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spk11: Thank you for joining this morning's teleconference. Your conference will begin shortly. Thank you. © transcript Emily Beynon Thank you. Thank you. Thank you.
spk00: Thank you. Thank you.
spk11: Greetings. Welcome to ChemoMap Therapeutics 2022 Second Quarter Earnings Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. I'll now turn the conference over to Barbara Lindheim, Consulting Vice President, Strategic Communications. Barbara, you may now begin.
spk02: Welcome to the ChemoMath Therapeutics 2022 Second Quarter Conference Call. Thank you for attending. I am Barbara Lindheim, Consulting Vice President of Strategic Communications at TemaMap. With me today are Dale Post, our Chairman and CEO, Don Marvin, CFO, Chief Operating Officer and Executive Vice President, Dr. David Wiener, Interim CMO, and Dr. Adi Moore, our Co-Founder and Chief Scientific Officer. Before turning the call over to Dale, please take note of our forward-looking statement. Today's call may contain forward-looking statements, which may be identified by words such as may, could, will, expect, intend, plan, and other similar words and expressions. All forward-looking statements made today are based on management's current expectations, assumptions, and beliefs about our business and the environment in which we operate. These statements are subject to risks and uncertainties that could cause our actual results to materially differ from those expressed or implied on today's call. Listeners should not place undue reliance on forward-looking statements and are encouraged to review our earnings press release that we issued this morning, together with our SEC filings, for more complete discussion of factors that could cause our actual results to differ materially from those expressed or implied in forward-looking statements. You can read a comprehensive list of those factors under the heading Risk Factors contained in our annual report on Form 10-K, together with factors under similar headings in the other reports and materials we file with the SEC. Except as required by federal security laws, TMMAB does not undertake to publicly update or revise any forward-looking statements subsequent to the date made. as a result of new information, future events, changing circumstances, or for any other reason. Let me now turn the call over to Dale. Dale.
spk08: Welcome to the QMMAB conference call covering the second quarter 2022. I am pleased to report we have continued to make good progress on multiple fronts since our last call. These include, first, advancing our clinical programs for CM101, our first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target at the confluence of fibrosis and inflammation. Second, adding to the intellectual property portfolio of CM101. Third, presenting important new preclinical data at major scientific meetings. And fourth, adding a number of highly experienced staff essential for the progression of our scientific and clinical programs. On the clinical development front, we continue to make good progress in our CM101 clinical programs as interim CMO, Dr. David Wiener, will discuss in greater detail shortly. In summary, we concluded the treatment phase of our Phase II liver fibrosis study. We finalized planned revisions and initiated global regulatory filings supporting expansion of our primary sclerosing cholangitis, or PFC, Phase II trial, and we made significant progress on delineating the design of our upcoming Phase II trial in systemic sclerosis, or SFC. Turning to our intellectual property, I am pleased to report that in June, the United States Patent and Trademark Office issued Chemomab a new method of use patent It covers the use of CM-101 and other anti-CCL24 antibodies in binding fragments for the treatment of a range of fibroinflammatory liver diseases, including PSC and other cholestatic-related disorders. Liver diseases are an important target for CM-101, which is currently in a Phase II trial for treatment of PSC, a potentially lethal disease affecting the bile ducts of the liver, and, as I noted, a Phase II liver fibrosis study in NASH patients that is nearing completion. In addition, there are a number of other liver diseases where CM-101 might have therapeutic value, so we believe that this new patent may be significant. This new patent adds to the protections provided by CM-101's core composition of matter patent that has already issued in the US, Europe, and other global markets. The new patent extends Chemimab's intellectual property protections for CM-101 in the U.S. for another three years through at least 2038, with additional extensions possible. We have also filed and intend to continue to file additional patents as warranted in an effort to assure the optimal protection for this key asset, which we believe may have wide applicability in a variety of fibroinflammatory diseases. In June, the company made a number of presentations at important European scientific meetings. These are good examples of our ongoing preclinical research designed to further elucidate and validate our CCL24 target and its role in disease, and to better understand how CM101 affects disease pathways. Additionally, by sharing this research at major scientific meetings, our scientists are helping further educate the broader scientific and medical communities about the role of CCL24 in fibroinflammatory disease, the therapeutic potential for CM101, and the interesting and robust science underlying our approach. First, in an oral presentation at the 2022 ESL International Liver