Q3 2021 Seres Therapeutics Inc Earnings Call
Good day, and thank you for standing by welcome.
To the series of Therapeutics third quarter earnings Conference call.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
Ask a question during this session you will need to press star one on your telephone please be advised that today's conference is being recorded.
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I would now like to hand, the conference over to your Speaker today, Dr. Carlo Tanzi Investor Relations. Please go ahead.
Thank you and good morning, our press release with the company's third quarter 2021 financial results and business update became available at seven am Eastern time. This morning. It can be found on the investors and news section of the company's website I would like to remind you there will be forward looking statements relating to the timing enrollment and <unk>.
So our clinical studies.
Anticipating the safety profile of our products regulatory approval. The success of our agreement with <unk> Health Science, the anticipated market with SER 109, and the promise and potential impact of any of our microbiome therapeutics.
<unk> results may differ materially. 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 in the future, but we disclaim any obligation to do so.
On today's call with prepared remarks, I am joined by our President and Chief Executive Officer, Eric Shaff, Dr. Lisa on multi our Chief Medical Officer, David <unk>, Our Chief Financial Officer, and Matthew Pan Our Chief Scientific Officer.
During the Q&A portion of the call. We will also be joined by Dr. Terry Young our chief commercial strategy Officer and Dr. David <unk>, Our Chief Technology Officer, and with that I'll pass the call to Eric.
Thank you Carlo and good morning, everyone.
The last several months has been a productive period for series, So where we have meaningfully advanced our microbiome therapeutic pipeline.
Our key recent highlights include the completion of enrollment in our open label SER 109 study.
The advancement of this program towards the BLA filing for recurrent C difficile infection and actions we have taken to prepare for a successful product launch.
We believe that SER 109 has the potential to become the first ever FDA approved microbiome therapeutic and important milestone for this emerging class of medicines.
We have also continued to perform microbiome data analysis following our <unk> seven phase II clinical results in ulcerative colitis announced earlier this summer our expectation is to communicate those results before the end of this year.
To remind you of the development progress of SER 109 during the summer of 2020, we announced successful phase III study results in patients with multiply recurrent C difficile infection.
These efficacy data surpassed statistical threshold that had been communicated to us by the FDA and as a result, we expect the data of this study to provide the efficacy data in support of our BLA filing.
The FDA had also communicated that our BLA filing should include a safety database of at least 300 subjects dosed at the phase III dose and with a 24 week follow up.
Following the phase III results, we enrolled an open label study to gather the required safety data to support this filing.
Notably in following discussion with the FDA. Our SER 109 open label study also includes patients with a first recurrence of C. Difficile infection and expanded patient group compared to the phase III study population, which included patients with multiply recurrent CDI.
In September we were pleased to have achieved target enrollment with our open label study of SER 109 in patients with recurrent CDI.
We were highly encouraged with the pace of that study's enrollment and believe that the accelerating rate of enrollment that we observe reflects an increasing level of interest about SER 109 within the physician community.
There is clearly demand for a new approach to treating our current CDI and we believe that the physician community is eager to see SER 109 become commercially available.
Recently, we initiated a SER 109 expanded access program at multiple sites across the United States.
This important program is designed to enable adults with recurrent C difficile infection to obtain access to SER 109 prior to a potential FDA product approval.
We continue to remain on track with our plan to begin a rolling submission of the BLA for SER 109 in the first half of next year and finalize the submission, including the required six month data set from the ongoing safety study in mid 2022.
Looking forward, our top corporate priorities are to be or to prepare for a high quality Center 109, BLA filing and alongside Nestle Health Science, our commercial partner, we are working to ensure that we are well positioned for a successful SER 109 product launch.
The approval and launch of SER 109 would represent a landmark event for the field and our organization continues to prepare for all aspects of a successful commercial launch.
We believe that SER 109 represents a substantial commercial opportunity for series the.
The cost of a patient with recurrent with a recurrence of CDI has been estimated to result in approximately $34000 in annual direct healthcare expenses.
The recurrent CDI population includes approximately 170000 cases in the U S.
And we believe we have the opportunity to address this entire patient group.
These patients do not have attractive treatment choices today.
Some of these patients are currently being provided regimens and procedures that are not FDA approved including fecal microbiota transplantation and extended courses of antibiotics.
