Mid-Day: The NASDAQ is DOWN -35.79 (-1.26%) to 2,803.29 while the Dow is also DOWN -165.29 (-1.32%) to 12,337.52.

Mid-Day Market Commentary: Some RegMed stocks have shown a notable move to the … downside in … mid-day … trading on Wednesday after ending the previous session roughly flat. The major averages have slid firmly into negative territory … amid worries that Greece could exit the euro zone and ahead of an informal EU Summit in Brussels. My message to the Greeks … “Let my sector go” … so we can thrive in a non-EU headline!!

The CBOE Volatility Index, <fear gauge> traded … now near 24 … up from 20, today! The weakness on reflects continued concerns about the financial situation in Europe amid a meeting of European leaders in Brussels.  The EU summit is expected to focus on ways to boost the struggling European economy as well as the ongoing uncertainty about Greece following the debt-plagued nation’s failure to form … a garbage collecting society.

Interesting quote from Vanguard’s CEO John Bogle: “Stocks can do what they wish and to some extent the market can do what it wishes. But when you look back at the grand wave of IPOs, the new economy and Internet and information age back in the late ’90s and early 2000s, it’s a fad. It’s in the price of the stock and people are looking for a free ride upward in the new world.”

Truth be told … the old world not, the new normal(s) persist in making its reality felt.

Today’s Gospel:  Many RegMed stocks are DOWN … Mid-day, Wednesday … there are NO leader(s) … few green (ups) … many reds (downs) and … 1 black (flats).

Did you receive the latest update … from Pluristem (PSTI) – 2 patients died … yet, they believe PLX cells will be effective in bone marrow transplantation … tells us … WHY ?? … We keep hearing PSTI is … going to initiate the CLI trial … so “boobie”, when?  And,  another … why … more pre-clinical activities … focus on one for once.  But, it is a card game so we must play all cards and if your going to get a government subsidy to keep the pot big … or to fund trial and R&D … there is nothing wrong in keeping people employeed … call it that and not an investment!

Finally, about, that call back … same old situation … nothing … at least I tried!! When you call CYTX (TB), ASTM (TM or BG) and even NBS (RS), you can guarantee a call within the hour … without fail!

My favorites: 

• Aastrom (ASTM) is down -$0.03 or 1.42%  to -$2.08 after a depreciating week  with a retreating and tightening …  mid-day range $2.06 – $2.12 with … small, volume of 175K shares;

• Cytori (CYTX) is down … +$0.01 or -0.48% to $2.09 in a retreating and tightening trading range of $2.04 – $2.14 with …  small trading of 124k;

• OSIR …. Drops … more as traders take their profits … OSIR declined -$0.39 or -6.55 % to $5.56.

Minimal upward moves: by the hairs … StemCells (STEM),NeoStem (Amex: NBS),Neuralstem (Amex: CUR).

Minimal downward moves: Advanced Cell Technology (OTC BB: ACTC), BioLife Solutions (OTC BB: BLFS), BioTime (Amex: BTX), Brainstorm (OTC BB: BCLI), Cryo-Cell (OTC BB: CCEL), Dendreon (DNDN), Geron (GERN), Opexa (OPXA), Pluristem (PSTI), ReNeuron (RENE.L), Tengion (TNGN), Athersys (ATHX), BioMimetic (BMTI), Cytomedix (OTC BB: CMXI), Fibrocell (OTC BB: FCSC), ImmunoCellular (OTC BB: IMUC),International Stem Cell (OTC BB: ISCO), Thermogenesis (KOOL) and Verastem (VSTM) .

EconRecon is now become … Econorama … so we can identify the drama within the dismal science announcements that affect and effect our universe’s moves.

What’s new in the regenerative medicine/stem cell market … see: www.scimitarequity.com/blog …

Mid-Day: The NASDAQ is UP +9.72 (+0.34%) to 2,856.93 while the Dow is also UP +46.89 (+0.37%) to 12,551.17.

Mid-Day Market Commentary: Some RegMed stocks selectively … climbed Tuesday after a shaky open, with all 10 S&P sectors trading in positive territory, buoyed by a better-than-expected existing home sales report and ahead of Wednesday’s informal EU summit.The CBOE Volatility Index, <fear gauge> traded … now near 20!

Great article by Matt Herper from Forbes: http://www.forbes.com/sites/matthewherper/2012/05/18/four-ways-to-make-medicine-more-like-facebook/2

Today’s Gospel:  Many RegMed stocks are up. … Mid-day, Tuesday … there are even leader(s) … than followers …. … a few more green (ups) and … moderate red (downs) and 1 black (flats) on the screen.

My favorites: 

• Aastrom (ASTM) is up +$0.02 or 0.93%  to -$2.18   with an … increasing …  mid-day range $2.18 – $2.32 with … moderate but, volume of 199K shares;

• Cytori (CYTX) is up … +$0.03 or 1.35% to $2.18 in an … increasing … trading range of $2.11 – $2.19 with …  large volume … of 454k;

• OSIR …. Drops … as traders take their profits … OSIR has declined -$0.37 or -5.82 % to $5.99 on large volume of 230K. 

Minimal upward moves:Athersys (ATHX),  BioLife Solutions (OTC BB: BLFS),  Cryo-Cell (OTC BB: CCEL), Cytomedix (OTC BB: CMXI),  ImmunoCellular (OTC BB: IMUC), International Stem Cell (OTC BB: ISCO), Opexa (OPXA), Pluristem (PSTI), ReNeuron (RENE.L), Tengion (TNGN).

Minimal downward moves: Advanced Cell Technology (OTC BB: ACTC), BioMimetic (BMTI), BioTime (Amex: BTX), Brainstorm (OTC BB: BCLI), Dendreon (DNDN),  Neuralstem (Amex: CUR), StemCells (STEM) and Thermogenesis (KOOL

 Flat: Geron (GERN),Fibrocell (OTC BB: FCSC), NeoStem (Amex: NBS), and Verastem (VSTM).

EconRecon:Existing home sales rose 3.4% to an annual rate of 4.62M units in April to their highest in almost 2 years, according to the National Association of Realtors. Economists polled forecast a 4.6M unit.

What’s new in the regenerative medicine/stem cell market … see: www.scimitarequity.com/bl0g …

Being that I was asked <multiple requests> to repost this … from a blog topic title:

•  Referencing our sector: 5/14/12, What is the message of the market; blame it on the Greeks or start wearing a hoodie?

Let’s get back to my “hoodie” comment at the beginning of the week, “to a tech geek, indifference to dress is a badge of pride because any creative endeavor, whether it’s coding software or writing novels, goes better if you can forget about yourself entirely, forget about how you look, what you’re wearing, how people perceive you”…  

• Bill Gates used to dress like a homeless guy;
• Steve Jobs wore a black turtleneck;
• Mark Zuckerberg wears the hoodie” …

So how would we envision … leading stem cell geeks … envision the current CEO’s … I will take a stab …

• Chris Calhoun, CEO of Cytori (CYTX) with a wetsuit and a surfboard waiting for the … “coming”  … perfect <regulatory> wave as it is swelling …

• Gil Von Bokkelen, CEO of Athersys (ATHX) on the bridge of a naval destroyer hoping to “launch” the hellfire missile of stock appreciation or push the “depth-charge button” on short sellers …

• Tim Mayleben, CEO of Aastrom (ASTM) as a mason and bricklayer … solidifying the stone of each upright as he builds the “Stonehenge” of tomorrow … or even:

• Dr. Robin Smith, CEO of NeoStem (Amex: NBS) as a fully armed to the teeth “whirling dervish” trying to … “fight off and exit” … the Chinese hordes!

 Do you agree … what do you think … email your thoughts … any others …?

Mid-Day: The NASDAQ is DOWN -21.66 (-0.75%) to 2,852.38 while the Dow is also DOWN -49.08 (-0.39%) to 12,549.47.

Mid-Day Market Commentary: Some RegMed stocks opened higher (ASTM, CYTX, OSIR and STEM) but, struggled with … buoyancy … and keep struggling  to gain footage and visibility … in choppy trading  from …  macro events on Thursday, as more economic reports … confuse the markets. The CBOE Volatility Index, <fear gauge> traded near 21, yet again.

RegMed stocks have moved modestly lower in …mid-day … trading on Thursday, extending the downward move seen in recent weeks. The major averages have slipped into negative territory after ending the previous session at their worst closing levels in over 3 months. The early weakness … continues and … likely reflects continued concerns about the financial situation in Europe, with traders keeping an eye on the latest developments in Greece. Traders are also digesting the initial jobless claims report, which showed that claims unexpectedly came in unchanged.

Today’s Gospel:  RegMed stocks are down. … Mid-day, Thursday … there are few leader(s) …an even green (ups) and red (downs) and 4 black (flats) on the screen. There doesn’t seem like there’s any specific news headline, but it’s more of the same worries in Europe and investors are nervous!

My favorites: 

• Aastrom (ASTM) is down +$0.04  to $2.21 with a … decreasing …  mid-day range $2.16 – $2.27 from yesterday’s $2.33 -$2.43 with … moderate but, better volume of 205K shares;

• Cytori (CYTX) is up and down … since yesterday … in an decreasing trading range of $2.16 – $2.27 with …  small trading of 165k as compared to yesterday’s162K;

• Ah ha, Osiris (OSIR) is up … yet again … $0.18 or +3.39% to $5.49 in moderate volume of 111K  but, increasing trading range of $5.32 -$5.65 as compared to yesterday’s $4.93 – $5.19 and Verastem (VSTM) was gyrating up but, was backing off, then up again … $0.24 or +2.47% to $9.96.  

Minimal upward moves: Advanced Cell Technology (OTC BB: ACTC), BioMimetic (BMTI), ImmunoCellular (OTC BB: IMUC), International Stem Cell (OTC BB: ISCO), Opexa (OPXA), Thermogenesis (KOOL)

Minimal downward moves: Athersys (ATHX), BioTime (Amex: BTX), Cytomedix (OTC BB: CMXI),Dendreon (DNDN), Geron (GERN), Neuralstem (Amex: CUR), Pluristem (PSTI), ReNeuron (RENE.L), StemCells (STEM), Tengion (TNGN).

Flat: Cryo-Cell (OTC BB: CCEL),Fibrocell (OTC BB: FCSC) and NeoStem (Amex: NBS).

EconRecon: Jobless claims came in at 370,000, unchanged from the previous week’s revised figure. Economists had expected jobless claims to edge down to 365,000 from the 367,000 originally reported for the previous week. On the economic front, leading indicators dipped 0.1 percent in April, falling for the first time in seven months.  Economists had expected the index to increase 0.1%. The pace of factory activity in the mid-Atlantic region unexpectedly contracted in May, plunging to minus 5.8 from 8.5 in April, according to the Philadelphia Federal Reserve Bank. Economists had expected for a reading of 10.0.

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

Dendreon’s (DNDN) rival J&J’s Zytiga is giving Provenge a run for share pricing dropped 11.83% in mid-day trading after Johnson & Johnson’s rival medicine Zytiga helped high-risk patients in a study. DNDN slid to $7.60.  Zytiga, approved last year to treat metastatic prostate cancer, helped eliminate tumors in people whose malignancy hadn’t yet spread beyond the prostate gland. Zytiga, the once-a-day drug costs about $5,000 a month, while Provenge treatment costs $93,000. DNDN had plunged 25% on May 8, the most in 6 months, after growth this year will be “modest” and its first-quarter loss fell short of estimates. DNDN also disclosed in a May 7 filing that the SEC opened a probe that may be related to the withdrawal of a revenue estimate last year.

Let’s get back to my “hoodie” comment at the beginning of the week, “to a tech geek, indifference to dress is a badge of pride because any creative endeavor, whether it’s coding software or writing novels, goes better if you can forget about yourself entirely, forget about how you look, what you’re wearing, how people perceive you”.  Bill Gates used to dress like a homeless guy, and Steve Jobs wore a black turtleneck, Zuckerberg wears the hoodie” …

We all need … levity … for this market! So how would we envision … leading stem cell geeks … envision the current CEO’s … I will take a stab … Chris Calhoun, CEO of Cytori (CYTX) with a wetsuit and a surfboard waiting for the … “coming”  … perfect <regulatory> wave as it is swelling … Gil Von Bokkelen, CEO of Athersys (ATHX) on the bridge of a naval destroyer hoping to “launch” the hellfire missile of stock appreciation or push the “depth-charge button” on short sellers … Tim Mayleben, CEO of Aastrom (ASTM) as a mason and bricklayer … solidifying the stone of each upright as he builds the “Stonehenge” of tomorrow … or even Dr. Robin Smith, CEO of NeoStem (Amex: NBS) as a fully armed to the teeth “whirling dervish” trying to … “fight off and exit” … the Chinese hordes!

STEM completed the first planned interim safety review of the P1/2 spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of HuCNS-SC® cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. All patients enrolled were transplanted with a dose of 20M cells at the site of injury in the thoracic spinal cord.

The Bottom Line: There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first 4 months following transplantation of the cells. All patients received HuCNS-SC cells through direct transplantation into the spinal cord and were temporarily immunosuppressed.  The trial, which is being conducted at Balgrist University Hospital, Zurich, Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in spinal cord injury. STEM is only up $0.14 or 1.655 to $0.862 in a down market.

Mid-Day: The NASDAQ is now Down - 1.45 (-0.05%) to 2,892.31 while the Dow is UP +12.31 (+0.17%) to 12,653.31.

Mid-Day Market Commentary: Some RegMed stocks opened higher (ASTM and OSIR) as others struggled to gain footage … in choppy trading Wednesday, as economic reports … get better. The CBOE Volatility Index, <fear gauge> traded near 21, again.

