Signs of life …

Shire ADR (SHPG +$0.90) and are the leaders as today’s market opens…

…followed by Osiris (OSIR +$0.14) ReNeuron (LON: RENE +$0.08), Dendreon (DNDN +$0.07), BioTime (NYSE MKT: BTX +$0.07), Pluristem (PSTI +$0.06), Stemline (STML +$0.05), Cytori (CYTX +$0.04), Cryo-Cell (OTC: CCEL +$0.03), MiMedx (MDXG +$0.03), International Stem Cell (PINK: ISCO +$0.023), Opexa (OPXA +$0.02), NeoStem (NYSE MKT: NBS +$0.004), and Advanced Cell Technology (OTC: ACTC +$0.0017)

A view of the downside at the open …

Verastem (VSTM -$0.16), and Wright-Medical (WMGI -$0.14) are the loss leaders…

…followed by BioLife Solutions (OTC: BLFS -$0.10), Tengion (PINK: TNGN -$0.002), and Aastrom (ASTM -$0.005)

And some of the sector is flat

Athersys (ATHX), Bioheart (PINK: BHRT), Brainstorm (OTC: BCLI) Cytomedix (OTC: CMXI), Fibrocell (NYSE MKT: FCSC), Geron (GERN), Harvard Bio (HBIO), ImmunoCellular (NYSE MKT: IMUC),  IntelliCell (PINK: SVFCE), StemCells (STEM), ThermoGenesis (KOOL Medistem) (PINK: MEDS), Mesoblast ADR (PINK: MBLTY), Neuralstem (NYSE MKT: CUR), Proteonomix (OTC: PROT), and Vitro Diagnostics (PINK: VODG)

The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission’s recommendation to fund 31 new proposals with the Maryland Stem Cell Research Fund’s (MSCRF) $10.4 M FY13 budget. These projects, which include pre-clinical research and a clinical trial, will advance the field of regenerative medicine.

This funding cycle, the Commission gave priority to proposals that focus on advancing regenerative medicine by selecting promising research targeting cancer, sickle cell anemia, ALS, Parkinson’s disease, heart disease, muscular dystrophy, diabetes, lupus, epilepsy, and spinal cord injuries as well as end stage lung disease and other debilitating medical conditions. Researchers will also study noninvasive in vivo imaging of transplanted stem cells to determine their location and longevity. In addition, the Commission will continue its collaboration with the California Institute of Regenerative Medicine (CIRM), now in its third year.

The Bottom Line:

Pre-Clinical Research Award — This new funding mechanism provides up  to $500,000 of direct costs per year for up to 3 years, and is designed for companies conducting pre-clinical research in Maryland that seek to advance medical therapies in the State. The goal of this proposal is clearance from the FDA to initiate a new clinical trial. This grant, awarded to a biotech company collaborating with a research institute and a hospital, is focused on developing a stem cell suture for tendon and ligament reconstruction in healing-impaired patients.

10 Investigator-Initiated Research Awards — These grants provide up to $600,000 of direct costs per year, for up to three years, and are designed for Maryland investigators who have preliminary data to support their hypotheses. Among other promising projects, new awardees in this category will work to create stem cells to treat spinal cord injuries; develop a novel therapy for liver fibrosis; visualize stem cells in brain tumors; characterize cardiac stem cells in newborns; develop a stem cell   therapy for diabetes; and conduct a clinical trial in patients with sickle cell disease and lupus.

10 Exploratory Research Awards — These grants provide up to $100,000 of  direct costs per year, for up to two years, and are designed for Maryland researchers who are new to the stem cell field (young investigators and scientists from other fields), or for exploratory projects that have  little or no preliminary data. FY2013 awards in this category will address such topics as stem cell imaging; nerve regeneration; a disease model of epilepsy; a deficient pathway in Parkinson’s disease; and  improving lung transplant outcomes.

10 Post-Doctoral Fellowship awards — These grants provide up to $55,000 per year, for up to two years, including direct and indirect costs and  fringe benefits, and are designed to train post-doctoral fellows who wish to conduct human stem cell research in Maryland. These grants will focus on ALS (Lou Gehrig’s disease), sickle cell disease, diabetes, colon cancer, and stroke, among other topics.

All MSCRF-funded research must be conducted in Maryland and must involve human stem cells.

