Q1 2022 Abeona Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, thank you for standing by welcome to the a b on our Q1 2022 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 over to the host Gretchen VP of Investor.

Operator: Good morning, ladies and gentlemen. Thank you for standing by.

Greg Gin: Welcome to the Abeona Q1 session. 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 over to the host, Greg Gin, VP of Investor Relations and Corporate Communications. Please go ahead. Thank you, Kelly. Good morning, everyone.

<unk> and corporate Communications. Please go ahead.

Thank you Kelly.

Good morning, everyone I would like to welcome and thank everyone for joining us on our first quarter 2022 conference call.

Greg Gin: I would like to welcome and thank everyone for joining us on our first quarter 2022 conference call. A press release announcing the results is available on our website at www.abeonatherapeutics.com. On the call today with prepared remarks are Vish Seshadri, Chief Executive Officer of Abeona, and Joe Vizzano, Chief Financial Officer. After the prepared remarks, we will host the Q&A session, and we are also joined by Dr. Brian Kevany, Chief Technical Officer and Head of Research.

Press release announcing the results is available on our website at Www Dot Avionic therapeutics Dot com.

On the call today with prepared remarks are ambitious seshadri, Chief Executive Officer may be Ona, and Joe Madonna Chief Financial Officer.

After the prepared remarks, we will host a Q&A session.

And we are also joined by Dr. Brian Kennedy, Chief Technical Officer, and head of research.

Before we start I will review, our safe Harbor statement.

Greg Gin: Before we start, I will review our Safe Harbor Statement. 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 securities laws. Such 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 statement. 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 other periodic reports filed by the company with the Securities and Exchange Commission.

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 Securities laws.

These forward looking statements are based on current expectations and are subject to change and actual results may vary differ.

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 risk factors in the company's annual report on Form 10-K, and other periodic reports filed by the company with the Securities and Exchange Commission.

These documents are available on our website at www Dot <unk> therapeutics Dot com.

With that I will now turn the call over to our CEO Mitch Seshadri fish.

Vishwas Seshadri: These documents are available on our website at www.abeonatherapeutics.com. With that, I will now turn the call over to our CEO, Vish Seshadri. Thank you. Thank you, Greg. Good morning, everybody, and thank you for joining us this morning. It has been only a few short weeks since we last spoke in late March when we announced a new strategic plan in which we reprioritized our portfolio investments to preserve capital and extend our projected cash runway into the second quarter of 2023.

Thank you Greg Good morning, everybody and thank you for joining us this morning.

It's been only a few short weeks since we last spoke in late March when we announced a new strategic plan in which we re prioritize our portfolio investments to preserve capital and extend our projected cash runway into the second quarter of 2023.

Since then we have moved quickly to divest a be owner of the MPS programs in a joint press release with Ultra genetic issued this morning, we reported an exclusive license agreement, where <unk> will assume all further development and commercialization responsibilities for <unk> 102 and in return.

Vishwas Seshadri: Since then, we have moved quickly to divest Abeona of the MPS program. In a joint press release with Ultragenyx issued this morning, we reported an exclusive license agreement where Ultragenyx will assume all further development and commercialization responsibilities for ABO 102, and in return, Abeona will be eligible to receive tiered royalties up to 10% on net sales and commercial milestone payments up to $30 million, following regulatory approval. We believe that Ultragenyx, with its deep expertise in rare genetic diseases, including MPS, is an ideal partner to potentially bring ABO102 to patients who have been waiting too long for a first treatment.

We'll be eligible to receive tiered royalties up to 10% on net sales and commercial milestone payments up to $30 million. Following regulatory approval, we believe that ultra <unk> with its deep expertise in rare genetic diseases, including NPS is an ideal partner to potentially bring in year, one or two patients who have.

Been waiting too long for a first treatment we.

Vishwas Seshadri: We have discontinued development of ABO 101 for MPS 3B, as we had announced in the previous earnings call. Offloading the MPS programs, in addition to seizing the build-out of additional AAV facilities, should significantly reduce our cash burn and allow Abeona to fund operations over the next 12 months.

