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spk02: Ladies and gentlemen, thank you for standing by, and welcome to the CERES Therapeutics Third Quarter 2020 Earnings Conference Call. At this time, I'm over to the sensor and listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that this call is being recorded. If you require any further assistance during the conference, please press star 0, and an operator will be happy to assist you. I would now like to hand the conference over to Dr. Carlo Tampi, Investor Relations. Thank you, and please go ahead, sir.
spk00: Thank you, and good morning. A press release with the company's third quarter 2020 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 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 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 today's call, I'm joined by President and Chief Executive Officer, Eric Schaaf, Chief Medical Officer, Dr. Lisa Von Wolke, and Dr. Matt Henn, Chief Scientific Officer. Dr. Terry Young, Chief Commercial and Strategy Officer, will also be available for the Q&A section. I'll now pass the call to Eric.
spk04: Thank you, Carlo, and good morning, everyone. I hope you and your families are staying safe and healthy. Over the past decade, Sirius has pioneered the translation of microbiome insights into an entirely new class of medicines. Our microbiome therapeutics are consortia of bacteria in oral capsules designed to produce specific functional changes in the gut microbiome to treat and prevent disease. This has been a landmark year for Sirius that has 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 CR109 phase three study success, we believe we are on track to become the first microbiome company to obtain an FDA product approval and bring a drug to market. Our aspiration with CR109 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 III ECOSPOR-3 study of sero109 in patients with recurrent C. difficile infection. Based on the strength of these results and the promise of sero109 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 SIR 109 study results, the FDA has reaffirmed its prior guidance regarding the efficacy requirements to support a SIR 109 BLA submission. The SIR 109 ECOSPOR-3 study 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 a SIR 109 BLA filing. The FDA also reaffirmed its guidance that at least 300 patients will be required for the 0109 safety database and to enable a BLA filing. Towards that end, we continue to enroll in our ongoing 0109 open label study in patients with recurrent CDI, and we expect this study 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 SIR 109 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 HCP and payer education efforts, including the deployment of an MSL team. With regard to SIR-19 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 Egge as our new Chief Technology Officer. Dave joined Ceres from Merck and his experience successfully leading the manufacturing of important pharmaceuticals, including Keytruda, will be vital for the company as we look ahead to the expected commercialization of CR109. Dave succeeds John Ahnens, who led Ceres 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, I'll now turn the call over to Lisa
spk03: Thanks, Eric, and good morning, everyone. I'll begin with a recap of our SEER-109 Phase III data that we announced in August. The top-line results demonstrated that SEER-109 met the study's primary eight-week endpoint, with SEER-109 showing a remarkable 30.2% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment. We were also extremely pleased to see that the results demonstrated a highly favorable safety profile, with SIR-109 adverse events looking similar to placebo. In late October, we presented a top-line Phase III results, 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-109 arm was consistent with the results seen at eight weeks, which was the study's primary endpoint. Additionally, we presented data demonstrating that SEER-109 administration resulted in similar efficacy when stratified by age or by the prior antibiotic received. We have heard substantial physician interest regarding SEER-109, and many have highlighted the enormous medical and financial burdens of this disease. and they have expressed enthusiasm that SIR-109 could represent a major advance for this field. Now moving to our SIR-287 program, which is an ongoing Phase IIb study in patients with mild to moderate clinically active ulcerative colitis. SIR-287 is an orally administered, biologically derived drug candidate comprised of commensal bacterial spores isolated from the healthy human gastrointestinal tract. Our objective with CR287 is to develop a first-in-class microbiome therapeutic that modulates the microbiome and microbiome-associated metabolites to treat ulcerative colitis. We believe that CR287 may provide a much-needed non-immunosuppressive treatment option for UC. CR287 is intended to reduce the impact of a dysfunctional microbiome as both a trigger and an amplifier of inflammation. we believe that SEER-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 2B 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 who have failed prior therapy. In arm A, 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 1B study that showed the highest clinical remission rate. In arm B, patients receive vancomycin preconditioning, followed by two weeks of the same CR287 daily regimen used in arm A, followed by eight weeks of a lower dose. In arm C, patients receive placebo. As we previously reported, the COVID-19 pandemic has had an impact on our currently enrolling clinical studies, including the SEER 287 Phase 2b trial. This study is now over 75% enrolled based on the study's 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 1b study for SIR-401 in our oncology portfolio. SIR-401 is an orally administered, biologically derived microbiome therapeutic candidate comprising bacteria reflective of the microbiome signature associated with response to checkpoint inhibitor immunotherapy. With SIR-01, 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 1B study of SIR-401 in patients with metastatic melanoma. All patients receive nivolumab, an FDA-approved anti-PD-1 therapy, and are randomized at a two-to-one ratio to either SIR-401 or placebo. The trial is evaluating the safety, tolerability, and drug activity measured as the engraftment of SEER-401 bacteria in the GI tract and its association with biomarkers of clinical response and outcome. With that, I'll now pass the call to Matt.
