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spk06: Hello, and thank you for standing by. Welcome to the G1 Therapeutics Third Quarter 2022 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, one, one, on your telephone. You will then hear an automated message advising that your hand is raised. I would now like to hand the conference over to your opening speaker, the Vice President of Communications, Will Roberts. Will, please proceed.
spk05: Thank you, Sheena. Good morning, everyone, and welcome to the G1 Conference Hall to discuss our third quarter 22 financial results and business updates. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, qntherapeutics.com. On this morning's call, the team will provide a business overview of the third quarter of 22, including an update on our clinical programs and our commercial progress in that period with COSELLA, which is approved and commercially available 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 ESSVLC. A Q&A session, as Sheena said, will follow the prepared remarks. Before we begin, I'd like 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 judgment as of today and may involve certain 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 risk 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, November 2nd, 22. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Raj Malek, our Chief Medical Officer, Andrew Perry, our Chief Commercial Officer, and Jen Moses, our Chief Financial Officer. I'll now turn the call over to Jack.
spk01: Jack? Good morning, everyone. Thank you for joining us on the call today. During the third quarter, we demonstrated continued execution on our clinical program, but also experienced lower COSELLA sales momentum versus what we achieved in the second quarter. I'll cover both in my opening comments, and then Raj and Andrew will each provide additional color to both topics. First, I'm proud of the progress the clinical team achieved. As Raj will discuss, among the clinical milestones that we've reached during the quarter and since our R&D day in September, we announced this morning that we are seeing encouraging initial safety results from our Phase II ADC trial with Salsituzumab-Govetikin that shows its potential to provide clinically meaningful reductions of over 50% in adverse events related to Salsituzumab such as myelosuppression, diarrhea, and potentially even alopecia, compared to previously published single agent safety profile of this ADC. We also completed enrollment in our phase three metastatic triple negative breast cancer trial, and for our phase two bladder cancer trial. And as we discussed on our last call, the trial cycle mechanism of action trial. Next, our phase two MOA trial results have been accepted for presentation at the San Antonio Breast Cancer Symposium meeting. Two abstracts providing additional non-clinical data on trilocyclin's potential anti-tumor effect have been accepted for presentation at the Society for Immunotherapy of Cancer meeting in November. Finally, and perhaps of most importance, our timelines for initial results remain intact for our pivotal phase three trials in colorectal cancer and in triple negative breast cancer. At the same time, we are cognizant of the fact that we did not deliver the level of sales results that we were expecting. As you'll hear from Andrew, we are working through some market variability due to new patient flow, pressure on organizational staffing, and account additions at different times of the year. Though this was balanced by a 12% increase in reorders from existing accounts. We are putting in place a variety of actions that Andrew will describe that will drive growth over the coming months. We hear every day from healthcare professionals and patients who have experienced the unique benefit that only Cocella provides. It's a paradigm changing drug that enables oncologists for the first time to proactively reduce or prevent the serious multi lineage hematologic side effects of chemotherapy rather than treating them reactively. we remain as confident in the potential of Casella today as ever. And as the initial results from our ADC trial underscore, extensive stage small cell lung cancer is just the start. We are convinced of its potential value in much bigger markets like colorectal cancer. Since this morning marks the first of many new clinical data disclosures over the coming months, I will first ask Raj to provide an overview of our clinical momentum during the quarter and since our R&D day, starting with an overview of the initial ADC safety results. Angie will then cover our recent commercial actions and results, including an update on the efforts of our field sales team during the third quarter of 2022. Finally, Jen will provide the financial results for the quarter. Then I'll be back for some concluding comments. With that, I'll turn the call over to Raj.