All of these approaches approaches have important limitations and based on our discussions with health care practitioners there isn't the ear, an eagerness for new safe effective and FDA approved treatment options. We believe that SER 109 could could provide a transformational new therapeutic option for Rick.
Current CDI and we are working with urgency to bring our therapeutic forward to the market as quickly as possible.
We recently announced the collaboration with back Sara.
A global leader in biopharmaceutical product manufacturing that further increases our longer term commercial product supply.
Following this agreement <unk> is establishing a dedicated facility for commercial manufacturing and its new microbiome center of excellence.
Manufacturing site dedicated to the production of live biotherapeutic products located in Switzerland.
We look forward to partnering with <unk> to expand upon our existing product production capacity to meet demand growth beyond the initial phase of launch.
And help ensure eligible patients can receive this potential new treatment option.
Following our SER 109 phase III study results.
One of our key initiatives has been to educate the medical community about our investigational therapeutics and our clinical data.
I'd like to now pass the call to Lisa to review several important datasets that we have presented at recent medical meetings.
These data reinforce the remarkably strong SER 109 clinical profile and provide notable findings regarding the potential application of our microbiome therapeutics and new indications.
Thanks, Eric.
<unk> 109 phase III study with a data rich trial and since obtaining the initial top line results in July of 2020.
Presented various datasets at a number of prominent conferences that are well attended by leading infectious disease physicians and gastroenterologists.
Last month, we presented at both IV week and at the American College of Gastroenterology annual meeting.
In total we presented eight posters and one oral presentation and.
In addition at I'd week, we sponsored a talk led by Dr. Paul for you Scott leading academic expert in the CDI field on the disease pathogenesis and the potential rule for microbiome therapeutics.
At the meeting we presented data from our lead SER 109 program as well as on our earlier stage SER 155 program.
I'd like to highlight some of the key results recently presented.
Data from an exploratory analysis presented at the ACG meeting in a late breaker poster session demonstrated that SER 109 reduced the risk of recurrent CDI compared to placebo, including in patients with significant risk factors for recurrent.
This includes those taking acid, reducing medications, such as proton pump inhibitors, and <unk> blockers, representing approximately 40% of our patients in our phase III study.
Importantly, SER 109 showed broad efficacy in the phase III study, including in these patients known to be at higher risk of recurrence.
As expected given the demographics of CDI more than half of the study population in our phase III study had at least one comorbidity, including diabetes cardiac disease and malignancy.
It was reassuring to see that SER 109 results and high levels of efficacy, including in these higher risk patient groups.
At I'd week in a late breaker oral presentation, we precedented results showing that SER 109 reduces the abundance of antimicrobial resistance genes in the Gi tract in patients with recurrent CDI.
This is an important finding given the public health concerns regarding escalating rates of antimicrobial resistance and the associated negative outcomes for patients.
We were pleased to see the impact of our therapeutic approach on this component of the antibiotic resistance paradigm.
We believe that our data support a potential role for microbiome therapeutics in the D colonization of bacteria that harbor antibiotic resistance genes.
Our novel therapeutic modality has the potential to become an important approach to reduce the transmission of anti microbial resistance.
We also presented an exploratory analysis derived from our phase III data, which demonstrated that SER 109 administration was associated with an improved overall mental health score compared to baseline regardless of clinical outcome.
In another poster we have highlighted the rigor of our SER 109 manufacturing processes, including methods employed to reduce the risk of transmission of emerging and undetected infections.
We believe that our approach has important potential safety advantages as compared to the use of untreated donor stool.
Overall the data we presented further validate the strength of our SER 109 product profile and we believe it provides further support for the potential of this investigational therapeutic to transform the management of patients with recurrent C difficile infection.
In addition, our presentations have meaningfully increased the awareness of SER 109, among the medical community as well as in the potential utility of microbiome therapeutics as a new class of medicines.
I'll now pass the call to Matt to discuss our earlier stage pipeline programs.
Thank you Lisa and good morning I'll.
I'll begin with tier one pipe piles.
<unk> five is an orally dosed rationally designed cultivated microbiome therapeutic candidate designed to decrease the incidence of gastrointestinal infections factor.
Bacteremia and graft versus host disease, and immuno compromised patients receiving allogeneic <unk> stem cell transplantation.
