Q3 2021 Abeona Therapeutics Inc Earnings Call
Operator: Ladies and gentlemen, thank you for standing by. Welcome to the ABONA Q-Q-3-21 earnings call. At this time, all participants are in a listen-only mode.
Good morning, ladies and gentlemen, thank you for standing by welcome to the <unk> Q3, 2021 earnings call. At this time all participants are in a listen only mode. After management's prepared remarks, there will be a question and answer session I would now like to turn the call.
Operator: After management's prepared remarks, there will be a question-and-answer session. I would now like to turn the call over to Greg Tien, head of investor relations. Please go ahead. Thank you, Kelly. Good morning, everyone.
All over to Greg Gin head of Investor Relations. Please go ahead.
Thank you Kelly good.
Morning, everyone I would like to welcome and thank you for joining us on our third quarter of 2021 conference call.
Gregory Gin: I would like to welcome and thank you for joining us on our third quarter 2021 conference call. The press release announcing the third quarter results and recent operational progress is available on our website at www.adaynitherapeutics.com. On the call today with prepared remarks are Vish Sashadri, CEO of Fabiana, and Ed Carr, CFO.
The press release announcing the third quarter results and recent operational progress is available on our website at www.
Maybe on the therapeutics Dot com.
On the call today with prepared remarks are ambitious to salary CEO of maybe ona.
And Ed Carr.
CFO.
Gregory Gin: After the prepared remarks, we'll host a Q&A session. We are also joined by Dr. Brian Kevenny, our Chief Technical Officer. Before we start, I will review our safe harbor statements. Remarks made during today's call may contain projections and forward-looking statements regarding future events. Forward-looking statements are made pursuant to the Safe Harbor provisions of the federal security laws.
After the prepared remarks, we will host the Q&A session.
We are also joined by Dr. Brian Kevin <unk>, our Chief Technical Officer.
First start I will review, our safe Harbor statement.
The remarks made during today's call may contain projections and forward looking statements regarding future events.
Looking statements are made pursuant to the safe Harbor provisions of the federal Securities laws.
Gregory Gin: These forward-looking statements are based on current expectations and are subject to change, and actual results may differ materially from those expressed or implied in the forward-looking statements. Various factors that could cause actual results to differ include, but are not limited to, those identified under the section entitled to, risk factors in the company's end report on form 10K and quarterly reports on form 10Q filed by the company with the SEC. These documents are available on our website at www.abionatherapeutics.com. And with that, I will now turn the call over to Vish.
These forward looking statements are based on current expectations and are subject to change and actual results may differ materially.
<unk> from those expressed or implied in the forward looking statements.
Various factors that could cause actual results to differ include but are not limited to those identified under the section entitled risk factors in the company's annual report on Form 10-K, and quarterly reports on Form 10-Q.
By the company with the SEC.
These documents are available.
On our web site at Www Dot Avionic therapeutics Dot com.
With that I will now turn the call over to vish.
Gregory Gin: Thank you Greg, thank you, and good morning everyone. This is my first quarterly call since transitioning to CEO about four weeks ago, and I'm happy to update you on our substantial progress this quarter and since quarter end.
Greg Thank you.
Good morning, everyone. Thank you for joining us. This morning. This is my first quarterly call since transitioning to CEO about four weeks ago and I'm happy to update you on our substantial progress.
The third quarter and since quarter end I am thrilled to be leading <unk>. During this exciting and critical time in our lifecycle.
Vishwas Seshadri: I'm thrilled to be leading Ediona during this exciting and critical time in our life cycle. We are advancing two late-stage pivotal assets with rare pediatric designations, transformational potential, and key anticipated milestones in the coming months, including finishing patient accrual for the EB 101 Phase 3 Vital study in the first quarter of 2022 and top-line data readout in the third quarter of 2022. We are continuing to work toward bringing our gene therapies as safely, effectively, and quickly as possible to patients who suffer from these diseases that have no approved treatments.
We are advancing to late stage pivotal assets with rare pediatric designation transformational potential and key anticipated milestones in the coming months, including finishing patient accrual for.
101 phase III vital study in the first quarter of 2022 and topline data readout in the third quarter of 2022, we are continuing to work towards bringing our gene therapies as safely effectively and quickly as possible to patients who suffer from these diseases that have no approved treatments.
Vishwas Seshadri: We have taken a big step toward that goal by recently enhancing our leadership and bench strength with gene therapy and biopharmaceutical industry veterans to prepare for two biologics license applications for our lead clinical programs in RDEB and MPS3A. These hires include John Voss as head of quality, Carl Denny as head of regulatory, and Kate Imhoff, a senior director of regulatory.
<unk> taken a big step towards that goal.
For the EIA recently, enhancing our leadership and bench strength with gene therapy, and Biopharma industry veterans to prepare for two biologics license application submissions for our lead clinical programs and our debt and <unk>.
These hires include John Voss, as head of quality Cot Denny as head of regulatory.
And Kate <unk> as senior director of regulatory all three bring considerable gene therapy experience with late stage clinical and commercialized products and companies like <unk> <unk> therapeutics and selective now let's take a closer look at <unk> 101, our investigational autologous gene corrected cell therapy that have demand.
Vishwas Seshadri: All three bring considerable gene therapy experience with late-stage clinical and commercialized products in companies like Avexis, Syrupta therapeutics, and Selectus. Now let's take a closer look at EB-101, our investigational orthologous gene-corrected cell therapy that has demonstrated a high rate of instantaneous wound healing and pain reduction for six years. the latest follow-up time point reported after treatment of large chronic wounds in R-DEP patients in the phase 1-2 study we are anticipating similar outstanding results from our ongoing phase three vital study as a reminder the target for the vital study is the treatment of approximately 35 large chronic wounds each treated wound being paired with an untreated control wound within the same patient large chronic wounds are the most severe and problematic wounds in R-Deb unlike small recurring wounds that can close spontaneously, these large chronic wounds have greater than 20 centimeters square of surface area and remain open for more than six months, very often for years, and cannot close themselves, and are associated with severe pain that is often managed with opioids.
<unk> created a high rate of instantaneous wound healing in pain reduction for six years. The latest follow up time point reported after treatment of large chronic wounds in <unk> patients in the phase <unk> study we are in.
Anticipating similar outstanding results from our ongoing phase III vital study as a reminder, the target for the vital study the treatment.
