Q3 2021 Omeros Corp Earnings Call

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Call is scheduled to begin momentarily until that time your lines will once again be placed on music hold it. Thank you for your patience and please do not disconnect.

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Okay.

Good afternoon, and welcome to todays earnings call <unk> Corporation at this time all participants are in a listen only mode. After the company's remarks, we will conduct a question and answer session.

Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website for one week from today.

Turn the call over to Jennifer Williams Investor Relations for <unk>.

Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward. Looking these statements are based on management's beliefs and expectations as of today only and are subject to change.

Forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward looking statements and the risk factors section in the company's quarterly report on Form 10-Q, which was filed today with the SEC and the risk factors section of the company's 2020 annual report on Form 10-K for a discussion of the.

Risks and uncertainties.

Now I would like to turn the call over to Dr. Greg Demopoulos, Omeara, Chairman and CEO.

Thank you Jennifer and good afternoon, everyone.

We appreciate you joining us for today's call will start with a corporate update and then provide an overview of our third quarter financial results.

With me today are Mike Jacobsen, Nordea dock, Cathy Melfi, and Steve Whittaker, our respective heads of finance commercial regulatory and clinical.

We will begin today with our supplement of our fully human monoclonal antibody targeting <unk> two.

Masked two is the effector enzyme of the lectin pathway of complement.

On October 18, we announced the receipt from FDA of a complete response letter or CRM.

Regarding our biologics license application or BLA.

For the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.

We will have a type a meeting with FDA to help determine the most expeditious route to approval.

Our briefing package for the type a meeting with FDA is nearly complete and once we have received all externally generated components.

We will submit the package together with a meeting request to FDA.

Because this is a type a meeting the meeting request can only be submitted in conjunction with the completed briefing package and no changes can be made to those materials.

The briefing package will address Fda's concerns noted in the CRO.

It will include a detailed history of communications with FDA.

Each has been reviewed and confirmed by outside regulatory legal counsel.

Once the briefing package is assembled and submitted with the meeting request FDA regulation requires that the type a meeting be scheduled within 30 days.

FDA has indicated that they are ready to work with us to identify the most expeditious and least onerous path to approval for in our supplement in Ta TMA.

In our conference call on October 18, we discussed that in the CRO FDA expressed difficulty interpreting <unk> treatment effect given.

Given the complexity and severity of both the disease and the patient population.

Indicating that additional information would be necessary to support approval.

There were no safety or CMS CMC issues.

Identified.

So there is no bleed over to other indications.

<unk> is not in our supplement issue.

Rather the issues are restricted to Ta TMA.

And FDA has said that they are resolvable.

We hope to have more answers after the type a meeting about whether additional information will be needed and if so.

What exactly that might entail.

Our goal is to bring a drug that met its prespecified efficacy endpoint with a favorable safety profile to patients with Ta TMA.

Too often lethal ultra orphan indication with no approved treatment.

We worked very closely with FDA throughout the clinical development process, including agreement that approval it could be based on a single arm <unk>.

Open label trial, using a primary efficacy endpoint developed in conjunction with.

And agreed by FDA.

To be clear, we believe that our agreements with FDA are unambiguous and that's in our supplemental BLA is already submitted is sufficient for approval.

Having followed the fda's directions recommendations and guidance throughout the program.

And having met the primary endpoint.

With all results from secondary endpoints supporting that achievement.

It is unclear to us.

Why FDA review division seemingly changed its position.

For that reason, we look forward to working collaboratively with FDA to resolve any remaining issues that are also.

Prepared.

To pursue all avenues for resolution.

Again, we are confident in the strength of our data.

Which had been presented by leaders in stem cell transplantation across a variety of scientific.

Medical venues internationally.

And that international expert support continues in.

In addition to two manuscripts pending publication the first detailing the findings from the pivotal trial in the second.

<unk> the role of the lectin pathway and masks to in Ta TMA.

Three oral presentations and one poster presentation related to <unk> and <unk> two inhibition in Ta TMA have been accepted for the 2021 International complement workshop in December.

<unk> is also being evaluated in three other indications.

<unk>, our Iga nephropathy, atypical hemolytic uremic syndrome, or <unk> and COVID-19.

Our phase III Artemis <unk> trial is enrolling internationally.

