Q2 2021 Regulus Therapeutics Inc Earnings Call
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Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Regulus Therapeutics second quarter 2021 financial results conference call. At this time, all participants' lines are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero.
Ladies and gentlemen, thank you and welcome to the Regulus Therapeutics second quarter 2021 financial results Conference call. At this time all participant lines are in listen only mode.
After the speaker's presentation, there will be a question on our decision to ask a question. During this session will be the price.
Star 1 on your telephone.
<unk> be advised that today's conference is being recorded.
Client. It further assistance. Please press star Zero I would now like to hand, the conference over to Chris call Sato, Chief Financial Officer of Regulus Therapeutics. Thank you. Please go ahead.
Operator: I would now like to hand the conference over to Cris Calsada, Chief Financial Officer of Regulus Therapeutics. Thank you. Please go ahead. Thank you.
Crispina Calsada: Good afternoon, and thank you for joining us to discuss Regulus Therapeutics' second quarter 2021 financial results and corporate highlights. Joining me on today's call is Jay Hagan, President and Chief Executive Officer, and Dennis Dryden, Chief Scientific Officer. Jay will provide opening remarks and share progress on our ADPKD program, and I will review the financial results before we open the line for questions. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning Regulus Therapeutics' future expectations, plans, prospects, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Security Litigation Reform Act of 1995.
Thank you good afternoon, and thank you for joining us to discuss Regulus Therapeutics second quarter 2021 financial results and corporate highlights.
Joining me on today's call is Jay Hagan, President and Chief Executive Officer, and Dennis <unk>, Chief Scientific Officer.
Jay will provide opening remarks on share progress on our ADP <unk> program and I 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 therapeutics future expectations plans prospects corporate strategy and performance.
Which constitute forward looking statements for the purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1095.
Crispina Calsada: 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 should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.
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 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.
Joseph P. Hagan: Thanks, Chris, and welcome, everyone, to our second quarter earnings call and business update. The team at Regulus had a very productive second quarter, continuing through the last several weeks, which I'm pleased to share with you today.
Thanks, Chris and welcome everyone to our second quarter earnings call on business update.
The team at Regulus had a very productive second quarter continuing through the last several weeks, which I'm pleased to share with you today.
We just completed our preparations and associated documents and have requested a type a meeting with FDA.
The objective for this meeting is to get feedback on our overall approach to addressing the remaining hold requirements and the data generated to date that forms the basis of the modeling requirements laid out by FDA.
Joseph P. Hagan: We have just completed our preparations and associated documents and have requested a type A meeting with FDA. The objective of this meeting is to get feedback on our overall approach to addressing the remaining hold requirements and the data generated to date that forms the basis of the modeling requirements laid out by FDA. When a type A meeting is requested, FDA typically grants a meeting or provides feedback within 30 days from receipt of the meeting request. We look forward to sharing updates on that progress.
When a type a meeting is requested FDA typically grants and meeting where provides feedback within 30 days from receipt of the meeting request.
We look forward to sharing updates on that progress.
This past June at PK be connect we announced additional data from the first cohort of patients in our phase <unk> clinical trial of <unk> 42.6.
In patients with ADP.
The additional data demonstrated clinical proof of mechanism by showing that short term treatment with <unk> 4 through 6 led to target engagement in the kidneys and consequently led to statistically significant increases in both probably system on 1 and probably system too.
The overall trend in these protein changes show increasing levels of both PC, 1 PCT over time with a sustained effect 1 month after completion of dosing.
Which suggests to us that less frequent dosing could be utilized.
Joseph P. Hagan: This past June at PKD Connect, we announced additional data from the first cohort of patients in our Phase 1b clinical trial of RGLS4326 in patients with ADPKD. The additional data demonstrated clinical proof of mechanism by showing that short-term treatment with RGLS 4326 led to target engagement in the kidneys and consequently led to statistically significant increases in both polycystin 1 and polycystin 2. The overall trend in these protein chains shows increasing levels of both PC1 and PC2 over time with a sustained effect one month after completion of dosing, which suggests to us that less frequent dosing could be utilized. Measured levels of PC1 and PC2 have previously been shown to be inversely correlated with disease severity.
