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spk08: Hello, and welcome to the Avail Oncology fourth quarter and full year 2021 financial results and 2022 guidance conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Hans Witzhum of LifeSci Advisors. Hans, please go ahead.
spk10: Thank you, Operator. Good morning, and thank you all for joining us on today's call to discuss Aveo's fourth quarter and full year 2021 financial results and 2022 guidance. I am joined today by Michael Bailey, Chief Executive Officer, Mike Ferraresso, Chief Commercial Officer, Eric Lucera, Chief Financial Officer, and Jeb Liddell, Chief Operating Officer. Before we begin today's call, let me remind you that during this discussion, we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to important risks and uncertainties, including those that are detailed in today's press release and in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC. that may cause actual results to differ materially from those results expressed in such statements. Furthermore, we caution you that these forward-looking statements represent our views only as of today, and we do not assume any obligation to update these statements, whether as a result of new information, future events, or otherwise, except as required by law. With that, I will now turn the call over to Aveo's President and Chief Executive Officer, Michael Bailey. Michael?
spk04: Thank you, Hans, and thank you to everyone for joining us on today's call. We're excited to share with you the continued progress we made across our portfolio during the fourth quarter of 2021. This past quarter capped what we believe was a successful and especially important year for Aveo, with the launch of our first commercial product, Batibda, or Tivozanib, for patients with relapsed refractory advanced RCC. The fourth quarter of 2021 marks our third full quarter of Fitib to Sale since its launch on March 22, 2021. The past few quarters have been busy as we focused on successfully executing our U.S. commercial strategy, which included hiring and training field teams and building commercial infrastructure, including distribution, patient access, and reimbursement. As a result of the team's execution on the strategic launch plan, we have experienced a steady increase in commercial uptake of Petibda. This positive momentum continued in the fourth quarter as we saw a 26% increase in prescriptions filled in this quarter compared to the third quarter. Once again, achieving our quarter-over-quarter revenue growth goal. We are pleased with these early results and believe that TIVDA's commercial performance to date validates its potential to serve as a standard of care for relapse refractory advanced RCC patients. As we previously indicated, the restrictions related to the ongoing COVID pandemic have impeded our ability to gain in-person access to customers, prescribers, and other healthcare professionals. We believe these access challenges have caused a protracted launch curve to date compared to the pre-COVID open access environment. However, we expect continued quarter-over-quarter growth and remain confident that Fatigda has the potential to become the third and fourth line RCC standard of care. I'd like to conclude my comments on Fatibda's commercial launch by announcing that starting in December 2021 and continuing through January 2022, Fatibda took a leadership position in the share of third and fourth line RCC new patient starts, according to Guy Cubia's brand impact report. As Mike Ferraresa would discuss in detail, this move for Fatibda to earlier line patients is an important part of our long-term strategy as it signals that Fatibda is being more broadly adopted by oncologists for third-line patients, which may also result in an expansion in the average treatment duration over time. As we look towards 2022, we're now in a more informed position to provide U.S. revenue guidance. Specifically, we currently expect to achieve 2022 net sales revenue of Fatibda between $100 to $110 million. Turning to our product development pipeline, we've issued several exciting clinical announcements recently, including positive clinical data updates for TIVDA at both ASCO-GU in February of 22 and ASCO-GI in January of 22. At ASCO-GU, we presented five-year follow-up data for progression-free survival and overall survival from our TIVO3 trial. These data show over five times the PFS rate for tavozinib versus serafinib at the three- and four-year landmarks. Importantly, this prolonged progression-free survival benefit has resulted in the continued improvement of the OS hazard ratio, which now stands at 0.89. At ASCO GI, we presented top-line efficacy and safety data from our Phase II deductive trials. This cohort consisted of 20 patients with advanced unresectable, previously untreated liver cancer, or HCC, who have not previously received treatments. Patients in this cohort were treated with a combination of 0.89 milligrams of tavozinib plus durvalumab. These top line results demonstrated that the combination of the 0.89 milligram of