We are also advancing to activate sites in China.

Given the size of the population and the prevalence of Iga nephropathy in China, we've identified a large number of investigational sites in that country and we expect that those will help us accelerate significantly the pace of enrollment in the trial.

Regulatory submissions have been made and we are working with authorities and our contract research organization to finalize those clearances and begin recruitment.

Here again, we see international thought leaders support for in our supplemental.

Last month, a manuscript for which the senior author is Dr. Mohammad Dahan Professor Emeritus of Leiden University in the Netherlands.

Was published in the journal of clinical Medicine.

The publication examine the role of the lectin pathway, and specifically matched to an <unk> inhibitor and our <unk> and Iga nephropathy.

Last week at the annual meeting of the American Society of Nephrology or ASN.

<unk> and Iga related disease was the subject of two presentations.

The first presented by Dr. Richard Lafayette Professor of Medicine, and Nephrology at Stanford University detailed results of nearly three years of follow up on the in our supplemental phase two Iga nephropathy patients.

During that time period patients received a median of 112 week course of <unk> annually.

With 58% of patients receiving only one course per year or less.

Overall patients renal function as assessed by estimated glomerular filtration rate or egfr improved or stabilized versus a control group matched for proteinuria and Egfr.

Using the same amount of political approach adopted by other companies to determine the impact of proteinuria reduction.

On long term risk of need for dialysis.

Proteinuria reduction seen in the phase two in our supplemental treated patients.

And unprecedented reduction of 64%.

As predicted to delay progression to renal dialysis by more than 41 years compared to standard of care.

This represents a substantially greater reduction in proteinuria, and a substantially longer projected delay to need for dialysis or end stage renal disease.

Than has been reported by any other drug in development for the treatment of renal disease.

The second presentation at ASN summarize the work conducted by a consortium from Denmark, and the UK led by Dr. Peter Garrett Chair and professor of clinical molecular medicine at the University of Copenhagen.

This was the first report disc.

Describing the effects of lectin pathway inhibition by in our supplemental on urinary complement levels in kidney disease.

The study assessed complement levels in urinary samples collected during the clinical course of a rapidly deteriorating young woman with Iga vasculitis.

Theyre thoughtful map treatment was associated with substantial reduction in markers of local complement activation and with stabilization of kidney function as measured by Egfr.

Further studies are ongoing to evaluate the use of urine as a noninvasive and readily accessible resource to monitor responses to our supplemental treatment.

Our other phase III and our supplement program is in patients with AAV <unk> phase III trial remains open although we have prioritized resources to other programs.

In our supplemental also continues to be evaluated as part of the nationwide <unk> by COVID-19 trial, a platform trial in severe COVID-19 patients.

The I spy trial is sponsored by a quantum leap healthcare collaborative.

And is funded in part by BARDA.

<unk> is the only complement inhibitors selected for inclusion in the trial.

<unk> has no involvement in running the trial other than providing drug and we look forward to seeing the results.

In the meantime.

Field, leading work in COVID-19 has continued at our laboratories and the University of Cambridge.

Two manuscripts are being prepared for publication.

The first is directed to a profile of disease specific complement marker abnormalities were identified by our team studying of hospitalized COVID-19 patients in the two major hospitals affiliated with the University of Cambridge, and a large number of Sera from the Uk's National Covid response biobank.

The data demonstrate that very early and severe COVID-19, lectin pathway activation is exceedingly high.

This lectin pathway hyper activation causes consumption of the complement components shared between the lectern and classical pathways impairing classical pathway function.

The classical pathway plays a central role in antibody production and the adaptive immune response.

In our supplement has now been shown to restore this classical pathway function in COVID-19 patients.

Specifically evaluation of blood samples from the Bergamo trial show that lectin pathway inhibition through our supplement can restore the loss of classical pathway functional activity caused by hyper activation of the lectin pathway.

<unk> is developing a broad intellectual property position directed to the profile of complement biomarkers and their associated assets as an early indicator of severe COVID-19, and as a means to assess therapeutic response.

This could also prove to be relevant and post acute sequela of Sars Covid two.

Or long haul disease, and we are exploring this as well.

The second manuscript builds on the first.

As just discussed lectin pathway activation is extremely high very early and severe COVID-19.