Treatment of approximately 35 large chronic wounds each treated wound being paired with an untreated control room within the same patient large chronic wounds are the most severe and problematic wound in our deb. Unlike small recurring wounds that can flow spontaneously. These large chronic wounds have greater than 20 centimeters quite a surface area and remain open.
For more than six months very often for years and cannot close themselves and are associated with severe pain that is often manage with opioids.
Vishwas Seshadri: I am very pleased to report that since the last earnings call, we have continued to treat patients, and we are close to accruing the vital study. We have identified and are scheduling treatment for the final patients, and anticipate treating them by the first quarter of 2022. We therefore expect top-line study results in the third quarter of 2022, upon completing the 24-week follow-up for the last patient treated. The anticipated timing for BLA filing is year-end 2022 or early 2023.
I am very pleased to report that since the last earnings call. We have continued to treat patients and we are close to accruing. The vital study we have identified and are scheduling treatment for the final patients.
<unk> and anticipate treating them by first quarter of 2022, we therefore expect top line study results in the third quarter of 2022 upon completing the 24 week follow up for the last patient treated the anticipated timing for BLA filing is year end 2022 early 2023 as previously mentioned.
Vishwas Seshadri: As previously mentioned, UMass Memorial Medical Center, the second clinical site in the vital study, is now active and pre-screening patients. Turning to EB 101 manufacturing, as a reminder, we are a non-CDMO-dependent company. We have manufactured the drug products for the PACE 3 vital study at our Cleveland facility. We have made significant progress in updating module 3 of the IND with information pertaining to the manufacture of EB 101 in-house.
Umass Memorial Medical Center, the second clinical site in the vital study is now active and prescreening patients turning to <unk> hundred one manufacturing.
As a reminder, we are a non CDM or dependent company we've.
Manufacture the drug product for the phase III vital study at our Cleveland facility, we have made significant progress in upgrading.
Module three of the IND with information pertaining to manufacturer of EB 101 in house. We have also been advancing process characterization work on other CMC activities to support our BLA filing for <unk> 101, we.
Vishwas Seshadri: We have also been advancing process capitalization, characterization work, and other CMC activities to support a BLA filing for EB 101. We believe that bringing manufacturing and critical analytical assays for our assets in-house at ABIona is a key strategic advantage in the cell and gene therapy space. Now, let's turn to our adeno-associated virus platform and our second clinical program, ABO 102, an investigational therapy for San Salipo Syndrome type A or MPS3A. In the previous earnings call, we reported that we had aligned with the FDA on the definition of the primary endpoint for the Pivotal Age study to enable registration.
We believe that bringing manufacturing in critical analytical assays for our assets in house at.
<unk> is a key strategic advantage in the cell and gene therapy space.
Let's turn to our <unk> associated virus platform and our second clinical program <unk> 102, investigational therapy for Sanfilippo syndrome type, a or <unk> 38 and.
In the previous earnings call, we reported that we align with the FDA on the definition.
The primary endpoint for the pivotal transfer a study to enable registration. The primary endpoint is a neurocognitive assessment using raw score of Bayley scales for infant and toddler development. The S. ICD and the Kaufmann assessment battery for children KABC too for children, who obtain developmental age of 42 months.
Vishwas Seshadri: The primary endpoint is a neurocognitive assessment using raw scores of the Bailey scales for infant and toddler development, BSITD, and the Kaufman Assessment Battery for Chisholm children KABC2 for children who attain a developmental age of 42 months.
Vishwas Seshadri: We have since submitted an amended trial protocol reflecting the agreed-upon endpoints. We have collaborated with experts in MPS3A to finalize the statistical analysis plan, or SAP, which we are scheduled to discuss with the FDA in the first quarter of 2022 through the RMAT mechanism. As a reminder, we have already treated 10 patients with ABO 102 in the therapeutic dose cohort, and preservation of neurocognitive development is being evaluated over a period of up to five years.
We have since submitted an amended trial protocol, reflecting the agreed upon endpoints, we have collaborated with exploration of the <unk> III.
To finalize the statistical analysis plan or SAP, which we are scheduled to discuss with the FDA in the first quarter of 2022 through the <unk> mechanism as a reminder, we have already.
The 3% to 10 patients with <unk> hundred one or two in the therapeutic dose cohorts. The preservation of Neurocognitive development is evaluated over a period of up to five years. Therefore, depending on the primary analysis methodology in the neuro cognitive performance observed in the more recently dosed patients we anticipate topline results from transfer a anywhere between the fourth.
Vishwas Seshadri: Therefore, depending on the primary analysis methodology and the neurocognitive performance observed in the more recently-dosed patients, we anticipate top-line results from transfer A anywhere between the fourth quarter of 2022 and the second quarter of 2023. We are excited about the safety and magnitude of benefits seen with ABO 102 in children treated early in age at the therapeutic dose, for whom we have reported unprecedented trends in patients. disease-specific biomarkers, preservation of neurocognitive development, as well as anatomical development using brain MRI, which will be presented at the International Symposium on MPS and related diseases in the third quarter of 2021.
2022, and second quarter of 2023.
We are excited about the safety and magnitude of benefit seen with <unk> 102, and children treated early in age at the therapeutic dose for whom we have reported unprecedented trends in disease specific biomarkers preservation of neurocognitive development as well as anatomical development using.
<unk> brain MRI, which was presented at the international symposium on NPS and related diseases, and the third quarter of 2021.
Vishwas Seshadri: The MIS data shows increased gray matter, corpus callosum, and amygdala volumes in the brain in three young patients with MPS3A treated at 24 months or before and at two years post-treatment as compared to afflicted patients without treatment, which is consistent with the preservation of neurocognitive development that we have previously reported. While the triangulation of results from biomarkers, neurocognitive development, and brain MRI builds clinical conviction about the treatment effect of ABO 102, this will also be important from a regulatory approval standpoint.
The data shows increased green matter Corpus callosum, and AMIC della volumes in the brain and three young patients with <unk> treated at 24 months before and at two years post treatment at compared to afflicted patients without.
Quarter treatment, which is consistent with the preservation of neurocognitive development that we have previously reported.
While the triangulation of results from biomarker Neurocognitive development in brain MRI builds clinical conviction about the treatment effect of <unk> 102. This will be important also from a regulatory approval standpoint. The FDA has indicated that they will consider all.