tavozinib and durvalumab was well tolerated, and demonstrated a 28% partial response rate with a median progression-free survival of 7.3 months and a one-year overall survival rate of 76%, which we believe positioned the combination well relative to other VEGF immune checkpoint inhibitor combinations in this setting. In conclusion, we believe these new data further support the future development of Tivozanib as an attractive VEGFR TKI for use in combination with Dervolumab in first-line advanced unresectable HCC patients, as well as provide further evidence of Fatibda's activity and selective profile that conveys the potential to reduce off-target toxicities. The deductive trial is currently enrolling a second cohort of patients that have previously received treatment with bevacizumab and atezolizumab. We expect this cohort will enroll another 20 subjects. We believe these data present an opportunity to generate the first clinical trial data in the emerging population of advanced unresectable HCC patients who have previously been treated with bevacizumab and atezolizumab. We recently amended the dosing in the Tenevo 2 trial to now use the 0.89 milligram Tobozanib dose in the combination arm. This change is based in part on the promising HCC-IO combination results I just covered using the 0.89 milligram dose of Tobozanib to optimize the potential risk-benefit profile for Tenevo, which we believe is also consistent with the FDA's recent guidance for companies to investigate optimal combination dosing. In addition, we recently entered into a clinical trial collaboration and supply agreement to evaluate Tobozonib in combination with NKT2152, NICANG's novel HIF-2-alpha inhibitor. which is an emerging target of interest in RCC. We believe that this new collaborative initiative with NICANG has the potential to further establish Fatibda as the combination VEGFR TKI of choice, and importantly, will only slightly increase our 2022 Tivozanib R&D spend. Eric will provide additional color on the 2022 OPEX guidance in a moment. Turning to phycotuzumab, We believe this asset is well positioned to potentially address the significant unmet medical need that exists for patients with HPV negative recurrent or metastatic head and neck cancer. A patient population is prognosis is very challenging. After being granted fast track designation by the FDA in the fourth quarter of 2021, We announced in January that we have entered into a clinical trial collaboration and supply agreement with Merck KGA Darmstadt, Germany, to evaluate ficletuzumab in combination with erbitux or cetuximab, an EGFR-targeted antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma. We also recently announced that we have started scaling up the manufacturing for ficletuzumab and expect to complete manufacturing drug substance for the clinical supply in the second quarter of 2022. This initiative will be followed by standard drug stability studies and drug preparation of the final clinical trial materials, which we expect will enable the initiation of the potential registration clinical trial in the first half of 23. In the meantime, the company expects to finalize the potential pivotal clinical trial design in consultation with the FDA, as well as to continue ongoing partnership discussions. For AV380, our anti-GDF15 antibody, we completed the enrollment of the healthy subject study in the fourth quarter of 2021. Initial data observed satisfactory drug safety and a reduction in the GDF-15 in subjects, and there were no drug-related adverse events identified. Though operational errors at the trial site caused data integrity concerns and are being discussed with the FDA to confirm the suitability of the data for regulatory purposes and our ability to publish the data from this trial. We do not expect the data quality issues in the Phase 1 clinical trial to impact our plan to initiate a Phase 1B clinical trial in cancer patients during the second half of this year. Finally, we recently announced a preclinical collaboration with Actinium to potentially expand our portfolio of oncology assets by creating a new ERBB3 antibody radioconjugate, or ARC. We believe in addition to the progress with the Fatibda launch, we continue to successfully advance our pipeline efforts to support future growth. In order to help manage the development of our pipeline in December, we appointed Jeb Liddell as Chief Operating Officer. Jeb is responsible for overseeing operational functions key to maximizing our organizational efficiency, advancing our pipeline, and escalating our strategic partnering initiatives in support of our three wholly owned antibody clinical stage product candidates. I am pleased to report that we believe that he has already made a positive impact on the company over the past few months by leveraging his experience leading organizations through changes in scale and that he is a valuable new member of the executive team. I'd like to now turn the call over to Mike Ferraresso to walk us through more detailed commercial update including fourth quarter 2021 metrics. Mike?