Today’s Gospel:  RegMed stocks are down. … Mid-day, Wednesday … there are few leader(s) …a few green (ups) and more red (downs) and 5 black (flats) on the screen. After trending lower in recent sessions, stocks are moving notably higher in early trading on Wednesday. The major averages have seen some further upside in the past hour, reaching new highs for these session. The early strength is partly due to … bargain hunting, with traders picking up stocks at reduced levels following the recent weakness in the markets. The markets have also benefited from some upbeat US economic data, including a report from the Fed showing a much bigger than expected increase in industrial production in April.

My favorites: 

• Aastrom (ASTM) is up +$0.03  to $2.35 with a … decreasing …  mid-day range $2.33 -$2.43 with … low volume to start the day but, picking up … volume of 112K shares;

• Cytori (CYTX) is down $0.085 <-3.87%< to $2.16 … in an decreasing trading range of $2.16 – $2.27 with …  small trading of 162K;

• Ah ha, Osiris (OSIR) is up $0.18 or +4.41% to $5.19 in a decreasing trading range of $4.93 – $5.19 and Verastem (VSTM) is down $0.12 or -1.24% to $9.57.

Minimal upward moves: Advanced Cell Technology (OTC BB: ACTC), BioTime (Amex: BTX), BioMimetic (BMTI), Dendreon (DNDN), ImmunoCellular (OTC BB: IMUC), Opexa (OPXA),

Minimal downward moves: Athersys (ATHX), Cytomedix (OTC BB: CMXI) – post earnings, Geron (GERN), Fibrocell (OTC BB: FCSC), NeoStem (Amex: NBS), Neuralstem (Amex: CUR), and Pluristem (PSTI), ReNeuron (RENE.L), StemCells (STEM), Tengion (TNGN).

Flat: Cryo-Cell (OTC BB: CCEL),International Stem Cell (OTC BB: ISCO) – post earnings,

EconRecon: Housing starts rose more than expected in April, gaining 2.6% to a seasonally adjusted annual rate of 717,000 units. Economists had forecast housing starts rising to 680,000-unit rate. Still, building permits fell 7%. And industrial production grew 1.1% in April, posting its fastest growth in over a year, according to the Federal Reserve, after being flat in February and March.

What’s new in the regenerative medicine/stem cell market … Earnings (LPS) Season is all but over …

Net loss of $6.1M, or $0.22 per share compared to a net loss of $8M, or $0.28 per diluted share, for Q1/11.

For Q1/12, BMTI reported total revenues of $0.5M consisting of sublicense fee income, royalty income and product sales. This compares to total revenues of $0.4M recorded for Q1/11.  R&D expenses totaled $2.8M for Q1/12, compared to $4.1M for Q1/11. R&D expenses include outside professional services expenses, as well as salaries, wages, benefits, payroll taxes and stock-based compensation expense for internal research and development personnel, and relate to clinical trials of our product candidates in the US, Canada, Australia and the EU, as well as continuing expenses associated with pre-clinical studies and regulatory filings. The 2012 expenses for professional services and manufacturing activities decreased by $0.5M, as costs associated with the  Augment Injectable clinical trial have decreased since voluntarily suspended additional screening and enrollment of patients to conserve resources and focus its attention on addressing the Augment PMA. Salaries, benefits, payroll taxes and stock-based compensation expense in the R&D function decreased in 2012 by a combined $0.7M due to a reduction in staffing. In addition, expenses for general business activities in the R&D function, such as travel, recruiting and relocation, lab supplies, and freight, decreased in 2012 by $0.1M. SG&A expenses totaled $3.4M for Q1/12, compared to $4M for Q1/11. The 2012 expenses for SG&A activities decreased primarily from efforts to carefully manage expenses and conserve resources given the uncertainty surrounding the FDA review process of its PMA application for Augment, offset partially by sales, marketing and customer service efforts, particularly in connection with activities surrounding the preparation for commercial launch of Augment and Augmatrix. Expenses for professional services decreased in 2012 by $0.4M, and expenses for general business activities in the SG&A function, such as travel, conferences and seminars, recruiting and relocation, dues and subscriptions, office supplies, rent and utilities, decreased in 2012 by $0.2M.

• BMTI ended Q1/12 with $54.5M of cash and cash equivalents and investments.

2012 Financial Guidance: Based on current operating plans, forecasted timing and costs of clinical trials and other product development programs, BMTI anticipates its 2012 year-end balance of cash, cash equivalents and investments to range from $32 to $39M, and anticipates its net cash use will be between $22 and $29M. Net loss for the year ending December 31, 2012 is forecasted to be in the range of $23 to $30M.

Q1/12 Highlights:

• In January 2012, announced receipt of a comprehensive post-panel response letter from the FDA related to the Pre-Market Approval (PMA) application for Augment®Bone Graft. The letter detailed the information needed to submit for the FDA to complete its review of the PMA application. Continues to work toward completion of the requested additional analyses and expects to submit the information in the form of an amendment to its PMA application by the middle of 2012. Although the timing and nature of the FDA’s response cannot be predicted with certainty, by statute the FDA has 6 months from the date of submission to respond to a PMA amendment.

• Pursuing regulatory approvals for Augment Bone Graft in several OUS (outside US) markets. In addition, the Company is awaiting reimbursement decisions in Australia and New Zealand where Augment has already received approval.

• In April, shipped its first orders of Augmatrix™ Biocomposite Bone Graft to its distributors who have begun the process of getting Augmatrix stocked in hospitals and surgical centers, while educating surgeons on the attributes of the product line. Augmatrix is a family of grafting materials that has been FDA cleared for use in orthopedic indications for which Augment will not initially be indicated. Augmatrix is comprised of carbonate-apatite and bovine Type I collagen and is designed to be combined with bone marrow aspirate (BMA).

• Continues to work with European Union (EU) regulatory authorities toward a final CE Mark decision for GEM 21S®. Luitpold Pharmaceuticals, a subsidiary of Daiichi Sankyo, Inc., which bought the rights to the dental and cranio-maxillofacial applications for BMTI’s rhPDGF-BB technology, has notified that it is evaluating whether the conditions for the $10M milestone payment it owes BMTI  upon approval of GEM 21S in the EU have been satisfied. Earlier this year, at the request of Luitpold, the EU regulatory authorities indicated they would be re-evaluating the CE Mark recently granted for the product to determine if the product was properly classified as a medical device rather than a medicinal. BMTI is considering its options in the event Luitpold does not make the payment.

Net loss of $4.1M or $0.05 per share in Q1/12 is compared to a net loss of $1.7M or $0.02 in Q1/11.

Revenues were $1.07M in Q1/12 compared to $1.5m in Q1/11. Cost of sales was $324K compared to $429K in Q1/11. R&D expenses were $937K versus $1M in Q1/11. Marking costs were $496K versus $318k in Q1/11. G&A expenses were $2.04M in Q1/12 reflecting an 8.5% decrease as compared to $2.23M in Q1/11. The decrease is primarily attributable to the absence of stock-based compensation for services provided by a consultant amounting to $303K and lower employee stock-based compensation of $112K. The decrease was partially offset by an increase in professional accounting fees and Sarbanes-Oxley compliance efforts of $107K, higher legal fees of $61K relating to corporate activities, higher consulting expense of $26K and higher personnel related expenses of $25K. Total development costs were $3.79M in Q1/12 as compared to $3.98M in Q1/11. Loss from development activities were $2.71m versus $2.46M in Q1/11. Net loss was $2.67M versus $1.49m in Q1/11. Net loss applicable to shareholders was $4.13M in Q1/12 versus $1.7m in Q1/11. Net cash used in operating activities was $2.03M for Q1/12, compared to $970K for q1/11. The primary factors contributing to the variability in the report cash flow amounts relate to the net loss after non-cash adjustments totaling $1.87M in Q1/12 compared to $1.16M in Q1/11. Furthermore, the timing of customer payments and billings, vendor payments and invoicing, lower deferred revenue balances resulting from lower sales generated from skin care products and lower inventory balances contributed to the increase in net cash used in operating activities inQ1/12. Weighted average of basic and diluted shares used in computing the net loss was 82.48m as compared to 75.36M in Q1/11.

• Cash and cash equivalents was $6M

The Bottom Line: Although ISCO primary focus relates to intellectual property developed internally, some of the patents utilized are licensed  by Advanced Cell Technology, which has licensed some of these from other parties, including the University of Massachusetts. These licenses are subject to termination under certain circumstances (including, for example, failure to make minimum royalty payments). The loss of any of such licenses, or the conversion of such licenses to non-exclusive licenses, could harm operations and/or enhance the prospects of competitors. Certain parts of know-how and technology are not patentable or are trade secrets. To protect proprietary position in such know-how and technology, ISCO intends to require all employees, consultants, advisors and collaborators to enter into confidentiality and invention ownership agreements. These agreements may not provide meaningful protection for trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure. Further, in the absence of patent protection, competitors who independently develop substantially equivalent technology may harm ISCO’s business. As long as the trading price of ISCO’s common stock is below $5.00 per share, the open market trading of common stock will be subject to the “penny stock” rules, unless  otherwise qualified for an exemption from the “penny stock” definition. The “penny stock” rules impose additional sales practice requirements on certain broker-dealers who sell securities to persons.

Net loss of $4.74M or $0.07 per share included $3.44M in non-recurring and/or non-cash expenses and transaction costs, compared with a net loss  of $1.50M or $0.03 per share.

Total revenues for Q1/12 were $3.02M, an increase of 121% compared with total revenues of $1.37M for Q1/11. The increase was largely attributable to the recognition of $1.33M in license revenue from the $4.50M in total non-refundable option fees received to date in connection with the potential agreement with a global pharmaceutical company, as well as from higher sales of the Angel and AutoloGel Systems. Sales from the Angel product line increased 18% to $1.51M from $1.28M in Q1/11. Record quarterly AutoloGel System sales of $164,000 increased 89% compared with Q1/11. Gross profit for Q1/12 increased 201% to $2.17M from $720K for Q1/11, primarily due to the $1.33M in licensing revenue that had no related cost of revenue. Gross profit on product sales increased 16% to $838K. Gross margin on product sales for Q1/12 was 50% compared with 53% for Q1/11 primarily the result of a shift in product mix to lower-margin products as CMXI recorded a significant number of Angel device sales to international distributors and wrote off some obsolete inventory. Q1/12 cash margin on product sales, excluding $116K in patent amortization and depreciation expense, was 56%. Cash margin is a non-GAAP financial measure, most directly comparable to gross margin, and should not be considered as an alternative thereto. CYMX defines cash margin as gross margin exclusive of patent amortization and depreciation expense, and it is a significant performance metric used by management to indicate cash profitability on product sales. Operating expenses for Q1/12 increased to $4.89M from $2.20M in q1/11. This increase was primarily attributable to transaction related costs associated with the Aldagen acquisition of approximately $528K, and approximately $979K in non-recurring, non-cash stock compensation expense for options granted to former Aldagen employees, consultants and board members. CMXI also incurred additional expenses in Q1/12 related to reimbursement, regulatory and marketing initiatives. Other expense for Q1/12 of $2M compared with other income of $78K in Q1/11.  The change was primarily due to approximately $1.5M in non-cash inducement expense associated with common stock issued in exchange for the early conversion of Series D preferred stock and incentive warrants issued in exchange for the early exercise of existing warrants. Additionally, there was an approximate $424K in expense associated with non-cash interest costs and change in fair value of derivative liabilities. CMXI used $509K in cash to fund operating activities during the first quarter 2012. An additional $1.18M in cash from warrant exercises was received post quarter end associated with the remaining binding commitments for warrant exercises by 6/30//12. Shares used in computing the net loss were 63.26M in Q1/12 and 46.05M in Q1/11.

• Cash and cash equivalents as of 3/31/12 were $8.5M, compared with $2.25M as of 12/31/11.

Q1/12 highlights:

• The acquisition of Aldagen broadened CMXI footprint in regenerative medicine and provided a robust pipeline of product candidates in areas of large unmet medical need. CMXI are in the process of integrating the Aldagen technology into the business and have made progress with ongoing development programs. CMXI has advanced the P2 RECOVER-Stroke trial, which is assessing ALD-401 to treat post-acute ischemic stroke, and saw positive data from a P1 clinical trial of ALD-201 to treat ischemic heart failure published in the American Heart Journal;
• CMXI continued to post significant revenue growth for the Angel® Whole Blood Separation System during the quarter, and looks forward to expanding its potential with enhanced targeted marketing efforts as well as expansion into other indications to increase utilization. CMXI has a 510(k) application on file with the FDAfor Angel to process bone marrow and are evaluating strategies to leverage the utility of this product in sports medicine and orthopedics where there is a growing market opportunity. In addition, CMXI also posted a record revenue quarter for AutoloGel even though commercial sales focus was on Angel while AutoloGel efforts were dedicated to reimbursement and partnership initiatives.

Net loss for Q1/12 was $9.45M, or $0.08 per share compared to $10.36M or 40.14 per share in Q1/11.

Consolidated revenues for Q1/12 were $22.1M, compared to $19.6M in Q1/11. Cost of revenues <COR> was $16.32M for a gross profit of $5.73M versus a Q1/11 COR of $14.27M and a gross profit of $5.31M. R&D expenses were $2.71M as compared to $2.75M in Q1/11. SG&A expenses were $9.452M in Q1/12 as compared to $9.63M in Q1/11, a decrease of 2%. R&D expenses were $2.71M compared to $2.75M for Q1/11, representing an decrease of approximately1%. Equity-based compensation included in R&D expenses for Q1/12 was approximately $161K compared to approximately $260K for Q1/11. Operating expenses totaled $12.16M as compared to $12.39m in Q1/11 with an operating loss of $6.43M in Q1/12 versus $7.07M in Q1/11. The net loss from continuing operations was $7.48M versus $8.77M in Q1/11. The net loss from discontinued operations was $9.2M as compared to $10.36M in Q1/11. The net loss from or attributable to non-controlling interests was $9.45M as compared to $10.36M in Q1/11. Shares utilized in computing the net loss in Q1/12 were 111.8M as compared to 73.65M in Q1/11.