Congress, we presented data from a preclinical PSC model that used advanced technologies to reveal unique liver macrophage subpopulations as the major source of CCL24 production in the area of the bile ducts that is damaged in PSC. Our scientists also demonstrated in this model that the treatment with CM-101 interfered with the core PFC disease pathways in a way that is potentially associated with therapeutic activity. Second, at the first International Extracellular Matrix, or ECM, pharmacology conference, CumaMab researchers presented a poster that included both preclinical and early clinical data demonstrating that CM-101 attenuates biomarkers associated with ECM expression. This is noteworthy because ECM expression is involved in PSC pathophysiology and is closely related to CM-101 mechanism of action. Importantly, this dataset supports our efforts to translate preclinical biomarker findings on ECM remodeling in the liver to the use of similar serum biomarkers in patients. Third, earlier in June, we presented data supporting the role of CCL24 as a therapeutic target for systemic sclerosis in a poster at the 2022 ULAR European Congress of Rheumatology. This study, which was conducted by our collaborator, Professor Francesco Delgado of Leeds University in the UK, examined the role of CCL24 in longitudinal cohorts of diffuse cutaneous SFC patients. The study reported elevated serum levels of CCL24 in these patients and showed that high circulating CCL24 levels were correlated with disease activity and worse prognosis, as reflected by high fibrotic activity and the deterioration of lung function over time. The findings further support the role of CCL24 as a potential therapeutic target for SFC. Our researchers received positive feedback on these presentations, and we look forward to further conference participation over the rest of the year. Since the start of the second quarter, we added a director and several senior level executives we view as critical to our continued success. Jill Quigley, JD, a highly accomplished biotechnology executive with broad experience in public company executive management, global operations, legal affairs, and finances, joined our board of directors. We are also welcoming Christine Crater, MD, as our new vice president of clinical development, who will be joining us at the end of August. Dr. Crater brings an extensive background in medical affairs and clinical trial design and execution across a broad range of therapeutic indications. We expect the addition of Dr. Crater to significantly augment our medical and clinical capabilities. Additionally, during the quarter, we appointed Ilan Vakman, PhD, as Vice President of Research and Development. Dr. Backman is a terrific addition, bringing Chemimab more than 20 years of highly relevant experience in immunology, antibody development, translational research, and biomarker development, including more than a decade in senior science roles at Compugen. Branding out the science and clinical team are several highly experienced mid-level professionals bringing vital skills to enhance our capabilities in clinical trial operations and planning. We feel confident we now have most of the right personnel in place to execute on our clinical programs. Let me now turn the call over to Dr. David Wiener, who has been leading our efforts to advance our clinical development program for CM-101.
spk06: Good morning. Today we will be providing updates on three key elements of our CM-101 clinical development. One, we will provide additional details on the status of our Phase II safety, pharmacokinetics, and biomarker study in liver fibrosis patients. Two, we will provide additional details on the revisions to our randomized placebo-controlled dose-finding study in primary sclerosing cholangitis patients. And three, we will update our progress towards finalizing the design of our planned phase two biological proof of concept trial of CM-101 in systemic sclerosis. Let me begin with the liver fibrosis trial, which we are in the process of wrapping up. For context on this trial, it is useful first to review some background on the phase one clinical studies of CM-101. We initiated the clinical development of CM-101 with a single ascending dose study in healthy subjects, which demonstrated the safety and tolerability of the intravenous administration of doses of CM-101 up to 10 milligrams per kilogram. We then progressed to a Phase 1b assessment of the safety, tolerability, and initial biological activity of multiple ascending doses of CM-101 in subjects with NAFLD, or non-alcoholic fatty liver disease. The trial was randomized and placebo-controlled, where two cohorts of eight subjects each received either placebo or CM-101. one group at 2.5 milligrams per kilogram intravenously, and the second group at 5 milligrams per kilogram subcutaneously. Both groups received five doses once every three weeks for a total treatment period of 12 weeks. It's instructive to review the key results of these studies as they provide the backdrop for the Phase II trial now underway. Administration of CM101 was found to be safe and well-tolerated. Favorable multiple-dose kinetics of CM101 were obtained, along with evidence for peripheral target engagement at both dose levels. Importantly, initial signs of activity of CM101 were observed on serum-based biological markers as well as liver stiffness assessed by the non-invasive elastographic method known as FibroScan. The serum biomarkers were ProC4 and TMP1. ProC4, a marker of collagen type 4 formation, was decreased by 10% from baseline in