Q1 2021 Seres Therapeutics Inc Earnings Call
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Yeah.
Ladies and gentlemen, thank you for standing by and you're welcome to the Harris Therapeutics first quarter 2021 earnings conference call. After the speaker's presentation. There will be a question and answer session. Please be advised that this conference call is being recorded.
I would now like to hand, the call on French over 80 of our speaker today.
Dr. Carlo Tanzi of Investor Relations Carlo. Please go ahead.
Thank you and good morning, our press release with the company's first quarter 2021 financial results and the business update became available at seven a M. Eastern time. This morning, and can be found on the investors and media section of the company's website.
I'd like to remind you that we'll be making forward looking statements relating to the timing enrollment and results of our clinical studies and.
Anticipated safety profile of our products regulatory approval and the promise and potential impact of any of our microbiome therapeutics additional results may differ materially. Additionally.
Additionally, these statements are subject to certain risks and uncertainties, which are discussed under 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, and joined by President and Chief Executive Officer, Eric Shaff, Chief Medical Officer, Dr lease of our multi <unk>.
<unk> Scientific officer, Dr. Matthew Han and Chief Technology Officer, Dr. David <unk>.
Dr. Terry Young Chief commercial and strategy Officer will also be available for Q&A and with that I'll pass the call to Eric.
Thank you Carlo and good morning, everyone.
Theories entered 2021 building on strong momentum created in 2020 catalyzed by the success of our SER 109 program.
We have continued to make progress across multiple functions within the company, including clinical regulatory manufacturing and commercial collectively.
Collectively these efforts to bring us closer to our goal of translating our scientific and micro by and insights into an entirely new class of medicines to treat serious human diseases.
And since reported positive data from our phase III, SER 109, because or three study and patients with recurrent C diff infection.
Our focus is centered around taking the necessary steps to enable a high quality of BLA submission and following potential FDA approval and preparing for a successful commercial launch our immediate priority has been the complete the required SER 109 safety database through our ongoing open label study we are.
Very pleased with the pace of the study's enrollment and we are and we now expect to achieve the full 300 patient target during the third quarter of this year.
Our organization is also preparing for a successful commercial launch we believe that the substantial commercial opportunity exists for SER 109.
And the recurrent C. The population includes approximately of 170000 patients in the U S.
Our medical education and awareness efforts continue and we have recently begun to deploy our medical science liaisons we're on.
And encouraged by the positive reception, we're receiving from the medical community.
And to the high level of unmet need in the category.
The importance of medical education is critical, especially when introducing a new approach and we feel we are already making important inroads.
We are also continuing support of market assessment work, including the primary research with physicians and payers just the port launch campaign development and pricing and reimbursement decision.
We look forward to continuing to engage with patient groups physicians and payers to educate the market about the substantial value of our microbiome therapeutic approach.
In addition to the SER 109, we are advancing the pipeline of investigation of our microbiome Therapeutics led by SER 287, and our phase two be candidate for ulcerative colitis.
There are two of these seven has the potential to transform the management of this disease and intended to provide an effective treatment approach that is well tolerated with what we expect will be a favorable safety profile.
As we announced last quarter the search.
Two of the seven phase <unk> study has achieved target enrollment and we look forward to report on the topline clinical data mid year with additional mechanistic results and the second half of the year.
Two of the seven has the potential to provide UC patients with the meaningful new therapy and we also believe that this investigational therapy could be a very meaningful value driver for the company.
We are eagerly looking forward to the phase <unk> study results in mid year.
With that I'll now turn the call over to Lisa for a more detailed overview of our clinical programs.
Thanks, Eric and good morning, everyone.
I'll begin with our SER 109 program.
Sir one of nine is a first in class investigation on microbiome therapeutics administered orally following antibiotics and designed to reduce recurrence of C difficile infection.
SER 109 is comprised of purified from acute bacterial spores.
This class of bacteria was specifically selected based on the impact they have on the growth and survival of C difficile and their broader functional importance in the microbiome of individuals' without disease.
Our previously reported equals four three phase III study results demonstrated that SER 109 net.
The study's primary efficacy endpoint in patients with recurrent C difficile infection.
Showing of substantial absolute reduction and recurrent infection compared to placebo at eight weeks post treatment, which was the study's primary endpoint.
The results demonstrated a remarkable sustained clinical response rate of approximately 88% at eight weeks post treatment. The primary endpoint showed an absolute reduction of recurrence of CDI of 27% compared to placebo at eight weeks post treatment and.
And the relative risk reduction of 68%.
Study results show that SER 109 administration resulted in similar efficacy when examined by group stratified by age or by the prior antibiotic therapy.
