Mersana Therapeutics, Inc. (0M40.F) Earnings Call Transcript & Summary

Great. Good afternoon, everyone. My name is Jess Fye. I'm a biotech analyst at JPMorgan, and we're continuing the 40th JPMorgan Healthcare Conference today with Mersana. I'm joined by the company's CEO, Anna Protopapas, who's going to give a presentation on the business, and then we're going to go into some Q&A. [Operator Instructions] So with that, let me pass it over to Anna.

Thank you, Jess. Before I begin, let me just remind you that this presentation, I will be making forward-looking statements. So at Mersana, our vision is to become an ADC leader. And we have made substantial progress towards realizing this vision. There are 4 fundamental pillars to our strategy. First is to build UpRi, a lead asset into a foundational therapy in ovarian cancer. Based on a robust and compelling set of clinical proof-of-concept data, we're executing on a development strategy involving 3 studies: UPLIFT, UP-NEXT and UPGRADE, that together have the potential to reach the broadest number of ovarian cancer patients that could benefit from UpRi in the most expeditious manner. Second, we are advancing an innovative and highly differentiated pipeline with XMT-1592 and 2 new molecules moving into the clinic this year: XMT-1660, a first-in-class B7-H4 Dolasynthen ADC; and 2056, our first Immunosynthen ADC targeting HER2. Thirdly, we are leveraging our innovative platforms as efficient product engines to continue to grow our ADC pipeline. We have 2 new development candidates advancing into IND-enabling studies this year. Our differentiated platforms and rich early pipeline, combined with the recognition by the industry of the importance of ADCs as a therapeutic modality, position us well to advance additional programs beyond our wholly owned pipeline through partnerships. Lastly, fundamental to our strategy is the strength of our organization, the depth of experience and the passion of the Mersana team to execute on our vision. ADCs are a validated therapeutic modality, but the field has not yet realized its full potential because platform innovation has been limited. We believe that our proprietary platforms address limitations of first-generation approaches and have the potential to advance the field and ultimately make a real difference to patients. Dolaflexin and Dolasynthen both carry a proprietary DolaLock payload with controlled by-standard effect. Dolaflexin allows for a high drug-to-antibody ratio, while Dolasynthen allows for a precise drug-to-antibody ratio that can be customized for a given target from 2 to 24. Both of these platforms overcome long-standing issues in ADC development by increasing therapeutic index while maintaining drug-like properties and have been clinically validated, demonstrating efficacy while maintaining a differentiated tolerability profile without the severe neutropenia, neuropathy or ocular toxicity that limit other ADC platforms. Immunosynthen takes our ADCs a step further beyond the traditional cytotoxic realm by delivering targeted stimulation of the innate immune system using our immuno lock payload, a proprietary STING agonist payload. Preclinical data demonstrates strong efficacy and a wide therapeutic index. We are excited to move our first Immunosynthen ADC to the clinic this year. As you can see here, our pipeline is maturing with first-in-class molecules addressing areas of high unmet medical need, spanning both early and late stages of development. Let me start with UpRi, our lead asset and our plans to build UpRi into a foundational medicine in ovarian cancer. UpRi is a first-in-class Dolaflexin ADC targeting NaPi2b, a sodium phosphate transporter broadly expressed in ovarian cancer but with limited healthy tissue expression, making it an excellent target for an ADC. In fact, NaPi2b was previously validated as an ADC target by Genentech, but limitations of the ADC platform use, such as severe neutropenia and neuropathy, led to discontinuation of the program. We are very excited about the profile of UpRi and its potential to become foundational in ovarian cancer. Our excitement is based on substantial clinical experience in almost 200 patients across indications and doses with almost 100 from an ovarian expansion cohort. As previously reported, we have seen a clinically meaningful profile with a 34% overall response rate in the 2/3 of patients with NaPi2b high ovarian cancer, including complete responses in late-stage platinum-resistant patients who have exhausted both PARP and bev. These patients are in desperate need for new therapeutic options. Current treatment for these patients is single-agent chemotherapy, which carries a 12% response rate and significant toxicities. What is particularly exciting beyond the efficacy is the tolerability. We have observed a differentiated tolerability profile with UpRi without the severe neutropenia, neuropathy and ocular toxicity seen with other ADC platforms. We have also developed a robust predictive and reproducible diagnostic for selection of NaPi2b high patients, an important part of our development strategy. And we have leveraged our extensive clinical experience to select an optimal dose. You can find more information about the profile of UpRi in the 5 scientific presentations we have made over the past 18 months that are available on our website. Let me move on to ovarian cancer in our development program. There are about 22,000 newly diagnosed ovarian cancer patients in the U.S. every year, plus additional patients with fallopian tube and primary peritoneal cancers treated with the same algorithm. Surgery followed by chemotherapy is the frontline treatment for these patients. Unfortunately, most of these patients will relapse after frontline therapy. There are limited therapeutic options for these patients and platinum-combination therapy remains the standard of care, a treatment that patients receive multiple times until they become platinum resistant, the terminal stage of the disease. In the past few years, PARP inhibitors that we introduced as maintenance therapy, but their efficacy is