MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2022 Results Conference Call September 8, 2022 5:00 PM ET
Company Participants
David Walsey – Senior Vice President and Corporate Affairs
Dan Gold – President and Chief Executive Officer
Brian Drazba – Chief Financial Officer
David Urso – Chief Operating Officer and General Counsel
Richard Ghalie – Chief Medical Officer
Conference Call Participants
Stephen Willey – Stifel
Robyn Karnauskas – Truist
Yale Jen – Laidlaw & Co
Nick Abbott – Wells Fargo
Operator
Good afternoon, and welcome to the MEI Pharma 2022 Fiscal Year End Conference Call. Please be advised that the call is being recorded at the Company’s request.
At this time, I would like to turn the call over to David Walsey, MEI Senior Vice President and Corporate Affairs. Please go ahead.
David Walsey
Thank you and good afternoon everyone and thank you for joining us today. After the market closed today, we followed our Form 10-K for the fiscal year ended June 30, 2022 with the Securities and Exchange Commission, and issued our financial results in corporate highlights press release. Both of which are available on our website at www.meipharma.com.
On our call today, we’ll provide a summary of financials from the fiscal year, ended June 30, 2022, and then review 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 meeting 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, 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 soon after its conclusion.
I’d now like you to, to introduce you to our speakers for today with me are Dan Gold, our President and Chief Executive Officer; and Brian Drazba, our Chief Financial Officer. Additionally David Urso, our Chief Operating Officer and General Counsel; as well as Richard Ghalie, our Chief Medical Officer are also with us today.
Brian will start with the summary of our financial results before Dan shares remarks reviewing the year and commenting on coming quarters. After that, we open the line for your questions.
I’ll now turn the call over to Brian.
Brian Drazba
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 our fiscal year 2022 with about $153 million in cash, cash equivalence and short-term investments with no outstanding debt.
For the year end of June 30, 2022, our net cash used in operations was $48.7 million compared to $52.4 million for 2021. The decrease primarily related to changes in working capital. Research and development expenses were $85.6 million through the year end of June 30, 2022, compared to 69.4 million in the prior year. The increase was primarily related to increased development costs associated zandelisib increased drug manufacturing costs and increased consulting fees to support our clinical trial activities.
General and administrative expenses were $30.5 million for the year end of June 30, 2022, compared to $24.4 million for 2021. The increase primarily related to increased personnel costs, professional services costs, and general corporate overhead expenses incurred during the year. MEI recognized revenues of $40.7 million for the year ended compared to $34.8 million in 2021. The increase in revenue related to increased reimbursement of expenses from Kyowa Kirin due to research and development activity related to zandelisib.
Net loss was 54.5 million or $0.44 per share for the year of June 30th, 2022, compared to a net loss of $41.3 million or $0.37 per share for 2021. We had 133 million, 152,045 shares of common stock outstanding at the end of June 30, 2022, compared with $112 million 614,643 shares as of June 30, 2021. Our adjusted net loss for the year ended June 30, 2022, excluding non-cash expenses related to changes in the fair value of our warrants, a non-GAAP measure was $75.2 million compared to an adjusted net loss of $59.4 million for 2021.
With that, I’ll turn the call over to Dan.
Dan Gold
Thanks, Brian. And thanks everyone for joining us this afternoon. I hope you all had an enjoyable summer. This past fiscal year was marked by several key events in our leads zandelisib program, starting with the announcement of the first patient dosed in our global Phase 3 COASTAL study. Shortly thereafter, we were very excited to report top line data from the Phase 2 TIDAL study demonstrating a 70.3% overall response rate in follicular lymphoma patients with at least two prior lines of therapy, about half of which obtained a complete remission.
On the safety and tolerability side at the data cut-off date, the discontinuation rate due to any adverse event in TIDAL was 9.9%. Notably, Grade 3 adverse events of special interest tended to occur in the first three cycles, which coincides with the period of daily continuous dosing in our intermittent dosing regimen. Recall patients that are administered zandelisib once daily for two 28-day cycles as a response induction regimen followed thereafter by once daily dosing for the first seven days of each subsequent 28-day cycle.
We now look forward to reporting complete TIDAL data at an upcoming medical meeting. It was very encouraging to see that the TIDAL data are consistent with the data from our previous Phase 1 experience, which was just published this July in the Lancet Oncology, should that consistency carry forward to patients administered zandelisib plus rituximab from the Phase 1b experience to patients being evaluated in COASTAL. We have the potential to provide a highly differentiated chemotherapy free regimen to patients that should provide significant benefit to patients.