spk11: Thank you, Michael. As Michael mentioned, we continue to be encouraged by the commercial launch of Fotivda, and I'm excited to share with you results from our third full quarter of sales. For the fourth quarter of 2021, U.S. net product revenue was 16.8 million, which reflects a 17% increase in U.S. net product revenue from the third quarter. For calendar year 2021, U.S. net product revenue was 38.9 million. Finally, during the fourth quarter, we recorded a total of 780 commercial prescriptions, representing a 26% increase in commercial prescriptions compared to the third quarter. During the fourth quarter, we added approximately 73 new accounts, bringing the total number of accounts to 333, an increase of 28% compared to September 30th, 2021. These FOTIVDA prescribing accounts represent over one-third of the RCC market potential. As Michael indicated, from the end of the fourth quarter and in early 2022, we see a notable increase in the FOTIVDA share of third-line new patient starts as recorded by IQVIA brand impact. From 10% in November to 25% in December, and continuing to grow in January. This increase has put us in a leadership position for new patient starts in our target population, representing positive progress in our goal of becoming the third-line standard of care in relapsed refractory RCC. In terms of outreach, we believe our teams are executing well, and we're seeing steady progress towards reaching all of our key customers in person or using technology to engage them remotely. In addition, we have supplemented the field sales team's efforts with extensive marketing outreach, peer-to-peer influence opportunities, and social media initiatives in order to increase awareness in areas facing access restrictions. Looking ahead, we expect to continue to invest in these strategies as well as emerging opportunities to enhance our awareness and utilization. We have already achieved a leading share of voice in the relapse refractory RCC setting as reported by Acuvia, which we believe is a positive reflection of the effectiveness of our efforts. In closing, we continue to be pleased with the significant progress that our commercial team has made since launch and the encouraging reception Fotivda has received from oncologists, patients, and the broader medical community. We look forward to updating you on our continued progress over the coming quarters. I will now turn the call over to Eric Lucera to discuss fourth quarter and full year 2021 financial results. Eric.
spk12: Thank you, Mike. Total net revenue for the fourth quarter of 2021 was $17.6 million, with U.S. net product revenue of $16.8 million. Selling general and administrative expense for the fourth quarter of 2021 was $15.7 million, a level consistent with the prior three quarters and compared with $9 million in the fourth quarter of 2020. Research and development expense for the fourth quarter of 2021 was $6.1 million compared with $4.6 million in the fourth quarter of 2020. Total revenue for the year ended December 31st, 2021 was $42.3 million and U.S. net product revenue was $38.9 million. Selling general and administrative expense for 2021 was $60.8 million compared with 22.2 million in 2020. Research and development expense for 2021 was 26.3 million compared with 22.7 million in 2020. Looking into the new year, we expect our commercial spending levels outside of R&D costs to remain relatively constant for 2022. Specifically, we expect commercial spend for 2022 to increase slightly over 2021 to approximately $50 million, reflecting the full year expenses of the commercial launch as compared to only three quarters of 2021. Gross margins are expected to remain in the mid to high 80th percentile. In addition, we expect general and administrative expense to remain flat at approximately 20 million for the year. In terms of our R&D expense for the year, we expect that to be in the range of 60 to 70 million for 2022, as this increase reflects increased clinical trial activity for the year. As Michael Bailey mentioned earlier, we currently expect to report $100 to $110 million of U.S. Fatibda net revenue in 2022, more than double of what we achieved in the three quarters of our 2021 launch. With the achievement of the sales milestone in December for the Hercules debt facility more than a quarter before the April 1st, 2022 deadline, we drew down the additional $5 million trounce on the facility, resulting in a total debt of $40 million. We are pleased to share that we ended the fourth quarter of 2021 with cash, cash equivalents and marketable securities of $87.3 million compared with $61.8 million at December 31st, 2020. We believe our existing cash, cash equivalents and marketable securities as of December 31st, 2021, along with our expected U.S. net product revenues from the sales of Fatibda, will enable us to maintain our current operations for a period of at least 12 months following the filing of our annual report on Form 10-K for the year ended December 31, 2021. A full overview of these results for the fourth quarter of 2021 is available in our annual report on Form 10-K. I will now turn the call back over to Michael Bailey. Michael.
