Q2 2022 Seres Therapeutics Inc Earnings Call

Good day and thank you for standing by welcome to the Q2 2022 series Therapeutics, Inc. Earnings Conference call. All lines have been placed on mute to prevent any background noise should you require any assistance. Please press star zero on your telephone keypad and an operator will assist you.

On today's call there will be a question and answer session. If you would like to ask a question. During this time. Please press star one on your telephone keypad I will now turn the conference over to Dr. Carlo Tanzi Investor Relations. Please go ahead.

Thank you and good morning, our press release for the company's second quarter 2022 financial results and a business update became global at seven a M. Eastern time. This morning, and can be found on the investors and use section of the company's website I'd like to remind you that we will be making forward looking statements, including the potential approval of tier one.

And its status as a first in class therapeutics, the timing of a BLA filing and potential product launch the market for SER 109, the ultimate safety and efficacy data for our products you use of cash to fund operations and other statements, which are not historical fact actual results may differ materially.

Additionally, these statements are subject to certain risks and uncertainties, which are discussed in the risk factors section of our recent SEC filings.

Any forward looking statements made on today's call represent our views as of today only.

We may update these statements in the future, but we disclaim any obligation to do so on today's call with prepared remarks, I'm joined by Eric Shaff serious President and CEO , David Archuleta CFO , Dr. Lisa problem, Oki, Chief Medical Officer, and Dr. Matthew <unk>, Chief Scientific officer additional members of our man.

Our team will also be available during the Q&A and with that I'll pass the call over to air.

Thank you Carlo and good morning, everyone.

We have continued to make meaningful progress across all areas of the business, including our clinical development efforts.

<unk> readiness.

Factoring.

And in strengthening the company's balance sheet.

Our top priority is fair one O nine our lead microbiome therapeutic candidate for recurrent C difficile infection.

We have now observed remarkable results from a phase III program that includes two robust clinical studies.

The program is progressing to FDA regulatory review and an anticipated product launch.

If approved by the FDA.

Tier one of nine could represent an important new option for those suffering from recurrent CDI.

The more the approval up to 109 could represent the first in a new class of microbiome therapeutics that we believe has tremendous potential to treat many serious diseases.

Based on well over a decade of research series has established a strong leadership position in the development of microbiome therapeutics, and we are well positioned to consume.

Discovering and developing novel medicines.

Earlier. This summer we were delighted to report confirmatory results from Eco sport for our SER 109 clinical study that is provided highly supportive safety and efficacy data in patients with recurrent CDI.

The overall safety profile observed in Dakota, four four was consistent with a favorable profile observed and the eco sport three study.

And we believe completes the F D. A pre defined safety database requirements to support a BLA filing.

Furthermore.

These study data also provides strong additional evidence confirming the remarkable remarkable efficacy profile observed to Nico sports III.

These data further build upon eagle's four three by evaluating a broad patient population, including patients with it first recurrence of CDI.

Together.

These data deepen our conviction in the potential of SER 109, if approved to transform how recurrent CDI is managed as well as the substantial commercial opportunity that we see in this therapeutic.

As we have previously discussed.

Our phase III SER 109, Eco sport three data surpassed statistical thresholds that <unk> communicated to us by the FDA, allowing that single pivotal clinical study to fulfill efficacy requirements for BLA.

Earlier this summer we initiated the rolling submission process to file the SER 109, DLA and we are pleased to report that we remain on track to complete the submission in the coming weeks.

<unk> has obtained the breakthrough therapy designation from the FDA and we expect to receive priority review.

Priority review should provide an expedited timeline, including a two month BLA acceptance period.

Led by a six month review period.

Therefore, we are anticipating the commercial launch of SER 109, pending FDA approval in the first half of 2023.

We believe the opportunity for SER 109 is clear with approximately 170000 cases of recurrent CDI in the U S per year.

This is a disease, where patients did not have adequate treatment options available today and resulted in over 20000 deaths per year.

Today dumb recurrent CDI patients are being treated with regimens and procedures that are not FDA approved which may be associated with significant risks.

