Q4 2021 Synthetic Biologics Inc Earnings Call

Greetings and welcome to the synthetic biologics fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen only mode.

Question and answer session will follow the formal presentation, if anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn this conference over to your host Mr. Chris Calabrese with life side advisors. Thank you Sir you may begin.

Thank you operator, and good afternoon, everyone welcome to the synthetic biologics 2021 year end Investor Conference call, leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of synthetic biologics Dr. Vince wait your head of corporate and product development of synthetic biologics Dr. Mendell.

Catch Guy out General director of D C and in European operations and Dr. Frank Tafaro. Currently had operations of Vcs are also on the call and will be available to answer questions. During the Q&A session.

Synthetic biologics issued a press release this afternoon, which provided operational highlights included the financial results for the quarter and year ending December 31 2021.

The press release can be found in the investors section of the company website at Www synthetic biologics dotcom together with the annual report on Form 10-K for the year ended December 31, 2021, which was filed today with the Securities Exchange Commission or as you see in.

In addition to the phone line. This call is being streamed live via webcast, which will be archived on the company website for 90 days.

During this call certain forward looking statements regarding synthetic biologics and DCM biosciences.

Our expectations and projections about future events will be made.

Generally the forward looking statements can be identified by terminology such as quote may should expects anticipates intends plans believes estimates and similar expressions. These statements are based upon current beliefs expectations and assumptions and are subject to a number of risks and uncertainty.

Including those set forth in synthetic biologics filings with the SEC many of which are difficult to predict no forward looking statements can be guaranteed and actual results may differ materially from such statements. The information on this call is provided only as of the date of this call and synthetic biologics undertakes no.

<unk> to update any forward looking statements contained on this conference call on account of new information future events or otherwise, except as required by law with that I'd like to turn the call over to Steve Steve.

Thanks, Chris and good afternoon, everyone and thank you for joining our 2021 year end Investor Conference call. We are extremely pleased with the significant advances over the past year that propelled our business forward offer new opportunities to enhance our existing pipeline and positioned us at the forefront of all.

Political virus development for cancer indications with high unmet needs.

I'd like to begin by highlighting the recently completed acquisition of <unk> Biosciences, a privately held clinical stage biotech company focused on developing a new athletic adenovirus R. O V platform.

With the V C N acquisition the newly combined company is developing a portfolio of systemically administered selectively replicating adenovirus therapies designed to break down the tumor stroma, which is a protective barrier that limits the efficacy of many cancer therapeutic agents.

Breaking down the stroma is intended to increase tumor access bio vs chemotherapy and immune oncology products ideally improving their anti tumor effects.

Importantly, the grading in Australia can also expose tumor antigens, turning cold tumors hot and enabling a sustained anti tumor response by the patient's immune system.

I'd like to now provide an overview of our pipeline and walk you through key updates.

Our lead oncology product be Seattle, one is a next generation Ob designed for intravenous into true more and it provides vitro delivery.

No one has been administered to 70 to cancer patients in phase one clinical studies to date with a focus on pancreatic ductal adenocarcinoma also known as <unk> and retinoblastoma.

PCL one was granted orphan drug designation in 2011 by the European Medicines agency for the treatment of P. Deck. It was granted orphan drug designation by the FDA in February of this year for the treatment of retinoblastoma.

If approved orphan drug designation provides critical marking exclusivity and we plan to take full advantage of the development benefits to which we are eligible under the drug orphan drug designation.

We are highly encouraged by the regulatory support and the promising clinical safety and efficacy data generated to date.

Building on this in the second half of 2022 we plan to initiate an international multicenter phase II clinical study of intravenous V. C. N. One in combination with standard of care chemotherapy.

Kevin side have been in depth Paclitaxel is are the two he knows that we plan to use in this clinical trial as first line therapy and newly diagnosed metastatic PD patients.

The study will be led by a doctor and then well have Danville internationally renowned physician scientists and academic and chief of the division of Hematology and medical oncology at Weill Cornell Medicine, New York Presbyterian Hospital as well as a member of the board of directors at Bristol Myers Squibb.

The proposed phase II clinical trial comprises a randomized open label study to be conducted at sites across the U S and Europe .

The study is projected to enroll up to 92 adult patients with first line metastatic P Act for whom established clinical standard of care therapy is chemotherapy.

The proposed study, which has not yet been agreed to by regulators is expected to have two treatment arms in arm one patients will receive standard of care chemotherapy. It harm to patients who receive U C. N O. One administered seven days prior to standard of care chemotherapy.

