Q2 2021 Seres Therapeutics Inc Earnings Call
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Good morning, ladies and gentlemen, and welcome to this theory Therapeutics Q2, 2021earnings conference call. At this time, all participants are in a listen only mode.
Later, we will conduct a question and answer session.
And instructions will follow at that time, if anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone.
As a reminder, this conference call is being recorded I would now like to turn the conference over to your host Dr. Carlo Tanzi of Investor Relations.
Thank you and good morning, our press release with the company's second quarter 2021 financial results and a business update became available at 7 a M. Eastern time. This morning, and can be found on the investors and news 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 resolve.
So were clinical studies, the anticipated safety profile of our products regulatory approval. The success of our agreement with Nestle, the sufficiency and availability of cash to fund operations and the promise and potential impact of any of our microbiome therapeutics actual results may differ materially. Additionally.
These statements are subject to certain risks and uncertainties, which are discussed on the risk factors section of our recent SEC filings any forward looking statements made on today's call represent our views as of today only we may update these statements in the future, but we disclaim any obligation to do so on.
On today's call with prepared remarks, I'm joined by <unk>, President and Chief Executive Officer, Eric Shaff, Chief Financial Officer, David <unk>, and Chief Scientific Officer, Matthew <unk>.
During the Q&A portion of the call. We will also be joined by our Chief Medical Officer lease up on Mulkey and Dr. Terry Young our chief commercial and strategy officer, and with that I'll pass the call to Eric.
Thank you Carlo and good morning, everyone.
The last several months have been an eventful period for series.
We have made substantial progress advancing our lead tier 1 of 9 program towards a BLA filing for recurrent C difficile infection.
We signed an important SER 109, co commercialization agreement with Nestle Health science, covering the North American region.
We obtained topline clinical results for our <unk> 7 program.
And we have also continued to make clinical development progress with SER 155, and SER 301, our next generation rationally designed pipeline candidates.
Last month, we held 2 conference calls focused on our C. D. I in ulcerative colitis programs and today, we intend to keep our remarks relatively brief.
I will begin today with SER 109.
Our top corporate priorities are to complete the required SER 109 safety database through our ongoing open label study.
And to prepare for a high quality BLA filing.
We are very pleased with our progress with the enrollment of the open label study and we are on track to achieve the full 300 patient target later this quarter.
Our.
<unk> is also preparing for a successful commercial launch to.
To support this effort in early July we entered into an agreement with Nestle Health science to jointly commercialize SER 109 in the United States from Canada.
We believe that through this agreement series is well positioned to effectively brings share 1.9 to patients suffering from recurrent CDI.
The transaction also provides series with substantial capital to drive the continued development of our earlier stage pipeline of microbiome therapeutics, including SER 301 answer 155, our preclinical stage programs as well as our platform capabilities.
Under the terms of the Nestle agreement serious received an upfront license payment of $175 million and is eligible for an additional 125 million upon FDA approval of SER 109, and 10 million upon approval in Canada.
The agreement includes sales target milestones, which if achieved could total up to $225 million.
Upon commercialization series will be entitled to an amount equal to 50% of the commercial profit.
We are very pleased with this transaction from both a strategic and financial perspective.
As you May remember Nestle previously owned ex North American rights to SER 109 based on our 2016 deal.
There are considerable efficiencies and benefits to our global approach to commercialize on SER 109 in terms of marketing pricing and reimbursement.
Executing an effective global regulatory strategy and other aspects of launch that will maximize value.
Sirius has necessarily it has been a great collaborator to series and we look forward to continuing to work closely with them moving forward.
We expect SER 109 to become the first ever FDA approved microbiome therapeutics.
Tier 1 and on an approval and launch would represent a landmark event for the field and in addition, we believe that SER 109 represents a substantial commercial opportunity for series.
Each recurrence of C. D. I has been estimated to result in approximately $34000 in direct health care expenses.
The recurrent CDI population includes approximately a 170000 cases on the U S and we believe we have the opportunity to address this entire patient group.