spk08: Thanks, Jack, and good morning, everyone. In September, we held our 2022 R&D Day and discussed a variety of topics, including the timing to initial results and what to expect from those results, and new preclinical data supporting the potential of Trilocyclic to work synergistically with other anti-cancer therapies. We've made good progress on all fronts since then. I will start with the encouraging initial Trilocyclic plus Acetuzumab Govitecan Phase II safety results, in patients with triple-negative breast cancer that we announced this morning. We are seeing consistent reductions by well over 50% in the rates of numerous adverse events associated with sasituzumab when traliciclib is administered prior to the ADC relative to the previously published single-agent safety profile of sasituzumab govitecan. We had hoped to present these data at a medical conference this fall, but small numbers at the time of abstract submission this summer precluded that. However, recent enrollment momentum provided the opportunity to evaluate key safety data in the first 18 of the 21 patients enrolled today. Though early and unaudited, the trends in treatment emergent adverse events have been consistent over the time we have been monitoring the safety results of the study. Specifically, Some examples of these reductions are in the rate of grade 3 and 4 neutropenia, which dropped from 52% in the sasituzumab data to 17% with trilocyclic and sasituzumab. The rate of any grade anemia, which dropped from 40% to 6%, and the rate of any grade diarrhea, which dropped from 65% to 28%, with no occurrences of grade 3 diarrhea with Tralacyclib and Sasituzumab, and 11% in the Sasituzumab data. We view these as on-target effects of Tralacyclib, not only in the expected reduction in the rate of myelosuppression related to Sasituzumab, but also in the rates of diarrhea and potentially alopecia. This is likely due to the presence of CDK4-6-expressing cells in the intestinal crypt and in hair follicles. Though the data will continue to mature, we are very encouraged by these early on-target results, as are the investigators who have reviewed the data, because they begin to clarify the potential for trilocyclic in combination with ADCs such as sasituzumab, govetican, across other indications. In addition, These data could read through to the full Fox theory regimen in our colorectal study, which also includes arena TCAM. We look forward to presenting a more comprehensive safety and efficacy data at a medical meeting in the second quarter of 2023. Next, I'll comment on our pivotal phase three trials. First, in Preserve 1, our 326-patient trial of trilocyclic and first-line metastatic colorectal cancer primary endpoints are assessments of the effect of Tralocyclib on myelosuppression compared with placebo as measured by the occurrence of severe or grade 4 neutropenia during induction and duration of severe neutropenia in cycles 1 through 4. We expect to release results in the first quarter of 2023 on myeloprotection and other on-target effects of Tralocyclib, like diarrhea, can be dose-limiting in colorectal cancer patients receiving Folfoxiri. This is a pivotal trial. If the model protection data read out positive, we will meet with regulatory authorities to discuss filing for approval in this indication. Next, we recently completed enrollment in PRESERVE-2, our first-line triple-negative breast cancer pivotal trial in 187 patients with PD-L1 positive and negative tumors, receiving first-line tralocyclic or placebo prior to gemcitabine and carboplatin. We expect the interim overall survival analysis to be conducted by our data monitoring committee in the second half of next year. If the trial meets the interim analysis stopping rule, it will terminate, and we will report the top-line results. If it does not, the trial will continue to the final analysis. Next, let's shift to progress on other ongoing Phase II trials. As we said during R&D Day, based on the mechanism of action of Trilocyclic, we expect to see the greatest effects on longer-term efficacy endpoints like overall survival and progression-free survival, and the least effect on response rate. We recently completed enrollment in Preserve 3, our Phase II trial of Trilocyclic in combination with chemotherapy and the immune checkpoint inhibitor Avelumab and 92 patients with bladder cancer. Initial safety and tumor response data are expected in the fourth quarter of this year, followed by data on the primary endpoint of progression-free survival in 2023. As we have said, we do not expect to see myeloprotection in this trial, likely as a result of the gemcitabine-containing backbone. Next, our abstract on the initial results of the Phase II Mechanism of Action Trial was accepted for poster presentation at the upcoming San Antonio Breast Cancer Symposium in December. The San Antonio poster will describe the initial immune endpoint results. Additional data, including pathological complete response and other immune and profiling data, are expected in 2023. In September, we discussed new preclinical data describing the potential for Tralocyclib to enhance the cancer immunity cycle by enhancing T-cell activation, favorably altering the tumor microenvironment, and improving long-term immune surveillance. As Jack mentioned, two abstracts on this work have been accepted for presentation at the CITSE 2022 Annual Meeting. In summary, we have made good recent progress, and we believe it positions us well for a data-rich period. Finally, I also will mention that we recently presented new data at the Precision Oncology Summit that continue to demonstrate the real-world impact that Casella can have on severe hematologic adverse events and supportive care needs. In real-world practice, Casella is used in a heterogeneous population of extensive-state small cell lung cancer patients. Despite this heterogeneity, Casella consistently shows the potential to reduce the occurrence of myelosuppression, supportive care utilization, and chemotherapy dose reductions and delay. With that, I'll turn the call over to Andrew for a commercial overview. Andrew?
