MEI Pharma Inc (MEIP) 2020 Q4 法說會逐字稿

Good afternoon, and welcome to the MEI Pharma 2020 Fiscal Year-end Conference Call. My name is Vanessa, and I'll be your operator for today's call. Please be advised that the call is being recorded at the company's request.

At this time, I'd like to turn the call over to David Walsey, MEI's Vice President, Investor Relations and Corporate Communications. Please proceed.

Thank you, Vanessa, and good afternoon, everyone, and thank you for joining us today. After the market closed today, we filed our Form 10-K for the fiscal year ended June 30, 2020, with the Securities and Exchange Commission and issued our financial results and corporate highlights press release, both of which are available in the Investors section of our website at www meipharma.com.

On our call today, we will provide a summary of financials from the fiscal year ended June 30, 2020, and then we do progress in our programs and business over the last year. We will then open the call to your questions.

Before we get started, I want to call your attention to the fact that this conference call may contain certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in its forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties as discussed in our SEC filings, including our most recent annual report on Form 10-K filed earlier today. A replay of this call will be available on our website approximately an hour after its conclusion.

I'd now like to introduce you to our speakers for today. With me today are Dan Gold, our President and Chief Executive Officer; and Brian Drazba, our Chief Financial Officer. Additionally, David Urso, our Chief Operating Officer, is also with us today. Brian will start with a summary of our financial results before Dan shares remarks reviewing the year and commenting on the coming quarters. After that, we will open the line for your questions. I'll now turn the call over to Brian.

Thank you, David. I'll provide a brief overview of financial results. For more detailed information regarding our financial results, I invite you to review our Form 10-K filed earlier today.

I'm pleased to report that we finished fiscal year 2020 with about $183 million in cash, cash equivalents and short-term investments with no outstanding debt. Additionally, we have a receivable of $20 million that is expected to be received from the Japanese taxing authorities in fiscal year 2021 that was withheld from the $100 million paid by KKC under the terms of our April 2020 global license development and commercialization agreement.

The withholding was a result of the U.S. Internal Revenue Service being closed because of the COVID pandemic, resulting in an inability to provide the necessary documentation to support an exemption from the required foreign withholding. This has us starting our new fiscal year pro forma with about $203 million in cash and short-term investments. We recognized revenues of $28.9 million for the year ended June 30, 2020, and compared to $4.9 million for the year ended June 30, 2019.

Revenues resulted from the recognition of license revenue associated with the Kyowa Kirin license agreement as well as fees allocated to research and development activities related to the Kyowa Kirin and health and license agreements.

The adjusted net loss for the fiscal year ended June 30, 2020, excluding noncash expenses related to changes in the fair value of the warrants issued in connection with our May 2008 financing, a non-GAAP measure, was $23.1 million. Net loss was $46 million or $0.51 per share for the fiscal year ended June 30, 2020, compared to net loss of $16.8 million or $0.24 per share for 2019.

The company has 111,513,689 shares -- the common shares outstanding as of June 30 compared with 73,545,000 shares as of June 30, 2019.

In summary, we started the fiscal year 2021 in a strong position to continue advancing our programs and general business efforts.

With that, I'll turn the call over to Dan.

Thanks, Brian, and thanks, everyone, for joining us this afternoon. This past year was marked by progress on multiple fronts, but particularly for ME-401, our lead drug candidate. As you may know, ME-401, our PI3 kinase delta inhibitor, is being developed to treat various B-cell malignancies as both a monotherapy and in combination with other therapeutics. It is currently in the Phase II TIDAL study, evaluating patients with relapsed or refractory follicular lymphoma that is intended to support an accelerated approval of marketing application with the FDA.

Before reviewing our achievements in the MEI-401 (sic) [ME-401] program and providing some insights on what to expect in the coming quarters, today, we are sharing the name issued to ME-401 by the International Nonproprietary Names, or INN programs. It's zandelisib, Z-A-N-D-E-L-I-S-I-B.