Since announcing our positive SER 109 phase III data last summer we've observed a steady increase in the awareness and excitement of the medical community community for this product.
The substantial interest in tier 1 on 9 has also been seen in the enrollment of our ongoing open label study and in fact July was our highest month of enrollment to date.
The SER 109 open label study is now approaching full enrollment and we believe to achieve target enrollment late in the third quarter.
The FDA has requested that 6 month 6 months a safety follow up from the study to be included in the safety database.
Completion of this database will support a SER 109, BLA filing and this would represent completing a major requirement to potentially enable SER 109 to become the first ever FDA approved microbiome therapeutics.
In addition to SER 109, we are advancing a pipeline of additional investigation on microbiome therapeutics.
Last month, we reported top line clinical results from our SER 287 Phase <unk> study.
The SER 2.7 phase 2 B study did not demonstrate clinical benefit in patients with mild to moderate UC.
The results of this study were unexpected and we are now focused on obtaining a microbiome results from that study.
We expect these data to provide us with a much deeper understanding of the study outcome and why the results were so different from the prior phase <unk> study data.
In addition.
These results will provide us with valuable information that will that will provide insights to inform continued development of our pipeline, including SER 301, our next generation investigational candidate for ulcerative colitis.
As we have successfully done with our SER 109 program in the coming months, we intend to perform an in depth scientific analysis of all phase to be steady results learn from the data and determined what modifications to implement in our future microbiome therapeutic development efforts.
I'll now pass the call to Matt to discuss our earlier stage pipeline programs.
Thanks, Eric.
With our ongoing SER 301 phase <unk> study SER 301 is a next generation orally dosed rationally design cultivated microbiome therapeutic candidate for the treatment of ulcerative colitis day.
Unique composition of SER, 301, and designed to optimize drug species and grassman and the pharmacological properties that are clinical and non clinical research have identified as potentially important drivers of a treatment effect.
Research over the past decade continues to support that individuals with IBD can have a GAAP to Tesco microbiome that differs from those that healthy individuals in terms of the specific bacteria that are found in and that dominate the G. I.
Further we know from the research literature, and our internal clinical and non clinical datasets that bacteria found in the gastrointestinal microbiome and the metabolites. They produce are associated with modulation of many of the immune pathways that have been associated with IBD and UC.
Unlike SER 287, a donor derived product candidate SER 301 is targeted at and contains bacteria specifically selected to optimize the reduction of pro inflammatory activity improve epithelioid barrier integrity, and TNF alpha driven inflammation and intestinal epithelium cells and modulate UC rather.
<unk> anti inflammatory and Nate and adaptive immune pathways to suppress inflammation.
We are enrolling our SER 301 phase <unk> study in adults with mild to moderate ulcerative colitis. The studies being conducted in Australia, and New Zealand with a target enrollment of 65 patients.
The objectives for the study are to evaluate drug safety and pharmacokinetics.
And to evaluate clinical remission and other measures of efficacy as secondary endpoints.
We anticipate obtaining additional clinical and biological information from this study to support growth.
Bust data driven decisions regarding the future development of the program.
Moving now to SER 155.
SER 155 is an orally dosed rationally designed cultivated microbiome therapeutic candidate designed to decrease the incidence of gastro intestinal bacterial infections, bacteremia and graft versus host disease, and immuno compromised patients receiving allogeneic.
Allogeneic, Nick Maddock stem cell transplantation.
Tier 155 built on the SER 1 on 9 data, we have obtained an infectious disease and has leveraged the company's reverse translational platforms and capabilities that can evaluate a high resolution how microbes in the gastrointestinal tract are interacting with 1 another and human cells and tissues to impact pathogen colony.
Nation, and modulate host pathways associated with various inflammatory and immune related diseases.
Here 155 is designed to prevent both bacterial bloodstream infections, particularly those that harbor antibiotic resistance genes as well as to modulate host immunity to reduce the onset of graft versus host disease.
We have obtained <unk> clearance for SER 155 to initiate clinical development and we expect to begin screening patients in a phase 1 B study later this quarter. This.
