Q3 2020 Seres Therapeutics Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the series Therapeutics third quarter 2020 earnings Conference call.
At this time all participants are in listen only mode. After the speakers presentation there'll be a question and answer session to ask a question. During the session you need to press star one on your telephone.
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I would now like to hand, the conference over to Dr. Carlo Tanzi Investor Relations. Thank you. Please go ahead Sir.
Thank you and good morning, a press release with the Companys third quarter 2020 financial results and the business update became available at seven am Eastern time. This morning, and can be found on the investors and news section of the company's web site.
I'd like to remind you that we will be making forward looking statements related to the timing enrollment and results of our clinical studies regulatory approval, the promise and potential impact of any of our microbiome therapeutics and the sufficiency of our cash and cash equivalents to fund operations actual results may differ materially due.
Additionally, these statements are subject to certain risks and uncertainties, which are discussed under the risk factor section of our recent SEC filings.
Any forward looking statements made on today's call represent our views as of today we.
We may update these statements in the future, but we disclaim any obligation to do so.
On today's call I'm joined by President and Chief Executive Officer, Eric Schoen, Chief Medical Officer, Dr. Lisa bulky.
And Dr., Matt and.
Chief Scientific officer.
Dr., Terry Young Chief commercial and strategy Officer will also available for the Cume in a section.
I'll now pass the call to Eric.
Thank you Carlo and good morning, everyone I Hope you and your families are staying safe and healthy.
Over the past decade series has pioneered the translation of microbiome insights into an entirely new classes of medicines.
Microbiome therapeutics or consortia of bacteria in oral capsule.
Designed to produce specific functional changes in the gut microbiome to treat and prevent disease.
This has been a landmark eager for series that is provided what we believe is definitive proof of the clinical utility of our microbiome therapeutic approach and that supports our transition towards becoming a commercial organization.
Based on our recent tier one of nine phase three study success. We believe we are on track to become the first microbiome company to obtain an FC a product approval.
And bring a drug to market.
Our aspiration with SER 109, and with other drug candidates is to transform the management of serious disease through our novel microbiome therapeutic approach.
Our success was highlighted by the positive statistically significant results from our phase three equals four three study of SER 109 in patients with recurrent c. difficile infection.
Based on the strength of these results and the promise of sort of what are known in the marketplace. We were able to fortify our balance sheet with a substantial equity raise adding approximately $264 million in new capital to the company.
Since we obtained our SER 109 study results of the FDA has reaffirmed its prior guidance regarding the efficacy requirements to support us there wouldn't be a lay submission.
The 690, plus four three set of results far exceeded the efficacy threshold provided by the FDA and as a result.
We expect this single study to provide the efficacy basis for our SER 109 deal they filings.
The FDA also reaffirmed its guidance that at least 300 patients will be required for the SER 100 safety database and to enable a BLE filing.
Towards that end, we continue to enroll in our ongoing SER 109 open label study in patients with recurrent CVI.
And we expect this study from to fulfill the remainder of our required safety database.
We are making substantial progress with the study activating new clinical sites across the U.S and Canada and enrolling subjects into the study.
We have initiated several key activities to prepare for an anticipated SER. One an end product launch we have conducted market assessment work primary research with physicians and payers pricing and reimbursement analysis and product naming work.
We plan to scale, our market education efforts in 2021.
With significant HBP and payer education efforts, including the deployment of an MSL team.
With regard to SER one of them into factory.
While we are already at commercial scale, we're expanding our capabilities in preparation for product launch and potential rapid uptake into the market.
We recently hired Dave Eggy, as our new Chief Technology Officer.
Dave joined series from Merck and.
And his experience successfully leading the manufacturing of important formative some pharmaceuticals, including Keytruda will be vital for the company as we look ahead to the expected commercialization of SER 109.
Dave succeeds John on Adams, who led series manufacturing efforts since the company was formed.
We are very pleased that John will continue to support the company in a senior advisor capacity.
With that ill now turn the call over to Lisa.
Thanks, Eric and good morning, everyone.
I'll begin with a recap of our SER 109 phase three data that we announced in August the topline results demonstrated that tier one on nine net the study's primary eight week endpoint with tier one or nine showing a remarkable 30.2% absolute reduction of recurrence of CVI compared to placebo at eight weeks.
Those treatment.
We were also extremely pleased to see that the results demonstrated a highly favorable safety profile with tier one or nine adverse events looking similar to placebo.
In late October we presented a topline phase three results as well as some additional clinical study data at the American College of Gastroenterology annual scientific meeting.
Well the data showed that at 12 weeks post administration the rate of recurrence in the Seer one online arm was consistent with the results seen at eight weeks, which was the study's primary endpoint.
Additionally, we presented data demonstrating that tier one of nine administration resulted in similar efficacy when stratified by age or by the prior antibiotic received.
We have heard substantial physician interest regarding tier one of nine and many have highlighted the enormous medical and financial burdens of this disease and they've expressed enthusiasm that tier one of nine could represent a major advance for this field.
Now moving to our C or 287 program, which is an ongoing phase twob study in patients with mild to moderate clinically active ulcerative colitis.
Year to 87 is an orally administered biologically derived drug candidate comprised of commences bacterial spores isolated from the healthy human gastrointestinal tract.
Our objective with seer to 87, it to develop a first in class microbiome therapeutic that modulates, the microbiome and microbiome associated metabolite to treat ulcerative colitis.
We believe that tier 287 may provide a much needed non immunosuppressive treatment option for you see here.
Year to 87 is intended to reduce the impact of a dysfunctional microbiome as both a trigger and an amplifier of inflammation.
We believe that tier 287 has the potential to be used as both a monotherapy and potentially also in combination with other approved agents.
To remind you the 287 phase to be equal reset study is a randomized placebo controlled three arm induction trial that was designed to enroll 201 patients with active mild to moderate ulcerative colitis, who have failed prior therapy.
In arm eight patients receive a short course of vancomycin Preconditioning followed by 10 weeks of the same daily regimen that was used in the arm of the previous one B study that showed the highest clinical remission rate.
In RMB patients receive vancomycin Preconditioning, followed by two weeks of the same tier 287 daily regimen used in on a followed by eight weeks of a lower dose.
In RCC patients receive placebo.
As we previously reported the COVID-19 pandemic has had an impact on our currently enrolling clinical studies, including the seer to 87 phase Twob trial.
This study is now over 75% enrolled based on the studies 201 patient target.