Have discontinued development of EB 101 for <unk> as we had announced in the previous earnings call Offloading. The MPS programs. In addition to seizing the build out of additional AAV facility should significantly reduce our cash burn and allow <unk> to fund operations over the next 12 months, we have now.

Vishwas Seshadri: We have now focused our finite resources more narrowly on EB-101 Pivotal Phase III Vital Study Readout, which is our most significant near-term clinical milestone. Having completed the approval of VITAL, we expect top-line results from the study in late the third quarter of 2022, which could support filing a biologics license application. Our increased focus on EB-101 is supported by the compelling long-term results from the Phase I-II study in recessive dystrophic EB.

How focused our finite resources more narrowly on <unk> hundred one pivotal phase III <unk> study readout, which is our most significant near term clinical milestone.

<unk> completed the accrual of vital we expect top line results of the study in late third quarter of 2022, which could support filing a biologics license application.

Our increased focus on EB 101 is supported by the compelling long term results from the phase one two study and recessive dystrophic CEB in that study as previously reported EBIT 101 demonstrated instantaneous wound healing and pain reduction and the majority of treated wounds up to <unk>.

Vishwas Seshadri: In that study, as previously reported, EB-101 demonstrated instantaneous wound healing and pain reduction in the majority of treated wounds up to six years after treatment of large chronic wounds in RDEV patients. Later this week, additional long-term follow-up data for up to eight years from the Phase I-II study will be featured during an oral presentation at the Society of Investigative Dermatology, SID, annual meeting. We therefore anticipate similar results from our Phase III vital study.

Six years after treatment of large chronic wounds in <unk> patients later this week additional long term follow up data for up to eight years from the phase. One two study will be featured during an oral presentation at the society of investigative dermatology.

Annual meeting, we therefore anticipate similar results from our phase III <unk> study remember in vital as the phase one two study we treated large chronic wounds that measure greater than 20 centimeters squared of body surface area at baseline. These are the most severe and problematic wounds inflicting intend.

Vishwas Seshadri: Remember, in vital, as in the Phase I and II study, we treated large chronic wounds that measured greater than 20 centimeters squared of body surface area at baseline. These are the most severe and problematic wounds, inflicting intense pain and causing the greatest clinical burden on our patients. Unlike small recurring wounds that can close spontaneously, large chronic wounds rarely close themselves and remain open for more than six months, and in many cases, they remain open for years.

Spain, and causing the greatest clinical burden on our patients.

Like small recurring wounds that can close spontaneously large chronic wounds rarely close themselves remain open for more than six months and in many cases remain open for years and.

Vishwas Seshadri: In VITAL, we treated a total of 43 randomized large chronic wounds in 11 patients, and each of the 43 wounds was paired with an untreated control wound within the same patient. Additionally, 14 non-randomized wounds were also treated with EB-101. So regarding baseline wound characteristics... The mean body surface area of randomized wounds treated with ED101 per patient was 156 cm2, the range being 80 to 200 cm2. If you include the non-randomized wounds, the mean treated body surface area per patient in the study was 207 cm2, the range being 120 to 240 cm2.

And vital we treated a total of 43 randomized large chronic wounds and 11 patients in each of the 43 wounds is paired with an untreated control wound within the same patient and additional 14 non randomized wounds were also treated with VB 101. So.

So regarding baseline wound characteristics.

<unk> body surface area of randomized wounds treated with <unk> 101 per patient was 156 centimeter square the range being 80 to 200 centimeter square. If you include the non randomized wounds. The mean treated body surface area per patient in the study was 270 centimeter square the range being 120.

240 centimeter squared.

These baseline wound characteristics underscore the potentially unique value proposition of our investigational <unk> 101 product in our debt as we await results from vital we are aggressively exploring partnerships for commercialization of VB 101.