Also patients may be treated with extended courses of antibiotics that we know may fuel the public health threat of antibiotic resistance.

In collaboration with Nestle Health Science, we continue to prepare for a successful commercial launch.

Leading up to the anticipated launch we will continue to prioritize our commercial preparedness activities, including the market education and payer engagements.

The external feedback we have received from the medical community related to the SER 109 profile has been highly encouraging and we are enthusiastic about the opportunity to help these patients in need.

In addition.

We continue to expand our commercial scale production of SER 109 to prepare for anticipated market demands and.

In addition, the theories internal manufacturing capabilities, we continue to work closely with our external manufacturing partners to both ensure patient needs are met at launch.

And increased longer term SER 109 product supply.

Phil anticipated worldwide demand both in the U S and potentially other markets as well.

Importantly, we also recently strengthened balance sheet with approximately $100 million in new capital.

This capital provides significant support for the company as we enter a critical period preparing for the approval of SER 109, and a successful commercial launch.

I'd like to now pass the call over to Lisa to discuss our clinical initiatives in more detail.

Thanks, Eric I'll begin by providing additional detail about our eco score for study results that we initially reported in June .

<unk> four four with a 24 week study that included 263 enrolled subjects with recurrent CDI.

Eco score four was designed to address the fda's feedback regarding the required safety database to support our SER 109 BLA filing.

In designing equals four four we also took the opportunity to obtain additional efficacy data, including in an expanded patient population.

Along with the SER 109 dose patients in the Eco score three study. This study provides a safety database of at least 300 patients as requested by the FDA.

With a total of 326 subjects, who received SER 109, completing 24 weeks of follow up.

Based on prior discussions with the FDA study also included 77 patients or 29% that have had only one recurrence of CDI.

We were very pleased to observe a high level of efficacy in this patient group.

These first occurrence patients reflect the group that was not included in our prior ethos for three study and are of interest to health care providers treating this disease.

And he goes four four we also included patients diagnosed at entry with either PCR or toxin Elisa assay.

Selecting the variations in current medical practice across the U S.

Overall, the safety profile through 24 weeks of follow up indicated that SER 109 was well tolerated consistent with a favorable data obtained from the prior equals four three study.

And <unk> for the most common treatment emergent adverse events were.

Diarrhea, flatulence nausea abdominal pain.

They'll distention.

Urinary tract infection and fatigue.

And these are all issues common to the CDI population.

Approximately 12, 5% of patients an ethos for four experienced a severe adverse event at <unk>.

May be expected in this older patient population with frequent comorbidities.

Importantly, none of these ftes were deemed related or possibly related to study drug by the study investigator.

From an efficacy perspective, we observed a sustained clinical response as measured at up to week, eight and approximately 91% subject.

Which was remarkably similar to the 88% rate observed in eco score three.

Response rates did not differ between those treated with vancomycin orphan <unk>.

And they were also similar regardless of the diagnostic method used for the qualifying episode of recurrent CDI.

We were very pleased to see the level of clinical activity observed in this study, which is substantially different from the 60% sustained clinical response rate in the placebo arm of eco score three.

We were also very happy to see a similar recurrence rate across the study population.

Godless up the number of prior episodes.

This includes first recurrence patients, where we observed a sustained clinical response rate of 93, 5%.

Our clinical results in this first recurrence population are consistent with the underlying pathophysiology of the disease.

It is believed to be similar cross for CVI patient, regardless of the number of prior episodes.

So to summarize the results of FICO score for provide robust additional support for the well tolerated SER 109 safety profile.

Also the results reaffirm and extend the SER 109 equals four three efficacy results.

The results provide compelling additional evidence of efficacy, suggesting a large benefit in sustained clinical response rates.

Moreover, our data suggests similar activity in patients with the first recurrent CDI.

Based on the clinical profile, we have observed to date, we believe that <unk> if approved could benefit patients across the entire recurrent CDI population.

However, the utilization of SER 109.