subjects who received 2.5 and 5 milligrams of CM-101. with no change observed in placebo patients. Similarly, a comparable reduction in TMP1, which is a component of the widely used composite ELF biomarker score, was observed in CM101-treated subjects, while it increased in subjects who received placebo. In addition to the effects observed on these important markers of extracellular matrix biology, Favorable and concordant changes were also observed in six additional fibrosis biomarkers in subjects receiving CM101. These biological markers are also outcome markers we're assessing in the ongoing liver fibrosis trial. Regarding liver physiology, we observed a decrease in liver stiffness reflected by an approximately 15% reduction from baseline in subjects receiving CM101, as compared to no change in subjects receiving placebo. Based on these promising early results, and with the intent to confirm and extend these findings, and to broaden our understanding of the mechanism of action, and potential beneficial clinical effects of CM-101 in fibroinflammatory liver disease, we initiated the CURRENT study, a randomized placebo-controlled trial in patients with non-alcoholic steatohepatitis, or NASH. Patients with stage F1C, F2, and F3 disease were enrolled in the trial and were randomized to either CM-101 at a dose level of five milligrams per kilogram administered subcutaneously or placebo. Patients received eight doses of study drug once every two weeks for a treatment period of 15 weeks. The primary outcome measure of the trial is safety and tolerability. Key secondary outcomes include Evaluation of multiple serum-based fibrotic markers, including ELF score, PROS-C3, C4, and CCK18. Evaluation of multiple serum-based inflammatory markers, including C-reactive protein, fibrinogen, haptoglobin, and alpha-2 macroglobulin. Changes from baseline in clinical laboratory measures utilized to evaluate hepatic function, including ALT, AST, total bilirubin, and lipid profiles. Evaluation of liver fat content by MRI and liver stiffness by fibroscan. And evaluation of the local tolerability in pharmacokinetics following subcutaneous delivery of CM-101. Regarding trial status, as of August 1st, of the 23 patients that were enrolled and randomized, all 23 have completed treatment, and four of those remain in the protocol-defined safety follow-up period. We are on target for a final readout in the fourth quarter and look forward to sharing the clinical trial data at that time. We believe that the data from this trial will provide useful insights in support of the CM101 development program. Although the sample size is small, based on the encouraging signs of activity we saw in the Phase 1b study in NAFLD patients, we believe that evaluating the same relevant outcomes that a patient population with more severe liver inflammation and fibrosis is likely to be informative. Importantly, these data represent the first readout of CM101's activity in patients with established liver disease. For the important secondary objective of exploring the safety and drug exposure achieved with our subcutaneous formulation, we believe the study results will also provide us the pharmacokinetic and tolerability data needed to inform next steps in the development of the current subcutaneous formulation of CM-101. Turning to our primary sclerosing cholangitis trial, we view PSC as a promising clinical indication for CM-101. based on the extensive preclinical and translational data generated by our researchers that highlights the potential role of CCL24 in PSC-related disease pathophysiology and the observed activity of CM101 in attenuating the fibroinflammatory processes that characterize the disease. As such, we previously indicated our interest in increasing our clinical efforts in this rare disease. including expanding the size and scope of our ongoing trial, and importantly, in adding a dose-finding component to better inform the optimal CM-101 dose to advance into late development. Today, we can report that we have finalized the trial revisions and have begun regulatory submissions with a major clinical trial protocol amendment to support trial expansion. However, it is useful to note that much in the trial design has not changed. The core design of the trial as a randomized placebo-controlled multiple-dose study remains unchanged. The patient population understudied, namely PSC patients with large duct disease of more than 24 weeks duration, also remains unchanged. The trial's double-blind treatment period, where all enrolled patients receive five administrations of study drugs, which is either CM-101 or placebo, intravenously every three weeks remains the same. Finally, all outcome measures in the trial, including evaluations of serum ALP level, serum biological markers, and fibro scans, remain unchanged. Revisions to the trial include the following, an increase in the total number of patients to be enrolled to 93, inclusion of two dose cohorts in addition to the current 10 milligram per kilogram cohort, a lower dose cohort to evaluate 5 milligrams per kilogram, and a higher dose cohort to evaluate 20 milligrams per kilogram. Each cohort will enroll 25 patients with PSC. An increase in the number of placebo patients to 18 to ensure enrollment of placebo patients contemporaneously to all CM101 dosing cohorts. The addition of an open-label extension to the trial with the additional administration of up to 11 doses of CM101 given every three weeks by intravenous infusion. The addition of the open-label portion of the trial brings the maximal total duration of treatment