As a result, the classical complement activation pathway, which critically supports the infection fighting adaptive immune response.

As severely impaired and its ability to fend off opportunistic infections.

This could well explain why a substantial incidents of life threatening secondary infections occurs and severe COVID-19.

Again, our supplement blocks the uncontrolled consumption of the complement components shared between the lectin and classical pathways, allowing the recovery of classical pathway functional activity and restoring its ability to prevent an fi secondary infections and severe COVID-19.

Patients.

This clearly suggests an important additional benefit of <unk>, and reducing morbidity and mortality and severe COVID-19.

Also it should further clarify that in our supplemental unlike other complement inhibitors in immuno modulators likely does not increase the infection risk and COVID-19 patients, but rather protect against infection by maintaining the complement dependent anti microbial defense of the adaptive.

Immune response.

We look forward to publishing these two important manuscripts.

Let's look now at our third quarter financial results.

Net revenue from sales of Omidria in the third quarter were $30 million up four 1% from the prior quarter's revenue of $28 8 million.

Our net loss for the third quarter was $22 7 million or <unk> 36 per share of which $6 4 million or <unk> 10 per share were noncash expenses.

As of September 30, we had $54 $4 million in cash cash equivalents and short term investments.

We are tightly managing our expenditures as we work to resolve than our supplemental BLA matter.

Given that we have not yet hired in our <unk> field sales force the delay in our supplement approval is either cash flow neutral or slightly positive.

We are temporarily deferring some of our research and development costs as we focus primarily on our complement programs and.

In addition, we have an unused line of credit with borrowing availability up to $50 million based on our accounts receivable.

And an additional $150 million available through an at the market facility.

During the fourth quarter Omidria revenues have continued to grow.

With weekly sales achieving repeated all time highs in the ambulatory surgery centers or afcs.

Our ASC customers continue to express increasing confidence and CMS is durable separate payment for omidria.

And it's outpatient prospective payment system final rule for 2022 issued last week CMS reconfirmed separate payment for Omidria in the ASC setting.

It was gratifying to see the strong public support for Omidria separate payment in both <unk> and hospitals from physicians as well as from National and State Hospital associations and <unk> professional societies.

These include the American Hospital Association, the Ohio Hospital Association, The California Hospital Association Americas essential hospitals.

The American Academy of Ophthalmology, The American Society of cataract and refractive surgery, the outpatient filmic surgery Society of American Society of retina specialists and the society for excellence in Eyecare.

From a legislative standpoint, we continue to see momentum gathering behind the non opioids prevent addiction in the nation or the no pain Act.

If passed the bill would provide separate payment for non opioid pain management drugs like Omidria.

Not only in <unk>, but also in hospital outpatient departments for a renewable period of five years.

Introduced in the spring of this year in both Chambers of Congress. The no Pain Act now has 34 Senators and 74 Representatives co sponsoring the bill.

As previously reported the growing roster of co sponsors is truly bipartisan with effectively equal support from Democrats and Republicans in both the house and Senate.

And includes leadership and key members on the committees of jurisdiction.

In both chambers.

The Bill is also well supported by a long list of major medical societies, and public health organizations, and we look forward to its passage in the current Congress.

It is important to note that Omidria has been shown in peer reviewed publications to significantly reduce the use of opioids. In addition to the two publications already detailing the benefits of Omidria and reducing opioid use two recent manuscripts further supporting those omidria.

Benefits were recently accepted for publication in the journal of Cataract and refractive surgery the.

First demonstrates that the administration of Omidria during cataract surgery significantly reduced use of intraoperative fentanyl, while concurrently decreasing pain scores versus an active comparator.

This publication, which is currently available online at Jay Crs further confirms the result of an earlier study published in clinical ophthalmology.

The second manuscript discusses the evolution of pain management, and they use and the associated risks of opioids and cataract surgery.

The manuscript, which should be available online at Jay Crs any day now.

Underscores the benefits of Omidria and limiting the risks of opioid use in cataract surgery patients.

With that.

Not a dock our chief commercial officer to provide an update on commercial activities for both our supplemental.

Omidria navios. Thank.

Thank you Greg our imagery business continued to see solid growth in the third quarter with revenue growing at four 1% driven once again by the ambulatory surgical center segment.