Regarding our achievements this past year, perhaps chief among them is the global license development and commercialization agreement with Kyowa Kirin announced in April for the global development and commercialization of zandelisib. We see our agreement with Kyowa Kirin as validation of the potential for zandelisib as a best-in-class PI3 delta inhibitor and key to broadly developing and commercializing it inside and outside the United States. The alliance stems from our successful pre-existing Japan licensing agreement with Kyowa Kirin and is grounded in our shared vision for the development and potential of zandelisib as a new potential option for patients and their physicians to treat B-cell malignancies.

Briefly, as you may recall, the transaction is a global development and commercialization agreement. It included a $100 million upfront payment and up to $582.5 million in potential additional milestone payments. If approved by the FDA in the United States, MEI and Kyowa Kirin will co-promote zandelisib with MEI booking all revenue from sales. MEI and Kyowa Kirin will share U.S. profits and costs, including development costs on a 50-50 basis. Outside the U.S., Kyowa Kirin has exclusive commercialization rights and books all revenues from sales of zandelisib. Kyowa Kirin will pay MEI escalating tiered royalties on ex U.S. sales starting in the teens and is responsible for all incremental ex U.S. clinical development costs and all ex-U. S. regulatory CMC and commercial costs.

Importantly, based on the shared vision for the potential of zandelisib, the companies incorporated into the deal and agreed upon development plan designed broadly to evaluate zandelisib in patients with various B-cell malignancies, including in combination with other agents. We believe this best optimizes the potential for zandelisib for patients and provides value to our investors.

As an example of this shared vision, I can announce today that we have filed an amendment to the TIDAL study to evaluate zandelisib as a monotherapy in patients with marginal zone lymphoma, who have received 2 prior lines of therapy. We expect the enrollment to commence by around year-end. Similar to our approach with the TIDAL study in third-line follicular lymphoma, we are also considering the accelerated approval pathway for third-line marginal zone lymphoma indication, if supported by the data.

I should point out that this new arm in the TIDAL study will not affect our plans to file on the follicular lymphoma patients if the data warrants such. In addition to expanding the potential utility of zandelisib, as mentioned above, MEI retained the right to book U.S. sales, providing a foundation to extend the company's capabilities and build out our commercial capability. Of course, underlying this alignment and the broad vision for zandelisib is a strong and maturing data set supporting best-in-class potential as a monotherapy and in combination with other therapeutics for the treatment of B-cell malignancies.

Our most recent data update is from the ASCO 2020 Virtual Scientific Program reported from our Phase Ib study in a total of 57 patients including 36 patients with relapsed/refractory follicular lymphoma. This group of 57 patients is on the same zandelisib treatment schedule being evaluated in TIDAL, that is once-daily for 2 28-day cycles, and after that, daily dosing for 7 days followed by no therapy for 21 days in the following 28-day cycle.

The overall response rate in 36 follicular lymphoma was 83%. The median duration of response was not yet reached in all follicular lymphoma patients and across all subsets analyzed. The median follow-up in all the follicular patient subsets was -- when analyzed was about a year, and it ranged from 3 months to 27 months.

Importantly, efficacy is only 1 part of the equation for assessing a drug's potential utility with tolerability being the other. The data presented demonstrated that zandelisib has been generally well tolerated and -- in this study, and the incidence of adverse special interest, which are historically associated with this class of drugs, has been low with minimal increased toxicity observed over time. In fact, no grade 3 or greater adverse events of special interest was reported after cycle 3 and the discontinuation rate for any adverse event was only 7%.

We are in the process of preparing a publication of the data from the Phase Ib study and expect to have it submitted for peer review in the next several months.

Based on the data in the Phase Ib, this past March, we received fast track designation from the FDA. Fast track products address serious conditions show some advantage over any available therapy to meet an unmet medical need and are eligible for certain regulatory considerations, including a rolling NDA pre-review process and often receive priority review, if supported by the clinical data at the time of the NDA submission.