This study will be conducted in collaboration with Memorial Sloan Kettering Cancer Center, and the University of Chicago field, leading academic centers.
Turning now to our earlier stage pipeline.
We continue to advance our core platforms and technologies and to evaluate several potential new indications for our microbiome therapeutics.
Since series inception, we have been building a research engine that can integrate insights and microbiome biomarker data from human data with screening data from human cell based assays and disease model results from customized in vivo models defined at high resolution microbiome signatures of disease and health.
Importantly, our platforms can interrogate the mechanisms of action of microbes both directly in humans to help derisk discovery and in combination with non clinical assays and models to maximize the translate ability of our lead candidates.
The company has established extensive insights in a database of microbiome drug <unk> targets with a mapping of these target modalities to disease correlates and existing therapeutics to inform the advancement of our future pipeline and to delineate the mechanism of action of our investigational drugs.
Our research platforms capabilities and knowledge base combined with a broad scope and the breadth of complexity of microbes, we can manufacture under GMP conditions positions us well as we advance and broaden our pipeline.
This knowhow and these technologies enable us to consider multiple diseases with high unmet medical needs with near term opportunities and biologically adjacent areas such as fighting antibiotic resistant infections and additional opportunities that span oncology inflammatory autoimmune metabolic and neurological disease.
Chris.
With that I'll now turn the call to David to provide a few overview of our financials.
Thank you Matt the details of our quarterly financials are included in this morning's press release, so I won't reiterate them here series ended the second quarter of 2021 with approximately $229 million in cash cash equivalents in marketable securities debt.
June 30, 2021 cash balance does not include the upfront fee of 175 million that has been received by series. Following the SER 109 co commercialization license agreement announced on July 1.2021 with Nestle health science, including this upfront fee from Nestle, our quarter end pro forma cash back.
<unk> was approximately $404 million. So we believe the company has a strong balance sheet and as well resource to optimally prepare for SER 100 on commercialization in the U S drive our ongoing development and discovery programs, while deploying resources to continue to advance our research platforms, where we believe we have <expletive>.
<unk> proprietary and sustainable advantages.
With respect to our operating expenses and efforts over the near term. We are focused on a number of critical SER 109 related activities, which include.
Completing the open label study.
<unk> the BLA submission Ram.
Ramping up manufacturing operations for commercial supply and in conjunction with Nestle accelerating our prelaunch commercialization efforts.
We believe that there is a significant commercial opportunity for SER 109 in the U S. Given the number of annual cases of recurrent C. Diff, but lack of current effective treatments and the stellar efficacy and safety profile of SER 109.
Moreover, as a result of our agreement with Nestle, we are able to leverage their commercial capabilities to maximize the commercial success of SER 109, while minimizing the cash burn to series.
As we have discussed previously naturally has a sizable and highly capable Gi sales force and well established marketing function as well as strong supporting functions such as sales operations and market access and our commercial team is already actively engaged with our counterparts from nationally.
As Matt discussed our pipeline is very promising and our research platforms and core capabilities are unique and differentiated we are committed to developing and advancing microbiome therapeutics to transform patient outcomes for serious diseases, and we will continue to invest to advance and expand our pipeline and <unk>.
Their build and enhance our platforms and capabilities.
While we capitalize on these opportunities.
We will be prudent and disciplined in managing this growth.
I'll now pass the call back to Eric.
As we conclude our remarks I'd like to recap several of the important milestones that we are looking forward to during the remainder of this year.
These include <unk>.
Cheating full enrollment in our SER 109 open label study later during the third quarter of the year and preparations for a BLA filing.
Continued progress executing on SER 109, pre commercial readiness working closely with nestle, including on expanded market education efforts.
Microbiome data analysis from the SER 287 phase <unk> study.
And continued enrollment of our SER 301, and the start of enrollment of our SER 155 phase 1 B study.
Our organization also continues to strengthen our microbiome therapeutics platform capabilities.
So supported by an extensive literature in over a decade of series research our belief in the promise of our therapeutic approach is deep rooted and we're optimistic for the future of this technology.
