Full Year 2022 ADC Therapeutics SA Earnings Call
Speaker 1: You.
Speaker 2: Welcome to the ADC, Therapeutics, Fourth Quarter, and Full Year 2022 Financial Results Conference call. My name is Andrea and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session.
Speaker 2: During the question and answer session, if you have a question, please press star, then one-one on your touch tone phone. I will now turn the call over to Amanda Lashba, Investor Relations Manager. Amanda, you may begin.
Speaker 3: Thank you, operator. This morning we issued a press release announcing our fourth quarter and full year 2022 financial results and business updates. This release is available on the ADCT website at ir.adcsarapeutics.com under the press releases section.
Speaker 3: On today's call, Amit Malik, Chief Executive Officer, Kristen Harrington-Smith, Chief Commercial Officer, Nohamed Baki, Chief Medical Officer, and Pepe Camona, Chief Financial Officer, will discuss recent business highlights and review our fourth quarter and full year 2022 financial results before opening the call for questions. Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meeting of the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include those related to our future financial and operating results.
Speaker 3: strategic partner products, future strategic partnerships and business development efforts, and our ability to repay our outstanding debt obligations. These forward-looking statements are subject to certain risks and uncertainties and actual results could differ materially.
Speaker 3: They are identified in this page in today's press release in the accompanying slide presentation on slide two and in the company's filings with the SEC on form 20 and is updated in ADCT recent periodic filings on form 6. ADCT is providing this information as of the date of today's conference call and does not undertake any obligation to update any four of those students. Sentin this conference call as a result of new information feature events or circumstances after the date here of except is required by law or otherwise.
Speaker 4: The company's costions investors not to place undue reliance on these forward-looking statements. Today's presentation also includes non-IFRS financial measures. These non-IFRS measures have limitations to financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. You should refer to the information contained in the company's fourth quarter and full year earning through these for definitional information and reconciliation of historical non-IFRS measures to the comparable IFRS financial measures. It is now my pleasure to pass the call over to a meet malloc, a meet. Thanks Amanda. Thank you all for joining us today. 2022 was a year of evolution for ADC therapeutics. A year in which we laid the groundwork to help optimize the launch of potential, prioritize our pipeline, strengthen our leadership team, and bolster our capital position, all with the intention of elevating the company to the next level. We are now positioned to execute our strategic initiative in 2023 and unlock the tremendous on-top value of the company. We expect to see this value unfold through our three core pillars of growth, maximizing the Zalanta opportunity, advancing our PVD-based pipeline, and expanding our ADC platform. Beginning with the highlights of the quarter, Zalanta and FALES were $19.8 million in the fourth quarter.
Speaker 4: Additional opportunity through partnerships X us regarding geographic expansion we were very pleased to season launch to receive approval in December on the European Commission and the U K MHRA for the treatment of relaped or refractory DLBCL subsequently on February seventh our European partner sobe received conditional marketing authorization we are encouraged that the team has making good progress and expect sobe to launch in Europe in the.
Speaker 4: opportunity for Zimbata. We made the decision not to pursue further clinical development of Kami on our own, but instead to seek a partnership based on its positive phase 2 data. We are strategically advancing the rest of our portfolio programs and Mohammed will provide a more detailed update in a few minutes. Touching briefly on the financials, at year end we have a strong balance sheet with $326 million in cash, and with the anticipated milestone payments and lower operating expenses, we expect our cash one way to extend into mid 2025. Moving to recent corporate events, and as disclosed in regulatory filings, our largest shareholder, Auburn Therapeutics, completed a secondary sale of a significant portion of its holdings to meet a debt obligation. The secondary offering of 12 million shares was placed in the hands of high-quality investors and has allowed us to broaden and strengthen our shareholder base. Following the completion of the transaction, Auburn Therapeutics has decreased from approximately 28% of our outstanding shares in December to roughly 8% after the offering, and its remaining shares are locked up for 12 months. The high level of interest shown by top-tier investors during the process was especially encouraging. Last but certainly not least.
Speaker 2: And in particular, in doing a few things really well. We are focusing our cross-functional team on three key imperative.