ESG segment has fully recovered following the decision last December by CMS to restore separate reimbursement for Omidria in the ASC.

Fact in the third quarter this important and largest segment of our business surpassed Q3, 2020, ASC sales performance just prior to leaving reimbursement by 7%.

Our efforts with establishing partnerships with ASC chains and group today is six owned and operated by private equity groups continues to drive momentum.

This growing segment now represents nearly 20% of our overall business.

The fourth quarter is already off to a strong start as I shared on the last call. We've been working on a brand new Omidria promotional campaign that is launching this week at the annual American Academy of Ophthalmology Conference in New Orleans.

Our sales force already has the new promotional material in their hands featuring a surge in performing a successful cataract procedure on the stage of intermediary of Io cap.

They will be using the new material in our booth at the <unk> conference during which we'll be engaging the healthcare practitioners to one to one discussions.

This compelling campaign with tested in both qualitative and quantitative research among 124, <unk> surgeons, some of whom were not familiar with omidria.

It consistently stood out as being memorable unique and clearly demonstrating that omidria helps pave the way for surgical success without detracting from the surgeons crucial role in the process to.

The focus of the new messaging will be on what surgeons in our research cited as most important to their procedure decision specifically omidria has effect on the reduction of both intra operative and post operative cataract surgery complications, including a reduction in inter operative floppy Iris syndrome postoperative steroids.

<unk> Demma breakthrough Iritis postoperative pain, and a reduction in the use of pupil expanding devices all of which have been demonstrated in published studies.

The campaign is also debuting online this month as we create a greater digital presence for our brand along with optimized search engine tools.

Turning to <unk>, our field team is continuing its focus on account profiling in top transplant institutions, creating center specific plans to ensure rapid access to <unk> post approval in.

In addition, we launched our disease education Speaker program last month.

Next month as planned our team will have a significant presence at the American society of hematology.

It is 906 dosing.

Once monthly subcutaneous and where intravenous dosing may be preferable.

Every other month Ivy dosing.

We've decided to forego the multiple a sending those portion of our phase one work in healthy subjects in favor of moving directly into patients with paroxysmal nocturnal hematuria or Pn H, who have an unsatisfactory response to the <unk> inhibitor Raviolis map.

This shift should meaningfully accelerate the development timeline for our nine O six program and peonage.

Our masks to lifecycle management programs beyond nurse Harper Mab are also advancing well.

10, 29 are second generation and long acting mass two antibody is on schedule to enter the clinic next summer.

We expect that Omm's 10, 29 will be dose subcutaneously at a frequency no greater than once monthly.

Similar to that four O nine O six are clinical plan for all of them is 10 29 is to combine our phase one and phase two clinical trials here also significantly shortening our development timeline.

In addition to <unk> 10, 29 for subcutaneous delivery or.

Our small molecule mass to inhibitors continue to progress.

Designed for once daily oral administration, we look forward to moving a lead candidate into the clinic.

Work also continues on <unk> five to seven or phosphodiesterase seven <unk> seven inhibitor for the treatment of addiction.

Clinical evidence clinical efforts, though are paused given a resource constraints, while we explore options for external funding sources for this program.

Finally, let's turn to our immuno oncology portfolio, while we continue to develop <unk> 174 inhibitors in to characterize the role that <unk> 174 plays and suppressing antitumor immune responses.

We are also initiated programs that address current shortcomings and both adoptive T cell therapies and pharmaceutical based immunotherapies.

Our novel cell therapy platform has the potential to markedly improved response rates for patients receiving T cell therapy for either liquid or solid tumors.

We expect both carty and adoptive tumor infiltrating T cell therapies to benefit from this new technology.

Importantly, we have validated this approach and an aggressive mouse tumor model and will continue to explore its potential and conventional and humanized mouse models of cancer immunotherapy.

In addition, our novel Therapeutics appeared to enhance endogenous anti tumor immune responses and overcome immunosuppressive features of the tumor micro environment and.

Around all of these programs, we continue to develop broad and exclusive intellectual property positions.

We will continue to release updates as these programs advance.

Through 2022.

With that I'll turn the call over to Mike Jacobson, Our Chief Accounting officer for an overview of our third quarter financial results.

Thank you Greg.

As we noted earlier.