Of course based on the product label pending FDA approval.

I will now pass the call to Matt discussed here 155, and additional R&D efforts.

Thanks, Lisa beyond SER 109, our most advanced program is tier 155, which we are.

Developing for individuals receiving allogeneic stem cell transplant.

Tier one five along with tier one of nine as part of our infection protection pipeline franchise.

The allogeneic stem cell transplant patients targeted price tier 155 are at very high risk for serious infection as well as graft versus host disease, and we believe that SER 155 has the potential to address both issues.

We are continuing to enroll a phase one b trial to assess the safety microbiome and graphene and efficacy of tier 155, alongside our partners at a number of leading cancer centers in the U S.

The subjects in this study will be undergoing treatment for hematologic malignancies, such as leukemia.

Based on historical data, we expect that over half of these subjects will experience infection or graft versus host disease.

Its tier 155 is able to reduce the incidence of either of these conditions. We believe we would meaningfully improve health outcomes for these patients.

The study is designed to evaluate safety and drug pharmacology, including the <unk> of SER, one five bacteria and patients gastro intestinal tracts in.

In addition data are being collected to evaluate clinical outcomes, including rates of bloodstream infection and acute graft versus host disease.

As they're being either a decarbonization of target antibiotic resistant bacteria or significantly reduced incidence of blood stream infections or reduced occurrence of acute graft versus host disease associated with tier one five administration would be clinically compelling.

The study will help inform future clinical efforts.

Which outcomes to prioritize with future studies.

Furthermore, this is a translational rich trial that will produce immunological biomarker data that will not only support assessments of graft versus host disease, but also will inform additional therapeutic opportunity priorities in the companys immune modulation portfolio more broadly.

Looking ahead the pipeline expansion, we have a strong R&D team in place.

And as we highlighted in detail during an investor event earlier. This year, we believe that both our clinical and preclinical data provides strong evidence supporting the potential for microbiome therapeutics and preventing infection in patients that are at high risk of bloodstream infections.

Particularly in large patient populations that are immunocompromised, such as cancer neutropenia zeros.

Cirrhosis and solid organ transplant.

Importantly, we believe our technology can provide a novel approach to tackle the continued an increasing threat of antimicrobial resistant infections for which therapeutic options are limited.

See the potential to reduce the abundance of targeted pathogens to decrease the potential for pathogen transmission.

<unk> epithelia barriers to further reduce the frequency of bloodstream infections, and modulate immune responses to tackle medical complications such as graft versus host disease.

<unk> has developed an integrated reverse translational MBT X platform that has enabled the discovery and development of novel therapeutic candidates.

This platform Leverages, both clinical and human data sets and data from a broad range of preclinical assays and models customized for the development of microbiome therapeutics.

We are building on the success of SER 109, clinical data with SER 155, and we are advancing additional preclinical programs targeting section and combating the slow pandemic of anti microbial resistant infections more broadly.

We anticipate initial clinical additional clinical programs into the clinic over the next three years starting next year.

With that I'll now turn the call to David to provide an overview of our financials.

Thanks, Matt the details of our second quarter financials are included in the press release issued this morning, So I won't reiterate all the figures here series ended the second quarter of 2022 with approximately $196 million in cash cash equivalents in marketable securities.

Subsequent to the end of the second quarter in July we announced a registered direct equity offering resulting in gross proceeds of $100 million.

We intend to use the proceeds from this offering to further support commercial readiness and manufacturer of share 109 for the U S market, including expanding longer term commercial manufacturing capacity as well as advancing our clinical development of SER 109 for the EU market.

Other general corporate and working capital purposes.

This capital meaningfully strengthens our balance sheet and enables the company to more effectively deliver on our mission to bring microbiome therapeutics for patients in need.

The June 32022 pro forma cash balance inclusive of the net proceeds from the registered direct equity offering was approximately $291 million.

With respect to our operating expenses and efforts over the near term we continue to be focused on a number of critical SER 109 related activities, which include continuing to ramp up manufacturing operations for commercial supply internally and with our partner <unk> as well as increasing longer term SER 109 products.

