G1 Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the G1 Therapeutics 2021 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. I would now like to hand the conference over to our speaker today, Mr. Will Roberts. Please go ahead.

Thank you, Jillian. Good afternoon, everyone, and welcome to the G1 conference call to discuss our first quarter 2021 financial results and business update. The press release on these financial results was issued after market closed this afternoon and can be found in the news section of our corporate website, g1therapeutics.com. On this afternoon's call, the team will provide a business overview of the first quarter including an update on our launch progress with COSELLA, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum etoposide-containing regimen or a topotecan-containing regimen for extensive-stage small-cell lung cancer, or ES-SCLC. And it became available in the channel in early March. A question and answer session will follow the prepared comments. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risks and uncertainties, please refer to our filings with the Securities and Exchange Commission which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, March 5, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Soma Gupta, our Chief Commercial Officer, Jen Moses, our Chief Financial Officer, and Raj Malek, our Chief Medical Officer. And with that, I'll turn the call over to Jack. Jack?

Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. We certainly hope that you and your families are healthy and well. Today's headline is one of progress toward our mission via continued execution by the G1 team on both our launch efforts for COSELLA in extensive stage small cell lung cancer and in our clinical efforts as we execute on our robust development plan. As many of you know, G1 was founded in 2008 by Dr. Norman Ned Sharpless, the current director of the National Cancer Institute, to discover novel therapeutics that target protein kinases that help mediate cell division. His mission even then was to improve the experience of chemotherapy and to improve and extend the lives of people living with cancer. And I'm happy to say that our mission has not changed as the company has evolved. The development, approval, and launch of COSELLA in extensive stage small cell lung cancer is one example of how we are actively advancing that mission. Another is our tumor agnostic clinical program with late stage clinical trials ongoing or soon to be initiated in multiple tumor types. SOMA will share that the early indicators are suggestive of a drug that is being well received by oncologists and oncology nurses, and is well covered by payers. COSELLA is already being administered to patients. It fits well into the oncologist's workflow. Oncology nurses are being actively educated on its benefits. It's reasonably priced and supported by strong budget impact data. It was quickly added to two NCCN guidelines, and it represents the start of a true paradigm shift in chemotherapy patient support from reactive single lineage treatment with multiple drugs depending on the side effect to that of proactive multi-lineage myeloprotection. Equally good progress has been made in our clinical efforts with Cocella. Since the beginning of the first quarter, we started dosing patients in our pivotal colorectal cancer trial We've initiated our pivotal TMBC trial. We also opened an investigator-initiated trial portal, which is generating a number of interesting potential opportunities. And we expect to initiate two more Phase II trials later this quarter in non-small cell lung cancer and bladder cancer. So by the end of the current quarter, we expect to have two Phase III registrational trials and three Phase II trials underway. Now, today's call will cover an important amount of information. I'll ask Soma to discuss our commercial efforts through the end of March, our first four weeks of being a commercial organization, and provide some leading and lagging indicators of COSELLA's access and uptake. Raj will then provide an update on our medical efforts and also our recent clinical milestones in the first quarter. Finally, Jen will provide the financial update for the first quarter of 2021. Then I'll be back for some concluding comments. I'll now turn the call over to Soma for her update on our commercial efforts and results over the first four weeks of sales. Soma?

