Regulus Therapeutics Inc (RGLS) Reports Year-End Earnings, Highlights Key Clinical Advancements
Net Loss: Reported a net loss of $8.1 million, or $0.40 per share, wider than the estimated loss per share of $0.21.
Research and Development Expenses: Increased to $5.8 million for Q4 and $21.2 million for the full year, reflecting ongoing investment in clinical programs.
Cash Position: Cash and cash equivalents stood at $23.8 million at year-end, bolstered by a subsequent $100 million private placement to extend the runway into H1 2026.
ADPKD Program Advancements: Positive topline data from Phase 1b MAD study of RGLS8429 and completion of enrollment for the third cohort.
Corporate Developments: Successful Type D meeting with FDA discussing accelerated approval pathway for RGLS8429.
On March 21, 2024, Regulus Therapeutics Inc (NASDAQ:RGLS) released its 8-K filing, detailing its financial results for the fourth quarter and year ended December 31, 2023, and providing updates on its clinical programs. Regulus Therapeutics Inc is a biopharmaceutical company dedicated to developing innovative medicines targeting microRNAs, with a focus on diseases such as cancer, metabolic diseases, fibrosis, and inflammatory diseases.
Financial Performance and Clinical Updates
Regulus Therapeutics Inc reported a net loss of $8.1 million, or $0.40 per share for the fourth quarter, which was wider than the estimated loss per share of $0.21. The net loss for the full year was $30.0 million, or $1.58 per share. Research and development expenses increased year-over-year, reflecting the company's continued investment in its clinical programs, particularly the RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The company highlighted significant advancements in its ADPKD program, including positive topline data from the second cohort of patients in the Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429. The treatment was well-tolerated, and the data suggested a potential impact on key biomarkers related to kidney volume and function. Enrollment for the third cohort was completed, with top-line data expected in mid-2024. A fourth cohort is planned, with an amended protocol to increase the sample size based on the results from the second cohort.
Regulus also reported a successful Type D meeting with the FDA to discuss an accelerated approval pathway for RGLS8429 based on a single pivotal Phase 2 study, with a post-marketing requirement to demonstrate improvement in estimated glomerular filtration rate (eGFR).
Financial Position and Outlook
The company's cash position was strengthened by an oversubscribed $100 million private placement, which is expected to extend its cash runway into the first half of 2026. As of December 31, 2023, Regulus had $23.8 million in cash and cash equivalents. General and administrative expenses were slightly up year-over-year, totaling $10.0 million for the full year.
Regulus Therapeutics Inc's commitment to advancing its clinical programs, coupled with a strengthened financial position, positions the company to continue its pursuit of novel therapies targeting microRNAs. The company's progress in the ADPKD program and the potential for accelerated approval pathway for RGLS8429 are particularly noteworthy as they may offer new hope for patients with this chronic kidney disease.
Investors and stakeholders will be watching closely for the mid-2024 data from the third cohort of the MAD study, which will be pivotal in determining the future of RGLS8429 and Regulus Therapeutics Inc's position in the biotechnology industry.
For detailed financial tables and further information, please refer to the full 8-K filing.
Regulus Therapeutics Inc continues to leverage its expertise in oligonucleotide drug discovery and development to advance a pipeline of microRNA-targeting medicines, maintaining its corporate headquarters in San Diego, CA.
For more in-depth analysis and updates on Regulus Therapeutics Inc and the biotechnology sector, stay tuned to GuruFocus.com.
Explore the complete 8-K earnings release (here) from Regulus Therapeutics Inc for further details.
This article first appeared on GuruFocus.