Speaker 3: One, driving awareness of the loss of differentiate profiles. Two, educating physicians to optimize the patient's benefit. And three, continuing to build advocacy with key thought leaders focusing on clear patient To executing on these three aspects of our strategy, I believe we will capture the opportunity for growth in the third line, third line process setting, both in the near term and over the longer term, recognizing the situation marathon and not as firm.
Speaker 3: Let me now spend a moment expanding on each of these three elements of our strategy. Starting with driving awareness, Zunwanda has a uniquely differentiated product profile which we believe positions it to become the standard of care in the third line, third line plus setting. First, it has strong single agent activity. It's associated with a rapid time to respond with a median of just 41 days. It has a manageable safety profile with no cytokine release syndrome and a low incidence of neuropathy. Lastly, it has a relatively patient-friendly administration schedule requiring a 30 minute infusion cycle once every three weeks. The second strategic initiative is to educate physicians and nurses on the process to offer dosing to achieve the best clinical outcome for patients and the manageable safety profiles in Zunwanda, what to expect and how to mitigate potential adverse events. We believe Zunwanda's safety profile is favorable in the third line, third line plus setting, and we need to keep reinforcing this important message. Lastly, we need to work closely with our thought leaders and for them to educate and share their Zunwanda experience with their peers in the community. The third line, third line plus setting landscape is increasingly complex with the availability of new innovative options. Now more than ever, the community is looking to the thought leaders to help identify the best options for post-carcuitations and for those who don't get to carcass.
Speaker 3: As a reminder, community centers account for roughly 60% of the few large B-cell and phoenix patients' volumes as compared to 40% in the academic centers where Zanlanta is mainly prescribed today. Taking a closer look at the academic versus community settings, we have already established a strong foundation in the academic center. Here around 80% of accounts have experienced with Zanlanta. Our focus will be on driving utilization in the post-carte patient since approximately 60% of these patients will unfortunately relapse. The bigger opportunity for us is in the community, where we have the potential to drive much greater breadth of experience. At the start of 2022, roughly 25% of community accounts had tried Zanlanta and we grew that to almost 35% by the end of the year. Based on the differentiated profile I discussed earlier, we believe Zanlanta is ideal for the community, but typically for the large proportion of patients, more than three quarters, who are unable to get to carcades due to the complexity, toxicity, or lack of access. Again, we want to reinforce that the community setting is our greatest opportunity to drive growth. We recognize adoption is lower as the market is highly fragmented, but we are making steady progress and are encouraged that once physicians are familiar with Zanlanta, they tend to continue to prescribe it. We have an opportunity to increase awareness of Zanlanta's differentiated profile and the advantages it can bring to patients and physicians. We know from brand impact data that roughly one in three treaters has unaided awareness of Zanlanta, which lags that of other two competitors in the market. We have seen a consistent improvement over the past year, but we can clearly do a lot more. By sharpening our execution, particularly our promotional efforts focusing on Zanlanta's unique profile.
Speaker 4: We are confident we can drive much higher levels of awareness so that Binlanta becomes top of mind with community physicians. All our focus initiatives are critical to expanding adoption and utilization. And what is really important here is that when healthcare systems tries in Lanta, they continue to order it. In fact, at the end of 2022, we thought 84% of the place repeat order. To close, we are very encouraged by the recent trends in Binlanta uptake and utilization. And we have signed through our strategy to fully capture the opportunity for this important medicine in the third line, third line plus seven. Now, I'll tend to call over to Mohammed, provided update on our pipeline. Mohammed. Thank you, Kristen. It is my pleasure to share an update on the pipeline. First, I want to discuss the life cycle management program for the Lanta. We see potential for the treatment to be a key player in selecting the Asian. As you see here, despite current treatment options and immersion therapy distinct, I need remains in all lines of therapy. Having spent my entire career in the hematology and oncology space, I have been trying to appreciate what the Lanta can do for patients.
