Navidea Biopharmaceuticals Inc. - A Follow Up?

On November 23rd I wrote an article entitled Navidea Biopharmaceuticals Inc.: There Will Be A Turnaround, But Have We Hit The Bottom Yet? While I believe that Navidea (NAVB) is a great company, I wasn't ready to call the bottom at that time. Maybe I should have called it because since then NAVB has climbed back up from a low of $1.46 to a high of $2.20, a 50% gain over the past 30 days. Rapid rises are usually followed by a pullback when traders and investors take some profits, but are then often followed by another rise.

(Click to enlarge)

#1: Nov 23rd: Navidea to Collaborate with University of Alabama-Birmingham on Clinical Study Evaluating the RIGS™ Monoclonal Antibody Targeting Agent

The first announcement was the partnership with the University of Alabama - Birmingham. The study will evaluate 20 patients with colorectal cancer (CRC) by administering the Radio-Immuno-Guided Surgery (RIGS) tumor-specific radiolabeled, CH2 domain-deleted, anti-TAG-72 Mab-targeting agent and assessing by SPECT/CT imaging for the presence of liver metastasis:

The tumor-associated glycoprotein (TAG-72) is a target for detection of the spread of CRC to the liver. TAG-72 is expressed on the surface of a wide range of carcinomas and prompted the development of antibodies to TAG-72 for investigation in the diagnosis and treatment of carcinomas.

NAVB has been promoting the use of RIGS and developing it in the treatments of various types of cancer, so this announcement should not have been groundbreaking. The results of the study should help to promote the use and marketing of RIGS across the medical community.

#2: Dec 17th: Navidea Biopharmaceuticals Submits Supplemental New Drug Application (sNDA) for Lymphoseek® for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer

I was very encouraged by the announcement that the company is still expanding their marketability for Lymphoseek. The company announced they were seeking approval for the use of Lymphoseek for sentinel lymph node (SLN) detection in patients with head and neck cancer. Since Head and Neck Cancer is pretty broad, I attempted to define it based on those listed by the National Cancer Institute to Thyroid, Oral Cavity and Pharynx, Brain and Other Nervous System, Esophageal, and Larynx Cancers. This would represent over 150,000 diagnosis per year.

(Click to enlarge)

#3: Dec 19th: European Medicines Agency (EMA) Continues Marketing Authorization Application (MAA) Review for Lymphoseek®

The company experienced a pull back after the announcement that the European Medicines Agency elected to continue the assessment of the Marketing Authorization Application for Lymphoseek after providing the Day 180 feedback. The company is pushing forward with preparing Lymphoseek to be marketed in Europe, which should be seen as a positive sign. The additional time required to submit additional data by the company to the EMA will delay the roll out, but should not be seen as a negative event.

Landmines

As with any company, there are always potential landmines that could destroy shareholder value. Some of the potential downfalls are:

1. Failure to gain approval from the EMA for the marketing and sale of Lymphoseek. Since the FDA has already approved it for sale in the US, it will likely be approved in Europe.


2. Additional offerings. The company is going through cash quickly in its aggressive research and development. The company has just over $44 million in cash, but is going through about $20 million a year in research and development. While it should have enough for continued research and development as well as marketing of new drugs, it may have to go back within the next two years.

Conclusion

Navidea has continued to develop the market for Lymphoseek by seeking approvals in new markets and expanding the use of Lymphoseek to treat various forms of cancer. In my previous article I received numerous comments from investors in the medical field saying they were beginning to see Lymphoseek arriving in their facilities. These announcements are further evidence of the company being able to successfully market Lymphoseek, gain market share, and improve shareholder positions.

Source: Navidea Biopharmaceuticals Inc. - A Follow Up?

Disclosure: I am long NAVB. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

This entry passed through the Full-Text RSS service — if this is your content and you're reading it on someone else's site, please read the FAQ at fivefilters.org/content-only/faq.php#publishers.