Our clinical team has implemented a number of mitigation strategies aimed at maintaining forward progress, including providing increased clinical support to trial sites and additional flexibility regarding data capture.
Now moving to our phase one study for seer for one in our oncology portfolio.
Therefore, one is an orally administered biologically derived microbiome therapeutic candidate comprising bacteria reflective of the Microbiomes signature associated with response to checkpoint inhibitor immunotherapy with.
With cereal one we are targeting an increase in efficacy of checkpoint inhibitor immunotherapy and improvement in patient outcomes.
In collaboration with the Parker Institute for cancer, Immunotherapy, and MD Anderson Cancer Center, we continue to enroll a randomized placebo controlled phase one b study of three or four one in patients with metastatic melanoma.
All patients receive Nivolumab and FDA approved anti PD, one therapy in a randomized at a two to one ratio to either see or for one or placebo.
The trial is evaluating the safety tolerability and drug activity measured at the Engraft Minister for one bacteria in the GI tract and its association with Biomarkers of clinical response and outcome.
With that I'll now pass the call to that.
Thank you Lisa and good morning, everyone.
We're very pleased to announce the dosing of the first patient in Rcs real one phase one B study here.
Here. We are one is a next generation orally dosed rationally design fermented microbiome therapeutic candidate for the treatment both strip quite as.
The consortia of bacteria in its your tier one is designed to modify the microbiome and microbe associated metabolites in the gastrointestinal tract to modulate pathway to gastro intestinal inflammation and empathy earlier barrier integrity and patients with ulcerative colitis.
Sure. So one was designed using series reverse translation discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments of microbial strains will consortia using human cell based assays in in vitro and in vivo disease models.
The design was incorporate has incorporate learnings from this year to 87 phase one b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy in that study.
Sure. It's real one is being evaluated in a phase one b study in adults with mild to moderate ulcerative colitis.
He is being conducted in Australia, and New Zealand and includes two cohorts comprising approximately 65 patients in total.
First open label cohort of 15 subjects will evaluate safety and pharmacokinetics as measured by bacterial engraftment.
In the subsequent second cohort 50 subjects will be randomized to receive either yes rail one or placebo.
The objectives for this cohort are to evaluate drug safety and T.K. and evaluate clinical remission and other measures of efficacy as secondary endpoints.
Moving now to tier 155.
Sure one size side is an orally dosed rationally designed fermented microbiome therapeutic candidate that we have advanced into clinical development.
155, built out our expertise in infectious disease and immunology.
It is designed to prevent mortality due to gastrointestinal bacterial infection and bacteremia in graft versus host disease in immunocompromised patients, including patients receiving allergenic, Turkmenistan Metacritic stem cell transplantation.
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We expect that the tier one fivefive clinical program will provide insights into the potential for the microbiome therapeutics to improve outcome in stem cell transplant patients and to adapt our novel technology to prevent and treat antibiotic resistant bacterial infections and bacterial sepsis more broadly.
The Seer 155 program is supported by a car back square provides financial and operational support.
We expect to advance the program into a phase one B study early in 2021 in collaboration with Memorial Sloan Kettering Cancer Center.
Both our cereal one and tier one side five programs represent important advances in series technology capabilities and drug pipeline.
So these programs series has continued to refine our knowledge on the underlying mechanisms by which microbes in the gastrointestinal tract gauge pathogenic bacteria and human cells and tissues to impact disease.
Further through these programs, we continue to advance our field, leading GMP manufacturing capability and the breadth of biological diversity that can be incorporated into our drugs with technologies that can deliver bacteria in both store and lyophilized vegetative cells formulations.
I'll now turn the call back to her.
Thanks, Matt turning now to an overview of our recent financings.
Theres reported a net loss of 30.3 million for the third quarter of 2020 as compared to a net loss of $15.4 million for the same period in 2019.
The third quarter net loss was driven primarily by clinical and development expenses personnel expenses and ongoing development of the company's microbiome therapeutics platform.
Additional financial information regarding the quarter can be found in our press release as well as our 10-Q that we intend to file later today.
[noise] series ended the third quarter in a strong financial position with approximately $320 million in cash cash equivalents and investments compared with 63.9 million at the end of the second quarter 2020.
In August 2020.
The company completed a public equity offering and the securities purchase agreement with Nestle that in total provided approximately 264 million in net proceeds.
We also anticipate receipt of a 10 million dollar serial one phase one associated milestone payment that series is entitled to as part of our Nestle collaborations.
We will use our strength from corporate resources to execute against our top objectives, our company priorities are to.
Prepare for SER, 100, commercialization, including augmenting our existing CMC infrastructure.
To advance our development stage assets to meaningful clinical milestones.
And to deepen our R&D capabilities and expand our pipeline into new disease areas, where we believe the microbiome therapeutics could be effective.
[noise] serious has long been leading the emerging field of microbiome therapeutics.
We intend to utilize the resources now available for the company to recruit additional world class talent and further extend our therapeutic category leadership position.
Before opening up the call to your questions.
I'd like to reiterate how excited we are by what lies ahead for series and the microbiome space in general.
Our highest priority is completing the work needed for our tier one or nine bln and preparing for the potential launch of the first ever microbiome therapy.
Our success in 2020 is the culmination of a decade of work with Medi contributors I want to thank our talented and dedicated team who never lost sight of the goal of pioneering this new field of medicine, and creating an important new treatment options for patients in need this.
This is an exciting time for series.
And we look forward to advancing this new therapeutic category and working tirelessly to help patients in the years ahead.
With that operator, we'll open up the call amount of questions.
As a reminder, ladies and gentlemen, if you have a question at this time. Please press Star then the number one and you touched on telephone. If your question has been answered any wish to remove yourself from the queue. Please press the pound key please standby, Sir Bobby compiled acuity master.
Our first question comes from the line of Ted Tenthoff with Piper Sandler Your line is open.
Great. Thank you some ripple through profit level progress, it's really to try that I wanted to get a sense for maybe where you are getting enrollment.
With the additional safety.
Cohort.
Edwin if you have any guidance on when maybe enrollments for that could be completed thank you.
Good morning, Ted and thanks for the question, let me start and then maybe I'll ask Lisa just to provide some color. So.
As a reminder, we started the we started the open label fairly recently I will say that I'm extremely pleased that we.
We did make a number of at risk investments prior to the phase three results that came in August to ensure that we were ready to move forward with the open label, but.
Certainly we're continuing to make progress we're continuing to open sites and maybe I can ask Lisa to provide some additional color.
