Regulus Announces $100 Mln Private Placement, Positive Data From Phase 1b MAD Trial Of RGLS8429

(RTTNews) - Tuesday, Regulus Therapeutics Inc. (RGLS) announced an oversubscribed $100 million private equity placement. Additionally, the company revealed positive results from the second cohort of patients in its Phase 1b Multiple-Ascending Dose or MAD Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease also known as ADPKD.

Following this news, the stock surged by 41% in the pre-market.

Regulus said that the oversubscribed financing includes participation from both new and existing institutional investors, including Adage Capital Partners L.P., Deep Track Capital, the Federated Hermes Kaufmann Funds, New Enterprise Associates, Octagon Capital, RA Capital Management, and Vivo Capital.

The company anticipates gross proceeds of about $100 million upon the completion of the financing around March 14, 2024, pending customary closing conditions.

As part of the securities purchase agreement, shares of the company were offered to investors at $1.60 per share, and a new class of non-voting Class A-6 convertible preferred stock was made available at $160.00 per share. Each preferred share can be converted into 100 shares of common stock, subject to specific beneficial ownership conversion limits.

The second cohort of RGLS8429 consisted of 14 patients who were randomly assigned to receive either 2 mg/kg of RGLS8429 or a placebo every other week for three months.

The results showed that RGLS8429 was well-tolerated with no safety concerns. A clear dose-response was observed at the 2mg/kg level based on urinary polycystins 1 and 2 (PC1 and PC2) levels, indicating greater biological activity compared to lower doses and the placebo, particularly after 3 months of dosing.

As a result of these promising findings, the third cohort will receive 3mg/kg of, while a fourth cohort will receive a fixed dose of 300 mg of RGLS8429 every other week for three months.

The data from the third cohort is expected in mid-2024, with screening for the fourth cohort set to begin in the second quarter of 2024.

In pre-market activity on the Nasdaq, the shares are trading at $1.95, up 41.30%.