Vishwas Seshadri: The FDA has indicated that they will consider all kinds of clinical data points holistically in regulatory decision-making. We have previously sourced the ABO 102 drug product from nationwide children's hospitals. Earlier this year, we commenced activities to be able to manufacture ABO 102 at our Cleveland facility.
All kinds of clinical data points, Holistically and regulatory decision, making.
We have previously sourced the ABL of one or two drug product from nationwide Children's hospital earlier. This year, we commenced activities to be able to manufacture <unk>, one or two at our Cleveland facility. We are on track to complete manufacturing of six GMP lots of ABL, one or two this year using animal.
Vishwas Seshadri: We are on track to complete manufacturing with six GMP lots of ABO 102 this year using animal-free materials. We expect analytical comparability studies to establish equivalence of ABONA-produced drug product with that source from nationwide children's hospitals in the first half of 2022 using the battery of tests as instructed by the FDA for ABO 102. Additionally, in preparation for the commercial supply of ABO 102, we have initiated the construction of a 12,000 square foot commercial AAV manufacturing facility at our Cleveland site.
Without three materials.
We expect analytical comparability studies to establish equivalents of AVR produce drug product that sourced from nationwide children's hospital in the first half of 2022, using the battery of tests as instructed by the FDA for ABL, one or two additionally.
Additionally, in preparation for commercial supply of <unk>.
We have initiated the construction of a 12000 square foot commercial AAV manufacturing facility at our Cleveland site. This facility will also have the capacity to support other AAV programs, including our preclinical author ocular programs in the future.
Vishwas Seshadri: This facility will also have the capacity to support other AV programs, including our preclinical ocular programs in the future. Now, let's move on to a brief update on our third clinical program, the ABO 101 TransferB study in Stensalipotide B or MPS3B. As we first mentioned on the second quarter call, we have closed enrollment in the transfer B study and are following patients treated in the study and under the compassionate use program in Germany for safety and efficacy of ABO 101. As reported earlier, biomarker and safety data look encouraging. We look forward to seeing two-year neurocognitive data to assess the efficacy of ABO 101 in the second half of 2022.
Let's move on to a brief update on our third clinical program the.
101 transfer B study in sanfilippo type B or <unk> as we first mentioned on our second quarter call. We have closed enrollment in the transfer B study and are following patients treated in the study and under the compassionate use program in Germany for safety and efficacy of <unk> hundred one as reported earlier biomarker.
The Abi data look encouraging we look forward to seeing two year neurocognitive data to assess efficacy of <unk> hundred one in the second half of 2022.
Vishwas Seshadri: I will now briefly turn to our preclinical programs. While we are currently focused on rare diseases in our clinical programs, we intend to address larger areas of unmet medical need, and our preclinical programs are investigating novel AAB capsids clips and five undisclosed ophthalmic conditions with estimated U.S. prevalence ranging from 5,000 to 15,000 patients. We previously shared data from non-human primates to determine optimal routes of administration with different novel capsids. Subsequently, we have made significant progress in generating mouse models for three indications, prepared the genetic constructs, produced the vectors with appropriate capsids, and developed assays to measure efficacy in the preclinical setting.
I will now briefly turn to our preclinical programs. While we are currently focused on rare diseases and our clinical programs, we intend to address larger areas of unmet medical need.
And our preclinical programs are investigating novel AAV capsid and five undisclosed ophthalmic conditions with estimated U S prevalence ranging from 5000 to 15000 patients.
We previously shared data from nonhuman primates to determine optimal routes of administration with different novel Capsid. Subsequently we have made.
And our significant progress in generating mouse models for three indications prepared the genetic construct produced the vectors with appropriate capsid and developed assays to measure efficacy in the preclinical setting we are encouraged by gene expression levels with our construct and in vitro studies, we're expanding the model mouse colonies and.
Vishwas Seshadri: We are encouraged by gene expression levels with our constructs in in vitro studies. We are expanding the model mouse colonies and have already started dosing animals. We expect animal proof of concept for Veda by mid-2020 and pre-IND meetings with the FZA in late 2022. Before I request Edge to review our financial results, I want to briefly comment on our formal settlement with Regenix Bio, which resolves our previously disclosed dispute over an arbitration award. The settlement provides for payments by Abeiona over a three-year period and, importantly, raises certain downside scenarios that could have made it challenging to make it to our next inflection points.
Made you started dosing animals, we expect animal proof of concept data by mid 2022, and pre IND meeting with the FDA in late 2022.
Before I request edge to review our financial results I want to briefly comment on our foremost settlement with <unk> bio which resolved our previously disclosed dispute.
<unk> already Arbitration award.
Settlement provides for payments by <unk> over three year period, and importantly, there is a certain downside scenarios that could have made it challenging to make it to our next inflection points with the arbitration uncertainty behind US we are focused on completing the registration enabling studies and.
Vishwas Seshadri: With the arbitration uncertainty behind us, we are focused on completing the registration enabling studies and submitting BLA filings for both EB 101 and ABA 102 to deliver these therapies to patients in need as quickly as we can. With that, I'll now turn over the call to Ed. Thank you, Vish. I would like to remind everyone that the Form 10Q is available on our website, where you can get additional details on our financial results for the three and nine months ended September 30th, 2021.
Overheating BLA filings for both <unk> hundred one and <unk> 102 to deliver these therapies to patients in need as quickly as we can with that I'll now turn over the call to Ed.
Thank you this I would like to remind everyone that the Form 10-Q is available on our web site, which is where you can get additional details on our financial results.
For the three and nine months ended September 32021.
Vishwas Seshadri: Starting with the financial reasons on our balance sheet, we had cash, cash equivalents, and short-term investments of $67 million as of September 30th, 2021. Net cash use in operating activities was $10.3 million for the third quarter of 2021.
Starting with the financial leases on our balance sheet, we had cash cash equivalents and short term investments of $67 million as of September 32021 net.
Net cash used in operating activities was $10 3 million for the third quarter of 2021.
Ed Carr: As part of the settlement with Regenix Bio, we have agreed to make payments to Regenix Bio of 20,000 in the fourth quarter of 2021, $5 million in November of 2022, and $5 million no later than November of 2024. As Vich mentioned, this settlement allows us to eliminate ongoing legal expenses, the deployment of resources, and risks related to the dispute. With our existing financial resources, we are continuing to drive our lead programs toward key milestones. Based on our existing cash, cash equivalents, and short-term investments, our ability to access additional financial resources, and our financial flexibility to reduce operating expenses if we are at the cost of the cost of cash equivalents, as required, we believe that we have sufficient resources to fund operations through at least the next 12 months.