Sure. So yes, as Eric said, we're making a lot of progress with site activation.
We're getting a lot of enthusiasm both because of the over onto results. The fact that theres no placebo. The fact that this trial allows for inclusion of first recurrent patients and the fact that FMT is currently constrained.
We are also mindful that the covance landscape, maybe changing and we're going to be very vigilant in looking for any new headwinds that this might cause us but right now we're we're making very good progress.
Well, obviously, okay yep startup expenses to finish.
Obviously, a key operational priority for us and.
And we're working extremely.
Extremely hard to know my personal forward.
Great excellent thanks, somewhere hurry up great there.
So the question that.
Okay.
And our next question comes from the line of Joseph.
Tell me with Cowen and company your line is open.
Hi, there. Thank you for taking my questions and congrats on the progress.
The first one is on one or nine.
As you did indicate that the open label study does include patients that have first recurrence.
What's sort of your best guess of where and the treatment paradigm. One on nine will fit once it's successfully launched in practice.
And then one more if I can just on to maybe seven and three a one.
How do you anticipate advancing both of those programs if they show solid data for both would you be taking both forward or is there a time, where where you would look at the data and see if you want to take one can afford versus the other thank you.
Yes, Joe good morning, and thanks for the for the two questions why don't we start with 109 and I think.
You're asking maybe about the label, but also the opportunity and I think it's important just to comment on both.
Of course, the label will be determined as part of the end of a negotiation with the FDA as part of that process.
Certainly we believe that SER 109.
Should be applicable for for a broad set of patients, including first recurrence and greater.
We've got data that encourages us, including as Lisa mentioned.
We could ask the FDA to allow first recurrent patients into our open label study to which they agreed so that's a data point that we think is it's it's helpful. But.
Maybe I can ask Lisa the comment just on the medical perspective as it relates to first versus multiply recurrent and then we can take or two or is that a question.
Yeah, So the medical underpinnings for first recurrence and and further recurrence are essentially the same in that in that once patients recur its indicative of the fact that they have a dysfunctional microbiome that need to repair. So you know our PEO wells as well as we internally.
The the medically the indication would be.
Completely appropriate, but as Eric stated in the label itself will be a discussion with the FDA.
Yep.
And Joe maybe I can I can move to your second question, which relates to 337, you know look I'd say as a team. We're incredibly excited about dosing the first patient with three I want it and we think it's.
It's a significant technological achievement for the company that we're really proud of.
Maybe I'll ask Matt to comment just on the learnings from 27 to 301, but I think this is illustrative of really our first in class and best in class strategy right. So as we leverage human data sets and it's hugely important to recognize that the human data sets are so important in understanding the microbiome for human.
301, really is really that next step forward and of course as you know we're conducting the one b study.
It's really in New Zealand, we think that there's this.
This rationale for geographic geographically separate in the two studies that they're not going to cannibalize each other.
But we really do think that there is a there is an opportunity to help patients with both.
Biologically source as well as a defined approach advantages for each right I'm on the three on one side. Obviously, there is the supply chain element, which is.
Which is more efficient.
But at the same time, you know with our our our 27 one be dataset.
We really have a lot of encouragement that this could be a program that could help patients in need I think that theres a misunderstanding about how effective existing therapies are in terms of successfully achieving remission for patients in the space, but maybe I can ask masters to comment further on the leverage between our two to 7.31 per.
Grams that really were a prudent applied in the design of three on one and gives us a lot of optimism or moving forward.
Yes, sure. So it's fair to 87 trial, Derek indicated give us direct insights into species and strains that engraft and our associated with clinical emission this as well as Microsoft associated with the lights.
At our as well associated with clinical clinical remission and these data on these metabolites. These pathways. These particular species.
Really helped guide.
The design of serial one and I think the real power through a one comes from combining those types of insights with.
With our work in the <unk> and non clinical setting using various different human cell based on assays, where we can add as well look and understand.
Fine level of detail, how the micros themselves and the metabolize as they're generating impact various different disease relevant profit and it's by combining these various different.
Pieces of information using what is really a research engine that series built up to do specifically that we've been able to pull together the design of the hubs of Seer trio and the selection of strain better and I think it really the strength comes from leveraging both those human insights because we have found across our clinical portfolio.
That the insights you get from human subjects are instrumental.
In designing our drugs.
Great that is very helpful. Thanks, and congrats again.
Thanks for the question Joe.
Our next question comes from the line of John Newman with Canaccord. Your line is open.
Hi, guys. Good morning, Thanks, very much for taking my question and congrats on the progress so.
The first question I had was wondering if you could give us some sense as to.
When we might see some initial data answer to a seven I know that that study is still enrolling.
And whether you might update us when it completes enrolling.
Second question I had is regarding seer floral one just curious if you see things that are interesting in that phase one study.
In melanoma.
How quickly could you move into a larger study and the reason I'm asking is because of the design of that study is very interesting essentially it's a phase one but its kind of control arm, which we normally don't see.
So just curious as to.
If you do see something interesting there how quickly you might move ahead with a larger study. Thanks.
Yes, John Good morning, and thank you for the questions. Let me sort of a first on 27 I might ask Lisa Lisa the comment and then we can we can ask Matt to comment on for one so for to do seven you know of course, we have been impacted by the pandemic as others that are conducting studies in the space of course, we require and.
Cost could be as part of our clinical protocol, so particularly into the spring.
And in the early part of the summer we were pretty constrained we.
We have said and I'll reiterate today, we've seen progress.
In terms of enrollment and we continue to screen and enroll.
And there have been times for encouragement both throughout the summer and into the fall.
Where are we are not today at the point of enrollment that we were at the beginning of the year. So we have implemented a number of.
Mitigation strategies related to the pandemic, which which give us encouragement in the abilities ability to enroll going forward, obviously, our crystal ball is no better than anybody else's as it relates to where the pin them. It goes next obviously would be highly highly encouraged with the with the vaccine data that came out this morning.
But we are excited about the opportunity to continue enrolling patients for the study Lisa anything to comment on that before we had four one.
Yeah, No I think that as you as you said you know weve, we and others have made a lot of adjustments in the clinical trials phase two to compensate for the various coated influences, but obviously of Cove. It does take off again, even if site stay open there's always the question about whether a patient.
Will reengage with the medical system for anything so we're going to keep an eye on it but we're we're liking are the changes that we've seen since the spring.
Yep.
Great and then John to your second question, maybe I can I can ask Matt to comment on on for a while it's probably important to say.