to 48 weeks, a change in the trial's primary outcome to an evaluation of CM101's safety and tolerability. Lastly, consistent with the fact that the primary outcome of the trial is safety, the study is not formally powered to assess efficacy. However, we have maintained cohort sizes sufficient to detect, with expected variability, a clinically relevant improvement in serum ALP levels, which is defined as change from baseline. Serum ALP is a key secondary outcome measure for studies in PSC. As we noted previously, we will be performing an interim blinded safety analysis of the currently enrolling dose cohort in the PSC study expected to be completed before the end of this year. The primary purpose is to facilitate a safety review by the data monitoring committee to support the planned higher dose cohort of 20 milligrams per kilogram in the trial. Since the study will remain blinded, we will not be reporting details of the safety analysis at that time. Based on a number of key factors, including our ongoing efforts to expand the number and geographic footprint of clinical trial sites, the current development landscape of trials in PSC, and the increased size of the study, we anticipate that the top-line data from this Phase II trial in PSC will be available in the second half of 2024. turning to our Phase II systemic sclerosis trial. We have, by working closely with a number of leading systemic sclerosis disease experts, made good progress towards the finalization of the clinical trial design. As we have discussed, we are focusing the goal of this trial towards establishing biological proof of concept on clinically relevant aspects of this complex disease. focusing on CM101's potential activity in modifying the skin, lung, and vascular pathophysiology observed in SSC patients. We remain on track to launch the trial by the end of this year. We plan to provide details on the final SSC trial design in the next couple of months, either on a special webcast prior to or at our next quarterly call. In summary, I'm pleased to report that we are making steady progress towards obtaining critical clinical data in our CM101 development program in rare inflammatory and fibrotic diseases, including evaluating safety, tolerability, pharmacokinetics, and biological and physiological data from our liver fibrosis trial, to provide further insight into CM101's mechanism of action, to support the evaluation of higher doses of CM101 in the clinical development program, and to inform the next steps in the development of a subcutaneous formulation of CM101. Expanding our efforts in primary sclerosing cholangitis to obtain safety, tolerability, biomarker, and clinical efficacy data on multiple dose levels of CM-101, and generating proof-of-concept biological data on clinically relevant aspects of systemic sclerosis to help guide the design of late-stage registrational trials. I will now turn the call over to Don.
spk07: Don? Good day. As CFO of Chemomab, I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders. Today, I will review highlights of our second quarter 2022 financial performance. Please see the press release we issued this morning for more detail. As you know, the market for biotech stocks remains very challenging. I want to note again that while we cannot change the markets, we can ensure that we are not distracted from focusing on what we need to do to build a successful company. And for Chemomab, that is to ensure we are pursuing the optimal development path for CM101, prudently managing our finances, conserving capital to the extent feasible, while advancing our clinical programs in as optimal fashion as possible and monitoring our ecosystem for potential opportunities to bring additional attractive assets in-house as resources permit and for tracking competitive challenges. We believe we are doing a good job delivering on these goals and we will strive to do so going forward. Let me now share a summary of our financial performance in the second quarter of 2022. Cash, cash equivalents, and bank deposits were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. R&D expenses. were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter over quarter primarily reflects the ramp up in activities supporting our clinical programs for CM101. G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.4 million for the same quarter in 2021. Please note that the 2022 figure includes a $700,000 non-cash stock-based compensation payment. The increase in cash G&A in the second quarter partly reflects key additions to the senior management team. In addition, about half of the year-over-year increase reflects a non-cash charge for previously disclosed equity-based compensation, plus a provision accrued for a potential tax liability arising from transactions that took place prior to the company's reverse merger in March 2021. Debt loss was $6.2 million or a net loss of approximately three cents per basic and diluted ordinary share for the second quarter of 2022, compared to 2.8 million, or a net loss of approximately one cent per basic and diluted ordinary share for the quarter ended June 30th, 2021. The weighted average number of ordinary shares outstanding, basic and diluted, were 228 million 173,276, which equals 11,408,664 American depository shares for the quarter ended June 30, 2022. We continue to prudently manage our cash and currently expect our runway to last through the end of 2023, as we have indicated in our last call. We appreciate your continuing support and invite you to reach out if you would like to communicate with us directly.