<unk> through our back there a collaboration and.

And in conjunction with Nestle, continuing and accelerating launch readiness activities in.

In addition, we continue to invest to advance and expand our pipeline with a focus on infection protection opportunities and further build upon and enhance our platforms and capabilities. As a result of these high priority and value generating activities. We expect we expect our expenses to increase in the coming quarters.

But at a moderating rate of growth as we have already expanded our capabilities across much of the organization.

In summary.

The company is well resource to prepare for SER 109 commercialization.

Drive our ongoing development and preclinical programs, while also deploying resources to continue to advance our research platforms, where we believe we have differentiated proprietary and sustainable advantages.

I'll now turn the call back to Eric.

Thank you David.

As you can see we are on a clear track to potentially bringing the first microbiome therapeutics to patients as.

As we expect to complete our rolling BLA submission in the coming weeks.

We are well positioned to succeed with a strong commercial launch as we believe we have a remarkable and a highly differentiated product product profile and SER 109.

Our highly capable collaborator and a strong balance sheet from which to support our execution plans.

Later this year, we plan to host an investor event to provide further details regarding the commercial opportunity, we envisioned with SER 109, as well as our commercial execution plans.

In addition to our lead program. We are also advancing in earlier stage pipeline of additional highly promising microbiome therapeutic candidates.

We look forward to moving to key inflection points.

I'd like to take this opportunity to thank the talented and dedicated series team for their unwavering commitment and ongoing passion for bringing new medicines to improve quality of life for patients.

Without their tireless efforts, we would not be where we are today.

With that now operator, we'll open the call up to questions.

Thank you, ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad. If you would like to remove yourself from the queue. You May press star one again.

One moment. Please for your first question.

Your first question comes from the line of Mark Breidenbach. Please go ahead.

Hey, good morning, guys and thanks for taking our questions.

Just a couple of probably probably both aimed at Eric.

I am wondering if you can just briefly summarize what work still needs are still remains to be done before a BLA filing can be completed and is the plan to inform the street when the filing processes complete or will you wait until the FDA has agreed to review the application.

And then a question kind of on the regulatory process in Europe .

Is that is that process is going to be spearheaded by nestle or by series in and do you have any thoughts around.

Timing of when an MAA application could be could be submitted.

Yes, Mark good morning, and thanks for both questions.

On the first.

I would say we haven't gotten in the past that the kind of the blow by blow in terms of the BLA process. What I can tell you is as.

As you might remember.

FICO score for study was was kind of the critical path item for us right that the FDA wanted to at least 300 subjects that one in six months.

Follow up.

The study came out.

In excess of what were already high expectations. So.

That was and is the kind.

Kind of gating item for us to move forward with finalizing the BLA of course, we are working on the other modules of the BLA alongside the eco score for data.

Without going further mark what I can tell you is we are in the final stages of the <unk>.

<unk>.

Guidance is.

Reconfirming mid year and actually staying in the coming weeks, so from where we sit today, we're doing everything that we think we need to be doing.

And we're very very pleased with our progress in.

We're very hopeful that that will be done very soon.

I won't comment in terms of what we Mike communicated or might not I think in general you have seen that when we have events, we tried to be pretty transparent in current as to when they come out.

On the second question, Mark just around Europe , I would say.

Of course, we believe that see that visit global issue right and well our focus has been on the FDA in the U S market.

We're excited about the prospects of bringing SER 109 globally. We're also excited about the idea that we're doing so with nestle.

As a single partner you might remember back to when we were.

In our process of thinking about potential partners for the U S.

There are unquestionably synergies and thinking about global issues of pricing and branding and marketing and reimbursement and even regulatory strategy, where it makes sense to have one unified partner, which is why it made sense to work with Nestle in the U S. In addition to our pre existing relationship in the EU and rest of world. So we continue to work.

Collaboratively and constructively with Nestle and I suspect, we'll have more to say in the short term on next steps.

Okay, and maybe just one quick last one from me.