Tier 155 is designed to prevent both bacterial bloodstream infections, particularly those that harbor antibiotic resistant genes as well as to modulate host community to reduce the onset of graft versus host disease.
Prior published studies by our collaborators at Memorial Sloan Kettering Cancer Center indicate that HFC to patients with a disruptive low diversity of microbiome are at substantially increased risk for bacterial infections, including antibiotic resistant infections and poor clinical outcomes.
At the recent <unk> conference and an oral presentation, we highlighted preclinical data showing that SER 109, five can decolonize patient isolated antibiotic resistant pathogens, including vancomycin resistant enterococcus and cobre, Panama resistant Enterobacter AC such as Enterococcus and Klebsiella.
Pneumonia, which are notable escape pathogens.
The continued emergence of antibiotic resistant bacterial infections as a top global health priority identified assessed by both the World Health organization and centers for disease control with significant clinical implications, particularly in immuno compromised patients.
Prior studies published by our collaborators at MSA indicate that <unk> <unk> patients with the disruptive low diversity microbiome substantially increased risk of bacterial infections, including antibiotic resistant.
Resistant infections and poor clinical outcomes.
Based on these observations.
And our clinical programs and our preclinical data supporting tier one five mechanisms of action. We believe <unk> five has the potential to reduce the risk of infection and individuals with compromised immune systems.
Our IND for tier one five was cleared by the FDA and we are in the late stages of prepping to dose our first patient in this tier 155 phase <unk> study.
In collaboration with MSA and the University of Chicago.
The phase <unk> study is a two part trial, including an open label and placebo controlled portion and the overall study is designed to enroll approximately 70 participants.
A first part of the study aims to primarily assess safety and tier 155, <unk> and the second part of the study will also evaluate the incidence of bloodstream infections gastrointestinal infections and the incidents of acute graft versus host disease.
We look forward to providing further updates soon on the progress of this important study.
Now moving onto our Ulster quite as efforts.
We continue to analyze data from our SER 287 phase III.
Study conducted in patients with mild to moderate also quite as we are in the process of obtaining and analyzing microbiome results as well as metabolomics and other functional data from that study.
We expect these data to provide us with a much deeper understanding of that studies unexpected clinical outcome and these results will form our decisions regarding next steps for 287 as well as any potential modifications to our ongoing SER 301 phase <unk> study.
Intend to communicate an update on our initial assessment findings before the end of the year.
As a reminder, SER 301 is a next generation orally dosed rationally designed cultivate microbiome therapeutic candidate for the treatment of ulcerative colitis. The composition of SER 301 is designed to optimize drug species and graphics and the pharmacological properties that are clinical and non clinical research have identified as potentially important drivers of.
A treatment effect.
Research indicates that individuals will also quite as can have a gastrointestinal microbiome that differ from those of healthy individuals and further that bacteria found in the gastrointestinal microbiome metabolites. They produce are associated with modulation of many of the immune pathways that had been associated with Ulster quietest and IBD more broadly.
Unlike SER 287, a donor derived product candidate SER 301 is comprised of a targeted set of bacteria selected.
To optimize the reduction of pro inflammatory activity improve epithelia barrier integrity, and modulate multiple UC relevant immune pathways to suppress inflammation.
We continue to enroll our SER 301 phase <unk> study in adults with mild to moderate ulcerative colitis.
As we had previously done several years ago with our SER 109 program. We are performing an in depth rigorous scientific analysis of all available also quite a study results based on the findings from our SER 287 assessment, we intend to make thoughtful determination regarding next steps for our <unk> franchise, and we maintain the opportunity to modest.
SER 301 study if warranted.
With that I'll now turn the call to David to provide an overview of our financials.
Thank you, Matt and good morning, with details of our quarterly financials are included in this morning's press release, so I won't reiterate them here.
<unk> ended the third quarter of 2021 with approximately $353 million in cash cash equivalents in marketable securities.
The September 32021 cash balance.
The upfront fee of $175 million at series received in July following the SER 109, co commercialization agreement announced on July one 2021.
Nestle Health Science.
I'll just remind you all of the deal terms in exchange for SER 109, co commercialization rights in North America.
<unk> Health Science provide series with an upfront payment of $175 million.
Series will also receive an additional $125 million upon FDA approval of SER 109.
A $10 million payment upon Canadian regulatory approval.