spk09: Thank you, Lisa, and good morning, everyone. We are very pleased to announce the dosing of the first patient in our SEER-301 Phase 1b study. SEER-301 is a next-generation orally dosed, rashly designed, fermented microbiome therapeutic candidate for the treatment of ulcerative colitis. The consortia of bacteria in SIRT301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. SEER 301 was designed using Siri's reverse translation discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments of microbial strains and consortia using human cell-based assays and in vitro and in vivo disease models. The design has incorporated learnings from the SEER 287 Phase 1B study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy in that study. SEER-301 is being evaluated in a Phase 1b study in adults with mild to moderate ulcerative colitis. The study is being conducted in Australia and New Zealand and includes two cohorts comprising approximately 65 patients in total. A 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 SIR 301 or placebo. The objectives for this cohort are to evaluate drug safety and PK and evaluate clinical remission and other measures of efficacy as secondary endpoints. Moving now to SIR 155. CR155 is an orally dosed, rationally designed fermented microbiome therapeutic cannabis that we have advanced into clinical development. CR155 builds on our expertise in infectious disease and immunology. It is designed to prevent mortality due to gastrointestinal bacterial infection and bacteremia and graft versus host disease in immunocompromised patients, including in patients receiving allogeneic hematopoietic stem cell transplantation. We expect that the SEER 155 clinical program will provide insights into the potential for the microbiome therapeutics to improve outcomes in stem cell transplant patients and to advance our novel technology to prevent and treat antibiotic-resistant bacterial infections and bacterial sepsis more broadly. The SEER155 program is supported by a CARB-X grant that provides financial and operational support. We expect to advance the program into a Phase 1b study early in 2021 in collaboration with Memorial Sloan Kettering Cancer Center. Both our SEER301 and SEER155 programs represent important advances in CIRES technology capabilities and drug pipeline. Through these programs, CIRES has continued to refine our knowledge from the underlying mechanisms by which microbes in the gastrointestinal tract engage pathogenic bacteria and human cells and tissues to impact disease. Further, through these programs, we have continued to advance our field-leading GMP manufacturing capabilities and the breadth of biological diversity that can be incorporated into our drugs with technologies that can deliver bacteria in both spore and lyophilized vegetative cell formulations. I'll now turn the call back to Eric.
spk04: Thanks, Matt. Turning now to an overview of our recent financials. Ceres 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 10Q that we intend to file later today. 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 a securities purchase agreement with Nestle that in total provided approximately $264 million in net proceeds. We also anticipate receipt of a $10 million 0301 Phase 1 associated milestone payment that Ceres is entitled to as part of our Nestle collaboration. We will use our strength in corporate resources to execute against our top objectives. Our company priorities are to prepare for serial monitoring 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. CIRES 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 CIRES and the microbiome space in general. Our highest priority is completing the work needed for our 0109 BLA 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 many 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 important new treatment options for patients in need. This is an exciting time for CERES, 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 to questions.