Now let me give you an update on the TIDAL study, the global Phase II trial evaluating zandelisib as a monotherapy for the treatment of adults with relapse and refractory follicular lymphoma after failure of at least 2 prior systemic therapies, including chemotherapy and an anti-CD1 antibody. Approximately 120 patients will be enrolled. Their primary efficacy endpoint will be the rate of the objective response rate to therapy within the first 6 months of treatment. Secondary endpoints include duration of response and tolerability of zandelisib. Subjects -- subject to the results upon completion of the TIDAL study, we are planning to seek an accelerated approval for zandelisib by the FDA. With respect to the impact of COVID-19, this pandemic that we're facing, on the TIDAL study, we were very proactive and successful to date in taking steps consistent with guidance from the FDA and other regulatory authorities to communicate with sites and investigators and in making accommodations to patients in order to maintain patients on study and preserve the overall integrity of the study.

With regards to enrollment, as previously disclosed, there was an impact. And while the extent of the impact remains subject to future developments, currently, our projections have us completing enrollment sometime in the first calendar quarter of 2021.

In Japan, Kyowa Kirin is actively pursuing a clinical strategy analogous to the TIDAL study to support a Japanese approval. We look forward to providing updates on those efforts over the next few months.

Further, we are currently in discussions with the FDA on the design of a global randomized Phase III study in patients with follicular and marginal zone lymphoma in combination with rituximab that we look forward to initiating sometime mid-2021. This study is intended to serve as a confirmatory study for TIDAL NDA under the accelerated approval pathway. It is also intended to support regulatory marketing approvals in other geographies.

Also ongoing as an arm in the Phase Ib study is the initial evaluation of zandelisib in combination with zanubrutinib, BeiGene's BTK inhibitor, under our clinical collaboration with that company. Subject to delays, also related to COVID-19, we expect to have an update on the combination sometime in the mid-2021.

The complete development effort to more fully explore zandelisib's potential across additional lines of treatment, other than other diseases like CLL, diffuse large B-cell lymphoma and mental cell lymphoma as well as in combination with other agents like rituximab and the BCL-2 inhibitors, is even more expansive, and we look forward to providing additional updates on these plans in the coming months as appropriate.

We believe that there remain important unmet medical needs across the B-cell malignancy landscape for a potential best-in-class candidate like zandelisib as a monotherapy and in combination with other treatments. Overall, we estimate the addressable market in these B-cell malignancies represent roughly 50,000 patients in the United States alone.

Given the broad opportunity, the progress in the zandelisib clinical program and the resources and expertise gained in connection with the Kyowa Kirin Alliance, we have also actively begun to focus on the stage build-out of our commercial infrastructure. To that end, this past year, we added strong commercialization expertise on our Board of Directors with the appointment of Cheryl Cohen this past April. Ms. Cohen has more than 25 years in the industry with a focus on sales and commercialization, including as the Chief Commercial Officer at Medivation.

I would now like to briefly update you on our other 3 pipeline programs. Voruciclib is our CDK inhibitor that we believe has potential to improve on existing treatments for B-cell malignancies and AML, particularly in combination with the BCL-2 inhibitor venetoclax. Voruciclib is an orally available CDK inhibitor differentiated by potent inhibition of CDK9 in addition to CDK6, 4 and 1. As well, it inhibits mix, a well-known transcription factor that is expressed at high levels in a significant proportion of human cancers. Currently, we are evaluating patients with hematologic malignancies in dose-ranging U.S.-based Phase I clinical trial designed to evaluate voruciclib dosing schedule before evaluating it in combination with venetoclax.

As might be expected, this program has been delayed by the pandemic, and we now look forward to updating you on this program later next year.

Next is ME-344, a novel and tumor selective mitochondrial inhibitor targeting the OXPHOS complex. As you may recall, we presented clinical data demonstrating the ability of ME-344 in combination with the anti-angiogenic antibody Avastin to reduce mean relative Ki67 levels in tumors of women with HER2-negative breast cancer compared to a control group of patients receiving Avastin alone. The next step for ME-344 is an advisory board we are convening later this year to consider our options that offer the most efficient path forward for the combination of ME-344 and anti-angiogenic inhibition, including the potential for clinical collaborations. We look forward to updating you as appropriate.

