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Regulus Therapeutics Inc.

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Msg  564 of 575  at  12/16/2019 8:28:28 AM  by

Steve_382


A little good news today.

 
 
 

Regulus Plans to Re-Initiate Clinical Studies in Q1 2020

$25.1 Million Achieved">Milestone for Second Tranche of Private Financing of Approximately $25.1 Million Achieved

Dec. 16, 2019 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced the U.S. Food and Drug Administration ("FDA") has lifted the Partial Clinical Hold on the Company's Phase 1 multiple ascending dose clinical study of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (ADPKD) (the "MAD study").  The Company plans to recommence the MAD study in the first quarter of 2020. With the Partial Clinical Hold on the MAD study lifted, the Company is also planning to enroll patients with ADPKD in an additional short-term dosing study in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity as part of its comprehensive Phase 1b program.  ">LA JOLLA, Calif., Dec. 16, 2019 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced the U.S. Food and Drug Administration ("FDA") has lifted the Partial Clinical Hold on the Company's Phase 1 multiple ascending dose clinical study of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (ADPKD) (the "MAD study"). The Company plans to recommence the MAD study in the first quarter of 2020. With the Partial Clinical Hold on the MAD study lifted, the Company is also planning to enroll patients with ADPKD in an additional short-term dosing study in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity as part of its comprehensive Phase 1b program.

Regulus Therapeutics Inc. Logo

As previously disclosed, FDA outlined the Partial Clinical Hold in two parts: certain requirements to re-initiate the MAD study and additional requirements to support studies of extended duration. In November 2019, the Company provided its complete response to the Partial Clinical Hold in order to recommence the MAD study. The FDA subsequently notified the Company of its decision to lift the Partial Clinical Hold on the MAD study. Information from the clinical studies together with information from additional nonclinical studies will be used to address the requirements to support studies of extended duration.

"We appreciate the productive dialog with FDA throughout this process," stated Jay Hagan, CEO of Regulus. "Next year will be pivotal for the Company in generating important safety, PK, and PD data on RGLS4326, as well as advancing other programs in our pipeline."

$25.1 million. The additional non-voting preferred stock will be sold at a price per share of $10.80 in the event the volume-weighted average price per share of Common Stock on Nasdaq ("VWAP") during the five full trading days following this announcement (the "5 Day VWAP") is at least $1.08.  In the event the 5 Day is less than $1.08, the price per share of the additional non-voting preferred stock will be the 5 Day VWAP  multiplied by 10 (each share of non-voting preferred will be convertible into 10 shares of common stock). If the 5 Day VWAP is less than $0.50, the Milestone Closing will not occur.  The Company expects the Milestone Closing to be completed later this month.  The Company believes the proceeds from the Milestone Closing, along with its existing cash, will be sufficient to fund currently planned operations into mid-2021.">As outlined in the May 2019 securities purchase agreement among the Company and the purchasers named therein (the "Purchase Agreement"), this announcement, which follows the unanimous resolution of the Company's Board of Directors to recommence the MAD study, triggers the second closing under the Purchase Agreement (the "Milestone Closing"). At the Milestone Closing, the purchasers will purchase, in a private placement transaction, shares of non-voting convertible preferred stock and accompanying warrants to purchase shares of Common Stock having an aggregate purchase price of approximately $25.1 million. The additional non-voting preferred stock will be sold at a price per share of $10.80 in the event the volume-weighted average price per share of Common Stock on Nasdaq ("VWAP") during the five full trading days following this announcement (the "5 Day VWAP") is at least $1.08. In the event the 5 Day is less than $1.08, the price per share of the additional non-voting preferred stock will be the 5 Day VWAP multiplied by 10 (each share of non-voting preferred will be convertible into 10 shares of common stock). If the 5 Day VWAP is less than $0.50, the Milestone Closing will not occur. The Company expects the Milestone Closing to be completed later this month. The Company believes the proceeds from the Milestone Closing, along with its existing cash, will be sufficient to fund currently planned operations into mid-2021.

 


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565 Re: A little good news today. Steve_382 0 12/16/2019 10:22:16 AM






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