Covered Companies

Navidea (NAVB) Note 12-06-13

downloadreportNavidea Analyst Science Day Reveals Permanent A-Code for Lymphoseek®
Lymphoseek Sales Trend Details – More Partnerships to Come
All Programs Remain on Track – Manocept™ Adds Tuberculosis

Download Full 6-Page Note with Important Disclosures: Morning Note 12-06-13 NAVB

Navidea held their Analyst Science Day event yesterday which described their pipeline in detail over 3 ½ hours and we encourage investors to review the webcast replay at http://www.navidea.com which will be available for 30 days. While the presentation focused on the science and the mechanism of action for their pipeline, some additional highlights that were incremental were as follows:

Lymphoseek – United States
=> While the CMS temporary pass-through reimbursement C-code went into effect on October 1st (allowing for separate pricing of Lymphoseek), Navidea announced that Lymphoseek was just assigned a permanent A-code which goes into effect on January 1, 2014. The Lymphoseek A-code is good for 2 years and will allow streamlined and standardized ordering for the administrative staff.

=> With respect to the private insurance market, there have been no rejections from a private insurance company since the May launch.

=> By all measures, customers, orders, reorders, per month and per day, Lymphoseek demand continues to increase.

=> 2014 marketing efforts will begin expanding the focus to surgeons.

U.S. Lymphoseek Growth in Both Customers and Paid Procedures per Day

clip_image002

clip_image004

Source: Navidea Analyst Science Day – December 5, 2013 NYC

Lymphoseek – Ex-US Ex-Europe
=> Navidea indicated that Canada and Taiwan as well as Asia and the Americas may be partnered shortly.

Lymphoseek – Regulatory
=> The final result of the NEO3-06 head & neck cancer trial were very strong with a False Negative Rate of 2.56% (1/39), Negative Predictive Value of 97.8% (44/45) with Overall Accuracy of 98.8%.

=> Additional marketing studies are expected including a.) an injection site pain comparative study 4Q13 b.) a head-to-head study in breast cancer 1Q14 and c.) a head-to-head study in melanoma 1Q14.

Manocept™ Platform
=> While proof-of-concept studies have been completed for Rheumatoid Arthritis (RA) and Kaposi Sarcoma (KS), which is beginning human trials in Q1, Navidea announced the completion of proof-of-concept studies for Tuberculosis (TB).

Cy3-Tilmanocept Co-localizes in Macrophages Infected with Mycobacterium Tuberculosis

clip_image002[4]

Source: Navidea Analyst Science Day – December 5, 2013 NYC

SUMMARY: In our opinion, the recent severe weakness in Navidea’s share price is not related to their science, strategic direction or balance sheet, but rather, it is a cumulative revaluation based on time. Navidea’s progress is approximately 9 to 12 months behind the investor expectations set during 2012. The unfortunate PDUFA delays along with the U.S. launch and C-code timing not only pushed out Lymphoseek’s commercial returns, it resulted in financial pressure, which in turn, delayed development for all the other pipeline candidates in Navidea’s portfolio. We believe the worst effects of these delays are now behind the company with the catalysts for December and 2014 combined with Navidea’s strong balance sheet expected to begin rebuilding investor confidence going forward. We are reiterating our Strong Speculative Buy rating with a 12-18 month price target of $3.75 based on a 35x multiple on projected fiscal year 2017 EPS and discounted 25% for cumulative risk.
Download Full 6-Page Note with Important Disclosures: Morning Note 12-06-13 NAVB

Echo (ECTE) Update 12-05-13

downloadreportEcho Results: The Good, The Bad and The Ugly
Symphony Fixes for Gen2 & Financing Risks Remain
Maintaining Neutral Rating with High Volatility

Download Full 20-Page Update Report with Important Disclosures: ECTE Update 12-05-13

The Good: Topline results for the tCGM Symphony trial were good with a MARD of 12.5%, CG-EGA of 97.9% and CG-EGA A+B of 99.7% in 32 patients (18 cardiac/14 non-cardiac) using over 630 glucose readings with a wide range of glucose values 49-324 mg/dL. This was the first controlled clinical trial using all three components of the tCGM Symphony system (Prelude, Biosensor and Wireless Monitor) and the topline data appears to be clinically acceptable. It also met the primary safety objectives as there were no unanticipated adverse events during the study.

