Q3 2020 GlycoMimetics Inc Earnings Call
Joining glycomimetics corporate update conference call at this time, all participants are in a listen only mode.
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I would now want to turn the call or would you Miss Sherry.
The Investor Relations group at Glycomimetics. Please go ahead.
Good morning today, we will review our accomplishments and financial results for the third quarter of 2020.
Also be updating you on several more recent achievements primarily related to emerging data from the phase three recent trial evaluating with a pencil in diesel occlusive crisis in sickle cell disease.
The press release, we issued this morning is available on the company's website at www dot like them and medics dotcom under the investors tab.
This call is being recorded dialing phone replay will be available for 24 hours after the close call.
A webcast replay will also be available in the Investor Relations section of the company's website for 30 days.
Joining me on the call from Glycomimetics or Rachel King Chief Executive Officer, Brian Han Senior VP, and Chief Financial Officer, and Dr., Helen that Gray, our senior VP of clinical development and Chief Medical Officer will.
We'll start today's call with comments from Rachel and after that how long will review the new data with grip of cancel following our sickle cell update Brian will provide an overview of the Companys financial position and we'll then open the call for Q money, our co founder and Chief Scientific Officer Dr., John money on me will join us in the Q and <unk> to address your.
Questions on the emerging preclinical data.
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 for less than that.
And so she is my 16 87, and she my 13th 59, and there are other pipeline programs as well as the potential impact of the ongoing global COVID-19 pandemic on our clinical development operations and cash burn.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties like human medics undertakes no obligation to update or revise any forward looking statements for information concerning the risk factors that could affect the company. Please refer to glycomimetics.
Filings with the FCC, which are available from the FCC around the Glycomimetics website I'd now like to turn the call over to Rachel.
Thank you Sheri. Thank you all for joining our call. This morning.
Let me begin by saying that the third quarter's momentum continues as we speak today.
We'll see oncology and sickle cell programs, we're making progress on two key objectives first.
First we completed enrollment of our phase three trials of used to lessen in the second half of next year and.
And second solving on encouraging additional analysis of the reset study data ever turned up our rights to work in sickle cell disease.
Identify whether there's an opportunity for glycomimetics to move ahead to develop the therapy to treat acute phase of occlusive crisis Rovio see in sickle cell disease.
I'll begin with you for Westland program.
Enrollment in the company sponsored pivotal phase three trial evaluating you for less land in patients with relapsed refractory acute myeloid leukemia or AML continues according to plan.
After a slow down at most of our sites in the earliest stages of the pandemic the pace of enrollment for the trial [laughter] returns to forecasted levels as a result of maintaining our prior guidance.
Next to complete enrollment in the second half to 2021.
In our collaboration with the National Cancer Institute or in CCI.
Moment and that seems to be pivotal trial is also recovered after the initial slowed down due to the pandemic.
Their focus just kicking the newly diagnosed CML patients who sit for intensive chemotherapy 60 years of age or older.
Does she has done for both of these trials continues to be strong.
Highlighting the last mile central to provide benefits across several clinical endpoints, including.
We've been chemotherapy outcomes, such as difficult duration of remission and overall survival.
I was reading some of the serious adverse events have subsided toxic chemotherapy.
As we've said before we believe our data supports our vision of people less land as a foundational treatment for yourself.
I suspect most patients and that's a key element of a variety therapeutic regimens.
To that end at the society team to logic oncology in September 2020.
Collaborators at MD Anderson Cancer Center presented statistically significant preclinical data points to the potential for a combination of people watch live with panetta clocks and HMH to prolong survival.
This was demonstrated as either graft model derived from the patient resistant to the medical explanation like it you make treatment alone.
Potentially important to distinguish it was underscored earlier this week when we announced it was also accepted for presentation at the upcoming December annual meeting of the American Society Hematology or ash.
Clinical investigators have recognized the significance of this data given the relatively short duration of response, Connecticut combination therapy. In this patient population. We're currently exploring options to take this combination corporate in the clinic.