Now moving to our fourth clinical candidate, pracinostat, an oral HDAC inhibitor. Pracinostat was licensed by MEI to the Helsinn Group in 2016. As announced in July, a Phase III study of pracinostat in AML was terminated by Helsinn based on our findings from an interim futility analysis. Pracinostat continues to be evaluated in a Phase II trial in patients with high or very high risk MDS.

Helsinn has communicated to us that pending further evaluation, patients currently enrolled in the Phase II study are continuing treatment until they help them decide on the status of the overall program. The program status is wholly within the realm of Helsinn's rights under the license agreement, and any future steps in the pracinostat program will be at Helsinn's decision.

In sum, fiscal 2020 was successful in advancing both key business and clinical objectives, particularly regarding our lead candidate, zandelisib.

Before opening the call to your questions, I'd like to note some additional developments, including the appointment of Tamar Howson to our Board at the beginning of fiscal 2019. Ms. Howson is a highly experienced business development executive with more than 30 years in the industry, including Executive VP of Corporate Business Development at Lexicon and Senior VP of Corporate and Business Development at BMS.

Finally, as Brian noted earlier, we significantly strengthened our cash position over the course of this year. With the approximate $52 million from our December 2019 financing, about $21 million in proceeds from our ATM facility and the upfront payment for Kyowa Kirin, we started this current fiscal year with about $183 million.

Taking into account our current cash, plus the approximate $20 million we expect to receive sometime this year from the Japanese tax authorities, that's about $203 million a pro forma basis, which we believe provides a sufficient cash runway to see us through at least 2023.

In terms of upcoming milestones, we expect, most importantly, completion of enrollment in TIDAL and top line data. The initiation of the marginal zone arm, TIDAL, initiation of a Phase II Japan study with Kyowa Kirin, initiation of a confirmatory Phase III study in follicular lymphoma, zandelisib and zanubrutinib combination data, zandelisib NDA submission for accelerated approval in follicular lymphoma, voruciclib data from our ongoing studies, all the while, we build out our commercial infrastructure to be prepared for a potential zandelisib launch.

As is evidenced from our milestones just mentioned, to maximize our success, we intend to primarily apply our resources, our efforts and our focus to zandelisib in order to fully optimize its potential to deliver benefits to patients and value to our investors, all the while, while we explore the potential utility of our other pipeline candidates.

With that update, I think we are now ready for questions. Operator?

(Operator Instructions) We have our first question from Stephen.

Congrats on a pretty productive quarter. Dan, just kind of curious, so I think you're now kind of speaking to completing enrollment in TIDAL first quarter of '21. I guess, where you stand right now? What's the level of confidence in that estimate just kind of based on what the last few months of enrollment have looked like? And do you think that completing enrollment in the first quarter of next year would allow you to kind of unblind and top line that trial before the end of calendar '21?

Sure. Hi, Steve. Yes. So I'd say, as we said last time or the -- most recently, when as we were running TIDAL, our first and foremost goal was to open clinical sites around the world, which we kind of completed by December last year, and then starting in the January, early February time frame is when we started to see what we thought was a reproducible enrollment rate. And then all that crush obviously come March, April, May. I'd say in the last 2, 2.5 months, the rate of enrollment has now come back to the same level it was pre-COVID. And based on that and sort of our projections on where we need to be on a monthly basis, I think we're pretty comfortable of saying first quarter. Now of course, we'll have to see if the COVID situation gets worse, then that will definitely -- could definitely impact and -- but as we were sitting here right now, I think we're pretty comfortable saying first quarter next year with the caveats of the COVID situation.

In terms of the data, there's really -- because it is now a single arm, it was -- as you know, it was 2 arms of continuous versus intermittent schedule. So there's really no unblinding per se. Once the last patient is treated, as we mentioned, the response rate as the primary endpoint will be measured at 6 months following the last patient treated. It takes about a month to get the data in.

So sometime in the fall, we expect to have kind of top line data. Whether it's completely cleaned at that point or not is unclear. We're going to work very hard to get the data clean through sensor radiology as we go. And then, of course, we'll have to describe how we top line that data. We don't want to do anything that would jeopardize the review by the FDA. So we will do our best to communicate whatever information we can at that time, whether it's expectation or what. But we will do our best to convey some message prior to the filing.

