The following message was updated on 3/8/2012 8:13:52 PM.
I had a chance to browse the 10K for new or notable info, and found these points:
Attempts to sell Cardiosonix thus far have not been successful.
(Lympho) The NEO3-06 clinical study was designed to expand the potential label for Lymphoseek as a SLNB agent after the initial marketing clearance for the product. However, based on the acceptance of the NDA by FDA, we now believe we do not need to complete the NEO3-06 study. Rather, we now believe an interim analysis may be achieved in mid-2012.
(RIGS) We believe that we may still be technically able to complete the necessary manufacturing steps to permit active clinical development by the end of 2012; however, as management continues to assess the scope and required resources for the RIGS program, particularly in light of other development opportunities such as for AZD4694 and/or 123I]-E-IACFT, the timing and scope of our development and commercialization plan for RIGScan may be affected.
(RIGS) We have successfully completed the initial steps in re-characterizing the drug cell line and believe, based on work done to date, that the cell line is still viable.
(RIGS) Laureate Biopharma has made progress in the re-validation of the manufacturing process and has completed certain biologic characterization activities. Our development plans for RIGScan also include the consideration of alternative radiolabeling processes. We will need to establish manufacturing and radiolabeling capabilities for the CC49 antibody in order to meet the regulatory needs for the RIGScan product.
We continue to believe it may be advantageous for us to identify a development partner for RIGScan.
We believe the most preferable and likely distribution partners for Lymphoseek would be entities with established radiopharmaceutical distribution channels, although it is possible that other entities with more traditional oncology or neurological pharmaceutical portfolios may also have interest. Examples of entities with established regional and/or global radiopharmaceutical distribution networks include Cardinal Health, Covidien, General Electric Healthcare, IBA, AAA, E&Z AG, Lantheus Medical Imaging and Bracco.(Possible hints at ex-U.S. distribution players)
Navidea will receive up to $3 million in payments upon the achievement of certain sales milestones by Cardinal Health. (Not sure what the amounts are. It's possible this is a 2012 event)
(Lympho) At this point, drug product produced by OSO Bio has been manufactured under clinical development agreements. A commercial supply agreement is being negotiated with OSO Bio. (Preparing for launch)
(Re: Amyvid, AZD's competing product) Eli Lilly has responded to these (FDA) concerns and the drug is expected to be approved in the near future. (We want this approval to happen).
We currently lease approximately 15,000 square feet of office space at 425 Metro Place North, Dublin, Ohio, as our principal offices. The current lease term is from June 1, 2007 through January 31, 2013, We believe these facilities are in good condition, but that we may need to expand our leased space related to our radiopharmaceutical development activities depending on the level of activities performed internally versus by third parties. (Expansion or relocation ?)
In February 2012, Navidea entered into an operating lease agreement for approximately 3,800 square feet of office space in Andover, Massachusetts, just outside of Boston... The new office will house the Company’s business development and commercialization team handling, in part, the activities surrounding the anticipated launch of Lymphoseek later this year. (It looks like Thom Tulip will be based out Andover, MA).
As of February 17, 2012, we had approximately 724 holders of common stock of record.
This was an interesting graph to put in a 10K...
There are 6,000,000+ warrants coming due by year end, which could generate almost $2 million for the company, provided they're not executed on a cashless basis.
Bupp owned a lot of stock. One of the consequences of his departure was a reduction in the percentage of the stock now owned by execs and insiders. It's down to 1.5%...
This was a good bullet point summary of all the milestones from the past year:
Our efforts in 2011 and to date in 2012 have resulted in the following milestone achievements:
· Achieved listing of our common stock on the NYSE Amex Stock Exchange
· Secured independent analyst coverage from several major brokerage firms
· Appointed Dr. Mark Pykett as President and Chief Executive Officer, and appointed Drs. Peter Drake, Jess Jones and Mark Pykett to the Navidea Board of Directors
· Filed a shelf registration on Form S-3 to allow the Company to raise capital as necessary through the sale of up to $100 million in a primary offering of securities
· Appointed Dr. Thomas Tulip as Executive Vice President and Chief Business Officer
· Completed the sale of our GDS Business to Devicor Medical Products, Inc., for $30.2 million in proceeds and up to an additional $20 million in potential future royalties
· Established a European business unit to support regulatory, development and commercial activities in the European Union (EU)
· Executed a Loan Agreement with Hercules Technology II, L.P. providing for a first advance of $7 million which was received in December 2011, and the availability of a second advance of an additional $3 million, subject to certain milestone conditions
· Completed strategic repositioning and rebranding activities of the Company as a pure-play radiopharmaceutical developer
· Completed a lease agreement for additional office space in Andover, Massachusetts to house the Company’s business development and commercialization team
· Announced that our second clinical study of Lymphoseek in subjects with breast cancer or melanoma (NEO3-09) reached its accrual goal
· Announced top-line data from the NEO3-09 clinical study with all primary and secondary endpoints achieved and presented full data from the study at major medical meetings
· Presented full data from the NEO3-09 clinical study at the American Society of Clinical Oncology and Society of Nuclear Medicine Meetings
· Obtained positive guidance from the European Medicines Agency (EMA) for Lymphoseek and announced our intent to file a Marketing Authorization Application (MAA) in the EU by the end of 2012 based on already completed clinical trials
· Executed a license agreement with AstraZeneca AB for the exclusive worldwide license of AZD4694, a proprietary compound intended for use in diagnosing Alzheimer’s Disease
· Completed a successful pre-investigational new drug meeting for RIGScan with the U.S. Food and drug Administration (FDA)
· Undertook process development and pilot production activities for RIGScan manufacturing
· Filed and received notice of the acceptance of the Lymphoseek New Drug Application (NDA) from FDA
· Completed a scientific advice meeting with the EMA for RIGScan development in the EU
· Entered into an option agreement with Alseres Pharmaceuticals, Inc. to license [123I]-E-IACFT Injection, also called Altropane®, an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders