H.C. Wainwright maintains Buy on Regulus stock, $10 target

Friday, H.C. Wainwright analysts maintained a Buy rating on Regulus Therapeutics (NASDAQ:RGLS) with a steady price target of $10.00, significantly above the current trading price of $1.38. According to InvestingPro data, analyst targets for the stock range from $3 to $28, with a strong consensus recommendation of 1.5 (between Strong Buy and Buy). The firm’s analysts highlighted the company’s recent financial and clinical progress, particularly the positive interim results from a study of its drug candidate, farabursen.

On Thursday, Regulus Therapeutics disclosed its financial results for the fourth quarter and the full year of 2024. The company reported a net loss of $12.8 million, or $0.20 per share for the quarter, which was below the $14.7 million loss anticipated by H.C. Wainwright. The full-year net loss amounted to $46.4 million, or $0.82 per share. InvestingPro analysis shows the company holds more cash than debt on its balance sheet, though it’s quickly burning through cash reserves. With a current ratio of 14.14, the company maintains strong liquidity to meet its short-term obligations.

The company has also shared promising interim analysis from the fourth cohort in the ongoing Phase 1b multiple-ascending dose study of farabursen, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The fourth cohort included 26 subjects who were administered a fixed dose of 300 mg of farabursen biweekly for three months. The interim results of the first 14 subjects indicated a continued mechanistic dose response, as evidenced by the levels of urinary polycystins 1 and 2, and a significant reduction in the growth rate of height adjusted total kidney volume.

The effects of the 300 mg fixed dose on polycystin biomarker levels were reported to be similar to those seen in the third cohort at a 3 mg/kg dose, which is believed to achieve optimal kidney exposure and miR-17 inhibition. Moreover, exploratory conditional probability analyses suggest there is a high likelihood of the study meeting or surpassing the targeted efficacy threshold for htTKV.

Regulus Therapeutics has also confirmed that farabursen was well tolerated according to the complete safety data from all 26 subjects in the fourth cohort. The company’s management is preparing to announce topline data from the entire cohort in the near future. This anticipation of forthcoming data, coupled with the recent positive interim results, underpins H.C. Wainwright’s reiterated Buy rating and $10 price target for Regulus Therapeutics stock.

In other recent news, Regulus Therapeutics Inc . has reported significant progress in its clinical and regulatory efforts for its Autosomal Dominant Polycystic Kidney Disease (ADPKD) program. The company shared positive interim results from the fourth cohort of its Phase 1b Multiple Ascending Dose study for the investigational drug farabursen. This study, which is placebo-controlled and double-blind, aims to assess the safety and efficacy of farabursen in adult patients with ADPKD. Interim efficacy data from the first 14 subjects indicated a mechanistic dose response and a reduction in the growth rate of height-adjusted total kidney volume, a key measure of disease progression. The safety data demonstrated that the drug was well tolerated among participants. Regulus also successfully concluded an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), aligning on the components of a Phase 3 trial design. This upcoming pivotal study could potentially lead to Accelerated Approval, focusing on a 12-month endpoint for accelerated approval and a 24-month endpoint for full approval. CEO Jay Hagan expressed encouragement by the FDA’s feedback and the interim results, reinforcing the company’s conviction in farabursen’s potential for ADPKD treatment. Regulus plans to advance farabursen into a pivotal study later in the year.

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