Speaker 4: And at this point, I believe we have barely scratched the surface. As Kristen described earlier, Zilanta has already demonstrated a compelling and uniquely differentiated profile in the third line setting. And our strategy here is to maximize patient utilization. The larger opportunity, however lies in early on lines and in combinations. Zilanta is the only approved TZM team directed treatment option outside of CAR team to have demonstrated single Asian activity in BLDCL and known overlapping to consistence in combinations currently being studied. We believe Zilanta has the potential to become the combination agent of choice. And eventually, the evac born therapy in all lines of BLDCL. When we think about the second line, BLDCL setting, the current treatment includes stem cell transplant, CARTI, targeted therapies, and key movies visionals. Going forward, we expect to see increasing years of CARTI, but even with this, there will still be unmet medical needs and opportunity for those who are not eligible or cannot access.
Speaker 4: transplant or CART-E. Here we are exploring the combination with retoxin. In our ongoing root of 5 study, for second line, to ask the LPCL patients not eligible for transplant. This combination could benefit patients even if they received prior CART-E or if they are not eligible for CART-E. The Lotus 5 safety run-in produced early encouraging efficacy data. And the enrollment of approximately 350 patients is expected to be completed next year. Another potential application for the ex-poxin-app combination is in the front line therapy where there is a great need among unfit or frail patients not able to tolerate fault doses of our chart. While approximately 85% of patients receive our chart and the resumment is curative in about 60% of patients. This leaves a significant population that is unable to tolerate our chart and has poor outcome. Physicians are looking for months' systemic key-mobiles resumment with better outcomes in this setting.
Speaker 5: Here's on this unmet need and the de-risk profile of the LONTA, we are conducting the Phase II LUTAS IX study. This is an open-level study in the onset and failed patients with results expected next year. We believe the potential benefit is supported by encouraging data from LUTAS II. The data showed that LONTA had a similar overall response in patients over and under 75 years of age, with no notable 50 issues in the older patients. In addition, data from 50 run in portion of LUTAS V further supports the use of this non-systemic chemo-combination and increases the likelihood of success.
Speaker 5: Beyond the combination with the epoxy map, we are exploring novel combinations. We are particularly excited about the possibility of combining the long-term bi-specifix with their distinct mechanism of action and toxicity profile. In the Luther 7 study, we are evaluating the combination with Droshek Lufidumat and Mousintusumat, as well as Poulotusumat. We expect to have early data from these studies next year. We also have a collaboration with IGM to combine with its bi-specifix input amant. Beyond our own clinical studies, we are impetrages.
Speaker 5: to see substantial interest from investigators to explore in long time in different combinations, including by specific in different treatment settings and in other indications. We are closely following those studies to further understand the long-distance potential. Investigators are keen to see whether the long-distance stronger profile in the challenging DLBKL indication could potentially translate into other areas of CV and TN disease biologists, such as CLL, follicular lymphoma and mental cell lymphoma. On my final slide, I would like to discuss our robust pipeline beyond the long-distance. Starting with our company's forms of program, EGCT 901 targeting CAAG1 is a novel, twisting class that target various solatumers.
Speaker 5: The fears won those escalations is proceeding, and we have not yet reached the maximum period of those. We have decided to amend the protocol to explore different dosing schedules to optimize the potential clinical outcomes for patients and to prepare for regulatory interactions as part of project options. We now expect to share preliminary data in the first half of 2024. Now looking at ADCT 601 targeting axle. Axial is a well-ordered target over expressed in many solid tumours including sarcoma and monosmosolon cancer. The fears won study to optimize the combination with gymsitabid and to explore single-eition activity is progressing. Inparer and IFCSA for possible biomarker approach is being finalized. Preliminary data from the fears won those escalations and expansion study are expected in the first half of 2024. ADCT 212 is in next generation PPV based ADC targeting PSMA. Evaluated target over expressed in the majority of metastatic test-arration resistant processes. We expect to initiate the fears won study in the first half of 2024. Now for our programs in collaboration, ADCT 602 targets CD22.