As part of it so I don't want <unk> bio we have agreed.
To make payments to <unk> by over $20 million in the fourth quarter of 2021 5 million in November 2022, and $5 million. No later than November 2024, as Rich mentioned this settlement allows us to eliminate ongoing legal expenses deployment of resources and risks related to the dispute.
With our existing financial resources, and we are continuing to drive our.
Programs toward key milestones based on our existing cash cash equivalents and short term investments our ability to access additional financial resources and our financial flexibility to reduce operating expenses. If required. We believe that we have sufficient resources to fund operations through at least the next 12 months to further strengthen the balance sheet and prepare for BLA.
<unk> filings commercial launch readiness and the AAV facility build out that refinished mentioned, we are exploring various options, including strategic partnering of pipeline assets and non dilutive funding.
Ed Carr: To further strengthen the balance sheet and prepare for BLA filings, commercial launch readiness, and the AAB facility build-out that Rich mentioned, we are exploring various options, including strategic partnering of pipeline assets and non-deluded funding. Turning to research and development activities in the third quarter of 2021, we spent 8 million, which is consistent with the 8 million spent in the third quarter of 2020. Our spend on general administrative activities was 6.1 million in the third quarter of 2021 compared to 4.4 million spent in the third quarter of 2020.
Turning to research and development activities in the third quarter of 2021, we spent $8 million, which is consistent with the 8 million spent in the third quarter of 2020.
Our spend on general and administrative activities was $6 1 million in the third quarter of 2021, compared with $4 4 million spent in the third quarter of 2020.
General and administrative expenses include the cost of personnel not working directly on clinical and preclinical activities as well as professional fees insurance rent and office expenses the increase in general administrative expenses.
In the third quarter of 2021 results, primarily from increased stock based compensation and professional fees, partially offset by decreased salary and related costs.
Ed Carr: General and administrative expenses include the cost of personnel not working directly on clinical and preclinical activities, as well as professional fees, insurance, rent, and office expenses. The increase in general administrative expenses in the third quarter of 2021 results primarily from increased stock-based compensation and professional fees, partially offset by decreased salary and related costs. Gain on settlement with licensure was 6.7 million in the third quarter of 2021, as compared to zero in the same period of 2020, and resulted from the accounting for the settlement agreement with Regenics Bio.
Gain on settlement.
Licensor was $6 7 million in the third quarter of 2021 as compared to zero in the same period of 2020 and resulted from the accounting for the settlement agreement with <unk>.
<unk>.
The PPP or Paycheck protection program loan forgiveness income was $1 8 million in the third quarter of 2021 as compared to zero in the same period of 2020 as a result of receiving as the SBA, our small business administration's forgiveness of our PPP loan in July 2021.
With that I'll turn the call over to the operator to come.
Is M&A session operator.
Certainly the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we ask that while posing a question that you. Please pickup your handset listening on a speaker phone to provide optimum sound quality. Please hold a few moments while we pull for questions.
Ed Carr: The PPP or Paycheck Protection Program loan forgiveness income was $1.8 million in the third quarter of 2021 as compared to zero in the same period of 2020, as a result of receiving the SBA's or Small Business Administration's forgiveness of our PPP loan in July 2021.
Your first question is coming from Maury Raycroft with Jefferies. Please pose your question.
Operator: With that, I'll turn the call over to the operator to commence the Q&A session. Operator? Yes. The floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while asking your question, you please pick up your handset if listening on a speaker phone to provide optimum sound quality.
Hi, good morning, everyone. Congrats on the update and thanks for taking my questions.
First I wanted to ask on the press release that came out this morning on <unk> 102.
<unk>.
Hence the QC.
I guess, maybe if you could just talk a little bit more about.
Operator: Please hold for a few moments while we pull for questions. Thank you. Your first question is coming from Maury Rakoff with Jeffries. Please pose your question.
What youre going to be presenting at the conference and how this is how that factors into the big picture plan for one or two.
Absolutely. Thank you Marni for the question I will take this one.
Maurice Thomas Raycroft: Congratulations on the updates and thanks for taking my questions. First, I wanted to ask about the press release that came out this morning about ADO 102 and the ICIEM conference. I guess maybe if you could just talk a little bit more about what you're going to be presenting at the conference and how this is, how this factors into the big picture plan for. Absolutely. Thank you, Maury, for the question. I will take this one.
This the data that were presenting at ICI and important part of the data is really the correlation that we see between daily scoring and Mullen.
Two different scales that are used in Europe cognitive assessment, what we have shared in the past the data from the country study in terms of development age equivalent then.
And the results that we've seen for the first three dose children are all based on the Marlin scores, but we have been collecting mainly as well. So the common question that arises is how will the neurocognitive assessment look when you switch over to the daily which is now what's been agreed with the FDA as our primary endpoint for the study so the data that shows correlation.
Vishwas Seshadri: The data that we are presenting at ICIEM, the important part of the data is really the correlation that we see between Bailey scoring and Mullen. These are two different scales that are used in neurocognitive assessment. What we have shared in the past, the data from the transfer A study in terms of developmental age equivalent, and the wonderful results that we've seen for the first three dose children are all based on the Mullen score, of course, but we've been collecting Bailey as well.
<unk>, one <unk> billion Mullen that we will be presenting IC IEM shows that those scores are correlated at approximately 95% correlation and therefore, what it implies is that you should almost expect similar results. If you put our bailey scores instead of Marlin in the current ongoing contrary study I hope that answers.
Vishwas Seshadri: So the common question that arises is, how will the neurocognitive assessment look when you switch over to Bailey, which is now what's been agreed with the FDA as our primary endpoint for the study. So the data that shows correlation between Bailey and Mullen, which we will be presenting at ICIEM, shows that those scores are correlated at approximately 95%. And therefore, what it implies is that you should almost expect similar results if you use our Bayley.
<unk> Marty happy to clarify if you have any other follow ups on that.
Yes that helps to answer and so it seems like this is going to be.
An update that would likely go right into the filing for this program.
I guess.
Aligned to make sure that the endpoints are aligned.
At this point.
Yes, yes.
Vishwas Seshadri: course instead of Mullen in the current ongoing transfer A study. I hope that answers this question. Maury, happy to clarify if you have any other follow-ups on that. Yeah, that helps the answer, and so it seems like this is going to be an important update that would likely go right into the filing for this program and help, I guess, align, make sure that the endpoints are aligned. Thank you. Yes. Yes. I've got it.