spk09: I will now turn the call back to Dale. Dale?
spk08: We are pleased with our progress to date and believe we are continuing on the right path to build value at ChemoMap. We look forward to sharing more details with you in the coming months. We currently are planning a virtual event this fall to provide more details on our upcoming systemic sclerosis trial, and as noted, we also expect to provide an initial readout on our liver fibrosis study and to complete an interim safety assessment of our PSC trial around the end of the year. We do appreciate your continued interest and support. Operator, we are now ready to open the floor to questions.
spk11: Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question today, please press star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions.
spk09: And once again, that is star 1. Thank you. Thank you, and our first question comes from the line of Jeff Jones with Oppenheimer.
spk11: Please receive your question.
spk10: Good afternoon, guys. Thanks for taking the question. Just a few here. In regards to the 5-meg sub-Q dose in the NASH or liver fibrosis study, do you have any data that speaks to how that compares from an exposure perspective to the 5, 10, and 20-mig IV doses used in the PSC trial. And then in terms of the interim safety readout on the PSC trial, I may not have caught it. Do you plan on sharing any information from that interim readout or not? And then on the systemic sclerosis trial, I know goal of starting end of this year, do you have any feedback on sort of when we would be looking for top line or interim results from that trial? Thank you very much. Happy to answer.
spk08: Go for it, Dave. Thank you. Yeah, happy to answer. questions.
spk06: So we do have some regarding your exposure question. The subcutaneous formulation in the phase 1b behaved with an exposure that was roughly 60% of an equivalent dose in the IV. So that's our initial data there gives us some anticipation of what we expect to see at the end of this year when we look more deeply at the PK data of the five milligrams per kilogram sub-Q in the liver fibrosis trial. Data on the 10 milligrams per kilogram is essentially linearly increased from the five, and that was observed in our phase one study, so it's roughly dose proportional, and we have yet to evaluate 20 milligrams per kilogram. We have done some modeling of doses to that, and once again, one of the critical elements there And one of the reasons we want to assess those three doses is to confirm do lead to increasing exposures and to correlate that with clinical outcomes. The second question that you asked was related to SSC. There, once we finalize the design, as I think Dale mentioned, we're going to have a special session to go through that trial design. We'll provide at that time, once we know all the final details, the actual readout timing for that. And I think the second question you asked related to the safety data, we do not intend that analysis will be blind. So we do not intend to give detailed descriptions on the safety data by group, but we will once we actually perform that analysis and the DMC does that review, we will provide external information on what the safety data cut looks like to date.
spk09: Great. Thank you very much. You got it. Our next question comes from the line of Kristin Kleska with Canterford Sherald.
spk11: Pleasure to see your question.
spk03: Hi. Good morning and good afternoon, everybody. Thanks for taking my questions. First, for PSD, can you help us walk through some of the timelines that you cited here as it relates to enrollment cadence and number of sites you're hoping to have open and how you're thinking about this relative to what we've seen for other studies?
spk09: Happy to do that.
spk06: Happy to do that. So, yeah, as you note, we are significantly increasing the size of the trial. And consistent, and actually even before that is being implemented, we have been spending significantly more effort into expanding the number of sites that we're engaging on this trial, including the locations. So as we've mentioned before, we've expanded the EU and the US, and those are ongoing processes now as we're building up additional sites, and that will continue as we amend the protocol. and to the point where we will get to a steady state level number of sites that should be sufficient to prosecute the trial and enroll the roughly 93 patients. Our current timeline to deliver the top line data there from the second half of 2024 is based very much on that site expansion and some of the historical enrollment rates in PSC that have been observed of late. Obviously, it is our desire, our hope to prosecute that to that metric or even better, but that is one of the factors that leads to our guidance on the second half of 2024. Thanks.
spk03: I appreciate that. And same indication, PSC. I know you've done a lot of sequencing work, and obviously there's been a lot of preclinical proof of concept as well, but Understand it's a very heterogeneous disease. There's a lot of comorbidities, particularly with IBD. So I wanted to ask if you think that there are certain populations where CCL24 as a target is more important than others, or do you think that broadly across the board, across the different patient profiles, that this could be relevant?
spk09: Thank you.
spk08: Dave, you want to start that off, and maybe Adi could round that out? Yes, that would be great.