In sickle cell disease emerging data from the phase three recent Kyle continue to highlight the importance of early intervention with fast acting you slipping antagonists.
Disrupt the underlying inflammatory mechanism describing acute phase of occlusive crisis.
Our additional analyses of data from the reset trial, providing valuable perspective to us not just listen programs primarily in support of the clinical benefit that can potentially be achieved by administering are targeting selected product candidates currently in acute CMC.
We presented findings at multiple sickle cell focus meetings and conferences at the upcoming Ash meeting we plan to recap key secondary endpoints subgroup and sub so neither.
We believe these data provide a clear biologic and clinical foundation for treatment.
Selected antagonistic PMC.
Yes, he recently granted with a pencil a rare pediatric disease designation for the treatment of sickle cell disease in patients under 18 years of age, which recognizes a significant need to pediatric patients.
The development of her to pass on the pediatric setting a batch its designation could provide us with a priority with me about you.
As we continue to roll out data from our completed post hoc analysis of the recent trial handle.
Analyze new data from the open label extension study and.
We continue to engage with the FDA may it's premature to provide any guidance as to whether we will take that as a counter program forward.
Therapeutic options available for patients with sickle cell disease have increased substantially this recent approval.
Even with these approved drugs. However, the acute pain crises of sickle cell disease remain at very high unmet need and to our knowledge. There are no. Other late stage therapies in development focused on acute pain crisis for adult and pediatric patients.
As we continue to refine our analysis and approve our understanding fast acting insulin antagonism options, if any will become more clear.
Were actively exploring all opportunities, including options with GE in my 16 87.
With regard to G. M. I six maybe seven it's a more potent and more specifically selected antagonistic has a pencil and importantly.
Mailable following subcutaneous administration.
As such we believe this product candidate maybe ideally suited for treatment of acute yossi outpatient setting potentially even providing patients with the opportunity to treat themselves at home in the early stages of Yossi.
Proceed to multiple invitations to give oral presentations at key sickle cell in hematology constant says Gee and my 67.
Highlights of Mitchell Schear after Ellen's comments.
Finally, I'd like to leave you with my thoughts for the remainder of the year as well as 2021.
End of 2020 will be data rich multiple presentations and posters at ash I think like other metrics for compounds Ukuleles man, that's a pencil to my 16, 87, and she and my 13 59.
At all we'll have three oral presentations and two poster presentations, which is a testament to the strength novelty and relevance of our data.
In the coming year, we anticipate the completion of enrollment in our phase three Leslie trial in relapsed refractory AML.
This will clearly be an important milestone for this protection foundational therapy.
Our lives our successes relapse refractory patient population could herald, the life with a new treatment option for patients with me now.
In addition, with enrollment continues in our phase one b trial with GE and my 13, 59 patients with advanced breast cancer.
I hope to share buybacks in the first half of 2021.
Okay, because that preclinical data at ash in December highlight the importance of the biological activity demonstrated by targeting see axiall for have you selected with that molecule.
Importantly, as we've always operated on a lean and focused budget.
Cash to get through these milestones.
And now I'd like to ask Helena to comment on the data we presented at the September meeting the foundation for sickle cell disease research at the CPR.
No scientific conference on sickle cell Intel's seem yeah.
For ASCAP meeting in October and the data accepted for presentation at ash selling.
Hello.
Thank you Rachel.
Oh first analysis of new supportive data from the <unk>. The pencil phase three reset trial was reported at virtual FFC yard meeting in September.
Fair investigators presented new efficacy and biomarker data.
Particular data point it to statistically significant improvements for patients treated early in acute phase occlusive crisis in the primary efficacy endpoint of time to readiness for discharge compared to placebo.
For the group treat ethnic and 26.4 hours of onset of pain, which represents the first core tile. This primary endpoint analysis demonstrated a P value of 0.03.
Hazard ratio of 0.58, an immediate improvement at 56.3 hours compared to placebo and.
In other words, if treatment with a pencil was initiated early patients receiving better cancel we're ready for discharge median over two days earlier than those patients randomized to placebo.
