Q4 2021 MEI Pharma Inc Earnings Call
Good afternoon, and welcome to the Emmy I Pharma 2021 fiscal year end conference call.
I supposed to call as being with the company.
At this time I would like to turn the call over to David Wallace E. M D. As senior Vice President Corporate Affairs. Please proceed.
Thank you good afternoon, everyone and thank you for joining us after the market closed today, we filed our Form 10-K for the fiscal year ended June 32021, with the Securities and Exchange Commission and issued our financial results and corporate highlights press release, both of which are available on our website at www <unk> pharma Dot com.
On our call today, we will provide a summary of financials from the fiscal year ended June 32021, and then review progress in our programs and business over the last year.
We'll 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 Securities Litigation Reform Act of 1095, you should be aware that our actual results could differ materially from those contained in its forward looking statements which are based upon.
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 relatively soon after its conclusion.
Now I'd like to introduce you to our speakers for today with me are Dan Gold, our President and Chief Executive Officer, and Brian <unk>, Our Chief Financial Officer. Additionally, David <unk>, Our Chief operating Officer and General Counsel is also with US today Brian.
Brian will start with a summary of our financial results before Dan shares your Mark for viewing the year, 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.
Ill provide a brief overview of financial results for more detailed information regarding our financial results I invite you to review our 10-K filed earlier today.
I am pleased to report that we finished fiscal year 2021 with about $153 million in cash cash equivalents and short term investments with no outstanding debt.
For the year ended June 32021, net cash used in operations was $56.0 million compared to $48.0 million for 2020, excluding upfront cash payments, we received from Tijuana Karen.
The increase primarily relates to increased costs associated with our clinical development programs.
Research and development expenses were $73.0 million for the year ended June 32021, compared to $35.0 million.
For 2020.
The increase was primarily related to increased development costs associated with Zander, Elisa, including startup costs related to the phase III postal study increased drug manufacturing costs and increased consulting fees to support clinical trial activities.
General and administrative expenses were $28.0 million for the year ended June 32021, compared to $23.0 million for 2020.
The increase primarily primarily relates to increased professional services costs increased personnel costs associated with increased head count to support our activities, including preparation for.
Commercial launch of samples.
And general corporate expenses incurred during 2021.
We recognized revenues of 25.5 million for the year ended June 32021, compared to $37.0 million for 2020.
The decrease in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations.
Revenue is also includes recognition of fees allocated to performance obligations in accordance with the <unk> license agreement.
Net loss was $56.0 million or <unk> 45 per share for the year ended June 32021, compared to a net loss of 46 million or <unk> 51 per share for 2020.
The company had $112 million 614643 shares of common stock outstanding as of June 32021, compared to $111 million 513689 shares as of June 32020.
The adjusted net loss for the year ended June 32021, excluding noncash expenses related to changes in the fair value of the warrants a non-GAAP measure was $75.0 million compared to an adjusted net loss of $24.0 million for 2020.
I will turn the call over to Dan.
Thanks, Brian and thanks for everyone for joining us this afternoon.
This past fiscal year was successful on multiple fronts Remy I am proud of the progress we have made across our pipeline to execute on our mission to develop and commercialize novel best in class cancer therapies intended to improve outcomes for patients.
Understandably our main focus is currently on the clinical development and pre commercialization activities for <unk>.
In particular, we are very focused on the top line results from title or potentially Registrational study for Zander listen expected by year end.
As you May know Zander listen formerly called <unk> hundred one is a selective pi three kinase delta inhibitor being investigated as an oral treatment for patients with b cell malignancies differentiated by its molecular structure and pharmacological properties Zander Lisa is administered on an optimized dose.
<unk> schedule, consisting of once daily administration for 228 day cycles as a response induction therapy fall.
<unk>, followed thereafter by intermittent dosing therapy, our IDT. The unique zander lists of IDT consists of once daily dosing for the first seven days of each subsequent 28 day cycle.
The ITT is intended to mitigate immune related adverse events, while providing continuous continuous therapeutic benefit.
