Comparisons: AspenBio Pharma (NASDAQ:APPY), Somaxon (NASDAQ:SOMX), Cell Therapeutics (NASDAQ:CTIC), Delcatch Systems (NASDAQ:DCTH).
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Amidst an uncertain market, Hana Biosciences has positioned itself nicely for the upcoming ASCO conference on June, 7th, 2010, where it will present its phase 2 rALLy results of the additional 9 patients requested by the FDA, with the general consensus being that the results are highly positive for Marqibo, a revolutionary drug that hopes to replace the use of generic vincistrine for acute lymphoblastic lukemia (ALL). The company has stated that an NDA is to be followed once the promising results are showcased. Many investors have placed the focus on the company’s flagship product while ignoring the potential of its oncology pipeline in Alcotrest (Breast and Lung Cancer), and Brakiva (Small-Cell and Ovarian Cancer), both of which are in phase I and could be initiated for phase II once the FDA makes its decision on Marqibo. With market cap of only $17.63M, a low float of 81 million shares, while currently sitting on only 92 million shares outstanding. For more information on Hana’s pipeline and potential, read the corporate presentation from January 11, 2010. Additionally, there are rumours that the company is coming close to becoming elligible for the recently announced Small to Mid-Sized $1B Biotech Grant. For these reasons, we believe Hana’s binary events will culminate into the perfect storm, leading to handsome gains in the next couple of weeks.
At the forefront of the storm lies their NDA submission, as Hana looks to capitalize on their unique situation revolving Marqibo and the FDA’s requirements. Hana is benefiting from the fact that the Marqibo NDA has already been submitted by Inex Pharmaceuticals in the past resulting in a non-approval, thus requiring the additional 9 patient rALLy study to satisfy the FDA’s conditions. Due to Inex’s inability to foster the necessary cash to conduct the additional trials, they decided to pass over this novel drug to Hana. The general concensus among the biotech industry is that most drugs never make it on their first try with the FDA, especially smaller players, and when Hana bought Marqibo from Inex they got a big bonus, a CRL where “the FDA provided a list of deficiencies that needed to be addressed prior to re-applying for approval”. For more information, visit this article courtesy of BioSpace.com.
If all goes as it should, Hana could be one of the biggest “BioShockers” of the year.
It looks like the perfect storm is now brewing for Hana Biosciences (OTC:HNAB). In December, this penny bio stock took a major hit for no reason other than an impatient investor sell off.
Despite the negative afterthoughts of a possible dilution following the NDA submission, the company should have more cash available through Deerfield Management, who has a seat on the board of directors. There is chatter amongst several trusted expert sources that a partnership or private / institutional investor financing could be on the way should results be highly positive, especially considering the predicted market potential of its flagship product is$2.5B annually.
Going into what should be a very positive year with a new drug application (NDA) filing for their drug Marqibo after successful trial results, this stock is prime for some major movement in the near future; first a reset to the $60-80 cent level, then a move higher as the NDA is filed. We have big expectations as this meeting at the ASCO will most likely be the binary event that decides the company’s survival, and several sources have confirmed that the data should be positive.
The December publication of results from the rALLy trial in acute lymphoblastic leukemia (ALL) in second relapse shows that the drug was highly efficient as a single-agent in a very sick patient population who have few other options. There are no safety concerns beyond what is expected for this type of drug. The FDA has a history of approving ALL treatments based on phase II single-arm clinical trials, and Hana intents to use the results of the rALLy trial in their NDA filing later on this year.