Following our announcement of the TIDAL data in December, we successfully completed a follow-on offering, raising gross proceeds in excess of $50 million to support our current programs during a rather turbulent time in the financial markets. With the addition of this raise, we now estimate we have sufficient cash to fund operations for about two years. Despite a good start to the year, our success was tempered by the changes at the FDA, relating to its approach to the type of study designs acquired for potential accelerated approval under 21 CFR Part 314.500, Subpart H.
The change in approach to accelerated approvals was first communicated to MEI in March of 2022 meeting with the FDA and then expanded upon publicly communicated during an ODAC meeting this past April. At the ODAC meeting, the FDA communicated a change in position regarding the benefit and risk assessment of PI3-kinase inhibitors due to a class associated toxicity concern, stating they would no longer consider granting accelerated approval based solely on single arm studies.
Subsequently, the FDA communicated a new initiative they call Project FrontRunner, replacing its longstanding approach to accelerated approvals generally. This new initiative follows decades where the FDA granted accelerated approvals based on single arm studies to open early access to new cancer drugs generally for patients who’ve already tried several other regimens, including a number of PI3-kinase inhibitors.
In brief, under Project FrontRunner, the FDA has communicated its intent to consider support accelerated approval of cancer drugs, based on data from randomized studies, rendering data generated from single arm studies such as TIDAL generally insufficient in the eyes of the FDA to adequately assess risk and benefit. And thus, support an accelerated approval marketing authorization.
Accordingly, in our meeting with the FDA earlier this year, the agency discouraged the submission based on the Phase 2 single-arm TIDAL study and emphasized that MEI and our partner, Kyowa Kirin, continue our efforts with the ongoing randomized Phase 3 COASTAL study as planned. As announced in March and in line with the FDA’s recommendation, the companies do not plan to submit an FDA marketing application, based solely on the single arm Phase 2 TIDAL data.
The meeting earlier this year with the FDA was the first instance that the agency indicated that data from TIDAL would not be sufficient to support an accelerated approval. While the agency essentially closed the opportunity for submission based on the Phase 2 TIDAL study, it did emphasize that the companies continue their efforts to evaluate zandelisib in the ongoing randomized Phase 3 COASTAL study.
In addition, while the agency has stated that the safety of our 60 milligram intermittent dosing schedule appears reasonable, as recommended, we will continue our efforts to further support the current dose and regimen, as we continue to evaluate our existing data and consider any other additional efforts as appropriate to ensure we address any concerning the selection of our current zandelisib dose and schedule.
As to the COASTAL, you may recall, this is a randomized Phase 3 study comparing zandelisib plus rituximab or anti-CD-20 to standard of care chemo immunotherapy. In patients with relapse to refractory follicular or marginal zone lymphomas who have received more than one or more prior lines of therapy. COASTAL is intended to support marketing applications in the U.S. and globally with our partner Kyowa Kirin. The first patient, as I mentioned, was dosed last August.
The study now has over 135 sites activated worldwide, and while COVID has impacted the study and sites have closed in response to the war in Ukraine, we are continuing to add new sites to meet our objective of completing enrollment by the end of the year 2024. These efforts are at the forefront of our corporate focus although various factors may impact our timelines and could push expected completion beyond the 2024 timeline.
With its pharmacological properties differentiating it from other PI3-kinase inhibitors that have been evaluated previously, we believe zandelisib may be ideally suited to be used eventually both as monotherapy or in combination with other important treatment modalities in various B-cell malignancies. Thus, in addition to our ongoing efforts to treat patients with follicular or marginal zone lymphoma, we are also evaluating zandelisib in patients with CLL, MCL and DLBCL in combination with venetoclax of BCL-2 inhibitor plus anti-CD-20, zanubrutinib, a BTK inhibitor, and RCHOP respectively.
Finally, in an effort to leverage the immunomodulatory properties of zandelisib, we are also evaluating potential opportunities in combination with other hematologic treatment modalities as well as in combinations in solid tumor settings. Beyond this zandelisib program, we also share data updates from our two clinical-stage programs as well as at various medical conferences over the past 12 months.
With respect to voruciclib, our orally available CDK-9 and MYC modulating drug candidate, we reported data from the Phase 1 data. Phase 1 study demonstrating the identification of a well tolerated dose and regimen, as well as demonstrating initial efficacy signals. We look forward to updating you on that progress from the combination phase of this study, which is now open to enrollment where we will add voruciclib to venetoclax in patients with relapsed refractory AML, and then subsequently in patients with B-cell malignancies.