To date, our data demonstrate that <unk> administered on the ITT is associated with a low incidence of grade three or greater adverse events of special interest. In addition, with longer follow up we've observed that the ITT continues to demonstrate durable responses and general Tullow Tolerability.
Of the regime.
We think this provides an exciting opportunity presumed illicit to deliver an improved clinical benefit and the opportunity to positively impact the standard of care for patients with B cell malignancies.
Currently the standard of care for Follicular lymphoma patients that have received two or more prior therapies is highly fractured treatments setting.
Despite this our research suggests that <unk> kinase Delta inhibitors are the most prescribed therapy in this setting where we are planning our initial submissions for marketing approval.
To date, there does not appear to be a pi three kinase inhibitor that can provide physicians and their patients and optimal risk benefit ratio to make any agent. The standard of care. Consequently, we believe there's a significant opportunity to consolidate treatment in this patient population.
If a treatment can provide high response rate along with a tolerability profile that can maintain patients on therapy for an extended period and provide durable responses.
We believe that other therapies, which have been unsuccessful at consolidating treatment are challenged by clinical profiles that do not offer an efficacy and safety profile didn't meet this hurdle.
Later this year, we plan to report top line data from the Phase II title study, providing an opportunity to update the <unk> emerging clinical profile.
Enrollment in the Follicular lymphoma primary efficacy population of 91 patients and enrollment in the full study population of 120 patients are now both complete.
Title is evaluating <unk> as monotherapy in adults with relapsed and refractory Follicular lymphoma. After a failure of at least two prior systemic therapies, including chemotherapy and an anti CD 20 antibodies.
Subject to the results and discussions with FDA, we plan to submit the title data to support an initial market approval via an accelerated approval marketing application.
Yes.
Our results suggest our research suggests excuse me that the annual incidence of Follicular lymphoma in the United States. There's about 14000 individuals' while the prevalence is about 100000 patients we estimate that over 40% of patients with Follicular lymphoma at some point will relapse after.
Each remission and then about 8000 patients relapsed or refractory with Follicular lymphoma are treated on an annual basis in the U S.
Earlier this year, we also initiated coastal a global phase III study as part of our plan to expand Zander lissouba valuation into earlier lines of Follicular lymphoma therapy in cooperation with our global partner key what Kieran.
For coastal we are evaluating zander lists have been combination with rituximab in Follicular and marginal zone lymphoma patients, who received one or more prior lines of therapy.
The first patient in this study was enrolled last month.
Coastal is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential for a potential accelerated approval of sand elicit in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Coastal is also intended to support marketing applications globally.
Because we are confident in the differentiation of <unk> profile and are committed to improving care in patients with relapsed and refractory follicular and marginal zone lymphoma, we initiated the coastal program at risk prior to seeing the results of title.
We believe that the patient population is being evaluated in title and coastal represent a significant commercial opportunity upwards of a $6.0 million in the underlying addressable relapsed and refractory follicular and marginal zone lymphoma populations.
Even with modest assumptions on potential Zander list of usage in the population of patients enrolled in the title study. This represents an important initial opportunity from which to build <unk> commercial value.
Subject to marketing approvals in new indications, particularly in combination with Rituximab and other therapies.
Efforts to expand this and Elisa development program. This year include initiation of a second arm in title evaluating <unk> monotherapy in patients with marginal zone lymphoma also after failure of at least two prior systemic therapies, including chemo and anti CD 20.
Subject to the results data from this arm are also intended to be submitted to the FDA to support an accelerated approval marketing application.
In addition to evaluating <unk> as a monotherapy and in combination with Rituximab, we are evaluating other combinations, including with Zanna brute nib PTK inhibitor developed and marketed by Beijing clinic.
Clinical evaluation of the combination is currently under a clinical collaboration with Beijing.
Initial results exploring the combination were presented at <unk> earlier. This year. The objective of our clinical efforts was to see if we could leverage dosing schedule to provide deeper and prolonged responses.
We reported that we identified a unique optimized dosing regimen.
For sand Elisa was the IGT IGT.
We believe may capture the synergistic potential of this combination in a well tolerated manner.
