Insider buying @ 1.34 back in May along with expanding their pipeline this month imo put this at minimal downside risk through Octobers catalyst from the FDA's review... "In March 2014, the FDA accepted for review the second sNDA to support broader and more flexible use of Lymphoseek in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other product capabilities. Under PDUFA, the FDA has set a target review date for the second sNDA of October 16, 2014." The downside is the dilution from the exiting CEO Mark J. Pykett. Though they managed to keep most of that under control with restricted shares and other measured distributions on a consulting basis executable on Dec and Jan 1st. That leaves NAVB in a fairly decent short term swing position.
Another upside though is the recent deal with R-Nav. This expands the pipeline and brings in new money from those following the research and possible future fruition.
Excerpt from that filing...
On July 15, 2014, Navidea Biopharmaceuticals, Inc. (the “Company”) entered into agreements relating to the formation of a limited liability company, R-NAV, LLC (R-NAV), which will pursue opportunities for use of the Company’s Manocept™ CD206 macrophage targeting platform technology in diagnosis and treatment of rheumatologic and arthritic diseases. The participants in R-NAV are the Company, Rheumco, LLC, a portfolio company of Essex Woodlands Health Ventures, and third party private investors affiliated with Essex Woodlands. Using a combination of the Company’s Manocept technology and Rheumco’s proprietary Tin-117m radioisotope technology, R-NAV will focus on the development of several diagnostic and therapeutic applications in the arthritis space, each to be conducted in a separate subsidiary of R-NAV:
Subsidiary 1: Detection of rheumatoid arthritis (RA) initially using Tc-99m tilmanocept, commercially known as Lymphoseek® (technetium Tc 99m tilmanocept) Injection,
Subsidiary 2: Combination of the Manocept platform with Tin-117m for detection and treatment of RA
Subsidiary 3: Detection and treatment of human and veterinary osteoarthritis (OA) using the Tin-117m technology, and
Subsidiary 4: Treatment of hemophilic arthropathy (HA), a rare pediatric condition.
The Company has three-year call options to acquire, at its sole discretion, all of the equity of subsidiary 1 prior to the launch of a Phase III clinical trial for its development program, and all of the equity of subsidiary 2 upon completion of radiochemistry and biodistribution studies for its development program. Navidea has an equity ownership position in R-NAV and each of its subsidiaries of approximately 30% on a fully converted basis, subject to potential future dilution.
Both Rheumco and Navidea have contributed licenses for intellectual property and technology to R-NAV in exchange for common units in R-NAV. Each of the licenses has grant-back provisions with respect to inventions and other intellectual property developed in these programs outside of the exclusive fields of use specified in the license.
R-NAV will be initially capitalized through a $4 million investment from the investors alongside a $1 million investment from the Company paid over three years, with $333,334 in cash contributed at inception and a promissory note in the principal amount of $666,666, payable in two equal installments on the first and second anniversaries of the transaction. The note will bear interest at the applicable federal rate, currently 0.31% per annum. In exchange for its capital and in-kind investment, the Company received 1,000,000 Series A preferred units of R-NAV (“Series A Units”), and an additional 500,000 Series A Units for management and technical services associated with the programs described above to be performed by the Company for R-NAV pursuant to a services agreement. The Series A Units are convertible into common units at the option of the holder for a conversion price of $1 per unit, subject to broad-based weighted average anti-dilution rights. R-NAV will be managed by a board of directors of 6 persons, consisting of one person designated by the holders of common units, two persons designated by the holders of the Series A Units, and three persons designated by the holders of the common units and Series A Units voting as a single class (with the holders of the Series A Units voting on an as-converted basis).
Here are the other investors...
SCHEDULE OF PURCHASERS
Notice Address Purchase Price Series A Preferred Units CVF, LLC 222 N. La Salle Street, Suite 2000
Chicago, IL 60601
Attn: Richard C. Goodman, General Partner
Fax: (312) 984-1489 $2,000,000 cash 2,000,000
Infinity Capital III, LLC
McRay Money Management, L.L.C.
c/o Infinity Capital III, LLC
3333 Allen Parkway, Suite 606
Houston, TX 77019
Attn: Laurie McRay
Fax: (713) 528-0288 $2,000,000 cash 2,000,000
Navidea Biopharmaceuticals, Inc.
5600 Blazer Parkway, Suite 200
Dublin, OH 43017
Attn: Chief Executive Officer
Fax: (614) 793-7522 $333,333 cash
Navidea Services Agreement** 333.333
*Delivery of the Navidea Note shall constitute payment for 666,666 of the Series A Preferred Units being purchased by Navidea, all subject to the terms of Section 2.2 of this Agreement. The parties agree that delivery of the Navidea Note will be deemed a “Capital Contribution” under the Restated LLC Agreement in the amount of $666.666.
** Delivery of the Navidea Services Agreement shall constitute payment for 500,000 of the Series A Preferred Units being purchased by Navidea, all subject to the terms of Section 2.2 of this Agreement. The parties agree that delivery of the Navidea Services Agreement will be deemed a “Capital Contribution” under the Restated LLC Agreement in the amount of $500,000.
Held 1.35, kept watching the bollingers to see if this would set up for the short squeeze. Still has the potential imo. Fundamentally this is a new start for Navidea. Still some dilution to get through to get the old CEO out of the picture but at the same time he'll be helping out. $27k a month? Sign me up. :-)
Multiple Catalyst Update for Navidea
PDUFA date 16 Oct, 2014 for broadening Lymphoseek
In March 2014, the FDA accepted for review the second sNDA to support broader and more flexible use of Lymphoseek in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other product capabilities. Under PDUFA, the FDA has set a target review date for the second sNDA of October 16, 2014.
