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RegMed Daily Dialogue, Mid-Day, 9/13/11, lack of conviction emanates from the buy side

The 6 W’s: Who, what, where, when, why and what of it…


Mid-Day: The NASDAQ is UP +23.15 (+0.93%) to 2,518.24. The Dow is also UP  +14.38 (+0.13%) to 11,075.50. Up and DOWN, round and round … I am getting dizzy watching this market.


Mid-Day Movers:  Athersys (NASDAQ:ATHX), BioMimetic (NASDAQ:BMTI), BioTime (AMEX: BTX), Cytori (NASDAQ:CYTX), ImmunoCellular (NYSEMKT:IMUC), Geron (NASDAQ:GERN), NeoStem (AMEX: NBS), Neuralstem (AMEX: CUR), Opexa (OPXA), Osiris (NASDAQ:OSIR), Pluristem (NASDAQ:PSTI), ReNeuron (LSE: RENE.L) and StemCells (STEM) …


What of it …. The fog of the market seems so … overblown based on its dependence on the EU (PIGS) banks/economies.  Studying the possibilities of the RegMed universe is lately focused on their depreciated status in relation to their comparables, also down but, defines the probabilities of the future growth of this universe but, based on the nuances of each company.

Thus, investors need to … decouple … from the fog that limits our sight and investment  I’ve never met a successful pessimist. Nobody knows what’s going to happen and the market hates uncertainty. We … know there are opportunities out there. It’s just that the outlook is so murky.

In the past months, more RegMed investors appear to have thrown in the towel than at any time in any period. I do … NOT … view this as a periodic portfolio clean-out process but a … downdraft … based on brokers, funds and investors locking in ANY PAST profit facilitated  by the short-sellers hedging ANY bet knowing they can spit out a few cents and get back in at the lower price rather than any thing more ominous.

Trading volume had been dominated by institutional investors such as mutual funds, pension funds, insurance companies, bank trust departments, etc. Their past accumulation of a stock clearly showed up on a price/volume chart. However, over the past year, high-frequency trading has come to comprise a purported 60% of all trading volume.

Doesn’t this fact make volume or momentum indicators that we see on stock and index charts less reliable as a means of detecting accumulation or appreciation? A big YES … most investors BUY high and SELL low … my opinion … re-enter and rebalance … NOW … as I have said … nibble every day!!


What’s new in the regenerative medicine/stem cell market …

Tengion (TNGN) resumes Patient Enrollment in Clinical Trial of Neo-Urinary Conduit Program: TNGN has reinitiated enrollment of patients in the ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit™, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy).  TNGN anticipates the 4th patient to be enrolled during the Q/4, followed by another patient during Q1/12. After enrolling the 5th patient and safety data permitting, we intend to discuss with clinical investigators and the Data Safety Monitoring Board a reduction in the amount of time between future patient implants. The bottom line, this ongoing trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit, as well as to allow the clinical investigators to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. The trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital inBaltimore, Maryland.  To date, 3 patients have been enrolled and implanted in the clinical trial. Data from these patients have allowed clinical investigators to make surgical modifications for the trial moving forward in an effort to address conduit patency and vascular supply.


Advances in cardiac gene therapy raise hopes of some experts: US researchers have come up with gene therapies that appear to be effective in treating heart failure, atrial fibrillation and other cardiac problems, raising hopes among experts that cardiac gene therapy will work. The bottom line, despite the recent advances, scientists have to overcome several hurdles, such as the challenge of getting “vectors,” or viral transporters, to zero in on cells in a tissue and preventing the immune system from targeting the introduced vectors.


ThermoGenesis (NASDAQ:KOOL) Reports Q4/11 and FY Results: KOOL reported a Q4/11 net loss of $1.2M or $0.07 per share versus a net loss of $171K, or $0.01 per share, in Q4/10. KOOL reported Q4/11 net revenues of $5.4M, compared to $7.2M in Q4/10 and $5.2M in Q3/11. Disposable sales were $3M, compared with $4.8M in Q4/10 and $3M in Q3/10. Cost of revenues was $3.5M with a gross profit of $1.866M. SG&A was $2.245M while R&D logged in at $789K for a total operating expense of $3.034M. KOOL realized measurable improvements in gross margins due to operating efficiencies and lower supplier costs, and a more than $1 million decline in operating expenses. Shares used in computing net loss per common shares were 16.346M. FY11: KOOL reported net loss of $2.6M, or $0.17 per share, compared with a net loss of $5.2M, or $0.37 per share, in FY10. For FY11, KOOL reported sales of $23.4M compared with revenues of $23.1M in FY10. Disposable sales were $13.8M, compared with $14.3M for FY10. KOOL reported a $2.6M reduction in annual net loss, or an improvement of 51% versus 2010. KOOL ended FY11 with $12.3M in cash and cash equivalents versus $13.5M at the end of Q3/11 and $10.7M at FY10’s end. KOOL strengthened its balance sheet through a $4M offering of stock and warrants. Guidance: Backlog at the end of fiscal 2011 was $1.1M. KOOL stated that it expects revenues for the 1st 2Q’s of FY12 will be relatively consistent with those of Q4/11.


ReNeuron (LSE: RENE.L) 1st stroke patient treated using higher dose of stem cell therapy discharged: The remainder of this dose group, known as a cohort, will be treated by the end of the year as part of the pilot investigation of stem cells in stroke, known as the PISCES study for short. In all 12 patients will be treated with varying doses of ReN001 as part of this early stage trial being carried out in Scotland at the Institute of Neurological Sciences. The bottom line, the 1st dose cohort of 3 patients was treated without any side-effects or safety issues. The development of stem cells in order to treat diseases is significant because of their ability to both renew themselves and create new cells of other kinds of tissues. The ReN001 therapy is based around ReNeuron’s lead neural stem cell line, designated CTX by virtue of its origin from the cortex region of the brain.