spk12: Thank you, Raj. I'm glad to be with you today to provide an update on a number of commercial topics, including third quarter sales performance, factors affecting growth, and a description of some of the actions we're putting in place that will drive growth going forward. The third quarter was our second complete period during which Clostella was promoted solely by our own team of G1 Oncology sales account managers. following the termination of our co-promotion agreement with Boring-Ringelheim in early March. Our goal this quarter was to build on the platform of volume and growth, which we demonstrated in Q2. We delivered similar volumes in Q3 as generated in Q2, and I'll discuss some of the factors affecting growth today. Beginning with sales activity, we ended the quarter with $8.3 million in net sales of Costella, representing approximately flat file volumes compared with Q2. Volume growth compared with same quarter last year was 129%, demonstrating the overall progress we have made with sales execution. As you might recall, we showed quarterly growth of approximately 60% in Q2 of this year compared with Q1, but when reporting those results, we remarked that the small cell lung cancer market can be variable from month to month due to patient flow and pressure on staffing at healthcare organizations at different times of the year. We've reviewed the most recent available patient patient-level claims, and we estimate that the number of new extensive-stage small-cell lung cancer patients declined around 10% in the first two months of Q3 compared with Q2. As a reminder, in the extensive-stage small-cell lung cancer market, our quarterly growth is highly reliant on gaining new patients, either from new accounts or from existing accounts, in order to compensate for patients who complete their chemotherapy regimen and drop off therapy. Similar to the same quarter last year, we added fewer new accounts in Q3 than in Q2, However, we did increase the volume of vials reordered from existing accounts by around 12%. We also added seven new top 100 organizations since the end of Q2, giving us a total of 64 of the top 100 which have ordered Cosella launched today. As a result, our overall estimate of Cosella patient share in Q3 actually increased to nearly 8% in the first-line market, which represents the majority of our users. We saw 71% of volume in the quarter come through community clinics and hospitals, and 29% of volume from academic centers representing an uptick in demand in academic centers this quarter. 98% of our volume in the quarter was in commercial supply, with 2% provided through our patient assistance program. So our Q3 performance was driven by diminished numbers of new extensive stage small cell patients in the market, and fewer new accounts added, which together resulted in fewer new CoSella patients. However, this was balanced by more depth of reorders in existing accounts. Our pair mix remains stable, with the majority covered by Medicare and third-party reimbursement has remained strong. CoSella brand awareness among oncologists remains high, as does intention to prescribe. Face-to-face calls continue to compose the majority of sales engagements in Q3, and our measures of Salesforce effectiveness continue to exceed oncology industry norms. Looking forward into Q4 with several new top 100 organizations having only recently come on board, we are moving quickly to ensure initial trial becomes advocacy and then adoption. In reviewing opportunities for further improving execution in Q4, we introduced territory level sales incentive goals for the first time so that all of our sales account managers are highly incentivized to deliver growth in the quarter. We introduced new marketing claims, including patient-reported outcomes, which many oncologists believe are a pivotal reason for considering COSELLA. We entered into negotiations for volume-based agreements with several large community oncology provider networks, with one already finalized. We anticipate beginning to see the impact of these in Q4. We also recently expanded our speaker bureau and completed our first live speaker training since launching COSELLA. Finally, we made some operational changes, including territory realignment, resulting in one fewer territory, making 33 in total. Overall, this was a quarter where we sustained the high levels of execution demonstrated in the prior quarter, despite some challenges in flow of new patients. Going forward, although we anticipate some variability in month-to-month patient flow, we now have 64 of the top 100 organizations and well over 500 accounts in total with Gosella experiences. Our customers strongly believe in the benefits of Clostella for their patients, and many are ready to share those experiences with their peers. This places us in a strong position to ensure that when new extensive stage patients are diagnosed, they have the opportunity to receive Clostella. Together with our new, more patient-focused marketing resources, territory-level sales incentives, and select volume-based provider network contracts, we believe we're well-positioned for stronger growth moving forward. With that, I'll turn the call over to Jen for a financial update. Jen?
