For Rucaparib, the effect was most notable in ovarian cancer, where there was an 89% clinical benefit to patients. In early studies of CO-1686, three of the four patients with the T790M resistance mutation demonstrated a partial response.
While certainly exciting, to believe that Clovis Oncology Inc (NASDAQ:CLVS) is worth anywhere near $2 billion is downright absurdity! This is a company whose most advanced drug, CO-101, failed to provide a statistical benefit in mid-stage metastatic pancreatic cancer trials in November and had to essentially start from scratch. Realistically, we’re probably looking at two or three more years of losses and cash burn from Clovis Oncology Inc (NASDAQ:CLVS) before Rucaparib, assuming that all the stars align and the data continues to impress, has a shot of adding sales to Clovis’ top line.
As of its most recent quarter, Clovis had nearly $130 million in cash, but I anticipate that it could burn through this entire amount over the next 18 months. This means that share dilution could be on the way unless Clovis finds a four-leaf clover in the form of an early-stage licensing partner. Following this week’s run, I wouldn’t be shocked to see a secondary offering filed later this week or early next week. Needless to say, this is prime short-sale material.
Regulus Therapeutics Inc (NASDAQ:RGLS)
Since presenting at the Deutsche Bank Healthcare Conference two weeks ago, shares of Regulus Therapeutics Inc (NASDAQ:RGLS) have been absolutely on fire. A mixture of ASCO and IPO fever have revived the love for newer issues, and having big name pharmaceutical companies gobbling up a majority of its IPO’d shares certainly helps its cause.
On paper, Regulus’ microRNA technology and oligonucleotide database are intriguing and border on some very cool research possibilities. As an investment, however, where “cool” doesn’t come into play, Regulus Therapeutics Inc (NASDAQ:RGLS) is a vampire company bound to suck the blood right out of investors if they dare invest at these levels.
The concern I have with Regulus Therapeutics Inc (NASDAQ:RGLS) is that its entire pipeline is purely based on preclinical studies with no interest in filing for an investigational new drug application until at least next year. This means that regardless of how many preclinical studies are under way, Regulus is going to be burning cash at an extraordinary rate for the foreseeable future.
Another head-scratcher is the company’s preclinical hepatitis-C treatment known as miR-122. It’s an intravenous treatment, partnered with GlaxoSmithKline plc (ADR) (NYSE:GSK), that’s only now in preclinical trials. Perhaps someone should alert Regulus Therapeutics Inc (NASDAQ:RGLS) that it shouldn’t waste its time as Gilead Sciences, Inc. (NASDAQ:GILD)‘ oral Sofosbuvir cleaned up in all four of its late-stage hep-C trials with a favorable safety profile, and is currently under review by the FDA. With oral medications under development for years, what incentive do patients have to go back to an intravenous treatment?
It’s questions like these that have me worried about Regulus’ long-term viability as a publicly traded company. While I wouldn’t write it off just yet, I also don’t feel its recent run is anywhere near warranted and would suggest a possible short sale of the company.
