My name is Ted Tenthoff. I'm a Senior Biotech Analyst at Piper Sandler. Before I begin, I'm required to point out certain disclosures regarding the relationship between Piper Sandler and our next presenting company, NextCure, which are listed both at the back of the room and also at the registration desk. NextCure is developing antibody-drug conjugates, including SIM0505, targeting cadherin-6 or CDH6, with partner Simcere, and also LNCB74, targeting B7-H4 with LigaChem, both of which should report data in the first half of next year. Here with us from the company is my good friend, Mike Richman, President and CEO. Mike, always good to see you. Good to see you, Ted. This summer, you guys in-licensed or partnered with Simcere to gain ex-China rights for SIM0505. Tell us about the deal terms and why it made sense to partner for this ADC. Great. Well, first of all, thank you very much for including us. Good to see you. And thanks for everyone who joined. Yeah, so we in-licensed SIM0505 in June of this year. And we had been shopping, looking for a strategic asset that would complement our other B7-H4 ADC program that you mentioned, LNCB74. And the criteria we were using was looking for something in the oncology space, in the gynecological area, but something that was either near or in phase I clinical trials. And we knew the Simcere team quite well. They had spun out the Zaiming ADC division, and they had initiated clinical development of what we now call SIM0505 in China. They were enrolling patients. They had actually submitted an IND in the United States. And quite surprisingly, the IND was just sitting there. So I think the timing was right to do the transaction. It brought in a phase I clinical asset. It brought in a very strong strategic partner that could enroll very quickly in China. And the way the collaboration has been structured is pretty much two companies working together to conduct a multinational study, which makes it seamless. So they're enrolling patients in China. We've already initiated enrolling patients here in the United States. We were able to start and much later dose cohorts. So we didn't have to eat up a lot of time on the clock because we were able to leverage the safety data profile that had already been established in China. The beauty of the program is, while there are a number of players in the CDH6 space, is Simcere developed a unique, novel proprietary topoisomerase inhibitor. It was designed from a medicinal chemistry perspective to be safer. It's much more hydrophilic. It's got a greater permeability index. And from that perspective, we've now kind of pretty much reached the end of our dose escalation set of cohorts. We have not hit any DLTs. The program has demonstrated very strong safety, unlike some of the competitive programs. And we're starting to see clinical responses. So we're really excited now of continuing the enrollment both in the United States and China and preparing for next year to move into the expansion phase. And Mike, is there anything special? So that's interesting about the topoisomerase. What linker are you guys using there? And are there any unique characteristics of that? Yeah, so we're kind of using a fairly standard tetravalent GGFG linker, similar to what others have done. But I think what's unique here are the other two elements within the ADC. The antibody itself recognizes a distinct epitope within the CDH6, which differs from what some of the competitors are doing. It's a high affinity antibody. It's well internalized. But I think most importantly is really the payload. So the payload, while it's a camptothecin derivative, similar to what others have evaluated, we believe it's been designed to be much safer due to its hydrophilicity and permeability index. And that so far has proven out quite nicely in preclinical tox studies. We did not see any significant adverse events in the non-human primates. And now having dosed a number of patients, also has proven out to be quite safe. When should we expect data? What should we anticipate in this first data set? Yeah, so we're currently planning on disclosing the phase I dose escalation data set first half of next year, hopefully sooner rather than later. We'll have probably around 35-40 patients within that denominator. Most of these subjects will be ovarian cancer patients. Some will be endometrial. We'll have the whole range of doses that have been evaluated, and we'll be now backfilling in some of the later dose cohorts where we think they're within that therapeutic window. And is that sort of the next step to kind of continue to build out? Or will you actually go into expansion cohorts in either ovarian or endometrial or both? Yeah, so the plan right now is probably ovarian and endometrial. Now, CDH6 is overexpressed in many other tumor types, like renal. There's a small subset of non-small cell lung cancer subjects that also express the target. But initially, we're going to stay with the validated approach and what others have seen in the ovarian and endometrial space. Gotcha. So I'll just pause and see if there's any questions on SIM0505. So switching gears to LNCB74, why does B7-H4 make a good ADC target? Yeah, so like a lot of these ADCs, these targets are overexpressed on multiple tumors. Now, what gets kind of lost in the story of why we were just talking about SIM0505, B7-H4 is also overexpressed on a number of tumor types, but in particular in the gynecological space. And if you actually look at the immunohistochemistry analysis, you see co-expression of both B7-H4 and CDH6 on many of the same biopsies from the gynecological subjects. So this opens up a whole unique opportunity to look at potential combinations, to look at sequencing of therapy. And while the SIM0505 is a topoisomerase payload, the LNCB74, B7-H4 ADC is a tubulin inhibitor. So now you've got two molecules co-expressed on similar tumor types, but with two different payloads, two different mechanisms of action. And I think it opens up a unique opportunity in a very crowded space of ADCs. Now, if I'm not mistaken, it's your guys' antibody here. You guys developed the antibody. And actually, maybe we're developing this before. But you did partner with LigaChem for the linker. Tell us about what's unique about that. Yeah, great question. So the co-development partnership with LigaChem brought their linker system, which entails beta-glucuronidase. And the reason we went with that linker is it has much greater stability. And that stability is important as these ADCs traffic through the bloodstream. You don't have a release of the toxin that you see with a lot of other types of linker systems. So