Q3 2022 Regulus Therapeutics Inc Earnings Call

We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.

If you're using a speaker phone please pick up your handset before pressing the keys.

Is that any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

Our first question today comes from Whitney a gym with Canaccord. Please go ahead.

Hey, guys.

The question I have I guess is around.

The expectations headed into the data mid next year can you remind us what you saw in animal studies with with slightly extended dosing I know the there's three months of dosing here versus a slightly shorter of course.

In the first Gen compound. So curious what you saw with longer dosing in animal studies and if you think there's read through there to what we should be expecting from the clinical data readout next year.

Yes, maybe ill touch on the clinical partners ask Dennis to comment on.

Dosing duration and a variety of animal models.

Which depending on the animal model, some or more rapid than others.

Offering less opportunity to dose for extended periods, but just to remind folks that at the one milligram per kilogram dose level that we're testing currently with our next gen compound.

We saw a statistically significant increase in both poly system, one in polycystic too from baseline of approximately 60% and 40% increases.

Increases in those at that dose level and as I mentioned earlier the PK between the molecules is very similar so we would anticipate with this next gen compound to see similar types of effects.

And if you recall the trajectory of the change from baseline would suggest that with continued dosing higher levels of polycystic could be achieved.

Prior to it.

Plateauing once we reach steady state in the kidney.

So that's what we'll be looking for in the clinic and Dennis on what you want to comment on duration of dosing in animals.

Thank you Jay.

Indeed, as Jay mentioned earlier, the majority of the models for <unk>.

Get aggressive and do not allow extended period of treatment.

However, we did.

Test.

Generation molecule in the longer.

Our followed this model, where the treatment was $4 seven weeks and with a longer treatment. There was more and more evidence of that inhibition of the <unk> expansion and growth.

Great. Thanks.

Sure.

Again, if you have a question. Please press Star then one.

The next question comes from Yanan, Zhu with Wells Fargo Securities. Please go ahead.

Hi, Thanks for taking my question.

We have a question about enrollment and.

Timeline.

Sure.

Ana for different from different cohorts.

So.

I think the.

Previously the data expectation for the first dose cohort might have been in first half 'twenty. Three please correct me if I'm wrong and this time, we here midyear could.

Could you.

Elaborate on.

This might be a small change first half versus midyear, but any changes in your expectations for enrollment speed or any other factors and also for the additional cohorts do you have any.

Uh huh.

Suggestion.

On the potential timeline for the data from those cohorts. Thank you.

Sure, Yes, so the guidance that we provided for data from the first cohort in the first half of 'twenty three dates back to when we did our financing in October November last year.

Outlining.

At that time, our expectation for both initiation of this ad.

Initiation of the Mad.

And as often the case.

As you work through these processes, sometimes things take a little bit longer to get up and going.

So.

We chose to update our guidance in terms of when we would have data now that the mad is actually initiated we're a year after that initial guidance was provided.

Where.

We're taking a look at how quickly we think we're going to enroll the study and think guidance of mid 'twenty three is more accurate than the first half of 'twenty three which includes the first quarter. So effectively we are saying in the first quarter is likely out we'd have to be done enrollment.

This month, probably to hit the first quarter.

Enrollment is obviously a forward looking statement actual results may differ.

We're pleased with the progress the team's making thus far.

Getting now six sites up and a good pipeline of patients in screening in two now in the study.

Of the total 12 that were targeting for the first cohort.

And so guidance for mid 'twenty three fields.

More appropriate and accurate with with how we project enrollment is going to go.

When the last patient in.

Is initiated we know quite clearly the time it'll take them to complete that.

I would have three months of dosing and one month of follow up after which we've got the analytical work that's needed. So that is forms the basis of the overall timeline for the first cohort as far as the subsequent cohorts.

Mentioned earlier that we have six sites up we're targeting up to 25 total sites currently and so as more sites come up.

Obviously more potential patients will come into the queue.

Geographically and otherwise and so while it's premature to estimate the time of enrollment ups. Subsequent cohorts one can anticipate that it could go more quickly than the first cohort just given more sites up and active.

What we've guided to for data from the second cohort is the second half of 'twenty three.

Got it thank you.

And thank you for the answer and congrats on the progress.

Thank you.

Again, if you have a question. Please press Star then one.

Seeing no further questions I would now like to turn the conference back over to Jay Hagan for any closing remarks.

Great. Thank you operator, and thanks, everyone for joining us today and for your support of Regulus, We look forward to providing you with future updates as the program advances take care.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

With regard.

With.

With regard.