Antibiotic resistance is a big deal, as you undoubtedly already know — and resistant strains of various cooties are becoming more and more of a problem, particularly in hospital settings where they seem to spread like wildfire among the sick, infirm and open-wounded, but elsewhere as well.
And the new wave of antibiotics is certainly making some fortunes as doctors look for new ways to fight these resistant bugs, and as the government in recent years has (belatedly) pushed on this oft-neglected part of the pharmaceutical research business — lots of big pharma companies stopped developing new antibiotics a decade or two ago, antibiotics in many ways became a victim of their own success when there seemed little additional profit to be wrung from that product category.
But now, of course, they’re back in the headlines — we need new antibiotics, and we need them now. The government has thrown drug developers a couple bones, in increasing the potential market for novel antibiotics and extending their patent life, and that has helped to make the investment case stronger… even if the market wasn’t obviously growing, as it is, thanks largely to overuse of antibiotics breeding ever more resistant strains of bacteria.
So that’s the context of the latest pitch for Stansberry Venture from Dave Lashmet — he recommended two biotech companies in this area last year that were bought out, Durata Therapeutics and Cubist, and he thinks he’s got another one that stands a good chance of a buyout later this year. Does he provide us with enough clues to tell you which company it is? Well, let’s see… here’s how he piques our interest:
“Phase 2 Showed 100% Success Rate
“Phase 3 Results Expected in 90 Days…
“One tiny firm set to explode….
“An announcement is scheduled for the middle of this year that will change the lives of millions of people… Including — most likely — your own.
“The announcement concerns the final clinical trial results of a drug so revolutionary, it’s the only one of its kind — and promises to cure a disease that kills more people than HIV and tuberculosis combined…
“This disease is caused by a class of pathogens that the Director of the U.S. Centers for Disease Control (CDC) says could ‘devastate our economy’ … and kill millions….Are you getting our free Daily Update
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“For Americans, and people all over the world, the release of this drug could be as monumental as the discovery of penicillin.
“And for investors, it could mean a windfall…
“Because once the drug’s final clinical trial results are announced, I believe one of the largest pharmaceutical companies in the world is going to swoop in and buy this tiny drug maker to get its hands on the valuable drug they’ve developed…”
There’s quite a bit in the ad about the threat of “superbugs” and antibiotic-resistant bacteria, I won’t go into all of it but you can always check out the ad yourself if you like.
There is, however, more than one smallish biotech firm developing new antibiotics — and even more than one that will likely be releasing Phase III data this year. So which one is he talking about? Let’s see if we can sniff out any further clues:
“We must buy into this tiny firm before the phase 3 results are announced – which could be in a matter of weeks.
“I’ve tracked the final trial’s completion date — and all testing should already be finished.
“All that’s left is for the small drug maker to compile its data and announce to the world if its potentially life-saving drug is a proven success…”
OK…. that’s not enough. Anything else we can scare up in this long ad?
“I expect we have about nine weeks… But we might have just a few short days or weeks before the results are made public….
“It’s a tiny startup, and consists of about 50 employees, most of them scientists….”
And then a bit about where they are in clinical trials…
“the results show that this tiny firm’s drug is working 30% better than the ‘standard of care’ in one of its Phase 3 studies.
“So from that perspective, the drug is already a success.
“The only thing we don’t know is if the drug works as a pill…
“See, the Phase 3 clinical trial for this drug was split into different studies to measure two objectives. First, to evaluate an intravenous (IV) version of the drug that’s already shown excellent results, and second, to explore the potential for a pill form of the drug.”
There are a number of relatively small, near “pure play” companies who are somewhere in the process of Phase III trials for new antibiotics (either just starting them or near completion), including Achaogen (AKAO), Cempra (CEMP) and Paratek (PRTK), but if we’re focusing on the likelihood of meaningful data in the next few months, and a planned filing for approval sometime in 2015, I agree with our reader who posted a guess yesterday: this is most likely Tetraphase Pharmaceuticals (TTPH), which is developing a drug called eravacycline.
The shares of TTPH more than doubled in 2014, and they took advantage and raised a lot of money — in two tranches, the first in October and a larger second offering, at $35, just last week — so they are flush with cash, close to $300 million probably now (and a market cap closing in on $1.2 billion — the numbers in places like Yahoo Finance won’t reflect the latest money raise just yet), and they also may be eligible for additional funding from government antibiotic-spurring programs… so they’re not going to run out of money anytime soon (even in Phase III trials, they’ve only been burning through $20 million or so per quarter).
So far in 2015 the stock has been fairly flat — plenty of volatility, like almost every biotech stock, but it’s still in the mid-$30s where it started the year. They did release the positive Phase III topline results for eravacycline back in December, which helped to complete that spectacular year for the stock — that trial was IGNITE 1, for Eravacycline in Complicated Intra-abdominal Infections. The second Phase III trial top line results, for a combination of IV and oral treatment of complicated urinary tract infections (“iv-to-oral,” specifically — a more convenient dosing regimen), are expected “mid year” — though they’ve also said that they anticipate releasing “lead-in data” from that trial at a conference in April (the conference is 4/25-28), so perhaps there’s some anticipation that meaningful information will squeak out then. And yes, they do have about 55 employees as of the last report — so they’re not big enough to commercialize and sell the drug on their own, most likely, but with $300 million in cash they may have options beyond just selling out to big pharma.
And that’s all I can tell you — I’m not 100% certain this is the stock Dave Lashmet is teasing for his Stansberry Venture, but it’s the best match I’ve found for the somewhat squishy clues. I am not much of a biotech investor, personally, and I don’t have a handle on the market for novel antibiotics or what kind of sales and earnings might eventually be generated — Dr. KSS, who leads biotech discussions among the irregulars and has written quite a bit about new antibiotics, has noted TTPH only briefly in the past — he wrote early last year that he expected approval for eravacycline, too, but was not particularly excited about the opportunity for wide use and a financial windfall — but that may not be his current opinion.
So I’ll leave it there for you, feel free to suggest if you think I’m wrong on this guess — and no, I don’t usually like to give you a ticker symbol when I’m not certain — and I’ll leave it to the many wiser minds than mine to discuss or dig into the actual drug and its prospects. The company itself is well-capitalized, likely to file for FDA approval by the end of the year, and already valued at over a billion dollars. Over to you, friends.