With respect to the ME-344 program, we reported preclinical data at our medical meeting, demonstrating that our candidates enhanced the anti-leukemic activity also of venetoclax against AML cells including venetoclax resistant AML. While we may consider further exploring applications for ME-344 in hematologic cancer, our current efforts are focused on solid tumors. Specifically the ME-344 program will be advancing into the next phase in development in the next few quarters to evaluate our candidate plus the VEGF inhibitor Avastin in patients with relapse and refractory colorectal cancer.
From the corporate perspective, over the course of this last year, we strengthened our team with some key hires including Anne Frese, as Chief People Officer; Yomara Gomez, as Senior Vice President of Quality; and Alejandro Ricart, as Senior Vice President of Clinical Development. Additionally, we added Sujay Kango to the Board who provides significant commercial and industry experience.
Together with Kyowa Kirin, we remain committed to the ultimate potential of zandelisib to address important medical needs as a single agent or in combination with other therapies to provide physicians and their patient important new treatment options. While the FDA’s sudden changing approach is undoubtedly a disappointing factor to our plans, it’s important to realize that our clinical program continues to deliver a consistent and positive data set that suggests the opportunity to ultimately have a very strong clinical profile and supports our investment in this program.
I am confident given the knowledge and experience of the team here at MEI and our partner Kyowa Kirin, along with our healthy cash position that we have set a good course for getting zandelisib to patients and building value for our shareholders. As we advanced this zandelisib program in general and in particular COASTAL, over the coming quarters, we look forward to providing updates as follows. We plan to provide an update on the complete TIDAL data likely at the upcoming medical meeting by the end of the calendar year.
Additionally, we look forward to dosing the first patients in the CORAL study evaluating zandelisib plus rituximab and venetoclax in patients with relapse CLL. And we look forward to the potential for certain additional investigator initiated studies to accompany the already ongoing investigator study of valuing zandelisib plus RCHOP in first line DLBCL. On the voruciclib front, we plan to share an update at on the Phase 1 program in particular on the combination with venetoclax in patients with AML, probably toward the end of the next calendar year.
For the ME-344 program, we look forward to initiating the Phase 1B study evaluating the combination with Avastin in the relapsed colorectal cancer patients in the first quarter of the calendar2023 and sharing initial data in and around the year end. In summary, we’ve achieved multiple successes over the last year and I am proud of the progress across our pipeline.
While the FDA’s adoption of Project FrontRunner outline the new requirements for accelerated approval necessitates, a reconfiguration of our zandelisib program, I think our ultimate success and the value we can deliver to our stakeholders can best be measured by how we approach and overcome obstacles to achieving our mission to improve outcomes for patients with cancer through our efforts to develop and commercialize novel best-in-class therapies.
I’ll now ask the operator to provide the instructions for asking questions, and then open the call for Q&A.
Question-and-Answer Session
Operator
We will now begin the question-and-answer session. [Operator Instructions] And our first question will come from Stephen Willey of Stifel. Please go ahead.
Stephen Willey
So, I think, last time we had had a conference call. There was some suggestion that you and Kyowa were going to try to engage FDA surrounding a potentially expeditious path to approval that may not necessarily be accelerated, but might allow for some data submission, I guess, ahead of a primary endpoint. So, is it safe to say now kind of post this Project FrontRunner mandate that FDA has pushed out since those comments were made that, it’s more likely than not that we see a final primary endpoint read on COASTAL?
Dan Gold
Yes, hi, Steve. I guess I was following you right up to the end of the question. I think that our plan — I mean, if you recall the Project FrontRunner, the FDA has said that they are still willing to entertain accelerated approval as an example based on randomized data and then the final primary endpoint as full approval.
We are continuing efforts to pursue this dialogue with the FDA to really understand what Project FrontRunner is intended and whether the randomized data from the COASTAL study could be used in some sort of an accelerated filing with a follow-up of PFS for the final endpoint, which is the final — the primary endpoint of the study. So, I think that, we will definitely keep you posted as we make progress on those discussions, but we do continue to dialogue with the agency on this very issue.
Stephen Willey
Okay. And then maybe just as a follow-up. I know one of the other FDA mandates here is project Optimus and I believe you had received some feedback regarding the agency’s desire to maybe see some additional dose exploration work. So is that something that you guys plan on initiating here at some point? Can you maybe just speak to how you plan on addressing some of those FDA concerns/feedback?