Maybe ground everybody in the in the the objectives of the study. So let me, let me sort of done that for a couple of comments.
Yes sure.
So as as as recent undergo early in the call. This trial is evaluating the safety tolerability and drug activity.
Yes worldwide in metastatic melanoma patients, where there is combination therapy with the volume add plus your flow one and done as you point out. This is a this is a placebo controlled trial and and we designed the trial at such because we have certainly learned through our clinical development experience.
The extreme value that comes from these placebo controlled trials, even if they are smaller in size and exploratory and we've gained very important insights.
From from running such such trial. So our goal with this trial is to.
Really understand how seer for a one.
What its activities in subjects. So we'll look at Engrafting as we as we as we typically do in our studies, but then also look to understand what types of biomarkers might be associated with and Grafton, our broader changes in the microbiome as as.
That engraftment of Seer Portland.
In terms of this is that this is an exploratory phase one one b trial and.
No pending results from this in the learnings from this will do is we always have done that series is to take a hard look at the data.
And then make decisions about what's the best best path forward is with respect to that the next trial and the drug modality.
Great. Thank you.
Thank you John.
Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is open.
Hey, good morning, and congrats on the really transformational quarter.
Maybe I can ask one question about sort of went to nine and one about search to each of them first can we expect to see 24 week data from Echo is worth three sometime in early 2021, and and I'm also wondering how much patient follow up yes. He is asking for in <unk>.
Yes were forced study to satisfy the safety database requirement for SER 109.
Yes, so so mark good morning. Thanks for the question now ill ask at least for the comment I will say that.
We are continuing to work with the FDA to clarify the schedule of of how we will present data to them as part of the open label study and maybe Lisa can comment further on on that as well as the the plan for additional.
Data disclosure from the studies.
Sure so with regard to the old one three study recall that we had already.
Yes.
Got into 105 safety patients if you will with the end of the old one too so with regard to the remainder of that 300.
Eric said, we've been discussing with an FDA exactly what the schedule for providing that and.
Also as Eric had noted we didnt waste any time, while we were waiting for those discussions to go ahead and get started now the overland to study. The final 24 week data is going to be available internally very very soon I.
Maybe you didn't do the math as based on on when we finished up with our 12 week announcements. This summer. So we will be looking for the correct venues to get information to you all as well as to the medical community and obviously, we would like to to be able to preserve the ability to disseminate that through.
Publications and things like that so we'll be working hard to identify those venues.
Okay got it and just with respect to the SER 207, I know you've previously mentioned eco route reset could serve as one of two pivotal trials that could support registration in ulcerative colitis.
Maybe be helpful. If you could give us a sense for how a potential second study would differ from echo reset in terms of size and endpoints and thanks for taking the questions.
As a reminder, ladies and gentlemen, if you have a question at this time. Please press Star then the number one.
Our next question comes from the line of Chris Howerton with Jefferies. Your line is open.
Hi, Hey, there I am not sure if you wanted to try and answer the previous question with respect to.
The eco reset trail here I'm fine with waiting a moment.
Oh, Hey, guys bear bear where those guys. It looks like we're having some technical difficulties from the south from the south to things that folks can just hold type for one second.
Operator, it looks like we lost.
Well folks you can look into that.
Yes I.
I do see Eric line is still connected.
He said you can't hear anything like it.
Okay. Just one moment. Please let me so maybe you can take a marks I think on the phase three yeah. I think a 287 result school will be incredibly important for designing the next study. So I think in terms of you know size a lot will depend on the effect size we.
I see and whether or not we need to think about a bigger trial or.
Similar trial to make sure that we are statistically significant so really without seeing the results of 287, it's really hard to to speculate on what the next trial would look like.
[noise] are you were you able to do that okay.
Hello.
Right. So this is Chris howerton.
No I heard you just find Lisa.
Don't know if you guys can you hear me.
I can hear you. We can hate me can you know Chris Yeah, Theres definitely some technical issues going on but we can we can hear you. Okay awesome I will very good the well maybe I'll just add a couple of questions that and then we'll see what happens so the.
For the for the first one maybe Lisa just to clarify what you had said previously for the 012 study, which I think was the.
The eco score three study you had 105 patients that comprise the safety database I just wanted to confirm that I heard that number right.
The second question that I had was what is the specific plans for CMC expansion I think obviously.
I've seen the facility in Boston, a beautiful there so what would be the plans in terms of expanding to a different facility to augment that and what are the kind of capabilities that you would like to see a augmented internally to either support.
Biologically sourced or rationally design consulting job. This leaves those are entering the clinic one more.
Yes.
For the Garden bar, I'm, sorry, sorry, I like to their [laughter], let Lisa weeks can you comment on the first the 105, Chris just to be clear was at the time that we announced.
The topline results for at least the ones you comment on the first one we conducted site.
Yeah, that's exactly yet so it was those that had been in in 012 as well as in the extension so had already been in the start of the old one three study.
That's exactly right.
Yep and.
And then Chris and hopefully I think my phone line hangs on here.
As it relates to CMC. So you know look what let's take a step back here.
We are.
Not only are we thrilled with the the phase three results for certain when an online we're now moving to a phase where we feel we have a significant responsibility to serve this patient group that really hasn't seen.
Innovation to the space in quite some time and we really do think we have the opportunity to help these patients. So we want to be sure that we are serving these patients with the right.
Capacity and at some point redundancy.
To ensure that there isn't an interruption in the availability of drugs.
We are currently at commercial scale, but with these phase three results.
And you mentioned that not only on the biology biologically side of the house, but also as evidenced by our dosing our first patient on three or one we think there's opportunities as the as the pipeline and the platform progresses.
To serve patients both in the biologically sourced side of the house as well as the synthetic too. So we will be looking to make investments and then I think bringing Dave onboard is perhaps an illustrative of the fact that we take very seriously the not only the supply chain, but also the manufacturing processes to ensure that we're providing drug for patients as we move forward both for the lender saved.
Outside of the pipeline as wealthy earlier is there sort of pipeline.
Okay, all right well very good I appreciate it.
Thanks for taking the questions. Thanks.
Thanks for the question Chris.
Thank you I'm not showing any further questions I'll now turn the call back over to management for closing remarks.
So again, thanks for your attention. This morning, we hope that you have a great week and we look forward to connecting with you soon be healthy and well thanks and good morning.
Ladies and gentlemen, this does conclude the program you may now disconnect. Thank you for participating have a wonderful day.
Oh.
