Q4 2020 GlycoMimetics Inc Earnings Call
Good morning, and thank you all for joining the quite cold Magnetics call. At this time, all participants are in a listen only mode.
Management's remarks, we low hold a question and answer session and at that time lines will be open for you.
Anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.
I'd now like to turn the call over to Sherri and as of the Investor Relations Group I fly called Magnetics. Please go ahead.
Thank you good morning today, we will review our accomplishments and financial results for both the three and 12 month periods ended December 31st 2020.
We'll also update you on recent.
The press release, we issued this morning is available on the company's website at www debt like them on medics dot com under the investors tab.
This call is being recorded a dial in phone replay will be available for 24 hours.
After the close of the call. The webcast replay will also be available on the Investor Relations section of the company's website for 30 days.
Joining me on the call today from Black on the medics, and Rachel King Chief Executive Officer, and Brian Hahn Senior VP and Chief Financial Officer will start today's call with comments from Rachel Brian will follow Rachel to provide an overview of the company's financial position and well then open the call for Q&A.
Our co founder and Chief Scientific Officer, Dr. John Many on me and our newly promoted senior VP and Chief Medical Officer, Dr. Eric Feldman will join us on the Q&A to address your questions.
I'd like to remind you that today's call will include forward looking statements based on current expectations forward looking.
Statements contained on this call include but are not limited to statements about the company's product candidates you per lesser land with a pencil.
P. M on 16, 87, and GMI 13, 59, and our other pipeline programs, along with operations and cash burn.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties.
On medics undertakes no obligation to update or revise any forward looking statement for information concerning the risk factors that could affect the company. Please refer to black on memetics filings with the SEC, which are available from the SEC around look like they'll pneumatics website.
I'd now like to turn the call over to Rachel.
Thank you Sherry.
Throughout 2020 likely met its primary operational focus was on advancing the use of less land registration program in AML.
Despite the challenges of COVID-19, you put less land continues to garner significant attention and interest of leading clinicians academic centers collaborative networks and regulatory agencies working with us here in the U S and abroad.
Like I'm on that pivotal phase III trial in relapsed refractory AML continued to enroll patients in the U S, Australia and in Europe, and a steady and predictable pace in the second half of 2020.
While the pandemic slowed enrollment during March and April of 2020 site activation continued to extend the global reach of the trial and by year end the company's interim target for enrollment had been achieved.
With momentum from the second half of 2020 carrying into 2021.
We can confirm that we anticipate completion of enrollment of all 380 patients in the second half of this year.
This demonstrates the high level of enthusiasm and scientific interest of investigators and it is a very significant accomplishment in the context of a global pandemic.
In addition, we've had productive interactions with the FDA under our breakthrough therapy designation.
The kinds of conversations that a company with having the normal course of moving towards a specific regulatory filing plan.
She talked so much on regulatory activities, we've completed certain other critical development work such as released released with the NDA batches initiation of the commercial batch manufacturing and completion of human AD network that is studies that evaluate the absorption distribution metabolism and excretion of a drug in development.
These are all measures of steady progress towards filing a new drug application or NDA should I read off deposits.
In parallel the NCI sponsored phase two three registration trial evaluating <unk> in newly diagnosed older adults with AML, we're fit for chemotherapy continues to accrue at a steady pace.
Based on the Ntis enrollment projections, we anticipate the trial will complete enrollment of the initial 262 patients necessary for the interim phase two event free survival or E cash analysis before year end.
Assuming the F S trigger would occur within six months of enrollment completion. We would then expect to see the read out from this analysis to occur sometime in the first half of 2022.
Together with our clients on that exit NCI sponsored programs will constitute a large data set of patients treated with U P less land and intensive chemotherapy.
The data for our phase III trial, and the NCI phase two U S analysis are likely to read out around the same timeframe.
Both are positive we would anticipate filing for approval for treatment of patients in both settings.
Further underscoring the global interest in your cholesterol in is our collaboration with Apple on mix announced last year.