It is proposed that two doses of you see no one will be administered approximately three months apart.

If this study the design is agreed to by regulatory agencies. We believe there will be one of the first clinical trials to include repeated systemic dosing of an accolade hypolithic virus.

Primary endpoints for the proposed study may include overall survival and safety and Tolerability.

Additional endpoints may include progression free survival progression free survival objective response rate and measures of bio distribution bias for application and immune response.

Since this is anticipated to be a two arm open label study we plan to monitor the studies progress very closely and May conduct an interim analysis is supported by the emerging data.

Now moving to our planned clinical study in advanced Retinoblastoma.

We believe you see no one holds tremendous promise as a novel rescue therapy for patients, who fail standard therapy or as an adjunct to chemotherapy to improve outcomes for these patients.

We're working closely with key opinion leaders and regulatory agencies to finalize the protocol for a phase three pivotal study of intra vitro P. C. N O. One is either an adjunct chemotherapy for a potential rescue therapy in pediatric patients with advanced retinoblastoma.

In addition to the planned company sponsored studies and <unk> and Retinoblastoma Bcl. One will also be evaluated in a number of investigator sponsored studies, including a study at the University of Pennsylvania, combining V. C. L. B C N O one with Mesothelin directed car.

T cell therapy in pancreatic and ovarian cancer patients and separate studies at University of Leeds and universities, Novara evaluating B C. N O. One in patients with brain tumors, we look forward to a number of potentially exciting upcoming milestones from the planned diversity C. N O one clinical programs over the next 12 months to 24.

Yes.

Our next product candidate P. C. N 11 is a modified version of V. C. N O. One that incorporates our proprietary albumin binding domain and the viruses outer shell.

Have you seen an 11 was designed to improve systemic delivery by enabling the virus ducote itself with host serum albumin and prevent it activation by antiviral neutralizing antibodies.

I N D. Enabling studies are being planned and are expected to commence following the completion of ongoing preclinical studies and CMC activities.

In parallel while we drive our Ob programs forward clinical development for Syn for Ensign 'twenty continue to progress.

Washington University continues to screen and enroll patients in our phase <unk> clinical study of Syn for right Vaccinate and alginate it come out of periodic cell transplant or <unk> recipients for the prevention of acute graft versus host disease and bone marrow transplant patients.

The phase <unk> study is designed to assess the feasibility of using <unk> for in this specific patient population. That's a variety of key information requested by the FDA regarding the safety and Tolerability of <unk> four in patients with impaired intestinal barrier function.

Last year, we announced that enrollment and patient dosing had commenced in the first of three sequential antibody of cohorts that will each be administered a different IV beta lactam antibiotic to treat fever following conditional therapy.

In total eight participants in each cohort will receive syn four and four will receive placebo.

To date, we have dosed 15, 10 that are considered available patients in this study.

If enrollment proceeds as planned we may be positioned to announce as many as three interim data readouts. During the next 12 to 18 months with the first one anticipated from this first antibiotic cohort towards the end of the first half of 2022 pandemic conditions permitting.

Okay.

We have also advanced our sin 'twenty intestinal alkaline phosphatase program.

The phase one placebo controlled multiple ascending dose study of Syn <unk> 'twenty in healthy volunteers has completed dosing and follow up in patient samples are undergoing pharmacokinetic and Pharmacodynamic analysis.

We expect to report topline data during the second quarter of 2022.

Results from this study in the previously completed phase one single ascending dose clinical study of Syn <unk> 'twenty will guide the clinical development of <unk> and 'twenty across multiple potential clinical indications that may include radiation neuropathy, celiac disease, non alcoholic fatty liver disease and Nash.

As part of our strategic transformation into an oncology focused company, we are exploring value, creating options around <unk> four in <unk> and 'twenty.

<unk> and 'twenty, both have significant potential opportunity in non oncology related indications.

We are currently evaluating the best path forward for these assets and whether to advance these programs internally or buy out licensing or partnering them.

As we look to the year ahead, the projected progress of our newly combined clinical development pipeline is expected to deliver numerous upcoming milestones that have the potential to drive significant value for shareholders.

Key near term clinical milestones over the next six months include.

The initiation of V C N O one dosing in an investigator sponsored study of brain tumors at the University of Leeds.

The initiation of V C N O one dosing in combination with Mesothelin directed car T cells in the investigator sponsored study of pancreatic and ovarian cancer at the University of Pennsylvania.

