Q3 2023 Verona Pharma PLC Earnings Call
Speaker 1: The third quarter continued our constant progress toward our goal of providing NC-Fentrin as a novel treatment for COPD patients.
The third quarter continued our constant progress toward our goal of providing empty pentron has a novel treatment for COPD patients.
Speaker 1: In August , the FDA accepted for review our new drug application seeking approval of ncfentrin for the maintenance treatment of patients with COPD.
In August the FDA accepted for review, our new drug application seeking approval of empty pension for the maintenance treatment of patients with COPD.
Speaker 1: The agency assigned a PDUFA target action date of June 26, 2024, and is not currently planning to hold an advisory committee meeting to discuss the application.
The agency assigned a <unk> target action date.
June 26, 2024 and is not currently planning to hold an advisory Committee meeting.
<unk> the application.
Speaker 1: We look forward to continuing our work with the FDA during their review.
We look forward to continuing our work with the FDA during their review.
If approved NT Pentron is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years.
Speaker 1: We believe it's bronchodilator and nonsteroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD.
We believe it's bronchodilator and nonsteroidal anti inflammatory activity has the potential to change the treatment paradigm for COPD.
Speaker 1: Recently, we hosted an in-person investor meeting in New York to provide an overview of our commercial preparation.
Recently, we hosted an in person Investor meeting in New York to provide an overview of our commercial preparations for the potential U S launch event defense and with the company's senior management team and key opinion leader Dr. Jamey Rutland.
Speaker 1: for the potential US launch of NC Fenton with the company's senior management team and key opinion leader Dr. Jamie Rutland.
Speaker 1: During the meeting, we shared detailed overview of preparations for the planned launch of NC Ventrin, including a review of the current COPD market.
During the meeting we shared detailed overview of preparations for the planned launch of empty pentron, including a review of the current COPD market.
Speaker 1: unmet treatment needs, launch access, distribution, reimbursement strategies, and plans for
Unmet treatment needs launch access distribution reimbursement strategies.
Plans for field deployment.
Speaker 1: For those who may have missed it, a replay of the meeting is available on our website.
For those who may have missed it a replay of the meeting is available on our website.
Speaker 1: Overall, we believe we are very well positioned to launch a defense conference with many key hires already in place across our commercial team and strong relationships being built on both the position and payer front.
Overall, we believe we are very well positioned to launch <unk> with many key hires already in place across our commercial team and strong relationships being built on both the physician and payer front.
Speaker 1: With this, we are confident we will be able to quickly capitalize on the US launch of NC pamphlet ending of
With this we are confident we will be able to quickly capitalize on the U S launch of empty pantry.
Pending approval next June.
Speaker 1: In September , we presented additional analyses of the enhanced one 24-week exacerbation data at ERAS, which demonstrated treatment with NC Ventron resulted in a substantial decrease in the rate and risk of moderate-in-care COPD exacerbation.
In September we presented additional analyses of the enhanced 124 week exacerbation data at Drs, which demonstrated treatment with empty pentron resulted in a substantial decrease in the rate and risk of moderate and severe COPD exacerbation.
Speaker 1: In addition, it highlighted the impact of MCFENTRAN treatment on healthcare resource utilization related to COPD, including fewer physicians off of visits.
In addition, it highlighted the impact of empty pension treatment on healthcare resource utilization related to COPD, including fewer physician's office visit.
Speaker 1: Emergency Department visits and hospitalizations compared with placebo treatments.
Emergency Department visits and hospitalizations compared with placebo treatment.
Speaker 1: In October , we presented additional analyses from the Enhance One and Enhance Two Study at the Chest Annual Meeting.
In October we presented additional analyses from the enhanced one and enhanced II study at the chest annual meeting.
Speaker 1: The data from pooled analyses demonstrated that treatment with NC Pencron resulted in substantial reductions in the rate and risk of COPD exacerbations regardless of recent exacerbation history. And the medication was well tolerated across patient groups.
The data from pooled analysis demonstrated that treatment with empty pentron resulted in substantial reduction in the rate and risk of PD exacerbations, regardless of recent exacerbation history.
And the medication was well tolerated across patient groups.
Speaker 1: Additionally, subgroup data analysis demonstrated treatment with NCP-Pencorin resulted in improvements in lung function, symptoms, quality of life endpoints, and reductions in the rate and risk of exacerbations, regardless of background therapy, as well as reductions in daily rescue medication use.
Additionally, subgroup data analyses demonstrated treatment with NFC pentron resulted in improvements in lung function symptoms quality of life endpoints and reductions in the rate and risks of exacerbations, regardless of background therapy as well as reductions in daily rescue medication use.
Speaker 1: Also at CHESC, we launched the DZ The Awareness Campaign titled Unspoken COPD.
Also at chest relaunched the disease awareness campaign titled.
Spoken COPD.
Speaker 1: The campaign highlights the severe impact COPD has on patients' daily life and encourages HCPs to engage in deeper conversations to fully understand COPD's impact on each patient in their practice.
The campaign highlights the severe impact COPD has on patients' daily lives and encourages HCP to engage in deeper conversation to fully understand copd's impact on each patient in their practice.
Speaker 1: Turning to our global partnering strategy, nuance Parma, our development partner in greater China, has continued their phase three trial evaluating and defense for the maintenance treatment of COPD in China.
Turning to our global partnering strategy nuanced pharma our development partner in Greater China has continued their phase III trial evaluating <unk> for the.
The maintenance treatment of COPD in China.
Speaker 1: As a reminder, Nuance Pharma has exclusive rights to develop and commercialize NC Fentron in Greater China, and as such, will play a key role in addressing the global need for novel treatment for COPD. We look forward to providing updates as the trial progresses.
As a reminder, nuance pharma has exclusive rights to develop and commercialize anti pension in greater China and as such will play a key role in addressing the global need for novel treatment for COPD.
We look forward to providing updates as the trial progresses.
Looking ahead we.
Speaker 1: We are expanding our pipeline, starting with a plan to initiate two clinical programs.
We are expanding our pipeline starting with a plan to initiate two clinical programs.
Speaker 1: We are developing a fixed dose combination formulation with NC Ventrine and Gleical Parallelate, a LAMA for the maintenance treatment of COPD delivered via a Nebulite.
We are developing a fixed dose combination formulation with NC pentron and clinical poorly.
Lama for the maintenance treatment of COPD delivery to be a nebulizer.
Speaker 1: Six dose combination therapies are commonly used in the treatment of COPD.