Thanks, Jack, and good afternoon, everyone. Thanks for joining us on the call. These are exciting and very busy times as we are launching COSELLA. And though we are very early in the launch cycle, the indicators to date have been positive and suggest a high-level interest in adopting COSELLA and the potential for strong coverage from payers. I'm very proud of the great work we have seen from this combined G1 and BI team. Thanks to their efforts, we booked approximately $600,000 in net sales as of March 31st in Coachella's first four weeks of availability. We're off to a solid start, and I'm optimistic that we can sustain this early momentum moving forward. Launching a drug during a pandemic is new territory for all of us, and the team has performed well. As we discussed on our last call, our sales training was completed the week of February 26th, and the team was in the field the following week to coincide with availability of drug on March 2nd. G1 and VI made good early progress, even though drug was available for only the last four weeks of the quarter. So a few highlights. First, thus far, our targeted priority payers have been covering COSELLA when written to label. Approximately 60% of it has been Medicare Part B, about 30% is commercial, and then 10% is government and other forms of coverage as we had expected. We are seeing good initial traction with prescribing docs and nurses with vitals being ordered by 20 unique organizations in the month of March alone. We've nearly doubled that number since. From an engagement perspective, as of the last week of March, again, only four weeks in, the team had already achieved a nearly 30% reach to our 2,500 target HCPs and more generally made an additional 3,000 calls to other prescription-enabling functions in the account. Almost a third of the calls were live, and with every week the country continues to open back up, we expect that trend to continue. That said, the team has proven itself to be entirely capable of virtual calls. And while not an indicator of usage, it's also good to see that the Salesforce shared voice among target physicians is already in the same range as that of other products used by treating oncologists like Neulasta, Teccentric, and Infinsi. And of course, we are leveraging our learnings from G1's initial national broadcast as well as other region-specific speaker programs that have been scheduled. We're very happy with the robust interest in these educational programs and also the strong interest in scheduling live programs versus virtual ones, which will likely have an even greater impact. Let's now go into a little more detail on sales performance, adoption, and market access. Sales performance for the first four weeks of product availability exceeded our internal demand target. As would be expected, approximately 60% of the demand came through community hospitals and clinics, with 40% coming from academic hospitals. Regarding adoption, again, we are seeing promising early metrics. Twenty unique organizations, what we call parent accounts, to which multiple accounts roll up, ordered COSELLA in March, and most of them have reordered, as would be expected given patients typically get six doses per cycle and four cycles per patient. 60% of these unique organizations did not participate in the clinical trials for COSELLA, suggesting that we are focusing on the right targets and are generating good interest and awareness outside of the already aware and experienced cohort. I'm also enthusiastic that seven of our 100 priority orgs, those that we consider critical to driving both depth and breadth of COSELLA adoption, had already ordered as of March 31st. Our best estimates indicate that approximately 30 small cell lung cancer patients were helped with the decision to start COSELLA in the first month of launch, which, given the infrequency of these patients presenting, is a good, strong start. The process to be made available for use in large institutions or community practices are individualized and very institution-specific. And as such, we'll take time to work through all of them. But we are happy to report that we made some very important early progress in March. For example, one of the largest GPO counts in the southeast is a big and very influential count that drives volume. Their highly controlled account, so the key to unlocking an account like this is through the key decision makers at the top. Our team immediately got to work on the key drivers, from touchdown, P&T review, EHR systems update, and formulary inclusion, from bottoms-up, nurse programs and C&E interactions, physician awareness, advocacy, and pull-through demand. That process was completed in late March, and since then, demand from them has been strong, and we are seeing orders nearly every day. This is a process that we will repeat with all of the large community practices, and while we are thrilled that this large GPO came on board with COSELLA so quickly after launch, we know each large community practice has its own process, and it will take some time to move through each one. Some will be like this one, where there's a high degree of institutional control, and acceptance can be determined by a few key decision makers. while others will prefer to stick to their system-dictated pathway, maybe something like clear value, and are awaiting that decision as part of their overall assessment. We will continue to work through all of them on an account-by-account basis, but the approach will be the same. Support P&T reviews and inclusion in EHR systems to open the account from the top, while driving HCP awareness, scheduling nurse and pharmacy programs, and activating patient advocacy so demand is being generated from the bottom. Many are also influenced by NCCN, and as Raj will discuss further in his remarks, Casella was added to two NCCN guidelines during the last week of the quarter, so we are leveraging that where appropriate. These steps are critical to selling a buy and build product that requires a total office call. By doing this critical upfront work, Casella will be made more easily available to interested prescribers. Those seven of our top priority orders who have already ordered have also added it to their formularies and their EHR order sets for small cell lung cancer. So we see things more generally going in the right direction. So while not every large community practice is the same, we do believe these are the right general steps to succeed. To do this successfully takes work and some time and will be our focus for the next two quarters or so. We have a great and experienced team that has done this before with over 20 different oncology products, and we will get there. Switching to market access, we make good early progress with payers, including completion of co-sell presentations to priority payers representing over 80% of covered lives. These split into approximately 70% Medicare Part B plans and 30% commercial plans. Anthem, a priority national payer, published our first formal policy on March 31st with a prior authorization to label as expected. All payers will issue policies based on these presentations over the coming months. Thus far, our priority payers are approving prescriptions that are written to label. We filed for our permanent J&C codes in March, and they should be approved by September. For those in the inpatient setting, we filed for what's called a new technology add-on payment. We should know that status by September as well. However, even prior to the permanent codes, we are seeing very little pushback in terms of reimbursement of filed claims. Of course, some practices, typically those of smaller size, will hold off until a permanent J code is issued. But overall, we are not seeing payer and reimbursement issues thanks to strong interest in the product, endorsement by NCCN, and of course, what we feel is a fairly priced offering. We have also discussed the importance of aided and unaided awareness of COSELL in the past, and we are enthusiastic about progress we have seen in that regard through the end of March. Both awareness measures are well above baseline, but it's a little early in the launch to attach significance to it. We will provide an update in that regard on the next call. So that was a lot of information. To summarize, we have seen good early metrics of engagement and ordering from priority orgs, Our demand sales came in line with our expectations for the first month of availability. We are making good progress with key large community GPO accounts, though the process to progress each one will take some time. And from a market access perspective, we have seen no issues in coverage and expect our permanent codes to issue in the second half of the year. So we are off to a solid start, and we believe we are well positioned to build on the momentum we've generated in these first four weeks. Thanks to the preparedness of our team, we've been able to meet every request for product and support. It is a very exciting time for the commercial team at G1 and at BI. And I'll now turn the call over to Raj Malik. Raj?

