RGLS - Regulus Therapeutics Reports Positive Phase 1b Topline Data and Oversubscribed $100 Million Private Placement of Equity

2024-03-12 07:48:27 ET

DENVER, Colo., Mar 12, 2024 ( 247marketnews.com )- Regulus Therapeutics Inc. (NASDAQ: RGLS ) reported, this morning, positive topline results from the second cohort of patients in its Phase 1b MAD double-blind, placebo-controlled study of RGLS8429 for the treatment of ADPKD.

RGLS is trading at $1.81, up $0.43 (+31.16%), on 2.48M shares.

“These results from cohort 2 are encouraging, with biomarker data that demonstrate increased activity of RGLS8429 at 2 mg/kg,” said Alan Yu, M.B., B.Chir, from the University of Kansas Medical Center. “Noting that several patients in this cohort who had the greatest reductions in kidney volume also had the greatest increases in PC1 and PC2 is certainly intriguing, and I look forward to seeing results from the higher doses planned in the study. As a physician managing patients with ADPKD, the continued development of a potential novel therapeutic is both important and welcome.”

“We are pleased with the data we have seen in the second cohort, in particular, the mechanistic dose response, as it continues to validate RGLS8429’s potential efficacy in ADPKD,” said Preston Klassen, M.D., President and Head of Research & Development of Regulus. “Based on these exciting results from cohort 2, we plan to increase the sample size of the cohort 4 fixed-dose open label enrollment up to 30 patients in order to further examine potential impact on cystic volume in patients with APDKD. The clear increases in polycystin levels we saw in the second cohort were encouraging, in particular their potential correlation with improvements in kidney volume and function. We look forward to seeing the topline data from the third cohort in the middle of this year.”

“These data represent another important step on our way to bringing a potential treatment to those living with ADPKD,” said Jay Hagan, CEO of Regulus. “RGLS8429 holds the potential to be able to address the underlying genetic causes of the disease, and we look forward to the data from our third and fourth cohorts to inform our potentially pivotal Phase 2 trial design. As always, I would like to thank the patients and investigators participating in our past and ongoing studies as well as our team who has worked so hard to bring us these data.”

The Company also stated that it recently held a Type D meeting with FDA to discuss the accelerated approval pathway and the meeting was confirmed the potential for an accelerated approval pathway based on a single Phase 2 study of RGLS8429 for the treatment of ADPKD.

Additionally, Regulus Therapeutics reported entering into a private placement with certain institutional investors and other accredited investors, which the Company expects to receive gross proceeds of approximately $100 million, at a purchase price of $1.60 per share.

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