Furthermore, the agreement includes meaningful sales milestones, which if achieved total up to $225 million in.
In summary, the aggregate value of the potential approval and sales milestones totals $360 million.
Upon commercialization of SER 109 series will be entitled to an amount equal to 50% of commercial profits.
We're very pleased with the collaboration which is financially attractive for series and provide series with both near term value and substantial longer term value.
We continue to work very closely with <unk> the division within necessarily responsible for this effort in preparing for the launch of SER 109, and as part of the agreement series is funding all prelaunch commercialization and medical affairs expenses up until launch.
As I've mentioned, one SER 109 is commercialized the profits will be split 50 50.
Immune has developed a highly effective pharmaceutical business, including a sizeable Gi sales force and top notch marketing team.
We believe that their commercial capabilities will help ensure a successful launch as well as provide meaningful efficiencies related to SER 109 commercialization.
I want to point out that our third quarter income statement reflects collaboration revenue of approximately $127 million.
Which is primarily from the accounting of the $175 million upfront fee from Nestle.
As a result of this revenue recognition series has generated a profit for the quarter. There are additional accounting implications related to the co commercialization agreement included in our financial statements for the third quarter and these are further outlined in our 10-Q.
With respect to our operating expenses and efforts over the near term we continue to be focused on a number of critical SER 109 related activities, which include filing the BLA submission.
Amping up manufacturing operations for commercial supply and.
And in conjunction with Amy and accelerating our prelaunch commercialization efforts and.
In addition, we continue to invest to advance and expand our pipeline and further build and enhance our platforms and capabilities.
As a result of these high priority and value generating activities.
We expect our expenses to increase in the coming quarters.
In summary, we believe the company is well resource to prepare for SER 109 commercialization.
Drive our ongoing development programs.
I'll also deploying resources to continue to advance our research platforms, where we believe we have differentiated proprietary and sustainable advantages.
With that I will pass the call back to Eric.
Thanks, David.
I will conclude our remarks by recapping the progress we have made across our microbiome therapeutic pipeline and key important milestones that we are looking forward to during the remainder of this year and into 2022.
These include our.
<unk> of over 300 subjects enrolled in our SER 109 open label study and our preparations for a BLA filing in the middle of next year.
Continued progress executing on SER 109, commercial readiness working closely with nestle, including expanded market education efforts.
The initiation of a SER 109 expanded access program.
The expansion of our longer term commercial supply capabilities and capacity, including our recent collaboration with Baxter era.
Completion of our SER 287 study data analysis and continued progress with our SER 155, and two to 301 earlier stage programs.
Our organization continues to strengthen our microbiome research platform and preclinical efforts in the coming year, we expect to advance our microbiome therapeutic candidates forward.
We plan to focus on areas, such as infectious disease, where we have clear clinical and mechanistic data demonstrating the utility of our approach.
Series is supported by a strong scientific foundation and solid balance sheet.
We believe that our company is well positioned to continue to lead the microbiome therapeutic field and.
And we look forward to executing on our mission.
Seeking to improve the lives of patients.
With that operator, we'll now open the call up to questions.
Yes.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Standby, while we compile the Q&A roster.
Your first question comes from the line of Joseph <unk> of Cowen <unk> Company. Your line is open.
Hi, good morning, Congrats on the progress and thank you for taking our questions.
Maybe the first one.
The commercial manufacturing agreement press releases this could be the first ever live biotherapeutic products commercially produce I guess is there anything from an FDA perspective that they are pointing to specifically that you would need to clarify.
Given that this could be.
Groundbreaking here and maybe how you are responding to them or getting data ready and then second question just on the potential for re treatment in patients that maybe relapsed. After SER 109 treatment is it possible to go back in with another course.
Mechanistically with this just makes sense great.
Great. Thank you.
Yes, Joe good morning, and thanks for the two questions.
On the first from a manufacturing perspective, maybe I'll start and I'll ask David to comment.
As a reminder.
Back there was not up up online yet so it will take some time to complete the facility and bring them online.
Taking into our commercial launch the same process that.
We took into our phase III study. So we're continuing to work through the elements of the BLA, we feel good about where we are.
Following the positive phase II results in the summer of 2020.
We pivoted pretty quickly to investing in and continuing to prepare but with the capabilities and the capacity to launch the product and in fact that included in some sense hiring Dave who bring us.
