Q3 2023 X4 Pharmaceuticals Inc Earnings Call
Greetings and welcome to explore pharmaceuticals third quarter financial and operating results conference call. At this time all participants are in a listen only mode. A question and answer session been followed the formal presentation. As a reminder, this conference is being written.
It is now my pleasure to introduce your host Dan Ferry from lifestyle advisors. Thank you. Mr. <unk> you may begin.
Thank you operator, and good morning, everyone.
Presenting on today's call will be X Force, Chief Executive Officer, Dr. Paula Ragan.
Chief Commercial officer, Mark Baldry.
And Chief Medical Officer, Dr. Christoph <unk> Ingalls.
Following prepared remarks by each we will open up the call to your questions.
And we'll be joined by Chief Financial Officer, Adam Mostafa <unk>.
<unk> scientific officer parts of Arris, and Chief operating Officer Mary Dibiase.
As a reminder, on today's call the company will be making forward looking statements regarding regulatory and product development plans as well as Richard research activities.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Description of these risks can be found in next four is the most recent filings with the SEC, including this quarters Form 10-Q.
It is expected to be filed after market closed today.
I'd now like to turn the call over to X Force, President and CEO, Dr. Paula Ragan.
Paula.
Thanks, Dan Good morning, everyone and thank you for joining us on the call today to start I'll be reviewing our third quarter event and reason highlight the first two of which will be the primary focus of our discussion today.
As you can see here, it's again been a very busy and productive period at export which culminated in the great News last week that our NDA seeking approval of our lead drug candidate Maverick before for the treatment of whim syndrome, what is it.
Accepted by the FDA for priority review.
He has set a producer or action date of April 32024, which sets us up for a potential second quarter 2020 for a launch in the U S. If a crew.
In anticipation of this we've continued to build out our fit for purpose commercial organization Mark Badri, Our chief commercial officer will run through some of the details of our launch readiness and prelaunch activities to date.
Which aim to further the understanding of a whim syndrome, and educate both patients and physicians and the importance and benefits of early diagnosis.
We do want to remind everyone here that do the Mavericks for rare pediatric disease designation for women syndrome in the U S. Export is eligible to receive a priority review voucher or P. R. V. S. Maverick before as it proves that we can use to either pay and priority review for a subsequent application or to sell to them.
They are driving faster.
Turning now to our Maverick before a chronic neutropenia program. We've continued to advance our phase two study and have now enrolled more than 15 participants in the trial and importantly key learnings from this ongoing study along with the data from previous trials and input from the FDA have enabled us to finalize the deal.
But we believe will be in a global pivotal phase III clinical trial that will be used as the basis for seeking approval of maverick for it in certain chronic neutropenia disorders.
As discussed on our last quarterly call Dr. Christoph <unk>, Angola has joined <unk> as our new Chief Medical Officer, we thought it would be a good opportunity to hear from him today as we approach some key milestones in our development of Maverick before in chronic neutropenia.
I'll be providing an update on this program later in the call.
During the quarter, we also strengthened our board of directors with the addition of Mr. Keith Wood.
Keith brings significant global commercial strategy and operations experience. Most recently at our Jennings, whereas chief operating officer, he helped to build a sustainable enterprise and successfully launch our rare disease product globally cause.
A meaningful experience and so our board as export aims to transition to a global R&D and commercial enterprise as well.
As also discussed on our last quarterly call. We completed an expanded loan facility with Hercules capital. In addition to the possible P. R V next year.
<unk> provides us the financial flexibility and importantly, non dilutive financing option.
Lastly, we believe our current cash and equivalents balance of just over $140 million at the end of the third quarter is sufficient to fund our operations into 2025 and note that this does not include the debt options or the potential proceeds of the sale of the PRD. If NDA approval is obtained.
<unk>.
Before I turn it over to Mark I'd like to present, a quick review of Whim syndrome, as a reminder to those not familiar with our lead indication.
Women syndrome is a rare primary immunodeficiency caused by the over signaling of the <unk> pathway, which in many cases results from genetic variance and the <unk> four receptor gene.
This pathway is a key regulator of normal trafficking of white blood cells, which include neutrophil lymphocyte and monocytes.
Women syndrome white blood cells become trapped in the bone marrow, which leads to chronic neutropenia and lymphopenia.
These immuno deficiency has lead to a number of clinical manifestations, most notably an increased risk of infection in the lungs skin and other key Oregon, and an increased and the incidence of HPV related cancers.