Got it Okay and then I also wanted to ask a question on <unk> 101 for our debt.
You noticed you mentioned that you were opening up the southern side on the East coast.
At school.
Just wanted.
Do you see how recruiting is going there and if you can provide any more perspective into enrollment for this study.
Maurice Thomas Raycroft: Okay. And then I also wanted to ask a question on EB 101 for our Deb. You mentioned that you were opening up the southern side of the East Coast UMass Med School. Just wanted to see how recruiting is going there and if you can provide any more perspective on enrollment for the study.
Sure. Thanks for that question Marty.
As we previously shared we have activated the <unk>.
Mass site now and they are actively.
At June patients. So we can expect patients to be treated there at any given point in time, we're definitely seeing more interest from patients who would not travel to the Stanford site.
Vishwas Seshadri: Sure, thanks for that question, Maury. As we previously shared, we have activated the UMass site now, and they are actively prescreening patients, so we can expect patients to be treated there at any given point in time. We're definitely seeing more interest from patients who would not travel to the Stanford site because it would take them from the East Coast a five-hour journey, and that's something that's prohibitive for many patients from participating. And we would like to stress the fact that we have already shared, which is that we have identified the patients that we need, the last final patients that we need to complete accrual in this vital study.
Was it would take from the East Coast, a five hour journey and that's something that's prohibitive for many patients from participating.
And we would like to stress the fact that we.
<unk>, which is we have identified the patients that we need the last final patients that we need to complete accrual in the vital study.
Importantly, and getting patients treated at Umass, we've done a lot of work transferring the knowledge from Sanford. So that Umass is fully up to speed with all the protocols and procedures because.
The the way of treating EBIT 101 product for the patient has a lot of intricacies and we wanted to make sure that.
Vishwas Seshadri: Most importantly, in getting patients treated at UMass, we have done a lot of work transferring the knowledge from Stanford so that UMass is fully up to speed with all the protocols and procedures because the way of treating EB-101 product for the patients has a lot of intricacies, and we wanted to make sure that nothing is missed in that tech transfer.
Nothing is missing that tech transfer so thats what.
Taken this time, but.
We are very confident that <unk> is an equally competent sites that can be 101, and they are actively screening patients.
Okay. Thanks for taking my questions and I'll hop back in the queue.
Thank you Martin.
Your next question is coming from Ross Silver Arce with H C. Wainwright. Please pose your question.
Vishwas Seshadri: So that's what has taken this time, but we are very confident that UMass is an equally competent site that can apply EB-101, and they are actively screening patients. Great, okay, thanks for taking my questions. I'll have back.
Hi, this is on for Rob Thanks, very much for taking our questions.
Firstly just regarding the enrollment.
<unk> for the Phase III <unk> study for <unk> 101 is there a significant reason you changed guidance on completion of enrollment from the end of this year too.
Maurice Thomas Raycroft: Thank you, Maure. Your next question is coming from Ram Silvaraju with H.C. Wainwright. Please ask your question. Hi, this is Mazanvohram.
Q1 2022.
Thanks for the question around the short answer is no it's not a significant change in the timing.
Ram Silvaraju: Thanks very much for taking our questions. So firstly, just regarding the enrollment for the Phase 3 Vital study for EB-101, is there a significant reason you changed guidance on completion of enrollment from the end of this year to Q1 2022? Thanks for the question, Rahm. The short answer is no, it's not a significant change in the timing, and it has nothing to do with patient availability for the study or patients interested in participating.
And it has nothing to do with patient availability for the study or patient interest in participating we have a lot of patients who are interested it's more a matter of logistics and experimental design as you would think in commercial setting any large chronic wound is absolutely appropriate for treatment of <unk> 101, but in our study.
We have to randomize intra patient wound students have symmetry in the body. So if you have a wound in the upper right arm you want the wound that is a controlled wouldn't be upper left her on which put some artificial constraints on who are the most appropriate patients and thats one factor, which is unique to the clinical trial, you will not see that in the commercial setting. So that's one.
Vishwas Seshadri: We have a lot of patients who are interested. It's more a matter of logistics and experimental design. As you would think, in a commercial setting, any large chronic wound is absolutely appropriate for treatment with EB-101, but in our study, we have to randomize intrapatient wounds to have symmetry in the body. So if you have a wound in the upper right arm, you want a wound that is a controlled wound in the upper left arm, which puts some artificial constraints on who are the most appropriate patients.
Second is we have the patients identified it as a matter of scheduling and it's also a matter of we have an annual routine cgmp shutdown that happened in the last half of December and at that time, we cannot manufacturer and this is something that we do every year. So if you missed it.
And biopsy data by end of November.
And we will start slot goes to.
Mid January so that is.
The primary reason why the spillover to quarter, one 2022, and we're very confident that we're going to be accrued in quarter one.
Vishwas Seshadri: And that's one factor which is unique to the clinical trial; you will not see that in the commercial setting. So that's one. And second, we have the patients identified. It's a matter of scheduling. And it's also a matter of, we have an annual routine CGMP shutdown that happens in the last half of December, and at that time, we cannot manufacture. And this is something that we do every year.
Okay I appreciate the clarification and then regarding the neurological assessment.
Phase one two.
101 study for NPS three b.
Has there been any current Q2.
Vishwas Seshadri: So if you missed a certain biopsy date by the end of November, the next available stock slot goes to mid-January. So that is the primary reason why this spilled over to quarter one, 2022, and we're very confident that we're going to be accrued in quarter one. Okay, appreciate the clarification.
Ongoing pandemic for this.
Assessment.
Thanks for the question Ron.
There is no specific hindrance for MTS.
<unk> neurocognitive assessments due to the pandemic per se.
Which is any different from the MPS III program.
Ram Silvaraju: And then regarding the neurological assessments for the Phase I, A.V.O. 101 study for MPS 3B, has there been any current hindrance due to the ongoing pandemic for this assessment? Thanks for the question, Rahm. There is no specific hindrance for MPS3B neurocognitive assessments due to the pandemic per se, which is any different from the MPS3A program.
As you as we've previously shared for the MPS <unk> program. The timing of when we will have meaningful neurocognitive assessment requires that follow up period.
That's what leads us to based on the seven patients that have been dosed already that meaningful time will be in the second half of 2022, where we would have two year follow up for at least four of five patients. So that's the time it can really make meaningful assessment of the <unk> patients.