The context for this is the phase III reset trial, which evaluated 345 patients who are experiencing a cute plc and required hospitalization for treatment.
We enrolled patients six years and above with a mean age of 22 years.
It's we're often asked I can explain that the time to readiness for discharge or TTR ft endpoint was the endpoint specifically agreed to with the FDA.
It reflects achievement of multiple clinical criteria assessing health care utilization and the patient's medical improvement prior to leaving the hospital, including no longer needing IB opioids, IB hydration or other related treatments beat.
These are generally the criteria that physicians and patients access to determine when the patient is ready to manage his or her care with oral medications and therefore to be discharged from the hospital to home.
Equally important we observed that patients treated with Rick a pencil showed a rapid deep sustained and statistically significant reduction in soluble easily often a biomarker a vascular inflammation that is known to increase from acute fancy <unk>.
We believe this shows that with a pencil has its intended on targeted biological effect with the resulting dancing or the inflammation in the vasculature.
The effect observed I'm totally reflected in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute C.
Data from the reset trial. Additionally, demonstrate a favorable safety profile for ready to cancel the same.
Safety profile for the pencil observed in this trial as evaluated in a large population with pediatric adolescent and adult patients strengthens the potential risk benefit proposition or to cancel.
At the European ASCAP meeting in October co hosted by the European Hematology Association and the British Society of Hematology, we were given the opportunity to share expanded findings from our analyses.
Glycomimetics coaster, specifically highlighted new subsets subgroup efficacy data from the phase three reset trial and additionally data from key secondary outcomes in patients treated with your canceled early in acute b or C. B.
These new findings confirm the critical role these selective and acute phase of accretion and the opportunity to resolve that condition and pain with effective intervention.
[noise] specifically the data for the pediatric patients who represented 41% of all patients treated in the reset trial are striking.
Data from children six to 17 years old and this study who were treated within 30 hours with iOS. The onset show a significant reduction in median time to readiness for discharge by 29.3 hours with a P value of 0.02.
A significant reduction in median time to discharge by 23.2 hours with a P value sequence here too I.
A significant reduction in median time to discontinuation of IB opioids by 15.4 hours with a P value of 0.04 or five.
And more children ready for discharge by 24, 48, 72 hours compared to placebo.
[noise] expanded data for the total population.
From the phase three trial.
Show that those treated within 26.4 hours at the onset of acute pain also achieved statistically significant improvements in the same two key secondary endpoints as just lifted for the pediatric group.
Family time to discharge and time to discontinuation of IP opioids.
Specifically.
Three studies 320, Evaluable patients 80 individuals were treated within 26.4 hours of pain onset earliest quarter of duration, a b and C until treatment for those 80 patients comparison as the interesting thing, but a pencil to those receiving placebo showed reduced median time to discharge by 41 point.
Five hours from 112.8 to 71.3 hours with a P value <unk> 0.02, and reduced medium trying to discontinuation of IB opioids by 50.5 hours, the Mone hundred and four to 53.5 hours with a P value <unk> 0.03.
In sum the new data demonstrate that treatment with Rick a pencil early in the course of the cute Yossi confirmed clinically meaningful improvements for two key secondary endpoints not previously reported shortening Ivy opioid use and decreasing the hospitals day for both the pediatric subgroup and for the total.
Agents group in the trial.
Furthermore, the favorable safety profile of worker counsel observed in the phase three reset trial as now evaluated in a population that includes pediatric adolescent and adult patients is highly encouraging to us.
We were very pleased that Ash has also chosen these data for an oral presentation at this years annual meeting yes.
Yeah. That's correct posted this week also recaps data could pediatric subgroup and for all ages on the key secondary endpoints as part of an oral presentation at Ash. We also intends to report on a new data analysis from the open label extension trial. This study evaluated rid of pencil in patients hospitalized for treatment of the year.
Subsequent to their initial administration study drug in the phase three reset trial.
In summary, the additional analyses are compelling for us and for the medical community as to the critical importance of early aggressive intervention targeting he selected for the treatment of acute b or C.