We believe the initial data from the run in portion of this study in 20 patients is very encouraging the optimized dosing schedule did not result in additive toxicity compared to each agent alone and we saw a 100% response rate in patients with relapsed and refractory indolent B cell malignancies.
Responses were durable as of the reporting of data they will follow up with limited as of the data cutoff.
Currently we are enrolling expansion cohorts evaluating follicular mantle cell lymphoma patients using this combination.
In addition to our coastal study other company initiated studies include a planned phase II study evaluating <unk> plus fanatical acts and rituximab in patients with relapsed chronic lymphocytic leukemia as well as the ongoing phase III pivotal study in Japan conducted by our partner.
What Kieran.
Evaluating <unk> in patients with indolent B cell non Hodgkin's lymphoma, without small lymphocytic lymphoma, lymphoblastic lymphoma, and Walden storms. This study is intended to support a Japanese filing with P. M D. A.
Finally, our efforts also include the support of ongoing and planned investigator initiated studies such as the study being conducted by the Cleveland clinic evaluating <unk> plus R chop to treat patients with newly diagnosed diffuse large b cell lymphoma.
We look forward to announcing additional updates to the clinical development plan as we continued to build out our evaluation of sand illicit for additional indications, particularly in combination with other cancer therapies.
All of this and a list of development activity I'm, describing and more to come leverage what we believe is a very strong and promising data set generated to date.
In addition to this <unk> plus Anna Brudenell data summarized above.
At <unk> and <unk> earlier this year, we reported updated data from a phase one b study exploring <unk> as a monotherapy and in combination with Rituximab.
Specifically with respect to relapsed and refractory Follicular lymphoma, we reported a 95% overall response rate in patients treated with <unk> plus rituximab in this phase one B study, it's interesting to note that the study subject population evaluated with similar to the study population in our.
Ongoing coastal study.
We also reported a 78% overall response rate in patients treated with sand Elisa best monotherapy response rates were high regardless of P. O D 24 status the line of therapy or tumor bulk median duration of response was not reached in any of these groups importantly treatment was generally well tolerated with a.
Low incidence of grade three or greater adverse events, no cumulative toxicity over time and an eight.
<unk> discontinuation rate due to adverse events.
We have been asked in the past if there was an impact of the ongoing COVID-19 pandemic on <unk> clinical program.
I can say that we did our best to be proactive in taking steps consistent with 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.
While the pandemic adds an element of uncertainty to our business and the ongoing impact remains subject to further developments. We are confident in our ability to navigate challenges across our business in a manner that can continue to minimize disruptions to the extent reasonably possible.
Given the broad opportunity presented the progress in this and elicit clinical program the resources and expertise that we're bringing to bear, including our continued pre commercialization activity and infrastructure build out we are excited about the potential we can bring to patients and the value that we can deliver to our.
<unk> with this program.
I would now like to briefly update you on some of our other pipeline programs.
<unk> is our oral CDK <unk> inhibitor that we believe has the potential to improve treatment options for patients with hematologic and solid tumors.
As you May know CDK nine is a transcriptional regulator of the myeloid leukemia cell differentiation protein or mcl, one a member of the family of anti apoptotic proteins, which when elevated may prevent the cell from undergoing apoptotic cell death.
Inhibition of CDK nine blocks the production of Mcl, one which is an established resistance mechanism to b cell lymphoma or to the b cell lymphoma, or Bcl two inhibitor Vanadic lax.
CDK nine it's also a transcriptional regulator of the MC proto-oncogene protein, which regulate cell proliferation and growth up regulation of MC is implicated in many human cancers and is frequently associated with poor prognosis and unfavorable patient survival.
With respect to the development for hematologic malignancies. We are currently conducting a phase one study evaluating the dose and schedule of <unk> as a monotherapy in patients with relapsed or refractory b cell malignancies, and acute myeloid leukemia or AML after failure of prior standard therapies to determine a safe.
<unk> preliminary efficacy and appropriate tolerated dose.
We plan to provide an update on this portion of the development program later this year, perhaps at Ash in December.
