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spk04: We're about to begin. Good day and welcome to the Sparrow Therapeutics Third Quarter 2020 Financial Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Sharon Clary, Vice President of Investor Relations and Strategic Finance. Please go ahead, Nan.
spk02: Great. Thank you, Operator, and thank you all for participating in today's conference call. Earlier today, Spiro Therapeutics released financial results and provided a pipeline update for the third quarter end of September 30th, 2020. If you've not yet seen the press release, it's available on the investor page of the Spiro Therapeutics website. Before we begin, I'd like to remind you that some of the information contained in this press release and on this conference call contain forward-looking statements based on our current expectations, including statements about the initiation, timing, and submission to the FDA and the NDA for W-BEN and HBR, and the potential approval of Tevipen and HBR by the FDA. Future commercialization, the potential number of patients to be treated by Tevipen and HBR, and the market demand for Tevipen and HBR genomics. Expected broad access across payer channels for Tevipen and HBR, the expected pricing of Tevipen and HBR, and the anticipated shift from intravenous to oral administration. The design, initiation, time, and progress, and the results of the company's preclinical studies and clinical trials, and its research and development programs. management assessment of the results of such preclinical studies and clinical trials, the impact of COVID-19 pandemic on the company's business and operations, and the company's cash forecast and the anticipated expenses and the sufficiency of its cash resources. Before-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Spiro Therapeutics' policy with the SEC, including in the risk factors section. of our quarterly report on Form 1025 today. These forward-looking statements speak only as of the date of this conference call, and the company only takes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of today's release and call. Participating in today's call from Spiro are Dr. Ankit Mahavidya, Chief Executive Officer, Dr. David Melnick, Chief Medical Officer, Christina Larkin, Chief Operating Officer, with Steve DePalma, interim chief financial officer. With that, I'd like to turn the call over to Dr. Ankit Mahadeva. Please go ahead, Ankit.
spk00: Thank you, Sharon, and good afternoon, everyone. This is a very exciting time for Sparrow, and I'm delighted to have the opportunity to review our progress with you today. First, I'd like to highlight our recent announcement indicating that the ADAPT-PO Phase III trial met its primary endpoint with data demonstrating that oral tebupenem HVR is non-inferior to IV ertapenem for the treatment of complicated urinary tract infections and acute pyelonephritis. The positive results from this trial comparing oral tebupenem HVR to IV ertapenem in a representative population are quite noteworthy, as they show that tebupenem HVR can provide the convenience of an oral therapy without making any compromises on clinical response, safety, or tolerability. These results represent an important achievement, not only for Sparrow, but also for the broader industry and our potential patients. ADAPT-TL was truly a landmark trial, as it was the first head-to-head comparison of an all oral regimen against an all IG regimen for the treatment of CVTI. The trial was designed to demonstrate robust clinical outcomes and give physicians the confidence to prescribe oral to become an HPR. It's approved to the millions of CUTI and AP patients who otherwise would be at risk for needing IV therapy and hospitalization. If approved, 10-E-Pen and HPI will be the first new oral therapy for CUTI in 26 years and the first oral carbapenem antibiotic approved for CUTI and AP. As previously discussed with FDA, positive results in the single well-controlled pivotal trial could be sufficient to support the approval of a new drug application or NDA for tebupenem-HVR. This trial, together with supporting phase one trials, will form the basis of our NDA submission for tebupenem-HVR in the U.S. We continue to expect to make an NDA submission to the FDA in the second quarter of 2021. We have also made progress on our other clinical programs, which like tebupenem, are designed to treat important unmet needs in infectious disease. We were excited to announce in August that the FDA accepted the INV4-SPR720, our orally administered agent, being developed for non-tuberculous microbacterial, or NTM, infections. We remain on track to initiate dosing in a Phase IIa NTM trial by year end. Before handing off the call to David to go into more detail on the pipeline, I'd like to provide a few comments on how we're managing our business during the COVID-19 pandemic and the impact it's having on the practice of medicine. We continue to monitor for potential impacts of COVID-19 on our business and our ability to conduct our operations. In this pandemic environment, the Sparrow team is diligently trying to stay ahead of any potential impacts from COVID-19. And I'm pleased to report that at the current time, we do not see material impacts on our operations. We continue to benefit from the investments we made in informational technology early on that enable a fully remote workforce as the pandemic continues. We should also note that COVID-19 has changed the way medicine is delivered, with physicians and patients seeking to prevent hospital admissions whenever possible. What we are hearing from physicians is that they would prefer to treat a complicated urinary tract infection outside of the hospital, but at the current time, with the increasing prevalence of bacterial resistance among the existing oral