The Bad: The current Gen1 tCGM Symphony system requires fixes to be commercially successfully. These range from minor fixes such as training and user manual operations to minimize variability among users, to significant issues requiring R&D such as an improved algorithm, more consistent Prelude skin ablation and a more consistent warm-up and calibration schedule. Of particular concern, IV acetaminophen (as used in ICU) interfered with the Biosensors and as a result, 3 patients were excluded from the trial. While management believes they have identified a solution, this is a known issue in the field and would hamper the commercial prospects for the Symphony system. The result is that Echo Therapeutics will be required to make all the fixes and perform another clinical trial. Assuming that all the fixes work and the trial is successful, Echo expects a limited launch of their Gen2 version in Europe in Q3/Q4 2014.

The Ugly: The clinical trial “do-over” necessarily delays Echo’s regulatory plan for the United States. The Gen2 version of the Symphony needs to be implemented and successfully complete the clinical trial before they can perform the clamping trial in healthy patients as required by the FDA. Only then can Echo conduct a pivotal clinical trial for the U.S. which would initiate enrollment Q4 2014 at the earliest with data around mid-2015.

Needing a Fistful of Dollars: There has been no public response to the Platinum-Montaur Life Sciences (Echo’s largest shareholder) August 30th proposal regarding a China partnership followed by a $10M common stock purchase at a premium to the share price. Instead, Echo filed an S-1 on December 2nd to sell 3,225,806 shares of common stock which also includes 3,225,806 warrants (current shares outstanding are 10,551,792). After three consecutive down rounds in the past 12 months ($9.50 Dec., $7.50 Feb., $2.70 June) there is significant risk of yet another down round.

Maintaining NEUTRAL: We continue to believe in the basic science of the tCGM Symphony system and that it should ultimately be successful. However, the near-term unknowns combined with the anticipated volatility surrounding both the product development and the financings prevent us from modeling Echo with any degree of confidence at this time.

Download Full 20-Page Update Report with Important Disclosures: ECTE Update 12-05-13

Navidea (NAVB) Update 12-02-13

downloadreportNavidea Frustrates Short-Term Investors
Multiple Catalysts Expected in December and 2014
Undervalued Assets with Strong Balance Sheet
Longer-Term Investors Should be Rewarded

Download Full 37-Page Update Report with Important Disclosures: NAVB Update 12-02-13

Navidea Frustrates Short-Term Investors: After two PDUFA delays last year (paperwork delay then 3rd party manufacturer QC issues) Navidea finally got Lymphoseek FDA approved and launched in the U.S. with partner Cardinal Health (NYSE:CAH). However, with the pass-through reimbursement C-code not taking effect until October 1st, sales revenues have been minimal to date, and are not expected to become material until 2014. Investors have also been waiting on an executed EU distribution partnership agreement, a CHMP EU recommendation and the sNDA FDA submission for Head & Neck cancer including sentinel lymph node claims. Against this backdrop, Navidea raised $30M in September and ramped up clinical trial spending on NAV4694 for Alzheimer’s disease imaging as the Phase III got underway along with two concurrent NAV5001 Phase III trials for Parkinson’s imaging commencing very soon. As a result, short-term investors have been frustrated by the perceived lack of progress in unlocking shareholder value thus far. However, we believe that longer-term investors will begin to be rewarded during 2014.

December Catalyst #1: On Thursday December 5th at 8:30am, Navidea will host a live webcast of their Analyst Science Day in NYC which we believe will give investors clarity on Navidea’s strengths throughout their product pipeline. Scientific and medical experts are also expected to participate.