I look forward to your questions later in the call at this point ill ask Rachel to continue Rachel.
Thank you Alan.
Addition to the exciting new with the powerful data, indicating that he slept in antagonism can reverse the course of acute painful episode diffused early but.
The data we've obtained with G.M.I. 16, 87 has been well received and recognized with oral presentations at recent conferences ended December at Ash.
This drug candidate isn't he selected antagonists, it's more potent than more specific than was a pamphlet. We believe self administration could move available treatment for acute feel see not only into the outpatient setting, but potentially also into the home setting.
On September 24, oral presentation of preliminary preclinical data at FSC D.R. meeting supported development of GE and my 16 87 as a possible follow onto the tangible including that this product candidate has the potential for subcutaneous self administration to me the bill for use in the outpatient setting.
At Ash got in late October another oral presentation disclose new data from two different preclinical models and shove the drug candidates efficacy as a subcutaneously administered treatment because you see the prevents she called Red blood cell adherence to wane, while still true.
But stressed vessel occlusion and restore normal blood flow.
At the upcoming Ash meeting an abstract has been accepted for presentation well once again highlight the product candidates potential for intravenous and subcutaneous administration. She PMC by inhibiting conclusions on restoring blood flow mouse model of DRC sickle cell disease was featured.
We believe we could be at a turning point in the treatment of acute Yossi. We now have statistically significant data shows the benefit of early intervention is finding has renewed interest in with a pencil, but also highlighted the relevance of GE. My 16, 87 as a possible superior follow on product candidate that could change the face of Yossi treatment while.
Ill patients to treat early in crisis at home.
Do you have treated early has numerous precedents, including most recently the evolving treatment of hereditary angioedema, another acute and planetary condition.
She treatment with GE in my 16, 87, potentially alter the treatment paradigm in a similar fashion patients being able potentially to treat themselves at home.
He signed to acute event to disrupt underlying swim choice.
Actually.
I'd now like to turn to Brian Both review the quarter's financial results and to provide his perspective on our financial position right.
Thank you Rachel.
September Thirtyth 2020, Glycomimetics had cash and cash equivalents of $142.9 million as compared to $150.2 million as of December 31st 2019.
During the quarter. The company received a 1 million dollar clinical development milestones I belong Ics pursuant to the company's collaboration and license agreement for the development and commercialization of the blast Lan G. My 67.
Mainland, China, Hong Kong, Macau and Taiwan.
The company's research and development expenses were $10.7 million for each of the quarters ended September Thirtyth 2000 22019.
The company's research and development expenses decreased to $33.2 million for the nine months ended September Thirtyth 2020, as compared to $35.6 million for the same period in 2019.
Manufacturing and formulation expenses decreased in the three and nine months ended September Thirtyth 2020, as compared to the same periods in 2019 as a result of lower raw material costs purchased in 2020.
These decreases were offset by higher clinical expenses due to the increased enrollment in the ongoing global phase III clinical trial people watch when individuals with relapsed refractory AML and the phase two three clinical trial being conducted by the National Cancer Institute in 2020 as compared to 2019.
Contract research services consulting and other costs were lower in the three and nine months ended September Thirtyth 2000, 22020 as research activities were affected it outside universities and travel by research and development personnel was largely eliminated.
The the cobot 19th Anthony.
Now turning to Genie expenses.
Somebody's general and administrative expenses increased to $4.1 million for the third quarter ended September Thirtyth 2020, as compared to $3.4 million third quarter of 2019.
No administrate expenses for the nine months ended September Thirtyth 2020 increased $12.7 million.
As compared to $10.5 million in the same period in 2019 personnel related expenses increased due to the additional general and administrative headcount annual salary adjustments for the first quarter of 2020.
And legal fees consulting and other professional expenses, including directors and officers insurance premiums increased as compared to 2019.
Other general and administrative expenses decreased for the three and nine months ended September Thirtyth 2020.
As compared to the same periods in 2019 due to lower travel meals and conference registration expenses as a result of travel restrictions imposed during the call the 19 pandemic.