spk02: As a reminder, ladies and gentlemen, if you have a question at this time, please press star and the number one on your touchtone telephone. If your question hasn't been answered or you wish to remove yourself from the queue, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from a line of Ted Tenhoff with Piper Sandler. Your line is open.
spk05: Great. Thank you so much, and congrats on all the progress. It's really exciting. I want to get a sense for maybe where you are in enrollment with the additional safety cohorts. and if you have any guidance on when maybe enrollment for that could be completed. Thank you.
spk04: Good morning, Ted, 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 open label fairly recently. I will say that I'm extremely pleased that we did make a number of at-risk investments prior to the Phase 3 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 acting on athletes that provide some additional color.
spk03: 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 012 results, the fact that there's no placebo, the fact that this trial allows for inclusion of first recurrent patients, and the fact that FMT is currently constrained. But we are also mindful that the COVID 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 making very good progress.
spk05: Excellent. Well, thank you for the update. Yep.
spk04: Sorry, I was just about to finish up. You know, obviously a key operational priority for us, and we're working extremely hard to move ourselves forward. Great.
spk05: Excellent. Thanks so much for the update.
spk04: Thanks for the question, Ted.
spk02: And our next question comes from the line of Joseph Tomei with Cow Winning Company. Your line is open.
spk07: Hi there. Thank you for taking my questions, and congrats on the progress. The first one is on 109. As you did indicate that the Opal Naval Study does include patients that have first recurrence, what's sort of your best guess of where in the treatment paradigm 109 will fit once it's successfully launched in practice? And then one more, if I can, just on 287 and 301, how do you anticipate advancing both of those programs? If they show, you know, solid data for both, would you be taking both forward, or is there a time where you would look at the data and see if you want to take one candidate forward versus the other? Thank you.
spk04: Yeah, Joe, good morning, and thanks 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 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 the BLA process. Certainly, we believe that SIR109 should be applicable for a broad set of patients, including first recurrence and greater. We've got data that encourages us, including, as Lisa mentioned, we had asked the FDA to allow first recurrent patients into our open-label study to which they agreed. So that's the data point that we think is helpful. But maybe I can ask Lisa to comment just on the medical perspective as it relates to first versus multiply recurrent, and then we can hit your two of the seven questions.
spk03: Yeah, so the medical underpinnings for first recurrence and further recurrence are essentially the same in that once patients recur, it's indicative of the fact that they have a dysfunctional microbiome that needs repair. So, you know, our KOLs, as well as we internally, see that medically the indication would be completely appropriate. But as Eric stated, you know, the label itself will be a discussion with FDA.
spk04: Yeah. And, Joe, maybe I can move to your second question, which relates to 301 and 287. And You know, look, I'd say as a team, we're incredibly excited about dosing the first patient with 301, and we think 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 that human data sets are so important in understanding the microbiome of a human, you know, 301 really is really that next step forward. And, of course, as you know, we're conducting the 1B study in Australia and New Zealand. We think that there's rationale for geographically separating the two studies. They're not going to cannibalize each other. But we really do think that there's an opportunity to help patients with both a biologically sourced as well as a defined approach. Advantages for each, right? On the 301 side, obviously there's the supply chain element, which is more efficient. But at the same time, you know, with our 287-1B data set, we really had a lot of encouragement that this could be a program that could help patients in need. I think that there's a misunderstanding about how effective existing therapies are in terms of successfully achieving remission for patients in this space. But maybe I can ask Matt just to comment further on the leverage between our 287 and 301 programs that really were accrued and applied in the design of 301 and gives us a lot of optimism moving forward.