Greatly affecting the quality and length of life of the estimated 1000 people diagnosed with women in the U S.
With earlier diagnosis, we believe the damage from these infections could be mitigated as you recall, we were able to show in our successful phase III trial, and whim syndrome statistically significant increases in both neutrophil and lymphocyte counts as well as clinically significant reductions in the rate frequency and severity of.
Sections versus placebo.
If approved next spring Maverick for it would be the first therapy available for those individuals diagnosed with <unk> syndrome, and the only disease modifying treatments.
I'm now going to turn it over to Mark to give you some of our insights and details on our progress and plans for commercializing Maverick for for women's syndrome Mark.
Thanks, Paul and thanks to all of you on the call today.
We thought it would be helpful to start by highlighting some of the ways that we've been engaging with the wind community.
Developing and understanding of the market landscape and establishing a foundation for successful introduction of Maverick support to physicians patients and payers.
As Paula mentioned there are currently no approved therapies for whim syndrome.
This is our limited to managing their patients symptoms using repurposed symptomatic treatments for example, immunoglobulin replacement therapy, which is injected or infused into the body and or prophylactic antibiotics, all of which carry their own challenges and do not address the underlying cause of the disease.
Diagnosing whim syndrome is also a challenge given that the clinical presentation of the disease is so variable.
In fact, only about 20% of patients present with all four of the hallmark symptoms and manifestations of whim.
Some physicians use genetic testing to help identify whim or confirm its diagnosis, while other physicians rely more on the clinical presentation of the patient.
Due to the rarity of the disease and lack of investment in treatment innovation. There is limited awareness of women's syndrome, and the general physician community and the patient journey often includes visits to multiple types of doctors as they try to uncover what might be causing the symptoms.
Given this lack of historical attention and investment we recognized the significant opportunity to not only address the unmet needs of currently diagnosed <unk> patients, but also to use our resources to identify additional patients and what we believe to be a larger population of undiagnosed people living with whim syndrome, who.
Could potentially benefit from Mavericks for treatment.
The next slide provides an overview of our efforts to date, which are focused on partnering with the women community driving earlier diagnosis of whim and.
Ensuring broad access for eligible patients and delivering on the promise of Maverick support.
I'll highlight a few of our key successes here.
First with regard to partnering with the wind community.
We have successfully identified kols with expertise in treatment experienced and win.
We've assembled an advisory panel several of whom you've met during our previous data presentation events.
And we've worked with numerous experts to offer many of our publications.
We've also developed and continue to foster collaborations with immunodeficiency patient advocacy groups and disease focused professional societies in the U S and abroad.
Through all of these partnerships and collaborations we believe <unk> four is playing a significant role in uniting the whim community around a common mission to advance the understanding and management of this rare disease.
Next to drive earlier diagnosis of whim, we've initiated a number of programs and websites to increase disease awareness.
Including our most recently launched what if it's women campaign.
As you can see here through the campaign, we're aiming to educate on the variable clinical presentation of whim syndrome, driving home the importance and urgency of early diagnosis, which can lead to better patient outcomes and providing easy access to additional resources, including direct contact with our field diagnostic.
Team as well as to free genetic testing.
We have also been analyzing medical databases and have completed a significant physician mapping exercise to build our prioritized list of target immunologist and Hematologists.
We've strengthened our presence at key medical conferences hosting peer to peer disease education, symposia and launching our new Congress exhibition booth, which pulled through or what if it's women campaign.
All of which have significantly increased the visibility of X four and whim syndrome and is connected this directly with a broader group of physicians and patients.
In fact, our patient finding efforts have been accelerating nicely and continue to give us confidence in our prevalence estimate of at least 1000 patients living with whim syndrome in the U S.
To ensure that eligible patients have access to therapy. After approval, we've engaged with payers and are developing materials to communicate the compelling value proposition of Maverick support.
Our published clinical data from the phase III for whim trial supports our value messaging by providing evidence of improved neutrophil in lymphocyte counts and importantly reductions in the rate of severity and duration of infections and trial participants treated with Maverick support.
We will be leveraging these points as we begin to discuss pricing and reimbursement going forward.
And finally, we've been building an organization that's truly fit for purpose. We've made key leadership hires across medical and commercial functions, all of whom have significant rare disease and launch experience.
And supports the ramp up of our go to market efforts as we head towards an anticipated second quarter 2020 for launch in the U S.
