Regulus Therapeutics Inc (RGLS) 2017 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, thank you for standing by. Welcome to Regulus Therapeutics Fourth Quarter 2017 Conference Call. (Operator Instructions) And as a reminder, this conference is being recorded. Now I would like to welcome and turn the call to Ms. Allison Wey, Vice President of Investor Relations and Corporate Communication. You may begin.

Thank you, Carmen. Good afternoon, everyone, and thank you for joining us to discuss Regulus' fourth quarter and year-end 2017 financial results and corporate highlights. We are joined today by Jay Hagan, President and CEO; Dr. Tim Wright, Chief R&D Officer; and Dan Chevallard, our CFO. Jay will provide opening remarks, Tim will share progress on our pipeline programs and Dan will review the financial results before we open the line for questions.

Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Regulus' future expectations, plans, prospects, corporate strategy and performance, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast and call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

I will now turn the call over to Jay.

Thanks, Allison. 2017 was a year of transition for Regulus. We had some setbacks, made significant organizational changes, focused the pipeline and added key talent. We've learned a tremendous amount over the last year from these experiences and are applying the learnings to all of our active programs, both the 2 clinical programs as well as our preclinical pipeline. Importantly, our strategy as a company has not changed. We focus on leveraging our expertise in microRNA biology to develop therapeutics for areas of significant unmet medical needs. We believe that our growing portfolio of programs represent attractive opportunities to further develop and expand our pipeline.

Key accomplishments in the quarter recent period included: getting the RG-012 study right with the changes in the protocols that we and our partner, Sanofi, believe will give the program the best chance for success; filing the IND for RGLS4326 for the treatment of autosomal dominant polycystic kidney disease and beginning first-in-human testing ahead of schedule; establishing the relationship with WuXi for manufacture of oligonucleotides to complement our existing relationships, which further strengthens our ability to develop and eventually commercialize these investigational products; and importantly, as you'll hear from Dan, ending the year in line with our financial plan. I'm proud of our team's efforts in accomplishing these milestones amidst the changes we implemented.

Our goals for 2018 are clear: advance our 2 clinical programs through key data events and milestones, prepare with Sanofi for a potential option decision in 2019 and advance of our preclinical portfolio towards the clinic. Regarding the RG-012 program, today's update includes an acknowledgment that we underestimated the time it would take to enroll the program. We previously had plans, together with our CRO, to have the approximately 40 sites across the 2 studies up by now. However, site initiation has taken longer than anticipated given the number of operational complexities.

We're about halfway through site initiations and the pace has accelerated from added resources we have applied. While we anticipate the completion of enrollment of HERA and data from the biopsy study around the end of Q1, this no longer looks achievable due to several factors, including the longer-than-anticipated study start of activities and difficult to recruit target patient population. Importantly, we have dozens of patients in the queue and more being added each day. Conservatively, though, we're guiding for completion of enrollment in the second half of 2018 for these 2 studies. We plan to update investors as we reach key enrollment milestones.

Now turning to RGLS4326. That program has progressed nicely through its early Phase I development. We have a period of follow-up but anticipate data analysis being complete in the second half of 2018. Meanwhile, we are making plans for initiation of the multi ascending dose, or MAD, portion of the study. Tim will share more about both programs shortly.

In summary then, 2018 looks to be a year of clinical execution and pipeline advancement. I'm particularly excited about the potential of microRNAs as a target class beyond what we and others have already demonstrated. MicroRNAs remain a promising and novel therapeutic frontier, which we are at the forefront of. Partnering interest in our microRNA platform remains strong. We have the opportunity to demonstrate proof of mechanism and proof of concept in 2 unique kidney programs within the next 12 to 18 months, further demonstrating the potential of microRNA therapeutics as an important target class. We've added key talent that, together with a highly focused management team, is making great progress in advancing our pipeline. We will plan to share more about them as they move towards the clinic.

And with that, I'll turn the call over to Tim to provide a more detailed R&D update. Tim?

Thanks, Jay. Over the past year, we've enhanced key internal capabilities in R&D and built relationships with CROs to support about preclinical and clinical programs. We continue to advance our knowledge about the optimal design of oligos to target microRNAs and deliver to specific cell types and tissues while minimizing potential off-target effects that have led to challenges with the development of other therapeutic oligonucleotides.

