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Regulus Stock Plunges on Cash Concerns Despite Restructuring


Regulus Therapeutics Inc.’s RGLS shares plunged 52% on Jul 6 following the announcement of drastic restructuring initiatives to extend its cash runway. Although the plans announced are expected to save $20 million annually and support the company’s operations till mid-2019, investors remain skeptical about the company’s cash position and are wary of its pipeline progress.

The company announced that it has stopped recruitment of patients in a phase II study of its lead candidate, RG-012, which is being evaluated for Alport Syndrome. Preliminary data from first patient evaluated in the RG-012 study showed encouraging results.

Although the results were positive, the company probably stopped recruiting due to lack of funds. Moreover, a failed discussion with Sanofi SNY will significantly impact Regulus’ financing options and will require the latter to look for new financing options.

It also paused a phase I study on another pipeline candidate, RGLS4326, following unfavorable results.

Shares of Regulus have declined 66.3% so far this year against the industry’s gain of 5.2%.

In order to preserve cash for a longer period, in addition to pausing recruitment activities in all clinical studies on RG-012 in Alport syndrome, Regulus is currently in discussion with Sanofi to restructure their partnership. The company also said it will reduce its workforce by 60% to focus on its pre-clinical research efforts on Hepatitis B virus (“HBV”) programs. The company is looking for partners for the rest of its pre-clinical research programs.

Investors are also skeptical about Sanofi’s willingness to continue the partnership. In March, Sanofi declined to opt into development of Alnylam Pharmaceuticals’ ALNY RNAi candidate, lumasiran, in spite of its clear efficacy and Breakthrough status.

Meanwhile, the voluntary stalling of the early-stage multiple ascending dose study for RGLS4326, evaluating it in autosomal dominant polycystic kidney disease along with RG-012 study, has effectively left Regulus with active pre-clinical candidates only.

Investors will remain focused on discussion updates with Sanofi and data from investigative studies on RGLS4326 initiated after consultation with the FDA.

Zacks Rank & Stock to Consider

Regulus currently carries a Zacks Rank #3 (Hold). Ionis Pharmaceuticals, Inc. IONS is a better-ranked stock in the same space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ionis’ loss estimates have narrowed from 13 cents to 4 cents for 2018 while earnings estimates for 2019 increased from 5 cents to 35 cents in the past 60 days. The company delivered positive earnings surprise in two of the trailing four quarters with an average beat of 16.48%.

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