Speaker 5: MDA's in cancer centers presented some encouraging signs of activity from the phase I study at ash in a small number of acute lymphoblastic leukemia patients. The phase I, those expansions that he expected to complete in the first half of 2024. And finally, ADCT-701 targeting DLK1, equal iteration with NCI in neuroindicrant malignancy. We expect the phase I study to be initiated in the second half of the year. I am really excited about the robust bioclide we have developed with multiple catalysms. Over the next 12 to 18 months. This is one of the reasons I came to the company. I look forward to 40 on the evolving useful from our pipeline over the coming months.
Speaker 5: With that, I will turn the call over to PPP to give a financial update. PPP. Thank you, Mohammed. Focusing with our financial, as of 31st December , we had cash and cash equivalent of $326 million. We're presenting a $55 million reduction from our position at the end of the third quarter. Subsequent to the year end, we received a $50 million milestone from SOBI, given European approval of Simblonta. And we also expect to receive a $75 million milestone from healthcare royalty partners on first commercial sales in Europe , expected in the second quarter of the year. I've admitted, based on our business plan, the milestone payment, I mentioned, and further productivity initiatives underway. We expect that our cash runway now extend into mid 2025. Turning to the PNL, Simblonta net sales were $19.8 million in the fourth quarter, up 16.5% versus Q4 2021. While full-year net sales more than doubled to $74.9 million with the first full-year sales, compared to $34 million in a partial year in 2021. And Mitsubishi Tanave. Cost of product sales amounted to $1.5 million in the fourth quarter and $4.6 million for the full year. In addition to a full year of commercial activity, this expense line reflected in permanent charges for products intermediates and antidepressants.
Speaker 5: had winds compared with 2022.
Speaker 5: Specifically, we expect a negative gross to net impact of approximately 2-3 percentage points from our GPO contracting. Together with a negative impact of need to high single-digit percentage points to reflect the new Medicare Part B wasteage Policy regarding discarded units that was implemented at the beginning of 2023. In terms of total operating expenses, we expect a decrease.
Speaker 5: in 2023 and 2024, as compared to 2022, reflecting pre-relication and productivity efforts across all expense categories. Finally, moving to the upcoming catalyst. We have a number of different value driving catalysts over the next 12-18 months and well within our cash-strike way. Starting with Simlonta, this year, in addition to double-digit growth, we also expect to achieve a commercial brand profitability, meaning we will more than offset the total cost of commercialization, medical affairs, and all related costs, so that Simlonta, by the end of the year, starts to pay for the development of new indications and the pipeline. Following European approval of Simlonta, we expect our partners, Robbie.
Speaker 5: to launch in the second quarter of this year. In the second half of the year, we expect to initiate the phase one study of ADCT 701 targeting DLK1. Next year, we will complete the involvement of our Lotus 5 confirmatory study in the second line study. We will also share some preliminary results from our Lotus 9 and Lotus 7 studies next year. In terms of the pipeline in the first half of 2024, we expect to share preliminary data from ADCT 901 targeting KAK1 and ADCT 601 targeting AHCSA. We also expect to initiate the phase one study of ADCT 12 targeting PSMA and for our partner, MD Anderson, to complete the phase one dose expansion study for ADCT 601. So to targeting CV 22.
Speaker 4: So a number of different milestones across the company, both with Simlonta and our pipeline. And of course, we're continuing to advance our technology plan. With that, I will turn the call back to Amid for closer remarks. Thank you, Kristen, Mohammed and Pepe. To conclude, we have a clear roadmap and the capabilities to execute in 2023 and to build ADC therapeutics for years to come. We are uniquely positioned in the growing ADC space with specialized capabilities from discovery through to commercialization and have over a decade of experience. We have a validated the technology platform, a rich pipeline of hematological and solid tumor programs and an innovative toolbox to develop next generation assets with novel antibiotic constructs and payloads. And last but not least, we have a strengthened and highly talented team in the place to execute on our strategies. We look forward to keeping you updated on our ongoing progress. Now the team will be available for questions. Operator? Thank you. We will now begin the question and answer session. If you have a question, please press star, then one one on your touchtone phone. If you wish to be removed from the queue, please press star one one again. If you're using a speaker phone, you may need to pick up the headset first before pressing the numbers. Once again, if you have a question, please press star one again. If you wish to be removed from the queue, please press star one again. If you wish to be removed from the queue, please press star one again. Please stand by while we compile the queue and the roster.