With SER 109, we expect to lead the field with the achievement of the first ever approved microbiome therapy.
We are also continuing to make progress advancing our pipeline and we expect we will transition new microbiome therapeutics into clinical development to treat serious diseases.
Sirius is supported by a strong scientific foundation and a solid balance sheet.
We believe that series is well positioned to continue to drive to lead and drive the microbiome therapeutic field forward. We are looking forward to continuing to execute on our mission to lead the microbiome field forward and improve the lives of patients.
With that operator, we will now open the call up to questions.
Yes.
Ladies and gentlemen, if you have a question at this time. Please press the star and then the number 1 key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Your first question comes from the line of Mark Breidenbach with Oppenheimer.
Hey, good morning, guys and thanks for taking the questions.
Just a couple of quick ones from me.
I was hoping you could give us some clarity on the expected timeline for filing.
If you wrap up enrollment of the open label in the quarter and 6 months of follow up can we realistically expect to BLA to be filed in the first half of 2022.
And.
Second question is just really housekeeping, we saw a pretty sharp uptick in opex in the second quarter should we I guess I'm wondering how we should be thinking about cash burn for the remainder of 2021. Thank you.
Yes, Mark good morning, and thank you for the question. So maybe I'll start on the first and I'll invite.
Invite Dave David to ask <unk> to answer the second 1 but just in terms of of timing for the BLA, We havent provided guidance, but obviously, we're moving with urgency and for us the the single largest.
Or or gating.
Critical path item is finishing on the open label study and.
Enrolling the.
At least 300 subjects in.
To support the safety database that the FDA had asked for as we said in our prepared remarks, we've really made great progress in the open label and in fact.
July was our highest enrollment months yet so we think that the message is really getting out.
In part based on the work that we're doing to to interact with key stakeholders across the field.
But at the same time, we're continuing to work on other aspects of the BLA and we will be looking to move as quickly as possible. So, whereas we haven't provided guidance. We're looking to finish the open label. We've got the 6 month follow up is as indicated previously and in the prepared remarks.
And then we will move as quickly as possible for patients that we know and and providers that we know are waiting for the therapy to be available.
The second question was on Opex and obviously as you know we entered into an agreement with Nestle.
Where we are responsible for leading the pre commercial efforts and maybe I can ask David to comment further on that yeah. Thank you. So so we have not provided guidance. We did talk about in our prepared remarks, our strong balance sheet pro forma quarter, ending cash balance of approximately $404 million.
And our on our activities over the near term are really focused on high value add efforts.
In terms of filing and preparing to file the BLA.
As well as preparing for the commercialization of SER 109 in the U S.
Important also to note debt under our agreement with Nestle there are future opportunities for additional milestones of 125 million upon the approval of SER 109, and up to 225 million in sales milestones as well as we will be splitting profits. Once here 1 on 9 is commercial so.
There is a lot of opportunities from an economic standpoint, and we are focused on ensuring that we are well prepared.
Once share 1 O 9 is approved to have a very successful launch.
And maybe I'll just finish.
Finished marked by adding to David's comments, we we think that that investment that is earmarked for pre commercial work has a very compelling return to it.
Based on the opportunity in the see the field.
The unmet need and the remarkable safety and efficacy profile that we showed in the phase III study.
Okay got it thanks for taking the questions.
Thanks for the questions Mark.
Your next question comes from the line of John Newman with Canaccord.
Hi, guys. Thanks for taking my question. So the question is.
Curious I know that you are still performing the microbiome analysis for 287.
Just curious.
On the work that you did see debt.
If you think there is a specific add on type.
<unk> at baseline.
<unk>.
Sure.
It might be more effective at share.
Feedstocks.
Given that it.
Very specific.
David just curious it's kind of a speculative question at this point, but just curious if that's tough.
A line of thought that you pursued during the analysis. Thanks.
Yeah, John Good morning, and thanks for the question, let me open and I'll ask Matt to comment more specifically and I'll just jump in with a more general comment which is you referenced the 109 analysis and.