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Ladies and gentlemen, thank you for standing by welcome to the series Therapeutics third quarter 2020 earnings Conference call.
This time, all participants are not only mode. After the speakers presentation, there will be a question and answer session.
That's the question during the session you need to press Star one on your telephone please be advised that this call is being recorded if.
If you acquire any further assistance during the conference. Please press star zero and an operator will be happy to assist you.
I would now like to hand the call.
France, Dr. Carlo Tanzi Investor Relations. Thank you. Please go ahead Sir.
Thank you and good morning.
Thanks to the company's third quarter 2020 financial results and the business update became available at seven am Eastern time. This morning.
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 results of our clinical studies regulatory approval, the promise and potential impact of any of our microbiome therapeutics and the sufficiency of our cash and cash equivalents to fund operations actual results may differ materially.
Additionally, these statements are subject to certain risks and uncertainties, which are discussed under the risk factor section of our recent SEC filings any.
Any forward looking statements made on today's call represent our views as of today.
We may update these statements in the future, but we disclaim any obligation to do so.
On today's call I'm joined by President and Chief Executive Officer, Eric Shop, Chief Medical Officer, Dr. Lisa bulky.
And Dr., Matt and.
Chief Scientific officer.
Dr., Terry Young Chief commercial and strategy officer, well also available for the QNX section.
I'll now pass the call to Eric.
Thank you Carlo and good morning, everyone I Hope you and your families are staying safe and healthy.
Over the past decade series has pioneered the translation of microbiome insights into an entirely new class of medicines.
Microbiome therapeutics or consortia of bacteria in oral capsule.
Designed to produce specific functional changes in the gut microbiome to treat and prevent disease.
This has been a landmark either for series that is provided what we believe is the Finland. The proof of the clinical utility of our microbiome therapeutic approach and that supports our transition towards becoming a commercial organization.
Based on our recent fear or one or nine phase three studies success. We believe we are on track to become the first Microturbine company to obtain an f. the product approval.
And bring drugs to market.
Our aspiration, what sort of went to nine and with other drug candidates is to transform the management of serious disease through our novel microbiome therapeutic approach.
Our success is highlighted by the positive statistically significant results from our phase three equals four three study of several 109 in patients with recurrent c. difficile infection.
Based on the strength of these results and the promise of Cerro <unk> in the marketplace.
We're able to fortify our balance sheet with a substantial equity raise adding approximately $264 million in new capital to the company.
Since we obtained our SER one an IDE study result will be FCTA has reaffirmed its prior guidance regarding the efficacy requirements to support there wouldn't be a lay submission.
But there are one or 90 foot sport free federal results far exceeded the efficacy threshold provided by the FDA and as a result, we expect this single study to provide the efficacy basis for us or one of the <unk> deal a filer.
The FDA also reaffirmed its guidance that at least 300 patients will be required for the SER, one named safety database and to enable a BLA filing.
Towards that end, we continue to enroll in our ongoing SER 109 open label study in patients with recurrent CVI.
We expect this study from to fulfill the remainder of our required safety database.
We are making substantial progress with the study activating new clinical sites across the USA and Canada and enrolling subjects into the study.
We have initiated several key activities to prepare for an anticipated SER one of that product launch we have conducted market assessment work primary research with physicians and payers pricing and reimbursement analysis.
Product naming work.
We plan to scale, our market education efforts in 2021.
With significant HCP impair education efforts, including the deployment of an NFL team.
With regard to SER one of their manufacturing.
While we are already at commercial scale, we are expanding our capabilities in preparation for product launch and potential rapid uptake into the market.
We recently hired Dave Eggy, as our new Chief Technology Officer.
Dave joined series from Merck and his experience successfully leading the manufacturing of important pharma to pharmaceuticals, including Keytruda will be vital for the company as we look ahead to the expected commercialization of tier one of nine.
Dave succeeds John audience, who led there is manufacturing efforts since the company was formed.
We're very pleased that John will continue to support the company in a senior advisor capacity.
With that ill now turn the call over to Lisa.
Thanks, Eric and good morning, everyone.
Ill begin with a recap of our tier one on nine phase three data that we announced in August the topline results demonstrated that fear one on nine net the study's primary eight week endpoint with tier one of nine showing a remarkable 30.2% absolute reduction of recurrences CDIY compared to placebo at eight weeks.
Those treatment.
We were also extremely pleased to see that the results demonstrated a highly favorable safety profile with tier one on nine adverse events looking similar to placebo.
In late October we presented a topline phase three result, as well as some additional clinical study data at the American College of Gastroenterology annual scientific meeting.
New data showed that at 12 weeks post administration the rate of recurrence in the Seer one online arm was consistent with the results seen at eight weeks, which was the study's primary endpoint.
Additionally, we presented data demonstrating that tier one on non administration resulted in similar efficacy when stratified by age or by the prior antibiotic received.
We have heard substantial physician interest regarding tier one of nine.
And many have highlighted the enormous medical and financial burdens of this disease and they have expressed enthusiasm that SER 109 could represent a major advance for this field.
Now moving to our tier 287 program, which is an ongoing phase twob study in patients with mild to moderate clinically active ulcerative colitis.
Year to 87 is an orally administered biologically derived drug candidate comprised of commences bacterial spores isolated from the healthy human gastrointestinal tract.
Our objective with tier 287, it to develop a first in class microbiome therapeutic that modulates, the microbiome and microbiome associated metabolite to treat ulcerative colitis.
We believe that seer to 87 may provide a much needed non immunosuppressive treatment option for you see here.
Year to 87 is intended to reduce the impact of a dysfunctional microbiome as both a trigger and an amplifier of inflammation.
We believe that tier 287 has the potential to be used as both a monotherapy and potentially also in combination with other approved agents.
To remind you the 287 phase to be eco reset study is a randomized placebo controlled three arm induction trial that was designed to enroll 201 patients with active mild to moderate ulcerative colitis with failed prior therapy.
In arm eight patients receive a short course of vancomycin Preconditioning followed by 10 weeks of the same daily regimen that was used in the arm of the previous one B study that showed the highest clinical remission rate.
In our B patients receive Echo my son, Preconditioning, followed by two weeks of the same tier 287 daily regimen used in on eight followed by eight weeks of a lower dose.
In RCC patients received placebo.
As we previously reported the COVID-19 pandemic has had an impact on our currently enrolling clinical studies, including the seer to 87 phase Twob trial.
This study is now over 75% enrolled based on this study 201 patient target.