Additionally, the phase III data to demonstrate that SER 109 efficacy is maintained over the duration of the 24 week study.
We are very pleased with our SER 109 clinical data and we believe that the clinical profile observed is highly differentiated from other therapeutics and development for recurrent CDI.
In addition to the differentiated clinical profile series of employees various manufacturing processes to support patient safety, including steps designed to inactivate and remove vegetative bacteria parasite and viruses we.
We believe these processes help to minimize risks for patients even from emerging infectious diseases, where diagnostic assays and may not yet be available.
We believe that our approach provides SER 109 with distinct safety advantages compared to minimally processed investigation on microbiome approaches.
From a tolerability perspective, we observed a highly favorable safety profile with SER 109 adverse events being similar to placebo.
And we're working towards publishing and the remarkable SER 109 phase III study results and a leading journal.
Overall, we believe our SER 109 phase III data represent a substantial advancement over the standard of care with the potential to fundamentally transform how CVI is managed.
Furthermore, we believe that SER 109 has the potential to meaningfully improve outcomes for patients with recurrent CDI of disease that results in the death of over 20000 people and the U S. Each year.
From a regulatory perspective, the SER 109 eco score of three study results far exceeded the efficacy threshold communicated to us by the FDA for the study to serve as a single pivotal trial.
As a result, we expect the single study to provide the efficacy basis for our SER 109 BLA filings.
The FDA has also communicated to us that at least 300 patients will be required for our SER 109, and safety database to support a BLA and product approval.
To this and we continue to enroll our SER 109 open label study and patients with recurrent CDI and as Eric mentioned, we have made excellent recent progress with this study we have added dozens of new clinical sites across the U S and Canada beyond those included and the phase III and we have seen.
The physician enthusiasm for SER 109.
We have also recently modified the open label study protocol to enable flexibility and the testing method used to diagnose patients entering into the study.
We expect this change to facilitate patient participation and the study and access to SER 109.
I'm happy to report the tier one of nine open label study is now over two thirds of enrolled and based on recent trends, we expect to achieve target enrollment during the third quarter of this year the.
FDA has requested that six months of safety follow up be included and the safety database and completion of the safety database will support our BLA filing and potentially enable SER 109 to become the first ever FDA approved microbiome therapeutics.
Now while the specifics of any potential product label would of course dependent on discussions with the FDA during BLA review.
Our expectation is it SER 109 could be indicated for the broad recurrent CDI patient population.
<unk> estimated to include approximately 170000 individuals in the U S on.
Also we would not expect the specific labeling requirements regarding diagnostic approach and this is typically left of the discretion of the treating physician and reflects local practice factors.
System with these expectations. The SER 109 open label study includes enrollment of the broad recurrent CDI patient population.
Next let's turn to our ongoing SER 287 phase <unk> study and patients with mild to moderate ulcerative colitis.
SER 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.
Several lines of evidence suggest that the gastrointestinal microbiome May act as an important underlying cause of inflammation in patients with ulcerative colitis SER.
SER 287, and designed to modulate the microbiome and these patients and potentially provide a much needed non immunosuppressive treatment option for UC.
Furthermore, because of the safety profile that we expect from our approach we believe that the SER 287 has the potential to also be used in combination with other approved agents.
Data from our completed Phase <unk> study demonstrated the SER 287 of administration was associated with the safe favorable safety profile as well as high rates of clinical remission endoscopic improvement and modulation of the gastrointestinal microbiome the.
These results and data supporting the underlying mechanisms of action were highlighted as the cover article and the January 2021 print edition of the peer reviewed journal Gastroenterology.
We are currently running of SER 287 phase <unk> study termed eco reset.
This is a randomized placebo controlled three arm induction trial.
The study is fully enrolled with 203 patients with active mild to moderate ulcerative colitis, who have had an inadequate response to prior therapy.
And in arm a patients receive a short course of vancomycin pre conditioning, followed by 10 weeks of the same daily regimen that was used and the arm of the previous <unk> study that showed the highest clinical remission rate.
In RMB.
And as receive vancomycin pre conditioning, followed by two weeks of the same SER 287 daily regimen used and army followed by eight weeks of a lower dose.
And our C patients receive placebo.
We expect top line clinical results from eco reset in mid 2021.
As a well designed and meaningfully sized phase <unk> study, we expect this to be a data rich study read out that will enable us to make well informed decisions regarding further development in.
In addition, we expect to obtain a great deal of information about the mechanism of our microbiome drugs and you see patients that will continue to inform our UC franchise and microbiome targets and other indications.
Clinically our primary objective and the phase <unk> study is to demonstrate that figure of $2 87 results and a significantly higher proportion of patients achieving clinical remission and those administered placebo.