As we think about types of despite doses or perhaps subgroup analysis or other different ways in which you can cut the data I think it's worth just reminding everybody that when we set out to do the 1 O 9 post phase 2 analysis, obviously, we ended up in a spot where we change the dose we changed the diagnosis and.
We ended up with an incredible result for patients on the heels on the phase III that didnt happen overnight right and we purposely didn't go into that analysis, saying hey.
Maybe if we increase the dose or change the diagnostic protocol then we'll end up in a great spot. It was only after the thorough objective scientific analysis that we came up with those 2 key hypotheses and by the way we rejected.
Many many others on all of it was based on on the data. It was those 2 key hypotheses that we're most compelling to us based on the microbiome analysis that led us to those those hypotheses.
But maybe I can ask Matt to comment more specifically on how we'll approach it with this analysis sure. Good morning, John Thanks for the question. So so we will certainly look at the baseline microbiome of patients prior to initiation of any treatment too to understand if there is any association that we may we may observe in terms of those who.
Had a response versus those that did not did not have a response.
We did that we've done that kind of work and continue to look at that across many different patient populations in different healthy individuals to understand those differences and how they may vary and are an important area of research at the company has been to understand for example, how our drug can cash in different patient backgrounds instead.
In settings, and we have observed some some trends in that in the past and that those kinds of insights are actually for example, incorporate it into our SER 301 drug designed to ensure that we have a a strong and grafman signature across a broad patient population.
So that's certainly an active area of research, we will certainly be looking at that and you know and we'll see what the data tell us.
Okay, great. Thank you.
Thanks for the question.
Your next question comes from the line.
Of Chris Howerton with Jefferies.
Good morning, Thanks for taking the questions and congratulations on all the progress recently and very excited for the 1 on 9 coming up very soon.
So for them I guess from me may be just 1 question as it relates to see them and see a ramp up I guess I was just curious if you could give us some more color on what specifically that would mean is it recruiting more donors is it.
Building up supply just a little more information on what exactly that ramp up would be and then the second question is on.
2 questions is focused on 155 first I don't think that we really know a whole lot about the trial design. So if you could provide some insight on that that would be really helpful. And then to the extent that you can manage it'd be really interesting to hear your thoughts on the putative mechanism for 155 and graft versus host disease.
Thanks.
Chris Good morning, and thank you for the questions on CMC I guess, what I would say is debt following.
Our phase III results last summer, we really accelerated the work in preparing for commercialization and there's multiple categories that that includes first and foremost it was recruiting David Icke as our new CTO and I know as you know Dave joined Us from Merck.
And has deep experience in moving to commercialize key products like Keytruda, So making sure that our CMC processes were in Dave's hands was what is the first step, but but yes to your question. Yes, we have continued to invest in <unk>.
Expanding our donor supply operations on our manufacturing capabilities and capacity and that work continues so.
We were at our commercial process and because of the fact that there was a phase III study, but since the phase III results. We've continued to invest to ensure that we're able to supply patients reliably and in network continues.
Maybe I can ask Matt to comment and then and if lease has a comment as well on 155 and why we're excited about 155 is.
Continuation of our work in infectious disease and with our partnership.
Yeah. Thanks for that thanks for the question Chris.
We're really excited about our SER 155 program.
We've been learning and continuously learn with our clinical experience and something that we have observed in different settings is the ability of our therapeutics to have an impact on reducing the carriage of of important antibiotic resistant bacterial infections, many of which could actually be a problem on particularly in immuno compromised patients such as those that are.
<unk> are undergoing hematic stem cell transplantation. These are highly immunocompromised patients so.
That the ideas of 155 are born many years ago, where we decided based on the insights and knowledge. We had based on all of our non clinical research as well as clinical research that we can design a drug that could reduce the carriage of important bacteria that harbor antibiotic resistance and often are the bacteria that cause bloodstream infections and that we.
Could also design it drove that kid repair the epithelia barrier to help prevent translocation events of these bacteria into into the bloodstream and then lastly, the drug the drug is designed to actually modulate.
