Q4 2020 Seres Therapeutics Inc Earnings Call
[music].
Ladies and gentlemen, and thank you for standing by and welcome to the Q4 2020 series Therapeutics Earnings Conference call. At this time all participants are in a listen only mode. After the speaker presentation there'll be a question and answer session basket question. During the session you will need to press star one on your telephone please be advised that todays call.
Vince is being recorded if you require any further assistance. Please press star zero and I would now like to hand, the conference over to your speaker today Doctor and Parnell Tansey of Investor Relations. Please go ahead.
Thank you and good morning, our press release with the company's fourth quarter 2020 financial results and a business update became available at seven a M. Eastern time. This morning, you can be found on the investors and media section of the company's website.
I would like to remind you that we'll be making forward looking statements related to the timing enrollment and results of our clinical studies and potential regulatory approval and the promise and potential of our microbiome therapeutics.
Results may differ materially. Additionally, these statements are subject to certain risks and uncertainties, which are discussed and 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.
Update these statements and the future, but we disclaim any obligation to do so.
On today's call with prepared remarks, I'm joined by President and Chief Executive Officer, Eric Shaff.
<unk> Medical officer, Doctor and lease up on Mulkey.
And Chief Scientific officer, Dr. Matthew him.
Terry Young Chief commercial and strategy Officer, and Dr. David Eggy, Chief Technology Officer will also be available for the Q&A portion of the call and with that I'll turn the call over to Eric.
Thank you Carlo and good morning, everyone.
2020 was a pivotal year for series as removed and and important important step closer to realizing our goal of translated and microbiome and insight into an entirely new class of medicines.
The year was highlighted by positive data from our phase III SER 100, 943 study and patients with recurrent C diff infection, marking our transition towards becoming a fully integrated commercial organization.
Since then we have been taking actions necessary to file a SER, one and nine BLA submission and preparing for a successful commercial launch following and FDA approval.
As an organization our top priority right now is to obtaining the required SER 109 safety database by completing our ongoing open label study.
We are also continuing supportive market assessment work, including primary research with physicians and payers and pricing and reimbursement analyses.
Furthermore, we have been scaling our market education efforts, including the hiring and training of and MSL team.
We recognize that as we are working and an entirely new field of medicine, there is understandably and knowledge gap and the health care community regarding the broad and important role of the microbiome and the health and disease.
We're looking forward to continuing to engage with patient groups physicians and payers to educate the market about the substantial value of our microbiome therapeutic approach.
We've also made strides to increase our drug supply capacity. Our SER 109 process is already at commercial scale and we have activities underway to expand our production capacity with a goal of ensuring that we were able to meet future commercial demand and assume rapid and broad uptake into the recurrent CDI populate.
And as well as support our expanded and clinical trial activity.
In addition to SER 109, we are advancing a pipeline of additional investigational microbiome therapeutics led by Spirit 27, our phase III candidate for ulcerative colitis SER.
Two of the seven has the potential to transform the management of this disease and.
Intended to provide an effective alternative treatment approach that is well tolerated and is not immunosuppressive.
We are very pleased to report today that the fear of 287 Phase <unk> study has achieved target enrollment of 201 subjects and we look forward to reported topline data in mid year.
With that I'll now turn the call over to Lisa.
Thanks, Eric and good morning, everyone I'll begin with a review of our SER 109 program.
Last summer.
Three efficacy endpoint in patients with recurrent C difficile infection, showing a substantial absolute reduction of recurrent infection compared to placebo and eight weeks post treatment.
Yeah.
Equals four three data through the final 24 week time point. These results reflect the final categorization of all subjects in the protocol specified intent to treat population following study completion and full unblinded.
This completed analysis reflected minimal changes from the interim analysis and demonstrated a remarkable sustained clinical response rate of approximately 88% and eight weeks post treatment.
Primary endpoint showed an absolute reduction of recurrence of C. D. I have 27 per cent compared to placebo at eight weeks post treatment, which is a relative risk reduction of 69%.
Study results show that SER 190 administration resulted in similar efficacy when examined and buy groups stratified by age or by the prior antibiotic therapy. Additionally, the day to demonstrate that SER 109 efficacy is maintained over the duration of the 24 week study.