Our clinical team has implemented a number of mitigation strategies aimed at maintaining forward progress.
Clothing, providing increased clinical support to trial sites and additional flexibility regarding data capture.
Now moving to our phase one study for CR for one in our oncology portfolio.
Therefore, one is an orally administered biologically derived microbiome therapeutic candidate comprising bacteria reflective of the microbiomes signature associated with response.
Checkpoint inhibitor immunotherapy.
With zero, one we are targeting an increase in efficacy of checkpoint inhibitor immunotherapy and improvement in patient outcome.
In collaboration with the Parker Institute for cancer, Immunotherapy, and MD Anderson Cancer Center, we continue to enroll a randomized placebo controlled phase one b study of tier four one in patients with metastatic melanoma.
All patients received Nivolumab and an FDA approved anti PD, one therapy and.
The randomized at a two to one ratio either seer for one or placebo.
The trial is evaluating the safety tolerability and drug activity measured at the Engraft Minister for one bacteria in the GI tract and its association with Biomarkers of clinical response and outcome.
With that I'll now pass the call to that.
Thank you Lisa and good morning, everyone.
We're very pleased to announce the dosing of the first patient in our CS rail one phase one study.
It's real one is a next generation orally dosed rationally designed fermented microbiome therapeutic candidate for the treatment bolster politesse.
The consortia of bacteria in its Jeff. Your line is designed to modify the microbiome and microbe associated metabolized in the gastrointestinal tract modulates pathway to gastrointestinal explanation and apathy earlier barrier integrity in patients with ulcerative colitis.
Sears real one was designed using series reverse translation discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments of microbial strains consortia using human cell based axeight in vitro and in vivo disease models.
The design was incorporate has incorporated learnings from this year to 87 phase one b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy in that study.
Sure. It's real one is being evaluated in a phase one b study in adults with mild to moderate ulcerative colitis.
He is being conducted in Australia, and New Zealand and includes two cohorts comprising approximately 65 patients in total.
First open label cohort of 15 subjects will evaluate safety and pharmacokinetics as measured by Raptorial Engraftment.
And the subsequent second cohort 50 subjects will be randomized to receive either three or one or placebo.
The objectives for this call are hard to evaluate drug safety and PK and evaluate clinical remission and other measures of efficacy as secondary endpoints.
Moving out to tier one five.
Sure what size size is an orally dosed rationally design fermented microbiome therapeutic candidate that we have advanced into clinical development.
Sure 155 built out our expertise in stature and immunology.
It is designed to prevent mortality due to gastrointestinal bacterial infection, and bacteremia and graft versus host disease in immunocompromised patients, including patients receiving allogenic, Turkmenistan Metacritic stem cell transplantation.
[music].
We expect that this tier 155 clinical program will provide insights into the potential for the microbiome therapeutics to improve outcomes in stem cell transplant patients and to adapt our novel technology to prevent and treat antibiotic resistant bacterial infections and bacterial sepsis more broadly.
This year one stock buyback program is supported by a car back Greg provides financial and operational support.
We expect to advance the program into a phase one B study early in 2021 in collaboration with Memorial Sloan Kettering cancers.
Both our cereal one and tier one slide five programs represent important advances in series technology capabilities and drug pipeline.
So these programs series has continued to refine our knowledge of the underlying mechanisms by which microbes in the gastrointestinal tract gauge pathogenic bacteria on human cells and tissues to impact.
Further through these programs, we have continued to advance our field, leading GMP manufacturing capability and the breadth of biological diversity that can be incorporated into our drugs. The technologies that can deliver bacteria in Gulf War and lay off like vegetative sell formulations.
I'll now turn the call back to her.
Thanks, Matt turning now to an overview of our recent financings.
Serious reported a net loss of 30.3 million for the third quarter of 2020 as compared to a net loss of 15.4 million for the same period in 2019.
The third quarter net loss was driven primarily by clinical and development expenses personnel expenses and ongoing development of the company's microbiome therapeutics platform.
Additional financial information regarding the quarter can be found in our press release as well as our 10-Q that we intend to file later today.
[noise] series ended the third quarter in a strong financial position with approximately $320 million in cash cash equivalents and investments compared with 63.9 million at the end of the second quarter 2020.
In August 2020.
The company completed a public equity offering and the security purchase agreement with Nestle that in total provided approximately 254 million in net proceeds.
We also anticipate receipt of a 10 million dollar serial one phase one associated milestone payment that serious isn't isn't title two as part of our Nestle collaboration.
We will use our strength from corporate resources to execute against our top objectives, our company priorities are to.
Prepare for SER, 100, commercialization, including augmenting our existing CMC infrastructure.
To advance our development stage assets to meaningful clinical milestones.
And to deepen our R&D capabilities and expand our pipeline into new disease areas, where we believe the microbiome therapeutics could be effective.
So Chris has long been a leading the emerging field of microbiome therapeutics.
We intend to utilize the resources now available to the company to recruit additional world class talent and further extend our therapeutic category leadership position.
Before opening up the call to your questions.
I'd like to reiterate how excited we are by what lies ahead for series and the microbiome space in general.
Our highest priority is completing the work needed for our SER 109 BLS.
And preparing for the potential launch of the first ever microbiome therapy.
Our success in 2020 is the culmination of a decade of work with Medi contributors I want to thank our talented and dedicated team who never lost sight of the goal of pioneering this new field of medicine, and creating an important new treatment options for patients in need.
This is an exciting time for us there is.
And we look forward to advancing this new therapeutic category and working tirelessly to help patients in the years ahead.
With that operator, we'll open up the call now for questions.
As a reminder, ladies and gentlemen, if you have a question at this time. Please press Star then the number one you touched on the telephone.
My question has been answered any wish to remove yourself from the queue. Please press the pound key please standby, Sir Bobby compiled acuity master.
Our first question comes from the line of Ted Tenthoff with Piper Sandler Your line is open.
Great. Thank you congrats on the progress is really exciting I wanted to get a sense for maybe where you are in enrollment with the additional safety code.
Cohort.
And when if you have any guidance on when baby enrollments for that could be completed thank you.
Good morning said and thanks for the question, let me start and then maybe I'll ask Lisa just to provide some color. So you know as a reminder, we started the we started the open label fairly recently I will say that that I'm extremely pleased that we.
We did make a number of at risk investments prior to the phase three results that came in August to ensure that we were ready to move forward with the open label, but.
Certainly we're continuing to make progress we're continuing to open sites and maybe I can ask leads to provide some additional color.
