MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2020 Earnings Conference Call September 9, 2020 5:00 PM ET
David Walsey – Vice President, Investor Relations and Corporate Communications
Brian Drazba – Chief Financial Officer
Dan Gold – President and Chief Executive Officer
Conference Call Participants
Robyn Karnauskas – SunTrust
Adam Evertts – LifeSci Capital
Yale Jen – Laidlaw & Company
Sudan Loganathan – H.C. Wainwright
Tom Shrader – BTIG
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 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 review progress in our programs and business over the last year. We’ll then open the call up to your questions.
Before we get started, I want to call your attention to the fact that this conference call may contain 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; 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 with you then commenting on the coming quarters. After that we’ll 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 our 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 the fiscal year 2020 with about a $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, 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 Helsinn license agreements. The adjusted net loss for the fiscal year ended June 30, 2020, excluding non-cash 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 of common shares outstanding as of June 30, compared with 73,545,000 shares as of June 30, 2019.
In summary, we started 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 2 title study evaluating patients with relapsed or refractory follicular lymphoma that is intended to support an accelerated approval marketing application with the FDA.
Before reviewing our achievements in the MEI-401 program and providing some insights on what to expect in the coming quarters, today we are sharing the name issue to MEI-401 by the International Nonproprietary Names or INN Programs it’s zandelisib, Z-I-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 promotes 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 teams 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 company is incorporated into the deal and agreed upon development plan designed broadly to evaluate and 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 title study to evaluate zandelisib as a monotherapy in patients with marginal zone lymphoma who have received two prior lines of therapy. We expect the enrollment to commence by around year-end, similar to our approach with the title 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 title 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 1b 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 title that is once daily for two 28 day cycles and after that daily dosing for seven 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 analyzed – when analyzed was about a year and it ranged from 3 months to 27 months.
Importantly, efficacy is only one 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 in this study, and the incidence of adverse of special interests, 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 Interests was reported after cycle three 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 1b study and expect to have it submitted for peer review in the next several months. Based on the data in the Phase 1b, this past March, we receive 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 title study. The global Phase 2 trial evaluating zandelisib as a monotherapy for the treatment of adults with relapse and refractory follicular lymphoma after failure of at least two 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 six months of treatment.
Secondary endpoints include duration of response and tolerability of zandelisib. Subject to the results upon completion of the title 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 all facing, on the title study, we were very proactive and successful today 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 our enrollment sometime in the first calendar quarter of 2021. In Japan, Kyowa Kirin is actively pursuing a clinical strategy analogous to the title 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 3 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 title 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 1b 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 explores zandelisib’s potential across additional lines of treatment other than other diseases like CLL diffuse large B-cell lymphoma and mantle cell lymphoma, as well as in combination with other agents like rituximab and the B-cell 2 inhibitors is even more expensive 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 this zandelisib clinical program and the resources and expertise gained in connection with the Kyowa Kirin alliance, we have also actively gotten 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 three 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 CDK-9, in addition to CDK, six, four and one. As well it inhibits MYC, 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, and dose ranging U.S. based Phase 1 clinical trial designed to evaluate Voruciclib dose and 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, our 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 main 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’re 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 3 study of pracinostat and AML was terminated by Helsinn based on our findings from an interim futility analysis. Pracinostat continues to be evaluated in a Phase 2 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 2 study are continuing treatment until Helsinn decides 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 and advancing both [keepers 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, but 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 authorizes, that’s about 203 million on 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 title and top line data. The initiation of the marginal zone arm entitle, initiation of a Phase 2 Japan study by Kyowa Kirin, initiation of a confirmatory Phase 3 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 potential zandelisib launch.
As is evidence 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?
Thank you. [Operator Instructions] We have our first question from – Stephen, your line is open.
Hi, good afternoon. Thanks for taking the questions and congrats on a pretty productive quarter. Dan, just kind of curious, so, I think you’re now kind of speaking to completing enrollment and title, first quarter of 2021. I guess where you stand right now? What’s the level of confidence in that estimate, just kind of based on the last few months of enrollment that look like? And do you think that, you know 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 2021?