Measured levels of PC, 1 in PCT, who have previously been shown to be inversely correlated with disease severity.
These data serve to further validate mere 17 as a target for <unk> treatment.
Also at PK day connect in June we presented new data generated by our collaborators at University of Texas southwestern Dr. Vishal Patel.
These new data were from a certain preclinical model that is very analogous to the human disease and showed that treatment with <unk> 4 <unk> hundred $2.6 results in increased gene and poly system levels in vitro as well as significant improvements in total kidney size CIS count and overall kidney health.
The model is relevant and that harbors a PD 1 mutation equivalent to human ADP could be.
With regards to safety as previously reported our <unk> for 3 to 6 was well tolerated by all 9 patients in this first cohort with no serious adverse events reported.
And all reported aes or adverse events were mild and generally transient in nature.
Returning to our ongoing phase 1 clinical study of <unk> $432.6.
We're also pleased to announce today that we've recently completed enrollment of the second cohort of patients now.
Now these patients are being administered <unk> 3 milligrams per kilogram of <unk> 4 <unk> hundred $2.6 every other week for 4 doses.
The dose of <unk> 4 through 2.6 for the third and final cohort will be chosen based on the results of this second cohort in relation to what we've been able to demonstrate already at 1 milligram per kilogram.
Joseph P. Hagan: Thus, these data serve to further validate MIR-17 as a target for ADPKD treatment. Also, at PKD Connect in June, we presented new data generated by our collaborator at the University of Texas Southwestern, Dr. Vishal Patel. These new data were from a certain preclinical model that is very analogous to the human disease and showed that treatment with RGLS4326 results in increased gene and polycystin levels in vitro, as well as significant improvements in total kidney size, cyst count, and overall kidney health.
On enrollment in that third and final cohort would be expected to commence sometime in the first fourth quarter. This year.
Anticipate topline data from the second cohort in the fourth quarter as well.
And finally after completing what we believe is a robust and extensive non GOP tox assessment of our next generation compounds targeting mid 2017, we.
We are formally nominated the molecule as a clinical candidate named <unk> SA for 2.9.
GMP manufacturing for GOP talks and phase 1 clinical studies is underway with an anticipated in the first quarter next year.
Recall this molecule was designed to have an overall improved product profile compared to <unk> $43.6 by retaining all of the key beneficial aspects, including its potency for the target mid 2017, as well as preferential kidney distributions, while also dialing out activity towards the putative receptor underlying the clinical signs associated.
At the dose limiting tox level margin less for 3 to 6.
And finally, a team back in our labs at Regulus continues to advance our understanding of the role of micro day important disease areas.
Joseph P. Hagan: The model is relevant in that it harbors a PKD1 mutation equivalent to human ADPKD. With regard to safety, as previously reported, RGLS 4326 was well tolerated by all nine patients in this first cohort with no serious adverse events reported, and all reported AEs or adverse events were mild and generally transient in nature. Returning to our ongoing Phase 1B clinical study of Argillus 4326,
I'll now turn the call back over to Chris for a discussion of our financial results before we get to your question, Chris Thanks, Jay turning to our financial results as of June 32021, our cash and cash equivalents totaled approximately $41.4 million, which is approximately $9.8 million more than on.
$31.6 million cash balance at the end of March 31, 2021.
During the 3 months ended June 32021, we raised $15.4 million on growth protein.
Our ATM facility at a weighted average price per share of $1.26.
With this addition to the balance sheet, we now expect our existing cash can fund planned activity into Q4.2022.
Research and development expenses for the second quarter of 2021 totaled $4.2 million compared to $4.2 million in the same period for 2020.