December Catalyst #2: We are anticipating a Committee for Medicinal Products for Human Use (CHMP) recommendation for Lymphoseek during their meeting on December 16th-19th. On December 18, 2012, Navidea announced they filed the European Marketing Authorization Application (MAA) for LymphoSeek® (technetium Tc 99m tilmanocept) injection for intraoperative lymphatic mapping (ILM) not restricted to any particular solid tumor type. The MAA submission package was similar to Navidea’s NDA submission to the FDA however it includes analysis versus the European standard of care, Nanocoll® (99mTc-labeled nanocolloid human serum albumin) which is used with vital blue dye. Investors should note that a published meta-analysis favorably comparing LymphoSeek to Nanocoll showed that Lymphoseek was statistically significant in superiority for localization rate (99.99% versus 95.91%) and for degree of localization (2.16 versus 1.6683). The papertitled “The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the 99mTc-labeled nanocolloid human serum albumin standard of care” compared primary endpoints of SLN localization rate and degree of localization. LymphoSeek in 148 patients, and pooled analysis revealed a 99.99% localization rate and degree of localization of 2.16, both of which were statistically significant in superiority to Nanocoll’s localization rate of 95.91% (6,134 patients) and degree of localization of 1.6683 (1,380 patients). The abstract can be seen at http://www.springerlink.com/content/080m6r071360ggj2 

December Catalyst #3: Navidea will file a sNDA for Lymphoseek in head & neck cancer and we believe the strong results seen in NEO03-06 make a solid case for a sentinel lymph node claim. For example, on April 11, 2013, Navidea announced that the interim data from their Phase III clinical trial of Lymphoseek in head and neck squamous cell carcinoma that were so strong that the Data Safety Monitoring Committee (DSMC) recommended the trial be ended early to speed an FDA sNDA submission. The primary endpoint for the NEO3-06 trial was based on the number of subjects with cancer-positive lymph nodes following a multiple level lymph node dissection and required a minimum of 38 patients whose lymph nodes contained pathology-confirmed disease. The interim results were for 39 patients with cancer-positive lymph nodes and Lymphoseek accurately identified 38 for an overall False Negative Rate (FNR) of 2.56%. This is a particularly strong result considering the goal of the trial was a FNR less than 10%. The results were also statistically significant (p=0.0205). It should also be noted that using Lymphoseek led to the removal of only 4 lymph nodes per patient on average versus an average of 38 lymph nodes per patient in the trial. LymphoSeek has the potential to provide a substantial reduction in lymph-related adverse side-effects for patients with head and neck cancer undergoing sentinel lymph node biopsy.

December Catalyst #4: During the November 6, 2013 conference call for Q3, Navidea indicated that they have chosen Norgine BV (http://www.norgine.com) as their distribution partner in Europe for Lymphoseek but that the details were not yet finalized. We expect Navidea to announce the final agreement and to also provide more details of the partnership going forward. Norgine was founded in 1906 and has subsidiaries in UK, Ireland, France, Germany, Belgium, The Netherlands, Nordic, Switzerland, Austria, Italy, Portugal and Spain. Outside Europe, there are Norgine companies in Australia and New Zealand, Middle East and North Africa and South Africa. Norgine also works through a number of distributors around the world. Norgine has a strong history in hospital practice and economics in Europe.

2014 Catalyst #1: We believe Lymphoseek sales in the United States will slowly become material during 2014 as the combination of C-code, Cardinal expanding their sales efforts from nuclear medicine professionals to include surgeons along with increasing general product awareness, begins to gain traction. Investors should note that the market demand for Lymphoseek is accelerating as management stated unit sales increased 7x from Q2 to Q3 and almost 90% of customers that ordered in May to August placed a repeat order. Of particular note is that in September, 75% of customers ordered multiple doses indicating that Lymphoseek is becoming the standard of care in those facilities.

2014 Catalyst #2: Lymphoseek European approval by the EMA is expected sometime in Q1. We expect the subsequent launch with partner Norgine BV will be modest during 2014 and will become material in 2015.

2014 Catalyst #3: We expect the Lymphoseek sNDA for head and neck cancer to be approved following a standard 10-month review cycle in Q4. We continue to believe that an approval that includes a sentinel lymph node claim would be a game changer for Navidea and position Lymphoseek as the standard of care.

Undervalued Assets with Long-Term Catalysts: Navidea has (or will soon have) late-stage clinical trials in both Alzheimer’s disease imaging (NAV4694) and Parkinson’s disease imaging (NAV5001). Of the two programs, we believe NAV5001 represents the smaller financial impact but has less reimbursement risk as there are treatments available for patients. The NAV4694 Alzheimer’s program is expected to have a much larger financial impact however reimbursement remains a risk. CMS has placed Eli Lilly’s Amyvid and GE’s Vizamyl first generation products under Coverage with Evidence Development (CED). However, we expect that CMS will ultimately grant reimbursement for this imaging class before Navidea’s NAV4694 reaches the market, which also negates the head start by competitors.

