Today, let's look at three things investors should be watching regarding BioSante Pharmaceuticals, as they will provide us with better insight into the company.
1. LibiGel versus Bio-T-Gel
First and foremost, LibiGel is the most important product that BioSante Pharmaceuticals has in its pipeline, despite the fact that its Bio-T-Gel is FDA-approved (and LibiGel isn't). As the Fool's biotechnology guru Brian Orelli has shown, both drugs work toward similar goals in men and women, but both have vastly different outcomes and could mean the difference between a marginal boost and a huge boost for BioSante's bottom line based on who it's targeted toward.
Bio-T-Gel, which is approved to treat male hypogonadism (low testosterone) and is being marketed with Teva Pharmaceuticals
LibiGel, which targets sexual dysfunction in women, has practically no competitors. BioSante owns the rights to the drug outright, and it has to share only a small portion of its royalties with Antares Pharmaceuticals
In December, LibiGel failed two clinical phase trials after the placebo effect masked the effectiveness of the drug. BioSante has plans to run two additional clinical trials with solutions that should take care of this masking effect, but it will take considerable amounts of time and money in order to get to those results.
2. The pipeline beyond LibiGel
Although few investors seems to care, there actually are other approved and clinical-phase drugs in BioSante's pipeline that bear watching -- even if they aren't the primary focus.
One such drug, Elestrin, has been approved by the FDA for the treatment of menopause symptoms in women. The drug had been licensed out to Azur Pharma, but with Jazz Pharmaceuticals
BioSante also has an exciting line of GVAX cancer vaccines in various early-to-mid-stage trials. Its unique vaccines work by irradiating cells prior to injection to prevent cell division, but still allowing them to be metabolically active and able to release an immunostimulant. Of course, we have to keep in mind that small biotechs and cancer drugs have a very poor track record of gaining approval.
BioSante's final pipeline drug worth watching is Pill-Plus, which is an oral contraceptive product for women that showed statistically favorable results in phase 2 clinical trials. BioSante has licensed out marketing rights within the U.S. to Pantarhei Bioscience, but retains the rights everywhere else if approved.
3. Watch that cash burn
The final factor worth keeping an eye on is BioSante's dangerous cash burn rate, given the need to rerun two clinical trials for LibiGel, continue to develop its cancer vaccines and Pill-Plus, and pay for general corporate purposes.
As of the end of the second quarter, BioSante had just $42.4 million remaining in cash and had been burning through anywhere from $2 million-$3 million each month. The company has cut costs where it can to curb losses, but statistically the company cannot reach its goal of maintaining all of these trials without issuing more shares or selling its interests in some of these FDA-approved or developing drugs. In just the past two weeks, BioSante has filed a registered offering to raise up to $3.3 million in cash. This could be the first of many offerings as the company aims to shore up its balance sheet prior to beginning its next phase of clinical trials for LibiGel.
Now that you know what to watch for, it should be easier to analyze BioSante Pharmaceuticals' successes and failures in the future and hopefully give you a competitive investing edge.
If you're still craving even more info on BioSante Pharmaceuticals, I would recommend adding the stock to your free and personalized watchlist so you can keep up on all of the latest news with the company.
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Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on Motley Fool CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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