A data readout from the first cohort of the <unk> study and allogeneic <unk> T patients and top line data from the multiple ascending dose study of Syn <unk> 'twenty in healthy volunteers.

During the second half of 2022, we expect to initiate key clinical trials, including the phase III study of V. C. N O one in pediatric patients and possibly a phase Iia study of Syn <unk> 'twenty.

Additionally, we anticipate the initiation of a phase <unk> pivotal study, our bcl, one and retinoblastoma either by the end of the year or very early in 2023.

Now I'd like to turn briefly to our financial results for the year ended December 31 2021.

General and administrative expenses increased to $6 $5 million for the year ended December 31, 2021 from $5 million for the year ended December 31, 2020. This increase is primarily comprised of consulting and legal costs related to the V. C N acquisition higher insurance cost audit fees and public racing relations expenses.

Yes.

Research and development expenses increased to $7 $8 million for the year ended December 31, 2021 from $5 $1 million for the year ended December 31 2020.

This increase was primarily the result of increased clinical trial expenses as we continue dosing patients in the phase <unk> clinical trial of Syn <unk>.

Dosing of healthy volunteers, and the sad and Mad Phase one clinical studies for <unk>, and 'twenty and higher indirect program costs for the year ended December 31, 2021, including an increase in manufacturing costs for Syn <unk> 'twenty.

Turning briefly to the balance sheet, we ended 2021 with over $67 million of cash on hand at December 31, 2021, which we believe will provide a significant runway to both support our existing programs as well as help accelerate the development of V. C N clinical pipeline, including B C N O one in.

C N 11 through the end of 2023 during which time, we expect to achieve a number of important milestones as I mentioned earlier.

As previously announced the VC and transaction was structured to preserve our strong balance sheet and enabled the planned advancement of our combined clinical development pipeline.

As previously disclosed we acquired 100% of the outstanding equity of V. C N, which will now operate as a wholly owned subsidiary of synthetic biologics.

The upfront consideration for the acquisition was $4 $7 million in cash plus the assumption of $2 $4 million of D. C N liabilities.

In addition, certain <unk> shareholders received 19, 99% of the total outstanding shares of synthetic biologics common stock as of December 14th 2021.

The balance of the V. C. N purchase price includes up to 70 in a quarter million dollars and future payments contingent upon the achievement of specific phase II and phase III clinical and regulatory approval milestones.

There will be no additional royalties or commercial sales milestones to the sellers.

Assuming we meet these milestones we believe the value created per shareholders will far exceed the payments made to V. C N.

With an advanced clinical pipeline and a strong cash position, we are more excited than ever about the outlook for the newly combined company.

We believe the recent acquisition will be truly transformational and we look forward to providing further updates as we continue to advance our combined technologies and products with that we're happy to take some questions.

At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad a confirmation from will indicate your line is in the question queue. You May Press Star two chair move your question from the queue for participants using speaker equipment.

Be necessary for you to pick up your handset before pressing the star keys, one moment, while we poll for questions.

First question comes from the line of Jim Molloy with Alliance Global Partners. You May proceed with your question.

Hey, guys. Good afternoon, and thank you so much for taking my question.

My questions. One question on V. C. N 11, what's the expectation for timing to wrap up with a preclinical and.

File Andes and start start going into these wounds.

So right now we're in the middle of completing some animal work on that asset and we're also aligning ourselves with the CMO. So that we can.

Produce some additional supply in and validate those runs for future use in human clinical trials. The idea is that sometime hopefully by the middle of 2023 will be positioned as a result of those activities probably in the second half of 2023 to five.

And I M D.

Excellent. Thank you and then on looking at potential partnerships or licensing or selling the sin programs could you speak a little bit about how the market.

How does how the market is looking in and be able to talk give us some color on interested parties for those programs.

Sure. So the reason I'm going back over the last couple of years that we continued to work diligently to advance the <unk> four and the send 20 programs is that in.

In order to attract the right interest at the right value we needed to generate some additional clinical data. So as it relates to write backs amaze, we're still ongoing in that trial, we will have our first cohort reporting out.

In the first half here, we still have two more cohorts to get through so I think you know, it's a little premature to discuss.

How much time, and who may be interested in that program until we we completed and generate the necessary clinical data that will sort of give us a tight package is to have a lit image legitimate discussion around.

The same 20 program, there's really interesting that's the intestinal alkaline phosphatase program.