I would like to conclude by highlighting the investment synergies here between the whim syndrome, and chronic neutropenia commercial opportunities.
We believe that if we're successful in developing Mavericks four for the treatment of chronic neutropenia, we expect to leverage much of the work in many of the relationships developed through commercializing and win with a future potential commercial launch in CN.
And now I'll hand, it back to Paul to discuss more about our ongoing development program in CN.
Paula.
Thanks, so much Martin.
Really great summary of all of our efforts to increase disease awareness.
Enable earlier diagnosis and support patients in need as we head towards our anticipated launch and win.
Let's now change gears, a bit and focus on our chronic neutropenia program.
We thought it would be helpful here as well to remind everyone. What would make the biggest difference to people living with chronic <unk> and their physician that is where are the greatest needs and those that we serve.
If you recall a little over a year ago, we held an investor event focused on CN and our initial phase one b trial results at that time, we shared that 100% of the 25 patients enrolled achieved robust ANC responses from a single dose of Maverick before regardless of background therapy. Additionally.
From our interviews, we gathered valuable insights from patients and physicians, where they highlighted their needs as it related to the product profile of a potential new treatment for CN.
Their preferred attributes included an oral formulation that is safe well tolerated and easy to administer or take.
And when that Durably increases and fees over time.
<unk> has already demonstrated these attributes across a number of population.
Additionally, peace and clinicians criteria for a new treatment includes a therapy that decreases infection burden and also decreases the Texas cities and challenges associated with taking like foreign G. CSF.
Our successful phase III trial, where infection rates severity and duration. We're meaningfully reduced provides evidence that this benefit of Maverick first could also translate into helping the CN community.
Most importantly, our CF phase II study is beginning to build direct evidence and chronic <unk> patients across the key metrics are durable AMC increases safety and reduction of G. CSF use.
I will now pass it over to Christophe Arbat angles, our chief Medical officer to share an update on the status of the promising CN program Christoph.
Thanks, so much Paula.
Following the successful completion of our phase <unk> clinical trial evaluating the ability of the single dose of Maverick before to raise absolute neutrophil count or ANC in CF patients.
Launched a phase two trial to evaluate quantity.
Before in the same patient population.
Without concurrent G CSF treatment.
The study is designed to assess maverix ability jewelry bleed rates.
Within the first few months.
<unk> was a patient could possibly reduce or eliminate the GTS as those longer term.
Importantly, we also assessed for safety of Maverick before in combination with G. CSF.
We have seen a nice acceleration in trial enrollment and now have more than 15 participants receiving treatments in the trials.
I will now last quarterly conference call.
<unk> presented initial data from the first three participants in the study all of whom were on DTC treatments.
Inflation that has identified unmet need.
All achieved large durable increases in A&P.
And the two neutropenia patients achieved normal A&P level.
Hi, having low AMC, while on G CSF therapy.
We entered this study.
No absolutely.
The increase in we'd need to responder criteria that we've established for the phase III study design, which I will go into more details shortly.
Importantly, the Rover.
You recall in the early months of the trial enabled the successful both decreased or complete withdrawal of the gcs that in some patients.
<unk> has also demonstrated an acceptable safety profile in combination with GPS.
The full dataset on discrete subject will be presented in a poster at the annual Ash meeting in December.
In addition, we expect to be able to present, a comprehensive update from at least 15 of the participants in the phase two trial during the first half of 2024.
Most importantly, we are pleased to rapidly move forward toward our pivotal phase three trial in <unk> given all the positive because today supporting this population.
The success, we've seen there.
For across the CF study as well as the positive impact that Margaret before has demonstrated in <unk> patients.
Inspires us to advance as quickly as we can by delivering an innovative oral therapy.
With our current insight and input from the FDA.
Now I'll provide a little more detail on our global pivotal phase three clinical trial, which we remain on track to initiate in the first half of 2024.
We've now completed multiple interactions with the FDA and have aligned on the current study design.
<unk> trial will be a global double blind randomized and placebo controlled trial and positive.
With or without concurrent G CSF treatment.
The dosing of Maverick before will be the same as ours.
Three four when clinical trial.
Participants from G. CSF at baseline, we will remain on a stable dosing regimen. During the 52 week study duration and adjustments and GPS that building will be allowed only for safety reasons.
Patients included in the study are required to have confirmed idiopathic or doing.