primarily limited to the BRCA mutant patients in the HRD-positive setting, leaving a substantial gap in the platinum-sensitive maintenance setting. We have designed a development plan with UPLIFT, UP-NEXT and UPGRADE that leverages our differentiated profile to build UpRi into this foundational medicine, addressing the needs of patients in both platinum-resistant and platinum-sensitive disease. Let me start with UPLIFT, our ongoing single-arm registrational trial in form by FDA feedback in platinum-resistant patients. There are about 14,000 deaths a year in the U.S. and the majority are at the platinum-resistant stage of the disease. These patients are at the terminal stage. Their only therapeutic options are single-agent chemotherapy, pegylated doxorubicin, topotecan with an overall response rate of less than 12%, a duration of response of less than 4 months and a median overall survival of less than a year, let alone the significant toxicities that these agents carry. We believe that the activity we have observed in platinum-resistant patients today, the ability to further enrich outcomes for NaPi2b high patients and the differentiated tolerability profile without the severe neutropenia, neuropathy and ocular toxicity seen with other ADCs will translate into both a successful UPLIFT registrational trial and a robust commercial launch. UPLIFT enrolls the broader -- the broadest group of platinum-resistant patients than other studies in this area with more flexibility with regard to prior lines of therapy, prior therapies like bevacizumab and underlying comorbidities like peripheral neuropathy. We have 2 shots on goal. The primary endpoint of the trial is the confirmed overall response rate in NaPi2b high patients. And the secondary endpoint is the confirmed overall response rate in the overall population, supporting a potential launch in either the NaPi2b high patient population, which is about 2/3 of all patients, or supporting approval in the total population. The trial is ongoing, and we expect to complete enrollment in Q3 of this year. Moving on to the platinum-sensitive setting. As is well known, there are 3 PARP inhibitors approved as platinum-sensitive maintenance therapies, and they have combined revenues of $1 billion in the U.S. and $2 billion worldwide in ovarian cancer. Despite this, there still remains a significant unmet medical need in this setting as watch and wait remains a recommended approach in the NCCN guidelines. UP-NEXT, our Phase III trial, is designed to address these unmet medical needs, which fall into 3 groups. First, there are patients who progress on PARP inhibitors and bevacizumab. For these patients, there is no standard of care. And as these 2 agents move to earlier lines of therapy, this group of patients is becoming larger. UpRi has shown activity in both PARP and bevacizumab pretreated patients. Second, there are many patients who are poorly served by current maintenance agents and who we want to watch and wait either because of the toxicities of these agents or because of the differential benefit based on whether the patient carries the BRCA mutation or not. UpRi has shown a differentiated tolerability profile, and we believe that especially the approximately 2/3 of ovarian cancer patients with a NaPi2b high, UpRi may offer a potential greater benefit. The third group is patients achieving only stable disease, which were excluded from the PARP trials. This is a growing group given that the emerging evidence that platinum responsiveness decreases with prior PARP treatment. Again, our data suggests that UpRi is active, including complete responses in heavily pretreated patients. The design of UP-NEXT has been informed by constructive discussions with both the FDA and the CHMP and could serve as our post-approval confirmatory trial in the U.S. as well as a global registration trial. UP-NEXT with enrolled patients who achieved complete response, partial response or stable disease immediately following platinum treatment, whether that's the second, third or fourth platinum treatment they have received. We are also requiring that all patients enrolled being NaPi2b high in order to optimize clinical outcomes. Prior to PARP therapy -- prior PARP therapy is only required for BRCA-mutant patients. In recognition of the lack of standard of care for these patients, the trial is randomized to placebo with PFS as the primary endpoint, overall response and overall survival as the secondary endpoints. UP-NEXT is expected to initiate in the second quarter of this year and will recruit 350 patients with a 2:1 randomization. Moving on to UPGRADE. Platinum, in combination with chemotherapy, typically paclitaxel, remains the standard of care in ovarian cancer, with patients receiving platinum treatment multiple times throughout their disease until they become platinum resistant. This combination is given for a fixed duration of 6 cycles due to its cumulative toxicity, including alopecia, neutropenia and neuropathy. Replacing paclitaxel with a well-tolerated targeted agents such as UpRi has the potential of eliminating burdens of toxicities and could allow for longer treatment, the potential for improved clinical outcomes. Other agents have not been able to combine with platinum because of overlapping toxicities. This is particularly true for agents that have neuropathy and neutropenia liabilities. If successful, UPGRADE data could establish UpRi as the combination agent of choice with platinum with the potential for longer treatment durations with lower toxicities. UPGRADE is a Phase I/II trial combining UpRi with carboplatin for 6 cycles, followed by treatment with UpRi as a single agent until progression. The trial includes a dose escalation on the combination followed by dose expansion. We will report interim data from this trial in the second half of the year. UPGRADE will provide important information that could help us chart the path to frontline therapy. Taken together with UPLIFT, UP-NEXT and UPGRADE, we believe we have a comprehensive development plan in place that would allow us to expeditiously bring UpRi to a broad population of ovarian cancer patients with significant unmet medical need, patients waiting for new options. Beyond UpRi, we have a growing pipeline of Dolasynthen ADCs utilizing the DolaLock payload. We have demonstrated that ADCs carrying the DolaLock payload have a profound efficacy, including CRs, in a heavily pretreated patients and a differentiated tolerability profile without the severe neutropenia, neuropathy or ocular toxicity. In addition, we believe that using our unique capabilities of selecting the right DAR for a given target allows for improved ADC profile in patients. 