From a tolerability perspective, we were also extremely pleased with the phase III study data.
We observed a highly favorable safety profile with SER 100 and I.
The need for it.
Weighted by the recent announcement from a major stool, thank stating that it plans to halt operations.
We believe our SER 109 phase III data represent a substantial advancement over the standard of care with the potential to transform how CDI is managed.
And the more we believe that SER 109 has the potential to improve treatment of CDI and disease that results in the deaths from over 20000 people and the U S. Each year.
In October of last year, we presented our preliminary SER 109 phase III study results.
And college of Gastroenterology annual scientific meeting and we plan to present additional data at medical meetings later this year.
Do you worry we price.
See I'm presenting mechanistic support for the efficacy observed in the phase III study and Matt will discuss those data in more detail.
We look forward to submitting the remarkable SER 109 phase III results for this novel treatment modality to a leading journal for publication.
Importantly, SER 109 equals four three study results.
And exceeded the efficacy thresholds communicated to us by the FDA and we expect this single study to provide the efficacy basis for our SER 109 BLA filing.
The F D. A position is that at least 300 patients will be required for our SER 109, and safety database to support the BLA and we continue to enroll our ongoing SER 109 open label study and patients with recurrent CDI.
We expect this study to fulfill the remainder of our required safety database we continue.
So all across the U S and Canada.
Now, let's turn to our ongoing SER 287 phase <unk> study and patients with mild to moderate.
Hi, there.
There are 287 is an orally administered drug candidate comprised of commensal bacterial spores isolated from the healthy human gastrointestinal tract.
Our objective with SER 287 is to develop a first in class microbiome therapeutics that modulates, the microbiome and microbiome associated metabolites to treat ulcerative colitis.
We believe that tier 287 may provide a much needed non immunosuppressive treatment option for UC.
There were 287 is intended to reduce the impact of a disrupted microbiome as both a trigger and and amplifier of inflammation.
We believe that SER 287 has the potential to be used as both a monotherapy and potentially also in combination with other approved agents.
Data from the Phase one B study demonstrated that SER 287 day administration was associated with high rates of clinical remission endoscopic improvement modulation of the gastrointestinal microbiome and a favorable safety profile.
These results and data supporting the underlying mechanisms of action were recently highlighted as the cover article and the January 2021 print edition of the peer reviewed journal Gastroenterology.
To remind you the SER 287 phase two be eco reset study is a randomized placebo controlled three arm induction.
201 patients with active mild to moderate ulcerative colitis, who have failed prior therapy.
And arm a patients receive a short course.
<unk> followed by 10 weeks of daily regimen that was used and the arm of the previous one beat study that showed the highest clinical remission rate.
And RMB patients receive vancomycin pre conditioning, followed by two weeks from the same tier 287 daily regimen used and army followed by eight weeks of a lower dose.
And arm C patients receive placebo.
As Eric mentioned, we have achieved target enrollment with several patients remaining and the screening process and.
And in and acceleration of our previous expectations. We now expect top line study results from eco reset in mid 2021.
And streets that SER, 287 result, and a significantly higher rate of patients achieving clinical remission and dose administered placebo.
We believe that the safety profile of our microbiome therapeutic approach based on commensal healthy bacteria is a major advantage and anticipate that the safety profile of SER 287 will be highly favorable, particularly as compared with the current standard of care, which can be immunosuppressive.
We expect that if we are able to achieve its clinical profile and with an orally administered therapy SER 287 would represent a highly attractive new medicine.
Tier 287 has the potential to provide mild to moderate UC patients representing a majority of all you see patients with an effective treatment.
Not immunosuppressive.
The SER 287 study will also be important to inform our broader multi product and longer term efforts to develop transformative new medicines for inflammatory bowel disease and more broadly modulating host immunity.
The development of the microbiome therapeutics field remains and its adolescence and as a learning data driven science based organization. We expected series will gain important insights both from our pending phase two b clinical data and from mechanistic data coming later this year that could inform that.
Further development of SER 287, as well as that of SER 301, and our future compositions designed to modulate host inflammation and immune pathways signaling.
With that I'll now turn the.
Okay.
