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RegMed Daily Dialogue, 8/5/11, still singing “Highway to the Danger Zone”

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

Stock futures turned solidly higher Friday, 8/5/11 after the government reported better news on the troubled labor market than expected which also showed the unemployment rate falling to 9.1% from 9.2% in June. After a 160 point initial leap, futures on the Dow were more recently up 72 points to 11,443, while S&P 500 futures were 9.4 point to 1,208.1 while Nasdaq 100 advanced 12.5 points to 2,222.

Stocks struck solid gains to begin Friday’s session but, then turned negative after 10am. Volumes are more than huge by 11am … but, by 12pm (noon) the dow was down by 245 points after a sharp stock reversal …

The NASDAQ is now … DOWN -39.08 <from 77.25 in 10 minutes) (-1.53%) to 2,517.31. The Dow is also … DOWN -24.07 <-179.82 in 10 minutes> (-0.21%) to 11,359.61. Remembering, my old and recent fear component; the DOW is UNDER 12,000.

Regenerative medicine/stem cell universe shares on 8/5/11 isresponding to market dynamics”; thank god for an initial rally and a slow pull-back  on this … l  o  n  g … week’s Friday. No interest or need to be long to/over the weekend as markets and EU or E  DISUNION news remains fluid but, hoping for a Monday rally … ice cubes will NOT survive this weekend!

Who is UP … NO ONE … a few were up … but are promptly taken down as the “tape” is v e r y … sensitive.

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

Osiris (NASDAQ:OSIR) Q2/11 Results: Net income was $1.79M and earnings per share were $0.05. Net income for Q2/11 was $1.8M compared to $1.7M in Q2/10. Revenues were $10.2M in Q2/11, consisting primarily of the amortization of license fees from collaboration agreements versus $10.3M in Q2/10. Product sales were $130K minus cost of goods sold, $55K for a gross profit of $75K. R&D expenses for Q2/11 were $5.2M, compared to $6.5M in Q2/10. G&A expenses were $3.3M compared to $1.6 million for Q2/10; including a one-time $1.7M non-cash charge related to the warrant extension approved by stockholders in 5/11. Net cash used in operations for Q2/11 was $5.5M. The basic earnings was based on a weighted average of diluted shares of 33.13M. As of 6/30/11, OSIR had $57.8M of cash, receivables and short-term investments.

BioMimetic Therapeutics (NASDAQ:BMTI) Q2/11 Results: A net loss of $8.2M, or $0.29 per diluted share. For Q2/11 BMTI, reported a net loss of $8.2M, or $0.29 per diluted share, compared to a net loss of $7.7M or $0.35 per diluted share for Q2/10.Q2/11 revenues were $0.4M consisting of product sales ($72.8K), royalty income ($24.2K) and sublicense fee ($242.1K) income compared to $0.4M in Q2/10. Cost of sales was $9.1K. R&D expenses totaled $3.8M for Q2/11, compared to $3.9M for Q2/10. R&D activities include outside professional services expenses, as well as salaries, wages and related benefits, payroll taxes and stock compensation expense for internal R&D personnel, and relate to new and ongoing clinical trials of product candidates in the US, Canada, Australia and the EU, as well as continuing expenses associated with pre-clinical studies and regulatory filings. G&A expenses totaled $4.7M for Q2/11 compared to $3.3M for Q2/10. Depreciation and capital lease amortization was $270K. Patent lease amortization was $9.5K. Loss from operations was $8.26M. Interest (net) expense $1.7K while interest income was $26.5K. Gain (loss) from equipment was $166. Net loss was $8.24M based on 27.98M basis and diluted shares. As of 6/30/11, BMTI had approximately $16.5M of cash and cash equivalents and $58.3M of investments in US government sponsored enterprise (“GSE”) securities, corporate bonds, municipal bonds and commercial paper. Total assets were $91M. These investments have maturity dates ranging from 7/11 through 12/12 with coupon rates ranging from 0.091% to 6.375%.

Germ cells from embryonic stem cells make sterile mice fertile: Sterile mice produced viable sperm after receiving transplants of primordial germ cells derived from mouse embryonic stem cells, scientists at Kyoto University reported in the journal Cell. They developed the germ cells by adding growth factors and other chemicals to stimulate the embryonic cells to develop into epiblastlike cells in a laboratory dish. Although the technique is considered a feat in fertility research, “we have a long way to go before it can be applied in humans,” said Mitinori Saitou, senior author of the study. This has huge implications for furthering understanding of how sperm are made, but may also one day lead to a clinical application whereby sperm could could be made for infertile men. The Kyoto paper was “quite a large step forward” in developing a process by which sperm could be made for infertile men, perhaps by taking as a starting point a cell from their skin or from something like bone marrow. More work needs to be done to refine this process … none of the attempts to make sperm from embryonic stem cells have been hugely successful.