Speaker 5: Kelly, she with Jeffries is online with the question. Please go ahead. Thank you for taking my questions. The first is regarding the OPEC's case share, more details on the OPEC's reduction in 2020 straight and the where do you plan to cut across the firm and how should we think about the magnitude of the plan the cost reduction. Thank you and I have four more. I can. Thanks for the question. So we're expected to reduce costs compared to 2022 for both years 2023 and 2024. Only around the line you should expect our reduction because we are focusing our resources in the most impactful and high return on investment projects that we have in the pipeline. As you know, we have this continuous several projects that we consider less attractive. Some of them might end up being potentially partnered like coming. And on the SNA side, we are driving for activity. We have an entire new team that have looked at the company cost structure with fresh eyes. So we believe the significant opportunity to reduce costs year over year. And the second question I couldn't hear you. You you you type on something else.
Speaker 4: Thank you. Yeah, I also have a question regarding the ADCT-601 program targeting EXO. Do you plan to screen patients with positive accession level for those escalation states, while also like Tacoma and the announcement cell, long cancer and cohorts? Oh, this is only applied to other communication. And also, what is the rationale for the combo arm with the Gen-Ditubing in Tacoma? And also, what information do we have regarding EXO 150 profile at the moment? Thank you. Thanks for the question. And we do or are planning to collect biopsies for all patients currently ongoing in the study in order for us to possibly test or, respectively, for active expression. The current protocol right now does not select patients, and the ASC is being developed in parallel. As I mentioned, what is ready will be able to test patients for expression. In terms of the combination with Gen-Ditubing, Gen-Ditubing is very active and considered one of the standard of care used in Tacoma. So it's naturally to combine and then add on a strategy in the combination and see if we can improve standard of care for a hopeful future. The study is from our regulatory perspective to be able to isolate the effect of the drug. So what was the third question? Sorry. This is the profile of the 601. The toxicity profile. We are currently controlling into the... the escalation thesis on the protocol. And so far, we have not reached the macron-terrated dose.
Speaker 4: Thank you very much. Thank you. One moment for our next question. Our next question comes from Gregory Rendo with RBC Capital Markets. Please go ahead. Thank you everyone. This is Sudan, Logan Nason, on for Gregory Rendo. Thank you for taking our questions. Yep. And congrats on the great quarter. I would send long time great year going forward. Specifically, one of the ask on how the how the competitive landscape may potentially change as you know, go forward with Lotus five, Lotus seven, Lotus nine programs and look for labor expansion in the early lines of DLBCL therapy. You know, are there, you know, kind of developments occurring kind of tandem at this point that may change how a compare arm is looked at or what standard of care. There may be that, you know, should be a competitor on for these and launch the trials and then, you know, you know, are these things developments that could occur in the one to five year timeframe. And just, you know, what it is, it gets you're going to take on how to go play out in the years to come. Yeah. So I think we all start and then, you know, I'm an increasing and feel free to add on to it. You know, as you said, the DLBCL market is quite dynamic and there has been a lot of change. I mean, for me. For example, CARTs are moving.
Speaker 4: pretty clearly, taking the academic institutions from third to second-line setting. That's, I would say, in the academic setting, shrinking some of the population that's not either going to get a CAR-T or a transplant. Now, of course, in the community, CAR-T uses much more limited, and so there still remains a quite a sizeable non-transplant non- CAR-T population, the second-line population. In terms of the comparator arm, which is our jam-ox, we don't anticipate any change. I mean, that's been geared to discuss, obviously, with the FDA from a regulatory standpoint. We feel like we still have the right comparator arm, the right study design to move towards approval on a broader label in that second-line setting. With the front-line setting, there is also a lot of competitive dynamics going on. As you know, 85% of patients can tolerate full doses of our chop, and our chop has very good outcomes. I mean, 60% of patients are going to get cured. So it really is the standard of caring. When you look at a lot of trials, whether it be with polarity or the bachelor's degree, or the ethics, many of them are trying to augment our chop and to try to deliver even better outcomes for those 85% of patients who can tolerate our chop. But for the 15% of patients who are frail and unfit, these are patients. There are eight years and above, you know, with or without comorbidities. These patients often have to can't tolerate full dose of our chop, and are getting many our chop, or other chemotherapy regimens. And our outcomes are much poorer. This is where we're playing right now. We're playing right now with some on-kill phosphatoxamab, but I'll notice nine study. And in this population, it's a single arm study. So it's not really a comparator at this point. You know, if we were to move forward, I would say the comparator, you know, for this is really many our chop, and that hasn't changed.