antibiotics, millions of CUTI patients just don't have that option. Physicians are looking for ways to streamline patient care and expand access in the outpatient setting. Further, outpatient treatment could reduce exposure to secondary infection, including COVID banking, offer financial benefit to the hospital, and free up capacity for the seriously ill patients who have no viable alternatives to hospitalization. The availability of an oral medication that could enable a shift in care to the outpatient setting could thus address critical unmet needs that have been made worse during these unprecedented times. The pandemic also highlights the need for a comprehensive approach to developing medicine to address current and future infectious threats. Policymakers, government agencies, and major pharmaceutical companies are joining us in in supporting the development of critical solutions to these threats. We're thrilled to collaborate with the ecosystem in these efforts, highlighted by our partnerships with several government agencies, including BARDA, the U.S. Department of Defense, and DTRA, as well as our relationships with corporate partners and private foundations. Finally, before handing it off to David, I want to mention our success on the financial front. During the third quarter, we completed an equity financing for net proceeds of $85.9 million, including the exercise of the over-allotment option. We have sufficient cash, cash equivalents, and marketable securities together with our non-believer financing commitments to fund the company into the first quarter of 2022 through the approval process for TBI. And with that, I will hand it over to David to review our clinical progress and provide greater detail on our pipeline. Thank you very much, Ankit, and good afternoon, everybody. We've continued to make significant progress on our pipeline programs through the third quarter, and I'm excited to review our clinical accomplishments today. I'll begin with our lead candidate, Kevipenem HBR, an oral carbapenem that recently completed its successful phase three clinical trial, ADAPT-DO, for the treatment of complicated urinary tract infections including acute pyelonephritis. The trial met its primary endpoint, demonstrating that oral tebupenem, HBR, is non-inferior to IV urtepenem in the treatment of patients with complicated urinary tract infections and acute pyelonephritis. The primary endpoint was met with an overall or combined clinical and microbiological response rate of 58.8%, with oral tebupenem HVR and 61.6% for IV ertapenem. This met the trial's pre-specified non-inferiority margin of 12.5% and was complemented by tebupenem's compelling safety and tolerability profile, which was similar to IV ertapenem. In October, we presented additional data from the ADAPT-PA trial as an oral late-break of presentation at ID Week 2020. You can find all 15 posters and presentations from ID Week 2020 on the Sparrow Therapeutics website. Data from the ADAPT-DO trial demonstrated that both the clinical cure and microbiological eradication rates were comparable between treatment groups at the end of treatment, the test of cure, and at the late follow-up visits. Clinical cure rates which are important to clinicians because they are a key determinant in the routine management of complicated UTI or acute pyelonephritis, were greater than 93% in both treatment groups at the primary outcome analysis of test of cure. The high clinical success rates were sustained through the late follow-up visits, demonstrating a durable clinical response with the complicated UTI or acute pyelonephritis. Favorable microbiological eradication rates and tests of cure were likewise comparable between treatment groups and were sustained up through the late formal visit in both treatment groups. There were no statistically significant differences in response rates across key subgroups of interest, including age, baseline diagnosis, and presence of bacteria at baseline. The pathogen microbiological response rates were generally balanced across the treatment groups for the predominant neuro pathogens. The safety and tolerability profile for oral TEP-dependent HPR was also similar to intravenously administered adipinem. Both the type and frequency of adverse events were well balanced across treatment groups, with treatment emerging adverse events reported being 26% of treated patients in both arms. The most commonly observed TEAEs were diarrhea and headaches, which were similar in frequency in both arms. There were no cases of clostridium diphtheria infection observed in the cabipenem HBR group, which compares to three cases observed in the IV adipenem arm. And fortunately, there were no deaths reported in this study. I want to take just a moment now to emphasize the highly demanding design of ADAPT-PO. This head-to-head comparison of an all-oral versus all-IV antibiotic treatment regimen was the first of its kind in complicated urinary tract infection. Specifically, we did not include an IV lead-in in the oral tebupenum HBR arm, nor an oral step-in in the IV ertapenum arm. because we wanted to provide physicians with direct evidence that they needed to feel confident in prescribing tebupenem HVR in place of IV carbapenem therapy. Treatment options for complicated UTI have become increasingly limited by antibiotic resistance, as well as safety concerns around existing oral antibiotics. Tebupenem HVR, if approved, could once again provide physicians with the opportunity to treat eligible patients with an oral agent outside of the hospital setting. All of the required Phase I clinical trials for NDA submission have now completed enrollment, and looking forward, we anticipate completing the NDA submission for TepiPam and HBR in the second quarter of 2021. I'll now move on to discuss SPR 720. our oral drug candidate for the