Thanks, Soma, and good afternoon, everyone. I'm going to cover three topics. First, I'll highlight some of our medical efforts during the quarter, including Casella's addition to the NCCN guidelines and how our interactions with HCPs are progressing. Second, I will describe some compelling budget impact model data that were recently presented at the Academy of Managed Care Pharmacy, or AMCP, meeting in April. Finally, I'll provide an overview of our recently initiated pivotal trial in triple negative breast cancer, or TNBC. Our medical science team has held over 350 medical-to-medical engagements since FDA approval. In addition to interactions with academic opinion leaders, our MSL team is actively engaging with community cancer clinics where the majority of small cell lung cancer patients actually present and are treated. The team is taking a total clinic approach with engagements with the oncologists and other allied healthcare professionals, especially nursing, pharmacy, and other clinic staff in the community cancer clinics and integrated delivery network key accounts. Some of the insights we've heard from community oncologists are around the importance of education on the novel mechanism of action of Casada. It's a proactive, multi-lineage approach to protecting the bone marrow, which is new and different from what they're used to. Most oncologists immediately think of neutropenia when it comes to myelosuppression. But when we discuss the other lineages, red blood cells and platelets, they begin to understand the novel mechanism. They're also used to thinking about oral CDK4-6 inhibitors that are administered chronically. However, what makes Casella unique is that it's administered IV, cleared rapidly, and only administered on days that chemo is given in order to provide a transient G1 arrest for myeloprotections. The nursing community is on the front lines of dealing with patients and managing chemo-related side effects, and the feedback from them has been resoundingly positive regarding the reduction of myelosuppressive chemo consequences by Casella. Many of the questions from nurses so far have been very practical and pragmatic in nature, mostly around choice of IV infusion sets, like which tubing and filters are compatible with IV administration of Casella. This is important since it indicates that they are interested and preparing to use Casella in their practice. The field medical team has also received a lot of practical questions from pharmacists in addition to requests for pharmacoeconomic information to inform their P&T and formulary decisions, like the data we presented at the AMCP meeting. Our MSLs have also seen a strong uptick in interest in the G1 scientific platform, and this not only helps to drive interest from additional investigators for our lifecycle management clinical trials, but also translates into new proposals for investigator-sponsored studies. Our medical team was instrumental in having COSELLA added to two updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology in late March, the Treatment Guidelines for Small Cell Lung Cancer, and the Supportive Care Guidelines for Hematopoietic Growth Factors. This type of simultaneous update of two NCCN guidelines is not only rare, but also a testament to the multidisciplinary importance of this breakthrough therapy. Gaining inclusion into relevant guidelines also drives inclusion into oncology care pathways, which is a vital part of our strategy to ensuring appropriate patient access, as these recommendations facilitate payer reimbursement and patient access. We have submitted data packages to the oncology care pathway committees via their formal submission processes. G1 has a very robust publications plan on which we are executing. For example, 18 trial-recycled peer-reviewed manuscripts have been published to date, eight of which were in 2020 or 2021, and several others have been submitted and are under review. In addition, we have submitted abstracts for presentation at eight different medical meetings in 2021. At the AMCP meeting, we presented the budget impact of prescribing Casella to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-state small cell lung cancer from the perspective of a third-party payer. The model created and compared two scenarios for this analysis over a five-year time horizon in a hypothetical plan with one million members in total. The first, which was a pre-launch scenario, outlined the economics and outcomes associated with standard extensive-state small-cell lung cancer treatments before COSELLA was available. The second, which was the post-launch scenario, displayed the economics and outcomes projected to evolve when those same standard treatments are needed with COSELLA being given. The results are compelling. Chemotherapy-induced adverse events in patients treated with extensive-state small cell lung cancer were estimated to be fewer over five years in the scenario where Casella is available, resulting in a net financial impact of Casella, which is estimated to be a budgetary cost saving. The presentation is available on the publications page of our corporate website. Next, regarding our clinical development progress, our first-line colorectal Phase III trial is continuing to enroll patients. In late April, we initiated Preserve II, our second pivotal Phase III trial, which is a randomized double-blind placebo-controlled study of COSELLA in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer. This cancer comprises up to 20% of all breast cancers and is an aggressive disease with poor outcomes. Because the tumor is negative for estrogen, progesterone, and HER2 receptors, thus the term triple negative, patients do not respond well to common medications that block hormone or HER2 receptors. Instead, treating TMBC typically consists of using chemotherapy combinations in addition to radiation and surgery. Therefore, there is a significant medical need for well-tolerated and efficacious therapies with novel mechanisms of action. The study is enrolling two cohorts of patients. Cohort 1 will enroll 170 patients receiving first-line therapy, regardless of tumor PD-L1 status, who have not been previously treated with a PD-1 or PD-L1 inhibitor. Cohort two will enroll 80 patients with a PD-L1 positive tumor receiving second-line therapy following prior PD-1 or PD-L1 inhibitor therapy. These two cohorts are adequately powered and considered independent of each other. Within each cohort, enrolled patients will be randomized one-to-one to receive either Casella or placebo prior to gemcitabine and carboplatin therapy administered intravenously on days one and eight in 21-day cycles, which is the same dosing regimen used in group two of our positive phase two study. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, investigator decision, or the end of the study, whichever occurs first. The primary endpoint in both cohorts is to evaluate the effect of Casella on overall survival compared with placebo. Secondary objectives in cohort one include assessments of Casella's impact on overall survival in PD-L1 positive and PD-L1 negative groups, and on progression-free survival compared to placebo. And for cohort two, on progression-free survival compared to placebo. The key secondary objective in both arms includes assessment of the effect of Casella on patient's quality of life as measured by time to first confirm deterioration of fatigue compared with placebo. Other secondary endpoints in both arms will evaluate the effect of Casella on measures of anti-tumor activity, including overall response rate, clinical benefit rate, and duration of response, and the myeloprotection effect of Casella on multiple measures of multilineage myelosuppression including neutrophils, red blood cells, and platelets. We expect these pivotal data to read out in the second half of 2023. We also remain on track to initiate two additional phase two trials of Casella this quarter, one in second and third line treatment of non-small cell lung cancer, and the other in first line treatment of locally advanced or metastatic bladder cancer or metastatic urethelial carcinoma. Finally, turning to rintodestrin, our oral surge. We will present phase two data from our combination of rintodestrin with palbocyclid in 40 patients with ER-positive HER2-negative breast cancer at ASCO later this quarter, and a press release will coincide. We will provide the details of the presentation as soon as embargo policy allows. With that, I'll turn the call over to Jen for her to review the results of the first quarter.