1592 is a Dolasynthen ADC, also targeting NaPi2b. In preclinical studies, XMT-1592 demonstrated improved efficacy, particularly in lung cancer. Strategically, 1592 is our second shot in goal on lung once we complete our dose exploration and determine the recommended Phase II dose, we will make a data-driven decision on the next steps and disclose the data. As we have said before, NaPi2b high has about half the prevalence in lung cancer than in ovarian, and the efficacy threshold would need to be appropriate to reflect the highly competitive nature of this indication. XMT-1660 is a first-in-class Dolasynthen ADC targeting B7-H4. B7-H4 is expressed broadly in tumors that has limited healthy tissue expression, making it a great target for an ADC. Breast cancer, both triple-negative breast cancer and HR-positive HER2-negative breast cancer, endometrial and ovarian cancer are all areas of high unmet medical need and are some of the key indications where B7-H4 is expressed. We have leveraged our unique DAR range of capabilities to select the optimal DAR among multiple variants tested. We expect 1660 to enter the clinic mid this year. Lastly, I'd like to take a few minutes to discuss our Immunosynthen pipeline with a focus on XMT-2056. Immunosynthen is our novel immunostimulatory ADC platform, delivering a proprietary immuno lock STING agonist payload. The STING pathway is a well-studied fundamental pathway for innate immune stimulation. An ADC approach to STING pathway activation allows for targeted stimulation in the tumor and tumor microenvironment and is superior to previous approaches such as systemic delivery or intratumoral injection. A STING agonist ADC approach is also differentiated from toll-like receptor based ADCs, because unlike those, STING is expressed and can be activated in both the tumor cells and the tumor-resident immune cells, providing a 1-2 punch potentially leading to greater efficacy. We have validated the potential of our Immunosynthen ADCs across multiple targets and have chosen XMT-2056 as our first Immunosynthen ADC to advance into the clinic. 2056 has demonstrated robust target-dependent antitumor immune responses in vitro and in vivo after a single well-tolerated dose across multiple preclinical models. Importantly, XMT-2056 was well tolerated in nonhuman primate studies at doses and exposures well above those that result in complete regression in vivo efficacy models indicated that the targeted nature of our Immunosynthen ADCs leads to STING pathway stimulation with the potential for a wide therapeutic index. XMT-2056 targets HER2, a well-characterized tumor antigen. However, we deliberately selected a proprietary antibody that targets a novel epitope of HER2 with differentiated binding from pertuzumab or trastuzumab, allowing for single agent activity and the potential for broad combinability with approved and investigation of HER2-targeted therapies. XMT-2056 showed excellent in vivo efficacy when combined with trastuzumab, supporting our selection of this antibody that is highly combinable with standard of care agents. We have also demonstrated increased efficacy in both high and low HER2 tumor-bearing mouse models compared to trastuzumab toll-like 7 and 8 and systemic STING agonist benchmarks, further supporting the differentiated mechanism of our approach and the stimulation -- distinct agonist innate immune stimulation in both the tumor and the tumor resident immune cell, the 1, 2 [ part ] . We expect 2056 to enter the clinic around midyear. We have another busy year ahead of us with many important anticipated goals and milestones. We plan for UP-NEXT, our first Phase III trial in platinum-sensitive recurrent maintenance, to be initiated and enrolling in Q2. We expect UPLIFT, our singular registration trial in platinum-resistant ovarian cancer, to complete enrollment in Q3. We plan to report interim data from UPGRADE, our combination dose escalation umbrella trial with -- in platinum sensitive ovarian cancer in the second half of the year. For XMT-1592, our Dolasynthen NaPi2b targeted ADC, we expect to complete dose exploration and provide an update on next steps. We plan to initiate dose escalation studies for both XMT-1660, our Dolasynthen B7-H4 targeted ADC; and XMT-2056, the Immunosynthen HER2-targeted STING agonist ADC, in the middle of 2022. And we plan to disclose 2 new development capitate in the first half of this year developed using an innovative platforms. In conclusion, Mersana is well positioned for a transformation into a commercial stage company with a deep pipeline of first-in-class molecules addressing areas of high unmet medical need. In 2025, only a short 3 years away, we expect UpRi to be on the market with a leading share in platinum-resistant disease and on the cusp of launching into platinum-sensitive setting. In addition to XMT-1592, during the next 3 years, we plan to advance XMT-1660, XMT-2056 and at least 2 additional molecules into the clinic, with the objective of advancing at least one of those into the later stages of development. We will continue to be a leader in innovation in the ADC field, a therapeutic modality recognized as a critical part of cancer treatment options and will leverage partnerships to maximize the potential to benefit patients wherever possible. And at the foundation of everything we do, are the people of Mersana who come to work every day committed to advancing important ADCs for the benefit of patients. Thank you very much, and we'll be open to answer to any of your questions.