Sure. So yes, as Eric said, we're making a lot of progress with site activation.
We're getting a lot of enthusiasm both because of the over onto results. The fact that theres no placebo. The fact that this trial allows for inclusion of first recurrent patients and the fact that FMT is currently constrained.
We are also mindful that the cobot landscape may be changing and we're going to be very vigilant in looking for any new headwinds that this might cause us but right now we're we're making very good progress.
Well, obviously I said, yes.
Yes, sorry, just to finish up.
Obviously, a key operational priority for us and.
And were working.
Really hard to move ourselves forward.
Great. Thanks, so much for every update.
Thanks for the question.
Okay.
And our next question comes from the line of Joseph.
Tell me with Cowen and company your line is open.
Hi, there. Thank you for taking my questions and congrats on the progress.
The first one is on what our nine yes.
As you did indicate that the open label study does include patients that have first recurrence.
What sort of your best guess of where and the treatment paradigm, what all nine will fit once it's successfully launched in practice.
And then one more if I can just on 287 and three a one.
How do you anticipate advancing both of those programs if they show solid data for both would you be taking both forward or is there a time, where where you would look at the data and see if you want to take one candidate forward versus the other thank you.
Yes, Joe good morning, and thanks for the for the two questions why don't we start with 109 and I think.
You're asking maybe about the label, but also the opportunity and I think the important just to comment on both.
Of course, the label will be determined as part of the end of a negotiation with the FDA as part of that process certainly we believe that SER 109.
Should be applicable for for a broad set of patients, including first recurrence and greater.
We've got data that encourages us, including as Lisa mentioned.
We could ask the FDA to allow first recurrent patients into our open label study to which they agreed so thats a data point that we think is good it's helpful. But.
Maybe I can ask Lee for the comment just on the medical perspective as it relates to first versus multiply recurrent and then we can take your team and is that a question.
Yes, so the medical underpinnings for first recurrence and and further recurrence are essentially the same in that in that once patients recur its indicative of the fact that they have a dysfunctional microbiome that need to repair. So you know.
Our Q wells as well as we internally see the medically the indication would be completely.
Completely appropriate, but as Eric stated in the label itself will be.
A discussion with the FDA.
Yep.
And Joe maybe I can I can move to your second question, which relates to the 337 look I'd say as a team. We are incredibly excited about dosing the first patient with three one and we pick ups.
It's a significant technological achievement for the company that we're really proud of.
Ill ask Matt to comment just on on the learnings from 27 to 301, but I think this is illustrative of really our first in class and best in class strategy right. So as we leverage human data sets and it's hugely important to recognize that that humid David said theres still important in understanding the microbiome of human.
[music].
301, really is really that next step forward and of course as you know we're conducting the one b study.
It's really in the deal and we think that there is.
His rationale for Jeff Rob geographically separated the two studies that they're not going to cannibalize each other.
But we really do think that there is a there is an opportunity to help patients with both.
Alas biologically source as well as a defined approach advantages for each right I'm on the three on one side. Obviously, there is the supply chain element, which is.
Which is more efficient.
But at the same time with our our our 27 one be dataset we.
We really had a lot of encouragement that this could be.
A program that could help patients in need I think that theres, a misunderstanding about how effective existing therapies are in terms of successfully achieving remission for for patients in the us in that space, but maybe I can ask Matt just to comment further on the leverage between our two seven and three on one programs that really were accrued and apply them the good.
Industrial wondering gives us from a lot of optimism or moving forward.
Yes sure. So what's your 27 trial, Derek indicated give us directly insights into species and strains that engraft and our associated with clinical emission less as well as my club associated highlights.
At our as well associated with clinical clinical remission and these data on these metabolites. These pathways. These particular species we.
We will help guide.
The design associates, we are one and I think the real power Israel one comes from combining those types of insights.
We are working and non clinical setting using various different human cell based assays were.
Where we can let as well look and understand.
At a fine level of detail.
The Microsoft themselves and the metabolize, if we're generating impact.
Various different disease relevant and it's by combining with various different.
Pieces of information using what is really a research engine that series built up to do specifically that.
We've been able to pull together the design hubs of Seer trio.
And the selection of strains that are and I think it really the strength comes from leveraging both those human sites, because we have found across our clinical portfolio.
That the insights you get from human subjects are instrumental.
In designing our drugs.
Great that is very helpful. Thanks, and congrats again.
Thanks for the question Joe.
Our next question comes from the line of John Newman with Canaccord. Your line is open.
Hi, guys. Good morning, Thanks, very much for taking my question and congrats on the progress.
The first question I had was I wondered if you could give us some sense as to.
When we might see some initial data on situate seven I know that that study is still enrolling.
And whether you might update us when it completes enrolling.
Second question I had is regarding.
So your floral one just curious if you see things that are interesting in that phase one study.
In melanoma.
How quickly could you move into a larger study and the reason I'm asking is because of the design of that study is very interesting is actually it's a phase one but its kind of control arm, which we normally don't see.
So just curious as to.
If you do see something interesting there how quickly you might move ahead with a larger study. Thanks.
Yes, John Good morning, and thank you for the questions. Let me sort of a first on 27 I might ask Lisa Lisa the comment and then we can we can pass.
That's not to comment on for one so for 37, you know of course, we have been impacted by the pandemic of others that are conducting studies in the space of course, we require endoscopy as part of our clinical protocol, so particularly into the spring.
And in the early part of the summer we were pretty constrained.
We have said and ill reiterate today, we've seen progress.
In terms of enrollment and we continue to screen and enroll.
And there have been times for encouragement both throughout the summer and into the fall.
Where are we are not today at the point of an enrollment that we were at the beginning of the year. So we have implemented a number of.
Mitigation strategies related to the pandemic, which which give us encouragement in the abilities ability to enroll going forward, obviously, our crystal ball is no better than anybody else's as it relates to where the pin them. It goes next obviously.
Highly highly encouraged with the with the vaccine data that came out this morning.
But.
We are excited about the opportunity to continue enrolling patients for the study Lisa anything to comment on that before we hit for one.
Yes, no I think that as you said you know weve, we and others have made a lot of adjustments in the clinical trials phase two to compensate for the various coated issuances.
Obviously, if cove it does take off again, even if site stay open there's always the question about whether patients will reengage with the medical system for anything so we're going to keep an eye on it but we're we're liking our the change that we've seen since the spring.
Yep Yep.