Thank you Lisa and good morning, everyone. We are aware that we're having some sound issues and we're resolving that.
And I'll continue series continues to invest significantly and our reverse translational and discovery and development platform that can delineate and high resolution microbiome biomarkers from human clinical data and integrate these data with preclinical assessments using human cell based assays and in vitro ex vivo and in vivo disease models to evaluate.
Drug mechanism of action and to design consortia of bacteria, which specific pharmacological properties.
We reported results from tier one and nine phase III predefined microbiome Readouts earlier this year at the Keystone Microbiome symposium that confirmed the drugs candidates mechanism of action. The phase III study data demonstrated that tier one and I and bacterial species rapidly and grafts into the gastrointestinal track Congrats and it was observed as early as <unk>.
One week post treatment and found to be durable through 24 weeks.
Presence of SER, one and I and bacteria with significantly greater and subjects that received shearwater line versus placebo and all differences were maintained and all subpopulation analyses.
Tier one and nine administration also rapidly shifted the gastrointestinal and metabolic landscape, including a significant decrease and primary bile acids, and an increase and secondary bile acids and providing a mechanistic basis for both the inhibition of C difficile spore germination and vegetative growth.
Notably and early time point sample C difficile and other bacterial pathogens known to harbor antibiotic resistant genes were significantly more prevalent and placebo treated subjects.
These data confirm observations from series prior trials that tier one and line resulted in a reduction of other clinically relevant bacterial pathogens. The detailed mechanistic learnings we have obtained from tier one and I and combined with our ability to link these learnings to clinical outcomes and confirm observations and human subjects and or not.
Non clinical setting to demonstrate causality has proven immensely beneficial and we're already applying this knowledge to the design and feature planned microbiome therapeutic compositions.
Moving now to our SER 301 program.
SER 301 is a next generation orally dose rationally designed cultivated microbiome therapeutic candidate for the treatment of ulcerative colitis the.
And the consortia of bacteria and SER 301 is designed to modify the microbiome and microbe associated metabolites in the gastrointestinal tract to reduce the presence of pro inflammatory bacteria and modulate pathways linked to gastrointestinal and inflammation and epithelioid barrier integrity and patients with ulcerative colitis.
Tier 301 was designed using series and reverse translational discovery and development platforms the design.
Incorporated learnings from the SER 287 phase <unk> study related to the bacterial species and the microbiome function functional signatures associated with clinical efficacy.
Additionally, the design incorporate and insights on the graph and dynamics of different bacteria and also the association of specific bacteria, but the modulation of inflammatory and immune pathways and human subjects that had been observed across our broader clinical portfolio and confirmed using our non human cell based assays and in vivo model.
Charles.
In November of 2020, we announced the dosing of our first patient and our SER 301 phase <unk> study in adults with mild to moderate ulcerative colitis and enrollment is ongoing.
The study is being conducted in Australia, and New Zealand with a target enrollment of 65 patients in total the objectives for the study are to evaluate drug safety and pharmacokinetics and further to evaluate clinical remission and other measures of efficacy as secondary endpoints.
The data safety monitoring board recently reviewed preliminary safety data from the first set of patients enrolled and we encourage to see that the drug tolerability has been favorable.
Turning to our phase <unk> study for SER 401.
And so your firewall is an orally administered microbiome therapeutic candidate comprised of bacteria associated with response to checkpoint inhibitor immunotherapy.
Our objective with SER 401 is to enhance the efficacy of approved immunotherapies by modulating the patient and be in response to these medicines as we have previously discussed.
[laughter] excuse me that the CFO and study has been impacted by COVID-19, and enrollment has therefore been slower than anticipated we are.
We are evaluating our SER 401 development plan with our study collaborators at the Parker Institute of cancer, Immunotherapy, and MD Anderson Cancer Center.
Now moving to tier one SIFI.
So your 155 and orally dose rationally designed cultivated and microbiome therapeutic candidate designed to prevent mortality due to gastrointestinal bacterial infections, bacteremia and graft versus host disease, and immuno compromised patients receiving allogeneic stem cell transplantation.
So your 155 builds on our expertise and both infectious disease and immunology and is designed to prevent bacterial infections, particularly those that harbor antibiotic resistant genes and the onset of graft versus host disease.