spk09: Yeah, sure. So, you know, the SEER 287 trial there indicated give us direct insights into species and strains that engraft. and are associated with clinical remission, as well as microbe-associated metabolites that are as well associated with clinical remission. And these data on these metabolites, these pathways, these particular species really helped guide the design of SEER 301. And I think the real power with 301 comes from combining those types of insights with with our work in a non-clinical setting using various different human cell-based assays where we can then as well look and understand at a fine level of detail how the microbes themselves and the metabolizers are generating impact, various different disease-relevant pathways. And it's by combining these various different pieces of information Using what is really a research engine at Ceres built up to do specifically this, we've been able to pull together the design of SEER 301 and the selection of strains that are in it. And I think 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.
spk07: Great. That is very helpful. Thanks, and congrats again. Thanks for the question, Joe.
spk02: Our next question comes from the line of John Newman with Canaccord. Your line is open.
spk01: 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 CR287. I know that that study is still enrolling and whether you might update us when it completes enrolling. Second question I had is regarding CR401. 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 the design of that study is very interesting. It's a phase one, but it's got a control arm, which we normally don't see. So I'm just curious as to if you do see something interesting there, how quickly you might move ahead with a larger study. Thanks.
spk04: Yeah, John, good morning, and thank you for the questions. Let me start in the first on 287. I might ask Lisa to comment, and then we can ask Matt to comment on 401. So for 287, you know, of course, we have been impacted by the pandemic, as others that are conducting studies in this 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 I'll reiterate today, we've seen progress in terms of enrollment, and we continue to screen and enroll, and there have been signs for encouragement both throughout the summer and into the fall. We are not today at the point of enrollment that we were at the beginning of the year, but we have implemented a number of mitigation strategies related to the pandemic that which give us encouragement in the ability to enroll going forward. Obviously, our crystal ball is no better than anybody else's as it relates to where the pandemic goes next. Obviously, we're highly, highly encouraged with the vaccine data that came out this morning. But, you know, we are excited about the opportunity to continue enrolling patients moving forward in this study. Lisa, anything to comment on that before we hit 401k?
spk03: Yeah, no, I think that, as you said, you know, we and others have made a lot of adjustments in the clinical trial space to compensate for the various COVID influences. But obviously, if COVID does take off again, even if sites stay open, there's always the question about whether patients will reengage with the medical system for anything. So, you know, we're going to keep an eye on it, but we're liking the change that we've seen since the spring.
spk04: Yeah. Yeah. Great. And then, John, to your second question, maybe I can ask Matt to comment on 401. It's probably important just to maybe ground everybody in the objectives of the study. So let me turn it to Matt for a couple of comments.
spk09: Yeah, sure. So as Lisa noted earlier in the call, this trial is evaluating the safety, tolerability, and drug activity of SEER-401 in metastatic melanoma patients where their combination therapy with nivolumab plus 0401. And as you point out, this is a placebo-controlled trial, and we designed the trial as 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 running such trials. So Our goal with this trial is to really understand how SEER-401, what its activity is in subjects. So we'll look at engrossment as we typically do in our studies, but then also look to understand what types of biomarkers might be associated with engrossment or broader changes in the microbiome as a result of that engrossment of SEER-401. In terms of, this is an exploratory phase one. 1B trial, and, you know, pending results from this and the learnings from this, what we'll do, as we always have done at CERES, is take a hard look at the data and then make decisions about what the best path forward is with respect to the next trial and the drug modality.
spk06: Okay, great. Thank you. Thank you, John.
spk02: Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is open.
spk06: Hey, good morning, and congrats on the really transformational quarter. Maybe I can ask one question about SIR-109 and one about SIR-287. First, can we expect to see 24-week data from ECOSPOR-3 sometime in early 2021? And I'm also wondering how much patient follow-up the FDA is asking for in the ECOSPOR-4 study to satisfy the safety database requirement for SARA-109?
spk04: Yeah, so, Mark, good morning. Thanks for the question. I'll ask Lisa to comment. I will say that we are continuing to work with the FDA to clarify the schedule for of how we will present data to them as part of the open-label study. And maybe Lisa can comment further on that as well as the plan for additional data disclosure from the study.