Thanks, Raj, and good afternoon, everyone. As Will mentioned, full financial results for the first quarter of 2021 are available in our press release and in the queue. Today, I'd like to focus on a few key points from our disclosures. Our total revenue for the first quarter of 2021 was $14.2 million, comprised of net product revenue of $0.6 million and license revenue of $13.6 million. We recognized product revenue upon delivery of Cosella to our specialty distributors. First quarter product revenue includes net product sales from our first shipments in March following FDA approval. Our license revenue was primarily related to development milestone payments from our license agreement with Sincere, which provides them with development and commercialization rights for Trilocyclib across all indications in greater China, and revenue from EQRX, with whom we have a license agreement for Lerocyclib. The revenue from EQRX relates to delivery of clinical drug supply and manufacturing services and reimbursement of clinical trial costs. In addition, we recognize revenue related to achievement of a development milestone by Genor. It's worth noting that while we do expect to continue to receive modest expense reimbursements and payments under our supply agreements from our partners, we do not expect to receive this amount of license revenue in any one quarter for the remainder of this year. Cost of goods sold for the three months ended March 31st, 2021 was minimal, as the majority of the manufacturing costs related to the first quarter of Casella sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. The prior expensing of these costs will continue to impact presentation of cost of goods sold in future periods until initial pre-launch inventory is depleted and additional inventory is manufactured and sold. G1's research and development expenses for the first quarter of 2021 were $16.5 million, compared to $20.4 million for the first quarter of 2020. The decrease was primarily due to a decrease in costs for manufacture of active pharmaceutical ingredients and drug products to support clinical trials, as well as a decrease in external costs related to discovery and preclinical development. Our selling, general, and administrative expenses for the first quarter of 2021 were $23 million, compared to $11.4 million for the first quarter of 2020. The increase was largely due to an increase in compensation costs due to increased headcount and increased commercialization activity. We ended the first quarter with cash and cash equivalents of $279 million. which included the $86.4 million in net proceeds from our at-the-market offering with Callen. As a reminder, this activity utilized all remaining capacity under the sales agreement, so this ATM offering is now closed. We also drew an additional $10 million on the debt financing facility with Hercules Capital and entered into an amendment to the agreement, which provided slightly lower interest charges and additional covenant relief on a future tranche of debts. There is currently 70 million of capacity remaining on the Hercules facility. We expect our current financial position to be sufficient to fund operations into 2023. With that, I'll turn the call back over to Jack. Jack?

