Okay, good morning, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler, and before I begin, I'm required to point out certain disclosures regarding the relationship between Piper and our next presenting company, Poseida, which are posted in the back of the room and at the registration desk. Poseida is developing next-gen cell and gene therapies based on a suite of proprietary technologies, including Super piggyBac gene insertion, Cas-CLOVER gene editing technologies, and also some proprietary lipid nanoparticles. The company has partnered with Genentech, Roche for hematologic CAR T, and recently received a strategic investment from Astellas for rights to the first negotiation for your lead solid tumor, CAR T, P-MUC1C-ALLO1. The company is also developing liver-targeted gene therapies, and if we have some time, we'll talk on those, but they're a little earlier in development. Joining us from Poseida is Mark Gergen, who is becoming Executive Chairman, and also our new CEO, Dr. Kristin Yarema, who previously served as President of Cell Therapy. So thank you both for being with us. So Mark, I've got to say, I know you're still going to be involved with Poseida, but it's been an absolute pleasure getting to know you and work with you, and I look forward to continued interactions, but also look forward to working with you as the new CEO. Yeah. Thanks, Ted. Well, thanks for having us. We're really happy to be here. So I'm excited about the transition, as is Kristin, as we move into the new year. B efore we start, I will also just say my disclaimer. I'll probably make some forward-looking statements, and so we refer you to our SEC filings and whatnot. So, but excited to be here. Lots of exciting things happening at the company. Yeah, it's a good time for the company. So you guys have a unique set of genetic engineering technologies, including piggyBac transposon technology for gene insertion. What are the benefits versus other techniques and technologies? Yeah. Well, thanks, Ted. So I agree. I mean, I think Poseida, we have said, has a very broad set of very differentiated technologies for genetic engineering. In fact, we believe we probably have the broadest set of technologies under one umbrella of anybody in the industry. PiggyBac, in particular, is really the workhorse. We use it both in allo CAR T, but also in our gene therapy program. It's our integrating technology. It's non-viral, which is interesting, and it has lots of other benefits. In CAR T, I guess I would make three observations, and Kristin can chime in as well. The three things that I think are probably most notable in CAR T is, first, PiggyBac uniquely preferentially inserts into T Stem Cell Memory T cells. And so you know the story. We're a big believer in the T Stem Cell Memory cell as the most important cell or the ideal cell type for cell therapy, and that's really unique. It is much, much different than other viral technologies in terms of its ability to do that and create products then that are high TSCM. So I would say that's number one. Number two, piggyBac has a lot of cargo capacity, so we can actually add in other bells and whistles. V iral technologies are fairly small. They can't have a lot of cargo. So our first dual CAR T, our CD19/20, is just starting up the phase I, so that's an example of that. But I would say also importantly, we have a safety switch in all of our products. We have the ability to do positive selection, so the cargo capacity of piggyBac enables a lot of benefits in cell therapy as well. And then the third thing I would just point to is that it is highly, highly efficient, and because it's now non-viral, that gives us great advantages in sort of the scalability on manufacturing and the production quality and size and reproducibility. We've shared some data recently on that, and so it really adds to being able to reproducibly create high-quality products at high volumes, and importantly, at low cost. Hmm. So I would say those are the three probably key ones in my mind. Anything to add there, Kristin? Yeah, no, I think you captured it well. I would also say we've been very planful in our approach. A ll of our programs are using the same technology, the same approach, and that's been very helpful to us as we have brought new assets through the pipeline. W e reference the INDs, that from previous programs, and that's made a very smooth path for us. Hmm, that's great. So, Poseida partnered your hematologic CAR T with Genentech Roche Alliance. Before we get into the products, maybe you can remind us about the deal terms. Why was Genentech the right partner? Yeah. Well, I think Genentech was the right partner because they take the same deep scientific approach to looking at these things as we do. Genentech really came to us for a number of reasons. I think they're a believer in the stem cell memory hypothesis. They wanted a product, and a platform that was scalable in terms of manufacturing, to really serve the need. They were definitely interested in allo, not auto, and so I think all of those things, plus they're just a major, major player in hematology, as you know. And so if you're bringing a commercial partner to the table with you, I think in hematology, you couldn't have picked somebody better. T he deal is quite broad. It's a license to the BCMA and the CD19/20 program. It's got an option for the next two programs in the pipeline on the heme side, which is our BCMA19, as well as our CD70 allo programs, and those will be coming up in the next year for them to decide if they want those. And then there's a research