• As of 3/31/12, NBS had between its US and China operations consolidated cash and cash equivalents of $21.8M, and an additional $2.5M in cash held in escrow.

The Bottom line: NBS is an accident in the making regarding monetizing its Erye, China pharmaceutical subsidiary through divestiture <by the end of 2012, as stated in the filing> but, remains focused on its stem cell therapeutic contract manufacturing business (PCT) which seems to be doing well and initiating enrollment of patients in the PreSERVE AMR-001 P2 clinical trial for preserving heart function after a heart attack. As I read through the recent SEC filing … the Chinese subsidiary is a train wreck of related party transactions … maybe, if, when and even Erye can be monetized or the divestiture can occur… It seems to be a legal case to be played out over the next … (?) years. Reading through the particular paragraphs related to the potential of a probable sale … will NBS … be subject or party to multiple suits? NBS is also subject to a right of first refusal from Erye or as I would surmise the Chinese Army … and in which or what time frame? What about the debt, borrowings and legal moves against this subsidiary? If the sale were to go through … why announce … pre the divestiture … and as it lingers … it is more of a bottomless pit of monetary and value drain of credibility and share value. While continuing to develop the US assets, NBS will probably have to cut the burn rate … discontinue operations that … don’t contribute to share price appreciation … As far as the consolidated cash and cash equivalents $ position … aren’t the accounts frozen in China? I personally like their CEO but, she needs to truly … actualize and articulate the facts …with a conference call … not, just let an SEC document do her talking.

Mid-Day: The NASDAQ is UP +21.69 (+0.75%) to 2,924.27 while the Dow is UP +42.12 (+0.33%) to 12,737.47.

 Mid-Day Market Commentary:RegMed stocks struggled to hold their gains in choppy trading Tuesday, as investors weighed a batch of Q1/12 earnings, better-than-expected economic reports against news that Greek party leaders failed to agree on a coalition government. The CBOE Volatility Index, <fear gauge> in the market traded near 21.

Today’s Gospel:  RegMed stocks are down, yet again in this choppy … EU driven market … Mid-day, Tuesday … there are few leader(s) …a few green (ups) and more red (downs) and 5 black (flats) on the screen.

My favorites: 

• Aastrom (ASTM) is up and down was +$0.08, now +$0.02  to $2.41 with an … increasing <from yesterday> …  mid-day range $2.36 -$2.47 with … large … volume of 86K shares;

• Cytori (CYTX) is down -$0.04 <-1.69%< to $2.33 … in an decreasing trading range of $2.29 to $2.39 from yesterday’s …$2.36 – $2.43 with …  small trading of 40K;

• Osiris (OSIR) is also down $0.01 or -0.20% to $5.07 in the day’s trading range of $4.99 – $5.15 and Verastem (VSTM) is up $0.14 or 1.47% to $9.67.

Minimal upward moves: Advanced Cell Technology (OTC BB: ACTC), BioMimetic (BMTI), Geron (GERN), Opexa (OPXA), NeoStem (Amex: NBS), Pluristem (PSTI), ReNeuron (RENE.L), StemCells (STEM), Tengion (TNGN).

Minimal downward moves: Athersys (ATHX), BioTime (Amex: BTX), Cryo-Cell (OTC BB: CCEL),Cytomedix (OTC BB: CMXI),Dendreon (DNDN), ImmunoCellular (OTC BB: IMUC), International Stem Cell (OTC BB: ISCO), Fibrocell (OTC BB: FCSC),Neuralstem (Amex: CUR), and

EconRecon: The homebuilder sentiment jumped to 29 in May from 24 in April, according to the National Association of Home Builders/Wells Fargo Housing Market index, beating expectations for 26 and hitting a 5-year high.

Net loss was $6.9M, or $0.47 per share compared to $1.2M, or $1.06 per share.

R&D expense was $4.8M compared to $675K for the 2011 Quarter. The $4.1M increase from Q1/11 to Q1/12 principally resulted from an increase of $1.4M in CRO expense, an increase of $1.4M for personnel costs, including stock-based compensation of $856K, an increase of $482K in license fee expense primarily related to the revaluation of a warrant that we have agreed to issue to Poniard Pharmaceutical (Poniard) upon achievement of a milestone and an increase of $315K for laboratory supplies. G&A expense was $2.1M compared to $471K for Q1/11. The $1.7M increase from Q1/11 to the Q2/12 principally resulted from an increase of $973K for personnel costs, including stock-based compensation of $620K, an increase of $274K in professional fees primarily related to additional legal and accounting fees for being a publicly traded company, an increase of $157K in consulting fees and an increase of $96K in insurance primarily related to being a publicly traded company. Net loss includes stock-based compensation expense of $1.5M for Q1/12 and $54K for Q1/12.  Net loss for Q1/12 includes a non-cash charge of $431K related to the revaluation of a warrant that VSTM agreed to issue to Poniard upon achievement of a milestone under a license agreement. Shares used to compute the net loss were 14.69M versus 1.09M in Q1/11.

• VSTM had cash, cash equivalents, short-term investments and long-term investments of $109.3M compared to $56.8M on 12/ 31/11.

Q1/12 Highlights:

• Completed IPO, resulting in approximately $56.8M of net proceeds;
• Broadened cancer stem cell product candidate and intellectual property portfolio through exclusive in-licensing and asset acquisition efforts: From the Broad Institute of Harvard and MIT: Three families of novel compounds discovered in a 300,000 compound screening campaign and from S*Bio: A novel mTOR/PI3K inhibitor program.

The Bottom line: VSTM closed Monday, 5/14/12 at $9.53 <on a depreciating market day> down $0.41 or 4.12%. A $200.69 M market cap with an enterprise value of 161.25 with 21.06 shares outstanding and a float of 8.12M but, a short ratio of 7.90% or 365.62K shares <3.50% of float> … and no debt …. Dream on other stem cell companies … they are newly public!

Net loss of $2.37M or $0.10 per share compared with a Q1/11 net loss of $1.3M or $0.06 per share.

OPXA reported no commercial revenues in Q1/12 or in Q1/11. R&D expenses were $1.49M compared with $685K for Q1/11. The increase in expenses was primarily related to an increase in the procurement and use of laboratory reagents and supplies, and increases in professional service fees, employee personnel costs, facility costs and non-cash stock compensation expense.  G&A expenses were $816K, compared with $592K for Q1/11. The increase in expense is due to increases in business development activities, legal expenses, employee compensation expense and non-cash stock compensation expense. Depreciation and amortization expenses were $67K, compared to $29.6K for Q1/11. The increase in expense is due to increases in depreciation for facility build-out costs, and increases in depreciation for laboratory, manufacturing and information technology equipment acquired during 2011 and 2012. The operating loss was $2.373M compared to $1.3M in Q1/11. Shares used in computing the net loss were 23.04M in q1/12 compared to 20.95M in Q1/11.

• Cash and cash equivalents were $4.67M, compared to $11.4M in Q1/11.  

Q1/12 highlights:

• Submission to the FDA for final review of the protocol for a P2b clinical trial for Tovaxin in patients with Secondary Progressive MS (SPMS) and, after receiving no additional comments from the FDA, being positioned to proceed with the trial from a regulatory perspective;
• Conducting a kick-off meeting with prospective clinical trial investigators at the 64th Annual American Academy of Neurology (AAN) meeting to review patient enrollment practices and the planned clinical trial details and protocol;
• Agreement with Pharmaceutical Research Associates (PRA) to provide CRO services to support the planned clinical trial.

The Bottom Line: OPXA is progressing to a clinical trial in Secondary Progressive MS patients. The clinical trial protocol was submitted to the FDA for final review and OPXA has received no additional comments OPXA … needs to secure additional financing.  The share price continues to drop <in a depreciated market, like the entire sector> and is trading well below the NASDAQ listing requirements. Monday, 5/13/12, OPXA traded down $0.0261 or 4.50% to $0.559. Interesting, the change in filing language in the 10Q – “from exploring to preparing” … a P3 in RR-MS … also depend(ing) on sufficient resources! One last fact, OPXA was last trading above $1.00 on 2/24/12. Nasdaq is watching … the delisting letter was issued 2/10/12 and OPXA has until 8/8/12 to regain compliance and as stated needs to recapitalize … is a split needed as well as a capital raise !

There are 5,046 tons of gold at Fort Knox

There are 7,716 tons of gold at Fed NY

Total = 12,762 tons… there are 32,000 ounces in a ton, 12,762 tons x 32,000 = 408,384,000 x $1,590 (price of Gold) = $649,330,560,000

Sorry… but $650 Billion doesn’t even pay for the stimulus that was thrown at us a couple of years ago! But… if the price of Gold were to be pushed up to, let’s say, $5,000… Then we would be talking about making some inroads to the debt! And if the price were pushed to $10,000, then we’re getting somewhere, but… we would still be left with a very large national debt…

You see that’s the problem with deficit spending… at some point, the numbers become so HUGE that you can’t make a difference in total unless you come in with both guns blazing! And then keep those guns blazing! Doing one-off corrections, are only chinks in the armor…

For long time readers… do you remember a few years ago, when I tried to show the knuckleheads at CNBC that the markets were being manipulated in the afterhours trading, and they laughed and told me to take the story to Hollywood? Well… CNBC has come a long way, I guess, for they allowed Eric Sprott to talk freely about manipulation the other day… Of course maybe not that long a way, as I wanted to include the link to the video here, but it’s not working… and the folks at CNBC did attempt to ridicule him…. But he would have none of it!

Maybe CNBC will have it fixed later, just Google Eric Sprott at CNBC, and look for the most recent video..

Anyway, Eric Sprott, Ted Butler, and others, including me, have done our best to inform the public of what’s going on… Maybe one day, We The People will get the message… and exercise our right to contact our representatives and discuss this with them…

Then There Was This… I saw this on Reuters… “Financial advisers increasingly warn that U.S. Treasury bonds are close to a bubble and suggest that clients look elsewhere for stable and safe returns. Alternatives recommended include investment-grade corporate and emerging-market bonds, master limited partnerships and preferred stocks.”

Chuck again… Hmmm… I liked that they had finally come around to noticing the Treasury bubble, but nowhere on their list of alternatives did I see Gold?

To recap… the mini-rally in a handful of currencies yesterday, was wiped out in the overnight markets, and the currencies and Gold are back to Wednesday’s levels. The Greeks agree to elect a government that keeps Greece in the euro. The U.S. posted a monthly surplus for the first time a very long time in April, but then tax collections are made in April, one would think that if they can’t book a surplus in April, when could they? And JP Morgan has really thrown a spanner in the works for a Risk On Day, with their aftermarket announcement yesterday…

Currencies today 5/11/12… American Style: A$ $1.0040, kiwi .7845, C$ .9950, euro 1.2935, sterling 1.6110, Swiss $ 1.0770, … European Style: rand 8.1150, krone 5.8650, SEK 6.9550, forint 224.20, zloty 3.2815, koruna 19.52, RUB 30.15, yen 80, sing 1.2520, HKD 7.7650, INR 52.64, China 6.31, pesos 13.54, BRL 1.9530, Dollar Index 80.25, Oil $96, 10-year 1.85%, Silver $28.66, and Gold… $1,582.70

That’s it for today… Well… Let’s see… today we will celebrate two birthdays on the trading desk, Lori/ Gidget and Aaron will see their birthdays this Sunday… So Happy Birthday Gidget & Aaron! Sunday, of course, is Mother’s Day… This is a day when I truly miss my mom… and not the mom that was devastated by MS later in life… the mom that would come downstairs and listen to me play the guitar. She loved it when the band got together to play in the basement, and most of all, she was always there for me, and sometimes I didn’t deserve to be “there for”, but that didn’t stop her… So, if your mom is around, give her a great big bear hug, and tell her you love her! OK… time to get this out the door… you’ve been a lovely audience, thank you for reading the Pfennig… I was here all week, I hope you tried the veal! Talk to you next week from Las Vegas… now go out and have a Fantastico Friday!

Mid-Day: The NASDAQ is UP +13.87 (+0.47%) to 2,947.51 while the Dow is UP +11.58 (+0.09%) to 12,866.62.

Mid-Day Market Commentary:  Stocks extended their gains Friday, thanks to a better-than-expected consumer sentiment report. The CBOE Volatility Index <fear gauge> slipped below 19. After moving lower at the start of trading on Friday, stocks have turned mixed over … mid-day trading. The major averages have bounced off their lows for the young session, with the NASDAQ climbing into positive territory. The major averages currently remain stuck on opposite sides of the unchanged line. Disappointing economic data from China also weighed on the markets, although selling pressure waned not long after the open. An upbeat reading on consumer sentiment has contributed to subsequent turnaround, with the Reuters/University ofMichigan’s consumer sentiment unexpectedly jumping to 77.8 in May from 76.4 in April.

Today’s Gospel:  RegMed stocks are up as traders … re-enter and “cover”a depreciated sector. RegMed stocks opened … up … in a mixed market and is still … bouncing … mid-day, Friday … with few leader(s) …a  few green (ups) and even red (downs) and 3 black (flats) on the screen. No pearls of wisdom … other than … more definition to the future is needed … TGIF – my model portfolio is crying from actionable intelligence neglect!!

My favorites: 

• Aastrom (ASTM) is up and down $0.01 to $0.02 to $2.50 with a … decreasing …  mid-day range ($2.50 – $2.57), with … thin … volume of 45K shares;

• Cytori (CYTX) is down $0.01 <-0.40%< to $2.47 … in an increasing trading range of $2.41 -$2.49 with …  thin trading of 92K as earnings conference call thoughts germinate with investors still trying to understand their regulatory pathway;

• Osiris (OSIR) is up $0.44 or +8.96% to $5.35 post conference call clarity and Verastem (VSTM) is up $0.25 or 2.53% to $10.13.