Understood. And when you speak to the update in the zanubrutinib combination trial, I guess, being kind of mid-next year, is -- should we anticipate that, that update to just include dose escalation data? Or could there be a little bit of expansion cohort data within that update as well? And I guess, as you think about the future development program, you've spoken to the inclusion of marginal zone, the confirmatory Phase III, I know part of the Kirin attractiveness was to kind of really expand the clinical development program. So I guess, how much more should we anticipate on top of some of the incremental development plans that were announced this afternoon?

Yes, sure. Sorry, I think I heard 2 questions perhaps, maybe I didn't. I mean in terms specifically about the agenda, yes, specifically with regard to zanubrutinib, we are now expanding in patient numbers. This was a U.S.-based only trial. And so we were handicapped with COVID, unlike TIDAL, which is global, and so sites were coming in and out over that time. I think that we are now in a position where we will be able to have a lot more data coming in, in the next many months. And then we will move to these sort of cohort individual disease expansion arms. As you can tell by our Phase III strategy, we are striving to become -- to examine chemotherapy lacking options. So zanubrutinib, rituximab, perhaps venetoclax as well coming in the future. But it's not to say that we aren't cognizant that there could be other potential applications in concert with chemotherapy, although I think that has to be carefully weighed with the history of this class of drug.

So there are other studies that we will plan on rolling out in, hopefully in the near future, and -- but the big one clearly is completion with TIDAL and getting the Phase III up and running. Those are the ones that are really our #1 priorities as well as getting the marginal zone because that is a potential label expansion study as well.

I think that's 5 answers, but I'm not sure, Steve.

Our next question comes from Robyn from Trust Securities.

Truist.

It's SunTrust or it's Truist. All right, so just 3 questions -- there's just 3 questions. The first one is on TIDAL first. So as you know, there's been a lot of -- there have been a few CRLs lately that have made people little spooked by the FDA in general. Could you comment a little bit about when is your next conversation with the FDA? What is the bar -- we talk about efficacy a lot, so what is the bar for safety in TIDAL that you think would be acceptable for the FDA, so that we know that there might not be any hiccups for accelerated approval? And then I have some follow up.

Yes. Robyn, you can tell that I kind of stumbled on the name as well. We just call it zan like for San Diego, right? I think that -- so we are -- as I mentioned on the call, we are in conversation with the FDA about our Phase III plans, which, of course, have to incorporate our experience with the drug and tolerability. And the fact that we're going into earlier line of follicular lymphoma is of great interest and importance to the FDA because of the history of this class of drug. So they are well aware of our ongoing safety and efficacy data. We do give them regular updates in conversation.

I don't -- there is no written regulation about this -- the tolerability question that you raised, but I mean, clearly, what we have said all along is that the drug needs to be tolerable, sufficiently differentiated from the pack or it's not going to be commercially successful, probably. So I think that, that has been why we have focused our attention so much on the tolerability. I mean it is -- the class is efficacious. We happen to think we are probably more efficacious, but we really have focused our energies and our discussions on the safety aspect of it. And of course, TIDAL will tell if what we saw in Phase Ib is -- will read through to the registration package. And I don't -- I can't say anything more about it right now because that trial is still running. But I get -- I understand the question. And all I can say is that tolerability is our #1 focus, and we keep our eye on it very carefully.

Great. And then just 2 quick ones. So just for the publication, can you just remind us big picture on what the additional data will be in the publication versus what you presented at ASCO? How much additional follow-up to be in there? And then for ME-3444 (sic) [ME-344], your CDK, could you talk a little bit about your thoughts on your development strategy? Would you partner that? Would you do a big global partnership? If so, when? Or would you just do a strategic partnership where you're getting drug from someone else as you're doing a combination trial? Just trying to figure out your strategy for the pipeline.

Okay. Sorry, could you repeat the first one? I got lost on the second half of your question, I apologize.