Vishwas Seshadri: These baseline wound characteristics underscore the potentially unique value proposition of our investigational ED101 product in RDEV. As we await results from VITAL, we are aggressively exploring partnerships for commercialization of ED101. Also remember, ED101 has a rare pediatric designation, which means we have a potential opportunity for a priority review voucher at approval. Now, turning briefly to our preclinical eye programs at Arvo 2022 annual, In early May, we reported non-human primate data for AAV204, a novel AAV capsid from our AIM capsid library.

Also remember <unk> 101 has a rare pediatric designation, which means we have a potential opportunity for a priority review voucher at approval.

Now turning briefly to our preclinical programs at ARVO 2022 annual meeting in early May we recorded non human primate data for AAV two zero for a novel AAV capsid from our aim capsid library.

Vishwas Seshadri: The results showed AAV204's ability to produce more robust transduction in the macular area of the eye following administration directly into the vitreous of the eye by pararetinal administration, which, unlike subretinal administration, does not create a retinal detachment. We're excited by AAV204's ability to achieve high macular and optic nerve transduction levels in non-human primates with a potentially less invasive and safer administration We are investigating our novel AAV capsid in four undisclosed ophthalmic conditions with estimated U.S. prevalence ranging from 5,000 to 15,000 patients.

The results showed AAV two zero for stability to produce more robust transduction in the macula area of the following.

Following administration directly into the vitreous of like Parenteral administration, which unlike sub retinal administration does not create a retinal detachment.

Excited by AAV two offers the ability to achieve high macular an optic nerve transduction levels in non human primates with potentially less invasive and safer administration route then sub retinal injection.

We are investigating our novel AAV capsid and four undisclosed ophthalmic conditions with estimated U S prevalence ranging from 5000 to 15000 patients looking ahead, we expect animal proof of concept data beginning in mid 2022 that could potentially support a pre.

Joe Vizzano: Looking ahead, we expect animal proof-of-concept data beginning in mid-2022 that could potentially support a pre-IND meeting with the FDA in the second half of 2022. I'll now turn the call over to Joe to review the financial results.

And meeting with the FDA in the second half of 2022.

I'll now turn the call over to Joe to review the financial results.

No.

Thank you very much fish.

Joe Vizzano: Thank you very much, Vish. I would like to remind everyone that the Forum 10Q is available on our website, where you can get additional details on our financial results for the three months ended March 31st, 2022. Starting with the financial resources on our balance sheet, we had cash, cash equivalents, restricted cash, and short-term investments of $37.2 million as of March 31, 2022. Net cash used in operating activities was $13.7 million for the three months ended March 31, 2020, based on the reprioritization of portfolio investments, which includes our strategic focus now on EB-101, and the disposition of the AB-102 and AB-101 programs.

I would like to remind everyone that the Form 10-Q is available on our website, where you can get additional details on our financial results for the three months ended March 31 2022.

Starting with the financial resources on our balance sheet, we had cash cash equivalents restricted cash and short term investments of $37 2 million as of March 31 2022.

Net cash used in operating activities was $13 7 million for three months ended March 31 2022.

Based on the re prioritization of portfolio investments, which includes our strategic focus now on the EV 101 and.

And the disposition of the of the one or two on <unk> 101 programs are estimated runway of current cash resources takes us into the second quarter of 2023.

Joe Vizzano: Our estimated runway of current cash resources takes us into the second quarter of 2020. License and other revenues for the first quarter of 2022 were 0.3 million compared to zero in the first quarter of 2021. The revenues in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the AB-102 and AB-101 development. Turning to research and development activities, we spent $10.5 million for the three months ended March 31st, 2022, compared to 8.3 million in the three months ended March 31st, 2021, our spend on general administrative activities.

License and other revenues for the first quarter of 2022 were <unk> 3 million compared to zero in the first quarter of 2021. The revenue in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the EV 102, and <unk> 101 development programs.

Turning to research and development activities, we spent $10 $5 million for the three months ended March 31, 2022, compared to $8 3 million in the three months ended March 31 2021.

Our spend on general and administrative activities was $4 2 million for Q1 2022 compared to $6 3 million in the same period of 2021.