Speaker 4: We don't think the competitive landscape is going to alter what our current development plans are. I think the big thing could be the introduction of bi-specific. You know, where they have the chance to start to, you know, over time potentially change the treatment landscape across all lines of therapy. And we think we're actually well positioned to partner with bi-specific. You know, as the only targeted CD-19 therapy with single agent efficacy and manageable side effect profile, and we believe has a potential even to be not overlapping. Of course, as to be tested, we are uniquely positioned to combine across different bi-specific. And we're doing that in our Lotus study as well as in partnership with IGM with our inviting us. So we think we actually have a chance to combine and actually ride with one of the biggest competitor changes that I think will affect the ability to be sale of the cover years. Thanks, really appreciate that, and congrats on the quarter again. Thank you. One moment for our next question. Our next question comes from Matthew Harrison with Morgan Stanley . Please go ahead. One moment for our next question. Our next question comes from Noureem Quibria with Capital One Securities. Please go ahead. Thanks. Good morning, congrats on the progress, and thanks for taking my questions. So, first one, please come back on site. Also, thanks for the questions. Thank you, Bess. I guess it's very basic. Are you able to comment on Sinlanta?
Speaker 4: And I know where the single arm, it's the market access process is going to take longer to have approval throughout Europe . So it's going to be a grab low growth. I'm going to see if I may want to add something. Yeah. As you know, I mean, market access is country by country in Europe . And if you take up to 12 months. And as Pepe said, given that it's approved with a single arm study, it's going to result in very favorable, your reimbursement to countries is more challenging in your reimbursement in other countries. So...
Speaker 4: I see the launch in Europe as kind of phase one with this current study. Lotus five whenever comparative study will open up a full opportunity in Europe . But if you think more of our term about the European opportunity, I think the volume potential in Europe may be even greater than it is in the US because quarantine kind of is much less. Okay, that's very helpful. And if I could just squeeze one more in from Mohammed with respect to the CAG-1901, can you talk a bit more about the amendment to the protocol and the different dosing schedules, what's the rationale behind that decision and and given that sort of shift, how many patients should we expect with in the upcoming update that that will come up. Thank you for that. Thank you for your questions. Yeah, thank you for question. The actually as you know, I came to the company was it the week to go with a fresh perspective and looking at the CAG-1 as a novel agent actually. So we also have quite an experience with discussion with the agency about project optimists which technically the agency is exploring multiple dosing schedules. So we took a decision to pose installation and amend the protocol to explore the from those of you as well to maximize the experience with the effortation and patient utilization to prepare for possible future.
Speaker 4: meeting with the regulators and also to prepare for the most convenient those ready for the equivalent study. So as you know also project optimists, the draft guidelines just got published in January 2023. So many companies around the world right now are preparing and adjusting the protocol to accommodate for the requirements, the new requirements as I say for for regulators to come to them with multiple doses with number of patients in each dose in each indication. So I hope that explains your question. Yeah, I think. Yeah, that's what we expect that dose that relation is going to be probably in general, you know, like their process, because you're going to have to dose that's based on expansion, you're going to have to expand it multiple doses. Yeah. Right. Okay. Thank you. That's all for me. Thank you. One moment for our next question. Our next question comes from. We have you, Harrison with Morgan Stanley . Please go ahead. Hi, this is Chris on for Matthew. Thank you for taking our questions. I know someone earlier asked about the potential impact of kind of new treatment pair of times entering the market.