Fixed dose combination therapies are commonly used in the treatment of COPD.
Speaker 1: Historically in DPI and PMDI therapies only.
Historically in DPI and PMD therapies only.
Speaker 1: Based on market research, there is an unmet need for unnebularized exhaust combination therapy.
Based on market research there is an unmet need for a nebulizer fixed dose combination therapy.
Speaker 1: We believe the combination of energy transfer and with alama will provide COPD patients with the first nebulous, thick-stose combination that has bronchodilation through a dual mechanism and also non-stroidal anti-inflammatory effect, the FPDE condition.
We believe the combination of empty pension with a Lama will provide COPD patients with the first nebulize fixed dose combination that has broncho dilation through a dual mechanism and also nonsteroidal anti inflammatory effects.
<unk> inhibition.
Speaker 1: If a feasible formulation is developed, we plan to submit an investigational drug application
That's a feasible formulation is developed we plan to submit an investigational new drug application.
Through the FDA and if cleared startup phase II clinical trial assessing the safety and efficacy of a fixed dose formulation of empty Pentron <unk> late in the second half of 2024.
Speaker 1: Additionally, based on the clinical profile of N-Cefentrin in COPD patients, including data that supports reduction in exacerbation burden, improvement in lung function, and the PDE3 and PDE4 mechanism of action supporting enhanced mucociliary clearance, we believe N-Cefentrin could be an effective treatment for non-cystic fibrosis bronchiectasis.
Additionally, based on the clinical profile of Mt's entrance in COPD patient <unk>.
Including data that supports reduction investor Bashan burden improvement in lung function and the PD <unk> three and PD for mechanism of action supporting enhanced Mucociliary clearance, we believe entry entrant could be an effective treatment for non cystic fibrosis bronchiectasis.
Speaker 1: This is a severe chronic condition where the airways of the lung become abnormally white, leading to a cycle of infection, inflammation, and exacerbation that caused lung tissue damage.
This is a severe chronic condition, where the airways other lung become abnormally wide.
Leading to a cycle of infection inflammation, and exacerbation that causes lung tissue damage.
Speaker 1: The condition affects approximately 370,000 patients in the U.S., and there are currently no therapies approved specifically for non-CF bronchiectasis.
The condition affects approximately 370000 patients in the U S.
And there are currently no therapies approved specifically for non CF bronchiectasis.
Speaker 1: Physicians use bronchodilators, antibiotics, steroids, and surgery to treat patients.
Physicians use bronchodilator antibiotics steroids and surgery to treat patients.
Speaker 1: If our NDA is approved, we plan to commence a phase two clinical trial to assess the efficacy and safety of nebulized density tension in patients with non-CF bronchiectasis in the second half of 2024, subject to clearance by the FDA.
If our NDA is approved we plan to commence a phase III clinical trial to assess the efficacy and safety of Nebulize NZ pension and patients with non CF bronchiectasis in the second half of 2024 subject to clearance by the FDA.
Speaker 1: We are pleased with our constant progress in all areas, including regulatory, commercial preparation, and new program development.
We are pleased with our constant progress in all areas, including regulatory commercial preparation and new program development.
Speaker 1: I will now turn the call over to Mark to review our financial results for the third quarter.
I will now turn the call over to Marc to review, our financial results for the third quarter.
Thank you, Dave and good morning, everyone.
Speaker 1: We ended the third quarter of 2023 with $257.4 million in cash and transferring the jakby
We ended the third quarter of 2023 with $257 $4 million in cash and equivalents.
Speaker 1: We believe our balance sheet remains strong with the cash currently on hand, expected cash receipts from the UK tax credit program and funding anticipated to be available under the Oxford Loan Facility. We expect to have sufficient runway at least through the end of 2025, including the planned commercial launch of NCFentron in the U.S. pending regulatory approval.
We believe our balance sheet remains strong with the cash currently on hand, and expected cash receipts from the UK tax credit program and funding anticipated to be available under the Oxford loan facility, we expect to have sufficient runway at least through the end of 2025, including the planned commercial launch of Etsy pension in the U S.
Pending regulatory approval.
Speaker 1: For the quarter ended September 30, 2023, net loss after tax was $14.7 million compared to a net loss after tax of $15.6 million for the same period in 2022.
For the quarter ended September 32023, net loss after tax was $14 7 million.
Compared to a net loss after tax of $15 6 million for the same period in 2022.
Speaker 1: This represents a loss of $0.02 per ordinary share or $0.18 per ADS for the quarter compared to a loss of $0.03 per ordinary share or $0.24 per ADS for the third quarter of 2022.
This represents a loss of <unk> <unk> per ordinary share or <unk> 18 per <unk> for the quarter compared to a loss of <unk> <unk> per ordinary share or <unk> 24 per <unk> for the third quarter of 2022.
Speaker 1: Research and Development costs were $3 million for the quarter ended September 30, 2023, compared to costs of $9.8 million for the third quarter of 2022.
Research and development costs were $3 million for the quarter ended September 32023, compared to cost of $9 8 million for the third quarter of 2022.
Speaker 2: The decrease was primarily due to a $7.9 million decrease in clinical trial costs as all study conduct and analyses under the Phase 3 Enhanced Program were complete, whereas in the same period in 2022.
The decrease was primarily due to a $7 $9 million decrease in clinical trial costs.
All study conduct and analysis under the phase III enhanced program were complete whereas in the same period in 2022.
Speaker 2: Significant cost-run curd associated with a van ongoing study conduct.
Significant costs were incurred associated with it than ongoing study conduct.
Speaker 2: The 2023 third quarter clinical trial and other development costs also include the impact of $2.2 million of credits received related to the final financial reconciliation of a Phase III Enhanced Program supplier.
The 2023 third quarter clinical trial and other development costs also include the impact of $2 $2 million of credits.
<unk> related to the final financial reconciliation of a phase III enhanced program supplier.
Speaker 2: This decrease was partially offset by an increase of $.7 million in people-related costs.
This decrease was partially offset by an increase of <unk> $7 million and people related costs.
Speaker 2: Selling general and administrative expenses were $13.4 million for the quarter ended September 30, 2023, compared to $5.3 million reported for the same period in 2022.
Selling general and administrative expenses were $13 $4 million for the quarter ended September 32023, compared to $5 3 million reported for the same period in 2022.
