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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 (Nasdaq: RGLS) announced promising top-line results from the first cohort of its Phase 1b clinical trial for RGLS4326, targeting patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Involving nine patients receiving 1 mg/kg doses, the trial demonstrated the drug's safety, with no serious adverse events and mild, transient effects observed. Notably, a significant increase of over 50% in the biomarker Polycystin 1 was recorded. Data from this cohort will be presented at the upcoming Kidney Week in November 2021.
Regulus Therapeutics Inc (Nasdaq: RGLS) has completed dosing for the first cohort of nine patients in its Phase 1b clinical trial of RGLS4326, focusing on autosomal dominant polycystic kidney disease (ADPKD). This trial aims to assess safety and pharmacokinetics of RGLS4326, with results expected in the coming weeks. The study includes multiple cohorts with varying doses, and RGLS4326 has shown promise in preclinical models by regulating Pkd1 and Pkd2. Notably, the drug is currently under a Partial Clinical Hold by the FDA for extended duration treatment.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that Jay Hagan, President and CEO, will present at the 20th Annual Needham Healthcare Conference on April 15, 2021, at 1:30 P.M. ET. The event will focus on the innovative medicines targeting microRNAs developed by Regulus.
A live webcast will be accessible on the company's investor relations website, with a replay available for 30 days post-event.
Regulus Therapeutics (RGLS) reported Q4 and 2020 financial results, highlighting revenue of $5 million for the quarter and $10 million for the year, driven by milestones in their collaboration with Sanofi for RG-012. R&D expenses increased to $4 million and $15.3 million for Q4 and the year, respectively, due to ongoing development activities. The net loss narrowed to $1.3 million in Q4 and $15.7 million for the year, compared to higher losses in 2019. Regulus also completed a $19 million private financing and advanced its RGLS4326 program into Phase 1b for ADPKD.
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicines, announced that its CEO, Jay Hagan, will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. A replay of the on-demand presentation will be accessible from March 9, 2021, on their website for 30 days. Regulus focuses on innovative drug discovery, maintaining a robust pipeline and intellectual property in the microRNA sector, headquartered in La Jolla, CA.
Regulus Therapeutics (Nasdaq: RGLS) has completed the enrollment of the first cohort in its Phase 1b clinical trial of RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This open-label study evaluates safety and pharmacokinetics, with the first cohort receiving 1mg/kg of RGLS4326. Interim safety data has led to the first patient in the second cohort receiving their dose. No serious adverse events have been reported, and results from the first cohort are anticipated in early Q2 2021.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the appointment of Alice S. Huang, Ph.D., to its board of directors, effective January 27, 2021. In addition to her board role, she will serve on the Compensation Committee. Dr. Huang is a Senior Faculty Associate at the California Institute of Technology and has an extensive background in biology and biomedical research, having held significant positions at prestigious institutions. The company believes her expertise will enhance its drug discovery and development efforts.
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on microRNA-targeted medicines, will be presenting at the H.C. Wainwright Virtual BioConnect Conference from January 11-14, 2021. Jay Hagan, President and CEO, will lead the presentation. An on-demand webcast will be accessible starting January 11, 2021, via the investor relations section of Regulus' website. The company, headquartered in La Jolla, CA, emphasizes its expertise in oligonucleotide drug discovery and holds a strong intellectual property portfolio.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the closing of a private placement, raising approximately $19.4 million by selling 24,341,607 shares of common stock at $0.622 each. Additionally, 272,970 shares of non-voting Class A-3 convertible preferred stock were sold at $6.22 per share. The proceeds will primarily support the advancement of RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease and for general corporate purposes. H.C. Wainwright and Co. acted as the exclusive placement agent for this financing.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a definitive securities purchase agreement for a private placement expected to raise approximately $19.4 million from existing and new institutional investors. The financing includes the sale of about 24.3 million shares of Common Stock priced at $0.7158 per share, along with accompanying warrants. Additionally, 272,970 shares of non-voting Class A-3 convertible preferred stock will be sold at $6.22 per share. The closing is anticipated on December 3, 2020, pending customary conditions.
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