In evaluating our upcoming data we plan to carefully examined and the overall rates of remission across the study cohorts and we will also exam and the impact of SER 287 on important secondary measures such as endoscopic improvement.
We believe that the safety of our microbiome therapeutic approach based on commensal healthy bacteria is of major advantage and anticipate that the safety profile of SER 287 will be highly favorable, especially as compared with current treatments, which are often immunosuppressive and expose patients to significant risks.
<unk>.
We expect that if we are able to achieve our target clinical profile, showing clear efficacy and favorable safety and with an orally administered therapy SER 287 could represent a highly attractive new medicine with the potential to transform the management of UC.
287, and could have the potential to provide mild to moderate UC patients representing the majority of all of UC patients with a novel and effective treatment option that is 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 from modulating host immunity.
We expect to gain important insights from our pending phase two b clinical data and from microbiome biomarker data coming later this year.
Both will inform the further development of SER 287, as well as that of SER 301, and other future compositions designed to modulate host inflammation and immune pathway signaling.
With that I'll now turn the call over to Matt.
Thank you Lisa and good morning, everyone.
<unk> continues to invest and focus on our reverse translational discovery and development platform that can delineate 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 to these models to evaluate drug and mechanisms of action.
And the design consortia of bacterial with specific pharmacological properties. Our drugs are designed to target and multiple disease relevant pathways. We reported earlier this year at the Keystone Microbiome Symposium on SER 109 phase III predefined microbiome readouts that confirmed the drug candidates mechanisms of action.
Let's see one of the nine phase III study data demonstrated that the bacterial species and the drug rapidly and graft into the gastrointestinal track and graphic was observed as early as one week post treatment and found to be durable through 24 weeks the.
Presence of SER, one of the nine bacteria with significantly greater and subjects that received SER 109 versus placebo and all of differences were maintained and all subpopulation of novelty.
Tier one and nine administration and also rapidly shifted the gastrointestinal and metabolic landscape. As an example, there was a significant decrease and primary bile acids, and an increase and secondary bile acids, providing a mechanistic basis for both the inhibition of C difficile, spore germination and vegetative growth.
Notably and early time point sample of C difficile and other bacterial pathogens known the hardware antibiotic resistant genes were significantly more prevalent and placebo treated subjects. These.
And these data confirm observations from series prior trials the tier one and.
And it resulted in a reduction of other clinically relevant bacterial pathogens the.
Detailed mechanistic learnings we have obtained from several of the nine combined of our ability to link these learnings the clinical outcome and confirm observation human subject and the non clinical studies to demonstrate causality of proven immensely beneficial and we continue to apply this knowledge to the design of future plans microbiome therapeutic competitions.
Moving now to our SER 301 program.
SER 301 of the next generation orally dose rationally designed cultivated microbiome therapeutic candidate for the treatment of ultra quite of the consortia of bacteria and tier three and one of its designed to modify the microbiome and microbe associated metabolites and the gastrointestinal tract to reduce the presence of pro inflammatory bacteria and modulate.
And linked to gastro intestinal inflammation and epithelia of barrier integrity and patients with ulcerative colitis.
301, the design using series of reverse translation of discovery and development platforms. The.
The design incorporate learnings from our SER 287 phase <unk> study related to the bacterial species and the microbiome functional signature associated with clinical efficacy. Additionally, the design took insights related to the and graphic dynamics of different bacteria and also the association of specific factory with the modulation of inflammatory.
And on the impact of in human subjects that have been observed across our broader clinical portfolio and confirmed using our non clinical human cell based assays and in vivo models as.
As a result, the unique composition of tier one on the tier 301 was designed to optimize drug species and graphics and the pharmacological properties that our clinical and preclinical research have identified as a potentially important microbiome drivers of the treatment effect.
We expect that we will continue to learn more about the activity of our microbiome therapeutic approach and also quite of from the SER 287 phase II results and that these translational of earnings will continue to inform of future development efforts and this indication and and biologically adjacent disease indications.
We are currently enrolling of fear 301 phase <unk> study in adults with mild to moderate ulcerative colitis. This study and being conducted in Australia, and New Zealand, where the target enrollment of 65 patients and total the objectives for this study are to evaluate drug safety and pharmacokinetics and to evaluate clinical remission and other <unk>.
And the efficacy of secondary endpoints.
Moving now to SER 155.
So the 155 and an orally dosed rationally designed cultivated microbiome therapeutic candidate designed and decrease the incidence of gastrointestinal bacterial infections, bacteremia and graft versus host disease immuno compromised patients receiving allogeneic hematopoietic stem cell transplantation.