Great. Thanks, Anna, for that presentation. [Operator Instructions] Maybe to start out, can you recap the amendments you've made to the study design for UPLIFT, including the changes to dose and the exclusion criteria? Are those changes fully in effect now in the trial?

Yes. We -- those changes really went through fairly seamlessly. As you know, it was a very modest adjustment to dose. And those are already in place. And we are enrolling at the 36 milligrams per meter squared.

Great. And when you made the dose adjustment, at the time, you talked about a starker correlation between dose and safety relative to dose and efficacy. Does that extend to duration of response as well? Or was that efficacy analysis just based on response rate?

Yes. So thanks for the question. So the efficacy analysis, it was based on the response rate. But I'll remind folks that in the expansion cohort, the data with the 36 was associated with not only similar response rates, but actually with a longer treatment duration, which potentially could translate into a longer duration of response, and this correlated with fewer AEs as well as actually fewer patients discontinuing before their first scan.

Got it. And in the UPLIFT trial, now that you've made the dose adjustment, are you targeting 100 patients for NaPi2b high at the go-forward dose? And how will the FDA look at patients enrolled prior to the dose change? Will they count in the primary endpoint analysis?

Yes. So our primary endpoint will be with 100 high NaPi2b 36 mg per meter squared of patients. Obviously, we'll utilize the broader set of information, including the 36 and 43, to establish a robust set of safety information, but the efficacy population will be based off of the 36 mg per meter squared.

Great. And how big is the revenue opportunity associated with the UPLIFT indication?

Well, maybe I can take that. As Anna noted, there are about 14,000 deaths from ovarian cancer each year in the United States. The majority of those patients are in the platinum-resistant ovarian cancer stage. And NaPi2b high is about 2/3 of that. So there's a really sizable market opportunity here. However, as you can see from the development plan, we're actually looking beyond platinum-resistant ovarian cancer, so platinum-sensitive disease, UP-NEXT and UPGRADE and even beyond that.