This tier one and five five program is supported by Carb X.
It provides financial and operational support and we're making continued progress advancing as tier one and 55 into the clinic and collaboration with our partners at Memorial Sloan Kettering Cancer Center, and we expect to submit and R&D during the first half of this year.
We continue to resource our microbiome pipeline and a number of indications beyond Bulks tier one and five five and SER 301, which over time will serve as a product engine for our growing commercial organization.
Our clinical programs and our reverse translational and discovery platforms continue to provide meaningful insights and knowledge into the underlying mechanisms by which microbes and the Gi tract and engage with pathogenic bacteria and human cells and tissues to impact disease.
Moreover, advances and series microbial cultivation, and bio processing Knowhow and commercial scale GMP campus capabilities continue to broaden access to the diversity of microbes in the human Gi that can be harnessed and potential new product candidates and development programs with that I'll now turn the call back to Eric.
Thanks, Matt and <unk>.
We are aware that we lost the piece of leases section and I think we lost her when she was talking about the fact from from a Tolerability perspective for SER 109, we were and are extremely pleased with the phase III data and that we observed a highly favorable safety profile with SER 109 adverse events being similar to placebo and and we will ensure that.
The script.
The transcript from this call is available after the call.
So let me.
Transition to our financials, our fourth quarter and full year P&L.
Are included in this morning's press release, so I won't reiterate them here series ended the year 2020, with approximately $303 4 million and cash cash equivalents and short and long term investments.
We entered 2021 and a position of strength poised for growth as we continue to advance our pipeline and transition to a fully integrated commercial organization.
Curious is building upon our microbiome platform leadership position and driving forward a multi product clinical pipeline that is led by SER 109.
We believe that our SER 109, eco sport three results provide validation and support for the broader series pipeline and our capabilities and this new area of medicine.
Sirius has advanced non commoditized unique platforms that are being deployed for the development of microbiome therapeutics beef technologies and our proprietary scientific insights have already generated a pipeline of promising and microbiome therapeutic candidates.
Each targeting a serious medical condition and each providing the potential to fundamentally transform how diseases are treated are.
Our top priority is preparing for a high quality BLA submission per center 109, as well as readying the company from a successful commercial launch for what we expect will be the first FDA approved microbiome products.
And we're continuing to advance what we believe to be a highly promising pipeline led by Sir 287.
In addition.
We intend to continue to invest and core microbiome drug discovery and CMC capabilities to ensure that series is well positioned to continue to lead the microbiome therapeutics field.
These important areas.
We expect 2021 to be an eventful year for the company.
We are looking forward to continued enrollment and our SER 109 open label study and progress with pre commercial activities.
<unk> line results from the 2% to seven phase <unk> study.
Advancement of our multiple earlier stage clinical programs and further strengthen our microbiome platform capabilities, enabling us to bring the next wave of therapeutic candidates and.
And to the clinic.
Sirius has a strong and experienced team in place and we are working with urgency to achieve our goals and fulfill our mission of transforming the lives of patients worldwide with revolutionary Microbiome Therapeutics, we look forward to keeping you informed on our progress.
With that operator, we'll open up the call and out of questions.
Thank you as a reminder to ask a question you will need to press star one on your telephone who is trying a question. Please press the pound key please standby and we compile the Q&A roster.
Our first question comes from them.
And talk with Piper Sandler you May proceed with your question.
Great. Thank you very much congrats on all the update and looking towards the ulcerative colitis data I think that's going to be and interesting.
Education to expand the applicability of the technology quick question I'm not sure if I missed it because of the line breaking up a little bit, but what is the latest with respect to one of them on enrollment.
And the open label extension study and can you give us or give us a sense for when that might be.
<unk> already and my report data on that thanks.
Yes Ted.
Good morning, and thanks for the question. So maybe just as a reminder, when we announced preliminary topline data in August.
<unk> said that we had 105 subjects.
On the dose that was of course successful and the phase III and then the number of patients that enrolled and to be open label from from the <unk> study. So what we said was that the FDA had asked us to have at least 300 subjects.
On on therapy. So we were moving forward with the open label study in order to fulfill that request and and we've continued to make progress.
