March 2, 2016 5:54pm

 

The stem, cell and gene therapy regenerative medicine stocks traded in a narrow range Wednesday but, joyfully UP …

 

Ranking Wednesday’s end-of-day pre-open indications – 5 hits and 3 misses. Subscribe:  http://www.regmedinvestors.com/create-account   

 

 

Investors suffer from the paradox of information overload. If you have a smartphone in your pocket, you can access more information about the financial markets than the world's top hedge funds did 20 years ago. Yet, I bet your investment returns have not improved one iota as a result.

·         But, who is interpreting that information … get it here!

 

 

U.S. stocks closed mildly higher Wednesday after their best start to a month in just over three years. Oil and data remained in focus ahead of Friday's jobs report.

The NASDAQ closed UP +13.83 or +0.29% to 4,703.42 and the DOW closed UP +34.24 or +0.20% to 16,899.32.

 

 

A day in the life of the stem, cell and gene therapy RegMed (SCGT & RM) sector – the advance/decline line scenario of our 43 covered companies.

  • Weednesday, the stem, cell and gene therapy RegMed sector opened positive with an A/DL of 27/14 and 2 flats;
  •  The mid-day stayed positive with an A/DL of 33/8 and 2 flats;
  •  The closing bell rang positive with A/DL of 35/6 and 2 flats

 

 

Henry’omics:

The stem, cell and gene therapy RegMed (SCGT&RM) sector opened positive, stayed positive at the mid-day  and closed positive (of 43 covered companies).

  • Considering yesterday's positive close, the NASDAQ being lower even I thought there would be a melt-down.  What we're seeing here is a sector that is chasing the oversold effect.

The iShares Nasdaq Biotechnology (IBB) closed at 268.12 UP + 2.85 or +1.07%.

 

 

Wednesday’s handicapping the sector pre-open indications – 5 hits and 3 miss: 

  • Applied Genetic Technologies (AGTC) closed UP - miss;
  • Asterias Biotherapeutics (NYSEMKT: AST) closed DOWN – hit;
  • Athersys (ATHX) closed UP – hit;
  • Cellectis ADR (CLLS) closed UP – miss;
  • Juno therapeutics (JUNO) closed UP – miss;
  • Kite Pharma (KITE) closed UP – hit;
  • Intrexon (XON) closed UP – hit;
  • Mesoblast (MESO) closed UP – hit;

 

 

Out and about;

Asterias Therapeutics (NYSEMKT: AST)

… Dumped some “ballast” -$0.04 or -0.78% to $5.06 after jumping +18.8% or +$0.81 <after yesterday’s +$0.65> to $5.11 after announcing a new CEO and board member.

 

 

BioLife Solutions (BLFS)

… dumped -$0.03 to $1.81 after jumping over the past days post the “earnings” call which illuminated a cash position of $3.8 M and an immediate resigning CFO – my question – is it on the block for sale (?);

 

 

Bellicum Pharma (BLCM)

… Also jumped +$0.76 or +7.84% to $10.45 after advancing yesterday +$0.67 or +$7.43% to $9.69. It certainly needed to retrace its most recent pricing history;

 

 

bluebird bio (BLUE)

…is re-gaining altitude yet again +6.63% or +3.35 to $53.86 after jumping yesterday +$4.29 or +9.28%, I am still a fan but, these past months have been more than hard for the believers;

 

 

Capricor (CAPR)

.. Jumped back and forth, ending +$0.10 to $2.23 from yesterdays -$0.35 to $2.11. Investors and traders COULD be getting smarter (?) as CAPR has just about ten (10) months of cash and the offering window is barely open.  CAPR needs a financing – be READY!

 

 

Cesca Therapeutics (KOOL) executes a reverse splits stock 1:20 …

In order to regain compliance with NASDAQ listing requirements, KOOL executed a 1:20 reverse split of its common stock effective at 5:00 pm March 4. Post-split shares will begin trading on Monday morning; 3/7/16 and closed at $0.24.

 

 

Harvard Apparatus RT (HART)

… Stock is feeling some uplift +$0.06 or +4.51% to $1.39 after experiencing the drip, drip of depreciation.  There’s potential that needs to be actualized, it’s all in the unfolding of value;

Laura Mondano has joined the company as Vice President of Regulatory Affairs, a new position at HART.

  • Ms. Mondano is charged with leading the company's major 2016 milestone of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for HART's newly developed "Celframe" technology for the esophagus. Much of the pre-clinical work for the IND is in process. The initial key large-animal data for HART's "Celframe" technology was announced in November 2015. In collaboration with Mayo Clinic, HART is currently anticipating a read out of additional large-animal data in May. These data are expected to positively confirm the regeneration seen in November and add to the Orphan Drug Designation and IND filings for the esophagus.

 

 

Juno Therapeutics (JUNO)

… Jumped again +7.06% or +$2.82 to $42.74 after yesterday’s +13.51% or +$4.75 after announcing its Q4/15 loss per share; what moved the stock up – its cash position of $1.22 Billion, no problems with a “runway” here. Talk about reversing the curse of the post earnings announcement!