Sure, I see. Yeah. So, I’d say, you know, as we said last time, or the, you know, most recently when, as we were running title, 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 timeframe is when we started to see what we thought was a reproducible enrollment rate. And then all that crash obviously, come March, April, May. I’d say in the last two, two and a half 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 than that could definitely impact, and – but as we’re sitting here right now, I think we’re pretty comfortable seeing 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 two arms, 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 six 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 cleaned through central radiology as we go. And then, of course, we’ll have to decide how we topline 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, you know, 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 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, you know, the future development program, you know, you’ve spoken to the inclusion of marginal zone, the confirmatory Phase 3, I know, part of the Kirin attractiveness was the 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]? Thanks.
Yeah, sure. So, I’m sorry. I think I heard two questions. Perhaps maybe I didn’t. I mean, in terms specifically about the agenda. Yeah. 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 with all 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.
You know, as you can tell by our Phase 3 strategy, we are striving to examine chemotherapy, lacking options, so zanubruti and rituximab perhaps venetoclax as well coming in the future. But that’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, with – there are other studies that we will plan on rolling out and hopefully in the near future, but the big one clearly is completion with TIDAL and getting the Phase 3 up and running. Those are the ones that are really our number one priorities, as well as getting the marginal zone because that is a potential label expansion study as well. I think that’s five answers, but I’m not sure Steve.
Thanks for taking the questions.
Our next question comes from [Robyn from SunTrust Securities].
Hi, guys. It’s SunTrust.
It’s okay. I’m getting confused by your drug name as well, alright. You always have [indiscernible], so it’s confusing me. All right. So, this is a question on TIDAL first. So, as you know, there’s been a lot there’s been a few [indiscernible] lately that have made people a little spooked by the FDA in general. Could you comment a little bit about, you know, when is your next conversation with the FDA? What is the bar – you talked about efficacy a lot, but what is the bar for safety entitled that you think would be acceptable for the FDA so that we know that there might not be any hiccups for solid approval? And then I have some follow ups?
Yeah, hi, Robyn. You can tell that I kind of stumbled on the name as well. We just call it [zan] like for San Diego, right. You know, I think that – we are as I mentioned on the call, we are in conversation with the FDA about our Phase 3 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 drugs. So they are well aware of our ongoing safety and efficacy data. We do give them regular updates when 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 1b is – we’ll read through to the registration package. And, you know, I don’t, I can’t say anything more about it right now because that trial is still running, but I guess I understand the question and all I can say is that tolerability is our number one focus and we keep our eye on it very carefully.
Great. And then just two quick ones. So, just for the publication, can you just remind us a picture of 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-34, 44 on 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 combinations trial, so 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.
For the Phase 1b publication…
…minus what, updated durability data, what will be new data we will see in there?
Right. Yes. Sorry. Thank you. Yeah, I think that the ASCO data, I’m not exactly sure what the true cut-off 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 one or two, but I think that for the most part, it will be just, you know, a longer follow-up from what we represented at the ASCO and the [indiscernible] meetings.
With respect to 344, and voruciclib, I think that we will go where the data tell us, you know, I think that part of the – having the resources now and, you know, wanting to have the commercial capability – building the commercial capabilities puts us in the 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 what the nature of the trials are and where the data take us. I really can’t say what our plan is right now, but certainly having, you know, taking the onus of building a commercial team makes us want to think a lot about how we would commercialize and develop future assets.
Got it. All right, thanks, guys.
Our next question comes from Jim Birchenough from Wells Fargo.
Good morning. It’s Nick on for Jim. Couple of questions on the pipeline, and Dan in the, let’s call it the squared…
That’s what we call it.
The protocol was invented sort of around I think May [indiscernible] in December 30 milligram dose [indiscernible] in addition [to the 160]. So, now that we’re looking out in about a year of the data so why is the study notwithstanding COVID? Why is the study running so slowly? You just being very, very careful about the dosing is [indiscernible] the safety profile of whatever it’s called now, [zandelisib]?