Enrolling patients increasing the number of sites I will say that we started a little bit more slowly than I would've liked.
Perhaps in part based on the pandemic, but we've really seen a lot of positive momentum and traction and the last and the last period of time. So so we're very encouraged about about getting this done just as a reminder.
We know that we can execute on this in part based on the fact that that the.
It has allowed US to include first recur and subjects into the study which of course increases the number of available subjects.
As we mentioned and I think this might have gotten lost and Lisa's comments, but one of the largest stool providers still bank providers had been shot actually has announced that they are winding down.
But really more than anything Ted it's the profile itself, it's the safety the efficacy.
And we are continuing to add sites so.
We're getting closer to the point, where we've got a sense of the slope of the curve I won't say, it's improving significantly and I think it will be and are positioned to provide more and more specific guidance at some point soon.
And that's really helpful. I appreciate that color and then maybe you could add.
Sort of explaining kind of what the process would be with respect to open label extension data and BLA filing.
Basically you know you unwind and the data reports of data and file or will you be reporting that due to just maybe a little bit more color and sort of the mechanics behind transitioning to the BLA filings. Thanks a ton.
Sure and maybe I'll ask Lisa to comment.
To start as a reminder, we do have breakthrough therapy designation with SER 109. So.
We are in dialogue with the FDA around the path forward, but maybe I can ask Lisa to comment about the mechanics of.
And the open label and folding that into the BLA process.
Yes sure.
We have been cleaning data and preparing the BLA shells and and everything as we've been going along so that we anticipate when we get our last patient out of that open label, we'll be able to immediately execute on the final analysis and drop that into the BLA. So we were set.
And it up to seamlessly be able to roll into the BLA as fast as is.
Humanly possible in terms of calculating and getting things and.
Sounds good thanks, so much for the update everybody.
Thanks for the question.
Thank you. Our next question comes from Joseph Thome, with Cowen and company and we have received and your question.
Hi, there. Thank you for taking my questions.
I know you detailed a little bit for us, but if you could just give a little bit more detail on sort of the initial physician response that youre seeing in terms of the data from tier one on line.
Is there a specific portion of the data package that physicians are finding compelling or how long do they want to see this response last.
And then on SER 287, how should we be thinking about a go forward decision here is there a specific clinical response rate that youre looking for I think it was mentioned additional mechanistic data are expected potentially later this year.
Sort of what are the inputs that you're looking for there to make that decision.
Yes, Joe good morning, and thanks for the questions I'm going to ask Lisa to comment on the physician response, I mean, I'll just start by saying, obviously with the currency that if this is a field that has been seen.
Meaningful innovation in quite some time.
And the feedback that we've gotten from from our Kols and from our PDI as its been has been incredible, but let me let me ask Richard to comment further on that and then we can we can comment on two and seven and how we're thinking about defining success.
Yeah. This is been a delta and efficacy result that the field has never seen foresee desk in terms of you know.
88% of people after eight weeks and continuing to be free of recurrence and so so that right away is important.
We know that when recurrences happen they tend to happen very quickly but in addition, our data is showing that not only are we good at eight weeks 12 weeks. We now can see that that that durability of response goes out to 24 weeks and we're looking forward to getting that data out there.
So that plus the safety profile.
Has it really been a complete package and it's not an understatement to say that that people are seeing this as a paradigm shift there.
And then Joe I think to your second question related to 287% and.
And for Us and again I'll ask Lisa to comment more more completely but.
There is obviously the clinical data there is the microbiome analysis that it's part of our approach. We think really go hand in hand, and it's one of the reasons that we're so excited about the the SER 109 result was not only do we have the the 109 clinical data the safety profile, but but.
As Matt talked about we've got the microbiome analysis that really corroborate the clinical result, but from my perspective is because we've continued to work in this field.
And so clear that there is an opportunity to help patients, particularly and the mild to moderate segment with.
And approach which is safe.
Which is effective and which is oral.
The number of agents that are on the market or are and are in development.
Tim carry with them significant side effects, including immunosuppression and what we have heard.
Is that there really is an opportunity from a non immune suppressant approach for these patients, but maybe I can ask Lisa to comment more completely on 2007.