Sure. For the Phase Ib publication, can you remind us what update and durability data, what will be new data we'll see in there?

Right. Yes. Sorry. Thank you. Yes, I think that the ASCO data, I'm not exactly sure what the true cutoff time was for that. We will certainly have several more months. There -- I don't believe there will be any new patients that were enrolled that weren't included in ASCO, perhaps there was 1 or 2. I think that for the most part, it will be just a longer follow-up from what we presented at the ASCO and the EHA meetings.

With respect to 344 and voruciclib, I think that we will go where the data tell us. I think that part of the -- having the resources now and wanting to have the commercial capability, the commercial capabilities, puts us in a position where we don't necessarily need to do large global partnerships in the future, although we always look at the numbers and if it makes more sense to do a larger deal or a more focused regional deals. It really just depends on where -- what the nature of the trials are, and where the data takes us. So I really can't say what our plan is right now. But certainly, having taking the onus of building a commercial team makes us want to think a lot about how we would commercialize and develop future assets.

Our next question comes from Jim from Wells Fargo.

It's Nick on for Jim. Just a couple of questions on the pipeline. Dan, in the -- let's call it, the square head.

That's what we call it.

The protocol was amended sort of around, I think, May to zanubrutinib. In December, 80-milligram dose has added in addition to 160 dose. So now that we're looking out perhaps an early year for the data, so why is the study notwithstanding COVID? Why isn't the study running so slowly? You're just being very, very careful about dosing here, it's still a solid safety profile or whatever it's called now, zandelisib.

Z.

Zandelisib.

Yes. It's a totally appropriate question, Nick. I think certainly, COVID has slowed us down. There's no question about it. I mentioned, it's a U.S.-based trial, and mostly the larger institutions that were really impacted by having to deal with their own COVID patients. So that is a problem. I think that from the outset, our advisers had always suggested, because they were -- most of them were involved in the early PI3 delta development with other agents, they were very cognizant of some of the problems that others had run into in doing their various combinations. And they really preached to us to be careful and to take it slowly and make sure we get both dose and schedule correct. Because the idea is that you may not need to have the highest dose monotherapy dose needed for each of them individually in order to do the combination. You may see that a synergistic effect, which would then, of course, reduce the potential for toxicity.

So I think the real -- that is the crux of it that we're going slowly, and we're looking at schedule and dose in order to see -- to make sure we can come up with a combination that makes sense. I mean we definitely want to move into earlier lines of therapy and challenge chemotherapy as our goal. And in order to go into earlier lines of treatment, we need to be very clean.

So I think that is the reasoning behind -- or the reason why this trial is moving slowly as -- in addition to being affected by COVID. It's sort of a 2 prong. But it's mainly driven by our desire to make sure we're getting it right and not having problems with the toxicity.

Next question comes from Adam Evertts from LifeSci Capital.

Just curious if you can give any additional color around the marginal zone lymphoma cohort in terms of expected number of patients? And maybe how long that might take to enroll?

Right. I think right now, we're contemplating in the amendment of 60 patients. This would be sort of an expansion of the -- our indolent lymphoma experience. So I think we're thinking about in that ballpark. These are not as available as follicular lymphoma patients are. So in terms of how long it would take to enroll those additional 60 patients if we started, say, year-end, I'm not quite comfortable saying right now until we kind of get a sense from the sites that we're working with. Sometimes these patients are siloed in other clinical practices and sometimes they're -- depending on the sites that we're going to. We are going to be taking this amendment to all the 100, whereabouts, clinical sites around the world that we have. So we're hopeful it will be a quick enrollment. But I just think it would be premature for me to give a projection just yet, Adam, until we know better on in terms of what the experience is with our clinical site.

Our next question comes from Yale from Laidlaw & Company.

I just want to follow-up a little bit on the previous one in terms of marginal zone lymphoma. Are you contemplating only the monotherapy or your contemplate potentially as a combo? As well as would you use the same regimen or you will do any changes on the regimen?