Exactly the right experience.
Be able to move quickly and bring a key product up to scale. So maybe I'll ask Dave to comment further and then we will take your second question in terms of re treatment.
Sure Thanks, Eric and so Joe you're asking about questions from the FDA and so I'd emphasize that because of our breakthrough designation, we have been in ongoing almost continuous interaction with the FDA.
So we have a really good dialogue with them and understanding.
What their expectations are in <unk>.
Addressing those things as we prepare the BLA itself.
And as Eric said just to reemphasize the point that our current supply chain is our launch supply chain.
New investment is not required for BLA filing or launch. So there is no change to that timeline as it relates to manufacturing the.
The same.
<unk> chain that we had was used for phase III same scale same facilities same equipment and same staff. So that's what I can share with you. This morning.
And Joe maybe we can take your second question in terms of the potential for re treatment in here I'll ask Lisa to comment, but just to start.
Just a couple of comments one is that.
The question on re treatment is an important one.
We've gotten to know these patients are incredibly well right and what I think hasnt.
Come to light as much as it could its just the the fear and emotional burden of the idea of a recurrence rate.
Once you get hit by antibiotics, just not knowing whether youre likely to recur again or not and one of the reasons that we were so gratified by our phase II results was certainly the efficacy that we saw in that study.
Medically no reason that we that we know of why you couldnt retreat, but one of the elements of the phase II results was that.
There werent that many patients in the active arm that actually recruited right. So maybe I can ask Lisa to comment further on that.
Yes, Eric.
Eric's exactly right Theres no medical reason not to retreat and in fact, we did have.
A few patients in the <unk> study that did recur rolled over into the open label and received re treatment and did well, but as Eric said, we had so few people in the active arm.
Recurring to begin with that it's just not large numbers.
That's great and Super helpful. Thanks again, Sir.
Thanks for the question Jeff.
Your next question comes from the line of Dan <unk>.
Viper Sandler your line is open.
Great. Thank you very much.
Just with respect to preparation for the BLA.
Since this is a new class is there anything.
<unk> unique kind of picking up on the last question.
That would be required.
So there is a microbiome therapy. Thanks.
Yes, thanks for the questions.
Look I would say.
Dave.
I mentioned before him.
We think we have a pretty good sense of what the FDA is looking for this is a new therapeutic it is a new modality, but.
Starting fresh in terms of our discussions with the FDA right and we've been in discussions with the FDA around release spec surround our approach obviously.
They have they have communicated to us the bar that they were looking for in terms of.
What would qualify from an efficacy perspective for one single pivotal study.
Not only do we meet that but we significantly surpassed that we've added.
The discussion around safety and the idea that they were looking for those 300 patients.
On the phase III dose, which we of course also executed as well so.
It's a breakthrough designated program, we continue to be in.
In contact with them, we think we have a pretty good sense of what they've asked for and we're providing it so.
That's the best that we can say at this point and we'll continue the dialogue with them and progressed on the line with a BLA.
And as you say.
Quality.
Clear.
Signal, both from safety and efficacy of really can be helpful. Awesome. Thanks looking forward to.
Continued updates on our pipeline.
Thanks, Thanks for the question.
Yes.
Your next question comes from the line of Chris Giovanni of Goldman Sachs. Your line is open.
Hi, This is CJ on for Chris. This morning, Thanks for taking the question. Congratulations on the quarter can you help us think a little longer term about the potential competitive commercial landscape for therapeutic approaches to recurrent C. Diff in particular I don't think we've discussed this as much previously, but Pfizer has a vaccine and where it is.
Through data could come in the near term, how do you see <unk> therapeutics and the potential vaccine fitting into the overall clinical management armamentarium. Thank you.
Yeah C. J. Thanks for the question, let me take the first part of it and then maybe I can ask Terry to comment on on.
More specifically vaccines or maybe ultimate.
Approaches.
Look we've been working this disease for a long time right.
What we know is what's needed in this space, which is something which is we think oral.
Highly efficacious.
GMP manufactured and incorporates the right safety dimensions that you'd look for and that.
That's what we think we have with SER 109.
The idea of having a limited number of capsules.
We think is highly.
Highly attractive for patients, we think that the safety dimension of.
Not just.