Dan Gold
Yes, that’s a really important and it’s a very proposed question, Steve. Thanks for asking. So just to — if you recall, we have done dose exploration in the program. We did start at a dose of 60 milligrams, which was much lower than what we were counseled to do based on our animal safety data. We went up by 60 to 120 and 180, and without seeing any change in safety signals and no importantly no change in efficacy signals. So, we drop back down to 60.
Further than, as we continue to study on the continuous and noted the toxicity profile following continuous doses, we in fact cut the dose again by 75% by moving to the intermittent dosing schedule. So we do think that, we have addressed a number of the FDA’s concern. However, as we have learned from the ODAC and from subsequent FDA postings that, the FDA is very concerned about the balance between efficacy and safety. It isn’t just about maximizing efficacy.
We think that we have done that. We have a large data set now of looking from TIDAL, as well as from our Phase I studies, as well as our partners’ Kyowa Kirin in the Mirage study. So, we have a very robust data set that we’re now analyzing for exposure response as well as exposure safety to see, if there really is an association. We believe unlike some of the other PI3-kinases, which are given on a daily dosing that you cannot achieve this balance unless you get to a non-efficacious dose.
But with the intermittent dosing, we think we may be able to achieve it. So that’s our first goal is to evaluate that data. And if need be, you can then consider other potential ways of doing some quicker studies and just making that final point in patients. But our first goal is to evaluate the data we have in hand. And recall, the FDA did say that, they felt that the 60 milligram dose, especially on the intermittent dosing schedule appeared reasonable and just asked us to do further work to justify that dose and schedule.
Operator
The next question comes from Robyn Karnauskas of Truist. Please go ahead.
Robyn Karnauskas
I know the focus is going to be on zandelisib for the call. Can you help me understand the cadence of news flow outside of that regarding our pipeline, including your 344 as well as other products, like help us understand like what we can look at over the next 12 months to see his catalyst for the Company?
David Walsey
Yes, that’s great question Robyn. Thanks for asking it. So, as we mentioned — I will just say voruciclib program because it is in recent relapsed/refractory AML specialty and the B-cell malignancies. It was deeply impacted by COVID and — but it’s definitely on track as we reported the — we’ve completed the dose escalation as monotherapy as requested by the FDA. We reported that data at ASCO or DASH.
And we now have — we have an agreement with the FDA on protocol. The protocol is now at IRBs and we expect it to be enrolling patients very shortly in AML patients first. So our hope is that there is a lot of — there is appears to be a lot of interest in the AML community on this particular combination. So, we’re hoping that the enrollment of the dose escalation enrollment with venetoclax will go rapidly, and we definitely look forward to being able to at least report some initial data from that in the coming year.
I think the important issue to point out about the CDK-9 inhibitors is there has been historically a significant amount of marrow toxicity, which combined with venetoclax is probably not a good recipe. We have never seen that to any significant degree with voruciclib. So the question, I think it’s going to be a little hard to tease out at AML because it is a marrow disease and treating with venetoclax, but certainly, we will start to get some information if these two drugs play well together and hopefully we’ll start to see some signals of activity as well.
So, for that program, I think that’s really the going to be the one that we’re focusing on is looking at the profile of the combination and then getting the final cohort completed in the B-cell arm. We do have a nonclinical collaboration with Matt David at the Dana-Farber, where he’s actually looking at inhibition of various important markers like MYC and MCL1 from blood samples from these patients. And we hope that that’ll help us interpret the dose and schedule that we’re using in these studies. So, I think in the coming year, we’ll have a lot of information on voruciclib especially in combination of venetoclax.
And then with 344, we’re finally at the point now we have a great group that we’re working with. It’s a — essentially a cooperative group that does a lot of early studies in this case in particular in third line colorectal. Everything is set to go. And so, we’re really hopeful that we’ll get those patients started in the first quarter next month — next year. And presumably, that should go pretty quickly because these patients are of there. And there’s not a lot of good available treatment with him. So I think, it’s going to be a very data rich year for us with our pipeline as well as zandelisib and some of the other studies that we hope to be rolling out in the near future.
Robyn Karnauskas
That’s helpful. One other big broad question, I don’t want to take up too much time in the call. People have questions, but you bring up two points, number one, the FDA. Do you think there are more changes in how they view development on for drugs in this space? Because you’re probably one of the few companies that have given that much color and you actually are in the midst of it.