Futures signaled a flat-to-lower open on Tuesday, as markets in Europe and Asia remained cautious ahead of Fed’s Bernanke’s testimony to the Senate on Wednesday.

RegMed sector traded lower on Monday … hopefully today will be better but I for see more of the same as share pricing is volatile a trader’ market.

DOW futures are FLAT 0.0% and the NASDAQ’s are DOWN -0.1.

European stock markets drop on Tuesday, taking a breather after climbing to multiyear highs in the prior day’s session while Australian stocks decline, Japanese and Hong Kong equities pull back from a 3 day winning run,

In the broader market … stocks closed slightly lower in choppy trading Monday, pulling back after the Dow and S&P 500 hit fresh all-time highs and amid ongoing worries that the Federal Reserve may taper its bond-purchase program. With no major economic reports on tap, investors have been focusing on if or when the Fed should start paring back on its bond-buying program. The talk grew louder … last week, further fueled by the comments of Fed hawks John Williams and Charles Plosser. Investors will be closely watching Fed Chairman Bernane’s testimony before the Senate on Wednesday, which may illuminate the central bank’s plans regarding reducing or ending bond purchases.

There were some bright spots … the big bat in the park … is Shire ADR (SHPG) being UP +$1.85 to $95.28 – buying back some stock. Mesoblast ADR (MBLTY) is UP +$0.16 to $27.11 followed by Verastem (VSTM) is UP +$0.12 at $9.31 with MiMedx (MDXG) UP at +$0.11 to $7.37 – after receiving a $3 M line of credit with B of A.  Athersys (ATHX) is swing the bat – UP +$0.07 to $1.93; while Opexa (OPXA) is also UP +$0.02  at $1.69. Aastrom (ASTM) is also out of the dugout … UP +$0.15 after slowly eroding up and down at $0.585 – just biding time to an offering – this is the most timed offering … I watched in a … l o n g … time!

Closing negative … stuck in the dugout was … Osiris (OSIR) was DOWN -$0.57 to $10.70; while BioTime (BTX) is DOWN – $0.20 to $3.92. Stemline (STML) is DOWN after an offering filing having felt the hot iron of downward trends -$0.08 to $14.67.  Cytori (CYTX) is also DOWN -$0.13 to $2.50. Wright-Medical (WMGI) was DOWN -$0.05 to $24.59 while Pluristem (PSTI) is DOWN -$0.05 to $3.00 while Dendreon (DNDN) is DOWN -$0.07 to $3.94.Fibrocell (NYSE MKT: FCSCD) who’s had very good days is DOWN -$0.25 to $4.75 after a stock reverse!

Other favorites closing … at bat or in the warm-up were … BioLife Solutions (BLFS) closed UP +$0.105 to $0.41 after very good earnings and guidance.  NeoStem (NYSE MKT: NBS) is DOWN -$0.025 to $0.595 along with Cytomedix (CMXI) who is also DOWN -$0.04 to $0.46 – wake up – a roaring -BUY – investors should wake to this one; just think <CYTX> hybrid and finally Medistem (PINK: MEDS) is FLAT at $1.20 on 1100 shares – barely a drop. Harvard BIO (HBIO) is DOWN -$0.02 at $5.18 – market adjustment following tax free spin-out versus HART IPO.

Measuring the close – NEGATIVE … 17 red (downs) led … 11 green (ups) followed by 9 black (flats) … The CBOE Volatility Index traded above 13.

Closing Bell: The NASDAQ closed DOWN -2.53 (-0.07%) to 3,496.43 while the DOW was DOWN -18.97 (-0.12%) to 15,335.43.

RegMed equities have been bouncing back and forth against the sector walls – Pacman anyone? Stocks were narrowly mixed Monday, as investors seemed to take a breather after the past weeks of even deeper breaths as earnings completed.  

The nature of this market always prevails but the RegMed sector consistently has been lagging as liquidity has trumped any semblance of fundamentals and technical.

The weakness in the RegMed sector came as some traders looked to cash in on … any recent strength in the markets, while … selling pressure is relatively subdued – traders remain reluctant to experience any further downside.

Measuring the day – POSITIVE– 14 green (ups) followed by 12 red (downs) 8 fluctuating black (flats)

Mid-Day – Stocks erased their early losses to poke higher Monday, with major averages extending their gains from last week and hovering around fresh all-time highs.