Vishwas Seshadri: As you know, as we previously shared for the MPS3B program, the timing of when we will have meaningful neurocognitive assessment requires that follow-up period. And that's what leads us to, based on the seven patients that have been dosed already, that meaningfully, time will be in the second half of 2022, where we would have two-year follow-up for at least four or five patients. So that's the time we can really make meaningful assessments of the MPS3B patients. Okay, and then just finally shifting to your gene therapy pipeline. You know, the MPS3 space is relatively crowded. What do you think differentiates your AAV-based therapies?
Okay.
And then just finally shifting too.
Your gene therapy pipeline and past three space is relatively crowded.
What do you think differentiates your AAV based therapies.
And.
In light of your AAV manufacturing facility do you anticipate.
Vishwas Seshadri: And, you know, in light of your AV manufacturing facility, do you anticipate any kind of clear competitive advantage arising from this? And if you have any plans to monetize your manufacturing facility or leverage it in some way, and thanks for taking our questions. Yeah, thanks for that question, Rahm. I will have to correct you on one point. The MPS3A and MPS3B space is not crowded, and we currently have nothing that works in this disease. There is no standard of care. In fact, there is no treatment at all.
Kind of clear competitive advantage arising from this.
And if you have any plans to monetize your manufacturing facility or leverage some way thanks for taking my questions.
Yes. Thanks for that question, Rob I will have to correct you on one point here.
<unk>.
Space is not crowded we currently have nothing that works in this disease. There is no standard of care. There is no treatment at all and.
Vishwas Seshadri: And our programs are the most advanced, and anything that is still in development is at least five to seven years away. We've only seen preclinical or clinical, preliminary biomarker clinical data, and that too, systemic data, not anything to do with central nervous systems.
Our programs are the most advanced and anything that is still in development is at least five to seven years away, we have only seen preclinical.
Our clinical preliminary biomarker clinical data in that to systemic data not anything to do with central nervous system. So we believe that this is unique there and the second part of your question, which had to do with manufacturing preparedness for we are we've made a strategic choice here, we don't want to be at the Mercy.
Vishwas Seshadri: So we believe that this is unique in that respect. And the second part of your question, which had to do with manufacturing preparedness, we've made a strategic choice here. We don't want to be at the mercy of a CDMO.
Vishwas Seshadri: We want to be a non-CDMO-dependent company, which is why, and even as we wait for our products to get approved, there are patients that are lined up for these therapies, which is why in our latest protocol amendments, we're making provisions for patients for patients to be continued to be treated in transfer A, even though we've gotten the necessary accrual done for an efficacy analysis for registration purposes. So we don't want to lose any time, and these patients are waiting, which is why we've already started work on building out our AV facility.
<unk>, we want to be a non CD ammo dependent company, which is why and even as we wait for our products to get approved there are patients that are lined up for these therapies, which is why in our latest protocol amendments were making provisions for patients to be continue to be treated and transfer a even though we've gotten the necessary.
<unk> done for an efficacy analysis for Registrational purposes. So we don't want to lose any time in these patients are waiting which is why we've already started.
On building out our AAV facility and it also has to do with Min 101 goes.
Vishwas Seshadri: And it also has to do with when EB 101 launches commercially; our current facility will become a single-source, single product facility, which means we cannot any longer manufacture NPS3A and APO 102 products there, which is why we have already started to construct this new facility, and we want to be in time to be able to dose patients in need. All right. Many thanks, Fish. Thank you, Rob.
Launches commercially our current facility will become a.
So our single product facility, which means we cannot any longer manufacture NBA <unk>, one or two product there, which is why we have already started to construct the new facility and we want to be in time to be able to dose patients in need.
Alright, Thanks Mitch.
Single thank.
Thank you Rob.
Yeah.
Operator: The next question is coming from Moni Furuhar with SCB Lyrink. Please pose your question. Thanks, guys.
The next question is coming from Mani <unk> with SVP Leerink. Please pose your question.
Thanks, guys.
Moni Furuhar: I guess a couple questions on how you're thinking about strategic alternatives versus sort of strategies for managing the balance sheet. Obviously, you mentioned some investments you have to make around, you know, the transition from EB2 single source manufacturing to some product manufacturing. Can you give them something exactly where your approximate cash funnel will be as you hit some of the key catalysts that you're talking about in terms of both the EB program and the gene therapy and the AV program?
I guess, a couple of questions on how youre thinking about strategic alternatives versus.
Our strategy of managing the balance sheet.
Obviously, you mentioned some vessel Jeff maker.
Transitions can you be just single source manufacturing for manufacturing.
Can you give us a exactly.
Where youre approximate cash level it will be as you hit some of the key catalysts that youre talking.
Talking about in terms of what the EBIT.
And the gene therapy and AAV program.
Moni Furuhar: And then secondarily, in a separate question, as you think about potentially licensing or partnering some of these assets, should we view the entire AED platform as a single asset? Is it operationally even possible to license these programs and assets out to different recipients? How should we think about the partnerable quantum of your AED programs?
And then secondarily.
And the second question as you think about.
Potentially out licensing or partnering some of these assets.
Should we view the entire AAV platform.
Single asset is it operationally.
<unk> even possible to licenses.
Graham with Africa.
That's it from us at the end.
Should we think about the partner of quantum.
Vishwas Seshadri: Yeah, so first we'll take the first question, Marni, and thank you for that. Ed will be addressing your question that relates to the cash balance and our build-out coming up to the next milestones. Sure. Sure, yes. Yes, I mean, as you know, there was 67 million on the balance sheet at the end of September. So just looking ahead, as we mentioned in my prepared remarks, I think we have enough cash. I'm at my company.
ADP programs.
Yes, So first we will take the first question.
Morning, and thank you for that Ed will be addressed.
<unk> your question that relates to cash balance and our build out coming up to the next milestones.
Sure Yes, yes.
As you May know there is the $67 million on the balance sheet at the end of September. So just looking forward as we've mentioned in my prepared remarks, I think we have enough cash on my comment we have enough cash and financial flexibility access to resource.
Ed Carr: We have enough cash and financial flexibility and access to resources to get to the key milestone next year, which is the phase three vital study readout. That would be a key inflection point for us. But there are also some other key inflection points as we think about that even forward. We have MPS 3A, top line data, hopefully, assuming the magnitude of the effect is still there. For late 2022, early 23, you've got BLA filings, and BLA approval.
