Q1 2024 X4 Pharmaceuticals Inc Earnings Call
Okay.
X for Pharmaceuticals first quarter 'twenty 'twenty four earnings conference call at this time all participants are in there.
Listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Mr. Dan Ferry from lifestyle advisors. Thank you. Mr. <unk> you may begin.
Daniel Ferry: Thank you operator, and good morning, everyone. Thank you for joining us today.
Daniel Ferry: Presenting on today's call will be Dr. Paula Ragan exports, president and CEO and the company's Chief Financial Officer, Adam Mostafa.
Speaker Change: Following prepared remarks, we will open up the call to your questions.
Speaker Change: And we'll be joined by Chief Commercial Officer, Mark Baldry, Chief Medical Officer, Dr. Christoph our bet angles.
Speaker Change: Chief operating officer, Dr. Mary Dibiase.
Speaker Change: Chief Scientific officer, Dr. <unk>, <unk> and Jose who is.
Speaker Change: Head of corporate and patient affairs.
Speaker Change: As a reminder.
Speaker Change: On today's call the company will be making forward looking statements regarding regulatory and product development and commercialization plans as well as research activities.
Speaker Change: These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Speaker Change: A description of these risks can be found in <unk>, most recent filings with the SEC.
Speaker Change: This year's Form 10-K, which was filed on March 21 2024.
Speaker Change: And in the company's Form 10-Q, which is expected to be filed later today.
Speaker Change: I'll now turn it over to Paula Ragan.
Speaker Change: Paula.
Paula Ragan: Thanks, So much Dan and welcome everyone. Following last week's approval as well Randy it's exciting to reiterate today why in this critical regulatory achievement represents a significant opportunity to improve the lives of patients.
Paula Ragan: And offers a strong platform for the company's growth.
Paula Ragan: More specifically I will touch on our plans for expanding its all remedies used in women geographically and for are quickly advancing into a potential larger indication chronic neutropenia.
Paula Ragan: But let's start with last Monday as transformative announcements.
Paula Ragan: As you know, there's all Randy our Maverick the floor is now approved by the FDA for use in the U S. In patients 12 years of age and older with whim syndrome to increase the number of circulating mature neutrophils and lymphocytes.
Paula Ragan: Wednesday, Jerome is an ultra rare disease caused by dysfunction of the CX tier four a receptor which helps regulate that movement of white blood cells, including neutrophils and lymphocytes throughout the body.
Paula Ragan: People with whim syndrome, characteristically have low blood levels of neat yourselves.
Paula Ragan: Japan, Yeah, and lymphocytes, lymphopenia and experienced serious and our frequent inflections that cause significant morbidities.
Paula Ragan: In our pivotal phase III clinical trial that supported our approval, there's all Remy and oral selective <unk> antagonist improve absolute neutrophil count and lymphocyte counts ANC, NLC and reduced the rate duration and severity of infections and.
Paula Ragan: Those treated versus placebo.
Paula Ragan: This was the largest clinical trials to date in a whim syndrome enrolling 31 patients.
Paula Ragan: We'd like to note that the full manuscript of these clinical results were recently published online in blood. The journal of the American Society of hematology or ash.
Paula Ragan: And that results from this trial and its open label extension Phase, our OLED, where just presented last week at the annual meeting of the clinical Immunology Society or C. I S.
Paula Ragan: Notably the Cif poster revealed that long term treatment with the remedy was associated with durable improvements in neutrophil and lymphocyte counts.
Paula Ragan: As well as reductions in annualized infection rate.
Paula Ragan: And that to date no new safety signals have been observed during the O N E phase of the trial.
Paula Ragan: As with most ultra rare diseases, it can be challenging to assess the true patient prevalence.
Paula Ragan: As awareness is often low and patients are frequently under or misdiagnosed.
Speaker Change: And since we didn't cover this in detail last week, we thought it might be useful to remind everyone of the market size estimates that we've shared on the U S wind market over the past several years.
Speaker Change: Since 2019, we completed several robust market research studies.
Speaker Change: Using both qualitative and quantitative analyses show not only support our prevalence estimates, but to also better understand the wham diagnostic journey and treatment paradigm.
Speaker Change: Across a number of methodologies, including direct market research and claims based research we continue to validate our current estimates.
Speaker Change: And through our growing number of conversations with physicians in the field and at medical conferences, we remain very confident in our estimate that there are at least 1000 confirmed diagnosed when patients today in the U S.