SER 109, five builds on our expertise and both infectious disease and immunology and is designed to both prevent bacterial infections, particularly those that harbor antibiotic resistant bacteria and the onset of graft versus host disease.
The fear of 155 program is supported by our Carb X grip that provides the financial and operational support.
Excellent recent progress towards advancing the tier one and five five in the clinic and collaboration with our partners and Memorial Sloan Kettering cancer and chip.
We expect to initiate clinical development later this quarter.
Turning now to our earlier stage pipeline we.
We are evaluating a number of potential new indications for our microbiome therapeutics or clinical programs and our reverse translation discovery platforms continue to provide meaningful insights and knowledge of the underlying mechanisms by which microbes and the Gi tracts engage pathogenic bacteria and human cells and tissues to impact the.
Moreover, advances and series of microbial cultivation, and bio processing Knowhow and commercial scale GMP capabilities continue to advance and broaden access to the diversity of microbes and the human Gi that can be harnessed and potential new product candidates and development programs on.
Now I'll turn the call over to Dr. David <unk>, our Chief Technology officer to provide more color on series differentiate it manufacturing capabilities.
Thank you, Matt and good morning, everyone.
We believe that series GMP manufacturing and quality control platforms are important core capabilities that provide our company with meaningful competitive advantage.
First and foremost is our differentiated products safety profile.
<unk> and activation and clearance steps are incorporated into the manufacturing process and validated coupled with rigorous GMP product testing using proprietary assays.
These measures are designed to maximize the patient safety, including against emerging pathogens, such as Sars COVID-19 two.
Second series has developed considerable proprietary expertise and knowhow regarding how to efficiently produce and test and aerobic bacterial strains and both the vegetative and spore formulations.
Our differentiated strategies and pursue both donor derived and cultivated rationally design complex consortia.
Has been highly synergistic and gives us a substantial technical advantage and how we advance our pipeline.
We believe these investments and manufacturing and quality control over many years now put series and a strong position to reliably support late stage development of our pipeline and commercial supply as well as the early stage programs.
And with that I'll now turn it back to Eric.
Thanks, Dave the day.
Details of our quarterly financials are included in this morning's press release, so I won't reiterate them here series ended the first quarter 2021, with approximately 272 and $5 million of cash cash equivalents and short and long term investments.
As we conclude our remarks I'd like to recap several of the important milestones that we're looking forward to during the remainder of this year.
Include first achieving full enrollment and our SER 109 open label study during the third quarter of this year.
Continued progress executing on theory of 190 pre commercial readiness, including our market education efforts.
Topline clinical results from the third of too many set of phase <unk> study midyear and.
And continue the enrollment of our SER 301 study and the advancement of our SER 155 study into the clinical development.
Our organization also continues to work to extend our microbiome therapeutic leadership position.
And your 109, we expect the paved the way towards achieving the first ever approved microbiome therapy.
Along with what we believe could be sort of wanted to and best in class of clinical profile. We expect to have a substantial first mover advantage that will support successful commercialization we were on.
Also continuing to make progress advancing our pipeline and we expect that in the coming years, we will be bringing additional new microbiome therapeutics into late stage development and hopefully the patients seeking new treatment options Phi.
Finally, we are devoting the meaningful resources to strengthen.
Our already feel of lead and core capabilities, including those focused on microbiome drug discovery and as well as with our advance microbiome manufacturing capabilities.
Supported by the solid Foundation, we believe the series is well positioned to continue to drive the microbiome therapeutic field forward.
Before I conclude I'd like to mention that as announced in our press release. This morning, we will be holding a virtual investor event on June 21.
Focus on ulcerative colitis, including a detailed review of our SER 207, and tier three of one programs.
This should be a very interesting program that will include one of the leading academic experts working and the area and we hope that you'll be joining us.
With that operator, and will turn the call over now the questions.
Thank you.
As a reminder, the asked the question. Please press Star then the number one on your telephone keypad.
And Thats Star one to ask the question.
Please stand by while we compile the gaining of Austria.
Okay.
Your first question comes from Mark Wade and back from Oppenheimer. Your line is open.
Hey, good morning, guys and congrats on on the progress this quarter.
I was wondering if you could first give us a little bit more color on the modification to the testing methodologies and thats being used to qualified patients for enrollment into the open label study of SER 109.
Yeah.
Sure Mark Good morning, and maybe I'll ask Lisa to comment on the on the BSA.
Sure so.
Recall that this is an open label study with no placebo arm and as such we wanted to facilitate as much access as we could for this population and this clinical trial. So physicians are now going to be able to use their local testing for study entry.
Toxin based testing approach will still be used to evaluate any potential recurrence while on study but to enter the study.
They can use whatever methodologies used at their institution or in their area.
Okay got it.
