Thursday, June 4, 2015

What to Watch for in RG-101 Post Regulus Therapeutics Executive Departures

As you will probably know already, Regulus Therapeutics surprised us this week with the sudden departures of both their CEO and CSO.  These two individuals also happened to be the insiders selling major positions in the stock earlier this year just days ahead of critical data to be released on their lead clinical candidate, RG-101 for the treatment of HCV ('Reading the tea leaves on Regulus insider sales').

While this would be a good reason for what looks like a sacking of the company’s two key executives (especially since the exodus came as a pair), for investors the all-important question is whether it is also related to bad news that we do not know about yet.  Most importantly, does this also have anything to do with the failure to report the viral resistance analysis which had been promised to us for the EASL meeting in April?

It is this analysis that will determine whether the miR-122 inhibitor can facilitate 4-week treatment regimens which must be the goal for this asset.  This is because RG-101 is the only serious long-acting agent out there in the HCV drug development arena and 4 weeks of oral, short-acting antivirals do not seem capable of getting rid of the virus. 

If there was no resistance to RG-101, based on the available data RG-101 given on week 4 would add ~6 weeks to deep viral suppression to the treatment regimen, in a way resembling a 10-week oral regimen which have much higher odds of viral clearance.  If viral resistance (and not waning drug levels as I am assuming) played a role in the rebounds seen in the single-dose study, then this would not necessarily be the case.  I say ‘not necessarily’ because even then, the risk of developing viral resistance to RG-101 should be much lower when given in combination with other agents as is the plan.

Take-home: I remain cautious (but not short any more) prepared to take advantage of another bout of panic selling that could come with the release of the resistance analysis.  The quality of the new leadership to lead the exciting microRNA platform will also indicate whether Regulus can finally live up to its original promise.  Long-term, whether precipitated by the insider sales or not, the changes should be good as morale at the company from what I can tell had been low.

PS: in more positive news, Regulus Therapeutics today reported that a first-in-man study with their second most advanced microRNA Therapeutic, RG-012 for the kidney-related orphan disease Alport Syndrome, has begun dosing.


Anonymous said...

Thanks very much for your comments. Kleanthis did leave a bad taste.

Anonymous said...

Kleanthis should be in leg irons and getting reamed up the kornhole by Bubba - his 6 ft. 8 - 425 lb cellmate

PfizerSloth said...

If MRK branded Moderna is to become the gatekeeper of mRNA, then where is PFE's cut of the pie? lol

Anonymous said...

Mr. X has left RGLS to pursue, what he must consider as better than staying at RGLS on a sky high salary with options for millions of dollars more if the science proves itself, investment opportunities in the biotech space.

That can tell us several things. One, that RGLS is not a good investment in his opinion and he has scarpered while the money was there to take and before the market gets wind of what it is he knows. The reasons for RGLS being a bad investment are probably many fold. Not the least being IP ownership.

Or two, that mRNA isn't all that and the breakthrough lies elsewhere.

The third and more likely is, that the biggest boom in life sciences is about to get underway and he wants to take his loot and grow it exponentially instead of the company from a position of anonymity because at the root of it all he is looking after himself first before anyone else.

To allege he was sacked because of insider trading is misleading. For goodness sake, why would the company issue stock and options if they did not expect them to be sold at some stage? The company could've requested they be put in escrow to ensure these sales didn't happen as a condition of issuance. The perception of what Dirk is alleging is all too easy to jump to otherwise.

And as the other comment touched on, where is the governance? They must have some.

The logical conclusion to this event is Dirk's conclusion is all too simple and convenient. Making it most likely contrived or naïve. Mr. X will be acting in a perfectly rational way given the information he has.

Dirk Haussecker said...

You leave out Mr. Y and what he had in common with Mr. X

PfizerSloth said...

Read didn't want either of them. Where's Art Krieg at this days?

Anonymous said...

Benitec to reverse into RGLS. Peter French to take the helm. The giveaway was Mr. X talking about sandwiches on CNBC and Dirk showing a Bacon Lettuce Tomato sandwich on his blog about RGLS.

It's the right fit. Right IP. Right people.

By Dirk Haussecker. All rights reserved.

Disclaimer: This blog is not intended for distribution to or use by any person or entity who is a citizen or resident of, or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would subject the author or any of his collaborators and contributors to any registration or licensing requirement within such jurisdiction. This blog expresses only my opinions, they may be flawed and are for entertainment purposes only. Opinions expressed are a direct result of information which may or may not be accurate, and I do not assume any responsibility for material errors or to provide updates should circumstances change. Opinions expressed in this blog may have been disseminated before to others. This blog should not be taken as investment, legal or tax advice. The investments referred to herein may not be suitable for you. Investments particularly in the field of RNAi Therapeutics and biotechnology carry a high risk of total loss. You, the reader must make your own investment decisions in consultation with your professional advisors in light of your specific circumstances. I reserve the right to buy, sell, or short any security including those that may or may not be discussed on my blog.