Regulus Therapeutics Dips After Warning Of Drug Development Delays

Shares of Regulus Therapeutics (RGLS) fell Wednesday after the company reported third quarter results, which included news of several delays in its drug development efforts.

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QUARTERLY RESULTS, DEVELOPMENT DELAYS: After the market close Tuesday, Regulus reported a Q3 loss per share of (37c) on revenue of $204,000, as compared to estimates of (40c) and $1.2M. Research and development spending rose about 33% from the prior year quarter to $14.6M, while the company's cash position dipped to $91.7M from $108M at June 30. Notably, Regulus also revealed that, "in order to address study design comments from European regulators," it will be temporarily shifting its RG-012 program to an interim study in healthy volunteers before continuing the drug's Phase 2 trial in Alport syndrome. The company said it expects the new study to be completed in 1H17, and now sees interim results from the Alport study in 1H18. Regulus also provided an update on the clinical hold for RG-101, saying that "based on the completion of additional mechanistic preclinical studies," it now expects a response from the FDA in 1Q17. The company had previously forecast submitting its response to the clinical hold by early Q4 and receiving an FDA reply within 30 days.

MANAGEMENT COMMENTARY: On the company's conference call Tuesday, Regulus executives said, "Recently, while in the process of expanding the study to our European sites, we received feedback from European regulators on the HERA study design. Based on this feedback, we've decided to implement a four-week multiple ascending dose, or MAD, study in healthy volunteers... We anticipate results from the MAD study in 1H17 at which time we plan to resume enrollments in HERA." Explaining the clinical hold delay, the company said, "Since the receipt of the letter detailing the request for additional data and analyses, we had initiated additional mechanistic work, the data of which we now believe will enhance the package we plan to submit. Furthermore, we've been formulating a plan that may provide a path forward. Based on the timing of the results of these additional studies, which we intend to include in our response, we pushed out our resubmission timeline several weeks and thus we'd now expect a response from the agency in 1Q17."

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