We anticipate that series, we'll be hiring any sales reps to support the launch or is the field force essentially already in place.

<unk> flash.

To support a potential launch.

You mean in the U S right Mark, Yes, yes, correct, yes.

Yes so.

Quick comment from me and then I'll turn it over to Teri, who I think.

To provide some additional perspective, but one of the aspects of working with Nestle that was attractive to us was.

The idea that we could leverage existing capabilities right. There was significant financial efficiency for us not hiring or building a commercial infrastructure and then having it sit idle until approval, where we would switch it on.

So there are capabilities that we can leverage from nestle.

Which we think will create value allow us to get the patients more quickly more effectively and ultimately more profitably than we could do ourselves, but maybe you can comment more specifically on the <unk>.

On your question around Salesforce.

Sure well, I guess, where I would start it will take to reach the HCP with the greatest potential for treating these patients. This is a gut infection. So it's no surprise that gastro neurology and infectious disease has the highest concentration of these patients relative to other specialty.

And we will continue to work with our colleagues at nestle's have an existing gastro neurology sales force that calls on the specialty in the large practices now to determine how we want.

To reach into infectious disease, and potentially into hospitals and institutions. So that's work that's ongoing now with the teams, but we have a lot of great experience and capabilities that naturally that will continue to leverage and our vision is that that's a nice efficient path forward versus building it means capabilities ourselves.

Thank you Eric.

So I think that answers it mark does that any.

Any other questions yes.

Perfect. Thank you for taking the questions and congrats on the progress.

Thanks for the questions Mark.

Your next question comes from the line of Pip Bon Bon Sac. Please go ahead.

Good morning. This is taken on for Joe Thanks for taking my questions I guess.

The first one would be when we'd be able to see any additional analysis and decreased four open label study would that be this year and would that be included in the investor event that you mentioned later this year or would it be released at a conference and then I've got another one after that thanks.

Sure good morning, and thanks for the questions.

Further data for <unk> portfolio.

Yeah. So.

We have a large okay.

And we're mindful of.

As soon and.

We're also mindful of the upcoming conferences this fall and as you know.

<unk> results are our announced there those are embargoed until we actually.

Does it released those results.

Back to see a little data.

<unk>.

Okay.

Great Awesome and then.

I guess kind of centimeters for data had been released some kind of the interactions with physicians and payers then.

I guess more specifically have.

Have you noticed an increasing things you're asking for using 790 <unk> first recurrent.

Yes, maybe maybe I can ask.

Lisa the start and then maybe Terry to comment just on the <unk>.

<unk> group has been active.

In the field.

And maybe Lisa can comment on the reaction to the ecosystem for data with us.

Question around first occurrence.

Yeah. So the excitement has been they have been high.

Anticipating these result, obviously based on what they saw and it goes for three and I think the fact that four looked not only asked because it even slightly better I mean, I think that just seal that with with so many folks.

I will say that that most of our kols had already been imagining using.

Tier one online apps.

Or any current disease, just based on the physiology of the pathophysiology of the disease once you under their recurrent tool.

You are there because of the fact that microbiome is no longer a resilient enough to keep those spores.

From germinating, so I think that the.

The fact that it worked well in first recurrence was not a surprise to anybody.

Particularly those that follow the field, but I just would say that people are so it's.

Very pleased with the strength of the data set and the consistency right. It looks good from all angles all groups.

And Thats really what you want to see.

Yes.

Okay.

Alright go ahead.

Hey, Eric.

Yes.

Yes.

Yes.

Okay.

And our nation to garden variety HCP prescribers kols audience.

It's very similar they don't necessarily discriminate between member for current just patient has and that's probably based on the biology pathophysiology that links the outlines youre either at primary patient or your current pool and they started treating the same.

And in the full of patients we know when we hear over and over that the largest unmet need is prevention of recurrent hcp's really want this indeed to go away.

And they don't have good options for that today as evidenced by the placebo arm of our <unk> III study and we need confirmatory results. It really just.