Also wondering if you can offer any guidance on the timing of data from the share of 301 phase one b and if you see the possibility of meeting modify sort of 300 one's composition and based on the insights you get from the microbiome biomarker data of eco.
Hi.
Yes, Mark let me maybe I'll answer the first part of the question and I'll ask Matt the comments on the second night.
We haven't provided guidance except to say the.
We're making great progress on 301, and we're thrilled to have.
What we think is a franchise within the UC and the IBD space right. We've got two of the seven we've got 301, there are different different shots on goal of different opportunities 301 is being studied in the.
And a one day study in Australia, and New Zealand, we've made great progress I think it's a technological achievement that we've been able to to construct this this cultivated or synthetic approach based on the learnings from the one the one day study from <unk> 87, but at the same time.
And incredibly excited about the signal we saw on the one day stays from 287 and and we're thrilled about the opportunity to see these and these.
We just happen to be the study results and midyear, maybe I can ask the Matt just to comment on the learnings from one of the other and how we think about that in general going forward.
Sure Good morning, Mark.
So as a reminder of SER 301 of the consortia of bacteria that was designed to reduce induction of pro inflammatory activity improve epithelial barrier integrity, and TNF alpha driven inflammation and epithelium cells and then also the modulate various different use development of anti inflammatory and Nate and adaptive immune pathways and and as we talked about previously the.
Results from the 287 phase <unk>, we're certainly part of the design and and use their for example of understanding which specific bacteria are.
<unk> with clinical remission, which bacteria and grafted and different and different patient population, but importantly, the design of SER 301 also includes that.
And that type of knowledge from across our clinical portfolio and our broad preclinical work, where we have been working to identify specific bacteria that modulate various different innate and adaptive immune pathways and so the way I'd like to think about 301 was that it was designed to optimize the drug species and grafman and the pharmacological properties.
And our our clinical and preclinical research and have identified a potentially important microbiome drivers of the treatment effect and so while there are similarities between the drug there are also differences in terms of the.
The targets that are that are that are optimized we will of course continue to learn from our portfolio. I think this is one of the values and Differentiators for series of debt we have.
And both biologically sourced more complex consortia as well as these defined the consortia both of which are in the clinic and we.
Can continue to and.
Prove our insights around and which parts of the microbiome are most important and and continued to design those into our drugs, but we have a high degree of confidence and both both of the 287 and 301.
Got it and when.
One final one from me.
And I'm just wondering if we can expect any clarity on European regular regulatory requirements for sort of 109 later this Europe if that's on.
So it's something we might get some news flow on in 2021.
Yes, Mark we're continuing to work with our partners at Nestle.
They were thrilled with the.
The phase III study results and.
And we're engaging with with Nestle, who owns ex North American rights.
Two two SER 109, and we continue to engage with the.
The non FDA regulators and the.
And those discussions continue.
Okay. Thanks for taking the questions and congrats again.
Thanks Mark.
Okay.
Your next question comes from Joan Tong from Cowen and company. Your line is open.
Hi, there and thank you for taking my questions first one on the open label SER 109 study.
Is there any way to estimate maybe how what proportion of patients would have only one recurrence and the study and do you think the proportion of patients that do have one recurrence.
And any of the Fda's labeling discussions.
And then maybe one on SER 287.
And just when we're thinking about remission rates here is there a level that you are shooting for and then the enrollment patient population is a little bit depends on the phase one b. So how should we be thinking about kind of the data and the context of what we've already seen from the program. Thanks.
Yes, Jeff Thanks for the questions and I think I'm going to ask Lisa to comment on both of the as the first one was just the.
As a reminder, in the open label study, we had asked the FDA to allow US to include the first referred subjects.
To which they agreed and we were pleased with that.
And that response and of course that opens up the pool of patients available to us.
In terms of enrollment for the open label study, but we also think and lease who made the comment on her prepared remarks that of course, the label will be determined and that's part of the negotiation with the FDA as part of the BLA process. It's an encouraging data point as we think about the field and how they may be looking at those.
Lisa do you want to comment on on Joe's question regarding the.
The the proportion of the first occurrence versus multi the multiple recurrence and.
And the in the.
And the open label study and and how we think about the the label and then maybe I'll ask Luis to comment further on on expectations around 2% to seven and with our midyear readout.
Sure.
Can't really estimate right now I mean, the trial is ongoing and I mean, we're really enrolling at a pretty good clip. So I mean, the profile could could change on the at any particular moment I would say that medically we view the first recurrence.
And our Kols the first recur and second recurrent all have the same pathophysiology based and the fact that they've had and initial.
<unk> of C. Diff, they've shown that they're microbiome is not resilient enough to keep C. Diff under control and they start in on this recurrent cycle. So.