spk04: Thank you, Eric. To close, we believe we are well-positioned for continued success with the commercial launch of Fatibda here in the U.S., as well as the clinical advancement of Tivozanib combinations in our pipeline products. We look forward to providing updates on our progress in the coming quarters as we continue on our mission of improving the lives of patients with cancer.
spk13: We'll now open the line to Q&A. Operator?
spk08: Thank you. And I'll be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment, please, while we poll for questions. Our first question is coming from Stephen Wiley from C4. Your line is now live.
spk06: Yeah, good morning, guys. Thanks for taking the questions, and congrats on the quarter. Maybe just a quick one on guidance first. So I know you did 17% sequential in the fourth quarter. It appears like the midpoint of the range is applying somewhere around 20% sequential growth throughout 2022. So not sure what you can tell us with respect to just what's assumed in there with respect to account growth, COVID restrictions in terms of how that impacts access. I guess just any commentary to provide that would be helpful.
spk04: Hey Steve, thanks for the question. I'm going to turn over the guidance question to Eric and then Mike can talk a little bit about any access and the follow up. Eric?
spk12: Yeah, I think with respect to the guidance assumptions, most of the commercial assumptions can be handled
spk11: by Mike Ferresso, but I think you're sort of generally correct in sort of thinking about how it should build over the year. Mike? Yeah, thanks, Eric, and thanks for the question, Steve. And so we now have three full quarters of launch trajectory behind us, so that really helps us to see how we can project forward. As was mentioned earlier on the call, we also have some leading indicators, which I think really encourage us in the progress going forward. And in particular, our areas of focus have been increasing our prescriber base, and we continue to make good progress there. Over a third of the RCC market is now covered by our prescribers. And moving into the third line setting, as we had guided previously, a lot of our early patient trials was in a very late line setting. And we don't think the performance of those patients is indicative as far as their duration on the drug of where we can go. And we're very pleased to see that we have now a leadership position, a new patient starts in the third line setting. And again, that's very much a leading indicator. Our total patient share in the third line setting is still modest, but we are now leading the new patient starts. And so if we can maintain that over time, which we believe we can, we will become the share leader there. So again, it's a combination of the great amount of history we have now to project forward as well as the leading indicators that give us confidence in these numbers.
spk06: Okay. That's actually very helpful. And just a clarification question, I know you spoke about the 0.89 milligram dose being optimal. So you said that's being now included into the Tenebo 2 protocol?
spk04: Yes, Steve, that's correct. We've modified or amended the protocol to go to the 0.89. And as I mentioned in the previous statement, that's based on a couple of things. One is the data we've seen in the deductive trial at the 0.89 in combination with Dervolumab. has shown activity that's on par, if not better, than the other VEGF combinations in full dose with a better tolerability profile. I'll also add, just as a point of reference, if you look at the CABO-NEVO Checkmate 9ER study, in the first line, they were using a reduced dose. Also, they had very positive results. They established them as a share leader in the first line of RCC. So, A couple of data points that I think are important to consider. Overall, we believe this will optimize the risk-benefit profile for the combination and second line, and will further establish TiVo as the best-tolerated agent. Think about this relative to the full-dose Cabo and Tezo in the contact O3, which will likely have lots of dose reductions and interruptions. Related to that, the FDA has recently announced Project Optimus, which is their effort to improve the risk-benefit for combinations by optimizing dose. We believe this change is very consistent with that. Importantly, though, the thing I want to make sure we all recognize is the control arm will remain at the 1.34 and the higher dose of tabozidine. And overall, just from an operational perspective, this change should have minimal impact on the enrollment time since we're just at the beginning of the study and we're initiating sites.
spk13: Okay.
spk06: So, have you had to pause enrollment to push the amendments through each trial site, or has this been a pretty seamless integration of an alternative dose?
spk04: No, we have paused enrollment. Importantly, we had two patients enrolled today. Both were on the single agent arm, so there's certainly no safety signal here. This is just really what we believe will optimize the
spk03: the combination dose and will be very consistent with Project Optimist, which the FDA just recently actually did a big symposium on last week.
spk13: Understood. Thanks for taking the questions.