Resources to get to the the key milestone next year, which is that which is the phase III vital study readout that would be a key inflection point for us, but there's also some other other key inflection points as we think about that even even if all we have the <unk>.
Topline data hopefully hope assuming the magnitude of effect is still there for late 2000.
'twenty two early 'twenty three you've got.
BLA filings BLA approval, so I think there is.
Ed Carr: So I think there's a really healthy pipeline of inflection points as we look forward. So the one that we are obviously most myopic on is getting to this phase 3 EB vital readout in Q3 of 2022. So that's how I would answer that question. Hopefully that's helpful. Thank you, Ed.
A really healthy pipeline of inflection points as we look forward so that.
One that we are obviously most myopic on is getting to this phase III EV.
Vital readout in Q3 of 2022 so.
That's how I would answer that question hopefully that's helpful.
Thank you Ed.
Vishwas Seshadri: On the second part of your question, Mani, which is the Qanta for OX licensing, it's a little premature to give a definitive answer, but as you see, there is a whole portfolio or a spectrum of different potential partners for out licensing, and their goals can be different. Some will be interested in the platform as a whole; some will be interested in late-stage assets where they have the ability to commercialize in certain geographies.
On the second part of your quest.
Question money, which is the quanta for Outfly sensing.
It is premature to give a definitive answer but as you see there is a whole portfolio or a spectrum of different potential partners for out licensing and their goals.
As can be different.
That would be interested in the platform as a whole some that will be interested in late stage assets, where they have the ability to commercialize in certain geographies, depending on and we've seen all of those different shade of.
Vishwas Seshadri: Depending on, and we've seen all those different shades of, you know, strategic positions of our potential partners, and we're open to all different types of arrangements, and that's all I could say right now. But, you know, our platform applies to multiple therapeutic areas as well. As you know, our preclinical programs are in the ocular space, so there could be players that are specifically interested in ocular programs. And, you know, MPS 3A and 3B are more in the neurological, neuropsychiatric kind of marketplace, and there are specific players that are interested in those types of assets. So we are in a position to develop quanta or packets as in how these conversations proceeded. Great, that's helpful. Thanks, guys. Thank you, Moni.
Strategic positions of our potential partners and we are open to.
All.
All different types of arrangements and Thats, all I could say right now but.
Our platform applies to multiple therapeutic areas as well as you know our preclinical programs that are in the ocular space. So there could be players that are specifically interested in ocular programs and are.
The <unk> are more R&D.
Neurological and neuropsychiatric kind of.
Marketplace and there are specific players that are interested in those types of assets. So we are in a position to.
Develop quanta our packets.
How.
How these conversations and soon.
Okay. That's helpful.
Thanks, guys.
Thank you Mani.
Operator: Your next question is coming from Kristen Klasker with Kendr-Fitz-Garrow. Please pose your question. Hi, good morning everybody.
Your next question is coming from Kristen <unk> with Cantor Fitzgerald. Please pose your question.
Hi, good morning, everybody. Thanks for taking the question. The first one I have is on EV 101 wonder.
Kristen Brianne Kluska: Thanks for taking the questions. The first one I have is on EB-101. I'm wondering if this data, when top-line readout next year, could include any longer-term findings beyond the six-month endpoint since some of these patients were enrolled early on ahead of the pandemic. And then, could you speak to the importance of your durability data from both this trial and then, of course, the phase one-two trial when potentially filing for VLA?
I'm wondering if you think the data top line readout.
Readout next year could include any longer term findings beyond the six month endpoint since some of these patients were enrolled early on ahead of the pandemic.
And then could you speak to the importance of your durability data from this trial and then of course, the phase one two trial when potentially filing for BLA.
Kristen Brianne Kluska: given the FDA stance and focus on the effects across cell and gene therapies and durability. Thank you, Kristen, for the question. First off, it's a very important question that you raise, the durability and the long-term benefits that we offer to patients. The regulatory requirement is a six-month time point.
Given the FDA stance and focus on the effects across cell and gene therapies and durability.
Thank you Kristen for the question.
First first off it's a very important question that you raised the durability and the long term benefits that we offer to patients the regulatory requests.
<unk> is a six month time point, so what you will see in a regulatory package is going to be six months from treatment and what is the level of wound healing and the pain reduction that we see however, the long term follow up data that we have presented from our phase <unk> study, so far tell us that there's a lot more value proposition.
Vishwas Seshadri: So what you will see in a regulatory package is going to be six months from treatment, and what is the level of wound healing and the pain reduction that we see, right? However, the long-term follow-up data that we have presented from our phase one-two study so far tell us that there's a lot more value proposition than the regulatory hurdle. We have seen up to six years of data, and a patient that had 80% of the wounds treated at six years showed 80% of the wounds showing greater than 75% closure, which is very significant, and also the pain reduction sustained that way.
Opposition then the regulatory hurdle, we have seen up to six years of data and a patient that had 80% of the wounds treated at six years, showing 80% of the wounds showing greater than 75% closure, which is very significant and also the pain reduction sustaining that way. So this is going to help us completely build out the value proposition.
Vishwas Seshadri: So this is going to help us completely build out the value proposition and appropriately price our assets and, you know, correlate with the value that we provide to patients. And to your question about whether phase three data will also be similar, there will be some patients that have a longer-term follow-up two, three years out that we will continue to publish and report on as the study continues. What is important to recognize is that in both phase one, two, and phase three, the patients are being followed for a period of 15 years.
And the appropriately pricing our asset.
Commensurate with the.
Value that we provide to patients and to your question about whether phase III data will also have similar so there will be some patients that have longer term follow up two to three years out that we will continue to.
Published reports on as the studies.
It continues what is important to recognize what both the phase one two and the phase III for patients are being followed for a period of 15 years. So this is going to be a continuous data update over time, showing the durability of our therapies. So I hope that gives you a good sense to the.
Vishwas Seshadri: So this is going to be a continuous data update over time showing the durability of our therapies. So I hope that gives you a good sense of the full value proposition of the drug more than just the regulatory endpoint that we're looking at to get the product into the market. Okay, I appreciate that.
The full value proposition of the drug more.
The regulatory endpoint that we're looking at to get the product into the market.
Okay. I appreciate that and then I had a question regarding the potential and exploration of strategic partnerships. So understand that you are late stage pipeline is rare disease focus and that the.