I'll now turn the call back over to Rachel.
Thank you Brian.
For opening up the call to your questions I'd like to reiterate our confidence in our clinical pipeline and of course in our specialized collect a medic chemistry platform chemistry insights to fuel several innovations that we believe have the potential to improve the standard of care in AML and May do the same in sickle cell disease and other diseases as well.
Now operator, please open the call for questions.
Your first question comes from Ed White with H.C. Wainwright.
So maybe I'll just start on regular pencil and 16 89.
You know I'm curious to know.
I know you haven't made a decision and you said that it is.
The timing isn't there yet to make the decision but what.
The information do you need to make a decision before rife with handful to advance and then also on 16 87. How are you thinking about that development will you be preparing if I can be and looking to move into clinical development or do you have to decide first on what Stuart.
Pencil before you make a decision on the path forward for 16.
Seven.
Yeah. Thanks. Thanks for your question. So let me put this into context.
As you recall a year ago, we watch doing anything in sickle cell disease and after the.
The disappointing outcomes. The reset studied we weren't anticipating to do anything in sickle cell disease, what's changed for us, which we think is exciting it up and open some opportunities for us potentially is that we have this new analysis from the reset study that shows the potential for only treatment benefit and in addition, as part of Pfizer turning back the program to US we now have the right.
Right to go forward in sickle cell disease, generally, which we did not have as long as the programs licensed to Pfizer. So that gives us an opportunity to look at the at the pipeline that we have to compare the opportunities and to decide what makes sense to go forward and we are very encouraged by both what we've seen with the reset study and what we see with the preclinical.
And it was 16 87, so we're reviewing those in each in context of the other and and there are couple of things that we're looking at as we decide what makes sense for us to go forward with respect to <unk> clay to complete the data analysis is telling described and we expect that at Ash. We will we will make a data presentation that will be substantially complete as to.
What we've learned from the from the reset study Weve also we will look at that in the context of that's getting.
Getting ft a input.
And looking at what we think it would require to take 16 87 forward and as we evaluate and compare the opportunities with those two programs I will be making a decision about what what makes sense, but again I think in the <unk>.
To put this into context, when we do feel that the combination of the recent data and the 67 data are both encouraging with respect to potential opportunities in sickle cell disease, and where we are now evaluating us determine what passport makes no sense.
Okay, great. Thank you and.
Just on you pro.
You happy we're a license agreement in greater China will you be giving any updates on that development, there and the potential.
You know for timelines and everything in greater.
Greater China.
And then also if you complete enrollment in the second half of 21.
In your phase three trial when could we expect to see data.
So with respect to your pro in China, We will give updates as that program progresses.
I think the next thing you might expect to hear would be an announcement when the study begins in China. So we will we will give give updates as that progression.
As far as the timing of data.
That depends on two things the data from the U. portrait one is of course completion of enrollment and the second is establishment or cheapened up a certain number of events.
And so.
We need to see how both of those both of those play out.
As we said, we do expect enrollment to complete in the second half of 2021, and then at that point you may have a sense of how we're booking in terms of number of beds.
Unfortunately in this trial bye bye, that's what I, what I mean by that is the number of patients who have died in the aggregate population that that would enable us to.
To compare.
The treatment for since the placebo arm, so we need to follow up for both of those and then and then we'll be able to you know to look today, but we do anticipate that the cash that the company. Currently has on hand would get us to that data readout.
Great. Thanks, and then my last question is just on 13 59.
Great to hear that the.
Study has restarted.
I think you had been expecting to enroll six to 12 patients can you give us an update as to how many have them both so far and.
What you said that we should expect to see did in the first half for 21, you know what data will we see at that time. Thank you sure sure. So.
So we havent given specific updates on numbers of patients, but as you indicated we do expect it to be a small number of patients and just let me remind you. What we are looking for in that study. That's the first trial of that of that drug candidate in patients and it gives us an opportunity to look at some PK PD biomarkers for the first.