Speaker 2: This increase was primarily due to a $4.7 million increase in people-related costs, as well as an increase of $2.9 million for costs primarily related to the buildout of the distribution network and work related to payer and disease education, as well as advancing the commercial and information technology infrastructure in preparation for potential commercial launch. I'll now turn the call back over to the operator.
This increase was primarily due to a $4 $7 million increase in people related costs as well as an increase of $2 9 million for cost primarily related to the build out of the distribution network and work related to payer and disease education as well as advancing the commercial and information technology infrastructure.
In preparation for potential commercial launch.
Now I'll turn the call back over to the operator for the Q&A.
Thank you. Thank you we will now begin the question and answer session.
Speaker 3: Thank you. We will now begin the question and answer.
Speaker 3: To ask a question, please press star and 1 to be joined into the queue.
Ask a question please press star and one to be joined into the queue.
Speaker 3: If you're using a speakerphone, please pick up your handset before pressing.
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Speaker 3: If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time we will pause momentarily.
If at any time. The question has been addressed and you would like to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble the roster.
Speaker 3: Our first question comes from Andrews, well, Jeff.
Our first question comes from Andrew.
Andrew Tsai with Jefferies. Please go ahead.
Hi, good morning, Thanks, so much for taking our questions.
Speaker 4: Hi, good morning. Thanks so much for taking our questions. Appreciate all the updates as well. So first question is, only to the extent you can share, how are FDA discussions going about the NDA? What kinds of questions has the agency asked you since accepting the filing? As it relates to the PDUFA, what exactly keeps you guys up at night? What would be the risks here, really, in your view?
Appreciate all the updates as well. So first question is only to the extent you can share how our FDA discussions going about the NDA what kinds of questions has the agency asked year since accepting the filing and as it relates to the <unk>.
What exactly it keeps you guys up at night, what would be the risks here really in EMEA and then secondly.
Speaker 4: And then secondly, let's just say antifension is approved as we think about your initial launch cadence.
Let's just say intervention is approved as we think about your initial launch cadence.
Speaker 4: Could it be realistic to think that an initial low-hanging fruit could be patients who are taking an additional therapy after it triples, specifically Dolarest? So can we expect encephalogen to immediately displace Dolarest specifically? Could that be the low-hanging fruit immediately upon launch? Thanks.
Could it could it be realistic to think that an initial low hanging fruit could be patients who are taking an additional therapy. After triple specifically dollar asked so can we expect <unk> to immediately displaced dollar specifically.
Could that be the low hanging fruit immediately.
Upon launch thanks.
Speaker 5: Right, thanks Andrew for the questions and maybe I'll start on the 1st 1 and then turn it over to Chris for his thoughts on.
Great. Thanks, Andrew for the questions and maybe I'll start on the first one and then turn it over to Chris for his thoughts on the launch.
Speaker 1: With regard to the FDA questions, they're, you know, what I would say is typical during the review process, as you'd expect, the FDA asks for, you know, data, different questions, clarifications.
With regard to the FDA question, there what I would say is typical during the review process as you would expect the FDA asks for.
Data different questions clarifications.
Speaker 5: And I would say it's very typical and normal in my experience, especially at this stage, of course.
And I would say it.
Typical of normal.
My experience, especially at this stage of course relatively early in the review.
Speaker 5: relatively early in the review, even prior to mid-cycle. So, I think it's going well from our view. With regard to what keeps us up at night and to do for risk, again, I think we feel we have an extremely
Even prior to mid cycle, So I think it's going well.
Well from our view with regard to what keeps us up at night and Paducah risks.
I think we feel we have an extremely strong package that we submitted across CMC non clinical clinical and the total benefit to risk of debentures. We believe is very compelling.
Speaker 5: package that we submitted across CMC, non-clinical, clinical, and the total benefit-to-risk of NC Fentron we believe is very compelling. So at this time, you know, I think we're comfortable where we're at in the FDA review process. So with that, I'll turn it over to Chris and talk about the launch.
At this time, you know I think we're comfortable where we're at and the FDA review process, So with that I'll turn it over to Chris and talk about the launch.
Thanks, Dave and Andrew I. Appreciate the question as we think about kind of that launch cadence cadence and who has the first patient.
Speaker 6: Thanks, Dave and Andrew. Appreciate the question. Um, as we think about kind of that launch cadence cadence and who's the first patient.
Speaker 6: uh... that opposition may prescribe uh... anti-fentron to i think it's important to kind of just ground everybody and what's happening with these patients today uh... we know today there's a eight point million patients treated with p o p maintenance medication
That a physician may prescribe MTF entering two I think it's important to kind of just ground everybody in what's happening with these patients today.
We know today there is eight 6 million patients treated with COPD maintenance medications. We also know today that at least half of them either if they're on a single a dual or triple agent, our remaining symptomatic and when a patient has persistent symptoms.
Speaker 6: We also know today that at least half of them, either if they're on a single, a dual, a triple agent, are remaining symptomatic, and when a patient has persistent symptoms.
Speaker 6: Physicians are very likely to add new therapies or try to help these patients start to feel better and hopefully prevent the risk of exacerbations in the future. So if we think about that 8.6 million, really, what we hear in our market research is there are two groups of patients that the physician see as low hanging fruit or patients that they would try and defend very quickly on. The first is the group of patients that are on single llama or alaba or alaba ICS product. And when they look at our.
<unk> are very likely to add new therapies or try to help these patients start to feel better and hopefully prevent the risk of exacerbations in the future. So if we think about that $8 6 million really what we hear in our market research is there are two groups of patients that the physician fee is.
Low hanging fruit or patient that they would try and 500 very quickly on the first is the group of patients that are on single Lama or LABA or a LABA Ics product and when they look at our data and they look at what the data Dave described they think of <unk> as being the potential drug to add to these patients if it's.
Speaker 6: and they look at what the data Dave described, they think of Encephentrin as being the potential drug to add to these patients if it's approved.
Speaker 6: And they think about doing that at very high rate. The second group of patients, which is the patients that potentially could even be on dali arrest today, are these patients on dual and triple therapy that are looking for additional symptom relief and help. And the physicians at NC Center in about 20 to 45% of the time in these patients treatment armament area. I think the important thing to keep in mind here is in that patient group that I'm talking about there, there's about 75 to 85,000 patients on dali arrest today that could potentially be an option for physicians to add a PDE 3 or mechanism 2. So we believe very strongly that there are two distinct patient populations, either those patients on single bronchodilator or lab ICS and those patients that are on dual and triple that NC Center could be added to very easily. And I think it's all driven by the fact that these patients remain symptomatic, they remain having issues in their daily lives and the physicians are actively looking for new mechanisms to be able to layer on top of the patient's treatment path so they can get them going back to doing some of the normal things that they want to do in their daily lives.