Speaker Change: And now we're targeted therapy available, we expect that increased physician awareness will bring more and more focus to the whim community, enabling earlier recognition and diagnosis.
Speaker Change: Actually expanding the number of those diagnosed with wham overtime.
Speaker Change: And as our Chief commercial officer, Mark Baldry. So after we put out last week. It is well established that earlier and definitive diagnosis leads to better patient outcomes and that is ultimately our goal for the wind community.
Mark Baldry: We believe we are well positioned to not only deliver on the commercial opportunity and whim syndrome.
Mark Baldry: Also advance our global regulatory submissions, but the golar potentially providing new options to patients across the world.
Mark Baldry: Our European submission preparation and win are underway and we anticipate submitting a marketing authorization application or MAA for potential European approval in late 2024 or early 2025.
Mark Baldry: Importantly, wed like to review, our development plans and upcoming milestones for Mavericks far beyond Wham Andy.
Mark Baldry: And to define what success might look like as we explore the use of maverick for in the treatment of chronic neutropenia or C N.
Mark Baldry: To help understand the benchmark for success I'd first like to start with what we've seen and whim syndrome.
Mark Baldry: As I mentioned, our win Phase III trial data were recently published in the peer reviewed journal blood.
Mark Baldry: Pacifically when patients were severely neutropenia at baseline with that mean AMC of less than 250 cells per microliter.
Mark Baldry: Patients on Maverick before achieved increases of about 500 cells per microliter, reaching ANC levels of about 800000 per microliter on average over the 52 week trial.
Mark Baldry: This increase neutrophil counts of approximately five to 600 cells per microliter corresponded with a 60% reduction in infection frequency versus placebo as well as reduced severity and duration of infection.
Mark Baldry: Additionally, the benchmark of increasing AMC by at least 500 cells per microliter.
Mark Baldry: Lines, well with what our CMS physician experts described as clinically meaningful in.
Mark Baldry: An increase of 500 cells per microliter was also the metric for success and our previously published <unk> Phase one B study and has been published on by the NIH and others across various neutropenia conditions.
Mark Baldry: I noticed here because these results help inform our assessments of success for the ongoing phase two clinical trial data and C N and our enthusiasm for advancing into the <unk> phase III study in the first half of 2024.
Mark Baldry: As with when patients chronic neutropenia patients faced an increased risk of infection every single day.
Mark Baldry: This risk is greatest when they are severely neutropenia or with an ANC below 500.
Mark Baldry: Increasing ANC from less than 500 to between 501000 cells per microliter correlates with a meaningful reduction in infection risk from severe to moderate <unk>.
Mark Baldry: Increasing AMC to between 1500 correlates with a risk reduction from moderate to mild and increasing ANC above 500 moves a patient into a normal infection risk category.
Mark Baldry: Additionally, based on our market research, we believe that physicians prescribing injectable granulocyte colony stimulating factor or G. CSF currently the only therapy approved to treat severe chronic neutropenia generally target ANC levels between 1015 hundred.
Mark Baldry: With enrollment now complete in our phase III trial, we will have studied more than 20 C. N patients approximately 40% of whom have been treated with Mavericks for monotherapy and the remainder a combination of maverick's four and G. CSF.
Mark Baldry: We're currently planning an investor event in late June to present interim results from at least 15 participants in this study which.
Mark Baldry: Which we anticipate will include data from those treated with Mavericks four as a monotherapy and there was also treated with combination with G. CSF.
Mark Baldry: We will be looking at increases in ANC, you on treatment with Mavericks before as well as the durability of increased AMC with time on treatments in those subjects with stable background therapy.
Mark Baldry: The complete dataset of the CN Phase II study is expected later this year and we're aiming to present final results hopefully at a major medical conference at that time.
Mark Baldry: Yeah.
Mark Baldry: More details on our planned investor event in June will be forthcoming and we look forward to further defining the potential of maverick's four and the first immune disorder beyond a whim.
Mark Baldry: In the meantime, we remain on track to initiate our phase III <unk> trial this quarter.
Mark Baldry: This will be a pivotal global phase III trial to evaluate the efficacy safety and Tolerability of oral once daily Maverick before with or without G. CSF and people with congenital or acquired primary autoimmune and idiopathic chronic neutropenia.
Mark Baldry: Experiencing recurrence and or serious infections.
