Exhibit 99.1

 

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Regulus Therapeutics Reports Second Quarter 2019 Financial Results and Recent Updates

Closing of First Tranche of $41.8 Million Private Placement of Equity

Term Loan Restructured Providing Up to Two Years of Interest Only and Extended Maturity Date to May 2022

Data Requirements Defined to Reinitiate Multiple Ascending Dose and Chronic Dose Studies with RGLS4326

Appointment of Cris Calsada as New Chief Financial Officer

LA JOLLA, Calif., August 8, 2019 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today reported financial results for the second quarter ended June 30, 2019 and provided a summary of recent events.

“With the completed financing and restructuring of our term loan, we believe we are in a good position to work expeditiously to address the clear requirements outlined by FDA to reinitiate the MAD clinical study for RGLS4326”, said Jay Hagan, CEO of Regulus. “We will also be evaluating potential options to initiate single dose studies in order to further characterize the molecule.”

Second Quarter 2019 Corporate Highlights and Recent Updates

 

   

Private Financing: In May 2019, the Company closed the first tranche of its $41.8 million private placement of equity (the “Private Placement”). The Company received net proceeds of approximately $15.7 million from the first tranche, after deducting placement agent fees and other offering expenses. Subject to the Company’s public announcement on or before December 31, 2019 of its plan to recommence the Phase 1 multiple ascending dose (“MAD”) clinical trial for RGLS4326 based upon correspondence from the United States Food and Drug Administration (“FDA”), the investors who purchased securities in the first tranche of the Private Placement have agreed to purchase shares of non-voting convertible preferred stock and accompanying warrants to purchase shares of common stock in a second closing (the “Milestone Closing”). If the Milestone Closing occurs, the gross proceeds to the Company from that closing will be approximately $25.1 million. The Company expects to use the proceeds from the Private Placement primarily to advance RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”), to advance select programs from its pipeline of microRNA therapies and for general corporate purposes. Excluding any potential proceeds from the Milestone Closing, the Company believes it has sufficient cash to fund operations into mid-2020.

 

   

Term Loan Amendments: In May 2019, and concurrently with the Private Placement, the Company amended its Term Loan with Oxford Finance to provide a new twelve-month period of interest-only payments, commencing May 2019, and a two-year extension of its maturity date from June 2020 to May 2022. Upon the closing of the second tranche of the Company’s Private Placement, the Company will receive an additional twelve-month period of interest-only payments, commencing May 2020.

 

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The following information was filed by Regulus Therapeutics Inc. (RGLS) on Thursday, August 8, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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