I'll start my update with the Alport syndrome program. As Jay said, realizing that recruitment of Alport syndrome patients was more challenging than initially anticipated, we've expanded our efforts to speed up the recruitment of our RG-012 studies, both the renal biopsy and HERA proof-of-concept study. We've also engaged additional external resources to help drive awareness within this target orphan patient community. Once fully enrolled, we'll be able to provide estimates for delivery of our top line results. And while the biopsy data won't be available this quarter, its value in determining whether any changes to dose and frequency prior to Phase III initiation remains the same. We just completed a partnership meeting with Sanofi a few weeks back, and it was very productive and engaging with them providing input and advice on how to drive the program forward given their leadership in rare disease.

Let's move now to our RGLS4326 program for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. While still early, I'm very excited about this program. This is our wholly-owned anti-miR-17 program utilizing our proprietary chemistry designed to selectively deliver the anti-miR to the kidney. As Jay indicated, we initiated first-in-human single ascending dose study, or SAD, in December 2017, and this study is progressing nicely through dose escalation. We are making plans for the initiation of the multiple ascending dose study that will incorporate ADPKD patients as a way to gain early information on the effects of RGLS4326 on disease-related biomarkers.

It's still too early to give time lines on this readout since the study has not yet been initiated, but our current estimate is we will have data in hand prior to initiating our Phase II program now slated for the middle of 2019. We continue to make significant progress on our early discovery efforts and have over half a dozen programs targeting diseases in the liver and kidney as well as new work on infectious diseases and immunology. In addition, over the past several months, we've been evaluating multiple delivery technologies that hold promise to deliver all of those efficiently to tissues outside of the liver and kidney. This highly focused effort is being performed in collaboration with companies who have advanced these technologies to late preclinical or clinical testing or delivery of other payloads, and we are now working on optimizing these platforms for oligo anti-miR delivery.

These new technologies are aligned with our research strategy and well-defined target product profiles. Stay tuned for future updates on these very exciting novel delivery approaches as well as our early pipeline programs.

I'll now turn the call over to Dan for the financial review.

Thanks, Tim. As Jay mentioned, 2017 was a transitional year for Regulus and one that resulted in significant operational improvements and changes.

Coming out of our financing last July and in light of organizational changes, impairing of spend in areas of research that were more exploratory in nature, we guided that our prospective operating cash burn would be reduced to approximately $12 million per quarter or $48 million per year. Our second half 2017 cash burn and operating results were in-line with these projections with a net cash burn of approximately $23 million over that period, finishing the year with $60.1 million in cash, cash equivalents and short-term investments. We expect this cash to extend nearly through the first quarter of 2019.

As you would expect, our Q4 activities, both from an organizational focus and financial allocation perspective, were concentrated around the ramp-up of key clinical activities for RG-012 and RGLS4326. Importantly, incremental resources were applied toward the successful IND filing for 4326 and subsequent initiation of the first-in-human Phase I study, which we announced in December. Cost to support these important initiatives were partially offset by reductions in spend associated with the wind down of ATHENA, our Natural History of Disease Study for Alport syndrome patients.

Turning now specifically to our financial results for the period. Research and development expenses were $10.5 million and $53.2 million for the quarter and year ended December 31, 2017, respectively, compared to $15 million and $64.3 million for the same period in 2016. This reflects a decrease of 30% and 17% versus the comparative period. The fourth quarter decrease was primarily the result of a reduction in personnel-related and associated fixed costs subsequent to our May 2017 corporate restructuring. The year-over-year decrease was further driven by the completion of wind-down activities and spend related to the RG-101 and cholestasis programs.

G&A expenses were $3.3 million and $17 million for the quarter and year ended December 31, 2017, compared to $4.8 million and $18.4 million for the same period in 2016. The decreases in G&A expenses were primarily attributable to a reduction in noncash stock-based compensation.

Net loss was $14.4 million and $71.9 million for the quarter and year ended December 31, 2017, compared to a net loss of $20 million and $81.8 million for the same period in 2016. The resulting basic and diluted net loss per share was $0.14 and $0.96 for the quarter and year ended December 31, 2017, compared to a net loss per share of $0.38 and $1.55 for the same period in 2016.

As we look ahead in 2018 and consistent with our past guidance, we anticipate a cash burn in line with our 2017 exit rate of approximately $12 million per quarter. Our 2018 cash burn will be focused, with approximately 80% of our operating plan committed to our R&D efforts comprised of our 2 clinical programs and the advancement of our preclinical research pipeline, as Tim outlined. We look forward to an exciting year ahead.

