"I am proud of the significant progress we have made thus far in 2019 to reposition Regulus with a strengthened balance sheet, restructured term loan and reduced operating cash burn rate. Importantly, the team has maintained its focus in its engagement with FDA, and we look forward to resuming our ADPKD clinical program pending FDA alignment. We believe the total potential proceeds from the recent financing, highlighted by a strong investor syndicate, provides sufficient capital to fund planned activities into the second half of 2021," said Jay Hagan, CEO of Regulus. "We look forward to providing future updates on our ADPKD program, as well as further advancements from our promising preclinical pipeline"
They need to get RGLS4326 back into the clinic by the end of the year in order to access the second tranche of the financing which will see them through to 2021. Given that they submitted 13 week tox data back in January, and are still working with the FDA, I hope the delay is because the FDA has asked for 26 week data (which should already be available) and that the ADPKD will get back in the clinic the the second half of this year.
The other benefit of now having cash through 2021, is that they are in a less desperate negotiating position for the GBM and NASH programmes that they have said they want to partner. So hopefully we'll have some positive news on these programmes in the coming months too.