In January of this year, you Polish language designated as a breakthrough therapy in China for treatment of AML complementing our prior designation by the F D. A.
In addition, <unk> announced the filing of an IND to begin clinical development of your philosophy on in China.
Our plan is to announce when the first patient was treated in greater China, which is anticipated later this year.
Beyond the ntis prestigious consortium and our partnership with Apple on mix. We're also receiving significant interest from clinicians at key centers of excellence, who would like to pair you flush land with other day in and out there.
In a few minutes I'll describe some preclinical work that validates this in particular with the research that combined your cholesterol in and out of clocks, and hypo mirth, leading agent or HMA.
Working in collaboration with clinical investigators consortia partners and regulatory agencies around the globe. We have one goal in mind, namely to establish new pro as a foundational therapy across the entire spectrum of AML.
Whereas most other AML therapies in development on <unk>.
On narrow a patient population that's defined by certain genetic markers.
Celestial on targets the bone marrow microenvironment by inhibiting those pro survival pathways.
Cancer cells protected from the effects of chemotherapy.
This is a novel approach that would be broadly applicable across the spectrum and range of therapies used for relapsed refractory or newly diagnosed patients fit for chemotherapy.
We soon hope to treat those not fit for a rigorous chemo regimen as well.
The scientific rationale for targeting E selectin in the role it plays within the bone marrow microenvironment as a driver for AML resistance, because it always been robust I'd still like to spend a few moments highlighting some of the new day to our research teams generated that were presented in oral and poster presentations at multiple scientific and medical meetings. This past year.
<unk>.
Of note throughout 2020 preclinical data on <unk> mechanism of action were published numerous scientific publication.
Including nature Communications in April and an independent review paper in the journal cancers in January of this year 2021.
These paper these papers detail the various mechanisms by which you could lessen that dampens AML blast regeneration and strongly synergizes with chemotherapy.
Importantly, they support the role and importance of targeting the tumor microenvironment. The key novel approach in cancer look like on that acts as a leadership position.
Your philosophy on was also featured in several major medical meetings, including the June 2020 ACR meeting.
Their investigators presented preclinical data supporting the use of the potential use of abuse of lush land on the treatment of AML as well as in the setting of stem cell transplantation.
Additionally, new information demonstrated the ability of transcript on profiling to identify additional tumor types, most likely to benefit from targeted E. Selectin antagonism. The key mechanism, both Super Leslie and Angie on my 13 59.
And finally in September at the meeting of the society of Hematology oncology and against the annual Ash meeting investigators from the MD Anderson Cancer Center Department of leukemia presented preclinical data in an oral presentation, showing how antagonizing E selectin with you collect Lynn.
Becomes microbiome microenvironment mediated resistance to the net o'clock HMA therapy.
Just to elaborate on the model. This experiment was conducted using a phone line from a patient who had acquired resistance to the net o'clock HMA.
In this setting. The addition of your professional and not only prolong survival of these mice, but also promoted normal HFC pro survival signaling.
The data were striking and we were pleased that it was selected as an oral presentation at ash.
It is here in this last setting that we look forward to initiating an investigator sponsored trial in the near future.
As you know uptake on the meta clocks HMA in the frontline unfit AML setting has been strong and while 60% to 70% of patients achieve a response the responses are incomplete and approximately half the patients reducing durability and reading to relax that.
Thus there remains a significant unmet need.
We're hearing from investigators eager to evaluate the triple combination to explore the potential of <unk> and overcoming some of the limitations related to the depth and durability of response with vantage EMEA alone.
Turning now to sickle cell disease I'd like to comment the 2020 gave us an opportunity to further explore opportunities for treating this disease, which we had previously been precluded from doing under our agreement with Pfizer Bye.
By April Pfizer had completed its transfer to us of all rights on licenses from originally granted dinner 2011 agreement as well as the river pencil I N D and the data sets on both the phase III reset study and the open label extension study.