How many first recurrence versus others, it's going to be subject to a lot of factors and I really couldn't give you a specific number.
And then did you want me to.
Take the next question as well or did you sure why don't you comment on two of the as evident as we think about expectations.
Yes, so recall that we're in mild to moderate ulcerative colitis and this is the biggest group of patients out there and the UC space.
Right now they can be on five assay, which is where many of them are and there's a big toxicity GAAP. If you will in terms of having the jump up into a much more.
The significant set of toxicities for the next therapeutics steps, so theres a lot of white space between five assay and the next thing. So we're looking to find a to have a therapy that provides a meaningful benefit of clear safety profile and is oral.
And with that I think these patients or smoldering alone on their Fi the essay and unable or unwilling to move to the next step we will have another option.
Okay. Thank you very much.
Thanks for the question Joe.
Yeah.
Your next question comes from Anthony <unk> from Piper Sandler Your line is open.
Hey, good morning, everyone and thank you so much for the update of exciting progress. My question is kind of has to do with sort of some of the commentary you were making on the manufacturing side, so with respect to the clinical supply for.
Auto lowering.
207, and also 301 with the fermentation is one that currently done in house or outsourced and if the outsourced when will it be broad and thank you.
Yes, hi, and thanks for the question and maybe it's worth a little bit of.
Per.
Respective her background and then I'll ask Dave to comment from PS.
With us this morning, and I think.
David is illustrative of some of the pivot that we're making of the company from from clinical to commercial but.
When the company was founded there was I think and appreciation that debt in order to really control your destiny of the new modality.
The fracturing and owning key aspects of manufacturing will be critical.
I think there is and general and underappreciated and of the importance of of what we do from the CMC perspective, and the quality perspective, and the fact that debt those capabilities both from the biologically sourced side of the house as well.
Synthetic or the ultimate inside of the house, they're just simply not commoditized right. So.
There is there is key steps and both sides of the house that we control that we own.
And that we think are again non commoditized.
We do work with outside parties for certain aspects of the supply chain and.
And the fashion and process, but but certainly we think that theres key capabilities that we've built up over the last decade.
And that position us to move forward and both sides of our platform.
With quality and with speed and maybe I can ask Dave just to comment a little bit further on that.
Sure, Thanks, and nice to be with you and I just we just had so.
Indeed, I have been with the series a little more than six months now and I've been really impressed with the work that they have gone to invest and and <unk>.
Both sides of the technology that that we're talking about here both of those donor derived programs as well as the COO.
Cultivated from added programs.
And so we do have the capability to support the pipeline of clinical supply for for both sides of that house and I think it's also really important to emphasize that the series has capabilities and enter.
The aerobic bacteria, both explore and non spore forming formulations and so we really see that differentiating us in terms of our internal capabilities and and with strategic partners that we do have to ensure that we're successful.
That's really helpful and I appreciate.
I appreciate the approach thank you very much.
Thanks for the questions debt.
Right.
Yes.
Your next question comes from Chris Howerton trend and Jefferies. Your line is open.
Thanks, so much for taking the questions and obviously very exciting times for the company.
Alright, so maybe maybe from me just a couple of kind of reminder, housekeeping questions might be most helpful.
First with respect to.
The BLA submission for SER 109.
Once kind of the open label safety database is completed can you kind of and just walk us through what the expected next steps and timeline might be.
And for that program.
And then yes go ahead of Exane.
Yes, sorry, Chris.
So.
We're continuing to do the work across functional areas to support the BLA I think we've said before and I'll reiterate this morning. The open label, we feel it's really the key critical path item in terms of moving forward. So as we said this morning, we're very pleased with the progress where over two thirds of enrolled.
Obviously, we've got the follow up as Lisa mentioned following the full enrollment that we expect on the third quarter.
We're continuing with the work around other aspects of the BLA.
And we expect to be and a good position following the open label completion.
Got it okay, and I think of it and then maybe just a couple of other ones if I may the.
I can't remember if we've discussed in the past just maybe are you expecting to have an advisory committee for this program would be another kind of just general housekeeping question.
And then the second maybe category could be as we're kind of approaching commercialization as well as some very meaningful readout and certainly for 287 can you remind us of what.
Any milestones might be achieved from your relationship with <unk> and any other.
If you want to remind us kind of what the commercial relationship is there for 192 and then the third question I guess, maybe is from Matt which is.
I think it's interesting that will get the.
On top line remission type data for 287, initially and then the biomarker data later, so just would love to hear your perspective on what that additional information, which would add to the story at that time. Thanks.
Sure. So let me I might lose the the mix three questions, but I think we start with the question around Advisory Committee.
