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Regulus Therapeutics Inc. (NASDAQ: RGLS) is a pioneering biopharmaceutical company dedicated to discovering and developing novel medicines that target microRNAs. With a strong foundation in oligonucleotide drug discovery and development, Regulus has established a comprehensive pipeline of microRNA-based therapeutics and an advanced biomarkers platform known as MicroMarkersSM. The company’s intellectual property estate further solidifies its leadership in the microRNA field.
Regulus is at the forefront of developing innovative treatments for critical health issues. One of its significant projects includes RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 aimed at treating chronic hepatitis C virus infection. Another promising drug candidate is RG-012, which targets microRNA-21 for treating Alport Syndrome, a severe kidney disease driven by genetic mutations with no approved therapies currently available.
Moreover, Regulus, in collaboration with AstraZeneca, is working on RG-125, an anti-miR targeting microRNA-103/107 for treating non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes/pre-diabetes, which has already entered Phase I clinical development. Additionally, RGLS8429, an anti-miR next-generation oligonucleotide targeting miR-17, is in Phase 1b clinical development for treating autosomal dominant polycystic kidney disease (ADPKD).
Recently, Regulus reported positive topline data from the first and second cohorts of the Phase 1b MAD study of RGLS8429. The company has completed enrollment for the third cohort of this study, with topline data expected in mid-2024. The latest updates indicate the initiation of the fourth cohort in May 2024, focusing on a fixed dose of 300 mg of RGLS8429, which will provide further insights into its efficacy and safety.
Financially, Regulus is in a stable position, having recently raised $100 million through a private placement to institutional investors, extending its cash runway until the first half of 2026. For the quarter ended March 31, 2024, the company reported $107.7 million in cash and investments.
Regulus is committed to advancing its pipeline and bringing life-changing therapeutics to patients, with a particular focus on orphan kidney diseases. The company’s strategic collaborations and solid financial base are instrumental in driving its innovative research and development initiatives.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the appointment of Amin Kamel, Ph.D., as Vice President of DMPK, to enhance its clinical development efforts, particularly for RGLS8429, aimed at treating autosomal dominant polycystic kidney disease (ADPKD). Dr. Kamel's previous roles at Takeda and Biogen equip him with extensive expertise. As part of his compensation, he received an option for 200,000 shares at an exercise price of $0.29 per share, vesting over four years. This strategic hire is expected to bolster Regulus's upcoming Phase 1 clinical study.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 7:00 a.m. ET. An on-demand webcast will be accessible through the investor relations section of their website and archived for 90 days post-presentation. Regulus focuses on microRNA-targeted biopharmaceuticals and boasts a robust pipeline and intellectual property portfolio in this area. The company, headquartered in San Diego, is navigating various risks, including those presented by the COVID-19 pandemic, which may impact its operations and stock value.
Regulus Therapeutics (RGLS) announced FDA acceptance of the IND for RGLS8429 targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD), with a Phase 1 study set for Q2 2022. The company reported Q1 2022 financial results: cash position at $53.9 million, R&D expenses increased to $3.7 million, and G&A expenses at $2.9 million. Net loss was $6.7 million, or $0.05 per share. Upcoming milestones include top-line data from the healthy volunteer study in H2 2022 and ADPKD patient data in H1 2023.
Regulus Therapeutics Inc (Nasdaq: RGLS) announced that the FDA has accepted its IND application for RGLS8429, a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). This approval allows the company to move forward with its planned Phase 1 clinical study in healthy volunteers, slated for the second quarter of 2022. The study aims to evaluate the safety and pharmacokinetics of RGLS8429, with subsequent Phase 1b trials to assess its efficacy in ADPKD patients. Regulus anticipates initiating patient dosing in the latter half of 2022.
Regulus Therapeutics Inc. (Nasdaq: RGLS) will report its first quarter 2022 financial results on May 12, 2022, after market close. A live conference call and webcast will be held at 5:00 PM ET the same day to discuss these results and offer a corporate update. Investors can access the call by dialing (866) 652-5200 domestically. Regulus focuses on developing innovative medicines targeting microRNAs and holds a strong intellectual property portfolio in this field.
Regulus Therapeutics (RGLS) has announced the initiation of preclinical studies targeting miR-155 for the treatment of Amyotrophic Lateral Sclerosis (ALS), in collaboration with Brigham and Women's Hospital. This collaboration, established in September 2021, aims to explore the efficacy of miR-155 inhibitors in both in vitro and in vivo models of ALS. Preliminary data is anticipated in the second half of 2022. Research indicates that blocking miR-155 can positively impact ALS progression, highlighting the potential of these compounds as therapeutic candidates for this severe neurodegenerative disease.
Regulus Therapeutics Inc. (Nasdaq: RGLS) reported financial results for the fourth quarter and full year ending December 31, 2021. The company had a net loss of $7.1 million for Q4 and $27.8 million for the year, compared to $1.3 million and $15.7 million in 2020, respectively. Cash and cash equivalents stood at $60.4 million at year-end. Significant progress was made in their ADPKD program with RGLS8429, having completed a Pre-IND meeting with the FDA. The company closed a $34.6 million private placement in November 2021 to support clinical development activities.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a conference call to discuss its fourth quarter and year-end 2021 financial results, scheduled for March 10, 2022, at 5:00 PM ET. Subsequently, management will provide updates on its developments, including its RGLS8429 program. Regulus emphasizes its focus on innovative medicines targeting microRNAs while cautioning that forward-looking statements about clinical studies and potential impacts from COVID-19 may vary from actual results. Access details for the live call and a replay option post-event are provided.
Regulus Therapeutics Inc. (Nasdaq: RGLS) has completed enrollment in the Phase 2 HERA clinical trial for lademirsen, targeting Alport Syndrome, a genetic nephrology disease with no current treatments. Under a partnership with Sanofi, the study will evaluate safety and efficacy in adult patients. Final results are anticipated in the first half of 2023. Regulus is eligible for up to $35 million in milestone payments from Sanofi, with $10 million already received for prior achievements. This trial represents a significant step in developing treatments for kidney diseases.
Regulus Therapeutics Inc (Nasdaq: RGLS) announced that its CEO, Jay Hagan, will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 3:00 p.m. ET. A live webcast of the event will be available on the investor relations section of the Company's website, with a replay accessible for 90 days post-event. Regulus focuses on developing innovative medicines targeting microRNAs and possesses a robust intellectual property portfolio in this field, headquartered in San Diego, CA.
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