spk04: Thanks, Andrew, and good morning, everyone. As Will mentioned, full financial results for the third quarter of 2022 are available in this morning's press release and will be in the 10Q, which we intend to file after market close. Our total revenue for the third quarter of 2022 was $23.6 million, comprised of net co-seller revenue of $8.3 million and license revenue of $15.3 million. For the same period in 2021, total revenue was $4.9 million and included $3.4 million of net product revenue for COSELLA and $1.3 million of license revenue. The license revenue from the current quarter is primarily related to revenue recognized from two development milestones related to the SIMSEER license agreement, including a $13 million milestone payment related to the approval of COSELLA in China. Cost of goods sold for the three months ended September 30th, 2022 with 1.1 million compared to 0.6 million for the same period in 2021. Our research and development expenses for the third quarter of 2022 were 19.6 million compared to 21.1 million for the third quarter of 2021. The decrease in R&D expenses was primarily due to a decrease in cost for manufacturing active pharmaceutical ingredients and drug products to support clinical trials. Our selling general and administrative expenses for the third quarter of 2022 were $24.4 million compared to $24.3 million for the third quarter of 2021. Comparing the two periods, we saw increases in personnel costs due to increased headcount and administrative costs, offset by decrease in medical affairs costs, commercialization spend, and professional and technology costs. Regarding our cash position, as described in the press release this morning, we ended the third quarter with cash, cash equivalents, and marketable securities of $123 million compared to $221.2 million as of December 31st, 2021. We have amended our agreement with Hercules to provide additional flexibility with our covenants and have extended the timeline we were able to draw the $25 million available to us into June of 2023. With that, I'll turn the call back over to Jack for some closing comments. Jack?
spk01: Thank you, Jen, Andrew, Raj, and Will. And as always, I want to thank people living with cancer for your inspiration. You drive the G1 team toward our goals every day. Before we move to Q&A, I just want to recap some of the points that you have heard today. We are very encouraged by the initial safety results from our Phase II ADC trial of Sustuzumab that show its potential to provide clinically meaningful reductions of well over 50% in numerous adverse events related to Sastatuzumab such as myelosuppression, diarrhea, and even potentially alopecia. We expect to provide initial results from our two ongoing pivotal trials in CRC and TMBC next year, starting with CRC data in the first quarter of 2023, and from two additional phase two trials later this year. The MOA data will be presented at San Antonio and the bladder cancer data will be issued via press release. We experienced lower closed-cell sales momentum versus what we achieved in the second quarter, largely due to variability in patient flow. And while we saw fewer new accounts coming on board during the quarter, this was offset by double-digit growth in existing accounts reordering. We've already initiated actions, including territory level of sales incentives, the addition of patient-reported outcomes in our marketing materials, and volume-based agreements with several large provider networks. We are confident that this will drive stronger Cosella growth over the coming months. Given the lower Cosella sales momentum, I do want to comment on our expectation for the remainder of 2022. As I said, we feel confident in the actions that we have put in place to drive Cosella growth rate, and we intend to provide formal guidance as soon as we have enough data on performance and impact. We anticipate that we will drive growth in the fourth quarter of 2023 over the third quarter as these initiatives roll out. And we expect that they will be effective as we head into and through 2023. Thank you for your time this morning. We will speak again in this format on the fourth quarter and full year 2022 call. And as you've heard today, we'll have a variety of opportunities to communicate with you regarding initial data from our phase two and phase three trials at medical meetings starting later this quarter and continuing throughout 2023. And with that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask the question?
spk06: Thank you. Yes, at this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press the star 1 1 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. Okay, so our first question comes from the line of Gil from Needham and Company. Gil, your line is open.
spk09: Hi, good morning, everyone, and thanks for taking our questions. So maybe a first one for Andrew. I've never thought of small cell lung cancer as a seasonal disease. I mean, usually pretty aggressive. Patients go on therapy immediately. Can you explain kind of maybe the dynamics here?
spk12: Yeah, thanks, Gil. No, I mean, I agree with you. I think once diagnosed, obviously patients can progress faster. I think though there is a bit of a process in picking up those diagnoses and we do hear from healthcare providers that the presentation of the symptoms that lead to a diagnosis are more likely at different times of the year. We did find, as I said, in the patient claims data that we looked at for Q3 that are available so far, that that is far and true in those data, that there was a decline of around 10% in new patients receiving any type of therapy for extensive stage in Q3. And then, of course, it's just harder to get hold of healthcare staff during that period to promote the product as well. So it's really a combination of those external factors that led to fewer new patients going on Cozella in Q3.