Joe Vizzano: 4.2 million for Q1 2022 compared to 6.3 million in the same period of 2020. The net loss was $20.8 million for the first quarter of 2022, or a loss of $0.14 per common share as compared to a net loss of $16 million, or a loss of $0.17 per common share in the first quarter of 2022. The net loss in the first quarter of 2022 includes 6.2 million dollars in non-cash impairment charges resulting from the disposition of AB-102 and AB-101 development programs as we focus resources on EB-101 and our preclinical eye gene therapy. The impairment charges have no impact on the company's future cash position or cash flow from operating activities.

Net loss was $20 8 million.

The first quarter of 2022 or a loss of <unk> 14 per common share as compared to a net loss of $16 million or a loss of <unk> 17 per common share in the first quarter of 2021.

The net loss in the first quarter of 2022 includes $6 2 million and noncash impairment charges, resulting from the disposition of <unk> 102, and <unk> 101 development programs as we focus resources on <unk> 101, and our preclinical gene therapy programs.

The impairment charges have no impact on the companys future cash position or cash flow from operating activities.

I'll now briefly touch on our initiatives to regain compliance with NASDAQ listing requirements. We recently requested a second 180 day period from NASDAQ to regain compliance with its minimum closing bid requirement of $1 per share.

Joe Vizzano: I'll now briefly touch on our initiatives to regain compliance with NASDAQ listing requirements. We recently requested a second 180-day period from NASDAQ to regain compliance with its minimum closing bid requirement of $1 per share. If the extension is granted, Abeona would have until November to meet this requirement. As part of our strategy to regain compliance, we have called a special meeting of stockholders for June 14, 2022, for the approval of a proposal to enact a reverse stock split of the outstanding shares of a common stock. Stockholders, as of the record date of May 3rd, 2022, are entitled to attend the online special meeting. View the proxy statement and vote.

The extension is granted ABL would have until November to meet this requirement.

As part of our strategy to regain compliance we have called a special meeting of stockholders for June 14th 2022 for the approval of our proposal to enact a reverse stock split of the outstanding shares of our common stock.

Doc holders as of the record date of May three 2022 are entitled to attend the online special meeting view, the proxy statement and vote.

Joe Vizzano: The link to participate is included in our first quarter results press release issued last week, which is available on the press releases page of our website. Also, earlier this month, we completed a $25 million private placement offering of convertible redeemable preferred stock. The preferred stock permits the holders to vote together with Abeona's common stockholders on a proposal to affect a reverse stock split of the company's common stock at the special meeting.

Linked to participate is included in our first quarter.

Results press release issued last week, which is available on the press releases page of our website.

Also earlier this month, we completed a $25 million private placement offering of convertible redeemable preferred stock.

The preferred stock permits the holders to vote together with AGL and its common stockholders on a proposal to effect a reverse stock split of the company's common stock at the special meeting.

We believe by implementing these initiatives that we will be able to maintain our NASDAQ listing as we look ahead towards the key expected milestones later this year.

Operator: We believe by implementing these initiatives, we'll be able to maintain our NASDAQ listing as we look ahead toward the key expected milestones later this year. With that, I'll turn the call back over to the operator for the Q&A session. Certainly. If you have any questions or comments, the floor is now open for this time. If you have any questions or comments, please press star 1. We ask that while asking your question, you please pick up your handset if you are listening on to provide optimum sound quality.

With that I'll turn the call back over to the operator for the Q&A session.

Certainly.

If you have any questions or comments. The floor is now open for this time, if you have any questions or comments. Please press star one on your phone we asset while posing your question. Please pickup your handset is listing on a speaker phone to provide optimum sound quality. Please hold just one moment, while we poll for questions.

Operator: Please hold just one moment while we poll for questions, and from Maury. Please pose your question. Your line is open. Hi. Good morning.

Your first question is coming from Maury Raycroft of Jefferies. Please pose your question your line is live.

Hi, good morning, Congrats on the update today and thanks for taking my questions.