Thank you, Jen, Raj, Sam, and Will. Before we conclude this portion of the call and go to Q&A, I want to thank the people living with cancer and their healthcare professionals for their inspiration. In particular, given that May is Oncology Nurse Month I'd like to personally thank these nursing professionals for the incredible work they do. You are truly the front line of care for people living with cancer and walk with them every step of the way from diagnosis onward. We appreciate the opportunity to be part of and help support your community. I would also like to thank the G1 team for your continued dedication to improving the lives of cancer patients as we execute on our clinical and commercial programs we will have the opportunity to impact a lot of lives. Your dedication and drive matters. Now, as I mentioned on the last call, the first quarter of 2021 was transformational for G1, and I'm happy to report that we are well along in turning the corner on becoming a commercial organization without losing focus on our clinical endeavors. We will keep you up to date as possible on our commercial rollout of COSELLA through these leading and lagging indicators of both interest and uptake, which we intend to provide every quarter, along with our revenue results. However, on this call, we describe some patient numbers to help you understand our early trajectory. We do not intend to provide them every quarter as we start to get into our revenue generation. Again, before we move to Q&A, let me just recap what you've heard today. The combined sales team is executing on its launch program and achieving good early metrics of engagement and adoption of COSELLA. We see no issues in coverage and expect to hear about our permanent J, C, and NTAP codes in the second half of this year. Our medical affairs team has held over 350 medical to medical engagements across the MSL team since FDA approval. driving education on COSELLA and interest in the G1 scientific platform. We have a strong publications program on which the medical team is executing, including the recent presentation of data showing that the net financial impact of COSELLA is estimated to be cost savings from a budget standpoint. COSELLA was added to two different NCCN guidelines in late March, which we expect to facilitate timely payer reimbursement and ongoing patient access. We've recently initiated our pivotal trial in TMDC with data expected in 2023. We also expect to initiate our phase two programs in non-small cell lung cancer and bladder cancer later this quarter, giving us five ongoing late stage trials and numerous readouts coming over the next 24 months. And finally, we have cash runway that takes us into 2023 with options to extend that further. Thank you for your time this afternoon. We will speak again in this format in the August call for Q2 earnings, but between now and then we look forward to connecting with many of you at the upcoming virtual healthcare conferences and non-field roadshows in the weeks ahead. With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question?