spk03: Sure. So with regard to the 013 study, recall that we had already gotten to 105 safety patients, if you will, with the end of the 012. So with regard to the remainder of that 300th, As Eric said, we've been discussing with FDA exactly what the schedule for providing that. And also, as Eric had noted, we didn't waste any time while we were waiting for those discussions to go ahead and get started. Now, the 012 study, the final 24-week data, is going to be available internally very, very soon. I mean, you can just do the math based 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 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.
spk06: Okay, got it. And just with respect to, Sarah, 287, I know you've previously mentioned echo reset could serve as one of two pivotal trials that could support registration in ulcerative colitis. May we 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.
spk02: As a reminder, ladies and gentlemen, if you have a question at this time, please press star, the number one. Our next question comes from the line of Chris Howerton with Jefferies. Your line is open.
spk08: Hey there. I'm not sure if you wanted to try and answer the previous question with respect to the eco-reset trial. I'm fine with waiting a moment. of Eric.
spk09: Bear with us, guys. It looks like we're having some technical difficulties from the sounds of things. If folks could just hold tight for one second. Operator, it looks like we've lost a couple folks. Maybe you can look into that, please.
spk02: Yes, of course. I do see Eric's line is still connected.
spk03: He says he can't hear anything. Okay, just one moment.
spk09: Lisa, maybe you can take Mark's question on phase three.
spk03: I think 287 results will be incredibly important for designing the next study. I think in terms of size, a lot will depend on the effect size we see and whether or not we need to think about a bigger trial or a similar trial to make sure that we are statistically significant. Really, without seeing the results of 287, it's really hard to speculate on what the next trial would look like. Were you able to hear that okay? Hello?
spk08: So this is Chris Howerton. I don't know. I heard you just fine, Lisa. I don't know if you guys can hear me.
spk03: I can hear you.
spk08: We can hear you, Chris, yeah. There's definitely some technical issues going on, but we can hear you. Okay, awesome. All right, well, very good. Well, maybe I'll just throw out a couple questions then, and then we'll see what happens. For the first one, maybe, Lisa, just to clarify what you had said previously for the 012 study, which I think was the ECOSPOR-3 study, You had 105 patients that comprise the safety database. I just wanted to confirm that I heard that number, right? Um, the second question that I had was, you know, what are the specific plans for CMC expansion? You know, I think obviously, um, I've seen the facility in, in the Boston area, beautiful there. So, you know, what, what would be the plans in terms of expanding to a different facility? to augment that and, you know, what are the kind of capabilities that you would like to see augmented internally to either support biologically sourced or rationally designed consortia, obviously, as those are entering the clinic more and more.
spk05: Chris, I'm back on. Sorry.
spk04: Sorry, I lost you there. Lisa can comment on the first. The 105, Chris, just to be clear, was at the time that we announced the top line results. But Lisa, why don't you comment on the first and then we can talk about the second.
spk03: Yeah, that's exactly it. So it was those that had been in 012 as well as in the extension. So had already been in the start of the 013 study. That's exactly right.
spk04: Yep. And then Chris, and hopefully my phone line hangs on here. As it relates to CMC, so, you know, look, let's take a step back here. We are, not only are we thrilled with the phase three results for SIR109, 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, you know, innovation in 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 drug. You know, we are currently at commercial scale, but with these phase three results, and you mentioned it, not only on the biologically side of the house, but also as evidenced by our dose in our first patient on 301, we think there's opportunities 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 on board is perhaps illustrative of the fact that we take very seriously not only the supply chain but also the manufacturing processes to ensure that we're providing drive for patients as we move forward, both for the later stage side of the pipeline as well as the earlier stage side of the pipeline.
spk08: Okay. All right. Well, very good. I appreciate it. And thanks for taking the questions.
spk04: Thanks for the question, Chris.
spk02: Thank you. I'm not showing any further questions, so I'll now turn the call back over to management for closing remarks.
spk04: 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.
spk02: Ladies and gentlemen, this does conclude the program. You may now disconnect. Thank you for participating and have a wonderful day.
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