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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 achievement of a $5 million milestone from its collaboration with Sanofi for the miR-21 programs, triggered by patient enrollment in the Phase 2 clinical study of RG-012 for Alport Syndrome. This funding will reduce the term loan with Oxford LLC to approximately $4.7 million and extend interest-only payments through 2021. The company previously reported positive trends in kidney disease markers from a Phase 1b study of RG-012, which has orphan designation in both the U.S. and Europe. Additionally, Regulus is eligible for another $25 million in 2023 upon reaching a development milestone.
Regulus Therapeutics (Nasdaq: RGLS) has initiated dosing in a Phase 1b clinical study of RGLS4326 for patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This study aims to assess safety, pharmacokinetics, and biomarker changes in up to three cohorts. The first cohort will consist of nine patients receiving RGLS4326 biweekly for six weeks, with results expected by the end of Q1 2021. Regulus aims to use these results to address FDA requirements for extended-duration studies. RGLS4326 targets microRNAs to elevate polycystin levels linked to ADPKD.
Regulus Therapeutics (Nasdaq: RGLS) announced the receipt of $5 million from Sanofi as part of milestone and material payments related to its miR-21 programs. The company utilized these funds to pay down its term loan to approximately $9.6 million. Regulus is eligible for additional payments, including $5 million upon achieving an interim milestone and $25 million for a development milestone. The loan agreement with Oxford includes provisions for an additional interest-only period if the company pays down another $5 million by April 30, 2021.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 11:00 AM EDT. This presentation will focus on the company’s innovative medicines targeting microRNAs. A live webcast will be available on the company’s investor relations website. Regulus specializes in oligonucleotide drug development and holds a robust intellectual property portfolio in the microRNA field.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the Wells Fargo Virtual Healthcare Conference on September 9, 2020, at 10:40 AM EDT. The event will be accessible via a live webcast on the company's website. Regulus focuses on developing medicines targeting microRNAs and possesses a robust intellectual property portfolio. The company is based in La Jolla, California.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced amendments to its loan agreement with Oxford LLC, allowing for up to seven months of interest-only payments if $10 million in principal is paid by April 30, 2021. Concurrently, the company restructured its agreement with Sanofi, resulting in a $1 million sale of materials and potential milestone payments totaling $9 million, with an additional $25 million milestone related to miR-21 compounds. CEO Jay Hagan expressed optimism about these agreements, which aim to ease financial pressures and extend operational flexibility.
Regulus Therapeutics (Nasdaq: RGLS) reported its Q2 2020 financial results, noting a net loss of $6.9 million, or $0.23 per share. Revenue was negligible, down from $6.8 million in Q2 2019. The company highlighted progress in its ADPKD program with the completion of the dosing for RGLS4326 in a clinical study. Additionally, RGLS4326 received Orphan Drug Designation from the FDA. The firm also announced advancements in its Hepatitis B program, where a lead compound demonstrated significant efficacy in preliminary studies.
Regulus Therapeutics Inc. (Nasdaq: RGLS) has announced that CEO Jay Hagan will present at the Wedbush PacGrow Healthcare Virtual Conference on August 12, 2020, at 2:20 PM EDT. Regulus focuses on innovative medicines targeting microRNAs, leveraging its expertise in oligonucleotide drug discovery. The company is based in La Jolla, California, and is actively engaged in preclinical and clinical studies, particularly with the RGLS4326 program. Forward-looking statements regarding its business, particularly amidst the COVID-19 pandemic, emphasize risks and uncertainties that could impact its operations.
Regulus Therapeutics (Nasdaq: RGLS) announced the appointment of Denis Drygin, Ph.D., as Chief Scientific Officer effective August 3, 2020. Dr. Drygin brings nearly 20 years of experience in drug discovery and development, previously serving at Pimera and Cylene Pharmaceuticals. CEO Jay Hagan expressed confidence in Dr. Drygin's expertise to enhance Regulus' innovative microRNA therapeutics pipeline. This strategic hire aims to strengthen the company's position in addressing high unmet medical needs in various indications.
Regulus Therapeutics (Nasdaq: RGLS) announced that the FDA has granted Orphan Drug Designation to its drug RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This designation offers significant benefits, including seven years of market exclusivity upon FDA approval, tax credits, and fee waivers. RGLS4326 is designed to inhibit miR-17 and targets the kidneys, demonstrating promising preclinical results in reducing cyst growth. A Phase 1b study for RGLS4326 in ADPKD patients is set to evaluate its safety and pharmacokinetics.
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