Proved.
And they think about doing that at a very high rate. The second group of patients, which is the patients that potentially could even beyond value rest of today are these patients on dual and triple therapy that are looking for additional symptom relief and help and.
Physicians, Adam if enter in and about.
20% to 45% of the time in these patients.
Treatment arm in the Memphis area I think the important thing to keep in mind here is in that patient group that I'm talking about there. There is about 75 to 85000 patients on <unk> today.
Are still.
That could potentially be an option for physicians to add PD three four mechanism too. So we believe very strongly that there are two distinct patient populations either of those patients on single bronchodilator or LABA Ics and those patients that are on dual and triple that empty venturing could be added to very easily and I.
I think it's all driven by the fact that these patients remain symptomatic they remain having issues in their daily lives and the physicians are actively looking for new mechanisms to be able to layer on top of the patients treatment.
Treatment path.
So they can get them going back to doing some of the normal things that they want to do in their daily lives.
Thanks, very clear thank you again.
Speaker 4: Thanks. Very clear.
Thanks, Andrew.
Your next question comes from Yasmin Rahimi with Piper Sandler. Please go ahead.
Speaker 3: Your next question comes from Yasmin Rahimi with Piper Sandler.
Speaker 7: Good morning, team. Thank you so much for all the updates. Would love to dig a little bit more into these two new studies that you spoke about. I guess where are you in the formulation process at this junction like?
Good morning team. Thank you so much for all the updates.
Dig a little bit more into these two new studies that you spoke about I guess, where are you in the formulation process at this junction like.
Speaker 7: If you could just give us some color beyond what you've said, like.
You can just give us some color beyond what he of satellite.
Speaker 7: and how soon could you have it completed? And then what would a design, what would like the study design look like for a fixed combo? Like what would the duration be and the size, et cetera? And then same goes for the second phase two study and that you're also planning to kick off. So I think a lot of clients would love to hear maybe beyond the initial indication around.
And how soon could you have it completed and then what that design would like the study design look like for fixed combo like well with the duration being tight et cetera, and then same goes for the second phase two study in that.
Did you also planning to kick off so I think a lot of clients would love to hear maybe beyond the initial indication around.
Speaker 7: size, costs associated with them, and what sort of the cadence of the next steps, just a little bit more granular, that would be really helpful for us.
Si cost associated with that and what sort of the cadence of the next steps just a little bit more granularity that would be really helpful for us.
Speaker 5: Great, good morning. So let me just talk briefly about the formulation and then I'll turn it over to Kathy to talk about both the trial design concepts for fixed combo as well as for bronchiectasis.
Great. Good morning, Yes. So let me just talk briefly about the formulation and then I'll turn it over to Kathy to.
To talk about both the trial design concepts for a fixed combo as well as for bronchiectasis.
Speaker 5: Within fixed combo product formulation development, you know, we are advancing with.
Within fixed combo.
Formulation development, we are advancing with.
Speaker 5: the typical formulation development where we're co-formulating.
The typical formulation development where were co formulating.
Speaker 5: both glycopyrrolate and antifentrin and the nebulized formulation. Of course, there's acute chemistry that we can look at. There's also longer term stability data that gets generated at three and six months, typically under normal and accelerated conditions to convince us that we have a commercially acceptable formulation. So, that work is ongoing as we speak. Certain aspects can't be sped up, especially when you're looking at six-month stability time points.
Both like apparel late and empty Pentron and nebulizer formulation of course, Theres a cute chemistry that we can look at there's also longer term stability data that gets generated at a three and six months typically under normal and accelerated conditions to convince us that we have a.
Actually acceptable formulation. So that work is ongoing as we speak certain aspects can't be sped up, especially when you're looking at six months stability time points.
Speaker 1: We expect to be more fully informed on the co-formulation somewhere in the first quarter of 2024 And that's why we we provided the guidance that we'd be looking to initiate the studies Especially for both Ixtocombo and bronchiectasis in the second half of 24 So with that I'll give it turn it over to Kathy for her thoughts on the design
We expect to be more fully informed.
On the co formulation.
Somewhere in the first quarter of 2024.
And that's why we provided the guidance that we'd be looking to initiate.
The studies.
Actually for both fixed dose combo in bronchiectasis in the second half of 'twenty four.
So with that I'll give it turn it over to Kathy for her thoughts on the design.
Speaker 8: Sure. So, let's talk about, first, the fixed-risk combination. So, certainly, we're in early stages of development of what a protocol will look like. We know what, in general, we would like to do or need to do in a Phase II-type program, so the initial studies for that. So, our goals would be to first establish efficacy and some initial safety in probably designs that are similar to our Phase II design.
Sure.
Talk about first the success.
Combination. So certainly we're in early stages of development of what a protocol will look like we know what in general we would like to do or need to do in our phase II type programs. So the initial studies for that so our goal would be to first establish efficacy and some initial safety.
And probably designed better similar to our phase two.
Speaker 8: Studies that we did for NCF Institute begin with more likely be a shorter design maybe up to anywhere up to about 12 weeks or so, but also we need to establish dose ranging. So that would be the goals of the studies that we would do for Phase II is to look at initial efficacy and safety and dose ranging. Live access levels if needed or still listening.
Studies that we did for ANZ pension should begin with.
More likely be a shorter design, maybe up to anywhere up to about 12 weeks or so but also we need to establish a dose ranging so that would be the key.
The goal.
The studies that we would do for phase two is to look at initial efficacy and safety and dose ranging.
If you look at the.
Speaker 8: The second study is the study for non-CF bronchi-axis.
The second study the study for non CF bronchiectasis.
Speaker 8: slightly different disease, slightly different type of design. We certainly would need to establish in the Phase 2, again, efficacy and safety.
Alright, you different disease slightly different type of design, we certainly would need to establish in the phase two again efficacy and safety.
Speaker 8: These studies may be, need to be a little longer because some of the primary end points for non-CSR practices relate to exacerbations. So they may be up to a six month type of design. But again, keep in mind that we are in the early phase of developing these designs, and we're starting to make more definite ideas about the design as we get further along into our development program.