Yes, Theres, a real GAAP, especially for the mild to moderate patients between eight five assay and then Theres a GAAP and you get into these big gun immuno modulators and in terms of the biologics the jacks and Theres a lot of patients who really are not fully <unk>.
Trolled and were well controlled on five assay and and we've heard that if if we could have a and orally administered non immunosuppressive agent and it was exactly what these patients are looking for so we're very excited to get the readout for 287.
Excellent. Thank you and congrats again and the progress.
Thanks for the question and we look forward to participating in the conference later today.
Thank you. Our next question comes from Mark and Reading back with Oppenheimer. You May proceed with your question.
Hey, good morning, guys and thanks for taking the question.
Not to harp too much on the open label trial, but.
I was wondering if you could give us an update on how many trial sites are now open for enrollment.
And with the open biome quarantine and shipping hold and place can you give us a sense for what forces are still competing for enrollment when it comes from CF patients.
Yes, Mark we've got about 70 sites that are up which is which is of course significantly higher than what we had and the phase.
Phase III study vehicles force III study, we've got a target of over 100.
And we have been making steady significant progress as I said before.
We are doing this in the midst of the pandemic and even though the pandemic is really trying to get the right direction, particularly.
Particularly from the infectious disease side of things, we are competing for resources at clinical sites with some of the Covid clinical work, but.
What I can tell you that we are highly highly and encourage with our.
Our momentum and the slope of the curve as we continue to get closer to our target again north of 100, I think we will have a better sense of.
The slope of the curve and being in a better position to provide definitive guidance.
Anything else to add on that.
Nope I agree completely once we get to a sort of a steady state we will be able to model out more exactly when we think that the trial will finish.
And.
Okay. That's helpful.
And with respect to eco reset and and sort of two eight and seven assuming eco reset is successful.
Can you give us a sense for what a second pivotal trial and you see could potentially look like at least in terms of size and scale and endpoints and whether or not and I wouldn't look very different from the current eco reset study.
Yes, Mark we haven't we haven't guided as to.
To the next study and what I will say is that.
We think there's an incredible opportunity with with our our approach not only in 2007 to 301 and that's that's what's so interesting to us but there is a.
First in class best in class approach, where we've got two significant shots on goal.
And each of them are unique and.
And our significant opportunities and the run rate so, whereas we haven't guided on the next step on 287.
We think that it's important to recognize that we've got both two and two seven and 301, which are moving forward and.
We'll see what the data says and we'll see what it shows.
But.
Obviously as we as we think about the paradigm moving forward, we're preparing for preparing for success and both.
Okay fair enough. Thanks for taking the questions and congrats on the progress.
Thanks, Mark Thanks for the question.
Thank you. Our next question comes from Terence Flynn with Goldman Sachs. You May proceed with your question.
Great. Thanks for taking the questions.
Just wondering Eric if you can give us any sense of what's embedded in your opex guidance for timing of your sales force built.
And again, maybe where you stand with with specifically I know the MSL teams at the leading edge of that but just is that fully hired yet at this point or is there still more to do and then any early feedback you guys can share from payers. It sounds like youre starting to have some of those conversations but would just be curious any insights you can provide there. Thank you.
Yes, Terry and thanks for the question Great question, we have not provided guidance on opex or burn and what I will say is that.
We're continuing the efforts to move forward and preparing to commercialize the product and maybe I can ask Terry that.
Comment on.
And on some of the feedback that we're hearing from the from the payer universe, but.
Let me kind of tick off your question. So from an MSL perspective, we have started I wouldn't say that it's complete.
We've made a lot of progress since the top line result of preliminary top line results in August.
Those.
We're in the process of bringing and MSL and we're in the process of training them.
But maybe I can ask Terry to comment on the last part of your question as it relates to.
The feedback from the from the payer universe.
Do we have.
She and mute.
Sorry.
And here you did.
So it's.
And so payer feedback to date really indicates that they realize this is a defined population relative to other areas that they actively managed and it really actively managing it today.
Definitely see the unmet need and this disease state and they are very receptive to our products that can more effectively treat these difficult to manage patients and prevent the recurrent since that involve additional hospitalizations and back east.