We committed to a detailed assessment of a full clinical dataset for Riva pencil on presentation of the full results on it.
Scientific Congress.
Our analyses were presented at several key sickle cell meeting the last of which was the December ash meeting.
The data highlighted the importance of early intervention and validated E. Selectin as a critical target for treating these are occlusive crisis for boc for adults as well as pediatric patients.
In parallel we were invited to make oral presentations on PMI 16, 87 at those key meetings as well.
I remind you that GMI 16, 87 is a significantly more potent E selectin antagonist than of a pencil and we've shown in animal models that it is fully bio available following subcutaneous dosing.
Specifically at each of these congresses.
We highlighted data demonstrating the compounds ability to prevent sickle red blood cells adherence to inflamed vasculature and HIPAA.
Hibbett vessel occlusion and restore normal blood flow within 90 minutes of administration.
There is not a surprise given the strength of this preclinical data.
Each of the abstracts was selected for oral presentation.
The data supports development on <unk> 16, 87 is the best in class E. Selectin antagonist for self administration at the time of Boc onset.
Potentially reducing the need for opioids acute care visits and in patient hospitalization.
I'd like to highlight that the GMI 16, 87 program Leverages, all the clinical safety efficacy and biomarker information gained with terrific cancel.
It can potentially be self administered outside the hospital setting at the earliest stage of Boc onset, which we now know as <unk>.
Critical for clinical benefit.
This is particularly important since the care of individuals with sickle cell disease has continued to shift to the outpatient setting.
Which has accelerated during the pandemic.
Based on input from the FDA with respect to pencil as well as kols in sickle cell disease. We will now focused development in this setting on GMI 16 87.
We are moving forward to complete the required I D, enabling activities with treatment of acute V O C as a potential lead indication.
We believe that <unk> 16, 87 may be ideally suited for this indication to ensure that patients can receive treatment early on there you'll see quite a bit.
Since it potentially can be self administered GMI 16, 87 also commands a much greater value proposition then they were canceled and therefore, we have decided to discontinue development of a pencil.
We will keep you updated as to progress with the GMI 16, 87 program as we get closer to filing the IND.
Which we anticipate will occur in 2022.
Our last clinical program I'd like to touch on is the ongoing phase <unk> study of <unk> 59, a dual function E. Selectin <unk> four antagonist being conducted by Duke University Medical center in patients with advanced breast cancer with bone metastasis.
This proof of concept studies evaluating pharmacodynamic or PD marker such.
Such as CD 34, mobilization globalization of circulating cancer cells into the periphery downregulation of soluble E Selectin and other biomarkers of biological activity. Following both single ascending and multiple doses within the same patient.
Our goal has been to use these PD marker to study dose response to inform our next trial, while also establishing the safety profile and PK of <unk> 13, 59 in patients with advanced disease.
While study enrolment has been impacted by COVID-19, I'm pleased to report that we have observed clear biologic clear evidence of biologic activity in the first patients treated in this trial.
We intend to present interim findings from this trial at an upcoming scientific conference.
Lastly, I'd like to highlight our specialized quite problematic chemistry platform continues to generate novel drug candidates as you may be aware, our chemists have been focusing their efforts on collecting three carbohydrate binding protein, whose expression has been shown to play a central role in fibrosis and cancer.
Over the past year, our chemists have rationally designed several highly quote collecting three antagonists that have shown activity in preclinical models of fibrotic diseases, including Nash IPF retinal degeneration and thrombosis as well as the pancreatic cancer model were on collecting three inhibitor was combined with an anti PD L. One.
On agent.
And fibrosis models administration of our collect and three antagonist resulted in robust statistically significant reductions in fibrosis, when given as a single agent.
In the pancreatic cancer model. The addition of collecting three optimized anti PD L. One therapeutic activity through shifts and fibrotic response in cellular infiltration, leading to a robust antitumor response.
We plan to share more details regarding these collective free inhibitors at upcoming scientific conferences, while we consider strategic options for this novel class of compounds.