treatment of non-tuberculous mycobacterial, or NTM, infections. In October, we presented data on SDR720 at IDE from the Phase I single and multiple ascending dose clinical trial, as well as pharmacokinetic and pharmacodynamic analyses based on data from our preclinical NTM infection models. These data and analyses indicated that the predicted therapeutic exposures could be attained with a 500 to 1,000 milligram dose administered once daily and have informed the design of our Phase IIa study. The IND application for SPR720 was accepted by the FDA in August 2020. and we were awarded Fast-Track designation for the treatment of adult patients with MGM pulmonary disease by the FDA in September. The next important milestone for this program will be the initiation of dosing in the Phase 2A clinical trial, which is expected before year end. This innovative trial is designed as a 28-day dose-ranging, placebo-controlled clinical trial evaluating SPR720 as monotherapy in 90 treatment inexperienced patients with NPM pulmonary disease caused by mycobacterium avian complex. The goal of the trial is not only to assess safety, tolerability, and the pharmacokinetics of SPR720, but also to assess early microbiologic response to the drug candidate and outcome that, if positive, will highlight the activity of SPR-720 as a single agent versus placebo. Regarding SPR-206, our next-generation IV polymixing agent that was developed as part of our potentiator platform, we continue to advance the compound with support from our partners at the Department of Defense and Everest Medicines. We remain on track to initiate our phase one bronchoalveolar levon or BAL clinical trial in the first half of 2021 and to initiate a renal impairment study next year. The phase one data in healthy volunteers announced earlier this year were encouraging. In the phase one SADMAD trial, healthy volunteers were given doses of SPR206 up to 300 milligrams daily of split doses for 14 consecutive days. There were no severe or serious adverse events reported in these volunteers. Furthermore, there was no evidence of nephrotoxicity or clinically significant changes in laboratory tests, which differentiates SPR206 from earlier generation polymixins. I will now turn the call over to Christina Larkin, our COO, who will provide you with a review of the market opportunity for our pipeline products and detail some of the preparations in-day for Pebucon and HBR's potential approval and commercial launch.
spk03: Thank you, David, and good afternoon, everyone. In addition to working on advancing our clinical programs and the planning for the potential approval of Pebucon and HBR, we've also been hard at work preparing for the much-anticipated launch. And so today, I'm going to focus on a few key areas as we prepare our go-to-market strategy, including our conviction around the broad market opportunities, our focus on building advocacy and feedback from our customers, and lastly, how we're progressing in building our commercial infrastructure and capabilities. So let's start with the market opportunity. As Ankit mentioned, it's been 26 years since the last oil drug has been approved in the United States for a CETI. And so we've been busy analyzing multiple data sets to help us triangulate the size of the opportunity. First, we've done a bottoms-up claims analysis of the diagnosed UTI patients in the U.S. And the data points us to roughly 2.7 million prescriptions where tebupen and HVR could be a potential replacement. These are patients that are either receiving multiple rounds of oral antibiotics or receiving a second-line IV therapy and could be a candidate for a new oral treatment. Next, we've reviewed the data on IV carbapenem use, and there's been more than 100% increase in carbapenem use over the last six years for CUTI, and a significant portion of that growth has been in the outpatient setting. All of this data combined with feedback from our customers support the broad market opportunity for new oral carbapenem. In fact, we've engaged more than 200 healthcare providers, and they consistently reinforce the unmet need and their significant interest in tebupenem HVR. They've reinforced that patients with a prior failure to an oral antibiotic or patients with resistant bacteria are the right targets for tebupenem HVR. They also agree that carbapenems are considered the drug's choice for these targeted patients. These interactions also support that the IV community are important influences for the use of a new oral carbapenem, and that urologists, are the largest treaters of these patients seeking second or third line treatment. Both specialties see the value of Kebepenem HBR and its potential in both the inpatient setting to help patients go home sooner and the outpatient setting to potentially stay home and avoid the hospital entirely. We've been engaging payers and they see the potential for value-based pricing and express their willingness to broadly cover Kebepenem HBR if approved. Finally, we are continuing to build our commercial, market access, and medical affairs infrastructure and capabilities. We have made several key hires in all three of these respective areas. These are high-quality individuals with deep expertise in antibiotics and in the payer landscape and have strong relationships with our key specialists and payers that are essential for our short-term and long-term success. We've made investment in digital tools to engage the healthcare provider community, and we find them open to engaging with us virtually. Now, the small size of our team has allowed us to remain nimble and productive as we manage these day-to-day activities and leverage technology where appropriate as we're preparing for our launch. Now, with that, I'm going to turn the call over to Steve, who will provide you with a financial update. Steve?