So those whom we've engaged to date, specifically indicate a willingness to pay for innovation and this category and in fact I would point you to slide 13, and our current corporate slide deck filed today.
And what shows that payers have given tier one and in line a very high value rating really anything neighborhood as some lifesaving HCV medications.
And finally, I would tell you what the EPS or three data, we have and very strong clinical value story to share and out for.
Once you are engaged in this important customer set with the actual profile.
Yeah.
Thanks for the question Terence why don't we.
Let's take the next one.
Thank you. Our next question comes from Chris Howerton with Jefferies. You May proceed with your question.
Great. Thanks, so much for taking my questions and.
Congratulations across the board lots of progress.
So I guess for me I have most of my questions on ulcerative colitis, so with respect to the 287.
Read out here I think one of the things Thats puzzling to me and.
Just trying to figure out translation moving forward is what kind of the expected performance might be on the placebo arm.
And obviously you had zero percent clinical remission and your previous study and and some more recent results have demonstrated a little bit higher.
Of a placebo response and this mild to moderate patient population so it would be.
Be helpful to get your thoughts.
On what the expected performance might be there.
The second question that I would have is just kind of thinking a little bit closer to.
Mark's question around what the go forward strategy would be is that what is the company's view of induction versus maintenance of remission and if there would be and opportunity as a maintenance therapy.
If the induction results were not what you would have hoped or expected for.
And then the third question that I have is with respect to manufacturing I think the comments you made Eric where around the idea that your processes at the scale that you would like it to be.
But the capacity is not where you would like it to be with respect to commercial scale. So what is the process like to get to the scale that you would like and I think in particular.
And im interested in knowing if theres anything associated with tech transfers opening up new sites or things of that nature.
Yes, Chris Good morning, and thanks for the questions maybe I can let me ask let's go through these and let me ask Lisa to comment on.
And her thoughts related to the placebo arm and this patient population from 287.
Sure to your point, we do not expect the placebo response rate is zero.
And I think we've worked with some kols to try to get a sense of what could be expected. We're using central reads in terms of endoscopy at baseline so that certainly.
It helps ensure disease to start with we also are allowing patients in this study who failed biologics. So obviously that for a portion of the patient is going to mean that there are not in this group necessarily that it has a higher rate of spontaneously improving.
So we do know that it would be likely higher potentially higher than you might see in <unk>.
And to severe but I.
And I think we'll be watching closely to see if it looks like what's been seen in.
A little lower given the factors that I mentioned.
Yes.
So Chris let me, let's look your second question related to the.
The strategy induction versus maintenance I think it's worth just reminding folks that the phase II is designed to inform both the induction and maintenance.
And we have.
I think the trial will inform our opportunity and maintenance right based on the the drug mechanism of action. We believe that there's a potential to have an impact on both induction and maintenance.
We'll say, we're looking first for induction.
But by no means does that preclude.
<unk>.
And other approaches and including maintenance potentially including combination therapy, I think that the safety dimension of our approach or what we expect will be the safety dimension of our approach.
Really brings up some really interesting options for these patients.
Obviously, you have happening from both the safety and efficacy side of side of things I think crystal and the last question related to manufacturing and what I'll tell you is that we feel very good about where we are.
And of course with the phase II results.
We expect and launched product right. So.
And are building the capacity to be able to support.
That.
That responsibility to the patients and.
And it's something that we take very seriously so.
Obviously.
Even though we're at commercial scale, we will be looking to continue to augment our capacity and ensure that we can reliably supply products not only on the commercial side of things, but also and what is a growing growing pipeline. Both on the biological side of the house as well as the synthetic side of the house and theirs.
<unk> unique capabilities from both sides of that.
Okay very very good yes, thanks, Eric.
Maybe if I I don't know if you'll answer it but a quick question with respect to the.
287, and could you give us some color in terms of how many patients you might expect would have seen prior biologics.
Yeah.
And we said they want to do you want to provide thoughts on that yeah.
We certainly will provide that kind of information when we read out, but we're really not.
And ready to discuss that or have actually and accurate information probably outside the immuno Inc.
Okay Alright.
I said I really appreciate the taking the questions and congratulations and thank you.