I hope you'll agree that the challenges of the pandemic notwithstanding our team has been incredibly productive.
While most of US worked almost exclusively out of our homes. We succeeded in continuing to advance both development and discovery.
We have a diversified portfolio, while remaining a lean organization with only about 55 full time individuals and an executive team that's been working together for many years.
1920, we were pleased to add veteran regulatory leader Dr. Meyer on Rosario Hurley to the management team as Vice President Regulatory Affairs Mira came to us from Abbvie, a leader in AML and the developer of the net o'clock.
And just last month, we promoted Dr. Eric Feldman, who will join our Q&A today Senior Vice President and Chief Medical Officer, Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemia and related bone marrow disorders.
Eric who spent the last two years at the company running our phase III registration trial and he has dedicated his career to patients with hematologic malignancies. He is especially well positioned to lead our <unk> program as it advances through registration trials.
As you know Dr. Helen <unk>, our outgoing CFO and senior Vice President of clinical development has accepted another position, giving her expanded role.
We wish her well in that endeavor for contributions to us have been substantial and this has been a pleasure working with her as a valued colleague.
Importantly, our cash position provides runway through key milestones and Hubert Leslie on program I've asked Brian now to comment in greater detail on our financial results fine. Thank.
Thank you Rachel.
December 31, 2020, <unk> had cash and cash equivalents of $137 million.
As compared to $158 $2 million as of December 31, 2019.
During the year ended December 31, 2020, as the company recognized revenue of $10 2 million on which was.
As a result of payments received under our agreements with Apple on mix for the development and commercialization of <unk>.
U S land in GMI $6 87 in greater China.
There was no revenue recognized during the year ended December 31 2019.
The company's research and development increased to $11 $7 million for the quarter ended December 31 2020.
As compared to $11 $5 million for the fourth quarter of 2019 due to higher clinical development expenses critical expenses were higher as a result of increased number of sites and enrollment of the Companys ongoing global phase III clinical trial of <unk> in individuals with relapsed refractory AML.
Research and development expenses for the year ended December 31, 2020 decreased $44 9 million as compared to $47 million on the prior year.
The decrease in expenses was due to lower raw material lower raw material purchases in the year ended December 31, 2020, offset by higher clinical development expenses due to the company's ongoing global phase III clinical trial would be plus loans.
Now turning to the G&A expenses, the company's general and administrative expenses increased to $4 million for the quarter ended December 31, 2020, as compared to $3 $9 million for the fourth quarter of 2019.
General administrative expenses for the year ended December 31, 2020 increased to $16 $7 million as compared to $14 $4 million on the prior year. These increases were due to a significant increase on the cost of directors and officers liability insurance in 2020 as compared to 2019.
In addition personnel related and stock based compensation expense increased due to additional headcount annual salary adjustments on retention bonuses other.
Other expenses decreased as compared to the prior year due to lower travel meals and conference registration expenses.
Salt of travel restrictions due to the COVID-19 pandemic.
I'd now like to turn the call back to Rachel.
Thank you Brian we.
We have a busy year on an important milestone ahead as we look towards completion of enrollment of our AML trial.
We're confident that will soon be able to share news of newly initiating trials with independent investigators as well as continue to share scientific data that broadens the scope and potential impact of our unique like on the medical platform.
Operator would you now please open the lines for a Q&A session.
If you'd like to ask a question at this time. Please press Star then the number one on your telephone keypad. If you would like to withdraw your question press. The pound key first question comes from Zach day, yellow with Roth capital partners.
Good morning, guys. Thanks for the update on cobalt, Oregon on promotion really exciting it sounds like you posed now you know tenant taken center stage with the plans to not move forward with them.
Protracted it I wish.
It's okay in our opinion, but I think that gets kind of why they just get some additional clarity on you know how you kind of came to that decision about are we proud and then also just kind of you know what can we expect next up on 16 seven.
Sure.
