4 Small Biotechs With Big Clinical Trials Presenting In 2013

by: Bio Insights

Here are a few small biotechs that are at vital stages in their clinical development process, and will provide some results this year. They are arranged in estimated chronological order, meaning that the most immediate catalysts/data releases are higher on the list.

1.) AEterna Zentaris (NASDAQ: AEZS) - the company stock shot up over 17% on Tuesday, January 29, 2013 in a buying spree that started right after the opening bell. While the company did not issue a press release or anything that is directly attributable to the actual jump, there was one article released on Seeking Alpha that pointed out that there may be renewed interest in AEZS based on the potential for good interim results for perifosine in a phase III trial for multiple myeloma.

Yes, we're talking about the perifosine - the same drug that murdered AEZS (and Keryx (NASDAQ:KERX)) in April 2012. Recall that the X-PECT trial, which was the phase III trial for perifosine in the treatment of metastatic colorectal cancer, failed to meet its primary endpoint and basically caused most people to think that perifosine was toast.

Well, that's not true, because AEterna Zentaris should be releasing a third party's interim analysis of the phase III trial before the end of this quarter (Q1 2013). While I'm not very optimistic about the end result of the perifosine program myself, it seems that there are a number of investors who now want to chase AEZS based on the notion that perifosine might end up as some sort of "sleeper-hit."

2.) Advaxis (NASDAQ:ADXS)

I haven't looked at this company in a while, although it's interesting to see how much this company has moved up since the start of the year.

Advaxis has an important clinical trial catalyst coming up in Q2 2013 (specifically in April). We will be seeing the completion of its phase II trial, which is studying the Listeria Vaccine in CIN 2+ patients. This is ultimately another treatment for cervical cancer that attempts to stop the mechanism by which human papilloma virus (HPV) causes cervical cancer.

I think that the company could definitely have another leg-up on solid results. It seems that recent buying interest in ADXS has been pushing shares up ahead of the release of this phase II cervical cancer trial.

3.) La Jolla Pharmaceutical Company (NASDAQ:LJPC) - I last mentioned this one on January 7th, when I was looking at a few of the many interesting cancer immunotherapy drugs in development. La Jolla's flagship product is GCS-100, which is the company's only compound in clinical development right now.

The compound targets a protein known as Galectin-3, which makes it a viable candidate for quite a few indications. La Jolla is developing it as a treatment for kidney disease, cancer immunotherapy, anti-chemotherapy, and as a supplementary treatment for renal transplantation. It's hard to tell which indication will garner the most interest this early on in clinical development, but I will personally be following its profile as a cancer drug most closely.

Recently, the company announced that the first patient has been dosed in the phase I/II trial for GCS-100 as a kidney disease treatment. This trial, if successful, will start to form an overall safety profile for GCS-100 and might draw some new interest towards the stock as a result (which could also provide some much-needed liquidity on this ticker).

Expect to see these results in Q3 2013.

4.) Venaxis (NASDAQ: APPY)

I recently took a look at Venaxis as well, which seems to have damaged the stock to some extent due to some skepticism I brought up. It's clear that a few longs got angry and thought I was attempting to bash the stock, but it's worth noting that its image is very fragile at this point and easy to disrupt. I implore shareholders to gauge the situation for APPY as they see fit.

Also, I had the opportunity to talk to company management to further discuss their strategy for their APPY1 diagnostic test for appendicitis which also ties in nicely to the company's upcoming Q3 2013 catalyst.

While the clearance situation for APPY1 with the FDA remains a bit shaky, it is good that APPY will go for progress in Europe. Venaxis aims to progress in that region very heavily for the next two quarters of 2013, and then we will see top-line results for a pivotal phase III trial that the company is conducting for the diagnostic test in Q3 2013 (according to estimates).

Another thing that was unmentioned in my last article was the price of the actual test - $80. Venaxis firmly believes that the price of the test will justify its potential to diagnose appendicitis (quickly).

Final Words

These companies all have catalysts that should drive the value of their stock this year.

Investors should be extremely careful with any investments in small biotech companies due to their extreme volatility in trading. These stocks are also much less liquid than larger companies, which makes them more suitable for long-term value investing rather than short-term scalping (something that I am very fond of myself) or intra-day trading.

Please do your own research on any company that you decide to invest in, but realize at the same time that huge risk means huge reward. It's also suggested that investors, if they decide to buy, should only bite off what they can chew.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.