Our plan now subject to FDA agreement is to evaluate the dose and schedule of <unk> in combination with the Bcl two inhibitors, such as Vanadic lax to assess synergies and the opportunity for combination treatments initially in patients with AML and subsequently across multiple b cell malignancy.
Vacations.
As mentioned above this would address the mcl wind resistance mechanisms associated with Bcl two inhibition.
Our board of cyclic development plans also include evaluation of patients with solid tumors. In addition to regulating Mick transcription CDK nine directly decreases phosphorylation of MC protein a property that is implicated in stabilizing Mick in K Ras mutant tumors.
Since K Ras mutated tumors are frequently associated with overexpression of MC, we believe or a cyclic could be an attractive therapeutic target for K Ras mutated cancers, particularly in combination with a K Ras inhibitor.
This is supported by data we reported at the ACR 2021 meetings in preclinical models supporting voice cyclic CDK nine activity relating to <unk> inhibition and degradation as well as showing that it's synergistically inhibits K Ras G 12 C mute in cancer cell lines in combination with <unk>.
<unk> G <unk> inhibitors, both in vitro and in vivo.
The research presented suggested that for a cyclic could be an attractive therapeutic target for cancers, driven by K Ras mutations.
Lastly.
Update you very briefly on the <unk> hundred four for our novel and tumor selective mitochondrial inhibitor targeting the ox Foss complex as you may recall, our clinical data demonstrates that <unk> hundred 44 in combination with the anti Angiogenic antibody avastin.
Reduces mean relative to <unk> 67 levels in tumors of women with her two negative breast cancer compared to a control group of patients receiving avastin alone.
Based on the output from our Advisory Board, we convened to review options that offer an efficient path forward for evaluating the combination of Ami 344 and Avastin.
We are planning to start a phase II study of <unk> plus avastin in patients with relapsed colorectal cancer, perhaps around the middle of calendar 2022.
In Sun.
Fiscal 2021 was a successful year in advancing our business, particularly with respect to this <unk> program. We look forward to continuing to provide updates as we advance towards potential commercialization and as we move forward with both the <unk> cyclic MA 344 programs to further explore their potential to deliver.
Benefit to patients with cancer.
We started the new fiscal year with approximately $153 million. This does not include the $10 million milestone payment payable to <unk> from key work here and that was triggered by the dosing of the first coastal patient last month.
Receipt of the milestone payment is expected in the quarter ending September 2021.
We believe we have runway to see us into 2023.
In terms of upcoming milestones, we expect topline title data by the year end updates on this and Elisa Zanna brute nib combination, including the Follicular mantle cell expansion cohorts start of additional Zander list of clinical trials, such as the <unk> trial and other investigator initiated studies.
For a cyclic data from our ongoing phase one study updates on potential timing of a study starting next year of recycling in combination with a K Ras inhibitor and the start of the phase II <unk> III for four study in combination with Avastin in colorectal cancer patients, we look forward to keep.
You updated as we work to deliver benefits to patients and value to our investors and with that I think we are now ready for questions operator.
We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Thank you are using a speakerphone please pick up your handset before pressing the keys.
Sorry. Your question. Please press Star then two.
Our first question today comes from Stephen Willey with Stifel.
Hi, This is Danny on for Steve Willey.
Wanted to ask about Europe.
Topline data for title and Follicular lymphoma can you set the stage for us in terms of what we should expect I'm not sure. If you can give us an idea of what the duration of follow up will be.
What do you think is important for us to pay attention to you at that median follow up time point.
Right. That's a great question, thanks for asking so.
To be sure.
To be clear the primary endpoint of this study for regulatory approval is overall response and that is the data that we are focusing right now.
And that is what we will report.
Sure.
When the data are ready to report.
In terms of the median follow up.
I don't know what that is now it's obviously it's.
It's related to the pace of accrual.
Accrual.
Well, we will be able to report.
With some clarity what that.
Follow up is at the time of the report, but obviously that is an ongoing.
Collection of data that will continue so that we can give a more precise durability.
Answer probably more towards the second half of next year.
Or the first half of next year.
So to be clear. The overall response will be in all patients who have had a minimum of six months of treatment.
And certainly many have had many more months of that but precisely I don't know.