At mid-day, the NASDAQ is UP +5.86 or 0.017% at 3442.29 while the Dow is DOWN -23.31 or -0.15% at 15,095.18. The CBOE volatility index traded above 13.

Research Notes:

• RegMed Daily – The Early Movers … http://www.scimitarequity.com/blog/2013/05/20/the-early-movers-whos-hot-whos-not-26

•  Advanced Cell Technology (ACTC.OB) Better vision after treatments … http://www.scimitarequity.com/blog/2013/05/20/advanced-cell-technology-actc-ob-better-vision-after-treatments

Roll Call:

• Aastrom (ASTM) is trading UP … +$0.01 to $0.57 with a pending offering about to dilute the price and share count. A SELL.

• Athersys (ATHX) is UP… +$0.06 at $1.92 post earnings. A HOLD.

• BioLife Solutions (OTC: BLFS) is UP… +$0.095 at $0.40 share at mid-day, compared to $0.31 Friday’s close with huge 190.4 K shares traded.  BLFS is growing its business, evidenced by its licensing of specific areas of intellectual property, while keeping high growth as the regenerative medicine market opportunity develops. BLFS hold the leading supplier position for pre-formulated, clinical grade biopreservation media products. A STRONG BUY.

• Cytori (CYTX) is DOWN … -$0.08 or to $2.55 with today’s mid-day trading range of $2.53 – $2.65 and a 177 K share volume.  A BUY.

•  Cytomedix (OTC: CMXI) is DOWN -$0.04 to $0.46, with a trading range of $0.46- $0.46 and tiny volume of 2 K shares compared to Friday’s close of $0.50.  A BUY.

• NeoStem (NYSE MKT: NBS) is DOWN …-$0.01 to $0.58 with moderate l share volume of 404 K at mid-day.   Both the trending 50 day and 200 day moving averages are at $0.63.  A STRONG BUY!

• Medistem (PINK: MEDS) is FLAT…at $1.00 … with no real news and nor share volume.  MEDS needs to generate some significance to differentiate itself and forward … any visibility standing… A very thinly or no trading volume stock. A HOLD.

News

• Neuralstem  (NYSE MKT: CUR) reported that Eva Feldman, MD, PhD, principal investigator, presented updated Phase I data from its spinal cord-derived human neural stem cell (NSI-566) trial in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) at the Neuro Diabetes Special Medical Symposium in Bucharest, Romania.   In a talk called “Recent Therapeutic Advances in Stem Cell Therapy,” Dr. Feldman reported that six study patients have a stable, very slowly progressing or improved disease course at more than 700-to-approximately-850 days post-surgery. Furthermore, she stated that these patients all share two common clinical characteristics:  They had no bulbar features of ALS, a form of the disease that destroys motor neurons in the corticobulbar area of the brainstem in the early stages and typically progresses faster than the limb-onset ALS. Additionally, these patients all received stem cell transplantation early in the course of their disease (at an average of 2 years, 1 month after symptom-onset). Two of the patients showing stabilization or improvement were among the three to receive transplants in both the lumbar and cervical regions. Of the 9 remaining patients in the trial, three subjects had a long disease course (5.6, 11.6 and 12.7 years of known disease), at the time of their transplantation, likely representing atypical ALS, and have had little change in the trajectory of their disease.  Finally, Dr. Feldman reported, six of the trial patients died of their disease, 7-to-30 months after surgery. Two of these patients had features of bulbar ALS at the time of their transplantation. Dr. Feldman is also Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System and an unpaid consultant to Neuralstem.

• Stemedica has added Robert L. Wilensky, MD, Professor of Medicine and Director of Interventional Cardiology Research at the University of Pennsylvania to its Scientific and Medical Advisory Board for Stemedica’s Cardiology Division.  At the University of Pennsylvania, Dr. Wilensky divides his time between the cardiac catheterization laboratories and the translational animal laboratory. His research interests include acute coronary syndromes, diagnosis and treatment of
  vulnerable coronary lesions and stem cell therapy for decreased left ventricular function and coronary artery disease.

• RNL BIO will offer adult stem cell banking in the United States beginning on June 20, 2013.  RNL BIO previously offered these services through another company, but will now provide the latest, safest technologies directly. As the sole global provider of its stem cell banking services, RNL BIO will provide clients with continuous quality assurance and constant innovation in adult stem cell technologies.  RNL BIO operates facilities in Maryland, Los Angeles and a FDA-registered stem cell banking facility in the Houston, Texas metroplex. It has opened a 15,000 square foot GMP laboratory facility in Sugar Land, Texas with extensive, state-of-the-art stem cell research and banking equipment, staffed by highly qualified scientists.