These amounts reflect internal and.
External costs associated with advancing our preclinical and clinical pipeline Gen.
Joseph P. Hagan: We're also pleased to announce today that we've recently completed enrollment in the second cohort of patients. Now, these patients are being administered 0.3 milligrams per kilogram of RGLS4326 every other week for four doses. The dose of RGLS4326 for the third and final cohort will be chosen based on the results of this second cohort in relation to what we've been able to demonstrate already at one milligram per kilogram, and enrollment in that third and final cohort would be expected to commence sometime in the fourth quarter of this year. We anticipate top-line data from the second cohort in the fourth quarter as well.
General and administrative expenses for the second quarter of 2021 totaled $2.5 million compared to 2.3.
$3 million per the same period in 2020.
These amounts reflect personnel related and ongoing general business operating costs.
Net loss for the second quarter of 2021 was $6 million compared to a net loss of $6.9 million for the same period in 2020.
Basic and diluted net loss per share for the second quarter of 2021 was <unk> <unk> per share compared to basic and diluted net loss per share of 23 cents.
Per share for the same period in 2020.
With that I will turn the call back over to Jay.
Thanks, Chris.
A quick update but a couple of important milestones that the team has hit on an hour whether to take your questions.
Operator, please open the lines.
As a reminder to ask a question you quite star 1 on your telephone to withdraw.
Your question press the pound key.
These standby, while we compile the Q&A roster.
And your first question is from the line of non Xu with Wells Fargo Securities.
Joseph P. Hagan: And finally, after completing what we believe is a robust and extensive non-GLP tox assessment of our next generation compound targeting miR-17. We have formally nominated the molecule as a clinical candidate named RGLSA-429. GMP Manufacturing for GLP Talks and Phase I Clinical Studies is underway, with an IND anticipated in the first quarter of next year. Recall, this molecule was designed to have an overall improved product profile compared to RGLS4326 by retaining all of the key beneficial aspects, including its potency for the target, miR-17, as well as preferential kidney distribution, while also dialing out activity towards the putative receptor underlying the clinical signs associated with the dose-limiting tox level of RGLS4327.
Hi, Thanks.
For taking my questions. So.
With regard to the.
FDA meeting that.
That you have requested.
The topic.
The meeting mainly be the model or would you also be talking about your clinical data.
From at least the first cohort.
And by the time and also.
With regards to the model could you.
Okay and elaborate a little more on what the inputs and what is the output of the model and what is FDA looking for in our model.
Yeah. Good question I'll try to tackle.
That in stride here so.
Yes, the our objective are twofold, 1 to get feedback on our approach, which is basically the model that we've built to predict exposure of extended duration.
That's number 1 and then the second objective would be then.
What.
Level of safety margins would they want us to see in any.
Any stimulated dosing.
Dose level on dose frequency.
And so the model incorporate data.
We've discussed this in the past we were waiting to get data from the first cohort to finalize the model because we wanted.
Joseph P. Hagan: And finally, a team back in our labs at Regulus continues to advance our understanding of the role of microRNA in important disease areas. I'll now turn the call back over to Cris for a discussion on our financial results before we get to your questions.
Data from.
From patients.
For plasma to predict exposure of extended durations. So we have that data that was the final piece that went into the model. It took us a bit of time to get it right. We wanted to be as prepared as possible before we requested the meeting. So we've included those data with the submission as well as the biomarker.
Changes in addition to the safety and PK data.
Great.
Crispina Calsada: Thanks, Jay. Turning to our financial results, as of June 30, 2021, our cash and cash equivalents totaled approximately $41.4 million, which is approximately $9.8 million more than our $31.6 million cash balance at the end of March 31, 2021. During the three months ended June 30, 2021, we raised $15.4 million in gross proceeds through our ATM facility at its weighted average price per share of $1.26. With this addition to the balance sheet, we now expect our existing cash can fund planned activities into Q4 2022.