Guys give them increased confidence with respect to how they might expect here 190 to perform near patient populations. So it's very clear we actually just completed a round of messaging research. So this is hot off the presses with Hcp's and cannot work it was abundantly clear that hcp's value.

High and durable efficacy.

Across our studies with <unk> 109, and this will be a key driver of trial and adoption.

And on the payer side you may recall, we deployed out I've spoken about this previously we deployed the necessarily pay your field team.

Back in the spring and in that field team is able to talk not only about the <unk> or <unk> results, but the fact that we are.

Enrolling and we're finishing up the coast Port for say, yes, there's a lot of excitement and interest with respect to what that trial may have shown and we're now able to obviously expand and ramp those conversation.

Particularly breaking out to the larger pbms in the near future with this remarkable data. So we're excited about that but the feedback that we're getting today upon deployment of that team.

<unk> already had preexisting deep relationships with the payer audience because the in line products that necessarily already have.

The reception has been very positive.

Okay, great. Thank you guys for all the color and congrats on the quarter.

Alright, thanks for the question.

Your next question comes from the line of John Newman. Please go ahead.

Hi, guys. Good morning, Thanks for taking my question I just had a question on SER 109, five obviously, there's a lot of excitement.

Around SER 109, thats going to be a marketed product pretty soon but.

A final one.

Really interesting as well because you're testing is that an area, where there's a very very high need.

Per treatment just curious you mentioned in the press release this morning.

That the.

Data and safety monitoring committee.

Recommended to.

To continue enrollment in cohort one just curious if you can remind me of the study design if that cohort is still sort of an open label cohort before you move into the randomized portion and then.

Curious if you could talk a bit about some of the efficacy end points that you are curious to investigate here in the phase <unk>.

Yes, John I'm going to ask Lisa to comment on your question I would just.

Agree with your sentiment that we are incredibly excited about 155 and of course there is.

Disproportionate amount of attention focus on 109.

<unk>.

But we really do think that 155 is really the tip of the iceberg as it relates to our future efforts in infection and it leverages some of the capabilities and insights.

And.

Knowledge that we have from 109 and from <unk> that we're leveraging and the expansion of the pipeline and that really is where the the early stage pipeline has pointed now but maybe at least I can answer to your question in terms of the <unk>.

Ft.

The trial design.

So just to remind you what the trial design looks like it started with.

Cohort a running cohort of 10 patients.

Breaks into a placebo controlled cohort of 60 patients.

Valuation was.

And three.

Pre staged at a after a certain number.

And went fine there were no.

We have not guided on.

Sort of patient by patient Parliament.

And I think that where we're <unk>.

Very pleased with the progress.

Progress in the trial, we've opened additional sites with more from just.

Our initial site at MFS K in and are now in a number of sites across the U S.

We're very pleased with how it's going with regard to endpoints.

We're interested in.

Safety of course, we're also interested in grassman.

And then from there we are very interested in looking at the power of this nation or our ability to decolonize patients.

With regard to pathogens.

We're interested in clinical outcome, such as blood stream infections are Gi infections, as well as acute graft versus host so the wave.

Set up we're able to actually drill down from <unk>, all the way through those other endpoints.

We'll also be looking at Biomarkers.

<unk> reflect that the community. So when you expect to get an enormous amount of information from this.

From the study.

Okay, great. Thank you.

Sure. Thanks for the question John .

Your next question comes from the line of Ted <unk>. Please go ahead.

Thank you very much and congrats on the progress huge milestone cover for the company as the patients typically kind of digging a little bit more on the prep work that you would lastly are doing can you comment on your guys' responsibilities, so little bit more in the.

Promotion here one on the line.

And is there anything that sort of come out as you discussed from the market research.

Any additional clarity in terms of where the initial focus will be obviously, the ultimate label and.

What patients are included in terms of relapse.

Sort of determined that but are there sort of greatest areas of needs that you think may be the initial focus thanks so much.

Yes, thanks for the question.

When we designed the.

Collaboration or the co commercialization with Nestle, we tried to focus on what each.