spk08: Thank you. Next question is coming from Swayam Pakula Ramakant from H.C. Wainwright. Your line is now live.
spk09: Thank you. Good morning, folks. Congratulations on I'm in a strong quarter and glad to see the bullish sentiment going forward. In general, I know most of your scripts have been in the fourth line and you're starting off to see new starts in the third line. But to date, what has been the average duration of treatment seen in the market?
spk13: Thanks for the question, RK. I'm going to turn that right over to Mike.
spk11: Yeah, thanks, RK. Great question. So as we look at our history now with only three full quarters of launch, the majority of our patients are less than six months old. So in TiVo 3, as you recall, the average duration was greater than a year with about 20% still progression-free at two years. So with such a short history, it's really too early for us to calculate duration. Now, that said, I think we have some really important information we've shared, and it's in our corporate deck that's live now, is that we did see more early drop-offs, and we define that as patients who discontinued after just one cycle. In the first two quarters of launch, so in Q2 and Q3, the rates were 24% and 27%. And in Q4, this early drop-off rate improved 14%. And we really think this is very likely due to the late-line patient trial in our initial launch. And now that we're seeing these new patient starts in the third line and taking that leadership position, we expect going forward these results in the future to be closer to the TiVo 3 experience. Okay, perfect.
spk09: And then on the Salesforce efficiency part, Do you see that at this point, is it optimum? And also with some of the areas of the United States opening up, do you need to add additional sales force than what you have currently? Which I would imagine, especially with with the encouraging adoption that you have been seeing recently?
spk03: Yeah, okay.
spk04: Again, thanks for the question. And I'll just start by saying we're very comfortable with the organizational size and the field force we have.
spk03: Mike's pointed out some of the key metrics, and I'll turn it over to Mike to just provide a little more color.
spk11: Great. Thanks, Michael. So, yeah, RK, we're really pleased with our oncology account manager team, our field sales team. we've maintained a leading share of voice in the relapse refractory RCC setting. So that really tells us that we have the right size team. It also tells us that we've gotten really creative in our promotional mix and continue to enhance our non-personal promotional efforts and getting more tools to the field team as well for non-personal engagement. So we're really pleased in our ability to execute where things are access restricted. We're also very excited that we do believe things are going to start opening up. Just recently, we had a pretty significant team at ASCO-GU finally engaging with the thought leaders in person. ASCO in June will be in person. So that really opens up a lot more opportunities for us as well. So we built this team to be right size for when things do open back up. And we also built this team to have the capabilities to have it as we have a leading share of voice when we do have access restrictions.
spk09: Okay. Thanks, Mike. One last question. You certainly made remarks on the new starts and the leadership position that Fatuida is gaining, but what's your commentary on the refills, on the refill status of the current patients?
spk13: I'm sorry, RK, is that a duration question or?
spk09: Or like, no, what percentage of patients are coming back for refills?
spk04: Oh, refills. Okay. Mike, you want to try to tackle that?
spk11: Yeah, okay. I think the best I can do is refer back to the early discontinuation rate that we've put out there now. So, as we initially had shared and we shared in our release in January, the majority of our initial patient trial was in very late line patients. So beyond fourth line, many of these patients. And so we did see a much higher portion of them discontinue after one cycle. So essentially our take is they were probably beyond the benefit of any treatment at that point. And so as we're moving into the earlier line, as we're seeing from the IQ via data, starting in December and continuing the latest report through January, we're seeing a corresponding decrease in that drop-off rate. So with a 14% early drop-off rate in the fourth quarter, that means the balance of those patients, 86% went on to get refills. And it's going to take us a while to answer the overall question you asked earlier. I know duration is a key question for all of us, but we just need more time, especially as we're having a shift in our patient population. it's going to take a fair amount of time with a fair amount of patients on treatment to really see where the average comes out because we believe we will see, as we did in our clinical trials, a pretty significant tail of the curve in patients who benefit from TIVDA for a very extended period of time.
spk09: Thank you, folks.
spk13: Thanks for taking the questions. Thanks for the questions, R.K.
