Regulus Therapeutics, Inc. (RGLS) Third Quarter 2022 Earnings Call Transcript

Regulus Therapeutics, Inc. (RGLS) Third Quarter 2022 Earnings Call Transcript

Regulus Therapeutics, Inc. (NASDAQ:RGLS) Third Quarter 2022 Earnings Conference Call November 10, 2022 5:00 pm ET

company participants

Crispina Calsada – CFO

Jay Hagan – President, CEO and Director

Denis Drygin – Scientific Director

Conference call participants

Yanan Zhu – Wells Fargo Securities

Operator

Hello, and welcome to the Regulus Therapeutics Inc. Third Quarter 2022 Earnings Conference Call. [Operator Instructions].

I would now like to turn the conference over to the Financial Director, Cris Calsada. Please go ahead.

Crispina Calsada

Thank you, good afternoon, and thank you for joining us to discuss Regulus Therapeutics Third Quarter 2022 Financial Results and Corporate Highlights. .

Joining me on today’s call are Jay Hagan, President and CEO; and Dr. Denis Drygin, Scientific Director. Jay will provide opening remarks and share the progress of our ADPKD program, and I will review the financial results before opening the line for questions.

Before we begin, I would like to remind you that this call will contain forward-looking statements regarding Regulus Therapeutics’ future expectations, plans, prospects, corporate strategy and performance, which constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated in these forward-looking statements as a result of various important factors, including those discussed in our SEC filings.

Furthermore, any forward-looking statements represent our views only as of the date of this webcast and should not be relied upon to represent our views as of any later date. We specifically disclaim any obligation to update such statements.

Now I’ll put the call through to Jay.

jay do

Thanks, Cris, and welcome everyone to our third quarter earnings call and trading update. I’ll start with a general update on our ADPKD program. We keep moving forward in clinic with RGLS8429. In September, we announced positive top-line pharmacokinetic and safety data from our phase I single ascending dose, or SAD, clinical trial of RGLS8429. RGLS8429 was well tolerated and no serious adverse events were reported.

Among the 32 subjects treated with RGLSA429 or placebo, there were only 9 adverse events, all mild except one, a sinus infection, which was rated as moderate in severity. Furthermore, more importantly, preliminary results suggest that plasma exposure is approximately linear across the 4 dose levels tested and is similar to the pharmacokinetic data for the first generation compound RGLS4326.

Last week, we announced the dosing of our first patient in our Multiple Ascending Dose, or MAD, Phase Ib study of RGLS8429. We have since enrolled the second patient and have several more under evaluation at the 6 sites that are now active. The study is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of RGLS8429 in adult patients with ADPKD.

The study will evaluate the safety and efficacy of treatment with 4329, excuse me, 8429 at 3 different dose levels, including measuring changes in Polysystems, cystic kidney volume or high-adjusted total kidney volume, and overall kidney function. The first cohort receives a 1 milligram per kilogram dose of RGLSA429 or placebo every two weeks for 3 months.

Top-line data from the first cohort of patients is now anticipated in mid-2023. Changing the subject, during the 3 months ending September 30, 2022, we sold and settled approximately 2.2 million shares for net proceeds of $4 .5 million at our ATM facility. Almost all of the shares were sold to a new institutional investor. With the completion of this transaction, we believe that our cash, cash equivalents and short-term investments will now fund current planned activities through 2023.

Last week, we presented data at the American Society of Nephrology Kidney Week meeting in Orlando. The poster presentation was titled Discovery of the Next Generation Anti-miR-17 Oligonucleotide RG-429 for the Treatment of Autodominant Polycystic Kidney Disease and highlighted data supporting the potential of A429 in this important disease.

We are excited about our progress, as well as the attention RGLS8429 is receiving in the marketplace, which helps validate the effort our team puts in each day to advance this therapy and its potential to improve the current standard of care.

With that, I’ll call Cris back for an update on our finances. Chris?

Crispina Calsada

Thanks Jay. Regarding our financial results. As of September 30, 2022, our cash, cash equivalents and short-term investments totaled approximately $45.3 million. We expect our cash trail to extend through 2023. Research and development expenses for the third quarter of 2022 totaled $5.3 million compared to $5.9 million in the same period in 2021.

These amounts reflect the internal and external costs associated with advancing our ADPKD program and other research efforts within our portfolio. General and administrative expenses for the third quarter of 2022 totaled $2.3 million compared to $2.5 million for the same period in 2021. These amounts reflect ongoing and related general business operating costs. Net loss for the third quarter of 2022 was $7.6 million compared to a net loss of $8.6 million for the same period in 2021. Basic and diluted net loss per share for the third quarter of 2022 was $0 .50 per share compared to a basic and diluted net loss of $0.99 per share for the same period in 2021.

