All right, let's go ahead and get started. Welcome everyone to the 42nd annual J.P. Morgan Healthcare conference. My name's Anupam Rama. I'm one of the senior biotech analysts here at J.P. Morgan. I'm joined by my squad, Priyanka Grover, Lyra Hall, and Malcolm Kuno. Our next presenting company is G1, and presenting on behalf of the company, we have CEO Jack Bailey. Jack? Thank you, Anupam. I am very excited to be here today because we believe 2024 holds enormous potential for G1, both as we return COSELA back to stronger growth in our initial indication of extensive-stage small cell lung cancer, following the resolution of the national supply platinum supply shortage this past year. But more importantly, the opportunity to become a triple-negative breast cancer leader, first, by providing potentially a new therapeutic option for women suffering from first-line metastatic triple-negative breast cancer, pending our Phase 3 readout this quarter. And second, coupling that with the opportunity to potentially enhance the effectiveness both safety and efficacy of the growing ADC class that is increasingly being used in the triple-negative space. Now, my presentation will include forward-looking statements in terms of these company developments, so the normal safe harbor applies. We think G1 is positioned to deliver significant growth, really driven by our pipeline in a molecule asset, trilaciclib, brand name COSELA. As seen here on slide three, we've got multiple specific drivers of growth, and I'm just gonna tick through, starting from the top and working down. First, we've got a unique in-market indication, as I said, in small, extensive-stage small cell lung cancer, promoted by the G1 sales team, which is growing in revenue and has significant potential in front of it, including, as I'll discuss a little later in this presentation, the ongoing evaluation to assess the potential survival benefit in this initial indication. More imminently, however, is the potential for G1 to add significant, a significant new therapeutic option to the treatment of metastatic triple-negative breast cancer, pending the near-term readout this quarter, as I mentioned, of our Phase 3 study. This is a replicate study of our Phase 2 study that produced extremely robust survival data, and that we believe has the potential to transform the triple-negative breast cancer space. In addition to that label expanding opportunity, we also have an opportunity with trilaciclib from a proof-of-concept standpoint, to improve both the safety and efficacy of ADCs in metastatic triple-negative breast cancer. The preliminary survival data, which I will also discuss later in this presentation. And all of this is coupled with the opportunity for further global expansion that positions the company for robust growth going forward. Now, let me spend a moment on each of these four drivers, and have a chance here to speak to each one. But first, just a quick reminder on how trilaciclib's unique design enables it to deliver the benefits that it does. By transiently arresting cells in the G1 phase of the cell cycle, COSELA protects the bone marrow and immune system from the cytotoxic damages of chemotherapy during treatment. In addition, we see due to improved long-term surveillance, there is a benefit that persists after treatment with trilaciclib, as we disclosed last month at the San Antonio Breast Cancer Symposium, and which I'll discuss more in depth today. It's the unique attributes of trilaciclib that were intentionally developed, including its controlled effect via an IV administration, a potent and clean G1 arrest, along with its short half-life, that enables it to provide the benefits of transient CDK4/6 inhibition. Now, in our initial indication of extensive-stage small cell lung cancer, we have a $700 million market opportunity just in the U.S., of which we've only penetrated approximately 10%. We believe we can continue to drive greater use in this space, given the high degree of satisfaction, more than 90%, that is expressed by early adopting physicians, as noted on the right of this slide. They cite both the reductions in hospitalizations, along with the ability to protect multiple lineages through the use of COSELA, as the reason for their strong adoption. While 2023 did have the headwind, as I noted earlier, of a national platinum supply shortage, of which we used trilaciclib on top of, that did begin to resolve itself in the third quarter of last year. As you see here in the fourth quarter, we've returned to nearly 20% quarter-on-quarter growth, and we certainly look forward to continuing to deliver healthy growth going forward into this year. Now, the ongoing development work in COSELA, specifically in extensive-stage small cell lung cancer, is equally encouraging, with numerous studies underway, as you can see here on the left of this slide, with the common theme being we're assessing the survival potential in this indication for trilaciclib. First, starting on the left, we have a Phase 2 investigator-initiated study underway for the use of COSELA