And with that, I'd like to turn it back over to Jay.

Thanks, Dan, and thank you very much for your interest today. Summing it all up, 2018 is a very important year for execution. And as an aside, we will be presenting in 2 upcoming investor conferences, Cowen next week and Needham the last week in March.

With that, we'd be happy to take your questions. Operator, could you please open the lines?

(Operator Instructions) And our first question is from the line of Liana Moussatos from Wedbush Securities.

The delay for starting up the sites -- the clinical sites for the HERA and liver -- I mean, kidney biopsy trials, what kind of issues are they having? And you mentioned that it's difficult to enroll target patients. How is -- can you talk about how ATHENA could help you with that? Or a little more color?

Sure. I'll take the first part of that, Liana, and then I'll ask Tim to chime in as well. With respect to the operational issues, we don't want to make excuses for the issues we'd confronted. But one can imagine that a trial that encompasses 2 biopsies as well a biology testing, site selection amidst end of the year and so forth and competing clinical trials affects our plans. And importantly, as I mentioned, the approximately 40 sites, that's an increased number of sites than we originally planned really to try to, again, accelerate development of the program to meet time lines. Tim, I don't know if you want to add anything more about that or the patient population?

Sure. Let me just add to the question about the hard-to-recruit patient population. Obviously, this is an orphan indication. And in particular, our intended population for the HERA study is one of X-linked males, which tends to be a younger demographic. And what's interesting is we've had tremendous support from the Alport syndrome community and a lot of interest. And what we're trying to work through now is sort of balancing the need to recruit this younger male population and the commitment to the trial. So we're trying to improve the ability to have subjects participate while making that participation not too onerous for them. So that's part of this last process of adjustments in the operational side of things. But obviously, this is a very different demographic than is usual for clinical trial settings, except for these rare diseases and in this particular case, a younger male population.

Yes, and Liana, just to add to that, too. I mean, recall there is nothing approved or available for these patients. So the frequency at which they see their nephrologist is such that driving awareness about this new investigational agent in clinical trials and reaching that target patient population is one that requires specialized outreach. And that's part of what we alluded to with the additional external resources that we're engaged with now to drive that awareness.

And you mentioned partnering interest. Do you have any comments on what areas, or any kind of color on that?

Yes, no, I mean, obviously RG-012 is already partnered with Sanofi. The anti-miR-17, which has been well published over the last several years, represents a very novel approach to treating another disease where there's significant unmet need, nothing approved in the U.S. and is one that represents an attractive potential commercial opportunity. So there's that and there's other things in our pipeline. We've done a really good job of creating awareness amongst potential partners over the last year, and I think that's starting to manifest in growing interest in the opportunity to target microRNAs in complex disease.

Are you thinking -- it was mentioned anti-infectious diseases and immunology for preclinical. Were those be partnerable? Are you thinking of developing something yourself?

We ultimately want to develop a program for ourselves, but we look at business development as an avenue to fund our aspiration relative to other ways to -- for capital formation. And so driving awareness in our pipeline and our capabilities is a must-do, and it's yielding fruit in terms of interest there. And I would also say that Tim's done a really good job of focusing our pipeline efforts in areas of significant unmet need and balancing the portfolio. So both of those things that were mentioned obviously represent opportunities for faster readouts in terms of endpoints. And so, I don't know, Tim, if you want to add anything?

Yes, just to say that, again, building on the portfolio that existed here, which was strong especially in renal disease, branching out into areas where we can, show faster proof of concepts, whether it's based on biomarkers or clinical efficacy and therefore driving value early either for ourselves or in a partnership mode, has been the focus over last several months to a year.

Yes, and further to that, Liana, leveraging on the validation of targeting miR-122 as a host factor in hepatitis C, there's a growing body of literature on the role of microRNAs in enabling infectious disease well beyond hep C, and it's that that's led us to some additional areas. And as those programs mature, we are excited to share data on those.

Okay. And for the MAD study for ADPKD, you mentioned biomarkers. And what are the steps to start up the trial?