A quick follow up would you be able to share any cohort 2 data with FDA by the time.
Meeting occurs.
And lastly, how would you like.
To communicate.
The SBA mutually talents to investors. Thank you, yes, yes, so as far as cohort 2 data just as we did with cohort 1 Jan on we are blinded and don't have access to the data on.
Until it's complete and.
So right now I wouldn't anticipate.
That will have cohort 2 data within the next month and as we've guided that the FDA typically provides.
Feedback or meeting date.
Within 30 days of the request.
So unlikely, but importantly, we don't need the data we don't believe because we've got the requisite.
Plasma.
Exposure data.
For which the model is built and we know earlier in our.
These studies in healthy volunteers that exposure was dose proportional so.
It wouldn't really serve to necessarily improve the model.
Significantly over what we have already longer term. We may included when we get to a complete response.
The step after this if we have.
Positive engagement with FDA and get this feedback would be a complete response to the remaining hold requirements, which we then could determine whether or not we want to include it and lastly, I will just make sure I know you didn't answer or ask the question, but the biomarker changes whether or not we see them on the second cohort is not necessarily relevant to address.
Crispina Calsada: Research and development expenses for the second quarter of 2021 totaled $4.2 million, compared to $4.2 million in the same period of 2020. These amounts reflect the internal and external costs associated with advancing our preclinical and clinical pipelines. General and administrative expenses for the second quarter of 2021 totaled $2.5 million, compared to $2.3 million for the same period in 2020. These amounts reflect personnel-related and ongoing general business operating costs. The net loss for the second quarter of 2021 was $6 million, compared to a net loss of $6.9 million for the same period in 2020.
The remaining hold requirements.
Got it.
And then as far as how we communicate with investors I think.
Let us have the meeting.
And then we'll figure out how best to communicate as you know.
From your experience, sometimes you choose to wait to get meeting minutes in the event, there's not clarity in the meeting so we'll we'll.
Make that call win.
When we Havent meeting.
Great. Thank you Jay.
Youre welcome.
And your next question is from the line of Andreas <unk> with Wedbush Securities.
Thank you operator.
Good afternoon guys.
So we all know.
Just a quick 1 from US following up from the FDA question what.
When can you expect following the meeting.
Okay.
On the feedback that you get.
What can you expect feedback from the FDA following the meeting.
Yes, so what's unusual timeline.
Yes, so typically the way it works on dresses that we may get even draft.
Feedback to the questions ahead of the meeting like within say 48 hours of the meeting we'll have a sense of going in is there additional.
Last minute prep, we need to make or otherwise then you and you can further define your.
Crispina Calsada: Basic and diluted net loss per share for the second quarter of 2021 was $0.08 per share compared to basic and diluted net loss per share of $0.23 per share for the same period in 2020. With that, I will turn the call back over to Jane.
Sort of topics of engagement with FDA based on the preliminary you see back you get right before the meeting.
And then you obviously have the meeting.
And.
They can choose to just provide written feedback and say, we don't see the need for meeting, but we don't suspect that to be the case here.
And then through the course of the meeting obviously discussion. There then the meeting minutes are finalized.
From which typically come.
Within a month after the meeting.
Joseph P. Hagan: Thanks, Chris. You know, obviously, a quick update, but a couple of important milestones that the team has hit, and now we're ready to take your questions. Operator, please open the line. As a reminder, to ask a question, you need to press star 1.
Okay.
That's all.
You guys are pretty straightforward on.
Home loans in Cornwall.
Sure.
And your next question is from the line of E Chen with H C. Ryan White.
Thank you for taking my questions Jay just to clarify.
You have completed all of the required tasks.
By the FDA.
Now you are just meeting with the FDA to see whether they are results meet their expectation is that correct.
Operator: As a reminder, to ask a question, you may need to press Star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. And your first question is from the line of Yanan Zhu with Wells Fargo Securities.