in second-line with lurbinectedin. And what we heard recently from the investigator is that he is quite encouraged both with the myelo and antitumor efficacy that he's seeing. Second, we have a company-sponsored study, survival study, in second-line extensive-stage small cell lung cancer that is already enrolling patients. And then finally, we continue to collect real-world evidence, both in first- and second-line small cell lung cancer, that shows some encouraging initial survival signals, as seen to the right of this slide, where trilaciclib patients are represented by the orange line, versus patients without trilaciclib are in the blue. We certainly look forward to continuing to keep everybody updated on these survival studies as the data matures. But as I mentioned, the truly exciting development underway that will read out this quarter is the opportunity for COSELA to transform the first-line metastatic triple-negative breast cancer treatment landscape by delivering improved survival. If you look at the metastatic triple-negative space across all three treatment lines, it has a population of more than 20,000 treated patients per year just in the U.S., which approaches a $1 billion market opportunity. As many of you know, this is one of the most aggressive forms of breast cancer. It's also one with limited treatment options. The current standard of care is cytotoxic therapy, with or without immune therapy, depending on the subpopulations. In our randomized Phase 2 study of approximately 100 patients across first, second, and third line, we demonstrated benefit across both the PD-L1 positive and negative populations. We believe, as I said, that trilaciclib has the potential to transform the treatment landscape in the metastatic triple-negative breast cancer based upon the robustness of these results. These are seen here on slide 12. You see in both arms, represented by the dark blue, which are two different dosing regimens for trilaciclib, showed significant improvement in survival, with reduction in all-cause risk of death between 60%-70%. Granted, this was a Phase 2 study, but if these results are replicated in the Phase 3 study, this will be the best survival improvement seen to date in triple-negative breast cancer. Now, it's important to note that the benefit of trilaciclib is most robust when it comes to overall survival. This is consistent, of course, with its ability to protect the immune system and improve long-term immune surveillance. This is particularly exciting, of course, as this is what improved overall survival is really the end goal that we all seek in oncology development. As I noted earlier, unlike existing treatment options that only benefit certain subpopulations, we observed overall survival improvement across all PD-L1 subpopulations, both positive and negative, with hazard ratios indicating greater than 50% reduction in the risk of death across both subpopulations, as shown here on slide 14. Now, what's also very intriguing to us from this study, as we continue to track these patients, is how they performed when they went on to receive subsequent anticancer therapies, like many patients do. On both of these Kaplan-Meier curves, shown here on slide 15, the blue line represents those patients who have received trilaciclib initially with their chemotherapy. And whether they went on to receive subsequent anticancer therapies, as seen on the left, or did not receive any additional cancer therapies, as shown on the right, those patients who did initially get trilaciclib did better in both cases over the longer term. And for patients who did receive subsequent anticancer therapy, the benefit of trilaciclib was both highly statistically significant, it was seen across all different subsequent anticancer therapies, and the benefit continued to increase over time, well beyond the initial treatment with trilaciclib. Digging slightly further into the same Phase 2 data, we looked at the overall survival from the time point when a patient first started their subsequent therapy, second line or later, to specifically evaluate the enduring effect of trilaciclib beyond the initial use. We again see on the left here, the blue line representing trilaciclib, those patients who received prior trilaciclib, compared to the orange line, representing patients who did not receive any prior trilaciclib. As you can see, for those patients who received prior trilaciclib, they meaningfully outperformed those who did not from the time when they started their second-line therapy, which is important to note, was typically chemotherapy, given the timing of this study. As seen on the right of this slide, there are two important points I want to call out when we compare these results to historical benchmarks. First, the patients receiving prior trilaciclib performed as expected compared to the chemotherapy arm in the ASCENT trial. We were at 6.7 months, 5.8 months for our study versus 6.7 months for the ASCENT trial. So very similar populations, I think, can be deduced from those control arms. But what is quite