spk00: Thank you, Christina. Thank you, Christina, and good evening, everyone. I'll provide an overview of Sparrow's financial results for the quarter ended September 30, 2020. Total revenue for the third quarter of 2020 was $4 million, compared with total revenue of $4.6 million in the third quarter of 2019. The decrease in the third quarter of 2020 was due to lower reimbursement under Sparrow's contract with the Biomedical Advanced Research and Development Authority, or BARDA, for qualified heavy tenant HPR expenses. As a reminder, we currently have total committed non-diluted funding from BARDA of $44 million, inclusive of $10 million in funding from the Defense Threat Reduction Agency. We have received $20.1 million of committed funding from BARDA as of the end of September. And there's a second option of $12.7 million that remains exercisable by BARDA. Research and development expenses for the third quarter of 2020 were $17.7 million. were lower than this 18.5 million reported for the same period of 2019. This year-over-year decrease was due to lower expenses in the Tegucigalpa HBR program following the completion of significant activities in the Phase III clinical trial. However, we do expect to incur some additional expenses related to Tegucigalpa HBR as we finalize activities related to the Phase III clinical trial and advance the potential NDA filing for Tegucigalpa HBR. General administrative expenses for the third quarter of 2020 of $5.3 million were higher than the $4.1 million reported in the same period of 2019, primarily due to increased headcount and professional fees to support pre-commercial activities and growth in the business. We continue to expect general and administrative expenses to increase to support the HBR through potential approval, as well as to support other pipeline products. We will report a net loss for the third quarter ended September 30, 2020 of $18.9 million or $0.86 per common share compared to a net loss of $17.7 million or $0.95 per common share reported for the same period in 2019. As of September 30, 2020, we had cash and cash equivalents of $127.2 million including $74.7 million in net proceeds from a follow-on offering that closed on September 15, 2020. Subsequent to quarter-end, we received an additional $11.2 million in net proceeds through the exercise of the over-allotment option for the underwriters, bringing the total net proceeds from this follow-on offering to $85.9 million. We believe that our existing cash, cash equivalents, and market old securities, together with Our non-diluted funding commitments will be sufficient to fund operations into the first quarter of 2022 due to the approval process for Tempe, Penn, and HBR. For further details on our financials, including comparisons to the quarters ended September 30, 2020 and September 30, 2019, please refer to our 10-K by the SEC today. We'd now like to open the call for questions. Operator?
spk04: Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that's star 1 to ask a question. And we'll take our first question from Luis Chen with Cantor.