And total revenues for the third quarter, one where sales are historically slower than other quarters, where $30 million, an increase of 1.2 million or 4.1% over the second quarter.

Our net loss for the quarter was $22.7 million or 36 cents per share.

This includes non-cash expenses of $6.4 million or 10 cents per share.

As of September 30th we.

We had $54 million of cash cash equivalents in short term investments.

Available for general operations.

We also have a 50 million dollar accounts receivable baseline of credit, which allows us to borrow up to 85% of our available accounts receivable borrowing base after certain reserves.

As you May recall, we also have an end at the market sales agreement that allows us to sell from time to time up to $150 million of our common stuff.

As usual partnering opportunities are also present.

During the third quarter and especially in September as we come out of the slower summer months, we have seen a steady increase in omidria sales too asc's.

Growth has continued into the fourth quarter as weekly units sold to Asc's have repeatedly said all times all time highs.

Hospital sales have remained consistent with the second quarter.

And are actually higher than expected.

This is particularly satisfying as we do not currently have separate Medicare payment in the hospital setting.

As Greg mentioned, we are pursuing a variety of options, including the no pain at.

To regain Medicare reimbursement in the hospital setting.

Costs and expenses for the third quarter were 48 $3 million a decrease of four $6 million from the second quarter of this year.

The decrease was primarily the result of reduced research and development costs due to the timing and certain preclinical research activities.

As Greg mentioned during our October conference call. We have been gaining are nice supplements sales and marketing expenses until we received the definitive answer on FDA approval.

As I stated previously we are expensing, our staff and our supplement manufacturing costs and time until the timing of a poodle and the U S is certain.

Interest expense for the third quarter was $4.9 million and consistent with the previous quarter.

Last week seem CMS issues, it's final O P. P. S rule for 2022, which reconfirmed payment for Omidria in the AFC setting.

With the reimbursement concern currently off the table for AFC customers, we expect a <unk> omidria revenues will continue to increase as ASC customers ramp up their use of Omidria and our customer base continues to grow.

We expect to overall research and development costs will remain effectively unchanged in the fourth quarter of 2021 compared to the third quarter of.

Of 2021.

We also expect that are selling general and administrative expenses during the fourth quarter of 2021 will be similar to those in the previous quarter.

Interest expense for the fourth quarter should be consistent with the third quarter.

Four $9 million.

With that.

I'll turn the call back over to Greg, Greg Vice Mike.

Brighter.

You can open the call. Please two questions.

Yes, ladies and gentlemen at this time, if you'd like to ask a question. Please press star and the number one on your telephone keypad.

First question comes from the line of calling first how limp eds.

Hey, good afternoon, and thanks for taking my question.

I appreciate it.

To comment on.

The CRM, but.

Bigger picture on the path forward.

And require a new controlled trial is this something that you would be willing to fund.

Or would you ultimately.

Better all rely on the capsule and other programs.

And then just on the IGN fate.

Could you give us an update on enrollment and the subsequent timing of the weed out that thanks.

Sure My answer to your first question call and I don't think we expect that that's going to be the result.

So.

Hold on that question on that again, I don't think that's something that.

Certainly that we're expecting.

I think.

With respect to the Ijn phase three reader.

I think.

We've been targeting end of 2022.

That is going to depend on resources with respect to these other programs specifically, obviously, the BLA, which is our primary focus.

Could that slip into into the following year I would things, possibly if it did I don't think it's going to move to.

To move much into it.

Great. Thank you.

Your next question comes from the line of Greg Harrison with Bank of America.

Hey, good afternoon, thanks for taking a question.

On the <unk> 906 program.

How fast can this move given that you're expedite in the.

The clinical program and and when can we see potentially derisking data and Pn H and then where do you see PSNH within the context of diseases that could potentially benefit from mask three and ambition.

Yeah, I think our current plan is to initiate.

The.

The piano edge program.

In early in 2022.

And again this would be a phase one b program.

So I think that we can move realm.

Relatively quickly through that.

I think with respect Greg to your question around where do we see <unk> fitting within the overall.

Sort of the overall pantheon of of indications for nine O six.

I think it is an initial four.

To demonstrate the.

The effect of nine O six and potentially the benefits.

The the advantages probably a better word of nine O six other over other.

Alternative pathway inhibitors with respect to dosing and we'll look and see what other advantages are there.