Maurice Raycroft: Congratulations on the updates today and thanks for taking my questions. And also, thank you for the details from the RDEV phase 3 study. I guess for the 14 non-randomized wounds treated, was it fair to say that those were particularly large wounds? And can you talk more about how the treatment worked for those wounds?

Thank you and also thank you for the details from the Ardeb Phase III study I guess for the 14 non randomized wounds treated is it fair to say that those were particularly large wounds and can you talk more about how the treatment work for those wounds and also talk about your total ardeb data and how that's going.

Vishwas Seshadri: And also talk about your total RDEV data and how that's going to fit into the BLA filing and the argument around the BLA. Thank you, Maury. As always, it's a pleasure talking to you.

To fit into the BLA filing in the argument around the BLA.

Thank you Maury as always pleasure talking to you. Thanks for the question. So your first question was about the 14 non randomized wounds.

Vishwas Seshadri: Thanks for the question. So your first question was about the 14 non-randomized wounds. And the 14 non-randomized wounds, just to be for the avoidance of doubt, will not be part of the primary data set for our efficacy endpoint. The reason they are non-randomized is mostly the inability to find an appropriate control wound.

The 14th non randomized won't just be for avoidance of doubt, we will not be part of the primary datasets for our efficacy endpoints.

The reason theyre non randomized is mostly inability to find an appropriate control wound. So we have the sheets created the.

Vishwas Seshadri: So we have the sheets created so the patient benefits by treatment, and that's pretty much the goal of treatment. We will obviously report the results for those wounds in terms of wound healing and pain scoring and such endpoints. So that's something about the trial.

The patient benefits by treating and Thats pretty much the goal of treatment. We will obviously report the results for those wounds in terms of wound healing and pain, scoring.

Such endpoints so that.

The thing about the trial. So the 43 randomized wounds that I mentioned first those are the primary analysis dataset.

Vishwas Seshadri: So the 43 randomized wounds that I mentioned first, those are the primary analysis datasets. Now, your second question was about how the treatment relates to the BNA filing. Now, as we announced on March 31st, that first quarter, we completed treating the last patient who went into vital. And as you know, it's a six-month data point, so from March through September is our follow-up. Our team is diligently cleaning data in real-time, so there's not a back-end lag after the database locks in order to report the results.

Now your second question was about how the treatment.

To the BLA filings now as we announced.

On March 31st that first quarter, we completed treating the last patient who went into vital and as you know it's a six month data point. So from March through September is our follow up our team is diligently cleaning data real time. So there is not a bakken lag after database lock.

In order to report the results. So we feel fairly confident that by the end of <unk>.

Vishwas Seshadri: So we feel fairly confident that by the end of quarter two, we should have those clinical results. As for BNA filing, our first goal is to get to the clinical results of the study in a very cost-efficient way. So we are certainly stage-gating capital-intensive BLA preparation work after the study reads out, so we're careful with the finite resources that we have today. So in the base case scenario, if we do that, we're going to look at a quarter two.

Quarter, two we should have those clinical results. So regarding BLA filing our first goal is to get to the clinical results of the study.

Very cost efficient way. So we are certainly stage gating capital intensive BLA preparation work. After the study reads out so we are careful with.

The finite resources that we have today so in the base case scenario. If we do that we're going to look at quarter. Two earlier, we had communicated a quarter, one but it'll be a quarter too.

Vishwas Seshadri: Earlier, we had, I think, communicated a quarter one, but it'll be a quarter two filing of the BLA in 2023. Now, that said, there is a scenario, an upside scenario, where we may be able to accelerate that if we have a source of non-dilutive funding, mainly from a partnership for commercialization. And if such partnership happens prior to the study readout itself, then we may be able to trigger some of these BLA preparation activities early on. I hope I have answered your questions, Mauri. If I missed something, please do reiterate.

Filing of the BLA in 2023 now that said there is the scenario an upside scenario, where we may be able to accelerate that if we have a source of non dilutive funding mainly from a partnership for commercialization and if such partnership happens prior to the study readout itself then we may.