Mark Baldry: We plan to enroll approximately 150 participants in the trial, which will be a 52 week double blinded placebo controlled trial with one to one randomization.
Mark Baldry: The primary endpoint will be a two components endpoint comprised of both the annualized infection rates and ANSI responder analysis across the study population.
Mark Baldry: Secondary endpoints will include the severity and duration of infections antibiotic use and quality of life measurements among others.
Mark Baldry: We continue to believe that there is a significant unmet need across the phase III patient population a market we estimate to represent approximately 15000 people in the U S alone who in many cases are being seen by the same practitioners who are also seeing those diagnosed with whim syndrome.
Mark Baldry: With that I'll now turn it over to our CFO, Adam Massawa to review the first quarter financials Adam.
Adam S. Mostafa: Thanks, Paul and thanks to all of you for being on the call with us today.
Adam S. Mostafa: At the end of the first quarter ended March 31 2024.
Adam S. Mostafa: <unk> had 81 $6 million in cash cash equivalents restricted cash and short term marketable securities.
Adam S. Mostafa: We believe that these funds are sufficient to support company operations into 2025.
Adam S. Mostafa: And note that this runway estimate does not include the potential monetization of the priority review voucher. We received as a result of the Fda's approval of absorb M D. In the U S.
Adam S. Mostafa: Our research and development expenses were $19 $9 million for the first quarter, which compares to $22 1 million for the comparable period in 2023.
Adam S. Mostafa: R&D expenses for the first quarter included zero point $8 million of certain noncash expenses.
Adam S. Mostafa: Our selling general and administrative expenses were $17 $4 million for the first quarter.
Adam S. Mostafa: As compared to $7 2 million for the comparable period in 2023.
Adam S. Mostafa: SG&A expenses included $1 million of certain noncash expenses for the quarter.
Speaker Change: We would like to note several factors affecting our expenses this quarter.
Speaker Change: These expenses reflect the hiring of an experienced field force now in place to drive the launches or MD in the U S and launch preparation activities across our commercial and medical organizations.
Speaker Change: Lastly, we reported a net loss of $51.8 million for the first quarter of 2024.
Speaker Change: As compared to $24 million for the comparable period in 2023.
Speaker Change: Net losses in the current period included a noncash loss of $13 $8 million related to the company's class B warrant liability, which is adjusted to fair value each reporting period.
Speaker Change: Net losses also included $1 $7 million of stock based compensation expense.
Speaker Change: And with that why don't we open up the call for your questions operator.
Speaker Change: Thank you.
Speaker Change: We'll now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Information tone will indicate your line is in the question queue. She Memphis stuff too if you would like to remove your questions from the queue.
Speaker Change: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment. Please while we poll for questions. The first question comes from the line of Stephen Willey with Stifel. Please go ahead.
Stephen Douglas Willey: Yes. Good morning, Thanks for taking my questions and looking forward to the update next month.
Stephen Douglas Willey: Maybe just a couple on the phase three for me so can.
Stephen Douglas Willey: Can you just remind us how you're specifically defining an infection events in the phase III.
Stephen Douglas Willey: I'm, assuming you'll be centrally adjudicating these events during the trial, but.
Stephen Douglas Willey: I'm just wondering if you're also trying to adjudicate those events that are required to be seen in each patient during the 12 months prior to randomization.
Speaker Change: Hey, Steve Thanks for the question. So I think I heard three three components there.
Steve: Or are we quantifying infection rates via central adjudication sort of a sub part and then the first one was for the inclusion criteria. How are we assessing infections is that the right yeah orientation, okay, perfect, Chris I'll kind of kick out sure. Yes. So we have a process during the study to educate.
Chris: So the infection patients will be reporting every.
Chris: Every adverse events of inspection and.
Chris: The use of antibiotics or husky utilization related to the <unk>.
Chris: And ultimately.
Chris: The safety committee will be adjudicated in the reviewing and educating these infections, then we'll be able to count them goes to define the annualized infection rate.
Chris: With regards to prior to the start of the study the key story of infection in this population.
Chris: We have defined some criteria I like to use of antibiotics of hospitalization.
Chris: Our criteria is to make sure that these patients have at least two.
Chris: Two inspections.
Chris: In the past year before they come into the study.
Speaker Change: Okay. That's helpful.
Chris: And then.
Speaker Change: Just maybe a statistical question can you.