spk08: Thank you. As a reminder, that's star 1 to be placed in the question queue. Our next question today is coming from Colleen Cousy from .
spk05: Hi, good morning. Thanks so much for taking our questions, and congrats on all the progress. So looking at 4Q, you had 17% revenue growth and 26% increase in script volume. So can you maybe comment on pricing in the quarter or any other pushes and pulls we should be thinking about?
spk13: Hey, Colleen. Thanks for the question.
spk04: I'll turn that over to Mike just to talk about that increase.
spk11: Sure. Thanks for the question, Colleen. So the main driver of the difference you see in those growth rates is inventory levels. So we added very little inventory in Q4 compared to Q3. And we expect our inventory levels to remain lean. They basically fluctuate between two and four weeks supply on hand based on the launch ordering patterns we've seen to date. The other thing that can have an impact quarter to quarter is the timing of the title transfer. So if we get an order right at the end of the quarter, the scripts can show up in one quarter, but the delivery date or the title transfer may happen a day or two later and can fall into a subsequent quarter. So there should be minor differences, but generally our growth to net was very stable between, so that's really the driver's going to be inventory level.
spk03: Yeah, and Colleen, you saw a little of that, obviously, in 2021.
spk05: Great, thank you. That's really helpful. And looking to 2022 now, so there's going to be an increase in R&D this year. Can you just talk about how you're prioritizing investment across the different programs in your pipeline?
spk02: Sure. Eric, do you want to talk about that guidance I can fill in afterwards?
spk11: Yeah, I'd say just in terms of the delta from last year to this year, there's about – initial $10 million for the Ficletuzumab manufacturing that we mentioned being pushed out from last year to this year. As you're aware, we're running the Tenevo 2 trial, which we previously disclosed is about a $40 to $45 million trial over three, maybe four years. And in the prior year, we only had about one quarter of that.
spk12: So you can think about that annualizing into this year. We also have incremental investments in 380 in terms of some milestone payments that we're going to make and some drug supply costs for potential trials at the end of the year.
spk11: And then as we mentioned earlier, just some minor things. But that should be able to reconcile you from last year's spend to this year's spend. And I think Michael can talk about how we prioritize the spending.
spk04: Yeah, Colleen, I think one of our key initiatives here in 2022 and beyond is really moving up in lines of treatment in kidney cancer with combinations. And that's a Cenevo 2 study, and that's probably our biggest spend. But, you know, we'll continue to spend on the deductive, again, showing that Tevo is the best combination drug to use with immunotherapy. And furthering that with, you know, the collaborations with NICANG, Again, with their HIF-2 alpha. So really, our big initiatives here this year with regard to TiVo are continuing on that combination work, establishing us as the combination of choice. But as Eric also pointed out, cyclotuzumab, getting ready for a potential phase three study is a really important initiative. This year, the primary cost around that is going to be manufacturing. We're in current dialogue with various collaboration partners or partnerships for specifically looking for the ex-U.S. territories. Certainly that could play a role in the overall expense that we end up committing to a phase three study.
spk03: But as we've guided, we don't expect to start that study until the first half of 23 after finalizing discussions with the FDA and hopefully finalizing a partnership.
spk05: Okay, great. Yeah, my last question was going to be on cyclotuzumab partnerships, but it looks like you actually touched on that in that answer. So I think that's it for me. Thanks so much for taking our questions.
spk03: Well, that's fantastic, Eileen. Thank you for the questions.
spk08: Thank you. Our next question today is coming from Sumit Roy from Jones Research. Your line is now live.
spk01: Hi, everyone. Congratulations on the commercial development. A quick question, if you can give us a little color on – Like the prescription growth, how many were new versus how many were refills? And what percent growth are you seeing? Is it primarily in the community centers or more established, larger academic centers? That would be great.
spk13: Super. Thanks for the question. I'll turn that over to Mike again.
