referred to the academic center? And if that's the case, would you see more bispecific use potentially in those earlier lines as some of those therapies move up in the line of therapy as they get those approvals? Yeah. I mean, I think that's going to be site-specific. Oh, sorry, Anna. I was just going to say commercially, I think that particularly in the later lines, there's been some truth to that. And I think particularly when there was a shortage of CAR-T capacity, the availability of a more off-the-shelf bispecific was a welcome thing and was good for patients. But again, back to Anna's point, if you have a CAR-T available from the data would suggest sequencing the CAR-T before T-cell engager is optimal for the patient outcome. These CAR-Ts will continue to be delivered primarily in more academic treatment centers, although we have expanded our treatment footprint and continue to do so. So again, I go back to Anna's comment earlier, which is that this is going to evolve over the next many years. We've said this all along, that commercially, the only thing certain is change, but this will evolve over time as data are generated and being first-to-market, first-in-class, and now expanding into hopefully into a larger indication. All are, I think, advantages for the brand and for the product. One more potentially. Oh, go ahead, Anna. Go ahead, Anna, please. I'd like to add a part that the multiple myeloma, many, many patients will be transplanted already in earlier lines, which also requires them a specific site of experience, which also it's not an unknown regimen to go to the site for a transplant for a transplant treatment. So it's not something that is only kind of used in the late line in myeloma. So patients have been used to go already to more specialized sites also in early line. But that's just a side note. Yeah. No. Got it. That's helpful. And maybe one more kind of hypothetical, but also rooted in some data. At ASH, there were some presentations that were talking about the risk of infection being greater with bispecifics than with CAR-T in terms of past mortality or, sorry, death from the actual tumor. Infection was the second greatest risk. I don't know. Has that come up in any of your conversations? Does that make some of your physicians maybe a little bit less likely to reach for the easier to administer bispecific as they think about the total risk to a patient? Again, it's all an individual patient discussion, again. But I would really say the infection risk is not something trivial. While myeloma hematologists are very well used to treat infections and cytopenias, it is not trivial because it also leads to disruption of therapy, but also increased mortality. And so that definitely is a consideration as we discussed before. Got it. Okay. Yeah. And And I would just add, I think the one-and-done nature of CAR-T therapy is certainly, as you think about all these different dynamics from a patient perspective, I think there's tremendous interest in that kind of modality and for the first time in a long time being free of thinking about your disease or going in for treatment on a regular schedule. So that's, we think, for the class is an advantage as well. Got it. Okay. And so I did have one question from an investor come through. They're asking, "How do you ensure patients get optimal bridging therapy in the 3-5L myeloma setting? And what is the optimal bridging therapy?" That's an incredibly good question. That also goes back to the treatment landscape of myeloma. The exposure to certain therapies in certain lines of therapy, every patient is treated differently in first line or newly diagnosed in second line and third line. Every selection of bridging therapy will be dependent on the pre-treatment history of the patient. That's kind of very, very important. It is important to understand refractory as a certain classes of therapies, certain also products, individual products. If patients are lenalidomide refractory, one probably goes to pomalidomide. If patients have seen daratumumab, maybe there is another kind of carfilzomib-containing regimens, maybe more playing a role. I do think it is really based on the treatment, big pre-treatment history where patients and physicians will be choosing the right bridging therapy. But because options are not limited, it is going to be less difficult to find an optimal bridging therapy, third to fifth line therapy, than it is for the much later line patient population. Got it. Okay. And I guess, how do you ensure those patients get the optimal? I mean, you mentioned earlier in the beginning of this call a little bit more about education. But is that something that you will be doing in close work with each physician, or is that just a part of the education process and then you let them make their choice? Absolutely. I mean, education is very, very important on the clinical trial data, but also what is optimal, what is setting up the patients for kind of the best prognosis under the CAR-T cell therapy. That absolutely belongs to the educational aspects of MSLs and medical affairs. Got it. Okay. Assuming you do get the approval, what factors in the third line, what factors would need to fall into place before you're