A few immune pathways that we believe are important in increasing the receptivity of of of grass and so there are 3 core mechanisms to the to the drug. This has been a collaboration. This has this program has come out of a long standing collaboration that we have with memorial Sloan Kettering.
Who has been working in this disease area for quite some time and as well.
Deploying our F N T to look at improved responses in these patients with very promising results much of that has been published in nature and science over the past couple of years. So we really built upon.
That those learnings and combining that with our internal knowledge to design. This to design. This drug and I think it's an important program for a couple of reasons.
1 obviously is the expansion of our infectious disease efforts, but we're also going to these immuno compromised patients. So this is a high risk population and as we demonstrate anticipate to demonstrate safety net population that's important and of course, secondly, antibiotic resistant bacterial infections are probably 1 of the the second biggest challenges facing humankind.
Right now I would argue outside of outside of Covid and so this is this is a and initial project program in that space with expectations to expand further.
And then Lisa do you want on just kind of it's a long answer. The question do you want to just quickly on the on the trial design share.
So on.
As you heard that this is this is for patients who are undergoing an allo stem cell transplant.
Usually for a heme malignancy.
And we will be looking at 10, and an open label portion and then 60 of them.
<unk> to placebo or 155.
And we'll be looking for excuse me my.
My voice.
Section or graft versus host disease, as well as safety outcomes.
Got it Okay, and then with respect to the graft versus host disease is it fair to say that you know.
You're expecting the greatest impact on Gi symptoms.
Yeah, we will be looking at Gi symptoms, but we'll also be following Pat.
Panic symptoms as well as skin symptoms.
Okay, all right well very good. Thank you for answering the questions. Yes, thanks for the questions Chris.
Yes.
Your next question comes from the line of Ted 10th off with Piper Sandler.
Yes.
Great. Thank you for taking the time today.
I wanted to ask again about.
287, just a little bit on appreciating that there's probably not a lot more you can say right now, but with respect to the process do you see similarities with sort of a root cause analysis that was done around 1 on low enough to the phase 2 is that sort of some of the places that.
You start as you digest per data and are there possibilities to adjust the 301 study or is that 1 pretty much set to go as for work.
Earnings from 287 would be applied to future studies. Thank you very much.
Yeah.
Yes, good morning, and thank you for the question, let me start and I'll ask Matt to comment a little bit more more comprehensively on on the data itself I think there's ways in which there are similarities and differences between where we are with with $2.7 and 1 on on.
Different programs different disease areas different patient populations different study designs.
There are differences right.
At the same time I think that we've got the benefit of having gone through it and the framework or the structure of the process I think is.
If not comparable certainly we can learn from what we did last time and.
On the bottom line is we're going to follow the science right and that's what we did last time and we ended up with a great result.
We're not going to predict where this will go but but we do have a lot of confidence debt.
We're set up to interrogate this outcome as thoroughly comprehensively as possible and I would also note that and maybe Matt can comment more fully on this I think our tools and our insights are actually far <unk>.
<unk> and better develop now than they were 4 odd years ago.
I'll answer the second question, then I'll hand over to Matt.
We've made great progress on 301, Ted but it is not too late for us to make adjustments to 301. If in fact, there is ways in which we take learnings from 2 of the 7 that we think could have accrued benefits. The 3 on 1 and that's of course, 1 of the reasons that we'll be working with a lot of urgency on this and this analysis, but maybe I can ask Matt to comment more fully.
Yes, Thanks, Eric.
Ted Thanks for the question and I think.
The 287 phase 2 trial was really designed to capture rich rich dataset to inform drug activity in pharmacology and so.
Given that we sit in that we sit in a strong position to really generate the types of data that we that we used to understand drug activity in pharmacology, so, including the meta genomic data and look at changes by on Metabolomics data transcriptional datasets and then we'll be looking at these changes and evaluating them in the context of the clinical parameters very similar to what we did in the concept.
So a very similar process and of course, it was well looking at any potential.