In addition, Navidea is expected to begin unlocking the value of their Manocept™ platform which was just featured in Nature Outlook-Medical Imaging (see http://www.nature.com/nature/outlook/medical-imaging/pdf/navidea-white-paper.pdf) The Manocept™ platform utilizes the CD206 mannose receptor targeting used in Lymphoseek. Navidea recently announced that investigators at the University of California, San Francisco (USCF) will begin a trial in early 2014 to evaluate HIV patients with various stages of Kaposi Sarcoma (KS).

Finally, Navidea’s RIGS humanized monoclonal antibody targeting program is expected to begin human safety and activity trials in Q1 at the University of Alabama at Birmingham in 20 patients with colorectal cancer by administering the 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.

SUMMARY: In our opinion, the recent severe weakness in Navidea’s share price is not related to their science, strategic direction or balance sheet, but rather, it is a cumulative revaluation based on time. Navidea’s progress is approximately 9 to 12 months behind the investor expectations set during 2012. The unfortunate PDUFA delays along with the U.S. launch and C-code timing not only pushed out Lymphoseek’s commercial returns, it resulted in financial pressure, which in turn, delayed development for all the other pipeline candidates in Navidea’s portfolio. We believe the worst effects of these delays are now behind the company with the catalysts for December and 2014 combined with Navidea’s strong balance sheet expected to begin rebuilding investor confidence going forward. We are reiterating our Strong Speculative Buy rating but reducing our 12-18 month price target to $3.75 (from $5.75) based on the cumulative effect of the delays. Our target is based on a 35x multiple on projected fiscal year 2017 EPS and discounted 25% for cumulative risk.

Download Full 37-Page Update Report with Important Disclosures: NAVB Update 12-02-13

StemCells Inc. (STEM) Note 10-29-13

downloadreport


StemCells Inc. Acquires Ownership of Neurospheres Patents

Download Full 6-Page Note with Important Disclosures: Morning Note 10-29-13 STEM

StemCells Inc. announced the full acquisition of a patent portfolio (US and Canadian patents), which StemCells Inc.had held an exclusive worldwide license, for 139,548 shares of common stock (approximately $200K) to Neurospheres Holdings Ltd., an IP holding company affiliated with the University of Calgary. The acquisition eliminates all milestone and royalty obligations that were contained in the license agreements for products derived from StemCells Inc. proprietary HuCNS-SC® cells (purified human neural stem cells). The portfolio broadly claims the manufacture and proliferation of purified populations of human neural stem cells and their use as therapeutics and as tools for drug discovery. Key claims of the acquired patents include, among other things, cultures of neural stem cells derived from any source, including embryonic, fetal, juvenile, or adult tissue; compositions of matter, again regardless of the source of the cells and regardless of whether the cells were grown in either suspension or adherent culture or derived from induced pluripotent stem (iPS) cell technologies. Of particular interest is patent #7,166,277 “Remyelination of neurons using multipotent neural stem cell progeny” with a term through 2024 (see http://1.usa.gov/1gXQybo ). Investors should note that these patents are subject to the patent infringement lawsuit with Neuralstem (NYSE MKT: CUR $2.40 Not Rated). Four of these patents were challenged by Neuralstem for reexamination by the U.S. Patent and Trademark Office and all four survived USPTO reexamination.

We believe the full ownership of these patents, which eliminates future milestone and royalty payments for a relatively small sum, makes good sense. We also believe this simplifies the situation for StemCells Inc. in the infringement action with Neuralstem Inc. which is expected to go to court next year.

StemCells Inc. Patent Infringement and Libel Suits Against Neuralstem Inc. (From Latest 10-Q)
In July 2006, StemCells Inc. filed suit against Neuralstem, Inc. in the Federal District Court for the District of Maryland, alleging that Neuralstem’s activities violate claims in four of the patents exclusively licensed from NeuroSpheres, specifically U.S. Patent No. 6,294,346 (claiming the use of human neural stem cells for drug screening), U.S. Patent No. 7,101,709 (claiming the use of human neural stem cells for screening biological agents), U.S. Patent No. 5,851,832 (claiming methods for proliferating human neural stem cells), and U.S. Patent No. 6,497,872 (claiming methods for transplanting human neural stem cells).