intriguing is the second point, which is how much better chemotherapy alone appears to do once you have prior trilaciclib exposure, with 14 months median overall survival. This is even slightly better, as shown on this slide, than the median OS of 12.1 months observed in the ASCENT trial by the ADC sacituzumab govitecan. So again, 14 months median overall survival just for chemotherapy following prior trilaciclib use. Now, as you can imagine, we look forward to seeing how this same data ends up in our Phase 3 study for patients receiving trilaciclib in the first-line setting, and then starting to imagine the impact the drug can have on the TNBC treatment landscape if we observe similar results. All of these benefits are why we're so excited for this Phase 3 readout. The schema of that study is shown here. As noted, it's with a GemCarbo regimen, and we do plan to evaluate similar subsequent anticancer therapy analysis for this Phase 3, like I just showed you from the Phase 2. Now, moving on to the other exciting area, which is for trilaciclib to be able to improve both the safety and efficacy of leading ADCs, a therapeutic class who we all know is increasing their role in triple-negative breast cancer. There are strong rationale for the use of trilaciclib with ADCs. As you see, the ability for trilaciclib during treatment to both reduce both the diarrhea and the myelotoxicities associated with leading Trop-2 ADCs, as we shared last year. This includes protecting the immune system from the harms of cytotoxic payloads, but the other benefit, shown in the dark blue box, speaks to the benefits after treatment with trilaciclib in the form of this improved long-term surveillance, as we discussed earlier. Now, this was a 30-patient study in combination with sacituzumab govitecan, which is currently the leading Trop-2 ADC in the space. First, this is. I'll show the latest cut of the safety and tolerability data. It continues to be aligned with what we initially reported out last year, that the use of trilaciclib, shown in the dark blue bars, shows clear reductions in the incidence of both diarrhea and all myelotoxicities, including neutropenia, anemia, and thrombocytopenia, versus sacituzumab govitecan, which is shown in the gray bars, and is from the ASCENT trial. These are all expected on-target effects provided by trilaciclib. Now, the preliminary efficacy data, shown here on slide 22 from the Phase 2 ADC study, is in the top row, and the historical ASCENT data is in the bottom row. First, I would note that for both studies, it appeared to have similar baseline characteristics in terms of the patient population, with one exception, and that is, in our study, 73% of the patients had prior PD-L1 treatment, versus in the ASCENT study, only 23% had prior PD-L1 treatment. Potentially reflecting, more of a, obviously a change in the, with the emergence of PD-L1 combination treatment, for earlier standard of care. Second, aligned with what I earlier covered about trilaciclib having the biggest impact on overall survival. We see the same pattern here, where a slightly a lower response rate was seen with, trilaciclib. A similar clinical benefit, which included, stable disease for more than six months, but then a 50% greater preliminary median overall survival, nearly 18 months versus 12 months from ASCENT. Again, which is particularly exciting since extended survival is really the ultimate goal that we all want in the development of oncolytic therapies. Looking at the 12-month overall survival, our trilaciclib ADC study stands at nearly 60% versus 50% for ASCENT, so a 20% improvement in terms of 12-month overall survival. Obviously, we're hoping to see this continued benefit over time, consistent with the trilaciclib mechanism of action, by the time we get to our next data cut on this study, which will be mid-year this year. But these preliminary data we feel are very, very encouraging and clearly what we were hoping for when we initiated this study several years ago. Now, let me conclude with a couple comments here about where we think we can go with trilaciclib as it relates to these pending two study results. The exciting thing is, I said at the opening, was we believe trilaciclib can be well-positioned in the TNBC treatment landscape based upon both its potential survival benefit, its persistent benefit, that when used initially, along with its ability to improve other agents like ADCs when used in combination. As shown in the blue in the middle of this slide, assuming positive readouts of existing studies, we will have demonstrated proof of concept for trilaciclib across many of the treatment settings in triple-negative breast cancer, including in combination with an array of established and emerging cytotoxic backgrounds, with and without immunotherapy. The existing proof of concept data, in combination with hopefully positive Phase 3 readout and other ongoing work, will help set the stage for our future commercialization and development opportunities as we look to become the leader, across multiple TNBC treatment settings