I think maybe it needs to be a little longer because some of the primary endpoints for non CF bronc actresses relate to exacerbations. So they may be up to six months type of design, but again keep in mind that we are in the early stages of developing new designs and we're starting to make more definite ideas about this.
I think as we get further along into our development program.
Thank you Kathy.
Thanks, Yes.
Speaker 3: Our next question comes from Andres Alvarez with BatBush Security.
Our next question comes from Andreas <unk> with debt Securities. Please go ahead.
Speaker 9: Good morning, guys, and thanks for taking my questions. A couple here. So, in expectations of approval for emphysema, can you remind us what the label is likely to look like from an efficacy and safety standpoint? And then, while you don't expect an outcome, the FDA has a curious history of changing its mind on a whim. Is there a threshold at which point an outcome would definitely not be held? And if there is an outcome, would it necessarily be a bad thing? Thanks.
Good morning, guys and thanks for taking my questions.
Couple here in.
And expectations of approval forms essentially can you remind us what the label is likely to look like from an efficacy and safety standpoint.
And then while you don't expect an outcome.
He has a curious as sort of changing its mind on a whim.
Threshold at which point on Alcon will definitely not be held in.
And if there isn't outcome would it necessarily be about there. Thanks.
Speaker 5: Great. Good morning, Andrea. Thanks for the questions. With regard to the label for NC Fentron, again, just to remind everybody that
Great. Good morning, Andrea Thanks for the questions.
With regard to.
The label.
<unk> pension again, just to remind everybody that.
Speaker 5: We expect and have provided data to support an indication of the maintenance treatment of COPD, which is a fairly broad indication and consistent with recent approvals. And we believe the data provided supports that indication. We'd, of course, expect the rest of the clinical data results.
We expect and have provided data to support indication of that.
Maintenance treatment of COPD.
Which is a fairly broad indication and consistent with recent approvals and we believe the data.
<unk> provided support that indication we would of course expect the rest of the <unk>.
Clinical data results.
Speaker 5: to be in the clinical section in the label as appropriate.
To be in the clinical section in the label as appropriate.
Speaker 5: Clearly, the FDA needs to continue their review, and we're quite some time away from specific labeling conversations. And so, I think we'll see how that comes out, you know, I'm sure in 2024. So, but otherwise, we think the indication is fairly broad.
Clearly any FDA needs to continue their review.
And there were quite some time away from specific labeling conversation and so I think we'll see how that comes out.
I'm sure in 2024.
So, but otherwise we think the indication is fairly broad.
Speaker 5: With regard to an ADCOM, yes, they've guided that they do not plan to have an ADCOM. And yes, you're correct. I think the FDA can decide on how they want to address that during the review. We don't expect one, you know, as time passes by, especially.
With regard to an ad com.
Yes, they have guided that they do not plan to have an ad com.
And yes, you are correct I think the FDA can you can decide how they want to address that during.
The review.
We don't expect one.
As time passes by especially after.
Speaker 5: you know, after mid-cycle review, for example, and even as we get into 2024, that timing gets shorter and shorter. So there's certain practicalities about it, but...
Mid cycle review for example, and even as we get into 2024 that timing gets shorter and shorter. So there are certain practicalities about it but nonetheless.
Speaker 5: I wouldn't comment any further on the outcome and of course it's in the FDA.
I wouldn't comment any further on.
The AD com and of course, it's in the Fda's hands.
Speaker 9: All right, and just one last follow-up from us. With regard to the two new potential indications, maybe just some thoughts on how this potentially unlocks strategic value for the company and its venture. Thanks.
Alright, and just one last follow up from us.
With regard to the two new potential indications, maybe just some thoughts on how this.
Pension Theyre unlocks strategic.
<unk> for the company and then she.
Sure.
Thanks.
Speaker 5: Yeah, well sure, I mean, I think it speaks loudly to what we believe NCF can do.
Yeah, well sure I mean, I think it speaks loudly to what we believe MMC pension can do.
Speaker 5: broadly in the treatment of COPD either by itself or in a combination therapy. We have seen excellent data from the enhanced trials that combining NC Penchrin with Alama.
And broadly in the treatment of COPD, either by itself or in combination.
Combination therapy.
We have clean and excellent data from the enhanced trials that combining <unk> with a llama.
Speaker 5: is quite advantageous as well. And so I think it speaks loudly too. He knows the power of NCFENTRAN, the PDE3, PDE4 mechanism and its application. And then of course broader than that, and as we've reviewed today, and not CF-Brunkey exercises.
It is quite advantageous as well and so I think it speaks loudly to the power of empty pentron the PD <unk> four mechanism.
And its application and then of course broader than that and as we read today in non CF bronchiectasis.
Speaker 5: because of the underlying pharmacology, which has been demonstrated so clearly in COPD. We think it's highly applicable in other diseases like bronchiectasis. I think ultimately, any partner can see that NCFentron's underlying pharmacology can be applied quite widely to various respiratory diseases, which we really stated from the beginning as the full potential of NCFentron.
Because of the underlying pharmacology, which has been demonstrated so clearly in COPD, we think it's highly applicable.
Other diseases like Bronchiectasis I think.
Ultimately any partner can see that.
Defend trends underlying pharmacology cannot be applied quite widely to various respiratory diseases, which we've really stated from the beginning.
As the full potential events et cetera.
Thanks, guys and congrats on all the partners.
Thanks Andrea.
The next question comes from Joon Lee with terrific counties. Please go ahead.
Speaker 3: The next question comes from June the 2nd Security.
Speaker 10: Good morning, this is awesome. One for June . Thanks for taking the questions. My first question is, what are you looking for in a European partner? And can you guide to any updates on that front?
Good morning. This is awesome on for Jim Thanks for taking the questions.
My first question is what are you looking for in a European partner and can you guide to any updates on that front.
Speaker 10: And then also just wondering if you could talk about the ramp in SG&A in preparation for launch, and one could expect hiring for the around 100 person sales force. Thank you.
And then also just wondering if you could talk about the ramp in SG&A and preparation for launch and one can expect hiring for the around 100 person sales force. Thank you.
Speaker 1: Great. Good morning. Thanks for the question. I'll speak to the partnering and then turn it over to Mark to talk about SG&A and Chris for
Great. Good morning, Thanks for the question I'll speak to the partnering and then turn it over to Mark to talk about SG&A and Chris for the reps, but I think that with regard to European partner or in general our partnering strategy continues to be the same that as we look to partner out.