Minimal upward moves:  Cryo-Cell (OTC BB: CCEL), Cytomedix (OTC BB: CMXI), Dendreon (DNDN), Geron (GERN), ImmunoCellular (OTC BB: IMUC), NeoStem (Amex: NBS), Pluristem (PSTI), ReNeuron (RENE.L), Tengion (TNGN) and ThermoGenesis (KOOL).

Minimal downward moves: Advanced Cell Technology (OTC BB: ACTC), Athersys (ATHX), BioTime (Amex: BTX), BioMimetic (BMTI), International Stem Cell (OTC BB: ISCO), Fibrocell (OTC BB: FCSC),Opexa (OPXA), Neuralstem (Amex: CUR) and StemCells (STEM).

Flats: BioLife Solutions (OTC BB: BLFS) and ReNeuron (RENE.L).

EconRecon: Consumer sentiment rose to its highest level since 2008, with the Thomson Reuters/University of Michigan’s preliminary May reading on the overall index on consumer sentiment improving to 77.8 from 76.4 in April. Economists expected a reading of 76.2 compared with 76.4 in the final April report

What’s new in the regenerative medicine/stem cell market … A Number of Earnings Releases … to know from yesterday:  

Aastrom Biosciences (ASTM) Q1/12 Results and Highlights: ASTM reported a net loss of $9.7M, or $0.25 per share, for Q1/12, compared to a net loss of $5M, or $0.13 per share, for Q1/11. The increase in net loss compared to Q1/11 is primarily due to non-cash changes in the fair value of the outstanding warrants and an increase in R&D expenses. http://www.scimitarequity.com/blog/2012/05/10/aastrom-biosciences-astm-q112-results-and-highlights

ThermoGenesis Q3/12 Results and Highlights: KOOL reported a net loss of $1.8M, or $0.11 per share, in Q3/12, compared to a net loss of $845K or $0.06 per share, in Q3/12. http://www.scimitarequity.com/blog/2012/05/11/thermogenesis-kool-q312-results-and-highlights/

Osiris (OSIR) Q1/12 Results and Highlights: Net loss was $1.3M or $0.04 compared to net income of $4M or $0.12 in Q1/11. http://www.scimitarequity.com/blog/2012/05/11/osiris-osir-q112-results-and-highlights/

StemCells (STEM) Q1/12 Results and Highlights: Net loss for Q1/12 was $10.23M, or $0.45 per share, compared with a net loss of $5.74M, or $0.42 per share in Q1/11. http://www.scimitarequity.com/blog/2012/05/11/stemcells-stem-q112-results-and-highlights/

BioTime (NYSE AMEX: BTX) Q1/12 Results and Highlights: Net loss was $5M or $0.10 per share, compared to a net loss of $3.4M or $0.07 per share for Q1/11. http://www.scimitarequity.com/blog/2012/05/11/biotime-nyse-amex-btx-q112-results-and-highlights

Net loss was $5M or $0.10 per share, compared to a net loss of $3.4M or $0.07 per share for Q1/11.

Q1/12 total revenue (including royalties from product sales and other revenue, revenue recognition of deferred license fees and grant income), on a consolidated basis, was $631.9K, compared to a down $193K from $824.6K for Q1/11.  The decrease in revenue year-over-year in Q1/12 is primarily attributable to a decrease in royalties and license fees from the sale of Hextend^®, proprietary blood plasma volume expander used in surgery and trauma care.  

R&D expenses were $4.178M compared to $2.948M in Q1/11. G&A expenses were $2.37M compared to $1.9M in Q1/11. Q1/12 total expense was $6.5M, compared to a total expense of $4.9M for Q1/11.  Operating expenses increased $1.6M year-over-year in Q1/11 due to increased expenses related to the amortization of patent assets from previous acquisitions, employee compensation and headcount-related costs, patent-related legal fees, and expenses related to increased efforts in the ReneviaTM (formerly HyStem^®-Rx) clinical development program slated for human clinical trials in FY12 and the PanC-Dx^TM diagnostic development program.  

Net cash used in operating activities was $5.7M for Q1/12 compared to $3.4M for Q1/11, reflecting the hiring of additional staff and increased headcount-related expenses, the payout of annual bonuses, and increased expense related to R&D programs in subsidiaries.  Excluding one-time discretionary expenses, which included bonuses and license payments, the net cash used in operations for Q1/12 was approximately $4.2M.  A BTX subsidiary, OncoCyte Corporation, currently holds 1,286,174 in BTX common shares.  The common shares are accounted for as Treasury Stock on a consolidated basis, but this investment account, currently valued at approximately $5M, is available to fund the operations of OncoCyte. Basic and diluted shares used in computing the net loss was 50.32M versus 48.3M in Q1/11.

• As of 3/31/12, BTX had cash and cash equivalents, on a consolidated basis, totaled $16.5M, compared with $22.2M as of 12/31/11.  .

Q1/12 Highlights:

Advanced Near-Term Product Development

• Provided an update on the development of Renevia^TM (formerly known as HyStem^®-Rx) including the product development milestones for thelaunch of Renevia^TM in Europe, the goal of obtaining the CE mark necessaryfor marketing Renevia^TM in European Union countries by year-end 2013, and the global distribution network marketing the HyStem^® line of research products being utilized in a wide array of medical research applications;
• BTX and its subsidiary OncoCyte Corporation provided an update on the development of PanC-DxTM, a novel diagnostic device to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups. Achieved several key advances, including: the evaluation of over 50 potential cancer biomarkers discovered by OncoCyte and BTX using antibody-based technology in blood samples from a proprietary sample bank derived from over 600 donors, including patients with cancers of the breast, colon, and pancreas, as well as healthy volunteers; and the selection of seven such serum markers for monoclonal antibody production.

Expanded Revenue Opportunities:

• BTX and its subsidiary LifeMap Sciences, Inc. announced a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences. XenneX holds the exclusive, worldwide licenses to market GeneCards^® and PanDaTox. GeneCards^® is a searchable, integrated database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease-related information, on all known and predicted human genes and generates revenue from customers worldwide, including biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property. PanDaTox is a recently developed, searchable, database that can be used to  identify genes and intergenic regions that are unclonable in E. coli, to aid in the discovery of new antibiotics and biotechnologically beneficial  functional genes, and to improve the efficiency of metabolic engineering.
• Announced intent to transfer to LifeMap the products and technologies necessary to be the principal marketing subsidiary for BioTime research products, including ACTCellerateTM human progenitor cell lines, GMP human embryonic stem (hES) cell lines, hES cell lines carrying inherited genetic diseases, and ESpanTM growth media for progenitor cell lines for non-therapeutic uses. LifeMap will utilize its databases as part of its online marketing strategy to reach life sciences researchers at biotech and pharmaceutical companies and at academic institutions and research hospitals worldwide;
• Initiation of the manufacture of progenitors of muscle stem cells bearing hereditary diseases. BTX will produce the products from 5 hES cell lines from Reproductive Genetics Institute. The muscle cell lines display the genes for Duchenne muscular dystrophy, Emery-Dreifuss muscular dystrophy, spinal muscular atrophy Type I, facioscapulohumeral  muscular dystrophy 1A, and Becker muscular dystrophy.

Advanced R&D Collaborations:

• Obtained an exclusive license from The Wistar Institute for technology related to a gene designated as SP100.  Wistar Institute researchers have demonstrated pivotal roles for this gene in both cancer and stem cell biology. In conjunction with the license agreement, BioTime agreed to fund  research at The Wistar Institute to advance the technology, and will receive certain rights to negotiate additional licenses for any technologies invented as a result of the research.

Expanded Board of Directors Involvement:

• Formation of a Science & Technology Committee of the BTX’s Board of Directors (BoD) to oversee the development and commercialization of technology and products in regenerative medicine and oncology. The committee will regularly report to the BoDand make recommendations as to the priorities, direction, quality, and execution for BTX’s technology and product development programs, as well as allocations of financial resources and potential acquisitions of  new technology and products.  The committee is chaired by director Andrew C. von Eschenbach, M.D., the former Commissioner of the US FDS and former Director of the NCI.

Net loss was $1.3M or $0.04 compared to net income of $4M or $0.12 in Q1/11

Total revenues were $4.6M in Q1/12, which include the final amortization of license fees from collaboration agreements compared to total revenues in Q1/11 of $10.4M consisting of almost exclusively of amortized license fees. Biosurgery product revenue rose 49% in Q1/12 compared to Q1/11of $1.14M. Revenues from collaborative research agreements and royalties were $3.4M for Q1/12 the compared to $10.4M for Q1/11.  During Q1/12, OSIR recognized the final $3.3M in revenue from the collaborative agreement with Genzyme and $108K of royalty revenues compared to Q1/11 revenues for consisted primarily of $10M from the Genzyme agreement, $240K from the JDRF collaboration and $115K of cost reimbursements from expanded access program for adult acute Graft verse Host Disease.

During Q1/12, OSIR continued to expand its distribution efforts in the Biosurgery segment, both through in-house personnel as well as through expanding distributor network. During Q1/12, OSIR recognized $1.1M of product revenues from the distribution of Grafix and Ovation and realized gross profit of $750K. Revenues from the distribution of Biosurgery products in Q1/11 were $37K, and gross profit was $22K. OSIR is continuing to distribute a substantial amount of these products for clinical evaluation and expect commercial distribution to ramp up slowly until such time as OSIR is able to build the commercial capabilities necessary to drive more widespread adoption. Until such time as OSIR ramps up Biosurgery manufacturing activities to fully utilize manufacturing facilities, costs to manufacture these products are likely to vary significantly.

R&D expenses for Q1/12 were $4M, compared to $4.7M incurred in Q1/11.   During Q1/12, OSIR incurred $2.7M of R&D costs in Therapeutics segment and $1.2M in the Biosurgery segment. G&A was $1.5M for Q1/12 compared to $1.7M for Q1/11.

G&A expenses were $1.5M compared to $1.7M for Q1/11. OSIR incurred $372K of SG&A expenses related to Biosurgery segment, compared to $197K in Q1/11. G&A expenses incurred in Therapeutics segment were $1.2M compared to $1.5M in q1/11. This decrease is the result of continued cost cutting efforts and the refinement of many of general business processes. Investment income, net, was $18K compared to $29K in Q1/11. Total operating expenses in Q1/12 were $5.4M compared to $6.4M I Q1/11.

Loss from operations in Q1/12 was $1.29M versus $4M in Q1/11. Net cash used in operations for Q1/12 was $4M. Basic and diluted shares used in Q1/12 to compute the net loss were 32.83M versus 33.113 in Q1/11.

• Osiris had $44.2M of cash, receivables and short-term investments.

Q1/12 Highlights:

• Strong demand for Grafix® and Ovation® fuels Biosurgery revenue growth to $1.14M for Q1/12, an increase of 49% over Q1/11;
• Manufacturing efficiencies drive gross margin on Biosurgery products up 8% over Q4/11 to 66%;
• Capacity expansion in manufacturing initiated to keep pace with product demand;
• CMS issues positive preliminary decision on request to establish HCPCS codes for Grafix product line with final decision to be rendered by the end of 2012;
• Biosurgery distribution expands its geographic coverage into 8 additional states;
• Full response filed to inquiries from the Biologics and Genetic Therapies Directorate of HealthCanadaregarding the Prochymal® (remestemcel-L) New Drug Submission and post marketing commitments;
• HealthCanada’s independent expert advisory panel issues a favorable decision on Prochymal;
• A decision on Prochymal is expected from HealthCanada during May;
• 4 new patents issued in the US and Canadacovering the use of mesenchymal stem cells for the treatment of graft versus host disease (GvHD) and cardiac disorders.

Sanofi Collaboration Notes:

In Q4/08, OSIR entered into a collaboration agreement with Genzyme Corporation, then an independent and now a Sanofi company, for the development and commercialization of Prochymal and Chondrogen. Under the terms of the agreement, OSIR retained the rights to commercialize Prochymal and Chondrogen in the US and Canada, and Genzyme was granted exclusive rights to commercialize Prochymal and Chondrogen in all other countries, except with respect to GvHD in Japan, where Prochymal has previously been licensed to JCR Pharmaceuticals Co., Ltd. Under the agreement, we were paid $130M for these rights. During Q1/12 OSIR recognized revenue of $3.3M, which was the final deferred revenue associated with the $130M upfront payment. During Q1/11 OSIR recognized $10M of revenue from the amortization of the upfront payment.

The collaboration agreement provides that it will expire upon the completion of all development plans stipulated in the agreement and the expiration of all payment obligations; however, in addition to certain opt out rights, Genzyme may terminate the agreement early and without further obligation at any time, and either party may terminate the agreement due to non-performance, material breach or insolvency.

In 2/12, Sanofi issued a press release which included an update on their R&D pipeline, stating that it has “discontinued” its project with Prochymal for GvHD. The statement issued by Sanofi was made without consultation with or knowledge by us. Through legal counsel, OSIR  has advised Sanofi that OSIR is treating these public statements as Sanofi’s election to terminate the collaboration agreement.

 The agreement provides for voluntary termination by Sanofi and that, upon such voluntary termination, all rights to Prochymal revert back to OSIR, and OSIR is free to commercialize or enter into commercialization agreements for Prochymal with other parties without restriction. While OSIR has been proceeding on the basis that Sanofi has terminated the collaboration agreement, Sanofi has since advised us that it disagrees with OSIR’s characterization of their press release. We have requested an explanation from Sanofi with respect to their statements regarding Prochymal. There can be no assurances as to the outcome of these matters. However, OSIR continues to proceed with Prochymal regulatory approval efforts and, if successful, commercialization, alone or with another collaborator.