News or congenital chronic neutropenia with the Nancy.
1500 cells per microliter.
Since you have demonstrated a history of infections, requiring medical intervention in the last 12 months prior to trial entry.
The trial currently in design with a two component primary endpoint assessing annually.
Churn rate and ANC response.
Secondary endpoints will include severity and duration of infection.
<unk> got key quality of life assessments and safety.
In section will be assessed by a centralized blinded adjudication committee the same approach used for infection.
Assessments in the successful phase III pivotal study.
Working group process as Tom Fleming.
Biostatistics adviser.
Is this telling the trial size to be 150 participants globally to achieve a power of greater than or equal to 90% for each of the annualized infection rate and in your response endpoint.
With this protocol finalized we are confident that we will be able to initiate the trial in the first half of 2024.
Further adding to our confidence we have selected our global <unk>, who have already begun advancing towards site activation and identifying potential participants for the trial.
By leveraging the existing <unk>.
Advocacy groups and global patient registry.
Our own efforts to align the large pool of existing patients with the identified sites will.
We believe we are now well positioned to achieve full enrollment in the phase III pivotal trial in approximately 12 months.
I'll now pass it back to Poland.
Thanks, So much Christophe we hope it is clear from our discussions today and why we are excited about the future of our company. We have a robust dataset maturing in our CN a phase II study given all the positive data in hand, and clear FDA guidance, we are gearing up for a potential launch of our global CN phase III pivotal trial.
And finally, we are headed for a potential first approval of Maverick explorer and <unk> syndrome in the U S.
And subsequent launch.
We look forward to the potential of delivering maverick before a much needed treatment option to this underserved group of patients.
We very much look forward to the continued periods of growth and accomplishment in the coming years and with that we'll now open up the call for your questions operator.
Thank you.
We will now be conducting a question and answer session.
If you would like to ask a question. Please press star one.
Telephone keypad.
Permission tone will indicate your line is in the question queue.
First off if you would like to move your questions from the queue for box plants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, please pull for questions.
Our first question comes from the line of Evo JV.
Channel.
Colin Please go ahead.
Hi, good morning, and thanks for taking our questions.
I was wondering if you could talk about the C. In patients who are on G. CSF, it's still a niche of peanuts.
What are the reasons for their inadequate response.
Mostly due to intolerance or other reasons they are refractory or have an adequate response.
I guess I'm trying to get a sense of how heterogeneous patient population.
It's an excellent question.
Christoph our CMO will provide some commentary on that yes.
Yes. Thanks, yes. It is indeed very mature genius population.
We do have.
The plan to have continued toll in idiopathic.
<unk> patients in our phase III study.
There are different reasons, obviously, if there is.
For instance, mutations in those congenital patience.
And the response with UCSF varies.
With this.
These patients for some have a defect in the maturation of the of the neutrophils in G. CSF may not address all aspects of the different phenotypes you can see in these patients.
Maybe just to add we have an excellent recent recent clinical meeting and what we've heard even from some of our clinicians is how happy some of these patients are to be considered for study around an oral therapy, given the very difficult tolerance level, even when they can respond to G. CSF, it's a tough treatment to take.
Great Thanks for that and second on wind.
Based on all your commercialization and market building, a search and win.
How do you expect the launch trajectory to look do you expect a bolus patients at lunch.
Yes, we've actually been really pleased with the level of engagement, we've had with physicians and patient groups to date.
It's actually given us.
Confidence in our prevalence estimates of about 1000 patients with women in the U S.
So we're building the foundations for.
Launch that will get the product to patients as quickly as possible after approval.
Great. Thank you so much for taking my questions.
Yeah.
Thank you next question comes from the line of Stephen believes with Stifel. Please go ahead.
Yes. Good morning, Thanks for taking the question.
Can you say, whether or not I guess, you've brought any additional.
Sites online and the phase two I think you had previously said you were at around six.
And then how many sites that you're planning for the phase III.
Sure. Thanks, Steve.
Some good lessons learned on the phase two we did have that we can maintain an excess of supply there is a little bit of a hiccup in enrollment but are very pleased with the 15 plus patients now enrolled that will have a robust dataset, but its a great lessons learned to prepare for the phase III and Christophe will share some more on that yes.
We've learned.
<unk>.
<unk> from the phase from the Phase II study and from the <unk>.
Phase II study, we're going to apply those.
Two the phase III.