Speaker 5: the reps. But I think that with regard to European partner or in general our partnering strategy, it continues to be the same. That is, we look to partner outside the U.S.
Side the U S. Much as we've done in greater China with nuance pharma. So the strategy has not changed.
Speaker 5: much as we've done in Greater China with Nuance Pharma, so the strategy has not changed.
Speaker 1: I think that ideally in a partner, European or otherwise.
I think that ideally in a partner European or otherwise.
Speaker 5: besides, of course, elements around expertise and regulatory, clinical and commercial in the respiratory spaces you'd expect. We also are looking for opportunities in partners that have expertise in device, PMDI, or DPI, device.
Besides of course elements around expertise in.
Our regulatory clinical and commercial in the respiratory space as you would expect.
So looking for opportunities in.
Partners that have expertise in device PMD DPI device.
Speaker 5: development manufacturing and or IP, which I think could be quite advantageous as we look for the full life cycle management and other indications for NC Ventrin, as well as ability to manufacture specifically drug product, but also potentially drug substance or API. And I think that this would serve as well having of course the second source.
<unk> manufacturing <unk> IP.
Which I think could be quite advantageous as we look toward the full lifecycle management and other indications for MTF entrants as well as ability to manufacture specifically.
Specifically drug product.
But also potentially.
Drug substance or API.
And I think that this would serve us well having of course, a second source.
Speaker 1: potentially a source with a lower cost point. Keep in mind that we're looking to supply the world with NC Fundra in different markets. And so I'm looking for somebody with that manufacturing capability as another feature of our partnering strategy. So with that I'll turn it over to Mark for ramp on.
Potentially a source with a lower cost point to keep in mind that we're looking to supply.
World with with MZ center in different markets and so on.
King for somebody with that manufacturing capability is another feature of our partnering strategy, so with that I'll turn it over to mark for ramp on SG&A.
Speaker 2: Sure, sure. Thanks. Thanks for the question. So if you look at SGNA over the last couple of years, you'll see that it has been wrapping.
Sure sure Thanks, and thanks for the question.
So if you if you look at SG&A over the last couple of years, you'll see that it has been ramping up.
Speaker 2: a year ago was $5-ish million in Q3, and this year it's $13-ish million. And I think what you should expect is that that ramp will continue for the next several quarters.
A year ago was five ish million dollars in Q3, and this year, it's 13 ish million.
And I think what you should expect is that that ramp will continue for the next several quarters.
Speaker 2: through Q2, I think that our total expense for Q2 next year, I think that our total expense.
Through Q2, I think that our total expense through Q2 of next year I think that our total expense.
Speaker 2: being the 20 to 25 million dollar range on a quarterly basis. That includes both SGNA and R&D. And then once we get to Q3, assuming approval at the end of June , you would see that the SGNA ramps again as we bring on the sales reps that Chris will talk about.
It should be in the 20% to $25 million range on a quarterly basis that includes both SG&A and R&D.
And then once we get to Q3, assuming approval at the end of June you would see that the SG&A ramps again as we bring on the sales reps that Chris will talk about.
Thanks Mark.
Speaker 6: Yeah, thanks mark on on that. As we think about, you know, June , the reps and and how we would
Yes, thanks, Mark on that as we think about you know.
In June the <unk>.
Reps in and how we would.
Speaker 6: potentially hire these people. We first have to think about how a structure looks like for that type of an organization.
Potentially hire these people.
We first have to think about how our structure looks like for that type of an organization and.
Speaker 6: You know, typically when we have a field force about 100, you're going to look at two area executive directors or executive sales directors that cover the yeast in the last, we brought those two individuals on. And then we are actively looking at the next level under that, which is the RIT.
Typically when we have a field force of about 100, Youre going to look at two area executive directors, our executive sales directors that cover the east and the West we brought those two individuals on.
And then we are actively looking at the next level under that which is the rfps are regional sales directors, which cover or are directly rep managers.
Speaker 6: our regional sales directors, which are directly rep managers, and you would expect those people to be hired maybe three to four months before PDUFA.
And you would expect those people to be hired maybe three to four months before <unk>.
Speaker 6: And then our plan for RAPS is to hire them around Act Padoo for a contingent on Padoo FUB. We've done this in the past as a team where we create a pool of candidates that were able to hire and kind of hold until the drug is approved around the Padoo Fuday and quickly convert those offers into active employees with an organization.
And then our plan for reps is to hire them.
Around at Purdue for contingent on Purdue.
We've done this in the past as a team where we are.
Create.
Our pool of candidates that we are able to hire and kind of hold until the drug is approved around the <unk> date and quickly convert those offers into.
Active employees with an organization. So our plan would be to have those reps come on right. After paducah.
Speaker 6: So our plan would be to have those reps come on right after a pedo-fa and then have them trained and ready to go sell NC Penchron if it's approved. I think the other important aspect here is we believe that, you know, a proper field force covering NC Penchron not only includes field-based reps.
And then have them trained and ready to go so empty pantry and if it's approved I think the other important aspect here is we believe that.
Proper field force covering the country not only include field base reps, but also ways that we can interact with doctors virtually and also support the reimbursement pathway with field reimbursement managers. So I think as you think about the totality of the commercial organization, we want to make sure that we cover the physicians and the patients.
Speaker 6: but also ways that we can interact with doctors virtually and also support the reimbursement pathway with field reimbursement managers. So I think as you think about the totality of the commercial organization.
Speaker 6: We want to make sure that we cover the positions and the patients in a way that they can...
The way that they can.
Speaker 6: They see how the utility of the product but then can also get the product to the patients that are most in need. And again, all those load that large number of representatives and people to support that would be coming around Purdue for right after Purdue.
See how the utility of the product, but then can also get the product to the patients that are most in need.
And again all of those load that large number of representatives and people to support that would be coming around Purdue for right. After paducah.
Thank you.
Yeah.
The next question comes from Tom Shrader with <unk>. Please go ahead.
Speaker 6: Good morning, thanks for holding the call. I have all combination questions. So the specific lawma you used, how de-risking is that for the class? The molecules ever not play together, or is it really the mechanisms you're working out?
Good morning, Thanks for holding the call I have all combination questions.
So.
The specific Lama you used how derisking is that for the class the molecules ever not play together or is it really the mechanisms you are working out and then there's some old data for <unk>. It was really quite striking that it made law must work faster maybe for Cathy does that data hold up in your mind and is that.