We see the breath of indications for Omesh nine O six as quiet as quite large.

There are indications that are focused obviously on an ultra orphan orphan indications.

That have life threatening implications there are other broader.

Indications.

That.

That don't have that same life threatening.

Component, but certainly have life altering.

Components to them and and those are also areas of focus so we say it is the initial foray.

And.

The objective would be to move from there more broadly.

Great. That's helpful. Thank you.

Thanks, Greg.

Your next question comes from the line at Steve by exactly.

P.

Yes, hi, Greg Thanks for taking the questions. Greg I know that you can't speak about what's taking place with FTA, but you've had significant support from the clinicians the clinical community and the Kols what are they doing right now what are they expressing to you and can you just remind us of what.

How how this plays into the standard course of therapy right now for the patients that are supplement would be appropriate for please thank you.

Sure Thanks to.

Look I think that the the response from the <unk>.

Leaders.

He was one of surprise.

Inc.

Clearly one of disappointment.

They remain strongly supportive.

Of the drug and what I think we all see.

As the benefits of the drug for for patients.

With with.

With T Atma.

I think that is underscored by.

A number of requests we continue to receive.

For compassionate use.

Not just for adults.

Four four children and some of those being for really very young children.

On the order of.

Several months or a year old who have failed other therapies and those therapies include actualism out.

And then the request for.

Use of supplement outcomes and.

We provided.

So.

I think the the.

Support remains strong we continue to work with.

With the thought leaders in this field and I think we are all.

Hopeful.

That we can get in our software mab over the finish line.

As quickly as possible there is no approved treatment for these patients.

And certainly in the in the adult population.

There really is it appears no good.

No good even off label alternative.

So there is an obvious urgency here and I think we're all feeling it I think the thought leaders are sharing that feeling and I think collectively with FDA, we need to figure out how to get there as quickly as possible, let me stop and see if.

Steven Whittaker.

Clinical has any other comments.

Well Gregg I think I would just think of what you said.

The thought leaders are disappointed who spoken with not just thought leaders split other physicians, who have used the drug investigators in trials or people who've used it under compassionate use and as you said compassion is request continue to come.

Is not a dangerous at all.

Thanks to.

Your next question comes from the line in France.

Wainwright.

Hello can you hear me.

I can't or how are Ya.

Pretty good thanks, very much for taking our questions. Firstly I was wondering if you could clarify kind of some of the potential scenarios for the path forward.

With nurse off the map and Ta TMA so.

If your upcoming interactions with the agency prove favourable.

Is there a situation in which this might not be treated like a class to resubmit shouldn't or should we be looking at that is kind of the default pathway.

Good good question look our hope is that when we meet with FDA and.

And have discussions and present.

Our analysis and other.

And other information that this could.

That this could.

Well result in a class one raise submission can we promised that absolutely not.

But that's certainly the objective and I think that is that is our focus so you've kind of put your finger directly on it that is our focus.

And again.

We believe in the strength of the data we believe in the interpret to ability of the data.

And I think that the five theaters concur.

So somehow we need to we need to navigate this and and get the drug approved as quickly as we can.

So that it is available for physicians and for their for their patience I mean, I know that that sounds like a very trite thing to say in a commonly used phrase, but I mean in this case, it's really true.

It's true which is why we continue to get the request for compassion of years. So.

So I think that underscores that.

So I don't know if that answered your question Rama, but if not let me know.

No that that's helpful.

Secondly, this is kind of a three part question I apologize but.

The three parts are as follows.

Firstly, if we look at specifically non stop them app in the context of necrology.

What other primary protein norick kidney diseases, you anticipate are likely to be promising avenues for future development, given what you're currently cream.

In for example, the IGN context, secondly, with the.

Development of nine O six.

Can you give us a sense of what the likely size up the total target.

Population might be in the context of for example, positioning that's drug post Raviolis Matthew.

Add in particular do you think that there is any potential for applicability or development of nine O six.

Nora Myelitis optical spectrum disorder, and lastly, can you just give us a little bit more information on how both not software mab at nine O six are going to be position relative to 10 29, the long acting.

Agent that you mentioned earlier, because I just wanted to try to get a sense of strategically how you are planning to position.

These pieces on the chess board. Thanks.

