On January 20, Regulus Therapeutics Inc. (RGLS) announced the successful completion of the pre-IND meeting for RGLS8429 with the FDA. Consequently, the stock advanced further in the after hours.
During the regular session, the stock fluctuated between $0.2500 and $0.2421 at 1.27 million shares. RGLS closed the session with a mild gain of 2.04% at $0.2449. Following the announcement, the stock added a further 6.12% at $0.2599 in the after-hours session.
The clinical-stage biopharmaceutical company, Regulus Therapeutics Inc. has a market capitalization of $35.03 million. Currently, the company has 145.97 million shares outstanding in the market.
RGLS’ Pre-IND Meeting
As per the announcement, the pre-IND meeting with the FDA regarding RGLS8429 as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The reason for the meeting was the FDA’s input on the pre-clinical, clinical, and regulatory matters of RGLS’ next-generation compound. Earlier this week, the company had received the formal minutes from the meeting.
Moreover, the meeting resulted in the FDA’s agreement with an overall agreement with the Phase 1 trial design of RGLS8429 along with its length and the proposed starting dose. Therefore, the company is on track for the submission of the IND application in Q2 of 2022 for clearance of Phase 1 trial commencement.
Phase 1 Clinical Trial of RGLS8429
The phase 1 clinical study of the product will have two parts:
Part 1
Part 1 will be a single-ascending dose (SAD) study for evaluating safety and tolerability for pharmacokinetics characterization in healthy volunteers. Further, 32 volunteers will be randomized to RGLS8429 or placebo in the part one cohort.
Part 2
Part 2 will be a multiple-ascending dose (MAD) study in ADPKD adult patients. Furthermore, it will evaluate the safety and tolerability of the product for pharmacokinetics characterization and the dose-response. 36 patients will be randomized in the cohorts of this part.
In addition, the updated clinical plans encompass extending dosing to three months in each cohort of ADPKD patients.
RGLS Financial Analysis
On November 10, the company declared its financial results for the third quarter of 2021.
In the third quarter of 2021, RGLS incurred a net loss of $8.6 million, against $1.5 million in the year-ago period. Resultantly, the net loss per basic and diluted share was $0.10 in Q3 of 2021 and $0.04 in Q3 of 2020.
Additionally, the company ended the quarter with cash and cash equivalents of $35.8 million.