We have had continued interest around this program over the I would say the last year and a half or so again, you know rather than jumping in to a partnership with somebody on that we needed to generate additional clinical data and complete additional.

Factoring work around that asset.

We've completed both of those phase one studies.

We will have the topline data coming out very very shortly.

The CMC work continues we have been aggressively scaling up production.

We're quite promise it's quite promising.

We've been able to observe already I. All I'll say is there's continued interest from multiple parties on the send 20 asset and as we've said in the past you know when we have something to talk about further about it you know, we'll we'll make sure we communicate that effectively to all of our shareholders.

Last question then.

Does that assume an excellent stewards of shareholder capital.

It ended the year with a good number it does.

I believe your guidance once the cash through 2023 does that include sort of any.

We ended the payouts for the V C N milestones that you could hit and then.

Maybe wrapped up in there.

You have $14 million.

It's a burn in 'twenty one is that the rate we should anticipate you guys staying up with the new Visteon programs is that going to go up or down.

The next couple of years.

So right now we're only prepared to give us give the guidance through 2023 for.

For modeling purposes at this point you could probably divide it in half yes. The guidance through 'twenty three includes the deal payments and the milestones that are scheduled out as we advance the VC and programs.

There's going to be a slight increase in our fixed burn as you guys know historically.

We've been operating cents at around 400000, a month in fixed burn that will that will scale up to probably closer to $6 50 to 700, a month with the addition of the BCN organization, they're a very lean organization as we are there's no there's no duplicity.

Both of our teams will complement each other very very nicely.

And then you can kind of back into what the rest of the burn looks like as it relates to CMC and see our work and you know as we are.

Our contract with these organizations will be in a position at a later date to give some more detailed guidance around each of those.

Those line items.

Understood. Thank you very much for taking my questions.

Our next question comes from the line of Jason Mccarthy with Maxim Group. You May proceed with your question.

Hey, guys, Hey, Stephen Thanks for taking the question can you.

Talk a little bit and a little bit more detail about the.

P that program I think you said it was going to be first line metastatic.

Attic feedback and if so you know what.

What are some general expectations around.

What Jim Decitabine in Nab Paclitaxel.

Survival or PFS.

It should be starting to think about what a benchmark might be their upcoming program.

And the second part to that question is related to the multi dosing par a potential multi dosing part given that there could be some.

Unity on a repeat dose of an uncle lytic virus, which I think is the basis of trying to do the V. C. N 11 program. So a bit of a complicated two part question, but if you can give us some more color that would be helpful. Thank you.

Okay. Thanks, <unk> I'll, let you take that question.

Yeah.

Sure. Thanks, Steve So just to give you a bit more color on how the.

Ah trial, that's going to be a controlled trial with two arms. Okay. So obviously the data that the historical data for overall survival for the <unk>.

Control arm so does your decitabine.

Arm, it's around normally between eight and 11 months, Okay. That's a spec with overall survival has been validated in several of the studies from the Brac approval two right now with different understudy, Jeff I.

Confirm this number so our phase one data.

In the at risk group of patients that we have treated with the same dose that we have.

To conduct a phase two study indicates that these numbers can be larger and we think that the problem.

Probably we can get closer or at least to 15 months or even more in fact in our phase one trial. In this population is close to 20 months. So.

Are quite optimistic about that but obviously the trial has to confirm these data and then that could be a really impressive in terms of a.

Our restaurant bright for essentially are expecting to be in one year overall survival overall restaurant right around let's say, 65% and probably it's the the numbers that we are contemplating for for statistical purposes at least okay.

Coming back to your question about the role of community and I assume youre, referring to neutralizing antibodies against the first administration. That's a very interesting question and you are right in the sense that it has been previously demonstrated that.

Any kind of nutrition.

I've been a wider set of sudden general several oncology viruses in general generates a peak of neutralizing antibodies.

We have a lot of data collected from our phase one program in different trials, where we have monitored closely what's the dynamics of regeneration and degradation of neutralizing antibodies in patients and we have observed that after the first administration with Cfe that normally of course, we can be.

Dean and basic denim based therapy, but normally by let's say.

Well weeks this decreased significantly and decrease to our levels of neutralizing antibodies that we know that we are able to overcome the doses of <unk> one.

Where we inject and that's something.

Something that we have validated in phase one brio, that's why in our scheme that we'd be seeing one the repeat administration of course in a three month period.