As a reminder, to ask a question, you will need to press par 1 on your telephone keypad. To withdraw your question, please press the pound key. Please stand by while we compile the training roster. Our first question comes from the line of Mr. Tom Shader from DTIG. Please go ahead.

Hi, this is Kaveri for Tom. Thanks for taking our question. I just have one on the oral certs. With all the updates from the other CERT programs, like Sanofi's and Genentech, has the bar for what has to be seen for reintroduction changed?

Yeah, thanks for the question. Really appreciate it. I would say our internal measure that we've communicated of CBR24 between 60% and 65% really remains. To your point, as more data comes out in the CERT class, both on the efficacy and the tolerability and side effects standpoint. We'll continue to monitor that, but we believe if we can match the safe profile and strong tolerability and hit a CBR in that range, we'll consider this a good result.

Great. Thank you, and congrats on the progress.

Thank you very much. Appreciate it. Our next question comes from the line of Mr. Tony Butler from Roth Capital. Please go ahead.

Thanks very much, Soma. I appreciate the presentation and the color, but I have to ask, can you describe any payers that had a pushback, but importantly, how are the field agents able to actually deal with that pushback? I think it's important as a lesson to be learned. And then the second question involves around discussions that you've been having with payers who have yet to sign contracts or incorporate COSELLA within their reimbursement. Again, can you discuss where the any rate limiting steps that may be occurring at least to date? Thanks very much.