Specifically, we're looking at Biomarkers related to mobilization of certain cell types. For example, mobilization of bubbles about aquatic stem cells and mobilization of cancer cells that could be resident in the bald.
So we were looking for a first indication of those of those PK PD Biomarkers also gathering some additional safety safety data.
In the aggregate what we anticipate is that data would that put us in a position to move into what you might consider to be a more traditional.
Traditional expanded trial in a patient population that we begin to look at that more traditional efficacy related endpoints, we've not yet defined what that patient population will be.
In this group obviously, we're looking at breast cancer patients you've also seen some preclinical data from this program at osteosarcoma.
As well as other interesting indication. So we think there are a number of ways. We could go with it but we do expect that the initial data would be biomarker related data.
Great. Thanks for taking my question for sure.
Your next question is from Stephen Willey with Stifel.
Hi, This is Allen on for Steve. Thank you for taking our questions and congratulate data even able to present recently, so I know you're pretty limited in what you can provide in terms of of Hansel and next steps, but can you provide any details on timing of maybe when you're having these discussions with FDA or when.
You expect to have these discussions with regards to next steps.
Yes, so we haven't provided specific guidance and we wouldn't on on any specific conversations that you might have with the agency above what we do what we will commit to is that once we have evaluated both any input we have from the agency as well as data that we have in hand.
But at that time, when we've made a decision about what what we think are are the definitive next steps. It then we will provide guidance on that.
Okay, Great and I think you mentioned this but with regards to the upcoming data presentations at Ash Forbo cancel it are those presentations representative of kind of the last batch of Ppas taconite post hoc analyses will be seeing from reset or do you expect to be sharing kind of more data I mean throughout early 21.
Oh, we do believe that the data presentation at ash will be substantially complete presentation.
The data from the written pounds of program to date and as Helen indicated we anticipate that will include data from the reset study as well as data analyzed from the open label extension trial. So we expect that the data at ash will be substantially complete.
Data presentation that I can't say that there might be some additional data that could be presented in publications going forward, but I think the ash data would be substantially complete presentation of the of the data.
Okay, Great and then maybe one on you for less Flynn with regard to that and I'll phase three trial I know you've mentioned that enrollment has resumed its normal pace and that being said as cogut is starting to spike in the U.S. again do you expect take any kobin mitigation measures going forward.
To make sure that enrollment kind of stayed on track or do you expect that to just not be an issue for whatever reason.
Well I catch obviously predict what the impact of Coke with may be and that's certainly a.
Concern I think for for all of us in many respects with respect to the clinical trial itself. So what we have seen is that.
Is it because of the way the the study's decided the way the patients are treated.
We think that it is well positioned to advance.
Advance through potential covert impact and.
If I could turn to held for more specific comments on that but but I'm generally observe that as compared to trials and other settings. We think a trial in acute and they'll setting may be better positioned.
As he said to to weather copas related delays, but it's.
No I certainly can't predict what those might look like us.
But progression, but how long could you comment further on the situation the clinical yes, yes. Thank you.
We we do.
We do know that patients with our.
Acutely diagnosed and refractory AML or relapse require treatment that is.
In the hospital setting pretty intensive chemotherapy that they receive that in an.
Acute need and.
One that proceed regardless of the situation with the pandemic, so patients do need to be hospitalized for treatment.
And that means that they are coming in for treatment and participating in the trial.
In terms of mitigation there.
There was one other element of the trial that I would.
Mention that and if.
We have seen Ah Ah.
Getting some advantage to continuing accrual over the course of the pandemic and that is the global nature of the trial.
So we are not limited to any one country or region in terms of the.
Sites participating in the trial we have.
Sites in North America in Europe, and in Australia.
And when we have seen one region or area with increased severity of the dynamic we've had other areas with won.
Operations in terms of their hospital procedures and patient care. So that has allowed the trial to have a steady.
The pace of enrollment as we would have expected.
Globally in the aggregate, while there may be more local effect here and there as a local areas are responding to to life.
In their engine.
Thank you Helen Okay got it yeah.