Speaker 6: and then there's some old data for NC Centrin it was really quite striking that it made Lama's work faster it may be for Kathy does that data hold up in your mind and is that something that you would be very eager to try to see if you can repeat and have a follow up on broad.
Something that you wouldnt be very eager to try to see if you can repeat that I have a follow up on bronchiectasis.
Speaker 5: Great, thanks Tom. Yeah, I'll turn it over to Cassie to talk about her sounds like a parallelite in general and potentially how NC pension and like a parallelite work together.
Great. Thanks, Tom Yeah, I'll turn it over to Kathy to talk about her sounds like apparel late in general and then.
Potentially how empty pension and <unk> worked together.
Speaker 8: Yes, thanks Tom for the question. So, collective perially is like other llamas, works very similar. They've been in use for a long time. So we know a lot about them from that perspective and they all work fairly similar. So, collective perially is like other llamas, works very similar.
Yeah. Thanks, Tom for the question, so Glasgow purely like other Lama works very similar.
<unk> been in use for a long time, so we know a lot about them from that perspective.
And they all work fairly similar.
Speaker 8: So I don't expect to have any surprises from their FSC or whatever that we look at in studies from that perspective. As far as acting faster, we do have some older data that shows that it's not just llamas, but also for data agonist that when you combine the two together, you do get a shortening of the response time to peak efficacy. Again, those were done in shorter studies.
I don't expect to have any surprises from there.
Or whatever that we look at studies from that perspective.
As far as acting fast and we do have some older data that shows that it's not just lumpiness, but also for beta agonist when.
When you combine the two together you get a shortening.
The response time to peak efficacy.
Again, those redundant shorter studies.
Speaker 8: But I wouldn't expect that that would go away. I would expect to still see that in the combination type of. I don't want to use them together from that perspective.
But I wouldn't expect that that would would go away I would expect to still see that in the combination typo.
When we use them together from that perspective.
Speaker 11: I don't, was there another question I'm forgetting? I haven't asked it yet. Okay. Okay. Go ahead, Tom. Just historically on bronchiectasis, have bronchodilators been tried and failed? Are you mostly betting or focused on the anti-inflammatory properties to show this is an effective drug?
Was there another question I'm forgetting.
Im going to ask it yet.
Okay. Okay.
Just historically on Bronchiectasis Bronchodilator has been tried and failed or are you, mostly bedding or focused on the anti inflammatory properties to show. This is an effective drug.
So Brian.
Speaker 8: Yeah, far from the dialers have not failed, per se. As was mentioned, there are no approved drugs for non-CF bronchi exorcist. Bronchi exorcist has some similar...
Yes.
Have not failed per.
Per se.
As mentioned there are no approved drugs for non CF bronchiectasis bronchiectasis has some similar.
Speaker 8: things that we see that are similar to COPD, for example, in sections, they have widening of the airways, and they have destruction in the airways and increased mucus. So many of the things that we see in projectives, we see effects of some incidental and COPD. So for example, a block of dilation may help clear out.
Yeah.
Things that we see that are similar to COPD for example infection. They have widening of the Airways and they have destruction in the Airways and increase mucus. So many of the things that we see in bronchiectasis.
See effects from MTF entrant in COPD. So for example.
Bunzl dilation may help clear out.
Speaker 8: The mucus better. It doesn't necessarily work like you would see in somebody with asthma where you're actually looking to actually bronch and dilate the airways, but you're looking
You could better it doesn't necessarily work like you would see in somebody with asthma, where youre actually looking to actually Banca dilate, the airwave, but youre looking for increasing getting rid of the mucus and all are sitting in the Airways and if that's what's causing all the underlying infection. When you have sitting there it gets infected and then.
Speaker 8: infections when you have stuff sitting there, it gets infected and then it leads to exacerbation. So, do we use them? Yes, we use them.
It leads to an exacerbation.
So do we use them, yes, we use.
Speaker 8: We use everything we have because we don't have anything else to use.
We use everything we have because we don't have anything else to use.
Speaker 8: So we're going to use bronchid dilators, or you can use steroids when you use whenever we have available, because that's what we have to use to treat bronchi-accesses. I think we also think prevent defense protection both in on serotonin and inflammatory effects, and its ability to increase nucleic acid clearance will help clear mucus out of the airways and help prevent and decrease exacerbations that we may see with patients with bronchi-accesses.
We're gonna use bronchodilator is where you're going to use steroids going to use whenever we have available because that's what we have to use to treat bronchiectasis.
I think we also think government defense protecting both the non steroidal anti inflammatory effect and its ability.
The increase Mucociliary clearance.
Help clear mucus out of the Airways and help prevent and decrease exacerbations that we may see with patients with bronchiectasis.
Great. Thank you.
Speaker 12: Think that.
Thanks, Tom.
Speaker 3: As a reminder, if you have a question, please press start and want to rejoin the
As a reminder, if you have a question please press star.
Anyone can be joined into the queue.
Speaker 13: Our next question comes from the base, but Dale with 8C main rights.
Our next question comes from the Beach.
Please go ahead.
Speaker 14: Hi guys, this is the Pesh, current football ball and HE win rights. In one of the HCP focused market research slides that you presented last month, we see that NCFN Finns twice a day dosing schedule was the least preferred attribute among seven others. So the score was not that bad. Thinking long term, how do you expect the twice a day regimen to potentially impact NCFN Finns market adoption?
Hi, guys. This is depeche covering football in HC Wainwright.
In one of the HCP focused market research slides that you presented last months, we see the NCI paintings twice a day dosing schedule was the least preferred attributes among seven others.
So the school was not that bad thinking long term, how do you expect the twice a day regimen to potentially impact and dependent brings market adoption.
Great Chris do you want to speak to it.
Speaker 6: Yeah, thanks Dave and appreciate the question and the push. I think you're referring to the slide on the attributes of drugs. I attribute to MCFenturin and how physicians rated that. I think it's really important to just ground ourselves in how impressive...
Yes, Thanks, David I appreciate the question.
I think I think you're referring to slide on the attributes of drugs attributes of empty pentron in how physicians right of that I think it's really important to just ground ourselves in how impressive.
Speaker 6: The response was from positions on the profile of NC centren. As you mentioned, that was the lowest score, but it still well about the median. For every attribute that's listed from...
The response was from physicians on the profile of <unk> as you mentioned and that was the lowest score, but it's still well above the median but for every attribute that's listed from least important the most important empty bedroom scores extraordinarily high within a physician mindset and I think that plays based on what we've heard in <unk>.