spk00: Hi, good afternoon. This is Cargit. I'm here with Luis today. Thank you for the color on COVID. I just want to dig deeper. How has COVID-19 impacted the treatment landscape for bacterial infections that require IV administrations? Have patients been switched to other types or other classes of treatment? Has COVID-19 impacted clinical trial speed in the infectious space? Secondly, what are the biggest competitors to oral teripenem HBRs? which drugs would take the most shares from, given the discussed pricing range, about $300 to $500 a day for a 10-day course. Thank you so much. Well, thanks very much for the questions. I will take the first one in terms of the impact of COVID-19, and I'll pass the competitive landscape on to Christina. So in terms of the impact of COVID-19, really the ethos generally in infectious disease has been to treat patients outside of the hospital whenever possible. And certainly in the setting of COVID-19, given the increased risk that a patient has as an inpatient in getting COVID-19, as well as the capacity issues that an unnecessary hospitalization can pose to the hospital, there has been a continued push to try to treat our patients in the outpatient setting wherever possible. As Christina mentioned, the reason that we cannot do so for patients with complicated urinary tract infections and acute pyelonephritis is that there isn't an oral agent that can treat those types of resistant infections. And so really, Kevin Penham is positioned well to be a part of the toolkit to help treat patients where they should be whenever possible, which is outside of the hospital. That was true prior to the advent of COVID-19, and it's especially true now. In terms of your question on clinical trials, certainly just throughout the ecosystem, COVID-19 has had and I think continues to have an impact on the enrollment and follow-up of patients with clinical trials. Fortunately for us, we have really been able to, with an excellent clinical operations team, manage that well and we're able to deliver ADAPT-PO on time with high quality data, number one, and number two, also the phase one studies that were outstanding for the filing of the NDA. Further, we've accounted for that in our operational timelines for our pipeline. And so the teams demonstrated their ability to navigate this and deliver, and we certainly accounted for that. Christina, I'll pass the question about the competitive landscape in the marketplace to you.
spk03: Thanks, Ankit. And, you know, there are two parts to it. I think you asked also about where we're going to take share from, which I think also plays into the competitive landscape a bit. And as we've seen the patient journey with it, You know, patients are often having to go to the emergency room or ultimately getting hospitalized because of the lack of oral treatment options, not because they're sick and require this. And so we do see a significant portion of the business in deflecting that or catching them on the other side of the hospitalization. So it's, you know, very telling to see that maybe ertapenem and the other carbapenems, much of the growth that we've seen, as I shared today, where we would take share from in addition to drugs such as piperacillin, taprobactam, which is also a drug that is often used for these ESBL and fluoroquinone resistant strains. You know, the reason why I don't point you to any oral agents is because there aren't any available oral agents that fit this criteria that will, you know, meet the resistance patterns that we're seeing today. There's nothing today in the marketplace, either branded or generic, that will meet that on the oral side, and there's nothing in the near-term pipeline either. I think that's why this needs a pretty broad and open market opportunity for us.
spk01: I thought it was super helpful. Thank you so much.
spk04: Thank you. And once again, that's star one for questions. And we'll take our next question from Ritu Baral of Cowen.
spk00: Hi, this is Bashar Alam for Ritu. A few questions regarding the upcoming NDA launch. Are there any remaining required items to the NDA in terms of kind of finishing up phase one studies? Any CNC data left to be generated? and a quick follow-up if the pre-MDA meeting has been scheduled yet for the FDA or if that happened yet. Thanks, guys. Yeah, thanks so much, Michelle, for the question. So the three parts to filing the MDA, number one is the Phase III data, of course. Secondly is the supportive non-clinical and Phase I studies. And then third is documentation around our CMC. And I would say that all three of those elements are on track as it relates to our overall timeline for NDA. Relative to our last earnings call, we have completed enrollment for the phase one studies that were outstanding. And again, that's been accounted for in our timelines.
spk01: Okay, perfect.
spk00: And any color on whether the pre-NDA meeting has occurred and if a date has been set yet? The pre-MBA meeting has not occurred, but we would expect that in 2021. Okay, perfect.
spk01: Thanks, guys. Thank you. Next, we'll hear from Steven Willey with Stiefel.
spk03: Hi, this is Ellen on for Steve. Thank you for taking the question. So, can you provide any updates with regards to potential partnership discussions for XDS commercialization of tebupenem?
spk02: or maybe where those competitions stand if they've started and how you're thinking about that opportunity.
spk00: Well, thanks so much for the question. I would maybe zoom out to 100,000 feet and we have a variety of opportunities to continue to build our balance sheet as well as our way with all to advance our medicines. And these include partnerships around the pipeline as well as partnerships around different regions of Teddy Penham, along with ability to collaborate with public agencies to complement what we're doing. And finally, just given the low loyalty burden on Teddy Penham, the ability to collaborate around the product itself. And so really the status of those discussions, certainly with the quality of data we've had, we continue to have dialogues about the best way to both build our balance sheet as well as continue to think about the best way to deploy Tevipan and our other pipeline medicines to patients. We won't comment further than that in terms of our public dialogue, but those conversations continue to go on and certainly the quality data we have around our pipeline has facilitated those.