That's quite consistent with custody and observe it in all of our obligations of adenovirus 40 cents.

Very popular especially needs for instance, the Kobe boxing.

<unk> for Astrazeneca that its also based upon I've been in wireless and as you probably know, but the law.

A lot of time between the two administration of these vaccine at fleets also in this three month period would you specifically.

The levels of neutralizing antibodies decreased significantly. So we are quite confident because our data previously generated would be seen one by systemic administration confirms that the second dose can be as effective as the person dose is.

Got it thank you and just as a.

Brief follow up to that.

What what is the expected timing for an outcome with regulators on the trial.

And getting things started and about how long do you think it would take to run that trial.

So maybe maybe I'll, let Frank take that piece of the question.

Yeah. So.

If I understand the question correctly. Then this is a standard submission to the FDA, which would cause the protocol, which was then they have 30 days to respond we're not really waiting for an approval just a.

Non response means we can proceed and during that period of time, we'd be.

Launching our initiating the sites and then getting ready to enroll patients.

We need to enroll the patients and I think the latest number was between 12 and 18 months.

And that's for statistical reasons, you have to get the patients into trials fairly quickly. However, as Steve mentioned before this is also open label. So we're gonna be able to start seeing the outcome much earlier than the completion of enrollment.

So we're pretty pretty excited about the the trial design.

And we're going to because of the unique nature of the VC and product, we're actually able to measure the effect of the second dose for example, we can actually take a blood test.

So that that's working so we think we have I'm going to be learning a lot during the trial as well, but we should be able to enroll within.

12 months to 18 months and then they'll correct me on that timing is that is.

Is that the enrollment time, we have set up currently.

Yes, yes, that's it so we are planning to finish enrollment between glass and 16 months okay.

We are quite optimistic on that we are taking a quite separate actually if the strategy just combining European and U S sites.

That allows certain flexibility.

We bought the geographic indications and our balanced approach to different sites.

Barry Barry.

<unk> talked about the size Halliburton.

So we expect to really comply with these timelines.

Great. Thank you for taking the questions guys.

Our next question comes from the line of Leland <unk> with Oppenheimer. You May proceed with your question.

Hi, good afternoon. Thanks, Steve for this update on who are taking my questions.

First question on the T. Rex study I believe you had mentioned you may.

Opt to include an interim analysis.

Wondering when we might hear on that decision to do.

To do so and what what I'm going to use what information may come to inform that decision.

<unk> you want to go ahead.

Yeah.

That is not contained a formal interim analysis because it's an open label study. So we have access to the data.

Okay. So we are expecting to have a significant number of patients for generating significant numbers probably.

Last month.

After the initiation of the trial, where it obviously depends on that.

The survival of the patients.

Actually survival of patients, but taking into account the D.

<unk> that eastern historical data for the standard.

Kara Albert.

We assume that's probably enough.

Two well to 15 months, we are going to have that position with probably we have some data to show yes.

Okay. Thank you and then my next question, which is tough to letting up blastoma.

I'm wondering if you could share the.

So it will be key for that trial, if you have thoughts there or what type of volume will look like and if you'll be able to take any advantage.

In terms of the F D a regulatory mechanisms to expedite approval, perhaps through accelerating approval from that study. Thank you.

Go ahead and Minto.

Yeah.

So we are just.

Finalizing the.

<unk> of this trial and.

It sure that the endpoint of this trial it has to be definitively agreed with the FDA.

Because there has not been any formal trial in retinoblastoma to date, so that's something that we need to do with.

As discussed with FDA and we are planning.

A discussion with them.

Our idea right now is the reduction of BDO seats as the primary endpoint of this trial and maybe the okra survival I saw.

Secondary endpoint, but that's.

That's not definitive yet because that needs to be agreed with the FDA and we are however, quite confident that that's going to be accept that because.

There's no formal approval for annual ranking over spot product and I'd be spine. So we anticipate that we are able to demonstrate a significant reduction in the number of seats in these patients that's going to be considered.

And marketing enabling.

Endpoint.

Great. That's very helpful. Thanks for taking my questions.

Our next question comes from the line of Michael kind of wage with Maxim Group. You May proceed with your question.

Hey, guys. Thanks for taking the questions.

So I'd I like to start to ask a bit about the the program with the music deal on car T. Who's developing Matt is that coming from.

Carl June over at U Penn and if so is it.

Similar in design to the Juno Celgene Bristol car T.

Good to know.