comfortable providing guidance for revenue again? I'm just trying to get a feel of what would need to happen before we start to see guidance from you. Yeah. I think we'd want to get a little further into the launch just to see what the shape of the curve is in terms of kind of month-on-month or kind of growth. And the good news is we track it weekly. You can see your enrollments, which lead to AIFs, which lead to treatments. And so you start to get a sense of kind of where you are today, what revenue looks like one or two months out. But I think we just want to get A, an understanding of the final label, and B, get to see those early months of launch. I think the way we're priced now assumes a vector never returns to growth. We and BMS believe that it will. As we sit here today to try and put a number out there, I don't know how helpful it is versus just actually posting the quarterly numbers and posting growth. I think if we do that, that'll go a long way. I think we'll look importantly to the second half of the year and to the fourth quarter to teach us and to teach the outside of what is that exit trajectory at the end of the year? What does that set us up for in 2025? But we certainly are optimistic and doing everything we can to be ready for that launch. Again, as we get into it, you guys will be the first to hear as we are able to both share results and then share perspectives on how we're thinking about the forecast in the future. Got it. Look forward to that. And so I get this question sometimes from investors. So maybe we can just talk about it here. Could you walk through the cost structure for ABECMA and how that influences the net revenue that goes to 2seventy? What are the factors that could be related to the potential label expansion that investors should be aware of as they think about future quarters of revenue? Yeah. Thanks, Sam. I think it's best to comment on that one. Yep. Thanks for the question. I think it's a helpful reminder because you don't see product sales directly in our P&L, given that we're not the principal selling agent of that. Obviously, BMS is taking a lead role there. We essentially share in 50% of the U.S. profit and loss. And so where you will see this show up in our P&L is in collaborative arrangement revenue or loss. And so what that essentially is, is our 50% share of revenue in the U.S., less COGS, our 50% share of COGS, and our share of U.S. selling expenses. We also, just as a reminder, share in about 32% of global ABECMA R&D expense. So you also will see that show up in our operating expenses on our P&L. So I think it's a good question and hopefully helpful reminder as to how the mechanics work in our financials. I will also just say that from a potential label perspective, part of the reason this is so exciting and potentially obviously with the unknown outcome is the current U.S. addressable market size is about 4,000 patients. We believe that we have the opportunity to expand that 4x. The number of total patients on label could potentially increase to 16,000. That's from an addressable perspective, obviously not talking about that as if there was a 100% market share, but it's a 4x size increase. Got it. Yeah. That's a helpful reminder. So, Vicki, maybe you could also remind us of your cash balance and the expectation for when you would return to cash flow positive. Yeah. Thank you. We actually haven't disclosed our most recent cash balance as of December 31st. So I'll just point investors on the call to our Q3 10-Q, which we filed in November. We had $284 million of cash on hand at that time. We do expect, especially post the Regeneron asset sale that Chip mentioned earlier, we expect to be able to see potential break-even as early as 2025, obviously cautioning that that is highly dependent upon what the third-line label is and the commercial performance of ABECMA as we sort of exit 2024. Got it. Okay. Well, that really brings me to the end of my questions. I just wanted to give you, Chip, Anna, Vicki, the opportunity to highlight anything else that I didn't ask today that you think is important for everyone to know. Sam, no. Thank you for the great questions. I think you covered it well in terms of everything that's coming up for us this year from a regulatory perspective, based on the clinical data and opportunities to educate there. Then, of course, the commercial side of our business and then how all that pulls through financially as people think about it as an investment. But hopefully, what comes across is I think we're well-positioned for this year. We're really excited about what's coming up. We think there's a lot of opportunity for growth and for value creation. As you've heard us say, that is our singular focus. We're going to be focused on execution and driving towards creating shareholder value in the near term. So look forward to more of these kinds of interactions. Sam, thanks to you and to the Citi team for hosting us today. Yeah. No. Wonderful. We were happy to. And yeah, definitely look forward to all of that, and in particular, the upcoming ODAC. So with that, thank you so much. I think we can end the session. Thank you to everyone that joined.
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