spk11: Hi, Sumit. Thanks for the question. I don't think I can break down the script growth quarter over quarter into new versus refill. I think what's important for us from a forward-looking trend is that we are seeing that we now lead the new patient starts in that third line setting, which is, again, a recent development just starting in January, December, and continuing to the latest January report. Again, we just don't have it broken out that way. As far as where we're seeing the growth, We're continuing to build our base. I think the fact that we've got a little over 330 accounts on board, about 3,000 targets out there, they represent about a third of the market potential, tells you that a lot of the larger centers who often are aware of new products sooner, a lot of the thought leaders are there, we're a bit, I guess, weighted towards those clinics that have more of the patients at the moment. But we're continuing to see growth and very excited to continue to build out our base as well as move into earlier lines, which is going to increase our duration of therapy, we believe.
spk01: Great. Thank you. And the last question is, on the deductive, the second line HCC trial where patients are being enrolled prior have asked in the TESO, when should we expect that data? Is it year end 22 should we expect or more like first half 23?
spk04: Yeah, thanks again for the question. Our expectation is that we would complete enrollment of that second cohort by the end of 22. So we'll probably be reporting that in the first half or middle of 2023.
spk01: Perfect. Thank you for taking the questions. Congratulations again.
spk13: Thank you.
spk08: Thank you. Next question is coming from Andrew Behrens from SVB Lyric. Your line is now live.
spk07: Hi, thanks, guys, for taking the question. Appreciate all the color. I guess I'm just trying to understand, I think you said 25% market share is where you guys are at now. Can you just give us some color on that? I'm trying to understand what that means for the overall size of the market. It still sounds like it sits around $300 million, which I think was the original guidance you gave before the drug got launched. And I guess since we don't know the duration question yet, Are you seeing patients that were traditionally not addressable coming into the market now that Tivo is available? I think that number was at 50% originally. So are you seeing the addressable market expand? Thanks a lot.
spk04: Yeah, Andy, great questions, and thank you for that. I'll just tackle one thing. We haven't given the 25% share. It is not guidance we've given or reported. Mike was talking about that.
spk03: new patient share, and I'll turn it over to Mike to add some color to that.
spk11: Yeah, great questions, Andy. So from the share perspective, and you can see this in our updated corporate deck, where we're leading now is in the share of new patient starts, and so that's newly presenting third-line patients, and that's where in December we had a 25% share of They also report from IQVIA total patient share, which is a combination of patients who are ongoing treatment as well as those who are just initiating. And our share there was only 6% in December. So if we can maintain the 25% or the leading new patient share over time, our total patient share will catch up to that number. So we don't want anyone to think we have a 25% total market share right now. We think the opportunity is very significant for our growth there. And your question about the addressable market size, so it's going to take time to see this play out, but we can say that Decision Resources, which is where we got the 50%, they updated their metrics a little bit toward the end of last year, and they're now reporting 58% of the growth third and fourth line plus patient population is going on to active treatment. So we can't say if we can fully take credit for that, but we do believe, especially given a lot of the patients we saw get the initial trial, that we're pushing hard here. We think we're a big part of it, and we hope to continue to improve that rate in the future.
spk04: Yeah, just to add a little more detail on that. I'm sorry, Andy, just to add a little more detail on that and link it to the 300 million number you referenced. Previously, Decision Resources had said the third-plus market was worth about $350 million.
spk03: The update that Mike talked about increased that to $480 million for 2022. So consistent with what we've been guiding.
spk13: Right.
spk07: Okay. I appreciate that. And then just on the dosing changes, what is the – Is there any specific toxicity that led to a decrease in the dose in the combination? No, Andy.
spk04: There was no toxicity we saw in the Tenevo 2 study. As I mentioned earlier to Steve's question, we only had two patients enrolled in the study. Both were on the signal agent 1.34 arm. So this is purely a strategic decision that's based on the growing body of data that shows that you really probably don't need the high dose. And, again, as you said, it's very consistent with the FDA's current Optimist program where they're really looking for industry to really kind of balance out that risk-benefit in considering combination doses in particular.
spk13: Okay. Thanks a lot. Appreciate it. Sure. Thanks for the question, Danny.
spk08: Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to management for any further closing comments.
spk04: Well, thank you very much, and thank you all for joining us today. We appreciate your continued support, and we look forward to updating you all on further progress in the coming quarters.
spk08: That will conclude the call. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.
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