And thanks, Steve Nice just nice to hear your voice yeah. So you're right <unk> is.
In fact at center stage as it has it has been operationally for some time with the focus that we've had on advancing the <unk> registration study of the company as well as the support we've been providing to the NCI as far as the decision around with a pencil. There are a number of factors that went into it.
One was the fact that as.
As we look at the landscape for treatment of patients with sickle cell disease, we see the treatments moving to the outpatient setting we see that becoming increasingly important.
As we announced in December we realized that additional data would be required to take referred pencil forward.
And we also realized debt.
687 is really optimally.
Potentially useful in the outpatient setting given that it can be administered subcutaneously. It is significantly more potent than revenue penciled. Therefore can be administered at a much lower dose.
And the fact that it could potentially be given on.
It's a self administered drug really would enable us to take advantage of the ability to treat patients earlier, and therefore actually to treat potentially more patients because we're not waiting for patients to be.
To presented then be admitted to the hospital. So there are a number of factors that made us feel that 16 87 really is ideally positioned for.
For use in the outpatient setting in.
Invasive occlusive crisis, we felt that that's therefore the of the best opportunity for the company as we look at <unk>.
Potentially applying our technologies and boc. So we're quite excited about moving 16 87.
To the clinic, we're going to be working towards filing an IND as I indicated in 2022 and as we get closer to that will provide you further updates, but we're very excited about the opportunity that 16 87 represents for the company.
Thank you Mitchell and then just on 13 15, you know its really nice day you guys saw some clear evidence of biological activity. So I was just wondering you know what's the next step as well with that program would it be another investigation investigator sponsored study or would you initiate something else on your guidance.
And so we're in the process of defining next steps on as I indicated we do intend to share that data at an upcoming scientific meeting and based on what we're learning in that trial and looking at the quite a wide range of potential opportunities for uses of $30 59 were in the process of defining where specifically we would go next with that with that trial on was that debt with that compound.
Thank you and then the last one is just on your flow.
I'm excited to see you know some of the combinations because that that's the science disappointed with that but just kind of want to know have you picked a potential.
Partner for the investigator sponsored study.
What needs to happen before we can start to see some of that.
Yes. So we've had we've been really gratified by the high level of interest from a number of investigators around potential other uses of <unk> and <unk>.
So we've been working with a number of investigators towards advancing these investigator sponsored trial, we will not we don't intend to announce details until the trials actually begin.
Because.
As you know with iced teas, theyre not fully under the control of the company, but we're very excited about the level of interest that we're getting on particularly as I indicated around the combination of <unk> with phonetic tax HMA and so we do expect debt in the coming months, we'll be able to say more about the details around those that trial or trials.
Thanks for the update.
Thanks for your question comes.
From Stephen Willey with Stifel.
Yes. Good morning, Thanks for good morning.
Sure.
How has it gone so so.
On the NCI trial.
As the event free survival analysis, that's going to be I guess triggered.
Presumably at some point maybe later this year is is that both the utility and an interim look.
And then can you just remind us with respect to the co primary endpoints within this trial I know it's event free survival on overall survival.
Are those true co primary endpoints or was there some kind of hierarchical analysis.
The analysis.
I'm just trying to think about this on the context.
Your commentary regarding being able to perhaps simultaneously file for both indications at the same time sure sure. So this is a question I think that's where I'll turn to Eric to answer the details up so Eric could you answer on that.
Yeah sure. Thanks, Rachel so with regard to your first question.
The trial is basically running two sequences first there's an event free survival, which is a phase <unk> randomized phase two.
And then following that if that is considered positive enough. It moves on to a phase III with an overall survival endpoint. So theyre not necessarily co primary end points. They are just two different analysis done at different times.
To trigger the phase II <unk> will trigger the phase III overall survival.
Understood.
I guess, how does that then extrapolate too.
What was Rachel's comment with respect to getting that data potentially around the same time its filings.
