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Summary

  • Biota Pharmaceuticals: Phase 2 trial of Laninamivir Octanoate for the treatment of influenza in adults.
  • Inovio Pharmaceuticals: Phase 2 VGX-3100 DNA vaccine delivered by electroporation.
  • Athersys: Phase 2 Ulcerative Colitis.

When it comes to small/mid size biotech companies, it's no secret clinical data is king, often pushing the stock prices to new highs upon positive results. Biota Pharmaceuticals (NASDAQ:BOTA), Inovio Pharmaceuticals (NYSEMKT:INO) and Athersys (NASDAQ:ATHX) will all be expecting to report top-line phase 2 data by mid 2014. These clinical catalysts will set out to validate the companies' science and approach. Top-line phase 2 data often plays a crucial role in determining whether a trial will carry on into phase 3 or not. Let's take a look below at each company's phase 2 trial.

Biota Pharmaceuticals

Biota Pharmaceuticals is a company focused on the treatment of serious and life threatening infectious disease. Top line phase 2 data expected mid-year is for the trial referred to as "IGLOO". The trial is designed to compare the safety and efficacy of 40 mg and 80 mg of LANI with placebo delivered by a TwinCaps inhaler in adults with presumed influenza A or B infection. In 2011 Biota was awarded a contract from the Biomedical Advanced Research and Development authority (BARDA). The contract provides financial support to complete the clinical development of laninamivir octanoate for the treatment of influenza A and B infections in the U.S. market. The World Health Organization estimates that annual influenza epidemics around the world cause between three and five million cases of severe illness, and between 250,000 and 500,000 deaths every year. According to ClinicalTrials.gov, final data collection date for primary outcome measure is March 2014. For more information on the trial, see here: Efficacy and Safety Study of Laninmarivir Octanoate Twin Caps.

Inovio Pharmaceuticals

Inovio Pharmaceuticals is a company set on revolutionizing vaccines for cancer indications and infectious disease. Inovio uses an approach of synthetic DNA vaccines delivered by electroporation. Shareholders experienced large gains in 2013 due to a string of successful preclinical and phase 1 results coupled with a partnership from big pharma giant Roche (RHBBY). VGX-3100, Inovio's flagship product, is a therapeutic cervical dyplasia DNA vaccine designed to treat pre-cancerous cervical dysplasias and cervical cancers. The vaccine is delivered by Inovio's Cellectra electroporation device. Efficacy and immunogenicity data will be reported mid-year 2014. Results for this phase 2 trial have long been anticipated by investors and those in the medical community, and happens to be Inovio's largest catalyst to date. Positive results on the trial will go a long way in validating the company's extensive pipeline of synthetic DNA vaccines. VGX-3100 has the potential to be a blockbuster cancer vaccine franchise with indications already being studied for cervical cancer, head/neck cancer, and anogenital cancer. Based upon results of the phase 2 trial, Inovio will be seeking orphan designation on the vaccine and its potentially wide reaching cancer indications are being explored. If all goes well, Inovio's potential gains in 2014 might just dwarf the bullish year investors experienced in 2013. For more information on the trial, see here: VGX-3100 SynCon.

Athersys, Inc.

Athersys is a clinical-stage biotechnology company developing novel proprietary therapies designed to extend and enhance the quality of human life. Athersys' focus is on the treatment of medical conditions where there is significant unmet clinical need. Athersys' phase 2 trial for Ulcerative Colitis is being conducted by its partner Pfizer (NYSE:PFE). Initial results from this double blind, placebo-controlled trial are expected by early May with additional results expected later in the second quarter. Positive results will be seen as validation of the MulitStem Platform. Arthersys' MultiStem platform consists of a special class of human stem cells that have the ability to express a range of therapeutically relevant proteins. For a more in depth look into the MultiStem platform, a well summarized article by Seeking Alpha author U.S. Biotech Investor published Jan. 22, 2014 provides a thorough breakdown, and I encourage those interested to view the article.

For more information regarding the trial, see here: Phase 2 Ulcerative Colitis.

Conclusion

Phase 2 studies often go a long way in validating companies' products and in some cases their entire pipeline. While it is true investors in small/mid cap biotechs can often see their largest gains come upon positive phase 2 results, I urge caution when investing, clinical outcomes are often unpredictable. Keep yourself informed by doing your own research and manage your risk accordingly. With biotech stocks experiencing a sector wide reset today, prices are lower than in previous trading sessions. On the good side, these lower prices often make for good buying levels for investors looking to add shares or investors sitting on the sidelines looking for a chance to initiate a position. Stay tuned as these three companies mentioned in the article will soon have top-line phase 2 data hitting the wires.

Source: 3 Biotechs Expecting Top Line Phase 2 Data Mid 2014