Speaker 4: specifically for biospecifics. Can you help us think about kind of the near term impact of that entering a market at the state penetrate the 3L plus DL BCl market? Thank you. Sure. So we expect by specific to play a role in the third line setting upon approval. We do think that uptake in the community will take longer in general the community slower to adopt new therapies and given the risk of CRS and I can't with biospecifics.
We think initial uptake will be limited to the academic center. When it comes to competing in that phase in the academic center, we've been competing with bi-specific for years now in that setting, given the multiple bi-specific that are being studied in clinical trials. Okay, thank you. I would just add that the penetration of any agent in the third bi-setting is still relatively low. So there's clearly room for bi-specific to penetrate particularly in the academic setting and for off-the-cated to grow in both the academic and the community settings. Great, thanks. Thank you. One moment for our next question. Our next question comes from Boris Peager with Cowan. Please go ahead. This is Nick on for Boris. Thanks for your question.
I just have a couple of queries in Lanta and the Lotus trials. For the Lotus 5 trial, I know this is confirmed for a trial from a single arm, but can this be used for an S&DA or regulatory submission for two LBPL, BPL and both the US and the EU? And then also second, for Lotus 7, which lines of therapy are you guys looking at and is that different based on which combination approach is, or what not? So regarding Lotus 5, you're absolutely correct. It is a regulatory study for both US and XUS. It is a confirmatory study with a potential also to get an S&DA for the second line plus setting. Remember, the Lanta is now in the third line plus setting at the single Asian. We are maximizing that and getting into the second line plus Asian with substantial number of patients in that setting and the plan is to go worldwide with that approach. Now, I'm sorry, I'm sorry. And then Lotus 7, yeah. For Lotus 7, we're actually, the 7 have multiple Asians in combination, including Polatismat, Glufutumat and Mosythusumat. We are trying to be the drug of choice. In combination with all by specific, not to mention also that we have a collaboration with IGM with their by specific. So pretty much we're combining with all by specific to be a.
Okay, so in terms of the split of academic birth community use, it's roughly 50, 50. We just started to see, as it we said, the penetration in the community is consistently growing and we just started to match the use from an academic perspective in terms of volume. Your second question was how long to penetrate the community? You know, they, they are, what we see is community treaters are generally slower to adopt new therapies.
For most new oncology launches, it probably takes about four to five years to really start to hit peak market share, but what we do see for communities, community traders is that because they're slower to adopt, it could take longer in that setting. But we will continue to chip away since we're at about 35% our goal is to really match what we're seeing in the academic setting. And I also had Brian that there's a long tail, so there's a lot of fragmentation in the community centers. A lot of community doctors are seeing a patient every few months, but they also tend to be a lot stickier. So behavior changes, works both ways. It takes longer to adopt what we see is the counts that are adopting are repeating and sticking with the product. And we keep growing penetration month over month. So I think as that happens, this is a great opportunity. And that's a point. So in this place where you had asked about bi-specific and I like Kristen, comment further, bi-specific are going to have a much more challenging time. We believe in the community initially just given the safety profile. In the academic setting where we've kind of traded about 80% of accounts, there's still room for death. We think even with bi-specific, but I'll let Kristen comment further on the bi-specific point.
And obviously, you know, any time on post the enrollment depends, it's an event driven study. So, you know, it's some way it's a longer post the peters, but it'll, it'll, it'll see depend on events. Once we complete enrollment and the study starts reading out, we'll share information.
post the enrollment depends it's an event driven study so you know it's some way it's a longer post the petter but it'll it'll it'll depend on events so yeah once we complete enrollment and the study starts reading out we'll share information. Great thank you.
Thank you. We have no further questions at this time. I'd now like to turn it back to Amit for closing remarks. Well, thank you all for joining so much, the webcast, that thanks for all the thoughtful questions. We're really excited about our ability to unlock the violence company by maximizing the launch of our advancing our PVD-based pipeline and expanding our ADC platform. We have multiple value-driving catalysts over the next 12 to 18 months, and we look forward to continuing to update you on our progress. Thank you so much for joining. Thank you for your participation in today's conference. This concludes the program. You may now disconnect. The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 11. Thank you.