And second, when you think about small molecule development in the face of the new requirements for the government with only nine years, like, what are you hearing from people who might want to collaborate about the struggles or thought processes and how you actually do that? How you act instead of going short, first line versus, or early line versus later line, are you seeing that as well with your partners?
Dan Gold
It’s a very packed question. I mean, I think, the first is about the space specifically. I mean, clearly, many of us have dialed into the ODAC presentation — FDA’s presentation. I mean, it is interesting that they — even though there is concerns and there are absolutely valid concerns. We think that zandelisib solves a lot of the problems that the previous entrance had. But nonetheless, there is certainly that concern at the FDA.
The FDA still has not formally pulled any of the formal approvals. Their two companies did voluntarily pull their accelerated approvals. But certainly, the other entrants that have been on the market are still on the market. So I’m not — I mean, I think there is a heightened concern, because the FDA was seeing signals that it didn’t like with different drugs of the same class.
We’ve always emphasized that we are actually not part of the chemical class of all the other entrances nor do we use our drug in a way that the others do based on our dose and schedule. So we’re hopeful that the FDA will evaluate us as any other drug rather than as a member of a class. And that’s what we alluding to Steve’s question. That’s what we hope to gain some clarity with the agency at the appropriate time.
In general, I mean, I think that the FDA is laying down some new ground that they’re encouraging sponsors to think about moving up in line of therapy, but in a randomized fashion, especially with combinations. I think, it’s a — it’s going to take a lot of time for all of us. And we have all three of our pipeline are small molecules.
So it is going to take some rethinking about clinical design, and how to satisfy the new mandates without making these studies take so long, especially the field that we’re playing in with at least follicular, it’s basically an orphan disease to some extent. And so getting patients and doing big studies that are being required, it does provide some challenges, but it’s what we signed up for. So we just have to learn how to accommodate the agency’s needs.
Operator
The next question comes from Yale Jen of Laidlaw & Co. Please go ahead.
Yale Jen
Good afternoon and thanks for taking the questions. Just going to start with housekeeping ones that, since the last quarter, the top line number is quite different from previous three. So starting the new fiscal years, is there any sort of suggestion or guidance to what we are looking for remaining for the fiscal 2023?
Dan Gold
I’m sorry, Yale. I’m not quite sure what you mean the top-line, the cash number?
Yale Jen
No, the revenue number and this quarter as compared to the previous three quarter is significantly lower, actually, the negative. So, I’m just curious what kind of quarterly top-line in general we should think about for fiscal ’23.
Dan Gold
Yes. I mean, yes, in large part the revenue reporting is really a function of our reimbursements, our cost sharing with KKC. So as the clinical activity ramps up or slows, it’s just reflected. It’s more of an accounting treatment than anything else. I mean, we did have a few milestone payments that came in, which I don’t think are counted as revenue. So, the revenue is really more of a reflection of the reimbursements in the way that the agreement is set up with KKC. So I think it’s pretty much straight. It may fluctuate quarter-to-quarter, but it’s pretty much consistent overtime, as our clinical activities either increase or decrease. TIDAL is unwinding down whereas COASTAL is ramping up.
Yale Jen
Okay, great. And then maybe two quick ones. The first one is the TIDAL study the sort of full top-line data. Should we consider that as ASH of this year or maybe there is other venues we could think about?
Dan Gold
Well, I think that ASH is always a very appropriate meeting for us, especially for the patient population that we treat. So I think that it’s quite reasonable to expect that, if the committee deems it warranted and a value that we would like to be able to report the final top-line data at a meeting like ASH, yes.
Yale Jen
And then maybe the last one a tuck-in here is for the [indiscernible] study. Any update or any thoughts, anything which you can review regarding the enrollment, patient enrollment status or situations at this point?
Dan Gold
Yes. I mean, well, in general, we don’t usually give numbers enrollment and I won’t right now. That’s why — as we have said in the past, the most critical thing you can do early in a clinical trial especially of this size and magnitude is get your sites open and initiate it, so they can start screening and treating patients. That’s where all of our efforts or the majority of our efforts have been over this past year.
As I mentioned, we are now open in over 135 sites all over the world essentially or almost, and we continue to open new sites. Hopefully, that will come to an end at some point soon. But we do continue to open more sites, and so that our trajectory of enrollment will continue to grow and will meet our objective of completing in ’24.