Yes, so actually, we're in the later stages of finalization. So once we're ready to get that going, we'll be submitting it through the typical regulatory and ethics committee review, IRB review, and then starting once we have all the operational components in place. As far as biomarkers, we'll be exploring those in both our healthy volunteer population. But more importantly, we've now prepared a plan that will integrate ADPKD patients into our MAD. And we haven't disclosed the final design on that, but I will tell you, it's an innovative design, one that we've been encouraged to pursue by regulators to integrate patients early in the program.

And our next question comes from the line of Eric Schmidt with Cowen and Company.

It's just a little unclear to me when we expect the data from the biomarker study given the revised time lines, and I think that study was supposed to enroll a total of 10 patients. Can you talk about exactly where you might be in the enrollment today?

Yes, thanks for the question, Eric. Yes, so we'll provide an update on when data can be anticipated when we complete enrollment in that. Enrollment is underway, and you're right. The protocol provides for up to 10 patients in 2 cohorts to look at an opportunity to compare dose frequency, to see if any adjustments would be appropriate prior to Phase III initiation. Tim, you want to add anything to that?

Yes, just that we're not going to give updates on specific numbers of subjects recruited. But as Jay mentioned, it is underway, and we're making progress with that study. The target is to deliver this in the second half of the year.

Deliver the data in the second half of the year?

Yes.

That's right.

Okay. And in terms of the natural history study, I think you were planning on publishing that at some point in time. Do you have a more specific time line?

Yes, the -- we got together with the authors at ASN late last year, and there's tons of work and analysis underway. And I think the plan is a medical conference in the second half of the year is where they're gearing towards.

And our next question comes from the line of Joseph Schwartz with Leerink Partners.

This is actually Dae Gon dialing in for Joe. So just wanted to get a little more clarification on the enrollment progress. Did I hear you right that you currently have 30 sites that you're currently enrolling in? And what exactly are you doing on the raising awareness aspect? And have you seen -- or I guess, timing wise, when have you commenced that effort? And have you seen the fruits of that effort?

Sure. Good question. So what we said was that we're targeting approximately 40 sites across the 2 studies. Some sites actually are involved in both studies. So we're not really breaking out what number for each. You can see online on ClinicalTrials.gov the numbers that are up thus far, and we're about halfway through that targeted number of sites. And also, when conducting mid-stage clinical research, you have some sites you put up don't enroll any patients. You decide to add sites and make other tactical moves to help drive the patient enrollment. And so that's where we are with respect to that. With respect to the point about additional tactics and resources, those are activities that are underway and engaged and include how to reach this targeted patient population. Tim alluded to X-linked males tend to be younger. And given the frequency on which they see their physician, you need other avenues in order to drive awareness that this trial is being conducted. So that includes different types of social media platforms and understanding influencers and ways to reach the target patient population in addition to other techniques. And as we roll them out and see the fruits of those, we'll be happy to share in more detail. But as you can imagine, it's one of an iterative nature, trying different tactics and seeing how that works, and we've got a lot of promising activities underway on that front.

I mean, what I would add is that since our site initiations have been a little slower than anticipated, it has given us an opportunity to see where some of the issues may be and then start to put some of these additional resources in place along the way instead of waiting till after all the sites were initiated. So as Jay said, it's an iterative process, and it's still a little too early to see the fruits of it, but we expect to see it in the very near future.

Yes, and one other thing I'll add, as you know, it's a genetic disease. And so oftentimes, you might have one person who's interested and you find out that they've got 6 family members with the disease as well, another way to leverage genetic information to reach the target patient population here.

Makes sense. Just to, I guess, branch off of that point, do you anticipate -- so you guided for about $12 million OpEx per quarter. Do you anticipate any material change to that if you were to see any trends that would require you to invest even more heavily in-patient identification for the remainder of the year?

I think we can manage to that budget. These are not significant investments per se in terms of additional tactics, and we're always finding opportunities for trade-offs and resource allocation to meet our projected burn rate. I don't know, Dan, if you want to add anything to that?

No, the only thing I'd add is just to clarify, $12 million in cash burn being a bit different than operating expense, as you mentioned, Dae Gon. But yes, I think our objective would be to manage within the confines of this guidance that we're putting out today or reiterating. And we'll be looking to provide for those additional activities to the extent that they require additional resources by identifying savings elsewhere.

And our next question is from the line of Alan Carr with Needham & Company.