Relying on donor screening and hoping that you.
Yes.
Capture pathogens that might be transferred we know that our CMC process is set up.
For additional steps to support patient safety and most importantly, we think we have an efficacy profile, which is represents a step function increase and how you treat these patients.
With the 88% so we feel very strongly about where we are.
And we're highly focused.
Really aware of the competitive landscape, but we're our focus really is first and foremost is just getting into the BLA and trying to get to the end of the regulatory finish line. So we can get this drug to patients but.
Maybe I can ask Terry our head of commercial to comment further and maybe <unk>.
The vaccine question.
Sure Eric.
The vaccine and just point out a couple of facts about them number one they're operating or aiming to operate quite far upstream from the market for recurrent C. Diff infection. So they are actually going for patients who are at risk of a primary C. Diff infection. So for example patients who are going.
In for surgery.
It's actually going to be exposed to the health care system and may encounter some sports.
Fourth in addition to administration of broad spectrum antibiotics.
Far extreme from US we haven't seen phase III data from them yet. So we don't really have a feel for their efficacy levels.
Thank for me then.
I think relevant piece of information is really around uptake what kind of uptake could you expect from the vaccine like this given uptake levels that we're seeing for Covid vaccines that have probably the best advertising campaign known to man.
<unk> seen it in the numbers still are not seeing many cases broad uptake.
Fight mandates and so on so forth.
What I would say about the vaccine and with respect to competitors.
They come along in the currency that space I would just close by echoing what Eric said that we are very happy with our drug's profile and the clear path to approval that we have with our phase III data serving as a single pivotal can you just a passing the FDA bar for efficacy and with clear direction on them the necessary safety database, and we really look forward to bringing.
Yes.
Product to patients as soon as they can.
For the question.
Great. Thank you.
Your next question comes from the line of Mark <unk> of Oppenheimer. Your line is open.
Hey, good morning, and thanks for taking the questions just a couple for me.
First I'm wondering if we should be interpreting the agreement went back there.
As an indication of any forward regulatory progress with the EMA.
Step towards.
Future European product launch or will it back there are primarily be manufacturing drug product for the North American market.
So I'm wondering if you can give us any numbers around manufacturing capacity within without the addition of <unk> in terms of drug supply per patient per year.
And finally, one last one for me.
Maybe you can give us a progress report on the enrollment of the SER 301 study and if we can reasonably expect to see any results from that trial in 2022. Thank you.
Mark Good morning, and thanks for the for I think it's three questions let me.
Let me take a stab at them, but the team can help me if I Miss something so.
The first.
We would prefer not to kind of parse out signaling. This are signaling that I think.
And for US is that we think this is going to be.
A major global drug right.
<unk>.
Cause of that.
We're looking to ensure that we've got the right.
The right commitment the right capacity to supply this drug globally that includes future regulatory work and includes future commercial work, but ultimately.
<unk>.
<unk>.
With London Christian Hansen, it's just the state of the art operation that we think industrialize is our ability to fulfill our commitment to patients to get this drug to them as quickly and as robustly as possible. So.
I think thats the answer to the first we haven't provided specificity in terms of numbers, except maybe I'll reiterate reiterate what Dave said earlier, which is we feel very good about where we are from a launch perspective I think this is a.
This is more forward looking in terms of our ability to supply globally and then the last question Mark in terms of 301.
Haven't provided guidance.
I can reiterate what Ive said beforehand, which is that.
We've made progress but at the same time, we're not so far along in this <unk> study, where if there are learnings from our analysis that we could apply.
We have the ability to do that so I.
I think on the last one is really more of a stay tuned.
Okay got it thanks for taking my questions and congrats on the progress.
Thanks for the questions Mark.
Your next question comes from the line of John Newman of Canaccord. Your line is open.
Hi, guys. Good morning. Thanks for taking my question just curious if you could talk a little bit about what type of <unk>.
Data.
You might be able to share from the microbiome analysis.
You mentioned.
You mentioned for later this year, just kind of curious as to what youre, hoping to learn from that analysis.
That can help inform.
Future studies thanks.
Yes, John Good morning, and thanks for the question and.
Let me start with the status and then maybe Matt can comment a little bit more specifically on the types of analysis that will that will run but.
As we've said, we're we're not finished with the analysis.
It is in process I think for US it's important to.