In May 2008, StemCells Inc. filed a second patent infringement suit against Neuralstem and its two founders, Karl Johe and Richard Garr. In this suit, filed in the Federal District Court for the Northern District of California, they allege that Neuralstem’s activities infringe claims in two patents exclusively license from NeuroSpheres, specifically U.S. Patent No. 7,361,505 (claiming composition of matter of human neural stem cells derived from any source material) and U.S. Patent No. 7,115,418 (claiming methods for proliferating human neural stem cells). In addition, they allege various state law causes of action against Neuralstem arising out of its repeated derogatory statements to the public about their patent portfolio. Also in May 2008, Neuralstem filed suit against StemCells Inc. and NeuroSpheres in the Federal District Court for the District of Maryland seeking a declaratory judgment that the ‘505 and ‘418 patents are either invalid or are not infringed by Neuralstem and that Neuralstem has not violated California state law. In August 2008, the California court transferred the lawsuit against Neuralstem to Maryland for resolution on the merits. In July 2009, the Maryland District Court granted StemCells Inc.’s motion to consolidate these two cases with the litigation they initiated against Neuralstem in 2006. Discovery is ongoing in these cases with an anticipated trial date in 2014.

Download Full 6-Page Note with Important Disclosures: Morning Note 10-29-13 STEM

Navidea (NAVB) Note 10-24-13

downloadreport

Navidea Publication Demonstrates Multi-Use Manocept™ CD206 Platform

 

Download Full 8-Page Note with Important Disclosures: Mid-Day Note 10-24-13 NAVB

Navidea announced a white paper titled “Innovations in receptor-targeted precision imaging at Navidea: Diagnosis up close and personal” which will be published in the special supplement Nature Outlook: Medical Imaging in the October 31 issue of Nature. The prepublication white paper is available for download at http://www.nature.com/nature/outlook/medical-imaging/pdf/navidea-white-paper.pdf and describes Navidea’s Manocept™ platform (CD206 mannose receptor targeting) which is currently being utilized in their FDA-approved Lymphoseek (technetium 99m tilmanocept) Injection product that binds to the CD206 mannose receptor for lymphatic mapping. The white paper describes Navidea’s new imaging candidate, tilmanocept-Cy3, utilizing CD206 mannose receptor binding combined with Cy3 Cyanine dye, to target macrophage inflammatory cells with imaging via yellow-green fluorescence. Macrophages are monocyte derived white blood cells that perform two functions, clean cellular pathogens and debris (phagocytosis) and to assist in initiating the adaptive immune system to respond to the pathogen. They play a role in multiple indications such as oncology, autoimmunity, infectious diseases, cardiology, and inflammation. The ability of fluorescent tilmanocept-Cy3 to target macrophages could be utilized in diseases such as Kaposi’s Sarcoma (KS), Tuberculosis (TB), Rheumatoid Arthritis, Lupus and Crohn’s disease. 

Tilmanocept-Cy3 Imaging in Arthritis

clip_image002[4]

Source: Cope, F et al, “Innovations in receptor-targeted precision imaging at
 Navidea: Diagnosis up close and personal” Nature  October 31, 2013

Investors are encouraged to read the paper to gain a fuller understanding of Navidea’s Manocept mechanism of action and future applications.  We believe Navidea management will begin unlocking the value of this platform during 2014.

Download Full 8-Page Note with Important Disclosures: Mid-Day Note 10-24-13 NAVB

Page 12 of 42« First...891011121314151617...3040...Last »
Disclaimers & Risks    Margin Disclosure    Day-Trading Risks     Privacy Policy    Patriot Act    Business Continuity

Copyright © 2009-2014 LifeTech Capital.   All Rights Reserved.   LifeTech Capital is a division of Aurora Capital LLC
Aurora Capital LLC is a member of FINRA (www.finra.org) and a member of SIPC (www.sipc.org).   SIPC provides protection of
up to $500,000, including a maximum of $100,000 for cash balances. SIPC does not guarantee the future value of any security.