that enables you to avoid a lot of the off-target toxicity. And this is playing out quite well, actually, in the clinic because we actually went to our highest dose. We did not hit a DLT. It's proven to be extremely safe. And that actually forced a strategic decision this past summer to file an amendment with the FDA to go to higher doses. So now we plan on going into 3.0 and 3.4 mg per kg doses, which is fairly high with an MMAE type of payload and looking at a tubulin inhibitor in general. So that's exciting. And that is currently being built into the clinical plan. Very exciting, and when do you think we would get data from on that, Mike? Yeah, so enrollment on that trial is a little bit slower than the SIM0505 because we're selecting patients that are B7-H4 high based on established cutoffs. But we're still probably planning and kind of our guidance still remains the first half of next year. But the ovarian cancer space, in all honesty, has become very crowded, complex. And you're starting to see the shift in enrollment rates going down. So we're making adjustments now to add more sites. And ultimately, we'll plan into Europe to add even additional sites. Cool. And it was very interesting to me what you were saying about this potential to either combo dose the ADCs. Obviously, toxicity is going to be something we need to be just aware of there, but more sequentially. Where do you see these fitting into the treatment paradigm? You mentioned how crowded ovarian is getting. Where do you think these two drugs might fit in? Yeah, I'm really excited about the ADC space because what the future looks like, most people are focused on new payloads, duality of payloads, bispecifics, but the future will be the medicine cabinet where the pharmacist is going to have all these ADCs available to them, different payloads, different antibodies, and a patient will come in, give a biopsy. You'll take that biopsy, and you'll look at the expression profiling of whether it's B7-H4, CDH6, folate receptor alpha as it relates to ovarian cancer, and other targets, and then based on those expression profiles, you're going to then decide which ADC is best to treat that patient, then the complication will come in is, are you giving everything in combination and putting a lot of pressure on the tumor? Or as we've talked about, can you sequence the therapy? And if you did that, in our case, would you go with a B7-H4 ADC first, and then a CDH6 ADC, or vice versa? Or would you then kind of, and then the question comes in is how frequently you're sequencing them. So this whole field of ADCs, while the medicinal chemists are making new payloads and people are looking at new linkers, there's a lot of targets already out there. And I think there's going to be a collective and collaborative use of multiple ADCs within a given tumor type. Even if you look beyond the antibody targeting moiety, will a patient's experience or exposure to a certain chemo class also depend on maybe they've become refractory to a topoisomerase? Now we hit them with something else. How much is that sort of going to fit into drug selection as well? Yeah. Well, we consider ourselves like the superheroes because the tumors are really aggressive. And their main thing is becoming resistant to the point you're making. So we've got these mechanistic effects of tubulin and Topo inhibitors. There'll be a whole new generation of payloads in the future. And our goal is to kind of figure out how to titrate the use of each of these drugs. And I do believe that if you fail a tubulin inhibitor, that doesn't mean you can't come in with another ADC that has a tubulin payload. And the same thing with Topo. So I think that opportunity is unique. I think what's really also untapped in looking at the potential of these drugs is when you look at a 40% or 50% response rate for a given ADC, that doesn't mean that when you come in with a similar target, but a different payload, that you have to target the same 40%-50%. You may be looking at the other non-responders in their case. Or you may be able to even tap into their progressors that have become resistant, but your angle is just a little bit different. Very interesting. Great. I'll just pause there and see if there's any questions on the pipeline. Now, beyond these ADCs, this is obviously where you guys are focused. But you do have a pipeline of other antibodies that you're seeking to partner. Can you tell us sort of what your BD efforts look like around those other programs? Yeah, we spent a lot of time on the BD side, and our strategy, in all honesty, has evolved. We have two non-oncology assets that we're trying now to actually spin out into new entities. We're going back to the venture capital community, the group that's willing to take on some of the early stage risk. One is a program for looking at osteogenesis imperfecta, an orphan indication in bone metabolism. The drug may also have applications in osteoporosis, and that's actually gaining interest. What we found out is there's a lot of people in the space that have done quite well financially, and now they're looking at their own longevity, and so they're very interested in chronic diseases, and that fits with our second drug too, which is NC181, which is in the Alzheimer's space, so this is an anti-amyloid drug, also about a year away from the clinic. So those two programs we're looking either for partners or most likely spinning out into new entities. I think we've got some other oncology targets through our platform that we're in discussions with different groups that want to develop next generation ADCs around different targets expressed on different tumor types. Cool. And if you do go down ADC route, is that something you would retain ownership in because of your focus on ADCs? Yeah, I think in the ADC world, yeah, we would definitely continue to maintain as much ownership as possible. And Mike, you guys ended the third quarter with cash of $21 million. I think you subsequently topped that off with a $21.5 million PIPE. How long does this fund NextCure? And what's it enable you guys to accomplish? Yeah, so we have a little bit less than $50 million in cash on the balance sheet. And that will take us into the first half of 2027. And that takes us through the deliverables and the value-added inflection points associated with data from both LNCB74 and SIM0505. And then we'll most likely, beginning of next year, do another financing to position ourselves into advancing the programs into phase II. Great. Excellent. Mike, thanks so much for being with us. Happy holidays. Happy holidays. Looking forward to a busy 2026. Yeah, thanks again, Ted.