• Advanced Cell Technology, Inc. (OTC:ACTC) confirmed that the vision of a patient enrolled in a clinical investigation of the company’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) has improved from 20/400 to 20/40 following treatment. The improvement was first reported on May 15, 2013, in a news article published by Reuters.

Signs of life …

Shire ADR (SHPG +$1.43) and Stemline (STML +$0.24) are the leaders as today’s market opens…

…followed by Wright-Medical (WMGI +$0.22), Verastem (VSTM +$0.20), Fibrocell (NYSE MKT: FCSC +$0.15), BioLife Solutions (OTC: BLFS +$0.05), Cryo-Cell (OTC: CCEL +$0.03), ImmunoCellular (NYSE MKT: IMUC +$0.03), Geron (GERN +$0.01) and Opexa (OPXA +$0.01),  

A view of the downside at the open …

Osiris (OSIR -$0.15) and ThermoGenesis (KOOL -$0.11) are the loss leaders…

… followed by MiMedx (MDXG -$0.10), Dendreon (DNDN -$0.06) BioTime (NYSE MKT: BTX -$0.05), Cytori (CYTX -$0.05), ReNeuron (LON: RENE -$0.03), Pluristem (PSTI -$0.03), NeoStem (NYSE MKT: NBS -$0.027), Neuralstem (NYSE MKT: CUR -$0.01), Athersys (ATHX -$0.01), Bioheart (PINK: BHRT -$0.002), Brainstorm (OTC: BCLI -$006) and Advanced Cell Technology (OTC: ACTC -$0.0018),

And some of the sector is flat

Aastrom (ASTM), Harvard Bio (HBIO), StemCells (STEM), IntelliCell (PINK: SVFCE), Cytomedix (OTC: CMXI), International Stem Cell (PINK: ISCO), Medistem (PINK: MEDS), Mesoblast ADR (PINK: MBLTY), Proteonomix (OTC: PROT), Tengion (PINK: TNGN), and Vitro Diagnostics (PINK: VODG)

    Clinical trial participant showed vision improvement from 20/400 to 20/40

The vision of a patient enrolled in a clinical investigation of the retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) has improved from 20/400 to 20/40 following treatment. The improvement was first reported on 5/15/13, in a news article published by Reuters.

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 SMD at 12 months, the study’s primary endpoint.

The Bottom Line:  ACTC is encouraged by the progress seen in ongoing clinical investigations, though the results included in the article were confidential and not intended for publication at that time. Their plan is still to publish additional results from the clinical investigations when they have a significant aggregation of data. 

 ACTC closed at $0.07 on 5/18/13. I just wish appreciation could be realized by a better outstanding share count.

Stock market index futures pointed to a lower open on Monday, with investors expected to take a breath after a blockbuster prior week and ongoing concerns the Fed may begin to taper off its quantitative easing program.

The RegMed sector share pricing is volatile. Sector sentiment and appreciation is fluctuating at a very dramatic rate – it is a trader’ market to why some pricing(s) have decreased and in some cases – increased.

DOW futures are DOWN -0.0% and the NASDAQ is DOWN -0.0.

European stock markets take a hint from an overnight rally in Asia and move higher on Monday.

Individual RegMed sector share pricing is volatile, and the average slope of the trend is negative. Sector sentiment and appreciation is fluctuating at a very … dramatic rate, but as it continues, there’s a noticeable non-link between the fundamentals and the market performance …there’s NO logic to … other than it is a trader’ market to why some pricing(s) have decreased and in some cases – increased.

The RegMed sector’s security blanket … of hope of new therapies has left investors thinking this … safety net has weak netting!

In the broader market … stocks closed out the week with strong gains, with the Dow and S&P 500 hitting fresh highs and all three major averages logging their fourth-straight weekly advance, boosted by a pair of positive economic reports.

There were some bright spots … the big bat in the park … is Osiris (OSIR) was +$0.67 to $11.27 while second on base was  MiMedx (MDXG) is UP at +$0.13 to $7.26. Dendreon (DNDN) is UP +$0.04 to $4.01. BioTime (BTX) is UP + $0.02 to $4.12.