Speaker Change: Can you tell us if the if the underlying statistical plan.
Speaker Change: Accommodates.
Speaker Change: Adoption of infections that could potentially be seen in the placebo arm.
Speaker Change: The trial and I only asked the question because I know because.
Speaker Change: These event rates can sometimes falloff in the setting of a trial and.
Chris: The level of care and patient.
Chris: Patient compliance improves.
Chris: So this study is randomized and we have.
Chris: So patients will be randomized to placebo or treatment treating.
Chris: Treatment Maverick before we.
Chris: We have.
Chris: Evaluated with visa.
Chris: With our experts and consultants a DFT profit to Tom Fleming.
Speaker Change: We've designed the study to power is to over 90% for.
Speaker Change: The infection rates in our population.
Speaker Change: We've taken some conservative assumptions with would be a fixed size will be.
Speaker Change: Do you remember in our win study we were able to show.
Speaker Change: A decrease.
Speaker Change: Or an increase of more than 500 or so.
Speaker Change: So for micro leader, we were able to see a decrease of 60% and our annualized infection rates, we've taken a more conservative approach in this particular population.
Speaker Change: Which we estimated to be around 40% 45%.
Speaker Change: So we feel confident that this is the statistical power.
Speaker Change: How we've set up the study and the sample size is reasonable to achieve what we're trying to achieve registration studies.
Speaker Change: Okay, and then maybe just one more question if I may so.
Speaker Change: I guess in this scenario, where you're being used on top of G. CSF.
Speaker Change: Is there consensus alignment around.
Speaker Change: The threshold level of background G. CSF that prescribers want patients to be kept below in order to avoid.
Speaker Change: Void risk of a.
Speaker Change: Transformation.
Speaker Change: M L or M D S.
Speaker Change: Yes, so there has been some publication related to this.
Speaker Change: I don't know we began full consensus can be entirely scientific community around that and some qualification.
Speaker Change: You mentioned eight microgram.
Speaker Change: <unk> per kilogram and.
Speaker Change: Thresholds for malignancy.
Speaker Change: We.
Speaker Change: We know our intention clearly.
Speaker Change: We know that the Dcs stuff is the risk for this population that is treated chronically.
Speaker Change: We believe that with Mavericks before we will be able to address.
Speaker Change: They are chronic neutropenia and potentially limit the use of <unk>. So.
Speaker Change: I think that's a that's a questions.
Speaker Change: The scientific community and we can potentially help resolve phase III studies.
Speaker Change: Okay very helpful. Thanks for taking the questions.
Speaker Change: Yes.
Speaker Change: Thank you next question comes from the line of Edward <unk> with Piper Sandler. Please go ahead great.
Edward: Great. Thank you very much can you hear me okay.
Edward: Yes, Thanks, Tim Great and excited on all the progress and obviously congratulations on all the recent approval. So appreciating we've talked about this a little bit and last weekend.
Edward: You know, it's so very thoroughly what kind of information are you guys can be providing to kind of explain and highlighted launch parameters.
Speaker Change: We continue to build patients. Thanks.
Speaker Change: Yeah. Thanks Ted.
Speaker Change: So everything we're pretty excited with all remedies being approved and our sales teams out there I'll turn it over to Mark with maybe just some early commentary and then longer term how all about.
Mark Baldry: Communicating our progress to the street.
Mark Baldry: Hi, good morning.
Mark Baldry: We had a terrific meeting at <unk>.
Mark Baldry: In Minneapolis last week.
Mark Baldry: We did you are now approved booth and there was lots of excitement.
Mark Baldry: And do you have something around there we were having our conversations with physicians in general those conversations were falling into three buckets. There are physicians, who already have a wound patient identified and so we were walking them through the label and the enrollment form.
Mark Baldry: There are other physicians, who are aware of win back or.
Mark Baldry: We're not as familiar with the disease and so we were discussing with them how to recognize the heterogeneous heterogeneous nature of the disease.
Mark Baldry: It's in their practice.
Mark Baldry: And then there are physicians, who are not aware of them at all and so this was this is exciting.
Mark Baldry: Hey, Matt.
Matt: So I think we'll be making progress engaging with these physicians educating them and.
Mark Baldry: At the same time engaging with payers.
Mark Baldry: Two to ensure access there as we go through the year, we'll share more with you on how we will be tracking our progress with these different groups.