Speaker 6: least important to most important NC-Fentrum scores extraordinarily high within a physician's mindset. And I think that plays based on what we've heard in qualitative and KOL interactions to the unmet need that still exists in the marketplace. As we discussed earlier, 50% of these patients are having persistent symptoms. So the physicians are looking for a drug that have the potential to have an effect on their patient lives that potentially NC-Fentrum could have.
Qualitative and kols interactions to the unmet need that still exist in the marketplace. As we discussed earlier, 50% of these patients are having persistent symptoms. So the physicians are looking for a drug for drugs that have the potential to have an effect on their patient lives that potentially empty pantry and could have when.
Speaker 6: You know, when we talk specifically to doctors about BID dosing, one of the things that's interesting is what we hear from them.
When we talk specifically to doctors about the IV dosing one of the things. That's interesting is what we hear from them is that many patients struggle and Kathy can talk about this but many patients struggle when they wake up in the morning, because single our once a day drug tend to lose their effect over time so.
Speaker 6: is that many patients struggle and Kathy can talk about this, but many patients struggle when they wake up in the morning.
Speaker 6: because single or once a day drugs tend to lose their effect over time. So in their mind sometimes the BID dosing is very beneficial for the patient because they get that evening dose that allows them to wake up in a better place and maybe they would have with a single once a day type.
So in their mind, sometimes the IV dosing is very beneficial for the patient because they get that evening dose that allows them to wake up in a better place than maybe they would have with a single once a day type product.
Speaker 6: So when we look at overall adoption and how physicians look at the profile we don't believe that the ID dose is a hit and during at all and you can see that on the second part of that slide which basically says
So when we look at overall adoption and how physicians will look at the profile. We don't believe that the IV doses a hindrance at all and you can see that on the second part of that slide, which basically says that 90% of the HCP believe that you know they'll.
Speaker 6: that 90% of the HCPs believe that they'll be adopting NC Ventron within the first year of launch. And that's a remarkably high adoption rate. And it, again, speaks to the unmet need and the overall differentiated profile that NC Ventron has.
<unk> will be adopting <unk> within the first year of launch and that is a remarkably high.
Adoption rate and it's again speaks to the unmet need in the overall differentiated profile that <unk> has.
Speaker 14: Great, thank you for the details. I have a couple more questions. You may have touched on this in some of the prior questions, but can you discuss the challenges you anticipate solving as you work on testing the convivability of ends of pencil and plus llama in a single nebulizer formulation? And I think you had noted earlier on just to confirm that you're going to be expecting the clinical trial to begin second half of 24 on that.
Great. Thank you for the details so I have a couple more questions.
You may have touched on this in some of the prior questions, but can you discuss the challenges you anticipate solving because you work on testing the combined ability of <unk> plus <unk> in a single maybe lines of formulation and I think you had noted earlier on just to confirm that you are going to be.
Expecting the clinical trial to begin second half of 2012 on that.
Speaker 5: Yeah, thanks for the question. Yeah, our general cadence for that development would be, you know, getting through those formulation development activities, which takes some time because you want to have seated durability of the formulation. That's nothing new in drug development. And where that work is ongoing. With regard to challenges, I think it.
Yes, thanks for the question.
Our general cadence for that development would be.
Getting through the formulation development activities, which takes some time because you want to see the durability of the formulation that's nothing new in drug development.
And that work is ongoing.
With regard to challenges I think it's.
Speaker 5: Nothing that we know of other than getting the work done and having the data to support the plan forward. We believe the formulation can work, but we need the data to support that. We need to make sure that the dose delivered for both NC Femton and glycoparolate when cool formulated is where they want it to be. So there's a lot of technical aspects.
Nothing that we know of other than getting the work done and having the data to support that.
<unk> forward.
We believe the formulation.
Can work, but we need the data to support that we need to make sure that the dose delivered for both empty pension and apparently when co formulated.
Where do we want it to be so there's a lot of technical aspects.
Speaker 5: in a formulation, the chemistry, the dose deliver, the particle size generation, all of that work, which of course we've done previously with Ben C. Fentron, we need to do with the combination. So that work will be ongoing. And that's why I put this in looking at a clinical trial in the second half of 2020.
In our formulation the chemistry, the dose deliver the particle size generation all of that work, which of course, we've done previously with empty pentron, we need to do with the combination so that work will be ongoing and thats why it puts us.
And looking at a clinical trial.
Trial in the second half of 2024.
Speaker 14: Got it. Thank you. And final question. How should we think about R&D expenses moving forward? Specifically, what will the remaining R&D expense relate to?
Got it thank you and final question.
How should we think about R&D expenses moving forward, specifically what will the remaining R&D expense relate to.
Glenmark Yep Yep. Thanks for the question so I think in the.
Speaker 2: Thank you very much. Yep, thanks for the question. So I think in the...
Very near term.
Speaker 2: expect R&D expenses to be fairly limited because we're not running any clinical trials. As we get into the back half of next year, they should go up marginally. These phase two programs that we're talking about are not of the same scope the U. years to seeing at anti-fentrum during our phase three program. They're much, much smaller. So the expense levels will be back more like like like we're on the had in the 2019 timeframe. I think.
You should expect R&D expenses to be fairly limited.
We're not running any clinical trials as we get into the back half of next year.
They should go up marginally these phase two programs that we're talking about are not no.
At the same scope that you used to seeing and chief Pentron during our phase III program, they're much much smaller so the expense levels will be back more like against like Verona had in the 2019 timeframe I think.
Speaker 2: single digit, load amid single digit quarterly R&D expense for the foreseeable future until we get to a phase three program. Dr.
Single digit low to mid single digit quarterly R&D expense for.
For the for the foreseeable future until we get to a phase III program.
Great. Thank you so much for the update guys.
Thank you.
Yeah.
Speaker 13: This concludes our question and answer session. I would like to turn the conference back over to Dr. David Zachardelli for any closing.
This concludes our question and answer session I would like to turn the conference back over to Dr. David Rocker Daly for any closing remarks.
Speaker 5: Great. Thank you everybody for attending today's call. We appreciate your support and we look forward to updating you in the future at conferences.
Great. Thank you everybody for attending today's call.
We appreciate your support and we look forward to updating you in the future at conferences.
Have a great day.
Speaker 13: conference is now concluded. Thank you for attending today's presentation. You may all
The conference has now concluded. Thank you for attending today's presentation you may all now disconnect.