Yes. Hi, Yale, yes, great question. So I think I mentioned it, but if I didn't, I apologize. So the plan is in the current amendment that we'll start shortly is to do monotherapy as exactly the same as the TIDAL. It will be the same schedule, and it is in the third line as monotherapy. In the confirmatory study, with Rituxan, it will be both in follicular and marginal zone for full approvals.

Okay. Great. Maybe just one follow-up here, which is in terms of the TIDAL, if you get a chance putting up the data and reporting the top line presumably second half of next year, do you think you guys can get a slot for the ASH toward the end of the year?

Well, we'll certainly try.

Our next question then comes from Andrew from H.C. Wainwright.

This is Sudan Loganathan in for Andrew. So my first question was in regards to the confirmatory Phase III study design. I just kind of wanted to see what your thoughts were on that, what kind of bar do you want -- the FDA will probably want to see on efficacy and tolerability and also how many patients you may need for that for them to feel comfortable with that study? And then secondly, kind of touching on to the operating expenses for the fiscal year '21, due to some of the enrollments being pushed into the first quarter of '21 or into later 2021, is there any changes in that guidance basically?

Sure. So I'm not -- I think it would be premature since we are still talking to the FDA about the Phase III confirmatory study with Rituxan. This will be a controlled study. And so in terms of -- it's not just dollar base, the primary endpoint will probably be PFS. Of course, tolerability is always going to be on their mind. And as I mentioned in my comments, with the history of this class of drug suggest that the potential tolerability issues as you go up early. We don't feel like that is the case. We have not seen that in our experience, but our experience is, of course, is limited.

So in terms of tolerability, I really don't know what to say. But clearly, our expectation is, our hope is that it will be as tolerable as it is as what we've seen already. In terms of operating expenses, I mean, it doesn't -- it's not a significant pushout. It's not like more patients or more cost. There is more CRO cost because the time is. And -- but of course, remember that all of our costs since April, we've been sharing with Kirin -- Kyowa Kirin. So going-forward basis, I don't think that pushing out these time lines on the -- the 1 quarter time line on the TIDAL study is going to have a significant impact on our financials.

Our last question comes from Tom from BTIG.

So on the marginal cell cohort, can you give us a sense of where you are with FDA buy in that this is for accelerated approval? Or is that discussion part of the current Phase III discussions?

Right. So for accelerated approval, of course, it will always depend on the data and the available therapies at the time. So if -- in looking at what has preceded us in other agents and at other compounds, we believe that we've designed the study sufficiently that it would be open for a discussion on an accelerated approval. But beyond that, I'd be hesitant to say anything more. They are very well aware of our plans. They haven't seen the amendment so we are proceeding along that path. But clearly, as in any study, for an accelerated approval, it really -- the data will drive the discussion more than anything else, than anything else.

Okay. And then and kind of an open-ended question on voruciclib. Given the MYC angle and how broadly MYC is implicated, are you considering some sort of solid tumor basket trial? Is that compelling? And any thoughts on target tumors?

Funny you should ask that question, Tom. So yes, we are -- certainly that has not escaped our attention, I should say. I mean there's been an interesting preclinical discussions, several now regarding the role of MYC expression in RAS-mutated tumors, and not just the G12Cs. So that is something -- I mean, we know that voruciclib in preclinical studies is active in multiple different RAS-mutated tumors even in in vivo studies, or this is all preclinical. So it is something that we are carefully thinking about as we look at the potential for this drug, and we are doing some preclinical work around that to see if there's a there, there. And I'm hopeful that within -- in the coming months or certainly, sometime next year, we'll have a lot more to say about that. But certainly, that is one of the attractiveness of voruciclib compared to the specific MCL-1 inhibitors that are being developed that have no MYC, anti-MYC activity that voruciclib does based on its profile.

There are no further questions at this time.

Okay. Well then in wrap up, I just want to thank you all again for joining us today. I think we begin our new fiscal year in a very strong position with continuing a record of successful execution on our development programs and our business strategy. And we very much all look forward to reporting our progress to you across the entire portfolio in the coming quarters. So with that, I think we'll end the call, and I just wish you all good health, and please be safe. Wear your masks.

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.