collaboration that would allow them to elect six new targets, all in hematology. So it's a very broad collaboration, a lot of economic power in the Roche collaboration. When we announced it, it was $110 million upfront, $110 million in near-term milestones, many of which have been earned, as well as up to $6 billion in payments and other milestones. We just announced last week that based on progress, Roche has agreed to accelerate and give us more certainty around some of those milestones, which helps us extend cash runway. So I think a lot of under-appreciated economic power there. Still more to come. Okay. So even last week's announcement is not all of it, so we're excited about it. Roche is a great partner, and I think particularly in heme, a great partner. Yeah, awesome. So you mentioned P-BCMA-ALLO1 for relapsed refractory multiple myeloma. Please remind us from the early phase I data that's reported, what are you gonna be, additionally talking about at ASH in, in the next two weeks or so? Yeah, thanks, Ted. So we gave a very, very early data update- Yeah about a year ago, at ESMO IO. So So this is the ASH presentation, which will be on Sunday, December tenth, will be much more significant. This will be an early efficacy and safety data update. We have been working very hard on that program and moving it along. We have been exploring various dosing regimens, various lymphodepletion regimens. So we're really focused on optimizing the right way to treat patients with this product and looking forward to sharing that data. Actually, Genentech Roche, in their curtain raiser for ASH, mentioned that they have over 45 different abstracts that are being presented, but were kind enough to call out as one of the key presentations to watch. Yeah Poseida's phase 1 data for this program. That's a big endorsement. Really exciting. But again, they've got $6 billion behind this thing, so it is a huge, huge effort for them. So I wanna kind of pick up because we cover Legend in this space, and we've just seen firsthand the stellar data that's come out from CARVYKTI. what is the continued opportunity here in relapsed refractory multiple myeloma, especially as CARVYKTI likely moves to earlier lines of therapy? Yeah. So Ted, I think we need to think about the myeloma opportunity broadly. So of course the data that we're presenting in the first trial is in relapsed refractory multiple myeloma. But with a partner like Roche you have to imagine that we're thinking for the full lifecycle opportunity in myeloma. And the data from CARVYKTI and the auto programs is undeniably impressive. we like to think of it as inspiring. Yeah. But our thesis is, and has always been, that the right allogeneic product, using the right technology, and for us, that is absolutely a T Stem Cell Memory rich product, has the ability to meet or exceed the product profile for auto programs, even like CARVYKTI. So that's certainly what we're aspiring to- Yeah ...and hoping to show. W ith that table stakes on the efficacy profile, I think a lot of other elements really need to be considered when you think about sustainable competitive advantage and capturing the opportunity. So if we just stick with the product profile safety and the safety profile becomes very important. We have long believed that the T Stem Cell Memory cells might also confer a really favorable, advantageous safety profile. So we will be looking hard, you can bet, at things like rates of CRS and neurotoxicity in general, as well as the grades thereof. As well as looking to see if we see, as CARVYKTI has seen, some of these rare but very troubling events like Parkinson's-like symptoms. So we really anticipate filling out not just the efficacy, but also the safety side of the equation. And then you really have to think about what does it mean to commercialize a product in the marketplace? So our vision is really that all patients who deserve to benefit from the promise of cell therapy will someday have the ability to do that. And we really think that in order to meet the needs of markets like multiple myeloma, where today, with approved products in a relapsed refractory setting, you're talking maybe a few thousand patients, but if you think about something like even second line, U.S. and EU5 that's 20,000 patients a year. So you really need a technology that can scale, that can be available broadly at geographic centers across the country, and you have to think about access, convenience, and cost. So can you treat the entire intent-to-treat population? Is your product at reliable quality and within spec? And what is the cost basis of your manufacturing? And that's where we think allogeneic will really shine. Great points. Really great. So, Mark, you also mentioned the first dual CD19, CD20 CAR-T IND cleared, again, allogeneic product. What's the benefit of combining these two for B-cell lymphoma? What do you think the phase 1 study or the development plan will look like? Yeah. So I mean, I think the benefit in CD19 is well known- Yeah ... that there's a significant number of patients that lose CD19 expression. And so we think by hitting a second target, you're gonna increase the opportunity to see probably more or longer durable responses. You might even be able to recover patients who have lost CD19 expression and relapse. So I think overall, we think that's it. I mean, I would also say that that program, we're excited about, Kristin referenced, it's leveraging all the learnings and all the platform we have in the allo-BCMA program. I mean, we're really trying to guide people to really think