That's going to fall once we.
Once we lock the data, but we will give them the best estimate we can at the time.
Okay, Great and will you also be lucky or analyzing the part 24 patients separately similarly to how you've done in the past and unless you can give us an idea of like the proportion of patients that.
<unk> 24, a would it be similar to what was seen in that it wouldn't be.
A portion of the trial.
Right. Yeah. So we are we are analyzing that.
I don't know in terms of the proportion of patients in this particular study where it falls.
Paired to the one b.
Clearly, we know that there are P. O D 20 fours that are enrolled.
And we will analyze that that's just a.
Exploratory analysis that will do probably won't have much to say about it.
At the top line data, but certainly we will have more to say.
Down the road once we've cleaned all the data and land lock the database.
Okay. Thanks, and my last question is about and easily fourth ward can you discuss where you see like why have you chosen.
Just target.
CRC patients and maybe some data that you have to the point that Tony.
Right so.
So based on the mechanism of action that we believe is operating for when you combine an anti angiogenic with Emmy 344.
We think that this is apical across all.
Potentially across all indications, where anti angiogenesis is important in controlling tumor growth.
As I mentioned, we did have an advisory panel.
Hum.
Very prominent physicians in the U S, who treat patients where anti angiogenic are used primarily which is really.
It was included colorectal and a couple of other indications. It was the consensus from that discussion that colorectal in third line is the best place to look because Avastin is currently used in the third line population.
And the the median durability or PFS of that is actually quite short and with very low response. So the feeling was that if you were able to expand PFS.
Regardless of response rate that would be a very meaningful outcome too.
Encourage further development.
So that was the decision we do have preclinical data in animal models looking at Xenograft studies looking at breast cancer, and colorectal and lung models. So again, we don't we don't think it's anything particular of the tumor type it's really how.
How.
Uh huh.
Deprived of oxygen these tumors are and when they grow.
And how the anti Angiogenic can reverse that and make $47.0 and more effective so it's really just a matter of.
Most of these cancers become hypoxic and that's that's the mechanism of action that we're going after with the combination.
Great. Thank you so much for taking my questions.
Absolutely.
Our next question comes from Yale Jen with Laidlaw <unk> co.
Okay, great congrats on reaching the.
Yeah.
And at this point so first just follow up from the previous question in terms of if you're going to have a positive title readout.
What may be the time line after or before the filing and the.
The preparation needed there for that.
Yeah, It's a really important question Yale thanks for asking.
So the timeline is completely driven following our.
Our pre NDA.
Discussions with the FDA.
Sure most of you are aware.
The primary endpoint for an accelerated approval in this disease setting is overall response.
But clearly the.
The agency is also interested in the risk benefit. So safety is a primary concern and we know with this class of drugs with other drugs that late term later onset toxicity has been observed. So there is an interest that part of the agency and they have given guidance to.
All companies.
To have sufficient follow up as well as durability.
And many of the cases of the prior Pi three kinase.
The durability and the toxicity sort of went hand in glove because.
If patients are being are.
Coming off study because of toxicities, then they get censored.
The ability to see a true durability measurement is somewhat obscure. So we'll have that conversation we will provide the agency with our follow up and with our safety.
And we'll gain there gain insight from them on when is the appropriate time to file and then it's just a matter of we're already doing the work.
This is a long process and where we've gotten a good head start on writing some of the modules being.
<unk> prepared so that when they tell us it's time will be ready.
But I can't give you a precise.
Date until we have that conversation.
Okay, Great. That's very helpful. Maybe two quick follow up questions. Here first one is in terms of the CLI trial.
Scheduled to start it soon do you have a timeline for when to start that one.
Betsy.
Yeah well.
Hi.
We definitely will start in the first half of the year, where we're working as hard as we can you know I'm sure you appreciate that it's.
Here, it's all hands on deck with everything and title is the main focus but this is an important study for us and where we are working our best we already have a CRO. We're already working on contracts. So we're hopeful we can get that study up and running in the first quarter.
Okay, maybe the last one just in terms of a title.