A couple of them [wanted to] go over the Alport trials a little bit here and in enrollment. It sounds like it's mostly finding patients. But as you do find them, are there any challenges with screening? And are all -- you mentioned that there was a little bit of trouble getting sites up and running. Are these all in the U.S.? And then the last question with the deal with Sanofi. Does the deal in terms of their option contemplate any of these kind of delays? Is there -- competition need to go(inaudible) a little bit longer than we plan (inaudible) patient continue to wait for proof of concept? Or is there some other clause about -- that ties to -- that's related to timing to when we get this data?

Yes, I'll touch on a few of those and ask Tim to amplify in areas that I miss. Those are all very good questions. So maybe I'll take the last one first and then we'll get to the operational piece. So our contract with Sanofi provides for them to have the opportunity to opt into the program, up through an outside date, which is defined as a short period of time after completion of a one-year proof-of-concept study, and the one year is 48 weeks of treatment for 30 patients. And so once we provide them that set of information, they have a fixed period of time to make an option decision. So there's no -- there's nothing per se that changes with the passage of time. With the passage of increased money spent, that just gets included in the reimbursement component. So if we invest more, we get more reimbursed. And as I said, we had a very productive meeting a couple of weeks ago and really appreciate their input on ways to improve outreach and drive awareness given their long experience in rare diseases. On the operational complexity front, it really is a constellation of things. If you don't have sites up, you can't get patients screened. And so you need to get sites up in key geographic regions where you know there's patients and where you've heard from investigators that they have patients to be treated. And it's one of these typical sort of hockey puck type analogies here where you get momentum in the study as the sites are up, as you drive awareness and patients come through. As far as screen failures, we don't want to get into all the detail around how the process is going. But as you've seen in our protocol, we're targeting X-linked males and we often get a lot of input from females interested in pursuing this trial. And obviously, they're not the target population for the HERA study based on what we've learned from ATHENA. So that sort of initial interest, and I think investigators are reaching out to their prospective patients and letting them know that females interested in participating in any trials with respect to RG-012 can be directed to the biopsy study where there are certain number of females allowed for that study. I don't know, Tim, if you want to add anything more?

Just a couple of other points. One is that our ATHENA study was based almost exclusively at academic sites. And just the contracting logistics of getting academic sites up and running is a longer process than the central IRB community-based sites. And so we saw some delays in that process, and we're now working through -- as Jay mentioned, we're in a nice clip in terms of getting a number of the academic sites up and running. Those were the sites that we've been working with for the last few years and have patients identified for potential participation. So that's part of the process that we've been working through in terms of operational logistics. And then the other regarding patient screening, yes, I mean, one of the challenges is not only this is a young population, but these patients progress. So some patients that have been identified to participate were actually a little too far beyond the progression in terms of their renal disease. So these are just some of the challenges we face in this kind of disease, not that I don't think we can overcome them. We're in the process of trying to do that right now.

And our next question comes from the line of Jim Birchenough with Wells Fargo Securities.

It's Nick in for Jim this afternoon. Maybe on 4326, is there any learning from Alport that you need to apply now? Do you expect there could be challenges enrolling patients for the multiple ascending dose and later trials?

Yes, I'll just take the first part of that. Thanks for the question, Nick. The team is doing a lot of work already on the feasibility as we're incorporating ADPKD patients into the Phase I trial design for the goal of demonstrating proof of mechanism here before mid-next year. And just a couple of points. One, the ADPKD diagnosed patient population is significantly larger than the Alport population. And as you know, there are therapies that are approved outside the U.S. and there have been trials done in the U.S., a number of investigational agents, which demonstrate an ability to recruit fairly large numbers of patients. Part of their disease as well and the progressive nature of it, I think there's greater awareness and just willing to mobilize what we've seen thus far when you look at precedent studies. So I don't think per se that we anticipate any issues, knock on wood. But we're certainly incorporating all the learnings we can into our feasibility planning here for the Phase I and ultimately, the trials after that. Tim?

And in terms of the single ascending dose, you're giving yourself around about 9 months or so to report data from this. I mean, is this because you're planning a lot of dose levels, you're going to collect a lot of data about dose selection? How do you intend to select a dose for the single ascending dose portion?