We are evaluating exactly the number of sites that we're going to have X U S and in the U S. At this time.
Our confidence we've identified.
A large proportion of the patients that we plan to enroll.
In the U S and ex U S and feasibility seems to really match with.
Tracking with what we our expectations are so we are confidence we can enroll this phase III study.
Yes, maybe just think just to give you a little bit of a benchmark Steve I think we had around 20 sites with using rough numbers for when they are about three times as many patients and CN. So you should expect about three times as many sites for the phase II trial ourselves and are finalizing those exact numbers, but it's definitely going to be a robust number to make sure we hit that one.
One year enrolment.
Okay.
That's helpful and then.
With respect to the phase three protocol and chronic neutropenia I guess.
How are you standardizing G CSF reduction withdrawal.
Is that just an investigator subjectivity.
And then is there a way that youre going to try to statistically quantify that at all.
Right. So G. CSF as you know is prescribing DVT will lead to patients and Theres lots of variability. So we're asking our patients in the phase III to remain stable, we want to establish the effect. These notes of maverick's before versus placebo.
<unk>.
We're going to maintain this we're going to allow only modifications of this.
Blinded adjudicated committee for.
For safety reasons. So for example, if their anti goes too high or if there is a <unk> event, but we're going to be.
Trying to enforce stable treatment of G. CSF for the 52 weeks of the trial.
Okay. Thanks for taking my questions.
Thank you next question comes from the line of Edward <unk> with Piper Sandler. Please go ahead.
Thank you very much and good morning, everyone.
Two questions if I may firstly I should know this but is there any.
Open label extension work being done and wins in other words other currently any patients on Maverick support.
And then the second question.
I think you mentioned if I heard you correctly that there will be the three patients more data on those three patients from us could there be more patients just because of additional time between abstract submission.
The actual presentation. Thank you.
Sure. So I'll just do a quick summary on the Whammo LTE is ongoing we expect to present data on that in the first half of next year.
I'll look forward to sharing some updates on the patient's heroes, who are on placebo moving into Mavericks foreign those on long term app. So stay tuned for that and then.
In terms of the three patients and the ash poster our intent is to really make sure. We have a robust data set around a 15 patients in the first half of next year I think that will tell basketball some story around how that drug backing but we're really looking forward to presenting the six month data on those three patients on GTS app.
There's a lot of exciting.
New information to and amongst those three patients so stay tuned for that as well Ted.
Great Awesome I'm looking forward to that and can you remind me I know the majority of patients rolled over how many patients are in.
Thanks.
So we haven't given any updates.
I think 90 plus percent of them rolled over and I'm actually not sure where the cut is at this point, but we'll certainly be disclosing that when we get the data update.
Thanks, Paul.
Thanks, Ed.
Thank you next question comes from the line of Dan <unk>.
Our lease Securities. Please go ahead.
Hey, good morning. This is Andy pleasure onto telephone. Thank you for taking the questions are you able to give any additional granularity on the timing of the next comprehensive update for the 15 patients or if theres a certain amount of follow up that you'll be looking for before presenting the results.
Sure Chris I'll go ahead, yes.
No there will be we will have all of those those data in a more comprehensive manner in the first half of <unk>.
Next year, the ash poster will help.
Sure some preliminary information and we hope to continue this.
To remind you that the phase II study is a six month study. It's an open label. So we can do different analysis, but it is important that we see those six months data and we see this.
The largest number of patients to raise the confidence of the preliminary data we are going to be seeing at ash.
Okay, and then as a follow up to that do you anticipate the phase two data to be enriched for cyclic agenda are idiopathic Xian.
So I think what we're doing for the phase III of course of the all comers because theres two questions are trying to answer obviously, making sure that our phase III study design is robustly incorporating any responses that we're seeing and then secondly, there is the longer term question around GTS asked though.
The question that need to be answered and Thats, why we are including a diverse population with no pre specified number than any of those categories.
That makes sense and then one final question from US from your market research can you speak about what level of GCI reduction is clinically meaningful to patients and prescribers.
Obviously more reduction is better but any color that you can provide on what success might look like would be helpful.
As an excellent question and our answer has come to the ash poster because we'll be we'll be actually providing some very meaningful market research around that exact question.
We look forward to seeing you there. Thank you.
Thank you.
Thank you next question comes from the line of Kristen Pascal with cancer.
Cantor Fitzgerald. Please go ahead.