and beyond. In transitioning to a therapeutic company upon a successful Phase 3, will also enable us to have greater global expansion beyond just China, where we're currently located. The more positive reimbursement dynamics around a therapeutic versus a supportive care agent will make it a more attractive opportunity in OUS markets, and we plan to accelerate our partnering discussions pending a positive Phase 3 readout. As we progress toward this TNBC leadership vision, we will continue to manage our capital extremely efficiently, similar to what we did in 2023, where we reduced our operating expenses by over 30%, strengthened our balance sheet, and increased the overall financial flexibility through various actions. All of which has enabled us to have cash runway through into 2025. In conclusion, with growing revenue in the small cell space, near-term TNBC leadership, and the potential growth in combination of the emerging ADC class, we believe G1 is well positioned to then start to look at leveraging business development for potentially synergistic assets and to leverage our trilaciclib learnings for next generation compounds as drivers of longer term growth. Thank you. Thanks. Thanks, Jack. So many of you have heard this from me for, like, 2.5 days, but there are three ways to ask a question. Number one is you can raise your hand the old school way, and I'll call on you. Number two is, if you have access to the portal, you can submit your question in the question portal. It'll show up on this iPad, and I'm happy to ask on your behalf. I guess there's, like, an intermediate strategy where if you just shoot me an email, and I'll read it. So, I'll ask the first question. Sure. If that's cool. Great. So for PRESERVE 2, would you be willing to comment on whether you have hit the pre-specified number of events for the interim as of right now, or is that something that DSMB will share with you, and then you kind of go into a quiet period? What are the logistics around that? Yeah. I'll give sort of a top line, and then Raj can walk through some of the specifics. So, to trigger the interim, it's an event-driven episode, so a certain number of events have to occur. We look at the projections of that regularly, and we're confident that will occur in Q1 of this year. In terms of the process, I'll let Raj walk through in terms of what we do with the Data Safety Monitoring Committee, et c. Yeah, happy to. So, once the required number of events have occurred, and I cannot comment if we've reached those yet, but we do expect, as Jack said, results this quarter, then the overall survival analysis results will, or the analyses will occur. The DMC will see the data. We have very specified criteria for stopping the study, using a statistical methodology called O'Brien-Fleming to determine the p-value. What that translates to is if the hazard ratio is 0.61 or less, then the study will stop for efficacy. If we're in that scenario, the DMC will let us know. We will be unblinded, and we will, of course, look at not only that data but a much more comprehensive data set for efficacy as well as safety, and then communicate those data, you know, via initially press release and then, of course, more fully in a medical meeting. What if, what if the DSMB says, "We haven't hit?" So what happens? Yeah. In that case, we remain blinded, and the study continues to the final analysis, which we also expect to occur this year. If we're in that scenario at the time of the interim, then we will communicate what that timeline is likely to be. It's worth adding, I mean, an interim analysis, as most of you know, is simply a statistical checkpoint. It's an opportunity if you meet the stopping criteria to get the product, hopefully to patients quicker. But again, if we go to final, we still believe this will have data that will be the most significant advancement in survival in triple-negative breast cancer. Yeah. But regardless, in 1 Q, we're gonna get a press release that says, "Here's the data," or, "We're going to final." You got it. You got it. Questions from the audience? We do have a portal question. Okay. So, trilaciclib, trilaciclib seems like it could be a companion drug to all treatments that attacks the immune system. If this is accurate, then the markets are much bigger than what you've identified. Why are you not collaborating with other clinical trials, given the constraints of your cash position? Yeah. Certainly, we've got a very experienced business development group, and there are lots of discussions ongoing. But you're right. When you look at this data, both the subsequent therapy data that shows this persistent benefit, along with some very robust initial data impact on survival, because you're protecting that bone marrow, protecting that immune system. Certainly, we see a great opportunity for the positioning of this product across not just triple-negative, obviously, but as I said, in combinations with ADCs. We also know that is probably ADCs are the biggest and fastest-growing class out there. Over 100 different ADC companies exist