Yes, correct, we were told that we needed to build a model.
To predict exposure of extended duration and obviously that's a.
That's a how do I describe it a mathematical simulation.
<unk> involves assumptions and all sorts of stuff. So we want to get their feedback on the approach. We've taken these are population PK models that you're building and so.
Yanan Zhu: Thanks for taking my call.
Joseph P. Hagan: Thank you for taking my questions. So, with regard to the FDA meeting that you have requested, would the topic of the meeting mainly be the model, or would you also be talking about your clinical data from at least the first cohort? With regard to the model, could you elaborate a little more on what the inputs and output of the model are, and what FDA is looking for in a model? Yeah, good question. I'll try to tackle that in stride here.
Do they find our model to be robust and predictive and so on.
That's question, 1 and question too.
If so.
At what dose level on dose frequency I E.
That equates to a safety margin or are they comfortable.
With us moving forward it and so those are the 2 main objectives.
Got it so if the FDA is satisfied with the output of the model and the PK data they should remove the remaining part of the partial clinical hold alright.
That's what we're hoping for okay.
Okay.
With respect to the new molecule.
For 2009 is that right 8429, yes pay for $2.4 Tonight Okay.
Joseph P. Hagan: So, yes, our objective is twofold. One, to get feedback on our approach, which is basically the model that we've built to predict exposure of extended duration. That's number one.
So what additional preclinical studies need to be conducted before just moving to enter clinical trials.
I'll ask my colleague, our Chief Scientific Officer, Dr. Dennis strategy to maybe chime in on what work is ongoing.
Good afternoon or content on the process.
Completing the IND, enabling study.
As well as manufacturing off their supply for that phase 1 trial there.
Joseph P. Hagan: And then the second objective would be, then, what level of safety margins would they want us to see in any simulated dosing, dose level, and dose frequency? And so the model incorporates data. And I think we've discussed this in the past, you know; we were waiting to get data from the first cohort to finalize the model because we wanted data from, you know, patients, for plasma to predict exposure of extended durations.
There are also some minor <unk> studies, which are just the common battery you'll go through before starting the clinical trial, which is still ongoing.
And we also.
Just from an exploratory standpoint.
We've been asked how does <unk>.
<unk> seen in our in our corporate deck how.
<unk> stacks up against pullback and we similarly have conducted some efficacy studies looking at head to head and also in combination and see nice additive effects there.
Those data are not yet been published but.
That is correct yes.
This is the work was done by.
<unk> our collaborator.
Got it so is the development status.
All 326 going to affect in any way.
Future development.
Any thoughts on demand.
Joseph P. Hagan: And so we have that data. That was the final piece that went into the model. It took us a bit of time to get it right, but we wanted to be as prepared as possible before we requested the meeting. So we've included that data with the submission, as well as the biomarker changes in addition to the safety and PK data.
That's a good question and we look at it as this is a 2 pronged.
2 pronged approach, providing optionality 1 is for lifecycle and we could spend a bit of time talking about that.
Greater detail right now <unk> is dosed in a weight based approach.
Milligrams per kilogram, and so unless we switch that to a fixed dose with an auto injector it presumably would be added.
Ministers in.
Joseph P. Hagan: Great. And a quick follow-up. Would you be able to share any Cohort 2 data with FDA by the time the meeting takes place?
Physician's office that's.
That's part of the reason why we're interested in looking at monthly dosing and then.
And then 8429.
It's earlier in development, obviously, not yet in the clinic could be positioned as a potential fixed dose approach with an auto injector and could ultimately cannibalize or put 4.3 to 6 in a different niche setting.
Joseph P. Hagan: The meeting occurs.
Joseph P. Hagan: And lastly, how would you like to communicate the FDA meeting results to investors? Thank you.
So there is some of the options that we're kicking around internally as we think about development.