Hi, Good morning, everyone. Thanks for taking the question when I look at your finalized phase III study design in a lot of ways. As you mentioned it really does mirror what you what the trial looks like for win which of course was successful. So can you talk about how you think that gives you the confidence.
In this particular study and any differences, we should really be thinking about related to the mechanism in the subset of patients versus when.
No no.
We have worked with one of our consultants profits flowing from the FDA in designing that study very closely with him.
Our confidence that we have the power for our primary endpoint to be achieved and we have the right sample size.
We have two population that we're going to be included in that study, which is the mono therapy and the patients from G CSF and because it's a randomized double blind controlled trial versus placebo, we will be able to establish the effectiveness the efficacy of Maverick Sephora. We also incorporated in that study the Ric.
<unk> from the feedback from the FDA that we received.
And so we believe we have all the elements to two recruits and.
And see positive data in this phase III study.
And maybe just to remind folks on the whim phase III, we thought about a 60% reduction across the patient populations. We actually took a fairly conservative approach, even reducing that to plan for the stats on the phase III, which is why we feel very confident.
Okay.
Okay. Thanks for that and it's nice to see the uptick in enrollment in this update can you maybe talk about what you think some of the factors are that it was originally slower than expected now that <unk> seen this uptick.
Things like seasonality and again, how this also help for planning for phase III. Thanks again.
Yes, Sir.
Thank God trial enrollment is a challenge for every biotech out there, especially in a new fields, such as chronic neutropenia, but I think what we just wondering is this summer it's tough for some of the younger patients we actually have fairly sick patients in this trial, but they certainly wanted to have some downtime as is expected enrollments.
Enrollment has picked up nicely I mean, more importantly phase III is theyre very different from phase III is theyre very heavy operational left you want to create a large pool of patients waiting that are co localized with your site, we actually have a very nice.
Start to that quite set with a quite a robust patient pool already identified the sites that are coming onboard. So we look forward to certainly hitting that 12 12 month enrollment with high confidence.
Are you done with your question Ms cluster.
Yes. Thank you.
Thank you.
Next question comes from the line of shrimp cooler.
Achieving Blake. Please go ahead.
Thank you good morning Paula.
Adam.
A lot of my questions have been on.
Onset.
Just looking into the phase III study in CNS disorders.
What's the label you are looking for.
Our loved ones.
Into the application stage and also.
Do you foresee.
Either.
Increasing the size of the trial as the trial progresses.
That you maintain them.
There's certain number of patients in these individuals.
Populations, so that you can get a broad.
Deborah.
So.
Regarding the label based on.
The previous label for G. CSF for example, we should see a label that addresses the reductions of infections in the patient populations that we included in this trial.
And so we haven't finalized the label guests with the FDA, obviously, but.
But this is what we think could be happening and we're looking at this reduced infection rates.
With regards to.
Yes, I think he was just asking about sub populations.
Similar to Gcs subpopulations, where kind of catch up catch can but it's based on the inclusion and then the label covered all the variable patient population right. Yes, we are.
We do.
The trial again is powered 90% for our primary endpoint.
So we're not planning we're planning to have this study executed as we as the sample size and we are confident that we should be.
Able to each of our primary endpoint was the current sample size.
Okay. Thank you thanks for taking my question.
Thank you next question comes from the line of David Bautz Zacks small cap research. Please go ahead.
Hey, good morning, everyone. Thanks for the update this morning, just one question for me.
I'm curious what type of Doctor ends up typically making the diagnosis for whim.
I guess, what I'm trying to get at is how are you sure that you're reaching them.
The correct physician population with your outreach program.
That's a great question.
Because of the variable presentation of the disease. These patients have.
Different journey diagnostic journey, depending on their symptoms. So some of the patients end up under the care of immunologist and some of the patients end up under the care of a hematologist are mark. So this is what we've been focused on.
For the past few months is really looking at the data and engaging with key institutions and learning about who are the physicians most likely to have these patients. So that once we get approved we know where to prioritize our efforts.
We've also been complementing this with our digital marketing, which I talked about earlier in the presentation and this is an efficient way of extending our reach.
Okay, great. Thanks for that.
This concludes today's question and answer session I would now like to turn the floor over to Paula Ragan for closing comments.
Thank you very much again today for joining the call and we look forward to providing continued updates in the future as we make our exciting progress as a company have a great day.
Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Okay.
Yes.
Yeah.
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Yes.