EU expansion of Lymphoseek
In April 2014, the Company announced its expectation that the CHMP would convene a meeting of the Scientific Advisory Group on Oncology (SAG-O) to discuss additional elements of the Lymphoseek clinical study in patients with head and neck cancer to provide an opportunity for Navidea and independent experts in head and neck cancer surgery to review clinical data in the MAA filing and discuss broad aspects of care for patients with head and neck cancer in Europe. Navidea expects that the SAG-O's opinion, though not binding, will be considered by the CHMP when it meets to review the Lymphoseek MAA later this year.
Pipeline expansion with R-NAV
In July 2014, Navidea announced that it has formed a joint enterprise with Essex Woodlands-backed Rheumco, LLC, to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, LLC, will combine Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need:
1) Detection of RA initially using Tc-99m tilmanocept, commercially known as Lymphoseek,
2) Combination of the Manocept platform with Tin-117m for detection and treatment of RA,
3) Detection and treatment of human and veterinary osteoarthritis (OA) using the Tin-117m technology, and
4) Treatment of pediatric hemophilic arthropathy (PHA), a rare rheumatologic condition.
Cost reduction aiming for cash flow positive in 2015
In May 2014, the Board of Directors made the decision to refocus the Company's resources to better align the funding of our pipeline programs with the expected growth in Lymphoseek revenue. This realignment primarily involves reducing our near-term support for our neurological product candidates, including NAV4694, as we seek to secure a development partner or partners for these programs. http://www.sec.gov/Archives/edgar/data/810509/000081050914000006/navb0630201410q .htm
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organization with a broad China focus in oncology and other therapeutic areas, who will develop and commercialize Lymphoseek® (technetium Tc 99m tilmanocept) Injection in China. In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones from Sinotau, including a $300,000 upfront payment. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved in the U.S. for use in lymphatic mapping to assist in the detection of lymph nodes in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.
As part of the agreement, Sinotau is responsible for costs and conduct of clinical studies and regulatory applications to obtain Lymphoseek approval by the China Food and Drug Administration (CFDA). Upon approval, Sinotau will be responsible for all Lymphoseek sales, marketing, market access and medical affairs activities in China and excluding Hong Kong, Macau and Taiwan. Navidea and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programs pending CFDA approval. In addition to the $300,000 upfront, Navidea is eligible for $700,000 in milestones up to and through product approval, and an additional $1.5 million in sales milestones.
SWEET!! Orphan Designation: For use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck Orphan Designation Status: Designated
Generic Name: technetium Tc 99m tilmanocept injection Trade Name: Lymphoseek Date Designated: 09-17-2014 Orphan Designation: For use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck Orphan Designation Status: Designated FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Sponsor: Navidea Biopharmaceuticals 5600 Blazer Parkway, Suite 200 Dublin, OH 43017
The sponsor address listed is the last reported by the sponsor to OOPD.
over 24M shares short on this puppy, SQUEEEEEZE me!
GREAT NEWS Navidea Receives Orphan Drug Designation from FDA for Use of Lymphoseek® in Head and Neck Cancers
DUBLIN, Ohio--(BUSINESS WIRE)--
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today announced that Lymphoseek® (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation is based upon an estimated 40,000 procedures being performed in this patient population. The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
“This Orphan Drug designation provides further validation of Lymphoseek for sentinel lymph node detection, underscores the need for new innovations in the treatment of patients with head and neck cancer, and, importantly strengthens Navidea’s competitive position by providing seven years of market exclusivity in this indication," said Michael Goldberg M.D., Navidea Interim CEO. "This decision follows the FDA Fast Track designation, Priority Review and subsequent sNDA approval of Lymphoseek for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity.”
The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent rare, or ‘orphan’, diseases and disorders, defined as affecting fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition in head and neck cancers as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees, which qualifies the Company to request a refund of previously paid filing fees of up to $1.1 million.
About Lymphoseek® Lymphoseek® (technetium Tc 99m tilmanocept) Injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma and head and neck cancer patients with oral cavity carcinoma. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. The Company anticipates continuing development of Lymphoseek into other solid tumor areas.
Lymphoseek Indication and Important Safety Information Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated, using a hand-held gamma counter, for: • Lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma; • Guiding sentinel lymph node biopsy, in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity.
Important Safety Information In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Navidea’s Lymphoseek® Recommended by CHMP for European Approval in Sentinel Lymph Node Detection for Melanoma, Breast and Certain Head and Neck CancersBusiness Wire(Fri 7:27AM EDT) 7:27 am Navidea Biopharma's Lymphoseek recommended by CHMP for European approval in sentinel lymph node detection for melanoma, breast and certain head and neck cancersBriefing.com(Fri 7:27AM EDT) NAVIDEA BIOPHARMACEUTICALS, INC. Files SEC form 8-K, Other Events, Financial Statements and ExhibitsEDGAR Online(Wed, Sep 24) Navidea Awarded $1.67M Fast Track NIH SBIR Grant for Evaluation of Lymphoseek® in Cervical CancerBusiness Wire(Tue, Sep 23) Navidea Receives Orphan Drug Designation from FDA for Use of Lymphoseek® in Head and Neck CancersBusiness Wire(Thu, Sep 18)
A lot happening with Navidia.
riding free from 1.03 and 1.20's. Sold 1.71. Keeping a position into 2015. Ready to add IF it pulls back to fill the gap @ 1.58.
Looks like this is really just getting noticed how they've managed to turn things around.