Sure I'll just note that that was four questions not three around but.

Your first question on on the extent of nephrology indications those are broad.

And.

And the data coming out.

Not just from us, but from multiple independent research groups show that.

The electron pathway is not just involved in Iga nephropathy.

So not just involved ethical I'm maryelle level, but also at the tube yellow interstitial level.

What's the implication of that while the implication of that is is quite large.

If if all of that is correct and it certainly appears that.

It is correct what that means is that.

The application here.

Is really.

And this is going to sound broad, but really any renal disease where protein area.

Is.

As a component.

So when you think about.

End stage renal disease or renal diseases that advance to end stage renal disease. The common pathway. There is two below interstitial disease.

And if <unk> is affecting that which it there is evidence that it is that moves from Dylan Mary alert diseases like IGN nephropathy, two two broader.

To broader indications.

So specifically.

Things like.

Lupus nephritis and and others. So if you think about renal disease in general.

That's that's a possibility.

Your second question about.

Nine O six.

And this pain.

Patient population versus treatment post.

Yeah, I think you were asking not about the patient population, but the size of the market.

<unk>.

<unk> with Raviolis, a map remember that she five inhibitors and pier on edge.

Create.

They treat the intervascular homolysis, but they create extravascular hemolysis through.

<unk> b deposition on the surfaces of those red cells are erythrocytes, which are then cleared by the reticuloendothelial system.

What we see and again, we haven't been in <unk> patients. So all of this is ex vivo or in vitro work that we've done what we have seen is that.

Is that inhibition.

Of mass three.

Blocks, both the Intravascular.

And the.

The extravascular hemolysis.

So we see it is really not not adjunct to to raviolis map or any other <unk> inhibitor.

But as but as a.

A replacement for.

And there are there is another approved drug.

AC three inhibitor for for that provides also inhibition of both intra and extravascular hemolysis I think the the dosing.

Of our masks are inhibitor will be significantly superior to that and then there's also the potential safety advantages that we will see how those are borne out in in clinical trials. So with respect to nine O six the.

<unk> R again.

Extremely broad.

Any alternative pathway.

Indication alternative pathway related indication, we think we'd be amenable.

Two <unk> you are you asked specifically about.

About neural license.

Up to Canada, and the answer to that is.

Neural myelitis off to Kansas, certainly, we think that that is.

An indication ripe for <unk> nine O six.

I think.

Your other question was tied to how do we differentiate.

Nine O six from 10 29 and from our supplements I think the answers there are.

Nine O six is alternative pathway mass various a key activator of the alternative path.

The other two are supplement and 10 29 are focused on the lectern pathway.

So I think the differentiation there is pretty clear.

And and readily.

Readily discernible.

With respect to in our supplement versus 10 29, there are indications where you want.

A shorter dosing cycle and for those nor sampler map could be.

Is ideal.

Longer acting really chronic diseases the.

The advantage of 10 29, a subcutaneous.

Subcutaneously delivered antibody.

With dosing monthly.

Or or longer.

I think the advantages there are pretty clear as well so let me see if I hit all of all of your questions.

Yes, you did thank you that this has been very very helpful. I will jump back in the queue. Thank you. Thanks wrong.

Our last question comes from the line of Eric Joseph J P. Morgan.

Good evening, Thanks for taking my questions.

Yes, Oh excuse from us the first on the top of the effort TNA.

Just wondering if you could.

You too which division at F D a.

And developing.

Revising endpoints election primary.

The TNA study is the same division that ultimately reviewed BLA package is trying to get a sense of whether review might've been impacted by the.

Reorganization.

A couple of years and then.

On nine O six three is no weather.

Q.

From the healthy volunteer feast, one harbour centre argued engagement anything outside of pathos discussion and select few of studies.

And how 'bout button form starting go selection.

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Okay sure with respect to your first question the division and again it was a little muffled, Eric but I think I got it.

The division with which we're working and Ta TMA as a non malignant hematology division, which is part of ocean.

The office of cardiology, hematology or non malignant hematology endocrinology and nephrology.

Now it is the same division, but as you're planning out.

During the reward during the reorganization of FDA.

This specific division moved out from under the office of oncology.

Which is Rick pastors group and then moved into Ocean.

The director of that office was zealous Unger.