He does best what are we each uniquely.

Positioned.

To maximize the value of the drive for patients.

No.

In general we have been focused on.

Driving the bus in terms of the <unk>.

Lisa outlined earlier.

I would add that that has been.

Supported enormously through the New England Journal of Medicine paper that January .

Yes.

Of course are continuing to two.

To lead the manufacturing effort.

With 100 days in.

One of the blessings and curses of being new in the category is that it's not easy to kind of access that technology off the shelf.

The walls of the company.

And we.

Really much of a decade been building towards this moment, where.

We are preparing to launch the product and support it.

And then we.

Work with vastly in terms of preparing for launch.

And some of the pre commercial.

Preparations are under Terry.

Maybe I'll ask Terry to comment.

Further, but as it relates to your question on label.

As I think Lisa mentioned earlier, we're thrilled with the eco score for data.

It's pretty remarks, the kind of a mid single digit reference rate in that first that first of all current group, but we were never counting on that number or that data those data to support our belief that.

And we think most physicians beliefs.

That theres really two categories of patients there's folks that have primary <unk>, and then folks whose microbiome or injured and happy to reoccur.

So.

Maybe I can ask Terry to comment on on your question around the initial.

But hopefully that provides color or.

Perspective on how we're thinking about things Terry.

Thank you.

Sure. Thanks, Good morning, Ted Thanks for the question and.

I think one thing I would add to how we work together across the alliances that you know it's very much a co commercialization agreement met affairs teams have staff at both companies. The marketing team has staff at both companies and really work together as one team we have joint governance committees, where all of the major decisions.

Around the launch are discussed and ratified.

No.

Very much as a partnership on where both companies are bringing.

<unk> expertise at the table to achieve the best decisions, that's really division for the partnership from the outset and with respect to your question around kind of the foothold I think the initial holding with respect to have in the marketplace.

Do you want to add this is building on the comment that Lisa made around the biology of the disease and that I mentioned earlier around how HCP see the patient pool. They don't differentiate necessarily between first recurrence second third plus four in a lot of conflicting them now.

So I view, the foothold as being less about the number of recurrences than I do about <unk>.

Just the natural progression of the launch over time, our ability in the first year to ultimately reach a broad HCP audience create awareness for the brand and.

Engage these positions over time.

The access ramp over time, our ability to get into the payer review cycle and open up those tools for patient.

Over time, our ability to open up the hospital tool, there's a pool of patients that transition from hospital to home as we call. It they receive SER 109 in the outpatient setting, but theres inpatient discharge team involvement so and these things as we launched the product in scale, our commercial footprint working with Nestle.

Where we have the reach and where we open up the patient pools, and where we have the first payer review those won't be ourselves.

Yes, very clear and I appreciate that.

That distinction that's helpful. Thanks.

Youre welcome.

Thanks for the question.

Your next question comes from the line of Chris Howerton. Please go ahead.

Great. Thanks, so much for taking my questions. Just two for me one would be with respect to the BLA submission.

Anticipated review.

Have you heard anything of competition with respect to re baltics chronic.

Actually been submitted and pending review just curious if you guys heard anything as that impacts you.

Anticipated timelines for anything and then secondly.

Just given the commentary with respect to manufacturing scale and kind of working that.

I was hoping that you could give us a little more information what type of demand you would expect to be able to say.

<unk> and <unk>.

Some of the scale of procedures will be able to.

And the timelines associated with that thank you.

Yes, Chris good morning, and thanks for the questions.

On the first I'll provide a pretty short answer which is I would say, where we're fully consumed with our own BLA path process. So.

I don't think well.

On.

On other folks.

On the second.

I would say.

And maybe reiterate what we said before and I can ask Dave to add some additional color but.

We've been preparing for launch for a fair amount of time. We're pleased that we're taking are physically process into launch and we feel that we'll be well positioned to support the launch of the product.

As we hope to continue to move forward on unplanned at one time, we did do the bat zero agreement.