Yes, sure, Tony. Nice to hear from you. So on both points, as I said in my comments, we have had very little pushback from payers at this stage. And so at this point, what's happening is physicians are choosing to write it, they're putting it in, and they're not having issues. And, in fact, as you know, we have this G1 to 1 service, you know, so the cases that have come through there, same thing, no problems. I think at this stage it's PA the label. And so to answer your second question, you know, the second question around the policies is that, The process is there's presentations that are given. We've done those presentations that cover about 80% of lives at this stage. They are well underway. And, you know, and then they all take their time to, you know, review the data, understand the data, understand the benefit, and then write the policy. And so, as I said, we got the first policy from Anthem at the end of March, so we were very happy about that. I think different, you know, different... companies basically handle that in different ways and take time on different timelines. So we think that might take, you know, anywhere between, you know, it could take six months for all of them to come on board and write their individual policies. Some of them came on, Anthem came on very early on the progress, but I would say overall You know, this is not an area with the payers where we're seeing a lot of pushback and an issue. And so even to answer your question about how the reps are handling it, the reps aren't really having to handle it because it hasn't really been that much of an issue to date. Again, we think we fairly priced it. We think people understand multi-lineage, that they're getting the benefit of not just what they get. with GCSF or others, but they're getting the other pieces. And I think that that goes a long way in terms of the value proposition on COSELLA. But we're very encouraged by the progress on the payer front to date.

Thank you very much.

Our next question comes from the line of Mr. Chad Messer, Jr. from Needham. Please go ahead.

Great. Thanks for taking my question, and thanks to the whole team for all the added color today, and my predecessor analyst, a special thanks to Soma for all of her color. Soma, I may need to replay parts of your prepared remarks today at two-thirds speed so I can absorb it all, and if inferiorly ability to process information clearly slower than yours. But if we could just dive into a couple of things I'm trying to get a hold on. And I get it. So we're talking about the very earliest days. It's a very flash time point in the launch. Things do sound like they're going well. But $600,000 in sales, you know, through that very end of March. I believe if I have my notes down correct, you guys are estimating that's about 30 patients that you treated. Maybe some context on that number. I know it's, you know, a month of early data, but, like, are we, you know, 2%, 20%, 40%? And then you also, I believe, again, I've got to read my own hastily written notes, but 60-40 on the community academic breakdown rate. and 60-30-10 on the Med-B commercial and government breakdown. Like, can you give us some context on where those are and where we think they need to be? Like, you know, again, I know it's just the first few weeks. We're all going to overanalyze it. That's what we do. But sort of where are we on those, if you could give us some context.

Yeah, absolutely. So, yes, I tend to be a fast-talking New Yorker, as you may know. So I appreciate that. But interestingly, you've got all the numbers correct. So that's the first thing. So on the 30 patients, so what I can tell you about the 30 patients is it is an estimate because the way that the data comes into us is we see different accounts. First of all, we see accounts. And so accounts will order, and we'll be able to see, okay, that person, they ordered five vials. That's probably a second-line patient. That person, they ordered six vials. That's probably a first-line patient. So we're doing a little bit of math to get at our best estimate around the patients. But we did think it was important to be able to give a perspective on how many patients we think went on drug. And we think it's about 30. Of that 30, we think, you know, we think about half of those are definitely first-line patients. We think about 25% of those might be second line, and then about 25% of the ship were just not sure based on the way the ordering came in. So that's a little bit of coloring, at least on the patient piece. And in terms of where we think that is, we think that's very positive. We think directionally. 30 patients was great for four weeks. This is a disease when you think about it. You know, there's only 30,000 patients that present in a given year. All of those, 17 to 18,000 are first line, about 10,000 are second line, and then kind of the remainder are third line. These patients don't really make it through multiple lines of therapy. So when you think about that, so you take that number that you kind of do it on a monthly basis, you know, the number of patients walking in every month is not that big. And so, you know, for us, we thought 30 patients was a good number for the first month of launch. That's the first thing. The other numbers that you mentioned, the 60-40 community split, we actually think that's going to move closer to 70-30 over time. We think that what might have happened in this instance is that the community, sometimes the community institutions, the larger practices, they have longer processes to kind of pull it through. And, you know, the whole process I talked through about getting PNT and opening it up from the top Sometimes that process is a little bit longer in some of the community accounts. And then some of the academic accounts, that just goes faster because they can get access to the things they need. So that might be why it weighs a little bit heavier on academics than what we, I think what we expect to see at Study State, which in my mind would be more like Harmony 30. On the payer mix of 60-30-10, that's actually what we expect to see, so that was actually right in line with exactly how we expected to come in. Again, these patients, the average age is 65, so we know that the heavily Medicare population, so to assume it's about 60% is reasonable, 30% commercial, and then 10% kind of VAD and others. So I think that in general, we think this is actually, the patient count, again, it's an estimate of But we feel very good about what the patient count is and where we were able to get to in the first month. And as I said, the other two metrics I feel are very in line with what we expected.