In prior years, OSIR entered into strategic agreements with other companies for the development and commercialization of select stem cell biologic drug candidates for specific indications and geographic markets. In 2007, OSIR entered into a collaborative agreement with the Juvenile Diabetes Research Foundation (JDRF) to conduct a P2 clinical trial evaluating Prochymal as a treatment for type 1 diabetes mellitus. In 2003, OSIR entered into an agreement with JCR Pharmaceuticals, granting it exclusive rights to Prochymal for the treatment of GvHD.

KOOL reported a net loss of $1.8M, or $0.11 per share, in q3/12, compared to a net loss of $845K or $0.06 per share, in Q3/12.

For the quarter (Q3) ended 3/31/12, KOOL reported sales of $4.9M. This compares to revenues of $5.2M in Q3/11and $4.8M in Q2/12. Gross profits were $1.81M. Disposable sales in Q3/12 were $2.9M, compared to $3M in Q3/11 and $3.5M in Q2/12. SG& expenses were $1.98M and R&D expenses were $959K with total operating expenses logging in at $2.94M. KOOL’s divestiture and reorganization efforts added approximately $700K in additional costs during Q3/12. However, KOOL expects the organizational focus and cost streamlining from these efforts to yield tangible benefits in the future quarters. KOOL indicated in Q3/12 included revenues of $765K for the final order of CryoSeal devices related to the wind down of the product line. These sales were offset by a $360K decline in the sales of its BioArchive® System, due to continued constrained capital budgets, and a $330K decrease in sales of ThermoLine devices as they discontinues that product line. Although revenues were consistent with Q2/13, the activities around the divestiture of CryoSeal and ThermoLine product lines compressed our gross margins by approximately $600K or 12 basis points in the third quarter. Despite these headwinds, the positive impact of our January reorganization and other cash containment efforts enabled us to reduce our use of cash in the quarter to approximately $200K. Shares used in computing the net loss were 16.4M

• KOOL ended Q3/12 with $8.5M in cash compared to $8.7M in Q2/12 and $12.3M at the end of FY11. KOOL’s backlog in Q3/12 was $1.3M.

For the 1^st 9 months of FY12:  

• KOOL reported revenues of $14.5M compared to revenues of $18M in the 1st 9 months of FY11. KOOL reported a net loss of $4.2M, or $0.26 per share, compared to a net loss of $1.4M, or $0.10 per share, in FY10.

Q3/12 Highlights:

• Registration approval for BioArchive System by China’s State Food and Drug Administration (SFDA) enabling direct commercial sale into the People’s Republic of China;
• Beike Biotechnology Co., Ltd., has committed to adoption of BioArchive and AXP® AutoXpress® Platform (AXP) became the 1st company in China to receive accreditation from the AABB, formerly the American Association of Blood Banks;
• Plan to finalize the purchase by Asahi Kasei Medical Co, Ltd. of the CryoSeal product line in Q4/12; which will also result in a cash payment of approximately $2M.  
  

Q1/12 revenue from product sales was $271K, an 82% increase over Q1/11. This growth was driven by increased unit volumes in SC Proven media and reagents business. Revenue from licensing agreements and grants was $373K, due mainly to receipt of fees from a license agreement with genOway. R&D expenses were $3.93M and 29% lower in Q1/12 compared to $5.52M in Q1/11, while SG&A expenses of $1.92M declined by 7%. The significant reduction in operating expenses was primarily attributable to the reduction in workforce affected in 5/11, relocation of corporate headquarters in 7/11 and other cost containment measures.  Loss from operations in Q1/12 was $5.3M, a 29% decrease compared to Q1/11. From a cash flow perspective, net cash used in operating activities in Q1/12 was $5.631M, which was 24% lower than Q1/11. Shares used in computing the net loss were 22.958M.

• At 3/31/12, pro forma cash, cash equivalents and marketable debt securities totaled $13.7M, which includes an estimated $2.1M in net proceeds from the exercise of Series B Warrants. A total of 8M Series B Warrants were issued in 12/11, of which 2.7M were exercised. The remaining 5.3M unexercised Series B Warrants expired by their terms on 5/2/12.

The Bottom Line: Net cash used in operating activities was down 24%; Revenue from SC Proven product sales were up 82%; Pro forma cash balance of $13.7M – includes $2.1M from warrant exercise; Series B Warrants expired 5/2 – no more outstanding; Anticipated 2012 Cash Burn $18-20M.

Q/1/12 Highlights:

Therapeutic Product Development

• In 1/12, STEM published preclinical data demonstrating that HuCNS-SC cells protect host photoreceptors and preserve vision in a well-established animal model of retinal disease. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period. The preclinical results are highly relevant to human disorders of vision loss, the most notable of which is dry age-related macular degeneration (AMD). The data was featured as the cover article in the February 2012 issue of the international peer-reviewed European Journal of Neuroscience;
• In 1/12, the FDA authorized the initiation of a P1/2 clinical trial of HuCNS-SC cells in dry AMD, the most common form of AMD. AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30M people worldwide are afflicted with the disease. There are no approved treatments for dry AMD;
• In 3/12, a summary of the results of P1 PMD trial were reported at the European Leukodystrophy Association Families/Scientists Meeting held in Paris, France. Data from the trial provided preliminary evidence of durable and progressive donor cell-derived myelination in all 4 patients transplanted with our HuCNS-SC cells. In addition, there were measurable gains in neurological and/or motor function in 3 of the 4 patients; the 4th patient was clinically stable.

Tools and Technologies Programs

• In 3/12, STEM entered into a license agreement under which granted genOway SA, a worldwide, exclusive license to Internal Ribosome Entry Site (IRES) technology for use in the development and commercialization of genetically engineered mice. STEM received an upfront license fee and could receive royalties on product sales.

Other Business Activities:

• In 1/12, STEM submitted 2 applications to the California Institute of Regenerative Medicine (CIRM) for “Disease Team Therapy Development Research Awards,” one for Alzheimer’s disease and 1 for cervical spinal cord injury. A Research Award may be up to $20M, payable over 4 years, to fund preclinical and IND-enabling activities with the aim of starting human clinical trials within a 4 year window.

Mid-Day: The NASDAQ is finally UP +6.23 (+0.21%) to 2,940.94 while the Dow is UP +63.23 (+0.49%) to 12,898.29.

Mid-Day Market Commentary:  Stocks struggled to trade in positive territory Thursday, but gains were limited as investors remained cautious over the euro zone. The CBOE Volatility Index, widely considered (the fear gauge> traded below 20.  We’re seeing a bit of calm in Europe, the euro has gained strength against the dollar, and unemployment claims helped to assuage fears of a major stalling, But the events in Europe are going to be episodic and we’re just waiting for the next piece of news.

Bargain hunting … contributed to the early strength in the market, with some traders picking up stocks at reduced levels following the recent weakness.  Nonetheless, buying interest appears somewhat … subdued amid continued concerns about uncertainty in burn-rates …  where where development programs are percieved to be floundering due to lack of “material” news effort . Traders are also digesting a batch of key economic data, including a report from the Labor Department showing a slight drop in initial jobless claims in the week ended May 5th.

Today’s Gospel:  RegMed stocks as traders …  are looking into re-entering … a depreciated sector for more “sandbox’ plays <i.e. throwing out the “broken” toys for further speculative trading – my question …just how much is “naked”trading>!  RegMed stocks opened … flat … in a down market and still … bouncing … mid-day, Thursday … with few leader(s) …a  few green (ups) and even red (downs) and 4 black (flats) on the screen.

My belief … “don’t waste a good/or/bad crisis … the next few months – NOT years – appreciation will bloom!

My favorites: 

• Aastrom (ASTM) is down $0.02 to $2.52 pre an earnings call after the close with a … decreasing …  mid-day range ($2.50 – $2.59), with … moderate volume of 61K shares; The initiation of the P3 trial and the cash position should help ASTM stand out in comparison to earnings to date …

• Cytori (CYTX) is up $0.24 <+10.62%< to $2.50 … post earnings cal/conference yesterday, which in my mind was expected but, with “implied but, not stated”  regulatory and partnership potential guidance … to  the future with a …in a incresing … trading range of $2.28 <from $2.21> to $2.69 <from $2.26> with LARGE trading of 4ooK;

• Osiris (OSIR) is up $0.08 or 1.66% to $4.91 with an increasing intra-day trading range of $4.81 to $4.93 but, LOW volume of 33K.

Minimal upward moves:  Athersys (ATHX), BioTime (Amex: BTX), Cytomedix (OTC BB: CMXI), Dendreon (DNDN), ImmunoCellular (OTC BB: IMUC), International Stem Cell (OTC BB: ISCO), Pluristem (PSTI), Opexa (OPXA), ReNeuron (RENE.L), Tengion (TNGN) – post earnings (LPS) and Verastem (VSTM).

Minimal downward moves: Advanced Cell Technology (OTC BB: ACTC), BioMimetic (BMTI), NeoStem (Amex: NBS) and StemCells (STEM)

Flats: BioLife Solutions (OTC BB: BLFS), Cryo-Cell (OTC BB: CCEL), Geron (GERN), Opexa (OPXA), Fibrocell (OTC BB: FCSC), Neuralstem (Amex: CUR),   and ThermoGenesis (KOOL),

What’s new in the regenerative medicine/stem cell market … A Number of Earnings Releases … to know from yesterday: 

Advanced Cell Technology (OTC BB: ACTC): http://www.scimitarequity.com/upload/ACTC%20Q1352217.pdf

Neuralstem (Amex: CUR); http://www.scimitarequity.com/upload/CUR%20Q1898693.pdf

Cytori Therapeutics (CYTX):http://www.scimitarequity.com/upload/ACTC%20Q1352217.pdf

Today – Look for Aastrom ASTM), StemCells (STEM) and ThermoGenesis (KOOL)

An earnings release is a ‘report card’ of sorts for a public stem cell company. The current LPS (loss per share) standings reflect the universes’ investing status.  By analyzing these comparisons, investors can begin to gauge the financial health versus the scientific opportunity of stem cell research and whether or not it deserves their investment.

• Advanced Cell Technology (OTC BB: ACTC): http://www.scimitarequity.com/upload/ACTC%20Q1352217.pdf

•  Neuralstem (Amex: CUR); http://www.scimitarequity.com/upload/CUR%20Q1898693.pdf

• Cytori Therapeutics (CYTX):http://www.scimitarequity.com/upload/ACTC%20Q1352217.pdf

Geron (GERN): http://www.scimitarequity.com/upload/GERN307282.pdf

 Tengion (TNGN):http://www.scimitarequity.com/upload/TNGN%20Q1%20Earnings998632.pdf

 Dendreon (DNDN): http://www.scimitarequity.com/upload/DNDN%20Q1%20Results229879.pdf

ACTC.OB reported a Q1/12 loss of $5.71M or $0.00 per share compared to a net loss in Q1/11 of $3.34M, or $(0.00) per share.

Revenue was $55.7K for a gross profit of $15.6K. R&D expenses were $2.44M. R&D expenditures increased from $1.47M in 2011 to $2.44M for 2012 for an increase of $966K. The increase in R&D expenditures during 2012 as compared to 2011 was primarily due to compensation increase of approximately $806K, clinical trials of approximately $67K, legal fees of approximately $77K and other expenses of approximately $15K. G&A expenses were $3.02M for Q1/12 compared to Q1/11 decreased by $178K to $3.02M in 2012. This expense decrease was primarily a result of a decrease in consultant expenses of approximately $1.07M offset by an increase in compensation and stock issued for services of approximately $391K and legal expenses of approximately $458K..Non-operating income (expense) was $233K. ACT reported a loss from operations of $5.4M compared to a loss from operations of $4.8M in Q1/11. Net cash used in operations for Q1/12 was $4.8M, compared to net cash used in operations of $3.4M in Q1/11.

• ACT had cash and cash equivalents of $10.8M, compared to $13.1M as of 12/31/11.

Q1/12 Highlights:

• IRB approval from Wills Eye Institute inPhiladelphia  to treat macular degeneration;
• Initiated Europe’s 1st human Embryonic Stem Cell transplant atMoorfieldsEyeHospital;
• Published first report of human Embryonic Stem Cell (hESC)-derived cells transplanted into patients to treat macular degeneration in leading medical journal, The Lancet;
• Dosed additional patients in the clinical trial treating Stargardt’s Disease;
• Added Aberdeen Royal Infirmary inScotlandas site for P1/2 Clinical Trial using hESC-derived RPE cells for macular degeneration.

The Bottom Line: A lot more transparency by having a real conference call. Investors should be encouraged by their openess and results from the early patients treated in each indication. ACT is filing reverse split <to be filed with NASDAQ in days but, executed when appropriately needed> paper work in an orderly fashion to address listing requirements. Q1/12 was a larger burn of cash than previously anticipation but, an anomaly in relation to following quarters.  ACT has access to any needed cash from an $11M equity commitment and could/would access the capital markets <to the future> and/or a partnership for continued cash input.

Net loss was $103.9M or $0.70 per share, compared to a net loss of $112.8M, or $0.78 per share for Q1/11.

Q1/12 net product revenue was $82M compared to $27M for Q1/11. Cost of operating revenue was $60.04M while R&D expenses were $17.34M; SG&A expenses were $95.3M and restructuring expenses were $124K. Loss from operations was $90.5M. Q1/12 results include approximately $17M in cash and non-cash severance expenses. Excluding these expenses, DNDN had a net loss of $87.1M or $0.59 per share. Shares used in computing the net loss were 147.59M.

• DNDN had approximately $559.1M in cash, cash equivalents, and short-term and long-term investments compared to $617.7M as of 12/31/11.