 

 

Kite Pharma (KITE)

… Stock rose another +5.10% or +$2.61 to $53.81 after yesterday’s +14.49% or +$6.48.  The cash position yesterday was reported to be $614.7 M – another “runway” positive! Another reversing the curse of the post earnings announcement!

 

 

MiMedx (MDXG +$0.43) and Osiris (OSIR +$0.17) …

Are trending after being so oversold, especially with product revenues that are missing in many sector “participants;

 

 

Opexa (OPXA) closed -$0.06 to $2.29

…After axing 30% of its workforce to extend “runway” into Q1/17 …

  • In a regulatory filing, Opexa Therapeutics (OPXA) disclosed implementing a re-structuring plan that includes a workforce reduction of 30% (11 positions) from its current staff of 36 employees, including CFO Karthik Radhakrishnan.

The aim of the initiative is to reduce operating expenses and conserve cash so it may complete its P2b study, Abili-T, assessing lead product candidate Tcelna in patients with secondary progressive multiple sclerosis. Top-line data are expected in Q4. The restructuring should extend the company's cash runway into Q1 2017.

 

 

Pluristem (PSTI) closed up +$0.02 at $1.29

… hope to light a fire with … questionable attributions … about its new cell therapy can … heal radiation damage and save lives following a dirty bomb detonation, nuclear attack, or nuclear power plant accident…

  • So, if it is so good … WHY hasn’t the Israel government not all over it and buying  while the US is subjecting their “compound” to further testing??

The Jerusalem Post broke the story on February 21 that “not only are PLX-R18 cells 100% effective in healing patients exposed to nuclear attack, it also revealed that Pluristem has agreed to "make available [a] supply of the radiation antidote to the U.S. if needed” <???>.   

  • PSTI hopes to go head-to-head with Amgen's (NASDAQ:AMGN) blockbuster cancer drug Neupogen®. First approved in 1991,

“With the FDA's blessing, PLX-R18 is also heading towards approval for treatment of the hematologic components of ARS <????> .  The U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) are initiating studies in large animals to determine the proper dosage for PLX-R18. Once the dose is established, NIAID will move into the pivotal and final trial for full FDA approval of PLX-R18 for use in humans<????>.

  • Hyperbole is to Pluristem what oxygen is to life!

Approval could come fast <????> For PLX-R18, with no need for Phase 1, 2 or 3 trials in humans. This is because the FDA can't require that humans be exposed to harmful levels of radiation for the purpose of a clinical trial <???>.

We need to replace hyperbole with reasonable, informed discussion about the status surrounding PSTI – as they lean too much to … partial … falsehoods without totally falling in the pool!!!

 

 

Dosing the sector – what a day for the 43 Patients:

  • The market opened: POSITIVE with 14 decliners, 27 advancers and 2 flats;
  • The mid-day (12:30 pm: POSITIVE with 8 decliners, 33 advancers and 2 flats;
  • Closing bell: POSITIVE with 6 decliners, 35 advancers and 2 flats

 

 

Review my fear gauge or the CBOE Volatility Index (VIX) which is scary:

·         Wednesday traded near 17, another decrease;

·         Tuesday traded near 18 – 10% decrease;

·         Monday traded below 20;

·         Friday traded near 19.8;

·         Thursday traded near 20;

·         Last, Wednesday traded at 20.5;

 

 

Riding the indexes and ETFs roller-coaster:

The iShares Biotechnology Stocks ETF (IBB) closed UP on Wednesday +2.85 or +1.07%

·         Tuesday +11.18 or +4.40%

·         Monday -7.40 or -2.83%

The NASDAQ Biotechnology index (NBI) closed UP on Wednesday +28.75 or +1.04%

·         Tuesday +114.28 or +4.30%

·         Monday -73.30 or -2.68%

The Russell 2000 (IWM) closed UP on Wednesday +1.08 or +1.03%

·         Tuesday +2.21 or +2.15%

·         Monday -0.46 or -0.45%

The SPDR SD&P Biotech ETF (XBI) closed UP on Wednesday +2.09 or +4.16%

·         Tuesday +2.31 or +4.82%

·         Monday -1.50 or -3.04%

 

 

Who was leading the declines – to of the bottom 5?

  • Opexa (OPXA) closed down -$0.06 to $2.29;
  • Histogenics (HSGX) -$0.03 to $2.78;
  • BioLife Solutions (BLFS) -$0.03 to $1.81;
  • Asterias Biosciences (NYSEMKT: AST) -$0.04 to $5.06;
  • BioTime (NYSEMKT: BTX) closed down -$0.01 to $2.66;

 

 

Who was UP – top 5:

  • Spark therapeutics (ONCE) closed up +$4.19 to $38.06;
  • bluebird bio (BLUE) +$3.35 to $53.86;
  • Intrexon (XON) +$3.29 to $37.02;
  • Juno Therapeutics (JUNO) +$2.82 to $42.74;
  • Kite Pharma (KITE) closed up +$2.61 to $53.81;

 

 

Who was FLAT?

  • Northwest Bio (NWBO) at $1.73;
  • ReNeuron (RENE.L) at $2.875;
  • VistaGen (VSTA) at $8.00                                    

 

 

Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice.

Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors.  All investments are subject to risks. Investors should consider investment objectives.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.