And maybe Lisa can comment I think our expectations of that.
It's certainly possible that we would have an advisory committee and maybe Lisa If you Wanna comment then I can take it back with the model question I think just as you said we would.
Eric said, it's a new modality totally new modality, so our expectation would be yes.
Yes.
We have not guided future milestones with Natalie Chris except just to remind folks that they've been a terrific partner for us.
It was a great deal that with them.
In 2016.
Their support has been critical for the company and the last couple of years.
And but we have not guided as to what future milestones would be from them for a clinical or commercial progress I will remind you that.
Net fleet owns ex North American rights to SER 109.
The commercial right so certainly.
As we have kind of driven the bus from.
From a clinical and regulatory perspective, and the U S. And then those responsibilities and or ownership lies with them ex North America and then the last question around 2% to seven I think of it for eight one and maybe I'll ask Matt to take that one just in terms of what we're expecting from a from what we may learn from a.
From the microbiome analysis from two of the seven I think Matt might of comment on this a little bit earlier, but the networks to take that one.
Sure. Thanks, Zack good morning, Chris.
Yeah. So thanks, thanks for the question.
Lisa said earlier I think first and foremost we got to remember this mild to moderate patient population is a is of major unmet need weighted that way.
And there's a real GAAP and also one of the least studied populations and you see so the SER 287 trial. The phase II trial was designed with all of our trials of our to be translation of the rich.
And including a fair number of time points, both and induction and maintenance.
Where we can evaluate the types of things, we typically evaluate which of the bacterial species that are the R&R and grafting, how is that driving broader changes and restructuring of the microbiome in terms of other bacteria that may either be pro inflammatory or other factor and we know play important roles.
And host immunology.
And then importantly digging into both the.
Functional changes that happen as a result of those changes and the microbiome and then also how changes in gene expression and.
On the coal and an epic epithelia, the barrier change and response to those changes and and I think where we are of the company as you know we've been investing heavily in.
And into our research engine of the company for 10, plus years now where we have a broad strain library of bacteria that are that are functionally characterize that are genetically characterized various different proprietary datasets.
And we can generate high resolution.
Information on species, and even strains and species.
All of which allow us to really dig into the key underlying mechanisms of the drug and identify which bacteria specifically associated with clinical remission or endoscopic improvement.
And as well as what metabolites matter and then I think the real power of our platform as we've invested just and significantly and all the various preclinical assays and human customized human cell based assay for doing microbiome studies and in vivo models, where we can take our learnings about those bacterial signature and biomarkers and the clinic and actually test cause.
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And the laboratory setting and it's the basis of that kind of work that has been at the heart of all of the rationally designed consortia as well.
Well.
Certainly do appreciate the add Matt and I think.
On the great work that you've done to kind of develop all of this and the field is certainly appreciated by me and so so thanks for answering the questions as well.
Thanks, Chris.
Thanks for the question on growth.
Yeah.
Your next question comes from Terence Flynn from Goldman and check your line is open.
Great. Thanks for taking the questions.
Just wondering if you could give us an update on where you stand with 100 on commercial prep and any latest perspective from payer conversations you might have had lately. Thank you so much.
Yes, Terence Thanks for the question, we continue to do work as we are.
Outlined in the prepared comments, but maybe I can ask.
Terry to comment a little bit more specifically on your question.
Sure. Thank you Terrence and on <unk> com.
Well, we've been quite busy even since our last earnings call and getting ready for commercialization and so I think Eric had mentioned some of the profits remarks, but and particular scaling our market education efforts right. We have an enormous effort around medical communications planning, which is included of law.
Deploying and MSL force.
And to the field.
We're also obviously doing an enormous amount of published publication.
Application planning as well as Congress involvement and abstract presentations at upcoming Congresses.
So the more and more of the data from the very successful acres force III trial, we will be reporting out.
Led by weeks of our Multis team and medical Affairs.
And also developing moving kind of to the payer.
I'll kind of dip in and out and then I'll go deeper into that at the end of my remarks.
We're developing and deploying a robust pay your value proposition, obviously with the help of those very important customers and we have lots of talk about with tier one of them on and so really narrowing the focus to what is important and most important inc.
To that very important customer audience and it's really the work that we're doing we have a great story to tell the feedback has been very positive.
We're also continuing to enhance our understanding of the commercial opportunity set many physicians, we have work underway to do that and really prioritize the physician audience in terms of who we're going to reach win and to prepare for launch we continue to do pricing and reimbursement analysis sort of in parallel.
And that value proposition work and what about the infrastructure I mentioned that the plumbing of the MSL team. We're also hiring of higher debt couple of commercial leadership all of the plate and we're beginning to build out the team.