With that, I’ll call Jay back.

jay do

Thanks Chris. At this time, we will be happy to answer any questions. Operator, please open the line. .

questions and answers session

Operator

[Operator Instructions]. Our first question today comes from Canaccord.

Unidentified analyst

The question that I have, I suppose, has to do with the expectations for the data in the middle of next year. Can you remind us of what you saw in animal studies with slightly extended doses? I know the 3 months of dosing here compared to a slightly shorter course on the first generation compound. It’s curious what you saw with longer doses in animal studies, and if you think there’s a reading of what we should expect from the clinical data reading next year.

jay do

Yes. Perhaps I will refer to the clinical part and ask Denis to comment on the duration of dosing in a variety of animal models, that depending on the animal model, some are faster than others and offer less opportunity to dose during periods prolonged.

But just to remind people that at the 1 milligram per kilogram dose level that we’re currently testing with our next-generation compound, we saw a statistically significant increase in both Polysystem 1 and Polysystem 2 from the baseline of about 60 % and 40% increases in those at that dose level. And as I mentioned earlier, the PK between the molecules is very similar. So we anticipate with this next generation compound to see similar types of effects.

And if you recall, the trajectory of change from the start would suggest that with continued dosing, higher levels of Polysystem could be achieved before it plateaus once we reach steady state in the kidney. So that’s what we’ll be looking for at the clinic. And Denis, I don’t know if you want to comment on the duration of dosing in animals.

Denis Drygin

Thanks Jay. In fact, as Jay mentioned earlier, most models for ADPKD are quite aggressive and don’t allow for a long period of treatment.

However, we tested the first generation molecule in a longer (inaudible) model where the treatment was 7 weeks. And with longer treatment, there was more and more evidence of the incubation of expansion and growth.

Operator

[Operator Instructions]. The next question comes from Yanan Zhu of Wells Fargo Securities.

yanan zhu

Mainly I have a question about the enrollment and timeline of data from different cohorts. So I think previously, the data expectation for the first dose cohort might have been the first half of the 23rd, correct me if I’m wrong, and this time, we’re hearing in the middle of the year.

Could you elaborate on this that might be a little change in the first half compared to the middle of the year, but is there a change in your enrollment expectations, speed or any other factors? And also for the additional cohorts, do you have any suggestions on the potential timeline for the data from those cohorts?

jay do

Of course. So the guidance that we provide for the first cohort data in the first half of ’23 goes back to when we did our funding in October, November of last year, outlining at that time, our expectation for both the start of SAD and the later start. love.

And as is often the case, as you go through these processes, sometimes it takes a little longer for things to get up and running. So we decided to update our guidance in terms of when we would have data. Now that the MAD has actually kicked off, we’re a year after the initial guidance was provided, where we’re looking at what, how quickly we think we’re going to enroll the study. And I think the mid-23 guidance is more accurate than the first half that includes the first quarter.

So, effectively, we say that the first quarter is likely to end, we would probably have to finish enrollment this month to get to the first quarter. And the inscription is obviously a forward-looking statement. Actual results may differ. We are pleased with the progress the team is making so far having now 6 sites and a good portfolio of patients in screening and 2 now in study out of the total of 12 we targeted for the first cohort.

And so guidance for mid-23 feels more appropriate and accurate to what we project enrollment to look like. When the last patient starts, we know pretty clearly how long it will take them to complete it. They will have 3 months of dosing and 1 month of follow-up, after which we will have the analytical work that is needed. That is the basis of the general timeline for the first cohort. As for subsequent cohorts, I mentioned earlier that we have 6 sites.

We are currently targeting up to 25 sites in total. And so, as more sites come up, obviously more potential patients will get into the queue geographically and otherwise. And so, while it’s premature to estimate the enrollment time of subsequent cohorts, one can anticipate that it could go faster than the first cohort that just had more active and active sites. So what we have guided for the second cohort data is the second half of ’23.

yanan zhu

Congratulations on the progress.

Operator

[Operator Instructions]. Seeing no more questions, I’d like to turn the conference over to Jay Hagan for final comments.

jay do

Excellent. Thank you operator, and thank you all for joining us today and for your support of Regulus. We look forward to providing you with future updates as the program progresses. Take care of yourself. .

Operator

The conference is now over. Thank you for attending today’s presentation. Now you can log out.

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