Operator
[Operator Instructions] And our next question will come from Nick Abbott of Wells Fargo. Please go ahead.
Nick Abbott
First one then, when do you expect Kyowa to report data from the Japanese Phase 2 trial of zandelisib, advanced lymphoma? And is the intention for Kyowa still to submit these data for full approval?
David Walsey
Right, Nick. Hi. I don’t believe that Kyowa has previously publicly stated what their plan was for announcing the data. I believe that the enrollment is completed and they’re doing their assessments. They intent — their intent in running that study was to seek a full approval. They don’t — I don’t know that they even have an accelerated approval mechanism, but their intent was always to seek a full approval in Japan.
I’m not sure exactly what their true — their timelines are for doing that now, but I think that we should know — and not too long what their intentions are, but they operate in a different way than we do here. And so, all we know is that to your question is that is their intent is to file when they ran that study was to file for full approval and to do it when they’re ready. I guess is the best way of saying it.
Nick Abbott
[indiscernible] in clinical trials have gone they completed accrual last October, 61 patients. So it’s a reasonably, a reasonable size trial and they’re sort of going to have 12 months of follow up data here in the fourth quarter.
David Walsey
Correct. Yes.
Nick Abbott
And then, I know you said you in discussion with FDA, have you made a proposal to FDA on revising COASTAL or revising the statistical analysis plan for COASTAL? Or is that something you’re still working on?
David Walsey
Right. So, again, I don’t — typically, we don’t like to discuss in depth what our operationally, how we approach our discussions with the FDA. It just to be give you a little color, it’s not a straightforward as it might appear, because as we know, one of the concerns that the FDA has raised in general, but in particular about this class is mortality. And they acknowledge that these are rare events. So how one does the statistical analysis around that and the penalties one may pay for taking a look or not? It’s very complicated.
We’ve spent a lot of time with statisticians and former FDA consultants, really trying to get our arms around all the issues so that we can have the most meaningful discussion with the FDA as possible. And that said, we do look forward to letting — to articulating once we’ve had those discussions and what the outcomes are. We will look forward to articulating that to you in as timely fashion as possible, but I guess I think that’s about as deep as I’m comfortable going with that question.
Nick Abbott
Sure. That’s good. Thank you. And then for me, there was this recent peer review publication for use of a PI3-kinase delta inhibitor neoadjuvant therapy in the clinic in head and neck cancer. They saw T-reg depletion, which is what they were obviously using the drug for, but was too toxic dose continuously and so part of the publication was also on preclinical data using intermittent dosing. So what do you think of these data? How interested is MEI in repeating the trial using intermittent dose zandelisib? Obviously of note is that these authors were around the — many of these authors were just around the corner from new scripts.
Dan Gold
Yes. So, it hasn’t escaped our attention, Nick, as you might imagine. In fact, the authors of that particular paper that you’re mentioning are have a faculty appointments here in La Jolla. So we know them. We were actually very heartened because I think it sort of supported our thesis that continuous dosing is going to be too toxic, especially as they pointed out in patients who are less heavily pretreated in their head neck experience.
And for them to see that intermittent dosing seems to be really important. I think that was very heartening to us. And I think as we have said previously, we have done some, a fair bit of preclinical work on dosing and scheduling in combination with PD-1 antibodies for example in models where CTLA-4 or T-regs are appear to be important in solid tumor setting.
And we do feel that with the known property of delta and its importance in regulatory T-cells could be taken advantage of or with an appropriate scheduling as a way of very surgically inhibiting T-regs in solid tumor setting as well as in B-cell malignancy setting. So I think, that we’re very interested in this, as I said, we know this group very well. And I think, for now, I’ll just say, stay tuned. This is on our radar.
Obviously, we don’t want to lose focus about COASTAL, but certainly we do think that there is significant opportunities to be had by exploring the immunoregulatory aspect of PI3 delta expression, because it is important in multiple different facets and T-regs and in homing and micro environment. So, we think that very analogous to the sort of lenalidomide situation where it’s really an immunomodulator. We really do want to explore the possibility of taking advantage of zandelisib in that respect.
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Dan Gold for any closing remarks.
Dan Gold
Thank you. And thank you all again for the time you spent with us today. We do look forward to continuing to share our progress as we advance all of our programs. And we wish you the best for the rest of the day and your coming weekend. All the best.
Operator
The conference is now concluded. Thank you for attending today’s presentation and you may now disconnect.
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