today. Certainly, we will look forward as this data matures on the Phase 2, and we have the Phase 3 readout this quarter to be looking at other opportunities to do exactly that. And then for me, so for PRESERVE 2, what are the reference comps in frontline TNBC that we should be thinking about from gemcarbo or the competitive landscape? Any differences in terms of patient demographics that you would point out for PRESERVE 2? Yeah. Raj, you wanna go ahead? Yeah. So regarding the, the comparator, the sort of the GemCarbo comparator arm, the most, contemporary data is from the Phase 3 study, KEYNOTE-355, where pembrolizumab was combined with chemotherapy, and the GemCarbo arm in that study had a median OS of 14.7 months. So that's sort of what we're expecting, around a 14.5-15-month median OS for the GemCarbo arm in our study. Any differences in the demographics of what's being enrolled in PRESERVE 2 versus, say, the KEYNOTE study? No, those are both, were both first-line studies. So I would expect a very similar type of patient population. We're stratifying by tumor PD-L1 status. In the first-line metastatic setting, about 40% of patients are PD-L1 positive. So we would expect about a similar number in our study as well, and most of the other characteristics would be similar as well. Questions from the audience? Maybe switching to COSELA commercial. Andrew, 19% growth quarter-over-quarter, that was a big jump, given what happened. So how much of that is like, the platinum, returning to normalization versus account growth, repeat prescribers, things like that? Yeah. So we've always had very strong repeat ordering for COSELA. Clearly, the pattern this year, you know, we grew at around 20% Q1, 4% Q2, 3% Q3, and now 19% in Q4. So and the platinum shortage really coincided completely with those two quarterly results in the middle of the year. So there's a high correlation with the platinum shortage, and it did affect our ability to execute. However, we did manage to actually grow our share consistently through Q3 and into Q4. So we were being more competitive with our execution, even though there was less opportunity to show volume growth. But we've also seen improvement in depth. So, you know, we've got 28 organizations that used over 100 vials within the quarter. That's up quite significantly from prior quarters. The growth in top 100 organizations was actually quite a bit higher than the 19%, and the proportion of our business in top 100 organizations is now around 60%. So what we actually have is a more robust business than we've ever had before, with a broader base of deeply adopting organizations. That's really what I think sets us up well for growth going forward, too. Have there been any impacts that you've seen from the inclusion of COSELA in the ASCO small cell lung cancer guidelines? Yeah. So we were very happy in October to see ASCO formally include COSELA in those guidelines. And of course, there's a number of effects you see. First of all, physicians pay attention to those guidelines. They do inform care, and they inform the standard of care at a clinic and a organizational level for customers. And we have seen that give credibility not only to our clinical arguments, but also in some cases, to our economic arguments, which are very strong for COSELA. But it also gives payers and reimbursement authorities, if you like, the confidence that the product is a standard of care going forward and that, you know, claims, et cetera, can be processed quickly and effectively. We see the guidelines as really shoring up what we already knew about the product, but doing it in a very public way with a very well-respected organization backing us up. Of course, we were very happy, very soon after the launch, to see NCCN give us dual committee endorsement. This is the icing on the cake for us. Questions from the audience? On your cash position, which you updated earlier this week, I believe, right? How do you think about scenarios around that, given, w hat's baked in that? Is that baked in a PRESERVE 2 interim up or going to final? Yeah. So we've got, a nd John can comment on it, but high level, what we announced on Monday was we finished 2023 with $82 million in cash. Gives us runway, as mentioned earlier, to 2024 into 2025, and that includes both some of the launch costs, assuming a successful PRESERVE 2. It does not include any revenues from a successful PRESERVE 2. So fairly conservative. John, other comments you'd make on that? I was gonna say the same thing. With the OpEx that you have in that burn, it would include, you know, the cost to get ready for launch for TNBC. It will? Yes, it does. Mm. But no revenues. But. But no revenues. But no revenues. But you see what I'm saying is, like, the dynamics would change if you get a first quarter versus later in the year. Yeah. PRESERVE 2 outcome. So we assumed a first quarter in that, obviously, those costs get pushed out as it goes to a final. Those costs we mentioned with TNBC launch costs. Any final questions from the audience? Thanks, Jack and team. Great. Thank you.