So thanks for the questions.
Thank you. Our next question comes from John Newman with Canaccord and you May proceed with your question.
Hi, guys. Thanks for taking my questions and congrats on the progress, especially with 207 enrollment.
Great News.
And two questions. The first one is.
Back when we are waiting for the initial.
SER 109 readout last summer there was a lot of discussion among investors about.
And the role of vancomycin, and whether that would actually.
And in of itself.
And effect on the currency the feel of course, the study turned out to be wildly successful just curious if you can comment on whether the.
And the vancomycin pre conditioning that youre using for the SER 287 study really would have any effect.
Just on its own action and also see if the agency has commented at all there.
And then the second question I have is if you could just.
Confirm that.
Part of the reason that the study has been able to sort of pick up and enrollment is due to.
The greater availability of of Endoscopy as COVID-19 starts to wane. Thank you.
Yes, John and thanks for the question and.
Let me answer the second one and then I'm and I'm going to ask Matt to maybe comment on the banking license piece, but so so the reasons for it and then Lisa can.
Help me with this one as well but.
We were incredibly pleased we are incredibly pleased to be at a point of of hidden and target enrollment today.
You might remember I think many others might remember that when the pandemic first hit and in the spring and in March and April.
There was kind of seizing of clinical activity and.
And it wasn't clear at that point was that initial shock.
We would be able to enroll the study and I am incredibly pleased that we're at a point now with.
Reaching target enrollment.
Think that Theres, a number of factors that contributed John.
One is of course as you mentioned.
The rebound or maybe the improvement and the availability of Endoscopies, we required dasa piece as part of our clinical protocol and and.
That was really shut down and.
April and May that has improved continues to improve that's first and the second is we really do think that there was a benefit from.
From the 109 study, even though it's a different patient population.
The validation of the platform, we think was really helpful.
Third is certainly the need and the space just as Lisa mentioned beforehand, and the fact that.
287 is intended to serve a patient population.
Before the biologics.
And there really is a significant need there the last comment I would just make is I think the reason that we're here is that we just had an exceptional effort and performance from our team I think that we've got a group of folks that are incredibly dedicated to.
See our programs through and.
Faced adversity that a lot of folks have been faced beforehand, and the clinical paradigm and they deserve a ton of credit for that.
Lisa unless you've got something else to add maybe I can ask Matt to comment on the Vancomycin question sure No go ahead.
Yeah, Hey, John Good morning.
Yeah. So.
It's a great question about the bank of mice and pre conditioning treatment and its potential impact on the outcome of course, we use that pre conditioning.
It needs to open and ecological niche in the microbiome of patients that we're treating to allow the and grasp of the bacteria and our drug.
Bacteria and our drive our Gram positive bacteria and vancomycin is particularly active against Gram positives that we know that will compete with the bacteria are drugs and thats. It.
The basis of that therapeutic treatment.
On the FERC, the bank and by some free conditional prior to the therapeutic treatment with SER 287, we use oral vancomycin and because it's a non absorbed antibiotic with it with a very strong safety profile, that's quite well understood and.
And then in terms of its potential impact on the.
The response from CMS data Theres been a handful of publications over the years looking at the potential use of antibiotics and the treatment paradigm for ulcerative colitis and.
And the results are not encouraging.
Have not been well supported and in fact, there's been recent publication and several in 2018.
Where.
And there was actual evidence that Banco <unk> and as a standalone agent for ulcerative colitis.
It actually lead to detrimental impacts keep in mind that microbiome debt that is.
Undergoing antibiotic treatment, just like and C. Diff right can be susceptible to C. Diff and other pathogens. So it's really combining that precondition to open that niche within following that with our therapeutic treatment, which then restructure the microbiome to get the impacts that we want that we believe is driving that therapeutic response.
Okay, great. Thank you very much.
Thanks for the question John.
Thank you and I'm not showing any further questions. At this time I would now like to turn the call back over to the company for any further remarks.
So thank you operator, and thanks for everyone and for your time.
As I mentioned before him and recognizing that we had a little bit of technical technical disruption, we will make sure that the transcript is available and we look forward to connecting with EWC and thanks be well be safe and have a great week.
Yeah.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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