spk09: Okay, that's helpful. And a couple of questions for Raj. First one, can you maybe put in context the significance of reducing AEs with the specific ADC that was tested? Do you think the tox will lead to, you know, does tox usually lead to reduced amount of treatment?
spk08: Hey, Gil. Yeah, so that's certainly what we're looking for in this study, right? So that model protection and better tolerability will allow greater exposure, which would then allow greater efficacy of Tredelvi. There was actually a paper presented at ASCO which showed a good relationship between exposure of Tredelvi to response. So that is exactly the rationale behind conducting the study. So we're encouraged by what we're seeing from a safety perspective so far.
spk09: Okay, and maybe a last one. So the activity of Priscilla in the gut, which you've mentioned briefly, is there additional evidence? I mean, diarrhea and gut-related tox, this is a very common dose-limiting toxicity across chemo.
spk08: Yeah, that's something that we've been following, actually. We've done some work ourselves. There was a paper published which showed that using inhibitor can actually reduce radiation-induced gut toxicity. And the hypothesis is that the stem-like cells in the intestinal crypt are dependent upon CDK4-6 for replication. So the similar protective mechanism that we see in the bone marrow could apply in the gut as well. You know, I think SN38, as you know, obviously causes a lot of diarrhea, and so we're encouraged by the early signs there. And as you also know, we pointed out in my remarks that arenotecan, which is, of course, the parent drug that gives rise to SN38 and is part of the full FOX3 regimen, also causes diarrhea in that regimen. So we'll be very interested to evaluate what happens to diarrhea in the colorectal trial also.
spk09: All right, thank you for taking our questions, and good luck on the rest of the year.
spk01: Thanks, Gil. Operator?
spk06: Oh, please stand by for the next question. Our next question comes from Dane from RJF. Dane, your line is open.
spk02: Hey, thanks for taking the questions. On the initial results that you're sharing today for the combination of trilocyclic ahead of Tredelvi, could you provide some more context for those 18 patients in terms of response rate in that cohort, how that compares to, I guess, the SENT study and or, you know, the number of cycles those patients had actually received of the ADC-based therapy, you know, and how that compares to maybe the, you know, median four cycles of therapy that they were getting, or median, sorry, six to seven cycles that they were getting in the SENS study. I think what we're looking for is just some way of comparing and understanding whether the table that you have presented today is within the context of drug exposure that the patients would have gotten in the comparable study. Thank you.
spk08: Yeah. Hey, Dane. Raj here. Yeah, so in terms of responses, we have seen responses in the study, first of all. You know, as I mentioned, the enrollment in the early part of the study was actually pretty slow. The first patient was enrolled in January, so we do have some long-term data to evaluate safety However, the bulk of the patients actually have come on in the last, say, three plus months. So it's really still early to make a true assessment of what the response rate could be. But clearly, as you know, toxicities like neutropenia and diarrhea do happen early on. And if enough patients have received enough cycles for us to make that assessment, and that was the reason why We thought it was important to put out these data. But ultimately, the goal, as you know and as Gil also asked, is to extend the duration of therapy on Tredelvi to allow us to not only potentially improve responses, although, as we mentioned before, we don't really anticipate seeing an improvement in responses based on the mechanism of action. It's really more on extending those longer-term events, such as PFFs.
spk02: Sorry to just follow up on that. What was the, for the 18 patients that you included in the preliminary safety dataset, what were the, you know, the criteria you used for including them in that valuable cohort in terms of exposure to sasituzumab goptigen? Thank you.
spk08: Yeah, patients have to have completed at least one cycle on therapy. And, you know, I'd received certainly the combination of Trilob plus Sassatuzumab.
spk02: Do you have a breakdown of how many patients were, you know, are included in that EE table that had more than one cycle of Sassatuzumab?
spk08: Yeah, actually the vast majority have had more than one.
spk02: Okay. And you can't disclose what, you know, the ORR is for that cohort. I don't think people are really looking for you to be better. They just want to make sure that for this AA table, it's comparable, which then validates the AA cross comparison that you're trying to make.