And the double clicking on the payer of little better I think you may have noticed and our slide deck on our website. We have the slide deck kind of summarizes the feedback that we're getting from payers and physicians that but what I would say is that the Hague of reception has been quite positive they recognize the value of that tier one of the nine and framing.
And they actually.
And you look at the value rating nature of it is very similar to that but not the recently launched a lifestyle. The HCV medications like first of all of the <unk>. So we're quite pleased with the response to the profile and our task now is to as we move forward to launch we have plenty of debt. We have time to do this but determined the right pricing corridor works.
And with these external customer.
And now I'll turn it back cash back.
The next question.
Your next question comes from building Shang from JMP. Your line is open.
Hi, and congratulations on the progress was hearing the ninth and thanks for taking the question I guess from me just curious I know Corona virus World, where we're seeing for example, lower rates of flu and and.
And probably increases and other diseases are you guys seeing any differences in terms of.
The CDI and the populations and compared to what it was before and would be curious if you can share of any comments about how patients are.
Doing on efficacy wise.
With the first time.
And I versus what was studied and the open label and and or if not maybe you'd be willing to help us.
How we should be thinking about the and then related to the prior program that you guys had and development I believe this was.
And one or $2 62, maybe four primary CDI.
The assuming theres a label that allows your broad applicability.
How should we be thinking about 262 coming forward if that all of them. Thanks.
Yes.
A few questions here, maybe I'll try to.
In terms of the Corona virus of good question in terms of are we seeing.
The fewer cases all of you can tell you that the.
There's only some of these data points that we have one of the data points of just the enrollment and the open label study right now.
From that perspective, I think we feel strongly that particularly with.
On the profile that is available with SER 109.
We have a lot of confidence is continues to be a major issue and sometimes.
When you have the type of profile of our step function, the advancement and the potential of helping patients that would that we're showing with one of nine.
The opportunity becomes even more acute so so in terms of those data points I think for where we.
And we certainly continue to be comfortable and confident that theres, a major unmet medical need that we can help.
In terms of efficacy and the open label.
And we.
We don't have that sort of maybe not commented on the data on all of the data.
On 206 two.
Let me just comment that I think that there is of major franchise.
Franchise scared that we're thinking about obviously with the data on 109.
We're thinking about how we can help patients across.
Certainly not just and.
Infectious disease or feed it but certainly the the our opportunity set and another indications more broadly, but within one O nine.
Within the currency of the population with the.
See the population we are thinking about other ways in which we can help patients and we're actively.
Involved in discussions on that I will say our efforts has been really titrate and focused on getting 192 patients first.
But certainly we're thinking of what other opportunities del patients within that franchise.
Thank you.
Thanks for the question.
Your next question comes from Gary non Bernardino from HC Wainwright and tool.
And.
Okay.
Hi, everyone and congrats on continued progress with all of the clinical programs definitely looking forward to.
The total of one of the name of review and approval.
The only question I had left was could you remind us what's <unk> role is and one on commercialization.
They currently are doing to prepare for the launch and will you provide any details on the results of your market research and Terry will provide some details I think.
And our thing.
And that you might talk about but just wondering what kind of details.
The deal from your market research. Thanks.
Yes, just just to remind you and and.
Group.
Nestle has ex North American commercial rights to two SER 100 on and so so series of loans.
S rights and.
And North Africa, and North American rights to consider one of the commercial.
So that's the structure of that relationship I do think we put out a fair amount of detail.
Including in our corporate deck related to some of the findings from from Terry's work and Terry has provided the.
And some additional color on the comments around that and I think it's likely that we'll continue to do that as we move forward but.
Bottom line is the the reception that we're getting from the field.
And has been continues to be very positive and gives us a lot of confidence in and.
The commercial opportunity and this age of going forward.
Non user defined comps non as defined.
Analog.
And it's simply just because there really hasnt been the the combination of efficacy and safety that we saw and vehicles forecasted results. So we do think that sort of wondering is going to stand by its own and.
And we're thrilled with the opportunity to operations with it.
Okay and.
Can you comment on what he.
He is doing ex North America.
Well as I mentioned before.
The processing the phase II results.
And we're in discussions with them around next steps and we continue to be and discussions with the ex North American regulated bodies as well in terms of how we move forward.
Okay. Thank you, we'll be staying tuned thanks, Greg.
Great.
Thanks, Brian.
Okay.
There is no further question and this time and make the thing.
So thanks to everyone and we appreciate your time. This morning, we look forward to continue the update you on our progress.
Including at our U C Investor event on June 20 <unk>.
And the healthy and well and have greatly and we look forward to speaking with you soon thanks very much.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participating you may now disconnect.
Yeah.
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