Q1/12 Highlights:

• Increased demand for PROVENGE(R) (sipuleucel-T): — Added 128 new infusion sites in the first quarter, totaling 723 infusion sites since launch;
• Increased use of PROVENGE in large community oncology practices and community urology practices
• Reimbursement landscape remains stable for physicians;
• Reported average time to payment remains less than 30 days for physicians;
• Q-Code will remain in effect according to recent CMS preliminary decision;
• Launched urology key account managers;

Executive appointments:

• Joe DePinto, Executive Vice President, Global Commercial Operations;
• Christine Mikail, Executive Vice President, Corporate Development, General Counsel and Secretary;
• Robert S. Poulton, Executive Vice President, Technical Operations.

The Bottom Line: DNDN reported better-than-expected results for Q1/12.   DNDN sales of its Provenge prostate cancer vaccine rose 6.5% and that it still expects only modest sequential growth through the rest of 2012. DNDN forecasted Q2/12 of Provenge would grow by low single digits over Q1/12 sales. Q2 may end up being a little bit conservative, but that’s not the kind of growth that’s going to wow anyone; DNDN needs to do a better job of controlling costs on the current sales level.

Despite having an expensive commercial product on the market for 2 years, DNDN is still reporting quarterly losses and it would take time and continued physician education to gain a higher level of acceptance for Provenge. As that process continues, however, easier to use rival products are gaining traction or moving through advanced stages of clinical testing. DNDN acknowledged a need to drive down the amount of cash it is spending as it strives to reach a breakeven point. It said it was still contemplating whether to close 1 of its 3 manufacturing plants in order to cut costs, but would not make such a decision lightly or hastily as it cost hundreds of millions of dollars to get those plants up and running.

Provenge was approved in 2010 as the first therapeutic cancer vaccine to use a patient’s immune system to attack cancer. Despite its hefty $93K per patient price tag, revenue has been disappointing. Sales have been hurt in part due to a cumbersome manufacturing and administration process and uncertainty over reimbursement. DNDN’s reimbursement has become “more consistent, reliable and fast.” It said the reported time to payment was now less than 30 days. It said it needed to work on getting physicians who had a difficult reimbursement experience early on to resume using the drug now that the payment picture has become clearer.

However, DNDN’s shares dropped 11% to $

In Q1/12, TNGN reported an adjusted net loss of$4.4M, or $0.18 per share, compared to an adjusted net loss of$6.5M, or$0.41 per common share  for Q1/11. The decreased adjusted net loss for the 2012 period was primarily due to a decrease in compensation-related expenses of $1M and a decrease in depreciation expense of $1M.

R&D expenses were $2.69M while G&A expenses were $1.38M. The decreased compensation-related expenses during the 2012 period, of which $0.6M were attributable to R&D personnel and$0.4M were attributable to G&A personnel, were primarily due to lower headcount resulting from 11/11 restructuring. The decreased depreciation expense during the 2012 period resulted from both a change during Q2/11 in the estimated useful life of leasehold improvements at the leased facility in Winston-Salem, North Carolina and an impairment during Q4/11 of the carrying value of the leased facility inEast Norriton,Pennsylvania.

Loss from operations were $4.52M and the net loss for the Q was $4.94M or $0.21 before the adjustment based on 23.6M basic and diluted shares.

 The loss per basic and diluted common share for Q1/12 was significantly affected by the issuance of common stock in connection with the equity financing completed3/11. Based upon TNGN’s currently expected level of operating expenditures and debt repayments, TNGN expects to be able to fund its operations to9/12.

• TNGN held$7.3M in cash and cash equivalents.

Q1/12 Highlights:

• Neo-Urinary Conduit Clinical Program Update:  TNGN has implanted 4 patients in the ongoing P1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. The ongoing initial trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland. Data from the 3 patients in this trial allowed clinical investigators to make surgical modifications to address stoma patency, conduit integrity, and vascular supply. Following implantation of the 4th patient in Q1/12, Tengion and its clinical investigators believe they have successfully translated the surgical technique used in animal models, which they believe will address the complications that arose in 3 patients. In addition, there have been important observations made in the 4 patients that reinforce the potential of a clinically meaningful product profile for the Neo-Urinary Conduit. TNGN is actively recruiting additional patients in the trial; anticipates that it will complete enrollment of up to 10 patients by the end of 2012.

• Neo-Kidney Augment Preclinical Program Update: TNGN’s lead preclinical program, the Neo-Kidney Augment, is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). TNGN has now commenced the good laboratory practice (GLP) animal study program required by the FDA to support an IND filing and initiation of a P1 clinical trial in CKD patients. These GLP studies are consistent with studies using several preclinical animal models of CKD already conducted, which yielded positive data demonstrating slowing of kidney disease progression and improved survival. TNGN anticipates that it will submit an IND filing for the Neo-Kidney Augment during the first half of 2013 and that its P1 trial will provide initial human proof-of-concept data in 2014. TNGN is also exploring an entry strategy in Europe for its Neo-Kidney Augment product candidate using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies. TNGN plans to define the European regulatory pathway for Neo-Kidney Augment program in the second half of 2012.

Today’s Gospel:   This has been a bad stretch for the RegMed universe and the economy as a whole. One after the other, companies and their CEO’s are being gutted or delayed by FDA regulators while traders – escorted by a volatile market are squealing “wee, wee, wee” all the way home. Short sellers are greasing the RegMed universe skid. Used and manipulated by the wrong hands, such practices have turned dangerous, even fatal in the battle for share price appreciation. However, the long list of financings, ATMs and warrant burdens to recount are but, are just a few of the most important non-catalysts. Bearish fundamentals keep this sector on the … Defensive!

RegMed stocks opened … flat … in a down market and are … bouncing back … mid-day, Monday … with few leader(s) … many more green (ups) and fewer red (downs) and 1 black (flats) on the screen.

• My favorites:  Aastrom (ASTM) is up $0.09 <+3.76%> to $2.46 with a dropping mid-day range ($2.31 – $2.47), with very thin volume of 101K shares as is Cytori (CYTX) $0.04 <+1.73%> to $2.35 in an also dropping trading range of $2.28 -$2.34 also with thin trading of 58K pre earnings announcement on Wednesday; Osiris (OSIR) was down but now up $0.03 <+0.63> to $4.81 and Verastem (VSTM) is up $0.58 <+6/11%> to $10.07;

• Also, Dendreon (DNDN) is up pre an earnings announcement at the market close, today … $0.27 <+2.38%> to $11.60; BioTime (Amex: BTX) is up $0.08 <+08 <+2.11%> to $3.88 as is ReNeuron (RENE.L) is up +$0.15 <+4%> to $3.90.

• Minimal upward moves:  Geron (GERN), Neuralstem (Amex: CUR), BioMimetic (BMTI), Fibrocell (OTC BB: FCSC), Geron (GERN), Pluristem (PSTI), StemCells (STEM), Tengion (TNGN) pre earnings (LPS) announcement, ThermoGenesis (KOOL), Opexa (OPXA), NeoStem (Amex: NBS) is up $0.025 <+6.38%> to $0.41.

• Minimal downward moves: Advanced Cell Technology (OTC BB: ACTC), Athersys (ATHX), Cytomedix (OTC BB: CMXI), International Stem Cell (OTC BB: ISCO)

• Flats: BioLife Solutions (OTC BB: BLFS), ImmunoCellular (OTC BB: IMUC), .

EconRecon: The CBOE Volatility Index < the best gauge of fear in the market> traded up near 19.

Mid-Day: The NASDAQ is UP +5.14  (+0.17%) to 2,961.48 while the Dow is DOWN -13.09 (-0.1%) to 13,025.18.

Mid-Day Market Commentary: Stocks struggled to turn higher Monday, led by financials, as investors tried to make sense of how the euro-zone will deal with its sovereign debt issues following the French and Greek elections over the weekend.

What’s new in the regenerative medicine/stem cell market … Not much … to know today …

Today’s Gospel:    RegMed stocks opened lower and again … still bouncing downward … mid-day, Friday …  share pricing is also again …flat in thin trading … with,  few leader(s) …  no green (ups) and much more red (downs) and 0 black (flats) on the screen.  It’s crystal clear that the economic recovery is in doubt …we have an economy that is in need of organic growth and you’re not getting it from these reports. Participation rate dropped and average working hours are down … if you’re lucky enough to have a job, your spending and investing power is still down.

• My favorites:  Aastrom (ASTM) is down with a dropping mid-day range ($2.32 – $2.45), with incresed <from yesterday> volume of 220K shares as is Cytori (CYTX) also in a dropping trading range of $2.32 -$2.45 also with greater trading <from yesterday>of 200K and Osiris (OSIR) who is down 1.20% to $4.93 in  a trading range of $4.81 – $5.00 on thin 33K volume.

• Minimal upward moves … who isn’t down … in this market condition:  Cytomedix (OTC  BB: CMXI), BioLife Solutions (OTC BB: BLFS), Geron (GERN) is $0.01 post earnings announcement, Opexa (OPXA), NeoStem (Amex: NBS) is up $0.012 to $0.395 and ReNeuron (RENE.L);

• Minimal downward moves … just about all the rest of the companies in the sector ….

EconRecon: Non-farm payrolls rose much less than expected, with employers adding just 115,000 jobs in April. Economists expected employers to increase hiring by 170,000 workers. Still, the unemployment rate slipped to 8.1%, the lowest since January 2009.

Mid-Day: The NASDAQ is DOWN -58.90 (-1.95%) to 2,965.40 while the Dow is DOWN -160.34 (-1.21%) to 13,046.25.

Mid-Day Market Commentary: With traders reacting negatively to another disappointing jobs report … stocks have moved notably lower in trading on Friday. The major averages have dropped firmly into negative territory, adding to the losses posted in the previous session. Mid-day, the major averages have moved roughly sideways in trading, lingering near their lows.

What’s new in the regenerative medicine/stem cell market … Not much … to know today …

Today’s Gospel:    RegMed stocks opened lower and again … still bouncing mid-day, Thursday …  share pricing is also again …flat in thin trading … with NO leader(s) …  few green (ups) and much more red (downs) and 0 black (flats) on the screen. Geron’s (GERN) earnings (LPs) announced a net loss of $15.8M or $0.15per share with $136.9M remaining in cash – not bad.

• My favorites:  Aastrom (ASTM) is flat with a dropping mid-day range ($2.45 – $2.54), with very thin volume of 97K shares; Cytori (CYTX) is down in an also dropping trading range of $2.38 -$2.46 also with thin trading of 77K;

• Minimal upward moves … who isn’t down … in this market condition:  BioLife Solutions (OTC BB: BLFS) and NeoStem (Amex: NBS) …

• Minimal downward moves … just about all companies in the sector ….

EconRecon: The pace of growth in the service sector slowed to 53.5 in April, slipping from 56.0 in the month prior, according to the ISM non-manufacturing index. Economists had expected a reading of 55.5. A reading above 50 signals expansion – contrary signal?  Weekly claims for jobless benefits fell more than expected, down 27,000 to a seasonally adjusted 365,000, the biggest weekly drop in almost a year. Economists polled expected claims falling to 380,000.  The report comes ahead of the key government jobs data for April, due Friday. The latest estimates from economists … call for a gain of 170,000 new positions, a gain from March’s tepid gain of 120,000.

Mid-Day: The NASDAQ is DOWN -27.41 (-0.09%) to 3,032.44 while the Dow is DOWN -42.61 (-0.32%) to 13,225.96.

Mid-Day Market Commentary: After ending the yesterday’s session mixed, stocks are turning in a lackluster performance in mid-day trading … on Thursday. The major averages are showing only modest moves. The choppy trading comes despite the release of a report from the Labor Department showing a much bigger than expected drop in initial jobless claims in the week ended April 28th. Traders may be staying on the sidelines ahead of the release of the Labor Department’s more closely watched monthly employment report on Friday.

What’s new in the regenerative medicine/stem cell market … 1 … to know today …

Geron Corporation (GERN) Q1/12 Financial Results and Highlights: Net loss for Q1/12 was $18.7M, or $0.15 per share, compared to $24.4M, or $0.20 per share, for Q1/11. http://www.scimitarequity.com/blog/2012/05/03/geron-corporation-gern-q112-financial-results-and-highlights . But, GERN ended Q1/12 with $136.9M in cash and investments.

Net loss for Q1/12 was $18.7M, or $0.15 per share, compared to $24.4M, or $0.20 per share, for Q1/11.

Q1/12 operating revenues were $1.3M with operating expenses of $20.2M, compared to Q1/11 of $1.5M with $25.9M. Q1/12 revenues included funding from collaborative agreements and royalty and license fee revenues under various agreements. Interest and other income was $176K, compared to $296K for the comparable 2011 period.   R&D expenses were $15.1M, compared to $16.8M for Q1/11. The decrease in R&D expenses reflected reduced personnel-related costs and lower scientific supplies expenses resulting from the discontinuation of the stem cell programs, partially offset by increased clinical trial expenses for the enrollment of 4 P2 clinical trials of imetelstat and 2 P2 clinical trials of GRN1005 and increased drug product purchases and manufacturing costs related to imetelstat and GRN1005. G&A expenses were $5.1M, compared to $9.1M for Q1/11. Reduced G&A expenses primarily reflected a decline in personnel-related expenses associated with management transition, including non-cash stock-based compensation expense. Non-cash operating expenses were approximately $2.3M for Q1/12 and $9.8M for Q1/11 primarily included stock-based compensation and expenses for stock issued for services.

• GERN ended Q1/12 with $136.9M in cash and investments.

Q1/12 Highlights:

• The randomized P2 clinical trial of imetelstat, in combination with paclitaxel, in patients with locally recurrent or metastatic breast cancer completed enrollment. The 166-patient P2 study enrolled in slightly over 1 year, ahead of expectations. The primary endpoint of the trial is progression-free survival. The trial requires that a sufficient number of progression events occur in order to perform the planned data analyses. GERN anticipates an accrual of events that will allow reporting top-line data from this study by the end of 2012. 