spk08: Yeah, as I said, I think there is a difference between exposure from a safety assessment and exposure from an efficacy assessment. Even though with Tridel, some of the responses happen early, like in the first cycle, there are significant number that happen with additional cycles. So I think it's really hard to make a call right now from an efficacy standpoint and response rate standpoint. I think the data would really not be mature. So all I can comment is we have seen responses, so we're encouraged from that perspective. And of course, we are interested in seeing that as well before we put out these data. Sorry, I can't directly answer that question.
spk02: Yeah, so let me ask you this way, which might be helpful to people on the line. You know, it sounds like to be comparable in terms of drug exposure of the ADC to a SEND, these patients, you know, the 18 patients that you have here still need more cycles of sasituzumab, gametekin. So plausibly, the AE table you're showing could go up in some of these rates. Do you have an idea of, for the comparison ultimately of the cohort, what you think is clinically meaningfully different for some of the key event rates, febrile neutropenia, thrombocytopenia, whatever you want to pick? That would be the target product profile that you're hoping for with this study.
spk08: Yeah. So, you know, as I mentioned, we've been following this safety data really right from the beginning, right? That's what you do in any trial. And so the rates for both the neutropenia and the diarrhea have remained relatively actually consistent with what we put out there with additional patients that have been enrolled. You're absolutely right. The numbers will definitely change with increased, you know, just with more patients in general and definitely with exposure potentially as well. But it has been consistent from the beginning. In terms of what are the most meaningful AEs where we would hope to show an improvement, it's really neutropenia and its consequences, including febrile neutropenia. Of course, I think diarrhea is a really intriguing early finding, I would say. And if you look at the... at the Sassatuzumab label, those are the two warnings on the label. So, you know, that's something else that we're following closely. Of course, we're encouraged with the effect on anemia as well, which speaks to sort of the multi-lineage early indicators of effect here.
spk02: Last question for me, just when do you expect to complete enrollment? Did I understand that correctly, that you have 21 enrolled now, so you'd still need 24 to hit the enrollment target in the study?
spk08: Yeah, we're talking approximately 40, but potentially even, yeah, and we're hoping by the end of the year that we'll have the required number of patients. And we'll present, as I said, the safety and the efficacy data set in the second quarter of next year. That's our target.
spk09: Thank you.
spk08: Sure.
spk06: Thank you, Dane. Please stand by while we bring the next question. Okay, our next question comes from Ed from H.C. Wainwright. Ed, your line is now open.
spk10: Good morning. Thanks for taking my questions. So you had mentioned in the third quarter the diagnoses were down. And it could be due to some seasonality. What is the historical trend for the fourth quarter as far as diagnosis goes? Do you have any of that information for small cell lung cancer?
spk12: Yeah, thanks, Ed. And I would say that the way we track it is through patient claims. So it's really patients going on to therapy for the first time rather than technically diagnoses. So it's patients going on to topside platinum with or without a tesolizumab that we track. Yeah, looking at seasonality, and it can be very month-to-month. For example, August was our best month launch to date within the quarter, within a relatively flat quarter. So it can certainly be very month-to-month. Looking back at Q4 of last year, we did show quarterly growth in Q4 of last year, I think of around 20%. But clearly there are periods, particularly towards the end of Q4, where there might be some seasonality. But overall, Q4 last year contained also some of our highest months at that point. So we believe with our improved capability in the marketplace that we have this year and with some of the new tactics that I've discussed, we're looking forward to a good Q4.
spk10: Okay, thanks, Andrew. And a couple of questions for Jen. R&D expenses were down the last two quarters sequentially. SB&A expenses were also down sequentially each of the last two quarters. I just wanted to know if we can get any of your thoughts on the fourth quarter.
spk04: Yeah, sure. Hi, Ed. Yeah, I would say I think we're going to be in line. I would expect R&D actually to be a little bit higher next quarter just because we're coming up on data readouts and there are some, as we, you know, do the stats and everything like that, that tends to add costs. But as these studies wind down, wind down but complete, we're just having sites and patients that we're not having to pay for anymore. So those costs will continue to come down. For SG&A, I would expect it to stay pretty in line with what we have, not anticipating any major changes there.
spk10: Thanks, Jen. And can you give us any guidance on cash runway?