Great and then John to your second question, maybe I can I can ask Matt to comment on for a while it's probably important just to maybe.
Maybe ground everybody in the in the the objectives of this study. So let me let me sort of done that for a couple of comments.
Yes sure.
So as as as we said undergo early in the call. This trial is evaluating the safety tolerability and drug activity.
Worldwide in metastatic melanoma patients, where they're at odds combination therapy with the volume add plus for a one and done that you point out. This is a this is a placebo controlled trial and we designed the trial at such because we certainly learned through our clinical development experience.
The extreme value that comes from these placebo controlled trials, even if they are smaller in size and exploratory and weve came very important insights.
From from running such such trial. So our goal with this trial is to.
Really understand how seer floral one.
What its activity in subjects. So we'll look at engraft and as we as we as we typically do in our studies, but then also look to understand what types of biomarkers might be associated with engraftment, our profit or changes in the microbiome.
Of that Engraftment of oral.
All right in terms of this is that this is an exploratory phase one one b trial and.
No pending results from this in the learnings from this what we'll do as we always have done thats, you're able to take a hard look at the data.
And then make decisions about what's the best best path forward is with respect to that the next trial and the drug modality.
Great. Thank you.
Thank you John.
Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is open.
Hey, good morning, and congrats on the really transformational quarter.
Maybe I can ask one question about SER 109, and one about search to each of them.
First can we expect to see 24 week data from Echo is worth three sometime in early 2021, and and I'm also wondering how much patient follow up yes. He is asking for in Echo square for study to satisfy the safety database requirement for SER 109.
Yes, so so much.
Mark Good morning. Thanks for the question now ill ask at least for the comment I will say that.
We are continuing to work with the FDA to clarify the schedule of of how we will present data to them as part of the open label study and maybe at least I can comment further on on that as well as the the plan for additional.
Data disclosure from the studies.
Sure So with regard to the one three study recall that we had already.
Yes.
Got into 105 safety patients if you will with the end of the old one too so with regard to the remainder of that 300.
Eric said, we've been discussing with an FDA exactly what the schedule for providing that and.
Also as Eric had noted we didnt waste any time, while we were waiting for those discussions to go ahead and get started now the overland to study. The final 24 week data is going to be available internally very very soon.
You can do the math as based on on when we finished up with our 12 week announcements. This summer. So we will be looking for that correct venue to get information to you all as well as to the medical community and obviously, we would like to to be able to preserve the ability to disseminate that through public.
Stations and things like that so we'll be working hard to identify those venues.
Okay got it and just with respect to its Kevin I.
I know you previously mentioned echo reset could serve as one of two pivotal trials that could support registration in ulcerative colitis.
Maybe be helpful. If you could give us a sense for how.
The potential second study would differ from echo reset in terms of size and endpoints and thanks for taking the questions.
As a reminder, ladies and gentlemen, if you have a question at this time, Please press star and the number one.
Our next question comes from the line of Chris Howerton with Jefferies. Your line is open.
Hi, Hey, there Im not sure if you wanted to try and answer the previous question with respect to.
You go reset button.
Great in a moment.
Hey, guys bear fairway those guys. It looks like we're having some technical difficulties from the south from the south and things that folks could just hold tight for one second.
Operator, it looks like we lost a couple of folks you can look into that please.
Yes of course.
I do see Eric line is still connected.
He said you can't hear anything like it.
Okay. Just one moment. Please let me so maybe you can take that marks.
Marks I think on the phase three.
Yeah, I think up to 87 results Bill will be incredibly important for designing the next study so I think in terms of size.
Size, a lot will depend on the effect size, we see and whether or not.
We need to think about a bigger trial or.
Similar trial to make sure that we are statistically significant so really without seeing the results of 287, it's really hard to to speculate on what the next trial would look like.
Okay.
Are you were you able to give out okay.
Hello.
Hi, So this is Chris howerton.
I don't know if I heard you just find Lisa.
If you guys can you hear me.
I can hear you get we can hate me getting out Chris Yes, there's definitely some technical issue going on but we can we can hear you.
Okay, I will very good the well maybe I'll just add a couple of questions that and then we'll see what happens so be it.
For the for the first one maybe lease and just to clarify what you had said previously for the one two study, which I think was the.
The Eco sport three study you had 105 patients that comprise the safety database I just wanted to confirm that I heard that number right.
The second question that I had was.
What is the specific plans for CMC expansion I think obviously.
I've seen the facility in the Boston area beautiful there so what would be the plans in terms of expanding to a different facility.
Augmented and what are the kind of capabilities that you would like to see augmented internally to either support biologically sourced or rationally design consulting job new seasons are entering the clinic one more.
Yes.
For the Garden bar, no I'm, sorry, sorry, I like to there.
Lisa can you comment on the first the 105, Chris just to be clear it was at the time that we announced.
The topline results, but at least I wanted to comment on the first one we can talk about cycle.
Yes, no thats exactly yet so it was those that had been in a one two as well as in the extension so had already been in the start of the old one three study.
That's exactly right.
And then Chris and hopefully I got from my phone line things on here.
As it relates to the CMC so.
Let's take a step back here.
We are.
Not only are we thrilled with the phase three results for certain want to know and we're now moving to a phase where we feel we have a significant responsibility to serve this patient group that really hasn't changed.
Innovation to the space in quite some time and we really do think we have the opportunity to help these patients so.
We want to be sure that we are serving those patients with the right.
Capacity and at some point redundancy.
To ensure that there isn't an interruption in the availability of drugs.
We are currently at commercial scale, but with these phase three results.
And you mentioned that not only on the biology biologically side of the house, but also as evidenced by our dosing our first patient on three on one we think there's opportunities as the as the pipeline and the platform progresses.
To serve patients both in the biologically sourced side of the house as well as the synthetic too. So we will be looking to make investments and I think bringing Dave onboard is perhaps an illustrative of the fact that we take very seriously the not only the supply chain, but also the manufacturing processes to ensure that we're providing drug for patients as we move forward both for the later stage.
Side of the pipeline as well as the earlier is there sort of the pipeline.
Okay.
Okay, all right very good I appreciate it.
Thanks for taking the questions.
Thanks for the question Chris.
Thank you I'm not showing any further questions I'll now turn the call back over to management for closing remarks.
So again, thanks for your attention. This morning, we hope that you have a great week and we look forward to connecting with you soon be healthy and well thanks and good morning.
Ladies and gentlemen, this does conclude the program you may now disconnect. Thank you for participating and have a wonderful day.