With the expectation that this is going to be a big drug and that there were opportunities to bring it to geographies beyond the U S and that would require.

Call it an industrialization of the manufacturing of this therapeutic.

And we're making good progress with the with back there as well so.

Dave.

Welcome additional perspective from you.

But hopefully that provides some color.

Yes, no. Thanks, Eric you.

You said it very well I mean, I think the thing just worth restating is we feel very confident about where we are with our ability to supply at launch and in the initial years until the additional back there are capacity comes on.

We're well positioned against the forecast that we have in mind with our partners at Nestle.

Okay.

No that's great I really appreciate the additional information and thanks again.

Thanks for the question Chris.

Your next question comes from the line of Chris <unk>. Please go ahead.

Yes.

Good morning, and thank you I was just wanting to touch base on two things one relating to the payer value perception.

I know that you have in the past and you continue based on the slides to frame the perception in the context of for instance, <unk> Hep C treatment.

The regimen that I believe that for SER 109, obviously from this study is a three day oral treatments.

So could you maybe comment on two things, obviously that perception is that framed against <unk>, including price and then secondly.

The clinical work has been about a single sort of episodic treatment for three days and clearly the data has showed some compelling efficacy there.

What if any information do you have to explore whether a patient would possibly be treated again in the future and perhaps on a longer term extension basis or.

The treatment is the first time did not work would it be part of our recommendation to re dose once again, what is the opportunity for any individual patient to be a repeat customer. Thank you.

Yes, Chris Thanks for good morning, and thanks for the questions I'm going to ask.

Terry to answer the first and then I'll provide some comments and at least that hit the second one.

Great. Thanks, Eric So with respect to the clinical value rating that you see noted in our corporate deck that essentially was the payer audience reaction to the clinical value that SER 109 would bring and how transformative it was and how large the unmet need is.

Day for preventing requirements. So they very much recognize that there was no good option.

Again, as evidenced by the placebo arm in our trial and so that was kind of the nature of their reaction on and when we ask the follow up question regarding okay. That's a very high clinical value rating what is that analogous to help us understand.

What product may be similar or.

When it came to market and that's when they went to the Hep.

<unk> market and that sort of next generation products. There. So it wasn't necessarily then benchmarking tier one of nine price products in that category, which I think was your question.

So Eric I'll turn it back to you and I think over to Lisa Yahr.

Yes, Chris I think your second question related to the possibility or.

B perspective around the idea of re dosing and it's something that we've spent some time thinking about.

I will say a pretty good problem for us to have is that there is so little data available.

From our studies of patients that didn't benefit from the drop it was it was an incredibly small number of patients who were on the active.

Who ultimately recurred.

And maybe I can ask Luis to comment on that but.

Our view is that there is no. There is no medical reason why if someone.

See this is treated with SER 109, hopefully as is.

Has the successful outcome and does not recur in the timeframe that we would expect someone would you.

A year later they go back to the hospital for whatever reason.

They get see if again, we don't think there's any reason why that couldnt be retreated with SER 109, but maybe I can ask Lisa to provide some additional perspective.

Yeah, No just based on the mechanism of action.

Would fully anticipate that is if somebody has recovered and then let's say that they are out in the community and receive another blast of broad spectrum antibiotics.

Interest the microbiome again.

The mechanism of action, which suggests that they would be a prime candidate for repair with SER 109 again so that's.

That's the.

There's nothing to suggest otherwise in our hand as Eric said, we have very few patients that we could actually.

Consider for retreating just given the fact that we had such a high rate of success.

And the.

SKU that we did we had no safety problems at all so there's again nothing to preclude.

Re dosing, but.

I think that based on mechanism of action targets case.

Got it. Thank you I appreciate the perspective.

Okay. Thanks for the questions Chris.

This concludes the question and answer session I will turn the call back to management.

So thanks, everyone for joining and thank you for the thoughtful questions. This morning.

Look forward to keeping you updated on our progress we hope everyone has a great day and a great week and we'll talk soon.

This concludes today's conference call you May now disconnect your line.

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