Joseph P. Hagan: Yeah, yeah, so as far as Cohort 2 data is concerned, you know, just as we did with Cohort 1, Yanan, we are blinded and don't have access to the data until it's complete. And so right now, I wouldn't anticipate that we'll have Cohort 2 data within the next month. And as we've guided, the FDA typically provides feedback or a meeting date within 30 days of the request. So unlikely, but importantly, we don't need the data, we don't believe, because we've got the requisite plasma exposure data for which the model is built. And we know earlier in our MAD studies in healthy volunteers that exposure was dose proportionate.
<unk>.
For 2 nights should benefit if I showed you the 2 structures they look awfully alike.
And so it should benefit.
From the work that we've done already validating.
Mere 17 with the changes in Polish system levels, both from a dose.
On dose frequency standpoint, such that the clinical development can be accelerated for 8 for Tonight, because we'll be doing less dose range finding work.
And.
Basically falling quickly in the footsteps here.
3 to 6.
And obviously as a contingency plan to if it turns out that in on.
Our discussions with FDA that.
Theres more extensive work that needs to be done such that for 3 to 6 no longer retains.
<unk> lead.
In terms of time potentially to market.
We may choose.
To pursue it for Tonight, So we'll see how that plays out, but we like where we are from a positioning standpoint, having this optionality and I think you and I have discussed in the past like every small molecule developer youre always developing nextgen molecules with improved profiles until we've similarly done that here.
Joseph P. Hagan: So it wouldn't really serve to improve the model significantly over what we have already. However, longer term, we may include it when we get to a complete response. Because the step after this, if we have positive engagement with FDA and get this feedback, would be a complete response to the remaining hold requirements, which we could then determine whether or not we want to include. And lastly, I'll just make sure. I know you didn't ask the question. But the biomarker changes, whether or not we see them in the second cohort, are not necessarily relevant to addressing the remaining hold requirements.
Got it thank you.
And Sir there are no further questions at this time I will now turn the call back over to Jay Hagan CEO of Regulus Therapeutics.
Well. Thank you very much for joining us today, everyone and I do want to mention that on the Investor front, we will be participating in the upcoming Wedbush pack growth Health care Conference Tomorrow, and we appreciate your time and support of Regulus.
Thank you.
Sure.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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Thanks.
Yes.
Okay.
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Yeah.
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Joseph P. Hagan: And then as far as how we communicate with investors, I think, you know, let us have the meeting, and then we'll figure out how best to communicate. As you know from your experience, sometimes you choose to wait to get meeting minutes in the event there's not enough clarity in the meeting. So we'll make that call when we have the meeting.
Andres Argue Rides: And your next question is from the line of Andres Argue on Rides with Wetbush Securities.
Andres Argue Rides: Thank you all for being here. Good afternoon.
Andres Argue Rides: Just a quick one from us, following up on the FDA question. When can you expect it following the meeting and the feedback that you get from there? Well, what can you expect feedback from the FDA following the meeting? Yes, so what was the usual timeline? Yeah, yes.
Joseph P. Hagan: Yes, typically, the way it works, Andres, is that we may get even drafts of the questions ahead of the meeting, like within, say, 48 hours of the meeting, so we'll have a sense of going in, you know, whether there is additional, you know, last-minute prep we need to make or otherwise. Then you can further define your sort of topics of engagement with FDA based on the preliminary feedback you get right before the meeting.
Joseph P. Hagan: And then you obviously have the meeting, and, you know, they can choose to just provide written feedback and say, we don't see the need to do that, or we don't see the need for a meeting, but we don't suspect that to be the case here. And then, you know, through the course of the meeting, obviously, discussion there, then the meeting minutes are finalized, from which typically come, you know, within a month after the meeting.
Andres Argue Rides: Okay, that was that's all. You guys are pretty straightforward on timelines and clear on all these things. So I appreciate it. Thanks. Sure.
Yi Chen: And your next question is from the line of Yi Chen with HC, Ryan White.