Not piecemeal data out, but rather get a sense of the total picture.
Before providing our analysis conclusions and potentially next steps so.
We've debated quite a bit about what we share and when I think that we our intent is to share a more full picture when we have it and I would say that we're certainly getting closer to that but maybe Matt you can comment on on the types of analyses and maybe some visibility as to how that informs our platform going forward.
Sure Good morning, John.
Yes, so our 287 phase two trial was designed to capture rich rich dataset around drug activity in pharmacology and that was done that of course understand what the drug is doing and also enable our reverse translational and discovery efforts more more broadly so we're generating managed gnomic microbiome data.
Metabolism datasets transcriptional datasets other functional data as well, which allow us to then look at specifically, how the microbiome changed what happened functionally.
Did where did we not elicit the changes in the metabolic landscape that we would've expected based on our aggregate knowledge across both our preclinical work as well as our phase <unk> study.
Where we did see meaningful changes that were associated with both treatment and clinical outcome.
And of course, we're looking more broadly as well I would say.
We're we're IBD.
IBD relevant inflammatory pathways modulating as we might have expected them to be.
And then also we're trying to understand is there any evidence of patient subpopulations that might be more amenable to treatment versus not so these are the kinds of things, we're looking at and digging into.
And really I'll, just close by saying that we've got this is a large rigorously collected intervention microbiome data set in these kinds of dataset don't exist out there.
Generally speaking and so I think we've got a lot of work ahead of us but there is there is much to learn here in terms of how we think about how microbes are interacting with each other as.
Human cells and tissues in the Gi and I think that has broad applicability across across our across our portfolio.
Okay, great. Thank you.
Thanks for the question John.
Your next question comes from the line of Vernon Bernardino of H C. Wainwright. Your line is open.
Hi.
Eric and team Thanks for taking my question.
Just a quick question as far as the back there.
Agreement capabilities and so on.
Part of the announcement.
Youll leveraged loans has kept a jill.
Encapsulation technology.
Are there any considerations as far as what would need to be done regarding.
Regarding any differences between.
The capsules that are used now and perhaps the stability testing.
Sure.
<unk> one back there was up in manufacturing everyone Tonight.
Yes, Arun and good morning, and thanks for the question.
Let me start let me start and I'll ask Dave to comment so.
Again, I don't think that I have.
Taking the vector a question there but.
I'm thrilled with this with this relationship but they really do provide for us.
A professional industrialization of <unk>.
Of manufacturing the drug going forward and we're thrilled that they kind of take the best of the two companies that really came together to form that Clara so theres aspects of what we're doing which we think.
Our best in our hands, there's aspects of what they're doing which we think that they can provide and share unique value with us and from that perspective, we think it's really a win win in terms of <unk>.
Partnership, but maybe Dave can comment more specifically around your question.
In regards to the capital.
Yes, Thanks, Eric and Vern and good morning, and thanks for the question I'll just briefly Echo what Eric said, having worked for 20 some years.
Pharmaceutical manufacturing and biologics and vaccines I'm really really enthused about this partnership with Baxter for permitting future expansion of supply.
Alonza and Christian Hansen have a long history in the this site is top notch as Eric said.
Specifically to your question.
This is being highlighted by Baxter and lines.
For their own purposes, the highlighted we've actually use those capsules throughout so capsid gel was acquired by Alonza at some point in time, but those particular capsules that we use have been part of the SER 109 program from from early on and we are indeed use in phase III. So there's in fact, no change with respect to that particular aspect.
Perfect that's exactly what I was asking thanks for taking my question and congrats on the progress.
Thanks for the question Brian.
Okay.
There are no further audio question at this time I will now turn the call over to management for closing remarks.
So thank you operator, I want to thank everybody for joining our call today and for your continued interest in series.
We look forward to keeping you up to date on our progress with that we will conclude have a great day and thanks again.
<unk>.
Yes.
This concludes today's conference call. Thank you for participating you may now disconnect.
Yes.
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Sure.
Yes.
Hi.
[music].
Yes.
Okay.
[music].
Enrollment.
[music].
Yes.
Okay.
[music].
Yes.
Okay.
Yes.
Yes.
Yes.
Sure.
Yes.
Yeah.
Yes.
[music].
Yes.
Good morning.
[music].
[music].