Matt: Great. Thank you and good luck with the launch.
Speaker Change: Thanks, Thanks Ted.
Speaker Change: Thank you next question comes from the line of Kristen <unk> with Cantor Fitzgerald. Please go ahead.
Kristen: Hi, good morning, everyone. Thanks for taking the questions first is on C. N R. K O L chat support that the the biggest complaint from the community is really around the bone pain that comes with G. CSF.
Kristen: No obviously no two patients in the trial or are going to appear identical but is there a certain threshold that reduction of G. CSF would lead to improvements across some of the pain to make it a little bit more tolerable for patients. If they were to go on our combination with <unk>.
Kristen: You know now which is safe in the world.
Kristen: Yeah.
Speaker Change: Great question about a year ago, we actually put a little bit of data in one of our posters around this just around what is meaningful for patients and of course dose and frequency are meaningful sort of anecdotal early information, but that 25% to 50% range, but certainly sort of being meaningful to them and anything improve down.
Speaker Change: That would certainly hit it out of the park, but maybe I'll just turn it over to Christophe I'm sure. He's heard some anecdotes from the patient community as well.
Christophe: Yes, so we agree on all our information what we hear from the <unk> and Kols with.
Christophe: With G CSF bone pain is a real issue for patients.
Christophe: Decreasing the volume of injections to frequency might help.
Christophe: And some of those patients will be will be held probably by using Mavericks before.
Christophe: Especially for the one using <unk>.
Christophe: <unk> is a chronically.
Christophe: Everyday injections, it's a real burden.
Christophe: And it can those bone pain are really.
Christophe: Having an effect on their lifestyle. So it's it's something that's where we're going to be trying to look at and trying to help patients better understand how we can use some G. CSF one top of Maverick Sephora no Dcs if at all the world sees where wherever we.
Christophe: Our studies will will help us with that.
Speaker Change: Okay. Thanks, and on that note is there you know good data out there supporting the amount or the frequency of this specifically so greater D. G. CSF usage, ultimately, resulting in greater pain and I guess for the phase three experience how is that.
Speaker Change: To help you and a potential commercial setting.
Christophe: A help to outweigh some of these things or do you think you know for the first couple of months, it's going to be a little bit of trial and error approaches with seeing whether you're decreasing G. CSF are doing less frequent or you know essentially to get to that sweet spot.
Christophe: So I would say probably the phase three study G. CSF will be stable. So our patients are stable in the <unk>.
Christophe: Following dose of G CSF and they remain on that or they are on monotherapy.
Christophe: Throughout the 12 months of the duration of the study we are exploring additional studies to see how we can.
Christophe: <unk>.
Christophe: The modification.
Christophe: Dosing regiments of Dcs that we have some experience some in our phase two study and we're gonna be continuing to explore how to best do this into our future programs.
Speaker Change: Thanks very much.
Speaker Change: Thank you next question comes from the line of swim Pakula from icon with Etsy Van <unk>. Please go ahead.
Swayampakula Ramakanth: Thank you and good morning folks.
Swayampakula Ramakanth: So just trying to figure it out.
Swayampakula Ramakanth: What sort of data you said, you'll get them get to publish complete data.
Swayampakula Ramakanth: <unk>.
Swayampakula Ramakanth: Hum.
Swayampakula Ramakanth: Nick Neutropenia studies at the end of the year.
Swayampakula Ramakanth: So is it just more patients or even <unk>.
Swayampakula Ramakanth: Additional data points in terms of primary endpoints and secondary endpoints, we will be able to get in the end of the year compared to June.
Swayampakula Ramakanth: It.
Speaker Change: Okay. Thanks, RK I'll I'll start and then Chris I can chime in but as we mentioned in our update we were enrolling patients through early in this year. So the data at the end of the year, we'll really let US complete the study on all patients and perhaps most importantly give us full insight into for those patients.
Speaker Change: Our varying there Dennis been G CSF, what kind of that average outcome for those patients we really need to have all patients complete the study so that we give them a full time to resolve and land on their stable that was a G. Within that six month window. So I think that's kind of the deepest lands our deepest component another study that.
Speaker Change: We will be able to update towards the end of the year.
Speaker Change: Fantastic. Thank you thanks for taking my question.
Golf: Thank you next question comes from the line of golf with Brookdale with B Riley. Please go ahead.
Speaker Change: Hi, This is Jeff Hello, Count peaked.