• Graham Cooper joined as EVP and CFO. Stephen N. Rosenfield joined the company as EVP, General Counsel and Corporate Secretary. V. Bryan Lawlis, PhD, joined the board of directors and as a member of the compensation committee.

Today’s Gospel:    RegMed stocks opened lower and still bouncing mid-day, Wednesday …  share pricing is flatter in thin trading  with the NASDAQ barely up … with,  few leader(s) … little green (ups) and equal red (downs) and 3 black (flats) on the screen. Geron (GERN) announces earnings (LPs) after market closes.

• My favorites:  Aastrom (ASTM) is down $0.02 to $2.51 with a moving mid-day range ($2.50 – $2.53, with very thin volume of 61K shares; Cytori (CYTX) is also down $0.03 to $2.45 in a trading range of $2.40 -$2.52 also with thin trading of 55K;

• Osiris (OSIR) is up $0.05 <0.98> to $5.17; Dendreon (DNDN) is up +$0.16;

• Minimal upward moves … are Athersys (ATHX), Cytomedix (OTC BB: CMXI), Cryo-Cell (OTC BB: CCEL), ImmunoCellular (OTC BB: IMUC), International Stem Cell (OTC BB: ISCO, ThermoGenesis (KOOL) and even NeoStem (Amex: NBS)

• Minimal downward moves … Advanced Cell Technology (OTC BB: ACTC), BioMimetic (BMTI), BioTime (Amex: BTX), Geron (GERN), Opexa (OPXA), Pluristem (PSTI), StemCells (STEM), Tengion (TNGN), ThermoGenesis (KOOL), Verastem (VSTM).

• Flat … Cryo-Cell (OTC BB: CCEL), Neuralstem (Amex: CUR) and ReNeuron (RENE.L)

EconRecon: Employers in the private sector added just 119,000 jobs in April, according to the ADP report, short of expectations for 170,000. The report is closely watched ahead of the key monthly government jobs report, due at the end of the week. Economists surveyed estimated employers added 170,000 jobs last month, following a tepid 120,000 gain in the month prior.  ADP said that private sector employment increased by 119,000 jobs in April following a downwardly revised increase of 201,000 jobs in March. Economists had expected an increase of about 183,000 jobs compared to the addition of 209,000 jobs originally reported for the previous month.  Factory orders slumped 1.5% in March, logging their biggest drop in 3 years. Economists had forecast orders falling 1.6%.

Mid-Day: The NASDAQ is UP +3.32 (+0.11%) to 3,053.76 while the Dow is DOWN -24.82 (-0.19%) to 13,254.50.

Mid-Day Market Commentary: Stocks opened in the red Wednesday, following a rally that helped push the Dow to its best closing level in more than four years, after the ADP employment report showed a much weaker-than-expected increase in private payrolls in April.   After seeing some strength in the previous session, stocks moved back to the downside, mid-day. The major averages moved notably lower at the open but have not seen much follow-through on the downward move. Weakness came on the heels of the release of the ADP showing weaker than expected private sector job growth in the month of April. The data has raised some concerns about Friday’s more closely watched monthly employment report from the Labor Department, which includes government jobs.

What’s new in the regenerative medicine/stem cell market … 2 … to know today …

Hamilton Thorne (CN: HTL-V) FDA Clearance for Clinical Applications: Multi-Pulse software has received FDA clearance for performing embryo biopsy in clinical settings. http://www.scimitarequity.com/blog/2012/05/02/hamilton-thorne-cn-htl-v-fda-clearance-for-clinical-applications . The Bottom Line: The Multi-Pulse capability provides the user with the ability to automatically fire the laser multiple times at relatively low power, will contribute significantly to the efficiency and safety of trophectoderm biopsy. Prior to release of the Multi-pulse software, individual laser shots were required to weaken or break the junctions between the trophectoderm cells so that they can be aspirated into the biopsy micropipette. The significant advantage of Multi-Pulse is that one press of the remote footswitch initiates multiple laser pulses in rapid succession for fast and easy cell separation, thereby limiting the amount of time the embryo spends outside the incubator.

Earnings Report Card, Regenerative Medicine Universe: As we slide into the Q1/12 earnings season … It is time to recap for comparison purposes, the relevant status of the Q4/11 previous quarter and final FY11 reporting.  http://www.scimitarequity.com/blog/2012/05/02/earnings-report-card-regenerative-medicine-universe-3

HTL-V’s Multi-Pulse feature provides rapid, repeated firing of the laser to facilitate removal of cells from an embryo during the trophectoderm biopsy process. Trophectoderm biopsy removes cells from the embryos of patients undergoing pre-implantation genetic diagnosis (PGD) to screen for genetic disease or aneuploidy.

The Bottom Line: The Multi-Pulse capability provides the user with the ability to automatically fire the laser multiple times at relatively low power, will contribute significantly to the efficiency and safety of trophectoderm biopsy. Prior to release of the Multi-pulse software, individual laser shots were required to weaken or break the junctions between the trophectoderm cells so that they can be aspirated into the biopsy micropipette. The significant advantage of Multi-Pulse is that one press of the remote footswitch initiates multiple laser pulses in rapid succession for fast and easy cell separation, thereby limiting the amount of time the embryo spends outside the incubator. HTl-V is trading at $0.15 in  flat range.

An earnings release is a ‘report card’ of sorts for a public stem cell company. The current LPS (loss per share) standings reflect the universes’ investing status. 

By analyzing these comparisons, investors can begin to gauge the financial health versus the scientific opportunity of stem cell research and whether or not it deserves their investment.

For Q4/11 ending 12/31/11:

• Aastrom (ASTM) net loss of $2.8M or $0.07 per share;
• Athersys (ATHX) net loss of $4.25M or $0.18 per share with $12.8M;
• BioMimetic (BMTI) a net loss of $9.9M or $0.35 per share;
• BioTime (Amex: BTX) net loss of $5.1M or $0.10 per share;
• Cytomedix (OTC BB: CXMI) net income of $0.81M or $0.02 per share:
• Cytori (CYTX) net loss of $6.9M or $0.12 per share;
• Geron (GERN) net loss of $31.19M or $0.25 per share;
• NeoStem (Amex: NBS) net loss of $19.37M or $0.19 per share;
• Osiris (OSIR) net income of $5M or $0.15 per share;
• Pluristem (PSTI) net loss of $1.992M or 0.05 per share;
• StemCells (STEM) net loss of $7.21M or $0.47 per share;
• ThermoGenesis Q2/12 net loss of $1.3M or $0.08 per share;

For FY11:

• Aastrom (ASTM) net loss of $19.7M or $0.51;
• Advanced Cell Technology (OTC BB: ACTC) net loss of $72.8M ot $0.05 per share;
• Athersys (ATHX) net loss of $13.M or $0.59 per share;
• BioMimetic (BMTI) a net loss of $33.2M or $1.19 per share;
• BioTime (Amex: BTX) net loss of $16.5M or $0.35 per share;
• Cytomedix (OTC BB: CXMI) net loss of $3.86M or $0.08 per share;
• Cytori (CYTX) net loss of $32.5M or $0.61 per share;
• Geron (GERN) net loss of $96.9M or $0.78 per share;
• International Stem Cell (OTC BB: ISCO) net loss of $9.6M or $0.12 per share;
• NeoStem (Amex: NBS) net loss of $47.8M or $0.54 per share;
• Neuralstem (Amex: CUR) net loss of $12.5M or $0.26 per share
• Opexa (OPXA) net loss of $5.96M or $0.26 per share;
• Osiris (OSIR) net income of $14.9M or $
• StemCells (STEM) net loss of $21.3M or $1.50 per share;
• Tengion (TNGN) adjusted net loss of $24.4M, or $1.13 per share;

The Bottom Line: The sector is maturing and creating potential value yet share prices continue their decline. Will it continue? The answer is … yes as development companies continue to spend to validate their potential!  As the aforementioned losses per share show, it’s a capital intensive industry that is still two to three years from having a commercial winner. All companies but, Mesoblast need money to fund trials to get them to eventual commercialization!

EOD Commentary: Stocks drifted …  in thin trading Monday, on pace to logging a loss for the month, following a handful of mixed economic reports while Aastrom (ASTM) continues to roll … upward.  It was another day of anemic trading in the market, with shares changing hands just hour left in the session.

Closing Bell: The NASDAQ closed DOWN -22.84 (-0.74%) to 3,046.36. The Dow closed DOWN -14.68 <-0.11%) to 13,213.63.

Who is up … at the close:

• Aastrom (ASTM) +$0.07 <+2.81%> to $2.56;
• Athersys (ATHX) +$0.03 <+2.17%> to $1.41;
• Dendreon (DNDN) +$0.30 <+2.60%> to $11.65;
• International Stem Cell (OTC BB: ISCO) +$0.057 <+14.25%> to $0.457;
• Opexa (OPXA) +$0.02 <+3.33%> to $0.62;
• StemCells (STEM) +$0.001 <+0.11%> to $0.936;
• Tengion (TNGN) +$0.024 <+5.36%> to $0.464;
• Verastem (VSTM) +$0.48 <+4.85%> to $10.38.

Today’s Gospel:  RegMed stocks were lower. Monday … as investors respond to economic dismay and anticipate the grouping of earnings (LPS -loss-per-share) cheered by a handful of stem cell companies (CYTX, ATHX, GERN – this week). RegMed stocks … are still slumping on low volume … with few leader(s) … few green (ups) and more red (downs) and few black (flats) on the screen

• Aastrom (ASTM) is up $0.08 or 3.21% to $2.57 and moving mid-day range ($2.473 – $2.58) with volume of 118K while many Funds and brokers recognize their better sustainability focus;

• Dendreon (DNDN) is up +$0.33 to $11.68 in a day’s range of $11.02 to $11.48 while Pluristem (PSTI) is up $0.03 on news of their R&D credit or subsidy versus their claim to a government investment;

• Minimal upward moves … are Athersys (ATHX), International Stem Cell (OTC BB: ISCO),  Opexa (OPXA), Tengion (TNGN) and Verastem (VSTM);

• Minimal downward moves … BioTime (Amex: BTX), BioMimetic (BMTI), Cytomedix (OTC BB: CMXI), Cytori (CYTX), Geron (GERN), ImmunoCellular (OTC BB: IMUC), ThermoGenesis (KOOL) and Osiris (OSIR).

EconRecon: Business activity in the Midwest fell to 56.2 in April from 62.2 in the prior month, according to the Chicago ISM. Economists expected a reading of 61.0. Any reading above 50 indicates expansion while readings below indicate contraction. Household income climbed 0.4% in March, the biggest gain in 3 months, according to the Commerce Department. Analysts had expected a gain of 0.3%; as consumer spending only edged up 0.3%.

Mid-Day: The NASDAQ is DOWN -19.77 (-0.64%) to 3,049.43 while the Dow is DOWN -27.93 (-0.21%) to 13,200.38.

Mid-Day Market Commentary: Stocks have experienced a moderate … decline in the mid-day Monday session, giving back … most … of the RegMed gains seen last week.  The economy is in focus … with the release of new figures on personal income and spending.

Who is UP … Mid-day:

• Aastrom (ASTM);
• Athersys (ATHX);
• Dendreon (DNDN);
• International Stem Cell (OTC BB: ISCO);
• Opexa (OPXA)
• Pluristem(PSTI);
• StemCells (STEM);
• Tengion (TNGN).

What’s new in the regenerative medicine/stem cell market … Nothing to speak about … to know today …

Today’s Gospel:  RegMed stocks were lower in a slightly higher market. Friday, as investors anticipate the grouping of earnings (LPS -loss-per-share) cheered by a handful of stem cell companies (CYTX, ATHX, GERN – next week). RegMed stocks … struggled on low volume … with, a few leader(s) … even green (ups) and red (downs) and few black (flats) on the screen

• Aastrom (ASTM) is in a flat and slipping mid-day range ($2.45 – $2.52) with volume of 110K while the NASDAQ is up.

• Athersys (ATHX) is up <$0.02> on news  … Athersys (ATHX) Meeting with FDA: A scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD). Additionally, discussed with the FDA were its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design.  The Bottom Line: Finalizing the parameters of a P2 clinical and statistical plan is just … the beginning … of the next steps of trial design.   ATHX’s P1 trial evaluated the safety and maximum tolerated dose of single or repeated dose administration of MultiStem following an allogeneic HSCT in patients being treated for leukemia or related cancers of the blood or immune system. But, GvHD is a frequent complication associated with their product, allogeneic HSCT, affecting approximately half or more of transplant recipients, as advanced GvHD can be severely debilitating or even fatal. This P2 efficacy trial is initiated by writing more checks and then more … by a soon-to-be … cash starved company; unless, in this newest normal, a partner is evident to balance the burn!

• Dendreon (DNDN) is up +$0.21 in a day’s range of $11.02 to $11.48, Athersys (ATHX) is up with the days range of $1.33 to $1.40 … on low (25K) volume;

• BioTime (Amex: BTX) is battling back <UP $0.18 or 4.90% to $3.85> a  “short” perception article … in a day’s range of $3.64 to $3.85 on low volume (39K);

• Minimal upward moves … are Cytori (CYTX), International Stem Cell (OTC BB: ISCO), Osiris (OSIR), Tengion (TNGN)  and Verastem (VSTM).

EconRecon: Consumer sentiment inched up slightly to 76.4 in April from 76.2 in March, according to the Thomson Reuters/University of Michigan’s final reading. Economists had projected a reading of 75.7.  Economic growth in the U.S. slowed in Q1 as GDP expanded at a 2.2% annual rate from Q4′s 3% growth. The reading was well below economists’ expectations for a 2.5% pace.

Mid-Day: The NASDAQ is UP +17.59 (+0.58%) to 3,068.20 while the Dow is UP +34.02 (+0.26%) to 13,238.64.