The full patient sets up a 120 recruited so is there any time, we should anticipate update on this more.
Well the data once they are mature and thanks, yes, right. So if you recall the primary endpoint efficacy analysis will be done on the first 91 patients the remaining 30 patients or so we're adding to increase the safety.
For the agency and so.
Of course, we will be analyzing the response rate, but they won't be part of the label.
Presumably.
To be negotiated.
So we do think we're at.
Hopeful that perhaps around midyear like the <unk> timeframe, we'll be able to give a much more robust update of the current title data.
Okay, great and congrats on reaching the important milestones.
Thank you yeah.
Our next question comes from Robyn Karnofsky true security.
Hey, guys. This is <unk> on for Robyn. Thank you so much for taking my question and congratulations on all the progress this year.
Couple of questions about <unk>.
What do we exactly.
<unk>.
The question is have you made the decision of what you expect to release obviously.
We're going to see.
Our but is there anything else or would you look at the data and then decide also depending on when you expect to present the data later.
Hmm.
Expect to see any durability data at all.
And then for Costa can.
Can you provide any granularity in terms of.
How the trial is.
Progressing you initiated the trial can you remind us how many sites you expect to run the trial and how many are open for enrollment are you seeing any hurdles with besides the delta variant. Thank you so much.
Sure all great questions.
I think in terms of the your first question about title and data reporting I mean, please appreciate that the overall responses.
Based on six months of treatment. So if the patient responded in the first.
After the first measurement, which is at two months.
The durability of that clock starts so the durability is four months at that point right. So I think that.
Our feeling is that whatever we have to say about durability.
It's probably should be taken with a bit measured because.
A lot of that there'll be a lot of noise on the right side until theres been sufficient follow up so.
I know I don't think even if we told you a durability number I don't think it would necessarily be as informative as if we were able to follow the patients for let's say another six months or so so that there we have a lot more confidence in that number and as I said, we will continue to follow all of the patients for durability.
City as well as for safety, because we know that those are both time events potentially and certainly durability is.
And so rather than misleading about.
Anything we just we need the time in order to.
To give a more accurate estimate for both of those outcomes. So I don't we haven't really I don't think we're focusing on as much is that on the durability is probably the street is in U.
But obviously, it's something that is critically important in our experiences with every study we've run with this drug that the durability and the way we use it is quite considerable and we have no reason to believe that won't be the case, but clearly you know when we see the data we'll know.
So I don't I don't have much more I can say about that.
And again, you know durability is also related to the pace of enrollment and with Covid. The enrolment was rather protracted a lot more patients were enrolled later in the trial than earlier in the trial. So the durability is probably <unk>.
Quite immature it in when we were finally locking them response data.
You asked a question about coastal.
Yeah, So I think what would be yeah.
Yes, right. So what we've said I think the trial itself is about 500, plus or minus patients in that ballpark and I think we our estimate is somewhere close to 200 clinical sites globally.
Globally.
As you May know.
It's probably more in the weeds and you care to hear but.
The most the biggest push one does at the beginning of opening a study is getting all the sites contracted I mean, you're literally we're building an army of lawyers here just to deal with the contracting because every site is a new contract and so that's where we spend all our of energy trying to get as many sites as we can.
Open as quickly as we can.
And that's going fine, we're not really seeing a lot of issues that are related to COVID-19 again being global is helpful. Because the impact of Covid is definitely different.
Around.
The world.
Because this is a large.
A large study in the patient population is very well defined.
All of the sites that are open can begin looking through their records at patients who are potentially or will be potentially.
Include could be included in such a study.
And they can start creating their list and that's happening.
Some of these patients may not have progressed, yet or may not want to go onto a clinical study in there all of those factors, but we are building a large data set of patients who are potentially available to the study and we are working as quickly as we can and as hard as we can to open as many of those 200 sites as we can and that's about.
All the color I can really give you and that's about all I really know.
Yeah very helpful. Thank you so much.
Sure.
Our next question comes from Adam efforts with lifestyle capital.
Great. Thanks for taking the questions here.
I hate to keep pushing this point, but maybe just to clarify one thing on the title readout I mean, it's.