Yeah, it’s totally appropriate question, Nick. I think, you know, certainly COVID has slowed us down. There’s no question about it. As I mentioned, it’s a U.S. based trial, and mostly it’s larger institutions that were really impacted by having to deal with their own COVID patients. So that is a problem. I think that, you know, from the outset, our advisors 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 they, you know, 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 will 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 because why this trial is moving slowly in addition to being affected by COVID. It’s a sort of a two prong, but it’s mainly driven by our desire to make sure we’re getting it right and not having problems with the toxicity.
Okay, thanks Dan.
Next question comes from Adam Evertts from LifeSci Capital.
Great. Thanks for taking the question, guys. 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 is would be, sort of an expansion of the, our indolent lymphoma experience. So, I think we’re thinking about in that 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 I – 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 taking this amendment to all the hundreds thereabouts, clinical sites around the world that we have. So, we’re hopeful it’ll 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 experiences with our clinical side.
Fair enough. Appreciate that. Thank you.
Our next question comes from Yale Jen from Laidlaw & Company.
Good afternoon and thanks for taking the questions. 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 you’re contemplating potentially as a combo, as well as would you use the same regimen or you will do any changes on the regimen?
Yeah. Hi, Yale. Yeah, great question. So, I think I mentioned it, but if I didn’t, I apologize. So the plan is in the current amendments that will start shortly, is to do monotherapies, exactly the same as the TIDAL. It’ll be the same schedule and it is in the third line as monotherapy. In the confirmatory study, with [rituximab], it’ll be both in follicular and marginal zone for full approvals.
Okay, great. Maybe just one follow up here which is in terms of the title if you get a sense for the thing of the data and reporting the topline is only 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’re certainly trying.
That’s a good answer.
Our next question comes from Andrew Fein from H.C. Wainwright.
Yes, thank you for taking my questions. This is Sudan Loganathan in for Andrew. So my first question was, in regards to the confirmatory Phase 3 study design, I just kind of wanted to see what your thoughts were on that. You know 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, you know, for the fiscal year 2021, due to some of the enrollments being pushed, you know, into, you know, the first quarter of 2021 or, you know, into later 2021, is there any changes in that guidance basically?
Sure. I think it would be premature since we are still talking to the FDA about the Phase 3 confirmatory study with [rituximab] and this will be a controlled study. And so in terms of it’s not just already 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, you know, the history of this class of drugs suggest that there are 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, you know, 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’s not a significant push out, it’s not like more patients are more cost. There’s more CRL costs, 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 in a going forward basis, I don’t think that pushing out these timelines on the one quarter timeline on the title study is going to have a significant impact on our financials.
Alright, thanks. Appreciate it.
Our last question comes from Tom from BTIG.
Hi. Thanks for taking the call. So on the marginal sell 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 3 discussion?
Right. So, you know, for accelerated approval, of course, it will always depend on the data and the available therapies at the time. So, you know, if, in looking at what has preceded us and other agents and other compounds, we believe that that we design this study sufficiently that it would be open for a discussion on accelerated approval, but you know, beyond that, I’d be hesitant to say anything more. They are very well aware of our plans. They have seen the amendment. So, we are, you know, 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 – then anything else?
Okay, and then, 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, yeah, you know, we are certainly that that has not escaped our attention, I should say. I mean, there’s been Interesting preclinical discussions, several now regarding the role of MYC expression in KRAS mutated tumors and not just the G12C’s. So that is something – I mean, we know that for Voruciclib in preclinical studies is active in multiple different KRAS mutated tumors, even in in-vivo studies 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 [indiscernible]. And you know, I’m hopeful that within the – in the coming months or you know, certainly sometime next year, we will have a lot more to say about that, but certainly, that is one of the attractiveness of Voruciclib compared to those specific MCL-1 inhibitors that are being developed that have no anti-MYC activity that Voruciclib does based on its profile.
All right, thanks. I’ll keep asking the question.
Okay. I’ll keep giving the same answer.
There are no further questions at this time.
Okay. Well, than in wrap-up, I just want to thank you all again for joining us today. You know, I think we begin our new fiscal year in a very strong position with continuing a record of successful execution on our development programs in our business strategy. And we very much will 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.