Jeff: For taking my questions.
Jeff: My first question is what's your expectations over the bar.
Jeff: In the upcoming Batesville scent.
Jeff: Perhaps could drive confidence for phase III, what's key pieces of what data do you recommend <unk> to June <unk>.
Speaker Change: Yeah. So I think we originally shared theres three ways that we're looking at a meaningful responses in C. M patients first.
Speaker Change: First this is similar to our winter phase III anywhere increases and 500 to 600 cells per microliter showed a 60% reduction in infection rates over a 12 month study. So we think in a minimum I'm certain clinical thresholds for meaningfulness is around the same numbers for AMC. So it will be able to place our sand data in context.
Speaker Change: Certainly number two it's the durability of those increases in neutrophil counts over time, and then of course finally, we will be applying our phase III criteria of success.
Speaker Change: So the subset of patients in a phase two that are relevant for the phase III to help build confidence and establish why are the tests.
Speaker Change: Power is where it is so hopefully that's those are the three lenses for success.
Speaker Change: Yeah.
Speaker Change: That's very helpful.
Speaker Change: My second question is that this trial has been for over a year curious easily will have at least six months or a photo op for the 15 or more patients on the <unk>.
Speaker Change: What's the split of our motto.
Speaker Change: 15 patients.
Speaker Change: I'm sorry could you just repeat your question a little bit of it was just coming in and out a little bit with the volume.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: My second question is that since these Chao has bee ronny for over a year.
Speaker Change: We are curious if we will have at least six months see all the follow up or the <unk> or more patients and once the split or the mono or well over the 15 patients.
Speaker Change: Yeah.
Speaker Change: Yeah. So I think if I heard you correctly, you're asking for you know are we getting six months of paid Ah patients worth of data across at least the 15 patients in the monotherapy therapy component of that I mean as you can appreciate I would say generally yes.
Speaker Change: A little bit of wiggle room in there of course, because it's when patients come in and when we do data cuts, but there will be a very robust data set across our 15, plus patient population and perhaps most meaningfully there'll be you know.
Speaker Change: As he mentioned about 40% of those patients are on monotherapy, which I think will really help clarify the potential benefit of maverick as far as a single agent in this patient population.
Speaker Change: Does that helpful.
Speaker Change: My last question is are we all the scripts of our lien detectable in the database may cause symphony or Bloomberg.
Speaker Change: And again I'm I'm not sure you asked about maybe youre talking about the database cuts I'm, sorry that I didn't follow the question.
Speaker Change: Yes, I mean, when we released it.
Speaker Change: Yeah.
Speaker Change: Okay I'm, sorry go ahead, whereas those grapes pool, well when the tractable own the database you symphony or pruned book.
Speaker Change: No our our distribution.
Speaker Change: So Randy and when will be through our specialty pharmacy.
Speaker Change: Sir.
Speaker Change: And that's in order to be able to provide.
Speaker Change: Some services to support our patients as they navigate.
Speaker Change: The therapy.
Randy: Okay. That's very helpful. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you next question comes from the line of David Bautz Zacks.
Speaker Change: Zacks small cap as such please.
Speaker Change: Hey, good morning, everyone. Just a quick one for me on the P. R. V. I'm just curious if you could give us a sense for how many companies are out there looking to purchase a P. R V. And then maybe if you characterize the negotiations and how they're going at this point.
Speaker Change: Yeah. So as we said, we do intend to monetize the priv. Shortly it's not currently part of our cash runway guidance.
Speaker Change: But we'll certainly give an update when we're ready to do that with respect to the PRA in terms of the market and who is out there and things like that but we won't.
Speaker Change: Kind of position other companies' interests at this point.
Speaker Change: Okay. Thanks, a lot.
Speaker Change: Thank you ladies and gentlemen, we have reached the end of question and answer session I would now like to turn the floor over to Paula Ragan for closing.
Paula Ragan: Thank you so much operator, thank you to everyone for joining us today and we hope you have a great rest of your day.
Speaker Change: Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Speaker Change: [music].
Paula Ragan: Yes.
Paula Ragan: Yeah.
Paula Ragan: [music].
Paula Ragan: Okay.
Paula Ragan: Okay.
Paula Ragan: [music].
Paula Ragan: Uh huh.
Paula Ragan: Okay.
Paula Ragan: [music].
Paula Ragan: Okay.
Paula Ragan: [music].