To be able to trigger some of these BLA preparation activities early on I hope I answered your questions Marty if I Miss something please do.

Right.

So that was really helpful perspective, and I guess.

Vishwas Seshadri: That was a really helpful perspective, and I guess for the partnership, if you can talk a little bit more about what you're looking for in the partner and where you're at with the process of finding a partner. Yes, as I mentioned, we are aggressively exploring partnerships. There are some discussions and diligence, and we are looking mainly for a partner who will take on all activities that are related to launch readiness.

For the partnership if you can talk a little bit more about what you are looking for with the partner and down where they are at what the process of finding a partner.

Yes, so as I mentioned, we are aggressively exploring partnerships there are some discussions and diligence.

And we are looking mainly for a partner who will take on all activities that are related to launch readiness.

Vishwas Seshadri: And you can consider our role as being a supplier or a transfer of technology. And obviously, when we are sitting at a positive phase 3 study, our expectation for a partnership would be recognition of that result with an up-front payment and potentially royalties at the back end. Got it. Okay, thanks for taking my questions. I'll hop back in the queue. Thank you, Maury. Good morning, this is Rick on behalf of Kristen. Thank you for taking our question. We just have one for you here.

And you can consider our role as being a supplier or transfer of technology and.

Obviously, when we are sitting at a positive phase III study our expectation for a partnership would be recognition of that result.

For an upfront payment and potentially royalties in the backend.

Got it okay. Thanks for taking my questions and I'll hop back in the queue.

Thank you Maury.

Your next question is coming from Kristen <unk> with Cantor Fitzgerald. Please post your question your line is live.

Good morning. This is Rick on for Christian. Thank you for taking our question. We just have one for you here. It's about the ARVO poster could you talk a little bit about the aim platform vector and pair of retinal delivery is there anything you can say about how the aim capsid used it's optimized for a pair of retinal delivery and is your plan to go forward with payer retinal delay.

Rick (on for Kristen Kluska): It's about the Arvo poster. Could you talk a little bit about the AIM platform vector and pararetinal delivery? Is there anything you can say about how the AIM capsid used is optimized for pararetinal delivery? And is your plan to go forward with pararetinal delivery for the other undisclosed ophthalmic indications? Thanks. Thank you for the question, Kristen. I'm going to request Brian Kevany, our Head of Research, to take this one. Yeah, so the AAV204 capsid was originally identified as being a potential candidate for intravitreal administration because of its ability to enter the retina after an intravitreal injection. There was a paper published last year, two years ago, from Dr. Paul Seeming's group at the NIH that demonstrated the ability of capsids to enter the retina after this so-called pararetinal injection.

Every for the other undisclosed ophthalmic indications thanks.

Thank you for the question Kristen I am going to request, Brian Kevin <unk>, our head of research to take this one.

Certainly yes.

So the AAV tool for capsid was originally identified.

Being a potential candidate for interim vitriol administration for its ability to enter the retina after an <unk> injection.

There was a paper published last year or two years ago from Doctor Pulse ceilings group at the NIH with demonstrated the ability of <unk> to enter the retina. After the so called parallel retinal injection.

Brian Kevany: This is a modified intravitreal injection where the virus is layered on top of the retina, beyond the vitreous, but does not cause retinal damage, thus representing a potentially safer and less invasive method for administration. And yes, there are several indications from our undisclosed eye programs where we are intending to try and leverage AB204 by a pararetinal administration to treat those indications. Thanks for taking the follow-up. I just wanted to ask a question about the ultragenic CL2. I'm wondering if there's any up front, and then for manufacturing at commercial scale, is that going to be a tech transfer of AAV9, or how is that going to work?

This is a modified <unk> injection, where the viruses layered on top of the retina beyond the vitreous, but does not cause a retinal detachment.

Thus, representing a potentially safer and less invasive method for administration.

And yes, there are several indications from our undisclosed programs, where we are intending to try and leverage <unk> or buy a pair of retinal administration.