spk04: Sure. So I think before we had given guidance into 24, I think in light of the fact that guidance was based on a couple of things, the utilization of the $25 million from Hercules, which we haven't pulled down yet, and also a continued sales ramp-up quarter over quarter. As Andrew just alluded to, we are seeing more variability in the sales line, so not giving guidance to 24 at this time, although we do have scenarios that get us there.
spk10: Okay. Thanks, Jen. That's all the questions I have. Thank you.
spk06: Thank you, Ed. Please stand by for the next question. Our next question comes from Anupam from JPM. Your line is open.
spk03: Hi, this is Malcolm Kuno for Autopart Morata. Thanks for taking the question. what are some of the key marketing hurdles or pushback that you're hearing in terms of getting new prescribers on board with Casella?
spk12: Yeah, thanks. You know, the barriers remain the same that we've been dealing with over the last year or so, which is, first of all, understanding the extent of the problem of myelosuppression because dose reduction has become chemotherapy treatment. We actually now have real-world evidence that's been presented at conferences and which is in our promotion which shows with thousands of patients in the real world the true extent of myelosuppression and it really is an incredible burden on patients with real consequences in terms of hospitalizations, et cetera. So we feel we're in a good position from a marketing perspective to tell that story. The next part is, you know, with many of these organizations, they do have complex processes to get a new product into consistent use. And so moving from trial to adoption usually involves going through a high-risk patient that may be the first patient that they trial with, seeing that benefit in that patient, and then wanting to use it with all eligible patients. To do that, you have to go through a formulary process, an EMR edition, order set edition, and it can take some time to work through that. And certainly in Q3, it was tougher to move from trial to adoption just because getting all of those staff members together, having all of those conversations means appointments, means taking time. And when staff aren't available to do that because of seasonal vacations or whatever, it could just slow the process down. And then finally, we have to make sure that we're persistent in our efforts because not many providers see a lot of expenses-based small-cell patients. So we have to get out there. We have to expand our peer-to-peer efforts. We have to expand our digital efforts. And we've actually made incredible strides forward over the last few months with that. Not only our digital efforts, but as I mentioned before, expanding our speaker bureau, having that first live speaker training. It was fantastic to see the energy in the room from our speakers. who have experience with Coachella as they really, you know, advocated with their peers for it. And we're looking forward to sharing their real-world stories too.
spk03: Great. Thanks for the background.
spk06: Thank you. Please stand by for our next question. And the next question comes from David from Wedbush-Catgirl. Your line is now open.
spk00: Hey, thanks for taking the questions. Two quick ones. First, could you remind us, was any other support agents, you know, the Neulasta or whatever, allowed for patients in the triple negative study? And then as a quick follow-up, in the Ascent study, Neulasta, I think, was allowed after the first cycle of Tredelvi Do you know if there are continued problems with neutropenia if you were to prophylax with GCFSF or what the rates might be of severe neutropenia in patients who might have a pretreatment with it? Thanks.
spk08: Hey, David, this is Raj. Yeah, so we allow supportive care, including growth factors and transfusions and so on. And you're right that it was also allowed in the ASCENT trial. I'm trying to recall what proportion received GCSF. I seem to recall around, yeah, I think in that kind of range. Yeah, so that's something clearly we're following as well in our study. But given the lower rate of neutropenia, we would expect that to be a lower proportion in the combination with Trilup.
spk00: Okay. And did any patients receive it so far in your study, GCFF?
spk08: You know, I am not aware of that.
spk12: Okay, thank you.
spk06: Thank you. Please stand by for our next question. And our next question comes from Choy of Cohen and Company. Your line is open.
spk07: Hi, everyone. Congrats on all the progress and thanks again for taking our questions. So I just have two questions on CRC, maybe one for Raj and then one for Andrew. So first, on the CRC data next quarter, can you just remind us of your expectations for the data and maybe like what level of neutropenia reduction would make you all feel excited? And then for Andrew, on opportunity in CRC, do you all have any idea how the top COSALA accounts compare to those in SELC? Do you all see a lot of overlap there? And if so, do you think you could possibly penetrate the market much faster given the established relationships that you already have at some of these centers?