Pretty clear, we'll see response rates next quarter durability of response will take some more time, but just again on what you might share on the safety side, given how important that component is for the class. For example will we see you know like a.
Preliminary rate of discontinuation due to adverse events something like that.
Yeah.
I understood Adam.
We will do.
Do our best to be as transparent I mean, we obviously, we understand the issue, but the durability and the safety and the response.
All three of those legs of that stool have to come in line and we will be as transparent as we can be.
I, just don't I don't want to promise right now because.
Uh huh.
Lot of that.
A lot of that.
Our goal right now is to have 100% clean data for a response.
And.
In order to make sure that when we say a patient has progressed has come off study for safety, we have to be 100% confident on the quality of the data and we're doing that actively now we have a whole army of <unk>.
People, who are working on.
I'm getting the data in and cleaning the data. So if we're ready to tell that if we're if we're ready to tell you that data we will tell you, but I don't I just can't promise right now because I just don't know the answer we're still several months away.
And the data are continually coming in in the careers are going out so.
We do understand the importance of those metrics and we absolutely want to be as transparent as we can be with reason and.
When we say, what we say we want to make sure.
It's absolutely rock solid information.
Totally understand I appreciate that and then maybe one quick question on CLO.
Banana clocks Rituximab combo has given it is a fixed duration just curious and maybe it's too early to think about how youll dose Santa list up there, but have you thought about whether you would use a fixed duration there as well.
Yeah, So we'll be very soon at them.
We will put out the trial would go up on Glen trials and will will give you exactly the dosing regimen I think my understanding and again I hate to speak out of school here I think we will be following murano on AR on the vanilla Clacks Rituxan.
Regiment and then.
Xander Elisa will be given for a fixed amount of time.
Great makes sense. Thanks, so much.
Our next question comes from Justin <unk> with B P. I G.
Hi team congrats on all the progress this year and very much looking forward to two results later this quarter on title, maybe if you could just walk us through as far as the development plan. Once you have in hand your monotherapy.
Follicular data.
Kind of how you are thinking about the strategy of expanding to other indications and of course you have your ongoing.
Studies, but if you could just.
Maybe walk us through when we should expect the cadence of releases.
Right so.
Just more of a general comment I think.
I think over the years, we've tried to be pretty consistent with our view on how are you.
Cancer is treated and we really we have taken a fairly.
Strong opinion that are the.
The most effective therapies are generally in combination and I think it's been clear to the field that there have been challenges in accomplishing combination therapies with pis prior Pi three kinase and that's why.
Obviously, we're so excited about the profile of <unk> and the way we're able to use it that we can really now explore these combinations like we're doing with Sannup route and they have like we're doing with Rituxan like we plan on doing with banana clocks, and Rituxan and C. L out so I think going forward, what you should be looking for from.
US is.
A number of studies in addition to the ones we've spoken about in other indications in earlier lines of therapy, where the where we're using the drug in combination with other standards of care again, and what we've said in the past is one of our goals is.
Whenever possible to see if we can bring a non chemotherapy combination regimen to patients to give them in the alternative it gives the physicians and alternatives. So I think we've been pretty clear about our near term plans.
In terms of coastal title designer Bruton hip combination C. L. L study the marginal zone study Zanna Bruton or is being studied in mantle as well as follicular and they are chop I mean, there is a situation where we are employing chemotherapy. So I think we do have other studies that will be of interest.
To you and to the investors is as time goes and we're going to try and roll those out as quickly as we can on many of these are with <unk>.
Investigator study some of those there'll be our own studies, but I think that as we really do feel that's an elisa has that potential to kind of form the backbone around which one can combine to other therapies and that's kind of how we're approaching its development.
Great. Thanks for taking the question.
Sure.
And again, if you have a question. Please press Star then one.
Our next question comes from Matthew Cross with Alliance Global Partners.
Good afternoon, and thanks for taking a couple of questions from me.
I will not ask you about the title data in Q4.
How about the durability.
Right.
But given that you I guess mentioned if I heard you correctly that now the whole primary endpoint population title has enrolled including Mcl.
Sorry, just to be clear we did.