Okay, Yes, you're right. So the program comes from Japan, and it comes from Paul Chung lap and that's in the saddle indirect talks yourselves as you as you probably know the problem from Novartis, just absolutely focusing and methodological okay in search and.

And that's an approvable indication for these product whoever a couch you drew up is working since a long since the last year.

Solid jewel box, okay and that represents additional.

Limitations for the car T therapy, because it's.

It's easy to treat a little we can do more so in mycological it too much because of the accessibility of the cockpit.

It works out it's immediate.

When you are dealing with solid tumor can be ovarian or pancreatic do you need to have the cockpit shelf able to reach that you're more and to penetrate with you more.

And these two limitations are basically the major assets that our product competes because have you seen a wanted to virus that express.

Enzyme Gallo debate and Moreover, we have demonstrated in our phase one program that the product each able to inflate.

When replicating okay. So direct the inflammation of the Dubai ethic of replication. It powering the hauling of car T cells into the solid tumor <unk> expression of yellow device, it's going to help talk to yourself to go into that so that's why that's a.

Our real very impressive synergy between the Bryan College and slot with our product and that's the purpose of the trial.

Yeah. Thank you very much.

I wanted to see if there are any plans for combinations with additional immunotherapies like say checkpoints or therapeutic monoclonal <unk> do to be.

Central to expose tumor antigens in cold tumors.

So I don't know maybe Frank that's best suited for you.

Yes. So that's a good question we are considering other immune therapies as you know many oncologic viruses.

Typically tried to combine with checkpoint inhibitors. In particular are we we would be interested in doing the same and we've started to internally at least discuss what that would look like the difference though between this program and some of the others is.

The initial data on P. DAC that D. C and has already generated has a signal we believe so.

And checkpoint doesn't typically work in that indication. So we think that's going to be kind of an additive.

Ah trial that we could do we wouldn't.

Likely added to the existing trial, because we think we're going to see a signal compared to control, but we could do another trial with something like <unk> for example, or a PD L. One inhibitor and even other immune drugs. The beauty of again I'm good biased here, but.

The interesting thing about D C and Ah Hi, al you're on a days is it actually opens up the tumor to allow other things to get in like drugs like timber elysium have been and chemotherapy. So.

It's almost like a.

Radiation sensitized or something where you're adding something that then allows other drugs to work. So we're seeing that's your question. We're very excited about the opportunity. We know that it can be done in D. C and is already doing a different trials.

With a combination therapy with a checkpoint drug.

Thank you very interesting and then just one last one I'd like ask just strategically on deployment of capital. Obviously, you have a lot of cash in your balance sheet. So how do you view your capital allocation going forward is it more focused on advancing the current programs that you have in the book and maintaining them at nice cash cushion to 'twenty.

Three.

Are you looking more at using it to expand the platform into additional indications and settings for the bcm programs or potential expansion of your oncology pipeline with further M&A opportunities, especially given the current pressure in the biotech market.

Yeah.

Boy, that's a that's a big question there Mike.

So the guidance that we gave in right now is that we have cash on hand to get us through 2023.

The focus right now is to complete what we started on the Sims four and this in 20 programs.

And a majority of the deployment of capital is going to be focused on the V. C N pipelines.

So right now I mean, we've got a lot on our plate, we will work diligently to get the wash U trial over the line we.

We will have the data coming out and send 20 very shortly.

And I would say you know 85% of our focus.

Though this year is going to be getting the pediatric trial up in the last quarter of this year and work diligently to get.

Agreement with the agency on what of Retinoblastoma pivotal trial looks like so we can.

Get that going either by the end of this year or early 'twenty three.

Alright. Thank you very much I really appreciate a lot of interesting stuff going on.

Ladies and gentlemen, we have reached the end of today's question and answer session I would like to turn this call back over to Mr. Steven Shallcross for closing remarks.

Thank you Laura and thank you everybody for taking the time to join US today on our call.

Extremely excited about the continued growth of our company and I Hope you share enthusiasm around the outlook for the business, including the prospects following the V C N transaction.

We look forward to executing as we stated earlier in a number of key objectives that we believe will drive significant value for our shareholders in the months and years ahead.

Like to thank our shareholders for their ongoing support and we look forward to providing additional updates on our progress before we conclude today's call I'd also like to thank our entire combined sin in D. C N team and to the many people who have been supportive along the way, including our patients.

Ah patient volunteers and their families. Thank you again and have a great week.

This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and enjoy the rest of your day.

Hum.

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