Kristen Brianne Kluska: And then I had a question regarding the potential and exploration of strategic partnerships. So, understand that your late-stage pipeline is focused on rare diseases and that the ophthalmology pipeline will not be disclosed. You have indicated that some of these indications are a little bit larger. I am wondering if we should be thinking or if the company is evaluating things on a geography basis, so perhaps there are certain regions where these diseases are more impacted.
Then Joe pipeline, while not disclosed you have indicated that some of these indications are a little bit larger. So wondering if we should be thinking or if the company is evaluating things on a geography.
<unk> basis, so perhaps are there certain regions, where these diseases are more impacted and then also separately looking at.
Kristen Brianne Kluska: And then also separately, looking at the earlier pipeline, the AIMCAPS library, could you discuss some areas that could be attractive for somebody to evaluate, including perhaps how some of these capsids could address some of the limitations that are currently observed in AAB-based gene therapies? Absolutely. So there are at least two parts to the question, Kristen.
<unk> earlier pipeline. The aim capsid library could you discuss some areas that could be attractive for somebody to evaluate including perhaps how some of these caps. It could address some of the limitations that are currently observed an AAV based gene therapies.
Absolutely.
So there is at least two parts to the question Kristen first let me talk about the strategic.
Vishwas Seshadri: First, let me talk about the strategic partnerships and your question about geographic prevalence of some of the diseases that we are more mature in developing. Our goal is to have these therapies commercialized in every geography. We currently do not, for MPS3A as well as EB, we do not have any variations on a per population basis, with the incidence levels of these diseases being very different in different geographies.
Partnerships on your question about geographic.
Prevalence of some of the diseases that we are.
More mature in development.
We our goal is to have these therapies commercialized.
Hey, geography, we currently don't for <unk> III as well as need be we do not have any variations on a population basis.
The incident levels of these diseases being very different in different geographies. As these are genetic disorders. That's happened in all different parts of the world Our initial focus for.
Vishwas Seshadri: These are genetic disorders that happen in all different parts of the world. Our initial focus for launches, of course, is the U.S. and Europe, but our goals are completely to expand beyond that to other geographies, including Asia-Pacific, and everywhere there's a need. And this is where we are looking at potential strategic partners that have more experience in those more emerging kinds of markets. And there is, I mean, we do know that there is interest in those types of geographic expansions where our data could be very useful. So the short answer is yes, but it's not based on how much prevalence there is in certain geographies.
Launches of course are U S and Europe focused but our goals are completely to expand beyond that to other geographies, including Asia Pacific and everywhere. There is a need and this is where we are looking at potential strategic partners that have more experience in those.
You can kind of market and there is.
I mean, we do know that there are there is interest in those types of jokes geographic expansion, where our data could be very useful. So the answer short answer is yes, but it's not based on how much prevalent there is in certain geographies. It's just based on we're going about this a.
Vishwas Seshadri: It's just based on how we're going about this in a little bit of a sequential way. The second part that you brought up is our Capsid Library and how that could differentiate. Part of the beauty of the aim capsid library is its tropism. So we have knowledge of what types of capsids have a preferential tropism for different types of tissues, and that's something that's going to be very helpful in addressing some of the current challenges because, as you know, immunological responses to AAB-based therapies are a big hindrance to optimizing the therapeutic effect of our drugs.
A little bit of a sequential way.
The second part.
You brought up is our aim capsid library.
And how that could differentiate.
Of the <unk>.
Beauty of the aim capsid library is the tropism, so we have not.
<unk> of what types of captive has a preferential tropism for different types of tissue.
That's something that's going to be very helpful. In addressing some of the current challenges because as you know immunological responses to AAV based therapy is a big hindrance to optimizing.
Therapeutic effects of our drug by engineering capsid that can have tissue tropism your.
Vishwas Seshadri: By engineering capsids that can do these things, you know, we're a big hindrance to optimizing the therapeutic effect of our drugs; we have tissue tropism, you're partly circumventing that, and this is definitely part of the value proposition that we come with our proprietary capsids, number one. The second is, beyond just the AIM capsis, we are also looking at how to circumvent other types of limitations in A For example, the size of the genes that you can package.
Party circumventing that and this is definitely part of the value proposition that we come with our proprietary Castor that's number one.
Second is beyond just the aim capsid. We are also looking at how to circumvent other types of limitations.
<unk> based therapies for example, the size of the genes that you can package you cannot put more than fortunate.
Vishwas Seshadri: You cannot put more than 4 kilobases into an AV capsid, and here is where we're developing other methodologies where you could have recombinations. At ARVO, we presented data on recombination-based techniques where you can have larger genes, for example, A, B, C, A4, delivered to the patients. And this is something that, beyond just the capsid engineering, we're focusing on I hope that gives you some flavor as to where we're likely to be differentiated and advances our knowledge, Kristen. Thank you, Vish. There appear to be no further questions in queue at this time.
<unk>.
An AAV capsid and here's where we are developing other methodologies, where you could have recombination based at ARVO. We presented in data on recombination based techniques, where you can have larger genes for example, <unk> <unk>.
Revert and.
To the patients and this is something that's beyond just the capsid engineering that we're focusing on overcoming some of the limitations of gene therapy as such I hope that gives you some flavor as to where we're likely to be differentiated in.
Advance our knowledge Kristen.
Thank you Vishal.
There appears to be no further questions in queue at this time I'd like to turn the floor back over to Dan for any closing remark.
Vishwas Seshadri: I'd like to turn the floor back over to DISH for any closing remarks. Thank you very much. I have full conviction about the transformative value that Aviona's lead assets can deliver to patients. We're focused on our roadmap and making progress through discipline execution. Our current leadership team is stronger than ever, especially with some important recent additions geared towards BLA readiness.
Thank you very much I.
I have full conviction about the transformative value that <unk> lead assets can deliver to patients.
We're focused on our roadmap and making progress through disciplined execution. Our current leadership team is stronger than ever, especially with some important. Recent addition geared towards BLA readiness I want to thank our shareholders and our stakeholders, who have listened to this call and we'll talk to you on our fourth quarter call. Thank you.
Vishwas Seshadri: I want to thank our shareholders and our stakeholders who have listened to this call, and we will talk to you on the fourth quarter call. Thank you. Thank you, ladies and gentlemen. This does conclude today's conference call. You need to connect your phone lines at this time, and have a wonderful day. Thank you for your participation.
<unk>.
Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.
Okay.