Right. So the time line to complete that study and have the final data from it is only driven by the duration of follow-up that we would have with a molecule like an oligo, and it doesn't relate to the real expanded number of dose groups. In fact, that's relatively small. It's purely that we want to ensure adequate follow up of all the healthy subjects before we lock the database. And what we have indicated is that we're actually planning to start the MAD in the not too distant future. We're actually hoping to do that in an interleaved fashion before the final data are in hand from the SAD. So we don't see that as rate limiting right now in terms of progressing the program. Obviously, it is part of the program and we'll complete that, but it's not right now in any way rate limiting.

Yes, so we have several months of follow up after the last dose -- last SAD cohort is dosed and then log the data, analyze the data and that's what we have at hand. So that's why we're guiding to where we are. But to your question about dose selection with the MAD, that's guided as much about what we've seen in terms of our repeat dose studies in mice as well as in monkey and the tissue exposures achieved. So we know what level is required to show efficacy in the mouse model and what's required to achieve a certain level of exposure in the nonhuman primate, which translates to our estimation for where to start dosing in the MAD portion and where we might see efficacy.

Just the last one, rounding back on HERA. You were going to have some interim data, I think, on -- 24-week interim data reported by the middle of the year. That's obviously going to be pushed back. What is the plan now for reporting the 28-week and the 48-week data from HERA?

Yes, the 24-week interim analysis is a blinded analysis. So the most likely situation that we'd guide investors to is that the data monitoring committee met, reviewed data from all patients through 24 weeks and instructed the sponsor to continue. We obviously don't want to break the blind in the study at the interim analysis. There is a chance that the trial could be wrapped up early by hitting the primary endpoint, but that's not what we're powered to show. So -- and then the 48-week data, upon completion of that and data analysis, we'll be reporting that.

Once we're fully enrolled, we can then provide some time line to those milestones.

So the interim would be based on 24 weeks sort of from the last patient in?

That's right.

Correct. Yes.

(Operator Instructions) And our next question is from the line of Matthew Luchini from BMO Capital.

A couple from me, please. So I guess, first, on the Alport program. You've mentioned a couple of times now 40 sites and you're about halfway -- about 40 sites and about halfway through site activation. Is it -- is the general plan just to stick with those 40 sites? Or are you looking at adding or identifying additional sites to bring the total number of active sites closer to that 40? And then secondly, you guys have mentioned a couple times the guidance that Sanofi has provided in terms of helping to move the trial along and accelerate recruitment. Maybe could you just give us a little sense as to what maybe the specific guidance was that they suggested, if it hasn't already been sort of discussed so far? And then finally, for 4326, how should we expect you to communicate results from the single ascending dose portion of the trial? And did I hear you correct that the data from the multi ascending dose portion should be expected before -- no later than midyear next year?

Sure. Thanks for those questions, Matthew. Yes, so adding additional sites, I think I alluded to earlier, when you're going through in the process, especially for a mid-phase clinical trial, you'll put sites up. They don't appear to be getting any traction, you might shut them down, move on, change based on constantly evaluating opportunities to add patients. So -- and we are evaluating adding additional sites where we feel like we might get traction with patient recruitment. So that's all in the mix. It's all in flux. With respect -- I'll just take the last one with respect to 4326, how should we expect communication. Yes, the single ascending dose portion of the study, once we've wrapped that up and have the results, we'll report those top line results. The MAD portion, you're correct. As Tim guided to, our current plan is to initiate the Phase II portion of that trial mid next year. And so we'd obviously have those results from the MAD and the proof of mechanism complete and communicated by that time. And with respect to the guide that Sanofi has provided, and Tim can share more in this, but they obviously have a long history in rare diseases, and just sharing anecdotes amongst the joint steering committee about things that they've seen and ways to drive awareness either through foundations, through regional outreach and engagement with physicians, different ways of driving a cooperative sense among the investigators. And so all those types of tactics we're evaluating and employing into our efforts.

Yes, this has been an ongoing dialogue over the last, well, couple of years at least. And I think it's been very helpful over the last several months, especially as we've gotten the trial up and running. We continue to dialogue in between our formal get-togethers. But certainly, having face-to-face and reviewing the program and as Jay said, sharing anecdotes and new ways to identify hard-to-recruit population, it's been very helpful for us.

And that ends our Q&A session for today. I would like to turn the call back to Mr. Jay Hagan for his final remarks.

Thanks very much for your time and attention today, and we look forward to providing updates as these programs move forward. Thank you.

And with that, ladies and gentlemen, we thank you for participating in today's conference. This concludes the program, and you may all disconnect. Have a wonderful day.