Okay. I guess speaking of UP-NEXT, can you elaborate more on the trial design in the maintenance setting for recurrent platinum-sensitive ovarian cancer? What's the enrollment criteria? And what's the treatment duration expected to be in that study?

Sure. So the UP-NEXT study was really designed to address really important unmet medical needs in this maintenance setting, getting us into the platinum-sensitive disease space. And it's an opportunity to actually treat, and potentially treat for longer a larger proportion of patients than what would come with the UPLIFT study. So in discussions not only with FDA, but also with the CHMP, we've come up with a study that we believe could actually serve as a potential confirmatory study to support full approval as well as actually support a broader global registration. Now to your question just about the eligibility criteria. We've been really quite thoughtful in relationship to including patients that after that treatment with platinum therapy, including patients with a CR and a PR, a complete or partial response, but as well as actually expanding to patients that have stable disease with the platinum therapy. It will be in the recurrent setting, so it will include patients that have received 2 to 4 prior lines of platinum therapy, and that does include the immediately preceding platinum therapy, meaning they would have had frontline therapy and then they would be eligible after that frontline therapy. We're enriching, and so we'll be selecting for high NaPi2b patients, which represent approximately 2/3 of the ovarian cancer space. And then notably, we're only requiring PARP inhibitor therapy for those patients that are BRCA mutant, meaning that patients [ can now ] receive PARP therapy but are not required to, unless they're BRCA mutant. And then finally, just an overall assessment of the study, the primary endpoint is progression-free survival for the primary endpoint. Now just in regards to your question about the treatment duration. Obviously, in this earlier line setting, we have an opportunity to treat these patients for longer, and we want to maximize the treatment course, so we'll be treating for 18 months. And obviously, in discussions with physicians and patients, if they want to extend, there could be a discussion in regards to that.

Got it. How do you think about what the control arm is likely to do in that study?

Yes. In the relapse setting, the patients will, unfortunately, likely have a progression-free survival shorter than in the frontline setting. And there is available information out there in relationship to the relapsed progression-free survival for those control arms. Now recognizing that the landscape has changed, however, because with PARP inhibitor therapy utilized in the frontline setting, one will also know that there's an association with responsiveness of platinum therapy with PARP therapy. So it's very likely that you'll have actually fewer patients in CR, PR and actually expand the stable disease patients. And so those patients actually may have a shorter progression-free survival on the placebo arm. So those are the parameters by which we've helped define the progression-free survival.

And when exactly is that trial expected to initiate? And when should we think about getting initial data? What would be considered a win when that study reads out?

So the study will initiate in Q2 of this year. As I think Arvin mentioned, we have both CHMP and FDA feedback and are well in our way to executing the work to start dosing patients in Q2. We have sized the trial in a way that will lead, we believe, to meaningful clinical benefit for these patients. As for -- there will be 350 patients enrolled, as we mentioned. And as for the timing of completion, it's obviously an event-driven study. And at this point, we haven't given specific guidance. But obviously, it will take a little bit of time before we have the results.

How large is the addressable patient population being evaluated in that study? And how do you think about the opportunity in that setting?

Yes, absolutely. Maybe I can take that. So we're obviously looking for the potential to bring the benefits of UpRi to platinum-sensitive patients earlier in their disease than the platinum-resistant setting. And there are really 3 groups of patients that could benefit that have really been left behind by the available therapies today. So there are patients who respond to platinum, but have been previously treated with PARP and/or bevacizumab and thus have no standard of care. There are patients who respond to platinum who, today, aren't offered maintenance therapy because the benefit risk of the current agents is not favorable, and those patients get watch and wait. And then there are those patients who get a stable disease to platinum, who really have no approved treatment options. That's a group of patients, which is increasing in size that is not within the label of the existing PARP agents. And so I would draw the comparison as to the market size back to the PARP inhibitors as maintenance therapy. That's a category that sells more than $2 billion in ovarian globally, and is mainly limited to the 20% of patients who harbor BRCA mutations. Cannot be combined with chemotherapy. It does not have evidence for activity in prior PARP pretreated patients and frankly is split across 3 companies.

Got it. What about the UPGRADE study? You talked about looking at UPGRADE in combination with carboplatin. Assuming it works, would that approach cannibalize any patients defined in the UP-NEXT study?