about us. We built a platform that can just leverage that platform for each subsequent product. So we would expect the CD nineteen twenty program to be equally rich in TSCM, to be equally productive in manufacturing, equally low in cost. And I think all of those things just put us in a great spot, to really go after that market. And I think we can deliver some results, and we'll have to prove it, obviously, that are competitive, if not equivalent or better to some of what we've seen in the market so far. That program is in phase I startup. We plan to dose the first patient, early in the year, and sometime later next year, we'll have the first update on that. But Roche, I would say, is equally excited about that program, obviously, given their focus and their core pipeline. Kristin, question for you, too, because obviously, Roche has such a broad portfolio of agents, including Tecentriq, other. Is there any view to combining your programs with their existing antibodies, checkpoint inhibitors, anything along those, to further augment activity? Yeah, absolutely. So that has always been something that Roche has thought about and talked about. Mark mentioned that our collaboration has a research component, and that allows us to look at a broad range of activities with Roche. Combination therapy is something that could fall in there. Yeah, really exciting. Again, a great partner. So I'm gonna switch gears to solid tumors here. I was so impressed that you were able to get those terms in silver chain all- everything on the solid tumor side. P-MUC1C Allo is the lead program here. Tell us maybe first a little bit about the target and how it's differentiated. What are some of the solid tumors you can pursue with that? I'll go first. The MUC1C, we think, is a really intriguing target. I mean, there are a number of mucin or MUC targets, I think 18 or so, maybe in total. MUC1, we think is, is very, very interesting. It is present on pretty much all endothelial-derived tumors, which makes it interesting. Most of our focus in preclinical work was on, breast cancer and ovarian cancer, so we're particularly intrigued by those. There are some other really high unmet need cancers that fall into that bucket, though, with fairly high levels of expression, like pancreatic cancer and colorectal cancer. So interesting target. We're actually targeting the C-terminal portion of that receptor, and I think that that is important in that there have been other MUC1, programs that targeted the N-terminal portion. Well, it's now known that the N-terminal portion is shed when the cells become cancerous. So we think it's a very unique target, even within the MUC1 space, to target that MUC1C portion. And so the trial is ongoing. It's complex, because it's a basket trial. We're taking all comers, any MUC1C-positive tumor. W e're also exploring different doses, different lymphodepletion, just like in the BCMA trial. T he interesting thing we're also looking at is because of that unique target and the shedding of MUC1 head, there's multiple potential patient enrichment or patient selection strategies looking at either MUC1C expression or MUC1N circulating in the periphery. And so I think an exciting program, very novel target. I mean, to our knowledge, we're well out ahead of anybody else- Mm-hmm. with that target in an Allo format or any other format for that matter. So really looking forward to kind of moving that program and having some data mid-next year, probably ASCO-ish. Perfect. That's really helpful. Astellas recently made a $25 million equity investment. They paid a $25 million, and I want to try to get this right. I'll, I'll do the best I can. 12-month right of exclusive negotiation, 18-month right of first refusal. Mm-hmm. So basically, they've, they paid to be first in line for this program, but no, no rights transferred yet. Seems like a great deal for you guys. What can you tell us about this, and what would occur how do you see this playing out over the next year and a half or so? Yeah. So great. I mean, yes. So Astellas gave us $50 million in total, right? For a small equity stake. They do actually have a board observer seat for those 18 months as well, and then the right of first negotiation on MUC1C. If Astellas, and especially in their latest strategic plan with their new CEO, they are highly focused on innovative medicines- Yeah. Cell and gene therapy. So strategically, their thinking is very aligned with ours of where's the industry going- Mm-hmm. And how do we think about these things? The right of first negotiation on MUC is only if we choose to partner it. Right. And they know, and we've told investors, we don't plan to partner it. So really, they have basically bought themselves a front row seat to watch the science and the programs continue to evolve. So I mean, Astellas, great company- Mm-hmm. Great engagement with them. I think they think. Yeah strategically about the space the same as us. I like the dynamic of having a second large pharma partner at the table. Mm. So for now, I think they're watching closely, and they're excited about what they're seeing, so- Great. Just like Roche is. In the time we have left, I'm gonna switch back to gene therapy, because this is a whole other area. Mm-hmm. -that probably doesn't get as much attention as the cell therapies, understandably, but really where truthfully, the underlying piggyback technology could be as transformational in terms of, therapeutic development. So, Takeda, you had a nice partnership with them. They terminated it. What was... Like, what's your understanding