Closing negative … with the leash was on … Stemline (STML) is DOWN after an offering filing having felt the hot iron of downward trends -$0.25 to $14.75 while Shire (SHPG) is DOWN -$0.13 to $93.43. Cytori (CYTX) is also DOWN -$0.02 to $2.63 with Athersys (ATHX) DOWN -$0.02 to $1.86 and Opexa (OPXA) at -$0.07 to $1.67. Verastem (VSTM) is DOWN again -$0.25 at $9.19 along with Wright-Medical (WMGI) was DOWN -$0.10 to $24.64. Pluristem (PSTI) DOWN -$0.02 to $3.03 while Aastrom (ASTM) is DOWN after slowly eroding up and down at -$0.02 to $0.57 just biding time to an offering – this is the most timed offering … I watched in a … l o n g … time!

Other favorites closing … BioLife Solutions (BLFS) closed UP +$0.004 to $0.305 after very good earnings and guidance.  NeoStem (NYSE MKT: NBS) id DOWN -$0.001 to $0.59 along with Cytomedix (CMXI) who is FLAT at $0.50 – a roaring -BUY – investors should wake to this one; just think <CYTX> hybrid and finally Medistem (PINK: MEDS) is UP +$0.30 at $1.20 on 1100 shares – barely a drop. Harvard BIO (HBIO) is DOWN -$0.03 at $5.20 – market adjustment following tax free spin-out versus HART IPO.  Fibrocell (NYSE MKT: FCSCD) who’s had very good days is FLAT having been UP at $4.70 after a stock reverse!

Measuring the close – NEGATIVE … 17 red (downs) led … 11 green (ups) followed by 9 black (flats) … The CBOE Volatility Index traded below 13.

Closing Bell: The NASDAQ closed UP +33.72 (+0.97%) to 3,498.97 while the DOW was UP +121.18 (+0.80%) to 15,354.40.

      Net loss of $6.4 M or $0.00 per share

A net loss of $6.4 M or $0.00 per share, compared to a loss in Q1/12 of $5.7 M or $(0.00) per share.

ACTC reported a loss from operations of $5.8 M compared to a loss from operations of $5.4 M in Q1/13 primarily as a result of higher clinical trial expenses. Net cash used in operations was $8.3 M, compared to net cash used in operations of $4.8 M during Q1/12. Cash utilization increased significantly as a result of $2.3 M used to settle litigation related to previously issued debentures. ACTC expects cash utilization to return to previous levels in the subsequent quarter. ACTC has 2.39 B shares outstanding and a 2.33 B float.

• ACTC ended Q1/13 with cash and cash equivalents of $4.1 M, compared to $7.2 M as of 12/31/12.

Q1/13 Highlights:  

• Reached the midway point in 3 clinical trials in the US and EU to investigate hESC-derived RPE cells for the treatment of dry AMD and SMD, both forms of macular degeneration. 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 SMD at 12 months, the study’s primary endpoint. With the addition of the new cohort 2a patients, each of the U.S. trials will now enroll a total of 16 patients across the ascending dosage format of 50,000 to 200,000 RPE cells;
• Received DSMB approval to initiate treatment of the 3rd patient cohort in 3 ongoing stem cell clinical trials in the US and EU. Per each trial’s protocol, the first patient of “cohort 3” was injected in April with 150,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. This represents a 50% increase in the dose of RPE cells as compared to the previously treated cohort of patients. The first patients treated at this escalated dose will be evaluated, with interim DSMB review after 6 weeks;
• Received DSMB approval to treat additional cohorts of patients with … better vision;
• Observed the persistence of visual acuity gains and engraftment of transplanted cells in clinical trial patients with no safety issues reported;
• ACTC announced a settlement agreement resolving litigation associated with previously issued debentures.

The Bottom Line:  Significant milestones in clinical trials and furthering the unraveling of past financial mistakes have been under-taken. Best part – they still have cash to advance the … vision and focus of the trials! Gary, Robert and Matt strives to take this “sows ear to a silk purse” but a reverse will only … unlock … any value to shareholders.

ACTC is trading at $0.07 – still with unbelievable million level trading volumes. Hopefully, the sins of the past are far gone and not forgotten to the future. When the trading volume runs from 6.6 M to 14.3 M – true and real … appreciation is hard to realize.