Mid-Day Market Commentary: After ending the previous session firmly in positive territory, stocks are showing a … lack of direction in mid-day … trading on Friday. The major averages moved higher at the start of trading but have given back some ground since then. The choppy trading comes as traders are weighing some positive earnings news against a disappointing report on first quarter GDP.The CBOE Volatility Index, <the fear gauge> in the market, is … slipped now, below 1

Who is UP … Mid-day:

• Athersys (ATHX);
• BioMimetic (BMTI);
• BioTime (Amex: BTX);
• Cytori (CYTX );
• Dendreon (DNDN);
• International Stem Cell (OTC BB: ISCO);
• Tengion (TNGN):
• Verastem (VSTM).

What’s new in the regenerative medicine/stem cell market … 1 … to know today …

Athersys (ATHX) Meeting with FDA: A scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD). Additionally, discussed with the FDA were its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design. 

Today’s Gospel:  Following a better-than-expected pending home sales report and worries over the weekly jobless claims report that showed the 4 week moving average rose to its highest since January but, has put a damper on RegMed stocks … struggled to hold gains Thursday but, a few are up marginally as NASDAQ is flat and the market deflates.  Leader(s) … few green (ups) and even red (downs) and quite a few black (flats) on the screen … Look at the bond market … yields are moving down … so what are we getting is … more risk!

• ASTM is up then down (marginally – $0.01) having been down after a “busy past few days” in the mid-day range ($2.44 – $2.52) with volume of 154K while the NASDAQ is up.

• Osiris (OSIR) is up <$0.12 or 2.33% to $5.28>. Dendreon (DNDN) is up +$0.06 < from $0.21>,

• Athersys (ATHX) is down <-$0.08 or -5.76%>  with the days range of $1.30 to $1.41 … on low (108K) volume as a position is unraveled; Cytori CYTX) is also down <-$0.09 or 3.67% to$2.37> in a day’s range of $2.36 – $2.455.

• BioTime (Amex: BTX) is “battling” perception … as SeekingAlpha came out with a scathing article …

• Minimal upward moves … are Cryo-Cell (OTC BB: CCEL), Geron (GERN), International Stem Cell (OTC BB: ISCO), Neuralstem (Amex: CUR), ThermoGenesis (KOOL) and Verastem (VSTM).

EconRecon: The choppy trading in the market …  comes after the Labor Department released a report showing a much smaller than expected drop in initial jobless claims in the week ended 4/21.The report showed that jobless claims edged down to 388,000 from the previous week’s revised figure of 389,000. Economists had been expecting jobless claims to fall to 375,000 from the 386,000 originally reported for the previous week. While jobless claims remained below the key 400,000 level, they came in above 380,000 for the 3^rd consecutive week. Housing stocks are seeing considerable strength in mid-day trading, resulting in a 1.1% gain by the Philadelphia Housing Sector Index.

Mid-Day: The NASDAQ is UP +9.75 (+0.32%) to 3,039.38 while the Dow is UP +73.41 (+0.56%) to 13,164.13.

Mid-Day Market Commentary: Stocks are turning in a lackluster performance in mid-day trading on Thursday following the release of a disappointing jobs report. The major averages are lingering near the unchanged line after ending the previous session firmly positive.

Who is UP … Mid-day:

• Cryo-Cell (OTC BB: CCel);
• Dendreon (DNDN);
• Osiris (OSIR);
• StemCells (STEM);
• ThermoGenesis (KOOL);

What’s new in the regenerative medicine/stem cell market … Nothing … to know today …

The US Appeals Court heard arguments (4/23/12) from lawyers supporting and opposing the US government’s funding for human embryonic stem-cell (hESC) research.  The panel of 3 judges of the US Court of Appeals for the District of Columbia Circuit  spent 34 minutes at a modestly attended hearing weighing the legal questions raised by lawyers for the plaintiffs and the government in Sherley versus Sebelius et al.  The lawsuit, filed in 2009, challenges the legality of the funding by the National Institutes of Health (NIH) of hESC research. Its plaintiffs, adult-stem-cell researchers James Sherley, a senior scientist at the Boston Biomedical Research Institute in Watertown, Massachusetts, and Theresa Deisher, the chief executive of AVM Biotechnology in Seattle, Washington, argue that US funding, which began in 2001, is illegal because it breaks a 16-year-old law, the Dickey-Wicker amendment.  The law bars theUS from supporting research in which a human embryo is “destroyed, discarded, or knowingly subjected to risk of injury or death”.  (Meridith Wadman, Nature)

The Bottom Line:  Lawyers argued for Sherley and Deisher that the current Appeals Court panel is not bound to agree with the earlier panel’s decision. Indeed, he noted that, under a 38-year-old precedent in a case called Berrigan v. Sigle:  The judges focused on important but arcane legal questions, Primary among the questions today was whether the current panel of three judges are “controlled” by the findings of a different 3 judge panel of the same court, which ruled a year ago.  Then, the panel was deciding whether to overturn a preliminary injunction that would have shut down federal funding for hESC research while the case wound its way through the courts.  That panel threw out the preliminary injunction in an April 2011 decision, on the grounds that Sherley and Deisher are unlikely to prevail in convincing the courts that funding for the research violates Dickey–Wicker.  Last summer, lower-court Judge Royce Lamberth agreed, ruling decisively against Sherley and Deisher and setting up today’s appeal. The plaintiffs are unlikely to prevail because Dickey–Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey–Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used. Whatever the outcome when the panel issues a decision several months from now, I would think that a petition [to the Supreme Court] would be likely.

Today’s Gospel:  A RegMed stocks experienced …incremental movement … on Wednesday … but, a few are up marginally as NASDAQ is rebounding and the market continues to inflate.  Leader(s) … Fewer green from market open, more red and no black (flats) on the screen … Earnings announcements are starting to get posted … the “burn rates” will continue to be exposed representing potential development progress… and hopefully catalyst guidance!

• Today, ASTM is down after a “busy day past few days” in the mid-day range ($2.46 – $2.55) with volume of 120K while the NASDAQ is up. As, traders “take any or all” profit of the past days.

• Athersys (ATHX) is up ($0.05 or 3.70% to $1.40) with the days range of $1.35 to $1.40 … on low (43K) volume;

• Cytori (CYTX) is “finally” moving again as they fight back short interests and is up $0.10 <+4.27%> to $2.44 on volume of 180K shares with new short increases of 9.2M <17.8% of float>  pre earnings announcement – it always happens – as CYTX is a development company and should not be judged as revenue generator – that is just a gift …

• BioTime (Amex: BTX) is “battling back” to +$0.03 or +0.75% to $3.97; research product sales will be the short breaker …ReNeuron (RENE.L) is back up $0.19 <4.79%> to $4.18.

• Minimal upward moves … are  Geron (GERN), ImmunoCellular (OTC BB: IMUC), Neuralstem (Amex: CUR), Osiris (OSIR), Tengion (TNGN) and Verastem (VSTM).

Mid-Day: The NASDAQ is UP +62.04 (+2.09%) to 3,023.64 while the Dow is UP +80.68 (+0.62%) to 13,082.24.

Mid-Day Market Commentary: After ending the previous session mixed, stocks have shown a strong move to the upside in … mid-day … trading on Wednesday. The major averages have all climbed into positive territory, with the tech-heavy NASDAQ showing a significant advance. The major averages have seen some further upside in recent trading, reaching new highs for the mid-day session.The S&P 500 and the NASDAQ were also sharply higher. The CBOE Volatility Index < fear gauge> in the market tumbled near 17 <19 yesterday>.

Who is UP … Mid-day:

• Athersys (ATHX);
• Cytori (CYTX);
• Cryo-Cell (OTC BB: CCEL);
• Dendreon (DNDN);
• Geron (GERN);
• Neuralstem (Amex: NBS);
• ReNeuron (RENE.L);
• Tengion (TNGN).

What’s new in the regenerative medicine/stem cell market … 1 … to know today …

VistaGen (OTCQB: VSTA) Secures Key US Patent Covering Stem Cell Technology Methods Used to Test Drug Candidates for Liver Toxicity. http://www.scimitarequity.com/blog/2012/04/25/vistagen-otcqb-vsta-secures-key-us-patent . The Bottom Line: This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. VSTA’s new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity.

OTCQB: VSTA has secured a new patent covering proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, 11445733or <733>, titled “Toxicity Typing Using Liver Stem Cells,” covers all mammalian liver stem cells — rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS). The Bottom Line: This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. VSTA’s new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity.

The Bottom Line: This is a big deal …The state-of-the-art manufacturing site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. It provides … crucial manufacturing capabilities to support the anticipated growth in demand for ChondroCelect for cartilage repair, and has sufficient capacity for the production of advanced stem cell therapy products. 

Today’s Gospel:  A RegMed stocks experienced …flat lines on Tuesday … but, a few are up marginally as NASDAQ is slightly down and the market continues to drift.  Leader(s) … More green, fewer red and 1 black (flats) on the screen …

• Today, my 2 double A batteries … ASTM is up and down after a “busy day yesterday” in the mid-days range ($2.57 – $2.72) while the NASDAQ is down. Yesterday, ASTM’s call volume was at 4,905% of average on Monday. There was no specific news to account for the option activity. The August 2.50 call was particularly active with volume at 5,030 contracts, compared with open interest of 961. ASTM had closed at $2.64 on Monday. While my second battery, Athersys (ATHX) is also … up and now down with the days range of $1.28 to $1.43 … on low (80K) volume. These energizering … stocks will and should … keep your portfolio “LIT” to the future!

• Cytori (CYTX) is up $0.06 <+2.63%> to $2.34;  

• Dendreon (DNDN) is up $0.57 <+5.2%> to $11.53 and Osiris (OSIR) is up $0.19 <+3.90%> to $5.06;

• Minimal upward moves … are Advanced Cell Technology (OTC BB: ACTC); BioMimetic (BMTI); BioTime (Amex: BTX), Cytori (CYTX), Dendreon (DNDN), Geron (GERN), ImmunoCellular (OTC BB: IMUC), NeoStem (Amex: NBS), Neuralstem (Amex: CUR), Opexa (OPXA), Osiris (OSIR), Tengion (TNGN) and Verastem (VSTM).

EconRecon: Home prices dropped in February for a 6 straight month, according to the Standard & Poor’s/Case-Shiller home-price index.  New home sales slid 7.1% in March to a seasonally adjusted 328K-unit rate, hitting their lowest level in four months, according to the Commerce Department. Still, the reading topped expectations for a 320K-unit rate.  And consumer confidence dipped slightly in April to 69.2 from a downwardly revised 69.5 in March. Economists had expected a reading of 69.7. EU shares closed higher after hitting a 3-month low in the previous session. Investor sentiment was lifted by the Netherlands’ successful $2.6B bond auction on Tuesday, despite the collapse of the Dutch government on Monday.

Mid-Day: The NASDAQ is DOWN -10.92 (-0.37%) to 2,959.53 while the Dow is UP +79.38 (0.61%) to 13,006.45

Mid-Day Market Commentary: While RegMed stocks have moved mostly sideways … in mid-day trading on Tuesday, weakness among stocks is contributing to a loss by the NASDAQ. The major averages are subsequently turning in a mixed performance on the day. The CBOE Volatility Index <fear gauge> traded near 19.

Who is UP … Mid-day:

• BioTime (Amex: BTX);
• Cryo-Cell (OTC BB: CCEL);
• Cytori (CYTX);
• Dendreon (DNDN);
• Fibrocell (OTC BB: FCSC);
• NeoStem (Amex: NBS);
• Opexa (OPXA);
• Osiris (OSIR);
• Pluristem (PSTI);
• StemCells (STEM);
• ThermoGenesis (KOOL);
• Tengion (TNGN);
• Verastem (VSTM).

What’s new in the regenerative medicine/stem cell market … 3 … to know today …

Hamilton Thorne (TSX VENTURE: HTL) Private Placement Unit Offering: Hamilton Thorne Ltd. (TSX VENTURE: HTL) is proposing to issue, on a non-brokered private placement basis, an aggregate of up to approximately 6,666,667 Units at an offering price of CDN$0.1125 per Unit for aggregate gross proceeds of US$750,000.http://www.scimitarequity.com/blog/2012/04/24/hamilton-thorne-tsx-venture-htl-private-placement-unit-offering . Each Unit will consist of 1 common share and 1/2 common share purchase warrant each warrant will provide the holder the right to purchase a Common Share at CDN$0.16875 for a period of 12 months following the closing.  HTL also announced that its board of directors has approved an amendment to the 2009 stock option plan to increase the number of common shares reserved for issuance under the Plan from 4.8M to 9.3M (representing approximately 19.95% of the currently issued and outstanding common shares). This amendment remains subject to shareholder approval and the approval of the TSX-V.

TiGenix (NYSE Euronext: TIG) obtains manufacturing license for European production facility:  http://www.scimitarequity.com/blog/2012/04/24/tigenix-nyse-euronext-tig-obtains-manufacturing-license-for-european-production-facility .NYSE Euronext: TIG announced today that further to the cGMP inspection by the Dutch authorities it has obtained the manufacturing authorization for human medicinal products for its European manufacturing plant in Sittard-Geleen in the Netherlands. The Bottom Line: This is a big deal …The state-of-the-art manufacturing site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. It provides … crucial manufacturing capabilities to support the anticipated growth in demand for ChondroCelect for cartilage repair, and has sufficient capacity for the production of advanced stem cell therapy products. 

Advanced Cell Technology (OTC BB: ACTC) Approval to Increase RPE Dosage for Stargardt’s Disease Patients in US. http://www.scimitarequity.com/blog/2012/04/24/advanced-cell-technology-otc-bb-actc-approval-to-increase-rpe-dosage-for-stargardts-disease-patients-in-us . The Bottom Line: ACTC is conducting 3 clinical trials in the US and EU using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of 3 patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt’s macular dystrophy (SMD) at 12 months, the study’s primary endpoint.