Unlike could left if there be that's I think that's the key point.
Right now the keathley, Okay. Yeah. Thank you so much for the color and again congrats on all the recent progress. Thank.
Thank you.
[noise] if he would like to ask a question. Please press Star then the number one on your telephone keypad.
Your next question is from type Madella with Roth capital.
Thanks.
Good morning, guys and again congrats on the App Shack was particularly oral presentations isn't really exciting I think I just have two quick ones here. The first one is on the panel I'm excited that you know this will be an all I'd asked so a lot of conditions, we'll have to see the updated I post hoc dot App I was just curious.
If he'd been engaging with that came out you know what some of that be back I had been like I know were planning to have our own kill call coming up that you just wondering what your feedback has been.
Yes, So I think that's a question I'd also turned to Hell and obviously at this point are.
Yeah, well, let me just from that to help.
[laughter], Thank you Rachel and.
Thanks, you for the question. That's it that's it's been very interesting we are hearing and I think and in discussions with the.
Investigators who've been involved in the trial.
Confidence that the inhibition of each laughter in having a clinical effect and feed in the fund group of patients in the trial who were treated early.
The biomarker data is extremely supportive of that and then if I.
I think.
Excitement about the potential for.
As a therapeutic candidate that could be used to treat their estimate and as you know that Barry there remains the increase unmet need for.
Therapies that would interrupt the acute need because the process and so there has been strong interest.
Each month and excitement from investigators around the evolving.
In fact, as we learn more about the effects of fruits, it's approaching those treated early in their acute PNC.
Yeah, I think another perspective that we could add to this is that there is a as we think about this there's the potential for the development of a new paradigm for how patients are council with respect to be you'll see currently many times patients are told to stay home.
Their counsel to do all they can to manage the pain at home and that's a kind of course, many people understandably reluctant to go to the emergency room, where where the standard of care is the delivery of opioids if.
If there were an alternative that could.
That could provide belief that that could actually change the change the paradigm of how patients are advised to may be wise to go earlier to the emergency room.
To seek an earlier intervention in the crisis, which I think is an interesting opportunity and something that is also.
Something that's being recognized by our by the K well. So we certainly also look forward to.
More payroll engagement as the data becomes even more widely known to the oral presentation at ash.
Thanks, guys and then just the follow up here I'm excited to see that that you put up plus eight Tammy I dabbled in old presentation as well, even though it's a preclinical study.
Steady outcome I got excited about this one when I thought the early data at Ash last year been pounding the table on it though quite excited I'm just thinking because you know these are huge studies and these are going to be long studies. If this is something that you're going to explore clinically as well. So are you thinking about potentially partnering doesn't and at what stage.
Would you want to you know kind of get it as far as you can before partnering or would you be open to some kind of partnership as early as possible.
Yeah. So thank you and yes. We are also very excited about the.
The.
Combination data with the few Proconnect clecs and and the economy as you know, but that of course is really.
Come in it as an important new treatment option for patients with AML, but sometimes the although the response rates are good the.
She artful she ours as a as a percentage of.
Total responses is not what you'd like to see it sometimes the responses are not as durable as one might like to see so the preclinical data really is exciting to us and that we do think that it does.
Importantly, this combination into the clinic.
So we remain very focused in terms of our operations on getting the phase three trial finished with the.
With you pro with it and relapsed refractory setting as you know, but we have had some very strong interest from investigators in pursuing these combination therapy. So we are looking at how we might in a very cost effective way take this forward in the clinic and when we have specific plans with regard to that we'll certainly let you know.
And so I think I guess I would I would have to say stay tuned.
What we're looking at is is there a cost effective way for us to.
To begin to get an early look at the potential of this combination in the clinic and as we as we bring together this class, we'll certainly let you know.
Thank you I appreciate it.
Right now.
I remembered caliente, yes, both.
Both of Us [laughter].
At this time there are no questions, but do you have any closing remarks.
Well just to thank everyone for participating in today's call and we really appreciate your your questions your interest and your support of the company. Thank you.
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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