spk03: Okay, great. Thank you for the color. And then maybe just one more from me. So for SPR206, you know, your partner to Everest Medicine, I'm just wondering if you could remind us to what extent going forward, say for future phase two of registrational trial design and clinical development planning, will Everest be involved in those decisions? Is this more of a collaboration effort between partners, or is it more SPHERA-centric? Thanks.
spk00: Well, yeah, and this speaks perhaps to our philosophy in terms of partners. And so along with Everest, we collaborate with both pharmaceutical companies and private foundations and public agencies throughout our pipeline. And as always, you know, we do see all of these partnerships as true partnerships and the opportunity to seek input from these partners who have thoughtful and well-informed ideas about drug development is something we enjoy and welcome. And so certainly we welcome all of our partners, including Everest, being put in the plan. And ultimately, we'll drive forward on 206 with, you know, certainly what's right for patients here in the U.S., Europe, but also in the rest of the world.
spk01: Okay, great. Thank you. Thank you. And next, from Oppenheimer, we'll hear from Kevin DeGieter.
spk03: Hi, this is Susan calling on behalf of Kevin. I had a couple questions on the SPHERA 720 program that I wanted to follow up on. When can we expect to get the complete design for a Phase II study? And I mean the clinical part, Phase IIb.
spk00: Yeah, thanks for the question. That is, just to be clear, the subsequent studies after the Phase IIa that we expect to begin dosing this year, are something that we continue to contemplate and collaborate with both the NTM physician community, but also our colleagues at FDA. And so I don't have a set time zone for when we will start to have that dialogue, but a few parameters that the team has already commented on publicly, which is number one, the phase 2A that we are embarking on is a crucial step ahead of subsequent clinical studies because what it does is it enables us to show that oral 720 can drive resolution of disease on its own and when we set it up well downstream for combining with other agents in the downstream phase TB. We've also said that there's an opportunity for those studies to go faster and be more attuned to the way that the care of MTM patients evolving by having a clinical endpoint. And in terms of further details, we're going to continue to collaborate with the physician community as well as our colleagues among the regulatory agencies to deliver more in a future date.
spk03: So just kind of to follow up on that, what was your view and maybe the physician community's view of the thrombocycline data for MTM? Because I know that they did something a little bit different by using a clinical
spk00: Yeah, and I'll have to say that, you know, we won't comment specifically on the CareTech data. I would say that the 100,000 feet that, you know, they are focused on mycobacterium abscessus, which is a smaller but also important indication, and I think that, you know, they that the limited data that we've seen today suggests that it could be a potential option, but we certainly look forward to more details on what measure they'll use in a more fulsome trial that can provide a more fulsome and statistically based platform for us to better understand the role of the metastasis. And certainly much like you, we'll look for the details and perhaps that'll be helpful for the community as we go forward as well.
spk01: Okay, great. Those are all the questions.
spk04: Thank you, and next we'll have a follow-up from Ritu Viral.
spk00: Hi, this is Vishal again. Thank you for taking my follow-up question. I just wanted to also ask about the NTM study with SCL720 and for the phase 2A, if any information has been given on power link, the assumed placebo effect, and if you're expecting a dose response from the two doses. Thank you. I'll pass that to David. David, over to you to talk about those two issues. Yeah. In terms of a dose response, the two doses that have been chosen for Phase IIa were derived from that combination of data that was actually presented in ID Week. We are bracketing our predicted therapeutic exposure with the two doses that we're using. It will depend on the pharmacodynamics in man. I think both doses are likely to be active. Will we see a dose response?
spk01: Not sure yet. And the first part of your question? Okay, perfect.
spk00: Yeah, regarding whether the powering for the study and what is the assumed placebo effect for the phase 2A? Yeah, for the Phase IIa study, the role of the placebo effect is, or the role of the placebo is created based on against which we can assess the microbiologic activity of the active compounds. So the response assessment will be based on demonstrating a change in the slope of the colony count over time compared to placebo.
spk01: Okay, perfect. Very helpful. Thank you very much. Thank you. I show no further questions in the queue.
spk04: We'll now turn the call back over to Dr. Mahadeva for additional comments.
spk00: Thank you, operator, and I appreciate everyone's time for joining us today. I invite everyone to join us at our next webcast presentation at the Stiepel-Nichols Healthcare Conference on November 18th.
spk01: Thank you very much, everyone, and have a great evening.
spk04: And that concludes today's conference call. We thank you for joining.
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