Joseph P. Hagan: Thank you for taking my questions. Jay, just to clarify, you have completed all the required tests by the FDA, and now you are just meeting with the FDA to see whether their results meet their expectations. Is that correct? Yeah, correct.
Joseph P. Hagan: We were told that we needed to build a model to predict exposure of extended duration. And obviously, that's a, how do I describe it? A mathematical simulation, you know, which involves assumptions and all sorts of stuff. So, we want to get their feedback on the approach we've taken. These are population PK models that you build. And so, you know, do they find our model to be robust and predictive? And so that's question one.
Joseph P. Hagan: And question two, you know, if so, at what dose level and dose frequency, i.e., that equates to a safety margin, are they comfortable with us moving forward? And so those are the two main objectives. So, if the FDA is satisfied with the output of the model and the PK data, they should remove the remaining part of the partial clinical hold. That's what we're hoping for.
Joseph P. Hagan: With respect to the new molecule, the 429, is that right? A429, yes. A429, okay. So, what additional preclinical studies need to be conducted before this molecule enters clinical trials? I'll ask my colleague, our Chief Scientific Officer, Dr. Dennis Dryden, to maybe chime in on what work is ongoing.
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Dennis Dryden: Good afternoon. We are currently in the process of completing the IND-enabling studies, as well as manufacturing the supply for the phase one trial. There are also some minor abne studies, which are just a common battery you go through before starting the clinical trial, which are still ongoing. And we also, you know, just from an exploratory standpoint, you know, we've been asked how 4326 stacks up against Tilbapta.
Dennis Dryden: And we similarly have conducted some efficacy studies, looking at them head to head and also in combination, and we see nice additive effects there. Those data have not yet been published, but that is correct. Yeah. This is the work done by Dr. Vishal Patel, our collaborator.
Joseph P. Hagan: Got it. So is the development status of 4326 going to affect in any way future development? You know, that's a good question. And you know, we look at it as this is a two-pronged, two-pronged approach, providing optionality. One is it's for the life cycle, and we could spend a bit of time talking about that in greater detail. Right now, 4,3,2,6 is dosed in a weight-based approach, milligrams per kilogram. And so, unless we switch that to a fixed dose with an autoinjector, it presumably would be administered in a physician's office.
Joseph P. Hagan: That's part of the reason why we're interested in looking at monthly dosing. And then 8,4,2,9, it's earlier in development, obviously, not yet in the clinic, could be positioned as a potential fixed dose approach with an autoinjector and could ultimately cannibalize or put 4,3,2,6 in a different niche setting. And so those are some of the options that we're kicking around internally as we think about development. We, you know, 8429 should benefit. If I showed you the two structures side by side, they would look awfully alike.
Joseph P. Hagan: And so it should benefit from the work that we've done already, validating miR-17 with the changes in polycystin levels, both from a dose and dose frequency standpoint, such that the clinical development can be accelerated for 8429 because we'll be doing less dose range finding work and basically following quickly in the footsteps here of 4326. And obviously, as a contingency plan, too. If it turns out, in our discussions with FDA, that there's more extensive work that needs to be done such that 4326 no longer retains a significant lead in terms of time potentially to market, then we may choose to pursue 8429.
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Joseph P. Hagan: So we'll see how that plays out. But we like where we are from a positioning standpoint, having this optionality. And as I think you and I have discussed in the past, like every small molecule developer, you know, you're always developing next-gen molecules with improved profiles. And so we've similarly done that here.
Yi Chen: Got it. Thank you.
Operator: And sir, there are no further questions at this time. I will now turn the call back over to Jay Hagan, CEO of Regulus Therapeutics. Well, thank you very much.
Joseph P. Hagan: Well, thank you very much for joining us today, everyone. And I do want to mention that on the investor front, we'll be participating in the upcoming Wedbush PAC Growth Healthcare Conference tomorrow. And we appreciate your time and support of Regulus. Thank you.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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