Up forwards and backwards with respect to sort of any manufacturing is as well as clinical so so each of those those 3 buckets will certainly be pursued and in terms of what we're looking for we'll be looking at drug activity things like an grassman changes and microbiome associated metabolites that we know modulate disease pathways and various.
Measures of host response, so I think I'll kind of close by leaving 2 thoughts with you riches, which is 1 this was a rigorously collect it sizable inc.
Interventional dataset those are very rare and so I think that provides us an important opportunity, particularly with the advancement of our tools is as Eric pointed out and our ability to really mine that information to inform both our UC program, but also our portfolio more more more broadly and look we have a rock solid R&D team and I'm confident in the team will drive, Florida data driven insights.
To inform this program and the rest of our programs.
A lot of sense I appreciate that extra color guys.
Thanks for the question Ted.
Yeah.
Your next question comes from the line of Peyton von <unk> with Cowen.
Hi, guys. This is patent on for Joe Good morning, Thanks for taking our questions. We were wondering really quickly if you could share what you expect the patient breakdown would be in terms of number of patients with recurrent secondary cards et cetera on the safety data.
Space will be and then also any insight you can share about how you expect the FDA will look at efficacy signal on the safety database or if the FDA had made any indications on what theyre looking for or if that's changed at all and then secondly relative I'm wondering if there were any plans to expand the SER 301 trial outside New Zealand, Australia to potentially accelerating them from that study. Thank you.
Yeah Peyton good morning, Thanks for the questions, maybe I'll take the first 1 which is.
From our perspective, what we're really looking for first and foremost from this study is to satisfy the safety database that the FDA has asked for.
As part of supporting the BLA and as we've said they've asked for at least weighted subjects on on what was the the winning dose from the phase III.
We're getting very close to fulfilling that requirement.
We will resist the urge to talk about the breakdown or maybe even projected breakdown of what.
<unk>.
First our current multiple recurrence or other data that may come from it until we actually have it but.
Again, just as a reminder, our first goal and objective with this study is really safety and.
There is.
Also as a reminder, there will not be a there is not a comparator arm.
So the insights into efficacy I think it will be certainly constrained relative to the placebo controlled phase III study.
As far as 301 patent its a good question I would just say.
We need to do the 287 analysis and see where it leads us and if there is an impact on 3 O..1 then we'll consider those.
Those potential adjustments as I I think I said in my last answer it's not too late for us to think about different adjustments in.
Hum.
But we'll follow the data so I think it's probably premature for us to speculate as to whether we could open up additional sites or new geographies, what let's see what the analysis says in and if it is relevant for for 3 on 1 and we'll go from there.
Yes.
Okay. Thank you that's very helpful.
Thanks for the questions Peyton.
Your next question comes from the line.
Chris.
Simple tani with Goldman Sachs.
Thank you very much to the opportunities for questions. Once you've completed enrollment of the safety database.
Youre going to go through the process on a follow up the BLA filing.
Anticipating potential approval in 2022, which would give US 90 day 12 months can you talk about what your ability is to continue to.
Provide 1 O 9 prior to approval too.
To clinicians physicians you talk about the pre commercialization work, but this is obviously going to be an educational effort can you talk specifically about what youre going to be able to do and if youre going to be gathering data during that process.
Yes, Chris it's good.
Good morning, and thank you for the question. It's a good question, it's something that we're talking about actively as a team.
But I don't have an answer for you as we as we stay on here. This morning, I think where we're keenly focused on finishing the open label and it's as we said we're pretty close to that but we are actively discussing what happens after the open label has been completed and.
I would say, let us come back to you on that on that very good question.
Fair enough to follow up from Mark question on the operating expenses in the second quarter was an incremental sequential step up should we think about that Q level of R&D and SG&A spend as a reasonable guide towards quarterly spend on a go forward basis or was it perhaps in a little bit more of an anomaly, reflecting the initiation and the necessary North American.
Agreement.
Well, let me ask let me ask David to comment.
More fully on that.
Yeah, Hey, Hey, Chris Thank you.
Look as we said, we're not we're not providing guidance.