No. Actually, the development plan we put together, we have to address 3 different groups that are not overlapping. UPLIFT is the platinum-resistant patient group, the terminal stage of the disease. UP-NEXT, is really the recurrent platinum-sensitive maintenance. So these are patients that are platinum sensitive, but have already been given the platinum combination therapy before they go on maintenance. And then of course, UPGRADE is being part of the platinum combination therapy. So it's not -- it's even earlier than the maintenance setting in the UP-NEXT. So 3 different very distinct patient groups, all 3 with high unmet medical need. So there isn't an overlapping patient population with these 3 trials.

Got it. And when could we expect to see data for UP-NEXT? And what's the bar for platinum that you would want to eat to get confidence that UPGRADE is adding a meaningful benefit?

So I think you're referring to UPGRADE. I know we're confusing everyone with the names of that trial. So we will be -- I'll take the first part, and maybe Arvin can take the second. We will be disclosing top line data in the second half of this year. As you know, there is a dose escalation and then a dose expansion portion. We'll have data from the dose escalation portion that we'll be able to share in the second half of the year.

Yes. And just with regards to expectations, obviously, the hypothesis here is that with the lower toxicities, we'll be able to have the nonoverlapping toxicities. We'll be able to combine the two and then be able to treat longer with the UpRi. So just in relationship to the activity, we would hope to then be able to see that reflection in the efficacy as well as in the safety profile. But we are continuing to do the dose escalation, and we'll be sharing the information toward the latter half of this year.

A couple of questions coming in from the portal. So thank you to people entering questions. This one is basically asking for a status update with 1592. What's happening with that asset? Yes, it seems like they were expecting to see data by now.

Yes. Sure. So we had set a high bar, just remember, 1592 has been a second shot on goal in relationship to lung cancer. So we've set a really high bar all along just in relationship to the benchmark to achieve. And we are continuing to do dose explorations in order to determine the recommended Phase II dose and do expect to have data later as we move forward. So we'll be sharing that information when it becomes available. But again, it was supported by the preclinical information that Anna had I had previously shared just in relationship to the greater efficacy that was seen in the preclinical models.

And there's another one here about the technology platform. Can you elaborate on how the DolaLock technology allows you to control the bystander effect?

Yes. Maybe Tim can take that question.

Sure, I'd be happy to. So we designed it to have a controlled bystander effect. And the way that we achieve that is that when our ADC binds and internalizes, the linker is cleaved and the initially released cytotoxic molecule is freely cell permeable. So it can cross the cell membrane in an antigen-independent fashion. And of course, as that occurs within the tumor microenvironment, that can be beneficial adding to efficacy. The difficulty is, if that is uncontrolled, that payload can go into systemic circulation and cause the severe neutropenia or peripheral neuropathy that is observed with other ADC platforms. Our payload has, by design, what I describe as a metabolic trigger. It has a C-terminal amide that as it diffuses in the tumor environment from tumor cell to tumor cell, that amide is hydrolyzed through the corresponding carboxylate. And because of that, we generate a highly active metabolite that is negatively charged. It's an even more potent [ antitubular ] agent, but loses the ability to cross the cell membrane, essentially locking it in the tumor cell in which it's formed. That tumor cell undergoes division. The agent kills the cell. And when that cell lysis and releases that payload into circulation, that payload, because of that charge, cannot enter the neutrophil or neuron, and therefore, does not have those toxicities.

Got it. With our limited time, I wanted to ask about 1660 as well as XMT-2056. I think you said both of those are going into the clinic midyear?

Yes, yes.

When can investors expect initial data for those products? And can you give any kind of framework for what's the kind of size of a data set that it gets to a point where you think it's kind of time to present?

So obviously, the dose escalation is the first part for both of those programs with Dolasynthen with the B7-H4 given that we have so much experience with the DolaLock payload, with 1536 and 1592, I think we should -- we have a good understanding or a very clear understanding of the path forward and how we would evaluate the dose selection. So we would expect, I think, clearly, some data in 2023. I think 2056 is a very novel approach. We have a very compelling set of preclinical data. I think we have a good plan with feedback from the FDA on the dose escalation. But obviously, we are introducing a new platform. We hope to have good -- the first data in 2023. But again, it's less of a -- it's a new field. That's what innovation brings there, sometimes more harder to predict the time lines. But probably data -- preliminary data from both of them in 2023.

Okay. Perfect. We'll leave it there. Thanks for the presentation and the thoughtful Q&A.

Thank you, and thanks, everybody. Have a good day. Bye.