So let me let me make a comment netsuite Eric wants to add anything so we do expect that the <unk> analysis will be completed.
On the same time DFS analysis on.
On the so called Phase II portion of that study would be completed around the same time as we get R.
Our data from our company sponsored phase III trial.
If that data is sufficiently positive that could we could potentially file on that data.
So there are several possible outcomes at that 0.1 is that we could file on that date. Another is that it's positive but the study would also continue toward its phase III.
Survival endpoint.
Or of course could be negative so you're hoping that's not the outcome, but but there are a number of possible outcomes at that point.
We do anticipate though that the event free survival analysis on that first group of patients would be performed at around the same time as the survival analysis on our overall survival analysis on our in our study.
Okay.
And I guess, it's safe to presume that with breakthrough you presumably had some of these conversations with FDA.
I'm, sorry, what did you say and.
And I guess, it's safe to presume that with breakthrough you you've had some of these conversations with FDA.
Deficit under the breakthrough therapy designations, we've had multiple conversations ongoing engagements with the FDA with respect to our program yes. Okay.
And then just lastly for me so on 16 87 I guess.
What is your preclinical pharmacology, telling you about the half life of this product.
Whether or not you can formulate this into kind of a single shot sub Q and then just from a clinical development perspective, given that the mechanism appears to be de risked in the context of acute POC just based upon some.
Some of the retrospective.
Channel data how quickly do you think you can.
Some of those kind of initial proof of concept work in the clinic.
So that's from the details we're not yet in a position to answer.
With respect to the pharmacology, we have put 687 into multiple on the.
Animal models, where we where we dose in a different a variety of different.
Times in settings, and actually on and indications. So we are building up what we think is a strong overall preclinical dataset showing excellent activity and showing the essentially.
Essentially full bioavailability by the sub Q dosing route so where.
We're very confident that it is.
It gives us a potentially.
Excellent positioning within the context of of of sickle cell disease.
As to whether its a single shot or as to whether people get give themselves, let's say multiple shots during the context of the of the crisis itself. We think that again based on the on the animal data that we've generated so far that there would be.
On that and is that a single dose again in the animal models.
Did abrogate the sickle cell crisis, whether one might need to follow with another dose some lump sum period of hours later to continue to maintain the effect, we'll have to study that when we get into the clinic.
But again the preclinical data so far is very strong and and strongly supportive of moving into sickle cell boc or potentially other indications as well do you think it could be if this compound could be used potentially even more more broadly I think your point about derisking is important.
Because we do feel that the clinical data that was generated with terrific cancel.
<unk> established that E. Selectin is an important biological targets and V. Oc and also established debt dosing early in the clinical.
In the context of <unk> is going to be important so we think that Ah.
Both of those are going to be very.
Helpful to us as we move forward to define the program was 16 87 details of which we will be sharing in the future I'm not in a position to share those today.
Okay. That's very helpful and yes. My question was just whether or not you could formulate a single dose of <unk> hundred 87 into a single sub Q administration.
I appreciate the feedback and congrats on progress.
Thanks, Steve.
Next question comes from Boris <unk> with Cowen.
Good morning. This is Cynthia on for Boris and congrats on all the progress on 2020 for your phase III trial, what kind of efficacy benchmark should we be keeping in mind for the readout on how should we be thinking about the market opportunity is the setting versus the NCI sponsored trial.
So I didn't hear your question clearly I heard about the market opportunity what was the first part of that I'm, sorry, Oh, just what kind of FX can you.
Just what kind of <unk> efficacy benchmark should we be keeping in mind for the readout in the first half of 2022.
Okay. So so I'll turn this to Eric Let me just answer generally that again, we're looking at overall survival for the one study and initially Etfs for the other study but.
I think I think Eric perhaps you could speak more broadly to how we see the potential of <unk> in AML.
Yeah. Thanks, Thanks, Rachel Yes to answer your question on the readout is an overall survival readout on arch study is powered to show.
A significant benefit for relapsed refractory patients over standard of care chemotherapy.