spk06: So, yes, in this initial trial, we are focusing on patients, as we mentioned, with large duct disease, established disease, who do not have significant or active IBD. But you are absolutely correct. One of the key things that we are discussing internally is whether that population is worthy of with CM-101, right? So whether as we advance our efforts, we specifically conduct a smaller trial in patients who have that concurrent physiological process is something that we're engaged in discussions currently. Very much for the reason you stated, which is unlike a lot of the prior attempts in this disease that were focused mainly on cholestatic disease, the promise or the potential of CM-101 is broader. So it behooves us to explore that in the clinical setting. Adi?
spk04: Yeah, I can only add on that. Thanks, Dave, that given the anti-inflammatory effect of CM-101 by targeting CCL24-1, we would have expected to see actually an improvement in all of those gastrocomorbidities, IBD included. There is data even in the public domain that supports the role of CCL24 generally in IBD and in alternative colitis and Crohn's specifically, and we do think that this is definitely a route that should be assessed in the future.
spk09: Thank you. Our next question comes from the line of Nathan Weinstein with AGES.
spk11: Please receive your questions.
spk05: Hey, good morning, Dale and ChemoMab team. Thank you for taking my questions. Just to comment first, it really feels like you're being very diligent and doing everything you can as an organization to give CM-101 its best chance across multiple indications. So I just had two questions. Firstly, around the phase two studies, it really feels like the intention and design is very safety focused. So if you just look out into the future for the clinical I mean, do you think we'd have to have another round of Phase II trials that were more efficacy-focused before we start to think about moving into registration studies? Thanks, Nathan. Dave, you want to take that?
spk06: Yep. So, Nathan, it depends on the indication. The design, you are correct, the primary outcome of the trials, many trials at this stage, are safety and tolerability, a foundation upon which we will build towards efficacy. With regards to PS, this is a robust trial with large group sizes with a significant duration of treatment. So depending on the outcome there, that's a trial that we can move directly into what could be registrational trials, right, in efficacy, because it should give us sufficient information on relevant outcomes like serum and others that have been used previously to de-risk molecules and to move directly into those larger studies. And as I'm sure you're aware, those larger studies usually hinge on histopathological outcomes related to liver biopsy. So from PSC, I think we can move rapidly into what could be a definitive trial. We'll have to actually assess the data at the time and understand what both the regulatory and treatment landscapes look like. I think with SSC, once we've that design, you know, we'll know a little better, but if we're correct in that disease, then the next step after the trial that we're contemplating currently could be a proof-of-concept phase two clinically-oriented study. And I think the challenge there is that disease heterogeneity and the need for us to read out on a clinical outcome prior potentially to doing the larger uh registrational type trial so it's a little bit of a mix i think in psc we could potentially move more rapidly and ssc data will have to what the next steps will be thank you great that's very clear and then just one follow-up regarding how the company continues to evolve i know you recently made some key hires
spk05: I guess what's just the overall confidence level, and I think you're going to have two of these mid-stage studies in PSC and SSC, I mean, correct me if I'm wrong, running simultaneously. What's the overall confidence in running two of those studies at the same time?
spk08: I can start that off, and Dave, perhaps you could round it out. Yeah, the organization has been developed very nicely over the last several months, and Jack Lawler has joined us in the clinical operations side. and the team has been filled out very, very well. So we're very pleased with our abilities to execute on the trials as put forward today, and the team is really the best I've worked with before. I'm very proud of the team and confident in their capabilities. Dave?
spk06: I can confirm, Dale, we are specifically targeting those key hires for exactly that purpose, Nathan, which is to make sure that not only prosecute those trials, but we'll also be prepared to respond to them rapidly and move the program forward with the appropriate staffing.
spk05: So I'm confident as well. Okay, great. So thanks again for taking my questions and I appreciate the updates today. Thank you, Nathan.
spk09: As a reminder, you may press star one to ask a question at this time. Thank you. At this time, I'll turn the floor back to Major for closing remarks.
spk08: Thank you very much for your attendance today, and I hope you've seen from our discussions and our presentation today that our confidence in CM101 is strong, and we see a great opportunity for us at QMMAB. The team is doing a great job. I'm very pleased with how the team has shaped up over the last year or so, and I building on the basis of the work that QMMAB did over the period of the greatest part of the last decade or so. So thank you very much for your participation. We'd be happy to follow up with any of you individually if you see fit. And thank you very much for attending.
spk11: This concludes today's conference. May disconnect your lines at this time. Thank you for your participation.
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