We're going to ensure that we're appropriately.
Sufficiently resourcing SER 109, pre commercialization activities in conjunction with Nestle.
So and we're going to do it we're going to do it thoughtfully, we're going to do it prudently.
Because we.
We only have 1 opportunity to launch the product and we're going to win and we're going to ensure that we're doing this as as thoughtfully as we can so.
I don't think it's helpful to provide additional.
Additional information as as it has how we're thinking about it but really just leave it at that yeah on it maybe I'll just add Chris I keep in mind. There are additional pieces that are we need additional clarity on in the system to be able to to.
Have a better sense going forward, including next steps with $2.7 as an example.
Got it and then 1 final Uruguay in September you provide you. The news released when you talked about correspondence with the FDA and that was after the positive efficacy results from zero, 1 of 9 which will obviously very positive on striking.
When you complete the safety database I imagine you will have another interaction with the FDA do you anticipate this to be on actual meeting and if that occurs when you provide us with an update on what occurs there.
Yeah, Chris.
I don't think we've guided.
Remember, we have breakthrough designation with this program and.
We have been connecting with the FDA, we will continue to connect with the FDA and I'm not sure that we can guide to the exact form of it but.
You know all I can say is that we are moving with urgency on behalf of patients in it.
And.
We look forward to working with the FDA to try to move this forward as quickly as possible obviously the the open label as we said is really the the.
Critical path item and once we clear that we're going to focus on on getting to the other aspects of the BLA to them as quickly as possible.
Great I'm glad to hear that July was strong wishing you well for August as well thanks.
Thanks for the questions Chris.
Yes.
Your next question comes from the line of Jay <unk> with Chardan.
It's a key income from Chardan.
Question for you got 301 study.
Specifically the.
Mild to moderate patient population, you're enrolling can you describe any differences in that patient population from the the 1 b or to be patient populations for 287.
Lisa do you want to take that 1.
Sure.
We have said that the.
301 study does include naive patients, which were not allowed in the.
287 study.
We do not allow biologic failures.
So there there are some differences in the populations.
Okay, and then just back to the manufacturing questions.
Have you talked about how much capital is involved in that ramp up.
And then also.
What aspects of that ramp up.
We will benefit the company with some of your future rationally designed products. Thanks.
Yes, it's a good question.
We havent provided guidance in terms of what a number of.
Of how we're allocating capital from a capex perspective.
Do think it's worth reminding folks that.
For 1 O 9, which I think was the beginning of the question.
I think oftentimes people are surprised that our manufacturer our manufacturing network is not typically 20000 liter stainless steel bioreactors right it tends to be.
Efficient nimble.
Small.
On an as a result, the capital required to support it even though the capabilities we think are differentiated.
Cause relatively modest versus versus the other therapeutic modalities.
As it relates to the synthetic side of things.
It too is a relatively efficient setup.
Even relative to the biologically sourced side of the house, because we don't have the complexity around the supply chain.
So we feel good about where we are our capabilities to continue to support our pipeline going forward and it will continue to be an area of investment.
At Jay Matt Here and just in addition.
There are there are important synergies between.
Between the different programs and manufacturing methodologies, particularly in terms of the release assays and identity purity potency assays that we developed and had been helping pioneer the field in terms of developing what those are and how they're how they're provided the FDA et cetera, and the other thing I'll point out is of course, we're in late stage and moving to commercial.
<unk> and the level of qualification and validation that's required for those assays and releases.
This is substantially higher than anything that's needed for a phase 1 or even a phase II and of course, we do that work internally here and so we're we feel well positioned to those those advances will help in a meaningful way.
Across the portfolio.
Okay, Great. That's all I have thanks.
Thanks for that.
Yeah.
Thank you.
I am showing no further questions at this time I would now like to turn the conference back over to management.
So thank you operator, and I want to thank everyone for joining our call today and for your continued interest in series, we look forward to continuing to keep you updated on our progress and with that we'll conclude have a great day. Thank you very much.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
Okay.
Okay.
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Yeah.
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Yes.
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