spk08: Hey, Troy. This is Raj. So I'll go first. Yeah. So, you know, this is a Phase III trial, and we have obviously defined the – the stats in a way to see the reduction, right? So just to give you a context, for colorectal with Folfoxiri, based on the TRIBE data, we expect a grade four neutropenia rate in about the 20-odd percent rate. And the trial is designed to show a statistically significant reduction over that. And if we meet that, I think that's going to be clinically meaningful. So I hope that helps answer your question. And I think that would be exciting because, as you know, the major hurdle for continuing full FOX theory is really myelotoxicity. So if we're able to improve upon that, we believe that's going to be a benefit for patients.
spk12: I'll tip in on the second one. Yeah, so I do think there will be significant overlap, and that will be particularly in the community setting where community oncologists really see all comers. They'll have a specialist within the network or within the office, but very often they'll see multiple tumor types. I think in the academic centers, that will be a little different, and we will have to engage with them both through our medical affairs organization as well as commercially to be able to get to those folks. but I do think a lot of CRC is treated in the community, so I do think there will be overlap there. Also, you know, in terms of the speed of uptake, you know, probably the single biggest thing on the wish list of our COSELLA champions out there today is when are you going to get more tumor types? I want to be able to use this with more of my patients. And so I do think that we will see some early adoption in people who just become more familiar with COSELLA by having multiple tumor types in the indication. So, you know, our customers are telling us they're incredibly excited about our future potential, and we can't wait to deliver that value to them.
spk07: All right. Awesome. Thanks so much for all the color. That helps a lot.
spk06: Operator, are you muted? Thank you. My apologies. Our last question comes from Tony from Ross Capital. Tony, your line is open.
spk11: Thanks very much. Good morning. Raj, first of all, I've got just three brief questions. Raj, if we go back to the triple negative breast cancer data for TRODELVI, Treatment interruptions, if you just do the straight math from the label of the scent, are in 63% of patients, which lead to treatment interruptions in roughly half or 47%. If you actually run the numbers on the 18 patients, five patients would have at least would have that dose interruption. Is that why you're making the statements about a reduction in 50%. I'm trying to frame this correctly. That's question one, if I may. Question two is, Andrew, I believe in Q2 you made reference to sales reps having some level of increase in face-to-face contact. If I've characterized it correctly, is that the same in Q3? Has it increased? Are we in the fifth inning that you would have expected to occur or is it too early to say? And then finally, do you get data, is it only after the fact, on surgeries per center, or do you get it as granular as the type of surgery per center when you look at your data on a quarter-to-quarter basis? Thanks very much.
spk08: Hey, Tony, this is Raj. So, yeah, I mean, I think that's certainly dose delays, dose reductions is something we're following very closely. Obviously, ongoing study, but we're encouraged by what we've seen to date, I think is all the color I can provide at the moment.
spk12: And I'll check then, Tony, on the, yeah, so face-to-face is over 70% of our engagements are face-to-face. It has gone up markedly since we introduced our new sales team, which is fantastic. Really interesting, I didn't mention it before, but although we saw access to customers a little bit limited in Q3 because of those seasonal variations, our share of voice actually remained stable during Q3. So that basically means that all companies have limited access to customers during that period, which again lends itself to the fact that there's some seasonality there. But overall, we've been very, very pleased with the ability of our folks to get to customers and have substantive face-to-face discussions. In terms of the last question, I'm not sure if I was quite tracking with you, and maybe Raj can answer it, but we don't track any kind of surgical procedure data in our commercial setting.
spk11: But you alluded to the fact that muscle lung cancers were down 10% in Q3. Is that the way Am I correct? Did I correctly hear that? So you had to actually track something that has information about surgeries. Whether or not it's diagnoses or otherwise, I assume all these patients would have surgery.
spk12: Great point. Thanks for the clarification. Actually, so it's based on claims data for etoposide platinum with or without epizolizumab. Okay. And without the presence of a diagnosis of extensive stage, and the vast majority of uses for that regimen is obviously extensive stage. So that's how we judge that. So it's basically a paid claim for that regimen. We'll tell us how many new-to-line patients are existing in the marketplace, but it's not related to the surgical procedures that would accompany that.
spk11: I understand. Thank you very much.
spk06: Thank you, Tony. I would now like to turn it back over to the CEO, Jack Bailey, for closing remarks.
spk01: Thank you, Operator. As always, we look forward to keeping you all updated as we progress. Certainly, thank you for joining us today. Please stay well, and we'll be in touch.
spk06: Thank you so much. This now concludes the call, we will now disconnect
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