Two.

Used for those indications.

Thank you.

There appear to be no questions in queue at this time.

I'd now like to turn the floor.

<unk> has popped back in the queue. Your line is <unk>. Please post your question.

Thanks, Thanks for taking the follow up.

Just wanted to ask a question about the ultra <unk>.

I'm wondering if if if there is any upfront and then for manufacturing at commercial scale.

Is that going to be a tech transfer of AAV nine or how is that going to work.

Yes, Thank you Martin for that question.

Maurice Raycroft: Yeah, thank you, Maury, for that question. The short answer to your first question, is there any upfront payment, is no. But I want to put context on that answer, which is our goal; our primary goal for Abeona is twofold. One is to have a partner take over all responsibility for further development, as you can appreciate. Clinical development, as well as CMC, are pretty capital-intensive, and we wanted to reduce our operating expenses. So that was our first goal. While still retaining our value from the program in the back end.

The short answer to your first question is there any upfront payment is.

No, but I want to put context for that answer which is our goal. Our primary goal for <unk> is two fold one is.

Vishwas Seshadri: So that's secured through the terms of the agreement that were disclosed. Now, secondly, our goal is for the stakeholders of patients and the community in MPS. We wanted to make sure that a partner is able to most aggressively develop this product and bring it to patients as early as possible. So I hope that gives you some context behind the timing of the deal and the terms. Yes, yeah that's helpful. And maybe just the last one on MPS3B: is it possible that you could end up outlicensing that program at some point as well?

Have a partner take overall responsibility for further development as you can appreciate clinical development as well as CMC are pretty capital intensive and we wanted to reduce our operating expense. So that was our first goal while still retaining our value from the program in the back end so that particular through the terms of the agreement that we have.

Now secondly.

Our goal is towards the stakeholders of patients and the community and MTS you wanted to make sure that our partner is able to.

Most aggressively develop this product and bring it to patients as early as possible. So I hope that gives you some context behind the timing of the deal and the terms.

Yes, yes, that's helpful and maybe just last one on NPS <unk> B is it possible that you could end up our licensing that program at some point as well.

It's very premature to comment on that Marty because only because the follow up for the study is.

Maurice Raycroft: It's very premature to comment on that, Maury, only because the follow-up for the study is very early, and we did not have the resources to have a lot of items in our portfolio, so we had to de-prioritize that. We have returned the license rights for that program to NCH. So if the data looks promising at a later date, hopefully, there are future development prospects for that asset for NPSBB.

Very early.

<unk>.

We did not have the resources to have a lot of.

Items in our portfolio. So we have to be prioritized that we have returned.

License rights for that program over to.

<unk> H. So if the data look promising at a later date.

Hopefully there is future development prospects for that asset for <unk>.

Got it okay. Thanks for taking my questions.

Vishwas Seshadri: Got it. Okay, thanks for taking my questions. Thank you, Maurice. There appear to be no further questions. I would now like to turn the floor back over to Vish. Thank you. We have implemented strategic changes to reduce operating expenses and extend our projected cash runway into the second quarter of 2023. Within that window, we plan to achieve a potentially value-creating milestone. I want to thank our team for their continued dedication in driving our efforts to make an impact on patients.

Thank you Molly.

There appear to be no further questions in queue. At this time I would now like to turn floor back over to Vishal Shah for any closing remarks.

Thank you.

So we have implemented strategic changes to reduce operating expenses and extend our projected cash runway into the second quarter of 2023 within that window, we plan to achieve a potentially value, creating milestone I want to thank our team for their continued dedication and driving our efforts to make an impact for our patients I also wanted to thank our shareholders and other stakeholders.

<unk>, who have listened to this call today and we'll talk to you on our next quarterly call.

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 parts.

Vishwas Seshadri: I also want to thank our shareholders and other stakeholders who have listened to this call today, and we'll talk to you on the next quarterly call. Thank you, ladies and gentlemen. This does conclude today's conference. Thank you. Please connect your phone lines at this time and have a wonderful day.