of what happened there? And I think even more importantly... You still got a lot from that partnership in the time that, you were there. What were the benefits that you walked away with? Well, the primary benefits were that we struck the partnership with Takeda in 2021. T hey paid us $45 million upfront. They paid for development of a number of programs along the way. And at the end of the day, we got all of those back. So what had happened is that earlier this year, Takeda announced, for strategic reasons, that they were moving away from both AAV gene therapy, but also moving away from rare hematology. And I think they had just concluded that in rare heme, they were too far behind, and they just had to focus their investments internally. So they love the program, we love Takeda as a partner, and we're sad to see it leave, but- and honestly, it was a gift, right? We got those programs back. We have said publicly that we are now doing a fulsome evaluation of those programs, plus our internal programs, and that early first half of next year, we'll sort of re-announce our focus and our pipeline, and what we'll do ourselves, and what we will look to partner. There's lots of stuff there that we could do, and, and we're in that evaluation, and we'll give some updates. Obviously, right now, Ted, as you said at the outset, all eyes are on ASH. Yeah. Yeah. We definitely think that the... We call gene therapy the- or gene editing, the other half of the company. So there's a lot of underappreciated value there, and like I say, today, we don't even get value for our cash. Yeah. Or the cell therapy, or the gene therapy. Exactly. One of the programs that did come back was a hemophilia A program, P-FVIII, or FVIII, I guess- Mm-hmm If I'm doing my Roman numerals properly, 101. I guess, and again, looking forward to more of, of an update, but how does that differentiate? How does that highlight some of the advantages of, of the piggyBac technology? Well, great question. So in a couple of weeks, we will do an update on that program at ASH. So we've got a poster presentation on the Factor VIII program at ASH. I think it's interesting because the hemophilia A space has been very crowded- Yeah ... right? But some of the results, frankly, have been disappointing. I mean, the Roctavian launch has not gone well. And so I think there is still, similar to myeloma, I think there is still a huge opportunity there. So the Factor VIII program, our Factor VIII program, was a fully nonviral program, delivering Factor VIII to treat hemophilia A. But one of the key differentiations of our gene therapy approach, which is true in that program, is we're actually integrating that gene into the DNA. So if you look at AAV approaches, whether it's BioMarin or others, they're transient. I mean, they and that's part of their struggle has been with their ability and, of course, toxicity. So our goal with that program is a number of things. One, we want to move to nonviral delivery, which opens up a whole lot of opportunities. We want to have a permanent correction of the DNA so that we're getting essentially, hopefully, a functional cure. But because of the nonviral component of it, we can actually take a lot of clinical leeway in thinking of redosing or dose titrating. Yeah. So it is really an awesome proof of concept program for the technology, and because factor VIII is such a large gene, we can deliver the full-length gene- Yeah - with piggyBac, where others have to deliver some truncated version. So it really is a great program to highlight all of the real key advantages of the piggyBac nonviral technology. Yeah, really, really exciting. And again, I had forgotten about the poster at ASH, so I'm looking forward to seeing that in just a couple of weeks, too. So you guys ended the Q3 with $239 million. You did announce acceleration of certain of the milestones. How long does this fund the company, and what does it enable Poseida to accomplish? Yeah, well, so our announced guidance at Q3 was exactly that, 239, plus some more clarity and certainty on milestones. So we've guided the market to cash runway, at least into the second half of 2025. I would say we believe there's probably upside to that in a number of areas. Even though we've sort of accounted for some of the Roche upside, there's more. Yeah. I mean, some of the things that we kind of referred to earlier aren't baked into that. We don't like to include it in cash runway until it's certain. So I think there's room to extend that. That would not include additional BD as well. So whether that's doing something in gene therapy or elsewhere, I think we've got a lot of, Yeah ... opportunity there, and I think we're starting to see, after the last couple of years of ugliness in the market things are happening that are actually highlighting more and more the unique value of our technology. Mm-hmm. So we feel good that we're in a good cash position. We don't need to run out and raise money at these levels. And so I think we're going to see more and more recognition, hopefully starting at ASH and beyond, that the technologies we've been talking about for a long time with you, Ted, are actually delivering on the promise, so we're excited about that. Mark- Absolutely ... I'm going to miss working directly with you, but I'm still here to call anytime anything's going on or you have questions about stocks. And, Chris, I'm really looking forward to working with you, and I agree, it's going to be a really exciting year for Poseida. Thanks very much. All right. Thanks, Ted. Appreciate it. Thanks so much, Ted.