All right. Well, really appreciate the action, caller, and please accept my permission to take a breath. Thank you.

Thank you.

Our next question comes from the line of Mr. Joe from Cohen and Company. Please go ahead.

Hi there. Thank you for taking my questions. First one, just on the P&T approval process, given kind of the COVID pandemic timeframe, what's the average time from sort of initial presentation to the hospital for it to get through the P&T committee? And then second, is it possible to use Casella concomitantly with other GM-CSF products in clinical practice? I know in clinical study we saw obviously reduced need, but is it still reimbursable after lunch? Thank you.

Great. Thanks, Joe. I'll quickly address the first one, then I'll flip the second one over to Raj. In terms of what is your, quote, typical P&T timeline, to Soma's point, this is really very individualized. It's on an account-by-account basis, depending on either the institution, a large hospital institution, versus a large community practice. So the team is monitoring this. We've got a good sense for a lot of them of when they will occur. But to be honest with you, the dates really, the duration of, A, when they start and how long it takes, really does vary account by account. But the team is heads down executing on this and making sure they have the information they need to be able to hopefully move through that process as quickly as possible. Rush, you want to grab the second question? Yeah, happy to.

So in our trials, we allowed the use of GCSF, and what we actually found was a substantial decrease in the need for GCSF when COSELLA was given, but there were no safety issues with giving both COSELLA and GCSF. So we think in practice, because of the proactive approach with COSELLA, You know, prescribers will initially use Casella and also having the multi-lineage benefit and could have the option of using GCSF if needed down the road.

Okay, perfect. Thank you very much. Thank you, Joe.

Our last question comes from the line of Mr. Ed White from HC Wainwright. Please go ahead.

Good evening. Thanks for taking my questions. Thanks for the update on Rinto. Just wondering, you know, if you can briefly review your strategy there again, and has there been interest from partners for that product? And then a quick question for Jen, just that the cash runway into 2023, does that include the $70 million left from the Hercules project? deal. Thanks.

Good to hear from you, Ed. I'll answer the first one and then flip it over to Jim to hit your second question. In terms of rent-to-destraint, we are still on the same path that we communicated last year. We believe, given the competitive nature of the class, the cost of the Phase 3 development programs, let alone the significant investment to commercialize it, we think the best use of shareholder capital is to partner that To your point, we have had interest in it and have had discussions. Obviously, as we release the data at ASCO, that will be the next logical milestone here where we'll follow up on a lot of those discussions. But we're still on path to be able to partner that and really fully deploy our capital behind Triad of Cyclists Development Plan. Jen, do you want to take a second one?

Sure. Sure. So, Ed, when we're giving guidance, we run it a number of different ways. And for early stages of revenue, looking at a bunch of different options. But we are not utilizing the full $70 million to get to 2023. So I hope that answers your question.

That does. Thank you. Thanks, Ed.

Okay, that looks like it's the last question. So let me just conclude by saying we are very excited to be bringing COSELLA to patients with extensive stage small cell lung cancer and through our clinical teams to many more patients with a variety of different cancers. As always, I look forward to keeping you all updated as we move forward, and certainly we will continue to be as transparent and proactive as possible in this regard. So to everyone listening, thank you for joining us today. Please stay healthy and well. We look forward to talking soon. Thank you.

This concludes today's conference. You may now disconnect.