Yes that is correct.
The entire 120 safety population for Follicular isn't fully enrolled the marginal zone study just opened earlier this past year. So that still has room to go.
Got it okay. So that kind of rephrase my question, a little bit, but nevertheless was kind of curious to get your updated thinking on the mcl cohort.
And.
And I know, it's been asked about what kind of your filing strategy would be for FL.
Wanted to get kind of the latest thinking based on what you are now seeing.
Mcl enrolls.
You would.
Ops to wait for <unk> or our data.
In the interest of collecting longer term safety as you alluded to.
Or we should kind of expect a staggered multi filing strategy for those two indications.
Right Yeah, no I think it's the latter.
Matt I think that I mean, we are pretty been pretty clear that we plan on getting the follicular arm in front of the FDA and.
Begin the filing if appropriate as quickly as we can and then the marginal zone would be an additional indication.
As soon as that trial enrolls I mean, obviously those there are fewer of those patients. Although the trial is smaller it's something like 61 patients or something for the efficacy evaluable.
So.
And the.
<unk> for US is that we didn't have to get the sites up and running as we did for Follicular study because we are using the same sites. So we hope that the enrollment will go a bit faster than it did for the follicular, even though there are less patients.
It's a rare population so.
That will be a separate filing based on the quality on the data on the outcome of the data.
Got it okay. That's helpful. Thanks, Tim.
The second that I had was just around the phase two and C. O L. For example spend plus rituximab.
Was just kind of curious to get the rationale for the inclusion of then in that combo.
Given what we saw I think a near 100% response rate certainly small numbers, but for <unk> plus rituximab in the phase one b in CLO.
Was curious about the.
Inclusion of even especially given some of the.
Dosing considerations that were brought up Adam.
Just curious to get your son.
<unk> take on that triplet and and whether we should be inferring anything about that in terms of the plane of therapy and in general positioning that you might be pursuing in CLO.
Right. So yeah, I think it's an important question and it's probably.
Needs a lot more time to answer that we have on this call, but we.
We have spent a lot of time with our advisors and we said this over in the past we've had multiple advisory meetings with our key opinion leaders both here and in the EU on really the landscape around CLO.
I don't think there is a 100% response rate by the way a plus rituxan, but what does appear to be clear is that the physicians.
Physicians are looking for time limited therapy and that is something that all of many companies are pursuing.
The Murano data was very impressive, but clearly could get better.
Specially for minimal residual disease in a time limited basis. So I think that is all of our goals is to get the patients into a good strong deep remission.
And allow them to stop therapy.
If you look back on the history and CLO.
<unk>.
B cell receptor engaging agents like.
Pi three or be Teekay are very effective in inducing remission and their emissions are actually pretty reasonable but.
The level of Crs are quite low and the feeling was in the advisors that.
That if you really want to get into an <unk> negativity you do have to combine a vanadic Lex.
At Banana clacks as part of the regimen, and so thats kind of the rationale of adding vanadic hikes, because clearly you are able to get into <unk> negativity, which isn't really seen with.
Either other the other classes of drugs.
And again these other classes of drugs do have very good durability as long as youre, taking the drug, but I think the real world experience, especially with the BT cases that patients don't continue to take drug.
And then they need something else because they will relapse. So that's kind of our thinking and why we're going down that road.
Sure. Okay, now that makes quite a bit of a sense I'm sorry, if I mumbled there the 100% response rate it was referring to was your owned with.
There thereabouts for ASEAN plus hours, yeah, yeah, yeah.
But looking forward to seeing what you can do in terms of them or do your negativity, adding and that makes that makes a lot right exactly. So thanks again, Dan and I think that does it for me have a great labor day weekend.
You too thank you.
This concludes our question and answer session I'd like to hand, the call back over to Dan gold for any closing remarks.
Oh, thanks, Thanks, again for joining us today.
We begin our new fiscal year, and a very strong position and we definitely we will look forward to reporting our progress to you across our entire portfolio in the coming quarters Engie.
Enjoy the long labor day weekend and be safe and we'll look forward to catching up with you.
In the near future.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.