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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 the successful completion of a pre-investigational new drug (Pre-IND) meeting with the FDA regarding its compound RGLS8429, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The FDA approved the trial design and dosing plan, allowing Regulus to submit an IND application in Q2 2022 for a Phase 1 clinical trial. The study will assess the drug's safety, tolerability, and dose response in healthy volunteers and ADPKD patients, with expected data releases in 2022 and 2023. The company also secured $34.6 million in funding to support this clinical development.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that Jay Hagan, President and CEO, will present at the H.C. Wainwright Virtual BioConnect Conference from January 10-13, 2022. An on-demand webcast will be available on January 10, 2022, at 7:00 a.m. ET. The presentation will focus on the company's innovative medicines targeting microRNAs. The webcast will be accessible via the investor relations section of their website, with a replay archived for 30 days.
Regulus, headquartered in San Diego, CA, has developed a robust pipeline and holds significant intellectual property in the microRNA domain.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the appointment of Mohammad Ahmadian, Ph.D., as Vice President of Chemistry and Pharmaceutical Development. Dr. Ahmadian brings over 20 years of experience in drug discovery, particularly in oligonucleotides, and will oversee the R&D of drug candidates, including RGLS8429 for autosomal dominant polycystic kidney disease (ADPKD). He was previously at Kinovate Life Sciences, focusing on operations and quality control. Alongside his role, he received an option to purchase 200,000 shares at $0.36 each, vesting over four years.
Regulus Therapeutics (Nasdaq: RGLS) presented at the first annual Rare & Genetic Kidney Disease Drug Development Summit, highlighting its research on microRNAs (miRs) for treating genetic kidney diseases. The Company reported a 58% and 38% increase in biomarkers PC1 and PC2 in ADPKD patients following treatment with its drug RGLS4326. Regulus is prioritizing its second-generation miR-17 inhibitor RGLS8429, with a pre-IND meeting scheduled with the FDA in December 2021, aiming for IND submission by Q2 2022.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the successful completion of a private equity placement, raising approximately $34.6 million. This was achieved by selling about 58.9 million shares of common stock at $0.36 per share and 3.7 million shares of non-voting convertible preferred stock at $3.60 per share. The proceeds will support non-clinical and clinical development activities. The financing was facilitated by SVB Leerink as the lead placement agent and H.C. Wainwright as co-placement agent.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a private placement financing led by Federated Hermes Kaufmann Funds and New Enterprise Associates, aiming to raise approximately $34.6 million. This financing involves the purchase of about 58.9 million shares of common stock at $0.36 per share and 3.7 million shares of non-voting Class A-4 convertible preferred stock at $3.60 per share, convertible into common stock. The closing is expected around November 30, 2021, pending customary conditions.
Regulus Therapeutics (Nasdaq: RGLS) reported its Q3 2021 financial results on November 10, 2021. The company had $35.8 million in cash as of September 30, 2021, with net losses of $8.6 million for the quarter. Regulus is focusing on the development of RGLS8429 for ADPKD, having discontinued RGLS4326 due to its limitations. A pre-IND meeting with the FDA is expected in December 2021, with clinical development anticipated in Q2 2022. The company reported increased R&D expenses of $5.9 million for the quarter, up from $4.0 million the previous year.
Regulus Therapeutics Inc. (RGLS) announced it will report its financial results for Q3 2021 on November 10, 2021, after market close. A conference call and webcast will also be held on the same day at 5:00 PM EDT. The call can be accessed domestically at (877) 257-8599 or internationally at (970) 315-0459, with a replay option available. The company focuses on microRNA-targeted medicines and notes potential risks affecting its business, including impacts from the COVID-19 pandemic.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a strategic focus on RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). Following the completion of IND-enabling toxicity studies, the firm plans to submit an Investigational New Drug (IND) application and has scheduled a Phase 1 study in Q2 2022, subject to FDA approval. The decision stems from recent data suggesting RGLS8429's improved pharmacological profile and absence of negative CNS effects previously seen with RGLS4326. Initial biomarker data is expected in early 2023.
Regulus Therapeutics (Nasdaq: RGLS) announced that its director, David Baltimore, Ph.D., received the 2021 Lasker-Koshland Special Achievement Award for his significant contributions to virology, immunology, and cancer. This prestigious award celebrates advances in medical science and highlights the importance of public support for research. The CEO, Jay Hagan, praised Dr. Baltimore's extensive work and its influence on biotechnology and public health, including his role during the AIDS crisis. Regulus continues to benefit from his guidance in advancing its pipeline of microRNA therapeutics.
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