Regulus Therapeutics, Inc. (RGLS) CEO Joseph Hagan on Q2 2022 Results – Earnings Call Transcript

Regulus Therapeutics, Inc. (NASDAQ:RGLS) Q2 2022 Earnings Conference Call August 11, 2022 5:00 PM ET

Company Participants

Crispina Calsada – CFO

Joseph Hagan – President & CEO

Conference Call Participants

Yi Chen – H.C. Wainwright & Co.

Operator

Good morning, and welcome to the Regulus Therapeutics Second Quarter Financial Results Conference Call.

All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Cris Calsada, Chief Financial Officer of Regulus. Please go ahead.

Crispina Calsada

Thank you. Good afternoon, everyone, and thank you for joining us to discuss Regulus Therapeutics Second Quarter 2022 Financial Results and Corporate Highlights. Joining me on today’s call is Jay Hagan, President and Chief Executive Officer; and Dr. Denis Drygin, Chief Scientific Officer. Jay will provide opening remarks and share progress on our ADPKD and other programs, 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 purpose 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 should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

I’ll now turn the call over to Jay.

Joseph Hagan

Thanks, Cris, and welcome everyone, to our second quarter earnings call and business update. I’ll begin first with a general update on our ADPKD program.

The second quarter was particularly eventful, beginning with the US Food and Drug Administration’s acceptance of our IND for RGLS8429 for the treatment of autosomal dominant polycystic kidney disease. This was followed by the dosing of the first subject in our Phase 1 single ascending dose study of RGLS8429 to assess the safety, tolerability in pharmacokinetics of the drug in healthy volunteers.

Following this study, we plan to initiate a Phase 1B multiple ascending dose study in adult patients with ADPKD to assess the safety, tolerability and pharmacokinetics of RGLS8429 treatment, as well as to evaluate the dose response of RGLS8429 on ADPKD biomarkers, including polycystins, cystic kidney volume and overall kidney function.

Our objective is to establish a dose response around the dose level where robust clinical biomarker effects were demonstrated with our first generation compound. We anticipate top line data from the healthy volunteer portion of the study later this year. And top line biomarker data from the first cohort of RGLS8429 treated ADPKD patients in the first half of 2023. The single ascending dose study is nearing completion consistent with our planned execution and timelines and the multiple ascending dose portion of the study is well on track for initiation shortly after completion of the SAD study.

Additionally RGLS8429 was granted orphan drug designation from the FDA. Orphan drug designation or ODD identifies drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States and with that helps facilitate drug development by providing potential financial and regulatory incentives.

Finally, we’re thrilled to welcome Dr. Amin Kamel as our new Vice President of DMPK, a key new hire for the regular team. We look forward to his contributions as we progress RGLS8429, as well as the rest of the pipeline.

With that, I’ll now turn the call back over to Cris for an update on our financial results. Chris?

Crispina Calsada

Thank you, Jay. Turning to our financial results as a June 30, 2022 our cash, cash equivalents and marketable securities totaled approximately $47.5 million. We expect our cash runway to extend into the fourth quarter of 2023. Research and development expenses for the second quarter of 2022 totaled $4.7 million compared to $4.2 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 pipeline.

General and administrative expenses for the second quarter of both 2021 and 2022, total $2.5 million. These amount reflect personnel related in ongoing general business operating costs.

Net loss for the second quarter of 2022 was $7.3 million compared to net loss of $6 million for the same period in 2021. Basic and diluted net loss per share for the second quarter of 2022 was $0.50 per share compared to basic and diluted net loss of $0.78 per share for the same period in 2021.

With that, I will turn the call back over to Jay.

Joseph Hagan

Thanks Chris. At this time, we’re happy to take any questions you might have. Operator, could you please open the lines?

Question-and-Answer Session

Operator

[Operator instructions] Your first question comes from Yi Chen with H.C. Wainwright. Please go ahead.

Yi Chen

Thank you. This is Yi from H.C. Wainwright. Thank you for taking my question. I’m sorry, if you mentioned on the call, so is there a plan for RG-012 now that Sanofi — sorry Sanofi has not going to, Sanofi didn’t really achieve the success in the syndrome trial. Is it still in the hand of Sanofi or regulars could do something about?

Joseph Hagan

So Sanofi notified us, which we shared in our 8-K update that they’re looking for other opportunities for the compound without giving any specifics to us. But you may know that ’21 is implicated in a number of different fibrotic diseases. And additionally you may ask around any specifics with respect to the data. We have not, per the terms of the agreement have had access yet to the data.

What we do know is that this was a planned pre-specified interim analysis when 24 subjects randomized two to one. So that’s 16 on active and eight on placebo had completed one-year of blinded treatment and that’s what the futility analysis was based upon.

Yi Chen

So do you know whether Sanofi will make a decision as to whether they will proceed with another indication before the end of this year?

Joseph Hagan

We don’t know the exact timing there’s standard diligence clauses in an agreement of this type where they have to use commercially reasonable efforts to work on the program.

Yi Chen

Got it. Okay. And regarding the SAD trial of 8429, we should have some initial data in the first quarter of this year, correct?

Joseph Hagan

Yes. We’ll plan an update Yi because we’ll obviously be announcing when we initiate the MAD. The initiation of the MAD comes after review of all the safety data from the SAD. And so once we’ve completed that and announced that we’re moving into the MAD we’ll plan to provide an update to investors at that time.

Yi Chen

Got it. Is the company considering any other pre-clinical stage candidates?

Joseph Hagan

Yes, we actively are. We don’t talk about them a lot, but we have quite an interesting early stage effort ongoing in a number of different CNS diseases. And we look forward to providing an update as those programs move through several in-vivo proof of concept studies. But the team is actively working on those and we look forward to providing that update sometime likely early next year.

Operator

[Operator instructions] There are no further questions at this time. I would now like to turn the conference back over to Jay Hargan for closing the marks.

Joseph Hagan

Well, thanks everyone for joining us today for this brief call. As I mentioned, the programs are all on track per our timelines, and we look forward to providing updates on them as they advance and reach key milestones. We appreciate your support and interest in Regulus and we’ll catch up soon. Thank you.

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.

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