And the frontline AML study as from the NCI launch of course is.
The Etfs initially and then the overall survival.
After that.
Relapsed AML.
It's still.
Huge problem and even though there are a number of new drugs that have been developed.
Phil is a huge unmet medical need most patients end up relapsing and dying and.
The only really are important treatment is to get those patients to an allogeneic transplant and the data that we showed in our phase one two demonstrated that a high percentage of our patients who got the spy who responded.
We ended up going to transplant.
I think that's going to be at a critical important endpoint that we will be looking for in addition to overall survival is the ability to undergo transplant.
On the frontline setting I think again.
There are advances obviously vanilla clock says is an important advance, but when we look at the data.
We know that a lot of the responses are incomplete and patients end up relapsing.
And also in particular patients with secondary at mills, and those with poor risk a biologic features may not do as well when you add but net of clocks.
Hooper less law on May have an advantage in some of those subsets. So it would be looking.
Free carefully at that data when it comes out.
Great. Thank you.
Once again to ask a question. Please press star one on your telephone Keypad next question comes from Byron Amin with Jefferies.
Yeah, Hi, guys. Thanks for taking my question Darren sure.
Are you Rachel.
So on I guess GMI 16 87.
Can you I think at Ash you presented some data on the town's model in sickle cell.
With 687 can you tell us how.
687 compares to ever have a powerful.
And that model or another preclinical models in terms of potency.
Yeah. So in terms of potency. It's it's many many times more potent 500, or so more times times more potent than <unk> with respect to the targeted E selectin.
Therefore, we're able to dose at much lower doses than than we're able to dose through the pencil and that's why we've been able to dose subcutaneously on those models. So that the it's the increase in potency.
It leads to the potential for sub Q availability.
On the market is also very soluble. So that's also been helpful. In looking at the subcutaneous dosing so far in animal models.
Theres not been direct head to head comparison in the same models of <unk>.
There's a handful with 16 87, but we believe these models are certainly comparable in terms of looking at the ability to affect us.
Two leases.
As well as preclinical models can predict.
The impact on on Boc in humans.
Got it okay.
And then on the.
Ooh Pro and the NCI study.
How many events.
With that study needed in order to conduct the Etfs analysis of the phase II portion that's expected at the end of the year.
So I don't believe that the NCI has disclosed that publicly and we don't want to get ahead of their public disclosure. So I don't know that I can comment on that on Eric do you know if that's been disclosed publicly.
I'm not aware of debt either Rachel.
So sorry, if youre on that we can't get ahead of the uncharged disclosure, but they have set on a certain number of events as you would expect us as one would so.
So it's driven by both enrollment and by events.
Got it and so ntis I guess.
Keeping you guys updated in terms of the number of events that are growing on.
Quarterly basis on a regular basis.
Sorry, guys. I was just said we have we do have regular regular updates on communications with the NCI group yes.
And then I guess, maybe last question on that study.
You mentioned that you potentially could approach FDA with PFS data.
What type of a scenario or improvement would you need to see a benefit.
And that <unk> analysis that would allow you to approach FDA and potentially file that data.
So again I don't believe that the NCI has disclosed the specific details around that analysis, and therefore, I don't think that we can but but I think suffice it to say that if they meet the if they meet their pre specified criteria for evaluation of PFS at that point, then that then you would be able to take that forward.
Okay.
I thought there was a poster or a few years ago that outlined on hazard ratio of <unk> six four.
For that analysis so.
If they meet that is that something where you could approach FDA with.
So I'm not so thank you for reminding me up here and I'm not I don't remember what the public disclosure was on that.
But if so they have to meet their thought to meet their criteria and I believe there's some alpha spend that needs to be accounted for in that analysis as well.
Great. Thanks.
And at this time I will turn the call over to MS. Rachel King.
Okay, well. Thank you very much for joining our call. We appreciate your interest and your questions.
Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program you may all disconnect everyone have a great day.
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